Sanofi Sa · EURONEXT:SAN
Sanofi Sa — Investor Day (March 2022)
58 slides from Sanofi Sa's investor day presentation, Mar 29, 2022
Slide 1: Immunology Investor Event
Immunology Investor Event Cambridge, MA March 29, 2022
Slide 2: Forward-looking statements
Forward-looking statements This document contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward- looking statements are statements that are not historical facts. These statements include projections and estimates and their underlyi
Slide 3: Agenda
Agenda Immunology Investor Event, March 29, 2022 8:00-8:05 Introduction, Eva Schaefer-Jansen 10:20-10:30 Moving to 2 breakout sessions 8:05-9:00 Presentation Play to Win in Immunology, Paul Hudson 10:30-11:00 Breakout session 1 Immunology Strategy, Bill Sibold Dermatology Leading with Dupixent®, Bri
Slide 4: Play to Win in Immunology
Play to Win in Immunology Paul Hudson Chief Executive Officer
Slide 5: Play to Win: Our six-year plan – ahead of schedule
Play to Win: Our six-year plan – ahead of schedule Today 2020-2022 2023-2025+ - Refocus with decisive actions - Transformative launches - Growth through winning assets - Agile and efficient resource deployment - Margin expansion - Leading R&D productivity 5 Immunology Investor Event
Slide 6: Our key growth drivers
Our key growth drivers Dupixent® Vaccines Pipeline €13bn+ >2x >90 projects sales by the end COPD not included1 Majority in of the decade2 Immunology, Oncology, Neurology, and Vaccines 1. €13bn+ refers to the peak sales ambition, not including COPD 2. vs. 2018, risk-adjusted, internal estimate, exclu
Slide 7: Dupixent - Strong driver of sustainable growth
Dupixent® - Strong driver of sustainable growth €13bn+ COPD not included1 Accretive to Economies of BOI margin scale driving in 2022 profitability Sales in €bn €5.2bn Manufacturing Expansion €3.5bn improvements into COPD continue €2.1bn €0.8bn €0.1bn 2017 2018 2019 2020 2021 1. €13bn+ refers to the
Slide 8: Our strategic roadmap to win in Immunology
Our strategic roadmap to win in Immunology Immunology Sales Building an Strong internal Immunology immunology science >4x Megabrand Combined with value-creating external Business Development World-class Advancing innovative leadership team pipeline €5.5bn Deep bench of First-in-Class/ talent with di
Slide 9: Immunology Strategy
Immunology Strategy Bill Sibold EVP, Global Head of Specialty Care
Slide 10: Immunology growth driven by priority areas
Immunology growth driven by priority areas 2020 WW 2026 WW Dermatology Market Sales Market Sales Priority Market today: Psoriasis, AD $85bn $116bn Upside: Accelerated AD and other indications CSU, HS, PN... $31bn Respiratory $47bn Market today: ~70% Asthma, ~30% IPF Upside: COPD $22bn $10bn $17bn Ga
Slide 11: Substantial growth potential for AD
Substantial growth potential for AD Adult advanced therapy penetration in years after launch (in %) AD market expected to continue to grow 16% faster than Psoriasis given high unmet need and competitive entrants 2022 Psoriasis AD adult penetration progressing Atopic Dermatitis strongly in the U.S. a
Slide 12: No effective therapies for severe COPD patients who failed standard of care
No effective therapies for severe COPD patients who failed standard of care Group D - 3rd leading cause of death worldwide, - Highly symptomatic COPD is a progressive disease that Gold Guidelines frequent exacerbations imposes a significant burden (2018)1 - Highest mortality Group C - Major driver o
Slide 13: Potential to lead in COPD with two biologics to cover >80% of GOLD D
Potential to lead in COPD with two biologics to cover >80% of GOLD D COPD patients Patient population G71 – 2035e Non-Type 2 Type 2 - Up to ~30-40%4 of patients with COPD have evidence of Dupixent®3 Type 2 inflammation Former itepekimab2 and smokers ~1,139K patients itepekimab2 - Both medicines have
Slide 14: Blazing the trail with Dupixent in priority areas
Blazing the trail with Dupixent® in priority areas Dermatology Respiratory Gastroenterology Atopic dermatitis Asthma COPD EoE or UC ® ® ® Type 2 Injectables Beyond Type 2 Orals Topical Dupixent® is under investigation in COPD, EoE and in infant population in AD, and not yet approved by any regulator
Slide 15: Playing to win with 10 novel molecules in 3 priority areas
Playing to win with 10 novel molecules in 3 priority areas Dermatology Respiratory Gastroenterology Atopic dermatitis Asthma COPD EoE or UC ® ® ® Type 2 - amlitelimab (anti-OX40L) Injectables - amlitelimab (anti-OX40L) - anti-IL13/TSLP - anti-TNFα/IL-23 - anti-IL13/OX40L Nanobody® VHH - itepekimab (
Slide 16: Immunology Franchise
Immunology Franchise Transforming the practice of medicine Core TAs Science driven Lead Expand Disrupt Key Type 2 Breakthrough medicines Transformative inflammatory diseases beyond Type 2 technologies 16 Immunology Investor Event
Slide 17: Dupixent Leading in Type 2 Inflammatory Diseases
Dupixent® Leading in Type 2 Inflammatory Diseases Brian Foard Global Head of Dupixent® Franchise
Slide 18: Dupixent - Building a megabrand
Dupixent® - Building a megabrand 2019 2022 Indications 4 61 Positive pivotal trials in AD, Asthma and CRSwNP 7 new positive pivotal trials Clinical program2 COPD and EoE initiated 12 new trials achieving FPI 7 new indications initiated >4.9 million >2 million PN, CSU, BP planned biologic eligible bi
Slide 19: The Leading Immunology Brand in Specialty Dermatology
The Leading Immunology Brand in Specialty Dermatology U.S. monthly dermatologist NBRx1 Outstanding performance 5,000 COVID19 8% AD 6Y+ biologic eligible patient penetration2 In 2021, Germany and Japan advanced therapy market grew >50% in a competitive Humira® environment Cosentyx® In competitive env
Slide 20: Dupixent - New MOA in CSU with positive Ph III data in bio-naïve patients
Dupixent® - New MOA in CSU with positive Ph III data in bio-naïve patients Primary endpoint Study A1: Mean changes from baselines at week 24 Chronic spontaneous urticaria (CSU) is a debilitating Type 2 Placebo + SoC2 Dupixent® + SoC2 inflammatory disease, defined by Itch reduction 35% intense itch a
Slide 21: The Leading Immunology brand in Specialty Respiratory
The Leading Immunology brand Outstanding performance in Specialty Respiratory - 19% Asthma 12Y+ biologic penetration2 - 5% Asthma 6-11Y biologic U.S. monthly respiratory NBRx1 penetration2 3,500 - #1 Asthma NBRx share (28%) QTD Q1’223 COVID19 - #1 in Asthma new patient share in Germany (31%)4 - #1 t
Slide 22: Dupixent: Potential best-in-disease in Type 2 Asthma
Dupixent®: Potential best-in-disease in Type 2 Asthma Dupixent® significantly reduced Asthma attacks and demonstrated rapid and sustained improvements in lung function across a broad population of Type 2 Asthma patients1 as young as 6 years ≥18 Progressively declining exacerbation rate 6-11 Rapid an
Slide 23: Pivotal results support Dupixent's potential as the first biologic for EoE
FDA Pivotal results support Dupixent’s® potential as Breakthrough Therapy Designation the first and only biologic for Eosinophilic Esophagitis U.S. regulatory submission completed, pending FDA acceptance Proportion of patients achieving peak esophageal Absolute change from baseline in DSQ score, sym
Slide 24: Dupixent China: 'All In' to build a Blockbuster
Dupixent® China: ‘All In’ to build a Blockbuster High unmet need in AD1 Major Milestones Achieved – in less than 2 years Atopic Dermatitis launch indication ~2-5% of - July 2020 – fastest BLA approval in China adult urban population Prevalence - December 2020 – Inclusion in NRDL - September 2021 – A
Slide 25: We are just at the beginning of our journey…
We are just at the beginning of our journey… Atopic Dermatitis Asthma Atopic Dermatitis CRSwNP Atopic Dermatitis Asthma Adult 18+ Adult /Adol 12+ Adolescent 12+ Adult 18+ Ped 6-11 Ped 6-11 Today CIndU-COLD CSU EoE Prurigo Nodularis EoE Atopic Dermatitis Adult / Adol 12+ Adult / Adol 12+ Ped 1-11 Adu
Slide 26: Immunology Franchise
Immunology Franchise Transforming the practice of medicine Core TAs Science driven Lead Expand Disrupt Key Type 2 Breakthrough medicines Transformative inflammatory diseases beyond Type 2 technologies 26 Immunology Investor Event
Slide 27: Leadership in Dermatology and Respiratory
Leadership in Dermatology and Respiratory Naimish Patel MD Global Head of Development, Immunology & Inflammation
Slide 28: Immunology achievements since 2021 Capital Markets Day
Immunology achievements since 2021 Capital Markets Day 1st Dupixent® COPD Study – BOREAS – completed enrollment Feb 2022 5 3 4 4 Regulatory Approvals 7 8 Phase 3 Pivotal Study Positive Readouts Submissions Phase 2 - Dupixent® Phase 1 - Dupixent® - AD 12-17y (CN) - Dupixent® - AD 6m – 5y (U.S., EU) -
Slide 29: Sanofi ambition to address unmet medical needs for a broad spectrum of AD and Asthma patients
Sanofi ambition to address unmet medical needs for a broad spectrum of AD and Asthma patients Mild Moderate-Severe Potential for higher efficacy biologics Inhalers Topicals Safe Orals Injectables disease control, but safe and efficacious for less severe AD novel MoAs noncompliance an issue Topical B
Slide 30: Beyond Type 2: Opportunity for amlitelimab and rilzabrutinib in mixed inflammatory response
Beyond Type 2: Opportunity for amlitelimab and rilzabrutinib in patients with mixed inflammatory response Upstream Initiation Tissue Effects Atopic Dermatitis Activation Amplification Precision Medicine Approach Virus Bacteria Allergens Epithelial Injury IL-5 Th2 dominant IL-33 Eosinophil Dupixent®
Slide 31: Amlitelimab, an anti-OX40L, rebalances inflammation without immunosuppressive cell depletion
Amlitelimab, an anti-OX40L, rebalances inflammation without immunosuppressive cell depletion in early studies Virus Allergens Epithelial Injury OX40L blockade with advantages to OX40 depletion OX40L OX40 Blocker Depleter TSLP, IL-33, IL-25 Limited expression at sites of inflammation APC amliteli
Slide 32: Amlitelimab treatment decreases key Type 2 and non-Type 2 pathway biomarkers in AD
Amlitelimab treatment decreases key Type 2 and non- Type 2 pathway biomarkers in AD1 patients IL-13 IL-22 IL-17A Log10(IL-13:Fold change vs Baseline) Log10(IL-17A:Fold change vs Baseline) Log10(IL-22:Fold change vs Baseline) ns ✱✱✱✱ ns ✱✱✱ 1.0 1.0 ns ✱✱✱✱ 0.2 ns ✱ ns ns (median ± 95%CI) (median ± 95
Slide 33: Amlitelimab - Priority Asset with a highly competitive target profile
Amlitelimab - Priority Asset with a highly competitive target profile Ph 2 study1: >40% with clear/almost Ph 2 study2: AMG451 (16 weeks Q2W) clear skin (16 weeks Q4W) 60 *** 60 Potential first-in-class anti-OX40L 50 44.4 *** 50 Proportion of vIGA 0/1 Proportion of vIGA 0/1 ** 37 Convenient subcutane
Slide 34: Amlitelimab - Accelerated development program following compelling Ph 2 data
Amlitelimab - Accelerated development program following compelling Ph 2 data Rapid Phase 2b start following positive Phase 2a in AD in 2021 2022 2023 2024 2025 Plan to run Phase 3 Phase 2b in Atopic Dermatitis concurrently to Phase 2 Atopic Phase 3 Dermatitis Phase 3 Ambition Asthma Phase 2b startin
Slide 35: Rilzabrutinib and Topical BTKi positioned to address earlier stage Atopic Dermatitis
Rilzabrutinib and Topical BTKi positioned to address earlier stage Atopic Dermatitis Innate Immune Adaptive Immune Mast Cell/ Autoreactive Topical BTKi Eosinophil B Cell (SAR444727) IgE-mediated FcεR activation and degranulation - Phase 2 study readout Inflammation in H1 2023 and Macrophage BTK sign
Slide 36: Rilzabrutinib is being evaluated in multiple Phase 2 clinical trials
Rilzabrutinib is being evaluated in multiple Phase 2 clinical trials across a range of indications AD Asthma CSU IgG4 Inadequately controlled with Add-on to ICS and second moderate-severe disease; Target Adult patients with topicals; adults 18 or older; controller; adults 18-70 yrs, inadequate respo
Slide 37: Itepekimab: A potent IL-33 blocker with sub-nanomolar affinity
Itepekimab: A potent IL-33 blocker with sub-nanomolar affinity - Binds to human IL-33 with high affinity (Kd = 42 pM) - Blocks the formation of the IL-33 / ST2 (IL-33 receptor) signaling complex and attenuates the downstream inflammatory cascade including both Type 2 and Type 1 immune responses IL-3
Slide 38: Itepekimab - Clear benefit in former smokers in COPD
Itepekimab - Clear benefit in former smokers in COPD Phase 2 demonstrated regardless of Type 2 status1 Higher IL-33 gene expression in lungs of former Itepekimab reduced exacerbations in COPD former smokers with COPD smokers, in Type 2 and non-Type 2 patients 42.5% RRR 39.5% RRR 53.1% RRR 8 3 IL-33
Slide 39: Address airway inflammation to improve lung function and reduce exacerbations in COPD
Address airway inflammation to improve lung function and reduce exacerbations in COPD Potential treatment paradigm Active Smoker High Blood eos Dupixent® Dupixent® High Blood eos Paula itepekimab Former Smoker 67 yr woman COPD for 10 years 3 exacerbations in last year Low Blood eos itepekimab Freque
Slide 40: Parallel studies to address both Type 2 and non-Type 2 COPD
Parallel studies to address both Type 2 and non-Type 2 COPD Itepekimab Phase 3 and Dupixent® Phase 3 in COPD are targeting Ambition to lead in COPD with two two distinct populations with minimal overlap complementary assets, Dupixent® and itepekimab, with potential to deliver 2021 2022 2023 2024 fir
Slide 41: Immunology Franchise
Immunology Franchise Transforming the practice of medicine Core TAs Science driven Lead Expand Disrupt Key Type 2 Breakthrough medicines Transformative inflammatory diseases beyond Type 2 technologies 41 Immunology Investor Event
Slide 42: Breaking into New Frontiers in Immunology
Breaking into New Frontiers in Immunology Frank Nestle Global Head of Research and Chief Scientific Officer
Slide 43: Disruptive technologies driving FiC/BiC medicines
Disruptive technologies driving FiC/BiC medicines Small Molecules Antibodies Nanobody® Molecules Synthetic Cytokines Degraders - rilzabrutinib - anti-CD40L - anti-IL-13/TSLP - Non-beta IL-2 - IRAK4 Degrader - eclitasertib/ - amlitelimab - anti-IL-13/OX40L RIPK1 Inhibitor - itepekimab - anti-TNFα/OX4
Slide 44: AI research factory
AI research factory Improving quality and productivity of immunology research portfolio << AI Empowered >> Target Discovery Drug Discovery Clinical Translation Target Identification Single-Cell DMTA based Digital Disease Endotyping & Engine Disease Maps Molecular Design Pathology Patient Stratificat
Slide 45: Nanobody molecules enable multi-targeting strategy
Nanobody® molecules enable multi-targeting strategy A strong early clinical pipeline delivering transformative medicines 12-15kDa Anti-HSA Aspirational Profile - Break efficacy ceiling anti-IL-13/TSLP Phase I Asthma - Broadening patient population anti-Target 1 anti-Target 2 Half-life extension - Br
Slide 46: Anti-IL-13/OX40L bispecific Nanobody molecule
Anti-IL-13/OX40L bispecific Nanobody® molecule Potential to break efficacy ceilings in Type 2 Inflammation Gene Expression Levels Anti-IL-13/OX40L Nanobody® VHH with potent picomolar binding affinity to in Skin both IL-13 and OX40L Albumin-binding designed to extend half-life Enhanced efficacy of bi
Slide 47: SAR444336/THOR-809: Precisely engineered non-β IL-2
SAR444336/THOR-809: Precisely engineered non-β IL-2 Selectively targeting regulatory T cells to restore immune homeostasis SAR444336 Tregs expanded in vivo are highly suppressive Unique platform leverages Dose-dependent Treg expansion Dose-dependent control of skin synthetic biology technology in vi
Slide 48: Next-generation of oral pathway medicines
Next-generation of oral pathway medicines Antibody-like efficacy with oral soluble IL-17A convenience TNFα TNFα Inh IL-17A Blocker Y IL1/IL18/IL33/IL36 - Soluble TNFα Inhibitor (SAR441566) selectively blocks TNFR1 signaling - Oral IL-17A Blocker target a key pro-inflammatory pathway TNFR1 INF-R TLR4
Slide 49: SAR441566: The first oral TNFα inhibitor
SAR441566: The first oral TNFα inhibitor Tackling the largest therapeutic class in immunology Antibody-like efficacy in arthritis model 60 SAR441566, small molecule 50 Antibody-like efficacy TNFα inhibitor, offers potential Arthritis score seen at 10mg/kg for antibody-like efficacy with membrane sol
Slide 50: SAR444656 (KT-474): Potent orally bioavailable IRAK4 degrader
SAR444656 (KT-474): Potent orally bioavailable IRAK4 degrader Ph1 MAD PBMC IRAK4 (Kymera) Degradation of IRAK4 protein abolishes its kinase activity and scaffold function Potential for oral immunology pathway drug across multiple indications SAR444656 treatment resulted LLOQ in potent IRAK4 protein
Slide 51: Expected advances in early Immunology Pipeline
Expected advances in early Immunology Pipeline 8 Phase 2 3 Phase 1b (PoM) readouts 6 Phase 1 readouts readouts 2022 H2 2022 - Topical BTKi: AD H1 2022 - anti-IL-13/TSLP Nanobody® VHH: 2023 - TNFα inhibitor oral Asthma - eclitasertib (RIPK1): CLE H2 2022 2023 - CD40L: SJS, SLE - anti-IL-13/OX40L Nano
Slide 52: Roadmap for leadership in Immunology Research
Roadmap for leadership in Immunology Research Focus Accelerate Leverage Key Nodal Pathways Technology Innovation Precision Immunology Our Ambition: Breaking efficacy ceilings, achieving durable response and expanding into new indications 52 Immunology Investor Event
Slide 53: Agenda
Agenda Immunology Investor Event, March 29, 2022 8:00-8:05 Introduction, Eva Schaefer-Jansen 10:20-10:30 Moving to 2 breakout sessions 8:05-9:00 Presentation Play to Win in Immunology, Paul Hudson 10:30-11:00 Breakout session 1 Immunology Strategy, Bill Sibold Dermatology Leading with Dupixent®, Bri
Slide 54: sanofi
sanofi
Slide 55: Collaborations
Collaborations Name Developed in collaboration with… Dupixent® Regeneron itepekimab Kevzara® eclitasertib (RiPK1i) Denali SAR444656 (IRAK-4) Kymera 55 Immunology Investor Event
Slide 56: Abbreviations (Part 1)
Abbreviations (Part 1) AD Atopic Dermatitis FPI first patient in AFRS Allergic Fungal Rhinosinusitis HCP HealthCare Partners AI Artificial Intelligence HS Hidradenitis Suppurativa APC antigen-presenting cell HSA human serum albumin BD Business Development IBD Inflammatory Bowel Disease BiC Best In C
Slide 57: Abbreviations (Part 2)
Abbreviations (Part 2) oral anti H1 Oral H1 antihistamines OX40L OX40 ligand PN Prurigo Nodularis PoM Proof of Mechanism Q2W Once every two-week dosing Q4W Once every four-week dosing QW Once weekly dosing RA Rheumatoid Arthritis RIPK1 Receptor-Interacting serine/threonine-Protein Kinase 1 RRR Relat
Slide 58: Building an industry-leading immunology pipeline
Building an industry-leading immunology pipeline amlitelimab SAR’726 Injectable Topical Oral Priority asset Anti-OX40L mAb Anti-IL13/OX40L Nanobody® VHH rilzabrutinib SAR’765 BTK inhibitor Anti-IL13/TSLP Nanobody® VHH Dupixent® SAR’727 SAR’970 Anti-IL4/IL13 mAb BTK inhibitor Anti-TNF/OX40L Nanobody®