Slide 1: YTD 2024 sales update
YTD 2024 sales update 23 October 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: Speakers
Speakers Presentation Joining for Q&A Head of R&D David Loew Aymeric Le Chatelier Christelle Huguet Chief Executive Officer Chief Financial Officer Head of R&D 3
Slide 4: Highlights
Highlights Strong growth momentum Further pipeline progress Total-sales growth E.U. regulatory approval Q3: +8.6% ` Iqirvo: 2L PBC YTD: +9.2% Headline performances E.U. regulatory approval Dysport & Bylvay Kayfanda: ALGS Launches on track E.U. regulatory submission Stephen Iqirvo & Onivyde Cabometyx
Slide 5: Sales performance
Gill Image O/S Living with primary biliary cholangitis Nottingham, U.K. Sales perfomance 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. 5
Slide 6: Oncology
Oncology Q3 Q3 Q3 Q3 +5.5% +10.7% -4.9% +19.1% North America: adverse Europe growth partly Increased competition & Competitive U.S. pricing, stable reflecting U.K. pricing pressure in environment in demand NICE approval in 1L Europe prevailing indication Europe: benefit of Strong RoW Challenging mar
Slide 7: 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 sept 24 janv 24
Slide 8: Rare Disease
Rare Disease Q3 Q3 €37m: +66% €3m PFIC: expanded patient population Low patient uptake in U.S. impacted by in the U.S. and reimbursement in more FOP clinical trials markets outside U.S. x x ALGS: continued growing uptake in U.S. Limited label & Kayfanda now approved in E.U. geographic rollout outsid
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: Neuroscience
Neuroscience Q3: +10.6% Aesthetics: +17.8% Continued growth in most aesthetics markets; share gains, notably by partner in U.S. & Brazil Limited market softening in U.S.; robust European markets Therapeutics: -1.2% Performance mainly impacted by unfavorable phasing & inventory movements Share gains
Slide 11: 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 12: 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 13: FY 2024 guidance increased
FY 2024 guidance increased CORE OPERATING MARGIN TOTAL-SALES GROWTH CORE OPERATING MARGIN >+8.0% >31.0% of total` sales at constant exchange rates of total sales Expected adverse impact of around 1.5% from currencies, based on average exchange rates in September 2024 13
Slide 14: 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 15: Questions
QUESTIONS
Slide 16: Appendix
APPENDIX SIPSEN
Slide 17: YTD 2024 total sales by key medicine
€m YTD 2024 total sales by key medicine €2,496m: growth of 9.2% 536 +1.1% €m Oncology: +5.8% 130 Rare Disease: +71.3% Neuroscience: +11.8% 1,830 +11.7% +15.0% -0.6% 794 529 449 401 +23.3% n/a +23.4% n/a n/a 148 94 35 13 8 Somatuline Dysport Cabometyx Decapeptyl Onivyde Bylvay Tazverik Sohonos Iqirvo
Slide 18: YTD 2024 total sales: unfavorable impact of fx rates
YTD 2024 total sales: unfavorable impact of fx rates YTD 2024 sales by currency Average rate changes (YTD 2024 vs. YTD 2023) USD: 1.09 AUD: 1.64 CNY: 7.82 BRL: 5.69 TRY: 35.14 Other 0% -1% -3% --66% -5% EUR EUR 25.2% 24.6% 33.2% 34% 4% 33.5% CNY 4% -46% 3.5% 4.4% 35% 33.7% USD USD AUD CNY BRL TRY Un
Slide 19: 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 20: 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 21: 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 22: 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 23: 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 24: Investor Relations
Investor Relations Nicolas Bogler Senior Manager Investor Relations +33 6 52 19 98 92 nicolas.bogler@ipsen.com 24
Slide 25: Thank you
Thank you Follow us: www.ipsen.com