Slide 1: H1 2024 results
H1 2024 results 25 July 2024 Gill Living with primary biliary cholangitis Nottingham, U.K.
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 statements
Slide 3: Speakers
Speakers David Loew Business update Chief Executive Officer Christelle Huguet R&D update Head of R&D Aymeric Le Chatelier Financials Chief Financial Officer 3
Slide 4: Business update
Business update David Loew Chief Executive Officer 4
Slide 5: Delivery & progress to date
Delivery & progress to date Strong Regulatory Pipeline & external- financial performance success innovation progress Total-sales Onivyde One late-stage deal growth approval: 1L mPDAC ex-U.S. licensing in 9.5%1 U.S. pediatric Oncology Core operating Iqirvo Four early-stage deals margin approval: 2L P
Slide 6: H1 2024 total sales by key medicine (€m)
H1 2024 total sales by key medicine (€m) €1,659m: growth of 9.5% 355 -1.1% Oncology: +5.8% 79 Rare Disease: +84.5% Neuroscience: +12.7% 1,226 +12.3% +17.3% +1.5% 522 349 304 277 +25.4% n/a +25.6% n/a n/a 97 57 23 10 1 Somatuline Dysport Cabometyx Decapeptyl Onivyde Bylvay Tazverik Sohonos Iqirvo All
Slide 7: Onivyde: on track to become a standard of care in U.S. in 1L mPDAC
Onivyde: on track to become a standard of care in U.S. in 1L mPDAC Accounts Market 34% demand growth mPDAC market growth ~ +2%1 in top-10 accounts1 Prescribers Demand 80% of prescribers with unrestricted 17% increase in ability to prescribe 1L Onivyde post-approval weekly demand Access 90% of payer
Slide 8: An encouraging early start for Iqirvo in U.S.
An encouraging early start for Iqirvo in U.S. SALES APPROVAL Patients covered & on treatment within first week of launch: first sales in June FDA Accelerated Approval: 10 June First & only approved PPAR agonist to market FEEDBACK ELATIVE UNMET MEDICAL NEED 50% of HCPs surveyed one week post launch w
Slide 9: Sustainable pipeline expansion
Oncology Information shown as at end of June 2024 Rare Disease Sustainable pipeline expansion Neuroscience Phase I Phase II Phase III Registration CABOMETYX 2L+ pNET & epNET CABOMETYX + ATEZOLIZUMAB 2L mCRPC TAZVERIK + R2 2L FL IPN01194 Solid tumors IQIRVO1 2L PBC ODEVIXIBAT1 Alagille syndrome BYLVA
Slide 10: An attractive addition to pipeline: in-licensing of tovorafenib
An attractive addition to pipeline: in-licensing of tovorafenib Ex-U.S. licensing in pediatric oncology U.S Ex-U.S. High unmet need Limited number of competitors FDA accelerated – Est. E5 pLGG patients1,2:~700 incident, ~2-3K prevalent approval – No clear SoC ex-US in pLGG in patients with BRAF V600
Slide 11: R&D update
R&D update Christelle Huguet Head of R&D 11
Slide 12: Focused strategy on innovation
Focused strategy on innovation Guided by science & patient needs across therapy areas Selectively sourcing innovation from biotech ecosystem Strong lifecycle opportunities to benefit as many patients as possible Accelerate development through clinical knowhow & regulatory excellence Across three the
Slide 13: Unlocking the potential of new oncology modalities
Unlocking the potential of new oncology modalities Selectively targeting & activating subsets of ADCs: promising evaluation in selected solid-tumor types T cells present in tumor-infiltrating lymphocytes August 2022 April 2024 June 2024 Exclusive global rights secured for two ADCs in final stages of
Slide 14: CABINET: evaluation of Cabometyx in neuroendocrine tumors
CABINET: evaluation of Cabometyx in neuroendocrine tumors Reduction in risk of disease progression or death of 73% and 55% for pNET & epNET, respectively CABINET: randomized, double-blinded Phase III trial 58% of patients presented 35 per 100,000 people with metastatic disease at living with NETs Tr
Slide 15: Tovorafenib as a treatment for pLGG
Tovorafenib as a treatment for pLGG Oral, once-weekly, type II pan-RAF inhibitor approved in U.S. following results of pivotal Phase II FIREFLY-1 trial Pivotal Phase II trial relapsed/refractory BRAF-altered pLGG patients who had received at least one prior therapy across two arms for efficacy and s
Slide 16: Expanding Iqirvo’s potential
Expanding Iqirvo’s potential Opportunity in wider patient population Data 2026 ELSPIRE: Global Phase III, randomized, double-blind, placebo-controlled trial Ipsen’s rare liver franchise Estimated 9,000 patients in U.S. are Comparable likelihood of negative classified as partially controlled on 1L wi
Slide 17: Major forthcoming pipeline milestones
Major forthcoming pipeline milestones Medicine 2024 2025 2026 Iqirvo 2L PBC, E.U. Odevixibat ALGS, E.U. Cabometyx 2L mCRPC, Phase III1 Cabometyx 2L+ pNET & epNET Fidrisertib FOP, Phase IIb2 Bylvay BA, Phase III Dysport Migraine, Phase III Tazverik 2L FL, Phase III3 Regulatory decision Data readout 2
Slide 18: Financials
Financials Aymeric Le Chatelier Chief Financial Officer 18
Slide 19: Financial highlights
Financial highlights Core Firepower Total Free Operating at 2x sales cash flow Income EBITDA €1,659m €538m €394m €2.0bn3 +9.5%1 +2.8%2 +5.9%2 +€150m4 Strong sales leveraging profitability & further cash generation 1 At constant exchange rates. 2 At actual exchange rates. 3 Based on net debt includin
Slide 20: Core P&L
Core P&L Strong sales growth; operating margin primarily reflected R&D & launch investments H1 2024 H1 2023 change Total sales €m €m % Adverse currencies impact Total Sales 1,659 1,537 8.0% Gross margin Other revenue 93 87 6.9% Unfavorable sales mix Cost of goods sold (317) (270) 17.4% & increase of
Slide 21: Core operating income to consolidated net profit
Core operating income to consolidated net profit H1 2024 H1 2023 change €m €m % Core Operating Income 538 523 2.8% IFRS Operating Income growing by 7.5% Amortization of intangible assets (123) (91) 35.7% Lower level of restructuring Restructuring & other operating expense (97) (125) -22.3% & other o
Slide 22: Cash-flow highlights & net debt
Cash-flow highlights & net debt H1 2024 H1 2023 change €m €m % Opening Net Cash 65 399 -83.7% Free cash-flow at €394m growing by +5.9% Free Cash Flow 394 372 5.9% ahead of EBITDA growth Dividends (100) (100) 0.0% Net investments for €338m Net investments (338) (946) -64.3% including milestone paid f
Slide 23: FY 2024 guidance upgraded
FY 2024 guidance upgraded CORE OPERATING MARGIN TOTAL-SALES GROWTH CORE OPERATING MARGIN >+7.0% >30.0% of total` sales at constant exchange rates of total sales Expected adverse impact of around 1% from currencies, based on average exchange rates in June 2024 23
Slide 24: Conclusion
Conclusion David Loew Chief Executive Officer 24
Slide 25: Conclusion
Conclusion Delivering on our ambitions Financials Strong top-line growth & core operating margin, significant cash generation Pipeline Further regulatory success & advancing pipeline Launches Onivyde & Iqirvo on track Execution Consistent commercial and pipeline performance, driven by focus on patie
Slide 26: Questions
QUESTIONS
Slide 27: Appendix
APPENDIX SIPSEN
Slide 28: H1 2024 total sales: unfavorable impact of fx rates
H1 2024 total sales: unfavorable impact of fx rates H1 2024 sales by currency Average rate changes (H1 2024 vs. H1 2023) Other USD: 1.08 BRL: 5.49 AUD: 1.64 CNY: 7.80 TRY: 34.27 0% 0% -3% -4% --66% EUR EUR 26,2% 24.6% 33,4% 34% 4% -59% 33.5% CNY 4% 3,5% 4,3% 35% 32,6% USD BRL AUD CNY TRY USD Unfavor
Slide 29: Focused strategy on innovation
Focused strategy on innovation Guided by science & patient needs across therapeutic areas Oncology • Selecting biomarker-driven indications • Right modalities, right niche tumors • Ipsen expertise, heritage & track record of strong partnerships Rare Disease • Building on existing rare liver-disease
Slide 30: Oncology
Oncology Key ongoing clinical-trial highlights PRIMARY TRIAL INDICATION PATIENTS DESIGN STATUS ENDPOINT(S) Second novel hormonal Cabometyx therapy (abiraterone & PFS endpoint met CONTACT-02 2L mCRPC 575 prednisone or enzalutamide) PFS, OS Phase III or Awaiting OS data NCT04446117 Cabometyx + atezoli
Slide 31: Oncology
Oncology Key ongoing clinical-trial highlights PRIMARY TRIAL INDICATION PATIENTS DESIGN STATUS ENDPOINT(S) R/R FL: following at least one prior Tazverik systemic Placebo + R2 SYMPHONY-1 chemotherapy, 612 or PFS Recruiting1 Phase III immunotherapy, or Tazverik + R2 NCT04224493 chemo- immunotherapy IP
Slide 32: Rare Disease
Rare Disease Key ongoing clinical-trial highlights PRIMARY TRIAL INDICATION PATIENTS DESIGN STATUS ENDPOINT Response to IQIRVO treatment defined as Placebo Regulatory decisions: ELATIVE ALP < 1.67 x ULN and 2L PBC 161 or U.S.: June 2024 (approval) Phase III total bilirubin ≤ ULN Iqirvo E.U.: H2 2024
Slide 33: Rare Disease
Rare Disease Key ongoing clinical-trial highlights PRIMARY TRIAL INDICATION PATIENTS DESIGN STATUS ENDPOINT(S) Odevixibat Placebo ASSERT Change from baseline in Regulatory decision: Alagille syndrome 52 or Phase III scratching score E.U.: H2 2024 odevixibat NCT04674761 Bylvay Placebo BOLD Time to fi
Slide 34: Neuroscience
Neuroscience Key ongoing clinical-trial highlights PRIMARY TRIAL POPULATION PATIENTS DESIGN STATUS ENDPOINT IPN10200 Ax Moderate to Dose escalation & LANTIC severe upper facial 727 dose-finding versus Safety Active, not recruiting1 Phase II NCT04821089 lines Dysport or placebo IPN10200 Tx Adult pati
Slide 35: Generation Ipsen: progress continues
GENERATION IPSEN Generation Ipsen: progress continues Environment Patients People Governance Caring for the planet Patients drive Passionate people Acting with integrity and everything we do making a real impact, transparency every day Key targets Key targets Key targets Key targets 50% reduction in
Slide 36: Investor Relations
Investor Relations Craig Marks Nicolas Bogler Vice President, Senior Manager Investor Relations Investor Relations +44 7564 349 193 +33 6 52 19 98 92 craig.marks@ipsen.com nicolas.bogler@ipsen.com 36
Slide 37: Thank you
Thank you Follow us: www.ipsen.com