Gilead2015-4季度研发进展

Q42015EarningsResultsFebruary2,2016Forward-lookingStatements2Theprojectedfinancialresultspresentedinthefollowingslidesrepresentmanagement'sestimatesofGilead’sfuturefinancialresults.Gileadcautionsreadersthatforward-lookingstatementsaresubjecttocertainrisksanduncertaintiesthatcouldcauseactualresultstodiffermaterially.Theserisksanduncertaintiesinclude:Gilead'sabilitytoachieveitsanticipatedfullyear2016financialresults;Gilead'sabilitytosustaingrowthinrevenuesforitsantiviralandotherprograms;availabilityoffundingforstateAIDSDrugAssistancePrograms(ADAPs);continuedfluctuationsinADAPpurchasesdrivenbyfederalandstategrantcycleswhichmaynotmirrorpatientdemandandmaycausefluctuationsinGilead'searnings;thepossibilityofunfavorableresultsfromclinicaltrialsinvolvinginvestigationalcompounds,includingGS-5734andfilgotinib;Gilead'sabilitytoinitiateclinicaltrialsinitscurrentlyanticipatedtimeframes;thelevelsofinventoryheldbywholesalersandretailerswhichmaycausefluctuationsinGilead'searnings;Gilead'sabilitytosubmitnewdrugapplicationsfornewproductcandidatesinthetimelinescurrentlyanticipated;Gilead'sabilitytoreceiveregulatoryapprovalsinatimelymanneroratall,fornewandcurrentproducts,includingF/TAF,R/F/TAFandSOF/VEL;Gilead'sabilitytosuccessfullycommercializeitsproducts,includingGenvoya;theriskthatphysiciansandpatientsmaynotseeadvantagesoftheseproductsoverothertherapiesandmaythereforebereluctanttoprescribetheproducts;theriskthatestimatesofpatientswithHCVoranticipatedpatientdemandmaynotbeaccurate;theriskthatprivateandpublicpayersmaybereluctanttoprovide,orcontinuetoprovide,coverageorreimbursementfornewproducts,includingSovaldiandHarvoni;Gilead'sabilitytosuccessfullydevelopitsoncology,inflammation,cardiovascularandrespiratoryprograms;safetyandefficacydatafromclinicalstudiesmaynotwarrantfurtherdevelopmentofGilead'sproductcandidates;thepotentialforpricingpressurefromadditionalcompetitiveHCVlaunchesorausteritymeasuresinEuropeancountriesandJapanthatmayincreasetheamountofdiscountrequiredonGilead'sproducts;Gilead'sabilitytocompleteitssharerepurchaseprogramduetochangesinitsstockprice,corporateorothermarketconditions;Gilead’sabilitytopaydividendsunderitsdividendprogramandtheriskthatitsBoardofDirectorsmayreducetheamountofthedividend;fluctuationsintheforeignexchangerateoftheU.S.dollarthatmaycauseanunfavorableforeigncurrencyexchangeimpactonGilead'sfuturerevenuesandpre-taxearnings;andotherrisksidentifiedfromtimetotimeinGilead'sreportsfiledwiththeU.S.SecuritiesandExchangeCommission(SEC).Inaddition,Gileadmakesestimatesandjudgmentsthataffectthereportedamountsofassets,liabilities,revenuesandexpensesandrelateddisclosures.Gileadbasesitsestimatesonhistoricalexperienceandonvariousothermarketspecificandotherrelevantassumptionsthatitbelievestobereasonableunderthecircumstances,theresultsofwhichformthebasisformakingjudgmentsaboutthecarryingvaluesofassetsandliabilitiesthatarenotreadilyapparentfromothersources.Actualresultsmaydiffersignificantlyfromtheseestimates.Youareurgedtoconsiderstatementsthatincludethewordsmay,will,would,could,should,might,believes,estimates,projects,potential,expects,plans,anticipates,intends,continues,forecast,designed,goal,orthenegativeofthosewordsorothercomparablewordstobeuncertainandforward-looking.Gileaddirectsreaderstoitspressreleases,QuarterlyReportonForm10-QforthequarterendedSeptember30,2015andothersubsequentdisclosuredocumentsfiledwiththeSEC.GileadclaimstheprotectionoftheSafeHarborcontainedinthePrivateSecuritiesLitigationReformActof1995forforward-lookingstatements.Allforward-lookingstatementsarebasedoninformationcurrentlyavailabletoGilead,andGileadassumesnoobligationtoupdateanysuchforward-lookingstatements.ThispresentationincludesGAAPandnon-GAAPfinancialmeasures,acompletereconciliationbetweenthesetwomeasuresisavailableontheCompany’swebsiteat’sGAAPfinancialstatements,becausemanagementusessuchinformationinternallyforitsoperating,budgetingandfinancialplanningpurposes.Non-GAAPinformationisnotpreparedunderacomprehensivesetofaccountingrulesandshouldonlybeusedtosupplementanunderstandingofGilead’soperatingresultsasreportedunderU.S.GAAP.Q42015EarningsCallAgendaIntroductionPatrickO’Brien,VP,InvestorRelationsCommentaryQ&AJohnMartin,ChairmanandCEOJohnMilligan,PresidentandCOOPaulCarter,EVP,CommercialOperationsRobinWashington,EVPandCFOAlso:NorbertBischofberger,EVP,R&DandCSO3TableofContentsDiscussionSlide#JohnMartin,ChairmanandCEOJohnMilligan,PresidentandCOOKeyAccomplishments,PipelineandMilestones6–11HIV12–14HBV15–16HCV17–18PaulCarter,EVP,CommercialOperationsProductPerformance20–23HCVPerformance24–30HIVPerformance31–39RobinWashington,EVPandCFOIncomeStatementPerformance40–46CashFlowsandReturnofCapitaltoShareholders47–502016Guidance51–52Appendix53–654JohnF.Milligan,Ph.D.PresidentandCOOKeyAccomplishmentsin2015HIV─GenvoyaapprovedintheU.S.andEUandaddedtotheDHHStreatmentguidelines─U.S.andEUregulatorysubmissionsforR/F/TAF