益普生 2023年第一季度报 Q1 2023 sales update

Q12023salesupdate

27April2023

Bring

Thefullpotentialofourinnovativemedicinestopatients

Build

Ahigh-valuesustainablepipeline

Deliver

Efficienciestoenabletargetedinvestment&growth

Boost

Acultureofcollaboration&excellence

Focus.Together.Forpatients&society

1

Disclaimerandsafeharbor

−Thispresentationincludesonlysummaryinformationanddoesnotpurporttobecomprehensive.Forward-lookingstatements,targetsandestimatescontainedhereinareforillustrativepurposesonlyandarebasedonmanagement’scurrentviewsandassumptions.Suchstatementsinvolveknownandunknownrisksanduncertaintiesthatmaycauseactualresults,performanceoreventstodiffermateriallyfromthoseanticipatedinthesummaryinformation.Actualresultsmaydepartsignificantlyfromthesetargetsgiventheoccurrenceofcertainrisksanduncertainties,notablygiventhatanewmedicinecanappeartobepromisingatapreparatorystageofdevelopmentorafterclinicaltrialsbutneverbelaunchedonthemarketorbelaunchedonthemarketbutfailtosellnotablyforregulatoryorcompetitivereasons.Ipsenmustdealwithormayhavetodealwithcompetitionfromgenericmedicinesthatmayresultinmarket-sharelosses,whichcouldaffectitslevelofgrowthinsalesorprofitability.TheCompanyexpresslydisclaimsanyobligationorundertakingtoupdateorreviseanyforward-lookingstatements,targetsorestimatescontainedinthispresentationtoreflectanychangeinevents,conditions,assumptionsorcircumstancesonwhichanysuchstatementsarebased,unlesssorequiredbyapplicablelaw.

−AllmedicinenameslistedinthisdocumentareeitherlicensedtoIpsenorareregisteredtrademarksofIpsenoritspartners.

−Theimplementationofthestrategyhastobesubmittedtotherelevantstaffrepresentationauthoritiesineachcountryconcerned,incompliancewiththespecificprocedures,termsandconditionssetforthbyeachnationallegislation.

−Inthosecountriesinwhichpublicorprivate-healthcoverisprovided,Ipsenisdependentonpricessetformedicines,pricingandreimbursement-regimereformsandisvulnerabletothepotentialwithdrawalofcertainmedicinesfromthelistofreimbursablemedicinesbygovernments,andtherelevantregulatoryauthoritiesinitslocations.

−Ipsenoperatesincertaingeographicalregionswhosegovernmentalfinances,localcurrenciesorinflationratescoulderodethelocalcompetitivenessofIpsen’smedicinesrelativetocompetitorsoperatinginlocalcurrency,and/orcouldbedetrimentaltoIpsen’smarginsinthoseregionswhereIpsen’ssalesarebilledinlocalcurrencies.

−Inanumberofcountries,Ipsenmarketsitsmedicinesviadistributorsoragents;someofthesepartners’financialstrengthscouldbeimpactedbychangingeconomicormarketconditions,potentiallysubjectingIpsentodifficultiesinrecoveringitsreceivables.Furthermore,incertaincountrieswhosefinancialequilibriumisthreatenedbychangingeconomicormarketconditions,andwhereIpsensellsitsmedicinesdirectlytohospitals,Ipsencouldbeforcedtolengthenitspaymenttermsorcouldexperiencedifficultiesinrecoveringitsreceivablesinfull.

−Ipsenalsofacesvariousrisksanduncertaintiesinherenttoitsactivitiesidentifiedunderthecaption‘RiskFactors’intheCompany’sUniversalRegistrationDocument.

−AlloftheaboveriskscouldaffectIpsen’sfutureabilitytoachieveitsfinancialtargets,whichweresetassumingreasonablemacroeconomicconditionsbasedontheinformationavailabletoday.

2

ForQ&AAymericLeChatelier

ChiefFinancialOfficer

Speakers

DavidLoew

ChiefExecutiveOfficer

3

Highlights

Consistentstrongdeliveryonthestrategicroadmap

Totalsales

•Q1salesgrowthof5.7%

•Growthplatforms,upby14.7%,ledbyDysport&Cabometyx

•Contributionfromnewlyacquiredmedicines

Albireo

•AlbireoacquisitioncompletedinMarch

•OnemonthofBylvaysalesinQ1

Pipelineupdate

•Onivyde1LPDAC

–FullPhaseIIIdatapresented

•ForthcomingPDUFAdates:

–15June:Bylvay(Alagillesyndrome)

–16August:palovarotene(FOP)

2023guidanceconfirmed

•Total-salesgrowthgreaterthan4.0%1

•Coreoperatingmarginaround30%2

Allgrowthratesareatconstantexchangerates.

1.Excludesadverseimpactofaround2%fromcurrenciesbasedontheaveragelevelofexchangeratesinQ12023.

2.Excludesanypotentialimpactofincrementalinvestmentsfromexternal-innovationtransactions.

4

Growthplatforms:Dysport,Decapeptyl,CabometyxandOnivyde;1L:firstline;PDAC:pancreaticductaladenocarcinoma;

PDUFA:PrescriptionDrugUserFeeAct;FOP:fibrodysplasiaossificansprogressiva.

Dysport

21%

18%

Cabometyx

Decapeptyl

17%

5%

Onivyde

Growthplatforms

61%

Tazverik

1%

1%

Bylvay

Newlyacquiredmedicines

2%

Somatuline

35%

Others

2%

TotalSales

100%

Saleshighlights

GrowthplatformsoutweighingthegradualdeclineofSomatuline

Q12023

€m

change

%oftotalsales

155

25.2%

130

31.0%

130

0.8%

37

-12.3%

452

14.7%

9

n/a

5

n/a

14

n/a

263

-9.8%

13

-20.8%

742

57%

5

Allgrowthratesareatconstantexchangerates.

+25.2%

Furtherstrong

performancein

aestheticsinIpsen&

partnermarkets

Continuedtherapeutics

growthacrossthe

regions

+31.0%

Furtherlaunchesofthe

comboinfirst-linerenal

cellcarcinoma

-12.3%

Performancereflected

shipmentphasingto

ex-U.S.partner

Momentuminsecond-line

renalcellcarcinoma

monotherapy

ReducedsalesinChina

reflectedCOVID-related

stockinginQ12022

Solidunderlyinggrowth

intheU.S.

Strongperformancefromgrowthplatformsof+14.7%

+0.8%

Continuedmarket-share

uptakesinanumberof

geographies

Allgrowthratesareatconstantexchangerates.

6

-25.7%

+7.3%

Genericcompetitionacross

moregeographies

(France,Spain&Italy)

Impactsthrougha

combinationof

volume&pricing

Solidunderlyinggrowth

Severalgeographies

performingwell,

includingLatinAmerica

Somatulinesalescontinuingtodeclinegradually

Q12023:-9.8%

NORTHAMERICA

58%ofSomatulinesales

EUROPE

30%ofSomatulinesales

RESTOFWORLD

12%ofSomatulinesales

-2.7%

Favorablewholesaler-

inventorycomparison

toQ12022

Solidvolume-demandgrowth

Ongoingadversepricing

Allgrowthratesareatconstantexchangerates.

Inthispresentation,EuropeisdefinedastheE.U.,theU.K.,Iceland,Liechtenstein,NorwayandSwitzerland.

7

Recentlyacquiredmedicines

€9m

Momentumin

NorthAmericaandEurope

Anincreasing

numberoftreatedPFICpatients

Anticipatedregulatorydecisionsthis

yearinAlagillesyndrome

Focusonall-comers,new-patientstarts&durationoftherapy

Growthof21%incommercialsales1

NCCNguidelinesrecentlyupdated

€5m

Allgrowthratesareatconstantexchangerates.1.ReferencetoEpizyme’spublishedQ12022performance.

8

PFIC:progressivefamilialintrahepaticcholestasis;NCCN:NationalComprehensiveCancerNetwork.

Registration

PhaseI

PhaseIII

IPN60210

R/Rmultiplemyeloma&R/RDLBCL

CABOMETYX+

ATEZOLIZUMAB

2LmCRPC

PALOVAROTENE

FOP

IPN60260(A2342)

Viralcholestaticdisease

BYLVAY

Alagillesyndrome

ONIVYDE+5-FU/LV+OXALIPLATIN

1LPDAC

TAZVERIK+R2

2LFL

IPN10200

Longer-actingneurotoxinTx

ELAFIBRANOR

2LPBC

BYLVAY

Biliaryatresia

Oncology

RareDisease

Neuroscience

MESDOPETAM

PD-LID

TAZVERIK

(variouscombinations)

R/Rmalignancies

Buildingahigh-value,sustainablepipeline

PhaseII

TAZVERIK

(+hormonotherapy)

mCRPC

FIDRISERTIB

FOP

ELAFIBRANOR

PSC

IPN60250(A3907)

PSC

IPN10200

Longer-actingneurotoxinAx

InformationshownasattheendofMarch2023.R/R:relapsed/refractory;DLBCL:diffuselargeB-celllymphoma;Tx:therapeutics;

mCRPC:metastaticcastration-resistantprostatecancer;FOP:fibrodysplasiaossificansprogressiva;PSC:primarysclerosingcholangitis;

9

Ax:aesthetics;2L:secondline;1L:firstline;PDAC:pancreaticductaladenocarcinoma;

R2:lenalidomide+rituximab;FL:follicularlymphoma;PBC:primarybiliarycholangitis.

Pipeline:near-termmajormilestones

Bylvay:Alagillesyndrome

PDUFAdate:15June2023(U.S.)

Regulatorydecision:H22023(E.U.)

Onivyde:1LPDAC

Regulatorysubmission(U.S.):H12023

Elafibranor:2LPBC

PhaseIIIdatareadout:endofH12023

Palovarotene:FOP

PDUFAdate:16August2023(U.S.)

Re-examinationofCHMPopinionrequested(E.U.)1

Cabometyx+atezolizumab:

2LmCRPC

PhaseIIIdatareadout(PFS):H22023

1.NegativeopinionpublishedinJanuary2023.PDUFA:PrescriptionDrugUserFeeAct;1L:firstline;PDAC:pancreaticductal

adenocarcinoma;2L:secondline;PBC:primarybiliarycholangitis;FOP:fibrodysplasiaossificansprogressiva;CHMP:theCommitteefor

10

MedicinalProductsforHumanUse,theEuropeanMedicinesAgency'scommitteeresponsibleforhumanmedicines;

mCRPC:metastaticcastration-resistantprostatecancer;PFS:progression-freesurvival.

Conclusion

Consistentstrongdeliveryonthestrategicroadmap

AstrongQ1salesperformance

Double-digitincreaseinthegrowthplatformsFinancialguidancefor2023confirmed

ExpandingthescopeinRareDisease

TheintegrationofAlbireo

Buildingahigh-value,sustainablepipeline

Severalnear-termmilestonesExternal-innovationfocuscontinues

11

12

QUESTIONS

APPENDIX

13

Other

5%

CNY

-29%

--66%

-16%

-3%

-1%

EUR

34%

4%

4%

CNY

GBP

35%

CNY

TRY

USD

AUD

BRL

Q12023totalsales:favorable2.1%impactoffxrates

Averageratechanges

(Q12023vs.Q12022)

Q12023salesbycurrency

USD:1.07

4%

BRL:5.57AUD:1.57CNY:7.34TRY:20.25

24%

35%

3%

5%

33%

USD

14

PRIMARY

ENDPOINT(S)

POPULATION

PATIENTS

STATUS

DESIGN

Recruiting1

PFSdata

anticipated

H22023

Secondnovelhormonal

therapy(abiraterone&

prednisoneorenzalutamide)

or

Cabometyx+atezolizumab

2LmCRPC

OS,PFS

580

R/RFL:following

atleastoneprior

systemic

chemotherapy,

immunotherapy,or

chemo-

immunotherapy

Placebo+R2

or

Tazverik+R2

PFS

Recruiting

540

Oncology

Keyongoingclinical-trialhighlights

TRIAL

CabometyxCONTACT-02

PhaseIIINCT04446117

Onivyde

NAPOLI-3

PhaseIIINCT04083235

1LPDAC

770

Nab-paclitaxel+gemcitabine

or

Onivyde+5-FU/LV+

oxaliplatin

OS

Primary

endpoint

met

TazverikSYMPHONY-1

PhaseIIINCT04224493

1.RecruitmentisanticipatedtocompleteinH22023.2L:secondline;mCRPC:metastaticcastration-resistantprostate

cancer;OS:overallsurvival;PFS:progression-freesurvival;1L:firstline;PDAC:pancreaticductaladenocarcinoma;

R/R:relapsed/refractory;FL:follicularlymphoma;R2:lenalidomide+rituximab.

15

mCRPC:patients

whohavenot

received

chemotherapy

Enzalutamide+Tazverik

or

abiraterone/prednisone

+Tazverik

PhaseIb:dosing,safety

Recruiting

104

PhaseII:rPFSTazverik+enzalutamide

Oncology

Keyongoingclinical-trialhighlights

STATUS

POPULATION

PATIENTS

DESIGN

TRIAL

PRIMARYENDPOINT(S)

Tazverik

ARIA

PhaseIb/IINCT05205252

Tazverikinvarious

combinations:multi-

cohort

R/Rhematologicmalignancies

Recruiting

156

PhaseIb:dosing,safetyPhaseII:ORR

IPN60210

PhaseI/IbNCT05121103

R/Rmultiple

myeloma&R/R

DLBCL

96

IPN60210

Treatment-emergentadverseevents,dosing&ORR

Recruiting

Tazverik

CELLO-1

PhaseIb/IINCT04179864

R/R:relapsed/refractory;ORR:objectiveresponserate;DLBCL:diffuselargeB-celllymphoma;

mCRPC:metastaticcastration-resistantprostatecancer;rPFS:radiographicprogression-freesurvival.

16

PRIMARY

ENDPOINT

POPULATION

PATIENTS

DESIGN

STATUS

Responsetotreatment

definedasALP<1.67x

ULNandtotalbilirubin≤

ULNandALPdecrease≥

15percent

Placebo

or

elafibranor

DataanticipatedH12023

2LPBC

161

Proportionofpatientswho

arealiveandhavenot

undergonealiver

transplantafter104weeks

ofstudytreatment

Placebo

or

Bylvay

Biliaryatresia

Recruiting

205

RareDisease

Keyongoingclinical-trialhighlights

TRIAL

Elafibranor

ELATIVE

PhaseIIINCT04526665

Bylvay

ASSERT

PhaseIIINCT04674761

Alagillesyndrome

63

Placebo

or

Bylvay

Changefrombaselineinscratchingscore

U.S.PDUFAdate

15June2023

E.U.regulatorydecisionanticipatedinH22023

Bylvay

BOLD

PhaseIII

2L:secondline;PBC:primarybiliarycholangitis;ALP:alkalinephosphatase;ULN:upperlimitnormal;PDUFA:PrescriptionDrugUserFeeAct.

17

Placeboor

twodosing

regimens

offidrisertib

Firstpatient

commenceddosing

Q12022

FOP(chronic)

AnnualizedchangeinnewHOvolumeandsafety

90

RareDisease

Keyongoingclinical-trialhighlights

POPULATION

PATIENTS

STATUS

DESIGN

TRIAL

PRIMARY

ENDPOINT(S)

Palovarotene-

5mgQDandupon

flare-up,20mgQD

for28days,

followedby10mg

for56days

PalovaroteneMOVE

PhaseIIINCT03312634

U.S.:PDUFAdate16August2023

FOP(chronic)

107

E.U.CHMP:negative

Annualizedchangein

newHOvolume

opinionJanuary2023-

re-examinationrequested

Fidrisertib

FALKON

PhaseIINCT05039515

FOP:fibrodysplasiaossificansprogressiva;QD:onceaday;HO:heterotopicossification;PDUFA:PrescriptionDrugUserFeeAct;CHMP:theCommitteeforMedicinalProductsforHumanUse,theEuropeanMedicinesAgency'scommitteeresponsibleforhumanmedicines.

18

Viralcholestaticdisease

Interventional

Tobeconfirmed

Recruiting

108

RareDisease

Keyongoingclinical-trialhighlights

POPULATION

PATIENTS

DESIGN

STATUS

TRIAL

PRIMARY

ENDP