Pfizer (PFE) Earnings Report: Q2 2015 Conference Call...
Transcript of Pfizer (PFE) Earnings Report: Q2 2015 Conference Call...
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
©2014TheStreet,Inc.Al l R ightsReserved Page1of23
Pfizer(PFE)EarningsReport:Q22015ConferenceCallTranscriptThefollowingPfizerconferencecalltookplaceonJuly28,2015,10:00AMET.Thisisatranscriptofthatearningscall:
CompanyPart icipants
ChuckTriano;PfizerInc.;SVPofIRIanRead;PfizerInc.;ChairmanandCEOFrankDAmelio;PfizerInc.;CFOMikaelDolsten;PfizerInc.;PresidentofWorldwideR&DGenoGermano;PfizerInc.;PresidentofGlobalInnovativePharmaAlbertBourla;PfizerInc.;PresidentofVaccinesOncology&ConsumerJohnYoung;PfizerInc.;PresidentofEstablishedPharma
OtherPart icipants
GreggGilbert;DeutscheBank;AnalystMarcGoodman;UBS;AnalystTimAnderson;Bernstein;AnalystJamiRubin;GoldmanSachs;AnalystMarkSchoenebaum;EvercoreISI;AnalystAndrewBaum;Citigroup;AnalystColinBristow;BofAMerrillLynch;AnalystVamilDivan;CreditSuisse;AnalystChrisSchott;JPMorgan;AnalystAlexArfaei;BMOCapitalMarkets;AnalystJohnBoris;SunTrustRobinsonHumphrey;AnalystJeffHolford;JefferiesLLC;AnalystDavidRisinger;MorganStanley;AnalystSeamusFernandez;LeerinkPartners;Analyst
MANAGEMENTDISCUSSIONSECTION
Operator :
WelcometoPfizer'ssecond-quarter2015earningsconferencecall.Today'scallisbeingrecorded.
Atthistime,IwouldliketoturnthecallovertoMr.ChuckTriano,SeniorVicePresidentofInvestorRelations.Pleasegoahead,sir.
ChuckT riano (SVPofIR):
Thankyou,operator.Goodmorning,andthanksforjoiningustodaytoreviewPfizer'ssecond-quarter2015performance.
Asusual,I'mjoinedtodaybyourChairmanandCEO,IanRead;FrankDAmelio,ourCFO;MikaelDolsten,PresidentofWorldwideR&D,AlbertBourla,PresidentofVaccines,Oncology,andConsumer;GenoGermano,PresidentofGlobalInnovativePharma;JohnYoung,PresidentofEstablishedPharma;andDoug
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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Lankler,ourGeneralCounsel.Theslidesthatwillbepresentedonthiscallcanbeviewedonourhomepage,Pfizer.com,byclickingonthelinkforPfizerquarterlycorporateperformancesecondquarter2015,whichislocatedintheInvestorPresentationsSectioninthelowerright-handcornerofthispage.
Beforewestart,I'dliketoremindyouthatourdiscussionsduringthisconferencecallwillincludeforward-lookingstatements,andactualresultscoulddiffermateriallyfromthoseprojectedinthesestatements.Factorsthatcouldcauseactualresultstodifferarediscussedinour2014AnnualReportonForm10-K,andinourreportsonForms10-Qand8-K.
DiscussionsduringthecallwillalsoincludecertainfinancialmeasuresthatwerenotpreparedinaccordancewithGenerallyAcceptedAccountingPrinciples.Reconciliationofthosenon-GAAPfinancialmeasurestothemostdirectly-comparableGAAPfinancialmeasurescanbefoundinourcurrentreportonForm8-K,datedtoday.
We'llnowmakesomepreparedremarks,andthenwe'llmovetoaQ&Asession.Withthat,I'llnowturnthecallovertoIanRead.Ian?
IanRead (ChairmanandCEO):
Thankyou,Chuck,andthankyouforjoiningourcallthismorning.DuringmyremarksthismorningIwillbrieflyrecapthehighlightsfromthequarter,providesomecommentsonkeyareasoffocuswithinthepipeline,andclosewithafewwordsaboutbusinessdevelopmentandthependingHospiraacquisition.
Startingwiththequarter,itwasanotherquarterofstrongoperationalperformance.Forthethirdconsecutivequarterwesawoperationalrevenuegrowth,excludingtheimpactofforeignexchange,anddespiteLOEheadwinds.Wecontinuetoseesolidrevenuegrowthfromournewerproducts,asaresultofinvestmentswe'vebeenmakinginR&Dandourcommercialoperations.
Specificallyinthesecondquarterascomparedtothesameperiodlastyear,Eliquisalliancerevenuesnearlytripledonaglobalbasis,andXeljanzrevenuenearlydoubled.Prevnar13revenueintheUSincreased87%,primarilyduetocontinuedstronguptakeinPrevnar13inadults,withmostofthegrowthintheoverallPrevnar13franchisecomingfromtheadultindicationinthisquarter.WehavedoneanexcellentjobforthefirsthalfofthisyearofgettingtopatientsandcapturingthepotentialofPrevnar13adultsintheUS,asevidencedbytheoutstandingyear-to-dateperformance,whichhasbeenprimarilydrivenbythecatch-upopportunity.
Overthenextfewyears,webelievethiscatch-upopportunityintheUSwillberobust.However,wewilllikelyneedtoexpendmoreefforttoreachtheseindividuals,andtheopportunitywillmoderateovertime,asthecatch-upopportunitybecomesfullyrealized.Andgivencurrentdemographicsandagingtrends,approximately4millionAmericanswillturn65eachyear,andapartoftheseadultswillbepartofourimmunizationeffort.
Aswemovethroughthecatch-uppopulationandgettoamorenormalizedadultimmunizationratedomestically,we'llbeexpandingoureffortstocaptureexpectednewgrowthoutsidetheUS.Giventheagingdemographictrends,weexpecttoobtainseveralpneumoniarecommendationsandreimbursementsbetween2016and2018inmanyinternationalmarkets.
Ibrancecontinuestobewell-receivedbyoncologiststreatingpostmenopausalwomenwithER-positiveHER2negativeadvancedbreastcancer,withapproximately3,000healthcarepractitionersalreadyprescribingIbrance.Thisisupfrom800attheendofthefirstquarter.Ourcurrentfirstlinemarketshareinthispatientpopulationwasapproximately22%duringthequarter,upfrom10%duringthefirstquarter.
WelookforwardtofilingforapprovalintheEUlaterthisyear,andareworkingtoaddthedatafromthe
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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PALOMA-3studytoourUSlabelforwomenwithHR-positiveHER2-negativemetastaticbreastcancer,whosediseasehasprogressedduringorafterendocrinetherapy.IwouldnotethatalloftheseproductsIjustmentionedarenowmeaningfulcontributorstoourbusiness.Wealsosawquarter-over-quarteroperationalgrowthfromseveralofourin-linekeyproducts,includingLyrica,Sutent,XalkoriandInlyta.
Inourconsumerbusiness,wesawquarter-over-quarteroperationalgrowthfromseveralbrandsincludingCentrum,Advil,Robitussinand[Immersion]CC.WeareseeingstrongperformancefromNexiumOTC,despiteadeclinethisquarter,duetothenon-recurrenceofinitialretailerstockingassociatedwiththelaunchlastMay.Sinceitslaunch,Nexiumhasgeneratedrevenuesofapproximately$300million,makingitoneofthelargestandmostsuccessfulRxtoOTCswitches.
RegardingotherRxtoOTCopportunities,wehavereceivedthetoplineresultsfromtheLipitoractualusetrialthatwascompletedlastDecember.Theresultsshowthatco-primaryendpointswerenotachieved.
BasedonouranalysisofthedataandrecentfeedbackfromtheFDAontheoverallprogram,wehavedecidedtoterminatetheprogram.Thatsaid,wecontinuetoevaluateotherproductsforpotentialRxtoOTCswitches.Andwithinemergingmarkets,revenuesincreased6%operationallycomparedtotheyear-agoquarter,drivenbyoperationalgrowthinPrevnar,Lyrica,andLipitor.
Thisquarterwasafavorableexampleofourtrackrecordofasolidoperatingperformance.Givenourstrongexecutionacrossthebusinessesduringthefirsthalfoftheyear,coupledwithanimprovedoperationaloutlookfortheremainderofthisyear,weareraisingthemidpointsofour2015financialguidanceforreportedrevenueby$500million,andforreporteddilutedEPSby$0.03pershareandadjustedEPSby$0.04.
Asweenterthesecondhalfofthisyear,ourstrategy,focusandprioritiesremainunchanged.Toplinegrowthremainsapriority.OverthelastthreequarterswehaveseentoplineoperationalgrowthonatotalCompanybasis.
Recentproductlaunchesinkeyin-lineproductshaveperformedwell,whiletheimpactfromtheremainingLOEshasdiminished.Forexample,theimpactfromtheCelebrexLOEwillbeannualizedafteranothertwoquarters,andZyvoxshortlyafterthat.Oncethishappens,we'llhaveputthemostsignificantLOEsbehindus,andexpecttoreturntoamoremeasuredcycleofproductlossofexclusivity.
Weremainsteadfastinoureffortstodeliverthenextwaveofpotentialnewinnovativetherapiesoverthecomingyears.Theareaswhereweseethelargestpotentialtobenefitpatients,andwherewe'refocusingourresourcesincludebuildingastrongimmuno-oncologyportfolio.ThroughourthroughouragreementwithMerckKGaA,webelievewehaveoneofthemostcomprehensiveIOplatformsindevelopmentinthepharmaindustrytoday.Wehave--weexpecttohavefivedifferentIOdrugsintheclinicthisyear,andupto10differentdrugsby2016.
Thekeytargetsincludeavelumab,theanti-PD-L1,OX40,4-1BB,ourvaccine-basedimmunotherapyregime,CCR2,[IDA1],andseveralbifunctionalantibodies.WebelievethatthesecombinationsarethekeytobetterpatientoutcomesinIO,andgiventhebreadthofourassets,wethinkwearewell-positionedtowinhere.Wewillbecollaboratingonupto20studieswithMerckKGaA,andweplantohaveuptosiximmunologyPhaseIIItrialsongoingbytheendoftheyearacrossseveraltumortypes,includingnon-smallcelllungcancer,ovarian,renal,bladder,andgastric.Oursecond-linenon-smallcelllungcancerregistrationstudyiscurrentlyrecruiting.
Andwherepossible,wewillbelookingtoacceleratethesestudies.Forexample,weareplanningtomovequicklyintoaregistrationstudywithavelumabincombinationwithInlytainkidneycancerlaterthisyear.
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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Wealsocontinuetobuildourpalbofranchise,movingourR&Deffortsintoearlystagesofthetreatmentparadigm,aswellasinnon-breastcancerindications.Incardiovascular,wehaveacomprehensivePhaseIIItrialprogramforbococizumab,ourinvestigationalPCSK9inhibitor,withpotentialtolowerlow-densitylipoproteincholesterolandimprovecardiovascularoutcomes.WeanticipateourLipitor-loweringtrialswillcompletein2016,andweestimatethatourCVoutcomesdatawillbeavailableinthefirsthalfof2018.
Theoutcomestudiesaretimetoeventtrials,soitisdifficulttopredictexactdates,butweanticipatethiswillbeconsistentwiththetimingofotherindustryoutcomestudiesexpectedbyourpeers.OurertugliflozinPhaseIIIprogramiswellunderway,andgivenJanuvia'srecentpositiveCVoutcomesclinicaltrialsresults,weremainenthusiasticaboutthedemandpotentialfortheertugliflozin-Januviacombination,inanareaofsignificantpatientneed.
Invaccines,werecentlystartedaPhaseIIbstudyforastaphaureusvaccine,anddependingupontheresults,itcouldserveasaregistrationalstudy.Also,thismonth,weinitiatedaPhaseIIstudytoevaluatethesafety,tolerability,andimmunogenicityofourinvestigationalCdifficilevaccine.Bothofthesevaccinescouldbekeytostemmingthespreadoftheleadingcausesofserioushealthcare-associatedinfections.
Inimmunology,theFDAacceptedourreviewforasupplementarynewdrugapplicationforXeljanzonce-a-daymodifiedreleasetablets.OurPDUFAdateisFebruaryofnextyear.Ifapproved,itwouldbringusonestepclosertoofferingthefirstandonlyonce-a-dayoralJAKkinaseinhibitortreatmentforthoselivingwithmoderatetosevereRA,whohavehadaninadequateresponseorintolerancetomethotrexate.Webelievethiswillbeanimportantproductmodification.
Inrarediseases,weenrolledthefirstpatientsinPhaseIIIclinicaltrialsassessingtheefficacyandsafetyofrivipansel,forthetreatmentofvaso-occlusivecrisisinhospitalizedindividualswithsicklecelldiseasewhoaresixyearsofageorolder.Andadditionalclinicalstudiesareunderwayforpreventionofsicklecellcrisisdisease.Webelievethiswasbuiltonourstrengthinresearchingandbringingtomarkettherapiesforhematologicalrarediseases,basedonourdeephistoryofhemophilia.
Inbiosimilars,westartedaPhaseIIIclinicaltrialofourpotentialbiosimilartoadalimumab,makingatotaloffivemonoclonalbiosimilarsnowinPhaseIIIdevelopment.Insterileinjectables,we'reexcitedabouttheopportunitytocombinePfizer'sbrandedportfolioinglobalcommercialorganization,withHospira'sdemonstratedR&Dcapability,andmanufacturingcapacityofsterileinjectableproducts,andthiswilloccuruponthecloseoftheacquisition.
Overall,asaresultoftheworkwehavedonetofocusourR&Deffortsintheareasthatwebelieveofferthegreatestpotentialfortherapeuticbenefitandchanceforcommercialsuccess,wearebuildingastrongerportfolioonbehalfofourpatientsthatwebelievewillcreatevalueforourshareholders.
Turningnowtoafewwordsonbusinessdevelopment.Itremainsenablerofourstrategies,andasI'vesaidbefore,isnotastrategyonitsown.Whileweareseeingstrongperformancefromourrecentproductlaunches,overthenextfewyears,wearelookingatbusinessdevelopmentasawaytoinvestingeneratingsustainednear-termandfuturegrowth.Knowingthatthenextwaveofourpotentialmajorregistrationsorlauncheswon'thappentill2017.Intheinterim,wehavethefinancialcapacitytoactuallyseekouttherightdealsattherightprice,thatwillcreatevalueforourshareholders.
Weareoptimisticthatwecanfindthesedealsaswegothroughtheperiodto2017.Inkeepingwiththisphilosophy,wehaveproactivelyevaluatedvirtuallyallofthedealsannouncedthisyear,andhavechosentopursueonlythosethatefficientlyusecapitaltostrengthenthebusiness,drivegrowth,andacceleratevalue.Forexample,wehaveenteredintoseveralagreementsyear-to-datethathave
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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bolsteredourscientificintegralcapabilities,andprovideduswiththepotentialfornewgrowthopportunities.OfparticularnotearethetwomostsignificanttransactionswithMerckKGaAinimmuno-oncology,andthependingacquisitionofHospira.
RegardingHospiraweareproceedingontrackandareawaitingregulatoryapprovalfromseveraljurisdictions.Wecontinuetoexpectthetransactiontocloseinthesecondhalfoftheyear.
Inclosing,Iampleasedwithourstrongfinancialposition,newandin-lineproductperformance,pipelineadvancements,andrecentbusinessdevelopmentactivity.Weareperformingwell,andfortheremainderofthisyear,wewillfocusonservice,strengtheningbothourinnovativeandestablishedbusinesses,tobestpositionthemfortheirlong-termsuccess.I'llnowturnitovertoFranktotakeyouthroughthefinancialdetailsofthequarter.
FrankDAmelio (CFO):
Thanks,Ian.Goodday,everyone.Asalways,thechartsIamreviewingtodayareincludedinourwebcast.
Second-quarter2015reportedrevenueswereapproximately$11.9billion,andreflectyear-over-yearoperationalgrowthof$125million,or1%,mainlydrivenbythestrongperformanceofPrevnar13adult,Eliquis,Ibrance,andXeljanz,allofwhichareearlyintheirlifecycles.TheadditionofvaccinesacquiredfromBaxterin2014,andoperationalgrowthof6%inemergingmarkets,mainlyduetoLipitorandPrevnar13.
ReportedrevenueswereunfavorablyimpactedbythelossofexclusivityofCelebrexandZyvoxintheUS,andLyricaincertaindevelopedEuropeanmarkets.AdjusteddilutedEPSwas$0.56versus$0.58intheyear-agoquarter.Thedecreasewasprimarilyduetothe$0.06negativeimpactofforeignexchange,andpartiallyoffsetbyalowereffectivetaxrate,andfewerdilutedweightedaveragesharesoutstanding,whichdeclinedby201millionsharesversustheyear-agoquarter,duetooursharerepurchaseprogram.Whichincludestheimpactofour$5billionacceleratedsharerepurchaseagreementexecutedinFebruaryof2015,andcompletedinJuly.
Iwanttopointoutthatexcludingtheunfavorableimpactofforeignexchange,adjusteddilutedEPSwouldhaveincreasedbyapproximately6%.ReporteddilutedEPSwas$0.42comparedwith$0.45intheyear-agoquarter,duetothepreviouslymentionedfactorsandtheunfavorableimpactofhigherlegalchargesandacquisition-relatedcostsassociatedwiththependingacquisitionofHospiraversustheyearagoquarter,aswellaschargesincurredduringthesecondquarterof2015forlegalentityalignmentactivities.Partiallyoffsetbylowerrestructuringandotherchargesassociatedwithcostreductionandproductivityinitiatives,lowerpurchaseaccountingadjustments,andalowereffectivetaxrateversustheyear-agoquarter.
Foreignexchangenegativelyimpactedsecond-quarterreportedrevenuesbyapproximately$1billionor8%,andpositivelyimpactedadjustedcostofsales,adjustedSI&Aexpenses,andadjustedR&Dexpensesintheaggregateby$518millionor7%.Asaresult,foreignexchangenegativelyimpactedsecond-quarteradjusteddilutedEPSbyapproximately$0.06comparedwiththeyear-agoquarter.
Nowmovingontothefinancialhighlightsofourbusinesssegments.Inthesecondquarter,globalinnovativepharmaceuticalrevenuesincreased8%operationallyyear-over-year,duetothestrongperformanceofrecently-launchedproductsincludingEliquisgloballyandXeljanzintheUS,andthecontinuedstrongperformanceofViagraintheUSandLyricaintheUSandJapan,whichwerepartiallyoffsetbydeclinesofRapamuneandBeneFIXintheUS.
Incomebeforetaxesincreased9%operationally,duetotheoperationalincreaseinrevenuesandthe2%operationaldecreaseincostofsales,partiallyoffsetbya6%operationalincreaseinSI&A
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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expenses,primarilyduetoadditionalpromotionalinvestmentincertainin-lineandrecentlylaunchedproducts.Andthe21%operationalincreaseinR&D,reflectingincrementalinvestmentsinourlate-stagepipeline,primarilyforbococizumab.
Second-quarterVOCrevenuesincreased29%operationally,duetothe52%operationalrevenuegrowthfromourglobalvaccinesbusinessasaresultofPrevnar13,whichgrew87%intheUS,duetocontinuedstronguptakeinadultsand10%internationally,andtheinclusionofBaxter'smarketedvaccinesinEurope.A36%operationalincreaseinoncologyrevenues,drivenbythelaunchofIbranceintheUSinFebruary,andtoalesserextentbySutent,Inlyta,andXalkori.
Incomebeforetaxesincreased51%operationally,mainlyduetoincreasedrevenuesandassociatedimprovementingrossmargin,anda16%operationaldecreaseinR&DexpensesasaresultoflowerclinicalspendforTrumenba,Prevnar13adult,andcertainoncologyproducts.Whichwerepartiallyoffsetbya15%operationalincreaseinSI&Aexpenses,duetoincreasedinvestmentinboththePrevnar13andIbrancelaunches.Inthesecondquarter,globalestablishedproductsrevenuesdecreased14%operationally,mainlyduetothelossofexclusivity,andimmediatemulti-sourcegenericcompetitionforCelebrexintheUS.
InDecemberof2014,genericcompetitionforZyvoxintheUS,andLyricaincertaindevelopedmarketsinEuropebeginninginthefirsthalfof2015.Andtoalesserextent,fromcontinuedgenericcompetitionforLipitorindevelopedmarkets,andtheterminationoftheSpirivaco-promotionagreementinmostcountries,includingtheUSinAprilof2014.Allofthesewerepartiallyoffsetbyoperationalgrowthof2%inemergingmarkets,primarilydrivenbyLipitor.
Incomebeforetaxesdeclined17%operationally,duetothedecreaseinrevenues,a1.5percentagepointoperationalincreaseincostofsalesasapercentageofrevenuesduetounfavorablechangeinproductmix,a3%operationalincreaseinR&Dexpensesreflectingincreasedspendinginourbiosimilarsandsterileinjectablesdevelopmentprograms,largelyoffsetbylowerpost-marketingclinicaltrialexpenses,allofwhichwerepartiallyoffsetbyan11%operationaldecreaseinSI&Aexpenses,drivenbycostreductionandproductivityinitiatives.
Becauseofourstrongoperationalperformanceandimprovedoperationaloutlookfortheremainderoftheyear,weareraisingthemidpointofour2015guidancerangesforreportedrevenuesby$500million,andthemidpointofouradjusteddilutedEPSguidanceby$0.04.Wenowexpectreportedrevenuestobeintherangeof$45billionto$46billion,andadjusteddilutedEPStobeintherangeof$2.01to$2.07.
WealsonowexpectreporteddilutedEPStobeintherangeof$1.38to$1.47.Inaddition,basedonouryear-to-dateresults,wenowexpectcostofsalesasapercentageofrevenuetobeintherangeof18%to18.5%versusourpreviousexpectationof18.5%to19.5%.
ToreflectincrementalexpensesforongoingPhaseIIIprograms,wenowexpectR&Dexpensestobeintherangeof$7.3billionto$7.6billionversus$6.9billionto$7.4billionpreviously.It'simportanttonotethatanychangesinforeignexchangeratessincemid-April,whichexcludetheimpactofpotentialdevaluationoftheVenezuelanBolivar,didnotmateriallyimpactourlatestguidance.
Ialsowanttopointoutthatwearecontinuingtoabsorbanestimated$3.4billionnegativeimpactduetocontinuingproductlossesofexclusivityanddecliningalliancerevenues,andanestimated$3.3billionnegativeimpactfromunfavorablechangesinessentiallyallforeignexchangeratesrelativetotheUSdollar,comparedtoforeignexchangeratesin2014.
Movingontokeytakeaways,weachievedanotherquarterofsolidfinancialperformance,primarilydrivenbyproductsthatareintheearlystagesoftheirlifecycles,Prevnar13adult,Eliquis,IbranceandXeljanz.AlsoIwanttopointoutthatthisisthethirdconsecutivequarterofoperationalrevenuegrowth.
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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Wehaveraisedthemidpointsofour2015reportedrevenueandEPSguidancerangestoreflectourstrongoperationalperformanceandimprovedoperationaloutlookfortheremainderof2015.WeachievedseveralkeyR&Dmilestonessinceourfirst-quarterupdate,includingFDAacceptanceofourNDAforXeljanzonce-daily,theanticipatedPDUFAdateFebruaryof2016,andthepresentationofdataforourimmuno-oncologyportfolioatASCO,whichincluded10abstractsonavelumabwithourpartnerMerckKGaA,andresultsfromourPhaseIstudyofouranti-4-1BBantibody.
Wecontinuetocreateshareholdervaluethroughprudentcapitalallocation.Todate,in2015,we'vereturned$9.6billiontoshareholdersthroughdividendsandsharerepurchases,andwecontinuetoexpecttoreturnapproximately$13billiontoshareholdersin2015throughacombinationofdividendsandsharerepurchases.
Finally,weremaincommittedtodeliveringattractiveshareholderreturnsin2015andbeyond.Now,I'llturnitbacktoChuck.
ChuckT riano (SVPofIR):
Thankyou,FrankandIan,forthesummary.Withthat,operator,canwepleasepollforquestions?
QUESTIONS&ANSWERS
Operator :
(OperatorInstructions)
GreggGilbert,DeutscheBank.
GreggGilbert (Analyst-DeutscheBank):
First,ontheimmuno-oncologyfranchise,whileyou'resomewhatbehind,Ian,canyoucommentonsomeoftheaspectsofyourstrategyinIOthatmightnotbefullyappreciatedbytheinvestmentcommunity?Andmysecondquestion,perhapsforeitherofyou,onthesubjectofwhatyoucallbusinessandlegalentityalignmentactivities,thosecostsaregrowingstrongly.Canyouofferanycolorastowhenthoseactivitiesmightwrapup,oratleastwhatsomekeymilemarkersarealongthewayonthatprocess?Thanks.
IanRead (ChairmanandCEO):
Thankyou,Gregg.WebelievethatwewillbefirstinsometumortypeswiththePD-L1fromMerck.Butwealsofeelit'sveryimportanttounderstandthatwe'rejustatthebeginningofthisimmuno-oncologywave,andwehave,asIhavecommentedpreviously,asubstantialnumberofassetsthatcanbecombinedandadded,bothwithimmuno-oncologyassets,andwiththebackbonetargetedtherapiesorchemotherapy,orwithInlyta,orwithXalkori,withIbrancepotentially.
Sowefeelthatasthismarketdevelops,what'sgoingtobereallyimportantistheabilitytohavecombinationproducts,andtheabilitytohaveamorefullercontrolofthetotalvalue,orthetotalpricingofthosecombinationproductstothepayers.SowebelievethatPfizerwillbeverywell-positioned,withmultiplecombinationsofimmuno-oncologyassets,andcombinationswithitsownin-lineassets,tobeveryeffectiveinthosecombinations.Frank,doyouwanttotalkaboutthe--
FrankDAmelio (CFO):
Sure.Onthebusinessandlegalentityalignment,letmerunthenumbersfirst,andI'llanswerthequestion.Whichisforthequarter,wespent$63millionyear-to-date,$164millioninbusinessandlegalentityalignmentcost.Isaidpreviously,weforecastedaspendofapproximately$400millionfortheyear,
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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we'llbegiveortakingthatrangeofapproximately$400million.Thespendwillcontinue,obviouslyfortherestof2015through2016,we'vetalkedaboutadecisiononalignmentinthefourthquarterof2016,bynolaterthanthefourthquarterof2016sospendingobviouslywouldcontinuethroughthen,atwhichpoint,wemakeadeterminationgoingforwardbasedonthedecision.
ChuckT riano (SVPofIR):
Thanks,Frank.Nextquestionplease,operator?
Operator :
MarcGoodman,UBS.
MarcGoodman (Analyst-UBS):
Firstquestionis,canyougiveusyourlatestthoughtsonwhat'sgoingoninChina,aswellasjustthebroaderemergingmarkets?Second,inthepressrelease,ittalkedaboutforPrevnar,theGAVIshipmentsandemergingmarketshadsomespecialprograms.Canyougiveusasenseofhowmuchofthatwasone-timersversuswhatweshouldexpectongoing?AndthenIthinkyoumentionedhowmuchFXhityourexpensesbutcanyoucarveoutthegrossmarginspecifically,andhowmuchthathadanimpact?Thanks.
IanRead (ChairmanandCEO):
Weremain,aswesaid,optimisticaboutthelong-terminChinaandtheemergingmarkets.Wecontinuetoseeasecularmovementtomiddle-classandwealthcreation.IwouldaskJohnYoung,whomanagesthemajorityofourbusinessintheemergingmarkets,tomakesomecommentsspecificallyonChina,andperhapshisviewoftheopportunitiesmorebroadlyinemergingmarkets.
JohnYoung (PresidentofEstablishedPharma):
Thanksforthequestion,Marc.IthinkIansaiditheadoninourview,insummaryform.It'sobviouslyasignificantpopulation,1.3billionpeople.Wecontinuetoseestrongeconomicgrowth,albeitmoderatingeconomicgrowth,butweenvisagethateconomicgrowthwillcontinue.
AndIthinkasIanhasalreadyflagged,weseeacontinuedcommitmentfromtheChinesegovernmenttoexpandaccesstohealthcare,toqualityhealthcare,tocitizens.Wedon'tseethattrendhaltingintheshorttomedium,eventhelonger-term.Andsowebelievethatactuallyformanufacturerssuchasourselves,whoareinpositionedwellinChinawithastrongexistingbase,astrongnetworkofjointventures,andaportfoliofranklythatiswell-suitedtotheneedsofChinesepatients,rangingfromourinnovativeportfoliowithoncologymedicinesandvaccinesinthefuture.Aswellastoday'sportfolio,suchasLipitor,whichisobviouslyaleadingtreatmenttohelptomanagecardiovasculardisease,whichisagrowingconcernforChinesepatients.
Sowhenyousumallofthatup,weknewthatwewillcontinuetoseesomepressuresonourbusinessinChinaandpricing.Wefactorthatintoourforward-lookingviews.ButwecontinuetoseeChinabeingasignificantopportunityforfuturegrowth.
IanRead (ChairmanandCEO):
Okay.Similarstoryhasplayedoutinmostoftheemergingmarketstooindifferingforms.Albert,doyouwanttotalkabouttheGAVIshipments,andthoseitemsthatwereraised?
Albert Bourla(PresidentofVaccinesOncology&Consumer):
Yes.Iwouldn'tcallthemone-time.WhatishappeningwiththeGAVIbusinessisthatthereisvolatility.
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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VolatilitydependswhenCDCwillplaceanorder,whenGAVIwillplaceanorder,orwhenNAPwilloccur,sothisvolatilitywillcontinue.Thisisthenormalcourseofavaccinesbusiness.Butingeneral,theoutlookisdoingverywellthisquarter,with5%overallgrowth.
IanRead (ChairmanandCEO):
Thankyou.Frank,ontheFX?
FrankDAmelio (CFO):
Sure.Marc,lotsofmovingparts,obviously,thatimpactgrossmargin.Favorableitemswouldbethingslikeouroncologyandalliancerevenuegrowth.AnunfavorableitemwouldbeourUSLOEs.
Butmaybetheeasiestwaytodothisismacrolevelwithnumbers.Q2lastyear,ourcostofsalesasapercentageofrevenue,18.9%.Thisquarter,17.9%.Ifweremoveforeignexchangefromthisquarter,whichreducedcostofsalesby$255million,that17.9%becomes18.4%,soroughlyflatyear-over-year.Ifyougoyear-to-date,lastyear,year-to-date17.9%,thisyear,year-to-date,17.3%.Ifweremoveforeign-exchange,that17.3%becomes18.2%.Onceagain,relativelyflatyear-over-year,withalotofmovingpartsimpactingthenumber.
ChuckT riano (SVPofIR):
Thankyou,Frank.Operator,nextquestion,please?
Operator :
TimAnderson,Bernstein.
T imAnderson (Analyst-Bernstein):
Thanks.IfIcouldgobacktothetopicofM&A,andIknowyoumadesomecommentsearlier.WatchingtheBigPharmaindustryforalmost20years,seemslikeBigPharmacompanieshaveveryoftennotparticipatedinbiotechM&A,becausethere'sbeenthislong-standingsensethatthevaluationsaretoohigh.AndifIlistentowhatseveralcompaniessay,nowatthecurrentpointintime,severalBigPharmacompaniesagain,raisethatconcern.IfIlookatwhatPfizerhasboughtovertheyears,it'sgenerallybeeneitherBigPharmacompaniesorothertypesoftargets,likeHospira.
Somyquestiontoyouis,howdoyoucurrentlyviewvaluationsinthebiotechspace,andhaveyouloosenedupatallonyourvaluationframework,suchthatyouthinkyoucanfindvalueinthebiotechlandscapeatthecurrentlevelsofvaluation?AndthenthesecondquestionisonEnbrel,andwhetheryouexpecttoseeanypressurecausedbybiosimilarRemicadenowbeingavailableinEurope,whetheryouexpectpressureinyour2016or2017,ormaybeeveninthecurrentyear?
IanRead (ChairmanandCEO):
Okay.I'llmakesomecommentsontheM&A,andthenI'llaskGenotocommentonEnbrelinEurope.Tim,Ibelievethatthemarketplaceisextremelyefficient,andthatthevaluationsinbiotechareinmanyways,pricedtoperfection.Butofthedealsthathavebeendone,wehavelookedatthem.Thedealsworkforsomecompaniesbecauseoftheirportfolio,becauseoftheirabilitytoachievesynergiesinwaysthatwecouldn't.
Wedoremaindisciplinedonourcostofcapital.Wethinklong-termthat'simportant,thatpeopleinvestinPfizerexpecttheirreturn--risk-adjustedreturnonthecostofcapital.Thatmeansthatwedon'texpecttofindvalueinthemarketplace.Therearealwaysopportunities.Westandready.Wehavethecash,wehavethecapability,wehavethemanagementteam.Wearecontinuallylookingforthoseopportunities.
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AsIsay,I'moptimisticthatwe'llbeabletodeployourcapitalinawaythatwillincrementvaluetoshareholders.Iwouldsay,further,thatifyoulookattheestablishedproductsbusinessandtheinnovativebusiness,ifthereweretwoprojectsandbothofthemwererisk-adjustedequal,ourinclinationwouldbetodo,forportfolioreasonssomethingininnovativespaceratherthantheestablishedspace,giventhatwe'vedonetheHospiraacquisitionforestablished.Soonceagain,I'mverywellawarethatthereisanactivemarketofbusinessdevelopment.Wethinkwe'vedonetheonesthatareprudent.Weevaluateallouropportunities,andwe'reoptimisticthatwe'regoingtofindandhavesufficientcouragetofindthoseopportunitiesthatcomeintothemarketplace.Sowiththat,I'llpassitovertoGenotolookatEnbrel.
GenoGermano (PresidentofGlobalInnovativePharma):
Sure,Tim.Enbrelcontinuestodowell.Wehadgood2%operationalgrowththisquarteroutsidetheUnitedStates,onaverylargebase,sothebusinesscontinuestodeliverforus.WithregardtoRemicadebiosimilars,we'renotseeingasignificantimpactontheEnbrelbusiness.Giventhedifferentadministrationroutes,Remicadebeinginfusion,andEnbrelandHumiraandothersbeingself-injectedtherapies,wedon'tseealotofoverlapbutthere.There'salotofexperimentationgoingoncountrybycountry,sothere'salwaysapossibilitythatwe'llseesomenewthingshappening,butoverall,we'renotseeingareexpectingamajorshiftintheEnbrelbusinessrelatedtotheRemicadebiosimilar.
ChuckT riano (SVPofIR):
Thankyou,Geno.Operator,canwemovetothenextquestion,please?
Operator :
JamiRubin,GoldmanSachs.
JamiRubin (Analyst-GoldmanSachs):
Ian,inyourpreparedremarks,yousignaledM&Aactivityfocusedontoplinegrowthbridgingthegapto2017filings.Twoquestionsrelatedtothat.AreyoubackingofffrombreakinguptheCompanyofstrategyyououtlined--orcertainlyoutlinedtheoptionalityforacoupleyearsago?Whereareyouonthat?
Andnumbertwohowbigwouldyouconsidergoing?Canyouthrowoutsomeparametersthereintermsofsize?Isitallabouttoplinegrowth?Issynergiesabigconsideration,andalso,youhadtalkedbeforeabouttaxinversionsbeinganimportantpartofthatequationtoo,soifyoucanputthatinperspective?AndthenmylastquestionrelatestoLipitorOTC.Nowthatproductdoesn'tappeartobegoingforward,wouldyouconsiderputtingyourconsumerbusinessupforsale?Thanks.
IanRead (ChairmanandCEO):
Jami,asalwaysthreebigquestions.Onthebreak-up,wehavenotchangedourviewsonwantingtohavetheoptionalityofthebreakup.Wecontinuetospendconsiderableamountsofmoneypreparingandputtingourselvesinaplacetotriggerthatoptionalityifwetakethatdecision.AndasIsaid,we'velaidoutthecriteriaforthat,whichincludesourbusinessisdoingwell.Dowethinktheycoulddowellontheirown?Istheretrapvalueandisthereafter-taxvaluethatcouldbeachieved?Andwewillmakethatdecision,bythelatest,fourth-quarterof2016onwhethertotriggerthatoptionality.
Onyourquestionaboutbig,small,growthopportunities,look,welookatitfromthepointofviewofasapharmaceuticalcompany,wewanttobuy,theidealofcourseistobuyapipelineandalsoproductsthataregrowing.Theseproductsandopportunitiesyouhavetohaveabeliefinthefuture,oftenthefuturepotentialoftheproductsyou'rebuying.There'salotinvolvedinanacquisitionthislarge.It'sa
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EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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combinationofwhatyouthinktheportfoliowilldo,whatyoubelievethesynergieswillcomethroughontheoperationalside,andofcourse,taxandtaxplanningplaysaroleinthat.
Sotoacertainextent,thediscussionsthataregoingoninWashingtonrightnowaboutapotentialinternationaltaxreformdoesaffectthewaywelookatthedifferentopportunitieswehaveinthemarketplace.You'dexpectustobelookingatthatverycarefully.Certainly,anyacquisitionwedomakewillhaveabiasonthenear-termrevenueopportunitiesandonaccretion.
OTC,look,theconsumerbusinessisatremendousbusiness,atremendousstoreofvalue.WetalkedNexiumOTC,andithasbeenanincrediblesuccess.Wecontinuetoinvestintheconsumerbusiness.Wealwayslookatourbusinesses,allofthem,onaregularbasisandourstrategicplanvis-a-viswhatparttheyplayinthetotalvalueofPfizershareholders.Wearealwaysreviewingthat.Atthismoment,IthinktheconsumerbusinessisaveryvaluableandgrowingassetforPfizer.
ChuckT riano (SVPofIR):
Thanks,Jami.Ournextquestionplease,operator?
Operator :
MarkSchoenebaum,EvercoreISI.
MarkSchoenebaum(Analyst-EvercoreISI):
Thankyouforaveryclearopeningstatement.Allofyou,it'salwaysveryhelpful.Iwanttogobackandbuildonsomeofthequestionsthathavealreadybeenasked,butthefirstoneis,Ian,andIknowyougetaskedthiseveryquarter,andI'msureChucktellsyougetaskedthiseveryquarter,butthisquarter,Ithinkit'sbecomealittlebitmoreofafocusforinvestors.
ThewidespreadWallStreetrumorsthatyoumightbeinterestedinsomethinglikeanAllergan.Iunderstandyouwouldn'tcommentonthat,butcanyoucommentingeneralonyourinterestininvertingatthispoint?Whatthethresholdswouldneedtobeversuswhattheofficialthresholdsrightnowtomakeyoucomfortablethatsuchinversioncouldbecompleted?IsinversionstillapriorityforPfizer?
SecondquestionwasforFrank.Maybeyou'vedisclosedthis,I'mnotsure,soit'sashameonmeifyouhave,butI'veheardfromlittlebirdiesthatmoneythatyou'vealreadyspentpreparingforseparation,thismighthavebeenembeddedtoanearlieranswer,itwasn'tcleartome,butthemoneythatyou'vealreadyspentpreparingforseparationofPfizerisontheorderof$1billion.I'djustliketoknowifthatnumber,ifyouarewillingpubliclytotalkaboutwhetherornotthatnumberisrealistic.
Andthenthefinalquestionis,andthisisatougherone,Idon'tknowifyou'llbeabletoanswerit,butsomeofushavebeennowthinkingabout,ifandwhenPfizersplits,perhapsinsteadoffloatingoneormoreofthesecompanies,theymightbestrategicacquirerforoneormoreofthesecompanies.AndIthinkwe'realltryingtogetasenseofwhatthecostbasisisforthesecompanies,sothatwecouldunderstandifit'srealisticthatsomeonecouldbuythem,orwouldthetaxburdenonsuchatransactionwouldbeprohibitive?Idon'tknowifthere'sanyfingerinthewind,wordsofwisdomyoucangiveus,Frank.Thankyou.
IanRead (ChairmanandCEO):
Mark,ontheinversionquestion,thereasonyoudoanydealis,aswesaidbefore,anditsoundslikemotherhoodandapplepie,butitisbecauseyoubelieveit'sgoingtocreatevalueforshareholderslong-term.Andsowecanremaininterestedinthepotentialofaninversion,becauseitwouldfacilitateandenablewealthcreationforshareholders.ItwouldcertainlyalsopositionPfizerundercurrenttaxlawsto
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
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be--itwouldliberateourbalancesheet,andwouldpositionustobefarmoreactiveintheM&Aspace,andcompetitive,whichiswhythereisallthispushtohavetaxreform,becauseatthemoment,theAmericancompaniesarenotascompetitiveasEuropeancompanies,giventhedifferenttaxrate.
SotheinversionisattractivebothbecauseitcreatesamajorvalueanditenablesyoutomeetthepremiumstoacquiretheCompany.Andit'sattractivebecauseitwillliberateyourbalancesheetforfutureactivityandspendingandcashflow.Andthat,initsturn,informsyouastowhatlevelofinversionyouwouldfindacceptable,whetheryouwantaninversionthatisbetween60and80orbelow60.Soit'sacomplexissue,andwe'renotfocusedtotallyoninversions.
It'sonlyacomponentofthebusinessdevelopmentstrategy,andonlycomesinwhenyoubelieveyouneedthatvaluethat'screatedbytheinversion,togettothepremiumtobuytheCompany.Butit'snotjust--inversionsisnotouronetrackbusinessdevelopmentstrategy.Withthat,I'llpassitovertoFranktoanswertheothertwodifficultquestions.
FrankDAmelio (CFO):
Thelittlebirdiequestions.Mark,year-to-datecumulativelytodate,becausethat'swhatyouasked,notyear-to-date,cumulativelytodate,wespent,giveortake,approximately$300million,whenIincludethe$164millionyear-to-datethisyear.Thethingtorememberaboutthesekindsofoptionalityprojects,thinkaboutcarve-outsasasense,there'samassiveamountofworkthatneedstobedone.Andwhenyou'relookingat--I'llcallitthetotalcoststructure,thesekindsofprojects,theydorunintothelowbillionsofdollars.That'sthenatureofwhattheydo.
Buthere'swhatyou'vegottoremember.Inthatnumber,there'staxleakage.Youdoeverythingyoucantominimizetaxleakage,butyou'vegottocreatemultiplelegalentities.Anytimeyou'recreatingmultiplelegalentities,ormorethanoneinthecountry,youcreatetaxexposure,taxleakage.There'spotentialleakageregardingdebtanddecision-makingyoumakearoundwhetherornotyou'regoingtorepurchasedebt.Andthenthere'sallthe,I'llcallitblockingandtackling,thatneedstobedoneinareaslikesystems.Legalentityandtaxplanning,regulatorywork,supplychain.It'samassiveamountofwork.
Andthinkaboutthevisual.ThisisaCompanythat'sbeenrestructuringforadecade.Integrating,puttingthingstogether,andnowyouwanttodosomethingwhereyou'retakingamajorpieceoftheCompanyandyou'regoingtocarveitoutinasense,undomuchoftheworkthatyou'vedonepreviously.Requiresalotofeffort,itcostsabunchofmoney.Butyear-to-date,whichiswhatyouaskedme,cumulativelytodate,it'sbeenabout$300million.
IanRead (ChairmanandCEO):
Thatbeingsaid,wedoseethelogicof,becausetherearetwodifferentbusinesses,andwedofeelthattheamountswewillneedtospendtoputourselvesinthepositiontocompleteoptionality,hasbeenmoneywellspentforshareholders,giventhepotentialupsideofwhatoptionalitycouldproduce.
FrankDAmelio (CFO):
It'sessentiallythecostofhavingtheoption,isreallywhatittranslatesto,Mark.It'sthecostofhavingtheoption.Andthenthelastpieceabouttaxbasis,obviously,it'sprematuretogetintotaxbasisofthebusinesses,butwhatIwouldsayis,tojustpunctuatewhatIansaid,thefourthcriteriaisbeingabletounlockthattrappedvalue,assumingthereissome,inataxefficientway.Soobviouslyanythingwewoulddowouldhaveextensivetaxplanning,andwouldminimizeobviously--ormaximizetheafter-taxreturnstoourshareholders.
ChuckT riano (SVPofIR):
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EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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Thanks,IanandFrank.Nextquestion,please,operator?
Operator :
AndrewBaum,Citigroup.
AndrewBaum(Analyst-Citigroup):
Threequestions,please.Firstly,justrevisitingthetaxquestion,couldyougiveussomesenseoverthenextthree,fiveyearswhereyoureffectivetaxrateisgoing,asthebusinesscurrentlystands,givingthechangeinmixofbusiness,particularlytheincreasingUScontribution?Andsecond,onthetax,viatheongoingdebatesinWashington,ortheprobabilityyoufeelofanymeaningfulchange,mayimprovetheeffectivetaxratethatyoupay?
Second,couldyoucommenthowtherecentTevaAllergandealimpactstheM&AlandscapefromthePfizerperspective?AndfinallyyouobviouslyreportedaverystrongquarterforPrevnar13.Towhatextentshouldweexpectaninventorydestockinthefollowingquarter?IE,howmuchofthisisindustrystocking,given,Iimagine,thatmostofthevaccinationsaregoingtohappeninadolescents.ButpleasecorrectmeifI'mwrong.
IanRead (ChairmanandCEO):
Thankyou,Andrew.Onthetaxquestion,wedon'tprojectourtaxrate.Therearejusttoomanyvariablesinthereincludingbusinessdevelopment,includingwherewemakeourearnings,includingpotentialchangesinUStaxlaw,andwegiveguidanceonayearlybasisonourtaxrate.Frank,youwanttoaddanything?
FrankDAmelio (CFO):
Justthatyear-to-date,ourtaxrate's25%.Ourguidancefortheyearis25%sofor2015,we'rerunningprettymuchrightaccordingtoourguidance.AndthenjusttopunctuatewhatIansaid,there'sjusttoomanymovingpartstotrytoprojectourtaxratesbeyondthecurrentyear,butwe'llobviouslyincludethe2016ratewhenweprovideour2016guidance.
IanRead (ChairmanandCEO):
Thankyou.OnDC,it'stoodifficulttospeculateonwhatwouldhappenontaxlegislation.IdothinkIamheartenedbytheconversationsthatareoccurring,andtheacknowledgmentinWashington,thatsomethinghastobedonetoallowglobalUScorporationstobecomecompetitive,giventhenatureoftheUStaxsystem.Andhopefullytheywilltakeactionearlierratherthanlatertoallowustobecompetitive,andIthinkwewillseethatunfoldinthenextfivemonths,astowhetherWashingtonwilltakeanyactiononthatornot.
OntheTevaAllergan,doesitchangelandscapeforus?Idon'tthinkitchangesthelandscapeforPfizerinanymaterialway.WecontinuetohaveourownstrategiesandpursueourownBDobjectivesandthisdoesn'timpactimpingeuponthat.Frank,wanttotalkaboutanythingelse?Andthenit'sAlbertonPrevnar13?
Albert Bourla(PresidentofVaccinesOncology&Consumer):
Yes,Andrew.I'mmonitoringtheinventories,andtherewasnosignificantinventorybuildinthequarter,soinventoriesdidn'tmateriallyaffecttheadultperformanceatall.
IanRead (ChairmanandCEO):
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
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SoIthinkAndrew,whatyouneedtodoonPrevnar--whatweneedonPrevnar13adult,isyouhavethreeinfluences,orfourinfluencesgoingon.One,youhavetheunderlyingrateofUScitizensbecoming65,whichisabout4millionayear.YouhavethenintheUS,thebolusofcatch-upwhichissignificant,andwebelievewilllastcertainlythisyearandnext,andmaybeintothethirdyear.AndthenyouhaveyouhavetheprogressintheG6countriesaswegetandhavehadforourregistrationandlabelingchanges,toenableadultvaccinetobesoldtothe65andabove.
Andthere,ofcourse,youhaveahugecohort,probablysubstantiallylargerthantheUS,probablytwicethesizeoftheUS.Andthat'sgoingtotakemarketdevelopment.We'regoingtohavetoworkonthatcountrybycountry,butweseetherealso,themovementofthepopulationtoover65,plusthecatch-upopportunity.Sooverall,whenyoulookatthosewavesofopportunities,IfeelthatwefeelthattheadultvaccineisaninterestingongoinglargefranchiseforPfizer.
ChuckT riano (SVPofIR):
Thankyou.Nextquestion,please?
Operator :
ColinBristow,BankofAmerica.
ColinBristow(Analyst-BofAMerrillLynch):
Coupleofquickones.OnyourAvastinbiosimilar,youstartedthePhaseIIItrialwithaprimaryendpointofobjectiveresponserate.Canyoutalkaboutthediscussionsyou'vehadwithregulators,andwhetheryouanticipateobjectiveresponseratewillbeanapprovalendpoint?AndthentwoontheIOpipeline.Canyouwalkusthroughthekeyreadoutsweshouldbepayingattentiontooverthenext12months?Thanks.
IanRead (ChairmanandCEO):
Okay.Technicalquestionthere,Colin,onthat.Idon'tknowifMikael,youwanttoaddressthat.
MikaelDolsten (PresidentofWorldwideR&D):
Allofourfivebiosimilarshavebeenevolvedintheirdevelopmentstrategiesincloseconsultationswiththemajorregulatoryagencies,andparticularlyFDA.Sothatwillreflecttheinputandrobustnessintrialdesign,andwhatshouldbepredictedthebestchoiceofendpointforapprovalopportunity.
IanRead (ChairmanandCEO):
SoIthinkwefeelsatisfiedthatwehaveanagreementwiththemajoragenciesandtheendpointswillbetheonesnecessarytogetapproval.IOpipeline,Mikael,doyouwanttorunthroughthatorwhatyouthinkofthesignificantthingsgoingforward?Andwhenwearelikelytobeissuingresults?
MikaelDolsten (PresidentofWorldwideR&D):
SoI'mreallyexcitedaboutourIOpipeline.Andstartingwithanchordrug,avelumab,wehavenowmorethan1,000patientsthathavebeenonavelumab,andwefeelthatweseeaconsistentgoodresponserate,substantialclinicaldurability,andresponses,androbustsafetyprofile.AndwereportthatsomestudiesatASCO,andnowwehavepositivereadoutsinline,gastric,ovarian,andbladder,you'reaware,andIanalludedtothatwe'vestartedasecondlinelungcancertrial.Weexpectinarelativelynear-termopportunitytomovetofirstlineinthatsetting.OurexperienceincostvariousindicationswillleadthisyeartoonumerousannouncementsofPhaseIII,uptosixpivotalstudiesthatincludeseveralinlinegastric,ovarian,bladder,andrenal.
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
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WealsoatASCOcommunicatedfavorabledateon4-1BB,alreadyseeninthePhaseIinfollicularlymphomashowinggoodtolerability,andtogetherwithrituximab,favorableresponses.Weareexpandingthatstudy.4-1BB,whichisauniquemolecule,oneofthefewIthinkinthisindustrythisadvanced,isalsoinstudieswithKeytruda,aswellasthesoon-to-beextensiveprogramwithavelumab.WealsohaverecentlyenteredclinicalstudieswithOX40asanotherpositiveeventforourimmuno-oncologypipeline,andwehavecommunicatedfavorabledatawithCCR2inpancreaticcancer.
Andlaterthisyear,weexpectvaccinetostartdosingforprostatecancer.Andwehavenumerouscompoundsandmeansthatwillalsoenternextyear.Soyouseereallyusevolvingaverycomprehensivemonotherapyandacombinationtherapy.Wewill,overtime,sharemoredata.ThereisanESMOconferencethatwillgiveyouanupdateonavelumabandwillincludeparticularlungcancer,ovarian,andalsosomebladder,weexpect.Andwewillcontinuetoinformyouabouttheprogressof4-1BB.
ChuckT riano (SVPofIR):
Thankyou,Mikael.Nextquestion,please?
Operator :
VamilDivan,CreditSuisse.
VamilDivan (Analyst-CreditSuisse):
TwoifIcould.Onebuildingalittlebitonwhatyoutalkedaboutearlieraroundtheamountofcostaroundplanningforapotentialsplit.DoyouhaveasenseofwhatthedissynergieswouldbetoactuallyexecuteasplitoftheCompanyatthispoint,ifyou'retryingtosplitintotwoparts?Ithinkyoumayhavesomesenseofthatbynow.AndasmoreofuscanundoonaPfizeronaself-enforcedbasisitwillbehelpfultohaveahowyouthinkthedissynergieswouldbe.
AndthenthesecondquestionIhadwasonthevaccineside,startingwiththeVOCbusiness,alotoffocusononcologyobviously,butcanyoutalkalittlemoregenerallyaboutyourstrategyinvaccines?You'reobviouslymakinggoodprogresswithPrevnarinadults.Staphismovingalong,thatobviouslylookspromising.Maybealittlebitmorebroadly,whereyouseeotherpotentialareasforvaluethere.Youhaveobviouslymadesomedeals,youhavematernalvaccines,youtalkedaboutCdiff.Whatyouthinkpeoplemightbeunderappreciatingwithyourvaccinesbusinessasopposedtohowyouseeitinternallyrightnow?Thanks.
IanRead (ChairmanandCEO):
Okay.Well,costofdissynergies,Frank,wanttomakeacommentonthat?
FrankDAmelio (CFO):
Justfrommyperspective,we'veobviouslybeenlookingatthis,we'vebeenanalyzingthedetail.IthinkI'dsummarizeitbysayingwedon'tseeitasbeingamaterialdissynergyrelativetooptionality,basedonourcurrentanalysis.
IanRead (ChairmanandCEO):
No.SoyourquestiononthevaccinesI'lltryanddoasummarizedanswer,andthenI'llaskAlbertifhewantstoaddanythingontoit.IthinkyouareseeinguscontinuetodriveandmaximizethePrevnar13opportunity,bothininfantsandadults.Webelievethattheopportunityinadultsisbroadanddeepanddurable,sowe'reconfidentinthat.WecontinuetoworkonPrevnar,onthePrevnarfamily,tolookatserverenhancements.
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:210.96BPriceasofEventDate:35.35
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Webelievethere'sarealopportunitytoacceleratethe--aslongasthePhaseIItrialonthebacksurgeryperformsasweexpect,wethinkthere'sanopportunitytoacceleratethestaphaureusvaccine.WeareinPhaseIIwithwhatwebelieveisaverygoodvaccinewithC.difficile,andthenwe'vemadeacquisitionsofothervaccinesliketheBaxteracquisition,toaddsomecriticalmasstoourwhatourfieldforcecarries.WehaveTrumenba,whichwethinkwilldevelopovertimeasanimportantvaccine,andthenwe'vedoneacquisitionsandlicensingof--forvaccinesforinfants.Soyouwanttoaddsomemoredetailtothat,Albert?
Albert Bourla(PresidentofVaccinesOncology&Consumer):
Veryfewthingstoadd,Ian.Ithinkinvaccines,wehavesubstantialscientificcapabilities,andsignificantsubstrate,researchsubstrate,thatallowsustoseeoptimisticallythefuture.Andtohaveverygoodtrackrecordofdelivery.Withstaph,wehavealreadyinitiated,asIansaid,thePhaseIIbstudy,andthat'sin2,600patients.IfthePhaseIIbdatashowconsiderableefficacy,wewillconsiderrequestinganacceleratedapprovalfromthisproduct,andthestudythatwe'rerunningnowcouldpotentiallyservetosupportregistration.
IanRead (ChairmanandCEO):
Theyhavebreakthroughstatus,right?
Albert Bourla(PresidentofVaccinesOncology&Consumer):
Andbreakthroughstatus.SameaswithC.difficile.Thathasbreakthroughstatus,butalso,asyourecall,wehadoutedrecruitmentandvaccinationsinapreviouslyinitiatedPhaseIIbstudy,asaresultofsomecasesofrednessthatweobservedattheinjectionsite.Now,wehavealreadyrecentlyreceivedapprovalfromtheFDAtoinitiateanewPhaseIIprogramwithadifferentformulation,sowearemovingfullspeedinmaterializingthataswell.
ChuckT riano (SVPofIR):
Thanks.Thenextquestion,please?
Operator :
ChrisSchott,JPMorgan.
ChrisSchott (Analyst-JPMorgan):
FirstonewasjustalittlebitmorecoloronPrevnar13adult.Iappreciatetheearliercomments,butcanyougiveusalittlebitmorecolor?WhenyouthinkabouttheUScatchupbolus,howlargeisthatbolus,andhowfarthroughareyouatthispoint?Doyouhavenumbersinthatfront,wouldbeprettyhelpful.
Second,onyourPD-L1,Iknowyou'vehighlightedinthepastahighdiseasecontrolratethatwehaveseenwithsomeofthestudies.Whencanweseemoresurvivaldatathatcouldhelpusassessthatdiseasecontrolrate,versusmaybesomehigheroverallresponserateswe'reseeingfromotherproducts,aswethinkaboutthisasacombinableagentlonger-term?
Andthefinalonewascomingbacktobusinessdevelopment,doesseemlikewe'reseeingasignificantconsolidationintheindustryatthesametimewe'reseeinganuptickininnovation.IknowPfizerhasprioritiesintermsofwhatitneedstodo,givenitsproductcycle,butcanyouelaboratealittlebitmorehowthisrapidly-changingenvironmentisimpactingyourbusinessdevelopmentpriorities,eitherintermsoffurthersenseofurgency,willingnesstobroadenthescopeofwhatyou'relookingat?I'mtryingtounderstandhowthebackdropofthesectoreffectshowyou'repursuingdeals.Thanksverymuch.
CompanyName:Pf izerIncCompanyTicker:PFESector:HealthCareIndustry:Drugs
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IanRead (ChairmanandCEO):
Prevnar13,Albert?
Albert Bourla(PresidentofVaccinesOncology&Consumer):
AgainIwillexpresshowmyexcitementaboutthesuccessthatthey'reofhavingsofarwithPrevnarintheUS.Andbasicallyweareabletomakepneumoniavaccinationforadultsanage-basedeventsopeoplewhogetvaccinatedwhentheycometoageof65,ratherthanaseasonalevent.Butofcourse,wewereverysuccessfulincatchingupalotofpreviouslyvaccinated.
TogiveyouasenseofthenumbersintheUS,asIansaid,approximately4millionpeopleareturning65everyyear.In2014,whenwestartedwithPrevnar,therewasalargecohortofapproximately27millionpeoplethatwerepreviouslyvaccinated.Withanoldtechnologyvaccine,andtherewasalsoanothercohortof18millionpeoplethathadneverreceivedavaccine.Sointotal,45millionpeople.Usually,thereis2.6milliondeathsalso,thatarehappeningperyearinthatcohort.
Somain,wedon'thaveexactsplitofhowmuchiscatch-upandhowmuchisnormalbusinessintheUS,butgiventhemassivenumberofvaccinationsthatareoccurring,abigpartiscomingfromcatch-up,andthisisalot,aswesaid.That'swhywesaidthatthisyearwillcontinuegrowing,andwillbeverybig.Nextyearalsowillbesubstantial,verybig,mightnotgrowversus2015,butwillbeverybig.
Andthenwemoveinternational.Internationally,theagingdemographicsaremorecompellingthaninUS,becausethepercentageofpeoplethatarelivingabove65ismuchhigher.CountrieslikeJapanforexampleisalmostdoublethaninUSintermsofpercentage,14%approximatelyintheUSto26%27%28%inJapan,andthisiswhereweexpectin2017tostartgettingawaveofrecommendations,nowthatwe'vegotapprovalinEuropeforpneumonia.Thataslongaswegetrecommendation,thenreinvestmentcomes,andthenwestartcommerciallypenetratingveryaggressively,aswedidintheUS.
IanRead (ChairmanandCEO):
Thankyou,Albert.IbelievethatcohortintheG6countriesarearound94million?
Albert Bourla(PresidentofVaccinesOncology&Consumer):
That'scorrect.DoubletheUS.
IanRead (ChairmanandCEO):
Okay.PD-L1data?ThatweareinpartnershipwithMerckKGaA?
Albert Bourla(PresidentofVaccinesOncology&Consumer):
Soatamorehigherlevel,wecansaywhenwecarefullygothroughdatafromlung,ovarian,gastricandbladder,wherewehaveextensivenumberofpatientsfollowedforsixmonthsormore,weseeresponseratesthatareverycomparabletootherPD-L1agents.Ofcourse,itdependsonhowyoucutyourdata.Wehavegenerallylookedatresponserates,includingallpatients,andnotsolelyPD-L1positive,andthat'spartofourlong-termstrategy,thatitseemsthatpatientsthatevenhavelowexpressionofPD-L1willbenefit,particularlywhenyoulaterdevelopcombinationtherapies,soweaccumulateexperiencesacrossallPD-L1spectrum,butwillofcourse,invariousendpoints,lookatPD-L1positive.
Thatwasthestrategyinoursecondlinelungcancer,whichisall-inclusiveforlungcancerpatientsinsecondline,buttheprimaryendpointisonPD-L1positive.Diseasecontrolratesareveryhighinourstudies.Ingeneral,50%orhigheracrossseveralindications.Andwhenweagaincomparedtoothers,wheredowelookatdiseasecontrolrates,sixmonthsprogression-freesurvivaletcetera,we'revery
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pleasedwithavelumab,bothforefficacyandtolerability.AndyouwillgetfurtherdataupdateatESMOoncologyconference.
IanRead (ChairmanandCEO):
Thankyou.GoingbacktoBD,welookatBDprobablyintwolargewaysatPfizer.Oneiswhenwe'relookingatindividualneedsofthebusinessunits,whichcanbelikeasmallertuck-inorcanbeanacquisitionofanindividualproduct.Whenwelookatindividualproducts,ittendstohavea--normally,because,veryoftenyou'rebuyingaproductatthebeginningofit's--eitherbeforeit'sapprovedorafterit'sapproved,butwe'relookingatitopportunitiestoexpandindications,andsowelookattherisk-adjustedreturn,andwemakeadecisionwhethertoparticipateinthatfranchise.Andthatcanbeinfluencedbytheabilitytocombineitwithourexistingtherapeuticareas,ifwecangetalsoadditionalsynergiesthroughoperationalsavings.Sothat'sonewaywe'relookingatBD,whichismoreopportunisticproductrelated.
ThesecondtypeofBDistryingtobuytechnology,likeperhapsgenetherapy,orselectuswhenwe'regoingtoCAR-Ttechnology,andthosetendtobelonger-terminvestments.AndthethirdtypeofBDiswhatyouwouldsayisamoretraditionalBD,wherewelookattotalcompanies,andtherethedriverofvalueoftenisexistingpipeline,existingproducts,potentialpipelineproducts,opportunitiesforsynergies,andpotentiallytaxsavingsandfutureliberationofthebalancesheet,becauseyou'renolongerconstrainedbytheUStaxsituation.SoIthinkwhatyou'vebeenseeinginthemarketplaceisforeigncompanieswithsignificanttaxadvantagestakingadvantageofacquisitionsintheUS,andbuildinguptheirorganization.
You'veseenarefocusingbysomecompanies,andyouhaveseen,aswiththeAllerganTevatransaction,whereoneCompanyistostrengthenitsportfolioandfocusbyacquiringthegenericoftheothercompany.Solook,weareactivelymonitoringthisprocess.Idon'tthinkwe'velostouttoanyopportunitiesthatwouldhavemadesensetoourshareholders.We'redeterminedifanopportunityisthere,thatwewillnotloseout.Wehavethewill,wehavethecapability,wehavethecapitalwehavethemanagementteam.SoIfeelthatfrankly,ourBDstrategyandphilosophyandapproachisappropriateforthispointintime,inthevaluecycles.
ChuckT riano (SVPofIR):
Thankyou,Ian.Nextquestion,please?
Operator :
AlexArfaei,BMOCapitalMarkets.
AlexArf aei(Analyst-BMOCapitalMarkets):
Congratulationsonastrongquarter.Firstonbiosimilars,youhavefiveantibodiesindevelopment.Youareobviouslymakingasignificantinvestmentthere.Canyouupdateusonyourupdatedviewsofthepotentialsizeofthebiosimilarmarket,inlightofwhatwe'reseeinginEurope,andhowweshouldthinkabouttheopportunityforPfizer?
Follow-uponthat,giventheseinvestments,howshouldwethinkaboutsomeoftheoverlappingassetsthatyou'regettingfromHospira?Andthenfinally,couldyoucommentontherecentPCSK9approvalandpotentialimplicationsforyourbococizumab?Thankyouverymuch.
IanRead (ChairmanandCEO):
Thanksforthequestion,Alex.Firstofall,intermsofyourquestionaboutthesizeofthemarket,we
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continuetoseearoundabout$100billionofcurrentlypatentedbiologicmedicinesthatwilllosepatentprotectionoverthenextfiveto10years.That'sasignificantmarketopportunityforcompaniesthathavethetechnologyplatformcapability,andcurrentbiosimilarportfoliotobeabletocapitalizeonthatopportunity.Sowecontinuetothinkthatweareverywell-placed.AndinrelationtoyourquestionaboutHospira,wecontinuetoseethatourportfolioandHospira'sarehighlycomplementary.Andwe'reveryexcitedabouttheopportunitythatpresentspostclose.
OnthePCSK9approvalbyEuropefromAmgenandtheUS,bySanofi,Regeneron,IthinkweexpectitonLDLlowering.Idon'tseesubstantial--Iseemodestuseoftheseproductsuntiltheoutcomesdatacomesthrough.Wedon'tthinkwewouldbethatfarbehindonoutcomesdata.Ithinkthesizeofthemarketisdifficulttopredictatthistime.
ItreallydependsonhowtheCTEPdevelopmentcomesthrough.IftheCTEPs,whichareoral,comethrough,Icouldseeamarketthatissegmentedthreeways,IEstatinusesoyoucangettogoals,statinplusaCTEPorCTEPaloneifyou'restatinintolerant,andthenpotentiallyPCSK9beingheldinreserve,iftheCTEPcan'tgettothegoalsofthestatin.Soit'svery,verydifficulttopredicthowthismarketwillshakeoutinvalue.AndIthinkit'sinterestingtoseewhatwillhappenin2016,iftheCTEPsareimprovedandwhattypelabel,whattypeofpricingtheycometothemarketwith,andwhattypeofpricingweseedeveloponthePCSK9sasnegotiationsoccurwithmanagedcare.
ChuckT riano (SVPofIR):
Thankyou,Ian.Nextquestionplease,operator?
Operator :
JohnBoris,SunTrust.
JohnBoris (Analyst-SunTrustRobinsonHumphrey):
Congratulationsonthequarter.JustbacktoPrevnar13,canyouquantifytheshipmentsthatyoumadeintoGAVIandthevaccinealliance,andalsoprovidesomeadditionalcoloronwhichnationalimmunizationprogramsincludedPrevnar13intotheirprogram?Andthensecondly,onyourXeljanzfilingintheEU,canyoureminduswhatledtotherejection,andwhatremediesthatyou'vemadetothefiling?Ibelieveyoumentionedyou'reontracktofilebeforetheendoftheyearintheEU.ThatwouldhelpenhancetheabilitytosecureapprovalonXeljanzinEurope.Thanks.
IanRead (ChairmanandCEO):
GenocandealwiththeXeljanzquestion,andthenI'llseeifAlberthasanydataathand.That'sprettyspecificonyourquestion,Johnorifwewilljusthavetoanswertogeneralitiesrightnow.Butlet'sgettoGenofirst.
GenoGermano (PresidentofGlobalInnovativePharma):
Thanks,John.IthinkthequestionsfromtheCHMPrevolvedalotaroundtheimmunesystemeffectsofXeljanz,understandingthesafetyprofile,primarily.Sowehavedonesomeadditionalpharmacologystudies.We'vedoneastudywithherpeszostervaccinetodemonstratealackofinterferencewiththeimmunogenicityofthevaccine,andofcourse,collectedlonger-termfollow-updatafromourlong-termextensionfilesandourpost-marketingsurveillancetrial.Soitwillbeacombinationofthesedatapointsthatwillcomprisetheresubmissionthatwe'replanningonforlaterthisyear.
IanRead (ChairmanandCEO):
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Okay.Albert?
Albert Bourla(PresidentofVaccinesOncology&Consumer):
Idon'thavehandythenumbers.I'llhavetocomebacktoyou,butgenerallyinemergingmarketsthegrowthwas18%forpediatric,approximatelyforthequarter.Andthisvolatilitywillcontinuetoexist.
IanRead (ChairmanandCEO):
DependsonthetimingofNIP,timingofGAVI.Notsomethingthatweareparticularlyfocusedon.Wehaveafull-yearforecastwhichtakesintoaccountallthesefluctuations,andwe'vebuiltthatintothechangeinourguide.
FrankDAmelio (CFO):
That'sallpartofourrevenueguidance.
ChuckT riano (SVPofIR):
Okay.Thankyou.Ournextquestion,please?
Operator :
JeffHolford,Jefferies.
Jef f Holf ord (Analyst-JefferiesLLC):
Firstone,justaroundbusinessdevelopment,ifyoufollowonhere,doyouhaveabiastowardsOUSdomiciledcompanies,whenyou'relookingatopportunitiestohelpgrowtheGIPbusiness,givenwhereyourcashisheld?Second,becauseofyourfocusondoingBDinafewyearstobridgeto2017,doesthatmeanweshouldexpectmuchlesscashtobedivertedtowardssharerepurchases?Andthenlastly,justaroundtheBD,givenyourwantordesiretohelpboostthebusinesspriorto2017,doesn'tthatmean,giventimeforantitrustrevieworanyotherreviewsofthetransaction,thatshouldweshouldbeexpectingyoutocomplete,announceadditionaldealsduringthesecondhalfofthisyearforthemtocomeintothattimeframe?Andthenlastquestion,justonaseparatearea,canyoumaybeoutlineforusjustacoupleofthebiggestOTCswitchopportunitiesthatyouseethebusinesspotentiallyinthenexttwotothreeyears?Thankyou.
IanRead (ChairmanandCEO):
OntheOTCswitch,Idon'twanttogetintothatbecauseit'sconfidentialandhelpscompetitorspreparealongwithusinthemarketplace.SoIthinkyoucanlookatourportfolioandmakeassumptionsonyourownastowhichproductsaremorelikelytobeswitchedornot.
OntheBD,IhavenobiastowardsaUSorforeignCompany.Ihaveabiastothevaluecreation.Ihavenobiastowards,well,Ihaveabiasonourportfolio.Ifvaluationsareequalandopportunitiesareequal,IprefertodoaBDdealthatstrengthensourinnovativebusiness,asIthinkwe'vedonequiteabittostrengthentheestablishedbusiness.
Onthelesscashdependingonanacquisition,Ithinkitdependsonthetypeofacquisition,howit'sstructured,andIthinkit'stooearlytosay,butofcourseanydealwedowhatwedowe'llbelookingattotalshareholderreturns,andwewouldfactorthatintothetypeofdealwithrestructuring.Ithinkthat'sthemostwecansayatthistime,franklywiththat.
Andthenontiming,whenItalkabout2017,I'mtalkingabout--franklyIusethatasamark,given
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conversationsIhavewithourowners,aboutthefactthatgreat,you'vegotgreatin-linemomentum,you'vegotthesenewproducts,you'vegotEliquis,andyou'vegotIbranceandadultvaccine,andalltheotherin-linesthataremovingwell.I'mjustlookingatwaysofincreasingourrevenuesaswedevelopourpipeline,andwestarttoseethatpipelinecometofruitionin2017andlaunchin2018,andwe'llseethoselaunches2017through2018through2019.
SoIthinkit'simportanttogetanyBDwedoright,andIdon'tfeelpressurizedtogetitrightby2017.What'simportantistogetitrighttocreatevalueforourshareholders.AndIdon'tthink,frankly,there'satimingpressureonustodoBD.
We'regoingtolookatit.WewanttodoBD.We'regoingtobeopportunistic,butwe'realsogoingtomakesurethatwemaketherightdecisionsforPfizershareholders.
ChuckT riano (SVPofIR):
Allright.Thankyou,Ian.Nextquestion,please?
Operator :
DavidRisinger,MorganStanley.
DavidRisinger (Analyst-MorganStanley):
Ihavetwoquestions.First,couldyouremindusabouttheex-USEnbrelexclusivitylosstiming?Andexpectationsfortimingofbiosimilarcompetitorlaunches?AndthenwithrespecttoIbrance,couldyoupleasediscusspotentialindicationsoutsideofbreastcancerandwhatkeytrialsweshouldbewatchingonthatfront?Thankyou.
IanRead (ChairmanandCEO):
Thankyou.Geno,couldyoudotheEnbrel?
GenoGermano (PresidentofGlobalInnovativePharma):
EnbrelexclusivityexpiresneartheendofthisyearsoweexpecttoseebiosimilarpenetrationbeginningnextyearinEurope.
IanRead (ChairmanandCEO):
Okay.Ibranceindicationsoutsideofbreastcancer?
Albert Bourla(PresidentofVaccinesOncology&Consumer):
We'reveryexcitedaboutthepotentialofIbrance.AndIthinkwehavearealuniqueproprietaryknowledgeinunderstandinghowtousesciencearoundIbrance,combinationnewindications.Sowehaveanextensivecollaborativeresearchclinicalprogramsthatyoumaybeawareof,butinadditiontothat,I'mpleasedtosaythatwearestartinganumberofPfizer-sponsorednewstudies.Andverysoon,we'llstartonestudyinheadandneckcancer,HPV-negativepatientsthatarerecurrentmetastatic,combiningIbrancewithErbitux,withpriorexperienceofthatcombinationinacollaborativestudy,andnowlaunchingaPfizer-sponsored,whichcouldhaveaveryinterestingpathforward,ifdataisstrong.
Inadditiontothat,wehavegeneratedverycompellingpre-clinicaldataonhumantumorsforpancreaticcancer,whereparticularlythecombinationofIbrancewithpaclitaxelorAbraxanewasverypromising,andwearesoonstartingaPhaseIIstudyprecededbysafetylead-inwithIbranceandAbraxaneinpancreaticadvancedcancer.Wealsohavesignificanteffortinunderstandingpatientsthatprogresson
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Ibranceafterhavinghadlongsignificantbenefitinbestcancer.AndyoulearnmoreaboutPfizer'sprogramindoubleandtriplecombination,thatalsocanfurtherexpandourstrongholdandleadershipinIbrance.
ChuckT riano (SVPofIR):
Thankyou.Ifwecouldtakeourlastquestion,please,operator?
Operator :
SeamusFernandez,Leerink.
SeamusFernandez (Analyst-LeerinkPartners):
Frank,maybecouldyouremindusthethresholdforcompletinganinversion?AndIaskthequestionparticularlysincesomesmallerdealsappeartohavegottenaslowas20%afterthetreasuryupdate.Soitwouldbehelpfultoknowwhatyourthoughtsareonthethresholdforinversion,becauseIthinkpreviouslyyouhadsaiditwasreally40%.Andthenseparatelyaspartofyouroptionalitycalculus,withthesplit,doyoualsoconsiderPfizerasapotentialtargetinthatcalculus,sincethiswouldappeartobeavalue-addoptionforshareholders?Thanks.
FrankDAmelio (CFO):
AreyousayingPfizerorthesplitofPfizer?
IanRead (ChairmanandCEO):
Seamuscan'treply.Okay.Probablythesplit,wethinkthatintheoptionality,bothcompanieswouldberobustandstrong,andwouldhavetheabilitytobesuccessfulcompaniesontheirown.Andwereallycan'tcommentonwhethertherewouldbeBDactivitytotryandbuythosecompanies.Theywouldbecompaniesthatwouldbeindependent,andcontinuetotryandprogresstheirownbusinessstrategies.Ontheinversion?
FrankDAmelio (CFO):
Priorto,I'llcallittheSeptember22proposedrulechangesbytheIRS,thehurdlewaslessthan80%,soourshareholdershadtoownlessthan80%ofthenewly-formedCompanythatweacquired,togetthefullbenefitsofaninversion.Thathurdlewasloweredtolessthan60%,whichmeanswe'dhavetodoalargeracquisitiontogetthefullbenefits.Solessthan80%tolessthan60%.
IanRead (ChairmanandCEO):
Theissuewiththis,Seamusisthatthefullbenefitornon-fullbenefitisveryidiosyncratic,dependingontheCompanyyou'redoingtheinversionon,andthecomplexityofthetaxrule.Soitmaybethatifyouareinbelow80butnotbelow60,youstillhavesubstantialbenefitsfromaninversion,andthereforedespitetheproposedrulechanges,oritmaybeondifferenttargetsyouneedtobeatbelowthe60threshold.Sotheuniverseisnotconstrictedorreducedtoonly60-40.It'sverydependentuponthetypeofassets,thestructure,wherethecashis,etceteraetcetera.
FrankDAmelio (CFO):
Verycompany-specific.
IanRead (ChairmanandCEO):
Verycompanyspecific.Thankyouverymuch.
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ChuckT riano (SVPofIR):
Thankyou,andthankyouallforyourattentiontoday.
Operator :
Ladiesandgentlemen,thisconcludesPfizer'ssecondquarter2015earningsconferencecall.
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