CompanyName:TevaPharmaceut icalIndustriesLtdCompanyTicker:TEVASector:HealthCare
Industry:DrugsEventDescription:Q4 2014 EarningsCall
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TevaPharmaceuticalIndustries(TEVA)EarningsReport:Q42014ConferenceCallTranscriptThefollowingTevaPharmaceuticalIndustriesconferencecalltookplaceonFebruary5,2015,08:00AMET.Thisisatranscriptofthatearningscall:
CompanyPart icipants
KevinMannix;TevaPharmaceuticalIndustries;VP&HeadofGlobalIRErezVigodman;TevaPharmaceuticalIndustries;CEOEyalDesheh;TevaPharmaceuticalIndustries;CFOMichaelHayden;TevaPharmaceuticalIndustries;HeadofR&D&ChiefScientificOfficerRobKoremans;TevaPharmaceuticalIndustriesLtd;GobalSpecialtyMedicines
OtherPart icipants
ShibaniMalhotra;Sterne,Agee&Leach;AnalystAndrewFinkelstein;SusquehannaFinancialGroup;AnalystSiggiOlafsson;TevaPharmaceuticalIndustries;GlobalGenericMedicinesLiavAbraham;Citigroup;AnalystCarloDeNotaristefani;TevaPharmaceuticalIndustries;GlobalOperationsSumantKulkami;BofAMerrillLynch;AnalystDavidMaris;BMOCapitalMarkets;AnalystGreggGilbert;DeutscheBank;AnalystLouiseChen;GuggenheimSecurities;AnalystManojGarg;Healthco;AnalystKenCacciatore;CowenandCompany;AnalystChrisSchott;JPMorgan;AnalystRonnyGal;SanfordC.Bernstein&Company;AnalystRandallStanicky;RBCCapitalMarkets;AnalystUmerRaffat;EvercoreISI;AnalystMarcGoodman;UBS;AnalystDavidSteinberg;Jefferies;AnalystJasonGerberry;LeerinkPartners;AnalystTimChiang;CRTCapitalGroup;Analyst
MANAGEMENTDISCUSSIONSECTION
Operator:
Ladiesandgentlemen,thankyouforstandingbyandwelcometotheSeniorVicePresident'sInvestorRelationscall.(OperatorInstructions).Imustadviseyouthatthecallisbeingrecordedtoday,Thursday,the5thofFebruary,2015.
Inowshallnowhandovertoyourfirstspeakertoday,KevinMannix.Pleasegoahead,sir.
KevinMannix(VP&HeadofGlobalIR):
Thankyou,operator.Goodmorningandgoodafternoon,everyone.ThankyouforjoiningustodaytodiscussTeva'sfourthquarterandfull-year2014financialresults.OnthecallwithmetodayareErezVigodman,Chief
CompanyName:TevaPharmaceut icalIndustriesLtdCompanyTicker:TEVASector:HealthCare
Industry:DrugsEventDescription:Q4 2014 EarningsCall
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ExecutiveOfficer;EyalDesheh,ChiefFinancialOfficer;SiggiOlafsson,GlobalGenericMedicines;Dr.RobKoremans,GlobalSpecialtyMedicines;Dr.MichaelHayden,HeadofR&DChiefScientificOfficer;Dr.CarloDeNotaristefani,GlobalOperations;andDavidStark,GeneralCounselforGlobalMarkets.
WewillstartthecallwithErezandEyal,whowillpresentforapproximately20minutesbeforeopeningthecallupforquestionsandanswers.Acopyoftheslides,aswellasthismorning'searningspressrelease,canbefoundonourwebsite,tevapharm.com,undertheInvestorRelationssection.
Duringthiscallwewillbemakingforward-lookingstatements,whicharepredictions,projectionsorotherstatementsaboutfutureevents.Thesestatementsarebasedoncurrentexpectationsandassumptionsthataresubjecttorisksanduncertainties.Actualresultscouldmateriallydifferbecauseoffactorsdiscussedintoday'searningspressreleaseandthecommentsmadeduringthisconferencecall,andintheriskfactorssectionofourForm20-F,Form6-KandotherreportsandfilingswiththeSecuritiesandExchangeCommission.
Discussionsduringthecallwillalsoincludecertainfinancialmeasuresthatwerenotpreparedinaccordancewithgenerallyacceptedaccountingprinciples.Reconciliationofthosenon-GAAPfinancialmeasures,tothemostdirectlycomparableGAAPfinancialmeasures,canbefoundinthismorning'spressreleaseandtheback-upsectionofthesidepresentation.Withthat,IwillnowturnthecallovertoourCEO,ErezVigodman.
Erez Vigodman(CEO):
Thankyou,Kevin.Goodmorningandgoodafternoon.In2014weembarkedonajourneytotransformTeva,solidifyingthefoundationfirst,unlockingsignificantvaluefromourexistingbusiness.Then,re-energizingourbusinessaroundcorecapabilities,calculatinggrowthenginesandestablishingastableunderlyingbasefromwhichwecouldgroworganicallyandinorganicallyinthecomingyears.
In2014wedelivered$600millioninnetcostreductions.Wesignificantlyimprovedcashflowfromoperations,from$3.2billionto$5.1billionandfreecashflowfrom$2.3billionto$4.3billion.Substantiallyelevatedqualityandgeneratedsignificantachievements.Andweareontracktodevelopthemostcompetitiveoperationalnetworkintermsofqualitystandards,scale,capabilityandefficiency.
Inourgenericbusiness,weimprovedoperatingprofitbeforeG&Aby510basispoints,from16.8%in2013to21.9%in2014.Welaunched19productsintheUS,29inEurope,87intherestoftheworld,delivering$1billioninrevenuesin2014.
Inourspecialtybusiness,Copaxone40mghasgained19.6%marketshareoftheMSspace.Anditaccountstodayfor63%ofourtotalfranchise,holdingstrongversusoralcompetition.
Welaunchedsuccessfullyfournewproductswithnetrevenuesof$200million.Wenarrowedourtherapeuticareasfocusonthosewehaveestablishedstrengthinandarepositionedtoclaimformarketleadership.
Andmostimportantly,wedeliveredonallourpromisesandrewardedourshareholders.Wecreatedaplatformtosupportcontinuedmarginimprovement.$5EPSfloorandgrowrevenuesandearningsorganicallyfrom2017onward.
Wedeliveredonthehighendofourguidance,achievingorexceedingallkeymetricsofour2014financialguidance,despitesignificantFXheadwindsandhighersharecount.Wereturned$1.65billionofcashtoshareholders,includingestimatedQ4dividendpayments.Wegeneratedtotalshareholderreturnsof47%in2014.
TodaywearestronglycommittedtodrivefurtherthetransformationofTevain2015andtheseareourkeyprioritiesforthisyear,generating$500millioninnetcostreductions;continuesolidifyingthegenerics
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Industry:DrugsEventDescription:Q4 2014 EarningsCall
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business,improveitsprofitabilitybyadditional400basispointsanddriveorganicgrowth;continueenhancingthecompetitivenessofouroperationalnetworkandelevatingfurtherthequalitybar;furthermaintaintheCopaxonefranchiseandmanagethelifecycleofkeyspecialtyproducts;deliveronthepromiseinourspecialtypipeline;strongfocusonbusinessdevelopmentand;continuethetransformationoftheCompanytocreateitsnewfuture.
2015isanimportantyearforourspecialtyfranchise.Wetargetfourapprovals:extendedreleaseofabuse-deterrenthydrocodoneintheUS;ProAirMDPIforasthmaintheUS;Copaxone40mgthreetimesaweekinEuropeand;SeasoniqueforcontraceptioninEurope.
We'llwitnessfourkeyclinicalmilestonesthatcandemonstratethepotentialinourspecialtyproductspipeline.SubmissionofReslizumabforasthma;alsoextendedreleaseofabuse-deterrenthydrocodonethatmightpossessatechnologyvalidationplatformforus;LBR-101forchronicandepisodicmigraine,phaseIIclinicalresultsbytheendofQ1,2015;thePridopidineinHuntington'sDisease,phaseII,IIIclinicalresults.
Andweplansevenlaunchesthatshouldgenerateforus$400millionofnetrevenues:QNASLPediatric;ProAirMDPIforasthma;Zecuity;extended-releasehydrocodoneintheUS;Copaxone40mg;DuoRespSpiromaxandLonquexintheEUandotherinternationalmarkets.
Ourtransformationisnotconfinedtojustprolongingthepast.Overtime,Tevawilladjustitsbusinessmodelinordertoclaimforauniquespaceintheindustry,developinganewdifferentiatednarrative.Westartedtoevolveourbusinessmodelin2014andwewillacceleratethepaceofthetransformationduring2015.
In2015wewillalsoshifttheorientationtowardsinorganicmovesthatsupportourbusinessmodelevolution,focusingoncomplexhard-to-producegenerics,growthmarkets,in-marketorclose-to-marketspecialtyassetsincoreTAs,attractivespecialtypipelineassetsorportfoliosincoreTAs.Andwemightalsolookatuniquehealthsolutiontechnologiesandservices.IwouldlikenowtohandovertoEyalDesheh.
EyalDesheh(CFO):
Thankyouverymuch,Erez.Goodmorningandgoodafternoon,everyone.Iamhappytoprovidethedetailsonthebusinessandfinancialresultsforthefourthquarterof2014,aswellasthefullyear.Asalways,wearepresentingmostofourresultsonanon-GAAPbasis,whileourGAAPresultsappearinourquarterlypressrelease,aswellasinthe20-SFormwhichwillbefilednextweek.
So,let'sbeginwiththeQ4review.Asyoucanseefromthesehighlights,ourrevenuedecreasedby5%duetotheimpactofforeignexchangeandduetothedivestmentofourUSOTCplants.However,operatingincomeincreasedby10%andnearly400basispointsyearoveryear.Also,positiveforthequarterandtheyearwasourstrongcashflowgeneration,morethandoublewhatwesawinQ4lastyear.
Foreignexchangefluctuationhadanegativeimpactof$227milliononourrevenuesand$55milliononoperatingincome.MostoftheimpactonoperatingprofitsresultedfromthedevaluationoftheRussianrubleagainstthedollar.
AsyoucanseefromthedetailsP&L,mostgrowthandoperatingmarginsshowedsubstantialimprovementfromlastyear.Totalexpenseswere$400millionlowerthaninQ42013,duetothestrongfocusoncostreductionandefficiency.Cashflowcontinuestoimprove,creatingadditionalfinancialresourcesof$1.75billionincashflowfromoperations,andover$1.5billioninfreecashflowdeliveredthisquarteralone.
Let'slookatthebreakdownofrevenuesbybusinesssegments.Thiswasverysimilartothepercentageswesawlastyear.However,ourgeographicalbreakdownshowsincreaseinUSsales,reflectingmostlytheforeignexchangeimpactonex-USsales.
Whilerevenueswereflatyearoveryearinrealterms,whencomparedtoQ42013,theresultsthisquarterdo
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notincludesalesofthedivestedOTCplantattheendofJune.Whilehavingnoplanonprofit,thisplantgeneratedannualsalesofapproximately$250million,whicharenolongerincludedinourresults.Youcanalsoseetheimprovementinsalesofspecialtyproducts,OTCandotherproductsallgoingupforthequarter.
Whenwelookattheprofitdistribution,weseetheimprovementinthegenericprofitandalowerdependencyonCopaxoneprofit,whichwearedeveloping.Wewillseethesameimpactsfortheentireyear.
So,nowlet'smovetotheannualnumbers.Saleswereflat,yearoveryear,butouroperatingincomeincreasedsignificantly,resultingfromtheimprovementinourgenericbusinessandthefocusoncostreduction.
Year-over-yearforeignexchangefluctuationhadasignificantnegativeimpactofalmost$350milliononrevenues,duetoourbalancedbusinessmodelwhichcreatessubstantialnaturalhedge.Thehittothebottomlinewassignificantlyless,reducingoperatingincomebymorethan$120million,comingmostlyfromtheimpactoftheRussianruble.
Lookingbackatourguidanceweprovidedfor2014,resultsweremostlyatthehighendofourrangeorbetter.OurfullP&Lreflectsimprovedmargin.Totalexpenseswereapproximately$600millionlessthanspentin2013.Andthisyearwealsoproducedover$5billionofcashflowfromoperations.
Thepercentageofrevenuesbybusinesssegmentweresimilartolastyear,verysimilardistribution.Andtheirgeographicalsplitwasalsoveryidenticaltowhatwehaveseenlastyear.
Asyoucanseehereinourannualrevenuebridge,revenuegrewnicelyinallourbusinessactivities.But,thisgrowthwasoffsetbythedevaluationofmostglobalcurrenciesversustheUSdollar;endedupinasimilarplace,2%increaseinrealterms.
Themostnotablecontributionwasgeneratedbyourgenericbusiness,improvingprofitabilitybymorethan500basispoints.Thecontributionofourgenericbusinesstothegrowthofotheroperatingprofitwasnearly$500million,increaseditsshareofthetotalto31%.
Now,letuslookatthecontributionofthedifferentpartstotheEPSimprovements.Whilethegrowthinoperatingprofitcontributed$0.78toincreaseinearningspershare,highertaxes,asanticipated,foreignexchangeandahighernumberofsharesdrivenbyover43%increaseinshareprice,hadtheoppositeimpact.
Let'stalkaboutforeigncurrencyimpactwhenwelookatthebusinessoutlookfor2015.Firstofall,wearereaffirmingourbusinessoutlookfor2015,despitethecurrencyvolatility.Wehaveabalancedbusinessmodel,whichcreatessubstantialnaturalhedge.TheonlyoutlieristheRussianruble,whichcausedmostofthenegativeFXimpactonprofitsin2014.
Iwouldalsoliketodiscussthequarterlyprogressionofourearningspershare.In2015,weseeasimilartrendofthedevelopmentinthequarterstotheonewesawin2014.Thismeansthatearningspershareforthefirsthalfwillbearound48%ofthetotal,andthesecondhalfwillbeabithigher,about52%ofthetotal.
Lookingatourfinancialresources,thefinancialperformanceof2014enabledustoreducedebtby$2billion,improveleverageto31%andreducedebt-to-EBITDAfrom2.16to1.67,asubstantialimprovementinallourcreditmetrics.Andlast,ourdividend.Weareincreasingquarterlydividendby10%,toILS1.33pershare.StartingQ12015,ourdividendwillbedeclaredandpaidinUSdollars.ThankyouallverymuchandIwouldlikenowtoopenthecallforquestions.
QUESTIONS&ANSWERS
Operator:
CompanyName:TevaPharmaceut icalIndustriesLtdCompanyTicker:TEVASector:HealthCare
Industry:DrugsEventDescription:Q4 2014 EarningsCall
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(OperatorInstructions)YourfirstquestioncomesfromthelineofShibaniMalhotrafromSterne,Agee.
ShibaniMalhotra (Analyst-Sterne,Agee&Leach):
Hi,thanksfortakingthequestion.Iguessabiggerpicturequestionforyouguys.ObviouslywesawabigtakeoutthismorningofHospira.It'ssomethingweassumedthatTevamightbelookingataswell,givenyourfocusoninjectables,oryourdesiretogetintoinjectables.Butyoualsomentionedmanytimesyouarelookingatspecialtypharma.Givenwhatishappeninginoursectorandithasbeengoingonforawhilenow,howshouldwebethinkingoftheactionsthatTevaislookingatoverthenextyearorso?Thankyou.
Erez Vigodman(CEO):
Hi,Shibani.First,wearenotlookingatHospira.Second,IwasveryclearwithalltheprioritiesthatpertaintopotentialBDmovesduring2015.
Wewillbelookingatgrowthmarkets.We'llbelookingatcomplexgenericsandhowtoproduceourproducts.Iwillbelookingatin-marketspecialtyproducts.Andwemightalsolookatattractivepipelineproductsorportfolios.Basicallythatistheagendaforusin2015.In2015wearere-routingthedirectiontowardbasicallyinorganicmovesinawaythatwillbecomingintoplayduringtheyear.
ShibaniMalhotra (Analyst-Sterne,Agee&Leach):
CanIjustfollow-uponthat?Intermsofthespecialtypharmaceuticals,areyoulookingtostayintheCNSspaceforleveragewithyourCopaxonefranchise?Orarewillingtolookbroaderatotherareasaswell?
Erez Vigodman(CEO):
ThefocushereisoncoreTAs,whichmeansCNS,pain,respiratory.
ShibaniMalhotra (Analyst-Sterne,Agee&Leach):
Okay,great.Thankyou.
Operator:
ThenextquestiontodaycomesfromthelineofAndrewFinkelsteinfromSusquehanna.
AndrewFinkelstein(Analyst-SusquehannaFinancialGroup):
Thanksverymuch.Youspokeabout,inthereleasethismorning,abouttakingboldstepsinorganically.CanyoucharacterizewhatkindsofrisksTEVAfeelsmostcomfortabletakingintermsofmovesyoumightmake?Iwouldsuspectthereareafewsituationsthesedaysthatarenoteitherexplicitlyoreffectivelyinauction.Isitawillingnesstoleveragepotentialsynergies,intermsofthevaluationsyou'rewillingtooffer,intermsoftheoperationalrisksofassetsthatyoumightbewillingtoassume?OrbeingboldintermsofgoingintonewareasfortheCompany?Maybeifyoucouldcharacterizehowyouthinkofboldactionsinorganically?
Erez Vigodman(CEO):
Basicallyitgoestowhereverwewanttobein2019.Tevain2019willbeaCompanythatisdrivenbypatientneeds,wherepatientinterventionwillbeequallyimportanttochemicalintervention.
Onthedrivefront,we'llputfocusoncomplexgenerics,howtoproduceproductsinthosepartandspace.Inthespecialtywe'llbasicallyhavenarrowedthefocusonareaswehaveestablishedstrengthandwearepositionedtoclaimforgloballeadership.
Alsowelookattheintersectionbetweengenericsandspecialtyinawaythatinvolvesuniquecombinations
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thatfitsstronglythecapabilitiesofTeva.Wewillalsodevelopovertimethemostcompetitiveoperationalnetworkintheindustryandwillincreaseourpresenceinemergingmarkets.
Nowalltheinitiativewillbederivedfrombasicallythefutureend-gamethewayI'vejustsharedwithyou.Whichmeanscomplexgenerics,whichmeanshowtoproduceproducts,whichmeansgoldmarkets,whichmeansboldmoves,potentiallyboldmoves,inthespecialtyspace,butwithstrongfocusoncoreTAs.
AndrewFinkelstein(Analyst-SusquehannaFinancialGroup):
Okay,thankyou.ThenifIcouldaskonespecificquestion.YougotanapprovalongenericNexiumintheUS.Isthereanycoloryoucanshareonthetimingofapotentiallaunch?AndwhattheopportunitymightberelativetowhatyouhadassumedinDecember?Thanks.
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
Hey,Andrew,it'sSiggihere.WegottheapprovalforgenericNexiumasyoumentioned.WewillbelaunchinginFebruary,verysooninFebruary.
Weseethemarketedsellthatisprobablyjustunder$2billionasatotalbrandvalueofthemarket.Wereallydon'tknowhowbigtheopportunitywillbe.ThereisquiteafewapplicationspendingattheFDA.Ofthose,quiteafewarealsoona30-monthstay.
Weincludeditinourguidance,butwerisk-adjusteditintheguidance,Ithinkappropriately,becausewedon'tknowwhatthefuturebrings.Forus,thisisexcitingopportunity.WeareexcitingtolaunchthisinFebruary.Wearereadytogosoon.
Thereasonwhywehaven'tgonealreadytothemarketissimple.Thebrandchangedthelabeljustbeforethegenericapproval,sowehadtorelabeltheproduct.Butwewillbecomingoutverysoon.
AndrewFinkelstein(Analyst-SusquehannaFinancialGroup):
That'shelpful,thanks.
Operator:
ThenextquestiontodayisfromLiavAbrahamfromCiti.
LiavAbraham(Analyst-Citigroup):
Goodmorning.Anotherquestiononthebiosimilarspacefollowingtoday'sannouncementofPfizeracquiringHospira.Iwouldbeinterestedinyourthoughtsonthespace,yourpresenceinthespaceandthesecondwaveofbiosimilarsgoingforward,giventhattoday'sacquisitionseemstolendcredencetobiosimilarsasalong-termvaluedriver.ThenIhaveafollow-upquestion.Thanks.
MichaelHayden(HeadofR&D&ChiefScientificOfficer):
Letmetakethat.IthinkfirstofallthisisaconsultationIthinkinthebiosimilarspace.PfizerwaslookingatitandHospirawasdoingthattoo.Ithinkthatspeakshighlytothatspace.
AlsoIthinkagoodindicationtothatspacewastheadvisorycommitteethatallofyousawrecentlyaroundtheSandozsubmissionintheUS.Wementionedthatpreviously.WementionedthatinourDecembermeeting,thatwehaveafewproductsinwavetwo.Wewouldlovetohavemore.Weareexploringtheopportunities.
IthinkTevahasextremelygoodcapabilitiesintermsofdevelopmentandcommercialization.Wearequitestronginwaveone,estimatedthisyeartobebetween$200millionand$300millioninrevenuethisyearfromwaveone.
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WelaunchedGranixintheUS,eventhoughit'snotabiosimilarproduct.Ithinkithasbeenanextremelysuccessfullaunch,aclosecooperationbetweenspecialtyandgenerics.SoIthinkwehavetheinfrastructuretodothiswell.Butatthispointintimeweneed,inaway,alittlebitbiggerpipelineinwavetwotobearealplayerinthe22%2021timeframe.
LiavAbraham(Analyst-Citigroup):
Asafollow-uptothat,canyoutalkabouttheinvestmentsthatyouaremakinginbiologicsmanufacturing,areasyou'vespokenabout.ThisisanareawhereTevapotentiallyneedstoimprove.Canyoutalkaboutwhatyou'redoingtoaddressthat?
Erez Vigodman(CEO):
Well,maybeCarlocanstartandIwilltakethenover.Carlo,please.
Carlo DeNotaristefani(GlobalOperations-TevaPharmaceuticalIndustries):
Yes,thanksforthequestion,Liav.Wecurrentlyhavecapabilitiesandcapacitybothinmammalianandmicrobialmanufacturingatsmallscale.Weneedtoexpandthatandwearecurrentlyassessingthebestlocationtodothis.Itisreallyaboutexpandingthecapacity,becausewecurrentlydohavecapabilitiesforallthekeytechnologieswithinthespaceofbiologicsmanufacturing.
Erez Vigodman(CEO):
Liav,wefeelfairlystrongonanumberofkeyfronts,[RA],IP,clinicaldrugcapabilities,R&Dcapabilities.Wehavethescale.Wearedevelopingbasically,westarttodevelopaplanfortheestablishmentofbiologicsproductionfacility,asignificantone.Thatisonegapwehave.Andwe'llovertimealsocraftaplantodealwithwhatwecallthego-to-marketcapability.Wemightthenpursueapartnertoacceleratethepaceoftheexecution.
LiavAbraham(Analyst-Citigroup):
Thankyou.
Operator:
ThenextquestiontodayisfromthelineofSumantKulkamifromBankofAmerica.
Sumant Kulkami(Analyst-BofAMerrillLynch):
Goodmorning,thanksfortakingmyquestions.Thefirstoneis,we'veseenTevatakesomeboldstepsinsometherapeuticareas,drainandpricing.Howdoyouthinkthat'sgoingtoevolveintheMultipleSclerosisspaceifandwhenaonce-dailygenericCopaxonecomesin?AndhowisTevapositionedtotakeadvantageinthat?
Andmyfollow-upis,youmentionedcomplexgenerics.Thatisacatch-alltermandcanmeandifferentthingstodifferentpeople.SoifyoucouldgivesomemorespecificsonwhatTevadefinesasacomplexgeneric,thatwouldbehelpful.Thanks.
Erez Vigodman(CEO):
Okay,somaybe,Rob,youstart?
RobKoremans (GobalSpecialtyMedicines):
Pleasure.Thanksforthequestion,Sumant.Obviouslyrightfully,youknowtodaythereisanincreased
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pressureinthepayorenvironmentwithourCopaxone,boththreetimesweeklyandthedailyinjection.Wehaveaverycompetitiveprice.Threetimesweeklyisaccepted.
Wehaveaccesstoabout90%ofallpatientsintheUSandwesecuredourcontractsfor2015,andinmanycaseswellbeyondthat.Wecontinuetobeinastrongdialogue,obviouslysomethingtomonitor.
ButatthemomentwhatweseeisCopaxone40isavery,verycompetitiveproduct,bothintermsofsafety,efficacyandpricing.Thatexplainstheexcellentmarketingpredictiontoalargeextent,aswell.
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
Andthen,onthecomplexgenerics.Asyourightlysay,it'sabroadterm.Buthowweidentifyitisalsoquitebroadlyatthispointintime,whenwe'rethinkingaboutthestrategy,itcanincludeeverythingfrombiosimilars.
Itincludesalsomoredifficulttodevelopdosageforms,forexample,intermsoflong-actinginjectables.Itcouldevencoververycomplextopicalswherehaven'tbeenanygenericcompetition,vaginalrings.Allthedosageformsthatreallyisassuredit'sinthemarketandwherethere'saspaceforustoclaimourownopportunities.
So,welookatitbroadlyatthispointintime.Butthere'snicheswithinthisbroadspectrumwherewethinkwecandobetterthananyothercompanytoexecute.
Erez Vigodman(CEO):
Andatthesametime,webelievewearepositionedtowinintwovery,Iwouldsay,challengingareas,injectablesandrespiratory.
Sumant Kulkami(Analyst-BofAMerrillLynch):
Thanks.
Operator:
ThenextquestiontodayisfromthelineofDavidMarisfromBMOCapitalMarkets.
DavidMaris (Analyst-BMOCapitalMarkets):
Morning.Acouplequestions.First,ErezandSiggi,doestherubledevaluationmakeyoumoregunshyaboutinvestmentsinthatpartoftheworld?Andmaybeinemergingmarketswherethereishighgrowthbutlotsofrisks?Andthenseparately,intheoralMSmarkettherearealimitednumberofprogramsinlate-stagedevelopment.Howattractivedoyouthinkthatareaisfromabusinessdevelopmentstandpoint,giventheinterestintheareabyothers?Inotherwords,isthissomethingthatyouhavetodotobuildouttheCopaxoneMSfranchise?Orisit,youknowwhat,ifit'stherightopportunitymaybeyouwilldoit?Howhighofafocusisthat?Thankyou.
Erez Vigodman(CEO):
Onthefirstone,yes,therearemorerisksinemergingmarkets,buttherearealsoopportunities.Everythingwedowillbeinaquesttobeabletomitigaterisks.Thereareopportunitiesoutthere.
PersonallyIthinkthatthereareverycompellingopportunitiestodayinRussia,especiallytoday.Andifyouareablereallytomitigatetherisksthewaywedotodayinothercountrieswheretherearefluctuationofcurrencies,wewillbeabletobasicallygeneratevalueforourshareholdersovertime.
Welookatemergingmarkets.Weseetheopportunitiesandweputthefocusonkeyonesinawaythatwill
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enableustotapintoopportunities,buttomitigatepotentialrisks.Andmaybe,Siggi,you'dliketoaddsomethingtothat?
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
Ithink,David,onRussia,perse,wearefullyalignedthatthisisstillanopportunity.Thisisstillaveryfast-growingmarketforus.WearenumberfiveinRussiatoday.
Ourvolumegrowthinthemarketandanypriceadjustmentwehavemade,wearestillbeingveryclosetokeepupwiththecurrency.WefeelthatwearewellpositionedonexpandingourbusinessinRussia.Wehaveamazingmanagementteaminthecountry.
Sowearenotgunshy,maybeforthereasonofthecurrencyperse,butweneedtobecareful.ThereisriskintheRussianmarket,butthereisalsoriskinotheremergingmarketsonthegrowthmarketswearelookingto.
MichaelHayden(HeadofR&D&ChiefScientificOfficer):
AndIwouldjustliketocommentontheoraltherapies.Ofcourse,wearemostinterestedintherapiesthataregoingtobeeffective.Numberone,dealingwithnovelmechanismsofactionthatreallyhaveachancetonotonly,callit,relapse,buthaveabigimpactonthethingthingsthatmattertopatients,whicharedisabilityandprogressionofillness.
Ofcourse,inourownpipelinenowinphaseIII,wehaveLaquinimod,averyinterestingmoleculethatplaysintothatparticularspaceintermsofhavingabigimpactondisabilityandalsoshowinggreatpromiseintheareaofhaltingordecreasingprogression.Then,ofcourse,andassuch,wehavealsobegunastudyofLaquinimodinprogressiveMS,becausewebelieveitmayplaytothatparticularverydifficult,andcurrently,forwhichthereisnotherapy.Verydifficultandadiseaseforwhichthereisnowaytohalttheillness.
Butofcourse,we'remostinterestedinotherpathwaysaswell.Pathwaysthatremyelinationpathways.Pathwaysthatwillimpactforthelongtermtopreventsomeofthedisabilityandearlytreatment.
So,Iwouldsaythecrucialissueisnotthemodeofadministration,butisreallyalsothepossibilityofreallyreducingillness.WehaveseenwithadruglikeCopaxone,whichissafe,hassuchasafetyrecord,thatsubQinjectionhasn'tbeenanobstacletopatientstakingthisparticulardrugup.
Soweareofcourseopentootheroralformsthatmatchourtargetnewmechanism.Butthekeythingisfindingawaytostopthedisabilityprogression.AndLaquinimodrepresentsamoleculethatwearequiteexcitedabout.
Erez Vigodman(CEO):
David,withoutdelegatingfromtheimportanceto,ofcourse,todevelopsolutionsintheoralspace,IthinkitisimportanttounderscorethatCopaxoneholdsverystrongversusBiogen.WehavetodayatthesamenumberofpatientswehadbeforethelaunchofTecfidera.SoweservetodayandtreatbyCopaxonebydefinitivesamenumberofpatientsthatwereservedbyusbeforethelaunchofTecfidera.
Copaxone40-milligramstodaybasicallywasabletogain19.7%marketshareintheMSspaceinawaythatbasicallyputsitinaleadingposition,toaddtoitTecfiderajustbeinglaunchedlessthan12monthsago.AndthatistodaybasicallyacompetitionbetweenTecfideraand40million-gramonastand-alonebasisonthelucrativepositionoftheMSspace.SowefeelstrongaboutthewaywecancompeteagainstBiogenwithoutdelegatingfromtheneed,ofcourse,tocomeupwiththerightsolution,ofcourse,forthatsegment.
DavidMaris (Analyst-BMOCapitalMarkets):
Great.Thankyouverymuch.
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Operator:
YournextquestiontodaycomesfromthelineofGreggGilbertfromDeutscheBank.
GreggGilbert (Analyst-DeutscheBank):
Thankyou,andIappreciatethat10%dividendincrease.Greatcallonthat.IhavetwoforSiggi.YouarecommittedtowesternEuropeinthegenericsbusinessinawaythatsomeothersarenot.AndIsuspectthat'sduetoyourscaleandtheeconomicbenefitsthataretiedtothat.Butcanyouprovideussomecoloronhowyouseegrowingthatbusinessprofitablyoverthenextcoupleofyears?Andhowmuchisinternallydrivenversusbeingabletoboltthingsonthere?Andthenmysmalladd-onquestionthereisaboutNasacort,thestorebrandNasacortOTC.Whenmightweseealaunchbyyourpartner,Perrigo,onthat?Thanks.
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
OnWesternEurope,IthinkweareinaverygoodpositioninWesternEurope.Wearethelargestplayer.Outofthe28markets,wearetop3in20markets.
Asyoumentioned,Gregg,itisallaboutscale.Itistheopportunityusingourscale.Wehaveaverygoodmanufacturingnetwork.Weworkcloselywithmanufacturingofselectingtherightportfolio.
IntermsofwhatwehavedoneinWesternEurope,itwasmentioningthatwehaveimprovedtheoperatingprofitfrom13%toapproximately20%in2014,from13%2013.ThisisagreatachievementbytheEuropeanteam.
Howthiswasdonewasinthreeways.Intermsofcostofgoodssoldwasveryimportant.Intermsofthefocusoftheportfolioandwheretodobusiness,bemoreselectiveinthebusiness,bemoreselectiveinthetender.Thatwaspartofit.Andobviously,costcontainment,bothontheG&Aandthesalesandmarketing.
Howdowegrowinthesemarkets?Wearethinkinginorganicterms.WesternEurope,acquisitionisnotourfocusatthispointintime.Westillthink,yousawthatwehadover200launchesinWesternEuropein2014.Wehaveanamazingpipeline.
IthinkonethingyoushouldnoticeiswearetheleadersinlaunchingatriskinEurope.WehaveanextremelystrongIPteamandregulatedR&Dteamtosupportthat.
Ifeelwiththemachinewehaveinplace,withtheinfrastructure,withoursize,wecancontinuetogrowtheWesternEuropeanmarket.YouseeafastergrowthinthebottomlinesimplyalsoduetotheFXimpactontherevenueline.TheFXimpactinEuropeisverylittle,asEyalmentioned,onthebottomline.SoIfeelthatthereisarealopportunityforustogrowthatbusinesswiththeinfrastructurewehaveinplace,asanorganicmove.
WithregardtotheNasacort,Ican'tcommentonit.ThisisaPerrigoproduct,perse.SoIthinkyouhavetoleavethatquestionwithPerrigo,howtheyseetheopportunityforthisproduct.
GreggGilbert (Analyst-DeutscheBank):
Okay,thankyou.
Operator:
ThenextquestiontodayisfromthelineofLouiseChenfromGuggenheim.
LouiseChen(Analyst-GuggenheimSecurities):
Hi,thanksfortakingmyquestions.Myfirstquestionis,withrespecttobusinessdevelopment,curiousifyouhaveanyinterestinexpandingintotheareasofanimalhealth,storebranddrugs,and/ororphandrugs.
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Andsecondquestionis,howconfidentyouareinanapprovalthisyearforanAB-ratedgenericversionofEpiPen.Andifyougotthatapproved,howmuchmarketsharedoyouthinkyoucouldtake?Thankyou.
Erez Vigodman(CEO):
So,wedon'tlookatwomenhealthmaybeopportunities.Wedon'twanttoallowthepossibilityoflookingatopendrugspotentialinitiatives.Siggi?
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
So,IthinkonEpiPen,aswementioned,wesubmitted,wedealtwithall-outslantingqueriesfromtheFDAinDecember.Wefeltwesubmittedaverystronginformationandwehavedealtwithanyoutstandingissue.
Ofcourse,asyouknow,MylansubmittedaCPafewweeksback.TheCPfocuswasmainlyaroundthedeviceandusabilityoftheproduct.We,ofcourse,willrespondthat,butwefeelthatinourfilingwehaveaddressedthat,butwewillrespondtotheCP.
ItisverydifficulttosaywhenyougetapprovalfromtheFDA.AswementionedinDecember,wehaveappropriatelyrisk-adjustedthisinourfocusfor2015.Butit'sstillinourforecast.Itisexcitingopportunity.Ithinkit'salargebrandandIthinkouropportunity,if,andIhighlightif,wegetanAB-rated,Ithinkwecanhaveasignificantgenericproductinourhand.
Erez Vigodman(CEO):
AndIunderstandthatyousaidanimalhealth,soIamstickingtotheanswerthatIprovided.Wearenotlookingatopportunitiesintheanimalhealthspace.
LouiseChen(Analyst-GuggenheimSecurities):
Thankyou.
Operator:
ThenextquestiontodaycomesfromthelineofManojGargfromHealthco.
ManojGarg(Analyst-Healthco):
Thankyoufortakingthequestion.Twoquestions.One,onainjectableandthen,two,onyourguidance.Onstoveinjectable,that'sisaspacethatyouknowwellfromyourpreviousSicoracquisitions.ButyouindicatedyouhadnotlookedatHospira.I'mjustcurious,doesthatspeaktoyourbeliefsoryourforwardbeliefsonthatsegment?
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
Letmetakethat.IthinkourstrategyhassimplybeenthatobviouslyTevawastheleaderinthefield,aftertheacquisitionofSicorandupuntilwehadchallengesinourmanufacturingafewyearsback.
Whatwearedoingnowiswearereenteringthemarket.AlreadyinJanuarywehaveintroducedthreeorfournewinjectableproducts.Wearebuildingupourportfolioagain.Ourthinkinghasnotbeentobeinalltheinjectablespace.Wearenotlookingforantibiotics.Wearebeingfocusedontherapeuticareas,onfocusedonwhetherthere'sapatientneedforourinjectables.
Wearealsolookingverycarefullyindevelopingthelong-actinginjectableswherewehaveanexcellentknowledgeandexpertiseduetocombinationofspecialtyandgenericdevelopmenttobringsomenichesinthemarket.Butwereally,ourstrategyhasnotbeeninthemassmarketofinjectables,moreinthenicheand
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theopportunisticmarketofthisspace.
ManojGarg(Analyst-Healthco):
Okay,thankyou,that'shelpful.Thenjustaquestiononyourguidance.AtyourAnalystDay,youhadindicatedthatyourguidanceassumesgenericentrybytwoANDAfilersinSeptemberonCopaxone.Iamcurious,areyouusingtwobecausethatisthemidpointofzerotofour,whichisthenumberofknownfilersweknow?Oristheresomethingabouttwoapplicationsthatgivesyouconfidencethattherewillbetwoapprovals?
EyalDesheh(CFO):
It'sEyal.Idon'tthinkthatwehaveanychangestoouroriginalestimationgenericentry,ofcourse,onthe20-milligramone.Betweenonetotwoplayers,thisiswhatwehaveguidedoriginallyandweseenochangetothatatthispoint.
Erez Vigodman(CEO):
No,andbytheway,noindicationtheconverseistrue.Wearejustcarefulandthat'sbasicallythewaywemountedthebusinessplan.Andwearetoassumethatinthecourseofthedaywemightsee,butnoindicationandwemightenduptherewithoutgenericcompetition.
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
Andjustonethingtoaddtothatisthatthenumberoneortwodoesnotindicateanyassessmentorconclusion,orevenperception,astothequalityofthesubmissionsorthequalityofthepurportedgenericsthathavebeensubmitted.Thisisunrelatedtothesubmissionsoranythingaboutthem.
ManojGarg(Analyst-Healthco):
Okay,thankyou.Thatisveryhelpful.
Operator:
YournextquestionisfromthelineofKenCacciatoreformCowenandCompany.
KenCacciatore (Analyst-CowenandCompany):
Thanks,guys,goodmorning.Youhavebeenveryclearaboutyouracquisitionstrategy,yettherehasbeennotransaction.SoI'mjustwondering,isitpriceorisitlackofopportunities?Andthenalso,Iwouldliketohearyourviewonwhetheryouwouldeverconsidergoinghostileasanapproachtoapotentialtargetifconversationsweren'tgoingthewayyouwanted?Thankyou.
Erez Vigodman(CEO):
Ourstrongfocusduring2014wasongettingourhouseinorderfirst,solidifyingthefoundation,developingthecylindersthatwillfireforusinyearstocome.Justnowwearesayingthatwearereorientingthedirectionduring2015towardsinorganicmoves,aswell.Sothingswillfallinlinewiththewaywehavedesignedasetofmeasuresfor2014versus2015.
Basicallywedon'twanttoholdupanypossibilityintheBDlandscape.Weprefernottogohostilebutwedon'twanttoruleoutanypossibility.Wewilldowhateverisneededinordertogofortransactionthatwillenableusfirsttogenerateanoutlookvalueforourshareholders.EPSaccretionisalsoimportant,butwhatreallymattersforusistobeabletogeneratevalueforourshareholdersinthelongterm,inawaythatreinforcesourprofitingdirection.
KenCacciatore (Analyst-CowenandCompany):
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Thankyou.
Operator:
ThenextquestiontodayisfromChrisSchottfromJPMorgan.
ChrisSchot t (Analyst-JPMorgan):
Great,thanksverymuchforthequestion.Justhadtwoquickoneshere.First,itseemslikemuchofthegenericspacerightnow,alotofpeoplearepursuingcomplexgenericsasagrowthdriver.Areyouconcernedatall,asyoubuildoutthiscomplexgenericportfolio,thatbythetimeyougettothesemarketsthatwe'regoingtoactuallyendupseeingtoomuchcompetitionandsomeoftheattractivepricingdynamicsmightnotbethereinafewyearsrelativetotoday?
AndthesecondquestioniscomingbacktothePfizer-Hospiratransactionthismorning.Iappreciatetheearliercomments,butwhenwethinkaboutthatcombinedentity,canyoutalkaboutwhatthatcombinedentitymeansintermsofindustrycompetitivenessandtherelativeattractivenessofthespace?Basicallydoesthiscreateamorepowerfulcompetitorasyoulookouttobuildoutyourinjectableportfolio?Thanksverymuch.
MichaelHayden(HeadofR&D&ChiefScientificOfficer):
Thanks,Chris.Ithinkonthefirstone,yes,itisalittlebitofabuzzwordtotalkaboutcomplexgenerics,butitisalsoeasiersaidthandone.Ithinkweareinaprimepositiontodothis.Wehavetheinfrastructureofdoingthis.Ithinkwehaveaprovencapability.Wehaverecentlywhatwasapossiblefirsttofile,whichincludedaninjectableandadeviceontheproteindrug.Soweareinaspecialposition.
Alsokeepinmind,evencomplexgenericslikethetransthermalpatches.Manycompanieshavetalkedaboutitforquiteafewyears,andstilltodayyousee,atmost,maybefourtofiveplayersinthemarket.SoIthinkyouareright,itiswidelytalkedabout.ButIthinktheexecutionwillbeharderandIthinkweareinabetterpositioninthisfieldplanthanmostothercompanies.
WithregardtoPfizer-Hospira,clearlyifthismergergoesahead,thiswillbeapowerhouseintheinjectablespace.Hospiraobviouslyisverystrongintheinjectablespace.Alsointhebiosimilarspace,Pfizerwasdoingsomeworkinthebiosimilarspace,andHospiraalso,bothwithjointventurepartners,butalsoalone.So,thereisnoquestionaboutit,thatthecombinedentitywillhaveastrongpresenceintheinjectablespace.
Butthatbeingsaid,IwanttomentionagainwhatIsaidpreviously.Ourportfoliostrategyandourapproachtothemarketisalittlebitdifferent.Wearemoreinthenichespaces.Weareinthesmallerproducts.Wearenotcompetingonthebigvolumeantibioticsoroncologyproducts,perse.Butclearlyifthismergergoesahead,itwillbeastrongcompetitorinthemarket.
Erez Vigodman(CEO):
And,Ken,Ithinkitisalsoimportanttounderscoremaybeanotionthatwasmentioned,butisimportanttoshareitwithallofyou.Althoughwesaidthatwewanttomovemoreandmoretoallthehard-to-producecomplexgenerics,itdoesn'ttakeawayfromthefactthatwehavetodaythecapability,theskill,thetechnology,theinfrastructureandthepipelinethatsupportsaleadingpositionincomplexgenerics.Sothatissomethingthatshouldbeclear.Wewanttoreinforceitmuchfurthergoingforward,butitdoesn'tdelegatefrombasicallypositionthatwehavetoday.
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
Andalsojusttoadd,forourpipelineaswetalkaboutthis,westartedin2014thepipelinewasaround35%ofourpipelinecomplexgenericsintheUSandalsoinEurope.ButinUSit'sgoingtobeabout75%in2015.Soit
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isamajorinvestmentandamajorcommitmenttospecificproductsinthecomplexgenericspace.
Operator:
ThenextquestiontodayisfromRonnyGalfromBernstein.
RonnyGal(Analyst-SanfordC.Bernstein&Company):
Goodmorningandthankyoufortakingmyquestion.I'mgoingtostartwithahousekeepingquestion,andthenI'vegotacontentone.Thehousekeepingoneisabouttheshapeoftheyear.Youmentionedthatyouexpectslightlymoreprofitinthesecondhalf.IbelieveyouwereassumingthePulmicortwillbelostduringtheyearandyouareassuminggenericCopaxonecomingin.Itfeelsasifthesecondhalfshouldbeactuallyalotlowerthanthefirsthalf.Whatisoffsettingthat?
Secondonthecontent.Canyoutalkabouttwoissues?ThefirstoneisthemarketingpracticeinvestigationinRussia.Ifyou'dmentionedtoustheriskthere.
Andthensecond,theZecuitylaunch,thisisoneIguessisupcoming.Canyoudiscussalittlebitthecoverageyouwereabletoobtainforthatdrug?Relativepricingversustheotherproductinthemarket,andwhatyouseeasthebigsalespotential.Mentiontousthepotentialofthisproduct.
EyalDesheh(CFO):
Ronny,Iwilltakethefirstoneregardingtheso-calledlinearityoftheyearandthequalityprogression.Yes,weseethesecondhalf,despiteeverythingthatyouhavementioned,morelaunchesofnewproducts.Ourlaunchesfortheyeararegoingtobesecond-halflaunches.Morerealizationofcostreductionastheyearprogresses.
So,allinall,whenwelookatit,itisprettybalanced.Butthefirsthalfwillbealittlelighter,thesecondhalfwillbealittleheavier.Notabigdifference,butinlinewithwhatwehaveguidedearlier.
RonnyGal(Analyst-SanfordC.Bernstein&Company):
Okay.
Erez Vigodman(CEO):
Onthesecondone,wehavenothingtoaddbeyondthenotetothefinancialstatements.AndontheZecuity,Rob?
RobKoremans (GobalSpecialtyMedicines):
Yes,Ronny.Zecuityisplanningtolaunchforquartertwo.Soatthemomentthisisallbeingprepared.Wewillbeable,asweseetoday,todothatlaunch.Andintermsofcoverage,itisabitearlytotalkthat,butyoucanbesurethatwehaveaworld-classteamonthat.Wehaveourassumptionbutnotactivenegotiationswithpayorsatthismoment.
RonnyGal(Analyst-SanfordC.Bernstein&Company):
Okay.Inyourmind,comparingtosomeoftheotherbrandedproductsthatyouhave,isthatlikeaQvarsize,aNuvogilsize,aCopaxone-sizeproduct?
RobKoremans (GobalSpecialtyMedicines):
No,itisnotaCopaxone-sizeproduct.Butitisanimportantproductforanichegroupofpatientswithmigraine.Verydifficulttotreat.Webelieveit'sgoingtobeaviableoption.Youshouldn'tlookatitasaproduct
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thatwillallofasuddendramaticallyexplodeinsales.Itwillbeaslow-growingproduct.
Itisacomplexsupplychain,perse,sothereisenoughchallengesonthat,butwebelieveitisarealniceopportunity.Anditisdefinitely,ifwemanagetogetittomarketwellandmanageeverythingwellthere,youarelookingatacoupleofhundredmillioninpotential.
Butitwillnotcomeinthefirstyear.Thisisprotecteduntilwayinto2020andweexpectpeaksalesnotbefore2024.Butitissomethingthatfitsfantasticallytoouroverallportfoliointhemigrainespace.AndwebelievewecanserveasmallbutimportantportionofmigrainesuffererswithZecuity.
RonnyGal(Analyst-SanfordC.Bernstein&Company):
Thankyouverymuch.
Erez Vigodman(CEO):
Ronnie,itplaysaverylimitedroleinourworkplanandinthenextfive-yearplan.Averylimitedrole.Wewantto,basically,towatchthingsaswegoalongandtodrawconclusions,basically,fromwhatweseeinthemarketplace.
RonnyGal(Analyst-SanfordC.Bernstein&Company):
Thankyou.
Operator:
ThenextquestiontodayisfromthelineofRandallStanickyfromRBCCapitalMarkets.
RandallStanicky(Analyst-RBCCapitalMarkets):
Great,thanks.Justtwoquestions.FirstforErez.Asyouthinkaboutcreatinglong-termvalue,howdoestheimportanceofdiversifyingawayfromCopaxoneoverthenextcoupleofyearsfactorintothatthinking,specificallytheM&Astrategy?
AndthenaquickoneforSiggionbudesonide.Youguysrecentlyhadahearing.Whatisyourlatestthinkingontimingastowhenwecouldgetanupdatethere?Thanks.
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
Randall,Iwilltakethebudesonidefirst.Soasyousaid,theclosingargumentswereattheendofJanuary.Youhavetokeepinmindwearenotpartofthistrial.ThisisAstraZenecaagainstallthegenericplayers.
Obviouslywedon'tknow.Wegavetheguidancethatweestimatedthatwewouldhaveadditionalgenericcompetitioninthefirsthalfoftheyear.Justkeepinmindthatevenifwegetadditionalgenericcompetitioninthefirstquarteritwillnotchangeourguidanceinanywayorform.
TheinjunctionisinplaceupuntilMarch1.Sowereallydon'tknowwhatthejudgeisgoingtodo,buttheseareroughlythetimeframes.Westillstickwithourguidance.
Wethinkitisappropriateatthispointintimetoestimateacompetitioninthefirsthalfoftheyear.WillthatbeinMarch,April,May,wedon'tknow.OrcoulditbeintothesecondhalfoftheyearorinfactobviouslythecasecouldgothewayofAstraZeneca.Wewouldcontinuetosellbudesonide.Soitisverydifficulttoreadintoit,butthesearethefactsofthemarket.
Erez Vigodman(CEO):
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So,basicallywe'veputstrongfocusoncorecapabilities.Wetookadecisiononwheretoplay.Weknowwherewewanttobein2019.Andbusinessstrategyisbeyondthat.Bythesametime,ofcourse,thequesttodiversifyawayfromCopaxoneisanimportantentityintheequation.
RandallStanicky(Analyst-RBCCapitalMarkets):
Okay.Thanks,guys.
Operator:
ThenextquestiontodayisfromthelineofUmerRaffatfromEvercoreISI.
UmerRaf fat (Analyst-EvercoreISI):
Hi,guys,thankssomuchfortakingmyquestion.Iwanttotouchonacoupleoftopics.Numberone,maybeaquickfollow-upontheHospirastuff.Iwantedto,Siggi,maybeaskyouhowlargeisyourspecialtyinjectablesbusinessintermsofrevenuesrightnow?AndwhatpercentageofitactuallyoverlapswithHospira?JusttryingtounderstandwhatpotentialcompetitioncouldlooklikeunderPfizer.
Andsecondly,onCopaxone.IknowtherehasbeenalotofdiscussiononCopaxonegenerics.MyquestionwasonCopaxone-likedrugsotherthangenerics.Specifically,theplovameracetatefrom,theweeklysubQfromMerckKGaA.Thoughtsthere.AndthemonthlyformdepoformofCopaxone.Justcurioushowyouguysthinkaboutthose.Thankyouverymuch.
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
So,Ithinkontheinjectablesbusiness,globallyweareprobablysomewherebetween$500millionin$700millioninrevenueofinjectablebusiness.IntheUSwearerelativelysmall.Weareapproximatelyjustover$100millionlastyear.
Butwearegrowingthatveryquickly.ImentionedthethreeorfourlaunchesthatwehadinJanuaryalready.AsImentionedinDecemberweassumethatthegrowthinUSweestimatetothree-foldthatrevenuein2015.
Intermsofoverlap,thereisobviouslysomeoverlap,especiallyintheEuropeanmarket.ButintheUSmarketthereislessofanoverlap.OneofourlargelaunchesthatwedidnowinJanuarywasgenericEnoxaparin,veryimportantworktous.Wehavelaunchedthatverysuccessfully.Thereisnooverlapthere.
WealsolaunchedLinezolidinJanuaryandourloanonthemarketthere.ThatisobviouslyaPfizerproduct,sothecombinedCompanywouldhavethatgoingforward.Soitisdifficultformetogiveyouanaccurateoverlapatthispointintime,butmaybeanindicationthereismoreinEuropethanthereisintheUSatthispointintime.
UmerRaf fat (Analyst-EvercoreISI):
Gotit.
MichaelHayden(HeadofR&D&ChiefScientificOfficer):
AndjusttocommentonotherCopaxone-likedrugsorCopaxone.Firstly,justtosaythatwhatwe'velearnedaboutCopaxoneoverthelastyear-and-a-halfinparticularlyingreatdetail,ishowCopaxoneworks.AndcertainlyweareveryinterestedinthepathwayswayCopaxoneworks.Weunderstandsomeofthemolecularbentunderlyingthosepathways.Andofcourseareinterestedindrugsthatmightmodulatethatpathway.
IntermsofotherformulationsofCopaxone,theyareinveryearlydevelopment.Wehaveofcoursedominatedthisworkourselves,butthereareothersalsodoingthis.Andwewatchthiswith,I'dsay,carefulinterest.
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Wedoknowaswehavegonefromoneinjection,oneeverydaytothreetimesasweek,thatthiswasveryconvenientforpatients.Itwouldhavetoseesignificantimprovementinoutcomeforpatientsandthesestudiesareveryfaraway.
Sowewatchwithinterest.Wepayattention,butwhatthewholeCopaxonestudieshavedoneisreallyalertustothepathways.Andalsootherdifferentandnewmolecularentitieswhereweareparticularlyinterestedtoplayarole.
UmerRaf fat (Analyst-EvercoreISI):
Thanksverymuch.
Operator:
ThenextquestiontodayisfromthelineofMarcGoodmanfromUBS.
MarcGoodman(Analyst-UBS):
Siggi,couldyougiveusalittlemorecoloronsomeofthekeymarketsforyououtsideoftheUSinthegenericsbusiness?Youknow,FranceandGermany.Andthenalsoinsomeoftherestoftheworld.ObviouslyRussiawasmentionedalittlebit,butmaybesomeoftheotherkeycountriesforyou.
Secondquestionis,isthereanyupdateonlifecycleextensionstrategiesforTreanda?Andthird,women'shealthseemedtobealittlebitweakinthequarter.Justpointoutwhy.Thanks.
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
Yes,soifIstartontheinternationalmarket.IthinkwehavehadgoodresultsinEurope.Ithinkthemarket,whichIwasverypleasedwith,wasfirstofallUK.UKdidverywell.
Ithinkwhatwemanagedtodothere,therewasanupsetinthesupplysituationofourcompetitorsandIthinkthisshowsthestrengthofoursupplyteam.Wewereabletostepinandtakeaspace.TherewasaneedforourproductandthatgrewourbusinessintheUK.
IamalsopleasedinmarketslikeGermany.TheGermanteamhasbeendoingextremelywell.Theyareobviouslybothworkingforthespecialtyandthegenerics.Theylaunchedspecialtyproductsverysuccessfullyontherespiratoryfield.
ButinthegenericsIthinkwehavetakenasmarterstrategy.Wearemoreselectiveonthetenderbusiness.Westillhaveavery,verystrongbrandinGermanyintheRationpharmbrand.AndalsoonourjointventurewithP&G,thePGTjointventure,wehaveaverystrongpositionintheOTCbusinessinGermany.
Spainhasbeenalittlebitmorechallenging.ThereissomeregionsinSpainthathavegoneintotenders.Wehavenotfollowedthat.Wereallydon'twanttogotoomuchintothetenderbusinessintheSpanishregion.
OntheFrenchmarket,Ithinkwearedoingokay.Ihavesaiditbefore,theFrenchsystemisquiteacomplexone,wherethepriceshavegonedown.Theutilizationisstillrelativelylow.Andyoustillhavetohaveasalesforceinplacetodrivetheusageofyourmedicine.SoIthinkweareafairlylargeCompanyinFrance,butIhopeinthefutureIcanseetheprofitabilitygoingupthere.
MaybethelastbittoadduptothiswasRussia,asyoumentioned.Ifitwasn'tfortheFXchallenges,IthinkRussiaprobablywouldbemybestmarketoutsideoftheUS.Bytheway,UShadanextremelygoodyearanddidextremelywell.ButRussiateamdidanoutstandingwork.
AsImentioned,intermsofvolumegrowthandanypriceactiontakeninthemarket,theynearlymanagedto
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keepupintermsgrowthwiththeplanwehaveinplace.Itisaverychallengingmarket,butalsoIthinkbeingnumberfiveintheRussianmarkethashelpedus.Andweseeasignificantgrowthgoingforwardinthatmarket.So,overall,Ithinkinternationally,beingtopthreein30marketsaroundtheworldgivesusaveryspecialpositionversusourcompetitors.
Erez Vigodman(CEO):
Marc,nothingnewonTreandasinceDecember2014.IthinkwemeantwearebasicallyalossofexclusivityisexpectedinMay2016.Wearecheckingallthepossibilitiestoextenditfurther.Rob,women'shealth?
RobKoremans (GobalSpecialtyMedicines):
Yes,thanks.Sotheperceptiononalittleweak,wehavedonesalesforthefullyearinwomen'shealthareinalmostthesamelevel,actuallyalmostexactlythesamelevelastheyearbefore.Maybeyourefertothefactthatfrom2012to2013therewasquitesignificantgrowthrelatedtosomeofthelaunches.Butthisisabusinesswemanageforsustainedprofitability,competitivebutverynicemarketplacetobein.
Ourtwokeyproducts,PLANBOne-StepandPARAGARDareactuallydoingverywell.NottobeatPLANBOne-Stephasexceededallofourexpectations.Also,goingforwardyouwillprobablyseemoreofthesame.Itisanicelyprofitablebusiness.Wehaveaveryniceposition.Wedon'tover-investinit.Itisimportanttokeepitgoing,andweareoptimisticalsogoingforwardforthis.
Operator:
ThenextquestiontodayisfromthelineofDavidSteinbergfromJefferies.
DavidSteinberg(Analyst-Jefferies):
Thanksverymuch.BacktoyourM&Astrategy.Youhavebeenveryconsistentaboutpayingdownyourdebt,Ithinkacouplebilliondollarsoverthelastfourquarters.What'syourcurrentthinkingintermsoftodoanall-cashdealandleverup,whatisyourcurrentdebtcapacity?
Thenontheequityside,youcontinuetobuybackstock,Iwouldthinksignalingthatyouhaveanundervaluedshareprice.Butifyouweretodoamuchlargertransaction,Iassumeyouwouldhavetouseequity.Wouldyoubecomfortableusingequitytomakealargeracquisitionatcurrentsharepricelevels?Thanks.
EyalDesheh(CFO):
Thanks,David,itisEyal.Withoutgoingintohypotheticaltransactions,becauseeverydealisdifferent,structureisdifferent,webelievethatourbalancesheetandequitypriceandcapabilitiesenableustogoafterallreasonabletransactionsinthemarket.Andputmoreofthatonthebalancesheet,dependingontheEBITDAcontributionoftargets.
Andthemixofdebtandequitywilldependonthetypeofthetransactionandtheappetiteforriskderivingfromit.SoIwouldrefrainfromdoingahypotheticalanalysis,butobviously2014hadincreasedourborrowingcapacity.Thatsaid,we'lllookspecificallyaseverdo.
DavidSteinberg(Analyst-Jefferies):
Thanks.Andthenyouhad,onyourslide,aboutpotentialgenericlaunchesforthisyear,youhadputongenericVenofer,ironsucrose.Justcurious,whatsortofprobabilitydoyouplaceonlaunchingthisyear?Whatsortofsharecouldyoutakeif,infact,youdogetapproval?
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
CompanyName:TevaPharmaceut icalIndustriesLtdCompanyTicker:TEVASector:HealthCare
Industry:DrugsEventDescription:Q4 2014 EarningsCall
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Thatisoneoftheinjectableproductsthatwehaveinourpipeline.Wehave,asIsaid,howwebuildourfocusandhowweguidethemarketiswehavemultipleopportunities.Wehavesomanygoal,butweareappropriatelyrisk-adjustedwhenweforecasttothemarket.
Wedon'tknowifwegetifapproved.Weareready.Ifwegettheapproval,wearereadytolaunchinthemarket.Theinjectablemarketisalittledifferent.Thereiscontractsinplace.ThereissometimeslongtermcontractswiththeDPOsandthingslikethat.Soitisdifficultformetogiveyouanestimationofthemarketshere.Butclearlyifwegettheapprovalintime,thiscouldbeagoodproduct,butitwillnotoverallaffectourguidancefortheyear,perse.
DavidSteinberg(Analyst-Jefferies):
Thanks.
Operator:
ThenextquestiontodayisfromthelineofJasonGerberryfromLeerinkPartners.
JasonGerberry(Analyst-LeerinkPartners):
Hi,goodmorning,thanksfortakingmyquestions.First,forSiggi,thinkingabouttheUSbiosimilarmarketandthinkingaboutthePfizer-HospiraentityandNovartis,youreallyhavetwoprettybigbehemothsinthespacethataregoingtohaveamixofinnovativeandlow-costbiosimilars.Ifthemarketultimatelyendsupevolvingintoapositionpull-throughtypecategory,wonderingyourviewsontheattractivenessofthatmarketfromaTevaperspective.
Andthenmysecondquestion,asyouguysthinkaboutbolsteringyoursecondwaveofbiologics,thereisanemerginggroupofsmallercompaniesouttherebuildingoutandrunningphaseIIItrialsonbiosimilars.Kindofcurious,yourgeneralthoughtsonthequalityofthoseassets,andifyouguysthinkaboutacquiringaportfolioofde-riskedphaseIIIassets.Thanks.
SiggiOlafsson(GlobalGenericMedicines-TevaPharmaceuticalIndustries):
IthinkontheUSbiosimilarproducts,Ithinkwearealigningwith,Ithink,mostofthemarket.Wedon'texpectanyinter-changeability,atleastinthefirstfewyears.Sotherehastobesomepull-throughwiththephysician.
IthinkTevaisideallypositionedforthis.Wehaveastrongspecialtybusinessandwehaveastronggenericbusiness.Becauseyouneedtomanagebothends.YouneedtomanagetheDPOs.Youneedtoworkwiththehospitalsettings.Andwedothatverystronglyonthegenericside.
Thenwehavethesalesforceonthespecialtysidetodrivetheprescriptionthrough.AndIthinkIwanttouseGranixasanexampleagain,whereweareover15-plusmarketsonthisproductintheUSmarket,eventhoughweonlyhaveoneindication.AswefiledisasaBLA,itisnotabiosimilar.ButIthinkitisanindicationofwhatwecandointhemarket.
Youareright.Pfizer,Hospira,Sandoz,Novartis,thesearepowerhousesintermsofbrandedmedicines,andtheyalsohavegenericbusinesses.ButoverallIthinkwearepositioned,veryideallypositioned,tobeabletotakeadvantageofthemarket.
Intermsofsecond-wavebiologics,yes,there'squiteafewcompaniesthatsaythattheyhaveassetsforthesecondwaveandthirdwave.Weobviouslyaremonitoringthat.Ithinkperourcount,there'sover100companiesthatsaytheyhaveassetsthatareusable.
Ithink,fromourpointofview,there'sclearlynot100assetsthatweareinterestedin.Wehavelimitedthat
CompanyName:TevaPharmaceut icalIndustriesLtdCompanyTicker:TEVASector:HealthCare
Industry:DrugsEventDescription:Q4 2014 EarningsCall
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downprobablyto5to10companiesthatreallyhaveastrongasset.Andanyoptioninbusinessdevelopmentisopen.Itcouldbeanacquisition,itcouldbeajointventure,itcouldbeaco-development.Weareveryopen.Wearelookingfortherightasset,fortherightpartner,wherewecanbearealplayerinthemarketinfivetosixyears.
JasonGerberry(Analyst-LeerinkPartners):
Great,thankyou.
Operator:
AndourlastquestiontodaycomesfromthelineofTimChiangfromCRTCapital.
TimChiang(Analyst-CRTCapitalGroup):
Hi,thanks.Erez,IthinkwhenyouguyshadyourpresentationlastDecember,oneoftheinitiativesyouhadsetwastoregainleadershipintheinjectablebusiness.IwanttogetyourthoughtsonwhatpreventedyoufromlookingatHospira.IthinkMylanalsohadlookedatHospiraandtheysteppedasideaswell.WastheresomethingthatyousawwithHospirathatyoudidn'tthinkwasagoodfitforTeva?
Erez Vigodman(CEO):
Wefailedtoregainleadershipinthegenericbusinessandbasicallywedon'twanttosayanythingwhichisnotappropriateonHospira.WeappreciateHospiraasacompetitor,butwebelievethatwecanbuildbasicallythefranchise,injectablefranchise,inanorganicmannerbasedoncapability,infrastructurethatwehavein-house.Wedon'tneedtoinvestinHospira.Wedidn'tneedtoinvestinHospirainordertoclaimforleadingpositioninthatspace.
TimChiang(Analyst-CRTCapitalGroup):
Andmaybejustonefollow-upthere,Erez.YouguyshavedoneprettywellwithGranixalready.WhatareyourexpectationsintermsofmarketsharewiththatproducthereintheUS?
RobKoremans (GobalSpecialtyMedicines):
Actually,sinceweareover15%now,actuallyapproaching17%,actuallyaswegotoalmost20%withitgoingforward.ItisaniceandinterestinggoodproductandaniceexampleofsynergybetweenthegenericsandspecialtygroupsintheUS.
TimChiang(Analyst-CRTCapitalGroup):
Okay,great.Thanksverymuch.
Operator:
Therearenofurtherquestionsatthistime.
Erez Vigodman(CEO):
So,thankyouforattendingthecallthismorning.Andforyourreallyactiveparticipation,verygoodquestions.Ilookforwardtocontinuingthedialoguewithyouduring2015.
Operator:
Iwouldliketoadviseallparticipantsforthoseofyouwishingtoreviewthisconference,thereplayfacilitycanbeaccessedbydialingwithintheUKon0-845-245-5205oralternativelyoncountrycode+441452-550000.
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