allergan inc (act) earnings report: q2 2015 conference...
TRANSCRIPT
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page1of21
ALLERGANINC(ACT)EarningsReport:Q22015ConferenceCallTranscriptThefollowingALLERGANINCconferencecalltookplaceonAugust6,2015,08:30AMET.Thisisatranscriptofthatearningscall:
CompanyPart icipants
LisaDeFrancesco;Allergan;VP-GlobalIRBrentSaunders;Allergan;President,CEOTessaHilado;Allergan;CFODavidNicholson;Allergan;EVP,President-GlobalBrandsR&DBillMeury;Allergan;President-GlobalGenerics,CommercialOperationsPhilippeSchaison;Allergan;President-AllerganMedical
OtherPart icipants
ChrisSchott;JPMorgan;AnalystJamiRubin;GoldmanSachs;AnalystLiavAbraham;Citigroup;AnalystSumantKulkarni;BankofAmericaMerrillLynch;AnalystMarcGoodman;UBS;AnalystRonnyGal;SanfordC.Bernstein;AnalystElliotWilbur;RaymondJames;AnalystRandallStanicky;RBCCapitalMarkets;AnalystUmerRaffat;EvercoreISI;AnalystGreggGilbert;DeutscheBank;AnalystDavidMaris;BMOCapitalMarkets;AnalystDavidRisinger;MorganStanley;Analyst
MANAGEMENTDISCUSSIONSECTION
Operator :
Atthistime,IwouldliketowelcomeeveryonetotheAllergan2015secondquarterearningsconferencecall.
(OperatorInstructions)
I'llnowturntheconferenceovertoLisaDeFrancesco,VicePresidentGlobalInvestorRelations.
Pleasegoahead.
LisaDeFrancesco (VP-GlobalIR):
Thankyou.Goodmorning,everyone.I'dliketowelcomeyoutotheAllergansecondquarter2015earningsconferencecall.EarlierthismorningweissuedapressreleasereportingAllergan'searningsforthesecondquarterendedJune30,2015.Thepressreleaseandourslidedeckwhicharewearepresentingthismorningareavailableonourcorporatewebsiteatwww.Allergan.com.
Weareconductingalivewebcastofthiscall,areplayofwhichwillbeavailableonourwebsiteafterits
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page2of21
conclusion.Pleasenotethattoday'scalliscopyrightedmaterialofAllerganandcannotberebroadcastwithouttheCompany'sexpresswrittenconsent.
Turningtoslide2,I'dalsoliketoremindyouthatduringthecourseofthiscallmanagementwillmakeprojectionsorotherforward-lookingremarksregardingfutureeventsorthefuturefinancialperformanceoftheCompany.It'simportanttonotethatsuchstatementsandeventsareforward-lookingstatementsandreflectourcurrentperspectiveofthebusinesstrendsandinformationasoftoday'sdate.ActualresultsmaydiffermateriallyfromcurrentexpectationsandprojectionsdependingonanumberoffactorsaffectingtheAllerganbusiness.ThesefactorsaredetailedinourpublicperiodicfilingswiththeSecuritiesandExchangeCommission.Allergandisclaimsanyintentorobligationtoupdatetheseforward-lookingstatementsexceptasexpresslyrequiredbylaw.
Withusontoday'scallareBrentSaundersourCEOandPresident,whoprovideanoverviewofoursecondquarterbusinesshighlights;TessaHilado,ourChiefFinancialOfficer,willthendiscusstheAllergansecondquarterresultsinmoredetail;andDavidNicholson,ExecutiveVicePresidentandPresidentofGlobalBrandsR&Dwillprovideanupdateonourbrands'R&Dprogressinthequarterandupcomingdevelopmentmilestones.AlsoonthecallandavailableduringtheQ&AarePaulBisaro,ourExecutiveChairman;BobStewart,PresidentofGlobalGenericsandCommercialOperations;BillMeury,MaryPresidentofBrandedPharma;PaulNavarre,PresidentofInternationalBrands;PhilippeSchaison,PresidentofAllerganMedical;andBobBailey,ourChiefLegalOfficer.
Withthat,IwillturnthecallovertoBrent.
BrentSaunders (President,CEO):
Thanks,Lisa.Andgoodmorning,everyone.It'sgreattobewithyoutoreviewourresultsforthesecondquarterof2015whichbuildsontheterrificresultswehadlastquarter.ThiswasalsoourfirstfullquarterofacombinedoperationsfollowingthecloseoftheAllerganacquisitiononMarch17.AndI'mveryproudofwhatourteamhasaccomplished,especiallythemomentumtheyhavecreatedtopropelourfuturegrowth.
Turningtoslide5,Allergan'ssecondquarterperformancehighlightsourabilitytoexecuteonourfourpillarsofourlong-termgrowthstrategy.Firstoperationalexcellenceisyieldingexceptionalfinancialperformanceandresultsinallkeybusinesssegments,keyproductsandkeygeographies.Second,therapeuticarealeadershipisleadingtodouble-digitgrowthamongmanyofourfranchises.
Third,ourproductiveandinnovativeR&Denginehasproducedmorethan100brandedproductapprovalsgloballyand56brandedregulatorysubmissionsyeartodate.Andfourth,weareexecutingonstrategicbusinessdealstosupportourgrowthinkeytherapyareasandchargeupourpipelineforthefuture.
WealsochangedournametoAllerganinthequartertosymbolizeourtransformationintoaleaderingrowthpharmawherebrandsnowcontributemorethantwo-thirdsofourCompany'srevenue.Withourfocusongrowthpharmawe'reencouragingouremployeesaroundtheworldtobeboldandsmartinthewaywethinkandact.
Turningtoslide6,theannouncementofourplanstocombineourglobalgenericsbusinesswithTevaina$40.5billiondealisthelatestboldmovebyourCompanytocontinueourtransformationtowardsbeingaleaderinbrandedgrowthPharma.Foryearswe'vebeenmovinguptheinnovationcurvetowardsespeciallyspecialtypharmaproducts.Thisagreementclearlyacceleratesourtransformation.
Thisdealallowsustodramaticallysimplifyouroperatingstructure,sharpenourfocusonsevencoretherapyareas,andreloadourcapitalstructuretocontinueourtransformation.There'scertainlymoreto
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page3of21
comeonthisstory.Weareconfidentthatwearecreatingthemostdynamiccompanyingrowthpharmawhileaddingourimpressiveglobalgenericcommercial,genericR&DoperatingcapabilitiestoTeva.
Nowlet'sturntoslide7andtalkaboutthebusinessperformanceinthesecondquarter.Oursecondquarterrevenuemorethandoubledonayear-over-yearbasisto$5.7billionasaresultoftheacquisitionsofAllerganandForest.Onaproformabasissaleswereup12%excludingtheimpactofforeigncurrency,NamendaIRanddivestitures,withdouble-digitgrowthinourbrandandglobalgenericssegments.ThestrongsalesincreasefromsynergiesfromtheintegrationofAllerganandForestweretheprimarydriversofthe29%increaseinearningspershareto$4.41.
Meanwhile,non-GAAPEBITDAroseto$2.6billionandcashflowfromoperationswasabout$1.7billionexcludingone-timecashpaymentsforseverance,acquisitionsandintegration.Tessawilltalkmoreaboutthefinancialsshortly.
Onslide8,ourglobalgenericsbusinessisdoingverywellandtheunitsthatcompriseitarefiringonallcylindersasweprepareforthecombinationwithTeva.Genericsalesareup17%excludingtheimpactofforeigncurrency.Genericprofitabilityisup.AndourexceptionalgenericR&Dcapabilitiesareevidentwith12newfirst-to-filedrugsthisyear.ThisbringsthetotalnumberofANDAsunderreviewtoaapproximately220,with76confirmedfirsttofiles.
USgenericrevenueswere$1.1billioninthequarter,andcontinuetobenefitfromnewproductintroductionsandcontributionfromhigh-barrierandsemi-exclusiveproductslikegenericConcerta.Meanwhile,ourinternationalgenericsteamcontinuestodriveexcellentperformanceinkeymarkets,excludingtheimpactofforeigncurrencysuchastheUK,whichwasup85%includingtheeffectoftheAudenMckenzietransactionthatclosedinMay,andRussiawhichwasup32%.
Turningtoslide9,ourbrandbusinesscontinuestodriveimpressiveperformance,with12ofthetop15globalbrandsgrowing,manywithdouble-digitproformayear-over-yeargrowth.Salesincreased11%excludingNamendaIR,thedivestituresandtheimpactofforeignexchange.Andthesuccessisbroad-based.
Excludingtheimpactofcurrencywedrovedouble-digitgrowthineyecare,GI,keywomenhealthproductsandcardiovascular;double-digitgrowthfromourlatestlargestleadingbrandslikeBotox,Restasis,NamendaXR,andourfillers,includingJuvederm;double-digitgrowthfromwell-establishedbrandslikeBystolic,LoLoestrinandEstrace;anddouble-digitgrowthfromLinzess,Ozurdex,andotherlaunchbrands,whichputsusinexcellentpositiontopowergrowthwellintothefuture.Itisaterrificlineupofbrandswithlongexclusivityandisbackedbyagreatteamonthegroundandourleadingpipelinewithmultipleshotsoneachofoursevenprioritytherapeuticareas.
Turningtoslide10,wecontinuetodriveconversionofpatientstoNamendaXR,rightuptotheendoftheNamendaIRexclusivity,reachingabout53%beforegenericentry.WithcontinuedpromotionandthelaunchofNamzaricwebelievethepenetrationrategoesevenhighertowardsourtargetof60%to65%astheyearprogresses.Andwithonce-a-daydosing,formularyaccessateveryoneofthetopeightplansandafocusedsalesteamwe'vemaintainedrelativelystablevolumesonNamendaXR,evenastheNamendaIRprescriptionsdrop.
We'renowdoingtheblockingandtacklingtobuilddemandandaccessforNamzaric.Withfullpromotionjustgettingunderway,ourDTCcampaignbeginninginSeptember,andananticipated7outofthetop10planshavingcoveragebythebeginningof2016,wethinkwearewellpreparedtodrivemarketexpansionin2016.Giventhebroaduseofcombinationdonepezilandmemantinetherapy,theefficacyofNamzaric,andthepatient,caregiverandsystembenefitsofonepillonceaday,wethinkthere'sagreatopportunityfortheinnovationofNamzarictobecomethecornerstoneofonce-a-daybranded
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page4of21
marketinAlzheimer'streatment.
Turningtoslide11,inafewmomentsDavidNicholsonwillgiveanupdateonthepipelinebutIwanttopointoutthatourpipelineremainsoneofthebest-keptsecretsofourCompany.With70projectsinmidtolatedevelopmentweareinanenviablepositionofhavingmultipleprogramsineachofourtherapeuticareastohelpussustainleadershipintheareaswechoosetocompete.Andwe'vethispipelinestepbystep,notbyinvestingbigdollarsondiscoverybutbyinvestinginsmartdevelopmentprojects.
EvenwiththeexcellentbreadthanddepthofourcurrentpipelinewearealwaysonthelookoutforR&Dassetsthatcanextendourleadershipbybringingnovelapproachestoexistingtherapyareas.Inthelasttwomonthsalonewe'veannouncedagreementsforfourplannedacquisitionsinaesthetics,eyecare,andCNS.Eachwillbringnoveltytoexistingareasandwilladdtoourabilitytoleadinthesetherapeuticareas.Andeachofthesedealsbringsgame-changerpotentialideastoourpipeline.
Kybellaisofftoastrongstartinaesthetics,withsalesalreadysurpassing$1millionandarecentapprovalinCanada.We'remakinggreatprogresstowardsclosingthetransactionnowthatwehaveclearedantitrustreviewintheUS.Andasweannouncedyesterday,wenolongerintendtoissueoursharestocompletethisacquisition.
TheOculeveacquisitionhasalsoclearedHSRintheUSandwelookforwardtoextendingourdryeyeopportunitieswithournovelnasalneurostimulationdevice.InCNSweareworkingtoclosedealstoextendourmigraineofferingwithMerck'sfirst-in-classoralCGRPantagonist,andtheNaurexnovelapproachtotreatingmooddisorders,includingseveredepressionwhichremainsaleadingcauseofsuicide.
Inclosing,ourteamcontinuestofocusonexecution.AndtheresultsindicatethatweareexceptionallyskilledatdeliveringstrongoperatingresultswhilealsodoingsurprisingthingsthatmakeourCompanythemostdynamicinallofhealthcare.I'msoproudofourteamfortheirperformanceandI'mlookingforwardtowhatwecandowiththestrengthandfocusonbrandedpharmaceuticalsandasignificantlyreducedoperatingstructureandreloadedcapitalstructure.
WiththatI'llnowturnthecallovertoTessa.
T essaHilado (CFO):
Thankyou,Brent.Goodmorning,everyone.Turningtoouroverallresultsforthesecondquarteronslide13,inQ2wedeliveredstrongperformancebothyearoveryearandquartertoquarter.Onanon-GAAPbasis,consolidatednetrevenueforthesecondquarterwas$5.7billion,anincreaseof36%versusQ12015.
Non-GAAPR&Dinvestmentforthequarterwas$406millioncomparedto$185millionintheprior-yearperiod.Non-GAAPSG&Aasapercentageofrevenuewas21.7%,anincreaseof3percentagepointsovertheprior-yearquarterasaresultoftheForestbrandedproductsandAllerganbusiness,whichwehavehigherSG&Aspend.
AdjustedEBITDAforthequarterwas$2.6billion,anincreaseof203%versustheprioryear,drivenbystrongrevenuesandhighergrossmarginsacrossoursegments.Non-GAAPearningsperdilutedshareforthequarterincreased29%to$4.41comparedto$3.42perdilutedshareinthesecondquarterof2014.Ournon-GAAPtaxrateimprovedfrom17.1%intheyear-agoperiodto14.5%inthecurrent-yearquarter,mainlyduetothegeographicmixofourbusinesses.
Cashflowfromoperationsforthesecondquarterwas$1.4billion,anincreaseof198%versustheyear-
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page5of21
agoquarter.Excludingacquisition-relatedrestructuringandintegrationpayments,oursecondquarterfreecashflowwouldbe$1.7billion.
Beforeturningtoourbusinesssegmentresults,Iwouldliketotakeamomenttoreviewournewsegmentreportingforthesecondquarter.Inthisquarterwearereportingresultsinfivesegments.
TheUSbrandsegmentrepresentssalesandexpensesrelatedtobrandedproductswithintheUnitedStates,includingBotoxtherapeutics.TheUSmedicalaestheticssegmentrepresentssalesandexpensesrelatedtoaestheticsanddermatologyproductswithintheUnitedStates,includingBotoxcosmetics.TheinternationalbrandsegmentrepresentsrevenuesandoperatingexpensesincountriesthathavethemajorityoftheirbusinessesrepresentedbybrandedsalesandrevenuesandexpensesrelatedtoproductsalesinCanada,SwitzerlandandAustria.
Theglobalgenericssegmentrepresentsrevenueandoperatingexpensesincountriesthathavethemajorityofthepresentedbygenericproductsales,ourthird-partymedicinebusinessandrevenuesandexpensesrelatedtoproductsalesintheUS,Canada,SwitzerlandandAustria.TheANDAdistractionsegmentresultsrepresentsalesandexpensesrelatedtodistributionofgenericandbrandpharmaceuticalproductsmanufacturedbythirdparties.
Also,asaresultofTeva'sacquisitionofAllergan'sgenericbusiness,Allerganwillreportthegenericsbusinessasdiscontinuedoperationsbeginninginthethirdquarterof2015.Sincethedivestedbusinessspansbothglobalgenericsandinternationalbrandsegments,itwillbedifficulttodaytomodeltheremainingAllerganbusiness.WewillprovidesomeguidanceinSeptember.
TurningnowtoourUSbrandresultsonslide15,thebusinessdeliveredstrongperformanceyearoveryearandquarteroverquarter.USbrandsrevenuewas$2.44billionforthequarter,up331%versustheprior-yearperiodand35%inthepriorquarter,drivenbytheadditionoftheForestandAllerganbusinessesandstronggrowthacrosskeyproductsincludingLinzessandNamendaXR.
AdjustedgrossmarginwithinUSbrandsremainedsteadyat87.4%.SG&Aasapercentageofrevenueincreasedto20.8%versus17.8%intheyear-agoquarter,drivenbyexpensesrelatedtotheForestandAllerganacquisitions.
Turningtoslide16andourUSmedicalaestheticsbusiness,secondquarterrevenueswere$487million,anincreaseof510%versusfirst-quarter2015results.Secondquartergrossmarginof93%andsegmentmarginof70.6%werelargelyinlinewithexpectations.SG&Ainthequarterremainedsteady.
Turningtoslide17andourinternationalbrandresults,secondquarterrevenueswere$717millionversus$169millionintheprior-yearperiod,anincreaseof324%.Grossmarginsincreased21.7percentagepointsto77.8%inthesecondquarterduelargelytotheinclusionofhigher-marginlegacyAllerganproducts.SegmentSG&Aimproved7.2percentagepointsto32%versusQ12015duelargelytosynergycapturerelatedtotheAllerganacquisition.
Onslide18,globalgenericsrevenuesinthequarterwere$1.6billion,up10%versustheprior-yearperiod.GrowthwasdrivenbystrongsalesinthebasebusinessincludinggenericConcerta,offsetinpartbyadditionalcompetitiononcertainproductsincludinggenericLidoderm.Adjustedgrossmarginsincreased1percentagepointcomparedtotheyear-agoquarter,duetocontinuedstrongperformancewithinourinternationalbusiness.
LowergrossmarginversusthepriorquarterwasmainlyduetolowercontributionofGuanfacineERandOxycodoneinthesecondquarterversusthefirstquarterof2015.SG&Aasapercentageofadjustednetrevenuedecreasedslightlyto15%from15.8%intheyear-agoquarter.
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page6of21
TurningtoourANDAbusinessonslide19,revenuesincreasedto$462million,upfrom$427millionintheprior-year,anincreaseof8%drivenbytrendsinourbasebusinessandahighermixofchaindrugstoressales.Slide20detailsourdebtcapitalizationfollowingthecompletionofourfirstfullquarterfollowingthecloseoftheAllerganacquisition.Weendedthesecondquarter2015withtotaldebtofapproximately$42.9billion,andequityof$72.1billionrelatedtotheAllerganacquisitionandpreviousfinancing.
Inthesecondquarter,wepaiddownapproximately$1.4billionofourdebt.Currentlyourleverageratiostandsat3.9timesdebttoproformaadjustedEBITDA,versus4.1timesinthepriorquarter.Weremaincommittedtousingstrongfreecashflowsfromourbusinesssegmentstoacceleratedebtrepayment.Andwecontinuetoremaincommittedtoinvestmentgraderatings.
I'dnowliketoturnthecallovertoDavidNicholsonwhowillprovideanupdateonourbrand'sR&Dprogressinthequarter.David?
DavidNicholson (EVP,President-GlobalBrandsR&D):
Thanks,Tessa.Andgoodmorning,everyone.Let'sgotoslide22.Ourbrand'sR&Dteamcontinuestobetremendouslyproductive.Year-to-dateandworldwideourstronglate-stagepipelinehasdeliveredmorethan100pharmaceuticalandmedicaldeviceapprovalsand56regulatorysubmissions.Iwillhighlightsomeofthemostsignificantoftheseinmyoverview.
Followingthefirstroundofintegrationprioritization,wenowhavemorethan70mid-tolate-stagedevelopmentproducts,withapproximately45projectsineitherlate-stagedevelopmentorregistration.TheproductivityofthelegacyAllerganR&Dorganizationsisdemonstratedbytheindustry-leadingfigureof14NMEapprovalsintheUnitedStatesoverthelastsix-and-a-halfyears.Goingforward,we'llcontinuetomakedata-drivenprioritizationdecisionsonallofourprograms.
Inadditiontorationalizinganddrivingproductivityfromourexistingpipeline,wearecommittedtoidentifyingandexecutingacquisitionsandlicensingagreementsthatfurtherstrengthenourlong-termleadershippositioninkeytherapeuticareas.ThisisexemplifiedbyourpendingacquisitionofKythera,OculeveandNaurex,andourlicensingofMerck'soralCGRPprogramduringthequarter.
Thenexttwoslidessummarizesomehighlightsanddescribetheprogressinourlate-stagepipeline.Slide23showslate-stagegame-changingopportunitiesacrossourtherapeuticareas.Inaesthetics,we'readdingKybellafromKytheratoourpipeline.OuraestheticpipelinealreadyincludesBimatoprostorhairgrowth,AczoneandSarecyclineforacne,aswellasmanylineextensionstoourfillers.
Ineyecare,we'readdingtheintranasaldryeyedevicefromOculevetoourdryeyefranchise,furtherenhancingourleadingpositioninthistherapeuticarea.MycolleaguesandIhavereviewedourRestasisdataandagainfindourefficacyandtolerabilitydataverycompellingincomparisontorecentlypublisheddatafromothercompoundsindevelopmentandregistration.InPhaseIII,wearedevelopingDARPinandhaveasustainedreleaseformulationofBimatoprost.
InCNSweareaddingtheNaurexanNMDAmodulatortoourpipeline.Thesecompoundshavethefirstnovelmechanismtomooddisordersformorethantwodecades.
We'realsoaddingoralCGRPantagonists.Thesecompounds,inlicensefromMerck,aredesignedbothfortheacutetreatmentaswellasfortheprophylaxisofmigraines.WealsohaveCariprazinindevelopmentandNamzaricwhichcombinestwocomplementarytherapeuticagents,NamendaandAricept.
RecentlymuchattentionhasturnedtopreventionofAlzheimer'sand,likeallofusIhope,aneffectivepreventativetherapywillbediscovered.DataonNamzaricwasrecentlypresentedatthe2015Alzheimer'sAssociationInternationalconference.TheefficacyofNamzaricinpatientswithAlzheimer'sis
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page7of21
atleastasimilarmagnitudetothatreportedwiththepresentpreventativeagentsindevelopment.
InGIdisorders,togetherwithourpartnerIronwood,wecontinuetodevelopdosageandformulationsofourIBS-CagentLinzesstoofferaverycompletepackagetophysiciansandpatients.Also,we'recompletingtheinitialdevelopmentofeluxadoline,Viberzi,forIBS-D.Inurology,togetherwithourpartnerSerenity,wehaveintranasaldesmopressincompletingPhaseIIIfornocturia.
Inouranti-infectivefranchisewe'vecontinuedtodevelopDalvanceandAvycaz.InbiologicsPhaseIIIwillbecompletedthisyearforbevacizumab,abiosimilarofAvastinwhichispartofourpartnershipwithAmgen.Last,butcertainlynotleast,isBotox.Wecontinuetofurtherdevelopandlaunchthisagentacrossouraesthetics,CNSandurologyfranchises.
Turningtoslide24,I'mgoingtoupdateyouonprogresswithregulatoryauthoritiesforkeylate-stageproducts.Inaesthetics,NatrelleInspiratexturedbreastimplantsreceivedFDAapprovalforwomenundergoingbreastreconstruction,augmentationorrevisionsurgery.Andwe'reontrackforFDAsubmissionofourVolbellafillerinthethirdquarterof2015.Yesterday,wereceivedFDAapprovaltomarket28additionalstylesofNatrelle410breastimplants.
InAsia,we'vereceivedlicensingrightsforcommercialsaleofJuvederminChina,andsubmittedanNDAforBotoxforcrow'sfeetlinesinJapan.Ineyecare,BotoxreceivedapprovalinJapanforthetreatmentofstrabismus.We'reontrackforFDAsubmissionofamulti-dosepreservative-freeformulationofRestasisinSeptember.
We'recurrentlyenrollingpatientsinPhaseIIItrialsforBimataprostintheUS.Andwe'veinitiatedpivotalPhaseIIItrialsofourleadDARPininage-relatedmaculardegenerationontargetinJunethisyear.
InCNSwehaveaPDUFAdateinSeptemberforcariprazineasatreatmentforschizophreniaandbipolarmania.AndthisquarterwelaunchedNamzaricandwe'llbefilingadditionaldosecombinationsofthisagentlaterthisyear.
InGIourstrongpipelinedoescontinuetodevelopnewopportunities.WeexpecttocompletethePhaseIIIstudyforalow-dosageformofLinzesstotreatchronicidiopathicconstipationinthesecondhalfoftheyear.AndweexpecttosubmitansNDAforthisindicationnextyear.
Meanwhile,Viberzi(eluxadoline)hasbeenapprovedbytheFDAasatwice-dailyoraltreatmentforIBS-D.We'reawaitingDEAschedulingofViberzipriortolaunchofthisproductintheUnitedStates.AndwesubmittedadossierofeluxadolineinEuropeinMay.
Inwomen'shealth,enrollmentinourPhaseIIItrialofEsmyaforthetreatmentofbleedingdisorderscausedbyuterinefibroidsisontrack.We'recommittedtocompletingtrialenrollmentthisyear.
Inurology,we'vecompletedourPhaseIIItrialsofSER120innocturia.ThedataisunderourreviewpriortosubmissiontotheAgency.
Andanti-infectives,ourdevelopmentofasingle-doseformulationofDalvanceremainsontrack.We'vemaderegulatorysubmissionsforapprovalinboththeUnitedStatesandEurope.We'realsoanticipatingapprovalforTeflaroinbacteremiaduringthecourseofthisyear.
Onslide25,weoutlinesomeofourmostrecentbusinessdevelopmentopportunities.Obviouslythesehelpustofurthersolidifyourleadershippositioninourcoretherapeuticareas.
WithKythera,weaddafirst-in-classagentKybellaforthetreatmentofsubmentalfatordoublechintoourproductline.TheproductislaunchedintheStatesandwasrecentlyimprovedinCanada.Inaddition,Kytherahasaninterestingandgeneticallyvalidatedhairgrowthproductinearlydevelopment.
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page8of21
OculevewillstrengthenourleadingpositionindryeyewiththeOD-01developmentprogram,intranasalneuro-stimulatorydevicethatincreasestearproductioninpatientswithdryeye.
OurlicensingagreementwithMerckbuildsonourcommitmenttothedevelopmentoftreatmentsformigraine.We'readdingoralformulationsofCGRPantagoniststoourproductline.TheuseofbothsmallmoleculesaswellasantibodieshasclearlyshownthatCGRPantagonismiseffectiveintreatingmigraines.Therearefourinjectableantibodiesindevelopment,whilstwewillhavetheonlyoralCGRPantagonist.
Finally,Naurex--theacquisitionofNaurexaddsinnovativedevelopmentprogramsindepressiontoourpipeline.Depressionisanareaofmedicinethathasseenminimalprogressforthelast20years.
TheNaurexcompoundsareNMDAmodulators,auniqueapproachforthetreatmentofdepression.Theseagentshavethepotentialtobefastonsetantidepressantsandhencemaybebeneficialinthealleviationofsuicidality,whichissooftenaterriblefeatureofthisdisorder.Inearly-stagedevelopment,theNaurexteamshowedtheircompoundto,indeed,tobefastinonset,andalsotobeeffectiveintreatingdepression,whichfailedtorespondtotraditionalantidepressants.
Inclosing,thesecondquarter2015wasanotherperiodofcontinuedstrongproductivityfortheAllerganR&Dteam.Welookforwardtocontinuetodeliveronthepromiseofmanyofourdevelopmentprogramsinourpipelinefortheremainderof2015andbeyond.
Withthat,I'dliketoturnitovertoBrentforclosingremarks.Brent?
BrentSaunders (President,CEO):
Thankyou,David.Asyou'veheard,wehavealotgoingonandlookforwardtogivingyouupdatesonourprogressoverthenextfewmonths.InmidtolateSeptemberwewillprovideupdatedguidanceforourcontinuingoperationsfortheremainderof2015.ThiswillreflectourglobalgenericsbusinessasdiscontinuedoperationsaswewaitforthecloseofthetransactionwithTevanextyear.
Inconjunctionwithourthird-quarterearningsresults,wealsoplantohostanR&DupdatemeetingonNovember4,inIrvine,Californiaatourcampus.ItwillbeouropportunityfortheR&DteamtoshineaspotlightontheprioritizationR&Dportfolio.
WiththatI'dliketoturnthecallbacktoLisaforQ&A.
LisaDeFrancesco (VP-GlobalIR):
Thankyou,Brent.We'llnowtakequestions.Ifyoucouldpleaselimityourselftoonequestiononly.Wehaveonly30minutestogetthroughallofyourquestions.Thankyou.
QUESTIONS&ANSWERS
Operator :
(OperatorInstructions
ChrisSchott,JPMorgan.
ChrisSchott (Analyst-JPMorgan):
Oneofthequestionswe'vebeengettingposttheTevadivestitureis,asyouguysareconsideringtransformationalacquisitions,it'sobviouslyaveryfluidmarketoutthererightnow,isitpossibleforAllergantopursuealargetransactionbeforetheTevadealclosesiftherighttransactionwereavailable,
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page9of21
bothfromanoperationalandfinancialstandpoint?
Andjustaveryquicksecondone--onthatguidanceinSeptember,isthatjust2015orcanwethinkaboutapreliminaryviewoneither2016oranupdateonthe$252017outlookatthattime,aswell?Thankssomuch.
BrentSaunders (President,CEO):
WithrespecttopotentialfortransformationalM&A,IthinkthewaytothinkaboutitisthemostlikelyscenariowouldbeafterthecloseofTevaif,infact,weweretodotransformationalM&A.Certainlyanythingispossiblepriortothat.Andwehavealwaysbeenboldinthinkingabouthowtoexecutethingsifthetimingwasright.
ButIthink,infairness,giventhecommitmenttoourinvestmentgraderatingandourabilitytodeploycashafterthedealhasclosedversusprior,orperhapsourflexibilitytodeploycashafterthedealcloses,isbetterthanprior.Ithinkthat'sprobablyhowyoushouldthinkaboutit.
Now,thatdoesn'tmeanwecouldn'tengageinanalysisordiscussionsorotherthingslikethatwithsomeonewhowasinterestedindoingadealwithusorwewereinterestedindoingadealwiththem.ButIwouldsaythatit'smostlikelyafterthecloseoftheTevatransaction.WithrespecttotheguidancemaybeI'llaskTessatotalkaboutthatforasecond.
T essaHilado (CFO):
InSeptember,whatwewillbeprovidingyouiswhattheremainingbusinesswilllooklikesinceTevawillbediscontinuedoperation.That'snotexactlyaveryeasyseparationtodo.Andalsojusttomanageexpectations,soweprovidethat.Giventheaccountingrulesitwillbeverydifficultatthispointintimeforyoutomodelwhattheremaining2015willlooklike.
Asanexample,forinstance,debtwillcontinuetoremainwiththeAllerganbrandedbusinessandnotgotothecontinuedoperations.There'snosuchthingasnon-GAAPdiscontinuedoperations.So,we'llprovidealittlebitmoreclaritycomeSeptember,butit'sreallylargelyfocusedontheremainderof2015.
ChrisSchott (Analyst-JPMorgan):
Thankyou.
Operator :
JamiRubin,GoldmanSachs.
JamiRubin (Analyst-GoldmanSachs):
Justtofollowuponthatearlierquestion,BrentorTessa,whenyougiveproformaearningsgoingforward,whichpresumablyonlyincludesthebrandedbusiness,willthatbrandedbusinessalsoincludealltheinterestexpensethatyou'recarryingonyourbooks?Inotherwords,Iwouldassumethatsomeofthat$40.5billionisgoingtoreducedebt.So,howdowethinkaboutthatwhenwethinkaboutthebasebusinessgoingforward?
Andthen,secondly,justtofollowuponthat$25number,that$25obviouslyincludesabout$5or$2.4billioninEBITfromthegenericbusiness.Brent,atwhatpointcanweexpectyoutoupdateusonthatguidance?Ithinkonthelastcallyoudidn'twithdrawthat$25.So,again,anycoloronhowweshouldthinkabouttheCompany'sabilitytoreplacethat$2.4billioninEBIT?Thanks.
T essaHilado (CFO):
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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Youdefinitelytouchedonsomeofthenuancesrelatedtodiscontinuedoperationsasitpertainstodebtasanexample,forinstance.Onago-forwardbasisintheSeptemberearningswhatyouwillseeisthatdebtwillresideintheremainingCompanyandnotallocatedtodiscontinuedops.Obviouslyasyouthinkaboutthatonago-forwardbasis,itwouldreallylargelydependonwhatwedowiththecapitalonago-forwardbasis.
WhatwehadindicatedinourcallrelatedtoTevathatwewoulduseaportionoftheproceedstopaydowndebt.But,again,it'slargelydependentonhowmuchweuseforcapitaldeployment.Havingsaidthat,though,wearecommittedtoourinvestmentgraderatingsowewillensurethattheappropriateamountofdebtispaiddown.
BrentSaunders (President,CEO):
Ithinkthenet-net,Jami,onguidance--andIknowthiswilldriveyourteamsnutsandmanyonthephonenuts--therulesaretherules.It'stheaccountingpolicy.So,thenextcouplequarters,tilweactuallyclosethetransaction,itwillbeverydifficultforyouguystorunmodelsanddocleancomparisons.
Weare,asalways,committedtoasmuchtransparencyaroundproductsales,likewewereinthispressrelease.Andwewilldothebestwecangiventherulesthatwehavetoalllivewith.Butitwillmakeforsometoughmodelingworkonyourguys'partoverthenexttwoorthreequarters.Andweapologizeinadvanceforthatandwilldoeverythingwecantohelpfacilitatethat.
Withrespecttothe$25aspiration,whatIsaid,Ithinkyouaskedthisquestiononthedealcall,ifIrecallcorrectly,Jami,wasthatweabsolutelyremainsteadfastinouraspirationtoincreaseourearningspersharetoashighaspossible,includingthe$25target.Whathaschangedobviouslyis,bysellingthegenericsbusinessandthe$2.4billionofEBITDAtoTeva,thetimingofthataspiration.
Andsoweneedtocontinuetolookathowwewilldeploythatcapitalandhowthetimingofthedeploymentofthatcapitalwillpullthroughtogiveamorepreciseviewofit.So,again,wearenotwithdrawingthe$25butwewillcomebackandhavetoaddsomevariablestoit,likecapitaldeploymentandtimingofcapitaldeploymenttogetthere.
JamiRubin (Analyst-GoldmanSachs):
Thankyou.
Operator :
LiavAbraham,Citi.
LiavAbraham(Analyst-Citigroup):
Brent,anotherquestiononthetopicofbusinessdevelopment.Iwantedtogetabetterunderstandingofyourappetiteforearlier-stageresearch.Yousaidthatyou'reinterestedinapotentiallytransformationaltransactionandinterestedinmovingupthevaluechain.You'vealsosaidthatyou'renotnecessarilyinfavorofearly-stageresearch.
I'mtryingtoreconcilethesecomments.Canyouengageinalargerpharmatransactionandmoveupthevaluechainwithoutagreatercommitmenttoearly-stageresearchgoingforward?Andisn'tthisnecessarytoatleastacertainextenttosecurelonger-termorganicgrowth?
AndthenveryquicklyforBill,canyoucommentonhowmuchyou'llbegivingawayincrementallyintermsofrebatesinordertosecureformularystatusforNamzaricnextyear?Thanks.
BrentSaunders (President,CEO):
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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Sure,Liav.Ithinktheanswertothefirstpartofyourquestionisyes,withanexclamationpointonit.Look,Ithinkweloveresearchandwehavenoissuewithresearch.Wejustdon'tliketodoitourselvesunless,ofcourse,it'suniqueresearchorsomethingthatisn'twidelyavailableinexternalresearch,likeventure-backedcompaniesorresearchoracademia-backedcompaniesorsmallerbiotechs.
IthinkifyoulookatwhatDavidandhisteamdidwithAllergan,wekepttheresearchcapabilitieswheretheyhaduniquestrengthsandproventrackrecords,likeinaestheticsandeyecare.Andwewillcontinuetofundthat,asappropriate.Whatwewon'tdoiswasteourmoneyonR&Dthatiswidelyavailableelsewhere.
So,Ithinkyouhavetoreallyconsiderusasverypracticalwhenitcomestoresearch,basicresearch.Butalsoavirtual-likecompanywhenitcomestoresearch,asdemonstratedbysomeofthedealswejustdid,likeNaurexoreventhelicensingoftheoralCGRPsfromMerck.David,anyothercommentsonresearch?
DavidNicholson (EVP,President-GlobalBrandsR&D):
OneofthepointsthatIalwaysliketomakeishowimpressedIamwiththebiotechindustrythesedays.I'veseenthebiotechindustrytodayfoundedbysomanybrilliantacademicscientists,coupledwithmoreandmorepeoplewithpharmaceuticalexecutiveexperience,excellentingeneratingearly-stagemolecules,whichwecanpickupandfurtherdevelopthroughtothemarket.Thereareplentyofopportunitiesoutthere.
Also,whenyoulookatwhat'sgoingonintheacademicworldyouincreasinglyseeacademicinstitutionssettingthemselvesuptogeneratemorespinoffopportunities.Andweareverykeenoninteractingwiththeexternalworld.Wethinkthat'swhereresearchwillbeperformed.
BrentSaunders (President,CEO):
Tobefair,andyou'veheardmesaythisbefore,Liav,Idon'tthinkwhatwedoisanydifferentthanthegreatotherinnovatorsinourindustry,andreallynotdoingdiscoverythemselves,butlicensingincompounds.Andthere'ssomefantasticcompaniesthathavesolvedforhugeunmetmedicalneedwithoutdiscoverylabs.Iwantgothroughnamingthembuttheygetthebiotechmonikerbuttheyreallyhavenodiscovery,butrathersmartbusinessdevelopmentandlicensing.
Andthat'sessentiallyourapproach.Wejustcomeatitwithaverypracticalapproachandarealbentfornotwastingmoney.Bill,doyouwanttotalkaboutNamzaric?
BillMeury(President-GlobalGenerics,CommercialOperations):
OnNamzaric,workingwithAdamas,wegotaproducttomarketthattheAlzheimer'scommunityhaswantedforover10yearssincewelaunchedNamendain2004.Wethinkitshouldbethestandardofcareforpatientswithmoderatetoseveredisease.Andwe'reattheveryearlystagesoftheexclusivityperiod.Andsoourprimaryaimisgoingtobemarketshareandvolumeandgivingaccesstophysiciansandcaregivers.
Asitrelatestothediscountrate,it'sgoingtobeconsistentwithwhatwehadforXRin2015.AndforXRIthinkitwillbeconsistentin2016.Nodramaticchanges.Wemanagetheprice-volumerelationshiponthatbusinessverycarefullyandwe'reatapricepointthatisattractivetohealthplansandacceptabletous.
LiavAbraham(Analyst-Citigroup):
That'sgreat.Thankyou.
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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Operator :
SumantKulkarni,BankofAmerica.
SumantKulkarni(Analyst-BankofAmericaMerrillLynch):
OnyourdryeyeprogramsafterthepurchaseofOculeve,doyouseeanygapsinthetypesofproductofferingsthatyouhaveinthatportfolio?And,veryquickly,howshouldwethinkaboutyourcardiovascularfranchisegiventhatBystolicisstillarelativelysignificantcontributorintermsofsales?
BrentSaunders (President,CEO):
David,doyouwanttotalkaboutourdryeyepipeline?
DavidNicholson (EVP,President-GlobalBrandsR&D):
Sure.Indryeye,itisanunderservedmarketatthemoment.There'sRestasisoutthereandacoupleofotherthingsindevelopment,buttherearenotmanyproductofferingsfordryeye.Andarelativelylowproportionofpatientssufferingfromdryeyeactuallyreceivetreatmentatthemoment.AndIthinkwithRestasis,obviouslywehavetheleadingproduct.
Oculeveisaveryinterestingdevice.Iuseditmyselfrecently.Icanassureyouitworksandit'sreallyaddingtoourproductline.
Inadditiontotheanti-inflammatoryagentslikeRestasis,therearesomeotheropportunitiesinthebiotechpipelinewithdifferentmechanismsofaction.Ithinkinthefuturewearegoingtoseeotheropportunitiesoutthere,whicharegoingtobeeffectiveapproachesindryeye.
BrentSaunders (President,CEO):
Bill,anythingtoadd?
BillMeury(President-GlobalGenerics,CommercialOperations):
Yes,Iwouldjustsay,rightnowwehavethewaterfrontlargelycovered.WehaveanOTC,orartificialtear.OculeveessentiallyisanaturaltearoptionandthenRestasisisananti-inflammatory.So,weofferamorecompleteproductlinefortheeyecarecommunitythananycompanyinthesector.AndIagreewithDavidthatthereareafewopportunitiesouttherebutwehavemostofthemarketcovered.
BrentSaunders (President,CEO):
Ithinkalsopeopleunderestimatetheimportanceofthemulti-dosepreservative-free,whichweintendtofileinSeptember.Havingworkedinthisspacebefore,oneofthebiggestissueswithchroniceyedrops,particularlyRestasisbecauseofitssingle-doseapplicator,isdosageandcompliancebecauseit'sveryhardtogetthatlittlesingle-doseintheeye.
So,forpatientconvenienceandpatientcomplianceanddosing,themulti-doseapplicatorisahugeinnovationandsomethingthatwe'reveryexcitedaboutbringingtomarketnextyear.AndthenkeepinmindwealsohavefourotherdevelopmentprogramsofbothRestasisandnovelmechanismsearlierinourpipeline.
OnBystolicandcardio,IthinkthewayIthinkaboutit--andBillcancertainlychimein--isBystolic,whilecertainlyacardiodrug,ismanagedabitmorelikeaprimarycaredrug.About80%ofitsvolumecomesfromourprimarycarefieldforce.WedohaveapartnershipwithTrevenaforanearlier-stageproductsowe'renotcompletelywalkingawayfromcardiobutit'snotoneofourcorefocustherapeuticareas.Billor
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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David,anythingyou'dadd?
BillMeury(President-GlobalGenerics,CommercialOperations):
That'sexactlyright.TheexclusivityperiodonBystolicextendsoutformanyyears.It'sabigprimarycareproduct.We'regoingtoincreasedetailinginthesecondhalfoftheyear.Wehavegreatformularycoverageandit'sgotaterrificfollowingincardiologyandprimarycare.
BrentSaunders (President,CEO):
Ialwayshearanecdotal,butIhearfromdoctorsallthetimeaboutitbeingtheirfavoritebetablockertoprescribe,solongastheycangetitthroughmanagedcare.
SumantKulkarni(Analyst-BankofAmericaMerrillLynch):
Thankyou.
Operator :
MarcGoodman,UBS.
MarcGoodman (Analyst-UBS):
BrentormaybeBill,canyoutalkaboutsomeofthekeyproductsintheportfolioandjustthedynamicsinthequarter?Restasisseemedtobeverystronginthequarter,muchbiggerthanwhatwethought,breastaestheticsismuchweakerthanwethought,Botox.JustsomeofthekeyproductsandjustthedynamicsUSversusinternational,what'sgoingon.Thanks.
BrentSaunders (President,CEO):
MaybeI'llaskBilltotalkabouthisandthen,Philippe,maybeyoucouldchimeinonafewofthekeyaestheticproducts.
BillMeury(President-GlobalGenerics,CommercialOperations):
I'llstartwithBotoxtherapeutic.We'refocusedontwohigh-growthareaswhichismigraineandoveractivebladder.Ourprioritiesrightnowaretoincreaseinjectorproductivityandexpandourinjectoruserbase.Andwehavecompletefocusonthat.
Wethinkthetrendsinthesecondquarterlookterrific.AndIthinktheoutlookfortherestoftheyearisthesame.Idon'tseeanythingthatwoulddisruptthereliabilityofthatsalesstream.
AsitrelatestoRestasis,we'refocusedonalargeOTCartificialtearmarket.Therearemillionsofpatientsoverusingartificialtears.Wehaveanefforttoincreasethediagnosisratethroughin-officescreeningsfordryeye,whichhavebeenlinkedtoblurredvision,adversepost-opoutcomes.So,there'saneducationaleffortsthere.
Andthen,finally,welaunchedaprimarycareeffortforRestasis.Andtheformularycoverageonthedrugisrocksolid.AndthenI'djustprobablyaddLinzessinthere.Wehaveourfootonthegas.Theresponsetooursecondwaveofdirect-to-consumeradvertisingisexceedingindustrynorms.
Wejustlaunchedaneffortintolong-termcareforthefirsttimesinceLinzesswasapproved,andthat'sabout25%ofthemarket.OurrelationshipwithIronwoodisexcellent.Andwe'rewaitingtolaunchalow-doseversionofLinzess.
So,Ifeelverygoodaboutourtopproducts.AndasBrentmentionedinhisopeningremarks,12ofour15
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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productsareincreasing--ifyoulookattheUSbusiness,12ofthe15productsareincreasingatadouble-digitrate.Andwe'vehadvirtually,inmyopinion,nodisruptionduetotheintegrationinthistotalfocusoncustomers.
BrentSaunders (President,CEO):
Philippe,doyouhavesomethoughts?
PhilippeSchaison (President-AllerganMedical):
Sure.Onthefacialbusiness,grewby13.5%versustheprioryearforthequarter,andyeartodatewegrewby13%.VerystronggrowthalsoinBotoxwhichgrewby12.5%.AllthisgrowthismostlylinkedtoourstrongDTCcampaign.AndyoumighthaveseenourBotoxadandourVolumaad.AndonVolumayoucanseethatbrandawarenessincreasedby42%from27%inQ1.So,averystrongbusinessandlinkedtoverystrongadvertisingduringthesecondquarter.
MarcGoodman (Analyst-UBS):
Great.Thanks.
Operator :
RonnyGal,Bernstein.
RonnyGal(Analyst-SanfordC.Bernstein):
Justaquickhousekeepingone--wouldyoubeabletoprovideustheconstantcurrencygrowthratefortheaestheticproducts.Thisisthewaywetrack(inaudible).Andthen,second,regardingthe[ossical]installmentfranchise,InoticedthatyouwereexcludedinbothCVSandExpressformulariesstartingin2016.Howshouldwethinkaboutthisfranchise?Isthereanotherphasetothisfranchiseoristhissomethingthatgenerallyweshouldthinkaboutasflattodeclining?
BrentSaunders (President,CEO):
Tessa,doyouwanttotakethefirstquestion?
T essaHilado (CFO):
Onanoverallbasis,excurrency,wegrewabout11%.Thinkaboutitthisway.MostofouraestheticsproductsaremostlyUSproducts.Thereareproductssoldinternationallybutit'snotsignificantasitrelatestotheportfolio,soagoodamountofthemdoesnothaveanycurrencyimpactgiventhey'reUS-based.
BillMeury(President-GlobalGenerics,CommercialOperations):
Yes.Andasitrelatestothemesalamineproductline,asyouknow,Ronny,youwinsomeandyoulosesome.WegotabigwinwithLinzessonthatsameformularyattheexpenseofAMITIZA.Butasitrelatedtothemesalamineproductlinetheyexcludedit.
Weviewitasamaturebusiness.ItispromotedbehindLinzess.Wehaveacoregroupofusers.We'remanagingvolumeandofcoursetakingpriceincreaseswhenandwhereappropriate.Andthat'showIwouldthinkaboutit,asanestablishedbusiness.
RonnyGal(Analyst-SanfordC.Bernstein):
Okay.Thanks.
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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Operator :
ElliotWilbur,RaymondJames.
Elliot Wilbur (Analyst-RaymondJames):
Injustrunningthroughthesegmentdata,itlookslikethegenericbusinesscontributedabout23%ofthesegmentprofitability,inclusiveofR&Dallocation.Andgoingforwardwe'realltaskedwithtryingtofigureouthowmuchoftheproceedsfromthegenericbusinesswillbeappliedtoimmediatedebtreductionversuspotentiallyusinginternalcashflowgenerationtopaydowndebtandtargetexternalopportunities.Butisthattherightpercentagetothinkaboutandjustaballparknumberwhenthinkingaboutyourpriorindicationsthatthecombinedbusinesswouldgenerate,around$8billioninfreecashflow?Wouldthegenericbusinessaccountforroughly20%,25%ofthat?
BrentSaunders (President,CEO):
Tessacancertainlyaddhertwocents.Elliot,Ithinkit'snotthatsimple.Andthat'stheissueweweretryingtohighlightwiththeearliercommentsarounditbeingverytoughforyouguys.Andourapologiesinadvanceforthatforthenextcouplequartersbecausewhat'sinthatbusiness,aswereportittoday,isn'tnecessarilywhat'sbeingsoldtoTevadownastraightline.Also,asyoudoGAAPreportingandreportingarounddiscontinuedoperationswhatgetsassignedtowhatpartofeachbusinessisalsonotintuitiveandnotnecessarilystraightforwardtorealityeither.
So,it'sgoingtomakeforsomedifficultquartersahead.Again,wearecommittedtoasmuchtransparencyaswecanpossiblyprovidearoundproductsales,andperhapscashflowmaybeagoodwaytolookatthebusiness.Butit'snotasstraightforwardorasintuitiveasyouwouldhopeorwantittobe,justinfairness.Idon'tknow,Tessa--?
T essaHilado (CFO):
IfImayjustaddtothat,justtogivealittleofcontext.Youhavetorememberthatwewerereallymanagingthebusinessonaconsolidatedbasis.Weweren'tmanagingthebusinessseparatelyassolelyagenericbusinessandabrandedbusiness.Wedidn'thavetheholdingcompanyapproach.Weactuallyweremanagingthebusinessonaconsolidatedbasis.Andfromasegmentreportingbasiseventoday,ininternationalbrandsorgenericproductsandinglobalgenerics,there'salsobrandedproducts.
Theotherthingtonote,whichyoualsohighlightedisfromabalancesheetperspectiveit'sreallyallintermingledasitrelatestodebtandthetaxrate,someofthethingsthatarenotnecessarilyoperationallyrelated.So,Ijustwantedtogivecontextastowhyit'snotasdifficulttostripoutanddoapercentageofcashflowandsaythat'swhat'sattributabletogenerics.
Operator :
RandallStanicky,RBCCapital.
RandallStanicky(Analyst-RBCCapitalMarkets):
Brent,justaquestionforyou.AlotofpeoplehavebeenwatchingthelegacyAllerganproductswaitingforsomemoderation.Thathasn'thappened.Infact,theywerereallystrong.AndsothequestionthatIhaveis,justgiventhedifferenceinspendingsupportlevelsonsalesandmarketingbetweenlegacyAllerganandwhereyou'reattoday--andI'mjustlookingatslide15--numberone,doyoufeellikethatinfrastructureisright-sized?Andthen,secondly,justyourconfidencelevelonsomeofthekeyproductsandbeingabletocontinuetosustainthatgrowth?BotoxandRestasiswereverystrong.
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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BrentSaunders (President,CEO):
Randall,it'sagreatquestion.Ithinkwehaverationalizedoursalesforceforouracquisitionsandforthemarketasweseeitoverthenextfewyears.So,wedon'tanticipateanyadditionalcutsinthefield.And,infact,wewouldselectivelyaddifwethoughttheopportunitypaidback.
Asanexample,withtheacquisitionofKythera,wewillincreaseourfacialaestheticssalesforcebyroughly75positions,makingusthestrongestfieldforceinaestheticsbyalargemargin.So,Ithinkyou'llseeuscontinuetolookforwayssolongasweareincreasingourtightstrategyofproductflow,eitherthroughourR&Dengineorthroughlicensingandacquisition,ofbuildingandmakingsurewemaintainstrongleadershippositionscommerciallyineachofourtherapeuticareas.
WithrespecttospendingonDTCandotherwise,wealwayslookatthereturnoninvestment.TotheextentwethinkwecanaddmoremoneytoBotoxorRestasisorLinzess,orevenNamzaric,whichwillkickoffinthefallinDTC,we'realwaysmonitoringthesituation,lookingatbothresponseandreturnonthoseinvestments,andhavenoissuemakingthemsolongasweseeastrongROI.
RandallStanicky(Analyst-RBCCapitalMarkets):
TheotherthingthatweheardlegacyAllergantalkalotaboutwastheinternationalemergingmarketinAsiangeographiesasabigopportunity.Isthatsomethingthatweshouldstillthinkaboutforyouguysthatisinfrontofyou?
BrentSaunders (President,CEO):
Yes.It'saslowerbuildbutbigopportunityovertime.Lookattheapprovals,forexample,ofJuvederminChinathisquarter.ThatgivesusagreatopportunitytobuildonBotoxinthatmarket.
I'llbedowninBrazilnextweekwithourteamlookingathowwecanleverageourinfrastructureinLatinAmericaandgrow.ClearlythedivestitureoftheTevabusinesshassomedrawbacksinmidmarketslikeEasternEuropeandRussiainthatweweregoingtoleveragetheoldlegacyActavisinfrastructureinthosemarkets.ButIthinkwecancompensateforthoseandcontinuetogrowandbuildinemergingmarkets.
RandallStanicky(Analyst-RBCCapitalMarkets):
Great.Thanks,Brent.
Operator :
UmerRaffat,EvercoreISI.
UmerRaf f at (Analyst-EvercoreISI):
MaybethefirstoneforDavid.David,what'sthestatusontheDARPinJapanesetrialthat'songoing?Shouldwebeexpectinganupdatesoonandwhatwouldthatlooklike?
AndthensecondoneforBrent,ifImay.OntransformationalM&A,thequestionweallkeepgettingfrominvestors,howdoyouthinkaboutcompanieswithgrowthprofilesthatmightbelowerthanyour10%,orcompanieswithpotentialbiosimilarheadwinds,orevenex-UScompanies,forthatmatter?Ijustwanttounderstandhowyouthinkaboutthis.
BrentSaunders (President,CEO):
Sure.David,doyouwanttotakeDARPinandI'llcomebacktothetransformationalM&Aquestion?
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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DavidNicholson (EVP,President-GlobalBrandsR&D):
Sure.ForDARPininJapan,weactuallywantJapantojoininourglobalPhaseIIIprogram.InordertodothatweneededtocompleteasmallstudyinJapanandcompareittoanadditionalsmallstudyintheUnitedStates.We'reintheprocessoffinalizingthosestudiespriortoincludingJapanesesitesinthePhaseIIItrialssometimenextyear.So,yes,therewillbesomeupdatesonthatgoingforward.
BrentSaunders (President,CEO):
Toyoursecondpoint,Umer,aroundtransformationalM&Awithcompanieswithlowergrowthprofilesorthelike,Ithink,infairness,itwouldbeverydifficultforustodoatransformationaldealwithacompanywithahighergrowthratebecauseIthink,basedonatleasttoday'smeasure,theonlyonewithahighergrowthrateisCelgene.So,thatwouldreallylimittheuniverse.
Thatbeingsaid,Ithinkthattheissueforusiswewanttobeingrowthpharma.Wouldwebewillingtogofrom,let'ssay,roughly10%toa9%top-linegrowthratetodoahighlyaccretivebottom-linedeal?Theanswerisabsolutely.Wouldwebewillingtogofrom10%to3%or4%top-linegrowthtodoahighlyaccretivedeal?Iwouldsayhighlyunlikely.Wewanttogooutandmakesurethatwecanacquiresomethingthatwebelievehasagrowthorientationtoit,thathaslongerdurationassets.
AndIthinkyoushouldalsokeepinmindwe'repretty,asIusetheword,boldinourthinking.Ithinkalotofpeoplelookattheuniverseoftransformationaldealsandsay--well,youcan'ttouchthisbecauseit'sgotthisparticularproductdragorthisparticularissue.We'vebeenknowntobeverycreativeinsolvingforthosethingsinthepast.
Albeitaverysmalldeal,IwouldpointtoFuriexasjustanillustrationwheretheyhadtwoassets.TheyhadtheNDAforeluxadolineandtheyhadaroyaltystreamfromTakeda.WedivestedtheroyaltystreamtoTakedatoRoyaltyPharmaatthetimeweannouncedthedeal.Wehadthatpre-wired.So,wekeptwhatwewantedandwesoldsomethingthatwasvaluabletosomebodyelsetohelppayforthedeal.So,totheextentwelookatcompaniesoropportunitiesthathavethingswelike,andsomethingsperhapswedon'tlike,therearealwayspotentialsolutionsforsolvingforthoseissues.
Operator :
GreggGilbert,DeutscheBank.
GreggGilbert (Analyst-DeutscheBank):
Brent,ifanotherpartyweretoboldlyapproachyouasaninversiontarget,otherthandoingwhat'sbestforshareholders,whichIthinkyouhaveareputationofdoing,alongwithPaulandtheBoard,aretherecertainelementsofthemodelanditsspecialnessingrowthprofilethatyou'dbeconcernedaboutthatmightplayintoyourthinkingaboutlonger-termshareholdervaluecreation?Thanks.
BrentSaunders (President,CEO):
Gregg,Ithinkyou'reright.Itwouldhavetobeaboldoffer.Second,IthinkPaulandIalwayswoulddebateandtalktoourBoardaboutthebestlong-terminterestofourshareholders.
IthinkasyoustepbackandlookatwhatIthinkissospecialaboutthisCompany,alotofitgoestothedepthandqualityofourmanagementteam.Totheextentsomeonewouldbeopentothinkingaboutculturalchangeandchangeandbalancetoleadershipandtalentandmanagement,Ithinkthatwouldbemorehelpfulforus.
IthinkclearlyourcommitmenttoR&DandthewaywethinkaboutR&Disalsoveryspecial.And
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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Ithinkourabilitytobenimbleandmovequicklyanddowhatwebelieveisalwaysintheshareholders'bestinterestisalsoabitunique.Thosearethetypesofdiscussionsthatwewouldhave.It'snotlimitedtothat,butthatwouldbe,Ithink,atleasttopofmindfordebate.IseePaulshakinghisheadsoIknowhe'sinagreement.
GreggGilbert (Analyst-DeutscheBank):
Thanks,guys.
Operator :
DavidMaris,BMOCapital.
DavidMaris (Analyst-BMOCapitalMarkets):
OnNaurex,thislookstobeapotential$1billion-plusdrug.AndIknowwe'llcovermoreofitduringtheR&Dday.Butifmaybeyoucantalkalittlebitaboutwhat'sattractedyoutothis,howit'sdifferentiatedinthemarket,butalso,mostimportantly,whatarethenextstepstowardthepathtoapproval?
BrentSaunders (President,CEO):
I'llaskDavidtocomment.I'lljustgiveyoumyquicktakeofwhyIwassoexcitedtodothedealwithNaurex,isthatthisisanarea,ahugemarketwithhugewhitespaceforunmetneed.Youcandebatethenumbersbutveryfewpatients,infact,aminorityofpatients,areadequatelyservedbySSRIorSNRI.Andthentheyhavetolivewith,insomecases,verydifficultsideeffectsfromthosemedicines,aswellasthelongonsetofactionforthosewithacuteissuesthatneedtobedealtwithmorequickly.
AndIthink,David,youmentionedthisinyourearlierremarks,there'sbeennorealnovelbreakthroughindepressioninabout20years.So,forustobeabletobeattheforefrontofpotentiallyrevolutionizingthetreatmentofthisverylargeandhorrificdiseaseissomethingIthinkthat'sveryexcitingforusgivenourcommitmenttoleadinginCNSandinparticularpsychiatry.David,yourtwocents?
DavidNicholson (EVP,President-GlobalBrandsR&D):
I'veonlygottimefortwocentsapparently,soI'llhavetobequick.I'vebeenworkinginpsychiatryfor20years.I'vetakencompoundsthroughtothemarket.Billandhisteamhavecommercializedsomeofthebiggest-sellingantidepressants.So,Ithinktheteamthatwe'vegothereknowsdepressionandtheareaoverthelast20decades.
So,whenanopportunitylikeNaurexcomesalongwithanovelmechanismofaction--overthelasttwodecades,I'mbeingcorrectedbymycolleagues--justfeelslike20.(laughter)Sowhenanewopportunitycomesalongwithanewmechanismofaction,Ithinktheteamherecanrecognizeandseizeitprettyquickly.
Thesethingsareexciting--completelynovelmechanismofaction,showingafastonsetofactionindepression,andnotonlyindepressionbutindepressionwherethepatientsfailtorespondtoSSRIs.So,that'sanexcitingopportunity.AndthenextstepsforusaretogettingtoPhaseIIIasquicklyaspossiblewithGLYX-13,theleadmolecule,andtogetintoPhaseIIbwiththesecondcompound,NRX-1074.Weaimtodothatasearlyaspossiblenextyear.
BrentSaunders (President,CEO):
Certainlywe'dliketocloseadealbutthenwe'llmoveprettyaggressivelyintodoingthat.
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page19of21
DavidMaris (Analyst-BMOCapitalMarkets):
Great.Thankyouverymuch.
Operator :
DavidRisinger,MorganStanley.
DavidRisinger (Analyst-MorganStanley):
Ihaveacoupleofquestionshere.Thefirstis,withrespecttothegenericsbusinessthatyou'resellingtoTeva,thereweresomeslightdifferencesbetweenthepressreleaseandtheslides.Couldyoujusttelluswhattheorganicgrowthwasinthesecondquarterofthegenericsbusinessthatyou'reselling?AndthenIhaveafollow-up.
BrentSaunders (President,CEO):
David,ifIunderstandthequestion,IthinkthedifferencesarebetweenwhatwehaveandwhatTevahadontheirslidedeck.Anditwouldbeverydifficultforustocommentonthedifferencesbetweenwhatwehaveandwhatanothercompanyhas.
T essaHilado (CFO):
IfIrecall,we'veprovidedthegenericsbusinessEBITDAfor2015andtheyprovidedanumberfor2016.Thatwasthedifference.Andobviouslywecan'tcommentontheir--.
BrentSaunders (President,CEO):
And,justtobefair,it'stheirnumberfor2016notournumberfor2016,justtobeclear.
DavidRisinger (Analyst-MorganStanley):
I'msorry,ImeantthedifferencebetweenAllergan'spressreleasetodayandAllergan'sslidestoday.Thereweresomeslightdifferencesintherevenuereportedonyourslides.
T essaHilado (CFO):
Wecanaddressthat.
LisaDeFrancesco (VP-GlobalIR):
HiDavid,it'sLisa.Inthetopglobalbrandedproducthighlightsslide,theex-USbrandedproductsfromForest,WarnerChilcottandAptalisarenotcountedasgenericproducts.They'recountedinthebrandtotal.Whenyoulookatourglobalgenericssegment,ourglobalgenericssegmentstillcountsthose,asperaccountingrules,aspartoftheglobalgenericsbusiness.That'sthedifference.
DavidRisinger (Analyst-MorganStanley):
Andintermsoftheorganicgrowthofthegenericsbusiness,whatwasthatinthesecondquarter?
LisaDeFrancesco (VP-GlobalIR):
That'swhatwegaveyouasthe--well,theglobalgenericssegmentitselfgrew17%onaconstantcurrencybasisquarteroverquarter.
BrentSaunders (President,CEO):
CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
©2014TheStreet,Inc.Al l R ightsReserved Page20of21
That'snotaclean--that'sthepointIwastryingtomakeearlieraboutwhyit'ssodifficulttomodel.That'snotapplestoapplesofwhat'sbeingsoldandwhat'sstaying.Thereareputsandtakesfromthesegmentsversuswhatwasactuallybeingsold.Andthat'swhatmakesitsocomplicated.
DavidRisinger (Analyst-MorganStanley):
Gotit.Okay.Icanfollowuponthat.Andthen,separately,withrespecttotheNamendaswitchhere,obviouslyit'stakingyoulongerthanexpectedtogettoyourtargetof60%to65%,butyou'releavingthatunchanged.I'malittlebitsurprisedthatyou'releavingthatunchanged.Whenyoutalkabout60%to65%,isthatapercentageofthetotalprescriptionsincludingthegenerics,oristhatjustthebrandedAllerganfranchisethatyou'renowforecasting?
BrentSaunders (President,CEO):
ThatwouldbethetotalNamendabusinessincludingbrandsandgenerics.AndthewaywethinkaboutitiswelaunchedNamzariconlytwo-and-a-halfweeksago.ADTCcampaignstartsinSeptember.
WeexpectexceptionalformularycoveragebyJanuary1andtheincrementalsalesfromNamzaricbyessentiallytakingadvantageofanuntappedcombinationmarket,especiallyinmoderateAlzheimer'sdisease,effectivelyisgoingtogetustoourtargetconversionrate.AsIsaidearlier,iftheformularycoveragehadnotdevelopedlikeithas,wemighthaveadifferentsituationrighthere.Butasitrelatesto2016,Namzaricisgoingtobehighlyeconomical,XRalreadyis,andIthinkthemajorityofpatientsaregoingtohaveanopportunitytogetit.
DavidRisinger (Analyst-MorganStanley):
Okay.That'sveryhelpful.Thankyouverymuch.
LisaDeFrancesco (VP-GlobalIR):
Thanks,everybody.Brent,wouldyouliketomakesomeclosingremarks?
BrentSaunders (President,CEO):
Yes.Iwouldjustliketothankeveryoneforjoiningthecalltoday,and,inclosing,justsummarize.Ithinkwehadaverystrongandwell-executedquarter.
Ithinkourplansareinmotiontocontinuetofocusonoperationalexcellenceanddrivingourgrowthagendaandourfocusonourkeytherapeuticcategories,andestablishinglong-durationleadershipinthosecategories.Ithinkourleadingpipeline,ourreloadedcapitalstructure,andournowfocusonbrandedpharmaceuticalsandwillingnesstotakeboldanddecisiveactionsmakeusthemostdynamiccompanyingrowthpharma.IthankyouforyourtimeandlookforwardtoupdatingyoulateragaininSeptember.
LisaDeFrancesco (VP-GlobalIR):
Thanks,everyone.Iknowwedidn'tgettoquiteafewpeopleintheQ&A,sowe'llfollow-upwithyoushortly.Thanks.
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CompanyName:AllerganPLCCompanyTicker:ACTSector:HealthCareIndustry:Drugs
EventDescription:Q22015EarningsCallMarketCapasofEventDate:117.33BPriceasofEventDate:339.5
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