allergan incorporated (agn) earnings report: q1 2016 ... · pharma. you can see it in the...
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CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page1of26
AllerganIncorporated(AGN)EarningsReport:Q12016ConferenceCallTranscriptThefollowingAllerganIncorporatedconferencecalltookplaceonMay10,2016,08:30AMET.Thisisatranscriptofthatearningscall:
CompanyPart icipants
LisaDeFrancesco;Allergan,Inc.;InvestorRelationsBrentSaunders;Allergan,Inc.;CEO&PresidentBillMeury;Allergan,Inc.;ChiefCommercialOfficerDavidNicholson;Allergan,Inc.;ChiefR&DOfficerRobStewart;Allergan,Inc.;COOTessaHilado;Allergan,Inc.;CFOPaulBisaro;Allergan,Inc.;ExecutiveChairman
OtherPart icipants
DavidRisinger;MorganStanley;AnalystJamiRubin;GoldmanSachs;AnalystGreggGilbert;DeutscheBank;AnalystRandallStanicky;RBCCapitalMarkets;AnalystMarcGoodman;UBS;AnalystDavidAmsellem;PiperJaffray&Co.;AnalystKenCacciatore;CowenandCompany;AnalystChrisSchott;JPMorgan;AnalystRonnyGal;SanfordC.Bernstein&Co.;AnalystLiavAbraham;Citigroup;AnalystLouiseChen;GuggenheimSecuritiesLLC;AnalystUmerRaffat;EvercoreISI;AnalystJasonGerberry;LeerinkPartners;AnalystDavidMaris;WellsFargoSecurities;Analyst
MANAGEMENTDISCUSSIONSECTION
Operator :
Goodmorningmynameis(Lashonda)andIwillbeyourconferenceoperatortoday.Atthistime,IwouldliketowelcomeeveryonetotheAllerganFirstQuarter2016EarningsConferenceCall.
Alllineshavebeenplacedonmutetopreventanybackgroundnoise.Afterthespeakersremarkstherewillbeaquestionandanswersession.
OperatorsInstructions)
I'llnowturntoday'scalltoLisaDeFrancesco,VicePresidentInvestorRelations,tobegin.Pleasegoahead.
LisaDeFrancesco (InvestorRelations):
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page2of26
Thankyou,Operator.Goodmorning,everyone.
I'dliketowelcomeyoutotheAllerganfirst-quarter2016earningsconferencecall.
Earlierthismorning,weissuedapressreleasereportingAllerganearningsfromcontinuingoperationsforthefirstquarterendedMarch31,2016.Thepressreleaseandourslidedeck,whichwearepresentingthismorning,areavailableonourcorporatewebsiteatwww.Allergan.com.
We'reconductingalivewebcastofthiscall,areplayofwhichwillbeavailableonourwebsiteafteritsconclusion.Pleasenotetoday'scalliscopyrightedmaterialofAllerganandcannotberebroadcastwithoutthecompany'sexpresswrittenconsent.
Turningtoslide2,I'dalsoliketoremindyouduringthecourseofthiscallmanagementwillmakeprojectionsorotherforward-lookingremarksregardingfutureeventsorthefuturefinancialperformanceofthecompany.
It'simportanttonotethatsuchstatementsandeventsareforward-lookingstatementsandreflectourcurrentperspectivesofthebusinesstrendsandinformationasoftoday'sdate.
ActualresultsmaydiffermateriallyfromcurrentexpectationsandprojectionsdependingonthenumberoffactorsaffectingtheAllerganbusiness.ThesefactorsaredetailedinourperiodicpublicfilingswiththeSecuritiesandExchangeCommission.Allergandisclaimsanyintentorobligationtoupdatetheseforward-lookingstatementsexceptasexpresslyrequiredbylaw.
Turningtoslide3inouragendathismorning,withusontoday'scallareBrentSaunders,ourCEOandPresident,whowillprovideanoverviewofourfirst-quarterbusinesshighlights;BillMeury,ourChiefCommercialOfficer,whowillprovideanoverviewofourcommercialperformanceinthequarter;DavidNicholson,ChiefR&DOfficer,whowillprovidehighlightsfromourpipelineachievementsin2016andupcomingmilestones;BobStewart,ourChiefOperatingOfficer,whowillprovideafewhighlightsonourglobalgenericsbusiness;andTessaHilado,ourChiefFinancialOfficerwillthediscusstheAllerganfirst-quartercontinuingoperationsresultsinmoredetail.AlsoonthecallandavailableduringtheQ&AarePaulBisaro,ourExecutiveChairman,andBobBailey,ourChiefLegalOfficer.
Withthat,I'llturnitovertoBrent.
BrentSaunders (CEO&President):
Thankyou,Lisa.Goodmorning,everyone.
Beginningonslide5,Allerganremainsthemostdynamicandexcitingcompanyinourindustry,andinmymind,thatmakesusthebestpharmaceuticalcompanyintheworld.Youcanseeitinourresultsthisquarter.
Youcanseeitinthewayourteamhaspivotedtofocusonourfutureasastandaloneleaderingrowthpharma.YoucanseeitintheoperationalexcellenceondisplayinteamsacrossourCompany.Youcanseeitinthewaywefocusonbuildingtherapeuticarealeadershipinthecategorieswherewechoosetocompete.
YoucanseeitinthewayweareusingOpenSciencetobuildanindustry-leadingR&Dpipelinetosustainourleadershipinthosetherapeuticareas.Andyoucanaskourcustomersaboutourhighlyresponsiveservice-orientedapproachtocustomerintimacy.Thosearejustafewreasonswhyweareespeciallyexcitedaboutourfuture.
AsweconsideredouroptionsfordeployingcashfollowingTeva'splanned$40.5billionacquisitionofour
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page3of26
globalgenericsbusinessinthesecondquarter,werealizedthattherewasnobetterinvestmentthanowningourfast-growingCompany.So,ourBoardhasauthorizedthecompany'sfirstsharerepurchaseprogramatavalueofupto$10billion.
We'llstartwith$4billionto$5billionduringtherestof2016,buyingasmuchasprudentlypossibleintheopenmarket.Iffavorablemarketconditionspersist,wewillhaveadditionalcapacitytoconsiderbuyingmoreaftersatisfyingthefirstpartoftheprogram.
Inadditiontothestockrepurchaseprogram,wewillhavetheabilitytopaydowndebttomaintainourinvestmentgradecreditratingsandpreservesignificantcapacitytoinvestforgrowth.Giventhestrengthofourcurrentbusinessandtheopportunitiesweseeahead,weremainfocusedonrunningoneofthefinestcompaniesinourindustry.Tessawilltalkmoreaboutthesharerepurchaseprograminjustafewminutes.
Turningtoslide6,Allergan'sfirst-quarterperformancereflectsourcontinuingexecutiononeachelementofourgrowthpharmastrategy.First,top-linegrowth.Inthefirstquarter,wepoweredanotherfinequarterwithtotalrevenueup48%andbrandedgrowthup71%versusprioryear.Onaproformabasisbrandedrevenuewasupdoubledigitsagainthisquarter.
Second,wemaintainedleadershippositionsinoursevencoretherapeuticareas.AndwiththerecentlaunchesofnewdrugslikeVIBERZI,VRAYLAR,andKYBELLA,wehaveaddedsignificantmuscleandgrowthpotentialtoourGI,CNS,andaesthetictherapeuticareas.
Third,ourR&Denginecontinuestoproduceatrecordpace.WedeliveredtwonewbrandedFDAapprovalsandfourFDAsubmissionsjustinthefirstquarter.InEuropewealsoreceivedapositiveopinionforZENPEP,namedENZEPI,toenhanceourcysticfibrosisandpancreasinsufficiencyoffering.
OurOpenSciencemodelishelpingusbuildasustainableR&DpipelinebybringingusnovelassetslikeXAF5forunder-eyebags,andfromHeptares,aportfolioofselectiveagentsformajorneurologicaldisorderslikeAlzheimer'sdiseasewherewearethemarketleader.Ourbest-in-classgenericsR&Denginecontinuestoperformwell,andRobStewartwillhighlightthislater.
Fourth,ourfocusonoperationalexcellencehelpedussimplifytheoperatingstructure,streamlineourITsystems,anddrivemorethana500basispointimprovementinouroperatingmarginsversusprioryear.OuroperationalexcellencealsohasbeenondisplaywiththelaunchofourgenericCrestorintheUS.Ourgenericsteam,togetherwithANDA,executedflawlesslytogetproductontopharmacyshelvesfastinordertotakeadvantageofthisfirst-to-marketopportunity.
Nowletmeturntocontinuingoperationsbusinessperformanceinthefirstquarter,onslide7.Ourfirst-quarternetrevenuegrew48%onayear-over-yearbasisto$3.8billionasaresultoftheAllerganacquisitionandstrongglobalgrowthwithinallofourkeytherapeuticcategories.Brandedrevenuewasthekeydriver,up71%.Strongsalesinkeyproductsandoperatingmarginexpansionacrossourbusinessdrovea15%increaseinnon-GAAPearningspershareto$3.04.
Meanwhile,non-GAAPoperatingincomeroseto$1.8billion,anincreaseof68%versusprioryear.Andcashflowfromoperationswas$1.45billionexcludingR&Dassetacquisitions,restructuringandintegrationpayments.Theseresultsillustratethestronglong-termgrowthprofileofAllergan.
Turningtoslide8,ourstrategyisbasedonutilizingallofourgrowthpharmaassetstogether,includingourbest-in-classcommercialenginetobringlife-changingmedicinestopatientsaroundtheworld.Aswelookatourproductportfolio,ourbrandedbusinesscontinuestothriveinthefirstquarterwith10%proformarevenuegrowthexcludingtheimpactofcurrencyandtheNamendaIRanddivestitures.
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page4of26
Ourtopglobalproducts,whichrepresentmorethan75%oftotalbrandedrevenue,grew13%excludingtheimpactofcurrencyandNamendaIR,withoverhalfthoseproductsgrowingatdouble-digitrates.Thisquarterperformanceisatruetestamenttothehardworkofourteamandthesuccessofourgrowthpharmastrategyandmindset.
Movingtoslide9,asweneartheconclusionofthegenericsdivestiture,Ihavebeencarefullyconsideringhowtostreamlineourmanagementstructuretobetteralignourresourcesasafocused,branded,growthpharmabusinesswithmanyleadingglobalbrands.We'veannouncedthestreamlinedexecutiveteamstoleadAllergangoingforward.
Inthisnewleadershipstructure,allofourcommercialbusinesseswillbecombinedunderBillMeury,whohasbeenemployedasourChiefCommercialOfficer.TherewillbethreemajorbusinesssegmentsunderBill.ThefirstsegmentisUSspecializedtherapeuticswhichincludeseyecare,medicalaesthetics,medicaldermatologyandBOTOXTherapeutics.
ThesecondsegmentisUSgeneralmedicine,whichincludesCNS,CV,GI,women'shealth,AI,andurology.Thethirdsegmentisinternational,whichincludesallofourbusinessesoutsidetheUSorganizedinmultipleregions.ANDA,ourfourthsegmentwillcontinuetoreporttoRobStewart.
Weremainfocusedondrivinggrowthbybuildingtherapeuticarealeadershipinoursevencoretherapeuticareas--eyecare,aestheticsandmedicaldermatology,CNS,GI,women'shealth,BOTOXTherapeutics,andanti-infectives.WewillcontinuetobeadrugdevelopmentpowerhouseandutilizeourOpenSciencemodeltoinvestininnovationandpropelfuturegrowthinthesetherapeuticareas.
Ibelievethisnewcommercialstructurewillfurtherenhanceourglobalfocus,speeddecision-making,andalignresourcesandprioritieswithourR&Dpriorities.
WearealsoappointingRobStewarttothepositionofChiefOperatingOfficer.InthisroleRobwillmakesureourmanufacturingoperationsrunsmoothlytomeetoursalesgoals,overseeharmonizationofourITsystemsandprocesses,andfinishpreviousintegrations.
Withthat,IwillturnthecallovertoBillMeury,ournewChiefCommercialOfficer.
BillMeury(ChiefCommercialOfficer):
Thanks,Brent.Goodmorning,everyone.
Twohallmarksofgrowthpharmaarecategoryleadershipandcustomerintimacy.TheyaretruedifferentiatorsforAllergan,especiallywithinourcommercialteam,whichconsistsofaworldwidesalesforceofmorethan7,500strong.
I'mlookingforwardtoleadingtheAllergancommercialorganization,whichisagreatportfolioofproducts,asyouknow,andanindustry-leadingteamwithdeepknowledgeandexpertiseofkeytherapyareas.
Allthetalentweneededforthefutureorganizationwasherewithinourfourwalls.Andwiththisnewintegratedstructure,wecanbegintoleverageresourcesglobally,andacrossproductlinesinlockstepwithourR&Dorganization.We'resquarelyfocusedonleadershipineachofourtherapeuticareasandonhavingauniqueconnectionwithourcustomers,bothofwhicharecompetitiveadvantages.
Turningtoslide11,thefundamentalsofourbusinessarestrong.Overallbasicdemand,marketshare,growthandsalesperformancewererobustinthefirstquarter.Andwe'rewellpositionedtosustainthegrowthforthesefranchisesfortheremainderof2016andbeyond.Inallsevenofourtherapeuticareasourteamsdeliveredhighsingle-ordouble-digitsalesgrowth,excludingtheimpactofforeignexchange,
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page5of26
versustheprioryear.
Ineyecare,salesincreasedby11%,poweredbycontinuedstrengthfromRestasis,Combigan,andOzurdex.USsalesforRestasis,ourflagshipproduct,increasedby22%.We'repreparingforthelaunchofRestasisMDPF,multi-dosepreservative-free,inthesecondhalfoftheyear,andlookingforwardtotheapprovalofOculeve,ournasalneuro-stimulator,inearly2017,whichwillsignificantlystrengthenourproductofferingforocularsurfacedisease.
Behindthesetwoproductswehaveacortisolanalogandamucinsecretagogue.Weare,asyouknow,aneyecarecompany,andwelookforwardtobuildingthedeepestandbroadestportfolioforocularsurfacedisease.
InCNS,wedelivered211%growthwithBOTOXMigraine,NamendaXR,andVRAYLAR.Thesewerethekeygrowthproductsinthequarterandareexpectedtocontinuedrivinggrowthin2016andbeyond.
Inaesthetics,salesincreasedby7%withBOTOXfillersandKYBELLA.Allthreebusinessesareinanexcellentpositionandweexpecttosustainhighgrowthratesin2016andbeyond,too.Salesinaestheticsincreasedatanimpressiverateof16%,excludingmedicaldermatology.Medicaldermrevenue,however,wasimpactedbyaone-timeharmonizationforallowancesinthequarter.However,prescriptiontrendswererelativelystableandweexpectgrowthinthebackhalfoftheyear.
InGI,LINZESS,ourflagship,continuestoexceedexpectationsandpostexceptionalgrowth.AndthelaunchofVIBERZIisofftoaverystrongstart.Weexpectsalesforthisfranchisetoincreaseatadouble-digitratein2016andbeyonddespiteadeclineinthe(ace-calldelta-call)productline.Wealsoseestronggrowthandcontinuetobeexcitedaboutourfutureinwomen'shealth,urology,andanti-infectives.
Onslide12wehaveeightproductsinlaunchphaseacrosseachofourleadingtherapeuticareas.Thisisimportantasitprovidesnewproductsforoursalesforces,newproductstodelivertoourcustomers,andnewinnovationtosolveunmetmedicalneedforpatients.Letmetalkalittlebitaboutthreeofournewestlaunches,VRAYLAR,VIBERZI,andKYBELLA,allofwhichhaveblockbusterpotential.
Turningtoslide13,welaunchedVIBERZI,ourtreatmentforIBS-D,rightattheendof2015andwe'reofftoastrongstart.Basedonsales,VIBERZIistrendingatapproximately80%ofLINZESSIBS-Cduringthesametimeperiodpostlaunch,whichisinlinewithourexpectations.
Morethan8,000physicianshaveprescribedVIBERZItodate,andabout65%ofthephysicianbasearerepeatprescribers.Andwe'reseeinganiceboosttoscriptsfollowingthestartofourDTCcampaigninApril.
LINZESS,ourtreatmentforIBS-Ccontinuestoexperiencestronggrowthfouryearspostlaunch.We'veseenincrementalgrowthfollowingthelaunchofourlong-termcarefocuseddetailingprogramandDTCadvertisingcampaigns.WenowhavetwoproductsthatcancoverarangeofIBSneedstotreatthesepatients.
Turningtoslide14andVRAYLAR,VRAYLARwaslaunchedinmidMarchintheUnitedStatesandistrackingstronglywithcompetitiveproducts,includingRexultiandLatudaatthetimeoftheirlaunches,exceedingourinternalexpectations.VRAYLARhashigherscripttrendsversusLatudaatlaunch.AndVRAYLAR'svolumeissimilartoRexaltiwithoutacurrentindicationinMDD.
Thefutureofthisproductisverypromising.VRAYLARcouldpotentiallybetheonlyapprovedtreatmentwithfivedifferentindicationsorclaims.Thatwouldbeasignificantadvantagefortheproductandwouldmakeitapotentialblockbusterinthemarketplace.
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page6of26
Nowturningtoslide15,KYBELLA,ourproductforsubmentalfatreduction,ordoublechin,isofftoastrongstart.SinceweacquiredtheproductfromKytherainOctoberof2015,we'veacceleratedthetrainingoftargetedaccounts.Sofarwe'vetrainedover4,000injectors,oralmost50%ofthepotentialuserbase,and,importantly,3,000ofthosetrainedhavealreadybegunordering.
Inthebackhalfoftheyear,weplantolaunchaDTCcampaignforKYBELLA.Thecampaignwillgreatlyenhancethecurrentpromotionaleffort,whichisreallylayingthegroundworkinthecreationanddevelopmentofthisnewmarketforinjectable.
Wecontinuetobelievethisproducthasaverystrongfuturepotential,andourR&Dteamisexploringanumberofnewindications.We'realsocontinuingtodevelopandprepareforthelaunchoftheproductex-USinvariousmarkets,includingtherecentlaunchinCanadaandotherinternationalmarketslaterthisyearandin2017.
Insummaryourcommercialbusinesscontinuestoperformwellandweplantocontinuetofocusonourcoretherapyarealeadershipandinleadingtheindustrywithlaunchesandultimatelyindouble-digittop-linegrowth.
Withthat,I'llturnthecallovertoDavid.
DavidNicholson (ChiefR&DOfficer):
Thanks,Bill.Goodmorning,everyone.
Let'smovetoslide17.Thispresentsourlate-stagedevelopmentpipeline.InQ1,wecontinuetomakeverysignificantprogress,2016beinganotherextremelybusyyearforourR&Dteam.
Weexpectmorethanadozenapprovalsandregulatorysubmissions,andweareontracktoachievingthesemilestones.I'mnotgoingtotalkabouteverythingonthisslidebutIwouldliketotalkaboutafewofthekeyhighlights.
First,approval.WereceivedUSapprovalofAczoneGel7.5%forthetreatmentofacne,providinganewconcentrationofdapsoneforonce-a-dayapplication.AndwereceivedFDAapprovalofDalvancesingle-doseasanantibioticforskinandskinstructureinfections.Thesingle-doseallowsfordeliveryofthisIVantibioticin30minutesintheemergencydepartmentandinfusioncenters,andwillprovideselectivepatientsthebenefitofreceivingacompletecourseofparenteraltreatment,whichmayavoidhospitaladmissions.
Regardingsubmissionstoregulatoryauthorities,wesubmittedanNDAforOxymetazolineasatreatmentforrosacea.Also,wesubmittedanSNDAforLINZESSlowdose,72micrograms,forthetreatmentofchronicidiopathicconstipation,orCIC,whichprovidesanotherimportantdosingoptionforphysiciansandpatientsandcouldacceleratetheconversiontotheOTCmarket.
WealsofiledanSNDAforasingle-handedinsertwithoptimizedpackagingforLiletta,ourintrauterinedevice.Ourpartner,SerenityPharmaceuticals,submitted,andtheFDAhasaccepted,anNDAforSer120,apotentialnewtreatmentfornocturia.
Turningtodevelopmentprograms,earlierthisweek,weannouncedpositivetop-lineresultsfromVenusI,oneoftwoPhaseIIIclinicaltrialsevaluatingtheefficacyandsafetyofulipristalacetateforthetreatmentofuterinefibroids.Inthetrial,both10-milligramand5-milligramtreatmentarmsmetallco-primaryandsecondaryendpointsversusplacebo,andtherewerenotreatmentrelatedseriousadverseevents.
ThisisimportantprogressforourEsmyaprogramandforpatients.It'sestimatedthatuterinefibroidsaccountformorethan200,000hysterectomiesannuallyintheUS.That'saboutone-thirdofall
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page7of26
hysterectomiesperformedintheUnitedStates.Esmyahasthepotentialtoofferthefirstandonlynon-surgicaloraltreatmentoptionforwomensufferingfromuterinefibroidsintheUnitedStates.Theresultsareveryexcitingandwecontinuetoanticipatethe2017submissionforthisproduct.
InadditioninQ1,togetherwithGedeonRichter,weinitiatedPhaseIIItrialsforCariprazineinbipolardepression.Twoparallelstudieswillbeconductedatapproximately85sitesintheUSandEurope.Bipolardepressionisoneofthemostdifficultmentalillnessestotreat,andresponseratesvarygreatlyfromonepatienttoanother.So,it'simportanttocontinuetoexplorenewtherapiesandincreasethenumberofoptionsthatareavailabletohelppatientsmanagetheirsymptoms.
Turningtoslide18,asBrentmentioned,Allergan'sR&Dpipelinecontinuestobeinnovativeandproductive,anditiscontinuingtogrowthroughourOpenSciencemodel.In2015,weacquired,inlicensed,orenteredintocollaborations,providingmorethantennewpipelineopportunitiesacrossourkeytherapeuticareas.WeachievedregistrationforfourNMEsintheUnitedStates.
In2016,wehavealreadyaddedtwoadditionaldevelopmentprogramsthroughOpenScience.First,ourdevelopmentandcommercializationpartnershipwithHeptaresaddsabroadclinicalandpreclinicalportfolioasmuscarinicM1,M4,anddualM1-M4agonists,includingHDL9936andHDL18318forthetreatmentofAlzheimer'sdisease.Thesemuscarinicagonistshavethepotentialtoimprovesymptomsofthisdisorder,suchascognitionandpsychosis.
MuscarinicagonistshavepreviouslybeendemonstratedtoimprovecognitioninAlzheimer'sbutdevelopmenthasbeenhinderedduetoofftargetsideeffects.WebelievethattheHeptarescompoundshaveselectivityadvantages,whichshouldresultinmaintenancewithabeneficialeffectwithoutthedeleterioussideeffects.OuracquisitionofTopokineaddsXAF5,apotentialfirst-in-classtreatmentfor(stiatobletheron),ormoreeasilyknownasundereyebags.
We'vehadagreatstartto2016inR&D.Wehavemanymoremilestonesaheadfortheremainderoftheyear.OurpipelinecontinuestovalidateourapproachtoR&DinnovationthroughourOpenSciencemodel.
Ithankourmorethan2,000AllerganR&Dcolleaguesaroundtheworldfortheirtremendousworkanddedicationindrivinginnovationinachievingtheseresultsandfortheircommitmenttotheworkahead.
IwillnowturnthecallovertoRobStewarttobrieflydiscussafewhighlightsoftheglobalgenericsbusiness.Rob?
RobStewart (COO):
Thanks,David.Goodmorning.
Turningtoslide20.Ourgenericsbusinessremainsabest-in-classasset,andIcouldnotbemoreproudoftheaccomplishmentsofourentireorganization.TheR&Dteamcontinuestoachieveanincrediblenumberoffilings,bothintheUnitedStatesaswellasinkeyinternationalmarkets.
Moreimpressivethanthenumbersarethequalityoftheassetsfiled,includingfirst-to-fileapplicationsforgenericAbraxane,aswellasgenericXifaxan.OutofallofthefirsttofilespublishedbyFDAin2016ourgenericteamholds50%ofthoseaccepted.They'vedonethisyearafteryear,andnowhaveamassedover98first-to-fileapplicationspendingattheAgency.OutsideoftheUnitedStates,wehavefiledover1,000marketingauthorizations.So,theperformanceremainsstrongnotonlyintheUSbutacrosstheglobe.
Priceerosionisalwaysaheadwindinthegenericindustryand2016isnodifferent.Companiesthat
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page8of26
investedindevelopinghigh-qualityassetsandinvestedintheirsupplychaincapabilityareabletocounterpriceerosionmoreeffectivelywithnewproductlaunches,strongquality,andreliablecustomerservice.
Thisyear,we'velaunched13newproductsintheUnitedStates,includinggenericCrestorlastweek.Internationallywelaunched62productsincludingpemetrexed.Wecontinuetoseeerosionwithinexpectationsaroundmidsingledigits,differentfromthemorecommoditizedgenericmodelsoutthere.
Movingtoslide21,ourentireorganizationremainsfocusedonclosingthetransactionwithTevainJune.Weareoperationallyreadytocloseoncewereceivetheanti-trustclearance.Wehaveregulatoryapprovalsinallcountries,withexceptionoftheUS,butbothteamsareworkingdiligentlytocompletethatprocess.
Inclosing,ourperformanceremainsstrong.Ourteamcontinuestoexecute.AndmostofourleadershipteamatAllerganGenericsiscontinuingonwithTevasoweexpecttoseecontinuedstrongperformancepostclose.
I'llnowturnthecallovertoTessatoreviewourfirst-quarterfinancialresults.Tessa?
T essaHilado (CFO):
Thankyou,Rob.Goodmorning,everyone.
Pleasenotethisdiscussionofresultsreflectscontinuingoperations,whichwehavebeenreportingsinceQ32015followingtheannouncementofthedivestitureofourglobalgenericsbusinesstoTeva.
Turningtoouroverallresultsforthefirstquarterof2016onslide23,inthefirstquarter,wedeliveredstrongyear-over-yearperformance.Onanon-GAAPbasisconsolidatednetrevenueforthefirstquarter2016was$3.8billion,anincreaseof48%versusthefirstquarterof2015,withbrandednetrevenuesincreasing71%to$3.4billion,primarilydrivenbytheAllerganacquisition.
SequentiallyresultswereimpactedbylowerANDArevenuesandtheimpactofanticipatedseasonalityontoppromotedbrandedproducts.Non-GAAPgrossmarginforthequarterwas80.1%,anincreaseof8.9percentagepointsversusfirst-quarter2015,whichreflectsarevenuemixfollowingtheacquisitionofAllerganandtheimpactfromANDA.
WhileANDA'srevenuehasdeclinedversusprioryearthelostrevenuewasattheverylowmargin.Non-GAAPR&Dinvestmentforthequarterwas$277millioncomparedto$172millionintheprior-yearperiod.
Non-GAAPSG&Awasrelativelyflatcomparedtolastquarterat$1.01billionasaresultofcontinuedspendingbehindournewproductlaunches,includingKYBELLA,VIBERZI,andVRAYLAR.SG&AincreasedfromthepreviousyearperiodasaresultoftheacquisitionofAllergan.
Non-GAAPoperatingincomeforthequarterwas$1.75billion,anincreaseof68%versustheprioryear,drivenbyhigherrevenuesandhighergrossmarginsacrossourbusinesssegments,mainlyasaresultoftheAllerganacquisition.Non-GAAPearningsperdilutedshareforthequarterincreased15%to$3.04comparedto$2.65perdilutedshareinthefirstquarterof2015.
Ournon-GAAPtaxratewas9.7%inthequarter.Thisratewasdriveninpartbytheentireinterestexpensebeingincludedinourcontinuingoperationsearnings.Cashflowfromoperationsforthefirstquarterwas$1.2billion,impactedbyrecentR&Dassetacquisitionsandintegrationexpenses.Excludingtheseitems,cashflowfromoperationswas$1.45billion.
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page9of26
TurningnowtoourUSbrandsresultsonslide24,thebusinesscontinuedtodeliverstrongperformanceyearoveryear.USbrandsrevenuewas$2.3billionforthequarter,up27%versustheprioryearperiod,drivenbytheadditionoftheAllerganbusiness,andstronggrowthacrossotherkeybrandedproducts,offsetbyadeclineinNamendaIRwiththelossofexclusivityforthatproductandlowerrevenueoftheAsacol/Delzicolfranchise.
AdjustedgrossmarginwithinUSbrandscontinuedtoshowimprovement,withmarginsofapproximately89%,up0.8percentagepointsversustheprior-yearquarter.SG&Aasapercentageofrevenuedecreasedto21.7%versus23.8%intheyear-agoquarter,drivenbyourcontinuedabilitytomaximizeourcommercialinfrastructureposttheAllerganacquisition
Andnowturningtoslide25,ourUSmedicalbusiness,first-quarterrevenueswere$450million.There'snosignificantprior-yearcomparisonforUSmedicalasitwasacquiredaspartoftheAllerganacquisitioninMarchof2015.OnaproformabasisUSmedicalbusinessrevenuegrew2percentageversusprioryearand14%excludingmedicaldermatology.GrowthwasdrivenbykeyproductsincludingBOTOXat12%,fillersat14%andKYBELLA.
Sequentiallyrevenuewasimpactedbytypicalseasonality.Ourmeddermbusinessnetrevenuedeclinedversustheprioryearonaproformabasisattributedtoaone-timeharmonizationofallowancesversusQ12015.Prescriptiontrendsfortheproductswerestableandweexpectstrongfull-yearperformancefromthisbusinessdrivenbyAczone.
First-quartergrossmarginscontinuedtobestableat93.1%.Sequentially,SG&AincreasedslightlyasaresultofcontinuedKYBELLApromotionalspendandsalesforceexpansionrelatedtothelaunchofthisproduct.
Turningtoslide26andourinternationalbrandresults,first-quarterrevenueswere$673millionversus$119millionintheprior-yearperiodlargelyduetotheAllerganacquisition.
ExcludingFX,onaproformabasisinternationalrevenuesinthefirstquartergrew16%,drivenbycontinuedstronggrowthofBOTOXcosmetic,fillersandOzurdex.
Grossmarginswere85.3%inthequarter.AndsegmentSG&Aincreased2percentagepointsto31.9%versusfourth-quarter2015,duelargelytonewproductlaunchesincluding(airfloral)andconstellainvariousmarkets.
TurningtoourANDAbusinessonslide27,revenuesincreased34%to$365millionversus$554millionintheprioryearperiod,drivenbyanticipatedlowerretailbusiness,primarilyfromtheCVSacquisitionofTargetin-storepharmacies.Grossmarginsincreased2.3percentagepointsto16.9%duetoproductmix.Resultsinallperiodsincludethird-partyrevenuesandrelatedexpensesofgenericproductsmanufacturedbythecompanyanddistributedthroughANDA.
Slide28detailsourdebtcapitalization.Weendedthefirst-quarter2016withtotaldebtofapproximately$42.6billionandequityof$77.5billion.Atquarterendourleverageratiowas4.43timesdebttoadjustedEBITDAversus4.07timesintheprioryearquarter.ThroughAprilwemadeapproximately$1.2billionindebtpayments,bringingouradjustedleverageratioto4.3timesdebttoadjustedEBITDA.
WeremaincommittedtomaintainingourinvestmentgraderatingsFollowingthecloseofthedivestitureofourgenericsbusinesstoTevaweanticipatepayingtheremainingtermloanbalanceofapproximately$8billion,whichisnoprepaymentpenalties.
Turningtoslide29,letmemakeafewcommentsonour2016guidance,whichwearereiteratingtoday.Wecontinuetoexpectfull-yearnetrevenuestobeapproximately$17billion,includingbranded
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
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businessrevenuesofapproximately$15billion,reflectingdouble-digitgrowthdrivenbystrongsalesofkeyproductsandnewlaunchesin2016.
Notethatrevenueswillbeback-halfweightedasaresultofcontributionfromlaunchesbeinggreaterinthesecondhalfandtypicalpharmaseasonality.Ourrevenueforecastreflectsloweryear-over-yearrevenueexpectationsforANDAofapproximately$500millionduetotheCVSacquisitionofTargetin-storepharmacy.
Wecontinuetoexpectourgrossmarginstoremainstrongwithnomaterialchangefromcurrentlevelsineachsegment.WecontinuetoanticipateSG&Aasapercentageofnon-GAAPrevenuetobeapproximately25%oftotalnetrevenue.AndweexpecttheSG&Aasapercentageofrevenuetotrenddownwardsthroughouttheyearnaturallyasrevenueisincreased,andaswecontinuetoseetheimpactofouranticipatedbusinesssimplificationactivitiesfollowingthedivestitureofourglobalgenericsbusinesstoTeva.
Aspartofthebusinesssimplificationplan,weannouncedanewstreamlinedseniorleadershipstructure.Thisnewstructurewillallowustoleverageresourcesacrosstherapeuticareasandproductcategoriesandfocusonthekeyattributesofgrowthpharma,includingstrongtop-linerevenuegrowthandoperationalexcellence,whichwillresultinindustry-leadingoperatingmargins.
R&Dspendisexpectedtobeapproximately$1.5billionasaresultofthemanyimportantlate-stageprogramsadvancinginourpipeline,includingthecommencementofPhaseIIIprogramsofour(pastanelandyabrugia)plansinthebackhalfofthisyear.Ourtaxrateshouldbegintotrendgraduallytowardnormalizedlevelsintherangeof14%followingthecloseofTeva.
Wewillprovideanupdatedforecastfor2016includingourexpectationsforearningspersharefollowingthecloseoftheTevatransaction,mostlikelyonoursecond-quarterearningscallinAugust.
Andnowstartingonslide30,IwouldliketospendafewminutesonourcapitaldeploymentexpectationsfollowingthecloseoftheTevatransaction.ToechoBrent'scommentsduringhisintroduction,wehavegreatconvictioninourgrowthpharmastrategyandinthestrongfutureprospectsofourCompany.Ourstrategyforcapitaldeploymentwillinvolveathree-prongedapproachwithoptionsthatarenotmutuallyexclusive,withagoalofprovidingthebestvalueandreturntoourshareholders.
Onslide31,thedivestitureofourglobalgenericsbusinessprovidesuswithsignificantliquidity.AsmentionedbyRobpreviously,Tevahasdoneagreatjobworkingthroughaveryintricateprocess.WorkingtogetherwithourcolleaguesatAllergan,Tevareadyforasuccessfuldayonefollowingtheclose,whichisontrackforJune.
Movingtoslide32,asyousawthismorningweannouncedourBoard'sauthorizationtorepurchaseupto$10billionofourownstockfollowingthecloseoftheTevatransaction.Werealizedthattherewasnobetterinvestmentthaninourownfast-growingCompany.Weexpecttoexecute$4billionto$5billionoverafour-tosix-monthperiod,buyingasmuchasprudentlypossibleinopenmarketpurchasessubjecttofavorablemarketconditions.Iffavorablemarketconditionspersist,wewillhavemoreliquiditytoconsiderbuyingmoreaftersatisfyingthefirstpartoftheprogram.
Inadditiontothestockrepurchaseprogram,wearealsocommittedtomaintainingourinvestmentgraderatingsandwillpaydownapproximately$8billionofdebtfollowingthecloseoftheTevatransaction.ThisleavesuswithsignificantcapacitytoinveststrategicallyinthegrowthofourCompany.
WiththatI'llturnthecallovertoBrentforclosingremarks.
BrentSaunders (CEO&President):
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
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Thankyou,Tessa.Nowtofinishletmeprovidesomecommentsontheoverallenvironment.Overthepastsixmonths,wehaveseenaparticularlytoughenvironmentforcompaniesrelyingonastrategyofhighleverageandbuyinglow-qualitynon-coreassets,significantlyraisingprices,anddrasticallycuttinglife-bloodinvestmentsatR&Dandcommercialinfrastructure.Whenthestrategyisflawed,theoutcomewillbebadevenifittakestime.
Whatisleftwillbehigh-qualitycompaniesthatcontinuetoinvestinR&Dandthosethatcomeupwithnewwaystospeedintroductionofmedicalinnovations.Thebestofthosehigh-qualitycompanieswillnotrelyonlyonwhattheirteamsdiscoverin-housebutwillalsohaveanopenmindanduseOpenSciencetoattractinnovationsfromacrosstheentireecosystem.
TheywillhaveexcellentR&Dcapabilitiestobringthoseinnovationsthroughtherigorsofclinicaltrialsandregulatoryreviewaroundtheworld.Andthemostdynamicofthosecompanieswillhavecommercialenginesthatareresilient,persistentandeffectiveatdrivinggrowth.
Allerganisoneofthosehigh-qualitydynamicgrowingpharmaceuticalcompanies.ThatishowwearerunningthisCompany.IamproudofourteamdoingthisgreatworkateverylevelandhonoredtobetheirCEO.
Withthat,let'sopenituptoquestions.Lisa?
LisaDeFrancesco (InvestorRelations):
Operator,we'llstarttakingquestions.Iwouldliketoaskeveryonetoaskonequestiononlysowecangettoeveryoneonthecallthistime.
Thankyou.
QUESTIONS&ANSWERS
Operator :
(OperatorInstructions)
DavidRisingerwithMorganStanley.
DavidRisinger (Analyst-MorganStanley):
Yes,thanksverymuch.Congratsonthenewstoday.IwantedtoaskanumberofquestionsbutI'lljustkeepittoonetostartandthenI'llcirclebackintothequeue.Withrespecttocapitalallocation,obviouslyinvestorsarefocusedonhowyou'regoingtousetheproceedsoncetheTevatransactioncloses.
So,Iwashopingthatyoucouldtalkalittlebitmoreaboutcapitalallocation.Specificallyslide32saystuck-indeals.Ithinkthat'swhatinvestorsarelookingfor.They'renotlookingforlargedeals.ButifyoucouldprovidealittlebitmorecolorontheM&Athatyou'refocusedon?
Andalsoifyoucouldcommentonanythoughtsonapotentialdividend?
Thankyou.
BrentSaunders (CEO&President):
Sure.I'lltakethequestion,David,andmaybeTessawilljumpin,aswell.Ithinkyou'reexactlyright.Asyoulookattheslide32thatTessahadup,wearecurrentlylookingatthreeareasforcapitalallocation--one,thesharerepurchasethatweannouncedtoday,upto$3billion;payingdowndebt,and
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
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maintainingourinvestmentgradecreditratings,andwillpaydownabout$8billionwithoutpenaltiesimmediatelyuponreceiptoftheproceedsfromTeva;andthencontinuingtolookatadvancingourgrowthpharmastrategy.
Webelievetodaythatthebestwaytoadvanceourgrowthpharmastrategyistobolsterourtherapeuticarealeadership,bothwithtuck-inproductacquisitionsandwithintellectualpropertyR&Dassetacquisitions.AndIthink,asDavidpointedout,wedidabout10ofthoselastyear,we'vedone2inthefirstquarter.Andthey'vebeen,Ithink,highlyproductiveandpotentiallyverysuccessfulforus.
So,we'regoingtosticktotheknittingofwhat'screatedgrowthpharma.IftherewasatransformationaldeallikeAllergan,whichwasabitofaone-in-a-milliontypeopportunity,tobeawhiteknighttobuyaonce-in-a-lifetimeassetlikeAllergan,certainlywearegoingtostayopenmindedtothat.Butourcorefocusisonrunningthebestpharmaceuticalcompanyintheworld,andsupportingthatgrowththroughthisthree-prongedcapitaldeploymentstrategy.
T essaHilado (CFO):
Yes,ondividends,ourcapitaldeploymentphilosophyactuallyreallycentersonwhatisinthelong-termgoodforourshareholdersfromavalueperspective.Andwedobelievelongertermthatdividendpresumablycouldbepartofthatstrategy.
DavidRisinger (Analyst-MorganStanley):
Thankyou.
Operator :
JamiRubinwithGoldmanSachs.
JamiRubin (Analyst-GoldmanSachs):
Thankyou.Brent,onthebackofthe$10billionauthorizedsharebuybackprogram,obviouslyverygoodnewsfrommyperspectiveandI'msuremanyinvestors.ButwhynotannounceabuybackthroughanASRordutchauctionratherthanwaitingoverasix-monthperiodtobuyback$4billionto5billionthroughtheopenmarket?Istherealimitationbecauseofthestructureofyourbusiness?Whynotacceleratethatprocess?Andalsocanyouspeaktomarketconditionsthatwouldpreventyoufromdoingtheentire$10billionbuyback?Thanksverymuch.
BrentSaunders (CEO&President):
Sure,I'llstartandmaybeTessacanjumpin.Ithinkinfairness,Jami,wewouldhavelovedtohaveboughtinanASRatthecurrentprices.But,tobefair,restrictionsinIrishlawmakeanopenmarketstructureourbestcourseofaction.IfyoulookatIrishcompanies,thereisnoIrishcompanythathaseverdoneanASR.Andthere'scertainreasonsforthat,whichwouldprobablytaketherestofourtimeonthecalltowalkthrough.Tessa,doyouwanttojumpin?
T essaHilado (CFO):
Yes,wealsoobviouslyevaluatethevariousstructuresthatcouldsatisfyandwouldlooklikeanASR.ButcurrentlytherearereallynostructuresthatcouldprovideusthebenefitsofatraditionalASRwithoutlegaloraccountingcomplications.AsBrentpointedout,therehasbeennoIrishcompanythathasactuallyexecutedanASR,reallylargelyduetothelimitationsinIrishlaw.
JamiRubin (Analyst-GoldmanSachs):
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
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Thesecondquestionwascanyouspeaktothemarketconditionsthatwouldpreventyoufromdoingtheentire$10billionbuyback?
T essaHilado (CFO):
Attheendoftheday,itreallydependsonvolumeonaregularbasisbecauseweobviouslywanttobuyprudently.Andthen,secondly,aswelookgoingforwardintermsofothercapitaldeploymentoptionsandhowthestockperforms,thatcouldpotentiallyaffectourthinking.
Inreality,thereasonwhyweannounced$4billionto$5billionsharebuybackprogrambecausereallythat'stheonlythingwecanbuyinthenextfourtosixmonths.Thatdoesn'tmeanwewon'tgouptothe$10billionbeforeweactuallyendthe$5billionprogram.Wewillthenassessputtinginadditional10b-5gridstoexecuteuptothe$10billion.
BrentSaunders (CEO&President):
Justtobeclear,Jami,becauseIthinkthisquestioncouldbeoutthere,toreiteratewhatTessasaid,doingthe$4billionto5billionoverthenextseveralmonths,inourview,isaboutthemaximumwecanbuygiventhevolumesofwhatourstockhashistoricallytradedat.Ifwecouldbuymorewewillandwe'llupdateyouatthattime.
Wewouldliketoexecutethefull$10billionbutwecanonlycommittowhatwecancommittoatthistime.Andwewillkeepallofyouupdated,probablyonourquarterlycalls,aswegoforward.ButourBoardwasverycommittedtothebuybackandthat'swhyitwas$10billion.Andrightnowwecanexecutewhatwecanexecutefortheforeseeablefutureandwewillcontinuetoupdateyouaswego.
JamiRubin (Analyst-GoldmanSachs):
Justaquickfollow-up,obviouslyyourdesireistodotuck-indealstohelpgrowthepipeline,buttheremaynotbetuck-inopportunities,ortuck-inopportunitiespresentthemselvesthroughoutthecourseoftheyear.Areyoulimitingyourselfto$10billion?Becausebasedonmynumbersyoucouldgoevenhigherthana$10billionbuyback.Isthissomethingyou'reconstantlybalancingandassessingoris$10billionasfarasyou'llgoonabuyback?
BrentSaunders (CEO&President):
Tobefair,we'reconstantlyevaluatingalloftheopportunitiesincludingdebtrepayment.Maintainingourinvestmentgraderatingisincrediblystrategictous,sothatisatthetopofourlist,aswell.
Thatbeingsaid,ifweexecutethefull$10billionandmarketconditionscontinuetogoupveryfavorable,IwouldcertainlybringtoourBoardwithalotofadvocacytocontinueandauthorizemore.Butatthispoint$10billionholdsusoverforthenextseveralmonthsorperhapsmore,sowe'reingoodshape.Wewillbeintheopenmarketbuyingourstockfortheforeseeablefuture,andwe'llkeepeverybodyupdated.And,tobefair,ifwecouldhavedoneitthroughanASR,ifitwereavailabletoIrishcompanies,wewouldhavedoneit.It'sjustnot.
JamiRubin (Analyst-GoldmanSachs):
Right.Thankyouverymuchandcongratulations.
Operator :
GreggGilbertwithDeutscheBank.
GreggGilbert (Analyst-DeutscheBank):
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page14of26
Thankyou.So,IguesstherearesomedrawbackstobeingIrish.(laughter)
BrentSaunders (CEO&President):
Theyhavegoodbeer,too,though.
GreggGilbert (Analyst-DeutscheBank):
Brent,youcouldspendyearsbolsteringyourpositionsinthoseseventherapeuticareas.Assumingtheyareallcore,isthatyourintention?Orwhatwouldittakeforyoutostrayfromthat?And,withinthat,areyougloballyorgeographicallywhereyouwanttobewithinthoseseven?Thanks.
BrentSaunders (CEO&President):
Ithinkyou'reright,Gregg,wecouldspendyearsbolsteringourpositioninthoseseventherapeuticareas.And,infact,atR&DdaylastNovemberweshowedalotofthewhitespaceopportunitiesineachofthosetherapeuticareas.Thosethatwanttogolookatit,Ithinkthatpresentationisstilluponourwebsite.
Andyouknowwhat?That'sthefoundationofourstrategy,Gregg,isthatthereissomuchopportunityforyearstocontinuetobolsterourposition,andsowewill.Welikeeveryoneofthetherapeuticareasthatwe'rein.Wethinkthere'shugeunmetmedicalneed,hugeopportunitiestohelppatientswithcuresandtreatments,andtremendousscientificadvance.So,sowe'regoingtocontinuetodeployOpenScienceandopportunitiestobringinselectedmarketedproductstobolsterourpositionandbecomenumberonegloballyineveryoneofthosetherapeuticareas.
Withrespecttoanewtherapeuticarea,Ithinkthebarwouldbehighforustoconsiderdenovoanewtherapeuticarea.Itwouldhavetobeanareawithstronggrowthpotential,lotsofwhitespace,andlimitedcompetitionforassetsinthatcategory.Thereareafewthatweevaluatethatmeetthosegoalsbutwe'renotfocusedondoingthatatthistime.
IthinkintermsofglobalexpansionthatwasahugeopportunityforusinthePfizertransaction.Wetalkedaboutthatasprobablyourmostcompellingrevenuesynergy.AndasastandaloneAllerganitremainsacompellingopportunityforus.
IthinkasyoulookatthegrowththatPaulNavarreandtheinternationalteamputupthisquarterandinpreviousquarters,it'sastrongproofpointinourinterestingrowingappropriatelyexUS.We'regoingtofocusoneyecare,onaestheticsanddermatology,andGIandwomen'shealth.Thosearetheareasthatwe'regoingtostayfocused,andlookatgoingintonewmarkets.
Ithink,Paul,we'veexpandedandtakenbacksomedistributerrights.Perhapsyoujustwanttocommentononeortwoofthosemarkets?
PaulBisaro (ExecutiveChairman):
Yes.WehaveexpandedinEasternEurope.Wewentdirectinto10newmarkets,includingRomania,Bulgaria,Hungary.WealsowentdirectinGreeceandIsrael.Andwearenowentering,orthissummerwe'regoingtoenterIran,whichisasignificantopportunityforusforthemedicalaestheticbusiness.So,wearecontinuingourexpansioninternationally.
GreggGilbert (Analyst-DeutscheBank):
Thanks.
Operator :
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page15of26
RandallStanickywithRBCCapitalMarkets.
RandallStanicky(Analyst-RBCCapitalMarkets):
Greatthanks.Brent,Allerganisaverybigcompanynow.Whatdoyoudefineasatuck-in?AndthenaquickoneforTessa,justthinkingaboutSG&Aandthat25%ofrevenue,aftertherestructuringpostTeva,asyouleave2016,whatpercentofrevenuedoyouthinkyou'regoingtobeat?Thanks.
BrentSaunders (CEO&President):
It'shardtodefinetuck-inbysize,Randall.Ithinkthatit'smoreofthecharacteristicsoftuck-ins.So,thinkaboutatuck-inbeinglimitedtotheseventherapeuticareasthatwe'rein.Thatwouldbeacriteria.
Itwouldhavetobeagrowthassettosupportthesevenareas.WewouldhavetoonlyneedtoaddlimitedadditionalcapabilitiestosupporttheproductortheR&Dasset.So,that'showIthinkoftuck-ins.Ithinkwithinsize,obviouslyit'sgoingtobeanywherefrom$50milliontoafewbilliondollars.Butthereareexceptionstoeachoneofthoserules,aswell.Tessa?
T essaHilado (CFO):
BasicallyforSG&Aasapercentageofrevenue,asweindicated,itwouldberoughlyat25%.Andaspreviouslydiscussedfirstquarterisreallythelowrevenuequarterforusbecauseoftypicalseasonality.So,wewouldexpectcomingoutof2016inthefourthquarterforSG&Aasapercentageofrevenuetobelowerthanthat.
Havingsaidthat,Ithinkwhatweneedtotakeintoconsideration,aswell,istheimportantlauncheswehavefor2016.AndactuallytheothermetricthatIwouldguideyoutoisprobablylookingatoperatingmargins,aswell,which,asyouknow,we'reatthetopoftheindustry.JustlookingatSG&Aasapercentageofrevenuewouldbealittledeceivingbecauseitwouldfluctuatethroughthequartersbecauseofseasonality.Butwewouldtrendlowerasrevenuesgrowfor2016.
BrentSaunders (CEO&President):
Randall,maybejusttocomebacktothefirstpartofyourquestion,ifIcould,forasecond,maybethebetterwaytothinkaboutitinsteadoftuck-insisreallysteppingstonestogrowth.Itwouldhavetobeapathfromourexistingpositioninatherapeuticarea,andthesteppingstonewouldbetodrivegrowthorleadershipinthattherapeuticarea.
RandallStanicky(Analyst-RBCCapitalMarkets):
Andthatincludespipeline,aswell?
BrentSaunders (CEO&President):
Thatincludespipeline,absolutely,becauseorgrowthhastobesustainable.I'vealwayssaidinnovationisourlifebloodandR&Disacriticalelementtothat.
RandallStanicky(Analyst-RBCCapitalMarkets):
That'sgreat,guys,thankyou.
Operator :
MarcGoodmanwithUBS.
MarcGoodman (Analyst-UBS):
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
©2014TheStreet,Inc.Al l R ightsReserved Page16of26
Yes,goodmorning.Justtocontinueontheexpensesconversation,whatamountofexpensesdoweneedtotakeoutfornextyear,justasastartingpoint?Andthecontextofthequestionis,there'sbeenalotofconsolidationintothisCompany.Therewasalotofcostcuttingandsynergythatwaspromisedpreviously,andalotofthatwentawaywhenyouweregoingtobeacquiredbyPfizer.Butnowwe'rebacksowe'recurious--howmuchonanabsolutebasisarewedefinitelytakingout?Andthenhowmuchexpenseswilljusttrendupbutrevenuestrenduphighersuchthatyougetsomebenefitonthemargin?
BrentSaunders (CEO&President):
Letmejuststart.Marc,justtokidyouabit.Thesynergieswe'vecommittedtowithrespecttoourpreviousintegrationsneverwentaway.Theymayhavefrompeoplewhofollowusbutinternallywehavemaintainedanincrediblyrigorousanddisciplinedprocessoftrackingandexecutingagainstthose.
ThereweresomethatweputontheshelfrelatedtobothActavis/AllerganintegrationandsomerelatedtotheTevadivestiture.Andwedidthatappropriatelyso.Buttheydidn'tgoaway.Wehavetakenthemofftheshelfandhavestartedtofocusonachievingthosethroughouttheremainingpartofthisyearandintonextyear.Butalloftheworkwehavecommittedtowewilldeliver.
T essaHilado (CFO):
Andjusttoremindeveryone,wewillprovidemoreclarityposttheTevatransactionintermsofEPS,andmoregranulardetailforthebackhalfof2016.Andin2017,asweplantolookat2017,wewillprovideguidanceinthenormalcourse,whichwouldbeinearly2017.
MarcGoodman (Analyst-UBS):
Well,Iguessifyoudon'twanttoanswerthatmaybewecouldaskoneotherquestion,whichis,BOTOXwasextremelystronginthequarter,constantcurrency.Canyoujustgiveusalittlemorecoloronwhat'sgoingonthere?
BrentSaunders (CEO&President):
Bill,doyouwanttotakethat?
BillMeury(ChiefCommercialOfficer):
Youknowthere'stwosidestothatbusiness.There'satherapeuticsideandthenthere'stheaestheticsside.Andthen,ofcourse,youcanlookatitthroughbothaUSandinternationallens.
Onthetherapeuticside,themaindriverscontinuetobeproductmigraineandoveractivebladder.Wealsogotanewindicationforneurorehabcondition,lowerlimbspasticity.JustyesterdayattheNationalUrologymeetinginSanDiego,therewasahead-to-headstudypublishedthatwasactuallyconductedbyNIHcomparingBOTOXforoveractivebladdertointerstintMedtronicsproduct,whichIthinktheurologycommunityfoundveryinstructive.Thatsideofthebusinessisverystrong.
Whenyouturntotheaestheticsside,asyouknow,it'stheleadingbrandintheworld.Ithasaworld-classeCommerceandcustomerloyaltyprogram,whichcontinuestosustainsaleslevels.Ifyouthinkaboutitgeographically,theinternationalbusiness,salesforBOTOXwereupalmost20%.
So,thisisjustarocksolidproductthathas11differentindications.It'sgotauniqueinjectionpatternthatusersunderstand.It'shighlyeconomical.And,ofcourse,,wehaveawholeseriesofnewindicationsindevelopmentonboththetherapeuticandtheaestheticsside.Thisisapuredemandstory.
Operator :
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
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DavidAmsellemwithPiperJaffrey.
DavidAmsellem(Analyst-PiperJaffray&Co.):
Thanks.IjustwantedtoaskaboutMemantinefranchiseandthisfocusonthatbusiness.Thequestionhereis,areyoudisappointedwithhowNAMZARICistracking?Andthen,secondly,whatareyourthoughtsonlongtermintermsoftheportionoftheMemantinemarketthatyouthinkyou'llbeabletoretain?Thanks.
BillMeury(ChiefCommercialOfficer):
It'sagoodquestion.Iwouldn'tsaydisappointedwithNAMZARIC.Ijustthinkit'satimingmatter.TheoriginalindicationforNAMZARICincludedpatientswhowereonessentiallythenon-sixcombination.Butitdidn'tincludepatientswhowereonlyreceivingAricept.
Ithinkforphysicians,that'sanimportantindication,whichweexpecttogetinthesecondhalfof2016.It'sclearamongneurologistsandprimarycarephysiciansthatNAMZARICissuperiortoanythingonthemarket,whetheritsNamendaXRorAricept.OncewegetthatindicationwewillessentiallylaunchitandIthinkyou'llseeaverydifferenttrajectory.
Overall,though,whetherit'sXRorNAMZARIC,thisisaverystablebusiness.Andwehaveaheavypromotionaleffort.We'retheonlyoneinthecategorythatisactive.Neurologistsandprimarycarephysiciansknowthat.
Ourformularycoveragein2016andin2017isverystrong.AndIbelievethatwe'regoingtoatleastmaintainthebusinessthatwehavetoday.AndthelaunchofthenewindicationforNAMZARICfornewpatients--thatis,patientsonlyanAricept--couldrestoregrowthtothisbusiness.So,I'mveryconfidentaboutthenext12-24months.
DavidAmsellem(Analyst-PiperJaffray&Co.):
Thankyou.
Operator :
KenCacciatorewithCowen.
KenCacciatore (Analyst-CowenandCompany):
Thankyou.Bill,congratulationsonyournewrole.Maybeaskaboutthepayerenvironmentingeneral,ifthere'sbeenanymeaningfulchangesoractionsingeneral.So,ifyoucouldjustdiscussthat.AndmaybewithsomespecificitytoVIBERZIfirst,vis-a-visXifaxan.Canyoutalkaboutcoveragethere?AndVRAYLAR,aswell,thecoverage,asyou'repursuingthatlaunchorcontinuingthatlaunch.Thankyou.
BillMeury(ChiefCommercialOfficer):
Yes,goodquestion.NaturallytheformularycoverageforVIBERZIisdeveloping.butthemajorityoftheclaimsforVIBERZIduringthefirstseveralweeksoflaunchhavebeenapproved,soI'mveryencouragedbyit.
ESIandCVSCaremarkplaceVIBERZIonformularYinanunrestrictedposition,whichIthoughtwasaterrificdevelopmentthisearlyinthelaunch.Iexpectoverthenext9to12monthstheformularycoverageforVIBERZIisgoingtolookjustliketheformularycoverageforLINZESS.
SpeakingaboutLINZESS,itwasaddedtoCVSCaremarkformulary,andinthePartDspace,WellCareand
CompanyName:AllerganPLCCompanyTicker:AGNSector:HealthCareIndustry:Drugs
EventDescription:Q12016EarningsCallMarketCapasofEventDate:83.02BPriceasofEventDate:223.21
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Aetna.Andthoseareverysignificantformularywinsfortheproductandreallyshoreup2016andIthinkinto2017.
There'snothing,really,inmyview,atleastasitrelatestoourproductline,thatisgoingtosurpriseus.Wealreadyhavealineofsightto2017.Theproductsetmostimportanttoourgrowthare,first,economical.Mostoftheirgrowthiscomingfromvolumeandsingle-digitpriceappreciation.So,Ithinkaslongaswecontinuetocommunicatewithpayersandwe'repredictableandtransparentaboutourfuturepricingdecisions,Ithinkwe'regoingtobeabletomaintainaccessacrossthisentireproductline.
AndthenasitrelatestoVRAYLAR,theproductisofftoaterrificstart.Weknowpsychiatryverywell.Thefeedbackthatwe'regettingisexceedingourexpectationsintermsoftheactualexperiencewiththedrug.Formularycoverageisdeveloping,asexpected.
Thisisacategorywhere,whiletherearealotofproducts,there'sagreatdealoftrialanderror,sohealthplansareinclinedtoplacetheproductonformularyevenifit'sbehindtheuseofaSeroqueloraRisperdalorZyprexa.AndIthinkessentiallywhat'sgoingtohappeninthiscategoryistherewillbeachangingoftheguardbetweentheolderatypicals,theonesIjustmentioned,toneweratypicalslikeVRAYLAR,oreventhetwoothers,LatudaandRexalti,becausewhenyoulookatthebenefit-riskratioofthenewerones,includingVRAYLAR,it'sclearlybetterthanwhatyouseewiththeolderanti-psychotics.We'reveryencouragedbywhat'sgoingonwithVRAYLARinthefirsteightweeks.
KenCacciatore (Analyst-CowenandCompany):
Thankyou.
Operator :
ChrisSchottwithJPMorgan.
ChrisSchott (Analyst-JPMorgan):
Great,thanksverymuch.Ijusthadaquestion,justcomingbacktoprice,givenallthefocusthesedays.Canyoujustcommentatalljustacrosstheentirebusinesswhenwethinkaboutthemixofpriceversusvolumesrelativetonewlaunches.WhenyouthinkaboutyourQ1salesandparticularlyyourQ1pharmagrowth,howmuchofthiswaspriceversusvolume?
Andthenjustaquicksecondone,comingbacktobusinessdevelopment,giventhefocuswhichseemstobemoreontuck-insatthispoint,isitstillfairtoassumethatyou'regoingtodeploythemajorityofthecashthatyou'regoingtoreceivefromtheTevadealoverthenext12to18months?Orcouldthattakealongerperiodoftimetoredeployintoyourbusiness?Thankyou.
BrentSaunders (CEO&President):
LetmequicklytouchonpriceandthenaskBilltocommentmorespecifically,becauseIthinkthisholdstrue,sinceyouasked,Chris,acrosstheentireportfolio.Ithinkbothinthebrandedandinthegenericbusinessthere'sbeenalotofdebateandconcern,Ithink,amongstthecommunityaroundpricing.Ithinktherealityiswhenyouhaveinnovativeproductsthatmeetunmetneed,thatcandistinguishthemselvesfromolderproducts,pricingreallyisn'tthecentralissue.It'stheabilitytocommercializeandsupportyourdrugwithdata.
Onthegenericsideit'saverysimilarstory.WhenyouinvestinR&D,asBobStewartpointedout,whenyouhaveateamthathas90firsttofileswaitingattheFDA,whentheygoaftercomplexgenericsandhigherbarrierproductsyougetabetterpricingenvironment.Ithinkthenet-netisthereareothersthathavereportedweaknessinpricebutthat'sbecausetheirportfoliolacksinnovation.Itlacks
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differentiation.
Andeveninhighlyinnovativeareasonthebrandedside,wherethere'smultipleentriesintothesamemarketwithverysimilarmechanismsofaction,itdrivespricedown.Whenyoustandalonewithyourdrug,likewedowithVIBERZI,asanexample,youtendtohavebetterpricingdynamicsintheenvironment.It'sreallythatstraightforward.Bill,doyouwanttocommentspecificallyonourportfolio?
BillMeury(ChiefCommercialOfficer):
Yes.Iwouldjustfirstcommentthatourpricingstrategystemsfromtheintellectualpropertysurroundingtheseproducts.Wehaveexclusivityperiodsthatextendwellintothe2020s,sowepriceforthelongterm.IfyouwanttolookatthebusinessoverallintheUnitedStates,thesplitwasroughly50/50withthepriceappreciation,ofcourse,beinginthemidsingledigits.Ifyouwanttolookatthoseproductsthatareresponsibleforthemajorityofourgrowthandsales,ourtopalmostdozenproducts,thegrowthiscoming70%fromvolumeand30%fromprice.
So,it'sjustasolidbusiness.Again,itgoesbacktothefactthatwe'replayingforthelongtermhere.Thesearecategoriesinwhichwehavetheproductofferingsandstrongcustomerrelationships.Wedon'thaveashort-termoutlookasitrelatestoprice.Andwehaven'tbuiltignitionto2016estimatesorevenbeyondthat'sunrealisticgiventhecurrentmarketdynamics.
BrentSaunders (CEO&President):
Ithinkwithrespecttobusinessdevelopment,tothesecondpartofyourquestion,perhapstuck-insisn'ttherightwaytothinkaboutit.IliketheanalogyIcameupearlierofsteppingstonesbecausewe'rereallylookingatsupportingthepathtogrowth.We'renotjustlookingatrandomtuck-instosupportnon-coreareasorthelike.It'saveryfocusedstrategymoreonapathway.That'swhyIthinkasteppingstoneapproachisprobablytherightwaytothinkaboutit.
And,look,wehaveenoughshotsongoal.Thereareenoughopportunitiesouttherethatwebelievethatthecurrentcapitalallocation,asdescribed,istherightwaytothinkaboutitforthemoment.Butwewillupdateyouquarterlyofourthoughts.Ifwethinktheopportunitieseitherdon'tworkbecausewedon'tlikethescienceortheproductprofileorit'stooexpensive,thenthatcouldfreeupmoremoneyforadditionalsharerepurchaseoradditionaldebtrepayment.Butrightnowwethinkwe'vegottherightbalancebasedonourviewoftheworldaswesitheretoday.
ChrisSchott (Analyst-JPMorgan):
Great,thankssomuch.
Operator :
RonnyGalwithBernstein.
RonnyGal(Analyst-SanfordC.Bernstein&Co.):
Goodmorning.Congratulationsonthequarter.Thankyoufortakingquestion.IfIcouldstartwithBillforjustaquickclarification.First,theharmonizationofallowancesthatyoumentionedforacoupleofproducts,whatexactlyisit?Itsoundsalittlebitlike--Ijustwanttomakesureit'snotessentiallyreversalofstuffinthechannelorsomethinglikethat.
T essaHilado (CFO):
I'lladdressthat,Ronny.Basicallyit'sreallyjustharmonizingallofouraccountingpolicies,andthisrelatesspecificallytoAczone.Thenumber,intermsofanincreaseinallowance,notadecreaseinallowance,is
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lessthan$20million.
BrentSaunders (CEO&President):
Justtobefair,Ronny,it'sone-timeandontheoverallbusinessit'sreallynotsignificant,asTessapointedout.Thereasonwecalleditoutspecifically,oneiswe'recommitmenttotransparency,but,two,itismeaningfultothegrowthratefortheUSmedicalsegment.Peopledofollowmedicalaestheticsverycloselysowewantedtobifurcateandshowthatbusinessisincrediblystrongat15%growth,andthatthedampeningoftheoverallsegmentwasreallyaone-timeevent.
T essaHilado (CFO):
Andjusttoclarify,ithadnothingtodowithinventoryorchannelstuffingatall.Prescriptionsspecificallyforthatproductisverystable.
RonnyGal(Analyst-SanfordC.Bernstein&Co.):
Okay.AndthenoneforDavid.David,youputouttheresultsonEsmyaacoupleofdaysago.Canyouputthequalityoflifemeasuresincontextforus?Itwasverystrongintermsofstatisticalsignificance.Butcanyoudiscussessentiallywhatisthebenefitthatthepatientshaveexperiencedintermsofhowthescaleisconstructed?Essentiallyhowmuchreliefarethepatientsgettinginthis?
DavidNicholson (ChiefR&DOfficer):
WedohaveapatientrecordedoutcomescaleaspartofthePhaseIIItrials.AndwehavediscussedwiththeAgencytowhatextentwearegoingtobeabletousethedatafromtheTROsinourlabel.
Intermsofactivitiesofdailyliving,wegotaverypositiveresultinthefirstPhaseIIItrialwherethepatientssawsignificantbenefitintheirdailyactivities.So,wearealsoveryhappyaboutthoseresults,notjustthetrial,wasn'tonlypositivebecauseofthechangesinthebleedingprofile.
BrentSaunders (CEO&President):
And,Bill,maybecommerciallydoyouwanttojusttouchonEsmyaforasecondrelatedtoitspositionvis-a-visasanoralandassubstantiallyahead?
BillMeury(ChiefCommercialOfficer):
Yes,Listen,pharmacologicallyit'sdifferentthanaGNRHmodulator.AndIthinkthat'sgoingtoflowrightthroughtothebenefit-riskprofileofEsmyarelativetoanotheroption.ThisisthefirststudyintheUnitedStateswhereanoralcompoundhasshownanexcellentefficacyforthetreatmentofuterinefibroids.Theimpactoftumorsizeandbleedingisgoingtobereallyimportant.
Thisisalargecategory.Over10millionwomensufferfromuterinefibroids.Thiswillbetheflagshipofourwomen'shealthbusinessinafewyears.OutsidetheUnitedStates,whereitsbeenlaunchedinCanadaandtheEU,onceyouadjustforpriceandpopulation,yearthreesalesisnear$400million.So,thisfirsttrialwassignificantnotonlyintermsofimportantforthecommunityofOG/GYNsandwomen'shealthingeneral,butalsoimportanttousintermsofabigpipelinedevelopment.
BrentSaunders (CEO&President):
TessaandIarewritingdownthe$400million.
T essaHilado (CFO):
That'sright.Dulynoted,Bill.
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Operator :
LiavAbrahamfromCiti.
LiavAbraham(Analyst-Citigroup):
Goodmorning.Brent,canyoucommentonyourcommitmenttodouble-digitunderlyingrevenuegrowthoverthemediumtermwithyourcurrentassetbasegivensomeofthepotential(inaudible)overtheneartomediumtermsituation,LifitegrasttoRestasis?Andtowhatextentwillthiscommitmentinformyourbusinessdevelopmentstrategy?Inotherwords,doyouhaveapreferenceforassetsthatareonthemarketorclosetothemarketversuspipelineassetsinearly-tomid-stagedevelopment,orareyouagnostic?Thankyou.
BrentSaunders (CEO&President):
Ourcommitmenttodouble-digitrevenuegrowthissincere,it'sstrong.Welookatourabilitytoexecuteonthatoverthenextfewyears.Andwethinkgivenourcurrentassetsandcurrentpipeline,onariskadjustedbasiswethinkwecangetthere.Obviouslytherearealwaysputsandtakesthatcometothatbutwehaveahighdegreeofconfidencethatwecoulddonootherdealsanddeliverthatgrowthoverthenextfewyears.
Aswethinkabouttuck-ins--orsteppingstonedeals,asI'vebeencallingthem--theintellectualpropertytypeofdealsorR&Ddealsaredesignedtogetuswellintothe2020swithdouble-digitgrowthbecausethat'sthenameofourbusiness.It'saboutnewproductlaunches,it'saboutinnovationandlookingformedicinesthatsupporttreatmentorcuresforunmetneed.So,we'regoingtocontinuetodothat.Butwe'rereallythinkingaboutwellintothe2020swherewehavetosupportourbusinesstomaintainthedouble-digitgrowth.
Ithinkwithrespecttooursteppingstoneapproachtomarketedproducts,we'rereallylookingforinnovativeproductsthatwethinkreallydoprovideameaningfuldifferentiationintermsofunmetneed,andthatfitneatlyintoourcurrenttherapeuticareasothatwecangetmoreleverageoutofourinfrastructure,whetherthatbeG&Aorsellingandmarketing.That'sreallyhowwesee.
Wehavethisgreatcommercialengine,bothintheUSandoutsidetheUS,thatwewanttocontinuetoleverageandmakemoreof,andfranklymakesourrepresentatives,itmakesourmedicalaffairsteams,itmakesourmanagedcareteamsmorerelevantwhenwetalkaboutthosetherapeuticareas.So,therearemultiplereasonswhywelikeourtherapeuticarealeadershipapproachwithmultipleproductsacrossanentirebroadspectrum.So,soIthinkwe'reinprettygoodpositiontocontinuetodeliverdoubledigitorabout10%top-linegrowth.Bill,anythingyou'dadd?
BillMeury(ChiefCommercialOfficer):
Yes,Liav,whatwe'refocusedon,ifyouthinkabout2016andhowdoesthathappen,inadditiontoVRAYLARorVIBERZIandKYBELLA,whicharetruenewproductlaunches,wehavenewindicationsorcombinationsorlineextensions,whichalsocansupportparticularlyhealthybusinesses.Forexample,(bivavilsun)willlaunchin2016.Then,ofcourse,wehavethenewindicationforNAMZARIC.We'lllaunchthemulti-dosepreserve-freeformofRESTASIS.Andinearly2017we'lllaunchalow-doseor72-microgramofLINZESS.
Eachofthoseproductimprovementsisagainstafairlysignificantandimportantpartofoursalesstream.That'showwethinkaboutthenext12to24months.
LiavAbraham(Analyst-Citigroup):
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Great,thankyou.
Operator :
LouiseChenwithGuggenheim.
LouiseChen (Analyst-GuggenheimSecuritiesLLC):
Hi,thanksfortakingmyquestions.Ijusthadtwoquickquestionshere.First,weoftengetasked,withrespecttoAllergan,whatyourstrategicvisionisforthecompanylongerterm--doyouwanttobeaspecialtypharma,growthpharmacompany,doyouwanttobealargecappharmaorbiotech.Iwaswonderingifyoucouldgiveusmorecolorhere.
Andthen,secondly,justonSG&Aleverage,justcuriousifyouplantoimprovethatovertime.And,ifso,whatgivesyouconfidencethatyoucanachievethisobjective?Thanks.
BrentSaunders (CEO&President):
Yes,thankyou.Greatquestion.It'sinteresting,thespecpharmalabel,whichishowIthinkmostpeopledescribeus,ispurelyacreationofmanyofyouinthatyou'respecpharmaanalysts--notallofyou,butmany.So,that'saWallStreetdesignation.
Wehaveafewyearsagodesignatedourselvesasgrowthpharmaandthat'sstrategicallywhatwewanttobeknownas.Wewanttobefocusedontop-linegrowth,therapeuticarealeadershipandasustainedR&DinvestmentthroughourOpenScienceapproach.So,that'sourstrategy.We'vearticulateditnowforafewyears.
IthinkpostTevaitbecomesevenclearerthatweareafocusedresearch-basedgrowth-orientedcompanywithstrongtherapeuticarealeadershipinthesevenareasthatwecompetein,withstrongpipelinetosupporteachofthoseareas,andacommitmenttobeingopen-mindedaroundopportunitiestoenhanceourleadershipandenhanceourgrowththroughasteppingstoneapproachtoM&A.
T essaHilado (CFO):
AndonSG&AasImentionedearlier,wehaveaveryefficientoperatingstructure.Aswenotedinoneofthecharts,wethinkwe'llbeatroughly25%exitingtheyearinthefourthquarter,withhigherrevenueatthelowerratethanthat.AndasIalsomentioned,Ithinkagoodmeasuretolookat,aswell,isoperatingmarginsgiventhefactthatwehaveagoodnumberoflaunchesthisyear.Andonoperatingmarginswecontinuetoimprovethatsequentiallyquarteroverquarter,andwebelievewe'reinthetopoftheindustry.
LouiseChen (Analyst-GuggenheimSecuritiesLLC):
Thankyou.
Operator :
UmerRaffatwithEvercoreISI.
UmerRaf f at (Analyst-EvercoreISI):
Hi,thankyoufortakingmyquestion.First,perhapsforBill,Bill,there'sbeenabunchoffeedbackonlineaboutsalesforcedisruptioninBOTOXurology.So,IthoughtitwasgoodtoseeyoureportBOTOXoveractivebladderasakeydriverofurologygrowth.Couldyoujustpleaseclarifywherethingsstandinthatdivision?
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Andthen,also,asecondoneongenericsdivision,Isawthe10-Q,itwasabout$1.3billioningenericssalesversusabout$1.7billioninQ1lastyear.AndIunderstandtheremustbechoppinessinproductlaunches.Ijustwantedtounderstandthattrendaswell.Thankyou.
BrentSaunders (CEO&President):
IthinkourBOTOXtherapeuticfranchise,theproofpointisinthenumbersthatweredelivered,andtheteamisfocused.ObviouslytherewassomeissuesinoururologyareathatwererelatedtofollowingCompanypolicy.Wetakethatveryseriously.WehaveaverystrongcomplianceandinternalauditprocessinsideourCompany.Internalcontrolsareattheforefrontofwhatwedoandwhenpeopleviolatethatwedealwithitverystrictlyandseverely.So,that'swhathappenedthere.
Iwouldn'tgettoocaughtupononlinechatter.Youcoulddriveyourselfcrazylookingatsomeofthosemessageboardsandthinktheworldwascomingtoanend,notjustatAllerganbutacrosstheentireworld,ifyoubelievemostofthestuffyou'seeonthosethings.Butsufficeittosaythebusinessisincrediblystable,resilientandgrowing.
BillMeury(ChiefCommercialOfficer):
Iwouldjustadd,Iwasatarecentsalesawardstrip,thatthemanagementteamthat'sinplaceandthemajorityofthatfieldforcewasfocusedonourcustomers,andnaturallyincreasingtheuseofBOTOXinOAB,whichisoneofthefastestgrowingsegmentsofthatproduct.So,it'sinourrearviewmirroratthispoint.
BrentSaunders (CEO&President):
Onthegenericsside--Bob?
RobStewart (COO):
Yes,whatIwouldsayonthegenericsside,thisbusinesscontinuestoperforminlinewithourexpectations.Youcan'tnecessarilygolookathistoricalyear-over-yearcomparisonsinthisbusinessaswe'repreparingforthisbusinesstomergewithTeva.There'salsoanumberofcyclicalthingswithinthebusinesswithproductlaunchesandtimingofthingslikethat.
Buttheunderlyingbusinessisperformingincrediblystrong.Wecontinuetoseepriceerosion,asImentionedinmypreparedremarks,asmidsingledigit.AndoverallitcontinuestofireonallcylinderswithrespecttoR&D,aswellascommercialexecutionoflaunches.
PaulBisaro (ExecutiveChairman):
ThisisPaul.Justremember,revenueisneveragoodviewofthegenericsbusinessperformancebecauseIcanassureyou,inthesecondquarter,withthelaunchofgenericCrestorwe'regoingtohaveblowoutnumbersontherevenueside.AndIagreewithRobthatourbusinessisperformingverywell.IthinktheTevafolksaregoingtobeveryhappytoclosethetransactionandcontinuethatstrength.
UmerRaf f at (Analyst-EvercoreISI):
Gotit.But,Paul,justtobeclear,versusQ4the$300milliondropinrevenue,isthereaknownlaunchthatfadedaway?
PaulBisaro (ExecutiveChairman):
No,there'salsocyclicalissuesinthegenericbusiness,aswell.Thefirstquarterisalwaysthetoughestquarter.We'veseenityearoveryear.Thatcontinuestobethesametrendthatwe'vealwayshad.
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UmerRaf f at (Analyst-EvercoreISI):
Thankyouverymuch.
Operator :
JasonGerberrywithLeerinkPartners.
JasonGerberry(Analyst-LeerinkPartners):
Hi,goodmorning,andthanksfortakingmyquestions,andcongratstoBillforthechangeinrole.MyquestionforBrent,actually,justthinkingaboutthechangeintoneregardingatransformationalM&AdealfromJulywhenyouannouncedtheTevadealtopresentwhereitseemslikemaybethere'salittlebitofde-emphasis,butstillkeepinganopenmindtotransformationaldeals,whatI'mwonderingiswhat'schangedinthatperiodoftimegiventhatvaluationshavepulledback?
Andthen,secondly,withthechangeinthetreasurynoticeandthelook-backrules,ifyoucanjustwalkusthroughtherestrictionsintermsofusingequityuntiltheWarnerandForestdeals.AndevenAllergandealshittheirthree-year(inaudible).Thanks.
BrentSaunders (CEO&President):
Ithinkthatperhapsifyoupickedupaslightchangeintoneit'sbecauseaswe'vegottenmorecomfortablewiththecurrentbusinessthatwehaveandoperate,aswe'vegottenmorecomfortablewithourpipeline,itgoestohowIopenedthecall--wehavethebestpharmaceuticalbusinessintheworld.It'sgrowingatproforma10%brandedsales.Ithasadeeppipelineofplus70mid-tolate-stagepipelineopportunities.Wehaveastrongcapitaldeploymentopportunity,bothwithsharebuybacks,debtrepaymentandsteppingstonedeals.Andwehaveaninvestmentgraderatedbalancesheet.
So,weareinthepullpositionandourfocusisgoingtobeonoperatingandrunningourCompanyandcontinuingtoputupquarter-after-quarterperformance.Ifwecansupportthatorturboboostthatwithopportunisticdealsthatmaycomealong,likeAllergancamealonginaveryuniquesituation,thenIthinkthisisaboldmanagementteamthat'sgoingtolookatwhat'sinthebestinterestofourshareholderstodriveshareholdervaluecreation,andwe'lldoit.
Buttherealityis--andI'vebeensayingthisforalongtime--99%ofourfocus,themanagementteamsittingaroundthephonerightnow,isonrunningourbusiness.Andwe'regoingtocontinuetoputupexecutionalexcellenceasourtopgoal,andwe'regoingtocontinuetosupportthebusinesswithgrowth-orientedsteppingstonedeals.But,really,ourfocusisonrunningthebusiness.
T essaHilado (CFO):
Withregardstothetreasuryyields,asyoucanimagine,weanalyzedthatextensively,andbasedonouranalysistwothingshavecomeout.Oneiswedon'texpectanymaterialchangeinourtaxrate.Andthen,two,thenewtreasuryrulesactuallyalsoaffirmourstatusasanIrish-domiciledcompany.
Withregardstoatransformationaldeal,webelievewecancontinuetomaintainourIrishdomicile.Asyouknow,thenewrulesprovideforathree-yearlook-backintermsofdeterminingwhatwecallgoodsharesforpurposesofcalculatinginversion.October2016isthethree-yearanniversarydatefortheWarnerChilcottacquisition,whichthengivesusmorecapacitytoissuesharestoatargetcompany.
Theonethingthatyouhavetonote,though,thatwealwayshavetheflexibilitytoissuesharesforcashwithoutactuallyaffectingourstatusasaforeigncompany.
BrentSaunders (CEO&President):
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Orsellintheopenmarket.
T essaHilado (CFO):
Orsellintheopenmarket,right.So,there'sreallynothinginthecurrentTreasuryrulestodaythatprecludeusfromexecutingonourstrategy,whetherthat'stuckinortransformationaldeals.
BrentSaunders (CEO&President):
Justtobeclear,Jason,I'dsaytwothings.One,theTreasuryruleshadnoimpactonthissmallshiftinthinking,asTessajustoutlined.Withperhapsjustsomeminormaneuvering,wecouldexecuteanytransformationaldealwewantedtodo.I'mnotworriedaboutthat.
Therealityis,whywouldweissueourstockatthispriceconsideringwejustannouncedupto$10billionofbuyback.Wethinkourstockorthatcurrencyistooinexpensivetoissuetoatargetatthispointanyway.
T essaHilado (CFO):
Plusevenifyoulookatfromaliquidityperspective,evenwitha$10billionsharerepurchaseauthorization,andifweexecuteuptothatamountandthepaymentofdebt,net-netwestillhavesufficientliquiditytopursuedeals.
JasonGerberry(Analyst-LeerinkPartners):
Gotit,okay,thankyou.
Operator :
AndourlastquestioncomesfromthelineofDavidMariswithWellsFargo.
DavidMaris (Analyst-WellsFargoSecurities):
Goodmorning.BrentandDavid,onthepipeline,IseetheonebiosimilarforAvastinonthepipelinechartthatyoustatewillfileinthesecondhalfof2016.Canyouupdateusonthestatusoftheothers?
And,Brent,whatroledothebiosimilarsplayinthebrandedpharmamodel?Isthisanotherassetthatyoucouldtradeorthatyou'dconsidertradingorisitcoretothegrowthpharmamodel?
BrentSaunders (CEO&President):
Yes,letmeanswerthebackpartandDavidcantalkaboutstatusoftheprograms.IthinkthewayIthinkaboutbiosimilars,atleastoverthenextfewyears,isthat,forus,forAllergan,we'vemademostoftheinvestmentalready.Andwe'veseengoodsuccesswithmostoftheprogramsincollaborationwithAmgen.So,forus,atthispoint,we'vemadetheinvestment,weshouldparticipateinthecommercializationand/orsalesofthoseproductsthroughourpartnershipwithAmgen.
IthinklongtermIdon'tthinkbiosimilarswillnecessarilybeacorepartofourstrategy.WemaydecidetocontinuetoinvestinthepartnershipwithAmgen,becauseitsbeenagoodcollaborationandsuccessfulpartnership.Wemaylookatselectiveopportunitiestoparticipateonaone-offbasis.AndwedohavecapabilitiesinourownorganizationinLiverpoolwherewewilllooktodosomeuniquethings.
Bthink,infairness,wearefocusedonsupportingourseventherapeuticareaswiththevastmajorityofourR&Ddollars,withthevastmajorityofourinvestment,tomakesurethatwecancontinuetoinnovatearoundunmetneedandtosupportourgrowthpharmaagenda.David,doyouwanttotouchonthe--?
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DavidNicholson (ChiefR&DOfficer):
Sure,sure,justbriefly,theotherbiosimilarsthatwe'reworkingontogetherwithAmgen,asI'msureyou'reallaware,arebiosimilarsforHerceptin,RituxanandErbitux.WeanticipategettingthePhaseIIIdataforHerceptinlaterintheyear.ObviouslyRituxanandErbituxareearlierinthepipeline.Erbituxisstillinpreclinicaldevelopment.Rituxanismovingintotheearlystagesofdevelopmentthisyearandthe(settle-line)developmentproceedsaccordingtoexpectations.
DavidMaris (Analyst-WellsFargoSecurities):
Great,thankyouverymuch.
LisaDeFrancesco (InvestorRelations):
Brent,wouldyouliketomakeanyclosingremarks?
BrentSaunders (CEO&President):
Yes.Ijustwanttothankeveryone.IknowitwasalittlebitofalongercallthannormalbutIthinkitwasworthourtime.Obviously,weremainveryfocusedonexecutionalexcellence,oncontinuingtodeliverourgoalsandagendawithrespecttogrowthpharma.Wedolookforwardtoprobablyournextcallwithrespecttosecond-quarterearningsinAugusttoupdateyoubothonearningsfortheremainderoftheyearandourlifepostcloseoftheTevatransaction.So,thankyouagainforyourtimeandlookforwardtocatchingupagain.
LisaDeFrancesco (InvestorRelations):
Thanks,everyone.
Operator :
Thisconcludestoday'sconferencecall.
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