Celgene (CELG) Earnings Report: Q1 2015 Conference Call...
Transcript of Celgene (CELG) Earnings Report: Q1 2015 Conference Call...
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
EventDescription:Q12015EarningsCallMarketCapasofEventDate:90.88BPriceasofEventDate:108.04
©2014TheStreet,Inc.Al l R ightsReserved Page1of22
Celgene(CELG)EarningsReport:Q12015ConferenceCallTranscriptThefollowingCelgeneconferencecalltookplaceonApril30,2015,09:00AMET.Thisisatranscriptofthatearningscall:
CompanyPart icipants
PatrickFlanigan;Celgene;VPofInvestorRelationsMarkAlles;Celgene;PresidentandCOOPeterKellogg;Celgene;CFOandExecutiveVicePresidentJacqualynFouse;Celgene;PresidentofGlobalHematologyandOncologyJean-PierreBizzari;Celgene;GlobalHeadofOncologyRobertHugin;Celgene;Chairman,CEOandChairmanofExecutiveCommitteeScottSmith;Celgene;PresidentofGlobalInflammationandImmunology
OtherPart icipants
GeoffreyPorges;SanfordC.Bernstein;AnalystCoryKasimov;JPMorganChase;AnalystMarkSchoenebaum;EvercoreISI;AnalystMatthewHarrison;MorganStanley;AnalystRobynKarnauskas;DeutscheBank;AnalystJohnNewman;CanaccordGenuity;AnalystEricSchmidt;CowenandCompany;AnalystMichaelYee;RBCCapitalMarkets;AnalystM.IanSomaiya;NomuraSecurities;AnalystChristopherRaymond;RobertW.Baird;AnalystGeoffreyMeacham;BarclaysCapital;AnalystMatthewRoden;UBSInvestmentBank;AnalystMaraGoldstein;CantorFitzgerald;AnalystHowardLiang;LeerinkSwann;AnalystMichaelKing;JMPSecurities;Analyst
MANAGEMENTDISCUSSIONSECTION
Operator :
Goodmorning,andwelcometoCelgene'sFirstQuarter2015EarningsConferenceCall.(OperatorInstructions)Iwouldliketoremindyouthatthiscallisbeingrecorded.
IwouldnowliketoturntheconferenceovertoPatrickFlanigan,VicePresidentofInvestorRelationsatCelgene.
PatrickFlanigan (VPofInvestorRelations):
Thanks,[Candace],andwelcome,everyone,toourfirstquarterearningsconferencecall.Thepressreleasereportingourfinancialresults,inadditiontothepresentationfortoday'swebcast,canbeaccessedbygoingtotheInvestorRelationssectionofthecorporatewebsiteatwww.celgene.com.
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
EventDescription:Q12015EarningsCallMarketCapasofEventDate:90.88BPriceasofEventDate:108.04
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JoiningmeintheroomtodaywithpreparedremarksareBobHugin,ourChairmanandChiefExecutiveOfficer;PeterKellogg,ourChiefFinancialOfficer;MarkAlles,ourChiefFinancial--ourChiefOperatingOfficer;JackieFouse,whoisGlobalHeadofourHematology&OncologyFranchise;andScottSmith,GlobalHeadofourInflammationandImmunologyFranchise.
Asareminder,duringtoday'scall,wewillbemakingforward-lookingstatementsregardingourfinancialoutlookinadditiontoregulatoryandproductdevelopmentplans.Thesestatementsaresubjecttorisksanduncertaintiesthatmaycauseactualresultstodifferfromthoseforecasted.Adescriptionoftheseriskscanbefoundinourmostrecent10-QonfilewiththeSEC.Thesestatementsspeakonlyasoftoday'sdate,andweundertakenodutytoupdateorrevisethem.
Finally,reconciliationoftheadjustedfinancialmeasurestothemostcomparableGAAPmeasuresareavailableaspartoftheearningsrelease.
IwouldnowliketoturnthecallovertoMark.
MarkAlles (PresidentandCOO):
Thankyou,Patrick.Goodmorning,everyone,andthankyouforjoiningustoday.
Duringthefirstquarter,wemadeoutstandingstrategicandoperationalprogressacrossfunctionsinmajormarketsandwithkeypartnerships.Ourteamsbuiltontheoperatingmomentumfromlastyearanddeliveredstrongfinancialperformance.Wearewellpositionedtoachieveour2015goals.
Peter,JackieandScottwillsummarizeourexcellentyear-on-yearfinancialandoperatingperformanceandprovideimportantdetailsaboutthestrengthofourbusiness,productandmarketdynamicsandthenear-termopportunitiesforourfranchises.Bobwilladdhisperspectiveonouroutlookbeforeweopenthecallforyourquestions.
The6regulatoryapprovalsforREVLIMID,POMALYST,ABRAXANEandOTEZLAareamongthemostnotableaccomplishmentsinthefirstquarter.Wecontinuetoleveragethesignificantinvestmentsinclinicaltrialsmadeovermanyyearstoenhancethevaluepropositionsofourtherapies.
Theseapprovalsprovideimportantnewtreatmentoptionsforthousandsofpatients,andtheycreatednewcommercialopportunitiesthatrepresentsomeofthemostimportantdriversofourfinancialoutlookfromnowuntil2020.
TheREVLIMIDnewlydiagnosedmultiplemyelomaapprovalsintheUnitedStatesandEuropeare,ofcourse,critical,astheyfurtherstrengthenthepositionofREVLIMIDasthebackboneoftreatmentformyeloma.
Wealsomadeexcellentprogressinthefirstquarterbuildingforthefuture.InadditiontoadvancingthecomprehensiveclinicaldevelopmentprogramforGED-0301inCrohn'sdisease,weaddedexcitingnewopportunitiestoourrobustinternalandexternalpipelinethathavethepotentialtomakeanincreasinglymeaningfuldifferenceinthelivesofpatientsandtocontributetoourlong-termgrowth.
OurrecentlyannouncedstrategiccollaborationwithAstraZenecastrengthensourcompetitivepositionintherapidlyemergingandevolvingimmuno-oncologymarket.Todate,wehavebeenopportunistic,anchoringtheclinicaladvantagesofABRAXANEandREVLIMIDincombinationstudieswithT-cellcheckpointinhibitors,acrosstumortypesandwithseveraldifferentpartners.ThisnewcollaborationwithAstraZenecagivesustheuniqueopportunitytoactivelydrivethedevelopmentandcommercializationoftheanti-PD-L1accessinhibitorMEDI4736asmonotherapyandwithourexistingcommercialandemergingclinicaltherapiesinhematology,acoreareaofstrength.
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
EventDescription:Q12015EarningsCallMarketCapasofEventDate:90.88BPriceasofEventDate:108.04
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Tofurtheradvanceourleadershipinthefieldofepigenetics,wecompletedadefinitivesharepurchaseagreementwithourpartner,Quanticel,committingtoanacquisitionthatwillbringQuanticel'sproprietaryplatformforsingle-cellgenomicanalysisofcancerstemcellsandtheirdevelopmentprogramstargetinghistonemethyltransferasesintoourresearchorganization.
WeexpandedourpartnershipwithAgiosbyexercisingouroptiontoanexclusivelicenseoutsidetheUnitedStatesforAG-120,adrugtargetingmutantIDH1inpatientswithAML,gliomaandselectivesarcomas.
WealsoenteredintoanewjointworldwidedevelopmentandcommercializationprogramforAG-881,Agios'IDH1andIDH2inhibitor,thathasshowninpreclinicalmodelstofullypenetratethebloodbrainbarrier.
InQ1,weadvancedourbiologicsprogram,initiatingPhaseItrialinmultiplemyelomaandsolidtumors,withCC-90002,ourantibody-targetingCD47receptor,ontumorcells.
AdditionalearlytrialswithCC-486wereinitiatedindiffuselargeB-celllymphoma,metastaticbreastcancerandnasopharyngealcarcinoma.
Takentogether,ourimmuno-oncologyprogramsnowreflectacomprehensivestrategy:testingIMiDsandrelatedcereblonmodulators;rationalcombinationswithT-cellcheckpointinhibitorsinsolidtumorsandwithMEDI4736inhematology;programsdirectedatamplifyinginnateantitumorimmunity;combinationsofCC-486deployingepigeneticprimingandengineeredT-cells.Theseandmanyotherdevelopmentsreflectourcommitmenttomedicalinnovationandsustaininglong-termgrowthandaresupportedbytheoperationalexcellenceandhigh-qualityfinancialresultsthatwedeliveredinthefirstquarter.
Iwouldliketoclosemyremarksbythankingourglobalteamsfortheiroutstandingworkandcommitmenttopatients.AndI'llnowturnthecallovertoPeter,whowillprovideadditionaldetailsonourfinancialresults.Thankyou.
PeterKellogg (CFOandExecutiveVicePresident):
Thankyou,Mark,andgoodmorning,everyone.AsMarkmentioned,weareofftoaverystrongstartthisyear.Ourkeyproductsaregrowingsignificantly,andweaddednewtoplinedriverswithseveralglobalapprovalsacrosstheportfolio,allofwhich,weexpect,willsustainourmomentumwellintothefuture.
Whilewearefocusedondeliveringcurrentperformance,wecontinuetoinvestforthelongterm.ThedealsweannouncedthismonthaddtothegrowingpipelineofpartneredandinternalprogramsthatrepresentthenextgenerationofgrowthdriversatCelgene.Today,wehaveover50uniqueprogramsadvancingthroughvariousstagesofpreclinicalandclinicaldevelopment.
Nowinvestingforthefutureisahighpriorityforthecompany.Andgiventhestrengthofourfinancialperformance,weareabletostrikeabalancebetweenmakingthesecriticalinvestmentsforthefutureandreturningcapitalbacktoshareholdersthroughthesharerepurchaseprogram.
Nowturningtothefirstquarterresults.Totalnetproductsalesgrew20.4%toapproximately$2.1billion.ThisgrowthacceleratedfrompriorperiodandwasdrivenbycontinuedstronggrowthinREVLIMID,inadditiontotheongoinglaunchesofPOMALYST/IMNOVID,ABRAXANEinpancreaticcancerandOTEZLA.
Volumeaccountedfor19.3percentagepointsofthegrowth,whilethemodestcontributionfrompricewaspartiallyoffsetbyforeignexchange.ThestrengtheningoftheU.S.dollardroveanegativeForEximpactofapproximately$27millionora1.6%negativeimpacttonetproductsalesgrowth.$22millionofthis$27millionimpactedREVLIMID.Yet,despitethisheadwind,totalnetREVLIMIDsalesgrew17%year-over-yearto$1.34billionandwasprimarilydrivenbyimpressivegrowthwithintheU.S.
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
EventDescription:Q12015EarningsCallMarketCapasofEventDate:90.88BPriceasofEventDate:108.04
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POMALYST/IMNOVID,ABRAXANEandOTEZLAcombinedfornetsalesof$482million,a50%increasecomparedtoQ1lastyear.Theseproductsareperformingstronglyinthemarketplace,andimportantly,theyarestillinrelativelyearlystagesoftheirgloballaunches.
Nowinlookingatthesequentialperformance,asImentionedonthefourthquarterearningscall,REVLIMIDandPOMALYSTarealwaysimpactedinQ1byhighergrossandnetadjustmentsrelatedtoearlyMedicaredonutholeandotherACApayments.It'salsoworthnotingthattheForEximpactonREVLIMIDbetweenQ4andQ1wasanegative$10million.
Inaddition,customerbuyingpatternsnegativelyimpactedABRAXANEbyapproximately$12millionto$14million.NowJackieandScottwillprovideadditionalcolorontheunderlyingproductdynamicslaterinthecall.
Thisrobusttoplineproductperformancedroveanadjustedearningspershareof$1.07,a29%year-over-yearincreaseandanaccelerationfrompriorperiods,aswecontinuetodeliver(inaudible)P&L.
Year-over-year,theadjustedoperatingmarginimproved190basispointsto52.4%.TheimprovementcameprimarilythroughtheSG&AlineasstrongG&Aleveragecontinues,andwearebeginningtoseesalesandmarketingleveragefromtheinvestmentsmadeinprioryears.Andweexpectthatleveragewillgrowthroughouttheremainderoftheyear.CombinedR&DandSG&Aexpensesgrew$119millionor15%year-over-year,reflectingourcontinuedinvestmentstoadvanceourverystrongpipelineandsupporttheglobalproductlaunches.
Sequentially,adjustedoperatingmarginimproved280basispoints,butwasfavorablyimpactedbyhigherspendinQ4relatedtocollaboration-relatedpayments,increasedparticipationatfourthquartermedicalconferencesandthetimingofclinicaltrialactivity.Goingforward,weexpectthepaceofR&Dspendtoincreaseduetoclinicaltrialactivityandcollaboration-relatedexpenses.
Wecontinuetoexpecttheadjustedoperatingmarginforthefullyeartobeapproximately52%.
Ouradjusted-earningsqualityremainedstrong,andoperatingincomeaccountedfor$0.21pershareoftheyear-over-yearincrease.Andthefinancialleversmodestlycontributedtheremaining$0.03pershare.
Weendedthequarterwith$7.3billionincashandmarketablesecurities,ofwhich,approximately85%islocatedoutsidetheU.S.Thecashflowfromoperationswas$858million.
DuringQ1,werepurchasedapproximately$1.1billionofshares.Nowthepaceofourrepurchasescanfluctuatethroughouttheyearasweprioritizeourcapitalallocationacrossinternalinvestmentsandexternalopportunities.However,wedoremaincommittedtoreturningexcesscapitaltoshareholdersthroughtherepurchaseprogram.
Tocompletethefinancialpicture.Weassessreturnoninvestedcapitalbothwithandwithoutcashinthecapitalbase.Thetrendforbothmetricsshowsacompetitivereturnthatimprovesovertime.Thisgivesusconfidencethatwearemakingtherightstrategicinvestmentstogeneratelong-termvalueforourshareholders.
Sotosummarize.ThefinancialandoperatingmomentuminQ1providesaverystrongfoundationforthefullyear.Wearewellontracktoachieveournetproductsalesguidanceof$9billionto$9.5billion.AndwiththeadditionalnewR&DinvestmentsassociatedwithmaximizingtheopportunitieswithAstraZeneca,QuanticelandAgiosthatwereannouncedjustthismonth,weexpecttodeliverourfullyearadjusteddilutedearningspershareof$4.60to$4.75.
Thankyou.Agreatfirstquarter.AndnowI'dliketoturnthecallovertomycolleague,Jackie.
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
EventDescription:Q12015EarningsCallMarketCapasofEventDate:90.88BPriceasofEventDate:108.04
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JacqualynFouse (PresidentofGlobalHematologyandOncology):
Thankyou,Peter.Goodmorning,everyone.TheHematology/OncologyteamdeliveredstellarresultsacrossthefranchiseinQ1.Ouroverallnetsalesgrew18%year-over-year,excludingthe1-percentage-pointnegativeimpactofforeignexchange,andREVLIMIDgrew19%year-over-year,excludingforeignexchange,drivenbyvolume.
Forallofourkeyproducts,wehitourgoals,andtheregulatoryachievementswe'dlandedinQ1setusupwellforstronggrowthtocomeovertheremainderofthisyearandbeyond.
Wemadegreatprogressadvancingourclinicaldevelopmentpipelineandaremovingforwardwithanumberofcollaborationsintheimmuno-oncologyspace,includingtheveryexciting,recentlyannouncedpartnershipwithAstraZeneca'sMedImmunethatwe'llspeakmoreaboutinamoment.
REVLIMIDisofftoanoutstandingstarttotheyear.Durationoftreatmentcontinuestoincreaseacrossourkeygeographies,andourmarketsharesarestrongacrossmyeloma,overallandintherelapsed/refractorysetting.WeareinlaunchmodefornewlydiagnosedmultiplemyelomainboththeU.S.andEuropefollowingregulatoryapprovalsduringQ1.
Weareonthemarketintheearly-accesscountriesinEurope,andourteamsarefocusedondrivingtosuccessfuloutcomeswithourongoingreimbursementdiscussionsacrosstheothercountriesinEurope.
ItisearlydaysforthelaunchesinboththeU.S.andEurope,andtheinitialpositivecommercialmomentuminbothgeographiesbodesverywellforREVLIMID'sfuturegrowthtrajectoryinnewlydiagnosedmyeloma.
Acrossbothrelapsed/refractoryandnewlydiagnosedmyeloma,wehavesignificantgrowthstillaheadofusinnumerousgeographies.WearelookingforwardtoincrementalcontributionsfrombothRussiaandMexicothisyear,andwe'llupdateyouonthosemarketsaswerolloutourlaunchesinrelapsed/refractorymyelomathere.
WewereveryhappywithprogressonourREVLIMIDclinicalprograminlymphoma,withthelast2initiatesofourcurrentprogramof5PhaseIIItrialsinlymphoma,therobusttrialfordiffusedlargeB-celllymphoma,nowenrolling.
AswewillseewhenItalkaboutASCOinamoment,theFLASHmeta-analysisinfollicularlymphomahasbeenacceptedfororalpresentations,andwelookforwardtothat.
ToputQ1'sREVLIMIDperformanceinperspective.Wegrewsequentiallyby2%versusQ4oflastyear,evenwiththeforeignexchangeheadwind.ThisisourbestQ1-over-Q4sequentialperformanceinthepast4years.Acrossallmajorgeographies,oursharesarestrongandtrendingupward,anddurationoftreatmentcontinuestoincreaseaswell.
IntheU.S.,REVLIMIDhitall-timerecordhighsinaveragedailytotalRxsandnewRxsinQ1.
WeareintheearlydaysofthenewlydiagnosedmyelomacountrylaunchesacrossEurope,andweanticipatesignificantmarketsharegainsofthatlargelyuntappedindicationoverthecomingmonthsandyearsaswegainreimbursementapprovalsovertime.WealsoseeincrementalsharegainopportunitiesintheU.S.nowthatwehaveabroadmyelomalabelfromwhichtopromotetheproduct.
WeexpectanapprovalfornewlydiagnosedmyelomainJapanaroundtheendofthisyear,andthen,anincrementalgrowthopportunityassociatedwiththatindicationinJapanstartingin2016andbeyond.
Finally,webelievetheongoingemergenceoftripletregimendatainmyeloma,somedetailsofwhichwe
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
EventDescription:Q12015EarningsCallMarketCapasofEventDate:90.88BPriceasofEventDate:108.04
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shouldseeatASCO,willfurthersupportREVLIMID'sbackbonepositioninthetreatmentparadigmsformyelomaandfurthersolidifytheproduct'smarketsharepositionsanddurationgaintrajectory.Thissummer,wecouldseethefirstU.S.regulatoryapprovalofoneofthesetripletregimenswithREVLIMID-basedbackbonetherapy.WeareextremelypleasedwithREVLIMID'sstrongstarttotheyearandnowexpectREVLIMIDrevenuesatorabovetheupperendofourproductsalesguidancerangeof$5.6to$5.7billion.
POMALYST/IMNOVID'sleadingpositioninthirdlineandgreatermyelomacontinuestosolidifyacrossmultiplegeographies.POMALYSTsharetrendsinboththeU.S.andEUarefavorable,anddurationoftreatmenthasbeenincreasingintheU.S.sincelaunch.IMNOVIDispenetratingrapidlyinEurope,andweanticipatethesamedurationtrendsovertime,aswhatwehaveseenintheU.S.
WerecentlyreceivedfinalregulatoryapprovalforPOMALYSTintheU.S.basedontheMM-003trialdata,andwe'vereceivedanupdatetoourlabelthatnowincludesoverallsurvivaldata.
WealsoachievedapprovalforPOMALYSTinJapaninFebruary,about18monthsorsoaheadofouroriginalplan,andwearenowworkingwiththereimbursementauthoritiesthereandexpectpricingapprovalinJune.
ClinicaldataforPOMALYSTincombinationregimensisemerging,andthatdatawillfurthersupporttheproduct'spositionintherelapsed/refractorymyelomasegment.
WehavePhaseIIcombinationtrialsenrollingforPOMALYSTforcheckpointinhibitors,HDACinhibitorsandproteasomeinhibitorsandareexcitedabouttheprospectsforthisprogram.
Onthisslide,youcanseethegrowthtrajectoryforPOMALYSTsinceourQ12013launchoftheproductintheU.S.UponU.S.launch,wesawveryrapiduptakeinmarketsharegainsoverthefirst4to5quarterspostlaunch,drivenbythemedicalneedfortreatmentoptionsinthethird-line-and-greatersetting.
WehavesinceseenmoremeasuredbutsteadysharegainscoupledwithincreasingdurationoftreatmentintheU.S.
Intheearly-launchEuropeanmarkets,weareseeingthissamepattern,aswearejustreachingthat4-to5-quarterpost-launchtimepointinmarketssuchasGermany.
InQ1,inEurope,wehadabitofheadwindforIMNOVIDasaresultofanincreaseinthegovernmentrebatepercentageintheU.K.thattookeffectJanuary1andthedelayinuptakeinSpainastheregionalreimbursementprocesshasbeenslowerthanexpected,thoughitisnowmovingalong.
OurQ12015POMALYST/IMNOVIDperformancesetanewQ1baselineforQ--forthequarter,andweseeastrongfuturegrowthtrajectoryaheadfortheproductasitapproachesblockbusterstatusthisyear.
MostmajormarketsinEuropehavenotyetreachedtheirfullfirstyearofsales,andweexpectreimbursementinItaly,Finland,IrelandandtheNetherlandsoverthecomingmonths.
DurationsoftreatmentarealsotrendingupacrossEuropeandhavenotyetreachedthesamelevelsasintheU.S.Furthermore,weareveryexcitedaboutthecontributiontoPOMALYST'sgrowthtocomefromJapanandothermarketslikeAustraliaandCanada.
TurningtoABRAXANE.OverallsharetrendsarepositiveforABRAXANEacrossitsindicationsintheU.S.andEuropeaswellasJapan,wherewearepartnerwithTaiho.Incombinationwithgemcitabine,theproducthasbecomethestandardofcareforfirst-linemetastaticpancreaticcancerintheU.S.,andweremaininearlydaysofthatlaunchinEurope.
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
EventDescription:Q12015EarningsCallMarketCapasofEventDate:90.88BPriceasofEventDate:108.04
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WeachievedEUapprovalfornon-smallcelllungcancerinFebruary,andGermanyandAustriaarelaunchinginthatindication,withothermarketstocomeaswereceivereimbursementapproval.
WehavemultipletrialscurrentlyenrollingforABRAXANE,includingthePhaseIItriplenegativebreastcancertrial,thePhaseIIIadjuvantandPhaseIIlocallyadvancedpancreatictrialsaswellastheABOUNDprogramof4trialsacrossvariousnon-smallcelllungcancerindications.
We'realsoextremelyexcitedaboutthefuturepotentialuseofABRAXANEincombinationwithavarietyofcheckpointinhibitoragentsandothernoveltherapiesandareworkingwithanumberofothercompaniesoncombinationtrialsintheimmunotherapyarena.
We'reofftoagreatstartto2015withABRAXANE,andwefinishedthequarterwellonourplan.
WhilewesawtheusualU.S.customerbuyingpatternsinQ1,globalproductdemandwasverysolid,andourglobalQ12015resultcomparesquitefavorablytoQ1frompastyears.WehavemultipledriversofgrowththatgiveABRAXANEpositivemomentumfortheremainderofthisyearandinto2016.
IntheEU,wejustreceivedreimbursementapprovalforpancreaticcancerinSpainandItalyduringQ1.WestillawaitapprovalsinFrance,BelgiumandotherEUcountries.ThecontributiontoEUABRAXANErevenuesfromnon-smallcelllungcancerisjustbeginningandwillrampupoverthecourseofthisyearandintonext.
Becausesomeofthesegrowthdriversarestillaheadofusandwillimpactfutureyearsmorethanthisyear,weseeglobalABRAXANErevenuesfallinginthelowerhalfofourproductguidancerangeof$1billionto$1.25billion,whilewearehighlyconfidentofachievingourtargetofbeingwithinthisrange.Andthisyear,ABRAXANEwillreachblockbusterstatus.
ThefutureforABRAXANEisbright,andthepotentialpositiveimpactfromongoingtrialsofABRAXANEincombinationwithimmunotherapyagentshasnotbeenincludedinanyofourforecastandrepresentsgreatoptionalityfortheproductinthemediumtolongterm.
We'reexcitedtogiveyouapreviewofsomeupcomingmedicalmeetingswhereourhematologyandoncologyproductsandprogramswillbefeatured.StartingwithASCO,forhematologyhighlights,wewillseeupdatedoverallsurvivaldatapresentedfromtheMM-020FIRSTtrial.TheFLASHanalysiscorrelatingcompleteresponsewithprogression-freesurvivalwillbeanoralpresentationforourfirst-linefollicularlymphoma.Finally,therewillbesignificantdatapresentationsformultipletripletregimensinmyelomawithREVLIMIDasthebackboneoftreatmenttherapy.
Foroncologyfeatures,wewillseePhaseIdataondemcizumab,thecompoundforwhichwe'repartneredwithOncoMed.Andweshouldseeadditionalprogramdetailsforimmunotherapycombinationworkbeingdone,includingABRAXANE,asacomponentofmultipletreatmentregimen.
ThebiannualMDSFoundationmeetingstartstoday,andweareveryhappywiththeexpandedpresencewehavetherecoveringourmyeloiddiseasefranchise.
WelookforwardtodatapresentationsforbothsotaterceptandluspaterceptinMDS,compoundscomingfromourcollaborationwithAcceleron.TogetherwithAcceleron,wehavenowchosenluspatercepttomoveforwardintoapivotalprograminMDS.
June'sEuropeanHematologyAssociationMeetingwillagainfeatureourstrongCelgenepresence,andweexpectdatapresentationsonanumberofourproducts,includingAG-221forIDH2mutationscomingfromourcollaborationwithAgios.
WerecentlyannouncedanimportantnewimmunotherapystrategiccollaborationwithAstraZeneca
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
EventDescription:Q12015EarningsCallMarketCapasofEventDate:90.88BPriceasofEventDate:108.04
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MedImmune.We'reextremelyexcitedtopartnerwithAZMedImmuneinthisareaandtoaggressivelybeginourinitialfocusonaportfolioofclinicaldevelopmentplansformultiplehematologicalindicationsstudyingAZMedImmune'sPD-L1inhibitor,MEDI4736,innovelcombinations.Webelievethiscollaborationwillleadtoexpandedopportunitiestocombinenovelassetsinhematology.
Together,our2companieshaveauniqueportfolioofcomplementarycompoundsfromwhichtocreatemultipledevelopmentpathoptionstopursueexciting,newtreatmentregimens.
Ourinitialagreementrepresentsthefirstwaveofdevelopmentcenteredoncheckpointinhibitionandgrouptherapies,andwelookforwardtoexpandingintothesubsequentwaysofimmunotherapypossibilitiestocome.
AftermakingourupfrontpaymenttoaccessAZ'sclinicalstagePD-L1asset,thefinancialtermsofthedealessentiallycreatea50-50sharingbyour2companiesofthePD-L1economicsinhematology,thus,creatingastructureunderwhichbothofusareincentivizedformaximumsuccess.
AtCelgene,ourHematology/Oncologyfranchiseisofftoanexcellentstarttotheyear,andourcontinuedinvestmentsinourpipelineandstrategiccollaborationslikethisonewithAZMedImmunepositionusforongoingsuccessandgrowthovertheverylongterm.
Thankyouverymuch,andletmenowturnthecallovertoScott.
Jean-PierreBizzari(GlobalHeadofOncology):
Thankyou,Jackie,andwelcometoeverybodyonthecall.Weareofftoaverystrongstartin2015.
Q1wasaquarterfullofadvancementandaccomplishmentwithintheI&Ifranchise.Duringthisquarter,wesawasignificantaccelerationofprescriptionsandrevenueforOTEZLAintheU.S.Revenuewas$60millionforQ1,andwearewellontracktoachieveourgoalsfortheyear.
Additionally,wereceivedapprovalsinEuropeandAustraliaforbothPsAandpsoriasis.
WearealsoadvancingcriticalaspectsoftheGED-0301registrationprogramaswellasotherkeypipelineprojects.
TurningnowtotheU.S.OTEZLAlaunch.Weseecontinuingstrongprescriptiongrowththatputsusaheadofallrecentlaunchesinthespaceafter52weeksofcommercialization.ThevastmajorityofuseinbothPsAandpsoriasisisforpatientswhoarecomingoffnon-biologictherapies.Approximately85%ofpatientswhoareinitiatingonOTEZLAwereprebiologicandonly15%werecomingtoOTEZLAfromabiologictherapy.
ThemajorityofOTEZLAprescribershaveprescribedformultiplepatients,anddespitethehighlymanagednatureofthiscategory,accesscontinuestobefavorablewithOTEZLAat99%formularycoverageand72%ofOTEZLAprescriptionssuccessfullysold.
Ifwelookspecificallyatnew-to-brandpatientshare,youcanclearlyseethatOTEZLAnowhastheleadingshareofnewpatients,aheadofallotherproducts,brandedorunbranded,forbothindications.New-to-brandpatientsarethosepatientswhoinitiateanewtherapyinagivenmonth,includingthosewhoswitch,addonorarenaïvetotherapy.Whilenew-to-brandpatientsrepresentonly10%ofthemarketinany1month,marketshareleadershipinthisareaisaverystrongleadingindicatoroffuturegrowthandalsoshowsthetremendouspotentialforOTEZLAinPsAandpsoriasis.
Theearly-launchdynamicsarestrongincountriesthathavelaunchedoutsideoftheU.S.aswell.InCanada,afteronly4months,OTEZLAleadsallpromotedbrandsandnew-to-brandshareontheprivate
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
EventDescription:Q12015EarningsCallMarketCapasofEventDate:90.88BPriceasofEventDate:108.04
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marketaheadofpubliclisting,andthereareveryencouragingearly-launchmetricsinGermany,theU.K.andotherEuropeancountries.
ThedatarolloutforOTEZLAisexpectedtocontinuethroughouttherestoftheyearthroughpublicationsandatmajormedicalmeetings.Thefocusoftheseabstractsandpresentationswillbemainlyonthelonger-termdataforOTEZLA,whichshowsahighlydifferentiatedbenefit/riskprofilerelativetotheothercompetitiveproducts.
Earlierthismonth,theNewEnglandJournalofMedicinepublisheddatafromPhaseIIproof-of-conceptstudyofOTEZLAinBehçet'sdisease.
TurningourattentiontoGED-0301.Weareaggressivelymovingclinicaldevelopmentplansforward,andregistrationenablingendoscopystudyisunderway.Start-upactivitiesforthelargePhaseIIIregistrationtrialsareongoing,andstudyinitiationsareexpectedmidyear.APhaseIIstudyinulcerativecolitiswillbegininthesecondhalfof2015,andwearepreparingforclinicaldevelopmentinadolescentCrohn'sdisease,withinitiationtargetedforQ4.
Asmanyofyouknow,datafromthePhaseII[IGON-1]studyofGED-0301inCrohn'sdiseasewaspublishedintheNewEnglandJournalofMedicineinMarch.
DDW,theDigestiveDiseaseWeekMeetinginMay,willprovideanopportunityforfurtherpresentationofthe[IGON-1]data,includingimportantsubsetanalysis.
Asstatedearlier,Q1wasaquarterfullofadvancementsforCelgeneI&I.Thebalanceoftheyearshouldalsobefullofmajormilestonesandaccomplishments.WearefocusedoncontinuingtobuildonthestrongU.S.OTEZLAlaunch,thesuccessfullaunchofOTEZLAinkeygeographiesoutsideoftheU.S.andalsotargetcompletingenrollmentofthePhaseIIIstudyinBehçet'sdiseaseandPhaseIIstudiesofOTEZLAinatopicdermatitisandulcerativecolitis.
WeareaggressivelyadvancingthedevelopmentofGED-0301andplanonmovingotherkeyclinicalprogramssuchasCC-220andsotaterceptforwardthroughimportantmedicalmilestonesin2015.
Weareexcited(inaudible)momentumthat'sbeencreated,andwelookforwardtofurtheringmanykeyaspectsoftheI&Ifranchisethroughout2015.
Thankyouverymuch,andI'dliketoturnthecallovertoBob.
RobertHugin (Chairman,CEOandChairmanofExecutiveCommittee):
Thankyou,Scott,andthankyoutoeveryoneatCelgeneforproducingtheoutstandingresultsreportedthismorningandforadvancingthe5strategicimperativesthatguideourcompany.
Ourcommitmenttoaspirationalobjectives,combinedwithourfocusontheseimperatives,strengthenourconfidenceintheachievementofournear-termgoalsandpositionsusforcontinuedlong-termgrowth.
Oursustainedinvestmentatourfranchises'keyprogramshascontributedtothenumerousrecentregulatoryaccompaniments,leadingtoincreasingcommercialopportunities.Andasoutlinedintheearlierpresentations,ourcommitmenttosustaininginnovationisbeingdemonstratedbytheprogressinadvancingourinternalprogramsandacceleratingourcollaborationswithstrategicpartners.
Ourmostrecentinvestmentsandpartnershipsleverageourleadershipandexpertiseinimportantareasofresearchandprovideafoundationforfuturegrowthinthetransformationalareasofimmuno-oncology,epigeneticsandcellulartherapy.
Ourfirstquarterperformancewascompellingevidenceofourteam'sintensefocusonoperational
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excellence,thefoundationofallofoursuccess.
Aswelooktothefuture,we'reexcitedaboutthenumerousnear-termmilestonesthathaveapotentialtofuelsignificantgrowth.Weexpectnewdataatmedicalconferencesthroughouttheyear,illustratingtheopportunitiesinourdeepanddiversepipeline.
AllofusatCelgeneareenergizedandcommittedtodeliveringexceptionalresultsandcapturingthefullpotentialofourcompany.
Thankyouforjoiningusthismorning,andoperator,wouldyoupleasenowopenthecalltoquestions?
QUESTIONS&ANSWERS
Operator :
(OperatorInstructions)AndourfirstquestioncomesfromGeoffPorgesofSanfordBernstein.
Geof f reyPorges (Analyst-SanfordC.Bernstein):
First,aquestionforPeter.Justononetimeitems.Andyoumentionedthegross-to-net,andpresumably,therewasastep-upinyourco-payassistancecontributionsinthequarter.Couldyoujustgiveusasenseofthemagnitudeofhowmuchyourgross-to-netwentupfromQ4toQ1?Andalso,potentially,howmuchtheco-payassistancewentup?Andanyotheronetimeitemsthatwashelpfultocurrency.
Andthen,justalittlebitontheAstraZenecacollaboration.It'scertainlyinteresting,butcouldyouperhapsexplaintous,whataretheassetsfromCelgenethataresharedwithAstraZenecathatgointothecollaboration?It'sprettyclearwhathappenswiththePD-L1,butwhatareyougivingupinreturnforthataccess?
PeterKellogg (CFOandExecutiveVicePresident):
Great.Geoff,thisisPeter.Thankyouverymuchforthequestions.SoI'mgoingtogoinreversesequence,ifIcan.Letmejusttalkaboutforeignexchangefirst,becauseIknowforeignexchangeisthetopicforalotofmultinationalcompanieslikeus.Andinfact,asImentioned,atthetopline,versusprioryear,foreignexchangewasanet1.6%negativeimpactor$27million.
Justtobreakthatoutforyouin--versuspriorquarters,sogoingfromQ4toQ1,itwasanegative0.6%impacttoourtotalcompanygrowth.Nowwehaveaveryactivehedgingprogram,soobviously,theforeignexchangeimpact,byitself,wasmuchlarger,butalotofthatwasoffsetbythebenefitsofhedgesthatwe'verolledinoverthelast3years.Andwehaveaveryactiveprogram,andthat'stomanageourexposures.
Justtogiveyoufeelforthat,versusprioryear,theforeignexchangeimpactonourP&Lalone,withoutthehedges,was5.8%negative,andwegota4.2%positiveimpactfromthehedges.Thatwasverygood.
Relativetoco-payandothergross-to-netitems,wedidhaveaslightlylargerco-paychargethisquarter.Andlikewise,thegross-to-netdidincrease.WhatI'dhavetodoiscomebacktoyoualittlebitonexactlythedetailsofgross-to-net.Wedon'toftenbreakthatoutinlotsofdetail.Butin--itistruethatthefirstquarteralwaysisalittlebitmorechallenging,particularlyforREVLIMIDandPOMALYST,becauseofthoseACApaymentsandthegross-to-netfillingthedonut-holecontributions.
Thatsaid,Ithink,often,that'swhyit'sgoodtocompareQ1-to-Q1prioryear,because,infact,wehavethateffecteveryyear.Soit's--asyoucansee,inouryear-over-yeargrowthrates,we'vedoneextremelywellevenwiththeforeignexchangeenvironment.Andit'sreallyagreatstarttotheyear.Forthe
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AstraZenecaassetsharing,maybeI'llturnittoJackieforthat.
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Allright,Geoff.Thanksforthequestion.SoIthink,thegistofyourquestionisrelatedtowhetherwewouldshareanyoftheeconomicsonCelgeneassets.Theanswerisno.SothecollaborationincludesjustthesharingonthePD-L1assetinhematology.
Geof f reyPorges (Analyst-SanfordC.Bernstein):
Okay.Sothere'sno--noneoftheassetsinyourpipelinewouldbeshared,assumingthey'resuccessfulinthoseindications.
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Thatisabsolutelycorrect.
Operator :
AndournextquestioncomesfromCoryKasimovofJPMorgan.
CoryKasimov(Analyst-JPMorganChase):
IwantedtoaskabouttheupdatethismorningwithluspaterceptinMDSandbeta-thalassemia.Isthereanythingthatyoucansaywithregardtothepotentialproposedtrialdesignandendpointsofthosetrials?AndwhereyouseethisproductultimatelybestfittingintothemarketassuccessfulinPhaseIII?
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Thanksforthequestion.SoIwouldjustsay,withrespecttothespecifictrialdesigns,Imean,Ithinkyou'llseemoredetailsontheprogramaswetakethatforwardovertime.Youhadalreadyheardusindicatethatwewouldtakeluspaterceptforwardinbeta-thalassemia.Nowwe'veformallytakenthedecisiontotakeitforwardinMDSaswell,andyou'llgetmoredetailsaboutthatPhaseIIIprogramaswemovealonginbothofthoseindications.Ourintentionswithourpartner,Acceleron,aretojustkeepthoseprogramsmovingasquicklyaspossibleandinitiatebytheendoftheyear.Sostaytunedformoreinthatregard.
Operator :
AndournextquestioncomesfromMarkSchoenebaumofEvercoreISI.
MarkSchoenebaum(Analyst-EvercoreISI):
IfImay--IthinkScott'son.Hey,Scott.CongratulationsontheNewEnglandJournalpublication.Iwasjustwonderingifyoucouldcommentmaybeonsomeofthepointstheeditorialistmade.Ithinktheeditorialsaidthattheefficacywasunprecedented,butthen,basicallytriedtomakethepointthattheauthorthoughtthere'salackcongruencebetweenclinicalandbiologicalsignsofremission.Justwouldlovetohearyourcommentaryonthat,ifyoumay.
Andthen,myfollow-upwouldjustbe,there'sbeenalotofStreetfocusontheupcomingEuropeanpatentruling.Just--Iknowthere'snotalotyouguyscansay,orarewillingtosay,ontheIPonthecall.Sojustas--butmaybejustingeneral,doyouthinkthere'sreadacrossfromthesituationintheU.S.,yesorno?
Scott Smith (PresidentofGlobalInflammationandImmunology):
Thankyouforthequestions.Sotherewasactually2articlespublishedintheNewEnglandJournalsincewelastspoke,oneonOTEZLAandBehçet'sdisease,oneinGED-0301andCrohn's.AndIassume
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you'respeakingtotheCrohn'spublication.Theeditorial,Ithought,wasverypositiveandbalanced.Unprecedentedefficacy,theopportunitytopotentiallychangethefaceoftreatmentofCrohn'sdisease,andmaybethefirststepsinthecureandsomeverypositivethings.Ithinkitwasbalancedwithsomethingsthatweknowandwedon'tknow.
Oneofthegoodpartsofthisis,Ithink,alotofthatquestionsthatwereraisedwillbeaddressedatDDW,intheabstractsandthepresentationstherethatarelookingatsomeofthesubsetanalyses,themoreseverepatients,therelationshipbetweendoseandclinicalresponseandremission.Sowe'regoingtogetachancethroughDDWtodigintothatdatamore,andIthinkthatwillanswersomeofthequestionsormostofthequestionsthatcameupintheeditorial.Butoverall,Ithoughttheeditorialwasverypositive.
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Hi,Mark.ThanksforthequestionontheEUpatentsituation.SothathearingwilltakeplaceonMay7.Wedonotbelievethat,thatcasewillbereadthroughtotheU.S.Whydowenotthinkthat?There'sacoupleofthingsthatIthinkpeopleareprettywellawareof.Fromastandpointofthedifferencesbetweenthe2geographiesontheseissues,therearebothsubstantiveaswellasproceduraldifferencesintermsofhowtheU.S.andtheEUlooksatthesepatentsintheU.S.ThelawlooksatpolymeraseasverydistinctcompoundsintheEU.It'salittlebitmorespecifictothefactaroundtheparticularpatentbeingexamined.Wehappentothinkthatourfactsareverystrong,andwe'llseeifthecourtagrees.Butbecauseofthosesubstantiveandproceduraldifferences,wedon'tthinkthere'saread-throughfromtheU.S.casetotheU.S.situation--Imean,fromtheEUcasetotheU.S.situation.
Operator :
AndournextquestioncomesfromthelineofMatthewHarrisonofMorganStanley.
MatthewHarrison (Analyst-MorganStanley):
Iwantedtoask2onOTEZLA,ifIcould.Socanyoujusttalkalittlebitaboutthegross-to-netandstocking,andifthathadanimpactontherevenuesforthequarter?AndthensomethingInoticedinthechartsthatyouprovided,especiallyonthenew-to-brand,itlookslikemethotrexateusedaresortofdecliningrelativetosortofOTEZLAsharerising.Isthatreallywhat'shappening?Thatthepeopleareusingthisinsteadofmethotrexate?Oristhatjustanaberrationinthegrass?
Scott Smith (PresidentofGlobalInflammationandImmunology):
Sofirst,the--sorryaboutthat.Thefirstcommentbeingongross-to-net.Youdoseedifferencesasyougothroughthequarterswithgross-to-netandwithOTEZLAaswellasintheimmuno-oncologyportfolio,andittendstobehighestinQ1.Andsoyouwillseeitgodownoverthecourseoftheyear.Sothatdidhavesomesmallimpactonrevenues.Methotrexate--
RobertHugin (Chairman,CEOandChairmanofExecutiveCommittee):
Wewerejustondistributioninventory,Ithink.
Scott Smith (PresidentofGlobalInflammationandImmunology):
WeexpandeddistributionattheendofQ4toincludewholesaleanddistribution,aproblemthathadaneffectin--andtowardstheendofQ4,andwesawthatdrawingdownduringthecourseofQ1.Sooverall,yougetasteadystatetherefromthispointforwardandGTNgoesdownduringthecourseoftheyear.
IntermsoftheutilizationofOTEZLArelativetomethotrexate,Ithinkwhatwe'reseeingfromthedatain
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particular,onlyinthelastfewmonths,you'reseeingitdipinmethotrexate,you'reseeingOTEZLAbeingusedearlyintheprebiologicspace,someofthatisasubstitutionformethotrexateoranearlierswitchofthemethotrexatetoanotheroralbeforegoingtoabiologic.Ithinkyou'realsoseeingsomedeclineinacoupleofthebiologics,whichareusedearlier,particularlyintheembryospace.SoIthinkwe'reseeingmarketsharebeinggainedfromOTEZLAatbothfromtheDMARDsandfromembryoandotherbiologics.
Operator :
OurnextquestioncomesfromthelineofRobynKarnauskasofDeutscheBank.
RobynKarnauskas (Analyst-DeutscheBank):
IguessfirstquestionisforScott.Soisthere--hastherebeenanyplansyetthathaveputastepaddedinplacetouseOTEZLAaheadofaTNF?Justevenoneplan?AndthensecondquestionismoreontheuseofKyprolis,becauseIknowthatASPIRE'scomingupandKyprolislookspuredeveloping.HaveyouseenanychangesinthepercentageofpeoplegettingREVLIMIDVelcadetoREVLIMIDKyprolisyetinthisspace?Isthatstartingtohappen?
Scott Smith (PresidentofGlobalInflammationandImmunology):
SothisisScott.Onthestep-addedquestion,wedosomeplansduringthecourseof--particularlyduringthecourseof2015,somesmallerplantswhohavetakenthatstepofputtingitpreferentiallyaheadofbiologictherapy.It'scertainlynotamajorityofplantsatthispoint.Ourgoalthroughthecourseoftheyearintermsofaccessistobeoncompletelyequalfooting,noadditionalstepadded.Andthenlongerterm,getputinapositionofstrongerforcedutilizationaheadofbiologics.Butwearestartingtoseesomeofthathappeninmarketplacetoday.
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Allright,Robyn,it'sJackie.SoIthinkwithrespectyourquestionaboutKyprolis.ImeanthedisseminationoftheASPIREdataisstillrelativelyfresh,Iwouldsay.We're--thecommentthatImadeinmypreparedremarksaboutpotentiallyseeingthefirstU.S.approvalofatripletregimenfromthat,comingthissummer,relatestothatcombination.
Ithinkit'salittlebitearlytostarttomakeacallontrendsthere.Whatwelikeabouttheevolutionofthisisthestorythat'splayingoutwithrespecttoREVLIMIDasaclearbackbonetherapyinthesetripletcombinationsandthebenefitfrompatientsthatwe'reseeingthePFSimprovementsandthetreatmentoutcomeimprovementswiththetripletregimen.SoIthinkoverthecourseoftheremainderoftheyearandaswegointoASH,we'llhavealittlebitmoredatatobeabletohavesomebetterideaoftruetrendsthatwewouldseeemergingfromthesetripletdatasetsandapprovals.
RobynKarnauskas (Analyst-DeutscheBank):
Great.AndIthinkIhaveafollow-up,Scott.Soalotofinvestorsnowaretalkingofbiosimilarscoming,potentially2017,andIassumethatOTEZLAwillbemuchmoreentrenchedbythen.Sowhatareyouseeinginthespace,like,sofargoingintopotentialcompetitionintheTNFspacethatmakesyoufeelcomfortablethatOTEZLAcanbeentrenchedinfrontoftheTNForinfrontofanypricesensitivityinthemarketinthenextfewyears?Imean,justhelpusthinkalittlebitgoingforwardhowyou'rethinkingaboutthespaceevolving.
Scott Smith (PresidentofGlobalInflammationandImmunology):
Wedon'tseenecessarilybiosimilarsaffectingwhat'sgoingonwithOTEZLAinthemarketplace.Wetakealookattheearlydata.85%oftheutilizationtodayofOTEZLA'saheadofbiologics.Theprofilethatwe
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haveishighlydifferentiatedversusbiologics,whetherbrandedorunbranded.Anditreallyisauniquevaluepropositionforthismarketplace.Thatitiscompletelydifferentthanyouseefromthebiologicsorfrombiosimilars.Sowedon'tseethisascompetitiveinthisspaceatall,andwethinkwe--really,thevaluepropositionofearlyusenon-biologicsspacehasreallyplayedoutinthefirstyearofcommercialization,particularlyinthefirstquarter,1.5quarterofpsoriasis.Youreallyseealotofearlyutilizationthere.So--
RobertHugin (Chairman,CEOandChairmanofExecutiveCommittee):
Andhavinganother2yearsinadvanceofbiosimilarstoreallybuildthismarketplace.Butjustacoupleofyearsago,peopledidn'tevenbelievethemarketplaceexisted,andnowit'squiteclear.Andsothat--this2yearsisveryvaluableeventhough,asyousaid,thevaluepropositionisveryclearintheproductprofile.Soit'sveryencouraging.
Operator :
AndournextquestioncomesfromJohnNeumannofCanaccord.
JohnNewman (Analyst-CanaccordGenuity):
I'mjustcuriousonABRAXANE,doyouthinkastheyeargoeson,theremaybesomepotentialforrevenuestomovekindofhigherinthatrangeofyourguidance?Andthenalsojustafollow-uponbiosimilars.Giventheguidancethatwesawfromtheagencyyesterday,whatdoyouultimatelyseeplayingoutintheTNFspace?Itseemslikeinterchangeability,eventhoughthat'saproductthatgoesthroughtheretailchannel,interchangeabilitycouldbealittlebitofatallorderatthemoment.
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Hi,John.Thanksforthequestion.WhatIwouldsayaboutABRAXANEiswethinkthatwe'regoingtoseeasignificantaccelerationintherevenuegrowthtrajectoryovertheremainderoftheyearforseveralreasons.We'restillintheveryearlystagesofthepancreaticlaunchinEurope,sotheearlylaunchcountriesarerampingup.We--basedontheexperiencethatwe'vehadintheU.S,expectfortheproducttobecomestandardofcareincombinationwithgemcitabineinpancreaticcancer.We'reseeingaverypositivesharetrendsoflightintheU.S.Andagain,weexpectthatsamepositiontobeachievedinEurope.
AsImentionedinmyremarks,wehaveanumberofcountrieswherewe'restillawaitingthereimbursementapproval.Ifthosecomein,thosewillpositivelycontributethereaswell.WealsohavejuststartedwiththelonglaunchinEurope,andthat'scompletelyincrementalforusaswell.SowejustgotthatapprovalinthemiddleofQ1,juststartingtolaunchintheearlyaccesscountrieslikeGermanyandAustria.AndalloftheapprovalsintheothercountriesacrosstheEuropeforpricingarestillaheadofus.
Andthenonemorethingthataswemoveovertimewillimpactevenmorethefuture,butisnotyetincludedinournumbers,isanypotentialforABRAXANEincombinationimmunotherapyregimensasthatphasecontinuestoevolve.Sowe'reseeingalotofenthusiasmaroundtheproduct,andwebelieveitwillbeacceleratingprettysignificantlyintermsoftherevenuegrowthovertheremainderoftheyearandinto2016andbeyond.
Scott Smith (PresidentofGlobalInflammationandImmunology):
SothequestionrelativetobiosimilarimpactontheTNFinhibitors,I'mnotreallyinapositiontosaywhatthat'sgoingtolooklikeandhowthemarket'sgoingtotransformtowhatextentpost-biosimilarinitiationintheU.S.Andagain,Ijustwantto--we'refocusedonadifferentspace.Weseealotofutilizationintheprebiologicspace,averydifferentvaluepropositionintermsofanoraldrug,differentbenefit/riskand
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otherthings.Soit'snotsomethingthatweseefundamentallynecessarilychangingourbusinessdynamicgoingforward.
Operator :
AndournextquestioncomesfromEricSchmidtofCowenandCompany.
EricSchmidt (Analyst-CowenandCompany):
MaybebacktothePD-1collaborationwithAZ.Canyougiveusyourthoughtsonsortofthegeneraloutlookforcheckpointinhibitorsandhememalignancies?AndImeanwhatspecificallyintermsofdatasetsorevidencethatyoudidduediligenceonallowedyoutomakeamajorbethere?
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Hi,Eric.It'sJackie.Thanksforthequestion.SoImean,it'sstillearlydaysintermsoftheevolutionofthedatainhememalignancies.Asyouknow,wedidsignificantdiligencewithourteamandtheAZteamandhavelookedatallofthedataavailabletousatthistime.Andwe'requiteexcitedaboutthepotentialforcombinationtherapiesinthisspace,whichiswhywewantedtomoveforwardwiththecollaboration.
AZhasinvestedquitesignificantlyacrosstheirsolidtumorclinicaldevelopmentplanforthisproduct,andthey'vestartedtogeneratepreclinicalandearlydatainthehematologicalmalignancies.Wefeellikewe'vebeeninthecomplementarynatureoftheassetsinourrespectiveportfolios,thatwehaveanopportunityastheleaderinhematology,wetakethisprogram,accelerateit,moveitveryfast.Andwiththat,those--thepotentialproductcombinationsseeksomemultipledifferentpathstoregulatoryapprovalsthatcouldpotentiallyincludesomeacceleratedtimelines.
Sowethinkwe'reinareallygoodpositionwiththis,andwe'requiteexcitedaboutthefirstwaveofthiswiththecheckpointinhibitor-anchoredtherapies.Andthenwe'vegottheopportunitytolookatmostofourrespectivepipelinesofearlierstageassetsandseewhatwemightbeabletodothereacross,again,arangeofhematologicalindications.
Operator :
AndournextquestioncomesfromMichaelYeeofRBCCapitalMarkets.
MichaelYee (Analyst-RBCCapitalMarkets):
AquestionforScott.Following-uponGED-0301.Ofcourse,yourendoscopystudy'sunderway.Maybeyoucanreminduswhenyoucanannouncesomethingfromthat,whatyoucouldactuallysay,whatendpoints,etcetera.HowmuchcolorcouldyougivetoTheStreetaswediscuss,obviously,thatpartoftheprogramandgetconfidencearoundendoscopyaspect?
Scott Smith (PresidentofGlobalInflammationandImmunology):
Sowe'llhaveadeepdivearoundthespecificstructureandalotofdetailaroundthewholeclinicalprogramforGED-0301andDDWnextmonth.WhatIcansayabouttheendoscopystudyisthatit'sa12-weekstudy.There'samucosalhealingendpointat12weeks,butthenthere'sa52-weekextensiononthattoseedurabilityofremissionovertime.
Andsothefullstudyforitscompletionis12plus52weeks,gettingusto64weeks.Andasalways,wewillmakethatdataavailablethroughmedicalmeetingsandothersourcesofappropriatepublicationwhenit'scompleted.Butit'sa12-weekstudywitha52-weekobservationperiod.Andagain,we'llgothroughalotofdetailonallthosestudiesatDDW.But--well,thatstudy'supandgoing,andwe'reveryexcitedaboutit.Andit'senrollingveryactively,andhopefully,that'llgetdonequickly.
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Operator :
AndournextquestioncomesfromIanSomaiyaofNomuraSecurities.
M.IanSomaiya(Analyst-NomuraSecurities):
JustbecauseIlookedatyourpipeline,you'vedoneatremendousjobofbuildingapipeline.Thatshoulddrivegrowthwellintothenextdecade.WhatIwashopingforismaybe--ifcouldprovidesomecoloronthelineextensionstrategy,specificallyforREVLIMID.As--despitethebreadthoftheportfoliothatyou'veputtogether,onecanimaginethatREVLIMIDstillwouldbe40%,50%ofoverallsales,despitesuccessfulforvastmajorityofpipelinedrug.SoIwasjusthopingyoucouldcommentonthat.
AndjustonGED-0301.IwassurprisedtoseeapediatricstudyinCrohn's.Justwhattypeofspacedoyouwork--wasrequiredtosortofmoveforwardinthat?AndIguesshowshouldwethinkaboutsortoftheoverallsafetyofthedruginlightofyourdecisiontomoveforwardthere?
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Hi,Ian,it'sJackie.SoletmestartwiththeREVLIMIDquestion.SoIthinkthemostsignificantprogramthatwewouldfocusonforthemomentisthelymphomaprogram.Sowehave5PhaseIIItrialsupandrunning,enrollinginlymphoma.Someofthosehavealreadycompletedacrossanumberofindications,diffusedlargeB-cell,follicular.Youwillsee,again,theFLASHanalysisthat'sbeenacceptedfororalpresentationatASCOaroundthesurrogateendpointofcompleteresponseforPFS.Andthenwewillhaveabetterideaandbeabletotalkaboutthepotentialimpactofthatontimeline.
Soweareveryhappywithwhereweareintermsofthemomentuminthecurrentcommercialbusinessaroundthenewlydiagnosedlaunch.We'reseeinggreatresultsfromthat,alreadyexpectedaccelerationofthatovertheremainderofthisyear.Soforthenextfewyears,quitehappywiththatwiththat,withhowwethinkREVLIMIDisgoingtoplayasbackbonetherapyinthemyelomaspace.
Andthenwhenwelookoutalittlebitfurther,we'vegotallthesepotentialindicationstocomeinlymphoma.It'sbeenalsopossiblethatinthefirstwaveoftheimmunotherapyregimensthatREVLIMIDcouldbeanenablingcompoundtobringnoveltherapiestomarket,incombinationoffasteraswell.Sogreatplaceforitintheportfolioandhelpingusgetontothenextroundofthingstocomeevenbeyond.
M.IanSomaiya(Analyst-NomuraSecurities):
Yes,IguesslikemyquestionwasmoregearedtowardshowdoyouultimatelyreplaceREVLIMID,andwhat'sthestrategythere?
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Well,Ithink--Imeanit'salittleearly.Butwithrespecttohowweseethemarketplayingout,ImeanIthinkaboutitnotexactlyas"replacingREVLIMID,"butit'smoreabouthowdowecontinuetoevolvethetreatmentparadigmstobestimpactpatients'livesanddothatinsuchawaythatthebusinesspropositionisthereforustosustainourgrowthprofileforalongperiodoftime,withaportfolioofproductsthatwouldallowustocontinuetobeleadersinmultiplemyelomaandbecomeleadersorhaveleadingpositionsinotherindicationsaswell.
SoIthinkaswecontinuetotakethingsforwardandwhatyouareseeingmoreandmoreofbetweentheevolutionofbiomarkerevidenceandotherthingsismoretargetedtherapies,whereyoucouldcontinuetoseesegmentationinthemarketandourproductstakingleadingpositionsindifferentsegmentsofthemarket.Soyoucanverymuchseeitbeingaportfolioofproductsthat,overtime,comesintosustainourREVLIMIDfranchiseforavery,verylongperiodoftimeratherthanjustoneproductreplacingREVLIMID.
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Sowewouldseeitplayingoutthatway,targetinghigh-riskandunmetmedicalneedsegmentsandmakingourwaythroughtheprocess.
RobertHugin (Chairman,CEOandChairmanofExecutiveCommittee):
Ijustwantalittleofthat.Ithink,Ian,thishasbeenclearlyalong-termstrategy,bothasJackiepointsout,thathaveveryfundamentalresearchinthespaceofthebiologythatleadstoB-cellmalignanciesandalltheproteinhomeostasisarea.Itgivesusconfidencethatasthetechnologiesincreasedourabilitiestosegmentpatientpopulationsintospecificbiologicalrespondersintargetedareas,wewillhavetheproductsfromourowninternalportfolioandthroughcollaboratorsthatwillallowustohavegreaterandgreaterimpactonthediseaseswhereREVLIMIDexisttodayinageneralway.Sowe'reveryoptimisticthatourowninternalresearchpipelineisgoingtodothat.Andatthesametime,wehavebuiltaportfolioandapipelineapproachthatwebelievewillhave,regardlessofwhathappens,averystronggrowthtrajectoryinadditiontothat.
Sowe'renotjustlookingtodealwithreplacingREVLIMID.We'regoingtocontinuetogrowthroughit,andwe'regoingtoprovidebetter--orbetteralternativesandtherapiestopatientsinthosespecificareasoverthenextdecade.
Scott Smith (PresidentofGlobalInflammationandImmunology):
SpecifictoadolescentCrohn's.Justacoupleofthoughtsonthat.Firstofall,it'sanarea--tremendouslylargenumberofpatientssufferfromadolescentCrohn's.It'saverydifficultdiseasetotreat.There'stremendousamountofhighunmetmedicalneedinthespace.Theconventionaltherapiesworkevenlesswellinthissubsetofthepopulationastheydointheadultpopulation.Soit'sanareaofreallyhighunmetmedicalneed.
GiventheprofilethatcameoutinPhaseIIthatlookedbalancedandlookedverysimilartoplacebointermsofallthedifferentdosecohortsforGED-0301intermsof(inaudible)sideeffectsandsevereSAEs.Giventhatsideeffectprofile,whenwehaddiscussionswithboththeEMEAandwiththeFDA,theywereveryencouragingofustostudythisparticularpatientpopulation.Alotofhighunmetneedandtherewasalotof--there'sbeenalsointhecommitteecarelocalcommunity,alotofenthusiasmtostudythedruginthiscommunity.AndthesafetydatawastherefromPhaseII,thatweweresupportedandencouragedtomoveforwardwiththat.ButtheadolescentCrohn'sstudyshouldinitiatebeforetheendofthisyear.
Operator :
AndournextquestioncomesfromChrisRaymondofRobertBaird.
ChristopherRaymond (Analyst-RobertW.Baird):
Andjust,like,aquestiononthecash.IthinkheardPetersayabout85%ofyourcashisex-U.S.Canyoutalkalittlebitaboutwhatthesortofcurrenttrajectoryis?Isyourcurrentfreecashflowratesortofinlinewiththatratio,orisithigher?Andsortofcouplingwiththat,IassumetheAstraZenecadealwaspaidforwithex-U.S.cash,ifyoucouldjustconfirmthat.AndcanyoumaybetalkaboutthatdynamicoftherelativeattractivenessofdealsoutsidetheU.S.,givenyourcashbaseintheU.S.dollarexchangerate,etcetera?
PeterKellogg (CFOandExecutiveVicePresident):
Great.AndChris,thankyou,thisisPeter.Soveryappropriatequestions.Youarerightthat--firstofall,I'mgoinginreversesequence.TheAstraZenecaupfrontpaymentwasdonewithoffshorecash,andtheIPwillbealmostout--outsidetheU.S.Soallthoseassumptionsarecorrect.I'llcomebacktothatrelativeto
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
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dealsandsoforthinaminute.
TheonethingIwouldsay,whenyoulookatacashbalanceofacompanylikeours,thecashflowfromoperationsisactuallymuchstrongerintheU.S.thanyoumightthink,relativetowherethecashendsup.Butwhatwedoiswedo,doalotofbusinessdevelopmentdealsintheU.S.andso,therefore,endupusingU.S.cashthereaswellasallofoursharerepurchaseactivityisutilizedinU.S.cash.Soactually,wehaveaverybalancedcashflowbetweentheU.S.andtherestoftheworld.WehaveverystrongcashflowintheU.S.Ijustwanttobesureyoureallyappreciatethat.Anditgivesus,asImentioned,amplestrengthto,ontheonehand,executethebusinessdevelopmentagendainarobustmanneras,certainly,this--Celgenehasdoneoverthelastfewyears,andit'sbeenexcellent.
Andyetatthesametime,reallymaintainanefficientcapitalstructureandreturncashtoshareholdersthroughthesharerepurchaseprogram.Thecashthat'soutsidetheU.S.isdeployedonmanydealsrelativetotherightsfornon-U.S.markets.Soeventhoughsomeofthedeals,forexample,maybeglobalinnature.Therearesomestructureswherewe'lluseacertainamountofU.S.cashandthenacertainamountofnon-U.S.cashtodomiciletheIPintherelevantmarketsintherightplaces.
Butoverall,we'reinverygoodshapeoncashflow.We'reveryfinanciallystrong.We'velookedatthisgoingforward,andwe'reinaverygoodpositiontobeabletocontinueourbusinessdevelopmentagendaandalsoreturncashtoshareholders.SoIthinkit's--we'recomingfromapositionofrealfinancialstrength.
Operator :
AndournextquestioncomesfromGeoffMeachamofBarclays.
Geof f reyMeacham(Analyst-BarclaysCapital):
OneforJackieandoneforScott.SoJackie,IknowearlydaysfortheEuropeanlaunchofREVinnewlydiagnosed.ButanycolorontheexperiencesofarinGermanywithrespecttothetypesofpatientsornewstartshare?Andthenwhenyoulooktonextyear,whatroledoyouthinkbudgetswillplay,budgetallocationsondemand?
AndthenforScott,realquick,onSlide29,itlookslikethepositioningofOTEZLAaheadofbiologicsisworkingalready.Wheredoyouthinkthenextlegofgrowthis,thebiggeropportunity?Isitnaivepatients,orisitjustexpandingthemarket?
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Thanksforthequestion.Hi,Geoff.Soit's--wejustgottheapprovalinthemiddleofthequarterandessentiallyareinlaunchmodeinEurope.Whatwe'reseeingintheearlyaccessmarkets,notablyGermanyasit'sthelargest,isthesamekindoftrendsthatwesawintheearlydaysintheU.S.Butthemessagingontheproductispositioninginthefrontlinesettingintermsofthetargetpatientprofile,andallofthosesortsofthingsareveryconsistent.Sowe'reseeingquiteaniceresponsethere.Remember,it'squiteearly,butIthinkwe'regoingtoseeextremelystrongmomentumoverthecourseofthisyear.
Wehave--areinactivenegotiationswiththeothercountries.Anditalreadystartedquitesometimeago,workingonthemodelingforhelpingeachcountryappreciatewhatthebudgetimpactofthisapprovalcouldbe.Therearesomeoffsetswhenyougetanewproductapproval.Andittakesshareincertainpatientsegments,andwe'vebeenhelpingtheauthoritiesmodelthose.Andwe'vebuiltintoourforecastsomeexpectationsforthenetimpactonpricingassociatedwithcomingtomarket,sowiththenewlydiagnosedindication.AndIthinkwefeelgoodaboutwhereweareonthatalready,andwherewe'regoingtoenduponit.
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Soit'sveryexcitingtimesforusinEuropewiththisaswe'reessentiallygoingfrompracticallyzeromarketshareandnowhavetheabilitytodrivetheproductthesamewaythatithasmovedintheU.S.
Scott Smith (PresidentofGlobalInflammationandImmunology):
The3majorareasthatIwouldseeforfutureOTEZLAgrowth,andwe'rejustattheverybeginninghere,sothere'salotofgrowthaheadofus.There'ssomethinglike10,000to20,000patientsintheU.S.whocomefortreatment,initiatetreatmenteverymonthinpsoriasisandPsA.Andsogettingaleadingshareofthosepatientsandmaintainingthemforaperiodoftimeisacriticalareaforus.
Iwouldalsosaythatthere'sacomponentofthis,whichismarketexpansionforpsoriasis.Ofthe2millionto3millionpatientsthathavemoderate-to-severepsoriasisintheUnitedStates,only10%ofthematanyonetimearebeingtreatedwitheffectivetherapy.Soexpandingthatmarket,providingotheroptionsforpatientsthatareeasierforthemtousethatareoral,thatare--don'trequiremonitoring,otherthingscanhopefullyexpandthatmarketplace.
AndthenspecifictoOTEZLA,we'rejustatthevery,verybeginningoflaunchoutsideoftheU.S.,andwe'vegotCanada,Australia,Europeanapproval.Wereallyneedtogetgoingwiththelaunchofthose.We'reworkingveryhard.Themetricslookreallygoodthere.Butgeographicexpansion,gettingreimbursementandrealgeographiccommercialexpansion,somethingoverthenext8,10,12,14months,Ithink,willhaveamajorimpact.
Operator :
AndournextquestioncomesfromMattRodenofUBS.
MatthewRoden (Analyst-UBSInvestmentBank):
YouroldfriendsfromABRAXISnowatSorrentohaveacompetingpaclitaxelnanoparticlethatitseemsthatthey'dbeinterestedinfilingtotheFDAandreferencingyourABRAXANEdata.SojustwantedtoseeifyoucouldspeaktowhyyouthinkthisisorifnotathreattoABRAXANE,andwhetherornotthisiscontemplatedinyourlonger-termABRAXANEtargets.
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Hi,Matt,It'sJackie.Thanksforthequestion.Soyes,wemonitorthosedevelopmentsveryclosely.ThefirstthingIwouldsayisthatwewouldnotcommentontheregulatoryfilingsorpotentialregulatoryfilingsorregulatorystrategyofothercompanies.Solet'sseehowthatgoes.
Youhaveprobablyseenandhadachancetolookintothedetailsofthedataandinformationpositionthatwe'vepresentedinourcitizens'petition.WefeelverystronglythatPKdataaloneisnotsufficienttoevaluatewhetheraproductwouldbecomparabletoABRAXANE,whereABRAXANE'sbeenstudiesinnumerousPhaseIIIclinicaltrialsandhasdemonstrateditsefficacyacrossmultipleindicationsovertime.Sowe'llseehowthisgoes.
We'requiteconfidentinABRAXANE'sfutureasachemotherapyagent,nanoparticletechnologythatdoesnotneedsteroiduseassociatedwithitandisofpotentialattractiveness.Andagain,withthebodyofclinicaldatabasedonmultiplePhaseIIItrialstosupportitsefficacythatwillgetusedincombinationwithothertherapiesintheimmuno-oncologyarenaasthatplaysout.Sowe'restandingonthestrengthofthebodyofclinicaldatabehindABRAXANE,andwe'llseehowitgoes.
Operator :
AndournextquestioncomesfromMaraGoldsteinofCantorFitzgerald.
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
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MaraGoldstein (Analyst-CantorFitzgerald):
Iknowit'searlydaysinpsoriasis,butperhaps,ifyouhadanyintelligenceyoucouldshareonOTEZLAandthepersistencyoftheprescriptions,andthatisforpatientsthatdiscontinuedtreatment.Isthatafunctionofcost,FLASH,[insurance]ortolerability?Isthereanythingyoucansharewithusthere?
Scott Smith (PresidentofGlobalInflammationandImmunology):
Sothere'scommentsI'dliketomakeonpersistency.Isusuallyyou'dliketohaveasignificantperiodofdata,12monthsorso.Wedohavesomeearly6monthspersistencydata.Itshowsthatweareinlinewithallanalogsinthisspace.Persistencedoesnotlookdifferentthanothers.
Iwouldsaythere--IthinkthereissomepotentialupsideforOTEZLArelativetopersistency.Ifyoutakealookatthisclinicaltrialprograminthefirst--betweenzeroand24months,dropoutratesinthecriticaltrialprogramsforOTEZLAlooksvery--lookverysimilartowhattheydoinbiologics.Youseeamarketchangeafter24monthsasyougooutto2and3years,wherethepersistencyofpatientsmaintainingtherapyonOTEZLAismuchhigherthanyousawonthecriticaltrialprograms.
Soit'searlyforus.Itlooksencouragingandinlinewithwhatwe'dexpect.Wethinktheremightbesomegoodupsiderelativetocompetitorsinthisspace,tokeeppatientsonlongeraswestarttoget1-yearand2-yearand3-yeardata.Butthere'snothingthereoutsideofanything--outsideoftheordinaryatallandit'sinlinewithourexpectations.
Operator :
OurnextquestioncomesfromHowardLiangofLeerink.
HowardLiang (Analyst-LeerinkSwann):
RegardingtheAstraZenecadeal.IsthereascientificreasonsuchasREVLIMIDeffectonNKcellsandDTCtogowithaPD-L1antibodyratherthanaPD-1antibody?Andalsocanyougiveussomesense--somecolorastothemechanismthatwillbeusedtodistinguishingbetweenhememalignanciessalesandsolidtumorsales?
JacqualynFouse (PresidentofGlobalHematologyandOncology):
Thanks,Howard.It'sJackie.SoImean--again,thedatainhematologicalmalignanciesisalittlebitearly,sowe'llhavetoseehowthisplaysout.You'dlookatsomeoftheearlyscience,includingnaturearticleandotherthingsthatareouttherewithrespecttothat.SoaswehavetheopportunitytoworkwithourpartnersatAZwithourearlyscientistsaswellasourclinicaldevelopmentteam,we'llbeabletoteasemoreofthatoutovertime.Butwe'reveryenthusiasticaboutthepossibilitieshere,andlet'sseehowitgoes.Welookforwardtoshowingmoredatawithyouaswemovealong.
Sowithrespectto--IthinkyourquestionwasaboutthecommercialdatathatwewilltheneventuallyhavetobeabletosplittherevenuesbetweensolidtumorsandhematologicalmalignanciesintheU.S.,that'sprettystraightforward.AlsobetweennumerousdatasourcesandourabilitytotriangulateacrossthosedatasourcesthatareoutsidetheU.S.,wethinkthat,that'sgoingtoturnouttoberelativelystraightforward.
Andthenjusttothepointonrevenues,thenitwingsalittlebitbacktothequestionthatIanasked.Anotherreasonwhywereallylikethisdeal,ontopoftheexcitingscienceandeverythingwethinkthat,thatholdsforusforthefuture,theshare--ourshareofthePD-L1revenuescouldstarttogeneraterevenuesforusinasearlyas2020.Wethinkit'sbroughtinverynicelytotheportfoliointermsofourfuturerevenuegenerationanddiversificationofthoserevenuesfromthevariousproductsintheportfolio
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
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beyondthe2020timeframe,sothanksforthequestion.
Operator :
AndourlastquestioncomesfromMikeKingofJMPSecurities.
MichaelKing (Analyst-JMPSecurities):
Acoupleofrelatedfinancialquestions.Iwouldnotethatitlookedlikeyour--boththeR&DandSG&Aspendwerebelowconsensus.SoIguess,myquestioniswhetheryoufeellikeyou'remakingtheappropriateinvestmentsinSG&Aagainsttheproducts.That'sthefirstpart.
Andthenthesecondpart,andIdon'tneedcommentonthisyet,butitseemslikeyouguysspentalotofmoneythisquarter.TheAZupfront,theQuanticellacquisition,theCRISPRinvestment,Agios.Howwouldwethinkaboutthatintermsofhowthat'sgoingtoaffectyournumbersforthisnext--forthesecondquarter?Willweexpectallofthesetobeinthenon-GAAPP&L,theGAAPP&Lorsomemixofboth?
PeterKellogg (CFOandExecutiveVicePresident):
Hi,Mike,it'sPeter.Sothanksforthequestion.Imean,firstofall,forthefirstquarter,asyousaw,wedidincreaseourspending.Ithinkitwas15%,incombinationofR&DandSG&Aversusprioryear.SothefirstquarterresultsdoreflectstronginvestmentthroughouttheworldcommerciallytoprepareandactuallyexecutelaunchesforABRAXANE,POMALYST/IMNOVIDandnowevenOTEZLA,gettingrampedupandwe'rereadytogoinmanyofthemarketsinEurope.Sowefeellikewe'remakingalltheinvestmentsthatarereallyimportantandnecessary,andwe'redrivingahead.Obviously,thetoplineperformancethisquarterwasverystrongso--evensequentiallyversusQ4.
Sowefeelalltheinvestmentsarebeingmade.IdidhighlightmycommentsgoingforwardthatwedoexpecttoseeR&Dcontinuetostepup,becausewehavebothinternallyandourpipeline,veryexcitingprogramsmovingforward,whichisreallygoodnewsandgreatforthefutureofthecompany.Likewise,wehavesomeofthekickoffactivitythatScotttalkedaboutinGED-0301.WewillbepickingupsomeoftheAstraZenecaMedImmuneclinicalactivitythrough2016.SowewillhaveadditionalspendingareasinR&D.
Ontheotherhand,ImentionedthatwecontinuetogetgreatleverageonourG&A.SoasasubsetofSG&A,certainly,theG&Ainfrastructurethat'sbeenbuiltishighlyleverageable.OurBoudryoperationisjustfantastic.TheteamsovertherehandletheinternationalarenaextremelywellandcanjustworkverywellwithallthelaunchesandexpansionofactivitythroughoutEuropeandthroughouttheworld.
Wealsothinkthattheinvestmentsthatwehavemadeoverthelastcoupleofyears,quitefrankly,arenownicelyleverageable.Atthispoint,quitefrankly,theinvestmentswe'vemadehavebeen,let'ssay,alittlebitaheadofthesalesandmarketingcurve.Andnowwe'restartingtoseethesalesandmarket--thesalescurve,rather,comeupthelinereally,reallynicely.
Nowintermsofourhandlingofdifferentinvestmentsthatwe'remaking,Iwouldjuststartbysaying,really,there'snothingthat'sgoingtobeanydifferentthanhasbeenourpracticeinthepastandbegladtogooff-lineandchattoeachofthosecomponents.Someoftheinvestmentswe'vemadearepurelyequityinvestments.AndsoIthinkthat'sprettystraightforward.Theupfrontbuy-in,itwillbehandledjustlikeallofourotherupfrontsfortheAstraZenecaMedImmuneImmuno-oncologytransaction.SoIdon'tthinkthere'sreallyanychangefromthestandpointofhowwepositionGAAPtonon-GAAP.
SoIthinkwe'llcontinuetorollforward.I'djustreiteratethatit'sjustgreattogetofftoastrongstartin
CompanyName:CelgeneCorpCompanyTicker:CELGSector:HealthCareIndustry:Drugs
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ourfirstquarterwithresultsthatwe'veposted.Ithinkthatitsetsusupextremelywellfor2015.Equallyimportantly,we'remakinginvestmentswhilewe'rehittingthesenumberstosetourselvesup,todriverightthrough2020andtheguidancewouldbeprovidedthere.
Andquitefrankly,asJackiehighlighted,thenumberoftheassetsthatwe'reinvestingin,quitefrankly,buildthepotentialofthiscompanyinthenextdecade.Soreally,someofthemmaynotbebigfactorsonarevenuestandpointbetweennowand2020,butreallystarttotakeoffhopefullyafter2020.AndsoIlikethewaywe'vegotthisnice,balancedinvestmentportfolioofshorttermandlongtermaswellasstrongperformancetothetoplineanddeliveryofresults.
Iwouldjustliketowrapup,ifIcould,becausethatwasthelastquestion,Ithink,Iknow--wereallyappreciateeverybodystayingwithusthislong.IthinkCelgeneiscontinuingitspathofbuildingitsfutureandinvestingwhiledeliveringverystrongresults.Theteamisveryexcited,thenumberofapprovalsandminimumindicationsthatwegotthisquarterisIthinkprobablyunprecedented.Wecontinuetohaveaveryactivebusinessdevelopmentagenda,andwe'renotdoneatall.Somuchmoretotalkaboutaswegothroughthisyear.Ithinkit'sgoingtobeanexcitingyear.Andwe'rereallypleasedtogetyoursupportandtalkabouttheactivitiesofCelgenegoingforward.Sothankyouverymuch.
Operator :
Ladiesandgentlemen,thankyouforparticipatingintoday'sconference.Thisdoesconcludetheprogram,andyoumayalldisconnect.Haveagoodday,everyone.
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