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Celltrion Inc 068270 KS

Celltrion Inc (068270): Fundamental Stock Analysis

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Celltrion Inc is a biopharmaceutical company specializing in development of biosimilars for monoclonal antibody drugs. Celltrion Inc’s biosimiliar portfolio is targeting drugs with patent expirations in the next few years, including Herceptin (breast cancer) and Rituxan (non‐Hodgkins lymphoma). Celltrion Inc’s biosimilar for the drug Remicade (rheumatoid arthritis) has already been approved in the European Union.

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  • CelltrionInc068270KS

  • LegalDisclaimer

    Thisreportisforeducationalpurposesonly.Nothinginthisdocumentoranyinformationhereinshouldbeconstruedasanoffer,invitation,marketingofservicesorproducts,advertisement,inducement,orrepresentationofanykind,norasinvestmentadviceorarecommendationtobuyorsellanyinvestmentproductsortomakeanytypeofinvestment,orasanopiniononthemeritsorotherwiseofanyparticularinvestmentorinvestmentstrategy.Anyexamplesofstrategiesortradeideasareintendedforillustrativepurposesonlyandarenotindicativeofthehistoricalorfuturestrategyorperformanceorthechancesofsuccessofanyparticularstrategy.Thisreportandanystatementsmadeinconnectionwithitaretheauthorsopinions,whichhavebeenbaseduponpubliclyavailablefacts,information,andanalysis,andarenotstatementsoffact.Youshouldassumethatasofthepublicationdateofthisreport,theauthorhasashortpositioninallstocks(and/oroptions,swaps,andotherderivativesrelatedtothestock)andbondscoveredherein,andthereforestandstorealizesignificantgainsintheeventthatthepriceofeitherdeclines.Theauthorintendstocontinuetransactinginthesecuritiesofissuerscoveredonthisreportforanindefiniteperiodandmaybelong,short,orneutralatanytimehereafterregardlessofher/hisinitialrecommendation.

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  • TableofContents Summary IntroductiontoCelltrion CompanyHistory SummaryoftheBullCase AccountingIssues

    Peercomparison Corporatestructure Aconsolidatedview Inventorybuild Revenuerecognition Relatedpartytransactions Revenuedoublecounting Disguisingleverageassales Sharepledges Expensecapitalization Celltrionseconomicincome 2014update SamsungSecuritiesInitiation Auditorchronology

    AcomparisontoDaewoo Otherrelatedpartyissues ThemarketopportunitiesofCelltrionsproducts

    Remsima Herceptinbiosimilar

    Conclusion

    3

  • SummaryAccountingissuesatCelltrionInchavedoggedthecompanythroughoutitshistory.Itappearsthattheirregularitiesuncoveredin2011bythelocalKoreanresearchfirm,CenterforGoodCorporateGovernance,haveonlyworsenedovertime1.Thelastseveralyearssawthecompanyanditsprivateaffiliatestakeonadditionalleverageintheformofpledgedshareloans,equityinjections,andwhatwebelieveishiddendebt,anditappearsthatthisleveragehasproppedupthesalesgrowthatthepubliclytradedentity.

    Ironically,webelievethatitispreciselybecauseCelltrionIncisonthecuspofrealizingactualendmarketsalesthatthissituationwillcometoahead.WeestimatethatCelltrion Inchasalreadyprebooked2outof3ofitsfullypenetrated,peaksalesyears.ThisimpliesthatwhenproductsareactuallylaunchedinearnestintheUnitedStatesandEurope,CelltrionInc willhavetofacethefactthatasignificantportionofitsinventorythatwasintheorypresoldisactuallyexpiredandobsolete.

    Itappearsthattheaccountingissuespresentedinthisreportareonlythetipoftheiceberg.Celltrionexecutives,asexDaewooemployees,shouldbewellversedinthemanyconvolutedmethodologieswithwhichtocommitaccountingfraud.AndevenasuperficialcomparisonofthetwocompaniesshowsCelltrionandDaewoosmanysimilarities.Thisreporthasnotevendelvedintothemany otherrelatedpartiesintheCelltrioncomplex.WebelievethatthereisamuchgreaternetworkofDaewooesqueaffiliatesbothdomesticallyandinternationally.

    WebelievethisiswhyCEOandfounderJJSeo failedtoattractstrategicbiddersoverthelasttwoyearsinhispublicstakesaleinCelltrionInc evenafterCelltrion Incs biosimilarRemsima wasapprovedintheEuropeanUnion2.

    Finally,itappearsthatthemarketpotentialforCelltrionIncsmainproductsislimitedinfinancialandtimescope.CelltrionIncsrealeconomicsforitsproductsarelimitedbyitswholesaleagreementswithitsdistributorsandthewindowofprofitswillclose as soonascompetitorbiosimilarscometomarket,includingoneownedbyCelltrionslargestdistributionpartner,Pfizer/Hospira.

    1. ReportbytheCenterofGoodCorporateGovernance10/11/112. WallStreetJournal,Celltrions FounderSaysInvestorsDontUnderstandtheCompany,4/26/13

    4

  • IntroductiontoCelltrionBusinessDescription:CelltrionIncisabiopharmaceuticalcompanyspecializingindevelopmentofbiosimilarsformonoclonalantibodydrugs.CelltrionIncsbiosimiliarportfolioistargetingdrugswithpatentexpirationsinthenextfewyears,includingHerceptin(breastcancer)andRituxan(nonHodgkinslymphoma).CelltrionIncsbiosimilarforthedrugRemicade(rheumatoidarthritis)hasalready beenapprovedintheEuropeanUnion.

    Leadership: JungJinSeo(JJSeo)hasservedastheChairmanandCEOofCelltrionIncsince2002.JJSeooverheardaconversationaboutbiosimilarsinthelobbyofaSanFranciscohotelwhichinspiredhimtostartthebusiness1.PriortoCelltrionInc,JJSeowastheStandingAdvisortotheGroupChairmanofDaewoo,WooChoongKim,from1993to1999.JJSeowasalsoinchargeofDaewooMotors2.Daewoocollapsedin1999inoneofthebiggestaccountingfraudsinhistory,committingadeceptionworthUSD15.3billion3.In2013,JJSeowasinvestigatedbytheKoreanfinancialregulatorsformultiplecountsofstockmanipulationfrom2011to2013relatedtoCelltrion Inc4.

    PublicScrutiny: In2011,alocalKoreanorganization,theCenterforGoodCorporateGovernance,publishedareportquestioningCelltrionIncsgovernanceandpractices.In2012,theWallStreetJournalfollowedupwithapieceontherevenuerecognitionissuesatCelltrionInc.

    1. TheFinancialTimes,KoreasBiotechComebackKid,3/18/122. BloombergBusinessProfile3. NorthwesternJournalofInternationalLawandBusiness,AForensicStudyofDaewoo'sCorporateGovernance:DoesResponsibility fortheMeltdownSolelyLiewith

    theChaebolandKorea?4. BloombergBusiness,CelltrionCEOFacesShareManipulationProbeinSouthKorea,10/8/13

    5

  • IntroductiontoCelltrionFinancials:CelltrionInc.(068270KS)isvaluedatKRW6,815BN(USD6,190MM)ofmarketcapitalization.Thesharestradesat35x2013salesand54x2013EBITDA.Basedonprelim2014results,sharestradeat17x2014sales.

    Despiteitslargemarketcapitalization,allbulgebracketbankshavedroppedcoverageofthecompany.Incidentally,twoofthethreelocalKoreanbankswhopublishresearchonCelltrionIncaredebtholdersofCelltrionHoldings(CelltrionHoldingsdebtiscollateralizedbysharesofCelltrionInc)1.

    Historical5yearfinancialandstockperformancebelow2:

    1. Companyfilings2. Bloomberg

    6

  • AHistoryofCelltrion

    2002:CelltrionIncwasfoundedin2002byaGenentechspinoffcalledVaxgen.VaxgenpartneredwithagroupofKoreaninvestors(NexolCorp,KoreaTobaccoandGinsengCorp,andJ.StephenandCo.VentureLtd.).TheoriginalmissionofCelltrionIncwastodevelopanAIDSvaccine.

    2005:CelltrionIncreceivedacontracttomanufactureOrenciaforBristolMyers.

    2008:CelltrionInclistsonKOSDAQthroughareversemerger.ValorEconomicoreportedthatCelltrionIncplannedtoinvestUSD329mminanethanolmillinthetownofBarra,Brazil.Theprojectwasexpectedtostartin2011.

    2009:CelltrionIncwonaKRW213billion(USD183mm)ordertosupplybreastcancerandarthritisdrugstoHospira.

    2010:TamasekinvestsinCelltrionGSC.BristolMyerscontractmanufacturingrelationshipterminated.

    2011:LocalKoreanpressallegesaccountingissuesatCelltrionInc.OneEquity(JPMorgan)investsinCelltrionHealthcare.

    2012:WallStreetJournalallegesaccountingissuesatCelltrionInc

    2013:Remsima(biosimilarforRemicade)approvedbytheEuropeanMedicinesAgency.CelltrionIncCEOfacesstockmanipulationinvestigationbyKoreanregulators.

    2014:CelltrionIncfilesforFDAapprovalofRemsima

    Source:FinancialTimes,CompanyWebsite

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  • BullCase:CelltrionIncisaleaderintheburgeoningbiosimilarsmarketBiosimilarsdefinition:Abiologicmedicineisalargemoleculederivedfromlivingcellsandusedinthetreatmentofdisease.Biosimilarsaresimilartobutnot identicalcopiesoftheoriginatorbiologic.Biosimilarsaredeterminedtobesimilartoanoriginalbiologicintermsofstructuralcharacteristics,safety,andefficacy1.

    ThebullcaseforCelltrionInc: WithanUSFDAapprovedproductionfacility,consistenttrackrecordinmanufacturingqualifiedbiodrugs,andsolidmarketingpartnershipsacrosstheglobe,weexpectCelltriontobealeadingbiosimilarandnewbiologicaldrugdeveloper/manufacturerintheglobalbiopharmaceuticalmarket.GiventheexpectedpatentexpirationsinEuropeandtheUSincomingyears,webelieveCelltrionisfullyleveragedtothefastgrowingglobalbiosimilarmarket...Thecompanyalreadyhassignedsalescontractwithdistributorsacrosstheglobalmarket,targetingamarketshareof50%intheemergingmarketsand20%inthedevelopedmarkets(exUS)by2015. JPMorganInitiationonCelltrionInc4/18/2011

    EarlyinitiationsonCelltrionIncfocusedonthehugemarketopportunityinreplicatingbiopharmaceuticals.Thebelowtables illustratethemarketsizesofbiopharmaceuticalstargetedbyCelltrionIncspipeline:

    Pastaccusationsofaccountingmanipulationdismissedbyinvestors:Botha2011localKoreanreportbytheCenterforCorporateGovernanceand a2012WallStreetJournalarticlepointedoutthelackofendsalesatCelltrionIncandthebuildupofinventoryatCelltrionHealthcare3. However,thesubsequentEuropeanUnionapprovalofRemsimain2013pushedtheseconcernstothebackgroundasinvestorslookedforwardtothedruglaunchandfutureendmarketsales.

    1. AmgenBiosimilarsOverview(http://www.amgen.com/pdfs/misc/Biologics_and_Biosimilars_Overview.pdf)2. WallStreetJournal,TheTaleBeneaththeTopLineatCelltrionInc,10/28/12

    Source:CLSACelltrionIncInitiation7/15/10

    8

  • SummaryofAccountingIssuesWebelievethatthedismissalofaccountingissuesisnaveespeciallysincetheprematurerecognitionofrevenuesatCelltrionInc.wasonlyonelayerofitsmultifacetedweb.ItappearsthatthesubsequentevolutionofeventshaveputCelltrionIncinanevenmoreprecariousfinancialposition.Thefollowingslideswilldemonstrate:

    CelltrionIncsmarginsappearabnormallyhighcomparedtopeerdrugdevelopers. CelltrionIncscomplexcorporatestructureallowsforthecompanytodothefollowing:

    CelltrionInc appearstobefundingitsaccumulatednegativecashwithamassivebuildupofleverage. CelltrionInchasminimalthirdpartysales.Themajorityofthesaleshavebeentoitselfwhichhasledtoinventorybuildup. Webelievethat57%oftheinventorystockpileatCelltrionHealthcaremaybeexpiredsincethedeterminedshelflifeof

    Remsimais36months.Iffullyimpaired,CelltrionHealthcarewillcarryanegative equityvalue. Celltrion Inc.appearstohavealreadybookedmorethantwoyears offullyrampedendmarketsalesaspresalesfor

    Remsima.CelltrionsabilitytorecognizefurthersalesfromRemsimaevenifmarketentriesandadoptionaresuccessfulappearstobeverylimited.

    CelltrionIncandCelltrionHealthcareengagedinarbitraryconsolidationanddeconsolidationofrelatedpartieswhichservedtoboostsalesinbothcases.

    Aggressivecapitalizationofbothresearchanddevelopmentexpenseandinterestexpense. Webelievethattheuseofpledgedsharesasloancollateralandtheuseofoutsidefinancingtofulfillcashneedscreatesan

    ecosystemwherethesharepriceandfalsesalesaremutuallydependent.ThismayhavemotivatedmanagementtocommittoactionstopropupCelltrionIncshareprice.

    91. HospiraJPMorganHealthcareConferencePresentation1/14/14

  • AccountingIssues PeerComparisonCelltrionIncreportshighermarginsthanbranded,proprietarydrugdevelopers 1.ThemargindisparityisevenmoreastonishingwhenconsideringthatCelltrionIncspriceshouldbediscountedtoaccountforitswholesaleagreements.

    CelltrionIncsreportedgrossmarginsare26%higherthanevenJPMsearliestbullishestimatesforfirstgenerationbiosimilar margins.

    Source:Bloomberg

    10Source:JPMorganInitiationonCelltrionInc4/18/2011

  • AccountingIssues CorporateStructure

    Source:Companyfilings

    JJSeo

    CelltrionHealthcare

    CelltrionPharm(public)

    CelltrionHoldings

    CelltrionInc(public)

    CelltrionGSC

    93.9% 20.1% 32%

    68.4%53.9%

    Inordertounderstandtheaccountingdisparities,onemustfirstvisualizeCelltrionIncswebofrelatedparties.

    BelowaretheidentifiedmaterialentitiesintheCelltrionsystemandownershipstructure. CelltrionHoldingisaholdingcompanywhichholdssharesinCelltrionInc. CelltrionInc(980employees)andCelltrionPharm(335employees)aremanufacturersofdrugs.CelltrionPharmisalso

    responsibleforthemarketinganddistributionofCelltrionIncsdrugsinKorea. CelltrionHealthcare(96employees)marketsandsellsCelltrionIncsproductsoutsideofKorea. CelltrionGSC(5employees)suppliesfiltersforR&Dandmanufacturespharmaceuticalproducts,referencedrugsfor

    R&D,andcomparatorsforclinicaltrials,andprovidescoldchainservicesforpharmaceuticalproductswhichrequirespecifictemperaturecontrol.

    CelltrionHealthcareleasesitswarehousefromCelltrionHoldings.CelltrionHealthcareisdownstairsfromCelltrionInc.andsalesarebookedassoonasproductsentertheCelltrionHealthcarewarehouse.

    2.7%

    OwnershipStructureoftheCelltrionSystem

    11

  • AccountingIssues AConsolidatedViewWhenfinancialsareconsolidatedacrosstheCelltrionsystemofcompanies,itappearsthattheconsolidatedholdingproducesalargenegativecashflowstreamwhichisfundedbycashfromfinancing.

    PositivenetincomeatCelltrionInc(listco)issupportedbygrowingleverageintheCelltrionsystem.

    TheCelltrionsystemasawholeproducesalargenegativefreecashstream

    12

  • AccountingIssues Inventory

    1. Est35%avggrossmarginforCelltrionHealthcare/Est50/50splitofRemsimaretailpricewithHospira

    ThemajorityofCelltrionIncssalesaretoCelltrionHealthcarebythecompanysownadmission.

    AhugeamountofinventoryhasbeenbuildingintheCelltrionsystemwithverylittlesoldtotrueendcustomers.TheinventoryatCelltrionHealthcarealoneequatetoapproximatelyUSD3bnofendsales1.

    ThemajorityofinventoryisatCelltrionHealthcare.

    13

  • BullswouldarguethattherelationshipbetweenCelltrionIncandCelltrionHealthcareishealthybecauseCelltrionHealthcareisbookingpreapprovedsalestoendcustomerslikeHospira,CelltrionslargestworldwidedistributorinkeymarketsliketheUnitedStatesandEurope.However,newdisclosuresfromHospirashowverylittleinventoryreceivedfromCelltrionHealthcareaswellastinyamountsofcashpaidoutrelativetoCelltrionHealthcaresrecognizedrevenue,raisingdoubtsaboutthevalidityoftheprebookedsales.

    Oddly,Hospiraappearedtotakeaninventorywritedowninthe3rd quarterof2014onitsinventoryreceivedfromCelltrionHealthcare,mostofwhichwasreceivedin2014.Inthesamequarter,HospirachangedtheirdisclosurearoundCelltrionadvancesandinventory.

    AccountingIssues Inventory

    Source:Hospirapublicfilings

    ImputedwritedownoninventoryreceivedfromCelltrionHealthcare

    14

    Increaseininventoryreserveonequarterbeforewritedown

  • AccountingIssues Inventory

    1. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Public_assessment_report/human/002576/WC500151486.pdf2. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000278/WC500074922.pdf

    Despitethemassiveincreaseininventory,inventoryreserveisactuallydeclining(from10.5%ofgrossinventoryin2010to2.4%in2013).Meanwhile,thestockpileoffinishedproductisbuildingupandgettingolder.AssoonasCelltrionIncrecognizessalestoCelltrionHealthcare,theclockshouldstarttotickontheshelflifeofthebiosimilarproducts.TheEuropeanMedicinesAgencydeterminedtheshelflifeis36monthsforRemsima1 and48monthsforHerceptin2.

    Usingpubliclyavailablesalescontracts,itappearsthatlargeportionsofinventorypurchasedbyCelltrionHealthcarefromCelltrionInciscurrentlyexpiredgiventheshelflifeofthedrugs.

    15

    Source:Celltrionpubliclydisclosedsalescontracts

    2013Expiration 2014Expiration

    2015Expiration

  • AccountingIssues InventoryIntheory,CelltrionHealthcareshouldhavewrittendown57%ofitsinventoryattheendof2014.ThiswouldhaveresultedinnegativeequityvalueforCelltrionHealthcare,whoisrumoredtobeseekingIPOintheKoreanmarket.

    Webelievethiswritedownmayhavecripplingimplications fortheentireCelltrionsystemsinceCelltrionIncdependsonHealthcareasitslargestandeffectivelyonlybuyerat99%ofsales.CelltrionHealthcaresfinancialhealthiscrucialinraisingequityanddebtfinancingfromoutsidetheCelltrionsystem.AcollapseinHealthcaresfinancialmetricscouldcutoffitsexternalfundingandthereforecutoffthesourceforCelltrionIncssales.

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    CelltrionHealthcare

    CelltrionInc(public)

    CelltrionGSC

    Temasek

    EquityInvestment

    LOAN

    Paymentforproductpurchases

    Source:Companyfilings

    OneEquity(JPMorgan)

    ExistingInvestors(IncJJSeo)

    EquityInvestment

    EquityInvestment

  • AccountingIssues RevenueRecognition

    17

    Source:Celltrionpubliclydisclosedsalescontracts

    ThesamesalescontractsshowthatCelltrionIncalreadyrecognized2.3yearsofRemsimaglobalsales assuming30%marketpenetrationata30%discounttothebrandeddrug1.Themagnitudeofthisisimportantbecause: Competitorbiosimilarswillhitthemarketinlate2017/2018,includingabiosimilarfromPfizer2.Pfizer/Hospirawillbehighly

    incentivizedtofocusdistributiononthewhollyowned,internallydevelopedbiosimlar.Therefore,webelievethatCelltriononlyhasathreeyearwindowbetween20152018duringwhichtorealizeitsfullyloadedsales.

    TheaboveassumptionlikelygivestoomuchcredittoCelltrion Inc.Typically,generics/biosimilarstakeyearstorampmarketpenetration.Forexample,inSouthKorea,ithastakenRemsima2yearstoreach20%marketpenetrationatapricingdiscountof2550%discounttoRemicade3.

    1. HospiraestimatesmarketpotentialbasedonHospiradistributionfootprint.Assume50/50splitofproceedsbetweenHospiraandCelltrionHealthcareandaveragegrossmarginof35%onHealthcarepurchasesfromCelltrionInc.

    2. Pfizerdisclosures3. MiraeAssetResearch2/24/15Report

  • AccountingIssues RelatedPartiesCelltrionHealthcaressalesaretorelatedparties,includingcompanieswhichwereconvenientlyrecentlydeconsolidated.

    In2013,CelltrionHealthcaredeconsolidated100%ownedequitymethodsubsthathadbeenpreviouslyconsolidatedin2012(CTHCHungaryKFT,CTHCPhilippines,CTHCDistribuiodeProdutosFarmacuticosdeBrasil).Thisarbitrarydeconsolidationboostedrevenuesby236%in2013.In2013relatedentitiesincludingCelltrionPharmrepresented78%ofsales forCelltrionHealthcare.

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    IfHealthcarehadnotdeconsolidatedtheserelatedparties,HealthcarewouldhavenegativeEBITDAin2013.

  • AccountingIssues RelatedParties

    Source:Hungariancompanyfilings.Additionally,KoreanfilingsconfirmthatCelltrionHungaryowesKRW45.5bntoCelltrionHealthcare.

    Webelievetherecentlydeconsolidatedsubsidiariesarealsoinvolvedintheinventorystuffing.Celltrion Hungaryhasnotsoldanyofitsinventory.PurchasesarefundedusingpayablestoCelltrionHealthcare.

    Additionally,intheHungariandisclosures,itisstatedthattheinventorywhichisattributedtotheHungariansubsidiaryisactuallystillsittinginSouthKorea,unshipped.

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  • AccountingIssues RevenueDoubleCounting

    Source:Companyfilings

    In2014,CelltrionPharmwasconsolidatedintoCelltrionInceventhoughCelltrionInconlyowns32%ofCelltrionPharm.ThismeansCelltrionIncisliterallysellingproducttoitself.

    TheconsolidationmeansthatCelltrionIncgetstorecognizerevenuetwice.CelltrionIncsellsproducttoHealthcarewhosellsittoPharm.WhenPharmsellsittothirdparties,CelltrionIncrecognizestherevenueagainbecausePharmisnowconsolidated.

    JJSeo

    CelltrionHealthcare

    CelltrionPharm(public)

    CelltrionHoldings

    CelltrionInc(public)

    Productsale RevenueRecognized1x Productsale

    32%/Consolidated

    Thirdparties

    Productsale RevenueRecognized2x

    20

    Source:Companyfilings

  • DisguisingLeverageasSales

    ThisexampleisCelltrionsstandardfinancingapproachthatthepublicisfamiliarwith.CelltrionIncusesitsrelatedentitiestobringliquidityintotheCelltrionsystem.Here,CelltrionHealthcareactedasafinancingvehicleforCelltrionInc. InDecember2011OneEquity,theformerJPMorganprivateequityvehicle,investedKRW254billionintoCelltrion

    Healthcare,thedistributioncompany. ExistinginvestorsincludingJJSeoinvestedKRW180billion. CelltrionHealthcarereceivesfinancingtopayforpurchasesfromCelltrionInc.The2011liquidityinjectionallowed

    Healthcaretomake80%ofits20122013purchasesfromCelltrionInc.

    JJSeo

    CelltrionHealthcare

    CelltrionPharm(public)

    CelltrionHoldings

    CelltrionInc(public)

    OneEquity(JPMorgan)

    KRW254bnKRW180bn

    ExistingInvestors(IncJJSeo)

    Paymentforproductpurchases

    Source:Companyfilings 21

  • DisguisingLeverageasSales

    Overtime,thisstandardfinancingmodelhasmushroomedinscaleandcomplexityasmoreinvestorsandintercompanyloansareintroduced.Inthisexample,CelltrionGSCactsasafinancingvehicleforCelltrionInc. InJune2013,TemasekHoldingspurchasedaKRW85.5billionstakeinCelltrionGSC. CelltrionGSCthenloanedKRW46.5billiontoCelltrionHoldings.ThisloanisalmostanexactplugforCelltrionHoldings

    cashneedsin2013.CelltrionHoldingscashbalancedeclinedbyKRW44.4bnin2013toalmostzero.JJSeoprovidedaguaranteeforthisloancollateralizedby37,000shares ofCelltrionHealthcareshares.

    CelltrionGSCalsoloanedKRW54.6billiontoCelltrionHealthcaretosupportfurtherpurchasesfromCelltrionInc.Thisloanfinanced~22%ofHealthcares2013purchases.

    JJSeo

    CelltrionHealthcare

    CelltrionPharm(public)

    CelltrionHoldings

    CelltrionInc(public)

    CelltrionGSC

    Temasek

    KRW85.5bnInvestment

    KRW46.5bnloan

    KRW54.6bnloan

    Paymentforproductpurchases

    Source:Companyfilings 22

  • DisguisingLeverageasSales

    Inthemostegregiousexample,themoneytravelsfullcirclethroughtheentities.CelltrionIncloanedmoneytoCelltrionPharm,whopaysCelltrionHealthcare,whothenpaysitbacktoCelltrionInc(Q2Q32013).NotethatthistransactionoccurredbeforePharmwasconsolidatedintoCelltrionInc. CelltrionIncloanedKRW50bntoCelltrionPharmaswellaspurchasesKRW60bnofPharmsbondsandwarrants. CelltrionPharmusespartoftheseproceedstopayoffKRW63bnofpayablestoCelltrionHealthcarewhichHealthcare

    usestomakefuturepurchasesfromCelltrionInc.

    JJSeo

    CelltrionHealthcare

    CelltrionPharm(public)

    CelltrionHoldings

    CelltrionInc(public) KRW50bn

    loan+KRW60bnpurchaseofbondsandwarrants

    KRW63bninpayables

    Paymentforpurchaseofgoods

    23Source:Companyfilings

  • SharePledgesCelltrionIncsharesarebeingusedascollateralbytheChairmanandrelatedparties.

    CelltrionHoldingsused10mmsharesofCelltrionIncascollateraltotakeout19loansworthKRW237billionfromWooriBank,DaewooSecurities,andNonghyupBankbetweenJune2006andMarch2013.

    CelltrionGSCborrowedKRW174.7billionusing6.94mmofCelltrionIncsharesascollateral.

    24

  • SharePledgesWebelievetheCelltrionsystemisthereforereliantonstockpriceperformancetoensurecontinuedinjectionofcashintoitssystem.ThisinterdependenceexplainstheactionsmanagementhastakeninthepasttopropupCelltrionIncsstockprice.Ifthestockgoesdown,thesharepledgesandtheassociatedliquiditywouldbewithdrawnandthesystemwouldcollapse.

    TheseexcerptsfromCelltrionIncsownshareholderletterexpressesthecompanysdesperationtopreserveshareprice:

    ThesystematicentanglementmayexplainwhyCEOJJSeowaswillingtofaceregulatoryactiontopropuptheshareprice.JJSeo alsopubliclyputhisCelltrion Inc stakeupforsaleinearly2013.Nostrategicbidderscameforwardaftertwoyears,evenafterRemsima wasapprovedintheEuropeanUnionin2013.

    Source:CelltrionIncShareholderLetter11/23/12

    Aproposedmeasureagainstshareholderswhoarelendingshares

    Unsubstantiatedscaretacticstodiscouragesharelendingbyshareholders

    25Source:KoreaHerald,10/8/13

    Source:WallStreetJournal,4/26/13

  • AggressiveCapitalizationofExpensesEvenassumingallofCelltrion Incssalespracticesarelegitimatesalestorealendmarketcustomers,CelltrionIncsaggressiveaccountingstillneedstobeexamined.

    ItappearsthatCelltrion IncusesanaggressivecapitalizationpolicytounderreportR+Dexpenseandinterestexpense.Accordingtoreported2013earnings,CelltrionIncistradingat68x2013EPS.IfthetrueR+Dandincomeexpenseswerereported,CelltrionIncwouldreportnegativenetincome andthemajorityofthereportednetincomefrom20092013wouldbewipedout.

    26

    Source:Companyfilings

  • EstimatedEconomicEarningsoftheEntireCelltrionSystemAnincomestatementbasedonCelltrionssalestoallNONRELATEDPARTIESpaintsanoutcomewhichismuchclosertothemagnitudeofthenegativecashflowsintheCelltrionsystem.Optically,CelltrionIncsenterprisevalueiscurrentlyamultipleof35x2013sales/17x2014sales.However,ifonlytrueendmarketsalesareconsidered,thismultipleskyrocketsto96x2013sales.

    Additionally,thisanalysisactuallyovercreditsCelltionIncbecauseitgivescreditto100%ofCelltrionPharmsendsaleswhileCelltrionInconlyowns32%ofCelltrionPharm.

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  • 2014Update

    28

    Korea

    Source:MiraeAssetResearch2/24/15Report

    CelltrionPharmreportedsellingKRW5.366bnofRemsimainthefirst9monthsof2014.

    Tonote,MerckwasforcedtodiscountRemicadeby30%whenRemsimalaunchedbasedonpricinglawsinKorea.

    Additionally,patientsreceivesubsidiesontheRemsimafromtheKoreaMedicalAssistanceFoundation.Theslidingscaleof2550%discountforthesubsidyisshownbelow:

    Source:MiraeAssetResearch2/24/15Report

    Source:WooriInvestments9/3/2012Report

    ThissubsidyactuallycomesfromCelltrionIncitself. CelltrionIncsignedanMOUin2012withtheKoreaMedicalAssistanceFoundationtomakedonationstothefoundationtobeusedtosubsidizeRemsima.

    Optically,Remsimaisata5%discounttoRemicadeintheKoreanmarket.However,thetruemarketpricinghasactuallydeclinedbyatotalof5067%sinceRemsimalaunch,whichinpartexplainsthesmallmagnitudeofCelltrionPharmRemsimasales.Evenwiththissteepdiscount,Remsimaonlyachieved20%marketshare2yearsafterlaunch.

  • 2014Update

    29

    Norway InNorway,Remsimawasintroducedin2014.In2014,thediscounttoRemicadewas39%.In2015,thediscountincreased

    to72%1. In2014,the39%discounttoRemicadeallowedRemsimatoachievejustundera10%marketshare 2. InJanuary2015,afterthe72%pricediscount,Remsimasharerosetoonly29% 3.

    Japan: RemsimaenteredtheJapanmarketinNovember,2014.BytheendofJanuary2015,Remsimahadachieved.5%market

    share.PricediscountinJapantoRemicadeis33% 4.

    Hungary: In2014,RemsimasalesinHungaryachieved4.6%marketshare.InJanuary2015,Remsimaachievedlessthan1%market

    shareinHungary 5.

    Hospira: InSeptember2014,HospiraenteredintoaconvertiblebondsubscriptionagreementwithCelltrionHealthcare.Hospira

    purchasedaUSD200mmconvertiblebondwitha6%interestrate,injectingliquidityintoCelltrionHealthcare.CelltrionHealthcarecanpaytheinterestincashorinbiosimilarproduct.Inexchangeforthisloan,CelltrionHealthcaregrantedHospiraexclusiverightstomarketRemsimaandHerceptinbiosimilarsintheUS(usedtobecoexclusive)andothermajormarkets,includingthemajorityofEurope5.

    1. BernsteinResearch2. JefferiesResearch3. IMSdata4. IMSdata5. IMSdata6. Hospirafilings,Q32014earningscall

  • SamsungInitiation3/13/15

    30

    DoesnotaccountforKRW846bn debtliability+KRW100bn ofminorityinterest

    InMarch2015,SamsungSecuritiesinitiatedonCelltrion.Notonlydoestheanalystcompletelyignorethetwomajorissuesofprerecognizedrevenuesandexpiredinventory,buttheSamsunginitiationisfraughtwithmathematical errors.Onceweadjustedforthesematherrors,wereachedaDCFNAVforCelltrion whichis50%belowtheSamsungtargetprice.

    TheanalystpresentedaDCFvaluationfilledwithobviouserrors:1. Hospiras revenuesplitisnotaccountedforatall.2. Koreancorporatetaxiscompletelyignored.3. ThecompanysdebtisnotsubtractedintheNAVcalculation.4. Itdoesnotaccountfor3yearsofrevenuethatwasrecognizedforproductssoldbutnotdelivered.Strangely,theSamsunganalyst

    actuallyacknowledgesthis,evenifRemsima salesincreaseonafullscalethisyear,itwouldbeawhilebeforeCelltrion enjoyssalesgrowth.

    Ifweadjustforthesesimpleassumptionerrors,wereachaNAVwhichis50%belowthetargetpricewhichispresentedinthis initiationreport.

    CorporatetaxNOTincludedinNAVcalculations

  • SamsungInitiation3/13/15

    31

    Doesnotaccountfor50%Hospira revenuesplit

    Doesnotincludetaxpayments

  • AccountingIssuesObscuredThroughAuditors

    WebelieveCelltrion isabletohideitssystemicproblemsofinventorybuildup,crossfunding,andlackoftruethirdpartysalesthroughusingdifferentauditorsforeachentityineveryyear.

    Notably,Samyoung,theauditorforCelltrionGSCandCelltrionHoldings,wastheauditorforOullimElses,OullimNetworks,andOullimInfoTech.Allthreecompaniesweredelistedduetofraudulentaccounting 1.

    AuditorsbyYear2009 2010 2011 2012 2013

    CelltrionInc DeloitteAnjin SamilPWC SamilPWC SamilPWC SamilPWCCelltrionPharma Lian Lian Lian Lian LianCelltrionHealthcare SamYoung SamYoung SamYoung DeloitteAnjin DeloitteAnjinCelltrionGSC SamYoung SamYoung SamYoung SamYoung SamilPWCCelltrionHoldings SamYoung SamYoung SamYoung SamYoung

    32

    1.http://www.hankyung.com/news/app/newsview.php?aid=2012082968471

    Source:Companyfilings

  • Daewoo Celltrion

    Strongrelianceondebtfinancing

    Holdingcompany isnottheprofitcenter

    Powerfulchairman/weak controls

    Inflatedrevenues

    Manipulationofassetsandrevenuesthroughoverseas subs

    Improved balancesheetthroughrelatedpartytransactions

    Scamsubstoskirtaccountingrules

    False revenues

    Falseinventories

    Offbalancesheetdebt

    RevisitingtheDaewooStory In1999,theDaewooGroupcollapsedinthebiggestaccountingfraudinhistory. Daewooschairman,WooChoongKim,livedasafugitiveoverseasfor6yearsandreturnedin2005tofacecriminal

    charges.Kimwassentencedto8.5yearsinprisonanddisgorgementof$USD17.9billion. HallmarksoftheDaewoostory:

    DaewoopursuedaggressiveexpansionintotheautomobileindustryduringtheheartoftheAsianfinancialcrisis. Inordertofunditsexpansion,Daewoosdebtballooned. DaewooCorp,theholdingcompany,directedtheuseofoffshoreentitiesasconduitsforaccountingfraudin

    ordertoinflateassetvaluesbyKRW22.9trillion(USD19.1billion)andhideimpairedcapital. InKorea,Daewooutilizedonshoreaffiliatestopurchaseovervaluedassetsabovemarketprices.Scam

    subsidiarieswerealsousedtobypassaccountingregulations. DaewoousedunreportedaffiliatestotakeonmoredebtwhichprovidedequityinjectionsintothekeyKorean

    entities.

    Source:NorthwesternJournalofInternationalLawandBusiness,AForensicStudyofDaewoo'sCorporateGovernance:DoesResponsibilityfortheMeltdownSolelyLiewiththeChaebolandKorea?

    33

  • CelltrionManagementDaewooConnectionsandMisconduct JJSeostartedthecompanywith10formerDaewooexecutives1. JJSeo,ChairmanandCEOofCelltrionInc.

    JJSeowastheStandingAdvisortotheGroupChairmanofDaewoo,WooChoongKim,from1993to1999.JJSeowasinchargeofDaewooMotors2.

    JJSeoconvictedofstockmanipulationandinsidertrading.

    TaeGuKim,ExecutiveDirectorofCelltrionPharm,PresidentofCelltrionGSC20082014,PresidentofCelltrionHealthcare20082010

    ServedprisontimeforinvolvementinDaewoofraud.KimwasthepresidentofDaewooMotors3.

    YJKim,theformerCEOofCelltrionPharm,wassentencedtothreeyearsinprisonforbreachoftrustduringhistenureasCEOwhichincludedtheembezzlementofKRW2.7bn4.

    DaewooEngineeringandConstructionmanagedtheconstructionofCelltrionIncsfacilitiesin20022003.DaewoohadanagreementwithJJSeotocapitalizeCelltrionIncthroughbuyingsharesofCelltrionpreferredstock.Uponthecompletionoffacilityconstruction,Daewoowouldsellthesesamesharesbackatthepurchaseprice5.

    1. TheFinancialTimesKoreasBiotechComebackKid2. BloombergBusinessProfiles3. NewYorkTimes,SouthKoreanCourtSentences7Daewood ExecutivestoPrison,7/25/014. Naver News,,12/11/095. Vaxgen 2007annualreport

    34

    Source:KoreaTimes,10/8/13

  • AdditionalRelatedPartyIssues

    Tozai Holdings Samyoung,theauditorforCelltrionGSCandCelltrionHoldings,wasalsotheauditorofTozaiHoldings(037700KS)

    1.Samyoungonlyaudits9companieswithanaggregatemarketcapitalizationof~USD900mm2. TozaiHoldingswasoriginallyaminingcompanywhichacquiredacompanycalledNovacell3. InFebruary2011,TozaisignedanagreementwithCelltriontoanalyzebiosimilars4. Laterin2011,Tozaiwasdelistedfromtheexchange,withchargesofaccountingfraudandstockmanipulation5. In2012,TozaichangeditsnametoProdizen.In2012,BrianKim,whowasanexecutiveatCelltrionfrom2009

    2012,becametheCEOofProdizen6.

    Tomato2SavingsBank In2010,Celltrion GSCmadeanequityinvestmentinTomato2SavingsBankandbecamea9.9%stakeholder.This

    equityinvestmentwaswrittenoffin20137. In2009,Celltrion Inc hadaKRW14bn lineofcreditatTomato2SavingsBank7. In2009,Celltrion GSCtookaKRW11bn loanfromTomato2SavingsBank7. Tomato2SavingsBankwasshutdownbyregulatorsin2012duetoabankrunamidallegationsofillicitlending.

    Oneofitscreditofficerscommittedsuicide8.

    35

    1. Companyfilings2. Bloomberg3. http://www.gobizkorea.com/catalog/about.jsp?blogId=tozaiholdings&pageNo=1&pageVol=6&listStyle=L4. http://www.prnewswire.com/newsreleases/theoutlookforpharmaceuticalsinnortheastasia130126873.html5. http://www.fsc.go.kr/info/ntc_news_view.jsp?menu=7210100&bbsid=BBS0030&no=28219 and

    http://alrha.news1.kr/articles/?11635476. http://dailymedi.com/news/news_print.html?section=1&category=8&no=7541517. Companyfilings8. WallStreetJournal,ThirdApparentSuicideinKoreaSavingsBankScandal,1/12/12

  • AdditionalRelatedPartyIssues Freezone

    Freezoneisafacilitiesmanagementandsecuritycompany1. FreezonesharesacorporateaddresswithCelltrionIncandCelltrionHealthcare1. CelltrionIncisFreezoneslargestcustomer,representing33%ofsales1. CelltrionWelfareFoundationowns30%ofFreezone1. ChoiSeungsikisthemajorityownerofFreezone,with35%1.HeisafriendandcollegeclassmateofJJSeo.Heis

    theheadofsecurityattheBlueHouse,theofficialresidencyoftheKoreanheadofstate2.

    CelltrionDBI WooshinSafetySystemsmanufacturesautoseatbeltsystems3. Upuntil2011,thebusinesswascalledCelltrionDBIandwas31%ownedbyCelltrionHoldingsand29%by

    CelltrionInc3.ThemajorityshareholderwasitsfounderInpyoHong,whowasthechairmanoftheAssociationofVendorsforDaewooMotors.

    Accordingtoinsiders,Celltrionboughtitsstakeinordertoimplantbiosensorsinseatbelts.Clearlytheywereaheadoftheirtime.

    In2012,WooshinincreaseditsstakeinCelltrionIncfrom85kto121kshares.Asof2013itstillownedsharesinCelltrion Inc3.

    36

    1. CorporateFilings2. http://www.konkuk.ac.kr/do/MessageBoard/ArticleRead.do?forum=people&id=5b0b04b&sort=63. Corporatefilings

    Source:OwnershipinFreezonefromSaramin.co.kr(http://www.saramin.co.kr/zf_user/recruit/companyinfo/idx/3208344)

  • AdditionalRelatedPartyIssues Celltrion Don

    AsofQ32014,Celltrion Inc owns100%ofCelltrion Don,anagriclutural projectdevelopmentinRussia.Itisinthebusinessofsellingsquashesandgrains1.

    371. CorporateFilings

    Source:http://exclusivernd.ru/photos/1293

    Source:http://www.perfectagro.ru/pdf/novosti/marga_2.pdf

    Source:Vaxgen2007AnnualReport

    Vaxgen Vaxgen isafailedAIDSandAnthraxvaccinedeveloperthatparticipatedinthefoundingofCelltrion. In2007,whenVaxgenwasstillreportingCelltrionIncasasegmentinitsSECfilings,Vaxgenreportednorevenuesfrom

    CelltrionIncwhileCelltrionIncreportedpositiverevenuesinKoreaofKRW60bn1.

  • AdditionalRelatedPartyIssues Celltrion PharmaUSA

    Celltrion PharmaUSAisawhollyownedentityofCelltrion Pharm1.ThecompanyslistingintheCaliforniacompanyregisterisbelow:

    Asearchoftheaddressshowsthatitisaunitinaresidentialapartmentcomplex:

    381. CorporateFilings

    Source:http://kepler.sos.ca.gov/

    Source:Googlestreetview

  • AdditionalRelatedPartyIssues IMMInvestment

    In2014,Celltrion Inc madeaKRW2bn investmentinaventurefundcalledIMM1. SungBaeJi,CEOofIMMInvestmentisadirectoratCelltrion Inc asof2014.Hispreviousworkexperiencealso

    includesSamil PriceWaterhouseCoopers,theauditorofCelltrion Inc andCelltrion GSC. Asitturnsout,IMMisinvestedinCelltrion Inc andCelltrion Healthcare.ThisVCfundholdsbothentitiesinits

    currentportfolio.

    391. CorporateFilings

    Source:http://www.immvc.co.kr/c_port.asp

  • AdditionalRelatedPartyIssues

    AppleSecuritiesandInvestments:Celltrion Inc hashelda9.5%stakeinAppleSecurities&InvestmentLtdsinceitsfoundationin2008.Appleliquidatedin2014.

    CelltrionST:AcompanyownedbyCelltrionHoldingsthatstandsforCelltrion SmartTechnologyandisacompanythatspecializesinthefieldofdigitalbroadcastingserviceandbiopharmaceuticalinformationsystem.Ostensibly,thecompanymanufacturesTVs.Theequityofthiscompanyhasbeenwipedout1.

    DreamE+M(EntertainmentandMusic):AcompanyownedbyCelltrionHoldingsthatproducesKoreanTVshows1.

    Hanskin:Askincarecompanywhichis80%owedbyCelltrionGSC1.

    40

    Source:CelltrionSTWebpage(http://www.celltrionst.com/)

    Source:HanskinWebpage(www.hanskin.com)

    1.Companyfilings

  • RemsimasMarketOpportunity

    TotalMarketSize: RemsimaistargetingthemonoclonalantibodyRemicade,producedbyJohnsonandJohnson.Hospira(Celltrionslargestdistributionpartner)estimatesthattheglobalmarketvaluefortheRemicadebiosimilarisUSD5.8billion,withUSD4billionintheUnitedStates1.

    CelltrionsRemsimahasreceivedapprovalinEuropewhereRemicadepatentsrolloffin20152.Remicadespatentrollsoffin2018intheUnitedStates.

    1. HospiraJPMorganConferencepresentation2. FiercePharmaHospira,CelltrionachievemilestoneinEUwithOKforRemicadebiosimilar

    41

  • RemsimasMarketOpportunityMarketPenetration: SumantRamachandra,SVPandCSOatHospira(Celltrionslargestdistributionpartner)commentedontheshapeoftheadoptioncurveforRemsima.SumantexpectsbetteradoptionthanEpogen,butperhapsnotasstrongasNeupogen(GCSF)1.NotethatEpogenispriced3040%discounttobrandedandNeupogenispricedat~70%discounttobrandedandmarketshareissplitacross3largeplayers.

    Source:BernsteinResearch

    ImplicationforCelltrion:IfRemsimaislaunchedinbothEuropeandtheUnitedStates(USD5.8billioninannualmarketvalue)andRemsimaattains30%marketadoptionata30%pricediscountforthethreeyearsbetween20152018beforeothergenericshitthemarketCelltrionInc.wouldreceiveUSD426mmperannumfor3years(beforeothergenericcompetitorshitthemarket).CelltrionInc.hasalreadyprebooked2yearsofthefuture3yearsofsalesbetweentheyearsof2009and2013.

    In2018,competitorbiosimilarsareslatedtoenterthemarket,includingPfizer/HospirasownproductwhichiscurrentlyinPhaseIII.PresumablyPfizerwillbeincentivizedtoprioritizetheirwhollyowneddrugatthatstagebecausetheyonlyreceive50%ofRemsimasalesundertheHospiradistributionagreement.

    1. BernsteinResearch,Biosimilars:NotesfromLongViewonBiosimilarsConference;AtthePrecipiceDec9,201442

  • RemsimasMarketOpportunityGeographies+Timing:

    RemicadepatentexpiredinEuropein2015.CelltrionproductsareenteringthemarketwithHospiraasprimarydistributor.

    CelltrionisapplyingforUSFDAapprovaltoentertheUS.TheFDAisplanningtodiscussthebiologicslicenseapplicationinameetingonMarch17,2015.

    CelltrionhasfiledasuitinafederalcourtseekingdeclaratoryjudgmentthatJ+JsremainingpatentsonRemicadeareinvalidandunenforceable.ThismoveispatternedafterasimilarSandozstrategytoclearthepatentpathforitsownEnbrelbiosimilar(amoveshutdownbyaCaliforniafederaljudge) 1.

    WhilethemarketviewsthisupcomingFDAhearingasverypositive,webelievethatPfizer/Hospiras motivationstosupportCelltrionsentryintobothEuropeandtheUnitedStatesaredebatable.

    1. http://www.bioworld.com/content/celltrionhopesblazepathfirstusbiosimilarmab043

  • PfizersIncentives BullsarenotconsideringPfizersincentiveswithregardstotheCelltrionrelationship.AsBernsteinResearchpointsout

    HospirahasfourofitsownproductsandhalfadozenproductsfromCelltrion.Thetwointernalproducts(Neupogen,Neulesta,Epogen,Aranesp)willbecarriedoverandaccelerated.Rationally,thosewilldobettergloballyinPfizerhands.TheCelltrionproductsareessentiallyaonetoonereplicaofPfizerprogramsandinvolvematerialprofitsharing(undisclosedbutnotfarfrom50%)withCelltrion.Further,wewouldarguePfizer'sdevelopmentprogramismuchmorerobust.ItisverylikelytheregulatorswillaskPfizertodivest,oreveniftheydont wethinkPfizerwilllikelycutmostoftheCelltrionproducts.

    PfizercurrentlyhasaRemicadebiosimilarproductunderPhaseIIIintheUnitedStates,withanestimatedlaunchattheendof2017.

    InEurope,PfizerownsthedrugEnbrel,acompetitortoRemicadeforrheumatoidarthritis.PfizerisincentivizedtoavoidheavydiscountinganddistributionofRemsimatopreventcannibalizationofitsownbrandeddrug.

    PfizereitherknowstoomuchortoolittleaboutCelltrion.

    Ithinkjusttohighlight,[Hospiras]marketedrecombinantproductsarenotdependentonCelltrion.Theyweredeveloped,asweunderstand,byHospiraalone. JohnYoung,Pfizer

    Wehaven'tsatdownwithCelltrionyet.WehavelookedatthecontractualrelationshipbetweenHospiraandCelltrion. IanRead,Pfizer

    Pfizerismorelikelytotrustitsowndevelopmentandmanufacturingprocess.InPfizersownwords:So,wehavethreebiosimilarsthatareinongoingPhaseIIIstudies,rituximab,trastuzumaborHerceptinandHerceptinandinfliximaborRemicade.We'reusingourdecadelongexperienceinbiopharmaceuticalsciencetomakesurethathealthcareorganizationsandpatientwillfeelthattheyuseabiosimilarthathasthebestmanufacturingandanalyticaldatabehindit. PfizerattheCowenHealthcareConference3/3/15

    44

  • MerckSponsoredCompetitor Recently,attheCowenHealthcareConference(3/2/15),Merckpresentedtheirownbiosimilar pipelineinpartnership

    withSamsungBioepis.SamsungBioepisisresponsiblefortheR+DwhileMerckwillmanufactureandcommercializetheproducts.ThepipelineincludesbiosimilarsforBOTHRemicadeandHerceptin.Withfilingtimelinesin20152016.

    PresumablyasMerckisthedeveloperoftheoriginalbrandedRemicade,thebiosimilarversionwillbewellfasttrackedintheapproval,manufacturing,andmarketingprocess.

    Source:Merckinvestorrelations

    45

  • HerceptinBiosimilarMarketOpportunity

    1. Rochecompanyfilings2. http://www.roche.com/media/store/releases/medcor20121208.htmhttp://www.roche.com/media/store/releases/medcor20120611.htmhttp://www.roche.com/media/store/releases/medcor20130305.htm

    TotalMarketSize: CelltrionsbiosimilartrastuzumabcandidateistargetingRochesblockbusterbreastcancerdrugHerceptin.Rochesannualworldwidesalesin2014ofHerceptinwasUSD6.856billion 1.

    MarketPenetration: TheHerceptinbiosimilarpenetrationshouldbenegligibleduetochangeinstandardofcareforbreastcancer.Previously,thecombinationofHerceptinandchemotherapywasstandardforHER2positivebreastcancer.

    RochesnewdrugPerjeta,whencombinedwithHerceptinandchemotherapy,hasbeenshowntoreduceriskofdeathby34%comparedtotreatmentswhereonlyHerceptinandchemotherapyareused 2.Perjeta+Herceptin+chemotherapywillpresumablybecomethestandardofcareforHER2positivebreastcancer.

    Additionally,theHerceptinbiosimilarpipelineisquiterobust,withPfizer,Amgen,andSamsungallintestingphases(seenextslide).

    46

  • Herceptinbiosimilarsfaceamplecompetition

    Source:BernsteinResearch

    47

  • ConclusionThepointsmadeinthisreportindicatethatCelltrion islikelytofacequestionsnotonlyfrominvestors whoreasonablymayaskwhetherthepossibilityofaFDAapprovalforRemsima isenoughtocompensatefortherisksofacompanywhichhasalreadyrecognizedthemajorityofsalesfromabestcaseregulatory,legal,andfinancialoutcome,andnowfacestheburdenofastaggeringandcomplexdebtloadsales butalsofromconsumers,regulators,partners,andtheKoreangovernment.

    Consumersmaynotfinditagoodvaluetousemedicationwhichispotentiallyexpiredfarpastitsshelflife,andwhichtheavailablefactssuggestoriginatedinaconvoluteddistributionscheme,foronlya30%pricediscount.

    Regulatorsmayquestionwhethertheycantrusttheclinicalresults,manufacturingprocess,andqualitycontrolofacompanythatthefactssuggestisproducingquestionablefinancials,engagingindeceptivepractices,andcreatingamassiveinventoryofexpireddrugs.

    PartnerssuchasPfizer/Hospira mayquestionwhethertheyshouldcontinuetopartnerwithacompanyaboutwhichquestionsarebeingraisedaboutitsfinancialandoperationpractices.

    AndtheKoreangovernmentmayconcludethatitdoesnotwishtocontinueprovidingsubsidiestoacompanyaboutwhichsubstantialquestionsarebeingraisedsuggestingthatitmaybedeceivinglocalshareholders.

    481.Companyfilings