Ipsen Sa · EURONEXT:IPN
Ipsen Sa — Investor Presentation (June 2021)
40 slides from Ipsen Sa's investor presentation, June 2021
Slide 1: Investor Presentation Spring 2021
Diana Living with post-stroke spasticity Sintra, Portugal Investor Presentation Spring 2021 1
Slide 2: Our Vision
Our Vision To be a leading global mid-size biopharmaceutical company with a focus on transformative medicines in oncology, rare disease & neuroscience 2
Slide 3: Focus. Together. For patients & society
Focus. Together. For patients & society Maximize Strengthen our brands pipeline Drive Focus on efficiencies culture 3
Slide 4: Strong & expanding global footprint
Strong & expanding global footprint North America Western Europe3 Rest of World 33% of Total Sales1 51% of Total Sales1 16% of Total Sales1 From 11% to 33% of Accelerated Continued market share Total Sales over the last development in China gains in all TAs five years2 Expansion in new geographies c
Slide 5: Growth drivers
Growth drivers Oncology Continued growth driven by 1L RCC & Limited growth until Group net sales1 potential indication other potential expansion CAGR 20-24 between indications +2% & 5% Continued growth Attractive growth despite challenging until generic erosion Chinese environment • At constant exch
Slide 6: Investing in R&D for growth
Investing in R&D for growth Build a strong and best-in-class R&D organization • Streamline organization and increase efficiencies • Build clinical operations excellence Increase R&D as a % of net sales Prioritize key internal development programs • Accelerate high-value programs driven by external •
Slide 7: Accelerate external innovation & strengthen pipeline
Accelerate external innovation & strengthen pipeline Oncology Rare disease Neuroscience €3bn cumulative • Solid & hematological • Disease areas with • Focus on in-house tumors unmet needs beyond recombinant long- firepower for endocrinology & bone acting toxins & TSIs pipeline • Niche tumors or dise
Slide 8: Transforming Ipsen R&D
Transforming Ipsen R&D • Defined therapeutic area units Organizational • Centralized clinical operations transformation • Strengthened R&D operations team • New governance model for major decisions Portfolio • Alignment of decisions with R&D strategy, priorities & resources governance • Assessment &
Slide 9: Significant potential in late-stage pipeline
Significant potential in late-stage pipeline Expected regulatory submission Potential 2021 2022 2023 peak sales1 1L HCC 2L NSCLC with with atezolizumab atezolizumab Pipeline in >€700M a product 2L mCRPC with atezolizumab Potential to establish SoC in 2L SCLC 1L PDAC >€300M hard-to-treat cancers Depe
Slide 10: Pipeline
Pipeline Phase I Phase II Phase III Registration Cabometyx + atezolizumab IPN60130 Cabometyx + atezolizumab Dysport solution Solid tumors FOP1 1L HCC Glabellar lines IPN59011 Cabometyx + atezolizumab Dysport Longer-acting neurotoxin 2L NSCLC NDO2 Ax IPN10200 Cabometyx + atezolizumab Longer-acting ne
Slide 11: Cabometyx: shifting landscape in 1&2L aRCC
Cabometyx®: shifting landscape in 1&2L aRCC Today’s landscape Tomorrow’s landscape CPI CPIs combos Compelling 1L 30% CPI 30% combination data CPI 55% (CheckMate-9ER) combos 70% Compelling 2L TKIs Compelling 2L TKIs monotherapy 70% monotherapy 70% TKIs data (METEOR) TKIs data (METEOR) 45% 30% EU5 >50
Slide 12: Cabometyx | COSMIC-312: significant expansion opportunity in HCC
Cabometyx® | COSMIC-312: significant expansion opportunity in HCC HCC (EU5) 1L HCC • CPI combinations to become Patients not receiving any active new SoC treatment / deceased patients • Approval expected in 2022 1L ~14K patients 2L ~5.6K 2L HCC patients 3L+ • Strong performance in key ~1.4K patients
Slide 13: Expanding Cabometyx potential: NSCLC & mCRPC
Expanding Cabometyx® potential: NSCLC & mCRPC Non-mutated NSCLC 2L+ (EU5) High risk mCRPC (EU5) Patients not receiving any Patients not receiving any active treatment / deceased active treatment / deceased patients patients 2L 1L ~50K patients ~22K patients 3L 2L ~16K patients ~13K patients DoT 6 mo
Slide 14: Onivyde LCM: expansion into new tumor types
Onivyde® LCM: expansion into new tumor types 2024+ 2023 Other possible LCM indications 2022 1L PDAC2 2L SCLC2 28K drug treated patients DoT 8 months 12K drug treated patients DoT 5 months 2019 2L PDAC 35% in post-gemcitabine 2L+1 12K drug treated patients DoT 3 months Peak sales for Onivyde® to exce
Slide 15: Decapeptyl: ongoing growth story
Decapeptyl®: ongoing growth story Key Facts Growth drivers Drivers of growth • Attractive market dynamics +3% CAGR Net sales growth 2015-2020 • Market share gains in EU and RoW • China performance impacted by competitive Market Leader in the EU environment Commercialized in • Focus on long-acting fo
Slide 16: Dysport: excellence in neurotoxins
Dysport®: excellence in neurotoxins Ipsen Dysport® Total Sales 2015-2020 €m Key Facts CAGR: +6% 388 +6% CAGR Total Sales growth 348 353 2015-2020 328 279 285 Leading market position Dysport® #2 globally #1 in several markets Complexity hurdles Specialized & highly regulated manufacturing process 201
Slide 17: Efficiency, focus and agility to fuel growth
Efficiency, focus and agility to fuel growth Generate efficiencies Focused and agile operating model Smart spending Simpler operations Manufacturing efficiencies Excellence in execution Digital enablement Transformed R&D organization 17
Slide 18: Focus & optimize resources
Focus & optimize resources Smart • Focus on high priority projects • Procurement savings Lower SG&A as a % spending • Centralization, outsourcing and right-sizing of net sales by 2024 Simpler • Process optimization & simplification • Organization & footprint adjustment operations • Adoption of new w
Slide 19: 5,700+ employees committed to society with clear KPIs by 2024
5,700+ employees committed to society with clear KPIs by 2024 Compensation of management & credit Employees Communities Environment facility include • Best place to work certification • 1/3+ of employees supporting • 21% reduction of greenhouse social in >75% of countries healthcare and environment
Slide 20: Financial outlook 2020 to 2024
Financial outlook1 2020 to 2024 Group net sales Commitment to invest €3bn cumulative CAGR 2020-24 in R&D supported by firepower for pipeline between +2% & +5% SG&A efficiencies expansion • At constant exchange rates and scope • Lower SG&A as a % of net sales driven • Excluding the sale of any assets
Slide 21: Capital allocation prioritized to external innovation
Capital allocation prioritized to external innovation PRIORITIES FOR CAPITAL €3bn cumulative ALLOCATION firepower for Sales growth and pipeline expansion higher conversion • Priority to external of EBITDA innovation and business by 2024 development INCREASED • Limited evolution of dividend based on
Slide 22: Investor Presentation Spring 2021
Diana Living with post-stroke spasticity Sintra, Portugal Investor Presentation Spring 2021 22
Slide 23: Appendix
APPENDIX 23
Slide 24: Q1 2021 Encouraging top-line and pipeline progress
Q1 2021 Encouraging top-line and pipeline progress Key highlights Total Sales +5.5% to €659m Regulatory EU approval • Specialty Care +6.4% to €612m • Cabometyx + nivolumab in 1L aRCC COVID-19 Near term • Limiting diagnoses, treatments and • Cabometyx 1L HCC data readout patient care • Palovarotene r
Slide 25: Q1 2021 sales highlights: Oncology
Q1 2021 sales highlights Oncology COVID-19 +4.9% limiting diagnoses and treatments €495m: 75% of Total Sales +2.5%, driven by North America (+5.1%) +4.9% €m Some stocking in Europe in Q1 2020 31 26 Continued share growth 72 83 +12.0%, driven by recovery in China 97 106 Gaining market share Focusing
Slide 26: Q1 2021 sales highlights: Consumer Healthcare
Q1 2021 sales highlights Consumer Healthcare +18.9% -5.4% €102m: 15% of Total Sales €47m: 7% of Total Sales +18.9% -5.4% €m • Aesthetics driving the €m • Smecta -4.9%, driven by 7 6 Other performance the slowdown of the 7 diarrhea market 7 Fortrans/ • Therapeutics and Europe overall 10 Eziclen 9 sti
Slide 27: Q1 2021 sales growth driven by Specialty Care
Q1 2021 sales growth driven by Specialty Care Specialty Care Consumer Healthcare Total Sales: €612m Total Sales: €47m €m +6.4% €m -5.4% +2.5% -4.9% Specialty Care €2,381.1m +5.9%1 -5.6% 277 -10.0% +12.0% +18.9% 16 +6.1% +16.4% -10.6% Consumer Healthcare 9 106 102 83 -6.9% 9 €210.6m 7 6 -23.9% -9.7%
Slide 28: Cabometyx | COSMIC-312: 1L HCC study design
Cabometyx® | COSMIC-312: 1L HCC study design Key inclusion criteria (N=740, global enrollment completed; continued Cabozantinib 40 mg QD + extended enrollment for China) Atezolizumab 1200 mg Q3W Primary endpoint • PFS-BIRC/OS • No prior systemic anticancer therapy (cabozantinib + • Child-Pugh Class
Slide 29: Cabometyx | CONTACT-01 & CONTACT-02: trial designs
Cabometyx® | CONTACT-011 & CONTACT-021: trial designs Phase III – NSCLC - CONTACT 01 Enrollment: N = 350; Key milestones: expected topline readout in 2022 • Radiographic progression during or following Primary endpoint Cabozantinib 40mg QD + platinum-containing and anti-PD-L1 therapy for • OS Atezol
Slide 30: Onivyde: 1L pancreatic ductal adenocarcinoma (PDAC)
Onivyde®: 1L pancreatic ductal adenocarcinoma (PDAC) Phase 2 results Phase 3 NAPOLI-3 study status & design • Phase 3 study ongoing sum target lesion diameter (%) Among 29 Best change from baseline in 70 60 50 40 30 evaluable • Received FDA Fast Track designation in June 2020 20 10 0 No No No change
Slide 31: Onivyde: 2L small cell lung cancer (SCLC)
Onivyde®: 2L small cell lung cancer (SCLC) Phase 2 results Phase 3 RESILIENT study status & design • Phase 3 study ongoing • Expected topline readout 2022 • Potential for accelerated regulatory review Onivyde® monotherapy R 2L SCLC 1:1 Topotecan IV monotherapy Resilient Study Part 1 – 70 mg/m2 Cohor
Slide 32: Targeting best-in-class approach to MAPK driven tumors
Targeting best-in-class approach to MAPK driven tumors Pan-RAFi: broader & more complete activity than current agents MAPK pathway is one of the most commonly IRICoR mutated oncogenic driver pathways in cancers with high unmet medical need ERKi: prevent pathway reactivation, more durable Room for im
Slide 33: FOP is an ultra-rare, severely disabling genetic disorder
FOP is an ultra-rare, Characteristic malformed great severely disabling genetic disorder toes & hallux valgus4 • FOP characterized by bilateral malformations of the great toes, & the formation of bone in soft connective tissues known as heterotopic ossification (HO)1 • HO leading to progressive, cum
Slide 34: Palovarotene: 62% reduction in mean annualized new HO volume
Palovarotene: 62% reduction in mean annualized new HO volume1 in Phase 3 MOVE trial 35,000 Annualized new HO (mm3 +SEM) • Demographics & baseline characteristics sufficiently 30,000 similar between MOVE & NHS to support comparison 25,000 20,000 23,318 • New HO volume used as a study endpoint to meas
Slide 35: LANTs: differentiated therapeutic properties
LANTs: differentiated therapeutic properties Therapeutic efficacy benefits: longer duration of action Safety benefits: higher therapeutic index enabling wider range of possible doses Less local and contralateral spread vs native toxins in non-clinical model Increased convenience: fewer injections/ye
Slide 36: Oncology: key ongoing clinical-trial highlights
Oncology Key ongoing clinical-trial highlights Trial Population Patients Design Endpoints Status Sorafenib Cabometyx Recruiting or Primary: PFS, OS COSMIC 312 1L HCC 740 Cabometyx + atezolizumab Secondary: PFS single-agent Phase III Data anticipated or Cabometyx arm NCT03755791 Q2 2021 Cabometyx Cab
Slide 37: Oncology: key ongoing clinical-trial highlights
Oncology Key ongoing clinical-trial highlights Trial Population Patients Design Endpoints Status Onivyde Nab-paclitaxel + gemcitabine Recruiting NAPOLI 3 or Primary: OS 1L PDAC 750 Phase III Onivyde + 5-FU/LV + Secondary: PFS, ORR, safety Data anticipated NCT04083235 oxaliplatin 2023 Onivyde Active,
Slide 38: Neuroscience: key ongoing clinical-trial highlights
Neuroscience Key ongoing clinical-trial highlights Trial Population Patients Design Endpoints Status IPN59011 Ax Moderate to LONG-SET Dose escalation and dose finding Primary: Safety severe upper 424 Recruiting Phase I versus Dysport or placebo Secondary: Efficacy facial lines NCT04736745 IPN10200 A
Slide 39: Rare Disease: key ongoing clinical-trial highlights
Rare Disease Key ongoing clinical-trial highlights Trial Population Patients Design Endpoints Status Primary: annualized change in Palovarotene Palovarotene - 5mg QD and new HO volume MOVE FOP upon flare-up, 20mg QD for Secondary: subjects with new 107 Active, not recruiting Phase III (chronic) 28 d
Slide 40: Investor Presentation Spring 2021
Diana Living with post-stroke spasticity Sintra, Portugal Investor Presentation Spring 2021 40