Slide 1: Capital Markets Day
Capital Markets Day December 1, 2020 1
Slide 2: Disclaimer & Safe Harbor
Disclaimer & 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: Agenda
Agenda 2:00pm Strategic outlook David Loew 2:30pm Strong financial sustainability Aymeric Le Chatelier 2:45pm Executing on R&D strategy Howard Mayer 3:15pm Break 3:25pm Delivering for patients in Specialty Care Bartek Bednarz 3:50pm Conclusion/ Q&A 3
Slide 4: Strategic outlook
Strategic outlook DAVID LOEW CHIEF EXECUTIVE OFFICER 4
Slide 5: Our Vision
Our Vision To be a leading global mid-size biopharmaceutical company with a focus on transformative medicines in oncology, rare disease & neuroscience 5
Slide 6: Building on solid foundations…
Building on solid foundations… Robust Specialty Care portfolio Growing contribution with leading market shares of innovative assets Strong global presence with In-house development capabilities highly engaged employees to leverage new assets & LCM 6 LCM: Life cycle management
Slide 7: … but facing challenges
… but facing challenges Potential entry of Above-average lanreotide generics cost structure Unbalanced External innovation R&D pipeline execution 7
Slide 8: Focus on three therapeutic areas
Focus on three therapeutic areas CORE DRIVERS NON-CORE Consumer Oncology Rare disease Neuroscience Healthcare Strengthen Expand Excel & Strategic review positioning scope accelerate proceeding 8
Slide 9: Focus. Together. For patients & society.
Focus. Together. For patients & society. Bring the full Deliver potential of our Build a high-value efficiencies to Boost culture of innovative sustainable enable targeted collaboration & medicines to pipeline investment & excellence patients growth 9
Slide 10: Bring the full potential of our innovative medicines to patients
Focus. Together. For patients & society. Bring the full potential of our innovative medicines to patients 10
Slide 11: Deliver full potential of brands
Deliver full potential of brands Maximize value of core products: Somatuline®, Decapeptyl® & Dysport® Capture full potential of innovative oncology portfolio: Cabometyx® & Onivyde® Successfully execute palovarotene launch Expand geographical presence Deliver transformative medicines to patients with
Slide 12: Significant potential in late-stage pipeline
Significant potential in late-stage pipeline Expected submission Potential 2020 2021 2022 2023 peak sales1 1L RCC 1L HCC 2L NSCLC with with with nivolumab atezolizumab atezolizumab Pipeline in >€700M a product 2L mCRPC with atezolizumab Potential to establish SoC in 2L SCLC 1L PDAC >€300M hard-to-tr
Slide 13: Build a high-value sustainable pipeline
Focus. Together. For patients & society. Build a high-value sustainable pipeline 13
Slide 14: 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 15: Committed to growth
Committed to growth External innovation Transition post-SSA Gx entry Innovative brands Drive growth of core & innovative brands Somatuline® Accelerate growth Net Sales with external innovation Core brands Time 15 SSA: Somatostatin analog; Gx: generic; LCM: Life cycle management
Slide 16: Deliver efficiencies to enable targeted investment & growth
Focus. Together. For patients & society. Deliver efficiencies to enable targeted investment & growth 16
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: Boost culture of collaboration & excellence
Focus. Together. For patients & society. Boost culture of collaboration & excellence 18
Slide 19: Capabilities & culture driving value for patients & society
Capabilities & culture driving value for patients & society Strengthen Attract, develop & Nurture culture of Enhance true core capabilities & retain highly focus & high patient-centricity foster engaged talent performance collaboration Examples of key initiatives Adopt insights- Create cross- Increa
Slide 20: 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 21: Focus. Together. For patients & society.
Focus. Together. For patients & society. Leadership in life-threatening & underserved diseases with transformative medicines Sustainable pipeline with ambitious & disciplined external innovation strategy Focused and agile organization with best-in-class execution Great place for talent committed to
Slide 22: Strong financial sustainability
Strong financial sustainability AYMERIC LE CHATELIER CHIEF FINANCIAL OFFICER 22
Slide 23: Solid financial profile
Solid financial profile Group net sales Core operating margin Free cashflow Specialty care Consumer > 30%1 > €2.5bn1 Healthcare of net sales > €450m1 • Attractive growing Specialty • Profitability in range of • High level of EBITDA Care portfolio specialty care peers • Disciplined management of • Co
Slide 24: Good performance in 2020 despite COVID-19
Good performance in 2020 despite COVID-19 Resilient sales growth 2020 guidance • Driven by oncology • Despite COVID-19 impact on neuroscience & CHC Group sales Solid core operating margin growth > +2% • Low impact of COVID-19 on manufacturing & at constant exchange clinical trials rates • SG&A savin
Slide 25: 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 26: Robust sales growth
Robust sales growth 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
Slide 27: 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 28: Invest in R&D for growth
Invest 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 • Di
Slide 29: 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 30: Value-creative external innovation
Value-creative external innovation Small to mid-size Strict financial Significant financing transactions discipline capacity • From early-stage research deal • Based on IRR & risk adjusted • > €2.0bn of existing long-term to bolt-on acquisitions DCF value-based assessment financing including €1.5bn
Slide 31: Executing on R&D strategy
Executing on R&D strategy HOWARD MAYER, MD EXECUTIVE VP, HEAD OF R&D 31
Slide 32: 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 33: Refining approach to external innovation
Refining approach to external innovation • Increased number of oncology approvals by >40%1 Strong disease • ~85% being targeted therapies hypothesis • ~40% involving pre-selection biomarkers & improved POS • Best-in-class assets clinically validated & with meaningful differentiation • First-in-class
Slide 34: Advancing pipeline with several significant registrational trials
Advancing pipeline with several significant registrational trials Projected internal pipeline end of 2020 Pre-clinical Phase I Phase II Phase III Registration Deprioritized Cabometyx® + IPN60130 Cabometyx® + Cabometyx® + Pan-RAFi atezolizumab (BLU-782) FOP2 atezolizumab nivolumab IPN60090 Solid tumo
Slide 35: Cabometyx | CheckMate-9ER: 1L RCC study design
Cabometyx® | CheckMate-9ER: 1L RCC study design Key inclusion criteria (N=651) • Previously untreated advanced or Cabozantinib 40 mg PO QD + metastatic RCC with a clear cell Nivolumab 240 mg flat dose IV Q2W1 component, including sarcomatoid Primary endpoint: features • PFS by BICR • Any IMDC risk g
Slide 36: Cabometyx | CheckMate-9ER: Topline findings
Cabometyx® | CheckMate-9ER: Topline findings Hazard ratio (95% CI), 0.51 (0.41–0.64) Progression-free survival (probability) Median PFS, months (95% CI) P < 0.0001 Cabozantinib + 16.6 (12.5-24.9) Nivolumab Sunitinib 8.3 (7.0-9.7) Median OS, months (95% CI) Overall survival (probability) Cabozantinib
Slide 37: Cabometyx | CheckMate-9ER: Objective response & best overall response
Cabometyx® | CheckMate-9ER: Objective response & best overall response1 ∆ 28.6% (21.7–35.6) P < 0.0001 CR Cabozantinib + 70 55.7% Sunitinib (50.1–61.2) PR Nivolumab 60 N 323 328 ORR, % (95% CI) 50 Complete Response, % 8.0 4.6 Partial Response, % 47.7 22.6 40 27.1% (22.4–32.3) Stable Disease, % 32.2
Slide 38: 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 39: Cabometyx | COSMIC-021: Ph Ib basket trial
Cabometyx® | COSMIC-021: Ph Ib basket trial – 2L/3L NSCLC post-CPI & 1L/2L mCRPC cohorts Best change from baseline in sum of target lesions Best change from baseline in sum of target lesions per investigator by RECIST v1.1 per investigator by RECIST v1.1 N=29 Partial response PD-L1 CPS ≥1% 60 Confir
Slide 40: 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 41: 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 42: 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 43: 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 44: 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 45: Palovarotene: 62% reduction in mean annualized new HO volume in Phase 3 MOVE
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 46: IPN60130: ALK-2 inhibitor with differentiated mechanism of action in FOP
IPN60130: ALK-2 inhibitor with differentiated mechanism of action in FOP Mutant receptor • Potential to target FOP specific Inflammation Activin A binds Activin BMP causative ALK2 receptor & offer greater inhibition of HO ALK-2 IPN 60130 • Different MoA potentially complementary to palovarotene Smad
Slide 47: Recombinant modified long-acting neurotoxins
Recombinant modified long-acting neurotoxins IPN59011 (mrBoNT/A) 100 kDa HC 50 kDa LC Seven-point mutations to introduce positively charged amino acids in the HC domain of BoNT/A LC: Proteolytic domain • Zinc endopeptidase HC: Binding domain responsible for • Responsible for catalytic activity neuro
Slide 48: 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 49: Targeted secretion inhibitors as a potential platform technology
Targeted secretion inhibitors as a potential platform technology Potential indications to include chronic serious pain conditions Can be engineered to target non-neuronal & Protease domain which Cell-specific binding neuronal cell types: potential platform opportunity enzymatically modifies moiety e
Slide 50: Targeted regulatory submissions 2020-2023+
Targeted regulatory submissions 2020-2023+ 2020 2021 2022 2023+ Cabometyx® Cabometyx® Onivyde® Cabometyx® 1L RCC 1L HCC 2L SCLC NSCLC (EU) (EU) (US) (EU) Palovarotene Cabometyx® FOP mCRPC (US, EU) (EU) Dysport® Onivyde® NDO 1L PDAC (EU) (US) Oncology Rare disease Neuroscience 50 RCC: Renal cell carc
Slide 51: Deliver meaningful treatments to patients living with cancer, rare disease & neurological disorders
Deliver meaningful treatments to patients living with cancer, rare disease & neurological disorders Executing current pipeline to launch Focusing & accelerating external innovation efforts Prioritizing pipeline to focus on high value programs Transforming R&D organization to deliver ambitious object
Slide 52: Break
Break 52
Slide 53: Delivering for patients in Specialty Care
Delivering for patients in Specialty Care BARTEK BEDNARZ EXECUTIVE VP, GLOBAL PRODUCT AND PORTFOLIO STRATEGY 53
Slide 54: Specialty Care roadmap: Deliver full potential of brands
Specialty Care roadmap: Deliver full potential of brands Maximize value of core products: Somatuline®, Decapeptyl® & Dysport® Capture full potential of innovative oncology portfolio: Cabometyx® & Onivyde® Successfully execute palovarotene launch Expand geographical presence Deliver transformative me
Slide 55: Transformative medicines
Transformative medicines Addressing life-threatening & underserved diseases Oncology Neuroendocrine tumors Second most prevalent gastrointestinal neoplasm Prostate cancer 31% 5Y survival rate for mPC Renal cell carcinoma 12% 5Y survival rate for mRCC Hepatocellular carcinoma 18% 5Y survival rate for
Slide 56: Attractive NET market
Attractive NET market Sustained growth of SSA market Attractive NET market dynamics In €Bn Somatostatin analog (SSA) market CAGR: +9% CAGR15-19 • Two main brands - Somatuline® 2.2 2.0 (Ipsen) & Sandostatin LAR (Novartis) 1.8 ROW +4% 1.7 1.6 Chronic treatment EU5 +6% • New patients represent 10-15% p
Slide 57: Somatuline: strong performance
Somatuline®: strong performance Strong value proposition Strong growth & in-market performance Evidence around symptom & + 27% Global net sales growth (CAGR 2015-2019) tumor control – expanded label in the US Patient share growth in the US Unique & new delivery system • Pre-filled syringe • Patients
Slide 58: Somatuline: continued market share gain despite octreotide generic in Europe
Somatuline®: continued market share gain despite octreotide generic in Europe 2017 – 2020 (Q2) European SSA 2020 monthly volume share across EU markets volume share1 with octreotide generic entry2 60% 53% 54% 60% 55% 56% 56% 56% 56% 56% 57% 51% 51% 40% 47% 49% 48% 40% 41% 41% 39% 38% 37% 37% 37% 36%
Slide 59: Somatuline outlook
Somatuline® outlook Impact of octreotide Gx: • EU: Somatuline® volume share continues to grow & limited pricing impact to date • US: Anticipated stronger impact through formulary step edits on new patients Potential impact of lanreotide Gx: • Substitutability likely to lead to greater impact than oc
Slide 60: Cabometyx: pipeline in a product
Cabometyx®: pipeline in a product Cabometyx® monotherapy Additional indications Cabometyx® in combination with atezolizumab based on basket trial (COSMIC-021) with IO1 2023+ 2021 2020 1L HCC 2L NSCLC 1L RCC with atezolizumab with atezolizumab with nivolumab 2L HCC 2L mCRPC with atezolizumab 1L RCC 2
Slide 61: Cabometyx positioned strongly as TKI of choice in RCC and HCC
Cabometyx® positioned strongly as TKI of choice in RCC and HCC CABOMETYX® SALES (Q1 2018 – Q3 2020) #1 TKI in 2L RCC EU5 market share >50% Reported sales Source: Q3’2020 RCC Rx Tracker (KANTAR). 2L RCC Patient share within the TKI Market. EARLY GROWTH IN 2L HCC Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Launc
Slide 62: 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 CPI 30% combination data 55% combo (CheckMate-9ER) s 70% Compelling 2L TKIs Compelling 2L TKIs monotherapy 70% monotherapy 70% TKIs data (METEOR) TKIs data (METEOR) 45% 30% EU5 >5
Slide 63: Cabometyx | CheckMate-9ER: significant expansion opportunity in RCC
Cabometyx® | CheckMate-9ER: significant expansion opportunity in RCC aRCC (EU5) 1L RCC • 1L opportunity driven Patients not receiving any active by eligible patient pool and treatment / deceased patients treatment duration 1L ~20K patients 2L • Approval expected H2 2021, ~14K leveraging compelling d
Slide 64: 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 65: 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 66: 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 67: Onivyde: potential to establish SoC in hard-to-treat cancers
Onivyde®: potential to establish SoC in hard-to-treat cancers 1L PDAC 2L SCLC 7% 5Y survival rate 6% 5Y survival rate Significant need for more effective Topotecan only FDA approved therapy, therapies with reduced toxicity highlighting need for new options Ability to build on our successful approval
Slide 68: Decapeptyl: ongoing growth story
Decapeptyl®: ongoing growth story Key Facts Growth drivers Drivers of growth • Attractive market dynamics +5% CAGR Net sales growth 2015-2019 • Market share gains in EU and RoW • China performance impacted by competitive Market Leader in EU environment Commercialized in • Focus on long-acting formul
Slide 69: Dysport: excellence in neurotoxins
Dysport®: excellence in neurotoxins Ipsen Dysport® sales 2015-2019 €m Key Facts +9% CAGR 388 Net sales growth 2015-2019 CAGR: +9% 348 328 280 285 Leading market position Dysport® #2 globally #1 in several markets Complexity hurdles Specialized & highly regulated manufacturing process 2015 2016 2017
Slide 70: Dysport: strong position in both markets
Dysport®: strong position in both markets Therapeutics Aesthetics Drivers of continued growth Drivers of continued growth • Robust mid-to-high single digit market growth • Favorable market dynamics, with high single digit • Differentiation as toxin delivering longer-lasting market growth symptom rel
Slide 71: Palovarotene: preparing for launch in FOP
Palovarotene: preparing for launch in FOP Ultra-rare population with Rare disease launch readiness & high unmet need capability build • Restarted after feedback from authorities – • Prevalence: 1.36 per 1 million lives1 clear path to regulatory submission • Patient incidence • Collaborations to iden
Slide 72: Strong & expanding global footprint
Strong & expanding global footprint North America Western Europe3 Rest of World 34% of sales1 33% of sales1 33% of sales1 Accelerated From 4% to 34% of sales Continued market share development in China over the last decade2 gains in all TAs Expansion in new geographies countries where countries with
Slide 73: Strong US presence
Strong US presence Outstanding track record of growth Ipsen US net sales 2015-2019 in the US 750 €m Strong commercial capabilities 600 positioning Ipsen as partner of choice 454 Diversified channel mix with sales split 50/50 between commercial & government channels 265 Drivers of continued growth wi
Slide 74: Specialty Care: positioned for long-term success
Specialty Care: positioned for long-term success Assets Leadership mindset Playing Field Best and/or first- #1 or #2 player in Niche markets with in-class key markets high unmet needs Proven Commercial Portfolio Footprint Capabilities Strong with LCM Global with further Platform for opportunities ge
Slide 75: Conclusion / Q&A
Conclusion / Q&A 75
Slide 76: Focus. Together. For patients & society.
Focus. Together. For patients & society. Leadership in life-threatening & underserved diseases with transformative medicines Sustainable pipeline with ambitious & disciplined external innovation strategy Focused and agile organization with best-in-class execution Great place for talent committed to
Slide 77: Q&A panel
Q&A panel David LOEW Howard MAYER, M.D. CHIEF EXECUTIVE OFFICER EXECUTIVE VICE PRESIDENT HEAD OF RESEARCH & DEVELOPMENT Aymeric LE CHATELIER Bartek BEDNARZ EXECUTIVE VICE PRESIDENT EXECUTIVE VICE PRESIDENT CHIEF FINANCIAL OFFICER GLOBAL PRODUCT & PORTFOLIO STRATEGY Philippe LOPES-FERNANDES Richard P