Sanofi Sa · EURONEXT:SAN
Sanofi Sa — American Thoracic Society Sanofi Investor Call 2023
49 slides from Sanofi Sa's conference presentation, May 22, 2023
Slide 1: Sanofi
sanofi
Slide 2: American Thoracic Society - Sanofi Investor Call
American Thoracic Society Sanofi Investor Call Washington, D.C. May 22, 2023
Slide 3: 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 underlyin
Slide 4: Agenda
Agenda American Thoracic Society - Sanofi Investor Call 01 Leadership in immunology 05 Expand and disrupt beyond Type 2 Dietmar Berger, MD, PhD Naimish Patel, MD Global Head of R&D ad interim Therapeutic Area Head, Immunology & Inflammation 02 Lead with Dupixent® in Type 2 06 Unlock sustainable grow
Slide 5: Leadership in immunology
Leadership in immunology Dietmar Berger MD PhD Global Head of R&D ad interim
Slide 6: Key Respiratory development milestones since March 2022
Key Respiratory development milestones since March 2022 Anti-IL-13/TSLP Amlitelimab Dupixent® Nanobody® VHH Positive Phase 3 results Initiated Phase 2b Demonstrated Proof of with dupilumab in COPD study in Asthma Mechanism in Phase 1 (BOREAS study) study in Asthma Immunology Event March 2022 Itepeki
Slide 7: Strong immunology pipeline with novel molecules
Strong immunology pipeline with 12 novel molecules to build and expand in leading franchise Orals Injectables rilzabrutinib (BTKi) Dupixent® AD IRAK4 degrader amlitelimab (anti-OX40L) Dermatology CSU rilzabrutinib (BTKi) Dupixent® Psoriasis Oral TNF inhibitor Dupixent® Asthma rilzabrutinib (BTKi) am
Slide 8: Ambition to transform the practice of medicine in Respiratory
Ambition to transform the practice of medicine in Respiratory itepekimab amlitelimab rilzabrutinib SAR’765 Lead Expand Disrupt Key Type 2 Breakthrough Transformative inflammatory medicines beyond technologies diseases Type 2 8 ATS Investor Call
Slide 9: Lead with Dupixent in Type 2
Lead with Dupixent® in Type 2 Elizabeth Laws, PhD Global Program Head, Dupixent
Slide 10: Tackling Type 2 inflammatory disease
Tackling Type 2 inflammatory disease Type 2 inflammatory pathway Leadership strategy Targets Lead with science Allergens and parasites Focus on highest unmet need with first-in-class Key immune cells Key cytokines and best-in-class opportunities Th2 ILC2 Mast cell B-cell Basophil Eosinophil IL-4 IL-
Slide 11: Lead with Dupixent in Type 2
Lead with Dupixent® in Type 2 Positive pivotal data across 12 indications in Efficacy & safety data across Dermatology, Respiratory, and Gastroenterology multiple Type 2 indications 60+ clinical trials with 10,000+ patients AD PN Asthma EoE 18y+ 18y+ 12+ 12y+ Safety data up to 5 years AD CSU Asthma
Slide 12: COPD – Following the science with decisive actions
COPD – Following the science with decisive actions Direct-to-Phase 3 program High unmet need with no approved Investment de-risked with interim analysis biologics IL4/IL13 plays a Prior data support • 3rd leading cause of death WW, COPD mechanistic role in Type 2 COPD guided carries a severe burden
Slide 13: Dupixent: Best-in-class execution in COPD
Dupixent®: Best-in-class execution in COPD 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 Pivotal program resulting in outstanding performance BOREAS 30%1 BOREAS recruited as many as 500 patients Triple therapy, >=300 cells/μL (screening), NO asthma history during COVID pandemic NOTUS H
Slide 14: Dupilumab for COPD with Type 2 Inflammation (NEJM)
The NEW ENGLAND JOURNAL of MEDICINE ORIGINAL ARTICLE Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts S.P. Bhatt, K.F. Rabe, N.A. Hanania, C.F. Vogelmeier, J. Cole, M. Bafadhel, S.A. Christenson, A. Papi, D. Singh, E. Laws, L.P. Mannent, N. Patel, H.W. Staudinger, G.D. Yanc
Slide 15: Background
Background • 50% of patients continue to have persistent symptoms and exacerbations despite optimization of existing therapy • COPD exacerbations are associated with: o Increased risk of subsequent exacerbations o Lung function decline o High morbidity and increased risk of all-cause mortality A sub
Slide 16: Pharmacological Treatment for COPD
Pharmacological Treatment for COPD DYSPNEA EXACERBATIONS LABA or LAMA LABA or LAMA if blood eos <300 if blood eos ≥300 LABA + LAMA LABA + LAMA if blood eos ≥100 if blood LABA + LAMA + ICS • Consider switching inhaler device eos <100 or molecules • Implement or escalate non- pharmacological treatment
Slide 17: COPD Endotypes: Type 2 High
COPD Endotypes: “Type 2 High” 17
Slide 18: COPD with Type 2 Inflammation and Frequent Exacerbations: COPDGene Study
COPD with Type 2 Inflammation is Associated with More Frequent COPD Exacerbations: The COPDGene Study Eosinophil <n ≥n IRR 95% CI cut-off 100 cells/μL 223 1330 1.16 0.90–1.52 200 cells/μL 814 739 1.24 1.04–1.48 300 cells/μL 1187 366 1.32 1.08–1.61 340 cells/μL 1350 203 1.50 1.18–1.91 400 cells/μL 13
Slide 19: Dupilumab Mechanism of Action
Dupilumab Mechanism of Action Viruses Bacteria Smoke/pollutants Airway epithelium Goblet cell Type 2 inflammatory cytokines hyperplasia IL-5 Dupilumab blocks the IL-4 IL-13 shared receptor component for IL-4 and IL-13 Mast cell Eosinophil TH2 cell degranulation activation differentiation Type 2 infl
Slide 20: BOREAS Clinical Trial Design
BOREAS Clinical Trial Design (NCT03930732) oA Randomized, e o le Double-Blind, l l ce oPlacebo-Controlled, o olle llel Parallel-Group, o l ce Multicenter, e h se Phase 3oStudyl e to Evaluate the Efficacy and Safety of Dupilumab Administered Every 2 Weeks in Patients with Moderate or Severe COPD with
Slide 21: BOREAS Eligibility Criteria
BOREAS Eligibility Criteria • Key inclusion criteria • e ≥ o ≤8 e s • Physician diagnosis of moderate-to-severe COPD • History of high exacerbation risk: ≥ o e e o ≥ se e e exacerbation(s) within the year o o sc ee • Background triple inhaler therapy (ICS+LAMA+LABA) for at least 3 months prior to
Slide 22: Primary, Secondary, and Other Endpoints
Primary, Secondary, and Other Endpoints 52-week treatment perioda Week −4 Baseline Week 52 Primary Annualized rate of moderate-to-severe exacerbations endpoint from baseline to Week 52 Change from baseline to Week 12 and 52 in lung function Secondary Change from baseline to Week 52 in SGRQ and other
Slide 23: Baseline Demographics and Disease Characteristics
Baseline Demographics and Disease Characteristics Placebo Dupilumab All Characteristic (N = 471) (N = 468) (N = 939) Age, mean (SD) — years 65.2 (8.1) 65.0 (8.0) 65.1 (8.1) Male, no. (%) 322 (68.4) 298 (63.7) 620 (66.0) Race — White, no. (%) 397 (84.3) 393 (84.0) 790 (84.1) Ethnicity – Hispanic or L
Slide 24: Baseline Demographics and Disease Characteristics
Baseline Demographics and Disease Characteristics Placebo Dupilumab All Characteristic (N = 471) (N = 468) (N = 939) Type 2 inflammation biomarkers Blood eosinophil count at randomization – 408 (331) 394 (261) 401 (298) cells/µL, mean (SD) Post-BD FeNO level, ppb, mean (SD) 23.5 (22.0) 25.2 (22.8) 2
Slide 25: Primary Outcome: Annualized Rate of Exacerbations
Primary Outcome: Annualized Rate of Exacerbations P<0.001 −30% 1.0 Placebo 1.2 severe COPD exacerbations ± 95% CI 0.9 Dupilumab Placeb Cumulative mean number o Annualized rate of moderate or 1.10 0.8 of events ± 95% CI 1.0 0.7 0.6 0.8 0.78 0.5 0.4 Dupilumab 0.6 0.3 0.4 0.2 0.1 0.2 0.0 0 4 8 12 16 20
Slide 26: Change in Lung Function Over Time
. 8 8 8 Change ee in Lung Function Over Time o. s l ce o l 8 Pre-BD 8 FEV1 8 Post-BD FEV1 e o cho l o F LS mean difference (95% CI) LS mean change from baseline baseline 0.32 Week 12: 83ml (42-125ml); p<0.001 0.32 sel e Week 52: 83ml (38-128ml); p<0.001 Placebo 0.28 0.28 Dupilumab 0.24 0.24 h e from
Slide 27: Change in Pre-BD FVC and Pre-BD FEF25–75% Over Time
Change in Pre-BD FVC and Pre-BD FEF25–75% Over Time Pre-BD FVC Pre-BD FEF25–75% 0.32 0.20 Placebo 0.28 Dupilumab 0.18 LS mean change LS mean change (L/sec) ± 95% CI 0.24 0.16 (L) ± 95% CI 0.20 0.14 0.16 0.12 0.12 0.10 0.08 0.08 0.04 0.06 0.00 0.04 Placebo − . 0.02 Dupilumab − . 8 0 024 8 12 24 36 44
Slide 28: Patient-Reported Outcomes: St. George's Respiratory Questionnaire
Patient-Reported Outcomes: St. George’s Respiratory Questionnaire 0 Placebo Dupilumab − LS mean change ± 95% CI SGRQ Total Score − − Week 52 LS mean difference (95% CI) −8 −3.4 (−5.5 to −1.3) − P=0.002 − − 0 4 12 24 36 52 Lower score indicates a Week better quality of life No. of participants with o
Slide 29: Patient-Reported Outcomes: Symptoms (E-RS:COPD)
Patient-Reported Outcomes: Symptoms (E-RS:COPD) 0.2 Placebo − . Dupilumab LS mean change ± 95% CI E-RS: COPD Total Score − . − . − . Week 52 − .8 LS mean difference (95% CI) − . −1.1 (−1.8 to −0.4) − . P=0.001 − . − . 01234 8 12 24 36 44 52 Lower score indicates Week less severe respiratory symptoms
Slide 30: Treatment-Emergent Adverse Events in the Safety Population
Treatment-Emergent Adverse Events in the Safety Population* Placebo Dupilumab (N = 470) (N = 469) Participants with any TEAE, no. (%) 357 (76.0) 363 (77.4) Participants with any treatment-emergent SAE, no. (%) 73 (15.5) 64 (13.6) Participants with any TEAE leading to death, no. (%) 8 (1.7) 7 (1.5) P
Slide 31: Treatment-Emergent Adverse Events in the Safety Population
Treatment-Emergent Adverse Events in the Safety Population* Placebo Dupilumab (N = 470) (N = 469) os co o s ≥ % o. % Nasopharyngitis 45 (9.6) 44 (9.4) Headache 32 (6.8) 38 (8.1) Upper respiratory tract infection 46 (9.8) 37 (7.9) Chronic obstructive pulmonary disease1 28 (6.0) 27 (5.8) Diarrhea 17 (
Slide 32: Conclusions
Conclusions • Dupilumab reduced the annualized rate of moderate-to-severe exacerbations by 30% compared to placebo • Dupilumab improved patient reported lung function and patient reported outcomes: o 83 mL improvement in FEV1 o Significant improvement in quality of life o Significant improvement in
Slide 33: Q&A session (Part 1)
Q&A session (Part 1)
Slide 34: Expand and disrupt beyond Type 2
Expand and disrupt beyond Type 2 Naimish Patel MD Global Head of Development, Immunology & Inflammation
Slide 35: Potential to lead in COPD with two biologics targeting uncontrolled COPD
Potential to lead in COPD with two biologics targeting uncontrolled COPD in patients who failed standard of care Dupixent® and itepekimab have two distinct mechanisms of Patient population G71 – 2035e action addressing different COPD populations with limited overlap Non-Type 2 Type 2 2023 2024 2025
Slide 36: Itepekimab: potent IL-33 blocker with sub-nanomolar affinity
Itepekimab: potent IL-33 blocker with sub-nanomolar affinity Potential to be best-in-class and first-in-class IL-33 biologic • Binds to human IL-33 with high affinity (Kd=42pM) IL-33 • Amongst the longest half-life of anti-IL-33 class • Amongst the best bioavailability of anti-IL-33 class • No immun
Slide 37: Itepekimab: First IL-33 in COPD with unprecedented exacerbation reduction
Itepekimab: First IL-33 in COPD with unprecedented exacerbation reduction in former smokers with and without Type 2 inflammation Former smokers into 20 weeks post-treatment period1 42.4% RRR 45.2% RRR 43.2% RRR • >40% reduction in exacerbations in 1,6 P=0.0081 P=0.0488 P=0.0023 former smokers 1,4 •
Slide 38: Itepekimab: Positive Aerify interim analysis
Itepekimab: Positive Aerify interim analysis AERIFY-1 Population Itepekimab Q2W SC Randomization 40-85 yrs FDA Fast Track Former Itepekimab Q4W SC Follow-up Smokers Mod-to-severe COPD w/smoking history of Designation for COPD in ≥10 pack-years Placebo SC former smokers in N=930 January 2023 PBO + MF
Slide 39: Potential to address remaining unmet need in asthma with first-in-class assets
Potential to address remaining unmet need asthma with disruptive first-in-class assets Amlitelimab Rilzabrutinib SAR’765 OX40L BTKi IL13xTSLP Antibody Small molecule Nanobody® VHH molecule • Non-depleting anti-OX40L addresses • Oral therapy being targeting type • Bispecific Nanobody® VHH against bot
Slide 40: SAR'765: IL-13/TSLP bispecific shows potential to break efficacy ceilings
SAR‘765: IL-13/TSLP bispecific shows potential to break efficacy ceilings in type 2 Inflammation and beyond Type 2 inflammation1–3 2022 2023 Phase 1b - Proof of • Mainly driven by IL-4, IL-5 and IL-13 mechanism in Asthma • Drives IgE synthesis, eosinophil recruitment, and SAR‘765 vs. PLACEBO • Mild/
Slide 41: Significant reduction in FeNO observed with SAR'765
Significant reduction in FeNO observed with SAR’765 suggests the potential for a highly competitive target product profile Mean ( SEM) change from baseline over time Results of SAR’765 on FeNO suggest a synergistic effect compared to TSLP or IL13 alone1-8 Placebo SAR443765 (400mg) 18,8 30 (n=12) (n
Slide 42: Lung function improvement corroborates SAR'765 mode of action
Lung function improvement corroborates SAR’765 mode of action Potential to suppress airway 0,4 Placebo SAR443765 400 mg inflammation and preserve airway function in asthma change from baseline (L) 0,26 0,3 0,198 Pre-BD FEV1 0,147 0,2 • Rapid, numerical improvement in 0,1 FEV1 after single dose of SA
Slide 43: Potential breakthrough medicines beyond Type 2
Potential breakthrough medicines beyond Type 2 COPD Asthma Itepekimab SAR’765 • Potent IL-33 blocker with best-in-class • Leveraging two proven pathways and first-in-class potential • Exciting results of SAR’765 on FeNO suggest a • Unprecedented exacerbation reduction synergistic effect in former sm
Slide 44: Unlock sustainable growth in Immunology
Unlock sustainable growth in Immunology Bill Sibold EVP, Global Head of Specialty Care
Slide 45: Dupixent is the leader in specialty Respiratory
Dupixent® is the leader in specialty Respiratory Outstanding performance Leading with Pulmonologist Weekly NBRx1 - #1 Asthma NBRx 300 share (25%) March 20232 250 - #1 total Asthma 200 patients share 41% and new patient share 150 NUCALA 39% in Japan3 FASENRA 100 TEZSPIRE - Ambition to be Best-in- XOL
Slide 46: Innovative portfolio to address remaining need in fast growing asthma market
Innovative portfolio to address significant remaining need in fast growing asthma market Global asthma advanced therapy market Portfolio with potential to address remaining unmet needs in asthma $11.5B Efficacy across subtypes SAR’765 Amlitelimab +~ 65% $7.0B Long-term disease control / disease modi
Slide 47: Opportunity to bring breakthroughs to large number of in-need COPD patients
Opportunity to bring breakthroughs to large number of in-need COPD patients Eligible patients in G7 countries Potential first-in-market with Dupixent® Large biologics COPD patients 1.7m • Impressive data in high need, lethal disease eligible patient • Addressing ~35% of severe patients at launch pop
Slide 48: Multiple blockbuster opportunities to expand Sanofi's leadership in specialty respiratory
Multiple blockbuster opportunities to expand Sanofi’s leadership in specialty respiratory Leadership today Developing blockbuster opportunities itepekimab amlitelimab rilzabrutinib SAR’765 #1 in Specialty Respiratory Promising data in hand for itepekimab and SAR’765 poised to driven by Dupixent lead
Slide 49: Q&A session (Part 2)
Q&A session (Part 2)
Sanofi — American Thoracic Society Sanofi Investor Call 2023 on 6ix