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Q12023EarningsCall
Presentation
April27,2023
CautionaryNoteRegardingForward-LookingStatements("FLS")
ThisdocumentcontainsFLS,includingregarding:ourfinances,financialguidance,andfinancialresults,includingexpectationsregardingsales,expenses,cashposition,andbalancesheetposition;ourstrategicpriorities;growthinproductsales;ouroperationalperformance;timingandresultsofourR&D,clinicaltrials,regulatorysubmissions,andnewproductinitiatives;drugefficacy,safety,andtolerability;trendsinprescriberandpatientbehaviorandadoptionofourproducts;ourplansregardingproductdevelopmentandlaunch;timingofFDAreviewofourregulatorysubmissions;prospectsforFDAapprovalofourregulatorysubmissions;andourintellectualpropertyrightsandpatentportfolio.
ImportantfactorscouldcauseactualresultstodiffermateriallyfromtheFLS,including:ourabilitytoincreasesalesasexpected;ourabilitytoestimatefuturefinancialneedsandresults;ourabilitytoexecuteonourstrategicprioritiesandtooperateeffectively;theFDAcouldtakelongerthanexpectedtoreviewourregulatorysubmissions;ourproductcandidatescouldnotreceiveFDAapprovalinatimelymanneroratall;theFDAcouldrequireustoprovideadditionalinformationthatisnottimelyoreconomicaltoprovide;wecouldbeunabletoaddresstothesatisfactionoftheFDAtheissuesraisedinitscompleteresponseletterofJune2020respondingtoourearliersubmission;therecouldbeefficacy,safety,ortolerabilityconcernsaboutourproductsorproductcandidates;ourproductsandproductcandidatescouldhavelesscommercialpotentialthananticipatedorcouldbesupersededbycompetingproducts;ifapproved,wecouldbelesseffectivethananticipatedinlaunchingOCAinNASHcommercially;wemaynotbeabletoobtainormaintainregulatoryapprovals;wemaynotbeabletosatisfypost-marketingrequirements,includingusingreal-worldevidence;theinitiation,timing,cost,conduct,progressandresultsofourR&Dactivities,preclinicalstudies,andclinicaltrials,includingregardingsafetyandefficacy;adversemedical,clinical,efficacy,quality,safety,orpharmacovigilanceeventsorresultsfromclinicaltrials;thesafetyandefficacyof,orpotentialsideeffectsassociatedwith,ourproductsandproductcandidates;thetimingandoutcomesofinteractionswithregulatorsincludingtheFDAregardingclinicaltrials,safetyandefficacy,productsandproductcandidates,andregulatoryapprovals;marketingconditions,limitations,orwarningsrequiredbyregulators;thedegreeofmarketacceptanceofourproductsamongphysicians,patients,andhealthcarepayors;ourabilitytoexecuteonthedriversofproductsalesgrowth(includingestimatedmarketsize,marketpenetration,patientsatisfaction,refillrates,andsalesprices);thesuccessofourcompetitorsandourfailuretooutperformoroutcompetethem;competitionfromneworexistingdrugs;theimpactofthesaleofourinternationalbusiness;ourabilitytomanageexpenses;ourabilitytomanagesuccessfullyourcommercialandoperationalperformanceandlegal,operational,andotherrisks;ourabilitytoattractandretainkeypersonnel;ourestimatesoffuturefinancialneedsandresults;ourabilitytoobtainandmaintainintellectualpropertyprotectionforourproductsandproductcandidates,includingourabilitytocost-effectivelyfile,prosecute,defendandenforceanypatentclaimsorotherintellectualpropertyrights;andotherfactorsdiscussedintheFLSandRiskFactorssectionsofourForm10-QandForm10-Kfilings,andinourForm8-Kreportingourquarterlyearnings.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.2
WelcomeandAgenda
NaregSagherian,ExecutiveDirector,InvestorRelations
KeyBusinessUpdatesandFirstQuarter2023Ocaliva?CommercialPerformance
JerryDurso,ChiefExecutiveOfficerandPresident
RegulatoryandClinicalUpdates
MichelleBerrey,ChiefMedicalOfficerandPresident,R&D
FirstQuarter2023FinancialUpdates
AndrewSaik,ChiefFinancialOfficer
NASHCommercialLaunchStrategyOverview
LindaRichardson,ChiefCommercialOfficer
Today'sAgenda
1
2
3
4
5
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.3
KeyBusinessUpdatesandFirstQuarter2023
Ocaliva?CommercialPerformance
JerryDurso
PresidentandChiefExecutiveOfficer
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.4
WeMadeSubstantialProgressAcrossOurBusinessin1Q23
GrowingfoundationalPBCbusiness
ProgressingOCAfor
pre-cirrhoticfibrosis
duetoNASH
Advancinginternalpipeline
inseverealcohol-associated
hepatitis
Ocaliva?netsalesof$68million;
15%growthovertheprioryear
quarter
Fixed-dosecombinationprogramfor
OCAandbezafibrateisprogressing;
newPhase2databeingpresentedat
EASLCongress2023
PreparingforGastrointestinalDrugs
AdvisoryCommitteeMeetingon
May19,2023;PDUFATargetAction
DateforNDAsetforJune22,2023
Progressinglaunchreadiness
activitiesforOCAforthetreatmentof
patientswithpre-cirrhoticfibrosisdue
toNASH
Phase1programinsAHcomplete
ProgressingthePhase2aFRESH
studyevaluating
INT-787inpatientswithsAH
StrongfinancialpositiontosupportgrowthofPBCbusiness,successfullaunchinNASHandcontinuationofpipelineprograms
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.5
ContinuedStrongPerformanceandReal-WorldDataReinforce
Long-TermStrengthofFoundationalPBCBusiness
Continuedexpansionofnewprescribers
Strongbasebusinessdrivenbypersistency
SatisfactionwithOcalivaremainshigh
4out
of10
prescribersofnewpatientsin
1Q23werefirst-timeOcaliva
writers1
~95%
ofbusinessdriven
byexisting
patients1
~90%
Refillratein1Q231
85%
ofcurrentOcaliva
patients–and95%
ofthoseenrolledin
Interconnect–
reportthehighest
satisfactionratings2
83%
ofOcalivapatients
reportastrong
intenttoremainon
therapy2
Improvedclinicaloutcomesisastrongdriverofintent-to-prescribe3
1.Dataonfile,April2023.2.Dataonfile,ZSAssociates,2021PatientATUStudy.3.Dataonfile,InCrowd,Q42022.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.6
RegulatoryandClinicalUpdates
MichelleBerrey
PresidentofResearchandDevelopment&ChiefMedicalOfficer
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.7
OpportunitytoDelivertheFirstTherapeuticforPatientswith
Pre-CirrhoticFibrosisduetoNASH
FDAAdvisoryCommitteeMeetingonMay19,2023PDUFATargetActionDateofJune22,2023
Riskofliver-specificandall-causemortalityincreasesexponentiallywithincreasingfibrosisstage1andpatientswithadvancedfibrosisareatthegreatestrisk
NoNASHmedicationsarecurrentlyapproved
OCAhasdemonstratedastrongand
confirmedantifibroticeffect,
particularlyinindividualswith
advancedfibrosiswithoutcirrhosis,
intwoindependenthistologic
evaluationmethodologies
1.DulaiPSetal.Hepatology.2017;65(5):1557–1565.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.8
OCA-BezafibrateFixed-DoseCombinationOffersPotentialto
EstablishBest-In-ClassClinicalBenefits
Phase1clinicalstudyassessingmultiple
dosecombinationsnowcomplete
Plannedinterimanalysesfromtwoongoing
Phase2studiesexpectedtocompletethisyear
Phase2interimanalyses,Phase1dataand
preclinicaldatawillserveasbasisof
anend-of-phase2meetingwithFDA
OCAandbezafibrate(aPPAR
agonist)havesynergistic
mechanismsofaction1offeringthe
potentialtonormalizeanarrayof
biochemicalsurrogatesassociated
withclinicaloutcomesina
substantialproportionofpeople
livingwithPBC
PlannedinterimanalysisfromfirstPhase2study(747-213)tobepresentedatEASLCongress2023
1.Soret,etal.AilmentPharmacology&Therapeutics.2021;00:1-9.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.9
FirstQuarter2023FinancialUpdates
AndrewSaik
ChiefFinancialOfficer
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.10
Q12023FinancialHighlights
Totalrevenue
2023
$68.0M
ThreeMonthsEnded
March31,
2022
$59.2M
$99.6M
$93.6M
$0.2M
$57.7M
$41.7M
GAAPoperatingexpenses
Non-GAAPadjustedoperatingexpenses(1)
Costofsales
SG&Aexpenses
R&Dexpenses
(1)Refertotheappendixforareconciliationofnon-GAAPadjustedoperatingexpensestototaloperatingexpenses
3/31/2023
$435.2M
$333.0M
Cash,cashequivalents,restrictedcash&investmentdebtsecuritiesavailableforsale
Totalcurrentandlong-termdebt(2)
(2)Totaloutstandingprincipaldebtis$336.3M;$110MofnotesdueJuly1,2023;Remainderofnotesdue2026
$85.6M
$79.9M
$0.2M
$37.8M
$47.6M
12/31/2022
$490.9M
$332.7M
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.11
Q12023FinancialKeyTakeaways
$99.6millionintotaloperatingexpensesand$93.6millioninnon-GAAPadjustedoperatingexpenses
2
Overallsalesandspendinlinewithpreviouslyissuedfull-year2023guidance?Ocalivanetsalesguidance:$310-$340million
?Non-GAAPadjustedOpExguidance:$360-$390million
?MaychoosetoreviseguidancependingregulatoryapprovalinNASH
4
StrongOcaliva?netsalesof$68.0million,representing15%growthoverprior
yearquarter
1
Strongbalancesheetwithsustainablecashlevelabovedebt;$435.2millionincash,cashequivalents,restrictedcashandinvestmentdebtsecurities
3
Disciplinedfinancialexecutionandcontinuedflexibilitytoinvestinourcorebusinessprioritiesandultimatelysustaingrowth
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.12
NASHCommercialLaunchStrategyOverview
LindaRichardson
ChiefCommercialOfficer
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.13
AmongthetargetpatientpopulationforOCAinNASH…
Riskformortalityexponentiallyincreasesasfibrosisprogressestocirrhosis1
1in5progresstocirrhosisasearlyas~2.5years2,3,4,5
Patientshave14xriskofsevereliverdiseasecomparedtocontrols6,7
Severeliverdiseaseriskjumpsto105xinthosewhoprogresstocirrhosis6,7
AdvancedFibrosiswithoutCirrhosisDuetoNASHPresents
aPatientPopulationwithHighUnmetNeedandUrgencytoTreat
ProjectedPopulationEstimates
U.S.NAFLDPrevalence8
ProportionofNAFLD
thatisNASH8
UnderPhysicianCarewith
likelyNASH9
UnderHep/GICare10~2.7M
TargetPatientPopulationforOCA
IdentifiedUsingNITs11:Advanced
fibrosiswithoutcirrhosis
~700K
~5.2M
~94M
~26M
1.EstesC,etal.Hepatology.2018;67(1):123-133.2.SanyalAJetal.Hepatology.2019;70:1913-1927.3.HarrisonSA,etal.JHepatol.2020;73(10):26-39.4.InastudyofpatientswithhistologicallyconfirmedNASH,48of217(22%)patientswithstage3fibrosis(F3)progressedtocirrhosisatmedianfollow-upof29months.Analysisuseddatafromtwolarge,randomized,placebo-controlled,phase2bstudiesofpatientswithF3fibrosisandcompensatedcirrhosisduetoNASHinwhichpatientsunderwentbiopsyatscreening,Week48,andWeek96.
5.Inarandomized,placebo-controlled,phase3studyofpatientswithhistologicallyconfirmedNASH,117of802(15%)patientswithstage3fibrosis(F3)whohadbiopsyresultsavailableatWeek48progressedtocirrhosisatamedianfollow-upof16.5months
6.Hagstr?mH,etal.JHepatol.2017;67:1265-12737.Fromaretrospectivecohortstudyof646biopsy-provenNAFLDpatients,eachmatchedto10controls.Severeliverdiseasewasdefinedascirrhosis,liverdecompensation/failure,orhepatocellularcarcinoma.8.RazaviH,Estes
C.Presentedat:NASH2022;September8-9,2022;Paris,France.9.Morganetal.EurJHealthEcon.2021.2022;Vlecketal.IntJMedInform.2019;10.Rinella.BMCGastroenterology.2022.11.Dataonfile.US-NAS-MED-01344;InterceptPharmaceuticals,Inc.
[REGENERATEsubanalysis.]
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.14
HCPsRecognizetheImportanceofFibrosisastheStrongest
PredictorofDiseaseProgressionandNegativeOutcomesinNASH
CumulativeSurvival,%
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
Fibrosisstagematters
Retrospectivestudyfindssurvivalfreeoflivertransplantsignificantlydecreaseswithfibrosis1,2
P=0.018
13579111315171921
Follow-Up(Years)
NASH,withoutfibrosis(n=335)NASH,withfibrosis(n=284)
Survivalisreducedasfibrosisprogresses
~6outof10
hepatologistsand
gastroenterologists
believefibrosisreversalof1+stagesismoreimportantthanimprovementofsteatohepatitisforpatientswithadvancedfibrosis3
believepreventingprogressiontocirrhosisandfibrosisreversalof≥1stagesaremostimportanttreatmentgoalsforpatientswithadvancedfibrosiswithoutcirrhosisduetoNASH3
70%
ofhepatologists,gastroenterologistsadvancedpracticeproviders(APPs)
and
1.Fromaretrospectiveanalysisof619patientsdiagnosedwithNAFLDfrom1975through2005atmedicalcentersintheUnitedStates,Europe,andThailand,whounderwentlaboratoryandliverbiopsyanalysis.NASHincludesborderlineNASHplusdefinitiveNASH(n=284).2.AnguloP,etal.Gastroenterology.2015;149:389-397.3.Dataonfile;ZSAssociatesQ12023.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.15
Hepatologists,GastroenterologistsandPatientsUnderTheirCare
BelieveAdvancedFibrosisDueToNASHShouldBeUrgentlyTreated
%OFHCPSINAGREEMENTWITHLAUNCH-SUPPORTIVEBELIEFS1
61%57%
81%
62%
71%62%
Gastroenterologists
…advfibrosispatientsrequireadifferentmanagementapproach
thanearlyfibrosispatients
…fibrosisreversalof1+stagesis
moreimportantthanimprovementofsteatohepatitis
…patientswithadvancedfibrosiswithoutcirrhosisshouldbeurgentlytreated
Hepatologists
1.Dataonfile,ZSAssociatesQ12023.
%OFNASHPATIENTSINAGREEMENTWITHLAUNCH-SUPPORTIVEBELIEFS1
…awareoftherisksassociatedwithadvancedfibrosisduetoNASH
…advfibrosisduetoNASH
mustbeurgentlymanaged
…intendtospeaktomyphysicianaboutNASHtreatmentoptions
69%
57%
72%
61%
68%
39%
NASHpatientsmanagedbyhepatologistsandgastroenterologists
NASHpatientsmanagedbyprimarycareprovidersandendocrinologists
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.16
ValueofNon-InvasiveTests(NITs)toAssessFibrosisProgressionin
NASHisWell-EstablishedAmongMultipleU.S.MedicalAssociations
TheAASLDpracticeguidanceincludesanalgorithmforclinicalpracticeandrecommends1:
?FIB-4toassesstheriskforadvancedfibrosis
?Measureliverstiffness(VCTE)orELFminat-riskpersons(i.e.,thosewithanindeterminateorhighFIB-4score)
TheAACE,withco-sponsorshipfromAASLD,practiceguidelinesincludeanalgorithmthatrecommends2:
?FIB-4toassesstheriskofliverfibrosis
?Measureliverstiffness(VCTE)orELFminat-riskpersons
TheAGAClinicalCarePathwayforPatientswithNAFLDincludesstepsforscreeningandassessingfibrosis3:
?UseFIB-4toscreenforadvancedfibrosis
?MeasureliverstiffnessinthosepatientswithindeterminateriskbasedonFIB-4score
TheACGandCLDF’sclinicalalgorithmincludesNITsforNAFLD/NASHriskstratification4:
?SerumNIT,suchasFIB-4,orimagingtechnique,suchastransientelastography,toassessriskforadvancedfibrosis
?AsecondNITwhoseinitialtestscoreisindeterminate
1.RinellaME,etal.Hepatology.2023.https://pubmed.ncbi./36727674/.2.CusiK,etal.EndocrinePractice.2022;28:528-562.3.KanwalF,etal.Gastroenterol.2021:1-13.4.YounossiZM,etal.AmJGastroenterol.2021;116:254–262.
/10.14309/ajg.0000000000001054
.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.17
TargetPrescribersConfidentlyUseNITsToAssessFibrosis
ProgressioninNASH
Approximately4outof5
hepatologists,
gastroenterologistsand
theirAPPsarealready
usingatleasttwoNITs
todiagnoseNASHandconfirmfibrosisstage1
Nearly3in4
NASHtreaterscall
FibroScanthemostideal
approachto
non-invasiveimaging1
14%
Only14%
ofconfirmed
orsuspected
NASHpatients
areeverbiopsied2
1.Dataonfile,ZSAssociates,Q12023.2.Dataonfile,KomodoHealth,January2023.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.18
Fibrogenesis
?InhibitsactivationandcontractionofHSCs1,3,4
?BlocksECMproteindeposition1,5
?Suppressesprofibroticgeneexpression1
?Stimulatesliverrepair1,5
Bile-AcidCytotoxicity
?ReducesBAsynthesis9-12
?ReducesBAabsorption/reuptake9-12
?Increasescholeresis9-12
OCARestoresImpairedFXRMediatedSignalinginNASH
FIBROSISRESOLUTION
throughdirectrestorationof
FXR-mediatedsignaling1,2
Inflammation
?RepressesproinflammatorygeneexpressiondownstreamofNF‐κB1,6,7
?Reducesbacterialtranslocationfromtheintestinetotheliver8
ProposedrolesbasedoninvivoandinvitrostudiesinmultipleanimalandcellmodelsusingdifferentFXRagonists.Invivo/invitrostudiesdonotnecessarilycorrelatewithclinicalresponse,andnotallFXRagonistsmayproducethesameeffects.BA,bileacid;ECM,extracellularmatrix;FXR,farnesoidXreceptor;HSC,hepaticstellatecell;NASH,nonalcoholicsteatohepatitis;OA,obeticholicacid;RXR,retinoidXreceptor.
1.VerbekeL,etal.SciRep.2016;6:33453.2.RadunR,TraunerM.SeminLiverDis.2021;41(4):461-475.3.FickertP,etal.AmJPathol.2009;175(6):2392-2405.4.LiJ,etal.PLoSOne.2010;5(11):e13955.5.PellicoroA,etal.NatRevImmunol.2014;14(3):181-194.6.WangYD,etal.Hepatology.2008;48(5):1632-1643.7.BertoliniA,etal.SeminImmunopathol.2022;44(4):547-564.8.MouriesJ,etal.JHepatol.2019;71(6):1216-1228.9.MatsubaraT,etal.MolCellEndocrinol.2013;368(1-2):17-29.10.KuipersF,etal.RevEndocrMetabDisord.2004;5(4):319-326.11.StofanM,etal.FrontMed(Lausanne).2020;7:544.12.PuriP,etal.Hepatology.2018;67(2):534-548.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.19
OCA25mgdemonstrateddoublethe
responserateofplaceboinreduction
ofliverfibrosiswithoutworseningof
NASH(regulatoryendpoint)1
40
p=0.0001
30
25
20
15
10
5
0
OCA25
n=308
Placebo
n=311
22.4%
mg
6%
35
9.
Improvementofliverfibrosiswas
observedin37%ofsubjectswith
availablebaselineandmonth18
liverbiopsies1
40
37.3%
30
25
20
15
10
5
0
OCA25mg
n=244
Placebo
n=248
19.8%
35
OCA’sCompellingAntifibroticEfficacyAddressesCriticalTreatment
DriverforHCPsTreatingTargetPatientPopulation
Antifibroticeffectwasmore
pronouncedinindividualswith
advancedfibrosiswithoutcirrhosis
(F3)atbaseline1
40
35
30
25
20
15
10
5
0
Placebo
n=169
OCA25
n=169
p=0.0001
25.4%
9.5%
mg
1.A.Sanyal,etal.,“ToplineResultsFromaNewAnalysisoftheREGENERATETrialofObeticholicAcidfortheTreatmentofNonalcoholicSteatohepatitis.”NASH-TAG,Jan5-7,2023.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.20
ExistingInfrastructure,ExperienceandLeadershiptoSupportEarly
LaunchSuccess
EstablishedU.S.fieldpresencewithbroadgeographicandbusinesspotentialcoverage
Recognizedindustryleadership
1.Dataonfile,ZSAssociates,Q12023.
ofhighestpotentialHeps/GIsarewithinourexistingPBCcustomerbase
Deepunderstandingofmulti-site
GIpractices,theirecosystems
Keenknowledgeofindividualsresponsibleforhandlingpriorauthorizations
andkeyindividualplayers
73%
RecognizedleadershipinNASH;ranked#1industryleaderamongcompetitors;toptwomosttrustworthycompanyinthisspace1
Significantpresenceatmajorliverandgastroenterologycongresses
advocacyorganizations
Ongoingengagement
patientskey
withand
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.21
CustomerDiseaseEducationisUnderwayviaSpeakerPrograms
andConferencePresence
Keymessages:
?UrgencytotreatadvancedfibrosiswithoutcirrhosisduetoNASH
?UseofNITsforpatientidentification
Marketingcampaigns
Speakerprograms
Conferencepresence
?HCPandpatientdiseasestatecampaigns,NASHTippingPoint?andNASHActually,arenowlive
?Diseasestatespeakerprogramsongoingatcongressesandinlocalvenues
?Focusededucationalpresenceatkeycongresses
?Interactiveeducationalboothshavecapturedstrongengagement
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.22
KeyAttribute
UnmetNeed
DiseaseSeverity
(ImportanceofTreating
AdvancedFibrosis)
UniqueMOA
PayerCommentary
“TreatmentforNASHislacking.Thereisanunmetneedforagents,notmanyexisttoday”
–PBM(6Mlives)
“IfadrugcanreverseafibrosisscoreandisindicatedforF3orF4patients,thatwouldbeagoodthing”
–PBM(45Mlives)
“ItisagoodthingthattheproductshavedifferentMOAs…wewilllooktoincludethembothonformulary”
-NationalHealthPlan(47Mlives)
PayersIndicateWillingnesstoProvideAccessforPatientswith
AdvancedFibrosiswithoutCirrhosis1
PayerObservations
UnanimousrecognitionofunmetneedforNASH
treatmentgivendiseaseprevalenceandlackofapproved
therapy
90%believetreatingadvancedfibrosis(F3+)isasor
moreimportantthantreatinglessseverefibrosisgivenelevated
riskofsevereoutcomesandtheircosts
2/3believethatuniqueMOAscanhelptosupportformularyplacementinthisclass
PayershaveexpressedreceptivitytoutilizingNITsthataresupportedbyKOLsandclinicalguidelines
1.Dataonfile,HaydenCG,Q12023.
Thispresentationisintendedforinvestorpurposesonlyandisnotintendedforpromotionalpurposes.23
InitialpayerinputsupportspricingOCAinNASHasachronicspecialtydrug
UponApproval,OCAforNASHWillBeLaunchedasaChronicSpecialty
TherapyforAdvancedFibrosisWithoutCirrhosisDuetoNASH
RetailDrugsChronicSpecialtyDrugsUltra-Rare
$20K-$110K
~$5K-$20K
>$110K
Finalpricingdecisionwillreflectr
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