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UNITED STATESSECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORTPURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): May 7, 2018
AMNEAL PHARMACEUTICALS, INC.(Exact Name of registrant as specified in its charter)
Delaware 001-38485 32-0546926
(State or other jurisdictionof incorporation)
(CommissionFile Number)
(IRS EmployerIdentification No.)
400 Crossing BlvdBridgewater, NJ 08807
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (908) 947-3120
Atlas Holdings, Inc.c/o Impax Laboratories, Inc.
30831 Huntwood AveHayward, CA
(Former Name or Former Address, if Changed Since Last Report)
ChecktheappropriateboxbelowiftheForm8-Kfilingisintendedtosimultaneouslysatisfythefilingobligationoftheregistrantunderanyofthefollowingprovisions:
☐ WrittencommunicationspursuanttoRule425undertheSecuritiesAct(17CFR230.425)
☐ SolicitingmaterialpursuanttoRule14a-12undertheExchangeAct(17CFR240.14a-12)
☐ Pre-commencementcommunicationspursuanttoRule14d-2(b)undertheExchangeAct(17CFR240.14d-2(b))
☐ Pre-commencementcommunicationspursuanttoRule13e-4(c)undertheExchangeAct(17CFR240.13e-4(c))
IndicatebycheckmarkwhethertheregistrantisanemerginggrowthcompanyasdefinedinRule405oftheSecuritiesActof1933(§230.405ofthischapter)orRule12b-2oftheSecuritiesExchangeActof1934(§240.12b-2ofthischapter).
Emerginggrowthcompany☐
Ifanemerginggrowthcompany,indicatebycheckmarkiftheregistranthaselectednottousetheextendedtransitionperiodforcomplyingwithanyneworrevisedfinancialaccountingstandardsprovidedpursuanttoSection13(a)oftheExchangeAct.☐
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Item 2.02. Results of Operations and Financial Condition.
OnMay7,2018,AmnealPharmaceuticalsLLCandImpaxLaboratories,Inc.announcedthecompletionoftheirbusinesscombinationtoformAmnealPharmaceuticals,Inc.(the“Company”).ThefulltextofthepressreleaseissuedinconnectionwiththeannouncementisfurnishedasExhibit99.1tothisCurrentReportonForm8-K.TheCompanyisscheduledtohostaconferencecallat8:30a.m.ETonMay7,2018todiscussthecompletionofthebusinesscombination.TheinvestorpresentationusedforthecallisfurnishedasExhibit99.2hereto.
TheinformationinthisCurrentReportonForm8-K(includingExhibits99.1and99.2)isbeingfurnishedandshallnotbedeemed“filed”forpurposesofSection18oftheSecuritiesExchangeActof1934(the“ExchangeAct”)orotherwisesubjecttotheliabilitiesofthatsection,norshallitbedeemedincorporatedbyreferenceinanyfilingundertheSecuritiesActof1933ortheExchangeAct,exceptasexpresslysetforthbyspecificreferenceinsuchafiling.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.ExhibitNumber Description
99.1 PressReleasedatedMay7,2018.
99.2 InvestorPresentationdatedMay7,2018.
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SIGNATURES
PursuanttotherequirementsoftheSecuritiesExchangeActof1934,theregistranthasdulycausedthisreporttobesignedonitsbehalfbytheundersignedhereuntodulyauthorized.
AMNEAL PHARMACEUTICALS, INC.
Date:May7,2018 By: /s/BryanReasons Name: BryanReasons Title: ChiefFinancialOfficer
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Exhibit 99.1
FOR IMMEDIATE RELEASE
CONTACT:MarkDonohue(215)558-4526
AMNEAL AND IMPAX COMPLETE BUSINESS COMBINATION
– Creates Diversified Pharmaceutical Company with 5th Largest Generics Business in the United States –– Combined First Quarter 2018 Total Revenues of $418 Million; GAAP Net Loss of $79 million; Adjusted EBITDA of $96 Million –
– Provides Full Year 2018 Financial Guidance –– Conference Call Scheduled for 8:30 AM ET –
BRIDGEWATER, NJ, May 7, 2018 – AmnealPharmaceuticalsLLCandImpaxLaboratories,Inc.(“Impax”)todayannouncedthattheyhavecompletedtheirbusinesscombinationtoformAmnealPharmaceuticals,Inc.(“Amneal”orthe“Company”).Asadiversifiedcompanywitharobustgenericsbusiness,Amnealisnowthe5thlargestgenericsbusinessintheUnitedStates,withagrowing,high-marginspecialtyfranchise.
SharesofImpax(IPXL)ceasedtradingontheNASDAQstockexchangeonMay4,2018.AmnealwillbegintradingtodayontheNewYorkStockExchange(NYSE)undertheticker“AMRX”.Pursuanttothebusinesscombinationagreement,eachshareofImpaxcommonstockwasconvertedintotherighttoreceiveoneshareofAmnealClassAcommonstock.
“WeareveryexcitedforthefutureofAmneal,andstronglybelievethatwithourteam,differentiatedproductportfolio,extensiveR&Dandmanufacturinginfrastructureandexpertise,Amnealiswellpositionedtobecomeanindustryleader,”saidChiragPatelandChintuPatel,Co-FoundersandCo-ChairmenofAmneal.“WeareveryproudoftheCompanywehavebuiltandlookforwardtoAmneal’scontinuedsuccessunderRobStewart’sleadership.”
RobertStewart,PresidentandChiefExecutiveOfficerofAmneal,said,“Asweenterournextstageofgrowth,welookforwardtoimplementingourintegrationplansandquicklystartingtorealizethemanybenefitsofthiscombination.Wewillpromptlybegintoleverageourenhancedproductportfoliotofuelorganicgrowthwhilecapturingnumeroussynergiestounlockvalueandgeneratestrongcashflowtosupporttherapidrepaymentofdebtandfurtherinvestmentingrowthopportunities.”
TheCompanyexpectstobenefitfromitsexpandedproductportfolio,differentiatedpipelineandcost-efficientglobalmanufacturinganddevelopmentcapabilitiesinnearlyalldosageforms.Amnealexpectstogenerateannualdouble-digitrevenueandadjustedEPSgrowthandtoachieveannualcostsynergiesofapproximately$200millionwithinthreeyears.
“ThisisatrulytransformativecombinationthatfirmlyestablishesAmnealasanindustryleader,withhigh-valuegenericproductpipelinesandagrowingspecialtybusiness,”saidPaulBisaro,ExecutiveChairmanofAmneal.“Withourcombinedresources,wearewell-positionedtoexecuteourplanstobringhigh-quality,affordablemedicinestopatientsandgeneratelong-termreturnsforourshareholders.”
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Review of the Strategic and Financial Benefits of the Combination
• TheCompanycurrentlyhasagenericsportfoliowithmorethan200differentiatedproductfamiliesmarketedinnearlyalldosageformsandholdsanumber
oneornumbertwopositioninasignificantnumberofitsmarketedproducts,andhasagrowingspecialtyfranchisetargetingCNSdisordersandanti-parasiticinfections.
• ThegenericproductspipelineiscurrentlyoneofthelargestintheUnitedStates,includingapproximately149ANDAsfiledattheFoodandDrugAdministrationand135projectsinactivestagesofdevelopment,withnearlyhalfofallpipelineproductsexclusivefirst-to-file,first-to-marketorotherhigh-valueopportunitieswiththreeorfewercompetitorsestimatedatthetimeoflaunch.Additionally,theCompanyhasafoundationforcommercialentryintobiosimilarsthroughin-licensedproductsinvariousstagesofdevelopment.
• TheCompanyiscommittedtoongoinginvestmentsinR&Dwithanexpectedannualinvestmentofapproximately10%ofnetrevenues,withafocusonthestrategicdevelopmentofhigh-valueproductswithingenericsandspecialtypharmaceuticals.TheCompanyhasanextensive,diversifiedglobalsupplychainsupportingcapabilitiesacrossnearlyalldosageformsincludingsolidoraldose,softgels,injectables,topicals,transdermals,inhalation,complexmoleculesanddrug-devicecombinations,withR&DandmanufacturingsitesintheUnitedStates,IndiaandIreland.
• TheCompanyexpectstogenerateannualdouble-digitgrowthinnetrevenue,adjustedEBITDAandadjustedEPSoverthenextthreeyears.
• TheCompanyexpectstoachievesignificantannualcostsavingopportunitiesofapproximately$200millionwithinthreeyears.Themajorityofthesavingswillresultfromthecomplementarynatureofthecompanies’combinedoperationsaswellasmargin-enhancingproducttransferopportunities.
Debt Structure
Thecombinedcompanies’debtwasrefinancedwitha$2.7billiontermloanatarateofthree-monthLIBORplus350basispoints.TheCompanycurrentlyexpectsthatsignificantcashflowgeneratedbythecombinationwillenablerapiddeleveraging,andenabletheCompanytocontinuetoinvestinR&Dandhigh-growthspecialtyassets.
Amneal Acquires Gemini Laboratories, LLC and Enters Into Biosimilar Partnership with mAbxience S.L.
Concurrentwiththeclosingofthebusinesscombination,AmnealacquiredGeminiLaboratories,LLC,acompanyfocusedonmarketingandsalesofbrandedpharmaceuticalsfor$117million.Gemini’sportfolioincludeslicensedandowned,nicheandmaturebrandedproducts,andapipelineof505(b)(2)productsfornichetherapeuticareas.
Gemini’sleadproduct,Unithroid®,isdetailedprimarilytoendocrinologistsandhighprescribingprimarycarephysiciansthroughacontractedsalesforce.Geminihasalong-termdistributionagreementforUnithroidwithJeromeStevensPharmaceuticals.
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Concurrentwiththeclosingofthebusinesscombination,AmnealenteredintoalicensingagreementfortheU.S.market,withMabXienceS.L.foritsbiosimilarcandidateforAvastin®(bevacizumab).ThisisthethirdbiosimilarproductlicensedbyAmneal,whichdemonstratesitscommitmenttostrategicallyinvestandexecuteinthebiosimilarspace.
First Quarter 2018 Combined Company Unaudited Financial Results
AssumingthecombinationhadbeencompletedasofJanuary1,2018,totalcombinedCompanynetrevenuesinthefirstquarter2018were$417.5million,anincreaseof1.8%,comparedto$410.1millionintheprioryearperiod.
Genericdivisionrevenues,net,inthefirstquarter2018were$358.3million,aslightdeclinecomparedto$359.8millionintheprioryearperiod,duetorevenuereductionsfromincreasedcompetitiononbudesonide,lidocaine,yuvafem-estradiol,mixedamphetaminesaltsandfenofibrate,partiallyoffsetbyincreasedrevenuefromnewproductlaunchesincludingoseltamivir,methylphenidateHCIERanderythromycin.Firstquarter2018saleswerenegativelyimpactedbylowerrevenuesofepinephrineauto-injectorduetoarecentsupplyshortageattheCompany’sthird-partymanufacturer,andlowerthanexpectedsalesofaspirindipyridamoleERduetolimitedrawmaterialavailability.
SpecialtyPharmadivisionrevenues,net,inthefirstquarter2018were$59.2million,anincreaseof17.8%,comparedto$50.3millionintheprioryearperiod,drivenbyhigherrevenuefromRytary®,Zomig®andtheanthelminticproductsfranchise.
Grossmargininthefirstquarter2018was41.9%,comparedto34.4%intheprioryearperiod.Theprioryeargrossmarginwasnegativelyimpactedbyanapproximate$39millionintangibleassetimpairmentcharge,forwhichtherewerenocomparableamountsinthecurrentyear.Adjustedgrossmarginwas48.0%forthefirstquarter2018,aslightdecreasecomparedto50.3%forthefirstquarter2017,partiallyduetothesupplyshortagesonepinephrineauto-injectorandaspirindipyridamoleER,aswellasproductsalesmix.
Netlossforthefirstquarter2018was$79.4million,comparedtoanetlossof$56.6millionintheprioryearperiod.AdjustedEBITDA(earningsbeforeinterest,taxes,depreciationandamortization)was$95.9millionforthefirstquarter2018,comparedto$96.0forthefirstquarter2017.
Refertothe“Non-GAAPFinancialMeasures”sectionforadditionalinformation,includingreconciliationsofallGAAPtonon-GAAPfinancialmeasures.
2018 Financial Guidance
Amneal’sfullyear2018estimatesarebasedonmanagement’scurrentexpectations,includingwithrespecttoprescriptiontrends,pricinglevels,inventorylevels,andtheanticipatedtimingoffutureproductlaunchesandevents.TheCompanydoesnotprovideforward-lookingguidancemetricsasoutlinedbelowonaGAAPbasis.Consequently,theCompanycannotprovideareconciliationbetweennon-GAAPexpectationsandcorrespondingGAAPmeasureswithoutunreasonableeffortsbecauseitisunabletopredictwithreasonablecertaintytheultimateoutcomeofcertainsignificantitemsrequiredforthereconciliation.Theitemsinclude,butarenotlimitedto,acquisition-relatedexpenses,restructuringexpenses,assetimpairmentsandcertainandothergainsandlosses.Theseitemsareuncertain,dependonvariousfactors,andcouldhaveamaterialimpactonU.S.GAAPreportedresultsfortheguidanceperiod.Thefollowingstatementsareforwardlookingandactualresultscoulddiffermateriallydependingonmarketconditionsandthefactorssetforthunder“SafeHarbor”below.
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2018KeyGuidanceAssumptions
• GrowthinadjustedEBITDAweightedtowardssecondhalfof2018duetoestimatedtimingofnewapprovalsandlaunches
• Genericdivisiongrowthdrivenbynewproductlauncheswhichareexpectedtomorethanoffsetadditionalcompetitiononexistingportfolio
• Potentialopportunitytolaunchapproximately60genericproducts
• SpecialtyPharmagrowthdrivenbyRytary®,Zomig®nasalsprayandEmverm®
• DeliveringoninvestmentsinR&D
• Currentlytargetingtofilemorethan30ANDAs
• Initiatingphase3studyforIPX203
• Targetingsynergiesof$30to$35million
• 50%R&D,30%SG&A,20%Manufacturing
Financial Guidance
Full Year
2018AdjustedGrossMargins 50%-55%AdjustedR&Dasa%ofTotalRevenues 10%-15%AdjustedSG&Aasa%ofTotalRevenues 13%-16%AdjustedEBITDA1 $600to$650millionAdjustedEPS $0.95-$1.10AdjustedEffectiveTaxRate 20%-22%CapitalExpenditures $80to$100millionDilutedSharesOutstanding Approximately300million
1 Includes$30millionto$35millionofcostsynergiesexpectedtoberealizedin2018.
Advisors
J.P.MorganSecuritiesLLCservedasfinancialadvisortoAmnealPharmaceuticalsLLCinconnectionwiththebusinesscombination,withLatham&WatkinsLLPactingasitslegaladvisor.
MorganStanleyservedasfinancialadvisortoImpax,withSullivan&CromwellLLPandMcDermott,Will&EmeryLLPactingasitslegaladvisors.Inaddition,ImpaxreceivedadvicefromBofAMerrillLynch.
Conference Call Information
AmnealwillholdaconferencecallonMay7,2018at8:30a.m.EasternTimetodiscussthetransaction.ThecallandpresentationcanalsobeaccessedviaaliveWebcastthroughtheInvestorRelationssectionofAmneal’sWebsiteathttps://investors.amneal.com/investor-relations,ordirectlyathttps://event.on24.com/wcc/r/1627874/508FEB8742DB6A45D45E06D703CE394D.ThenumbertocallfromwithintheUnitedStatesis(877)356-3814and(706)758-0033internationally.TheconferenceIDis4364429.Areplayoftheconferencecallwillbeavailableshortlyafterthecallforaperiodofsevendays.Toaccessthereplay,dial(855)859-2056(intheU.S.)and(404)537-3406(internationalcallers).
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About Amneal
AmnealPharmaceuticals,Inc.(NYSE:AMRX),headquarteredinBridgewater,NJ,isanintegratedspecialtypharmaceuticalcompanyfocusedondeveloping,manufacturinganddistributinggeneric,brandandbiosimilarproducts.TheCompanyhasapproximately6,500employeesinitsoperationsinNorthAmerica,Asia,andEurope,workingtogethertobringhigh-qualitymedicinestopatientsprimarilywithintheUnitedStates.
AmnealisoneofthelargestandfastestgrowinggenericpharmaceuticalmanufacturersintheUnitedStates,withanexpandingportfolioofgenericproductstoincludecomplexdosageformsinabroadrangeoftherapeuticareas.TheCompanymarketsaportfolioofbrandedpharmaceuticalproductsthroughitsImpaxSpecialtyPharmadivisionfocusedprincipallyoncentralnervoussystemdisordersandparasiticinfections.Formoreinformation,visitwww.amneal.com.
Safe Harbor Statement
Certainstatementscontainedherein,regardingmattersthatarenothistoricalfacts,maybeforward-lookingstatements(asdefinedinSection27AoftheUnitedStatesSecuritiesActof1933,asamended,andSection21EoftheUnitedStatesSecuritiesExchangeActof1934,asamended).Weintendsuchforward-lookingstatementstobecoveredbythesafeharborprovisionsforforward-lookingstatementscontainedinthePrivateSecuritiesLitigationReformActof1995andincludethisstatementforpurposesofcomplyingwiththesafeharborprovisions.Suchforward-lookingstatementsincludestatementsregardingmanagement’sintentions,plans,beliefs,expectationsorforecastsforthefuture.Thewordssuchas“may,”“will,”“could,”“should,”“expect,”“plan,”“anticipate,”“intend,”“believe,”“estimate,”“continue,”andsimilarwordsareintendedtoidentifyestimatesandforward-lookingstatements.
Suchforward-lookingstatementsarebasedontheexpectationsofAmnealPharmaceuticals,Inc.(“our”orthe“Company”)andinvolverisksanduncertainties;consequently,actualresultsmaydiffermateriallyfromthoseexpressedorimpliedinthestatements.Suchrisksanduncertaintiesinclude,butarenotlimitedto(i)ourabilitytointegratetheoperationsofAmnealPharmaceuticalsLLC(“Amneal”)andImpaxLaboratories,Inc.(“Impax”)pursuanttothetransactions(the“Combination”)contemplatedbythatcertainBusinessCombinationAgreementdatedasofOctober17,2017byandamongtheCompany,Amneal,ImpaxandK2MergerSubCorporationasamendedbyAmendmentNo.1,datedNovember21,2017andAmendmentNo.2datedDecember16,2017andourabilitytorealizetheanticipatedsynergiesandotherbenefitsoftheCombination,(ii)thefactthatcertainofourstockholdersholdingoveramajorityofoursharesmayhaveinterestsdifferentfromthoseofourotherstockholders,(iii)thetransactioncostsrelatedtotheCombination,(iv)resultsfromthepublicunauditedfinancialinformationofImpaxandAmnealmaynotbeindicativeoftheCompany’sfutureoperatingperformance,(v)businessissuesfacedbyeitherAmnealorImpaxmaybeimputedtotheoperationsoftheCompany,(vi)theimpactofaseparationofImpaxorAmnealasasubsidiaryoftheCompany,(vii)thechangeofcontrolorearlyterminationrightsincertainofImpax’sorAmneal’scontractsthatmaybeimplicatedbytheCombination,(viii)paymentsrequiredbytheCompany’sTaxReceivablesAgreement,(ix)theimpactofglobaleconomicconditions,(x)ourabilitytosuccessfullydeveloporcommercializenewproducts,(xi)ourabilitytoobtainexclusivemarketingrightsforourproductsortointroduceproductsonatimelybasis,(xii)thecompetitionwefaceinthepharmaceuticalindustryfrombrandandgenericdrugproductcompanies,(xiii)ourabilitytomanageourgrowth,(xiv)theimpactofcompetition,(xv)theillegaldistributionandsalebythirdpartiesofcounterfeitversionsofourproductsorofstolenproducts,(xvi)marketperceptionsofusandthesafetyandqualityofourproducts,(xvii)thesubstantialportionofourtotalrevenuesderivedfromsalesofalimitednumberofproducts,(xviii)ourability
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todevelop,licenseoracquireandintroducenewproductsonatimelybasis,(xix)theabilityofourapprovedproductstoachieveexpectedlevelsofmarketacceptance,(xx)theriskthatwemaydiscontinuethemanufactureanddistributionofcertainexistingproducts,(xxi)theimpactofmanufacturingorqualitycontrolproblems,(xxii)productliabilityrisks,(xxiii)risksrelatedtochangesintheregulatoryenvironment,includingUnitedStatesfederalandstatelawsrelatedtohealthcarefraudabuseandhealthinformationprivacyandsecurityandchangesinsuchlaws,(xxiv)changestoFDAproductapprovalrequirements,(xxv)risksrelatedtofederalregulationofarrangementsbetweenmanufacturersofbrandedandgenericproducts,(xxvi)theimpactofhealthcarereform,(xxvii)businessinterruptionsatoneofourfewlocationsthatproducethemajorityofourproducts,(xxviii)relationshipswithourmajorcustomers,(xxix)thecontinuingtrendofconsolidationofcertaincustomergroups,(xxx)ourrelianceoncertainlicensestoproprietarytechnologies,(xxxi)ourdependenceonthirdpartysuppliersanddistributorsforrawmaterialsforourproducts,(xxxii)thetimenecessarytodevelopgenericandbrandeddrugproducts,(xxxiii)ourdependenceonthirdpartiesfortestingrequiredforregulatoryapprovalofourproducts,(xxxiv)ourdependenceonthirdpartyagreementsforaportionofourproductofferings,(xxxv)ourabilitytomakeacquisitionsoforinvestmentsincomplementarybusinessesandproducts,(xxxvi)regulatoryoversightininternationalmarkets,(xxxvii)ourincreasedexposuretotaxliabilitiesandtheimpactofrecentUnitedStatetaxlegislation,(xxxviii)thirdparties’infringementofourintellectualpropertyrights,(xxxix)ourinvolvementinvariouslegalproceedings,(xl)increasedgovernmentscrutinyrelatedtoouragreementstosettlepatentlitigation,(xli)theimpactoflegal,regulatoryandlegislativestrategiesbyourbrandcompetitors,(xlii)thesignificantamountofresourcesweexpendonresearchanddevelopment,(xliii)oursubstantialamountofindebtedness,(xliv)risksinherentinconductingclinicaltrials,(xlv)ourreportingandpaymentobligationsundertheMedicaidandothergovernmentrebateprograms,(xlvi)fluctuationsinouroperatingresults,(xlvii)adjustmentstoourreservesbasedonpriceadjustmentsandsalesallowances,(xlviii)impactofimpairmentonourgoodwillandotherintangibleassets,(xlix)investigationsandlitigationconcerningthecalculationofaveragewholesaleprices,(l)cybersecurityanddataleakagerisks,(li)ourabilitytoattractandretaintalentedemployeesandconsultants,(lii)uncertaintiesinvolvedinthepreparationofourfinancialstatements,(liii)impactofterroristattacksandotheractsofviolence,(liv)expansionofsocialmediaplatforms,(lv)ourneedtoraiseadditionalfundsinthefuture,(lvi)therestrictionsimposedbythetermsofourcreditagreement,(lvii)ourabilitytogeneratesufficientcashtoserviceourindebtednessinthefutureand(lviii)suchotherfactorsasmaybesetforthintheCompany’spublicfilingswiththeSecuritiesandExchangeCommission.
Forward-lookingstatementsincludedhereinspeakonlyasofthedatehereofandweundertakenoobligationtoreviseorupdatesuchstatementstoreflecteventsorcircumstancesafterthedatehereofortoreflecttheoccurrenceofunanticipatedeventsorcircumstances.
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Amneal Pharmaceuticals, Inc.Combined Statements of Operations
(Unaudited;Inthousands)
TheCombinedStatementsofOperationspresentedbelowrepresentsthecombinationofthestand-aloneresultsforeachofAmnealPharmaceuticalsLLCandImpaxLaboratoriesLLC(formerlyImpaxLaboratories,Inc.)andfortheperiodsendedMarch31,2018and2017.TheCombinedStatementsofOperationsarenotpreparedonaproformabasisanddonotreflecttheadjustmentsthatwouldbenecessarytopresentthefinancialresultsofthecombinedcompanyasifthecombinationhadbeencompletedatthebeginningoftheperiodspresented. Three months ended
March 31,
2018 March 31,
2017 Revenues:
Generics,net $358,330 $359,828SpecialtyPharma,net 59,214 50,256
Totalrevenues 417,544 410,084
Costofrevenues 242,669 229,897Costofrevenuesimpairmentcharges — 39,280
Grossprofit 174,875 140,907
Operatingexpenses: Selling,generalandadministrative 94,183 81,033Researchanddevelopment 56,477 61,799In-processresearchanddevelopmentimpairmentcharges — 6,079Litigation,settlementsandrelatedcharges 85,537 1,072
Totaloperatingexpenses 236,197 149,983
Lossfromoperations (61,322) (9,076)
Otherexpense,net: Interestexpense,net (34,743) (27,387)Foreignexchangegain 9,486 14,597Lossondebtextinguishment — (1,215)Other,net 373 (1,185)
Lossbeforeincometaxes (86,206) (24,266)(Benefitfrom)provisionforincometaxes (6,926) 31,904
Netloss $ (79,280) $ (56,170)Less:Netincomeattributabletononcontrollinginterests $ (117) $ (408)
NetlossattributabletoAmneal $ (79,397) $ (56,578)
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Amneal Pharmaceuticals LLCConsolidated Statements of Operations
(Unaudited;Inthousands) Three months ended
March 31,
2018 March 31,
2017 Revenues:
Generics,net $275,189 $225,681
Costofrevenues 130,594 109,665
Grossprofit 144,595 116,016
Operatingexpenses: Selling,generalandadministrative 36,860 33,978Researchanddevelopment 44,181 39,310
Totaloperatingexpenses 81,041 73,288
Incomefromoperations 63,554 42,728
Otherexpense,net: Interestexpense,net (21,051) (14,161)Foreignexchangegain 8,565 14,597Other,net 948 100
Incomebeforeincometaxes 52,016 43,264Provisionforincometaxes 364 1,003
Netincome $ 51,652 $ 42,261Less:Netincomeattributabletononcontrollinginterests $ (117) $ (408)
NetincomeattributabletoAmneal $ 51,535 $ 41,853
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Impax Laboratories LLC(formerly Impax Laboratories, Inc.)
Consolidated Statements of Operations(Unaudited;Inthousands)
Three months ended
March 31,
2018 March 31,
2017 Revenues:
Generics,net $ 83,141 $134,147SpecialtyPharma,net 59,214 50,256
Totalrevenues 142,355 184,403
Costofrevenues 112,075 120,232Costofrevenuesimpairmentcharges — 39,280
Grossprofit 30,280 24,891
Operatingexpenses: Selling,generalandadministrative 57,323 47,055Researchanddevelopment 12,296 22,489In-processresearchanddevelopmentimpairmentcharges — 6,079Litigation,settlementsandrelatedcharges 85,537 1,072
Totaloperatingexpenses 155,156 76,695
Lossfromoperations (124,876) (51,804)
Otherexpense,net: Interestexpense,net (13,692) (13,226)Foreignexchangegain 921 —Lossondebtextinguishment — (1,215)Other,net (575) (1,285)
Lossbeforeincometaxes (138,222) (67,530)(Benefitfrom)provisionforincometaxes (7,290) 30,901
Netloss $(130,932) $ (98,431)
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Amneal Pharmaceuticals, Inc.Non-GAAP Financial Measures
EBITDA,adjustedEBITDA,adjustedcostofrevenuesandadjustedearningspersharearenotmeasuresoffinancialperformanceundergenerallyacceptedaccountingprinciples(GAAP)andshouldnotbeconstruedasameasureoffinancialperformance.However,managementusesbothGAAPfinancialmeasuresandthedisclosednon-GAAPfinancialmeasuresinternallytoevaluateandmanagetheCompany’soperationsandtobetterunderstanditsbusiness.Further,managementbelievestheadditionofnon-GAAPfinancialmeasuresprovidesmeaningfulsupplementaryinformationto,andfacilitatesanalysisby,investorsinevaluatingtheCompany’sfinancialperformance,resultsofoperationsandtrends.TheCompany’scalculationsofEBITDA,adjustedEBITDA,adjustedcostofrevenuesandadjustedearningspersharemaynotbecomparabletosimilarlydesignatedmeasuresreportedbyothercompanies,sincecompaniesandinvestorsmaydifferastowhattypeofeventswarrantadjustment.
ThefollowingtablereconcilesthecombinedAmnealPharmaceuticalsLLCandImpaxLaboratoriesLLCreportednetlosstoadjustedEBITDA:(unaudited,Inthousands)
Three months ended
March 31,
2018 March 31,
2017 Netloss $ (79,397) $ (56,578)Adjustedtoadd(deduct):
Interestexpense,net 34,743 27,387Incometaxes (6,926) 31,904Depreciationandamortization 32,727 34,698
EBITDA (18,853) 37,411
Adjustedtoadd(deduct): GeminiLaboratories,LLCEBITDA(a) 4,100 4,150Share-basedcompensationexpense 4,816 6,957Businessdevelopmentexpenses(b) 13,679 50Restructuringandseverancecharges 4,900 9,455Lossonextinguishmentofdebt — 1,215Inventoryrelatedcharges 6,889 —Litigation,settlementsandrelatedcharges(c) 90,099 (495)Assetimpairmentcharges 53 45,359Royaltyexpense — 3,763Exchangegain (9,486) (14,596)Other (293) 2,709
AdjustedEBITDA $ 95,904 $ 95,978
(a) RepresentstheEBITDAgeneratedbyGeminiLaboratories,LLC,whichAmnealacquiredonMay7,2018.(b) PrimarilyrepresentsprofessionalfeesincurredinconnectionwiththecombinationofAmnealandImpax.(c) DuringMarch2018,ImpaxseparatelysettledclaimsassociatedwithitsSolodyn®AntitrustClassActionsforatotalsettlementof$84.5million.
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Amneal Pharmaceuticals, Inc.Non-GAAP Financial Measures
ThefollowingtablereconcilescombinedAmnealPharmaceuticalsLLCandImpaxLaboratoriesLLCreportedcostofrevenuestoadjustedcostofrevenuesforpurposesofdeterminingadjustedgrossmargin(unaudited,inthousands).
Three months ended
March 31,
2018 March 31,
2017 Totalrevenues $417,544 $410,084
Costofrevenues 242,669 $229,897Costofrevenuesimpairmentcharges — 39,280Adjustedtodeduct:
Amortization 16,233 18,118Intangibleassetimpairmentcharges — 39,280Restructuringandseverancecharges 2,555 7,775Inventoryrelatedcharges 6,889 —
Adjustedcostofrevenues $216,992 $204,004
Adjustedgrossprofit(a) $200,552 $206,080Adjustedgrossmargin(a) 48.0% 50.3%
(a) Adjustedgrossprofitiscalculatedastotalrevenueslessadjustedcostofrevenues.Adjustedgrossmarginiscalculatedasadjustedgrossprofitdividedby
totalrevenues.
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Amneal&ImpaxCompleteCombinationAStrategicCombinationforLong-TermGrowthMay7,2018“Wemakehealthypossible”Exhibit99.2
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SafeHarborStatementCertainstatementscontainedherein,regardingmattersthatarenothistoricalfacts,maybeforward-lookingstatements(asdefinedinSection27AoftheUnitedStatesSecuritiesActof1933,asamended,andSection21EoftheUnitedStatesSecuritiesExchangeActof1934,asamended).Weintendsuchforward-lookingstatementstobecoveredbythesafeharborprovisionsforforward-lookingstatementscontainedinthePrivateSecuritiesLitigationReformActof1995andincludethisstatementforpurposesofcomplyingwiththesafeharborprovisions.Suchforward-lookingstatementsincludestatementsregardingmanagement’sintentions,plans,beliefs,expectationsorforecastsforthefuture.Thewordssuchas“may,”“will,”“could,”“should,”“expect,”“plan,”“anticipate,”“intend,”“believe,”“estimate,”“continue,”andsimilarwordsareintendedtoidentifyestimatesandforward-lookingstatements.Suchforward-lookingstatementsarebasedontheexpectationsofAmnealPharmaceuticals,Inc.(“our”orthe“Company”)andinvolverisksanduncertainties;consequently,actualresultsmaydiffermateriallyfromthoseexpressedorimpliedinthestatements.Suchrisksanduncertaintiesinclude,butarenotlimitedto(i)ourabilitytointegratetheoperationsofAmnealPharmaceuticalsLLC(“Amneal”)andImpaxLaboratories,Inc.(“Impax”)pursuanttothetransactions(the“Combination”)contemplatedbythatcertainBusinessCombinationAgreementdatedasofOctober17,2017byandamongtheCompany,Amneal,ImpaxandK2MergerSubCorporationasamendedbyAmendmentNo.1,datedNovember21,2017andAmendmentNo.2datedDecember16,2017andourabilitytorealizetheanticipatedsynergiesandotherbenefitsoftheCombination,(ii)thefactthatcertainofourstockholdersholdingoveramajorityofourshares(the“AmnealGroupMembers”)mayhaveinterestsdifferentfromthoseofourotherstockholders,(iii)thetransactioncostsrelatedtotheCombination,(iv)resultsfromthepublicunauditedfinancialinformationofImpaxandAmnealmaynotbeindicativeoftheCompany’sfutureoperatingperformance,(v)businessissuesfacedbyeitherAmnealorImpaxmaybeimputedtotheoperationsoftheCompany,(vi)theimpactofaseparationofImpaxorAmnealasasubsidiaryoftheCompany,(vii)thechangeofcontrolorearlyterminationrightsincertainofImpax’sorAmneal’scontractsthatmaybeimplicatedbytheCombination,(viii)paymentsrequiredbytheCompany’sTaxReceivablesAgreement,(ix)theimpactofglobaleconomicconditions,(x)ourabilitytosuccessfullydeveloporcommercializenewproducts,(xi)ourabilitytoobtainexclusivemarketingrightsforourproductsortointroduceproductsonatimelybasis,(xii)thecompetitionwefaceinthepharmaceuticalindustryfrombrandandgenericdrugproductcompanies,(xiii)ourabilitytomanageourgrowth,(xiv)theimpactofcompetition,(xv)theillegaldistributionandsalebythirdpartiesofcounterfeitversionsofourproductsorofstolenproducts,(xvi)marketperceptionsofusandthesafetyandqualityofourproducts,(xvii)thesubstantialportionofourtotalrevenuesderivedfromsalesofalimitednumberofproducts,(xviii)ourabilitytodevelop,licenseoracquireandintroducenewproductsonatimelybasis,(xix)theabilityofourapprovedproductstoachieveexpectedlevelsofmarketacceptance,(xx)theriskthatwemaydiscontinuethemanufactureanddistributionofcertainexistingproducts,(xxi)theimpactofmanufacturingorqualitycontrolproblems,(xxii)productliabilityrisks,(xxiii)risksrelatedtochangesintheregulatoryenvironment,includingUnitedStatesfederalandstatelawsrelatedtohealthcarefraudabuseandhealthinformationprivacyandsecurityandchangesinsuchlaws,(xxiv)changestoFDAproductapprovalrequirements,(xxv)risksrelatedtofederalregulationofarrangementsbetweenmanufacturersofbrandedandgenericproducts,(xxvi)theimpactofhealthcarereform,(xxvii)businessinterruptionsatoneofourfewlocationsthatproducethemajorityofourproducts,(xxviii)relationshipswithourmajorcustomers,(xxix)thecontinuingtrendofconsolidationofcertaincustomergroups,(xxx)ourrelianceoncertainlicensestoproprietarytechnologies,(xxxi)ourdependenceonthirdpartysuppliersanddistributorsforrawmaterialsforourproducts,(xxxii)thetimenecessarytodevelopgenericandbrandeddrugproducts,(xxxiii)ourdependenceonthirdpartiesfortestingrequiredforregulatoryapprovalofourproducts,(xxxiv)ourdependenceonthirdpartyagreementsforaportionofourproductofferings,(xxxv)ourabilitytomakeacquisitionsoforinvestmentsincomplementarybusinessesandproducts,(xxvi)regulatoryoversightininternationalmarkets,(xxxvii)ourincreasedexposuretotaxliabilitiesandtheimpactofrecentUnitedStatetaxlegislation,(xxxviii)thirdparties’infringementofourintellectualpropertyrights,(xxxix)ourinvolvementinvariouslegalproceedings,(xl)increasedgovernmentscrutinyrelatedtoouragreementstosettlepatentlitigation,(xli)theimpactoflegal,regulatoryandlegislativestrategiesbyourbrandcompetitors,(xlii)thesignificantamountofresourcesweexpendonresearchanddevelopment,(xliii)oursubstantialamountofindebtedness,(xliv)risksinherentinconductingclinicaltrials,(xlv)ourreportingandpaymentobligationsundertheMedicaidandothergovernmentrebateprograms,(xlvi)fluctuationsinouroperatingresults,(xlvii)adjustmentstoourreservesbasedonpriceadjustmentsandsalesallowances,(xlviii)impactofimpairmentonourgoodwillandotherintangibleassets,(xlix)investigationsandlitigationconcerningthecalculationofaveragewholesaleprices,(l)cybersecurityanddataleakagerisks,(li)ourabilitytoattractandretaintalentedemployeesandconsultants,(lii)uncertaintiesinvolvedinthepreparationofourfinancialstatements,(liii)impactofterroristattacksandotheractsofviolence,(liv)expansionofsocialmediaplatforms,(lv)ourneedtoraiseadditionalfundsinthefuture,(lvi)therestrictionsimposedbythetermsofourcreditagreement,(lvii)ourabilitytogeneratesufficientcashtoserviceourindebtednessinthefutureand(lviii)suchotherfactorsasmaybesetforthintheCompany’spublicfilingswiththeSecuritiesandExchangeCommission.Forward-lookingstatementsincludedhereinspeakonlyasofthedatehereofandweundertakenoobligationtoreviseorupdatesuchstatementstoreflecteventsorcircumstancesafterthedatehereofortoreflecttheoccurrenceofunanticipatedeventsorcircumstances.Trademarksreferencedhereinarethepropertyoftheirrespectiveowners.©2018AmnealPharmaceuticals,Inc.AllRightsReserved.
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AgendaStrongFoundationforGrowth•PaulBisaro,ExecutiveChairmanTheNewAmneal•RobStewart,President&CEOFinancialUpdate&CapitalStructure•BryanReasons,CFOClosingRemarks•RobStewartQuestions&Answers12345
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StrongFoundationforGrowthPaulBisaroExecutiveChairman
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AStrongFoundationtoDeliverLong-TermGrowth200+1495IPX20311~20~10%GenericsBiosimilarsSpecialtyProductsOURPORTFOLIOFOCUSBIOSIMILARSPIPELINEMANUFACTURINGCAPACITYANNUALR&DINVESTMENTGENERICPRODUCTFAMILIESSPECIALTYPRODUCTSGENERICSPIPELINESPECIALTYPIPELINE(Parkinson’sdisease)BillionunitsofannualrevenuesProductfiledNear-termfilingopportunity811R&DCENTERSGLOBALMANUFACTURINGFACILITIESSupportedbyStrongCashFlowTargetedforContinuedInvestmentinGrowthInitiativesandDebtReductionDataasofApril1,20181UnderDevelopment135ProductsfiledUnderDevelopment
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TheNewAmnealRobertStewartPresidentandCEO
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Well-PositionedGenericPipelinetoDriveGrowthWithoneofthelargestU.S.genericproductspipelines,wearepositionedtobealeaderinanevolvingmarketandmeettheever-changingneedsoftomorrowAmnealdataasofApril1,2018.IncludesproductsonfilewiththeFDAandtentativeapprovalsnotyetlaunched.1Publiclydiscloseddataasofdatelisted:Teva–Dec.31,2017,Mylan–Apr.11,2018,Endo–Feb.27,2018,Akorn–Jan.8,2018,Lannett–Mar.20,2018.ExcludesIndianGxplayers.U.S.GENERICSPLAYERS:FILEDANDAs1
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OseltamivirCapsules~$80mm+AspirinandExtended-ReleaseDipyridamole~$90mm+Adrenaclick(epinephrineauto-injector)~$108mm+DiclofenacSodiumTopicalGel1%~$95mm+Yuvafem(EstradiolVaginalTablets)~$124mm+DiversifiedGenericProductsCommercialPortfolioFortheTop5Genericproductsshown,netrevenuesreflectthelasttwelvemonthsendedMarch31,2018.1Top5genericproductnetrevenueasapercentoftotalcompanynetrevenueforthelast12monthsendedMarch31,2018.Ourportfolioconsistsofmorethan200productfamiliesincludingdifficult-to-manufactureandhighbarrier-to-entryproductsacrossmultipledosageformsRevenueDiversification-Top5GenericProductRevenueContribution~27%1
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StableCashFlowfromSpecialtyFranchiseProprietarymarketedproductsCentralnervoussystemdisordersParasiticinfectionsOthertherapeuticareasEstablishedU.S.salesandmarketingfunction130salesrepsPrimarilytargetingneurologists,movementdisorderspecialistsandotherhigh-prescribingphysiciansinkeymarketsCommittedtoInvestinginOrganicandExternalOpportunitiestoCreateLong-TermGrowth
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BroadR&DCapabilitiesORALSOLIDS&LIQUIDS•IR/ERtablets•HardGelatinCapsules•SoftgelCapsules•Hormonals•ControlledSubstances•Suspensions/SolutionsTOPICALS•Gels•Creams•Ointments&Devices•HormonalsINJECTABLES&STERILE•Peptides•Microspheres•Liposomes•Hormonals•GeneralInjectables•OncologyInjectables•Ophthalmics•OticsTRANSDERMALS•Matrix•Hydrogel•FormFillSeal•HormonalsRESPIRATORY•MeteredDose•DryPowder•NasalSprayPumps•BFSInhalation8GlobalR&DFacilitiesOfferingaFullSuiteofIn-HouseCapabilities
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DiversifiedandHigh-ValueGenericPipelineApproximately284totalprojectsofwhich~50%arehighvalueopportunities1Note:%numbersinpiechartsaboverepresentpercentageofproductswithineachdosageform;$amountsrepresentrespectivesalesdataperIQVIA,asnotedbelow.1HighvalueopportunitiesareeFTF,FTF,FTMandotherhighvalueopportunitieswith0to3competitors.2PipelinedataasofApril1,2018.3SalesdataperIQVIALTMFebruary2018Filings149ANDAs2U.S.Brand/GenericSales~$75Billion3DevelopmentPipeline:135projects2U.S.Brand/GenericSales~$45Billion3
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PendingANDAPipelineOffersNumerousPotentialHigh-ValueOpportunitiestoDriveGrowth$millions.PendingproductsasofApril1,2018withIQVIAsalesgreaterthan$1billion.IQVIAsalesdataasofFebruary2018.ProductsBrandLTMIMSSalesDimethylFumarateDRCapsulesTecfidera®$3,548GlatiramerInjection40mgCopaxoneHD®$3,457LisdexamfetamineDimesylateCapsuleVyvanse®$3,242LurasidoneTablets,20mg,40mg,60mg,80mgand120mgLatuda®$2,962Emtricitabine+TenofovirDisoproxilFumarateTruvada®$2,888CinacalcetHCl30mg,60mgand90mgTabletsSensipar®$1,831TeriflunomideTabletsAubagio®$1,487SildenafilCitrateTabletsViagra®$1,428AbirateroneAcetateTablets,250mgZytiga®$1,393LacosamideTabletVimpat®$1,191SodiumOxybateOralSolutionXyrem®$1,187ImatinibMesylateTabletsGleevec®$1,113MesalamineDelayedReleaseTablet,1.2gmLialda®$1,087TestosteroneMeteredGel1.62%PumpAndrogel®$1,062BiosimilarOpportunitiesPegfilgrastimNeulasta®$4,235BevacizumabAvastin®$2,926FilgrastimNeupogen®$353Asnapshotofonlyafewofthemanyhigh-valueopportunitiesinourpipeline
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OngoingCommitmenttoInvestinBiosimilarPipelineAmnealenteredintoalicensingandsupplyagreementforbiosimilarcandidateAvastin®(bevacizumab)AmnealwillbetheexclusivepartnerforthebevacizumabproductintheUSmarketAmnealwillpayup-front,developmentandregulatorymilestonepaymentstomAbxienceaswellasone-timecommercialmilestonepaymentsonreachingpre-agreedsalestargetsinthemarketProductFiledExpectedtobeFiled2H2018ExistingPartnershipNewPartnership
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DiverseandExtensiveManufacturingCapabilitiesDahej,India:ActivePharmaceuticalIngredientsVizag,India:ActivePharmaceuticalIngredientsHyderabad,India:Oncology(vialsandPFS)Ahmedabad,India:3Facilities:2OralSolids1Injectables(Peptides,LAdepot,Liposomes,PFSandOphthalmics)Cashel,Ireland:MDI,DPI,HormonalInjectablesGlasgow,KY:DistributioncenterBrookhaven,NY:OralSolids,ControlledSubstances,SoftGel,HighPotencyandHormonalProductsPiscataway,NJ:ComplexandHighValueProducts,Topicals,Transdermals,HighPotencyandHormonalProductsHauppauge,NY:OralSolidsHayward,CA:OralSolids,ControlledSubstancesManufacturingDistributionBranchburg,NJ:OralLiquidProducts,NasalSpraysCapacitytoSupportGrowthfortheForeseeableFuture;~20BillionUnitCapacity
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SubstantialSynergyOpportunityExpected$200+millioninannualincrementalsynergieswithin3yearsofclose1$30-$35$40-$45SynergiesbyFunctionManufacturing/CMO~60%SG&A~20%R&D~20%PreviouslyDisclosedRun-RateSynergies2$80-$120$125-$150$200Within12monthsWithin24monthsWithin36months$65-$70$50+1Estimatedcashcostsof$65to$75milliontoachieveexpectedsynergiespfapproximately$200million.2Run-ratecostsynergiescalculatedusingtheestimatedachievednetsynergieswithin24monthsoftherespective.($inmillions)$200+
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AmnealAcquiresGeminiLaboratoriesLLCGeminiLaboratoriesisfocusedonmarketingandsalesofbrandedandspecialtyproductsPortfolioincludeslicensedandowned,nicheandmaturebrands,andapipelineof505(b)(2)’sfornichetherapeuticareasOperatingsynergybetweenGeminiandourSpecialtyPharmadivisionLeadproductUnithroid®-detailedprimarilytoendocrinologistsandhigh-prescribingprimarycarephysiciansUnithroid®isanicheproductin~$1billionlevothyroxinetabsmarketCoveredunderalong-termlicensefromJeromeStevensPharmaceuticalsGeminiholdsdistributionrightstothebrandonly,doesnothavegenericdistributionrightsContractsalesforcethroughSyneosHealthGemini’s505(b)(2)developmentinitiativeswillfitstrategicallywithintheoverallAmnealportfolioTwoproductsinactivedevelopment
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FinancialUpdate&CapitalStructureBryanReasonsSVP,ChiefFinancialOfficer
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$millions1Q20181Q2017Change1Q/1QTotalRevenues,net$417.5$410.12%Genericrevenues,net$358.3$359.80%SpecialtyPharmarevenues,net$59.2$50.318%GAAPGrossMargin41.9%34.4%750bpsAdjustedGrossMargin48.0%50.3%(230bps)Netloss($79.4)($56.6)(40%)AdjustedEBITDA$95.9$96.00%CombinedCompany1Q18FinancialResultsTheresultspresentedrepresentthecombinationofthestand-aloneresultsforeachofAmnealPharmaceuticalsLLCandImpaxLaboratoriesLLC(formerlyImpaxLaboratories,Inc.)fortheperiodsendedMarch31,2018and2017.Theresultspresentedarenotpreparedonaproformabasisanddonotreflecttheadjustmentsthatwouldbenecessarytopresentthefinancialresultsofthecombinedcompanyasifthecombinationhadbeencompletedatthebeginningoftheperiodspresented.Genericrevenuedrivers:Productlaunchesincludingoseltamivir,methylphenidateHCIERanderythromycinReducedsalesofbudesonide,lidocaine,yuvafem-estradiol,mixedamphetaminesaltsandfenofibrateduetoincreasedcompetitionLowersalesofepinephrineauto-injectorduetorecentsupplyshortageatthird-partymanufacturerLowerthanexpectedsalesofaspirindipyridamoleERduetorawmaterialconstraintsSpecialtyrevenuedrivers:HighersalesofRytary®,Zomig®andanthelminticproductsGAAPGrossmarginPrioryearincludedimpactofimpairmentchargeof~$39millionAdjustedgrossmargin:ImpactedbysupplyshortageandproductsalesmixCertainpricinginitiativesduring1Q18thatareexpectedtobenefitfutureperiods
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DebtandCapitalStructureCashandcashequivalentsof~$100million1$2.7billiontermloan;LIBOR+350basispoints$500millionrevolveravailableCashFlowTargetedforDebtReductionandInvestmentinGrowthInitiativesEstimatedsharecount:LegacyImpax:~75millionNewshares:~225millionTotalshares:~300million21DataasofMay4,2018.2Totalsharesconsistof(i)approximately75millionClassAshares(includingsharesunderlyingoptions)issuedtoformerImpaxstockholders,(ii)approximately47millionClassAandClassB-1sharessoldtoPIPEinvestorsand(iii)approximately179millionClassAsharesissuableonexchangeofLLCunitsheldbytheAmnealGroup(subjecttoa180daylock-upandwithacorrespondingnumberofClassBsharesissuedtoprovideforvotingrights).Approximately110millionClassAsharesarecurrentlylistedandpubliclytradedontheNYSE.
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ClosingRemarksRobertStewartPresidentandCEO
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2018KeyGuidanceAssumptionsGrowthinadjustedEBITDAweightedtowardssecondhalfof2018duetoestimatedtimingofnewapprovalsandlaunchesGenericdivisiongrowthdrivenbynewproductlauncheswhichareexpectedtomorethanoffsetadditionalcompetitiononexistingportfolioPotentialopportunitytolaunchapproximately60genericproductsYear-to-date;11ANDAsapprovedand11productslaunchedSpecialtyPharmagrowthdrivenbyRytary®,Zomig®nasalsprayandEmverm®DeliveringoninvestmentsinR&DCurrentlytargetingtofilemorethan30ANDAsInitiatingphase3studyforIPX203Targetingsynergiesof$30to$35million50%R&D,30%SG&A,20%ManufacturingDataasofMay4,2018.
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FullYear2018FinancialGuidanceGuidanceRangeFullYear2018AdjustedGrossMargins50%-55%AdjustedR&DExpenseasa%ofTotalRevenues110%-15%AdjustedSG&AExpenseasa%ofTotalRevenues13%-16%AdjustedEBITDA2$600to$650millionAdjustedEPS$0.95-$1.10AdjustedEffectiveTaxRate20%to22%CapitalExpenditures$80to$100millionDilutedSharesOutstandingApproximately300million1TargetedannualizedR&Dspendisapproximately10%oftotalrevenues.DelayedclosingofbusinesscombinationresultinginhigherR&Dspendin2018.2Includescostsynergiesof~$30-$35millioncurrentlyexpectedtoberealizedin2018.Amneal’sfullyear2018estimatesarebasedonmanagement'scurrentexpectations,includingwithrespecttoprescriptiontrends,pricinglevels,inventorylevels,andtheanticipatedtimingoffutureproductlaunchesandevents.TheCompanydoesnotprovideforward-lookingguidancemetricsasoutlinedbelowonaGAAPbasis.Consequently,theCompanycannotprovideareconciliationbetweennon-GAAPexpectationsandcorrespondingGAAPmeasureswithoutunreasonableeffortsbecauseitisunabletopredictwithreasonablecertaintytheultimateoutcomeofcertainsignificantitemsrequiredforthereconciliation.Theitemsinclude,butarenotlimitedto,acquisition-relatedexpenses,restructuringexpenses,assetimpairmentsandcertainandothergainsandlosses.Theseitemsareuncertain,dependonvariousfactors,andcouldhaveamaterialimpactonU.S.GAAPreportedresultsfortheguidanceperiod.Thefollowingstatementsareforwardlookingandactualresultscoulddiffermateriallydependingonmarketconditionsandthefactorssetforthunder"SafeHarbor"below.
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AdjustedEBITDABridgetoFullYear2018Guidance1Q2018AnnualizedAdjustedEBITDABacklogEpinephrineAuto-injectorMid-PointFullYear2018AdjustedEBITDAGuidanceVolume/PriceSpecialtyPharmaGrowthEBITDAAdjustedEBITDAGuidance$600to$650Million$millions
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FocusedonOperationalExecution…RapidlyandseamlesslycombineAmnealandImpaxFocusonsynergycaptureandcostcontrolMaintainhighlevelofqualityandcomplianceContinuetoprovidesuperiorservicetoourcustomersMaximizevalueofenhancedcommercialportfoliotogrowrevenueandprofits
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…AndContinuedInvestmentinGrowthInitiativesInvestinorganicgrowththroughfocusedR&DPursuecreativebusinessdevelopmenttostrengthenourfranchisesandotheradjacenciesGenericsBiosimilarsSpecialtyProductsOURPORTFOLIOFOCUS
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Questions&Answers
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Appendix&Non-GAAPReconciliations
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DisclosedANDAPendingPipeline$millions.Sourceofsalesdata:IMSNPSFebruary2018;PipelinedataasofApril1,2018.ProductBrandLTMIMSSalesProductBrandLTMIMSSalesPemetrexedinjectionAlimta®$1,053PitavastatinCalciumTabletLivalo®$292LubiprostoneCapsuleAmitiza®$489GuaifenesinTabletMucinex®$75TestosteroneGel1.62%Androgel®$1,062Guaifenesin+DextromethorphanHBrMucinex®DM$61TeriflunomideTabletAubagio®$1,487DronaderoneTabletMultaq®$450TestosteroneTopicalSolutionAxiron®$158RitonavirTabletNorvir®$200RisedronateSodiumDRtabletAtelvia®$18SaxagliptinHClTabletOnglyza®$404TicagrelorTabletBrilinta®$749DoxycyclineERCapsule40mgOracea®$300ExenatideInjectionByetta®$237OxycodoneERTabletOxyContin®$1,875MesalamineRectalSuppositoryCanasa®$245DiclofenacNaTopicalSolution2%Pennsaid®2%$953ColchicineTabletColcrys®$574DexmedetomidineHClInjectionPrecedex®$119GlatiramerInjectionCopaxone®HD$3,457AsenapineMaleateSublingualTabletSaphris®$292CarvedilolERcapsuleCoregCR®$192CinacalcetHClTabletSensipar®$1,739PrasugrelHClTabletEffient®$516QuetiapineFumarateERTabletSeroquel®XR$629ApixabanIRtabletEliquis®$4,956DimethylFumarateDRCapsuleTecfidera®$3,548DarifenacinHBrERTabletEnablex®$35FesoterodineFumarateTabletToviaz®$200RivastigmineTDSPatchExelon®$262Emtricitabine+TenofovirDFTabletTruvada®$2,888FulvestrantInjectionFaslodex®$503BortezomibInjectionVelcade®$637FentanylBuccalIRtabletFentora®$103SildenafilCitrateTabletViagra®$1,428LevomilnacipranHClERCapsuleFetzima®$118LacosamideTabletVimpat®$1,191ImatinibMesylateTabletGleevec®$1,113LisdexamfetamineDimesylateCapsuleVyvanse®$3,242SaxagliptinHCl+MetforminERTabletKombiglyze®XR$194ColesevelamIRtabletWelchol®$526LamotrigineERTabletLamictal®XR$323SodiumOxybateSolutionXyrem®$1,187LurasidoneHClTabletLatuda®$2,962AzithromycinPowderforSuspensionZithromax®$74MesalamineDRTabletLialda®$1,087AbirateroneAcetateTabletZytiga®$1,393
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GAAPtoNon-GAAPReconciliationThreemonthsendedMarch31,2018March31,2017Totalrevenues$417,544$410,084Costofrevenues242,669$229,897Costofrevenuesimpairmentcharges-39,280Adjustedtodeduct:Amortization16,23318,118Intangibleassetimpairmentcharges-39,280Restructuringandseverancecharges2,5557,775Inventoryrelatedcharges6,889-Adjustedcostofrevenues$216,992$204,004Adjustedgrossprofit(a)$200,552$206,080Adjustedgrossmargin(a)48.0%50.3%ThefollowingtablereconcilescombinedAmnealPharmaceuticalsLLCandImpaxLaboratoriesLLCreportedcostofrevenuestoadjustedcostofrevenuesforpurposesofdeterminingadjustedgrossmargin(unaudited,inthousands).(a)Adjustedgrossprofitiscalculatedastotalrevenueslessadjustedcostofrevenues.Adjustedgrossmarginiscalculatedasadjustedgrossprofitdividedbytotalrevenues.
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GAAPtoNon-GAAPReconciliationThefollowingtablereconcilesthecombinedAmnealPharmaceuticalsLLCandImpaxLaboratoriesLLCreportednetlosstoadjustedEBITDA:(unaudited,inthousands).(a)RepresentstheEBITDAgeneratedbyGeminiLaboratories,LLC,whichAmnealacquiredonMay7,2018.(b)PrimarilyrepresentsprofessionalfeesincurredinconnectionwiththecombinationofAmnealandImpax.(c)DuringMarch2018,ImpaxseparatelysettledclaimsassociatedwithitsSolodyn®AntitrustClassActionsforatotalsettlementof$84.5million.ThreemonthsendedMarch31,2018March31,2017Netloss$(79,397)$(56,578)Adjustedtoadd(deduct):Interestexpense,net34,74327,387Incometaxes(6,926)31,904Depreciationandamortization32,72734,698EBITDA(18,853)37,411Adjustedtoadd(deduct):GeminiLaboratories,LLCEBITDA(a)4,1004,150Share-basedcompensationexpense4,8166,957Businessdevelopmentexpenses(b)13,67950Restructuringandseverancecharges4,9009,455Lossonextinguishmentofdebt-1,215Inventoryrelatedcharges6,889-Litigation,settlementsandrelatedcharges(c)90,099(495)Assetimpairmentcharges5345,359Royaltyexpense-3,763Exchangegain(9,486)(14,596)Other(293)2,709AdjustedEBITDA$95,904$95,978