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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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098
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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
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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
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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
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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
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Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877
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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
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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
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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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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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ilippineam
AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354
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ietnamCam odia ao
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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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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
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
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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
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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
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Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877
JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862
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Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059
South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844
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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
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
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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
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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
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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
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Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490
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India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460
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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
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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
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
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Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600
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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
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J apan
India
4 3March 2017 |
Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012
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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
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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
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
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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
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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
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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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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
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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
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
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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
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Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151
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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
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
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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
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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
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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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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
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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
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
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South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844
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Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600
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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
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J apan
India
4 3March 2017 |
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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
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
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EY Life Sciences sector leaders
40 | EY Life Sciences Report Asia
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JapanSouth Korea
India
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Greater China
ASEAN
41March 2017 |
E Y L ife S ciences service line leaders
Lifesciencescontacts
China ainland
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4 2 | EY Life Sciences Report Asia
G reater China
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AS E AN
Lifesciencescontacts
Japan HironaoYazaki Assurance Tokyo yazaki-hrnshinnihonorjp +81 3 3503 1566
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India
4 3March 2017 |
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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
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
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EY Life Sciences sector leaders
40 | EY Life Sciences Report Asia
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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
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South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844
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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
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
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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
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Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151
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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
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
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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
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India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460
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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
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JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098
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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
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Felix FeiGreaterChinaLifeSciencesCo-LeaderShanghaifelixfeicneycom+86 21 2228 2586
Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566
JapanSouth Korea
India
Oceania
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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
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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
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tralia GaminiMartinus Assurance Sydney gaminimartinusaueycom +61 2 9248 4702
Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555
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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
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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
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ietnamCam odia ao
Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210
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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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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
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
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
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South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844
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Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600
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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
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J apan
India
4 3March 2017 |
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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
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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
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
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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
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JosephIanCanlas Advisory Makati City josephianmcanlaspheycom +63 2 891 0307
Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151
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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
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
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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
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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
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
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Aaron Quintal Tax Auckland aaronquintalnzeycom +64 9 300 7059
South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844
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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
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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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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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ilippineam
AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354
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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
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098
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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
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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
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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
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Oceania
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4 2 | EY Life Sciences Report Asia
G reater China
SingaporeB runei
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Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151
AS E AN
Lifesciencescontacts
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J apan
India
4 3March 2017 |
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ilippineam
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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098
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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
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098
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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
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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
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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
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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
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Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877
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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
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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
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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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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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ilippineam
AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354
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ietnamCam odia ao
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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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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
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
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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
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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
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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
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J apan
India
4 3March 2017 |
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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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ailandanmar
Saifon Inkaew Assurance Bangkok saifoninkaewtheycom +66 2 264 9090
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ilippineam
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ietnamCam odia ao
Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210
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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
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
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Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555
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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
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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
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India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460
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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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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
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098
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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
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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
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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
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098
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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
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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
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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
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ilippineam
AnaLeaCBergado Assurance Makati City analeacbergadopheycom +63 2 894 8354
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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
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
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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
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
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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
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
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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
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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
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Tetsuro Sano Advisory Tokyo tetsurosanojpeycom +81 3 3503 1490
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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
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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
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
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
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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
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
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Pamela SpenceGlobalLifeSciencesIndustryLeaderLondonpspence2ukeycom+44 207 951 3523
Patrick FlochelEYLifeSciencesGlobalLeadershipTeamJapanTokyopatrickflocheljpeycom+81 3 3503 1542
EY Life Sciences sector leaders
40 | EY Life Sciences Report Asia
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Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566
JapanSouth Korea
India
Oceania
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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
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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
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Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877
JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862
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Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555
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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
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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
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ietnamCam odia ao
Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210
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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098
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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
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Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566
JapanSouth Korea
India
Oceania
Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884
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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
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on onM acau
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Karina Wong Tax HongKong karinawonghkeycom +852 2849 9175
Edward Chang AdvisoryCo-Leader Shanghai edwardchangcneycom +86 10 5815 2321
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Oceania
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4 2 | EY Life Sciences Report Asia
G reater China
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Abhay Bangi Transactions Singapore abhaybangisgeycom +65 6309 6151
AS E AN
Lifesciencescontacts
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J apan
India
4 3March 2017 |
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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
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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
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
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EY Life Sciences sector leaders
40 | EY Life Sciences Report Asia
Sung Yeon ChoSouthKoreaLifeSciencesLeaderSeoulsung-yeonchokreycom+82 2 3787 6844
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Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566
JapanSouth Korea
India
Oceania
Titus von dem Bongart GreaterChinaLifeSciencesCo-LeaderShanghaititusbongartcneycom+86 21 2228 2884
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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
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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
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JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862
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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
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South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844
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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
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ietnamCam odia ao
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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
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
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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
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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
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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
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Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877
JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862
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Oceania
S outh K orea
4 2 | EY Life Sciences Report Asia
G reater China
SingaporeB runei
SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238
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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
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J apan
India
4 3March 2017 |
Indonesia PeterSurja Assurance Jakarta petersurjaideycom +62 21 5289 4012
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Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005
ailandanmar
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ilippineam
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
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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
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Hironao YazakiJapanLifeSciencesLeaderTokyoyazaki-hrnshinnihonorjp+81 3 3503 1566
JapanSouth Korea
India
Oceania
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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
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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
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Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877
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Michael Anderson Tax Sydney michaelandersonaueycom +61 2 9248 5555
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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
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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
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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
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ietnamCam odia ao
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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
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
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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
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
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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
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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
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Taiwan LinTu AssuranceCo-Leader Taipei lintutweycom +886 2 2757 8888 ext 88810
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Ann Shen Tax Taipei annshentweycom +886 2 2757 8888 ext 88877
JonHuang Advisory Taipei jonhuangtweycom +886 2 2757 8888 ext 88862
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South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844
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Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600
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Oceania
S outh K orea
4 2 | EY Life Sciences Report Asia
G reater China
SingaporeB runei
SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238
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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
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J apan
India
4 3March 2017 |
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SabineDettwiler Advisory Singapore sabinedettwilersgeycom +65 9028 5228
Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005
ailandanmar
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ilippineam
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ietnamCam odia ao
Ernest Yoong Assurance HoChiMinhCity ernestyoongvneycom +84 8 3824 8210
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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
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
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Rick FonteAsia-PacificLifeSciencesTaxLeaderSingaporerichardfontesgeycom+65 6309 8105
Hugo WalkinshawAsia-PacificLifeSciences AdvisoryLeaderSingaporehugowalkinshawsgeycom+65 6309 8098
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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
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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
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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
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e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124
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South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844
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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
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India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460
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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
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ilippineam
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ietnamCam odia ao
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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
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
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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
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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
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e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124
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Oceania
S outh K orea
4 2 | EY Life Sciences Report Asia
G reater China
SingaporeB runei
SweeHoTan Assurance Singapore sweehotansgeycom +65 6309 8238
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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
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J apan
India
4 3March 2017 |
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Bernard Ng Transactions Jakarta bernardngideycom +86 21 2228 2005
ailandanmar
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ilippineam
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ietnamCam odia ao
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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
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
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
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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
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Yong Sik Kim Advisory Seoul yong-sikkimkreycom +82 2 3787 6600
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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
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India RaviBansal Assurance Mumbai ravibansalineycom +91 22 6192 0460
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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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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
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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
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
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
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
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e ealand JonHooper Assurance Auckland jonhoopernzeycom +64 9 300 8124
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South K orea Sung Yeon Cho Assurance Seoul sung-yeonchokreycom +82 2 3787 6844
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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
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
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
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
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