Slide 1: Investor Presentation November 2024
Investor Presentation November 2024 Clare Pharmaceutical Process Technician Wrexham, 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: Focus. Together. Our vision & strategy
Focus. Together. Our vision & strategy For patients & society To be a leading global mid-sized biopharmaceutical company with a focus on transformative medicines Bringing Building full potential of our a high-value, innovative medicines sustainable pipeline to patients Oncology Rare Disease Neurosci
Slide 4: Ipsen's Investment case
Ipsen’s Investment case Focus External- Global Expanding Strong balance on Specialty innovation footprint pipeline sheet Care strategy Opportunities for Well-balanced Good mix of 35+ assets Solid free further growth geographical new molecules since 2020 across cashflow across the 3 presence and life
Slide 5: 2027 mid-term outlook
2027 mid-term outlook Priority for Excluding potential additional late-stage1 capital allocation: external-innovation opportunities External Innovation TOTAL-SALES: CAGR 2023-2027 ≥+7% Cumulative firepower of up to €5bn by 2027, based on net debt2 at 2.0x EBITDA at constant exchange rates Multiple t
Slide 6: Highlights YTD 2024
Highlights YTD 2024 Strong growth momentum Further pipeline progress Total-sales growth E.U. regulatory approval Q3: +8.6% Iqirvo: 2L PBC YTD: +9.2% ` Key product highlights E.U. regulatory approval Dysport & Bylvay delivering Kayfanda: ALGS strong results; Iqirvo & Onivyde launches on track. E.U. r
Slide 7: Sales performance YTD 2024
Gill Image O/S Living with primary biliary cholangitis Nottingham, U.K. Sales perfomance YTD 2024 Q3 2024 YTD 2024 % % €m €m change change Oncology 604 5.6% 1,830 5.8% Rare Disease 51 54.4% 130 71.3% Neuroscience 182 10.1% 536 11.8% Total Sales 837 8.6% 2,496 9.2% Growth at constant exchange rates.
Slide 8: Onivyde: launch progress on track
Onivyde: launch progress on track U.S. sales: Q3 +26.0%; YTD +20.2% U.S. Onivyde weekly demand (units) Launch in 1L mPDAC • 7% share of 1L new-patient starts1 • 289 HCPs have initiated NALIRIFOX treatment this year • 24% growth2 in top-25 accounts3 • Real-world overall survival data mars 24 janv 24
Slide 9: Iqirvo: launch progress on track
Iqirvo: launch progress on track Q3 sales: €6m; YTD sales: €8m • Majority of Iqirvo patients 2L PBC naïve Cumulative persistent reimbursed U.S. patients1 • Patient initiation uptake across severity range: 17% at 100-170 ALP IU/L • >50% of commercial lives covered in U.S., with positive ongoing traje
Slide 10: Pipeline highlights
Oncology Information shown as at end of September Rare Disease 2024 Pipeline highlights Neuroscience Phase I Phase II Phase III Registration Cabometyx: CABINET 2L+ pNET & epNET Tovorafenib: FIREFLY-2 1L pLGG Tazverik + R2: SYMPHONY-1 2L FL Tovorafenib: FIREFLY-1 R/R pLGG IPN01194 Solid tumors Bylvay
Slide 11: Major forthcoming pipeline milestones
Oncology Rare Disease Information shown as at end of September 2024 Major forthcoming pipeline milestones Neuroscience Medicine 2025 2026 Tovorafenib FIREFLY-1 R/R pLGG Fidrisertib FALKON FOP, Phase IIb1 Tazverik + R2 SYMPHONY-1 2L FL, Phase III2 Iqirvo ELSPIRE 2L PBC3, Phase III Bylvay BOLD BA, Pha
Slide 12: Conclusion
Conclusion Strategic success driving strong 2024 results Top-line momentum driven by growth across therapy areas; launches on track Further pipeline & regulatory achievements Full-year guidance increased Mathilde Vincent, Scientist,R&D Senior Scientist, R&D, Les Ulis, France Les Ulis, France
Slide 13: Questions
QUESTIONS
Slide 14: Appendix
APPENDIX SIPSEN
Slide 15: Oncology: Key ongoing clinical-trial highlights
Oncology Key ongoing clinical-trial highlights PRIMARY TRIAL INDICATION PATIENTS DESIGN STATUS ENDPOINT(S) Primary endpoint met Tovorafenib FIREFLY-1 R/R pLGG 140 Tovorafenib ORR & safety Anticipated Phase II regulatory submission NCT04775485 2025 Tovorafenib Tovorafenib FIREFLY-2 1L pLGG 400 or ORR
Slide 16: Oncology: Key ongoing clinical-trial highlights
Oncology Key ongoing clinical-trial highlights PRIMARY TRIAL INDICATION PATIENTS DESIGN STATUS ENDPOINT(S) R/R FL: following at least one prior Tazverik systemic Tazverik + R2 SYMPHONY-1 chemotherapy, 612 or PFS Recruiting1 Phase III immunotherapy, or placebo + R2 NCT04224493 chemo- immunotherapy IP
Slide 17: Rare Disease: Key ongoing clinical-trial highlights
Rare Disease Key ongoing clinical-trial highlights PRIMARY TRIAL INDICATION PATIENTS DESIGN STATUS ENDPOINT Iqirvo Placebo ELMWOOD PSC 68 or Safety and tolerability Fully recruited1 Phase II Iqirvo NCT05627362 Iqirvo Placebo ELSPIRE2 2L PBC 72 or Normalisation of ALP Recruiting1 Phase III Iqirvo NCT
Slide 18: Rare Disease: Key ongoing clinical-trial highlights
Rare Disease Key ongoing clinical-trial highlights PRIMARY TRIAL INDICATION PATIENTS DESIGN STATUS ENDPOINT(S) Bylvay Placebo BOLD Time to first occurrence of Biliary atresia 254 or Fully recruited1 Phase III liver transplant, or death Bylvay NCT04336722 Fidrisertib Placebo or FALKON* FOP two dosing
Slide 19: Neuroscience: Key ongoing clinical-trial highlights
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 Recruiting1 Phase II NCT04821089 lines Dysport or placebo IPN10200 Tx Adult patients Dose es
Slide 20: Investor Relations
Investor Relations Nicolas Bogler Senior Manager Investor Relations +33 6 52 19 98 92 nicolas.bogler@ipsen.com 20
Slide 21: Thank you
Thank you Follow us: www.ipsen.com