Ipsen Sa · EURONEXT:IPN
Ipsen Sa — 2023 Deutsche Bank Depositary Receipts Virtual Investor Conference
32 slides from Ipsen Sa's conference presentation, May 2023
Slide 1: Focus. Together. For patients & society
Bring The full potential of our innovative medicines to patients Build A high-value sustainable pipeline Deliver Efficiencies to 2023 Deutsche Bank Depositary enable targeted Receipts Virtual Investor Conference investment & growth Focus. Together. For patients & society Boost A culture of collabora
Slide 2: Disclaimer and safe harbor
Disclaimer and safe harbor − This presentation includes only summary information and does not purport to be comprehensive. Forward-looking statements, targets and estimates contained herein are for illustrative purposes only and are based on management’s current views and assumptions. Such statement
Slide 3: Q1 messages
Q1 messages Consistent strong delivery on the strategic roadmap Total sales Pipeline update • Q1 sales growth of 5.7% • Onivyde 1L PDAC – Full Phase III data presented • Growth platforms, up by 14.7%, led • Forthcoming PDUFA dates: by Dysport & Cabometyx – 15 June: Bylvay (Alagille syndrome) – 16 Au
Slide 4: A future focused on Specialty Care
A future focused on Specialty Care Consumer HealthCare divested last year To be a leading global, mid-sized biopharmaceutical Our company with a focus on transformative medicines vision in Oncology, Rare Disease & Neuroscience ONCOLOGY RARE DISEASE NEUROSCIENCE Strengthening Expanding Excelling the
Slide 5: A strong & expanded global footprint
A strong & expanded global footprint NORTH AMERICA REST OF WORLD 34% 25% OF TOTAL SALES OF TOTAL SALES 30+ EUROPE 100+ countries with countries where Ipsen 41% Ipsen presence medicines are marketed OF TOTAL SALES Based on 2022 total sales. Europe is defined as the E.U., the U.K., Iceland, Liechtenst
Slide 6: The Ipsen strategy
Maximize brands Strengthen pipeline The Ipsen strategy Drive efficiencies Focus on culture 6
Slide 7: Environment, Patients, People, Governance
Environment Patients People Governance Emissions Access Diversity Certification GHG emission-reduction Partnership with Access Females: 48% of the ISO 37001 certification for trajectory: officially certified Accelerated: continued to Global Leadership Team anti-corruption management by the Science B
Slide 8: The Ipsen investment case
The Ipsen investment case Entire focus Strong balance Expanding on Specialty sheet & cash pipeline External- Care Global generation innovation footprint strategy A good mix of €1.5bn Opportunities for new molecules firepower1 further growth A well-balanced and lifecycle 20 assets Free cash flow acro
Slide 9: FY 2022: sales increased by 8.5%
FY 2022: sales increased by 8.5% Growth platforms up by 20.9% €m Neuroscience Motor muscular disorders Medical aesthetics 594 +29.4% P L AT F O R M S GROWTH Oncology Metastatic prostate cancer 530 +12.4% Oncology RCC: monotherapy & in combination 449 + 23.9% Oncology Metastatic pancreatic cancer 162
Slide 10: A strong platform for sustainable growth
A strong platform for sustainable growth T O TA L S A L E S Accelerate growth with external innovation External innovation Transition Somatuline Somatuline post-SSA competition entry Growth platforms Drive performance of growth platforms TIME SSA: somatostatin analogue. 10
Slide 11: Consistent execution of the external-innovation strategy
Consistent execution of the external-innovation strategy 20 assets added in two years O N C O L O G Y: 1 2 a s s e t s RARE DISEASE: 5 assets Tazverik ERK-inhibitor METTL3 Elafibranor Bylvay Epizyme1 AGV Discovery Accent GENFIT ALBIREO2 Therapeutics Approved Preclinical Preclinical Phase III Approve
Slide 12: Albireo: expanding Ipsen's scope in Rare Disease
Albireo: expanding Ipsen’s scope in Rare Disease Perfectly aligned to the external-innovation strategy Global rights1 Multiple opportunities • Bylvay: a potentially best-in-class • Bylvay: progressive familial rare liver-disease medicine intrahepatic cholestasis, Alagille approved in the U.S. & E.U.
Slide 13: Elafibranor: peak-sales outlook around €500m
Elafibranor Peak-sales outlook: around €500m In Phase III clinical development for 2L PBC - data anticipated in H1 2023 Expanding A first-in-class, Compelling Exclusive Ipsen’s position innovative Phase II data worldwide in Rare Disease potential licence3 Beyond PBC: treatment Breakthrough ELMWOOD H
Slide 14: Building a high-value, sustainable pipeline
Building a high-value, sustainable pipeline Phase I Phase II Phase III Registration IPN60210 TAZVERIK CABOMETYX + R/R multiple myeloma ATEZOLIZUMAB PALOVAROTENE (various combinations) & R/R DLBCL 2L mCRPC FOP R/R malignancies TAZVERIK ONIVYDE + 5-FU/LV + IPN60260 (A2342) BYLVAY (+ hormonotherapy) OX
Slide 15: Onivyde: potential in 1L PDAC
Onivyde Potential in 1L PDAC 1L data presented at ASCO GI, San Francisco Potential to Onivyde Trial met key A potential Leveraging expand regimen secondary advance in an Ipsen’s existing Onivyde’s peak- endpoint of aggressive and in-market sales potential progression- difficult-to-treat presence & f
Slide 16: Pipeline: near-term major milestones
Pipeline: near-term major milestones Bylvay: Alagille syndrome PDUFA date: 15 June 2023 (U.S.) Regulatory decision: H2 2023 (E.U.) Onivyde: 1L PDAC Regulatory submission (U.S.): H1 2023 Elafibranor: 2L PBC Phase III data readout: end of H1 2023 Palovarotene: FOP PDUFA date: 16 August 2023 (U.S.) Re-
Slide 17: Conclusion
Conclusion Successfully executing on our strategy FOCUSING ON DELIVERING ADVANCING EXTERNAL STRONG RESULTS THE PIPELINE INNOVATION Strong progress on the Significant firepower Number of assets four strategic pillars & trials Adding pipeline assets; Growth platforms expanding the scope in Rare Opport
Slide 18: Appendix
APPENDIX SIPSEN
Slide 19: Q1 sales highlights
Q1 sales highlights Growth platforms outweighing the gradual decline of Somatuline Q1 2023 €m change % of total sales Dysport 155 25.2% 21% Cabometyx 130 31.0% 18% Decapeptyl 130 0.8% 17% Onivyde 37 -12.3% 5% Growth platforms 452 14.7% 61% Tazverik 9 n/a 1% Bylvay 5 n/a 1% Newly acquired medicines 1
Slide 20: Strong performance from growth platforms in Q1: +14.7%
Strong performance from growth platforms in Q1: +14.7% +25.2% +31.0% +0.8% -12.3% Further strong Further launches of the Continued market-share Performance reflected performance in combo in first-line renal uptakes in a number of shipment phasing to aesthetics in Ipsen & cell carcinoma geographies e
Slide 21: Somatuline sales continuing to decline gradually
Somatuline sales continuing to decline gradually Q1 2023: -9.8% NORTH AMERICA EUROPE REST OF WORLD 58% of Somatuline sales 30% of Somatuline sales 12% of Somatuline sales -2.7% -25.7% +7.3% Favorable wholesaler- Generic competition across Solid underlying growth inventory comparison more geographies
Slide 22: Recently acquired medicines: Q1 2023
Recently acquired medicines: Q1 2023 €5m €9m Momentum in Growth of 21% in commercial sales1 North America and Europe An increasing Focus on all-comers, new-patient number of treated PFIC patients starts & duration of therapy Anticipated regulatory decisions this NCCN guidelines recently updated year
Slide 23: FY 2022 financial highlights
FY 2022 financial highlights Total sales €3,025m +8.5% Core operating income €1,115m +13.5% Core operating margin1 36.9% -0.3 pts Core EPS2 €10.51 +18.4% Free cash flow €817m +4.7% Total-sales growth is at constant exchange rates; all other growth rates are at actual exchange rates. 1. As a ratio of
Slide 24: Oncology: key ongoing clinical-trial highlights
Oncology Key ongoing clinical-trial highlights P R I M ARY TRIAL P O P U L AT I O N PAT I E N T S DESIGN S TAT U S ENDPOINT(S) Second novel hormonal Recruiting1 Cabometyx therapy (abiraterone & CONTACT-02 2L mCRPC 580 prednisone or enzalutamide) OS, PFS PFS data Phase III or anticipated NCT04446117
Slide 25: Oncology: key ongoing clinical-trial highlights
Oncology Key ongoing clinical-trial highlights P R I M ARY TRI AL P O P U L AT I O N PAT I E N T S DESIGN S TAT U S ENDPOINT(S) Tazverik Tazverik in various ARIA R/R hematologic Phase Ib: dosing, safety 156 combinations: multi- Recruiting Phase Ib/II malignancies Phase II: ORR cohort NCT05205252 IPN
Slide 26: Rare Disease: key ongoing clinical-trial highlights
Rare Disease Key ongoing clinical-trial highlights P R I M ARY TRIAL P O P U L AT I O N PAT I E N T S DESIGN S TAT U S ENDPOINT Response to treatment Elafibranor Placebo defined as ALP < 1.67 x ELATIVE Data anticipated 2L PBC 161 or ULN and total bilirubin ≤ Phase III H1 2023 elafibranor ULN and ALP
Slide 27: Rare Disease: key ongoing clinical-trial highlights
Rare Disease Key ongoing clinical-trial highlights P R I M ARY TRIAL P O P U L AT I O N PAT I E N T S DESIGN S TAT U S ENDPOINT(S) Palovarotene - U.S.: PDUFA date Palovarotene 5mg QD and upon 16 August 2023 MOVE FOP flare-up, 20mg QD Annualized change in 107 E.U. CHMP: negative Phase III (chronic) f
Slide 28: Rare Disease: key ongoing clinical-trial highlights
Rare Disease Key ongoing clinical-trial highlights P R I M ARY TRIAL P O P U L AT I O N PAT I E N T S DESIGN S TAT U S ENDPOINT(S) 10mg IPN60250 tablet QD for 12 IPN60250 (A3907) weeks Primary sclerosing Treatment-related Phase II 12 Recruiting cholangitis adverse events NCT05642468 30mg (3x10 mg)
Slide 29: Neuroscience: key ongoing clinical-trial highlights
Neuroscience Key ongoing clinical-trial highlights P R I M ARY TRIAL P O P U L AT I O N PAT I E N T S DESIGN S TAT U S ENDPOINT IPN10200 Ax Dose escalation & Moderate to LANTIC dose finding First patient commenced severe upper 424 Safety Phase II versus Dysport or dosing Q1 2023 NCT04821089 facial l
Slide 30: Thank you
THANK YOU 30
Slide 31: Investor Relations
Investor Relations Adrien DUPIN DE SAINT-CYR Adrien DUPIN DE SAINT-CYR CraigRelations Investor MARKS Manager Nicolas BOGLER Investor Relations Manager Vice President, Investor Relations Investor Relations Senior Manager +44 7564 349 193 +33 6 52 19 98 92 craig.marks@ipsen.com nicolas.bogler@ipsen.co
Slide 32: Follow us
| ° Follow us Wwww.ipsen.com
Ipsen — 2023 Deutsche Bank Depositary Receipts Virtual Investor Conference on 6ix