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1、Q1 2025 update16 April 2025Packaging OperatorManufacturingSignes,FranceQ1 2025 update16 April 2025Packaging OperatorManufacturingSignes,France2This presentation includes only summary information and does not purport to be comprehensive.Forward-looking statements,targets and estimates contained herei
2、n are for illustrative purposes only and are based on managements current views and assumptions.Such statements involve known and unknown risks and uncertainties that may cause actual results,performance or events to differ materially from those anticipated in the summary information.Actual results
3、may depart significantly from these targets given the occurrence of certain risks and uncertainties,notably given that a new medicine can appear to be promising at a preparatory stage of development or after clinical trials but never be launched on the market or be launched on the market but fail to
4、 sell notably for regulatory or competitive reasons.Ipsen must deal with or may have to deal with competition from generic medicines that may result in market-share losses,which could affect its level of growth in sales or profitability.The Company expressly disclaims any obligation or undertaking t
5、o update or revise any forward-looking statements,targets or estimates contained in this presentation to reflect any change in events,conditions,assumptions or circumstances on which any such statements are based,unless so required by applicable law.All medicine names listed in this document are eit
6、her licensed to Ipsen or are registered trademarks of Ipsen or its partners.The implementation of the strategy has to be submitted to the relevant staff representation authorities in each country concerned,in compliance with the specific procedures,terms and conditions set forth by each national leg
7、islation.In those countries in which public or private-health cover is provided,Ipsen is dependent on prices set for medicines,pricing and reimbursement-regime reforms and is vulnerable to the potential withdrawal of certain medicines from the list of reimbursable medicines by governments,and the re
8、levant regulatory authorities in its locations.Ipsen operates in certain geographical regions whose governmental finances,local currencies or inflation rates could erode the local competitiveness of Ipsens medicines relative to competitors operating in local currency,and/or could be detrimental to I
9、psens margins in those regions where Ipsens sales are billed in local currencies.In a number of countries,Ipsen markets its medicines via distributors or agents;some of these partners financial strengths could be impacted by changing economic or market conditions,potentially subjecting Ipsen to diff
10、iculties in recovering its receivables.Furthermore,in certain countries whose financial equilibrium is threatened by changing economic or market conditions,and where Ipsen sells its medicines directly to hospitals,Ipsen could be forced to lengthen its payment terms or could experience difficulties i
11、n recovering its receivables in full.Ipsen also faces various risks and uncertainties inherent to its activities identified under the caption Risk Factors in the Companys Universal Registration Document.All of the above risks could affect Ipsens future ability to achieve its financial targets,which
12、were set assuming reasonable macroeconomic conditions based on the information available today.Forward-looking statementsSpeakers David LoewChief Executive OfficerBusiness updateAymeric Le ChatelierChief Financial OfficerFor Q&A31 At constant exchange rates 2 European Medicines Agency 3 LANT:Long Ac
13、ting NeuroToxin 4 Excludes any impact of potential late-stage external-innovation opportunitiesStrong top line performance with total sales growth at 11.6%1Pipeline progress including EMA2regulatory submission of tovorafenib and entry in Phase I of IPN01195(RAF inhibitor)Refinancing completed for 2b
14、n including 500m rated public bond supported by Investment Grade ratings from S&P and MoodysQ1 key achievementsUpcoming catalysts including Cabometyx NET EMA2 regulatory decision,fidrisertib pivotal data and LANT3 Proof of Concept data in aestheticsConfirmation of 2025 guidance4 with total sales gro
15、wth+5.0%1 and core operating margin 30.0%of total sales2025 outlook4Ipsen Pharma BiotechPharmaceutical product manufacturing site Signes,FranceQ1 2025 highlightsQ1 2025 salesGrowth across all three therapeutic areasm%changeOncology6558.0%Rare Disease7074.6%Neuroscience1949.6%Total Sales91911.6%5Grow
16、th at constant exchange ratesJennyProduct Development ScientistDreux,FranceOncology portfolioQ1 2025 sales growth of 8.0%1L:First Line;2L:Second Line;RCC:Renal Cell Carcinoma;mPDAC:Metastatic Pancreatic Ductal Adenocarcinoma;Growth at constant exchange ratesContinued generic-lanreotide shortages in
17、NA,Europe&strong performance in Rest of the World310m+19.1%Solid performance in Europe from increased volumes in 1L and 2L RCCLower sales in RoW from high 2024 baseline in some countriesVolume growth in Europe and China,with continued competition and pricing pressureLimited market share growth in th
18、e U.S.in the 1L mPDAC indicationHigher sales to Ipsens ex-U.S.partner driven by first launch in 1L indication52m+6.3%6136m+3.4%147m-3.2%PFIC:Progressive Familial Intrahepatic Cholestasis;ALGS:Alagille SyndromeGrowth at constant exchange rates 7Rare Diseases portfolioQ1 2025 sales growth of 74.6%Stro
19、ng growth in the U.S driven by increased global sales in PFIC and ALGS indicationsSolid performance ex-US driven by PFIC and additional countriesAccelerated sales growth in the U.S.based on increasing patient uptake from new patients,switch&market expansionSuccessful launches in Germany&UK with addi
20、tional launches expected in 202543m+63.3%23m-Neuroscience portfolio Q1 2025 sales growth of 9.6%xxSolid performance across all markets notably North America and Europe offset by impact of phasing&2024 baseline in Brazil73m-0.2%Strong performance driven by continued growth in most aesthetics markets
21、including the U.S.and Europe from both Galderma and Ipsens territories117m+16.0%AestheticsTherapeuticsGrowth at constant exchange rates 8Phase IPhase IIPhase IIIIPN01194(ERKi)Solid tumorstovorafenib:FIREFLY-2*1L pLGG2L FLTazverik+R2:SYMPHONY-1PSCritivixibatPSCIqirvo:ELMWOODFOPfidrisertib:FALKON1PBCI
22、qirvo:ELSPIREAxIPN10200(LANT):LANTICTxIPN10200(LANT):LANTIMAChronic migraine Dysport:C-BEONDBiliary atresiaBylvay:BOLD2L:Second Line;R2:lenalidomide+rituximab;FL:Follicular Lymphoma;1L:First Line;pLGG:pediatric Low-Grade Gliomas;PBC:Primary Biliary Cholangitis;PSC:Primary Sclerosing Cholangitis;FOP:
23、Fibrodysplasia Ossificans Progressiva;Ax:Aesthetics;Tx:Therapeutics*Executed by Day One Biopharmaceuticals 1Registrational trialEpisodic migraine Dysport:E-BEONDLong-acting neurotoxin:TxIPN10200(LANT):MERANTIChronic&Episodic Migraine9IPN01195(RAFi)Solid tumorsPipeline UpdateBalanced across therapeut
24、ic areasOncologyRare DiseaseNeuroscienceInformation shown as of March 2025Upcoming pipeline milestonesSeveral milestones across all therapeutic areas in 2025&2026102L:Second Line;pNET:pancreatic NeuroEndocrine Tumor;epNET:extrapancreatic NeuroEndocrine Tumor;FOP:Fibrodysplasia Ossificans Progressiva
25、;LANT:Long-Acting Neurotoxin;R/R:Relapsed/Refractory;pLGG:pediatric Low-Grade Gliomas;BA:Biliary Atresia;PBC:Primary Biliary Cholangitis;CM:Chronic Migraine;EM:Episodic Migraine;R2:lenalidomide+rituximab;FL:Follicular Lymphoma;1Executed by Day One Biopharmaceuticals 2Registrational trial 3Interim da
26、ta readoutDisclaimer:trials are event-driven&timings can change Medicine20252026Cabometyx(CABINET):fidrisertib(FALKON):LANT(LANTIC):tovorafenib(FIREFLY-11):Bylvay(BOLD)Iqirvo(ELSPIRE)Dysport(C-BEOND)Dysport(E-BEOND)Tazverik+R2(SYMPHONY-1)2L FL,Phase III3BA,Phase IIIFOP,Phase IIb2EM,Phase III2L+pNET&
27、epNETR/R pLGGPBC,Phase IIICM,Phase IIIAx,Phase IIData readoutRegulatory decisionProof of conceptConclusion and outlook 2025On track to deliver 2025 roadmapVincentScientist,R&D,Les Ulis,FranceInvesting in launches,growth products and further advancing pipelineGrowing topline fueled by launches and po
28、rtfolio performanceActive external innovation based on significant firepowerQUESTIONSAPPENDIX34%35%4%4%EUR33.5%24.6%USDBRLCNYTRYEURUSDOtherCNY32.2%36.3%4.4%3.2%23.9%3%2%2%-14%-15%-16%-66%GBP:0.84TRY:38.18USD:1.05MXN:21.47CNY:7.65GBPBRL:6.15MXNQ1 2025 sales by currencyAverage rate changes(Q1 2025 vs.
29、Q1 2024)14Currency impact on Q1 2025 salesLimited impact of+0,1%OncologyKey ongoing clinical-trial highlightsR/R:relapsed/refractory;FL:follicular lymphoma;R2:lenalidomide+rituximab;PFS:progression-free survival ORR:overall response rate;pLGG:pediatric low-grade glioma1 following at least one prior
30、systemic chemotherapeutic,immunotherapeutic or chemo-immunotherapeutic 2 Recruitment status as per ct.gov,April 2025 TRIALINDICATIONPATIENTSDESIGNPRIMARY ENDPOINT(S)STATUSTazverikSYMPHONY-1Phase IIINCT04224493R/R FL612Tazverik+R2 or placebo+R2 PFSRecruiting2tovorafenibFIREFLY-2Phase IIINCT055667951L
31、 pLGG400tovorafenib orchemotherapeuticORRRecruiting1IPN01195Phase I/IIaNCT06833008Solid tumors(advanced)85IPN01195Safety and efficacyRecruiting1IPN01194Phase I/IIaNCT06305247Solid tumors(advanced)220IPN01194Safety and efficacyRecruiting115TRIALINDICATIONPATIENTSDESIGNPRIMARY ENDPOINT(S)STATUSBylvayB
32、OLDPhase IIINCT04336722Biliary atresia254Placebo or BylvayTime to first occurrence of liver transplant,or deathActive,not recruiting1IqirvoELSPIRE2Phase IIINCT063834032L PBC72Placebo orIqirvoNormalisation of ALPRecruiting1IqirvoELMWOODPhase IINCT05627362PSC68Placebo or IqirvoSafety and tolerabilityA
33、ctive,not recruiting1ritivixibatPhase IINCT05642468PSC2410mg ritivixibator30mg ritivixibatSafety and tolerabilityRecruiting1fidrisertibFALKON*Phase IINCT05039515FOP(chronic)98Placebo ortwo dosingof fidrisertibAnnualized change in new HO volume and safetyActive,not recruiting1Rare DiseaseKey ongoing
34、clinical-trial highlights16PSC:primary sclerosing cholangitis;2L:second line;PBC:primary biliary cholangitis;ALP:alkaline phosphatase;FOP:Fibrodysplasia ossificans progressiva1 Recruitment status as per ct.gov,April 2025 2 Based on ALP 1.00 ULN and 1.67 ULN*Registration trial.TRIALPOPULATIONPATIENTS
35、DESIGNPRIMARY ENDPOINTSTATUSDysportC-BEONDPhase IIINCT06047444Chronic migraine720Two dosing regimes of Dysport or placeboEfficacy and safetyRecruiting1DysportE-BEONDPhase IIINCT06047457Episodic migraine714Two dosing regimes of Dysport or placebo Efficacy and safetyRecruiting1IPN10200 AxLANTICPhase I
36、INCT04821089Moderate to severe upper facial lines727Dose escalation&dose-finding versus Dysport or placeboEfficacy and safetyRecruiting1IPN10200 TxLANTIMAPhase IINCT04752774Adult patients with upper-limb spasticity209Dose escalation&dose-finding versus Dysport or placeboEfficacy and safetyActive,not
37、 recruiting2MERANTIPhase IINCT06625060Adults with chronic or episodic migraine641Dose escalation&dose-finding versus placeboEfficacy and safetyRecruiting2 1 Pre-defined step of trial design 2 Recruitment status as per ct.gov,April 2025NeuroscienceKey ongoing clinical-trial highlights17Investor Relations18+33 6 66 01 95 Khalid DeojeeSenior ManagerInvestor RelationsFollow us:Thank you