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EY Life Sciences Report: Asia Asia-Pacific | Japan | India March 2017

EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

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Page 1: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

EY Life Sciences Report AsiaAsia-Pacific | Japan | India

March 2017

EY Life Sciences Report Asia

Contents2 Market insights

10 Taxupdatessignificantdevelopments

16 Featured articles 16 Better with age

22 Australiarsquosdivertedprofitstaxandthe life sciences industry

26 Building a better customer experience what life sciences companies in APAC should consider

32 Mergers and acquisitions (MampA)

36 Financing and IPOs

38 Appendix 38 EY thought leadership 40 Contacts

1March 2017 |

To our clients and friends

Welcome to the third edition of our EY Life Sciences Report for Asia providing coverage forthekeymarketsinAsia-PacificJapanandIndia

WecontinuetoreceiveveryusefulsuggestionsfromreadersonhowtofurtherrefinethereportformatandcontentAnumberofyouhaverequestedthatweincludeadditionalregulartaxcontenthighlightingdevelopmentsapplicabletothesectorInresponsewehave added a new section to the report a pdate i nificant de elopment

Weareexcitedalsotoincludethreefeaturedarticlesinthiseditionallwrittenspecificallyforthispublication

Thefirstarticleldquo B etter with agerdquo exploreshowtheagingpopulationinJapanandthe resulting ldquosilver economyrdquo provides a unique opportunity for pharmaceutical companiesJapanrsquosagingpopulationiscreatingmajorhealthcarechallengesforboththegovernmentandsocietyAtthesametimethepotentialforinnovativesolutionsfrompharmaceuticalcompaniestohelpmeetthesechallengesisrobustButplanningforandseizing opportunities for innovation will require fresh thinking not only in terms of technical possibilities but also in relation to expanding offerings into new areas seeking unorthodox partnershipsanddevelopinguniquebusinessmodels

The second article tralia di erted profit ta and t e li e cience ind tr exploresAustraliarsquosrecentlyproposeddivertedprofitstax(DPT)andconsidersthepotentialimplications for multinational life sciences companies operating in Australia with centralized intellectualpropertyhubsCentralizationwhiledeliveringcommerciallegalandsupplyefficiencybenefitshasalsocreatedsignificantconcernswithintheAustralianGovernmentandtheAustralianTaxationOffice(ATO)inparticularaboutwhetherthetaxoutcomesofsucharrangementsreflecttheireconomicsubstanceorinsteadarebeingusedinappropriatelytodivertprofitsoutsideofAustraliaGiventhecomplexityandpotentialimplications of this new proposed regime it is vitally important that multinationals quickly understandthepotentialscopeoftheDPTandwhererelevantdevelopastrategyforproactivelysupportinganddefendingtheirlegalstructuresandsupplychains

The third article B ildin a etter c tomer e perience at li e cience companie in C o ld con ider explores how many life sciences companies are increasing their focus on the customer experience and engagement across multiple channels and what companiesneedtoconsiderwhenembarkingonajourneytoenhancesuchexperienceWhile ldquomultichannelrdquo is still relatively new territory for many life sciences companies in Asia-Pacificcustomersrsquoexpectationsintermsofhowtheywanttobeengagedarehighandquitediverseacrossthedifferentmarkets

In addition to our featured articles our M arket insights section highlights a number of sector trends and provides brief yet informative updates on various regulatory andlegislativedevelopmentsforanumberofkeymarketsinAsiaOurM ergers and acq uisitions and F inancing and IPO s sections provide helpful summaries of recent global andlocaltrendsviachartsandshortcaptionswithanincreasedfocusonAsianmarkets

WehopeyouenjoythisissueYoursquollfindthisreportmdashandmuchmoremdashatourdigitalhomeVitalSigns(eycomvitalsigns)andyoucanengagewithusviaTwitter(EY_LifeSciences)oremail

Rick F onteEYAsia-PacificLifeSciences TaxLeader

atric loc elEYLifeSciencesGlobalLeadershipTeamJapan

riram rini a anEYGlobalLifeSciencesEmergingMarketsLeaderandEYGlobalGenericPharmaceuticalLeader

2 | EY Life Sciences Report Asia

Market insights

In this edition we highlight key sector regulatory and legislative trends for the following markets

AS E ANbull Indonesia

bull Malaysia

bull Philippines

bull Vietnam

Australia

China (mainland)

India

J apan

S outh K orea

Taiwan

3March 2017 |

AS E AN Indonesia tightening regulatory pathways to improve affordability and q uality of drugs

TheIndonesianGovernmentiscontinuallytryingtostrengthenthecountryrsquospharmaceuticalmarketHoweverrecentamendment to ndone ia intellect al propert ri t regime have brought aboutsignificantchangesfortheindustryplayersProhibitingpatent claims for second medical use and allowing import of lower-priced copies of patented products during the exclusivity period have made the regulatory environment more challenging for innovativedrugmanufacturers1

Meanwhileamajorco nter eitin accine candal was exposed inthecountryafterwhichIndonesianauthoritiesorderedamajoroverhaulofthecountryrsquosNationalDrugandFoodControlAgency(NA-DFC)2 The nationwide scandal has unveiled striking gaps in the distribution chain of the vaccine system and the quality control mechanismadoptedbytheregulatorinthecountry3 The Ministry ofHealthisprovidingre-immunizationforchildrenexposedtofakevaccines4TheNA-DFCoverhaulmayaddfurtherregulatoryhurdlesformanufacturers

Malaysia controlling health care expenditure and strengthening sector regulations

TheMalaysianGovernmentisconsideringoradoptingseveralmea re to control ri in ealt care co t TheConsumersAssociation of Penang has requested the introduction of a national drugpricingcontrolsystem5 Meanwhile the government is trying toincreasetheuseofgenericsandbiosimilarsinthecountryCurrently both generic and branded medicines are being used inequalproportion(byvalue)inMalaysia6 Further the country recentlysawthelaunchofitsfirstbiosimilarinsulinwhichwillincreasetheavailabilityofthetherapyatanaffordablerate7

Concurrently under the raditional and Complementar edicine ( TCM ) Act 2016 Malaysia is set to have a council for TCM that will regulate the traditional medicine industry and will mandate the registrationofTCMpractitionersinthecountryThisshouldhelpthe government enhance the safety and quality of TCM services providedathospitals8

On the medical de ice fronttheMalaysianMedicalDeviceAuthority(MDA)hasproposedatwo-yeartransitionperiodformedical device manufacturers for complying with new labeling rules detailedintheSixthScheduleoftheMedicalDeviceRegulation2012AlsoMDAhaslaiddownnewguidelinesonhowmedicaldevices meant for clinical research can qualify for exemption from theregistrationrequirementsofthecountryFurthermoreMDAhas allowed advertisement only for those medical devices that are registeredinMalaysiaforsale9

China refers to mainland China in this publication

K ey highlightsbull Markets across Asia are continually acting to increase the

competitiveness and attractiveness of the life sciences industryforforeignmultinationalsForinstanceIndiahasundertaken several initiatives including encouraging public-privatepartnerships(PPPs)inRampDprojectsandincreasingfocus on infrastructure to establish India as one of the worldrsquos majorpharmaceuticalinnovationhubsAustraliaandChinahave implemented sector-focused innovation plans to boost investmentsalongwithreformstoexpeditedrugapprovalsSouth Korea is working toward becoming a global biotech and medical industry hub with focus on biosimilars stem cell therapiesand3DprintingofmedicaldevicesMeanwhileTaiwanhasdedicatedaninitiativetoenhanceitspositionasamajorbiomedical market in Asia and Vietnam has lifted the cap on foreigninvestmentsinthepharmasector

bull Malaysia Australia India and South Korea are also adopting adequate measures to bring their sector regulations for biosimilars and medical devices to par with international practices

bull Concurrently many Asian countries are grappling with the problem of counterfeiting and patientsrsquo inadequate trust of the industryIndonesiaandthePhilippinesareadoptingstringent

measures to contain the spread of counterfeit medicines while Australia and South Korea are increasing transparency between pharma-physician-patient relationship through mandatory physicianpaymentdisclosuresandheftypenaltiesSimilarlyIndiais strengthening its pharmacovigilance program by making the pharmacompaniestakeonmoreaccountabilityfordrugsafety

bull The life sciences industry in the region is also inching toward digitization with both industry and government playing an importantroleTheGovernmentofChinaisdevelopinganationaldigital platform that will enable data sharing and is introducing digitalmedicalidentificationandsignaturesAtthesametimepharma companies in India and the Philippines are developing mobile applications to enhance patient experience and to educate differentstakeholders

bull IncreasinglifeexpectancyiscreatingamajorhealthcareburdenformanycountriesincludingJapanandAustraliaJapanisrevisiting its prescription drug pricing system and continuing itspushtowardgenericsSimilarlyMalaysiaisconsideringincreasing generics usage while Australia is trying to expand the listofdrugsanddeviceseligibleforpricecuts

Market insights

4 | EY Life Sciences Report Asia

Philippines curbing illegal drug manufacturing via better control and awarenessTheFoodandDrugAdministration(FDA)ofthePhilippinesis ti tenin it noo e or entitie in ol ed in t e ale o counterfeit drugsinthecountryIthascautionedthepublicandhasalsoadvisedittopurchasemedicinesfromFDA-licensedestablishmentsonly10 Also the provincial government has formed aProvincialBuildingInspectionTeamtoconfirmthatnoillegaldrugsarebeingmanufacturedintheterritory11 Further the government has been successful in its initial efforts to combat fake drugs with more than 600000 drug users and manufacturers surrenderingtoofficials12

In addition the Philippines is witnessing the launch of several mo ile app to impro e a arene among the people and industry playersExamplesinclude

bull AppforHIVpatientsmdashJohnsonampJohnson(JampJ)incollaborationwithSustainedHealthInitiativesofthePhilippinesdevelopedanapptohelpreducetheburdenofHIVinthecountry13

bull PharmacyappmdashInassociationwiththeDrugstoresAssociationofthePhilippines(DSAP)JampJintroducedtheDSAPMobileDrugstoreappfortrainingandhelpingDSAPmemberpharmacists14

V ietnam improving the funding support for the sector

Vietnamrsquos pharmaceutical market is undergoing liberalization withtheGovernmentli tin t e cap on orei n o ner ip in pharmacompaniesTheongoingreformhasincreasedtheappealofthe domestic pharmaceutical sector and has recently led to a boom in inbound MampA deals with foreign pharma giants15

bull CFRInternational(Chile)apartofUS-basedAbbottLaboratoriesincreaseditsequityshareinDomescoto517

bull AbbottacquiredGlomedPharmaceuticalaleadingVietnamesedrugmaker and propelled itself into the top 10 local pharma companiesinthecountry

bull TaishoPharmaceuticalpurchaseda245stakeinDHGPharmaceutical

Furtheraspartofits2020strategytheVietnameseGovernmentintendstomeet80ofitsdomesticpharmaceuticaldemandthroughlocaldrugmanufacturersThepolicyishavingamajorimpact on the vaccine market with the country now able to produce 11 of the 12 vaccines included in the national expanded immunizationprogramTheGovernmentisfurthergearingupto el finance it accine pro ram by reducing its reliance oninternationalfundingTheaimistoachievemassvaccineproduction in the country through government-supported investmentsinmanufacturinginfrastructureandtechnology16

Market insights

5March 2017 |

AustraliaReforms toward an environment conducive to sector innovation

Australia currently ranked the second-most attractive pharmaceuticalmarketinAsia-Pacificisundertakingmea re to

rt er oo t t e ector competiti ene through enhanced innovationandbetterproductivityA10-yearsectorrevitalizationplan introduced by the Medical Technologies and Pharmaceuticals IndustryGrowthCentre(MTP)isoneofthecriticalstepsinthisdirection17 As part of this program MTPConnect an organization formedunderthefederalgovernmentrsquosIndustryGrowthCentresinitiativeshasidentifiedsevengrowthprioritieswithfocusonspecificaspectsofthesectorvaluechainIthasalreadymadeanannouncementtoinjectUS$56million(AU$74million)a in 14sector-specificprojectsandisfurtherawaitingUS$24million(AU$32million)fromvariousindustrypartners18

Additionally the industry is working to rid e t e ap et een re earc and cce l commerciali ationAconsortiumofpharmaceutical companies that includes AbbVie Boehringer Ingelheim Celgene and Novartis has teamed up with Medicines AustraliatolaunchaUS$076million(AU$1million)educationalprogramTheBridgeInitiativescheduledtostartin1Q17Theprogram is expected to run for two years with a target of training 100people19 Further to encourage real-world application of innovation the Victorian state government plans to expend US$3million(AU$4million)tobuildaworld-classinnovationcenter the Medicines Manufacturing Innovation Centre led by MonashUniversity20ThenationhasalreadyestablishedaUS$380million(AU$500million)BiomedicalTranslationFundtoaidthedevelopmentandcommercializationofbiomedicaldiscoveries21

To further promote innovation the country is simultaneously e peditin t e dr appro al proce TheAustraliandrugregulatortheTherapeuticGoodsAdministrationiscurrentlyintheprocessofrollingoutreformsoverthenext18to24monthsOneofthemajorchangesincludespotentialintroductionoftwoexpedited pathways for the registration of novel medicines focusing on drugs that are already approved in countries with comparable regulatoryprocesses22

e ali ation o medical canna i is offering new opportunities toAustralianlifesciencescompaniesTheTherapeuticGoodsAdministration has now allowed cultivation of cannabis for medical purposesbutunderstrictgovernmentlicensingandguidelines23

Australia continues to c rtail ri in ealt care co t through tighterregulationsandpricecutsInits2017pricedisclosurecyclethegovernmentrsquosPharmaceuticalBenefitsSchemedisclosedtheaddition of several drugs particularly biologics and a deepening of pricecutsThegovernmenthasalsoannouncedreformstolowerthe costs of medical devices and prostheses including a reduction in listcostofcardiacdevicesandintraocularlensesby10andinhipandkneereplacementsby7524

Pharma companies in Australia have begun disclosing physician payments under the new code laid by the regulator thus inching towardamoretransparentpharma-physician-patientrelationship25

aConvertedusingspotrateasof31July2016(AU$1equalsUS$07595)accessed3January2017

Market insights

6 | EY Life Sciences Report Asia

ChinaE asing the regulatory environment building digital resource sharing capabilities

TheChineseGovernmentisactivelyinvolvedinboostinginnovationandinjectingfreshinvestmentinthesectorAnnouncementofthe13th Five Year Plan (2015ndash20) has provided further momentum to inno ation and re orm in the country with biomedicine being identifiedasakeypriorityInnovationformsthecorestrategyofthecurrentfive-yearplanalongsideahugefocusonimprovingthequalityofinnovativedrugs26AspartofthistheChinaFDA(CFDA)and the State Council have approved a three-year pilot called ldquoMarketingAuthorizationHolderrdquotowidentheeligibilitycriteriaforcompaniesapplyingfordrugmarketingauthorizationTheprogramallows domestic researchers and smaller operations to apply for drug approvals even without having in-house manufacturing capabilitiesTheaimofthepilotistohelpcompaniesbringdrugsto market at a lower cost by leveraging contract manufacturing arrangements27

Simultaneously China has pledged to create an ind trial cale o medical er ice on a national di ital plat orm28 The planisexpectedtocreateadigitalhealthtrailforcitizensTheplaninvolves establishing

bull National and provincial population health platforms

bull Interconnected application platforms for national medicine bidding and purchasing

bull 100 regional clinical medicine data demonstration centers

bull Digitalmedicalidentificationandsignatures

Sharing of health and medical data resources is likely to accelerate the use of big data applications in health and medical industry management clinical research and development and digital health andmedicalequipment29

In addition the country is enco ra in t e e o lo co t met od o ellin dr and medical prod ct to increase competitionandslashpricesTheCFDAhadbeenattemptingtointroducepilotprogramsforonlinedrugsalesHoweverduetoadeficienttrackingsystemandincreaseddrugcounterfeitingtheinitiative has been put to a halt and the sale of online prescription drugshasbeenbannedinChina30

InthepastfiveyearsChinahasinvestedapproximately US$359billion(RMB22trillion)toimpro e medical de ice re lation andharmonizethemwithinternationalpracticesRecentlytheCFDAannouncedthatitspriorityreviewandapprovalprocedureformedicaldeviceswillbeenforcedstarting1January2017MoreovertheCFDAhasalsoreleasedanexpandedlistofdevicesthatstandexemptedfromclinicaltrials31 In addition the country has decided to remove tariffs on 201 technology products includingsomemedicaldevices32 These moves are expected to strengthen the approval systems for drugs and devices and help in meetingclinicaldemandformedicaldevices33

Market insights

7March 2017 |

IndiaContinued efforts to elevate Indiarsquo s reputation and to make strides in digital pharma

InlinewiththePharmaVision2020documentoftheDepartmentofPharmaceuticals(DOP)Indiahasembarkedonitsjourneytobecome a leadin co ntr or end to end dr man act rin and inno ationTheGovernmentaimstoaugmentinfrastructurethrough a ldquoMake in Indiardquo initiative improve the quality of the workforceandincreasefundsforinnovationSpecificallytheGovernmentaimstopositionIndiaasoneofthetopfivepharmaceutical innovation hubs by 2020 and establish the nation asoneofthemostpreferreddestinationsforclinicaltrials34 Toward thisefforttheDrugControllerGeneralofIndiahasremovedthemaximum limit of three clinical trials and eliminated the restriction on the number of beds to enable smoother entry of pharma companiesintoresearchanddiscoveryTheGovernmentisfurthercontemplatinginvestments(ofupto50)inpublic-privatepartnership(PPP)modelsforundertakingRampDprojectsinadditiontotheexistingweightedtaxdeductionrateof150onRampDspendSimultaneouslytheMinistryofHealthampFamilyWelfare(MoHFW)has established eligibility criteria for all personnel employed in any pharma manufacturing to bring the sector up to par with internationalstandards35

Bol terin dr a et mean o p armaco i ilance is another focusareafortheindustryWiththePharmacovigilanceProgramofIndiaalreadyreceiving023millioninstancesofadversedrugreactionstheHealthMinistryiscontinuingtoaddnewadversedrugreaction monitoring centers and is also integrating information receivedfromthepharmacompaniesTheministryhasmandatedthatmarketauthorizationholders(MHAs)establishpharmacovigilancecellsintheircompanies36 These cells can either becaptiveoroutsourcedbutmustenabletheMHAstocollectprocess and forward adverse drug reports to the licensing authorities37

The i ital ndia initiati e is also making a big push in the industry mdashrangingfrome-detailingtoolstosmartphoneappsforunderstandingpatientbehaviorSomeoftherecentannouncementsin this direction include

bull SunPharmarsquosRespiTrackappforeducatingasthmapatientsandenhancing their adherence to therapies

bull GlaxoSmithKlineIndiarsquosuseofwebinarsvideochatsinformationportals and platforms such as Viva for doctors

bull AbbottHealthcareIndiarsquoseducationalappKnowledgeGenieforpatients with heart or liver diseases

InadditiontotheseindustryeffortstheGovernmentisattemptingto digitize medical health records on an Aadhar-linked electronic healthrecordsystemb To aid this development it is planning to

introduceabillforcreationofanationale-healthauthority38 AdditionallytheGovernmentisworkingonguidelinesforregulatinge-pharmaciestoreducetheirmisuse

In the area of medical de ice theMoHFWhasreleasedadraftofMedicalDevicesRulesforfurtherdiscussionwithanaimtoaligntheindustrywithglobalpracticesonaprioritybasis39 Certain measuresofthedraftsuchasafive-yearcapontheshelflifeofmedicaldevicescompliancewithuniqueidentificationnormsandallowance for contract manufacturing are expected to be implementedbyearly2017Additionallytocontrolthepriceofstents the government has added coronary stents to the national listofessentialmedicinesfor201540

OnthebiotechfronttheCentralDrugsStandardControlOrganizationandtheDepartmentofBiotechnologyannouncedare i ed io imilar polic providing a detailed regulatory pathway formanufacturingprocessesthataimstodeliversafetyefficacyandqualityThedocumentalsoaddressesissuesconcerningpre-andpost-marketregulatoryrequirementsforsimilarbiologicsThe policy is expected to accelerate the Indian biosimilars market sizetoUS$40billionby203041

bAadharisauniqueidentificationnumberissuedbytheGovernmentofIndiatoall residents of the country to eliminate duplicate and fake identities and to make verificationandauthenticationeasyandeffective

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 2: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

EY Life Sciences Report Asia

Contents2 Market insights

10 Taxupdatessignificantdevelopments

16 Featured articles 16 Better with age

22 Australiarsquosdivertedprofitstaxandthe life sciences industry

26 Building a better customer experience what life sciences companies in APAC should consider

32 Mergers and acquisitions (MampA)

36 Financing and IPOs

38 Appendix 38 EY thought leadership 40 Contacts

1March 2017 |

To our clients and friends

Welcome to the third edition of our EY Life Sciences Report for Asia providing coverage forthekeymarketsinAsia-PacificJapanandIndia

WecontinuetoreceiveveryusefulsuggestionsfromreadersonhowtofurtherrefinethereportformatandcontentAnumberofyouhaverequestedthatweincludeadditionalregulartaxcontenthighlightingdevelopmentsapplicabletothesectorInresponsewehave added a new section to the report a pdate i nificant de elopment

Weareexcitedalsotoincludethreefeaturedarticlesinthiseditionallwrittenspecificallyforthispublication

Thefirstarticleldquo B etter with agerdquo exploreshowtheagingpopulationinJapanandthe resulting ldquosilver economyrdquo provides a unique opportunity for pharmaceutical companiesJapanrsquosagingpopulationiscreatingmajorhealthcarechallengesforboththegovernmentandsocietyAtthesametimethepotentialforinnovativesolutionsfrompharmaceuticalcompaniestohelpmeetthesechallengesisrobustButplanningforandseizing opportunities for innovation will require fresh thinking not only in terms of technical possibilities but also in relation to expanding offerings into new areas seeking unorthodox partnershipsanddevelopinguniquebusinessmodels

The second article tralia di erted profit ta and t e li e cience ind tr exploresAustraliarsquosrecentlyproposeddivertedprofitstax(DPT)andconsidersthepotentialimplications for multinational life sciences companies operating in Australia with centralized intellectualpropertyhubsCentralizationwhiledeliveringcommerciallegalandsupplyefficiencybenefitshasalsocreatedsignificantconcernswithintheAustralianGovernmentandtheAustralianTaxationOffice(ATO)inparticularaboutwhetherthetaxoutcomesofsucharrangementsreflecttheireconomicsubstanceorinsteadarebeingusedinappropriatelytodivertprofitsoutsideofAustraliaGiventhecomplexityandpotentialimplications of this new proposed regime it is vitally important that multinationals quickly understandthepotentialscopeoftheDPTandwhererelevantdevelopastrategyforproactivelysupportinganddefendingtheirlegalstructuresandsupplychains

The third article B ildin a etter c tomer e perience at li e cience companie in C o ld con ider explores how many life sciences companies are increasing their focus on the customer experience and engagement across multiple channels and what companiesneedtoconsiderwhenembarkingonajourneytoenhancesuchexperienceWhile ldquomultichannelrdquo is still relatively new territory for many life sciences companies in Asia-Pacificcustomersrsquoexpectationsintermsofhowtheywanttobeengagedarehighandquitediverseacrossthedifferentmarkets

In addition to our featured articles our M arket insights section highlights a number of sector trends and provides brief yet informative updates on various regulatory andlegislativedevelopmentsforanumberofkeymarketsinAsiaOurM ergers and acq uisitions and F inancing and IPO s sections provide helpful summaries of recent global andlocaltrendsviachartsandshortcaptionswithanincreasedfocusonAsianmarkets

WehopeyouenjoythisissueYoursquollfindthisreportmdashandmuchmoremdashatourdigitalhomeVitalSigns(eycomvitalsigns)andyoucanengagewithusviaTwitter(EY_LifeSciences)oremail

Rick F onteEYAsia-PacificLifeSciences TaxLeader

atric loc elEYLifeSciencesGlobalLeadershipTeamJapan

riram rini a anEYGlobalLifeSciencesEmergingMarketsLeaderandEYGlobalGenericPharmaceuticalLeader

2 | EY Life Sciences Report Asia

Market insights

In this edition we highlight key sector regulatory and legislative trends for the following markets

AS E ANbull Indonesia

bull Malaysia

bull Philippines

bull Vietnam

Australia

China (mainland)

India

J apan

S outh K orea

Taiwan

3March 2017 |

AS E AN Indonesia tightening regulatory pathways to improve affordability and q uality of drugs

TheIndonesianGovernmentiscontinuallytryingtostrengthenthecountryrsquospharmaceuticalmarketHoweverrecentamendment to ndone ia intellect al propert ri t regime have brought aboutsignificantchangesfortheindustryplayersProhibitingpatent claims for second medical use and allowing import of lower-priced copies of patented products during the exclusivity period have made the regulatory environment more challenging for innovativedrugmanufacturers1

Meanwhileamajorco nter eitin accine candal was exposed inthecountryafterwhichIndonesianauthoritiesorderedamajoroverhaulofthecountryrsquosNationalDrugandFoodControlAgency(NA-DFC)2 The nationwide scandal has unveiled striking gaps in the distribution chain of the vaccine system and the quality control mechanismadoptedbytheregulatorinthecountry3 The Ministry ofHealthisprovidingre-immunizationforchildrenexposedtofakevaccines4TheNA-DFCoverhaulmayaddfurtherregulatoryhurdlesformanufacturers

Malaysia controlling health care expenditure and strengthening sector regulations

TheMalaysianGovernmentisconsideringoradoptingseveralmea re to control ri in ealt care co t TheConsumersAssociation of Penang has requested the introduction of a national drugpricingcontrolsystem5 Meanwhile the government is trying toincreasetheuseofgenericsandbiosimilarsinthecountryCurrently both generic and branded medicines are being used inequalproportion(byvalue)inMalaysia6 Further the country recentlysawthelaunchofitsfirstbiosimilarinsulinwhichwillincreasetheavailabilityofthetherapyatanaffordablerate7

Concurrently under the raditional and Complementar edicine ( TCM ) Act 2016 Malaysia is set to have a council for TCM that will regulate the traditional medicine industry and will mandate the registrationofTCMpractitionersinthecountryThisshouldhelpthe government enhance the safety and quality of TCM services providedathospitals8

On the medical de ice fronttheMalaysianMedicalDeviceAuthority(MDA)hasproposedatwo-yeartransitionperiodformedical device manufacturers for complying with new labeling rules detailedintheSixthScheduleoftheMedicalDeviceRegulation2012AlsoMDAhaslaiddownnewguidelinesonhowmedicaldevices meant for clinical research can qualify for exemption from theregistrationrequirementsofthecountryFurthermoreMDAhas allowed advertisement only for those medical devices that are registeredinMalaysiaforsale9

China refers to mainland China in this publication

K ey highlightsbull Markets across Asia are continually acting to increase the

competitiveness and attractiveness of the life sciences industryforforeignmultinationalsForinstanceIndiahasundertaken several initiatives including encouraging public-privatepartnerships(PPPs)inRampDprojectsandincreasingfocus on infrastructure to establish India as one of the worldrsquos majorpharmaceuticalinnovationhubsAustraliaandChinahave implemented sector-focused innovation plans to boost investmentsalongwithreformstoexpeditedrugapprovalsSouth Korea is working toward becoming a global biotech and medical industry hub with focus on biosimilars stem cell therapiesand3DprintingofmedicaldevicesMeanwhileTaiwanhasdedicatedaninitiativetoenhanceitspositionasamajorbiomedical market in Asia and Vietnam has lifted the cap on foreigninvestmentsinthepharmasector

bull Malaysia Australia India and South Korea are also adopting adequate measures to bring their sector regulations for biosimilars and medical devices to par with international practices

bull Concurrently many Asian countries are grappling with the problem of counterfeiting and patientsrsquo inadequate trust of the industryIndonesiaandthePhilippinesareadoptingstringent

measures to contain the spread of counterfeit medicines while Australia and South Korea are increasing transparency between pharma-physician-patient relationship through mandatory physicianpaymentdisclosuresandheftypenaltiesSimilarlyIndiais strengthening its pharmacovigilance program by making the pharmacompaniestakeonmoreaccountabilityfordrugsafety

bull The life sciences industry in the region is also inching toward digitization with both industry and government playing an importantroleTheGovernmentofChinaisdevelopinganationaldigital platform that will enable data sharing and is introducing digitalmedicalidentificationandsignaturesAtthesametimepharma companies in India and the Philippines are developing mobile applications to enhance patient experience and to educate differentstakeholders

bull IncreasinglifeexpectancyiscreatingamajorhealthcareburdenformanycountriesincludingJapanandAustraliaJapanisrevisiting its prescription drug pricing system and continuing itspushtowardgenericsSimilarlyMalaysiaisconsideringincreasing generics usage while Australia is trying to expand the listofdrugsanddeviceseligibleforpricecuts

Market insights

4 | EY Life Sciences Report Asia

Philippines curbing illegal drug manufacturing via better control and awarenessTheFoodandDrugAdministration(FDA)ofthePhilippinesis ti tenin it noo e or entitie in ol ed in t e ale o counterfeit drugsinthecountryIthascautionedthepublicandhasalsoadvisedittopurchasemedicinesfromFDA-licensedestablishmentsonly10 Also the provincial government has formed aProvincialBuildingInspectionTeamtoconfirmthatnoillegaldrugsarebeingmanufacturedintheterritory11 Further the government has been successful in its initial efforts to combat fake drugs with more than 600000 drug users and manufacturers surrenderingtoofficials12

In addition the Philippines is witnessing the launch of several mo ile app to impro e a arene among the people and industry playersExamplesinclude

bull AppforHIVpatientsmdashJohnsonampJohnson(JampJ)incollaborationwithSustainedHealthInitiativesofthePhilippinesdevelopedanapptohelpreducetheburdenofHIVinthecountry13

bull PharmacyappmdashInassociationwiththeDrugstoresAssociationofthePhilippines(DSAP)JampJintroducedtheDSAPMobileDrugstoreappfortrainingandhelpingDSAPmemberpharmacists14

V ietnam improving the funding support for the sector

Vietnamrsquos pharmaceutical market is undergoing liberalization withtheGovernmentli tin t e cap on orei n o ner ip in pharmacompaniesTheongoingreformhasincreasedtheappealofthe domestic pharmaceutical sector and has recently led to a boom in inbound MampA deals with foreign pharma giants15

bull CFRInternational(Chile)apartofUS-basedAbbottLaboratoriesincreaseditsequityshareinDomescoto517

bull AbbottacquiredGlomedPharmaceuticalaleadingVietnamesedrugmaker and propelled itself into the top 10 local pharma companiesinthecountry

bull TaishoPharmaceuticalpurchaseda245stakeinDHGPharmaceutical

Furtheraspartofits2020strategytheVietnameseGovernmentintendstomeet80ofitsdomesticpharmaceuticaldemandthroughlocaldrugmanufacturersThepolicyishavingamajorimpact on the vaccine market with the country now able to produce 11 of the 12 vaccines included in the national expanded immunizationprogramTheGovernmentisfurthergearingupto el finance it accine pro ram by reducing its reliance oninternationalfundingTheaimistoachievemassvaccineproduction in the country through government-supported investmentsinmanufacturinginfrastructureandtechnology16

Market insights

5March 2017 |

AustraliaReforms toward an environment conducive to sector innovation

Australia currently ranked the second-most attractive pharmaceuticalmarketinAsia-Pacificisundertakingmea re to

rt er oo t t e ector competiti ene through enhanced innovationandbetterproductivityA10-yearsectorrevitalizationplan introduced by the Medical Technologies and Pharmaceuticals IndustryGrowthCentre(MTP)isoneofthecriticalstepsinthisdirection17 As part of this program MTPConnect an organization formedunderthefederalgovernmentrsquosIndustryGrowthCentresinitiativeshasidentifiedsevengrowthprioritieswithfocusonspecificaspectsofthesectorvaluechainIthasalreadymadeanannouncementtoinjectUS$56million(AU$74million)a in 14sector-specificprojectsandisfurtherawaitingUS$24million(AU$32million)fromvariousindustrypartners18

Additionally the industry is working to rid e t e ap et een re earc and cce l commerciali ationAconsortiumofpharmaceutical companies that includes AbbVie Boehringer Ingelheim Celgene and Novartis has teamed up with Medicines AustraliatolaunchaUS$076million(AU$1million)educationalprogramTheBridgeInitiativescheduledtostartin1Q17Theprogram is expected to run for two years with a target of training 100people19 Further to encourage real-world application of innovation the Victorian state government plans to expend US$3million(AU$4million)tobuildaworld-classinnovationcenter the Medicines Manufacturing Innovation Centre led by MonashUniversity20ThenationhasalreadyestablishedaUS$380million(AU$500million)BiomedicalTranslationFundtoaidthedevelopmentandcommercializationofbiomedicaldiscoveries21

To further promote innovation the country is simultaneously e peditin t e dr appro al proce TheAustraliandrugregulatortheTherapeuticGoodsAdministrationiscurrentlyintheprocessofrollingoutreformsoverthenext18to24monthsOneofthemajorchangesincludespotentialintroductionoftwoexpedited pathways for the registration of novel medicines focusing on drugs that are already approved in countries with comparable regulatoryprocesses22

e ali ation o medical canna i is offering new opportunities toAustralianlifesciencescompaniesTheTherapeuticGoodsAdministration has now allowed cultivation of cannabis for medical purposesbutunderstrictgovernmentlicensingandguidelines23

Australia continues to c rtail ri in ealt care co t through tighterregulationsandpricecutsInits2017pricedisclosurecyclethegovernmentrsquosPharmaceuticalBenefitsSchemedisclosedtheaddition of several drugs particularly biologics and a deepening of pricecutsThegovernmenthasalsoannouncedreformstolowerthe costs of medical devices and prostheses including a reduction in listcostofcardiacdevicesandintraocularlensesby10andinhipandkneereplacementsby7524

Pharma companies in Australia have begun disclosing physician payments under the new code laid by the regulator thus inching towardamoretransparentpharma-physician-patientrelationship25

aConvertedusingspotrateasof31July2016(AU$1equalsUS$07595)accessed3January2017

Market insights

6 | EY Life Sciences Report Asia

ChinaE asing the regulatory environment building digital resource sharing capabilities

TheChineseGovernmentisactivelyinvolvedinboostinginnovationandinjectingfreshinvestmentinthesectorAnnouncementofthe13th Five Year Plan (2015ndash20) has provided further momentum to inno ation and re orm in the country with biomedicine being identifiedasakeypriorityInnovationformsthecorestrategyofthecurrentfive-yearplanalongsideahugefocusonimprovingthequalityofinnovativedrugs26AspartofthistheChinaFDA(CFDA)and the State Council have approved a three-year pilot called ldquoMarketingAuthorizationHolderrdquotowidentheeligibilitycriteriaforcompaniesapplyingfordrugmarketingauthorizationTheprogramallows domestic researchers and smaller operations to apply for drug approvals even without having in-house manufacturing capabilitiesTheaimofthepilotistohelpcompaniesbringdrugsto market at a lower cost by leveraging contract manufacturing arrangements27

Simultaneously China has pledged to create an ind trial cale o medical er ice on a national di ital plat orm28 The planisexpectedtocreateadigitalhealthtrailforcitizensTheplaninvolves establishing

bull National and provincial population health platforms

bull Interconnected application platforms for national medicine bidding and purchasing

bull 100 regional clinical medicine data demonstration centers

bull Digitalmedicalidentificationandsignatures

Sharing of health and medical data resources is likely to accelerate the use of big data applications in health and medical industry management clinical research and development and digital health andmedicalequipment29

In addition the country is enco ra in t e e o lo co t met od o ellin dr and medical prod ct to increase competitionandslashpricesTheCFDAhadbeenattemptingtointroducepilotprogramsforonlinedrugsalesHoweverduetoadeficienttrackingsystemandincreaseddrugcounterfeitingtheinitiative has been put to a halt and the sale of online prescription drugshasbeenbannedinChina30

InthepastfiveyearsChinahasinvestedapproximately US$359billion(RMB22trillion)toimpro e medical de ice re lation andharmonizethemwithinternationalpracticesRecentlytheCFDAannouncedthatitspriorityreviewandapprovalprocedureformedicaldeviceswillbeenforcedstarting1January2017MoreovertheCFDAhasalsoreleasedanexpandedlistofdevicesthatstandexemptedfromclinicaltrials31 In addition the country has decided to remove tariffs on 201 technology products includingsomemedicaldevices32 These moves are expected to strengthen the approval systems for drugs and devices and help in meetingclinicaldemandformedicaldevices33

Market insights

7March 2017 |

IndiaContinued efforts to elevate Indiarsquo s reputation and to make strides in digital pharma

InlinewiththePharmaVision2020documentoftheDepartmentofPharmaceuticals(DOP)Indiahasembarkedonitsjourneytobecome a leadin co ntr or end to end dr man act rin and inno ationTheGovernmentaimstoaugmentinfrastructurethrough a ldquoMake in Indiardquo initiative improve the quality of the workforceandincreasefundsforinnovationSpecificallytheGovernmentaimstopositionIndiaasoneofthetopfivepharmaceutical innovation hubs by 2020 and establish the nation asoneofthemostpreferreddestinationsforclinicaltrials34 Toward thisefforttheDrugControllerGeneralofIndiahasremovedthemaximum limit of three clinical trials and eliminated the restriction on the number of beds to enable smoother entry of pharma companiesintoresearchanddiscoveryTheGovernmentisfurthercontemplatinginvestments(ofupto50)inpublic-privatepartnership(PPP)modelsforundertakingRampDprojectsinadditiontotheexistingweightedtaxdeductionrateof150onRampDspendSimultaneouslytheMinistryofHealthampFamilyWelfare(MoHFW)has established eligibility criteria for all personnel employed in any pharma manufacturing to bring the sector up to par with internationalstandards35

Bol terin dr a et mean o p armaco i ilance is another focusareafortheindustryWiththePharmacovigilanceProgramofIndiaalreadyreceiving023millioninstancesofadversedrugreactionstheHealthMinistryiscontinuingtoaddnewadversedrugreaction monitoring centers and is also integrating information receivedfromthepharmacompaniesTheministryhasmandatedthatmarketauthorizationholders(MHAs)establishpharmacovigilancecellsintheircompanies36 These cells can either becaptiveoroutsourcedbutmustenabletheMHAstocollectprocess and forward adverse drug reports to the licensing authorities37

The i ital ndia initiati e is also making a big push in the industry mdashrangingfrome-detailingtoolstosmartphoneappsforunderstandingpatientbehaviorSomeoftherecentannouncementsin this direction include

bull SunPharmarsquosRespiTrackappforeducatingasthmapatientsandenhancing their adherence to therapies

bull GlaxoSmithKlineIndiarsquosuseofwebinarsvideochatsinformationportals and platforms such as Viva for doctors

bull AbbottHealthcareIndiarsquoseducationalappKnowledgeGenieforpatients with heart or liver diseases

InadditiontotheseindustryeffortstheGovernmentisattemptingto digitize medical health records on an Aadhar-linked electronic healthrecordsystemb To aid this development it is planning to

introduceabillforcreationofanationale-healthauthority38 AdditionallytheGovernmentisworkingonguidelinesforregulatinge-pharmaciestoreducetheirmisuse

In the area of medical de ice theMoHFWhasreleasedadraftofMedicalDevicesRulesforfurtherdiscussionwithanaimtoaligntheindustrywithglobalpracticesonaprioritybasis39 Certain measuresofthedraftsuchasafive-yearcapontheshelflifeofmedicaldevicescompliancewithuniqueidentificationnormsandallowance for contract manufacturing are expected to be implementedbyearly2017Additionallytocontrolthepriceofstents the government has added coronary stents to the national listofessentialmedicinesfor201540

OnthebiotechfronttheCentralDrugsStandardControlOrganizationandtheDepartmentofBiotechnologyannouncedare i ed io imilar polic providing a detailed regulatory pathway formanufacturingprocessesthataimstodeliversafetyefficacyandqualityThedocumentalsoaddressesissuesconcerningpre-andpost-marketregulatoryrequirementsforsimilarbiologicsThe policy is expected to accelerate the Indian biosimilars market sizetoUS$40billionby203041

bAadharisauniqueidentificationnumberissuedbytheGovernmentofIndiatoall residents of the country to eliminate duplicate and fake identities and to make verificationandauthenticationeasyandeffective

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

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ilippineam

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FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 3: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

1March 2017 |

To our clients and friends

Welcome to the third edition of our EY Life Sciences Report for Asia providing coverage forthekeymarketsinAsia-PacificJapanandIndia

WecontinuetoreceiveveryusefulsuggestionsfromreadersonhowtofurtherrefinethereportformatandcontentAnumberofyouhaverequestedthatweincludeadditionalregulartaxcontenthighlightingdevelopmentsapplicabletothesectorInresponsewehave added a new section to the report a pdate i nificant de elopment

Weareexcitedalsotoincludethreefeaturedarticlesinthiseditionallwrittenspecificallyforthispublication

Thefirstarticleldquo B etter with agerdquo exploreshowtheagingpopulationinJapanandthe resulting ldquosilver economyrdquo provides a unique opportunity for pharmaceutical companiesJapanrsquosagingpopulationiscreatingmajorhealthcarechallengesforboththegovernmentandsocietyAtthesametimethepotentialforinnovativesolutionsfrompharmaceuticalcompaniestohelpmeetthesechallengesisrobustButplanningforandseizing opportunities for innovation will require fresh thinking not only in terms of technical possibilities but also in relation to expanding offerings into new areas seeking unorthodox partnershipsanddevelopinguniquebusinessmodels

The second article tralia di erted profit ta and t e li e cience ind tr exploresAustraliarsquosrecentlyproposeddivertedprofitstax(DPT)andconsidersthepotentialimplications for multinational life sciences companies operating in Australia with centralized intellectualpropertyhubsCentralizationwhiledeliveringcommerciallegalandsupplyefficiencybenefitshasalsocreatedsignificantconcernswithintheAustralianGovernmentandtheAustralianTaxationOffice(ATO)inparticularaboutwhetherthetaxoutcomesofsucharrangementsreflecttheireconomicsubstanceorinsteadarebeingusedinappropriatelytodivertprofitsoutsideofAustraliaGiventhecomplexityandpotentialimplications of this new proposed regime it is vitally important that multinationals quickly understandthepotentialscopeoftheDPTandwhererelevantdevelopastrategyforproactivelysupportinganddefendingtheirlegalstructuresandsupplychains

The third article B ildin a etter c tomer e perience at li e cience companie in C o ld con ider explores how many life sciences companies are increasing their focus on the customer experience and engagement across multiple channels and what companiesneedtoconsiderwhenembarkingonajourneytoenhancesuchexperienceWhile ldquomultichannelrdquo is still relatively new territory for many life sciences companies in Asia-Pacificcustomersrsquoexpectationsintermsofhowtheywanttobeengagedarehighandquitediverseacrossthedifferentmarkets

In addition to our featured articles our M arket insights section highlights a number of sector trends and provides brief yet informative updates on various regulatory andlegislativedevelopmentsforanumberofkeymarketsinAsiaOurM ergers and acq uisitions and F inancing and IPO s sections provide helpful summaries of recent global andlocaltrendsviachartsandshortcaptionswithanincreasedfocusonAsianmarkets

WehopeyouenjoythisissueYoursquollfindthisreportmdashandmuchmoremdashatourdigitalhomeVitalSigns(eycomvitalsigns)andyoucanengagewithusviaTwitter(EY_LifeSciences)oremail

Rick F onteEYAsia-PacificLifeSciences TaxLeader

atric loc elEYLifeSciencesGlobalLeadershipTeamJapan

riram rini a anEYGlobalLifeSciencesEmergingMarketsLeaderandEYGlobalGenericPharmaceuticalLeader

2 | EY Life Sciences Report Asia

Market insights

In this edition we highlight key sector regulatory and legislative trends for the following markets

AS E ANbull Indonesia

bull Malaysia

bull Philippines

bull Vietnam

Australia

China (mainland)

India

J apan

S outh K orea

Taiwan

3March 2017 |

AS E AN Indonesia tightening regulatory pathways to improve affordability and q uality of drugs

TheIndonesianGovernmentiscontinuallytryingtostrengthenthecountryrsquospharmaceuticalmarketHoweverrecentamendment to ndone ia intellect al propert ri t regime have brought aboutsignificantchangesfortheindustryplayersProhibitingpatent claims for second medical use and allowing import of lower-priced copies of patented products during the exclusivity period have made the regulatory environment more challenging for innovativedrugmanufacturers1

Meanwhileamajorco nter eitin accine candal was exposed inthecountryafterwhichIndonesianauthoritiesorderedamajoroverhaulofthecountryrsquosNationalDrugandFoodControlAgency(NA-DFC)2 The nationwide scandal has unveiled striking gaps in the distribution chain of the vaccine system and the quality control mechanismadoptedbytheregulatorinthecountry3 The Ministry ofHealthisprovidingre-immunizationforchildrenexposedtofakevaccines4TheNA-DFCoverhaulmayaddfurtherregulatoryhurdlesformanufacturers

Malaysia controlling health care expenditure and strengthening sector regulations

TheMalaysianGovernmentisconsideringoradoptingseveralmea re to control ri in ealt care co t TheConsumersAssociation of Penang has requested the introduction of a national drugpricingcontrolsystem5 Meanwhile the government is trying toincreasetheuseofgenericsandbiosimilarsinthecountryCurrently both generic and branded medicines are being used inequalproportion(byvalue)inMalaysia6 Further the country recentlysawthelaunchofitsfirstbiosimilarinsulinwhichwillincreasetheavailabilityofthetherapyatanaffordablerate7

Concurrently under the raditional and Complementar edicine ( TCM ) Act 2016 Malaysia is set to have a council for TCM that will regulate the traditional medicine industry and will mandate the registrationofTCMpractitionersinthecountryThisshouldhelpthe government enhance the safety and quality of TCM services providedathospitals8

On the medical de ice fronttheMalaysianMedicalDeviceAuthority(MDA)hasproposedatwo-yeartransitionperiodformedical device manufacturers for complying with new labeling rules detailedintheSixthScheduleoftheMedicalDeviceRegulation2012AlsoMDAhaslaiddownnewguidelinesonhowmedicaldevices meant for clinical research can qualify for exemption from theregistrationrequirementsofthecountryFurthermoreMDAhas allowed advertisement only for those medical devices that are registeredinMalaysiaforsale9

China refers to mainland China in this publication

K ey highlightsbull Markets across Asia are continually acting to increase the

competitiveness and attractiveness of the life sciences industryforforeignmultinationalsForinstanceIndiahasundertaken several initiatives including encouraging public-privatepartnerships(PPPs)inRampDprojectsandincreasingfocus on infrastructure to establish India as one of the worldrsquos majorpharmaceuticalinnovationhubsAustraliaandChinahave implemented sector-focused innovation plans to boost investmentsalongwithreformstoexpeditedrugapprovalsSouth Korea is working toward becoming a global biotech and medical industry hub with focus on biosimilars stem cell therapiesand3DprintingofmedicaldevicesMeanwhileTaiwanhasdedicatedaninitiativetoenhanceitspositionasamajorbiomedical market in Asia and Vietnam has lifted the cap on foreigninvestmentsinthepharmasector

bull Malaysia Australia India and South Korea are also adopting adequate measures to bring their sector regulations for biosimilars and medical devices to par with international practices

bull Concurrently many Asian countries are grappling with the problem of counterfeiting and patientsrsquo inadequate trust of the industryIndonesiaandthePhilippinesareadoptingstringent

measures to contain the spread of counterfeit medicines while Australia and South Korea are increasing transparency between pharma-physician-patient relationship through mandatory physicianpaymentdisclosuresandheftypenaltiesSimilarlyIndiais strengthening its pharmacovigilance program by making the pharmacompaniestakeonmoreaccountabilityfordrugsafety

bull The life sciences industry in the region is also inching toward digitization with both industry and government playing an importantroleTheGovernmentofChinaisdevelopinganationaldigital platform that will enable data sharing and is introducing digitalmedicalidentificationandsignaturesAtthesametimepharma companies in India and the Philippines are developing mobile applications to enhance patient experience and to educate differentstakeholders

bull IncreasinglifeexpectancyiscreatingamajorhealthcareburdenformanycountriesincludingJapanandAustraliaJapanisrevisiting its prescription drug pricing system and continuing itspushtowardgenericsSimilarlyMalaysiaisconsideringincreasing generics usage while Australia is trying to expand the listofdrugsanddeviceseligibleforpricecuts

Market insights

4 | EY Life Sciences Report Asia

Philippines curbing illegal drug manufacturing via better control and awarenessTheFoodandDrugAdministration(FDA)ofthePhilippinesis ti tenin it noo e or entitie in ol ed in t e ale o counterfeit drugsinthecountryIthascautionedthepublicandhasalsoadvisedittopurchasemedicinesfromFDA-licensedestablishmentsonly10 Also the provincial government has formed aProvincialBuildingInspectionTeamtoconfirmthatnoillegaldrugsarebeingmanufacturedintheterritory11 Further the government has been successful in its initial efforts to combat fake drugs with more than 600000 drug users and manufacturers surrenderingtoofficials12

In addition the Philippines is witnessing the launch of several mo ile app to impro e a arene among the people and industry playersExamplesinclude

bull AppforHIVpatientsmdashJohnsonampJohnson(JampJ)incollaborationwithSustainedHealthInitiativesofthePhilippinesdevelopedanapptohelpreducetheburdenofHIVinthecountry13

bull PharmacyappmdashInassociationwiththeDrugstoresAssociationofthePhilippines(DSAP)JampJintroducedtheDSAPMobileDrugstoreappfortrainingandhelpingDSAPmemberpharmacists14

V ietnam improving the funding support for the sector

Vietnamrsquos pharmaceutical market is undergoing liberalization withtheGovernmentli tin t e cap on orei n o ner ip in pharmacompaniesTheongoingreformhasincreasedtheappealofthe domestic pharmaceutical sector and has recently led to a boom in inbound MampA deals with foreign pharma giants15

bull CFRInternational(Chile)apartofUS-basedAbbottLaboratoriesincreaseditsequityshareinDomescoto517

bull AbbottacquiredGlomedPharmaceuticalaleadingVietnamesedrugmaker and propelled itself into the top 10 local pharma companiesinthecountry

bull TaishoPharmaceuticalpurchaseda245stakeinDHGPharmaceutical

Furtheraspartofits2020strategytheVietnameseGovernmentintendstomeet80ofitsdomesticpharmaceuticaldemandthroughlocaldrugmanufacturersThepolicyishavingamajorimpact on the vaccine market with the country now able to produce 11 of the 12 vaccines included in the national expanded immunizationprogramTheGovernmentisfurthergearingupto el finance it accine pro ram by reducing its reliance oninternationalfundingTheaimistoachievemassvaccineproduction in the country through government-supported investmentsinmanufacturinginfrastructureandtechnology16

Market insights

5March 2017 |

AustraliaReforms toward an environment conducive to sector innovation

Australia currently ranked the second-most attractive pharmaceuticalmarketinAsia-Pacificisundertakingmea re to

rt er oo t t e ector competiti ene through enhanced innovationandbetterproductivityA10-yearsectorrevitalizationplan introduced by the Medical Technologies and Pharmaceuticals IndustryGrowthCentre(MTP)isoneofthecriticalstepsinthisdirection17 As part of this program MTPConnect an organization formedunderthefederalgovernmentrsquosIndustryGrowthCentresinitiativeshasidentifiedsevengrowthprioritieswithfocusonspecificaspectsofthesectorvaluechainIthasalreadymadeanannouncementtoinjectUS$56million(AU$74million)a in 14sector-specificprojectsandisfurtherawaitingUS$24million(AU$32million)fromvariousindustrypartners18

Additionally the industry is working to rid e t e ap et een re earc and cce l commerciali ationAconsortiumofpharmaceutical companies that includes AbbVie Boehringer Ingelheim Celgene and Novartis has teamed up with Medicines AustraliatolaunchaUS$076million(AU$1million)educationalprogramTheBridgeInitiativescheduledtostartin1Q17Theprogram is expected to run for two years with a target of training 100people19 Further to encourage real-world application of innovation the Victorian state government plans to expend US$3million(AU$4million)tobuildaworld-classinnovationcenter the Medicines Manufacturing Innovation Centre led by MonashUniversity20ThenationhasalreadyestablishedaUS$380million(AU$500million)BiomedicalTranslationFundtoaidthedevelopmentandcommercializationofbiomedicaldiscoveries21

To further promote innovation the country is simultaneously e peditin t e dr appro al proce TheAustraliandrugregulatortheTherapeuticGoodsAdministrationiscurrentlyintheprocessofrollingoutreformsoverthenext18to24monthsOneofthemajorchangesincludespotentialintroductionoftwoexpedited pathways for the registration of novel medicines focusing on drugs that are already approved in countries with comparable regulatoryprocesses22

e ali ation o medical canna i is offering new opportunities toAustralianlifesciencescompaniesTheTherapeuticGoodsAdministration has now allowed cultivation of cannabis for medical purposesbutunderstrictgovernmentlicensingandguidelines23

Australia continues to c rtail ri in ealt care co t through tighterregulationsandpricecutsInits2017pricedisclosurecyclethegovernmentrsquosPharmaceuticalBenefitsSchemedisclosedtheaddition of several drugs particularly biologics and a deepening of pricecutsThegovernmenthasalsoannouncedreformstolowerthe costs of medical devices and prostheses including a reduction in listcostofcardiacdevicesandintraocularlensesby10andinhipandkneereplacementsby7524

Pharma companies in Australia have begun disclosing physician payments under the new code laid by the regulator thus inching towardamoretransparentpharma-physician-patientrelationship25

aConvertedusingspotrateasof31July2016(AU$1equalsUS$07595)accessed3January2017

Market insights

6 | EY Life Sciences Report Asia

ChinaE asing the regulatory environment building digital resource sharing capabilities

TheChineseGovernmentisactivelyinvolvedinboostinginnovationandinjectingfreshinvestmentinthesectorAnnouncementofthe13th Five Year Plan (2015ndash20) has provided further momentum to inno ation and re orm in the country with biomedicine being identifiedasakeypriorityInnovationformsthecorestrategyofthecurrentfive-yearplanalongsideahugefocusonimprovingthequalityofinnovativedrugs26AspartofthistheChinaFDA(CFDA)and the State Council have approved a three-year pilot called ldquoMarketingAuthorizationHolderrdquotowidentheeligibilitycriteriaforcompaniesapplyingfordrugmarketingauthorizationTheprogramallows domestic researchers and smaller operations to apply for drug approvals even without having in-house manufacturing capabilitiesTheaimofthepilotistohelpcompaniesbringdrugsto market at a lower cost by leveraging contract manufacturing arrangements27

Simultaneously China has pledged to create an ind trial cale o medical er ice on a national di ital plat orm28 The planisexpectedtocreateadigitalhealthtrailforcitizensTheplaninvolves establishing

bull National and provincial population health platforms

bull Interconnected application platforms for national medicine bidding and purchasing

bull 100 regional clinical medicine data demonstration centers

bull Digitalmedicalidentificationandsignatures

Sharing of health and medical data resources is likely to accelerate the use of big data applications in health and medical industry management clinical research and development and digital health andmedicalequipment29

In addition the country is enco ra in t e e o lo co t met od o ellin dr and medical prod ct to increase competitionandslashpricesTheCFDAhadbeenattemptingtointroducepilotprogramsforonlinedrugsalesHoweverduetoadeficienttrackingsystemandincreaseddrugcounterfeitingtheinitiative has been put to a halt and the sale of online prescription drugshasbeenbannedinChina30

InthepastfiveyearsChinahasinvestedapproximately US$359billion(RMB22trillion)toimpro e medical de ice re lation andharmonizethemwithinternationalpracticesRecentlytheCFDAannouncedthatitspriorityreviewandapprovalprocedureformedicaldeviceswillbeenforcedstarting1January2017MoreovertheCFDAhasalsoreleasedanexpandedlistofdevicesthatstandexemptedfromclinicaltrials31 In addition the country has decided to remove tariffs on 201 technology products includingsomemedicaldevices32 These moves are expected to strengthen the approval systems for drugs and devices and help in meetingclinicaldemandformedicaldevices33

Market insights

7March 2017 |

IndiaContinued efforts to elevate Indiarsquo s reputation and to make strides in digital pharma

InlinewiththePharmaVision2020documentoftheDepartmentofPharmaceuticals(DOP)Indiahasembarkedonitsjourneytobecome a leadin co ntr or end to end dr man act rin and inno ationTheGovernmentaimstoaugmentinfrastructurethrough a ldquoMake in Indiardquo initiative improve the quality of the workforceandincreasefundsforinnovationSpecificallytheGovernmentaimstopositionIndiaasoneofthetopfivepharmaceutical innovation hubs by 2020 and establish the nation asoneofthemostpreferreddestinationsforclinicaltrials34 Toward thisefforttheDrugControllerGeneralofIndiahasremovedthemaximum limit of three clinical trials and eliminated the restriction on the number of beds to enable smoother entry of pharma companiesintoresearchanddiscoveryTheGovernmentisfurthercontemplatinginvestments(ofupto50)inpublic-privatepartnership(PPP)modelsforundertakingRampDprojectsinadditiontotheexistingweightedtaxdeductionrateof150onRampDspendSimultaneouslytheMinistryofHealthampFamilyWelfare(MoHFW)has established eligibility criteria for all personnel employed in any pharma manufacturing to bring the sector up to par with internationalstandards35

Bol terin dr a et mean o p armaco i ilance is another focusareafortheindustryWiththePharmacovigilanceProgramofIndiaalreadyreceiving023millioninstancesofadversedrugreactionstheHealthMinistryiscontinuingtoaddnewadversedrugreaction monitoring centers and is also integrating information receivedfromthepharmacompaniesTheministryhasmandatedthatmarketauthorizationholders(MHAs)establishpharmacovigilancecellsintheircompanies36 These cells can either becaptiveoroutsourcedbutmustenabletheMHAstocollectprocess and forward adverse drug reports to the licensing authorities37

The i ital ndia initiati e is also making a big push in the industry mdashrangingfrome-detailingtoolstosmartphoneappsforunderstandingpatientbehaviorSomeoftherecentannouncementsin this direction include

bull SunPharmarsquosRespiTrackappforeducatingasthmapatientsandenhancing their adherence to therapies

bull GlaxoSmithKlineIndiarsquosuseofwebinarsvideochatsinformationportals and platforms such as Viva for doctors

bull AbbottHealthcareIndiarsquoseducationalappKnowledgeGenieforpatients with heart or liver diseases

InadditiontotheseindustryeffortstheGovernmentisattemptingto digitize medical health records on an Aadhar-linked electronic healthrecordsystemb To aid this development it is planning to

introduceabillforcreationofanationale-healthauthority38 AdditionallytheGovernmentisworkingonguidelinesforregulatinge-pharmaciestoreducetheirmisuse

In the area of medical de ice theMoHFWhasreleasedadraftofMedicalDevicesRulesforfurtherdiscussionwithanaimtoaligntheindustrywithglobalpracticesonaprioritybasis39 Certain measuresofthedraftsuchasafive-yearcapontheshelflifeofmedicaldevicescompliancewithuniqueidentificationnormsandallowance for contract manufacturing are expected to be implementedbyearly2017Additionallytocontrolthepriceofstents the government has added coronary stents to the national listofessentialmedicinesfor201540

OnthebiotechfronttheCentralDrugsStandardControlOrganizationandtheDepartmentofBiotechnologyannouncedare i ed io imilar polic providing a detailed regulatory pathway formanufacturingprocessesthataimstodeliversafetyefficacyandqualityThedocumentalsoaddressesissuesconcerningpre-andpost-marketregulatoryrequirementsforsimilarbiologicsThe policy is expected to accelerate the Indian biosimilars market sizetoUS$40billionby203041

bAadharisauniqueidentificationnumberissuedbytheGovernmentofIndiatoall residents of the country to eliminate duplicate and fake identities and to make verificationandauthenticationeasyandeffective

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

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Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

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21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 4: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

2 | EY Life Sciences Report Asia

Market insights

In this edition we highlight key sector regulatory and legislative trends for the following markets

AS E ANbull Indonesia

bull Malaysia

bull Philippines

bull Vietnam

Australia

China (mainland)

India

J apan

S outh K orea

Taiwan

3March 2017 |

AS E AN Indonesia tightening regulatory pathways to improve affordability and q uality of drugs

TheIndonesianGovernmentiscontinuallytryingtostrengthenthecountryrsquospharmaceuticalmarketHoweverrecentamendment to ndone ia intellect al propert ri t regime have brought aboutsignificantchangesfortheindustryplayersProhibitingpatent claims for second medical use and allowing import of lower-priced copies of patented products during the exclusivity period have made the regulatory environment more challenging for innovativedrugmanufacturers1

Meanwhileamajorco nter eitin accine candal was exposed inthecountryafterwhichIndonesianauthoritiesorderedamajoroverhaulofthecountryrsquosNationalDrugandFoodControlAgency(NA-DFC)2 The nationwide scandal has unveiled striking gaps in the distribution chain of the vaccine system and the quality control mechanismadoptedbytheregulatorinthecountry3 The Ministry ofHealthisprovidingre-immunizationforchildrenexposedtofakevaccines4TheNA-DFCoverhaulmayaddfurtherregulatoryhurdlesformanufacturers

Malaysia controlling health care expenditure and strengthening sector regulations

TheMalaysianGovernmentisconsideringoradoptingseveralmea re to control ri in ealt care co t TheConsumersAssociation of Penang has requested the introduction of a national drugpricingcontrolsystem5 Meanwhile the government is trying toincreasetheuseofgenericsandbiosimilarsinthecountryCurrently both generic and branded medicines are being used inequalproportion(byvalue)inMalaysia6 Further the country recentlysawthelaunchofitsfirstbiosimilarinsulinwhichwillincreasetheavailabilityofthetherapyatanaffordablerate7

Concurrently under the raditional and Complementar edicine ( TCM ) Act 2016 Malaysia is set to have a council for TCM that will regulate the traditional medicine industry and will mandate the registrationofTCMpractitionersinthecountryThisshouldhelpthe government enhance the safety and quality of TCM services providedathospitals8

On the medical de ice fronttheMalaysianMedicalDeviceAuthority(MDA)hasproposedatwo-yeartransitionperiodformedical device manufacturers for complying with new labeling rules detailedintheSixthScheduleoftheMedicalDeviceRegulation2012AlsoMDAhaslaiddownnewguidelinesonhowmedicaldevices meant for clinical research can qualify for exemption from theregistrationrequirementsofthecountryFurthermoreMDAhas allowed advertisement only for those medical devices that are registeredinMalaysiaforsale9

China refers to mainland China in this publication

K ey highlightsbull Markets across Asia are continually acting to increase the

competitiveness and attractiveness of the life sciences industryforforeignmultinationalsForinstanceIndiahasundertaken several initiatives including encouraging public-privatepartnerships(PPPs)inRampDprojectsandincreasingfocus on infrastructure to establish India as one of the worldrsquos majorpharmaceuticalinnovationhubsAustraliaandChinahave implemented sector-focused innovation plans to boost investmentsalongwithreformstoexpeditedrugapprovalsSouth Korea is working toward becoming a global biotech and medical industry hub with focus on biosimilars stem cell therapiesand3DprintingofmedicaldevicesMeanwhileTaiwanhasdedicatedaninitiativetoenhanceitspositionasamajorbiomedical market in Asia and Vietnam has lifted the cap on foreigninvestmentsinthepharmasector

bull Malaysia Australia India and South Korea are also adopting adequate measures to bring their sector regulations for biosimilars and medical devices to par with international practices

bull Concurrently many Asian countries are grappling with the problem of counterfeiting and patientsrsquo inadequate trust of the industryIndonesiaandthePhilippinesareadoptingstringent

measures to contain the spread of counterfeit medicines while Australia and South Korea are increasing transparency between pharma-physician-patient relationship through mandatory physicianpaymentdisclosuresandheftypenaltiesSimilarlyIndiais strengthening its pharmacovigilance program by making the pharmacompaniestakeonmoreaccountabilityfordrugsafety

bull The life sciences industry in the region is also inching toward digitization with both industry and government playing an importantroleTheGovernmentofChinaisdevelopinganationaldigital platform that will enable data sharing and is introducing digitalmedicalidentificationandsignaturesAtthesametimepharma companies in India and the Philippines are developing mobile applications to enhance patient experience and to educate differentstakeholders

bull IncreasinglifeexpectancyiscreatingamajorhealthcareburdenformanycountriesincludingJapanandAustraliaJapanisrevisiting its prescription drug pricing system and continuing itspushtowardgenericsSimilarlyMalaysiaisconsideringincreasing generics usage while Australia is trying to expand the listofdrugsanddeviceseligibleforpricecuts

Market insights

4 | EY Life Sciences Report Asia

Philippines curbing illegal drug manufacturing via better control and awarenessTheFoodandDrugAdministration(FDA)ofthePhilippinesis ti tenin it noo e or entitie in ol ed in t e ale o counterfeit drugsinthecountryIthascautionedthepublicandhasalsoadvisedittopurchasemedicinesfromFDA-licensedestablishmentsonly10 Also the provincial government has formed aProvincialBuildingInspectionTeamtoconfirmthatnoillegaldrugsarebeingmanufacturedintheterritory11 Further the government has been successful in its initial efforts to combat fake drugs with more than 600000 drug users and manufacturers surrenderingtoofficials12

In addition the Philippines is witnessing the launch of several mo ile app to impro e a arene among the people and industry playersExamplesinclude

bull AppforHIVpatientsmdashJohnsonampJohnson(JampJ)incollaborationwithSustainedHealthInitiativesofthePhilippinesdevelopedanapptohelpreducetheburdenofHIVinthecountry13

bull PharmacyappmdashInassociationwiththeDrugstoresAssociationofthePhilippines(DSAP)JampJintroducedtheDSAPMobileDrugstoreappfortrainingandhelpingDSAPmemberpharmacists14

V ietnam improving the funding support for the sector

Vietnamrsquos pharmaceutical market is undergoing liberalization withtheGovernmentli tin t e cap on orei n o ner ip in pharmacompaniesTheongoingreformhasincreasedtheappealofthe domestic pharmaceutical sector and has recently led to a boom in inbound MampA deals with foreign pharma giants15

bull CFRInternational(Chile)apartofUS-basedAbbottLaboratoriesincreaseditsequityshareinDomescoto517

bull AbbottacquiredGlomedPharmaceuticalaleadingVietnamesedrugmaker and propelled itself into the top 10 local pharma companiesinthecountry

bull TaishoPharmaceuticalpurchaseda245stakeinDHGPharmaceutical

Furtheraspartofits2020strategytheVietnameseGovernmentintendstomeet80ofitsdomesticpharmaceuticaldemandthroughlocaldrugmanufacturersThepolicyishavingamajorimpact on the vaccine market with the country now able to produce 11 of the 12 vaccines included in the national expanded immunizationprogramTheGovernmentisfurthergearingupto el finance it accine pro ram by reducing its reliance oninternationalfundingTheaimistoachievemassvaccineproduction in the country through government-supported investmentsinmanufacturinginfrastructureandtechnology16

Market insights

5March 2017 |

AustraliaReforms toward an environment conducive to sector innovation

Australia currently ranked the second-most attractive pharmaceuticalmarketinAsia-Pacificisundertakingmea re to

rt er oo t t e ector competiti ene through enhanced innovationandbetterproductivityA10-yearsectorrevitalizationplan introduced by the Medical Technologies and Pharmaceuticals IndustryGrowthCentre(MTP)isoneofthecriticalstepsinthisdirection17 As part of this program MTPConnect an organization formedunderthefederalgovernmentrsquosIndustryGrowthCentresinitiativeshasidentifiedsevengrowthprioritieswithfocusonspecificaspectsofthesectorvaluechainIthasalreadymadeanannouncementtoinjectUS$56million(AU$74million)a in 14sector-specificprojectsandisfurtherawaitingUS$24million(AU$32million)fromvariousindustrypartners18

Additionally the industry is working to rid e t e ap et een re earc and cce l commerciali ationAconsortiumofpharmaceutical companies that includes AbbVie Boehringer Ingelheim Celgene and Novartis has teamed up with Medicines AustraliatolaunchaUS$076million(AU$1million)educationalprogramTheBridgeInitiativescheduledtostartin1Q17Theprogram is expected to run for two years with a target of training 100people19 Further to encourage real-world application of innovation the Victorian state government plans to expend US$3million(AU$4million)tobuildaworld-classinnovationcenter the Medicines Manufacturing Innovation Centre led by MonashUniversity20ThenationhasalreadyestablishedaUS$380million(AU$500million)BiomedicalTranslationFundtoaidthedevelopmentandcommercializationofbiomedicaldiscoveries21

To further promote innovation the country is simultaneously e peditin t e dr appro al proce TheAustraliandrugregulatortheTherapeuticGoodsAdministrationiscurrentlyintheprocessofrollingoutreformsoverthenext18to24monthsOneofthemajorchangesincludespotentialintroductionoftwoexpedited pathways for the registration of novel medicines focusing on drugs that are already approved in countries with comparable regulatoryprocesses22

e ali ation o medical canna i is offering new opportunities toAustralianlifesciencescompaniesTheTherapeuticGoodsAdministration has now allowed cultivation of cannabis for medical purposesbutunderstrictgovernmentlicensingandguidelines23

Australia continues to c rtail ri in ealt care co t through tighterregulationsandpricecutsInits2017pricedisclosurecyclethegovernmentrsquosPharmaceuticalBenefitsSchemedisclosedtheaddition of several drugs particularly biologics and a deepening of pricecutsThegovernmenthasalsoannouncedreformstolowerthe costs of medical devices and prostheses including a reduction in listcostofcardiacdevicesandintraocularlensesby10andinhipandkneereplacementsby7524

Pharma companies in Australia have begun disclosing physician payments under the new code laid by the regulator thus inching towardamoretransparentpharma-physician-patientrelationship25

aConvertedusingspotrateasof31July2016(AU$1equalsUS$07595)accessed3January2017

Market insights

6 | EY Life Sciences Report Asia

ChinaE asing the regulatory environment building digital resource sharing capabilities

TheChineseGovernmentisactivelyinvolvedinboostinginnovationandinjectingfreshinvestmentinthesectorAnnouncementofthe13th Five Year Plan (2015ndash20) has provided further momentum to inno ation and re orm in the country with biomedicine being identifiedasakeypriorityInnovationformsthecorestrategyofthecurrentfive-yearplanalongsideahugefocusonimprovingthequalityofinnovativedrugs26AspartofthistheChinaFDA(CFDA)and the State Council have approved a three-year pilot called ldquoMarketingAuthorizationHolderrdquotowidentheeligibilitycriteriaforcompaniesapplyingfordrugmarketingauthorizationTheprogramallows domestic researchers and smaller operations to apply for drug approvals even without having in-house manufacturing capabilitiesTheaimofthepilotistohelpcompaniesbringdrugsto market at a lower cost by leveraging contract manufacturing arrangements27

Simultaneously China has pledged to create an ind trial cale o medical er ice on a national di ital plat orm28 The planisexpectedtocreateadigitalhealthtrailforcitizensTheplaninvolves establishing

bull National and provincial population health platforms

bull Interconnected application platforms for national medicine bidding and purchasing

bull 100 regional clinical medicine data demonstration centers

bull Digitalmedicalidentificationandsignatures

Sharing of health and medical data resources is likely to accelerate the use of big data applications in health and medical industry management clinical research and development and digital health andmedicalequipment29

In addition the country is enco ra in t e e o lo co t met od o ellin dr and medical prod ct to increase competitionandslashpricesTheCFDAhadbeenattemptingtointroducepilotprogramsforonlinedrugsalesHoweverduetoadeficienttrackingsystemandincreaseddrugcounterfeitingtheinitiative has been put to a halt and the sale of online prescription drugshasbeenbannedinChina30

InthepastfiveyearsChinahasinvestedapproximately US$359billion(RMB22trillion)toimpro e medical de ice re lation andharmonizethemwithinternationalpracticesRecentlytheCFDAannouncedthatitspriorityreviewandapprovalprocedureformedicaldeviceswillbeenforcedstarting1January2017MoreovertheCFDAhasalsoreleasedanexpandedlistofdevicesthatstandexemptedfromclinicaltrials31 In addition the country has decided to remove tariffs on 201 technology products includingsomemedicaldevices32 These moves are expected to strengthen the approval systems for drugs and devices and help in meetingclinicaldemandformedicaldevices33

Market insights

7March 2017 |

IndiaContinued efforts to elevate Indiarsquo s reputation and to make strides in digital pharma

InlinewiththePharmaVision2020documentoftheDepartmentofPharmaceuticals(DOP)Indiahasembarkedonitsjourneytobecome a leadin co ntr or end to end dr man act rin and inno ationTheGovernmentaimstoaugmentinfrastructurethrough a ldquoMake in Indiardquo initiative improve the quality of the workforceandincreasefundsforinnovationSpecificallytheGovernmentaimstopositionIndiaasoneofthetopfivepharmaceutical innovation hubs by 2020 and establish the nation asoneofthemostpreferreddestinationsforclinicaltrials34 Toward thisefforttheDrugControllerGeneralofIndiahasremovedthemaximum limit of three clinical trials and eliminated the restriction on the number of beds to enable smoother entry of pharma companiesintoresearchanddiscoveryTheGovernmentisfurthercontemplatinginvestments(ofupto50)inpublic-privatepartnership(PPP)modelsforundertakingRampDprojectsinadditiontotheexistingweightedtaxdeductionrateof150onRampDspendSimultaneouslytheMinistryofHealthampFamilyWelfare(MoHFW)has established eligibility criteria for all personnel employed in any pharma manufacturing to bring the sector up to par with internationalstandards35

Bol terin dr a et mean o p armaco i ilance is another focusareafortheindustryWiththePharmacovigilanceProgramofIndiaalreadyreceiving023millioninstancesofadversedrugreactionstheHealthMinistryiscontinuingtoaddnewadversedrugreaction monitoring centers and is also integrating information receivedfromthepharmacompaniesTheministryhasmandatedthatmarketauthorizationholders(MHAs)establishpharmacovigilancecellsintheircompanies36 These cells can either becaptiveoroutsourcedbutmustenabletheMHAstocollectprocess and forward adverse drug reports to the licensing authorities37

The i ital ndia initiati e is also making a big push in the industry mdashrangingfrome-detailingtoolstosmartphoneappsforunderstandingpatientbehaviorSomeoftherecentannouncementsin this direction include

bull SunPharmarsquosRespiTrackappforeducatingasthmapatientsandenhancing their adherence to therapies

bull GlaxoSmithKlineIndiarsquosuseofwebinarsvideochatsinformationportals and platforms such as Viva for doctors

bull AbbottHealthcareIndiarsquoseducationalappKnowledgeGenieforpatients with heart or liver diseases

InadditiontotheseindustryeffortstheGovernmentisattemptingto digitize medical health records on an Aadhar-linked electronic healthrecordsystemb To aid this development it is planning to

introduceabillforcreationofanationale-healthauthority38 AdditionallytheGovernmentisworkingonguidelinesforregulatinge-pharmaciestoreducetheirmisuse

In the area of medical de ice theMoHFWhasreleasedadraftofMedicalDevicesRulesforfurtherdiscussionwithanaimtoaligntheindustrywithglobalpracticesonaprioritybasis39 Certain measuresofthedraftsuchasafive-yearcapontheshelflifeofmedicaldevicescompliancewithuniqueidentificationnormsandallowance for contract manufacturing are expected to be implementedbyearly2017Additionallytocontrolthepriceofstents the government has added coronary stents to the national listofessentialmedicinesfor201540

OnthebiotechfronttheCentralDrugsStandardControlOrganizationandtheDepartmentofBiotechnologyannouncedare i ed io imilar polic providing a detailed regulatory pathway formanufacturingprocessesthataimstodeliversafetyefficacyandqualityThedocumentalsoaddressesissuesconcerningpre-andpost-marketregulatoryrequirementsforsimilarbiologicsThe policy is expected to accelerate the Indian biosimilars market sizetoUS$40billionby203041

bAadharisauniqueidentificationnumberissuedbytheGovernmentofIndiatoall residents of the country to eliminate duplicate and fake identities and to make verificationandauthenticationeasyandeffective

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 5: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

3March 2017 |

AS E AN Indonesia tightening regulatory pathways to improve affordability and q uality of drugs

TheIndonesianGovernmentiscontinuallytryingtostrengthenthecountryrsquospharmaceuticalmarketHoweverrecentamendment to ndone ia intellect al propert ri t regime have brought aboutsignificantchangesfortheindustryplayersProhibitingpatent claims for second medical use and allowing import of lower-priced copies of patented products during the exclusivity period have made the regulatory environment more challenging for innovativedrugmanufacturers1

Meanwhileamajorco nter eitin accine candal was exposed inthecountryafterwhichIndonesianauthoritiesorderedamajoroverhaulofthecountryrsquosNationalDrugandFoodControlAgency(NA-DFC)2 The nationwide scandal has unveiled striking gaps in the distribution chain of the vaccine system and the quality control mechanismadoptedbytheregulatorinthecountry3 The Ministry ofHealthisprovidingre-immunizationforchildrenexposedtofakevaccines4TheNA-DFCoverhaulmayaddfurtherregulatoryhurdlesformanufacturers

Malaysia controlling health care expenditure and strengthening sector regulations

TheMalaysianGovernmentisconsideringoradoptingseveralmea re to control ri in ealt care co t TheConsumersAssociation of Penang has requested the introduction of a national drugpricingcontrolsystem5 Meanwhile the government is trying toincreasetheuseofgenericsandbiosimilarsinthecountryCurrently both generic and branded medicines are being used inequalproportion(byvalue)inMalaysia6 Further the country recentlysawthelaunchofitsfirstbiosimilarinsulinwhichwillincreasetheavailabilityofthetherapyatanaffordablerate7

Concurrently under the raditional and Complementar edicine ( TCM ) Act 2016 Malaysia is set to have a council for TCM that will regulate the traditional medicine industry and will mandate the registrationofTCMpractitionersinthecountryThisshouldhelpthe government enhance the safety and quality of TCM services providedathospitals8

On the medical de ice fronttheMalaysianMedicalDeviceAuthority(MDA)hasproposedatwo-yeartransitionperiodformedical device manufacturers for complying with new labeling rules detailedintheSixthScheduleoftheMedicalDeviceRegulation2012AlsoMDAhaslaiddownnewguidelinesonhowmedicaldevices meant for clinical research can qualify for exemption from theregistrationrequirementsofthecountryFurthermoreMDAhas allowed advertisement only for those medical devices that are registeredinMalaysiaforsale9

China refers to mainland China in this publication

K ey highlightsbull Markets across Asia are continually acting to increase the

competitiveness and attractiveness of the life sciences industryforforeignmultinationalsForinstanceIndiahasundertaken several initiatives including encouraging public-privatepartnerships(PPPs)inRampDprojectsandincreasingfocus on infrastructure to establish India as one of the worldrsquos majorpharmaceuticalinnovationhubsAustraliaandChinahave implemented sector-focused innovation plans to boost investmentsalongwithreformstoexpeditedrugapprovalsSouth Korea is working toward becoming a global biotech and medical industry hub with focus on biosimilars stem cell therapiesand3DprintingofmedicaldevicesMeanwhileTaiwanhasdedicatedaninitiativetoenhanceitspositionasamajorbiomedical market in Asia and Vietnam has lifted the cap on foreigninvestmentsinthepharmasector

bull Malaysia Australia India and South Korea are also adopting adequate measures to bring their sector regulations for biosimilars and medical devices to par with international practices

bull Concurrently many Asian countries are grappling with the problem of counterfeiting and patientsrsquo inadequate trust of the industryIndonesiaandthePhilippinesareadoptingstringent

measures to contain the spread of counterfeit medicines while Australia and South Korea are increasing transparency between pharma-physician-patient relationship through mandatory physicianpaymentdisclosuresandheftypenaltiesSimilarlyIndiais strengthening its pharmacovigilance program by making the pharmacompaniestakeonmoreaccountabilityfordrugsafety

bull The life sciences industry in the region is also inching toward digitization with both industry and government playing an importantroleTheGovernmentofChinaisdevelopinganationaldigital platform that will enable data sharing and is introducing digitalmedicalidentificationandsignaturesAtthesametimepharma companies in India and the Philippines are developing mobile applications to enhance patient experience and to educate differentstakeholders

bull IncreasinglifeexpectancyiscreatingamajorhealthcareburdenformanycountriesincludingJapanandAustraliaJapanisrevisiting its prescription drug pricing system and continuing itspushtowardgenericsSimilarlyMalaysiaisconsideringincreasing generics usage while Australia is trying to expand the listofdrugsanddeviceseligibleforpricecuts

Market insights

4 | EY Life Sciences Report Asia

Philippines curbing illegal drug manufacturing via better control and awarenessTheFoodandDrugAdministration(FDA)ofthePhilippinesis ti tenin it noo e or entitie in ol ed in t e ale o counterfeit drugsinthecountryIthascautionedthepublicandhasalsoadvisedittopurchasemedicinesfromFDA-licensedestablishmentsonly10 Also the provincial government has formed aProvincialBuildingInspectionTeamtoconfirmthatnoillegaldrugsarebeingmanufacturedintheterritory11 Further the government has been successful in its initial efforts to combat fake drugs with more than 600000 drug users and manufacturers surrenderingtoofficials12

In addition the Philippines is witnessing the launch of several mo ile app to impro e a arene among the people and industry playersExamplesinclude

bull AppforHIVpatientsmdashJohnsonampJohnson(JampJ)incollaborationwithSustainedHealthInitiativesofthePhilippinesdevelopedanapptohelpreducetheburdenofHIVinthecountry13

bull PharmacyappmdashInassociationwiththeDrugstoresAssociationofthePhilippines(DSAP)JampJintroducedtheDSAPMobileDrugstoreappfortrainingandhelpingDSAPmemberpharmacists14

V ietnam improving the funding support for the sector

Vietnamrsquos pharmaceutical market is undergoing liberalization withtheGovernmentli tin t e cap on orei n o ner ip in pharmacompaniesTheongoingreformhasincreasedtheappealofthe domestic pharmaceutical sector and has recently led to a boom in inbound MampA deals with foreign pharma giants15

bull CFRInternational(Chile)apartofUS-basedAbbottLaboratoriesincreaseditsequityshareinDomescoto517

bull AbbottacquiredGlomedPharmaceuticalaleadingVietnamesedrugmaker and propelled itself into the top 10 local pharma companiesinthecountry

bull TaishoPharmaceuticalpurchaseda245stakeinDHGPharmaceutical

Furtheraspartofits2020strategytheVietnameseGovernmentintendstomeet80ofitsdomesticpharmaceuticaldemandthroughlocaldrugmanufacturersThepolicyishavingamajorimpact on the vaccine market with the country now able to produce 11 of the 12 vaccines included in the national expanded immunizationprogramTheGovernmentisfurthergearingupto el finance it accine pro ram by reducing its reliance oninternationalfundingTheaimistoachievemassvaccineproduction in the country through government-supported investmentsinmanufacturinginfrastructureandtechnology16

Market insights

5March 2017 |

AustraliaReforms toward an environment conducive to sector innovation

Australia currently ranked the second-most attractive pharmaceuticalmarketinAsia-Pacificisundertakingmea re to

rt er oo t t e ector competiti ene through enhanced innovationandbetterproductivityA10-yearsectorrevitalizationplan introduced by the Medical Technologies and Pharmaceuticals IndustryGrowthCentre(MTP)isoneofthecriticalstepsinthisdirection17 As part of this program MTPConnect an organization formedunderthefederalgovernmentrsquosIndustryGrowthCentresinitiativeshasidentifiedsevengrowthprioritieswithfocusonspecificaspectsofthesectorvaluechainIthasalreadymadeanannouncementtoinjectUS$56million(AU$74million)a in 14sector-specificprojectsandisfurtherawaitingUS$24million(AU$32million)fromvariousindustrypartners18

Additionally the industry is working to rid e t e ap et een re earc and cce l commerciali ationAconsortiumofpharmaceutical companies that includes AbbVie Boehringer Ingelheim Celgene and Novartis has teamed up with Medicines AustraliatolaunchaUS$076million(AU$1million)educationalprogramTheBridgeInitiativescheduledtostartin1Q17Theprogram is expected to run for two years with a target of training 100people19 Further to encourage real-world application of innovation the Victorian state government plans to expend US$3million(AU$4million)tobuildaworld-classinnovationcenter the Medicines Manufacturing Innovation Centre led by MonashUniversity20ThenationhasalreadyestablishedaUS$380million(AU$500million)BiomedicalTranslationFundtoaidthedevelopmentandcommercializationofbiomedicaldiscoveries21

To further promote innovation the country is simultaneously e peditin t e dr appro al proce TheAustraliandrugregulatortheTherapeuticGoodsAdministrationiscurrentlyintheprocessofrollingoutreformsoverthenext18to24monthsOneofthemajorchangesincludespotentialintroductionoftwoexpedited pathways for the registration of novel medicines focusing on drugs that are already approved in countries with comparable regulatoryprocesses22

e ali ation o medical canna i is offering new opportunities toAustralianlifesciencescompaniesTheTherapeuticGoodsAdministration has now allowed cultivation of cannabis for medical purposesbutunderstrictgovernmentlicensingandguidelines23

Australia continues to c rtail ri in ealt care co t through tighterregulationsandpricecutsInits2017pricedisclosurecyclethegovernmentrsquosPharmaceuticalBenefitsSchemedisclosedtheaddition of several drugs particularly biologics and a deepening of pricecutsThegovernmenthasalsoannouncedreformstolowerthe costs of medical devices and prostheses including a reduction in listcostofcardiacdevicesandintraocularlensesby10andinhipandkneereplacementsby7524

Pharma companies in Australia have begun disclosing physician payments under the new code laid by the regulator thus inching towardamoretransparentpharma-physician-patientrelationship25

aConvertedusingspotrateasof31July2016(AU$1equalsUS$07595)accessed3January2017

Market insights

6 | EY Life Sciences Report Asia

ChinaE asing the regulatory environment building digital resource sharing capabilities

TheChineseGovernmentisactivelyinvolvedinboostinginnovationandinjectingfreshinvestmentinthesectorAnnouncementofthe13th Five Year Plan (2015ndash20) has provided further momentum to inno ation and re orm in the country with biomedicine being identifiedasakeypriorityInnovationformsthecorestrategyofthecurrentfive-yearplanalongsideahugefocusonimprovingthequalityofinnovativedrugs26AspartofthistheChinaFDA(CFDA)and the State Council have approved a three-year pilot called ldquoMarketingAuthorizationHolderrdquotowidentheeligibilitycriteriaforcompaniesapplyingfordrugmarketingauthorizationTheprogramallows domestic researchers and smaller operations to apply for drug approvals even without having in-house manufacturing capabilitiesTheaimofthepilotistohelpcompaniesbringdrugsto market at a lower cost by leveraging contract manufacturing arrangements27

Simultaneously China has pledged to create an ind trial cale o medical er ice on a national di ital plat orm28 The planisexpectedtocreateadigitalhealthtrailforcitizensTheplaninvolves establishing

bull National and provincial population health platforms

bull Interconnected application platforms for national medicine bidding and purchasing

bull 100 regional clinical medicine data demonstration centers

bull Digitalmedicalidentificationandsignatures

Sharing of health and medical data resources is likely to accelerate the use of big data applications in health and medical industry management clinical research and development and digital health andmedicalequipment29

In addition the country is enco ra in t e e o lo co t met od o ellin dr and medical prod ct to increase competitionandslashpricesTheCFDAhadbeenattemptingtointroducepilotprogramsforonlinedrugsalesHoweverduetoadeficienttrackingsystemandincreaseddrugcounterfeitingtheinitiative has been put to a halt and the sale of online prescription drugshasbeenbannedinChina30

InthepastfiveyearsChinahasinvestedapproximately US$359billion(RMB22trillion)toimpro e medical de ice re lation andharmonizethemwithinternationalpracticesRecentlytheCFDAannouncedthatitspriorityreviewandapprovalprocedureformedicaldeviceswillbeenforcedstarting1January2017MoreovertheCFDAhasalsoreleasedanexpandedlistofdevicesthatstandexemptedfromclinicaltrials31 In addition the country has decided to remove tariffs on 201 technology products includingsomemedicaldevices32 These moves are expected to strengthen the approval systems for drugs and devices and help in meetingclinicaldemandformedicaldevices33

Market insights

7March 2017 |

IndiaContinued efforts to elevate Indiarsquo s reputation and to make strides in digital pharma

InlinewiththePharmaVision2020documentoftheDepartmentofPharmaceuticals(DOP)Indiahasembarkedonitsjourneytobecome a leadin co ntr or end to end dr man act rin and inno ationTheGovernmentaimstoaugmentinfrastructurethrough a ldquoMake in Indiardquo initiative improve the quality of the workforceandincreasefundsforinnovationSpecificallytheGovernmentaimstopositionIndiaasoneofthetopfivepharmaceutical innovation hubs by 2020 and establish the nation asoneofthemostpreferreddestinationsforclinicaltrials34 Toward thisefforttheDrugControllerGeneralofIndiahasremovedthemaximum limit of three clinical trials and eliminated the restriction on the number of beds to enable smoother entry of pharma companiesintoresearchanddiscoveryTheGovernmentisfurthercontemplatinginvestments(ofupto50)inpublic-privatepartnership(PPP)modelsforundertakingRampDprojectsinadditiontotheexistingweightedtaxdeductionrateof150onRampDspendSimultaneouslytheMinistryofHealthampFamilyWelfare(MoHFW)has established eligibility criteria for all personnel employed in any pharma manufacturing to bring the sector up to par with internationalstandards35

Bol terin dr a et mean o p armaco i ilance is another focusareafortheindustryWiththePharmacovigilanceProgramofIndiaalreadyreceiving023millioninstancesofadversedrugreactionstheHealthMinistryiscontinuingtoaddnewadversedrugreaction monitoring centers and is also integrating information receivedfromthepharmacompaniesTheministryhasmandatedthatmarketauthorizationholders(MHAs)establishpharmacovigilancecellsintheircompanies36 These cells can either becaptiveoroutsourcedbutmustenabletheMHAstocollectprocess and forward adverse drug reports to the licensing authorities37

The i ital ndia initiati e is also making a big push in the industry mdashrangingfrome-detailingtoolstosmartphoneappsforunderstandingpatientbehaviorSomeoftherecentannouncementsin this direction include

bull SunPharmarsquosRespiTrackappforeducatingasthmapatientsandenhancing their adherence to therapies

bull GlaxoSmithKlineIndiarsquosuseofwebinarsvideochatsinformationportals and platforms such as Viva for doctors

bull AbbottHealthcareIndiarsquoseducationalappKnowledgeGenieforpatients with heart or liver diseases

InadditiontotheseindustryeffortstheGovernmentisattemptingto digitize medical health records on an Aadhar-linked electronic healthrecordsystemb To aid this development it is planning to

introduceabillforcreationofanationale-healthauthority38 AdditionallytheGovernmentisworkingonguidelinesforregulatinge-pharmaciestoreducetheirmisuse

In the area of medical de ice theMoHFWhasreleasedadraftofMedicalDevicesRulesforfurtherdiscussionwithanaimtoaligntheindustrywithglobalpracticesonaprioritybasis39 Certain measuresofthedraftsuchasafive-yearcapontheshelflifeofmedicaldevicescompliancewithuniqueidentificationnormsandallowance for contract manufacturing are expected to be implementedbyearly2017Additionallytocontrolthepriceofstents the government has added coronary stents to the national listofessentialmedicinesfor201540

OnthebiotechfronttheCentralDrugsStandardControlOrganizationandtheDepartmentofBiotechnologyannouncedare i ed io imilar polic providing a detailed regulatory pathway formanufacturingprocessesthataimstodeliversafetyefficacyandqualityThedocumentalsoaddressesissuesconcerningpre-andpost-marketregulatoryrequirementsforsimilarbiologicsThe policy is expected to accelerate the Indian biosimilars market sizetoUS$40billionby203041

bAadharisauniqueidentificationnumberissuedbytheGovernmentofIndiatoall residents of the country to eliminate duplicate and fake identities and to make verificationandauthenticationeasyandeffective

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 6: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Market insights

4 | EY Life Sciences Report Asia

Philippines curbing illegal drug manufacturing via better control and awarenessTheFoodandDrugAdministration(FDA)ofthePhilippinesis ti tenin it noo e or entitie in ol ed in t e ale o counterfeit drugsinthecountryIthascautionedthepublicandhasalsoadvisedittopurchasemedicinesfromFDA-licensedestablishmentsonly10 Also the provincial government has formed aProvincialBuildingInspectionTeamtoconfirmthatnoillegaldrugsarebeingmanufacturedintheterritory11 Further the government has been successful in its initial efforts to combat fake drugs with more than 600000 drug users and manufacturers surrenderingtoofficials12

In addition the Philippines is witnessing the launch of several mo ile app to impro e a arene among the people and industry playersExamplesinclude

bull AppforHIVpatientsmdashJohnsonampJohnson(JampJ)incollaborationwithSustainedHealthInitiativesofthePhilippinesdevelopedanapptohelpreducetheburdenofHIVinthecountry13

bull PharmacyappmdashInassociationwiththeDrugstoresAssociationofthePhilippines(DSAP)JampJintroducedtheDSAPMobileDrugstoreappfortrainingandhelpingDSAPmemberpharmacists14

V ietnam improving the funding support for the sector

Vietnamrsquos pharmaceutical market is undergoing liberalization withtheGovernmentli tin t e cap on orei n o ner ip in pharmacompaniesTheongoingreformhasincreasedtheappealofthe domestic pharmaceutical sector and has recently led to a boom in inbound MampA deals with foreign pharma giants15

bull CFRInternational(Chile)apartofUS-basedAbbottLaboratoriesincreaseditsequityshareinDomescoto517

bull AbbottacquiredGlomedPharmaceuticalaleadingVietnamesedrugmaker and propelled itself into the top 10 local pharma companiesinthecountry

bull TaishoPharmaceuticalpurchaseda245stakeinDHGPharmaceutical

Furtheraspartofits2020strategytheVietnameseGovernmentintendstomeet80ofitsdomesticpharmaceuticaldemandthroughlocaldrugmanufacturersThepolicyishavingamajorimpact on the vaccine market with the country now able to produce 11 of the 12 vaccines included in the national expanded immunizationprogramTheGovernmentisfurthergearingupto el finance it accine pro ram by reducing its reliance oninternationalfundingTheaimistoachievemassvaccineproduction in the country through government-supported investmentsinmanufacturinginfrastructureandtechnology16

Market insights

5March 2017 |

AustraliaReforms toward an environment conducive to sector innovation

Australia currently ranked the second-most attractive pharmaceuticalmarketinAsia-Pacificisundertakingmea re to

rt er oo t t e ector competiti ene through enhanced innovationandbetterproductivityA10-yearsectorrevitalizationplan introduced by the Medical Technologies and Pharmaceuticals IndustryGrowthCentre(MTP)isoneofthecriticalstepsinthisdirection17 As part of this program MTPConnect an organization formedunderthefederalgovernmentrsquosIndustryGrowthCentresinitiativeshasidentifiedsevengrowthprioritieswithfocusonspecificaspectsofthesectorvaluechainIthasalreadymadeanannouncementtoinjectUS$56million(AU$74million)a in 14sector-specificprojectsandisfurtherawaitingUS$24million(AU$32million)fromvariousindustrypartners18

Additionally the industry is working to rid e t e ap et een re earc and cce l commerciali ationAconsortiumofpharmaceutical companies that includes AbbVie Boehringer Ingelheim Celgene and Novartis has teamed up with Medicines AustraliatolaunchaUS$076million(AU$1million)educationalprogramTheBridgeInitiativescheduledtostartin1Q17Theprogram is expected to run for two years with a target of training 100people19 Further to encourage real-world application of innovation the Victorian state government plans to expend US$3million(AU$4million)tobuildaworld-classinnovationcenter the Medicines Manufacturing Innovation Centre led by MonashUniversity20ThenationhasalreadyestablishedaUS$380million(AU$500million)BiomedicalTranslationFundtoaidthedevelopmentandcommercializationofbiomedicaldiscoveries21

To further promote innovation the country is simultaneously e peditin t e dr appro al proce TheAustraliandrugregulatortheTherapeuticGoodsAdministrationiscurrentlyintheprocessofrollingoutreformsoverthenext18to24monthsOneofthemajorchangesincludespotentialintroductionoftwoexpedited pathways for the registration of novel medicines focusing on drugs that are already approved in countries with comparable regulatoryprocesses22

e ali ation o medical canna i is offering new opportunities toAustralianlifesciencescompaniesTheTherapeuticGoodsAdministration has now allowed cultivation of cannabis for medical purposesbutunderstrictgovernmentlicensingandguidelines23

Australia continues to c rtail ri in ealt care co t through tighterregulationsandpricecutsInits2017pricedisclosurecyclethegovernmentrsquosPharmaceuticalBenefitsSchemedisclosedtheaddition of several drugs particularly biologics and a deepening of pricecutsThegovernmenthasalsoannouncedreformstolowerthe costs of medical devices and prostheses including a reduction in listcostofcardiacdevicesandintraocularlensesby10andinhipandkneereplacementsby7524

Pharma companies in Australia have begun disclosing physician payments under the new code laid by the regulator thus inching towardamoretransparentpharma-physician-patientrelationship25

aConvertedusingspotrateasof31July2016(AU$1equalsUS$07595)accessed3January2017

Market insights

6 | EY Life Sciences Report Asia

ChinaE asing the regulatory environment building digital resource sharing capabilities

TheChineseGovernmentisactivelyinvolvedinboostinginnovationandinjectingfreshinvestmentinthesectorAnnouncementofthe13th Five Year Plan (2015ndash20) has provided further momentum to inno ation and re orm in the country with biomedicine being identifiedasakeypriorityInnovationformsthecorestrategyofthecurrentfive-yearplanalongsideahugefocusonimprovingthequalityofinnovativedrugs26AspartofthistheChinaFDA(CFDA)and the State Council have approved a three-year pilot called ldquoMarketingAuthorizationHolderrdquotowidentheeligibilitycriteriaforcompaniesapplyingfordrugmarketingauthorizationTheprogramallows domestic researchers and smaller operations to apply for drug approvals even without having in-house manufacturing capabilitiesTheaimofthepilotistohelpcompaniesbringdrugsto market at a lower cost by leveraging contract manufacturing arrangements27

Simultaneously China has pledged to create an ind trial cale o medical er ice on a national di ital plat orm28 The planisexpectedtocreateadigitalhealthtrailforcitizensTheplaninvolves establishing

bull National and provincial population health platforms

bull Interconnected application platforms for national medicine bidding and purchasing

bull 100 regional clinical medicine data demonstration centers

bull Digitalmedicalidentificationandsignatures

Sharing of health and medical data resources is likely to accelerate the use of big data applications in health and medical industry management clinical research and development and digital health andmedicalequipment29

In addition the country is enco ra in t e e o lo co t met od o ellin dr and medical prod ct to increase competitionandslashpricesTheCFDAhadbeenattemptingtointroducepilotprogramsforonlinedrugsalesHoweverduetoadeficienttrackingsystemandincreaseddrugcounterfeitingtheinitiative has been put to a halt and the sale of online prescription drugshasbeenbannedinChina30

InthepastfiveyearsChinahasinvestedapproximately US$359billion(RMB22trillion)toimpro e medical de ice re lation andharmonizethemwithinternationalpracticesRecentlytheCFDAannouncedthatitspriorityreviewandapprovalprocedureformedicaldeviceswillbeenforcedstarting1January2017MoreovertheCFDAhasalsoreleasedanexpandedlistofdevicesthatstandexemptedfromclinicaltrials31 In addition the country has decided to remove tariffs on 201 technology products includingsomemedicaldevices32 These moves are expected to strengthen the approval systems for drugs and devices and help in meetingclinicaldemandformedicaldevices33

Market insights

7March 2017 |

IndiaContinued efforts to elevate Indiarsquo s reputation and to make strides in digital pharma

InlinewiththePharmaVision2020documentoftheDepartmentofPharmaceuticals(DOP)Indiahasembarkedonitsjourneytobecome a leadin co ntr or end to end dr man act rin and inno ationTheGovernmentaimstoaugmentinfrastructurethrough a ldquoMake in Indiardquo initiative improve the quality of the workforceandincreasefundsforinnovationSpecificallytheGovernmentaimstopositionIndiaasoneofthetopfivepharmaceutical innovation hubs by 2020 and establish the nation asoneofthemostpreferreddestinationsforclinicaltrials34 Toward thisefforttheDrugControllerGeneralofIndiahasremovedthemaximum limit of three clinical trials and eliminated the restriction on the number of beds to enable smoother entry of pharma companiesintoresearchanddiscoveryTheGovernmentisfurthercontemplatinginvestments(ofupto50)inpublic-privatepartnership(PPP)modelsforundertakingRampDprojectsinadditiontotheexistingweightedtaxdeductionrateof150onRampDspendSimultaneouslytheMinistryofHealthampFamilyWelfare(MoHFW)has established eligibility criteria for all personnel employed in any pharma manufacturing to bring the sector up to par with internationalstandards35

Bol terin dr a et mean o p armaco i ilance is another focusareafortheindustryWiththePharmacovigilanceProgramofIndiaalreadyreceiving023millioninstancesofadversedrugreactionstheHealthMinistryiscontinuingtoaddnewadversedrugreaction monitoring centers and is also integrating information receivedfromthepharmacompaniesTheministryhasmandatedthatmarketauthorizationholders(MHAs)establishpharmacovigilancecellsintheircompanies36 These cells can either becaptiveoroutsourcedbutmustenabletheMHAstocollectprocess and forward adverse drug reports to the licensing authorities37

The i ital ndia initiati e is also making a big push in the industry mdashrangingfrome-detailingtoolstosmartphoneappsforunderstandingpatientbehaviorSomeoftherecentannouncementsin this direction include

bull SunPharmarsquosRespiTrackappforeducatingasthmapatientsandenhancing their adherence to therapies

bull GlaxoSmithKlineIndiarsquosuseofwebinarsvideochatsinformationportals and platforms such as Viva for doctors

bull AbbottHealthcareIndiarsquoseducationalappKnowledgeGenieforpatients with heart or liver diseases

InadditiontotheseindustryeffortstheGovernmentisattemptingto digitize medical health records on an Aadhar-linked electronic healthrecordsystemb To aid this development it is planning to

introduceabillforcreationofanationale-healthauthority38 AdditionallytheGovernmentisworkingonguidelinesforregulatinge-pharmaciestoreducetheirmisuse

In the area of medical de ice theMoHFWhasreleasedadraftofMedicalDevicesRulesforfurtherdiscussionwithanaimtoaligntheindustrywithglobalpracticesonaprioritybasis39 Certain measuresofthedraftsuchasafive-yearcapontheshelflifeofmedicaldevicescompliancewithuniqueidentificationnormsandallowance for contract manufacturing are expected to be implementedbyearly2017Additionallytocontrolthepriceofstents the government has added coronary stents to the national listofessentialmedicinesfor201540

OnthebiotechfronttheCentralDrugsStandardControlOrganizationandtheDepartmentofBiotechnologyannouncedare i ed io imilar polic providing a detailed regulatory pathway formanufacturingprocessesthataimstodeliversafetyefficacyandqualityThedocumentalsoaddressesissuesconcerningpre-andpost-marketregulatoryrequirementsforsimilarbiologicsThe policy is expected to accelerate the Indian biosimilars market sizetoUS$40billionby203041

bAadharisauniqueidentificationnumberissuedbytheGovernmentofIndiatoall residents of the country to eliminate duplicate and fake identities and to make verificationandauthenticationeasyandeffective

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 7: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Market insights

5March 2017 |

AustraliaReforms toward an environment conducive to sector innovation

Australia currently ranked the second-most attractive pharmaceuticalmarketinAsia-Pacificisundertakingmea re to

rt er oo t t e ector competiti ene through enhanced innovationandbetterproductivityA10-yearsectorrevitalizationplan introduced by the Medical Technologies and Pharmaceuticals IndustryGrowthCentre(MTP)isoneofthecriticalstepsinthisdirection17 As part of this program MTPConnect an organization formedunderthefederalgovernmentrsquosIndustryGrowthCentresinitiativeshasidentifiedsevengrowthprioritieswithfocusonspecificaspectsofthesectorvaluechainIthasalreadymadeanannouncementtoinjectUS$56million(AU$74million)a in 14sector-specificprojectsandisfurtherawaitingUS$24million(AU$32million)fromvariousindustrypartners18

Additionally the industry is working to rid e t e ap et een re earc and cce l commerciali ationAconsortiumofpharmaceutical companies that includes AbbVie Boehringer Ingelheim Celgene and Novartis has teamed up with Medicines AustraliatolaunchaUS$076million(AU$1million)educationalprogramTheBridgeInitiativescheduledtostartin1Q17Theprogram is expected to run for two years with a target of training 100people19 Further to encourage real-world application of innovation the Victorian state government plans to expend US$3million(AU$4million)tobuildaworld-classinnovationcenter the Medicines Manufacturing Innovation Centre led by MonashUniversity20ThenationhasalreadyestablishedaUS$380million(AU$500million)BiomedicalTranslationFundtoaidthedevelopmentandcommercializationofbiomedicaldiscoveries21

To further promote innovation the country is simultaneously e peditin t e dr appro al proce TheAustraliandrugregulatortheTherapeuticGoodsAdministrationiscurrentlyintheprocessofrollingoutreformsoverthenext18to24monthsOneofthemajorchangesincludespotentialintroductionoftwoexpedited pathways for the registration of novel medicines focusing on drugs that are already approved in countries with comparable regulatoryprocesses22

e ali ation o medical canna i is offering new opportunities toAustralianlifesciencescompaniesTheTherapeuticGoodsAdministration has now allowed cultivation of cannabis for medical purposesbutunderstrictgovernmentlicensingandguidelines23

Australia continues to c rtail ri in ealt care co t through tighterregulationsandpricecutsInits2017pricedisclosurecyclethegovernmentrsquosPharmaceuticalBenefitsSchemedisclosedtheaddition of several drugs particularly biologics and a deepening of pricecutsThegovernmenthasalsoannouncedreformstolowerthe costs of medical devices and prostheses including a reduction in listcostofcardiacdevicesandintraocularlensesby10andinhipandkneereplacementsby7524

Pharma companies in Australia have begun disclosing physician payments under the new code laid by the regulator thus inching towardamoretransparentpharma-physician-patientrelationship25

aConvertedusingspotrateasof31July2016(AU$1equalsUS$07595)accessed3January2017

Market insights

6 | EY Life Sciences Report Asia

ChinaE asing the regulatory environment building digital resource sharing capabilities

TheChineseGovernmentisactivelyinvolvedinboostinginnovationandinjectingfreshinvestmentinthesectorAnnouncementofthe13th Five Year Plan (2015ndash20) has provided further momentum to inno ation and re orm in the country with biomedicine being identifiedasakeypriorityInnovationformsthecorestrategyofthecurrentfive-yearplanalongsideahugefocusonimprovingthequalityofinnovativedrugs26AspartofthistheChinaFDA(CFDA)and the State Council have approved a three-year pilot called ldquoMarketingAuthorizationHolderrdquotowidentheeligibilitycriteriaforcompaniesapplyingfordrugmarketingauthorizationTheprogramallows domestic researchers and smaller operations to apply for drug approvals even without having in-house manufacturing capabilitiesTheaimofthepilotistohelpcompaniesbringdrugsto market at a lower cost by leveraging contract manufacturing arrangements27

Simultaneously China has pledged to create an ind trial cale o medical er ice on a national di ital plat orm28 The planisexpectedtocreateadigitalhealthtrailforcitizensTheplaninvolves establishing

bull National and provincial population health platforms

bull Interconnected application platforms for national medicine bidding and purchasing

bull 100 regional clinical medicine data demonstration centers

bull Digitalmedicalidentificationandsignatures

Sharing of health and medical data resources is likely to accelerate the use of big data applications in health and medical industry management clinical research and development and digital health andmedicalequipment29

In addition the country is enco ra in t e e o lo co t met od o ellin dr and medical prod ct to increase competitionandslashpricesTheCFDAhadbeenattemptingtointroducepilotprogramsforonlinedrugsalesHoweverduetoadeficienttrackingsystemandincreaseddrugcounterfeitingtheinitiative has been put to a halt and the sale of online prescription drugshasbeenbannedinChina30

InthepastfiveyearsChinahasinvestedapproximately US$359billion(RMB22trillion)toimpro e medical de ice re lation andharmonizethemwithinternationalpracticesRecentlytheCFDAannouncedthatitspriorityreviewandapprovalprocedureformedicaldeviceswillbeenforcedstarting1January2017MoreovertheCFDAhasalsoreleasedanexpandedlistofdevicesthatstandexemptedfromclinicaltrials31 In addition the country has decided to remove tariffs on 201 technology products includingsomemedicaldevices32 These moves are expected to strengthen the approval systems for drugs and devices and help in meetingclinicaldemandformedicaldevices33

Market insights

7March 2017 |

IndiaContinued efforts to elevate Indiarsquo s reputation and to make strides in digital pharma

InlinewiththePharmaVision2020documentoftheDepartmentofPharmaceuticals(DOP)Indiahasembarkedonitsjourneytobecome a leadin co ntr or end to end dr man act rin and inno ationTheGovernmentaimstoaugmentinfrastructurethrough a ldquoMake in Indiardquo initiative improve the quality of the workforceandincreasefundsforinnovationSpecificallytheGovernmentaimstopositionIndiaasoneofthetopfivepharmaceutical innovation hubs by 2020 and establish the nation asoneofthemostpreferreddestinationsforclinicaltrials34 Toward thisefforttheDrugControllerGeneralofIndiahasremovedthemaximum limit of three clinical trials and eliminated the restriction on the number of beds to enable smoother entry of pharma companiesintoresearchanddiscoveryTheGovernmentisfurthercontemplatinginvestments(ofupto50)inpublic-privatepartnership(PPP)modelsforundertakingRampDprojectsinadditiontotheexistingweightedtaxdeductionrateof150onRampDspendSimultaneouslytheMinistryofHealthampFamilyWelfare(MoHFW)has established eligibility criteria for all personnel employed in any pharma manufacturing to bring the sector up to par with internationalstandards35

Bol terin dr a et mean o p armaco i ilance is another focusareafortheindustryWiththePharmacovigilanceProgramofIndiaalreadyreceiving023millioninstancesofadversedrugreactionstheHealthMinistryiscontinuingtoaddnewadversedrugreaction monitoring centers and is also integrating information receivedfromthepharmacompaniesTheministryhasmandatedthatmarketauthorizationholders(MHAs)establishpharmacovigilancecellsintheircompanies36 These cells can either becaptiveoroutsourcedbutmustenabletheMHAstocollectprocess and forward adverse drug reports to the licensing authorities37

The i ital ndia initiati e is also making a big push in the industry mdashrangingfrome-detailingtoolstosmartphoneappsforunderstandingpatientbehaviorSomeoftherecentannouncementsin this direction include

bull SunPharmarsquosRespiTrackappforeducatingasthmapatientsandenhancing their adherence to therapies

bull GlaxoSmithKlineIndiarsquosuseofwebinarsvideochatsinformationportals and platforms such as Viva for doctors

bull AbbottHealthcareIndiarsquoseducationalappKnowledgeGenieforpatients with heart or liver diseases

InadditiontotheseindustryeffortstheGovernmentisattemptingto digitize medical health records on an Aadhar-linked electronic healthrecordsystemb To aid this development it is planning to

introduceabillforcreationofanationale-healthauthority38 AdditionallytheGovernmentisworkingonguidelinesforregulatinge-pharmaciestoreducetheirmisuse

In the area of medical de ice theMoHFWhasreleasedadraftofMedicalDevicesRulesforfurtherdiscussionwithanaimtoaligntheindustrywithglobalpracticesonaprioritybasis39 Certain measuresofthedraftsuchasafive-yearcapontheshelflifeofmedicaldevicescompliancewithuniqueidentificationnormsandallowance for contract manufacturing are expected to be implementedbyearly2017Additionallytocontrolthepriceofstents the government has added coronary stents to the national listofessentialmedicinesfor201540

OnthebiotechfronttheCentralDrugsStandardControlOrganizationandtheDepartmentofBiotechnologyannouncedare i ed io imilar polic providing a detailed regulatory pathway formanufacturingprocessesthataimstodeliversafetyefficacyandqualityThedocumentalsoaddressesissuesconcerningpre-andpost-marketregulatoryrequirementsforsimilarbiologicsThe policy is expected to accelerate the Indian biosimilars market sizetoUS$40billionby203041

bAadharisauniqueidentificationnumberissuedbytheGovernmentofIndiatoall residents of the country to eliminate duplicate and fake identities and to make verificationandauthenticationeasyandeffective

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 8: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Market insights

6 | EY Life Sciences Report Asia

ChinaE asing the regulatory environment building digital resource sharing capabilities

TheChineseGovernmentisactivelyinvolvedinboostinginnovationandinjectingfreshinvestmentinthesectorAnnouncementofthe13th Five Year Plan (2015ndash20) has provided further momentum to inno ation and re orm in the country with biomedicine being identifiedasakeypriorityInnovationformsthecorestrategyofthecurrentfive-yearplanalongsideahugefocusonimprovingthequalityofinnovativedrugs26AspartofthistheChinaFDA(CFDA)and the State Council have approved a three-year pilot called ldquoMarketingAuthorizationHolderrdquotowidentheeligibilitycriteriaforcompaniesapplyingfordrugmarketingauthorizationTheprogramallows domestic researchers and smaller operations to apply for drug approvals even without having in-house manufacturing capabilitiesTheaimofthepilotistohelpcompaniesbringdrugsto market at a lower cost by leveraging contract manufacturing arrangements27

Simultaneously China has pledged to create an ind trial cale o medical er ice on a national di ital plat orm28 The planisexpectedtocreateadigitalhealthtrailforcitizensTheplaninvolves establishing

bull National and provincial population health platforms

bull Interconnected application platforms for national medicine bidding and purchasing

bull 100 regional clinical medicine data demonstration centers

bull Digitalmedicalidentificationandsignatures

Sharing of health and medical data resources is likely to accelerate the use of big data applications in health and medical industry management clinical research and development and digital health andmedicalequipment29

In addition the country is enco ra in t e e o lo co t met od o ellin dr and medical prod ct to increase competitionandslashpricesTheCFDAhadbeenattemptingtointroducepilotprogramsforonlinedrugsalesHoweverduetoadeficienttrackingsystemandincreaseddrugcounterfeitingtheinitiative has been put to a halt and the sale of online prescription drugshasbeenbannedinChina30

InthepastfiveyearsChinahasinvestedapproximately US$359billion(RMB22trillion)toimpro e medical de ice re lation andharmonizethemwithinternationalpracticesRecentlytheCFDAannouncedthatitspriorityreviewandapprovalprocedureformedicaldeviceswillbeenforcedstarting1January2017MoreovertheCFDAhasalsoreleasedanexpandedlistofdevicesthatstandexemptedfromclinicaltrials31 In addition the country has decided to remove tariffs on 201 technology products includingsomemedicaldevices32 These moves are expected to strengthen the approval systems for drugs and devices and help in meetingclinicaldemandformedicaldevices33

Market insights

7March 2017 |

IndiaContinued efforts to elevate Indiarsquo s reputation and to make strides in digital pharma

InlinewiththePharmaVision2020documentoftheDepartmentofPharmaceuticals(DOP)Indiahasembarkedonitsjourneytobecome a leadin co ntr or end to end dr man act rin and inno ationTheGovernmentaimstoaugmentinfrastructurethrough a ldquoMake in Indiardquo initiative improve the quality of the workforceandincreasefundsforinnovationSpecificallytheGovernmentaimstopositionIndiaasoneofthetopfivepharmaceutical innovation hubs by 2020 and establish the nation asoneofthemostpreferreddestinationsforclinicaltrials34 Toward thisefforttheDrugControllerGeneralofIndiahasremovedthemaximum limit of three clinical trials and eliminated the restriction on the number of beds to enable smoother entry of pharma companiesintoresearchanddiscoveryTheGovernmentisfurthercontemplatinginvestments(ofupto50)inpublic-privatepartnership(PPP)modelsforundertakingRampDprojectsinadditiontotheexistingweightedtaxdeductionrateof150onRampDspendSimultaneouslytheMinistryofHealthampFamilyWelfare(MoHFW)has established eligibility criteria for all personnel employed in any pharma manufacturing to bring the sector up to par with internationalstandards35

Bol terin dr a et mean o p armaco i ilance is another focusareafortheindustryWiththePharmacovigilanceProgramofIndiaalreadyreceiving023millioninstancesofadversedrugreactionstheHealthMinistryiscontinuingtoaddnewadversedrugreaction monitoring centers and is also integrating information receivedfromthepharmacompaniesTheministryhasmandatedthatmarketauthorizationholders(MHAs)establishpharmacovigilancecellsintheircompanies36 These cells can either becaptiveoroutsourcedbutmustenabletheMHAstocollectprocess and forward adverse drug reports to the licensing authorities37

The i ital ndia initiati e is also making a big push in the industry mdashrangingfrome-detailingtoolstosmartphoneappsforunderstandingpatientbehaviorSomeoftherecentannouncementsin this direction include

bull SunPharmarsquosRespiTrackappforeducatingasthmapatientsandenhancing their adherence to therapies

bull GlaxoSmithKlineIndiarsquosuseofwebinarsvideochatsinformationportals and platforms such as Viva for doctors

bull AbbottHealthcareIndiarsquoseducationalappKnowledgeGenieforpatients with heart or liver diseases

InadditiontotheseindustryeffortstheGovernmentisattemptingto digitize medical health records on an Aadhar-linked electronic healthrecordsystemb To aid this development it is planning to

introduceabillforcreationofanationale-healthauthority38 AdditionallytheGovernmentisworkingonguidelinesforregulatinge-pharmaciestoreducetheirmisuse

In the area of medical de ice theMoHFWhasreleasedadraftofMedicalDevicesRulesforfurtherdiscussionwithanaimtoaligntheindustrywithglobalpracticesonaprioritybasis39 Certain measuresofthedraftsuchasafive-yearcapontheshelflifeofmedicaldevicescompliancewithuniqueidentificationnormsandallowance for contract manufacturing are expected to be implementedbyearly2017Additionallytocontrolthepriceofstents the government has added coronary stents to the national listofessentialmedicinesfor201540

OnthebiotechfronttheCentralDrugsStandardControlOrganizationandtheDepartmentofBiotechnologyannouncedare i ed io imilar polic providing a detailed regulatory pathway formanufacturingprocessesthataimstodeliversafetyefficacyandqualityThedocumentalsoaddressesissuesconcerningpre-andpost-marketregulatoryrequirementsforsimilarbiologicsThe policy is expected to accelerate the Indian biosimilars market sizetoUS$40billionby203041

bAadharisauniqueidentificationnumberissuedbytheGovernmentofIndiatoall residents of the country to eliminate duplicate and fake identities and to make verificationandauthenticationeasyandeffective

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 9: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Market insights

7March 2017 |

IndiaContinued efforts to elevate Indiarsquo s reputation and to make strides in digital pharma

InlinewiththePharmaVision2020documentoftheDepartmentofPharmaceuticals(DOP)Indiahasembarkedonitsjourneytobecome a leadin co ntr or end to end dr man act rin and inno ationTheGovernmentaimstoaugmentinfrastructurethrough a ldquoMake in Indiardquo initiative improve the quality of the workforceandincreasefundsforinnovationSpecificallytheGovernmentaimstopositionIndiaasoneofthetopfivepharmaceutical innovation hubs by 2020 and establish the nation asoneofthemostpreferreddestinationsforclinicaltrials34 Toward thisefforttheDrugControllerGeneralofIndiahasremovedthemaximum limit of three clinical trials and eliminated the restriction on the number of beds to enable smoother entry of pharma companiesintoresearchanddiscoveryTheGovernmentisfurthercontemplatinginvestments(ofupto50)inpublic-privatepartnership(PPP)modelsforundertakingRampDprojectsinadditiontotheexistingweightedtaxdeductionrateof150onRampDspendSimultaneouslytheMinistryofHealthampFamilyWelfare(MoHFW)has established eligibility criteria for all personnel employed in any pharma manufacturing to bring the sector up to par with internationalstandards35

Bol terin dr a et mean o p armaco i ilance is another focusareafortheindustryWiththePharmacovigilanceProgramofIndiaalreadyreceiving023millioninstancesofadversedrugreactionstheHealthMinistryiscontinuingtoaddnewadversedrugreaction monitoring centers and is also integrating information receivedfromthepharmacompaniesTheministryhasmandatedthatmarketauthorizationholders(MHAs)establishpharmacovigilancecellsintheircompanies36 These cells can either becaptiveoroutsourcedbutmustenabletheMHAstocollectprocess and forward adverse drug reports to the licensing authorities37

The i ital ndia initiati e is also making a big push in the industry mdashrangingfrome-detailingtoolstosmartphoneappsforunderstandingpatientbehaviorSomeoftherecentannouncementsin this direction include

bull SunPharmarsquosRespiTrackappforeducatingasthmapatientsandenhancing their adherence to therapies

bull GlaxoSmithKlineIndiarsquosuseofwebinarsvideochatsinformationportals and platforms such as Viva for doctors

bull AbbottHealthcareIndiarsquoseducationalappKnowledgeGenieforpatients with heart or liver diseases

InadditiontotheseindustryeffortstheGovernmentisattemptingto digitize medical health records on an Aadhar-linked electronic healthrecordsystemb To aid this development it is planning to

introduceabillforcreationofanationale-healthauthority38 AdditionallytheGovernmentisworkingonguidelinesforregulatinge-pharmaciestoreducetheirmisuse

In the area of medical de ice theMoHFWhasreleasedadraftofMedicalDevicesRulesforfurtherdiscussionwithanaimtoaligntheindustrywithglobalpracticesonaprioritybasis39 Certain measuresofthedraftsuchasafive-yearcapontheshelflifeofmedicaldevicescompliancewithuniqueidentificationnormsandallowance for contract manufacturing are expected to be implementedbyearly2017Additionallytocontrolthepriceofstents the government has added coronary stents to the national listofessentialmedicinesfor201540

OnthebiotechfronttheCentralDrugsStandardControlOrganizationandtheDepartmentofBiotechnologyannouncedare i ed io imilar polic providing a detailed regulatory pathway formanufacturingprocessesthataimstodeliversafetyefficacyandqualityThedocumentalsoaddressesissuesconcerningpre-andpost-marketregulatoryrequirementsforsimilarbiologicsThe policy is expected to accelerate the Indian biosimilars market sizetoUS$40billionby203041

bAadharisauniqueidentificationnumberissuedbytheGovernmentofIndiatoall residents of the country to eliminate duplicate and fake identities and to make verificationandauthenticationeasyandeffective

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 10: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Market insights

8 | EY Life Sciences Report Asia

J apanRevamping drug pricing system to reduce the cost burden on government

JapaniscurrentlyexperiencinglowGDPgrowthalongwithahugeburdenfromanagingpopulationWiththesituationunlikelytoimprovesoontheGovernmentofJapanisadoptingseverecostcontainmentmeasuresTheMinistryofFinanceisproposing a complete o er a l o t e pre cription dr pricin tem through the following changes42

bull Annual revision of drug prices to replace the current system of biennial price changes

bull Lowergovernment-sanctionedpricesforgenericdrugstoboosttheir penetration

bull Disclosureofmanufacturingcostsbydrugmakersatthetimeoffiling43

RegulatorshavealreadytakenastepinthisdirectionbyslashingthepriceofOnoPharmaceuticalCorsquoscancerdrugOpdivoby50muchmorethanitsscheduledpricerevisionHoweverthese

proposed changes are facing strong resistance from doctors and drugmakers who fear a loss of revenue and increased complexity inpricing44 Adding to these pressures the Pharmaceuticals and MedicalDevicesAgencyiscontemplatinganincreaseinreviewfeesfordrugsandmedicaldevices45

Concurrently the health ministry is targeting March 2017 to issue a ldquoblue bookrdquo to help p alit eneric in t e mar etThe blue book will include information on generic drugs by active pharmaceutical ingredients and can be used by hospitals and pharmaciestodecidewhichgenericstostockanddispense46

In addition to ta ili e t e ppl o accine inJapananewearthquake-resistant warehouse is being set up in southwestern JapanTheMinistryofHealthLabourandWelfarehasprovidedfundingofUS$1826million(yen2157million)cfortheprojectwhichwill help in stocking the vaccinations included in the Preventive VaccinationLaw47

c Convertedusingspotrateasof3January2017(1yenequalsUS$00085)accessed3January2017

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 11: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Market insights

9March 2017 |

S outh K oreaPromoting indigenous and novel product development and manufacturing

The pharmaceutical industry in South Korea is transforming from generic drug manufacturing to new drug development mainly centeredonbiosimilarsandstemcelltreatmentsTheGovernmenthas rolled out several measures to de elop t e nation a a lo al iotec and medical ind tr by2020Thecomprehensive

plan encompasses the following

bull HighertaxbenefitsandincentivesforclinicaltrialsofindigenousdrugsandinvestmentinRampDfacilities

bull Support for local pharma

bull ExpansionoftheGovernmentrsquosRampDbudgetformedicaldevices

bull Enhancement of exports by improving distribution channels

bull Streamlining policies for commercialization of stem cell and precisionmedicinesprojects48

TheGovernmentisalsosettingupabioclusterthatwillserveasa center for pharma companies and universities to collaborate onRampDTomaketheinvestmentlucrativetheKoreanResearch-based Pharmaceutical Industry Association has offered a 15-year corporatetaxexemptionora5to15relaxationforpharmaMNCs49 In addition the government is planning to set up high-tech medical industrial clusters by 2018 and foster a culture of innovation

On the medical de ice front the state has been making strides in3DprintingSouthKoreaiscontemplatingtheintroductionoffast-trackapprovaloptionsfor3Dprintingofmedicaldevicesalongwithtaxexemptions50 Proposed changes include a maximum taxexemptionof30ofRampDforsmallandmedium3Dprintingcompaniesand20forlargecompanies51

However man re o rce a aila ilit remain a c allen e for the growthoftheindustryIndustryplayersincollaborationwithlocaleducationalinstitutesareworkingtoaddressthischallenge52 For exampleGEHealthcareKoreaisbuildingthefirstAPACFastTrakCentreinSongdowithaninvestmentofUS$20millionby2020toprovidetrainingandmanufacturingsupport53

Concurrently the Korean government has drafted a ne anti ra t la to try to stop pharma companies from offering hefty rebates to doctors for prescribing the companiesrsquo medicines and as a way to presscompaniestorevisetheirinternalcodesofconductViolatorsfaceapenaltyofuptoUS$24800(KRW30million)d or a maximum threeyearsrsquoimprisonment54

TaiwanG aining technological experience to improve its competitiveness in Asia

To tran orm ai an into a iotec nolo and medical in AsiatheGovernmenthasapprovedabudgetofUS$34632million(NT$1094million)for2017Furtherafive-plus-twoinnovativeindustries initiative has been started to enhance human resources financesandintellectualpropertyinthesectorThisinitiativeincludes the following measures

bull Establish a north-south biomedical corridor to enrich the research capabilities of the three main science parks of Taiwan

bull Expand into the international health care market particularly in ASEAN countries by enhancing exports and expanding cooperation on health care education

bull Developprecisionmedicinespecializedclinicsandhealth-relatedperipheral industries

bull Launch80nichemedicaldevices20newdrugsandatleast10biotechandhealth-relatedflagshipbrandsby2025

bull Advance technological capabilities through arrangements with majorbiomedicalRampDhubsintheUSandEurope55

d Convertedusingspotrateasof2January2017(KRW1equalsUS$000083)accessed2January2017

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 12: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

10 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

In this edition we highlight significant tax developments and trends that are directly impacting or are likely to impact the sector in the following markets

Australia

China (mainland)

J apan

S outh K orea

Indonesia

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 13: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

11March 2017 |

AustraliaThepharmaceuticalindustryhasseenasignificantincreaseingovernmentandAustralianTaxationOffice(ATO)scrutinyinthepasttwoyearsInmid-2015representativesofsomeofthelargestpharmaceutical MNEs operating in Australia were summoned to give evidencebeforetheSenateInquiryintoCorporateTaxAvoidanceSince that time the ATO has increased the intensity of tax audits and has challenged a number of positions held by pharmaceutical MNEs

We recently met with members of the ATOrsquos pharmaceutical working group to discuss their views on and approach regarding thesector

ATO comments on pharmaceutical sector

The ATO is heavily involved in the pharmaceutical sector and consultsbroadlywithindustryplayersgovernmentNGOsandprofessionalservicesfirmstoincreaseitsunderstandingTheATOcurrently has 19 ldquoactive taxpayer casesrdquo in the pharmaceutical industry (which includes audits risk reviews and the advance pricing agreementprocesses)

The ATOrsquos review activity of the pharmaceutical industry is primarily focused on transfer pricing and it has the following concerns

bull A number of MNEs in the industry may be incorrectly classifying theirAustralianoperationsaslimitedriskdistributors(LRDs)andthus have adopted inappropriate comparables for benchmarking purposesTheATOconsidersthatldquovalue-addsrdquosuchasregulatory approval skills and the Australia direct distribution systemmeanthattheAustralianoperationsaremoresignificantTheATOisseekingtochallengetaxpayersrsquoldquoLRDclassificationsrdquoon the basis that these operations are more appropriately classifiedasfullriskdistributorsandareentitledtogreaterreturns

bull Duetothedifficultyoffindingqualitybenchmarkcomparablesanumber of MNEs are using the Transactional Net Margin Method (TNMM) as a default methodology to establish appropriate transfer prices without considering whether it is the most appropriatemethodologyMostAustralianpharmaceuticalsusingtheTNMMreportmarginsofbetween2and10

bull The transfer of intellectual property from Australia to a foreign entity within the MNE group is a concern from a transfer pricing perspectiveTheATOmayseektoexaminetheissuefromananti-avoidanceorbaseerosionandprofitshifting(BEPS)perspective

The ATO economist practice is reviewing the above matters in detail to determine whether risk and value are appropriately allocated toAustralianoperationsTheATOintendstoreleaseguidanceonthe pharmaceutical industry in 1Q 2017 as either a Taxation Alert (which sets out types of transactions the ATO wishes to investigate furtherorchallenge)orasPracticalComplianceGuidelines(whichset out a practical administration approach to assist taxpayers in complyingwithrelevanttaxlaws)

Our observations

The ATOrsquos time frame to release guidance by 1Q 2017 (before completion of the active taxpayer cases) appears to be driven by the governmentrsquos desire to be seen as taking more aggressive action on multinationaltaxavoidanceInthisregardinourdiscussionswiththe ATO on the time frame for guidance the Senate inquiry was referencedanumberoftimes

TheATOrsquosviewsregardingincorrectclassificationasLRDsandtheinappropriate use of the TNMM are likely part of an overall attempt toincreasetheprofitabilitylevelofthesectorhavingregardtothepharmaceuticalMNErsquosoverallsystemprofitsInthisregardtaxpayers should be prepared to see the ATO developing guidance and arguments to support margins at the high end of the current industryrangeifnotslightlyhigherEquallyweexpecttoseetheATO continuing to develop its thinking on value-added activities and whethersuchactivitiesshouldattractadifferentialreturn

ic ael nder onOceaniaLifeSciencesTaxLeaderEYPartner Ernst amp Young (Australia) michaelandersonaueycom

Craig Jackson Partner Tax Controversy Ernst amp Young (Australia) craigwjacksonaueycom

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 14: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

12 | EY Life Sciences Report Asia

Taxupdatessignificantdevelopments

ChinaN ew req uirements for invoicing of medicine and potential V AT impacts

TheChineseGovernmentcontinuesitseffortstocontrolpricesforpharmaceutical products and reduce the complexity of the previous systemAccordinglytheChinaMinistryofHealthandotherrelevantgovernmental organizations have issued a new requirement related to the issuing of invoices for medicine sold to state-owned medical institutionsnamedtheldquoDualInvoiceSystemrdquoTherequirementwas released with immediate effect at the end of 2016 and will be implementedacrossallofmainlandChinaby2018

Underthissystemonlyoneinvoiceshouldbeissuedbythemanufacturer to the distributor and only one invoice from the distributortothemedicalinstitutionWhiletherewouldbeanexemption from the rule for intragroup invoicing the multiple-layer distribution channels that were common in the past need tobeconsolidatedgoingforwardThisrequirespharmaceuticalcompanies to strengthen control with respect to VAT management sothatinvoicesareissuedonlytoqualifieddistributorsTheGovernmenthasannouncedstrictsupervisionofcompliancewiththeDualInvoiceSystemandnon-compliancecanleadtoexclusionoffuturebiddingprocesses

B ig data management

For several years the Chinese tax administration has undertaken effortstoincreaseitslevelofefficiencyindealingwith(large)corporate taxpayers in terms of information gathering processing andanalysisIncreasinglythetaxadministrationisrelyingontechnology-basedtoolstoachieveitsgoalsForexampletherecentlylaunchedGoldenTaxSystemisaninformationsystemconnecting the various tax information streams online including information from the annual income tax return VAT return transfer pricingdocumentationandbeyondImportanttaxpayerinformationwill be available in one system and eventually will be accessible acrossthecountrybytaxauthorities

Our observation is that tax digitalization will become more prevalentparticularlywiththeimplementationoftheOECDrsquosBEPSActionsinChinaTherewillbegreateraccesstoinformationasaresultofmoredisclosureunderBEPSTheChinesetaxadministration is evaluating how to capture all the information in oneplaceandusetheinformationtoidentifyhigh-risktaxpayers

In 2016 the State Administration of Taxation introduced the Thousand Enterprise initiative targeted at large groups in China requiringthemtoprovideasignificantamountoftaxfinancialandnon-financialinformationTherequirementwasfortaxpayersto submit the information in an electronic format or for the tax administration to extract the information directly from the entitiesrsquo ERPsystemsTheinformationrequiredwasmassiveandcreatedsignificantchallengesforcompaniesintermsofdatacollectionscreeningandconcernsregardingdatasecurity

The selected companies of the Thousand Enterprise initiative were from wide-ranging industries with a small number from thepharmaceuticalindustryAninitiativesimilartoThousandEnterprisewassubsequentlylaunchedinJiangsuprovincetargetingthepharmaceuticalindustryManycompaniesfromwithintheindustry received similar requests to those from the Thousand EnterpriseinitiativeTherequestshaveresultedinfurthertaxandtransferpricinginquiriesforanumberoftaxpayers

Very recently the SAT issued an internal Circular outlining their 2017actionplanwithrespecttotheThousandEnterpriseinitiativeFor 2017 the SAT is planning on performing detailed tax risk analysis on 268 of the 1000 large enterprises for which data was previouslyrequestedfortaxyears2011-2015Underthisplanthe5thbranchofBeijingSTB(SATrsquoscenterfortaxriskanalysis)willbe utilizing tax data analytic tool(s) they have developed to analyse three years of data (tax years 2013-2015) previously received fromthe268selectedcompaniesSuchdatawillbeanalysedforpurposesofidentifyingpotentialissuesandareasofconcernFormostindustriesitisexpectedthatthe5thbranchoftheBeijingSTBwillprepareananalyticsorinitialfindingsreportbasedupontheresults of their data analytics review which they will then submit to provincialleveltaxauthoritiesforfurtherdetailedriskanalysisWeunderstand however that for the pharmaceutical industry given the increased level of focus on the sector that the 5th branch of theBeijingSTBwillitselfbecentrallyperformingthedetailedlevelreviewWeexpectthattheinitialtaxdataanalyticsexercisegivingrisetotheanalyticsorinitialfindingsreportwillbecompletedinthenexttwotothreemonths

In addition the circular expands the scope of the Thousand Enterprise initiative with respect to 2017 and forward to include companieswithtaxpaymentamountsoverRMB100millionascomparedtothepreviousthresholdofRMB300millionMeaninginthefuturemorecompanieswillbesubjecttothistypeofdatagathering exercise and review process with the total number of companies for which data is to be requested exceeding the initial 1000

GiventhesedevelopmentswebelievetheSATwillcontinuetoapplya heightened level of audit scrutiny to the pharmaceutical industry goingforwardItisalsoclearthattheSATintendstoutilizetaxdata analytics as a key component of its audit strategy and that itwillbeexpandingthescopeandnumberofcompaniessubjecttothislevelofreviewWestronglyencouragethatallcompaniesincluding pharmaceuticals and life sciences more broadly quickly begindevelopingarobustChinadigitaltaxdataanalyticsandriskmanagementstrategyifnotalreadyinplace

it on dem Bon artPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) titusbongartcneycom

Joanne SuTransferPricingPartnerChinaLifeSciencesTaxCo-Leader Ernst amp Young (China) joannesucneycom

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

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Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

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21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 15: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

13March 2017 |

Taxupdatessignificantdevelopments

J apan2017 J apan tax reform

TheJapaneseGovernmenthasannounceditsproposalsforthe2017TaxReformwhichareexpectedtobeenactedby31March2017andingeneraltotakeeffectfrom1April2017TheproposalsincludechangestoRampDtaxcreditswithhighercreditsavailablewhereRampDspendingisonanupwardtrendTherewillalsobegreater scope for deductibility of directorsrsquo compensation in the formofstockexpandeddefinitionsoftax-freereorganizationsanda welcome exemption from inheritance tax applicable to foreigners livinginJapanforlessthan10years

The proposal that has attracted the most attention is the reform oftheJapanesecontrolledforeigncorporation(CFC)rulesThiswillaffectmanyJapan-headquarteredlifesciencescompanieswithoverseassubsidiariesThechangesexpandthedefinitionoftaxableldquopassiveincomerdquoandintroduceanewclassificationofldquopapercompaniesrdquoExamplesofstructuresthatmaybeimpactedincludeoffshore holding companies in locations such as the Netherlands theUKSingaporeandHongKongcashandtreasurymanagementoperationsandwhereintellectualpropertyhasbeentransferredorlicensedoffshoreThesenewtougherruleswilltakeeffectforaccountingperiodsbeginningonorafter1April2018Werecommend that companies review the potential impact of the new rulesandconsiderrestructuringoptions

Transfer pricing and U PE req uirements

Withthe2016TaxReformtheJapaneseNationalTaxAgency(NTA) included BEPS Action 13 requirements for country-by-countryreportingmasterfileandlocalfileLaterin2016theNTA further introduced the requirement for ultimate parent entity (UPE)notificationThemostpressingofthedeadlinesrelatestonotificationandthelocalfile

notification Content and languageTheUPEnotificationisastraightforwardformrequiringbasicinformationsuchasthenameandlocationofUPEandconstituententity(CE)ThelanguageoftheUPEisnotspecifiedthoughtheformisinJapanese

Who needs to fileCompaniesinJapanorpermanentestablishmentsofforeigncompanieswhichareaffiliatesofamultinationalgroupwithmorethanyen100billioninrevenueinthepreviousfiscalyearneedtofileIftherearemultipleentitiesinJapaninthesamegrouponemaybedesignatedastherepresentativetofileonbehalfoftheothers

F irst year and deadlineTheUPEnotificationmustbefiledviae-tax(thesamesystemusedforfilingcorporatetaxreturns)bythelastdayofthefiscalyearoftheUPEbeginningonorafter1April2016HencecompanieswhoseUPEhasaMarchyear-endneedtofiletheUPEnotificationby31March2017

Contemporaneo local fileContent and languageThecontentsofalocalfileareoutlinedinArticle22-10oftheSpecialProvisionsforTaxationofTransactionwithForeignRelatedPartiesTherequirementsarebroaderinsomeaspectsthanthosesetoutbytheOECDincludingtherequirementforalocalmarketanalysisandcounterpartysegmentedprofitandlossaccountsTherequiredlanguageofthelocalfileisnotspecifiedbutaJapanesetranslation could be requested for documentation prepared in languagesotherthanJapanese

Who needs to prepareJapanesecompaniesthathavetransactionswithaforeignrelatedparty(appliedperforeignentity)exceedingyen5billionintheprecedingfiscalyearorintangibletransactionsexceedingyen300million(alsoappliedperforeignentity)mustprepareacontemporaneouslocalfile

F irst year and deadlineTherequirementforthelocalfileisforyearscommencingonorafter1April2017ThelocalfilemustbecompletedbythetimeofthesubmissionofthetaxreturnThelocalfiledoesnotneedto be submitted itself but it must be ready in the event of request byataxexaminerThedeadlineforsubmissionwillbesetbytheexaminer at a maximum of 45 days for those companies that have tomeetthecontemporaneousrequirementForothercompaniesthe deadline set by the auditor may be up to a maximum of 60 daysThetaxauthoritieshavethelegalrighttousepresumptivetaxation or secret comparables if these deadlines are not adhered toInpracticethedeadlinemaybemuchshorterthanthemaximums outlined above for example if the examiner believes the documentationshouldalreadybeavailable

Tatsuhide K anenariPartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) tatsuhidekanenarieycom

onat an t art mit PartnerJapanLifeSciencesTaxCo-Leader ErnstampYoung(Japan) jonathanstuart-smithjpeycom

eit oma ExecutiveDirectorTransferPricing ErnstampYoung(Japan) keiththomasjpeycom

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 16: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

14 | EY Life Sciences Report Asia

S outh K oreaControversy trends

a a dit oc ed on ille al or improper ale re ateRecentlytheKoreantaxauthoritybeganperformingspecialtaxaudits investigating the legitimacy of certain companiesrsquo sales and marketing expenditures in particular sales rebates purported to be incurred for stimulating local sales and facilitating relationships with doctorsandhospitalsAsaresultoftheseauditsthetaxauthoritycollected a considerable tax revenue from disallowing deductions claimed with respect to improper or illegal ldquosales rebatesrdquo which is broadlydefinedtoincludeanumberofdifferenttypesofpayments(egexcessivespeakerfeespaidtodoctorsfinancialassistancefor doctors in relation to golf or other entertainment offered at seminarsorspecialcashbackarrangementsforcustomers)Somecompanieswerealsocriminallycharged

Arecentcourtcase(ReferencetotheSupremeCourt2011do1373020150129)concludedthattheprovisionofillegalsalesrebates shall be regarded as an expenditure for non-business purposesandthussuchexpendituresshallnotbedeductibleInaddition the Supreme Court recently stated that the tax authority is authorized to charge pharmaceutical companies with criminal responsibilityfortheprovisionofillegalrebates

L egislative activity

dditional ta relie and pport or in e tmentIn 2016 the government legislated special tax relief to promote the development of new drugs including biomedical products and innovativesmarthealthcaremedicaldevicesCurrentlydomesticcompanies engaging in the life sciences and health care industry canclaima20RampDtaxcredit(30forsmallandmedium-sizedenterprises(SMEs))uponfilingtheirtaxreturnsThisexceedsthenormalRampDtaxcreditrateof3forcompaniesinotherindustries(25forSMEs)

TheKoreanGovernmentisnowconsideringagrantofadditionaltaxrelieftofurthersupportRampDinvestmentstargetingnewdrugdevelopmentBasedonacurrentdraftproposalthetaxcreditrateforRampDinvestmentindevelopingnewdrugsandinnovativesmarthealthcaremedicaldeviceswouldbeincreasedfrom20to30

pecial ta credit or a ne in e tment to ac ire a ent re ine

Based on a new tax provision effective from 2016 a domestic pharmaceutical company can claim a special tax credit for new investments(ie10ofthenewinvestmentlessnetbookvaluex130xshareholdingratio)whenacquiringsharesoftheventurecompanythatisdevelopinganewdrugorinnovativesmarthealthcaremedicaldevice

Recent rulings and precedents

a ri nal r lin o im eo TheTaxTribunalruledinfavoroftheapplicant(iepharmaceuticalcompany)ontheissueofthedeductibilityofmeal-relatedexpensesThe applicantrsquos sales representatives visited health care institutions toprovidepresentationsonprescriptiondrugsFollowingthepresentation the participants were provided meals in restaurants located outside the health care institutions during which QampA on theprescriptiondrugswasheldTheapplicanttreatedtheentireamountmdashforpresentationandmealsmdashasadeductiblebusinessexpense which the tax authority later disallowed as nondeductible entertainment

The Tax Tribunal ruled in favor of the applicant as it viewed the meals provided to medical professionals in restaurants outside of health care institutions as not entertainment in nature but a necessary sales-related expense incurred in the ordinary course of business

ae C eol imPartnerSouthKoreaLifeSciencesTaxLeader Ernst amp Young (South Korea) jae-cheolkimkreycom

Taxupdatessignificantdevelopments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 17: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

15March 2017 |

IndonesiaN ew transfer pricing documentation req uirements

eneral o er ieThe Indonesian Ministry of Finance has issued Minister of Finance Regulationnumber213PMK032016(PMK-213)titledldquoThetypeofadditionaldocumentsandorinformationmandatorytobekeptby taxpayers who conduct transactions with related parties and its proceduresrdquoPMK-213implementsinIndonesiatheguidanceontransferpricingdocumentationcontainedinOECDBEPSActionPlan13PMK-213hasimmediateeffectfromitsstipulationdateof30December2016

Taxpayers are recommended to consider immediate action steps for complianceRecommendedimmediateactionincludescommencingthepreparationofthemasterfileandlocalfileforthe2016fiscalyear given the tight deadlines for preparation and considering the potentialneedtoprepareacountry-by-countryreport(CbCR)

ran er pricin doc mentation nder ma ter file and local fileIndonesiantaxpayersarenowrequiredtoprepareamasterfileandalocalfiletotheextenttheyconductrelated-partytransactionsthatexceedoneormorerelativelylowthresholdsTheestablishedtransactionalandrevenuethresholdsarebasedonthepriorfiscalyearrsquostransactionalandrevenueinformation

Thecontentsofamasterfilearelargelyconsistentwiththosecontained in BEPS Action Plan 13 and there is a detailed list of specifieditemsthatarerequiredtobecontainedinthemasterfileinanappendixtoPMK-213Thecontentsofalocalfilewhilerelyingon the guidance contained within Action Plan 13 are broader than thesuggestedcontentsofalocalfileasoutlinedinActionPlan13SimilartothemasterfilethereisadetailedlistofspecifieditemsthatarerequiredtobecontainedinthelocalfileinanappendixtoPMK-213

ThemasterfileandlocalfilemustbepreparedinBahasaIndonesiaand must be available no later than 4 months after the taxpayerrsquos fiscalyear-endTheimplicationsfornothavingthefilesavailablebythisdatearenotentirelyclearHoweverthereareclear(andsevere)implicationsfornothavingthefilesavailablebythetimethetaxreturnisdueTheDirectorGeneralofTaxwilltrackavailabilitybyboth(i)requiringthetaxpayertofileadisclosureformwithitstaxreturnstatingthedatethemasterfileandlocalfilewereavailable and (ii) requiring the taxpayer to provide a statement letter certifyingthedatethemasterfileandlocalfilewereavailable

In a change from the prior rules the prior exemption for documenting domestic related-party transactions has been removed and once a taxpayer has exceeded the thresholds it will need to document all of its related-party transactions versus simply thosetransactionsthatexceedthepriortransactionalthresholds

Co ntr co ntr reportACbCRmayberequiredtobepreparedandfiledinIndonesiabybothIndonesiantaxpayersclassifiedasaParentEntityofaBusinessGroupandIndonesiantaxpayerswhoseParentEntitiesareforeigntaxpayersSuchrequirementwillbedependentuponcertainconditions including revenue thresholds and certain taxpayers mayneedtofileaCbCRinIndonesiadespitenotbeingtheultimateparententityofanMNE

TheCbCRrequiredtobefiledbytaxpayersinIndonesiaismoredetailedthanthatrequiredtobepreparedandfiledundertheguidancecontainedinActionPlan13InadditionPMK-213introducesathirdreporttheldquoCbCRworkingpaperrdquowhichisrequiredtobesubmittedaspartoftheCbCRandisoverandabovethe two reports required to be prepared and issued under Action Plan13

LikethemasterfileandlocalfiletheCbCRmustbepreparedinBahasaIndonesiaTheCbCRmustbeavailablenolaterthan12monthsafterfiscalyear-endTheCbCRmustbefiledtogetherwiththecorporateincometaxreturnofthefollowingfiscalyear

onat on cCart Partner Transfer Pricing Ernst amp Young (Indonesia) jonathonmccarthyideycom

Taxupdatessignificantdevelopments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 18: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

16 | EY Life Sciences Report Asia

Source Japanese Ministry of Health Labour and Welfare

Chart 1 TrendsindeathratesbymajorcauseofdeathforJapaneseaged65andover 1990ndash2013

12009470

5610

3750

3372

2194

1990

(per 100000 population of elderly persons aged 65 and over)

Malignant neoplasms (Cancers) Heartdiseases

Pneumonia Cerebrovascular diseases

Senility

1995 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

800

400

0

A silver opportunity

GloballifeexpectancyisrisingrelentlesslyandJapanisleadingthewayTheaveragelifeexpectancyatbirthinJapanis837years(WHO2015)andisnotfarbehindforhighlydevelopednationssuchasSwitzerlandSingaporeandAustraliaInthisenvironmentgovernments are looking at addressing an array of challenges associatedwithagingtocontainandminimizeitsfinancialburdenonboththesocialandhealthcaresystems

Decliningbirthratesinmanydevelopedcountriesandtheriseinlife expectancy will rapidly increase the percentage of citizens over 65yearsoldAsof201426ofJapanrsquospopulationwasover65With a birth rate of less than 8 per 1000 inhabitants (2015) the over-65cohortisexpectedtoriseto316in2030and399in206056

Better with age

eat red article

atric loc el PartnerLifeSciencesAdvisoryEY(Japan)

patrickflocheljpeycom

ran mli ExecutiveDirector LifeSciencesAdvisoryEY (Switzerland)

frankkumlicheycom

tep an nmac t ManagerLifeSciencesAdvisoryEY (Switzerland)

stephanohnmachtcheycom

By

HealthcarebudgetsaroundtheworldareunderenormouspressurefromrisinghealthcarecostsAmaindriverofthiscostescalationistheagingsocietyThestrainonhealthcarebudgetshasledtocost containment initiatives by many governments targeting all businessstakeholdersincludingthepharmaceuticalindustryTheinitiatives have put pressure on drug pricing and reimbursement andfueledeffortstoacceleratetheuptakeofgenericsJapanrecently communicated its aim to increase the use of generic drugsto80by2020withtwoJapanesemultinationalsTakeda

armace tical Compan td (in collaboration with e a armace tical nd trie td ) and aiic i an o p a

(the generics business of aiic i an o Compan td ) already communicating their aims of becoming front-runners in the Japanesegenericsmarket

TheJapanesegovernmenthasfocusedstronglyonchronicdiseases where the anticipated cost burden associated with the agingpopulationishighestDiseasessuchasdementiacancerand diabetes as well as cardio respiratory and cerebrovascular pathologiesleadthewayindrivingupcostsThesemorbidities(orcomorbidities) require frequent prescriptions regular interaction with medical staff and in many cases hospitalization part- or full-timecarecentersupportorpalliativecare

Over the last half century there has been great progress in increasinglifeexpectancyOfprimaryimportancenowisreducingthenumberofyearsindividualsmustlivewithdisease

Japanesemenonaveragelivewithatleastonediseaseforthefinal9yearsoftheirliveswomenfor12yearsThesenumbershavenotchangedconsiderablyoverthelastdecadeorsoAchievingevenaseemingly small decrease of 6 to 10 months across the population would have a profound impact on health care and social care budgets

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 19: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

17March 2017 |

We see the aging society or ldquothe silver economyrdquo as an opportunity forthepharmaceuticalindustryWebelieveinnovationforthiseconomy can and will have a lasting impact by improving health and reducing costs in a number of areas especially the following

1 Innovation targeting aging and age-related diseases on a molecular level

aTherapeuticarea-specificmolecularinnovation

bPreventivesolutions

cAgingbiologyinnovation

2 Innovation targeting aging and age-related diseases with added services

aFeedbackloops

bOtherinnovativeapproaches

3 Exploring new territories

aCaseexamplehomecare

To capture these business opportunities pharmaceutical companies will need to recognize which innovations are likely to have the biggest impact on reducing the burden of the aging society but also howtheywillbereimbursedfortheirefforts

1 Innovation targeting aging and age-related diseases on a molecular levelContinuedRampDeffortstodiscovernovelmoleculartreatmentsfor age-related pathologies such as Alzheimerrsquos disease cancer chronic obstructive pulmonary disease and cardiovascular and cerebrovascular pathologies as well as diabetes will be the industryrsquosbackboneandkeytoscientificclinicalandcommercialsuccessBeyondtraditionalRampDfurtherdedicatedeffortsindiseaseprevention and regenerative medicine which includes gene therapy andtissueengineeringshowpronouncedpromise

Source Life expectancy at birth mdash ldquoAbridged life tablerdquo MHLW for 2001 2004 2007 and 2013 and ldquoComplete life tablerdquo MHLW for 2010 Healthy life expectancy at birth mdash ldquoProjection of the healthy life expectancy and the study on the cost-effectiveness of the measures against lifestyle diseasesrdquo Health and Labour Sciences Research Grant for 2001 2004 2007 and 2010 and estimate derived from ldquoComprehensive Survey of Living Conditionsrdquo by MHLW for 2013

Chart 2 LifeexpectancyatbirthcomparedwithhealthylifeexpectancyatbirthJapan2001ndash13

90emale

85

80

75

70

652001

7265 7269 7336 7362 7421

86618630859985598493

2004 2007 2010 2013

Lifeexpectancyatbirth Healthylifeexpectancyatbirth

(Age

)

90ale

85

80

75

70

652001

6940 6947 7033 7042 7119

80217955791978647807

2004 2007 2010 2013

(Age

)

a erape tic area pecific molec lar inno ation o mann a oc e oc e has been active in recruiting

participants over 70 years old for selected geriatric clinical trials such as the AvastinregtrialaimedattreatingovariancancerInaddition

oc e Venclextareg Mabtherareg and Tarcevareg have all been tested specificallyinindividualsovertheageof60showingthecompanyrsquoscommitmenttothissideoftheagespectrum

AlzheimerrsquosdiseaseisanareaofgreatinterestLeadingplayersinclude Bio en nc li ill and Co Roche and a eda in andel

armace tical nc the latter recently completing recruitment foritsTOMMORROWPhase3trial57 with its investigative agent ActosregThistrialisanexcellentexampleofhowtherapiesoriginallyaimedatonespecificchronicmorbidity(diabetes)maybeextendedand ldquorepurposedrdquo to address another chronic disease in this case AlzheimerrsquosAdditionallyintheAlzheimerrsquosspace i ai Co td ( Eisai) has signed and commenced a collaboration with B iogen aimed atdiscoveringnewchemicalentities

la o mit line plc ilead cience nc Ba er and aiic i an o have all conducted or are currently conducting

trialsonnoveltreatmentsforpatientsover60mdashforawiderangeofmorbiditiesincludingHIVhypertensionandrogendeficiencyandhypogonadism

We will likely see many more such examples as drug manufacturers identify new chemical or biological entities or revive and retest their currentdrugrepositoriestofocusonchronicandage-relateddiseases

re enti e ol tionOn the preventive side o n on o n on hasbeenactive

createdtheJanssenPreventionCenter58 where dedicated teams work to identify prevention markers which direct search for preventive solutions such as vaccines oral drugs and interventions influencingthehumanmicrobiomeMeasuringmaintainingandextending healthy lives is the stated focus and aim of visionary program

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 20: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

18 | EY Life Sciences Report Asia

DO-HEALTH59afive-yearclinicaltrialonpreventivemeasuressponsoredbytheUniversityofZurich(withsupportfrom o al DSM Roche and e tl ) aims to establish whether vitamin Domega-3fattyacidsandhomeexercisewillhelppreventdiseaseatanolderageFurtherTakeda60 and aiic i an o61 together with the C emo ero erape tic e earc n tit te ( K aketsuken) haveinitiatedanexpandedJapanesedistributionnetworkofseasonalflushotsfortheelderly(regularvaccinationsarerequiredundertheJapanesePreventiveVaccinationLaw)

Othergloballeadersintheimmunologyfieldinclude anofi Pasteur M SD and tella arma rope td All have created initiativesonhealthyaging

c in iolo inno ationIntheregenerativemedicineareaJapan-based tella arma nc recently formed a dedicated research unit62 with the goal of deliveringcelltherapytransplantinnovationsaimedatrecoveringand restoring organ and tissue function lost as a result of aging amongotherfactorsThecompanyalsoseesitsresearchintheurology space as crucial given that treatments for overactive bladderwilllikelybeinincreaseddemand

o arti nternational a leading industry voice and innovator inthefieldofagingboastsawiderangeofprogramsfocusingonthebiologyofagingandage-relateddiseasesExamplesincludeitsAfinitorregeverolimus(arapamycinanalogue)anti-agingwork

Featured article

Chart 3 Nine-box innovation model highlighting business model opportunities and potential strategies

Innovative molecular

portfolio targeted at

aging

Traditional molecular

portfolio adapted to

aging

olec lar inno ation

N ow products

Add ne er ice

N ew services

plore ne territories

N ex t outcomes

Traditional molecular

portfolio

21

on mice and the companyrsquos progress toward addressing various geriatricmedicalchallengessuchashearingandvisionlossAdditionally o arti actively researches ways to address the challengesofosteoporosisandmusclelosswastinginagedindividualsbothmajorcausesoflossofindependenceintheelderly

Calico a company founded by oo le nc in 2013 also focuses heavily on research into the biology of aging as well as age-related diseasesStrategiccollaborationisakeyelementofCalico businessplanandseveralagreementshavebeensignedtodatemdashnamely with ie nc the ni er it o e a o t e tern

edical Center the B road Institute and the B uck Institute for Research on AgingCalico collaboration with the Cali ornia n tit te or antitati e Bio cience 63 recently made headlines whenanimalstudieshighlightedthatadjustingcertainproteinlevelsinagedrodentsresultedinthemicelivingsignificantlylongerFirst-in-humantrialsareexpectedinthefuture

In another collaboration centa e arma and nit Biotec nolo nc have teamed up to develop new and innovative senolytic drugs based on their experience in age-related diseases andcutting-edgetechnologiesrespectivelyInJapan aiic i

an o recently established a dedicated research unit named VentureScienceLaboratoriesfocusingandcollaboratingsolelyonresearchtargetsthoughttoberelatedtoaging

2 Innovation targeting aging and age-related diseases with added services

While continued advances to molecular therapies are of paramount importance some recent examples of inventive strategies have openedupalternativepathwaystoinnovationInmanycasesthesepaths include or are based on creating feedback loops through datacollectionandanalysismdasharguablythesinglemostcriticalrequirement for health outcomes monitoring and reimbursement inthedecadestocomeOtherinnovativeapproachesincludegamificationbioelectronicsandartificialintelligence

a eed ac loopA number of business models highlight how preventive medicine and wellness can be taken directly to individuals who have not yet ormightneverbecomepatients ri ale nc 64 offers customers fourhealthldquopathsrdquoonetitledAgeOptimallyGeneticbloodsaliva gut microbiome and lifestyle data are collected analyzed and evaluated helping individuals make lifestyle and health decisionsbasedontheirpersonalinformationandscientificdataPersonal coaches who interact with physicians in the background are available and support Arivalersquos customers to address health risksrelatedtotheirwellness neo C a start-up company has specialized in storing vital-sign data of healthy individuals for extensive periods of time allowing physicians to use the data in the futureifeverneeded

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

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JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 21: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

19March 2017 |

Co n l65 another start-up helps individuals make decisions about their own and their childrenrsquos futures via pre- or post-conception genetic testing enabling a potentially healthier future by identifyingrisksfordiseaseEstablishedtestingforthewell-knownbreastcancergene(BRCA1)isalsoavailable in i ion66 and

e rotrac ec nolo ie 67 also focus on early disease detection mdashformelanomaandAlzheimerrsquosrespectivelyFurther ealt

cle a venture formed by man on e it nc 68 aims to provide self-paying individuals as well as up to 200 million South AfricansandUKresidentsinsuredbyhealthinsurer i co er withwholeexomewholegenomeandcancergenomesequencingThe company intends to create the worldrsquos most comprehensive databaseofwholegenomephenotypeandclinicaldata

InJapan aiic i an o announced it is looking to obtain real world data on and therewith insights into non-valvular atrial fibrillationintheJapaneseelderlypopulation(75andover)69 The companyrsquos ANAFIE (All Nippon Atrial Fibrillation In Elderly) study is collecting data to investigate the use of anticoagulants and their impact on outcomes and thus identify issues that are barriers to idealtreatmentinthispopulationThestudyfurtheraimstoidentifyrisk factors for thrombotic and bleeding events to determine the populationinwhichdirectoralanticoagulantsmayprovidebenefits

t er inno ati e approac efi er nc has recently shared updates on its double-blind

Alzheimerrsquos study run in collaboration with ili nteracti e a anexpertingamification fi er efforts are aimed at early non-invasive detection of Alzheimerrsquos via interpretation of a combination ofdigitalandchemicalbiomarkersBa er has initiated digital healthcareactivitiesintheAsia-PacificregionaimedattheelderlypopulationwithitsGrants4AppsregSingaporeproject70 looking for innovative solutions to improve medication adherence in elderly

peoplewithchronicmedicalconditions

Otherinnovativeapproachestotreatdiseaseincludethefieldofbioelectronics where G SK recently signed a partnership with eril Life Sciences ( lp a et nc life sciences unit) to codevelop products for chronic diseases such as arthritis asthma and diabetes basedonbioelectronicmedicines

Artificialintelligence(AI)anddeeplearninghavebeenusedforproduct development by some life sciences businesses namely Life Ex tension71 a Florida-based foundation providing nutritional andhormonalsupplementsThecompanyrecentlysignedacollaborationwithAIanddeeplearningfirm n ilico edicine nc todevelopanti-agingtechnologies

3 E xploring new territories

In addition to novel molecular treatments repurposing of drugs identificationofbiomarkersandgeroprotectorsfurtherinnovationin the areas of medical devices in vitro diagnostics and telehealth willlikelyhaveapronouncedimpactontheagingsocietymdashespeciallyastheyimpacthomecare

a Ca e e ample ome careTheJapanesegovernmenthasidentifiedhomecareasakeyareawithanimmediateneedforimprovementResearchconductedfortheGovernmentillustratesthatmanyelderlycanmaintaintheirindependentlifestyleswithonlyminimalsupportLeadingJapanesepharmaceuticalmanufacturershaveforyearsdonateddozensofambulancesandwheelchair-friendlyvehiclestoJapanesecommunitiesWhilethisisanimmenselyvaluablecontributiontothe health and social care ecosystem and will certainly contribute todecreasingtheincidenceoflong-termdisabilities(egfasttransporttreatmentonboardanambulancegreatlyreducesthe

Better with age

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 22: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

20 | EY Life Sciences Report Asia

risk of long-term disability after a stroke or fall) other more radical innovationswillbeneededtotackletheagingchallenge

IBM Corp Apple Inc and Japan Post Holdings (JP)72 have begun an initiative customized for the senior population connecting the elderly and their families directly with health care providers via computertabletsandcloudservicesTheaimistoimprovepatientquality of life by bringing app-based experiences and services such as reminders medication alerts exercise and diet updates and local community activity opportunities to up to 5 million householdsby2020WhileApple and IBM provide IT solutions JPrsquoscontributioncomesfromitsnationwideinfrastructureThisinfrastructure is able to reach many citizens as illustrated by the companyrsquos current service offering to ldquocheck inldquo on the elderly as partofdailymaildeliveriesJPhasmorethan24000postofficesandfinancialrelationshipswithmillionsofcustomerslargelythroughprovidinglifeinsuranceservices

JapanrsquosEisai73 hasidentifiedasimilaropportunityandpartneredwith NTT ITNTT East (Nippon Telegraph and Telephone) to roll out an interprofessional program for medical treatment and careallowingtheelderlytocontinuetoliveintheircommunitiesThecollaborationnamedldquoHikariOneTeamSPrdquo(ldquoSPrdquoforSolveProblem) aims to use the experience of all parties to deliver a comprehensive solution and give peace of mind and safety to the elderlyandtheirfamiliesathome

Remotemonitoringandtelehealthprovidefurtheropportunities

for pharmaceutical businesses to collaborate with non-traditional playerstogetclosertotheircustomersAcademicinstitutionssuchas the University of California Irvine have conducted pilot studies in remote monitoring of elderly patients using tools such as the universityrsquos CardioMEMS sensor capable of remotely monitoring patientpulmonaryarterypressureandheartrate

JapanagloballeaderinroboticsandAIhasalsoseenavastincrease in investments into robotics aimed at the home care and nursinghomemarketsNumerousrobotstargetingthesemarketsalready exist two examples being Pepper and Paro which will bepartofaUS$6millionreal-worldstudybyJapanrsquosAgencyforMedicalResearchandDevelopmentinvestigatingthetherapeuticeffectsofsuchdevicesinnursinghomes

While the pharmaceutical industry will likely remain hesitant to get involved in robotics these examples show that potential opportunities for portfolio expansions and innovation may come fromnewandevenradicalcollaborationsthatatfirstseemunlikelyInfactcollaborationswithroboticsanddigitalassistantmanufacturers could become critical as they may provide pharmaceutical businesses with much-needed outcomes data that will be required for reimbursement of their therapies and servicesFurthernotonlyoutcomesdataarevaluablebuttheimproved understanding of end customersrsquo routines daily struggles challengesandconcernsareaswell

Featured article

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 23: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

21March 2017 |

B usiness models

The examples and discussion above highlight that the pharmaceutical and life sciences industry has already embraced someofthechallengesandopportunitiestheagingsocietybringsBusinesses often try to identify opportunities within reach of their current therapeutic areas and strategies but in many cases do not gobeyondthatWhileprovenbusinessmodelsareindispensablecollaborating with digital IT and cutting-edge technology businesses experienced in data collection and interpretation will becomenotonlyvaluablebutessentialAccesstodatastillremainsthe biggest challenge for pharmaceutical companies attempting to gatherhealthoutcomesinformationBusinessmodelswillneedto(be allowed to) evolve to include alternative paths to prevention or anticipationofdiseaseTherapeuticeffectsandthevectorsdefiningormeasuringthesewillneedtobebroadenedThiscanonlybedone via a collective push and comprehensive alignment of all stakeholders

The current model of separation between health care and social carewillneedtobechallengedInaworldwherehealthoutcomesdataiskeytophysicianand(elderly)patientconfidenceandwill trigger reimbursement by payers health care and social carebudgetsneedtobemanagedinparallelGovernmentsandlegislators will need to urge and request innovative organizations to show their contributions to both of these systems and align with businesses as early as during the ideation and design phases of a newproductorserviceOnlyoncethisintegrationandtrulycross-functional approach have been achieved will health outcomes data finditstruepower

S tarting with q uestions

It is clear there is no single solution to effectively address the growinghealthneedsoftheagingsocietyPharmaceuticalprofessionals will need to address a multitude of questions to be competitive and to adapt to the ever-changing commercial andregulatoryenvironmentTheimpactoftheagingsocietywillneed to be evaluated on a regular basis with dedicated teams closely aligned with regulators governments academics payers andevendisruptiveplayersTorisetothechallengeandtomakethe appropriate strategic decisions the industry may consider questions such as

1 What are the current needs of the elderly and what will these be in 10 to 15 years

2 How can these needs be addressed through molecular innovation services or new approaches

3 How can new solutions be delivered best and with which partners

4 How can we make the case for the value these solutions will provide and to whom How will they be reimbursed and paid for

5 Which data can and needs to be collected and how

6 What is the optimal portfolio of molecular innovation services and new approaches to capture the current opportunity while getting ready for the future

7 What are the innovative technologies or potential partners that are emerging and how can they be used to deliver disruptive services

In this patient-centric world likely one of the best places to start is by asking the affected population itself what are elderly people worried about what are their struggles and what is it t e need

Better with age

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 24: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

22 | EY Life Sciences Report Asia

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is oneofthemaindriversofefficiencyandriskmanagementforlifesciencesmultinationalenterprises(MNEs)

Such centralization can however also give rise to questions of whetherthetaxoutcomeofsuchanarrangementreflectstheeconomic substance of the arrangement and whether the legal form ofthearrangementisusedtoinappropriatelydivertprofitsfromahighertaxjurisdictionThishasbeenoneofthekeythemesthebaseerosionandprofitshifting(BEPS)initiativeoftheOrganisationforEconomicCo-operationandDevelopment(OECD)hassoughttoaddress

In light of these concerns Australia has recently announced its intenttointroducefrom1July2017theDivertedProfitsTax(DPT)regimetofacilitateincreasedscrutinymoreefficientdisputeresolution and a tighter focus on economic substance over legal forminrelationtoMNEswithAustralianoperationsTheDPTbroadlyaimstoachievetheseobjectivesby

bull Further strengthening Australiarsquos anti-avoidance provisions

bull Imposing tax at a higher rate than the corporate income tax rate where it applies

bull Applyingwheretheprofitsrecognizedbyeachentityinthesupplychainarenotreflectiveoftheeconomicsubstanceofthearrangement

bull Compressingthefact-gatheringstageinaDPTtaxdisputeto12months

bull Imposing evidentiary restrictions on any information or documentsnotvolunteeredtotheAustralianTaxationOffice(ATO) within the 12-month fact-gathering period

With the increased focus by the ATO on transactions within the life sciences sector it is important to consider how to manage the technicalandproceduralissuesarisingfromtheDPT

Australiarsquosdivertedprofitstax and the life sciences industry

Michael Anderson OceaniaLifeSciences TaxLeaderPartner Ernst amp Young Australia

michaelandersonaueycom

Christian Chan Manager International Tax Services Ernst amp Young Australia

christianchanaueycom

Maria IvanovaManager International Tax Services Ernst amp Young Australia

mariaivanovaaueycom

By

Featured article

The centralization of intellectual property (such as patents licenses and trademarks) and functions (such as procurement marketing manufacturing and distribution) into regional or global hubs is one ofthemaindriversofefficiencyandrisk management for life sciences multinationalenterprises(MNEs)

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 25: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

23March 2017 |

DPT rules

BroadlystatedtheDPTwillapplywhereanMNEentersintoaschemeinvolvingalowtaxjurisdictionforaprincipalpurposeofobtainingataxbenefit(iereducingitsAustraliantaxliability)andachievesthisoutcomeTheremustalsobeamismatchbetweentheoutcomeoftheschemeandtheeconomicsubstanceoftheschemeMorespecificallyallofthefollowingrequirementsmustbemetfortheDPTtoapply

bull The MNE has a global turnover equal to or greater than AU$1billionandAustralianturnoverofgreaterthan AU$25million

bull Thereisascheme(whichcanincludeseveralstepsorjustasinglestep)involvingforeignassociatedentitieslocatedinjurisdictionswithacorporatetaxratelessthan24(lessthan80ofAustraliarsquoscorporateincometaxrate)

bull TheAustralianentityintheMNEreceivesataxbenefitinconnectionwiththeschemeThetaxbenefitisdeterminedbycomparisontoahypotheticalalternativetaxcalculation(iewhat might reasonably be expected to have happened absent the scheme)

bull The principal purpose of the MNE in entering into the scheme wastoobtainataxbenefitThisisanobjectivetestandcanapplyeventhoughtheoverallpurposeofthetransactioniscommercial

bull Theresultoftheschemedoesnotreflecttheeconomicsubstanceoftheschemersquosparticipants

TheDPThasasimilaroperationtothesecondlimboftheUKrsquosDPTregime(thefirstlimbcoveredbyAustraliarsquosMultinationalAnti-AvoidanceLawwhichappliedfrom1January2016)inthatbothsets of rules target arrangements with related foreign entities in low-taxjurisdictionswherethereisinsufficienteconomicsubstanceHowevertheAustralianDPTdoesnotcurrentlyincorporateblanketcarve-outsforcertaincommontransactions(suchasfinancingarrangements)

The ATO has seven years after an income tax assessment is issued toapplytheDPTtothatincomeyearTheDPTwilloverridetheoperation of Australiarsquos double tax agreements to the extent that it applies to the MNErsquos circumstances and Mutual Agreement Procedures under the relevant double tax agreement will not be availabletoproviderelieftotaximposedundertheDPT

IftheDPTappliestoanMNEtheCommissionermayimposeapenaltytaxat40ofprofitsdivertedfromAustralia(comparedtothe30Australiancorporatetaxrate)ChallengingtheapplicationoftheDPTiscomplicatedbyadministrativeandproceduralrulesthathavetheeffectofrequiringpaymentoftheDPTliabilityupfront and imposes a period of 12 months in which no appeal can be lodgedtochallengetheapplicationoftheDPT

Duringthis12-monthperiodtheMNEwillberequiredtoprovideinformation on its position to the ATO and any information not providedwillbeinadmissibleinanappealThebaronadmissibilityapplies regardless of whether the ATO had requested the informationSpecifically

bull From the time the ATO informs the MNE of its intention to apply theDPTtheMNEhas60daystomakesubmissionsbeforethefinalDPTassessmentisissued

bull PaymentoftheDPTamountisduewithin21daysoftheATOissuingaDPTassessment

bull There is a 12-month review period in which an MNE may provide the ATO with further information (this period may be shortened insomecircumstances)

bull DuringthereviewperiodtheMNEcannotappealtheDPTassessmenttoobtainarefundoftheDPTamountpaidAfterthe review period the MNE can only appeal to the Federal Court (instead of either the Federal Court or the Administrative Appeals Tribunal)andhasashortenedwindowinwhichtofileanappeal

bull Any evidence not provided to the ATO in the 12-month period isinadmissibleincourtproceedingstochallengetheDPTassessment

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 26: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

24 | EY Life Sciences Report Asia

Featured article

Considerations for the life sciences sector

LifesciencesMNEstypicallyhaveanumberofcascadinglicenseandserviceagreementsthroughoutvariousjurisdictionswiththeeffectof centralizing the ownership of intellectual property (IP) in one ormorejurisdictionsfromwhichthedevelopmentenhancementmaintenanceprotectionandexploitation(DEMPE)ofthoseIPrightsaremanagedConsiderthefollowingexample

Following a third-party acquisition of an entity with valuable IP the legacy IP is transferred (at market value) by the newly acquired entity to an MNErsquos IP hub which then charges the transferor for accesstoorbenefitsinrespectofthelegacyIPWhilelegalandfinancialriskinrespectofthelegacyIPistransferredtotheIPhub this entity may not have the full capacity to manage make decisionsoroverseealloftherisksassociatedwiththeDEMPEactivities (or its corresponding impact on the IP) instead relying on the originating entity (or other related parties) to support it in this regardInsuchacaseaquestionarisesastowhethertheIPhubshouldbeentitledtoallresidualofprofitsorshouldinfactonlybeentitled to a lesser return and consequently whether any of the charges paid or payable by the legacy transferor for access to or the benefitsofthelegacyIPcouldbeconsideredexcessiveandsubjecttotheDPT

ForthepurposeoftheDPTlifesciencesMNEswillneedtoconsidertheprofitsgeneratedateachstageoftheirsupplychainandconsiderwhetherthatreflectstheeconomicsubstanceofthearrangementasawhole(similartoapplyingtheprofit-splitmethodologyintransferpricing)Inmanyinstancestherealsomay not be a simple chain of bilateral agreements but rather a multilateral web of various contractual relationships between membersoftheMNEThiswouldfurthercomplicatetheanalysisthatneedstobecarriedout

Further evidence will also need to be gathered on which reasonable hypothetical counterfactual may apply (which goes to whether there isarequisitetaxbenefit)andwhethertheprincipalpurposeofthearrangementwastoobtainthattaxbenefitortoobtainataxbenefitand a reduction in a foreign tax liability (whether of the payer or anotherentityrelatedtoorconnectedwiththearrangement)

Challenging a DPT assessment

The ATO has been aggressively investigating and challenging MNEsontheirtaxaffairsinAustraliaArmedwithanincreasedbudget and a government mandate to crack down on perceived multinational tax avoidance the ATO will likely not shy away from prosecutingDPTmattersalbeitweanticipatethattriggeringtheDPTwillbereservedformoreextremecasesThepharmaceuticalindustryhasbeenaparticularfocusoftheATOwithsignificantlyincreasedauditactivityinthesectorMNEsinthepharmaceuticalsectorshouldexpectATOinquiriesinthisregardoncetheDPTlegislationispassedbythegovernment

BeforechallengingaDPTassessmenttaxpayerswillneedtoconsider

bull CashflowconsiderationsinrelationtopayingtheDPTamountupfront

bull Legalformvseconomicsubstanceonawhole-of-supply-chainbasis

bull Whether the hub entity can operationally manage the totality of commercialrisksfacedinthebusiness(asopposedtojusttakingonfinancingrisk)

bull Which evidence to provide the ATO during the review period in order to preserve admissibility on appeal

bull The short time frame for gathering the necessary evidence and seeking legal advice

bull Thecostbenefitofsettlingonatransferpricingbasisorobtaininganadvancepricingagreementvstheriskofpayingtaxat40

bull Potential reputational risk arising from tax avoidance litigation

Conclusion and recommendations

TheAustralianGovernmentintroducedtheDPTlegislationintoParliamenton9February2017withtheintentionoftheDPTapplyingtoincomeyearscommencingonorafter1July2017Werecommend that taxpayers begin to consider their organizational structures and supply chains from the perspective of economic substanceasfarastheymayberelevanttotheDPTIftheATOdoesimposeaDPTassessmenttherewillbeanextremelycompressed time frame in which to consider onersquos position and gatherthenecessaryevidencetosupportanappeal

In the interim and if not already under review consideration should be given to either the feasibility of obtaining an advance pricing agreement (a choice we acknowledge that will require considerationanddiscussionwiththeATOofoverallsystemprofits)or reviewing and refreshing current transfer pricing arrangements anddocumentationfordefenseagainsttheDPTandforthechangesintroducedmorebroadlywithBEPSActionItems8through10

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

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EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 27: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

25March 2017 |

Australiarsquosdivertedprofitstaxandthelifesciencesindustry

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 28: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

26 | EY Life Sciences Report Asia

In every industry customers are more informed and empowered thaneverTheycomparepricescheckonlinereviewsandareincreasinglyselectiveaboutthebrandstheychooseTheyformimpressions from every interaction with a company and share their opinionswithintheirnetworksandcommunitiesTheycomparecustomerexperienceacrossbrandscompaniesandindustriesToday a productrsquos features are rarely enough to drive a sale as the customer will choose a product based on the overall total experiencederivedfrominteractingwiththebrandorcompany

Thisshiftinbuyingbehaviorandexpectationspresentssignificantchallengesaswellasopportunitiesforcompaniesinallindustries

Inresponsecompaniesareredefiningthecustomerexperiencethreateningdisruptionofmainlinebusinesses

ThepotentialfordisruptionisjustashighinthelifesciencessectorcustomerexperiencehasbecomethenewbattlegroundTosurviveand thrive today life sciences companies must engage the right customers with the right messages through the right channels at therighttimeAndsincehealthcaredeliveryissohighlyregulatedtheymustalsoengageintherightway

Whatdoesthismeanspecificallyforlifesciencescompaniesoperating in APAC

Building a better customer experience what life sciences companies in APAC should consider

F igure 1 Customer experience is the new battleground

hellip target the right customers hellip

hellip with the right messagecontent hellip

hellip through the right channels hellip

hellip in the right format hellip

hellip at the right time hellip

hellip in the right way (compliant)

Personalized

Trustworthy

Transparent

Easy to deal with

Relevant

Convenient

Engaging

Different engagement channels are used to

Customer experience is

the new battleground

Transparent

eat red article

a ine ett iler ExecutiveDirectorAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

sabinedettwilersgeycom

ita amani Senior ManagerAsia-PacificLifeSciencesErnstampYoungAdvisoryPteLtdSingapore

ishitadhamanisgeycom

By

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 29: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

27March 2017 |

Building a better customer experience what life sciences companies in APAC should consider

F igure 2 Channel penetration rate by Asia-Pac marketCustomerpreferencesforchannelusevaryacrossAPACmarketsThemajorityofthemarketshaveahighersocialmediapenetrationrate(viamobile)thantheglobalaverageSuchdynamicsneedtobeconsideredwhendevelopingmultichannelstrategies

E xternal market conditions

Lifesciencescompanieshavethreeprimarycustomerstowardswhom they direct their marketing efforts health care practitioners payers(bothpublicandprivate)andpatientsIntheUSandEuropecompanies have started to engage with these different customers indifferentwaysemphasizingenhancedexperiencesThesituationinAPAChoweverisstillevolvingPartofthereasonisAPACrsquoscomplexity every country has different laws and regulations cultures and languages as well as economies and government structuresThesedynamicsneedtobeconsideredonamarket-by-market basis when life sciences companies seek to establish integrated cross-channel customer engagement opportunities in APAC so as to limit risk exposure including capital reputational andoperationalrisks

In addition different markets show different levels of digital maturity and the extent to which they provide favorable environmentsfordigitaltransformationvariesSingaporetopstheEconomistIntelligenceUnitrsquosAsianDigitalTransformationIndexdue to its well-developed digital infrastructure but the country lags behindwhenitcomestoprovidingtherightskillsandcapabilities

Furthermore customersrsquo readiness for and receptiveness to technology in these markets varies widely which affects the development and deployment of tactics that involve multiple channels including traditional and digital ones that are increasingly integratedandsupportingoneanother

DatasuchasinFigure2mayprovideinsightsintowhatneedstobeconsideredineachmarketintermsofcustomerengagementForexample are customers more likely to use their mobile phones than theirpersonalcomputersforshoppingDotheyliketobeengagedvia social networks or do they prefer a phone call

Dependingonacountryrsquosdigitalmaturityandcustomersrsquopreferences there may be limited alternatives to the traditional face-to-face customer engagement approach at least for the time beingButcompaniesneedtobereadytorevisetheirpracticesquickly given the potential for rapid technological and customer changeAfterallSouthKoreaSingaporeandHongKongnowhavesomeofthefastestinternetconnectionsintheworld(seeFigure3)There is no question that connectivity will change how health care providersdelivercaretopatientsAtthesametimeconnectivitymeans that customers have better access to information which will heightentheirexpectationsforbetterdiseasetreatmentoutcomes

Change is happening fast at the broadest level and rising customer expectations will be a reality in the near future even in markets that seemmorenascenttodayAgainamarket-by-marketcustomerengagement approach is required to adapt to local dynamics and enhancethelocalcustomersrsquoexperiencewhilebenefitingthepatient

0

10

20

30

40

50

60

70

80

90

Social media penetrationvia mobile

Active e-commercepenetration

Active m-commercepenetration via phone

Global average for socialmedia penetration

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

(mainland)

Philippines

Japan

Vietnam

IndonesiaIndia

Sources We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 30: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

28 | EY Life Sciences Report Asia

Featured article

F igure 3 Internet penetration vs internet speed by Asia-Pac marketMostAPACmarketshavehigherinternetpenetrationratesthantheglobalaverageHoweverinternetspeedvariesdrasticallywhichwillaffecthowlifesciencescompaniesdelivercontentorservicestotheircustomers

In addition to dealing with varying levels of digital maturity life sciences companies working in APAC must understand the disparate andrapidlyevolvinghealthcaresystemsoftheregionIndividualmarkets have undertaken reforms addressing a range of concerns including streamlining the drug approval process promoting health care accessibility putting downward pressure on product pricing andencouraginginnovationBasedonagivencountryrsquosdigitalreadinessanditsotherhealthpolicyobjectivesitmaybedifficulttodrivetheadoptionofdigitaltechnologyinameaningfulwayFinallyas in other nations life sciences companies operating in APAC struggle to keep up with the multitude and diversity of stakeholders and decision-makers that may or may not need to be considered as customers

In many APAC countries regulations prohibiting promotional interactions prevent companies from interacting directly with patients who are not only the consumers but very often also thedirectpayersHenceinmanyAPACmarketsphysiciansareconsidered the primary customer and the traditional sales model stillholdsface-to-faceinteractionsbetweenthephysicianandthesales representative are believed to be the sole effective source of revenuegenerationThisrequirescompaniestohavesalesteamswithstrongrelationshipswiththephysicianHowevercompetitionfor talent means many life sciences players struggle with high sales forceturnoverThisturnoverlimitstheabilityofacompanytogainin-depth customer insights through its sales force and requires companies to think about how they can obtain such information in otherways

Bribery scandals in China and elsewhere have also left deep scars fundamentally increasing the compliance risk associated with interactingwithphysiciansAsaresultcompanieshavehadtocompletelyredefinehowtheyapproachphysiciansThesenewpracticessometimesconflictwithtraditionalcultureinwhichitmight be normal to provide customers with gifts as a token of appreciationoftherelationshipAdditionallybecauseoftheperceived risks the compliance measures create barriers to adopting more creative ways to engage with customers including ldquopullrdquo that allows tailored engagement based on the needs and preferencesofthecustomer

Internal challenges

Some life sciences companies in APAC have only recently introduced medical affairs and market access as functions with customer-facingpersonnelWhilethesefunctionscontinuetooutline their roles and responsibilities as part of the customer-facing organizationtheiractivitiesareoftendefinedbytaskstobedoneratherthancustomerneedCoordinationinrelationtocustomersremainsdifficultespeciallywiththeintroductionofadditionalchannelsMultiplechannelsmeanscustomerscanhaveldquomultipleidentitiesrdquoandbetargetedbyvariousentitiesinconsistentlyWhilemany companies have started to collect customer data they still struggletomakesenseofitAspectslikedataqualityandtheabilityto get a holistic view of the customer across different functions continue to pose challenges and will need to be addressed to master multichannelmarketing

0

10

20

30

40

50

60

70

80

90

100

Internet penetration

Internet speed (compared to global leader)

Global ave

rage

United Sta

tes

South Kore

a

Singapore

Hong Kong

Malaysia

Thailand

Australia

China

Philippines

Japan

Vietnam

IndonesiaIndia

(mainland)

Source We Are Social and Hootsuite Digital in 2017 httpbitlyGD2017RO

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 31: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

29March 2017 |

Source EY analysis

Building a better customer experience

F igure 4 Internal and external challenges slowing the adoption of multichannel in APAC marketsManychallengesareldquohomegrownrdquoandcanbeovercomewiththerightmeasures

New technologies for customer engagement are typically being evaluatedbasedontheirsuitabilityforUSandEuropeanmarketsAs a consequence rollout in APAC countries is sometimes done half-heartedly either because the new technology does not bring any perceived value to the country or because local people have notbeentrainedtodeployanduseitInadditionITteamsinsomeAPAC markets are still primarily concerned with providing the business with stable internet access and canrsquot be bothered to roll out new tools that are not being supported by existing broadband speedAsaresultsomeofthenewchannelsusedtoengagecustomers in other parts of the world are not being used in every APACcountryAtthesametimethereareuniquesolutionsbeingofferedinselectmarketsthataddresslocalneedsmdashforexampleWeChat has been widely used in China to communicate with customersincludingphysicians

WhileaffiliatesarebeginningtointeractwiththeircustomersthroughmultiplechannelsthesechannelsareoftennotintegratedThis results in a fragmented landscape where stand-alone technologysolutionsarisethataredifficulttointegrateandmaintainFurthermorethesesolutionsarenotsetuptofacilitatecross-country insights so they are soon abandoned by marketing teamswhoseethemashavinglimitedvalue

F inding the right talent

WithtechnologiesevolvingrapidlyitcanbedifficulttohirepeoplecapableofsupportingtheirrolloutandmaintenanceThisisespeciallytrueinmarketswheredigitalisnascentWithouttherightskill sets to support the technology side of the business customer

engagement through digital channels will be patchy and will not be integratedacrosschannelsUnfortunatelyinsomeAPACmarketstherightskillsetsareveryhardtofind

At the same time itrsquos not always clear who in the organization ldquoownsrdquo new digital technologies (and this is by no means an APAC-specificphenomenon)InAPACbrandteamshavelaunchedmultiple technology initiatives but itrsquos not always clear who can helpdeploythenewtoolssuccessfullytogetthemostoutofthemSales and marketing teams in APAC will have access to local IT support but the IT team frequently lacks the required knowledge or bandwidthDigitalasafunctionisstillnotwidelyrepresenteddueto budget constraints in an economically challenging environment lack of acknowledgment by the local business leader of the importanceofsuchcapabilitiesanddifficultiesinfindingpeoplewiththerightskills

As companies integrate more kinds of data using multiple channels to precisely target and interact with different customers is the ultimategoalAtthemomentdatamanagementanduseinmanyAPACmarketsisstillemergingmdashinsomeinstancesemployeesstill prefer to use their own spreadsheets to collect data instead of enteringthemintoanintegratedsystemInmanymarketssalesteamsarenotusingexistingCRMsystemsconsistentlytotrackcustomer data thereby missing out on insights that might change businesspracticesandperformanceAlsoforcompliancereasonsdifferent functions sometimes lack access to the same data within theCRMsystemlimitingitsuseasatruerelationshipmanagementtool

Internal Externalbull Understandingandaddressingcustomerneedsandexpectationsasopposedtodelivering

product-focused messages

bull Uncertaintyaboutcorrectcustomerengagementpracticesafterbriberyscandals

bull Siloed thinking and lack of collaboration across different functions

bull Difficultytranslatingbusinessneedsintotechnologyfeatures

bull Lackofthenecessaryskillsetsandcapabilities

bull Belief in traditional face-to-face selling approach

bull Poor data quality and management limit the use of data to generate customer insights

bull Highturnoverofsalesforcelimitingdataknowledgetransfer

bull Complexity of APAC as a market with a wide range of digital maturity levels

bull Evolving health care and regulatory systems

bull Vast diversity of customers with different behaviors and needs

bull Consumerism setting new expectations for pharma

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 32: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

3 0 | EY Life Sciences Report Asia

Featured article

F igure 5 S etting your ambitionsTodesignaroadmapforyourjourneyaffiliatesshouldfirstverifytheircurrentlevelofdigitalcapability

What is next

DespitechallengingmarketconditionslifesciencescompaniesinAPACneedtofirsttackletheirinternalchallengesmdashtheyneedtodrivethecustomerengagementtransformationjourneybymovingawayfrombeingproduct-focusedandbecomingcustomer-centricIn traditional sales lingo that means moving from a push model to a pullmodel

Considering the different maturity levels of customer engagement capabilitiesincountriesacrossAPACteamswillneedtodefinetheir own ambitions in terms of where they want to be within a particular time frame so that they can develop and deploy the right initiativesNoteveryaffiliateinAPACneedstobecomeamasteratmultichannelmarketingmdashsomemayneedtofocusonfixingthebase(seeFigure5)ThatalonewillbesufficienttohelpthemdelivertheircustomerpromiseandachievetheirvisionintheshorttermCompanies will need to think through which markets to prioritize for investments

Once a vision has been set it is imperative to put strong governance inplaceDifferentcompanieswillhavedifferentwaystodrivemultichanneleffortswithintheirAPACmarketregionsmdashitwillhelp to have a dedicated central ldquocustomer leadrdquo for each region sponsored at the regional or global level to at least initiate the transformationanddrivechangeacrossaffiliatesThisleadcan

promoteleadingpracticesandmakesuresolutionsacrossaffiliatesare deployed in ways that comply with legal and regulatory requirementsAtthesametimethisprojectmanagershouldwork with counterparts in other regions to learn what is working and what is not and avoid reinventing processes or investing in approachesthataresuboptimal

In each market teams must move away from simply targeting historically high-prescribing physicians to understanding their customersacrossallpossibledimensionsInsightsoncustomersshould be collected and analyzed across the entire organization andeachcustomerrelationshipmustbeviewedindividuallyTocreate an optimal experience multiple business functions must drivethecustomerencounterinadditiontocommercialteamsthefieldforceandback-officefunctionsincludingITandfinancehaveimportantrolestoplayForexamplethinkabouttheimpactaterribleinvoicingexperiencebetweenyourfinanceteamandyour largest hospital customerrsquos procurement team may have on yourrevenuesAffiliatesneedtodefinenewareasthatcanleadtocustomerinsightsForexamplewhiledifferentteamsmaybesending multiple emails to their respective customers not many marketswillbetrackingwhethertheseemailsareopenedandread

Technologies and systems need to be integrated to support multichannelactivitiesDatawillneedtobecollectedandanalyzedacross multiple dimensions to support fast learning and generate

Chan

nel p

erfo

rman

ce im

prov

emen

t

Digital process improvement

1

2

3

4

5 Omnichannel customer experienceCustomer needs (not brands) are driving innovative campaigns to satisfy customer outcomes

Integrated cross-channel customer experienceCustomer experience is integrated into brand plans driving differentiated cross-channel campaigns

Integrated cross-channel digital campaignsThe brand plan tactics are organized in campaignsusing traditional and digital channels in an integrated way

2 Ad hoc digital initiativesThe brand plan tactics are supported by sporadic ad hoc digital initiatives

Isolated digital channelsThe brand plan tactics are mainly focused on traditional channels with some support of digital technologies

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 33: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

31March 2017 |

Building a better customer experience

insightsthatcanenhancecustomerexperienceAspartoftheseefforts companies must also continue to understand how their customersnowdefinevalueandhowtheywilldosointhefutureso that they can develop products and services that meet the changingexpectations

Itrsquos becoming more important to identify trends early while at the sametimeunderstandingwhichoneswilllastLocalcustomerinsights should also be used to inform drug development to appeal toanAPACpatientbaseForexamplewithapproximately 13billionpeopleinChinausingtraditionalChinesemedicineas their primary approach to treat and manage diseases further insights on patientsrsquo preferences may help improve the development of ldquoWesternrdquo medicine in such a way as to appeal to a ChineseaudienceConsideringlocalpracticesculturesandtastesintheir product portfolios has made multinationals in many industries extremelysuccessfulinAPAC

Atthesametimelifesciencesaffiliatesneedtochangethemindsetof all their employees to become more customer-centric and embed ldquowhat they want to stand forrdquo in every interaction they have with customers(againthisalsoholdstrueforthefinanceteamthatisissuinganinvoicetoyourlargestcustomer)Thistransformationneedstobedrivenbothtop-downandbottom-upItmayevenrequire reorganizing the commercial organization hiring new talentandadjustingKPIstomeasurecustomerengagementandexperiencenotjustproductsales

Finally a culture of failing fast and learning by doing needs to be infusedintotheorganizationIntodayrsquosfast-pacedanddynamicenvironment itrsquos sometimes very hard to predict successful initiativesorestimateROICompaniesneedtocreateanenvironment that allows teams to experiment piloting different initiativesandmovingquicklyThisincludesventuringintonewpartnerships with local companies to further drive the ambition of providingcustomerswithagreatexperience

While multichannel is still new territory for many life sciences companies in some APAC markets customersrsquo expectations are increasingdirectlywithdigitaluse

DigitalhealthistodayrsquosrealityLifesciencescompaniesmuststayabreastofnewinnovationsorlosemarketshareToriseabovethe competition life sciences companies in APAC need to focus on what matters most to their customers and deliver a best-in-class experience to them despite some of the complex and unique challenges that arise because of regulatory demands and market variabilitiesinAPAC

Sources 1 Clinical Search mdash AI1 understanding of healthcare professionalsrsquo attitudes

needs and challenges GGM2 lndegene survey on The Digital Sawy HCP 20153 2012 DXY survey of Chinese physicians4 Taking the Pulse Global 2016

of doctors in APAC use search engines (includingGoogle)

as a clinical decision support tool1

of Australian physicians regularly use search engines

for professional purposes4

Search engines

E-detailing

Emails

Smartphones

Networking appssocial media

90 ~90

HCPsinChinaandIndiaprefer

In India prefer emailsfor engaging with pharma companies2

one in two

gt4 emails a month2

ofHCPsinChinaaccess medical information through their mobile phones which is double the usage trend

amongtheHCPsintheUS2

~50

of Chinese physicians use social media regularly3

More than 50

of physicians use WeChat on a daily basis in China480

InChinaHCPsaremore inclined toward online detailing over face-to-face detailing using tablets2

two times

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 34: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

3 2 | EY Life Sciences Report Asia

Mergers and acq uisitions mdash global 2016 saw the cancellation of what was potentially the largest-ever life sciences transactionthePfizer-AllergandealduetoregulatorychangesbytheUSTreasuryDepartmentaimed atreducingtheattractivenessoftax-inversiondealsThechanges have led to a decline in deal value over the last two years with 2014 now the peakyearforMampAoverthelastfiveyearsthanks to two mega-ticket tax inversion deals involvingCovidienandAllergan

Total global deal value in life sciences was approximatelyUS$265billionin2016downnearly6yearoveryear(YOY)despiteamoreactive1Hcomparedto1H2015ThedeclinewasdueprimarilytoasignificantdropinUSMampAactivityresultingfromuncertainty surrounding the outcome of theUSpresidentialelectionMonthsaftertheelectionUScompaniesstillappearto be waiting for clarity on regulations of drugpricingandthefateofObamacareInaddition the pool of suitable targets has shrunk due to the high pace of MampA activity in the last two years thus forcing multiple potential acquirers to target the same companyThishasinturnledtoadeclineindeal count for all but small deals as well as a slowingofthedealprocess

Dealvolumewitnessedaslightincreaseof4from2015thankstoahighernumberofsmall-valuetransactionsTherewere39dealsvaluedatUS$1billionormorein2016downfrom50suchtransactionsin2015Compared to other sectors life sciences was fifthintotaldealvaluefollowingtechnologydiversifiedindustrialproductsoilandgasandconsumerproductsandretail

Global MampA activity in life sciences 2012ndash16

Source Thomson ONE

0

100

200

300

400

Asia MampA activity in life sciences

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

600

1200

1800

2400

Mergers and acquisitions (MampA)

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 35: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

3 3March 2017 |

Life sciences MampA value share by subsector 2012ndash16

Source Thomson ONE

Source Thomson ONE Capital IQ

ar et compan ector Co ntr c irin compan Co ntr eal al e eal tat

Baxalta Specialty US ShirePLC Ireland 352 Completed

StJudeMedical Medical devices US AbbottLaboratories US 305 Pending

Medivation Big pharma US Pfizer US 138 Completed

Sanofi SA ndash AnimalHealthBusiness

Big pharma France Boehringer Ingelheim

Germany 126 Completed

Meda Generics Sweden Mylan US 99 Completed

Alere Big pharma US AbbottLaboratories US 83 Pending

Stemcentrx Big pharma US AbbVie US 64 Completed

Toshiba Medical Systems

Medical devices Japan Canon Japan 59 Completed

Capsugel Pharmaceutical US Lonza Switzerland 55 Pending

Anacor Pharmaceuticals

Big pharma US Pfizer US 55 Completed

The Shire-Baxalta deal was completed in 2016 after the initial offer in August 2015 wasdeclinedBaxaltahadearlierspunofffromitsparentBaxterInternationalinJuly2015 and it was soon targeted by Shire withanofferofUS$35billionShireexpectsthe completed deal to catapult the company to global leader status in rare disease drugswithaportfolioworthUS$20billionin2020Thedealisoneofthe10biggesttakeoversbyaUK-listedcompany

2016alsosawthesecondmajorassetswapdeal involving big pharma in the form of theyet-to-closetransactionbetweenSanofiandBoehringerIngelheimSanofiistradingitsill-fittinganimalhealthbusinessMerialfor Boehringer Ingelheimrsquos consumer brandscreatingawin-winforbothfirmsBig pharma was also engaged in bolt-on acquisitionsincludingPfizerrsquosacquisitionofMedivation and Anacor Pharmaceuticals to bolsterspecificportfoliosofoncologyandinflammationandimmunologyrespectively

Top 10 global life sciences MampA 2016

Life Sciences MampA value share by sub-sector 2012-16

BiotechnologyMedical devicesHealth research and testingPharmaceuticals

2012 2013 2014 2015 20160

20

40

60

80

100

The medical devices subsector appears to be going through another phase of consolidation owing partially to healthy revenue growth in 2015 following the high levelofMampAinthesubsectorin2014TheacquisitionsofStJudeMedicalandToshibaMedicalSystemsCorpbyAbbottLaboratoriesandCanonrespectivelyillustratethistrendThetwodealsmadethe medical devices subsector the biggest gainer in terms of total deal value in 2016 the subsector registered a staggering 123YOYrisewhileallothersubsectorsrecordeddeclinesAmongallsubsectorspharmaceuticals accounted for the largest share of life sciences deal value in 2016 at54(downfrom69in2015)Medicaldevicescontributed29(upfrom12in2015)

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

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ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

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Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 36: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Mergers and acq uisitions mdash Asia

Source Thomson ONE

Mergers and acquisitions

3 4 | EY Life Sciences Report Asia

In line with the global picture Asia deal valueslowedin2016declining14YOYtoUS$494billionHoweverthenumberofdealsincreasedto801from786in2015Asiaaccountedfor36ofglobalindustrydealmakingbycountByvaluehowevertheregionrsquoscontributionstoodat19implyingasignificantdifferenceinaveragedealsizebetweenAsiaandtherestoftheworld

RegionalMampAvaluegrewata32CAGRduring 2012ndash16 with volume growing at a 10rateThesestrongfigureshighlighttheimportance of the region in the global life sciencesindustry

Asia MampA activity in life sciences 2012ndash16

Source Thomson ONE

By subsector dealmaking in Asia witnessed asimilartrendtotheglobalpicturein2016Medical devices recorded the highest YOY growthindealvalue39duelargelytoCanonrsquos acquisition of Toshiba Medical SystemsBycontrasttheremainingthreesubsectorsreporteddeclinesindealvalue

StilldealvalueCAGRsince2012waspositiveforallsubsectorsMedicaldevicespostedthehighestrate40followedbypharmaceuticalsat33

Asia life sciences Mamp A value by subsector 2012ndash 16

0

10

20

30

40

50

60

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

150

300

450

600

750

900

Medical devicesHealth research and testingPharmaceuticals

2012

US$

b

2013 2014 2015 2016

Biotechnology

0

10

20

30

40

50

60

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 37: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Source Thomson ONE

China includes Hong Kong ldquoOthersrdquo includes target companies based out of Thailand Malaysia Vietnam Indonesia and New Zealand

Source Thomson ONE Capital IQ

Mergers and acquisitions

3 5March 2017 |

China(includingHongKong)aloneaccountedforasmuchas64ofthetotalregionallifesciencesdealvaluein2016This was driven by four deals worth more thanUS$1billioneachoutofthetotaleightsuchdealsrecordedinAsiain2016This64figurerepresentsasignificantdecline from 2015 when China accounted formorethan80oftheregionrsquosMampAvaluemdashasignofthegrowingimportanceofothermarketsinAsiaJapanwasabright spot with total deal value roughly quadrupling and its total contribution to theregionrisingfrom5in2015to20in2016SouthKoreawasadistantthirdaccountingfor8ofAsiandealvalueAllthe remaining regions combined accounted foronly8oftotalAsiaMampAdealvalueByvolume China again accounted for more than50ofAsiantransactionsin2016JapanandSouthKoreamadeup29

As in 2015 China MampA deals in 2016 were largely domestic consolidation and included manysub-billion-dollardealsAmajorityofthedealswerewithinAsiaContinuingconsolidation signals the maturation of domesticplayersCompetitionforassetswill only increase limiting the MampA window formultinationals

Asia life sciences Mamp A by target market 2016

In 2016 there were eight MampA deals worth 1048677104867710486771048677more than US$1 billion1048677 and 1048677104867714worth morethanUS$500millionThiswasabigdeclinefrom 2015 when there were 12 deals valuedaboveUS$1billionand29dealsvaluedaboveUS$500millionOfthe14dealsworthmorethanUS$500millionin2016 12 involved both target and acquirer domiciledinthesamenationChinawasresponsible for 5 of the 10 largest deals in theyear

In the largest deal of 2016 Canon acquired Toshiba Medical Systems as part of Canonrsquos strategic transformation program aimed at expanding new businesses and growing its health care business alongside safety and securitysegmentsAcquisitionofToshibawill help Canon reinforce this strategy and will give a boost to its medical equipment businessbothinJapanandglobally

Co ntr Year Target Acq uirer al e m

eal de cription rationale

1Q Toshiba MedicalSystems Corp

CanonInc 5902 bull Canon agreed to acquire the entire share capital of Toshiba MedicalSystemsCorp

4Q Yunnan Baiyao HoldingCo

NewHuaduIndustrial GroupCo

3648 bull YunnanBaiyaoHoldingagreedtosella50stakeinYunnanBaiyaoGrouptofunditsrepurchaseprogram

4Q Wako Pure Chemical Industries

Fujifilm 1322 bull Fujifilmagreedtoacquirea70stakeincludingthe35stakesoldbyTakedainWakoPureChemical

2Q Chongqing Pharmaceutical Group

Chongqing JianfengChemicalCo

1260 bull ChongqingJianFengChemicalagreedtoacquirea966interestinChongqingPharmaceuticalfrommultipleentities

3Q GlandPharma Shanghai Fosun Pharmaceutical GroupCo

1260 bull ShanghaiFosunPharmaceuticaldefinitivelyagreedtoacquirean86interestinIndia-basedGlandPharma

3Q LGLifeSciences LGChem 1246 bull LGChemagreedtomergewithLGLifeSciencesinastockswaptransaction

2Q Shandong Weigao Orthopaedic DeviceCo

ZhuhaiWinbaseInternational Chemical Tank TerminalCo

1109 bull ZhuhaiWinbaseInternationalChemicalTankagreedtoacquiretheentiresharecapitalofShandongWeigaoOrthopaedicDevicefromitsjointventurepartners

4Q Wako Pure Chemical Industries

Wako Pure Chemical Industries

829 bull Takedaagreedtodivestits35stakeinWakoPureChemical

4Q ZiboQixiangTengda ChemicalCo

KingvisionGroup 765 bull KingVisionGrouplaunchedamandatorytenderofferfora453stakeinZiboQixiangTengdaChemical

4Q BeijingBerryGenomicsCo

Chengdu Tianxing Instrument amp MeterCo

654 bull Chengdu Tianxing agreed to acquire the entire share capital of BeijingBerryGenomicsBiotechnology

Top 10 Asia life sciences MampAs 2016

0

10

20

30

40Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

China

SingaporeAustralia

JapanTaiwan

OthersIndia

South Korea 0

110

220

330

440

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 38: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Asia IPOs

3 6 | EY Life Sciences Report Asia

IPO activity in Asia continued to gain momentum in 2016 particularly in terms ofcapitalraised2016aloneaccountedfor38ofthecapitalraisedsince2012Thirty-nine Asia-headquartered companies raisedatotalofUS$55billioninIPOsin2016a28YOYincreaseanda51CAGRsince2012Howeverthenumberof IPOs dropped from 54 in 2015 to 39 in 2016 implying a greater number of big-valueIPOs

Source Capital IQ

Asia IPO activity in life sciences

Financing and IPOs

0

2

4

6

Deal volumeDeal value (US$b)

US$

b

Num

ber

of d

eals

2012 2013 2014 2015 2016 0

15

30

45

60

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 39: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

3 7March 2017 |

Of the total 39 IPOs 10 each were raised by Chinese and South Korean companies in2016EightAustraliancompaniesalso completed public offerings during theperiodhowevernoneoftheseIPOsgeneratedmorethanUS$10millionincapitalThreeIndiancompaniesandtwofirmseachbasedinVietnamJapanandMalaysiaclosedIPOsTheremainingtwoIPOs were by Indonesian and Bangladeshi companiesAveragecapitalraisedperIPO was highest among companies headquartered in China followed closely by SouthKorea

Source Capital IQ

Source Capital IQ

Asia life sciences IPOs by headquartered market 2016

WhiletheIPOwindowintheUSandEurope showed signs of closing in 2016 itwasthrownwideopeninAsiaDespiteasignificantdeclineinthenumberofIPOscompleted across all the subsectors in Asia in 2016 total capital raised witnessed a steep climb in pharmaceutical and life sciences tools and services with respect to 2015Thiswasprimarilyspurredbytwoof the three biggest IPOs globally being completedinAsiain2016

In 2016 pharmaceutical companies accountedfornearly48ofthetotalcapitalraisedLifesciencestoolsandservicescompaniesraised40ofthecapitalinthequarter while the remaining two subsectors contributedonly12

Asia life sciences IPOs by subsector (US$b)

Source Capital IQ

A total of six IPOs raised more than US$100millioneachin2016SouthKorea-based life sciences tools and servicesfirmSamsungBiologicslistingon the Korean Stock Exchange was the largest Asian IPO and the largest global IPOoftheyearThecompanygarneredtotalcapitalofnearlyUS$2billionThiswasfollowedcloselybyaHong-Kong-based pharmaceutical company China ResourcesPharmaceuticalwhichraised morethanUS$18billion

Top 10 Asia life sciences IPOs 2016

e compan ead arter co ntr

ector mo nt rai ed m

Ex change

SamsungBiologicsCo South Korea Lifesciencestoolsandservices

19505 KOSE

ChinaResourcesPharmaceuticalGroup

HongKong(China)

Pharmaceutical 18109 HongKong

Shandong Buchang PharmaceuticalCo

China Pharmaceutical 5756 Shanghai

SillaJen South Korea Biotech 1284 KOSDAQ

STPharmCo South Korea Lifesciencestoolsandservices

1175 KOSDAQ

PT Prodia Widyahusada Indonesia Lifesciencestoolsandservices

1145 Jakarta

AutobioDiagnosticsCo China Medical devices 921 Shanghai

Rayence South Korea Medical devices 863 KOSDAQ

JacobsonPharmaCorp HongKong(China)

Pharmaceutical 846 HongKong

Shanghai Kindly Enterprise DevelopmentGroup

China Medical devices 735 Shanghai

0

500

1000

1500

2000

2500

3000IPO volumeIPO value (US$m)

US$

m

Num

ber

of d

eals

ChinaIndonesia

Bangladesh

AustraliaVietnam

JapanMalaysia India

South Korea 0

2

4

6

8

10

12

Biotechnology Life sciences tools and servicesMedical devicesPharmaceuticals

2012

US$

b

2013 2014 2015 20160

1

2

3

4

5

6

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 40: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

3 8 | EY Life Sciences Report Asia

E Y thought leadership EY perspective on life sciencesThe following is a sample of recent life sciences-related thoughtleadershipproducedbyEYPleasevisiteycomvitalsignsforEYrsquosfulllibraryofindustryinsightsandreports

EY MampA Outlook and Firepower Report 2017 PayerpressureisgrowingacrossawidespectrumofthehealthcaresectorPriceincreaseshave been blunted by election-year rhetoric and competition in key global pharmaceutical marketsContinuedportfoliorationalizationaprofessedpreferenceforbolt-ondealsandlower target company valuations continue to sharpen global appetites for acquisitions into 2017AdistinctfirepoweradvantagecombinedwithsuddenlyfriendlypoliticalandtaxclimatesintheUSshouldallowbigpharmatoseizetheMampAagenda

Payer pressure is growing across a wide spectrum of the health care sector Price increases have been blunted by election-year rhetoric and competition in key global pharmaceutical markets Continued portfolio rationalization a professed preference for bolt-on deals and lower target company valuations continue to sharpen global appetites for acquisitions into 2017 A distinct repower advantage combined with suddenly friendly political and tax climates in the US should allow big pharma to seize the MampA agenda

EY MampA Outlook and Firepower Report 2017

Will payer leverage and post-election optimism shift dealmaking into a higher gear

Pulse of the industry EY medical technology report 2016Despiteabuoyantmergersandacquisitions(MampA)marketandasolidperformanceinventurecapitalfinancingotherfinancialmetricssuggesttheglobalmedtechindustryisstrugglingtogrowassignificantchangesintechnologyandreimbursementcombinewiththegreaterempowermentofconsumerstoreshapehealthcare

Pulse of the industry

Medical technology report 2016

Appendix

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 41: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

3 9March 2017 |

The new innovation imperative reshaping biopharma business models NewtechnologiescustomersandcompetitionareforcingmdashandenablingmdashbiopharmaceuticalcompaniestofindnovelwaystocreateandcapturevalueTechnological economic competitive and consumer-driven pressures are forcing fundamentalchangesinhowpharmaceuticalandbiotechnology(biopharma)firmsdobusiness

The new innovation imperative reshaping biopharma business models 1

The new innovation imperativeReshaping biopharma business models

January 2017

Multichannel is about customer experience Wersquove got that Now what For years there has been talk about how best to evolve the commercial model to move frompush-basedtopull-basedmodelsWhatittakestowininmarketshasfundamentallychangedCustomerleaders(suchasUberAlphabetandApple)havefundamentallyredefinedwhatcustomersexpectacrossallindustriesMorethanevercustomersareshapedbytheirexperiencesindealingwithcompaniesinallwalksoflife

This article is an extract from Performance Volume 8 Issue 4 November 2016 The full journal is available at eycomperformance

Volume 8 Issue 4

Providing insight and analysis for business professionals

Improve performanceapid profit transformation

Sale or failen dimensions of excellence

Cloud ERPMyth or future

If you could outperform the competition what would you aim for

Life sciences is finally catching up with other sectors regarding the importance it is placing on delivering a leading and differentiated customer experience as a means of creating a sustainable competitive advantage However the emphasis and approach for doing this is rapidly evolving Life sciences companies are now preparing for a new era of competing on experience and those that donrsquot keep up will quickly find themselves becoming outdated

Multichannel is about customer experience Weve got that Now what

46 Volume 8 Issue 4

Cash on prescription 2016 Cash on prescription is part of our annual series of industry reports based on EY researchonworkingcapital(WC)managementAmongthefindingsinourlatestCashonprescriptionwereportthatpharmacompanieshavebetweenUS$22billionandUS$47billionofcashunnecessarilytiedupinWCprocessesCash on

prescriptionPharmaceutical companies and working capital management 2016

Capital Confidence Barometer ndash Life Sciences t edition InEYrsquos15thCapitalConfidenceBarometersurveyoflifesciencesexecutiveswefoundthatMampA expectations although not quite back to the penultimate high of October 2015 have continuedatnear-recordlevelsInfactdespitetheeconomicandpoliticaluncertaintiesatthetimeofthissurvey54oflifesciencesexecutivesexpecttopursuedealsinthenext12monthsupfrom45sixmonthsagoDoes seizing

competitive advantage mean deals take center stageTransactions of all types are in the spotlight as companies seek innovation to accelerate strategic growth

Life SciencesCapital Confidence BarometerNovember 2016 | eycomccb | 15th edition

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 42: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Contacts

Sriram ShrinivasanGlobalEmergingMarketsLeaderandGlobalGenericPharmaceuticalLeaderMumbaisriramshrinivasanineycom+91 22 6192 0380

Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105

Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098

Andrew ChenAsia-PacificLifeSciencesTransactionsCo-LeaderShanghaiandrewchenparthenoneycom+86 21 2228 3939

Abhay BangiAsia-PacificLifeSciencesTransactionsCo-LeaderSingaporeabhaybangisgeycom+65 6309 6151

Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523

Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542

EY Life Sciences sector leaders

40 | EY Life Sciences Report Asia

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 43: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844

Hitesh SharmaIndiaLifeSciencesLeaderampTaxPartnerErnstampYoungLLPMumbaihiteshsharmaineycom+91 22 6192 0620

Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586

Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566

JapanSouth Korea

India

Oceania

Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884

Sabine DettwilerASEANLifeSciencesLeaderSingaporesabinedettwilersgeycom+65 9028 5228

Gamini MartinusOceaniaLifeSciencesLeaderSydneygaminimartinusaueycom+61 2 9248 4702

Greater China

ASEAN

41March 2017 |

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 44: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

E Y L ife S ciences service line leaders

Lifesciencescontacts

China ainland

Felix Fei Assurance Shanghai felixfeicneycom +86 21 2228 2586

Titus von dem Bongart TaxCo-Leader Shanghai titusbongartcneycom +86 21 2228 2884

JoanneSu TaxCo-Leader Beijing joannesucneycom +86 10 5815 3380

Steve Au Yeung Advisory Shanghai steveauyeungcneycom +86 21 2228 8888

Andrew Chen Transactions Shanghai andrewchenparthenoneycom +86 21 2228 3939

on onM acau

Cary Wu Assurance HongKong carywuhkeycom +852 2849 9122

Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175

Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321

JudyTsang Transactions HongKong judytsanghkeycom +852 2846 9016

Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810

KyKyLin AssuranceCo-Leader Hsinchu kykylintweycom +886 2 2757 8888 ext 88856

Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877

JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862

AudryHo Transactions Taipei audryhotweycom +886 2 2757 8888 ext 88898

tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702

Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555

DeniseBrotherton Tax Melbourne denisebrothertonaueycom +61 3 9288 8758

Milan Milosevic Advisory Sydney milanmilosevicaueycom +61 2 9248 5028

JasonWrigley Transactions Sydney jasonwrigleyaueycom +61 2 9248 5303

e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124

Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059

South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844

JaeCheolKim Tax Seoul jae-cheolkimkreycom +82 2 3770 0961

Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600

HyoSukHan Transactions Seoul hyo-sukhankreycom +82 2 3770 0907

Oceania

S outh K orea

4 2 | EY Life Sciences Report Asia

G reater China

SingaporeB runei

SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238

Ching Khee Tan Tax Singapore ching-kheetansgeycom +65 6309 8358

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 45: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

Lifesciencescontacts

Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566

JonathanStuart-Smith TaxCo-Leader Tokyo jonathanstuart-smithjpeycom +81 3 3506 2426

Tatsuhide Kanenari TaxCo-Leader Tokyo tatsuhidekanenarijpeycom +81 3 3506 1364

Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490

Takayuki Ooka Transactions Tokyo takayukiookajpeycom +81 3 4582 6422

India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460

RahulPatni Tax Mumbai rahulpatniineycom +91 22 6192 1544

Murali Nair Advisory Mumbai muralinairineycom +91 22 6192 0380

Krishnakumar V Transactions Mumbai krishnakumarvineycom +91 22 6192 0950

J apan

India

4 3March 2017 |

Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012

Peter Ng Tax Jakarta peterngideycom +62 21 5289 5228

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005

ailandanmar

Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090

SuSanLeong Tax Bangkok su-sanleongtheycom +66 2 264 9090

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ilippineam

AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354

FrancisRicamora Tax Makati City francisjricamorapheycom +63 2 891 0307

JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ala ia YoonHoongHoh Assurance KualaLumpur yoon-hoonghohmyeycom +60 3 7495 8608

JaniceWong Tax KualaLumpur janicewongmyeycom +60 3 7495 8223

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

ietnamCam odia ao

Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210

Thinh X Than Tax HoChiMinhCity thinhxuanthanvneycom +84 8 3824 8360

SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228

Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151

AS E AN (contrsquo d)

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 46: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

1 ldquoBMI Industry Trend Analysisrdquo BMI Researchaccessed4January20172 ldquoIndonesian authorities plan drug-agency reform after counterfeit vaccine scandalrdquo

IHS Global Insight Daily Analysis18July2016viaFactivacopy2016IHSGlobalInsightLimitedldquoIndonesiaordersoverhaulofdrugagencyafterfakevaccinescandalrdquo Reuters Health E-Line15July2016viaFactivacopy2016ThomsonReuters

3 ldquoDistributionchainblamedforfakevaccinecirculationrdquoThe Jakarta Post30June2016viaFactivacopy2016TheJakartaPost

4 ldquoMinistryofHealthPreparesRe-ImmunizationrdquoIndonesia Government News 29 June2016viaFactivacopy2016IndonesiaGovernmentNews

5 ldquoMalaysiaPharmaceuticalsandHealthcareReportrdquoBMI ResearchDecember20166 ldquoHealthMinistrytomakegreateruseofgenericmedicinestocutcostsrdquoNew Straits

Times11October2016viaFactivacopy2016NewStraitsTimesPress(Malaysia)Berhad

7 ldquoCCM launches countryrsquos 1st biosimilar insulinrdquo The Malaysian Reserve 14 November2016viaFactivacopy2016TheMalaysianReserve

8 ldquoRegistrationofTCMPractitionersMandatoryByYear-EndrdquoBernama Daily Malaysian News5September2016viaFactivacopy2016Bernama-MalaysianNationalNewsAgency

9 ldquoMalaysiaUpdatesLabelingExemptionsAdvertisingRulesrdquoFDAnews Device Daily Bulletin15August2016viaFactivacopy2016WashingtonBusinessInformationInc

10ldquoPhilippinesBewaryofcounterfeitdrugproductsndashFDArdquoEmiratesNewsAgency(WAM)25November2016viaFactivacopy2016EmiratesNewsAgency(WAM)

11 ldquoPhilippines Provl govt forms inspection team vs illegal drugsrdquo Algeria Press Service11November2016viaFactivacopy2016AlgeriaPressService

12 ldquoPhilippineslsquosuccessfulrsquoon1stphaseinwaragainstillegaldrugsofficialrdquoXinhuaNewsAgency1September2016viaFactivacopy2016XinhuaNewsAgency

13 ldquoMobileapptoassistHIVpatientslaunchedrdquoManila Bulletin 30 November 2016 viaFactivacopy2016ManilaBulletinPublishingCorp

14 ldquoPhilippinesPharmaceuticalsampHealthcareReportrdquoBMI ResearchDecember2016

15 ldquoIndustry Vietnam Sees MampA Boom in Pharmaceutical Industryrdquo Vietnam News Brief Service13December2016viaFactivacopy2016ToanVietLimitedCompanyldquoForeign investors make more MampA deals in Vietnamrsquos pharmaceutical industryrdquo Vietnam News Summary12December2016viaFactivacopy2016VianCompanyLimited

16 ldquoVietnamgetsreadytoself-financevaccineprogramrdquoVietnam News Summary 30December2016viaFactivacopy2016VianCompanyLimitedldquoSeizingtheopportunity to export vaccinesrdquo Vietnam News Summary17December2016viaFactivacopy2016VianCompanyLimitedldquoVietnamtomass-producevaccinestoaddress national shortagesrdquo IHS Global Insight Daily Analysis 28 November 2016 viaFactivacopy2016IHSGlobalInsightLimitedldquoVietnamesePrimeMinisterpushesfor mass production of vaccinesrdquo Vietnam News Summary 26 November 2016 viaFactivacopy2016VianCompanyLimited

17 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotech and Pharmaceutical Sectorrdquo Business Wire24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

18 ldquoMTPConnectUnveils10-YearPlantoBoostCompetitivenessofMedtechBiotechandPharmaceuticalSectorrdquo24July2016httpwwwbusinesswirecomnewshome20160724005007enMTPConnect-Unveils-10-Year-Plan-Boost-Competitiveness-Medtech

19 ldquoPharma plan to bridge gap between research and commercial successrdquo The Australian23November2016httpwwwtheaustraliancomaubusinesspharma-plan-to-bridge-gap-between-research-and-commercial-successnews-story4a4b17f93aa5eab1aa869f47e41e7a9e

20 ldquo$434millionannouncedtodriveinnovationinpharmaceuticalsandmedtecharoundAustraliardquo24October2016httpwwwstartupsmartcomauadvicefunding43-4-million-announced-to-drive-innovation-in-pharmaceuticals-and-medtech-around-australia

21 ldquoMedicinesAustraliaMemberToPlayACrucialRoleInTheBiomedicalTranslationFundrdquo Medicines Australia13December2016httpsmedicinesaustraliacomaumedia-releasemedicines-australia-member-to-play-a-crucial-role-in-the-biomedical-translation-fund

22 ldquoAustralia to change medical regulations to allow faster access to new drugs and devicesrdquo The Guardian15September2016httpswwwtheguardiancomaustralia-news2016sep15australia-to-change-medical-regulations-to-allow-faster-access-to-new-drugs-and-devices

23 ldquoAustralialegalizesmedicalmarijuanacultivationrdquoRT31October2016httpswwwrtcomnews364779-australia-medical-marijuana-cultivation

24 ldquoCutting medical device and prostheses costs should lower health premiums says ministerrdquo The Guardian19October2016httpswwwtheguardiancommoney2016oct19cutting-medical-device-and-prostheses-costs-should-lower-health-premiums-says-minister

25 ldquoCode delivers new standard of transparencyrdquo Medicines Australia 31 August 2016httpsmedicinesaustraliacomaumedia-releasecode-delivers-new-standard-of-transparency

26 ldquoPromoting a quantity-to-quality transition in Chinarsquos drug innovationrdquo The Pharma Letter1November2016httpwwwthepharmalettercomarticlepromoting-a-quantity-to-quality-transition-in-china-s-drug-innovation

27 ldquoChina pilot eyes easier marketing authorizationrdquo Fierce Pharma19June2016httpwwwfiercepharmacomnode343031

28 ldquoChina details on big data in healthcare include digital trailrdquo Fierce Pharma 27 June2016httpwwwfiercepharmacomnode344161

29 ldquoChinaaimsforBigDatahealthcareflowsby2020rdquoFierce Pharma19June2016httpwwwfiercepharmacomnode343081

30 ldquoChinese regulator may put the brakes on all online drug sale pilotsrdquo Fierce Pharma3June2016httpwwwfiercepharmacomnode340896

31 ldquoChinaExpandsListOfDevicesExemptedFromClinicalTrialsrdquoMed Device Online 4October2016httpwwwmeddeviceonlinecomdocchina-expands-list-of-devices-exempted-from-clinical-trials-0001

32 ldquoChinatoRemoveTariffson201TechnologyProductsrdquoCaixin Online 14 September2016httpenglishcaixincom2016-09-14100988591html

33 ldquoChinatoBeginPriorityReviewsofMedicalDevicesinJanuary2017rdquoRegulatory Affairs Professionals Society website27October2016httpwwwrapsorgRegulatory-FocusNews2016102726081China-to-Begin-Priority-Reviews-of-Medical-Devices-in-January-2017

34 ldquoIndiatobeamongsttopfiveglobalpharmainnovationhubsby2020AssochamrdquoBusiness Standard29August2016httpwwwbusiness-standardcomarticlecompaniesindia-to-be-amongst-top-five-global-pharma-innovation-hubs-by-2020-assocham-116082900730_1html

35 ldquoIndianpharmaindustrytohireonlyqualifiedpersonnelnowrdquoBioSpectrum 9 December2016httpwwwbiospectrumasiacombiospectrumnews224572indian-pharma-industry-hire-qualified-personnel

36 ldquoIPC-PvPI adds 23 new AMCS under its ambit bringing total to 202rdquo Pharmabizcom25June2016httpwwwpharmabizcomNewsDetailsaspxaid=95938ampsid=1

37 ldquoPvPIcollectsover2lakhADRswith25contributionfromMHAsrdquoPharmabizcom15December2016httpwwwpharmabizcomNewsDetailsaspxaid=99245ampsid=1

38 ldquoHealthenablrurgesgovttomakeitmandatoryforhealthfacilitiestodigitizepatientsrsquo medical recordrdquo Pharmabizcom24June2016httpwwwpharmabizcomNewsDetailsaspxaid=95886ampsid=1

39 ldquo5-year cap on shelf-life of medical devices likely rules by year-endrdquo Business Standard15December2016httpwwwbusiness-standardcomarticleeconomy-policy5-year-cap-on-shelf-life-of-medical-devices-likely-rules-by-year-end-116121401426_1html

40 ldquoGovernmentaddsstentstoNLEMtocomeunderpricecontrolrdquoLive Mint 21July2016httpwwwlivemintcomPolitics5taSVnHx9Ojv5n3bPcRUbMGovernment-adds-stents-to-NLEM-to-come-under-price-controlhtml

41 ldquoIndianbiosimilarsmarkettoreach$40bnby2030rdquoBusiness Standard 7 October2016httpwwwbusiness-standardcomcontentb2b-pharmaindian-biosimilars-market-to-reach-40-bn-by-2030-study-116100700705_1html

42 ldquoBIOStatementonRecentDevelopmentsinJapanrsquosPharmaceuticalReimbursementandPricingSystemrdquoBusinesswire22November2016httpwwwbusinesswirecomnewshome20161122006065enBIO-Statement-Developments-JapanE28099s-Pharmaceutical-Reimbursement-Pricing

43 ldquoJapandrug-pricingreformtogetblueprintbyyear-endrdquoNikkei Asian Review 26 November2016httpasianikkeicomPolitics-EconomyPolicy-PoliticsJapan-drug-pricing-reform-to-get-blueprint-by-year-end

44 ldquoJapanweighsfurtherclampdownondrugpricingwithOpdivoandRepathainits sightsrdquo Fierce Pharma21September2016httpwwwfiercepharmacompharma-asiafacing-soaring-medicine-costs-japan-considers-further-clampdown-pricing

45 ldquoPMDAMullsFeeRaiseforDrugDeviceReviewsrdquoPharma Japan 7 November 2016viaFactivacopy2016JihoIncaccessed26December2016

46 ldquoBlueBooklsquoWillBeUsedasReferenceWhenSelectingGenericsrsquoPanelChairrdquoPharma Japan19September2016viaFactivacopy2016JihoIncldquoMHLWtoIssuelsquoBlueBookrsquoonQualityofGenericsbyMarch-EndrdquoPharmaJapan4July2016viaFactivacopy2016JihoIncaccessed26December2016

47 ldquoMHLWtoSetUpQuake-ResistantWarehousetoStockpileVaccinesUsingSupplementary Budget for FY2016rdquo Pharma Japan 28 November 2016 via Factivacopy2016JihoIncaccessed26December2016

48 ldquoSKoreareleasescomprehensivestrategyonbioindustryrdquoYonhapNewsAgency8September2016httpenglishyonhapnewscokrnews20160908200200000000AEN20160908004000320Fhtml

49 ldquoPharma MNCs call for South Korea to build lsquobio clusterrsquo to foster bio industryrdquo The Pharma Letter21June2016httpwwwthepharmalettercomarticlepharma-mncs-call-for-south-korea-to-build-bio-cluster-to-foster-bio-industry

Sources

| EY Life Sciences Report Asia44

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 47: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

4 5March 2017 |

a e o i ited ital i n

For one-stop access to EYrsquos breadth of materials published on the life sciences industrymdashreport re earc article e t per pecti e lo po t pre entation in o rap ic r e c art and anal i mdashvisit Vital Signs (eycomvitalsigns)

Browse the easy-to-use navigation to quickly findthelate t in i t and per pecti e on t e topic mo t important to p armace tical iotec medtec and pecialt p arma companie

While visiting Vital Signs click on cri e to receive once-a-week email alerts (eAlerts) when newpublicationsarepostedonVitalSigns

e com ital i n

mo ile riendl ite or li e cience

e ec ti e50 ldquoSouth Korea easing regulations and taxes to encourage domestic additive manufacturinggrowthrdquo3dersorg15August2016httpwww3dersorgarticles20160815-south-korea-easing-regulations-and-taxes-to-encourage-domestic-additive-manufacturing-growthhtml

51 ldquoSouthKoreangovernmenttooffersignificanttaxexemptionsfor3DprintingRampDrdquo3dersorg29July2016httpwww3dersorgarticles20160729-south-korean-government-to-offer-significant-tax-exemptions-for-3d-printing-rdhtml

52 ldquo(NewsFocus)GlobalhealthcarefirmseyeSKoreaasnewhubrdquoYonhapNewsAgency5October2016httpenglishyonhapnewscokrfocus20161005301700000000AEN20161005011000320Fhtml

53 Ibid54 ldquoForeignfirmsgrapplewithanti-graftlawrdquoThe Korea Herald 28 September

2016httpwwwkoreaheraldcomviewphpud=2016100900030355 ldquoTaiwan govtrsquos new plans to bolster the biomedical sectorrdquo BioSpectrum

15November2016httpwwwbiospectrumasiacombiospectrumnews224523taiwan-govts-plans-bolster-biomedical-sector

56 httpdataworldbankorg57 ldquoTakedaandZinfandelPharmaceuticalsCompleteEnrollmentinTOMMORROW

Trialrdquotakedacomhttpswwwtakedacomnews201620160210_7298htmlaccessed17February2017

58 httpwwwjanssencomjanssen-prevention-centeraccessed17February2017

59 httpdo-healtheuwordpressaccessed17February201760 ldquoTakedaAnnouncesSeasonalInfluenzaVaccineSalesAgreement

withKaketsukeninJapanrdquotakedacomhttpswwwtakedacomnews201520150519_6993htmlaccessed17February2017

61 DaiichiSankyoAnnouncesCooperativeSalesAgreementfortheInfluenzaHAVaccinelsquoKaketsukenrsquordquodaiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006296htmlaccessed17 February

62 ldquoAstellasEstablishmentofRegenerativeMedicineUnitrdquoastellascomhttpswwwastellascomencorporatenewsdetailastellas-establishment-of-regehtmlaccessed17February2017

63 ldquoCalico and QB3 announce partnership to conduct research into the biology of aging and to identify potential therapeutics for age-related diseasesrdquo calicolabscomhttpswwwcalicolabscomnews20150324accessed17February2017

64 httpswwwarivalecomyour-journeyaccessed17February201765 httpswwwcounsylcomaccessed17February201766 httpsskinvisioncomaccessed17February201767 httpsneurotrackcom_k=434zj4accessed17February201768 ldquoHumanLongevityIncLaunchestheHealthNucleusaComprehensiveand

PersonalizedHealthPlatformforIndividualsrdquohumanlongevitycomhttpwwwhumanlongevitycomhuman-longevity-inc-launches-the-health-nucleus-a-comprehensive-and-personalized-health-platform-for-individualsaccessed17February2017

69 DaiichiSankyoAnnouncesLarge-ScaleRegistryofNonvalvularAtrialFibrillation in the Elderlyrdquo daiichisankyocomhttpwwwdaiichisankyocommedia_investorsmedia_relationspress_releasesdetail006520htmlaccessed17February2017

70 httpswwwgrants4appscomsingaporeaccessed17February201771 ldquoLifeExtensiontradejoinswithInsilicoMedicinetodevelopadvancedanti-

agingtechnologiesutilizingartificialintelligencerdquoprnewswirecomhttpwwwprnewswirecomnews-releaseslife-extension-joins-with-insilico-medicine-to-develop-advanced-anti-aging-technologies-utilizing-artificial-intelligence-300280735htmlaccessed17February2017

72 ldquoJapanPostGroupIBMandAppleDeliveriPadsandCustomAppstoConnectElderlyinJapantoServicesFamilyandCommunityrdquoapplecomhttpswwwapplecomprlibrary20150430Japan-Post-Group-IBM-and-Apple-Deliver-iPads-and-Custom-Apps-to-Connect-Elderly-in-Japan-to-Services-Family-and-Communityhtmlaccessed17February2017

73 ldquoNTTITNTTEastandEisaiRolloutInterprofessionalCollaborationBusinessfor Medical Treatment and Carerdquo eisaicomhttpwwweisaicomnewsnews201649htmlaccessed17February2017

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience

Page 48: EY Life Sciences Report: Asia - March 2017FILE/ey-life-sciences-report-asia-march-2017.pdf · ie ienes eport: sia. Contents. 2. ar et insihts. 10. Tax updates:significant eveloments

E Y | Assurance | Tax | Transactions | Advisory

About E YEY is a global leader in assurance tax transaction and advisoryservicesTheinsightsandqualityserviceswedeliverhelpbuildtrustandconfidenceinthecapitalmarketsandineconomiestheworldoverWedevelop outstanding leaders who team to deliver on our promises to allofourstakeholdersInsodoingweplayacriticalroleinbuildingabetterworkingworldforourpeopleforourclientsandforourcommunities

EY refers to the global organization and may refer to one or more of thememberfirmsofErnstampYoungGlobalLimitedeachofwhichisaseparatelegalentityErnstampYoungGlobalLimitedaUKcompanylimitedbyguaranteedoesnotprovideservicestoclientsFormoreinformationaboutourorganizationpleasevisiteycom

How EYrsquos Global Life Sciences Sector can help your business As populations age and chronic diseases become commonplace health carewilltakeaneverlargershareofGDPScientificprogressaugmentedintelligence and a more empowered patient are driving changes in the delivery of health care to a personalized experience that demands health outcomesasthecoremetricThisiscausingapowershiftamongtraditionalstakeholder groups with new entrants (often not driven by profit) disrupting incumbentsInnovationproductivityandaccesstopatientsremaintheindustryrsquosbiggestchallengesThesetrendschallengethecapitalstrategyofeverylinkinthelifesciencesvaluechainfromRampDandproductsupplytoproductlaunchandpatient-centricoperatingmodels

OurGlobalLifeSciencesSectorbringstogetheraworldwidenetworkof11000 sector-focused professionals to anticipate trends identify their implicationsandhelpourclientscreatecompetitiveadvantageWecanhelpyou navigate your way forward and achieve sustainable success in the new health-outcomes-drivenecosystem

copy2017EYGMLimitedAllRightsReserved

EYGno01063-174Gbl1612-2139246

EDNone

This material has been prepared for general informational purposes only and is not intended to be relied upon as accounting tax or other professional advicePleaserefertoyouradvisorsforspecificadvice

e com li e cience