Ipsen Sa · EURONEXT:IPN
Ipsen Sa — Investor Presentation (February 2024)
46 slides from Ipsen Sa's investor presentation, February 2024
Slide 1: Investor presentation Spring 2024
Investor presentation Spring 2024
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: Our vision
Our vision To be a leading global mid-sized biopharmaceutical company with a focus on transformative medicines Oncology Rare Disease Neuroscience
Slide 4: Our strategy: Focus. Together. For patients
Our strategy Bringing full potential of our Building innovative medicines a high-value, to patients sustainable pipeline Focus. Together. For patients Delivering & society efficiencies to enable Boosting investments & a culture of support growth collaboration, excellence & impact on society 4
Slide 5: Ipsen’s eight major in-market medicines
Ipsen’s eight major in-market medicines Motor muscular disorders Neuroscience Medical aesthetics Oncology Metastatic prostate cancer Growth platforms Oncology RCC: monotherapy & in combination Oncology Metastatic pancreatic cancer Oncology Neuroendocrine tumors Rare Disease Rare cholestatic-liver di
Slide 6: Ipsen’s total sales: FY 2023
Ipsen’s total sales: FY 2023 Oncology Neuroscience Somatuline Decapeptyl Rare Cabometyx Disease Onivyde Tazverik Other Oncology Bylvay Sohonos NutropinAq Increlex Dysport Other Neuroscience 6
Slide 7: Bringing full potential of innovative medicines to patients
Bringing full potential of innovative medicines to patients Growth platforms Growth platforms: sales growth 20% 21% 13% FY 2021 FY 2022 FY 2023 Growth rates at actual exchange rates. 7
Slide 8: A strong platform for growth
A strong platform for growth Growth platforms & new medicines continue to drive momentum External innovation elafibranor New Total sales medicines Growth platforms Somatuline Today Time 8
Slide 9: More balanced split of sales by three therapy areas
More balanced split of sales by three therapy areas Oncology Rare Disease Neuroscience 75% 4% 21% of total of total of total sales1 sales1 sales1 Growth driven by Multiple launches: Sustained growth Onivyde 1L mPDAC & Bylvay, elafibranor & of Dysport in Tx & Ax Cabometyx Sohonos Future growth: Futur
Slide 10: Increasingly diversified portfolio
Increasingly diversified portfolio Seven medicines: potential sales ≥€500m 2027+ elafibranor Four medicines: sales ≥€500m 2023 One medicine: sales ≥€500m 2020 10
Slide 11: Global leader with growth across all regions
Global leader with growth across all regions North America Europe Rest of World 33% 40% 27% of total sales1 of total sales1 of total sales1 Leveraging platform through Sustained growth driven by Multiple opportunities in multiple launches Dysport & Cabometyx Asia-Pacific & Latin America Future growt
Slide 12: Our growth journey
Our growth journey Next phase of transformation built on strong foundations 2028+ Lasting momentum 2024-2027 Balanced & diversified Dynamic growth portfolio across three therapy areas 2020-2023 Several launches Sustained growth, Setting foundations supported by pipeline & Further pipeline expansion
Slide 13: Launching four new medicines or new indications in 2024
Launching four new medicines or new indications in 2024 Expected Indication Market regulatory-decision date Approved 1L mPDAC U.S. only 13 February 2024 U.S. launch underway ALGS Global1 EMA: H2 2024 FDA: 10 June 2024 Elafibranor 2L PBC Global2 EMA: H2 2024 FOP U.S. & selected RoW U.S. launch underw
Slide 14: Continued pipeline execution
Continued pipeline execution Achieve up to three Complete up to five potential regulatory pivotal trials by 2026 approvals by 2024 Advance Expansion of LANT trials early-stage programs LANT: longer-acting neurotoxin. 14
Slide 15: A high-value, sustainable pipeline
A high-value, sustainable pipeline Phase I Phase II Phase III Registration IPN60210 FIDRISERTIB CABOMETYX + ONIVYDE + 5-FU/LV + R/R multiple myeloma ATEZOLIZUMAB OXALIPLATIN1 & R/R DLBCL FOP 2L mCRPC 1L mPDAC IPN60260 ELAFIBRANOR TAZVERIK + R2 ODEVIXIBAT2 Viral cholestatic disease PSC 2L FL Alagille
Slide 16: Near to mid-term outlook
Data Regulatory Near to mid-term outlook readout decision Key milestones Medicine 2024 2025 2026 Onivyde 1L mPDAC, FDA Elafibranor 2L PBC, FDA Odevixibat ALGS, E.U. Cabometyx mCRPC, Phase III Fidrisertib FOP, Phase II Bylvay BA, Phase III Dysport Migraine, Phase III Tazverik 2L FL, Phase III1 1L: fi
Slide 17: Generation Ipsen: sustainability-performance update
Generation Ipsen: sustainability-performance update Pillars KPIs 2023 performance Science-based GHG-emission reductions1 vs 2019 baseline by 2030 Environment Scope 1&2: -50% Scope 1&2: -36% Scope 3: -20% Scope 3: -29% Reduce time to make non-FDA/EMA Patients regulatory submissions by 25% First data
Slide 18: 2027 mid-term outlook
2027 mid-term outlook Excluding potential additional late-stage1 external-innovation opportunities TOTAL-SALES: CORE OPERATING CAGR 2023-2027 MARGIN 2027 ≥+7% ≥32% of total sales at constant exchange rates ` Launches of new medicines & Limited decline in additional indications gross-margin Growth pl
Slide 19: Drivers of 2027 core operating margin
Drivers of 2027 core operating margin Gross margin R&D SG&A ≥85% ≥20% ≤35% Manufacturing gains Investment to support Leverage commercial to lower unit costs internal & external infrastructure & targeted innovation pipeline investment for launches Unfavorable sales mix Optimization of footprint Syner
Slide 20: Capital-allocation framework
Capital-allocation framework Cumulative firepower of up Increased free Limited to €5bn by 2027, based on net cash-flow evolution debt1 at 2.0x EBITDA generation of dividend Priority for capital allocation Multiple transactions from licensing & acquisitions External Innovation Financial discipline ba
Slide 21: Investor presentation Spring 2024
Investor presentation Spring 2024
Slide 22: Appendix
APPENDIX SIPSEN
Slide 23: Multiple growth opportunities by medicine
Multiple growth opportunities by medicine Global peak sales / direction Peak sales >€700m1 Peak sales >€500m Oncology Peak sales >€500m2 Mid-single digit growth3 Peak sales >€700m4 Rare Disease Elafibranor Peak sales >€500m5 Peak sales >€100m Neuroscience High-single digit growth3 1 Excluding additi
Slide 24: FY 2023 highlights
FY 2023 highlights Financial results 2024 key milestones Total-sales: +6.7%1 Regulatory decisions Growth platforms: +13.0%1 Onivyde: U.S. elafibranor: U.S., E.U. Core operating margin: 32.0% odevixibat: E.U. Q4 pipeline progress 2024 guidance2 Regulatory submissions Total-sales growth elafibranor: U
Slide 25: 2023 sales highlights
Image O/S 2023 sales highlights FY 2023 Q4 2023 €m % change €m % change Growth platforms 1,893 13.0% 486 4.9% New medicines 119 n/a 42 n/a Somatuline 1,066 -10.4% 278 -5.4% Other 51 -10.7% 13 18.9% Total Sales 3,128 6.7% 818 5.4% Packaging Operator Production All growth rates at constant exchange ra
Slide 26: Growth platforms: +13.0% in FY 2023
Growth platforms: +13.0% in FY 2023 Q4 Q4 Q4 Q4 -7.0% +19.0% +7.0% +14.7%1 Strong underlying Strong volume uptakes Good growth Further growth in aesthetic & therapeutics across most in China post-gemcitabine setting performance geographies Challenging baseline & Momentum in Robust performance 1L PDA
Slide 27: New medicines
New medicines FY 2023 FY 2023 FY 2023 €74m €38m €7m H2 U.S. launch in second indication, Completed strategic re-build of Recent launch in U.S.: first & only ALGS operational capabilities treatment for patients with FOP PFIC: increasing Focus on community setting & Sales from special-licence sales nu
Slide 28: Somatuline sales: Q4 -5.4%; FY -10.4%
Somatuline sales: Q4 -5.4%; FY -10.4% North Rest of America Europe Q4 World Q4 Q4 -4.5% -1.9% -17.6% Volumes stable in a Reduced baseline: one year after Impact from growing market generic launch in key countries generic launch in Australia Favorable one-off Benefit from Effects from phasing & tende
Slide 29: Core P&L
Core P&L Solid sales growth; operating margin primarily reflects R&D investment from acquisitions FY 2023 FY 2022 change Total sales €m €m % Adverse impact from currencies Other revenue Total Sales 3,128 3,025 3.4% Favorable impact from license rights to Onivyde Other revenue 179 131 36.1% Cost of g
Slide 30: 2023 core operating margin evolution
2023 core operating margin evolution Reflective of dilutive impact from recent acquisitions Base business • Strong contribution of growth platforms • Pre-launch investment • Gradual decline of Somatuline Acquisitions • Dilutive Epizyme & Albireo impacts driven by commercial & R&D investments Onivyde
Slide 31: Core operating income to consolidated net profit
Core operating income to consolidated net profit FY 2023 FY 2022 change Amortization of €m €m % intangible assets Increase mainly related to new assets: Bylvay, Core Operating Income 1,001 1,115 -10.3% Tazverik & Sohonos Amortization of intangible assets (207) (103) n/a Restructuring & other Restruc
Slide 32: Cash flow & net debt
Cash flow & net debt FY 2023 FY 2022 change Free cash-flow decline €m €m % driven by lower core operating income & higher Opening Net Cash 399 28 n/a level of capital expenditures & improved working capital Free cash flow 711 817 -13.0% Dividends (100) (100) - Net investments primarily reflected Alb
Slide 33: FY 2024 guidance
FY 2024 guidance Excluding any impact from potential late-stage1 external-innovation transactions CORE OPERATING TOTAL-SALES GROWTH MARGIN CORE OPERATING MARGIN >+6% ~30% of total` sales at constant exchange rates of total sales Expected adverse impact of around 1% Includes additional R&D expenses f
Slide 34: Oncology: key ongoing clinical-trial highlights
Oncology Key ongoing clinical-trial highlights PRIMARY TRIAL POPULATION 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 35: Oncology: key ongoing clinical-trial highlights
Oncology Key ongoing clinical-trial highlights PRIMARY TRIAL POPULATION PATIENTS DESIGN STATUS ENDPOINT(S) R/R FL: following at least one prior Tazverik systemic Placebo + R2 SYMPHONY-1 chemotherapy, 540 or PFS Recruiting1 Phase III immunotherapy, or Tazverik + R2 NCT04224493 chemo- immunotherapy IP
Slide 36: Rare Disease: key ongoing clinical-trial highlights
Rare Disease Key ongoing clinical-trial highlights TRIAL POPULATION PATIENTS DESIGN PRIMARY ENDPOINT STATUS Elafibranor Response to treatment Placebo Regulatory decisions: ELATIVE defined as ALP < 1.67 x ULN 2L PBC 161 or U.S.: June 2024 Phase III and total bilirubin ≤ ULN and elafibranor E.U.: H2 2
Slide 37: Rare Disease: key ongoing clinical-trial highlights
Rare Disease Key ongoing clinical-trial highlights PRIMARY TRIAL POPULATION PATIENTS DESIGN STATUS ENDPOINT(S) 10mg IPN60250 tablet QD for IPN60250 12 weeks Primary sclerosing Phase II 12 Safety and tolerability Recruiting1 cholangitis NCT05642468 30mg (3 x 10mg) IPN60250 tablets QD for 12 weeks Ela
Slide 38: 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 191 dose-finding versus Safety Fully recruited1 Phase II NCT04821089 lines Dysport or placebo IPN10200 Tx Adult patients Do
Slide 39: Bylvay: expanding position in rare liver disease
Bylvay: expanding position in rare liver disease Bylvay sales (€m)1 Outlook & drivers 23 Strong uptake in PFIC & ALGS 18 – Increasing number of new patients 15 9 7 – Weight-based dose increases 11 6 7 – Ease of administration, fosters patients’ 4 3 11 13 convenience 9 4 6 – Geographic expansion Q3’2
Slide 40: Bylvay: U.S. growth based on two approved indications
Bylvay: U.S. growth based on two approved indications Bylvay – reimbursed U.S. PFIC patients U.S. outlook & drivers PFIC 150 143 – Addressing pediatric & adult patients 125 – Drive growth from iBAT-naïve physicians 106 – Expanding into secondary hepatology 100 centers to accelerate patient finding 8
Slide 41: Bylvay: growth enhanced by geographic expansion
Bylvay: growth enhanced by geographic expansion Bylvay launch sequence: Ex. U.S. outlook & drivers national reimbursement 2021 2022 2023 Further patient uptake from existing markets PFIC U.S. France Netherlands Multiple additional countries with regulatory approval & pricing/reimbursement in Germany
Slide 42: Elafibranor: PBC, a rare autoimmune liver disease
Elafibranor: PBC, a rare autoimmune liver disease U.S. E5 RoW ~100k ~95k ~190k Patients diagnosed with PBC Patients diagnosed with PBC Patients diagnosed with PBC ~75k ~75k ~140k Patients treated in 1L Patients treated in 1L Patients treated in 1L PBC: primary biliary cholangitis; 1L: first line; E5
Slide 43: Elafibranor: opportunity to expand global 2L PBC market
Elafibranor: opportunity to expand global 2L PBC market U.S. example: 2L PBC patient flow: Underdeveloped global 2L PBC market number of U.S. patients Significant unmet medical need – Dissatisfaction with current treatment options – Uncontrolled disease Limited share (20-40%) of eligible patients Pa
Slide 44: Elafibranor: U.S. launch readiness on track
Elafibranor: U.S. launch readiness on track Patient profile & landscape U.S. launch readiness 80% of patients are women Established U.S. Rare Disease organization preparing Mean age of first diagnosis is 50 years old for rapid launch 70% of patients have at least one – Educating HCPs & patients on n
Slide 45: Investor Relations
Investor Relations Craig Marks Nicolas Bogler 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.com 45
Slide 46: Thank you
Thank you Follow us: www.ipsen.com