Professional Documents
Culture Documents
Investor Deck
Investor Deck
Investor Deck
Acquisitionof
Lumara Health
MaternalHealthBusiness
September29,2014
AMAGPharmaceuticals,Inc.
1100WinterStreet
Waltham,MA02451
o 617.498.3300
www.amagpharma.com
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
ASPECIALTYPHARMACEUTICALCOMPANY
DEDICATEDTOBRINGINGTOMARKET
THERAPIESTHATIMPROVEPATIENTSLIVES.
ForwardLookingStatements
`
ThispresentationcontainsforwardlookingstatementswithinthemeaningofthePrivateSecuritiesLitigationReformActof1995(PSLRA)andotherfederalsecuritieslaws.Anystatements
containedhereinwhichdonotdescribehistoricalfacts,includingbutnotlimitedto,statementsregarding:(1)ourplansto buildamultiproductspecialtypharmaceuticalcompany;(2)the
transactionwithLumaraHealthandtheadditionofMakenatoourproductportfolio,includingexpectedbenefits,opportunities,synergies,financing,resultsandtheimpactonadjusted
earningspershare(EPS),EBITDAandshareholdervalue,theimpactonourfinancialprofile,aswellasthetimingoftheclosingofthetransactionandtheissuanceofstockconsideration;
(3)expectationsthatthecombinedcompanywillhave$350millioninU.S.productsalesin2015andwillbeimmediatelyaccretivetoadjustedEPS;(4)anticipatedcombinedcompany
adjustedEPS;(5)AMAGsintentionstoprovidefurtherguidance;(6)anticipatedcostsynergiesofatleast$20million;(7)beliefsthatMakenaenjoyssignificantadvantagesoverpossible
competitionfromgenericalternatives;(8)expectationsthatMakenawillretainlongtermgrowthafterexclusivityexpiresinFebruary2018;(9)expectationsforMakenaslifecycle
managementprogram;(10)anticipatedbenefitsfromrulesandregulations,includingtheDrugQualityandSecurityAct,andproductreimbursementtrends;(11)thesizeofthemarketfor
Makena(potentially$1billionplusinrevenue);(12)expectationsfortheLumaraHealthmaternalhealthcommercialplatformand ourentryintoamarketimportantforthefuturegrowth
ofFeraheme (ferumoxytol)injection;(13)ourbeliefthatthisisatransformativetransactionthatpropelsusintoaprofitable,highgrowthmultiproductspecialtypharmaceutical
companypositionedforcontinuedrevenueandbottomlinegrowth,furtherdiversificationandshareholdervaluecreation;(14)expectationsregardingLumaraHealthsimpactonfuture
productacquisitions;(15)beliefsaboutthecommercialplatformandthestrategicfitofLumaraHealth;(16)ourplanstoexpandthemarketforFeraheme;(17)beliefsaboutMakenaand
itsbenefits,includingthatitisauniqueproductthatservesanimportantmedicalneed;(18)theimpactofMakenaonourproductportfolio;(19)beliefsregardingtheopportunityfor
Makenaandthepotentialtoleverageourinofficeinjectablescommercialexpertise;(20)expectationsregardingtheMakenacommercialteam,includingitsabilitytogrowthebrand;(21)
beliefsregardingthecombinedcompanysscale,portfoliodiversification,resourcesandcommercialexpertise,includingtheimpactonAMAGslongtermgrowthopportunitiesand
patientservice;(22)AMAGbeingtherightpartnertosupportthecontinuedgrowthofMakenaanditsmaternalhealthbusiness;(23)plansforLumaraHealthfollowingtheclosing;(24)
expectationsregardingthefinancingforandthetimelinefortheLumaraHealthtransaction;(25)ourtaxattributesandexpectationsregardingtheshareholderrightsplanamendment;
(26)ourplanstoexpandourportfoliothroughtheinlicenseorpurchaseofadditionalpharmaceuticalproductsorcompanies;and(27)ourgoalofbringingtomarkettherapiesthat
provideclearbenefitsandimprovepatientslivesareforwardlookingstatementswhichinvolverisksanduncertaintiesthatcouldcauseactualresultstodiffermateriallyfromthose
discussedinsuchforwardlookingstatements.StatementsaboutAMAGsorLumaraHealthspastfinancialresultsdonot,andare notmeantto,predictfutureresults.AMAGcanprovide
noassurancethatsuchresultsandperformancewillcontinue.Fortheavoidanceofdoubt,anystatementshereinthatrelatetotheacquisitionofLumaraHealthareforwardlooking
statementswithinthemeaningofthePSLRAandotherfederalsecuritieslaws.
Suchrisksanduncertaintiesinclude,amongothers:(1)thepossibilitythattheclosingconditionssetforthinthedefinitive acquisitionagreement,includingthoseconditionsrelatedto
antitrustclearance,willnotbemetandthatthepartieswillbeunabletoconsummatetheproposedtransaction,(2)thechancethat,despitehavingacommitmentinplace,wewillbe
unabletosecurefinancing,orfinancingonsatisfactoryterms,inamountssufficienttoconsummatetheacquisition,(3)thepossibilitythatiftheacquisitionisconsummated,wemaynot
realizetheexpectedbenefits,synergiesandopportunitiesanticipatedinconnectionwiththetransaction,includingtheanticipatedcostssynergiesof$20million,annualizedsalesofmore
than$180millionandcontinuedrevenuegrowth,annualizedEBITDAof$100million,the$1billionmarketopportunity,theaccelerateduseofcombined$500millioninnetoperating
lossesandthatthetransactionwillbeimmediatelyaccretivetoadjustedEPS,(4)thechallengesofintegratingtheMakenacommercialteamintoAMAG,(5)theimpactonsalesofMakena
fromcompetitive,commercialpayor,government(includingfederalandstateMedicaidreimbursementpolicies),physician,patient orpublicresponseswithrespecttoproductpricing,
productaccessandsalesandmarketinginitiatives,(6)theimpactofpatientcomplianceonunitssales,(7)theuncertaintyofachievingsalesofFerahemetoOB/GYNspecialistsforthe
treatmentofwomenwhosufferfromirondeficiencyanemia(IDA),evenassumingFDAapprovalforthebroaderindication,(8)wemayfacechallengesinleveragingourinoffice
injectablescommercialexpertise,whichcouldresultinunforeseenexpensesanddisruptbusinessoperations,(9)liabilitiesweassumefromLumaraHealth,includingtheclassaction
litigationInReKVPharmaceuticalCompanySecuritiesLitigation,CaseNo.4:11CV1816AGF,maybehigherthanexpected,(10)thepossibilitythatsalesofMakenawillnotmeet
expectationsasaresultofcurrentandfuturecompetitionfromcompoundedproductsand/orfuturecompetitionfromgenericalternativesuponexpirationofexclusivityinFebruary2018,
(11)theimpactofreimbursementpoliciesforMakenaandtheresultingcoveragedecisionsand/orimpactonpricing,(12)thenumberofpretermbirthriskpregnanciesforwhichMakena
maybeprescribed,itssafetyandsideeffectsprofileandacceptanceofpricing,
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
ForwardLookingStatements(cont.)
(13)inconnectionwiththeLumaraHealthacquisition,wewillincurasubstantialamountofindebtednessandwillhavetocomplywithrestrictiveandaffirmativedebtcovenants,
includingarequirementthatwereduceourleverageovertime,(14)thepossibilitythatwewillneedtoraiseadditionalcapitalfromthesaleofourcommonstock,whichwillcause
significantdilutiontoourstockholders,inordertosatisfyourcontractualobligations,includingourdebtservice,milestone paymentsthatmaybecomepayabletoLumaraHealths
stockholders/orinordertopursuebusinessdevelopmentactivities,(15)uponconsummationoftheLumaraHealthtransaction, we willbehighlyleveragedandhavelimitedcashand
cashequivalentresourceswhichmaylimitourabilitytotakeadvantageofattractivebusinessdevelopmentopportunitiesandexecuteonourstrategicplan,(16)thepossibilitythatour
stockholderswillnotapprovetheamendmenttoourshareholderrightsplanandthatourtaxbenefits,includingthoseacquireduponconsummationoftheLumaraHealthacquisition,
willnotbeavailableinthefuture,(17)thelikelihoodandtimingofpotentialapprovalofFerahemeintheU.S.inthebroader IDAindicationinlightofthecompleteresponseletterwe
receivedfromtheFDAinformingusthatoursupplementalnewdrugapplication(sNDA)forthebroaderindicationcouldnotbeapprovedinitspresentformandstatingthatwehadnot
providedsufficientinformationtopermitlabelingofFerahemeforsafeandeffectiveusefortheproposedbroaderindication,(18)thepossibilitythatfollowingFDAreviewofpost
marketingsafetydata,includingreportsofseriousanaphylaxis,cardiovascularevents,anddeath,and/orinlightofthelabelchangesrequestedbytheEuropeanMedicinesAgencys
(EMA)PharmacovigilanceRiskAssessmentCommittee(PRAC)andconfirmedbytheCommitteeforMedicinalProductsforHumanUse(CHMP),theFDA(orotherregulators)willrequest
additionaltechnicalorscientificinformation,newstudiesorreanalysisofexistingdata,onlabelwarnings,postmarketingrequirements/commitmentsorriskevaluationandmitigation
strategies(REMS)inthecurrentindicationforFerahemeforIDAinadultpatientswithchronickidneydisease(CKD)andtheadditionalcostsandexpensesthatwillormaybeincurredin
connectionwithsuchactivities,(19)whetherourproposedlabelchangeswillbeacceptabletotheFDAorotherregulatoryauthoritiesandwhatimpactsuchchanges,orsuchadditional
changesastheFDA,CHMPorotherregulatorsmayrequire,willhaveonsalesofFeraheme/Rienso(RiensoisthetradenameforferumoxytoloutsideoftheU.S.andCanada),(20)our
andTakedaPharmaceuticalLimitedsabilitytosuccessfullycompeteintheIVironreplacementmarketbothintheU.S.andoutsidetheU.S.,includingtheEU,asaresultoflimitations,
restrictionsorwarningsinFerahemes/Riensoscurrentorfuturelabel,includingthechangesrecommendedbyPRACandconfirmed byCHMPthatRiensobeadministeredtopatientsby
infusionoveratleast15minutes(replacinginjection)andthatitbecontraindicatedforpatientswithanyknownhistoryofdrugallergy,(21)ourabilitytoexecuteonourlongterm
strategicplanortorealizetheexpectedresultsfromourlongtermstrategicplan,(22)TakedasabilitytoobtainregulatoryapprovalforFerahemeinCanada,andRiensointheEU,inthe
broaderIDApatientpopulation,(23)thepossibilitythatsignificantsafetyordruginteractionproblemscouldarisewithrespecttoFeraheme/Riensoandinturnaffectsales,orourability
tomarkettheproductbothintheU.S.andoutsideoftheU.S.,includingtheEU,(24)therelationshipbetweenTakedaandAMAGandtheimpactoncommercializationeffortsfor
Feraheme/RiensointheEUandCanada,(25)thelikelihoodandtimingofmilestonepayments,ifany,inconnectionwithAMAGs licensingarrangementwithTakeda,(26)the
manufactureofFeraheme/RiensoorMuGard(orMakenaiftheacquisitionisconsummated),includinganysignificantinterruptioninthesupplyofrawmaterialsorfinishedproduct,(27)
ourpatentsandproprietaryrightsbothintheU.S.andoutsidetheU.S.(includingthoseacquiredintheacquisition),(28)the riskofanAbbreviatedNewDrugApplication(ANDA)filing
followingtheFDAsdraftbioequivalencerecommendationforferumoxytolpublishedinDecember2012,(29)thepossibilitythat AMAGwilldisseminatefutureDearHealthcareProvider
lettersintheU.S.(or,workingTakeda,inEuropeorothermarkets),(30)uncertaintiesregardingourabilitytocompeteinthe oralmucositismarketintheU.S.andinthewomens
maternalhealthmarketand(31)otherrisksidentifiedinourfilingswiththeU.S.SecuritiesandExchangeCommission(SEC), includingourQuarterlyReportonForm10Qforthequarter
endedJune30,2014andsubsequentfilingswiththeSEC.Anyoftheaboverisksanduncertaintiescouldmateriallyandadverselyaffectourresultsofoperations,ourprofitabilityand
ourcashflows,whichwould,inturn,haveasignificantandadverseimpactonourstockprice.Useofthetermincluding in thetwoparagraphsaboveshallmeanineachcase
including,butnotlimitedto.Wecautionyounottoplaceunduerelianceonanyforwardlookingstatements,whichspeakonly asofthedatetheyaremade.
Wedisclaimanyobligationtopubliclyupdateorreviseanysuchstatementstoreflectanychangeinexpectationsorinevents,conditionsorcircumstancesonwhichanysuchstatements
maybebased,orthatmayaffectthelikelihoodthatactualresultswilldifferfromthosesetforthintheforwardlookingstatements.AMAGPharmaceuticalsandFerahemeareregistered
trademarksofAMAGPharmaceuticals,Inc.MuGardisaregisteredtrademarkofAccessPharmaceuticals,Inc.Riensoisatrademark ofTakedaPharmaceuticalCompanyLimited.Makena
isaregisteredtrademarkofLumaraHealthInc.LumaraHealthisatrademarkofLumaraHealthInc.
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
AcquisitionofLumara HealthtransformsAMAGintoaprofitable,
highgrowthmultiproductspecialtypharmaceuticalcompany,well
positionedforcontinuedexpansionoftheproductportfolio
Product#5
MAKENA
LUMARA MATERNALHEALTH
Product#4
FERAHEME
MUGARD
HEMATOLOGY/ONCOLOGY,
HOSPITAL,NEPHROLOGY
HIGHPERFORMING
SPECIALTY
COMMERCIALTEAMS
STRONGFINANCIALPROFILE
EXPERIENCEDMANAGEMENTTEAM
CORPORATEINFRASTRUCTURE
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
TransactionHighlights
AcquisitionofLumara Healthanditsmaternalhealthdivision
Annualizedsalesof>$180millionandEBITDAof$110million*
72%revenuegrowth*
AddshighgrowthMakena product
OnlyFDAapprovedproducttolowertheriskofpretermsingletonbirthincertainatriskwomen
Rapidlyevolvingpositivemarketdynamics
7yearorphandrugexclusivitywithactivelineextension/lifecycleprogram
Strongstrategicrationale&anaturalfitforAMAG
Entryintospecialtywomenshealth,anareaofstrategicinterestforIDAmarketexpansion**
Enablesfutureproductacquisitionsonanewcommercialplatform
Transformsfinancialprofile
Estimatedproformacombined2015productsalesof~$350million
Immediatelyaccretivetoadjustedearningspershare
Acceleratesutilizationofcombined$500millioninnetoperatinglosses(subjecttolimitations)
Annualsynergiesof$20million
*Seeslide7
**IfFDAregulatoryapprovalinbroaderIDApopulationissoughtandreceived
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
TransactionTerms
Performance
BasedFinancial
Structure
Operational
Structure
Sourcesof
Consideration
Timing
$675MMconsideration(~3.75timesannualizedsales)
Upto$350MMofadditionalconsiderationbasedonMakena sales,including
milestonesof$300MM,$400MMand$500MM*
Lumara HealthwilloperateasseparatebusinessunitwithinAMAG
EasyintegrationofMakena commercialteam,including75personsalesforce
$340MMcommittedtermloanBfinancing,attractiveterms
$260MMinexistingAMAGcash
$75MMequity(subjecttolockupagreement)
HartScottRodino (HSR)review
Expecttocompletetransactionin4Q14
*Basedonconsecutive12monthsnetsales
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
LumaraMaternalHealthBusiness
Privatelyheldspecialty
pharmaceuticalcompanyfocused
onmaternalhealth
Makenaisaprogestinusedtolower
theriskofpretermbirthinwomen
whoarepregnantwithonebabyand
whohavespontaneouslydeliveredone
pretermbabyinthepast
Flagshipproduct,Makena
Commercialteamwithdeep
experiencewithOB/GYNsub
specialty
Weeklyintramuscular
injectionsfrom16to37
weeksofpregnancy,
1822totalinjections
Lumara Healthsnewcommercial
leadershipispursuingpatientcentric
businessstrategy
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
Makena:AValuableAsset
Significanttoplinerevenueand
growth
Strongsequentialquartergrowthlast
2+years
>$180MMannualizedMakenasales
basedonmostrecenttrailing3month
actuals*
72%revenuegrowthlasttwelvemonths
(endedAugust2014)vs.previous12
months
SignificantMakena UnitandDollarGrowth
18,000
$40MM
16,000
$35MM
14,000
$30MM
12,000
$25MM
10,000
$20MM
8,000
$15MM
6,000
$10MM
4,000
$5MM
2,000
$0MM
thatdrivesrobustbottomlinegrowth
Robustquarterlyearningsgrowth
Trailing3monthannualizedEBITDA
>$110MM*
20,000
$45MM
DemonstratedEBITDAGrowth
$30MM
$25MM
115%
Increase
$20MM
$15MM
$10MM
$5MM
*PeriodcoveringJuneAugust2014
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
$0MM
JuneAugust2013
JuneAugust2014
8
Lumara Health:NaturalFitforAMAG
Womenshealthsegment
includesoneofthelargest
poolsofirondeficiency
anemia(IDA)patients,not
yettreatedwithIViron
Establishesimmediate
presencewithinwomens
healthsubspecialtyfor
futureFeraheme growth*
AMAGworkingwithFDAto
finalizepathforwardfor
Feraheme labelexpansion,
expected4Q14
*IfFDAregulatoryapprovalinbroaderIDApopulationissoughtandreceived
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
Makena:StandardofCareTherapy
Lengthofpregnancyisoneofthemostimportantfactorsinanewbornsoverallhealthand
survival(1)
PrematurebirthintheU.S.costs$26.2billionannually(2)
Averagefirstyearmedicalcostsareapproximately10timesgreaterforpreterminfantsthanfor
fullterminfants(3)
StrongMakena EfficacyData(4,5)
32%Improvement
RateofBirth
31%Improvement
39%Improvement
Before 37 weeks
Before 35 weeks
Before 32 weeks
ControlN=153(%)
MakenaN=310(%)
(1)Whyatleast39weeksisbestforyourbaby.(2012,September).MarchofDimes.(2)Behrman,R.E.,&Butler,A.(2007).(3)ThomsonReuters.(2008,October28).TheCost
ofPrematurityandComplicatedDeliveriestoU.S.Employers.ReportpreparedfortheMarchofDimes.(4)Makena USPrescribingInformation(5)TheeffectivenessofMakena
isbasedonimprovementintheproportionofwomenwhodelivered<37weeksofgestation.
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
10
Makena:$1BMarketOpportunity(1)
Market Share Based on Patients(2)
Orphanpatientpopulation:
~140k160kestimatedpatients
peryear
Potentialtoincreasemarket
share
+30%revenueopportunitywith
enhancedpatientcompliance
(injectionsperpatient)
Off guidance(3)
~42K(30%)
Compounded
hydroxyprogesterone
caproate
~65K(46%)
Makena
~33K(24%)
Favorablemarketdynamicsand
reimbursementtrends
(1)Basedon140,000patients,>16injections/patientandnetrevenueof~$450/injection
(2)EstimatesbasedoncurrentMakena distributedunitsandquantitativephysicianmarketresearchdataoncompoundedhydroxyprogesterone caproate
(3)OffguidancerepresentspatientstreatedoutsideSocietyforMaternalFetalMedicine(SMFM)combinedwithuntreatedpatients
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
11
11
FavorableMarketDynamics
FederalDrugQualityandSecurityAct(enacted11/2013)
ClarifiesrolesoftraditionalcompoundingandFDAapprovedmedicines
MakesclearFDA'sauthorityoverdrugcompoundingandrequiresagencytoengageand
coordinatewithstates
IfFDAidentifiesaregistered
outsourcingfacilitythat
compoundsanydrugproductsthat
areessentiallycopiesofMakenaas
definedundersection503B,FDA
intendstotakeactionasitdeems
appropriate.
FDAWebsite,posted7/13/2014
12
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
12
SuccessFactorsforAchieving
Makena GrowthPotential
Operational
Excellence
Increasephysicianandpatientawareness
Expandcommercial/Medicaidaccessandreimbursement
Partner withhighpotentialdistributionchannelsincludingcompounding
pharmacies
Improvepatientcompliance(moreinjectionsperpatient)
Lifecycle
Management
Strategies
Uniquedistributionmodelreducesimpactofpotentialfuturegenerics
Lifecyclemanagementactivitiesalreadyunderway,usingestablished
approachestoimprovelikelihoodofsuccess
Routeofadministration
Drugdeliverytechnologies
Reformulationtechnologies
Portfolio
Expansion
Broadenproductofferinginmaternalhealth
Acquire/licenseassetswithinwomenshealthsegment
Leveragehighperformingspecialtycommercialteam
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
13
FinanciallyTransformativeTransaction
Preliminary2015ViewofCombinedCompany
BalanceSheet
AtClosing
(inmillions)
IncomeStatement
(in millions)
Cashandinvestments
$100
U.S. productsales
Seniordebt
$340
Operatingsynergies
Convertibledebt
$200
Basic sharesoutstanding
25.2
Netoperatinglosses*
2015
ProForma
~$350
$20
~$500
*Subjecttolimitations
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
14
TransactionCreatesSignificant
ShareholderValue
TransformsAMAG intoaprofitable,highgrowth,
multiproductspecialtypharmaceuticalcompany
Addsaprovenproduct inatherapeuticareaof
strategicinterestforFeraheme
Providesa newcommercialplatformforportfolio
expansionthroughbusinessdevelopment
Offerscompellingfinancialbenefits addssignificant
revenues,profitabilityandsynergies
Copyright2014AMAGPharmaceuticals.AllRightsReserved.
15