Sanofi Sa · EURONEXT:SAN
Sanofi Sa — Investor Day (June 2023)
118 slides from Sanofi Sa's investor day presentation, Jun 29, 2023
Slide 1: Innovation to drive sustainable growth in Vaccines
Innovation to drive sustainable growth in Vaccines Part 1 Vaccines Investor Event June 29, 2023
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 underlyin
Slide 3: Agenda
Agenda Vaccines Investor Event, June 29, 2023 2:00-2:10 Introduction 3:40-4:30 New growth areas in vaccines - Enter multi-billion PCV market - Establish Best-in-Class meningitis portfolio 2:10-3:00 Expand leadership - Leverage leading-edge mRNA platform - Deliver Best-in-Class RSV franchise - New fr
Slide 4: Introduction
Introduction Paul Hudson Chief Executive Officer
Slide 5: Driving growth with strategic choices
Driving growth with strategic choices Dupixent® Vaccines Pipeline Maximize patient benefits Expected mid-to-high Prioritize and accelerate with ambition to achieve single-digit growth1, through portfolio of potentially >€13bn peak sales across differentiated products, transformative therapies type 2
Slide 6: Strategic transformation delivered first set of guidance targets
Strategic transformation delivered first set of guidance targets 2020 - 2022 10 consecutive quarters of growth 540bps BOI margin improvement EPS growth BOI margin ~16% from 2019 to 20221 €2.7bn cost savings re-invested in growth drivers 30% growth at CER >25 value-creating BD and M&A deals Accelerat
Slide 7: Powerful business and pipeline momentum in 2023
Powerful business and pipeline momentum in 2023 Pivotal Early to Launches mid-stage pipeline readouts Expansion into COPD 27 readouts in immunology, tolebrutinib (BTKi) Relapsing MS vaccines, neurology, rare diseases, fitusiran and oncology Hemophilia A/B Baring unforeseen events. 7 Vaccines Investo
Slide 8: Strong positive pipeline news flow in H1 2023
Strong positive pipeline news flow in H1 2023 Submissions Dupixent® CSU US 300,000 people with CSU inadequately controlled by antihistamines Read-outs Dupixent® COPD Phase 3 Around 900,000 patients in G7 itepekimab (IL-33) COPD Phase 3 IA Around 1.8m patients in G7 amlitelimab (OX40L) AD Phase 2b Mo
Slide 9: Play to Win: Leverage innovation to drive next growth chapter
Play to Win: Leverage innovation to drive next growth chapter Toda y 2020-2022 2023-2025 2026-2030 Refocus with Transformative Industry leader in immunology decisive actions launches with >€22bn sales by 2030 Guidance of BOI margin of Growth through Agile and efficient Doubling vaccines sales by 203
Slide 10: Expand leadership in vaccines
Expand leadership in vaccines Thomas Triomphe Head of Vaccines GBU Jean-François Toussaint Head of Vaccines R&D
Slide 11: Our ambition in Vaccines
Our ambition in Vaccines Continued strong growth Unlock the potential Build an industry driven by four core of mRNA in Vaccines with leading pipeline to franchises: Influenza, Next-Generation platform address unmet needs Meningitis, PPH & Boosters, RSV More than double Vaccine sales by 20301 1. Vs.
Slide 12: Execution of Play To Win strategy in Vaccines
Execution of Play To Win strategy in Vaccines Focus on growth Lead with innovation Accelerate efficiency Reinvent how we work Sales growth Countries with Vaccines profitability TBio experts retained +8% 32 +6pts +90% 2018-2022 CAGR Beyfortus licenses from 2018 to 2022 across mRNA Center of Excellenc
Slide 13: R&D transformation has started to deliver strong results
R&D transformation has started to deliver strong results Innovative antigens designed, including State-of-the-art immunology mRNA-encoded bacterial vaccine approach & antigen design High throughput translational science & proprietary MIMIC® technology introduced Selecting the best technology 9 vacci
Slide 14: At least 5 new FiC / BiC programs expected to enter phase 3 by 2025
At least 5 new FiC / BiC programs expected to enter phase 3 by 2025 2022-2023 progress Pipeline moving at pace Phase 3 & 3 new products registered 6 new phase 1/2 programs Registration mRNA Flu QIV Beyfortus RSV Older Adult RSV OA/PIV/hMPV Phase 1/2 MenPenta Acne NextGen Flu Pre-clinical 2021 2023e
Slide 15: Recent highlights from our leading-edge mRNA platform
Recent highlights from our leading-edge mRNA platform AI/ML augmented Next generation Rapid deployment mRNA Workforce mRNA products across the pipeline >600 experts and more than As many as 5 distinct LNPs Pivot to modified mRNA and 30 collaborations across all clinically tested by 2023 clinical val
Slide 16: Sanofi Vaccines is built on strong foundations
Sanofi Vaccines is built on strong foundations R&D toolbox Industrial powerhouse 9 vaccine technologies Ability to deliver at scale employed across the pipeline We have what it takes to win in protection against preventable Extensive medical expertise Commercial strength diseases Innovative approach
Slide 17: Sanofi societal commitments embedded in our business
Sanofi societal commitments embedded in our business Affordable R&D for unmet Planet care In and beyond access needs the workplace Ensuring access to Acting for the most Building sustainability Building an inclusive medicines for the poorest vulnerable communities for a healthy planet workplace coun
Slide 18: Yellow Fever program with thorough Global Access Plan
Yellow Fever program with thorough Global Access Plan South & Central America: 13 countries >500 million doses distributed worldwide since 1953 Major partner and supplier of Africa: 29 UNICEF, committed to stay countries/regions ready to respond to outbreaks 109,000 severe infections Positive phase
Slide 19: Ambition to manufacture 100% blister-free packaging by 2027
Ambition to manufacture 100% blister-free packaging by 2027 Saving ~330 tons of plastic per year Reducing the amount of microplastics in the environment Up to 50% reduction of transported pallets Reducing the need for cold chain space and transport by ~1/3rd 30% reduction in distribution costs 40% o
Slide 20: New data from 12 assets featured today
New data from 12 assets featured today Deepen our leadership in existing franchises New growth areas Meningitis Influenza RSV Pneumo New frontiers Travel & Endemic Fluzone HD MenQuadfi Beyfortus PCV21 Chlamydia Influenza QIV MenB RSV toddler Acne mRNA MenPenta RSV older Next-gen mRNA adult (OA) Flu
Slide 21: Deliver Best-in-Class RSV franchise
Deliver Best-in-Class RSV franchise Kimberly Tutwiler Head of RSV Franchise Jean-François Toussaint Head of Vaccines R&D
Slide 22: Ambition to lead in RSV across all target populations
Ambition to lead in RSV across all target populations Beyfortus: Best-in-Class immunization for All Infant Older Adult Infant Protection in first season 60% 30% RSV Market RSV Toddler ~€8bn SP0125: First-in-Class vaccine for 2030 protection from second season onwards Toddler 10% RSV Older Adult SP02
Slide 23: U.S. Advisory committee votes 21-0 in favor of nirsevimab
U.S. Advisory committee votes 21-0 in favor of nirsevimab Unanimously voted in favor for 1st season - Favorable benefit/risk profile for prevention of RSV LRTD in newborns & infants born during or entering 1st season Voted 19-2 in favor for 2nd season - Favorable benefit/risk profile for prevention
Slide 24: HARMONIE study confirms pivotal trial data in real world setting
HARMONIE study confirms pivotal trial data in real world setting Primary endpoint Days 1 181 366 1st visit: Monthly Primary 1 year Reduction of hospitalization randomization follow up completion follow-up due to RSV Lower- Respiratory-Tract-Infection (LRTI) Study objectives Beyfortus Participants: N
Slide 25: Excellent safety and tolerability profile confirmed
Excellent safety and tolerability profile confirmed Adverse Events Category Nirsevimab No Intervention Adverse Events type (N=4,016) N, (%) (N=4,020) N, (%) Any treatment emergent adverse event (TEAE) 1,479 (36.8) 1,326 (33.0) Leading to discontinuation of study 1 (< 0.1) 1 (< 0.1) Leading to death
Slide 26: Impressive 83% reduction of RSV-LRTI hospitalizations confirmed in real world setting
Impressive 83% reduction of RSV-LRTI hospitalizations confirmed in real world setting Incidence of RSV-LRTI hospitalization RSV is the leading cause of 83.2% hospitalization in infants Relative Risk Reduction (95% CI: 67.8-92.0; p<0.001) Efficacy of Beyfortus has been 1.5% consistent across all stud
Slide 27: Nirsevimab expected to prevent 3x more RSV events than maternal vaccine
Nirsevimab expected to prevent 3x more RSV events than maternal vaccine Modeled impact of nirsevimab and maternal immunization in a U.S. birth cohort for first RSV season Key input nirsevimab Maternal Vaccine Prevented RSV-related Events: [Modelled with clinical data & assumptions from CDC Hospitali
Slide 28: Ready to launch Beyfortus in the 2023 season
Ready to launch Beyfortus in the 2023 season Production is already underway Stakeholders fully engaged Licensed in EU, Great Britain, Canada Broad population programs expected in Spain and France License, ACIP recommendation and VFC inclusion expected soon Contracting and reimbursement underway Prio
Slide 29: RSV in toddlers: significant burden in 2nd season and beyond
RSV in toddlers: significant burden in 2nd season and beyond RSV Burden in Toddlers High rate of GP consultations due to diseases caused by RSV (0 to 5 years of age) 200 Incidence Rates per 1000 Bronchiolitis 16.1 150 Antibiotic 6.9 prescription 100 Respiratory 4.4 50 disease Acute respiratory 3.7 0
Slide 30: SP0125 is the first RSV vaccine designed to protect all toddlers
SP0125 is the first RSV vaccine designed to protect all toddlers Intranasal delivery design for complete toddler protection URTD - RSV inhibition at its point of entry LRTD - Broad protection against both upper and lower respiratory tract disease Live attenuated vaccine uniquely designed to ensure s
Slide 31: Beyfortus and RSV Toddler vaccine provide continuous protection
Beyfortus and RSV Toddler vaccine provide continuous protection First RSV Season Second RSV Season April - September (October – March) (October – March) Protected from second RSV season Beyfortus administered 1st dose of 2nd dose of onwards ahead or during first season RSV Toddler RSV Toddler vaccin
Slide 32: Live attenuated vaccine (SP0125) Phase 1/2 design
Live attenuated vaccine (SP0125) Phase 1/2 design Days 1 56 84 Safety Adverse events following vaccination RSVt RSVt Dose -ALow 2x dose n=61 Immunogenicity Toddlers Neutralizing antibody RSVt - High dose n=57 responses 6-18 mo Vaccine response rate Placebo n=61 Composite endpoint factoring immunogen
Slide 33: SP0125 demonstrated safety profile similar to placebo
SP0125 demonstrated safety profile similar to placebo First administration Second administration Participants experiencing at least one RSVt LD RSVt HD Placebo RSVt LD RSVt HD Placebo unsolicited AE within 28 days after vaccination (n=61) (n=57) (n=61) (n=48) (n=48) (n=54) n (%) n (%) n (%) n (%) n
Slide 34: Strong vaccine response observed with SP0125
Strong vaccine response observed with SP0125 First Two dose administration regimen 100 subjects never exposed to RSV* vaccine response rate (%) in Strong (93%) vaccine 80 response after two administrations of the High 60 dose formulation 40 Marginal difference between the Low and High dose formulati
Slide 35: Both formulations induced a robust immune response
Both formulations induced a robust immune response Serum neutralizing antibody levels Robust neutralizing antibody 100 response in toddlers not previously exposed to RSV1 80 Similar immune response % volunteers 60 observed for the Low and High dose formulations 40 20 Immune response in line with pri
Slide 36: RSV Older Adult: addressing important unmet need with combination vaccine
RSV Older Adult: addressing important unmet need with the most compelling respiratory combination vaccine Disease burden from RSV-hMPV-PIV similar to Influenza Limited antigenic drift of RSV, hMPV and PIV removes need for annual vaccination8 Estimated burden in US >65 population:1-6 1. Widmer et al.
Slide 37: SP0256 Phase 1/2 trial design of mono vaccine in older adults
SP0256 Phase 1/2 trial design of mono vaccine in older adults 1 Days 29 mRNA Dose 1 ; LNP #1 n= 10 & 100 Safety Adverse events following mRNA Dose 1 ; LNP #2 n= 10 & 100 vaccination Adults mRNA Dose 2 ; LNP #1 n= 10 & 100 Immunogenicity 18-49 n= 10 & 100 mRNA Dose 2 ; LNP #2 Serum neutralizing antib
Slide 38: Positive phase 1/2 results support SP0256 as backbone for combo respiratory vaccine
Positive phase 1/2 results support SP0256 as the backbone for the combo respiratory vaccine Reactogenicity Boosted RSV-A Neutralizing (selected formulation) Antibodies (selected formulation) mRNA RSV OA vaccine 100 25 was well tolerated Neut Ab GMTR (D29/D1)* 80 20 mRNA RSV OA vaccine solicited reac
Slide 39: Only Sanofi has the potential to offer Best-in-Class protection for all targeted ages
Only Sanofi has the potential to offer Best-in-Class protection for all targeted ages Beyfortus SP0125 SP0256 PROFILE Best-in-Class for All Infant First-in-Class vaccine for First-in-Class with RSV-hMPV- Protection in first season second season onwards PIV mRNA combination NEXT STEPS Ready for launc
Slide 40: Win in Influenza
Win in Influenza Bill Averbeck Head of Influenza Franchise Saranya Sridhar Head of Translational Medicine
Slide 41: Sanofi is the global leader in Influenza vaccines
Sanofi is the global leader in Influenza vaccines Pioneered the Worldwide Established Pursuing the transition to market leader Protection Beyond next chapter in quadrivalent with €3bn sales in Flu as the new flu with mRNA flu vaccines 2022 standard of care technology Leading with innovation rooted i
Slide 42: Three attributes imperative for winning in seasonal flu
Three attributes imperative for winning in seasonal flu Demonstrated efficacy in hospitalization and infection reduction Protection Beyond Flu through high quality / consistent data – not just immunogenicity Safety & tolerability Excellent tolerability profile Fully liquid formulation, pre-filled sy
Slide 43: It takes Protection Beyond Flu to win
PBF It takes Protection Beyond Flu to win Fluzone HD share of U.S. 65+ years old flu market value, $bn Fluzone HD and Flublok in CDC preferential recommendation for 65+ Immunogenicity Superior Efficacy Protection Beyond Flu 1.7 1.6 1.4 1.0 1.1 0.8 0.7 0.6 0.4 0.5 0.3 0.3 0.3 2010 2011 2012 2013 2014
Slide 44: Fluzone High-Dose/Efluelda set the bar high in 60/65+
PBF Fluzone High-Dose/Efluelda set the bar high in 60/65+ Outstanding results confirmed in most recent randomized Driving global expansion real-world studies DANFLU-11 DANFLU-22 Recommendations or Objective Impact of QIV HD vs SD on Impact of QIV HD vs SD on pneumonia and influenza P&I and other hos
Slide 45: Tolerability: HCPs and consumers unlikely to use vaccines with severe side effects
Tolerability HCPs and consumers are unlikely to use vaccines with 3x severe side effect burden compared to Standard Dose HCPs Consumers % Preference Share % Preference Share -69% -69% mRNA vaccine with mRNA vaccine with mRNA vaccine with mRNA vaccine with SoC 2x Grade 2 side 3x Grade 3 side SoC 2x G
Slide 46: HCPs do not accept administration hurdles for flu vaccines
Administration HCPs do not accept administration hurdles for flu vaccines Doctor’s Pharmacy office Lack of refrigerator-stable, full-season product Flu vaccination networks set could decrease HCP up to maximize access; uptake/use by unfit to manage ultra-cold Workplace chains and short shelf life Sc
Slide 47: Comprehensive mRNA flu vaccine program
Comprehensive mRNA flu vaccine program SP0273 1 Days 29 mRNA Flu QIV mRNA Flu QIV Dose 1 n=65 & 65 Phase 1/2 study mRNA Flu QIV Dose 2 n=65 & 65 Adults Adults mRNA Flu QIV Dose 3 n=65 & 65 Flu QIV (modified mRNA) & 18-64 yo ≥65 yo Fluzone Standard Dose n=60 & 60 - Safety and immunogenicity Flublok n
Slide 48: Strong immune responses against A strains
Strong immune responses against A strains Hemagglutination inhibition titers in 18-64 years old SP0273 results 32 100 - Immune response for A 16 80 strains comparable to SoC % Seroconversion GMTR D29/D01 8 60 - Immune responses for B 4 40 strains trend lower than SoC 2 20 1 0 A/H3N2 A/H1N1 B/YAM B/V
Slide 49: Immune response in line with other mRNA flu vaccine program
Immune response in line with other mRNA flu vaccine program Hemagglutination inhibition titers mRNA flu QIV results Sanofi 18-64 years Competitor data1 >18years 32 In both mRNA trials: 16 GMTR D29/D01 8 - A strain results similar to 4 comparator 2 - Low B response is a class 1 effect across mRNA A/H
Slide 50: SP0273 reactogenicity compares favorably to other mRNA trial
SP0273 reactogenicity compares favorably to other mRNA trial Reactogenicity in 18-64 years SP0273 results 20 20 - Reactogenicity higher 15.8 compared to current % Any Grade 3 solicited % Any Grade 3 solicited licensed flu vaccines injection site reactions 15 15 systemic reactions - Systemic reaction
Slide 51: Ambition to match Standard of Care with next-generation mRNA flu vaccine
Ambition to match our Standard of Care in influenza with Sanofi’s next-generation mRNA vaccine Utilize advanced computational techniques Machine learning to optimize strain selection Focus on neuraminidase to improve Antigen composition vaccine effectiveness Protection Beyond Flu is the centerpiece
Slide 52: Potential to improve coverage with Machine Learning
Potential to improve coverage with Machine Learning Proof of concept achieved for H3 & H1 strains ML model robustly selects strains ML-strains cover broader H1 Seasonal with greater breadth1 Influenza Space vs WHO strain2 6B.1A.5a.2 8.00 Antigenic space 2 6B.1 6B.1A.5a.2 4.00 0.00 WHO strain -4.00 6
Slide 53: Comprehensive mRNA flu vaccine program
Comprehensive mRNA flu vaccine program SP0273 1 Days 29 mRNA Flu QIV mRNA Flu QIV Dose 1 n=65 & 65 mRNA Flu QIV Dose 2 n=65 & 65 Phase 1/2 study Adults Adults mRNA Flu QIV Dose 3 n=65 & 65 Flu QIV (modified mRNA) & 18-64 yo ≥65 yo Fluzone Standard Dose n=60 & 60 - Safety and immunogenicity Flublok n
Slide 54: mRNA neuraminidase immunogenicity as strong as Fluzone HD
mRNA neuraminidase immunogenicity as strong as Fluzone HD Neuraminidase inhibition titers (N2) mRNA neuraminidase results 8 100 - Immune responses comparable to Fluzone HD 80 - NB: Fluzone HD has 2.5 to 3 % Seroconversion GMTR D29/D01 4 times higher NA concentrations 60 than SD vaccines and sets the
Slide 55: Offering superior flu protection for key age groups at risk
Offering superior flu protection for key age groups at risk Vaxigrip Tetra / Fluzone SD Flublok / Supemtek Fluzone HD / Efluelda PBF SoC SP0273 Next-generation mRNA flu Enhance B strain immune response, improve immunogenicity, upgrade antigen design & optimize strain selection via machine learning A
Slide 56: Q&A session Part 1
Q&A session Part 1 Thomas Triomphe Jean-François Toussaint Head of Vaccines GBU Head of Vaccines R&D Kimberly Tutwiler Bill Averbeck Saranya Sridhar Head of RSV Franchise Head of Influenza Franchise Head of Translational Medicine
Slide 57: Innovation to drive sustainable growth in Vaccines (Part 2)
Innovation to drive sustainable growth in Vaccines Part 2 Vaccines Investor Event June 29, 2023
Slide 58: Agenda
Agenda Vaccines Investor Event, June 29, 2023 2:00-2:10 Introduction 3:40-4:30 New growth areas in vaccines - Enter multi-billion PCV market - Establish Best-in-Class meningitis portfolio 2:10-3:00 Expand leadership - Leverage leading-edge mRNA platform - Deliver Best-in-Class RSV franchise - New fr
Slide 59: Enter multi-billion PCV market
Enter multi-billion PCV market Thomas Grenier Head of Franchise & Product Strategy Jean-François Toussaint Head of Vaccines R&D
Slide 60: Drive growth with PCV21 in attractive pediatric market
Drive growth with PCV21 in attractive pediatric market Large pneumococcal vaccine market PCV21: growth driver with strong portfolio fit Focus on pediatric development First-in-Class PCV20+ in pediatric population ~80% Synergy with Sanofi pediatric vaccine portfolio €6.8bn (Global, 2022) Strong colla
Slide 61: First PCV21 pediatric vaccine extends protection against disease
First PCV21 pediatric vaccine extends protection against disease Serotype composition per vaccine IPD incremental coverage rate in all ages1 Significant residual burden 1 3 4 5 6A 6B 7F 9V 14 18C 19A 19F 23F 22F 33F 8 10A 11A 12F 15B 9N 2 17F 20 in U.S. pediatrics < 5 years2 27% 37% NVT/Others - ~1,
Slide 62: PCV21 (SP0202) Phase 2 designed to enable pivotal program
PCV21 (SP0202) Phase 2 designed to enable pivotal program Study design Months 4-dose Safety regimen 2 4 6 7 12 - 15 13-16 Immunogenicity - Post-dose 3 IgG geometric mean PCV21 Formulation #1 n= 175 concentration and seroresponse - Post-dose 4 IgG geometric mean PCV21 Formulation #2 n= 175 concentrat
Slide 63: PCV21 (SP0202) well-tolerated in pediatric population
PCV21 (SP0202) well-tolerated in pediatric population Safety profile comparable with PCV13 across all 4 doses Solicited injection site reactions Solicited systemic reactions 100 100 % of participants reporting % of participants reporting 80 80 60 60 40 40 20 20 0 0 Dose 1 Dose 2 Dose 3 Dose 4 Dose 1
Slide 64: Favorable PCV21 immune responses when compared to PCV20
Favorable PCV21 immune responses when compared to PCV20 Serotypes shared by PCV13, PCV20 and PCV21 IgG GMC ratio and difference % seroresponse vs PCV13 Post Dose 3: IgG GMC ratio Post Dose 3: Difference seroresponse Post Dose 4: IgG GMC ratio 1 1 1 3 3 3 4 4 4 5 5 5 6A 6A 6A PCV21 Phase 2 6B 6B 6B P
Slide 65: Favorable PCV21 immune responses when compared to PCV20
Favorable PCV21 immune responses when compared to PCV20 Serotypes shared with PCV20 or unique to PCV21 IgG GMC ratio and difference % seroresponse vs lowest in PCV13 group Post Dose 3: IgG GMC ratio Post Dose 3: Difference seroresponse Post Dose 4: IgG GMC ratio 8 8 8 9N 9N 9N 10A 10A 10A PCV21 Phas
Slide 66: Innovative carrier to break serotype composition ceiling
Innovative carrier to break serotype composition ceiling Introducing new carrier for 4 serotypes to improve Robust performance of the 4 serotypes performance conjugated to TT Post Dose 4: IgG GMC ratio 16 GMC ratio vs Prevnar 13 1 3 4 5 6A 6B 7F 9V 14 18C 19A 19F 23F 8 9N 10A 11A 12F 15B 22F 33F 4 P
Slide 67: Phase 2 interchangeability data support PCV21 as booster
Phase 2 interchangeability data support PCV21 as booster Single Boosting effect is comparable to Robust immune response for booster 0 Days 30 PCV13 for common serotypes the additional serotypes dose 100 100 PCV21 Formulation #1 n= 35 10 GMC µg / mL GMC µg / mL 10 PCV21 Formulation #2 n= 35 Toddlers
Slide 68: Ambitious program with first pediatric PCV20+ vaccine
Ambitious program with first pediatric PCV20+ vaccine; clear blockbuster potential Phase 3 starts in H1 2024 Expected submission in 2027 Initiating development of next generation PCV21+ vaccines 68 Vaccines Investor Event
Slide 69: Establish Best-in-Class meningitis portfolio
Establish Best-in-Class meningitis portfolio Thomas Grenier Head of Franchise & Product Strategy Saranya Sridhar Head of Translational Medicine
Slide 70: Consolidate MenQuadfi market leadership
Consolidate MenQuadfi market leadership Best-in-Class MenACWY profile - Novel serogroup-specific design, unique chemical and structural features - Higher serogroup C responses - Fully-liquid presentation - Broad age-indication - Up to 7 years persistence in different age groups Leadership in the U.S
Slide 71: New clinical evidence reinforces MenQuadfi's Best-in-Class profile
New clinical evidence reinforces MenQuadfi’s Best-in-Class profile Immune response vs. competition Adolescents (10-17 years) Infants & Toddlers (2-12 months) Higher or comparable immune response vs. Higher immune response with 3 doses of MenQuadfi Pfizer’s ACWY in adolescents vs. 4 doses of GSK’s AC
Slide 72: MenQuadfi first and only ready-to-use syringe
MenQuadfi first and only ready-to-use syringe ~80% preference by U.S. HCPs1 when ready-to-use syringe option is available Unique presentation competitive advantage: no other ACWY syringe available U.S. FDA submission in July 2023, available early 2024 Source: Sanofi data on file 72 Vaccines Investor
Slide 73: MenQuadfi addresses current recommendation for quadrivalent MenACWY immunization
MenQuadfi addresses current recommendation for quadrivalent MenACWY immunization in most markets Complex and various routine recommendations1 due to different IMD incidence by serogroup, age, geography MenQuadfi currently has the most complete product profile Infants Toddlers Adolescents U.S. MenACW
Slide 74: Novel MenB formulation (SP0230) to provide optimal protection
Novel MenB formulation (SP0230) to provide optimal protection Phase 1/2 clinical study design Days MenB antigen formulation 1 31 61 Non-Lipidated Non-Lipidated MenB Formulation #1 n=72 fHBP A fHBP B MenB Formulation #2 n=72 Outer n=72 NadA MenB Formulation #3 Membrane Vesicle Adolescents MenB Formul
Slide 75: MenB strong phase 1/2 results demonstrate competitiveness
MenB strong phase 1/2 results demonstrate competitiveness and support move to next phase hSBA seroresponse rate1 – Sanofi MenB vs Bexsero² Cross-protection against strains Vaccine strains2 Sanofi formulations were not in the vaccine3 well tolerated MenB Formulation 1 MenB Formulation 3 All antigens
Slide 76: Strong preclinical data support advancement of MenPenta program
Strong preclinical data support advancement of MenPenta program in ready-to-use syringe to phase 1/2 in H2 2023 Liquid MenPenta stability data give No immune interference between MenPenta high confidence in PFS formulation components (rabbit model) % of Free Polysaccharide ACWY of MenPenta % of resp
Slide 77: Comprehensive and competitive meningococcal portfolio provides new source of growth
Comprehensive and competitive meningococcal portfolio provides new source of growth MenQuadfi Best-in-Class MenACWY vaccine MenB formulation demonstrates strong potential for cross-protection across B strains Advancing MenPenta development in ready-to-use syringe with expected U.S. submission in 202
Slide 78: Leverage leading-edge mRNA platform
Leverage leading-edge mRNA platform Jean-François Toussaint Head of Vaccines R&D Frank DeRosa Head of Research for mRNA CoE
Slide 79: Built a leading-edge mRNA platform in just 18 months
Built a leading-edge mRNA platform in just 18 months Execution Innovation - 7 mRNA Phase 1/2 clinical trials: Flu, RSV, - Innovative antigen, mRNA and LNP designs platform, 3 LNPs screened across viral and bacterial targets - >600 dedicated employees, of which >250 - Highly competitive LNP selected
Slide 80: Accelerated learnings from holistic data integration leveraging AI/ML models
Accelerated learnings from holistic data integration leveraging AI/ML models Antigen Rationally designed for high design immunogenicity and stability Adverse Immunogenicity events & durability Clinical profile 5 generative and active deep understanding mRNA learning ML models design mRNA design spac
Slide 81: Platform now includes both viral and bacterial protein targets
Platform now includes both viral and bacterial protein targets Robust preclinical antibodies titers across many target antigens (viral & bacterial) Viral Bacterial RSV hMPV PIV3 Acne 1 Acne 2 Chlamydia 8 Neutralizing titer-1 (log2) Neutralizing titer-1 (log2) Neutralizing titer-1 (log2) ELISA titer
Slide 82: Leverage leading-edge mRNA platform for Best-in-Class / First-in-Class vaccines
Leverage leading-edge mRNA platform for Best-in-Class / First-in-Class mRNA vaccines and therapeutics Potency Reactogenicity Thermostability Viral Targets Bacterial Targets Target Generate Utilize balanced efficacy enhanced HCP and broad spectrum and tolerability patient experience of applications 8
Slide 83: Our new platform enables improved mRNA performance
Potency Our new platform enables improved mRNA performance mRNA Sequence Optimization Process Increased Translation Efficiency Increased Protein Expression (Polysome Profiling) (Immunofluorescence) 5’ cap 5’ UTR Coding Region 3’ UTR Poly (A) Tail 15 Control sequence Codon optimized Start Codon Stop
Slide 84: All four LNP components leave significant room for optimization
Potency All four LNP components leave significant room for optimization + Ionizable lipid The ionizable lipid wraps around the mRNA and helps transport and release it to the targeted cell The helper lipid helps create the lipid membrane of Helper lipid the LNP, and it allows for the LNP to easily fu
Slide 85: Sanofi novel science supports improved LNP and better potency
Potency Sanofi novel science supports improved LNP and better potency + Ionizable Lipid Helper Lipid Sterol 100 (1) (1) (1) LNP1 150 150 80 6 0 LNP2 (1) (1) Protein (ng/mL) LNP3 Protein (ng/mL) Protein (ng/ml) 60 Intramuscular 100 100 4 0 6h (3) 24 h 40 2 0 50 50 20 SM-102 0 0 LNP1 LNP1 LNP2 LNP2 LN
Slide 86: Fast learnings from diverse clinical trials with mRNA and LNP
Reactogenicity Fast learnings from diverse clinical trials with mRNA and LNP Multiple Sanofi LNP candidates Clinical trials LNP3 (RSV) Unmodified vs modified Immunogenicity Mono- vs multi-valent LNP2 LNP1 (RSV) LNP3 (Flu) (Flu) Multiple targets LNP2 LNP1 (Flu) (Flu) Multiple LNPs (4+) LNP2 (Flu) Rea
Slide 87: Sanofi's proprietary MIMIC system to increase efficiency of mRNA screening
Reactogenicity Sanofi’s proprietary MIMIC® system to increase efficiency of mRNA screening Preclinical MIMIC Prediction Clinical Outcomes Unmodified Modified 2021 2023 comparator Solicited Systemic Reactions (%) 100 Grade 1-2 80 Grade 3 50 60 40 log2 fold-change in cytokines 40 20 0 rHA Dose Dose Do
Slide 88: Significant progress toward improved thermostability
Thermostability Significant progress toward improved thermostability Monovalent LNP Multivalent LNP Scale-up Industrial environment Increasing complexity Prototype LNP demonstrating QIV LNP demonstrating 12-months+ stability as 2-8oC liquid ~9 months stability as 2-8oC liquid 100 Change in % mRNA In
Slide 89: Our leading-edge mRNA platform is poised to break grounds in vaccine innovation
Our leading-edge mRNA platform is poised to break grounds in vaccine innovation Potency Reactogenicity Thermostability Viral Targets Bacterial Targets Competitive platform in just 18 …to cross new frontiers months with 7 clinical trials… mRNA LNP Novel Antigen Optimization Optimization Design …innov
Slide 90: New frontiers
New frontiers Dr William Geisler, MD, MPH Professor of Medicine and Epidemiology, University of Alabama at Birmingham Sally Mossman Head of Vaccine Research Portfolio Strategy
Slide 91: Innovation to address unmet needs in infectious diseases
Innovation to address unmet needs in infectious diseases Chlamydia Acne - Dr William Geisler on the burden of chlamydia - Key preclinical data support clinical evaluation disease of therapeutic vaccine candidate - Positive data enable selection of final vaccine - GMP production to enable clinical ev
Slide 92: Chlamydia
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Slide 93: Dr William Geisler, MD, MPH
Dr William Geisler, MD, MPH Professor of Medicine and Epidemiology, University of Alabama at Birmingham
Slide 94: Chlamydia Burden and Need for a Vaccine
Chlamydia Burden and Need for a Vaccine 94
Slide 95: Chlamydia is the most common bacterial STI worldwide
Chlamydia is the most common bacterial STI worldwide (~129 million new cases annually) These numbers represent incident cases of chlamydia, gonorrhea, trichomoniasis and syphilis in 2016. 2020: WHO estimated 377 million new cases of four STIs • Chlamydia: 129 million new cases • Gonorrhea: 82 millio
Slide 96: Chlamydia is a chronic infection and most infected persons do not have symptoms
Chlamydia is a chronic infection and most infected persons do not have symptoms or signs of infection Women Men Natural Course of Chlamydia in 83 Asymptomatic Colombian Women <25% <50% >50% >75% ~50% of infections persist at 1 year Asymptomatic Symptomatic Farley et al. Prev Med. 2003 Molano et al.
Slide 97: Chlamydia has important health consequences
Chlamydia has important health consequences, and the burden of morbidity is greater in women Causes upper genital tract inflammation in 10%-15% of women (PID),1,2 which may be complicated by: • Infertility (up to 18%)1 • Chronic pelvic pain (up to 33%)3 • Ectopic pregnancy (3-fold risk)4 Associated
Slide 98: Chlamydia control programs provide a comprehensive approach
Chlamydia control programs provide a comprehensive approach to preventing and treating chlamydia Chlamydia Prevention Measures • Abstinence • Sexual health education • Barrier methods (e.g., condoms) • NO VACCINE AVAILABLE Chlamydia Testing (with highly accurate NAAT) • Routine screening in young wo
Slide 99: Control programs have been ineffective in decreasing chlamydia rates
Control programs have been ineffective in decreasing chlamydia rates, justifying need for a preventative vaccine Rates of Reported Chlamydia Cases, U.S., 1984–2021* (* Per 100,000) • Many chlamydia cases go undetected and untreated • Natural infection does not elicit long-lived protective immunity i
Slide 100: Thank you
Thank you wgeisler@uabmc.edu 100
Slide 101: Significant direct medical costs in STI attributed to chlamydia
Significant direct medical costs in STI attributed to chlamydia Chlamydia next to HPV in terms of costs in STIs HBV HSV-2 Trichomoniasis Syphilis Gonorrhea Chlamydia HPV HIV $46 M $91 M $144 M $174 M $271 M $691 M $775 M $13.7 B Direct medical costs by infection in U.S. Queensland government in Aust
Slide 102: Chlamydia biology requires sophisticated vaccine design
Chlamydia biology requires sophisticated vaccine design Chlamydia trachomatis (CT) is a bacterium Targeted immune profile that lives inside human cells EB (elementary body) IFN Antibodies may contribute to CD4 T Anti- protection cells bodies RB (reticulate body) - Antibodies and CD4 T cell response
Slide 103: Innovative multi-antigen vaccine candidate achieves targeted immune profile
Innovative multi-antigen vaccine candidate achieves targeted immune profile, moving to phase 1/2 in 2024 Broad cross-serovar T cell Cross-serovar antibodies recognizing responses native elementary bodies IFN spots/ 106 splenocytes ELISA titer anti-EB (log10EU) ELISA titer anti-EB (log10EU) 10000 10
Slide 104: Acne
Acne
Slide 105: Acne is chronic inflammatory skin disease and the 8th most common medical condition
Acne is chronic inflammatory skin disease and the 8th most common medical condition globally Mild Moderate Severe acne acne acne High burden of disease Incidence and prevalence significant and - Chronic nature of condition increasing - Psycho-social impact on patients - 8.6 million prevalent cases i
Slide 106: Recent market research points to gaps in treatment landscape
Recent market research points to gaps in treatment landscape driving a significant need for novel approaches “Isotretinoin has the efficacy, but it’s complicated Reliable and has risks – none of the options we have give efficacy us everything we need in one treatment’’ Easy No skin administration –
Slide 107: Our ambitious approach in the acne immunotherapeutic space
Our ambitious approach in the acne immunotherapeutic space Recombinant protein antigens obtained Targeted intervention designed to restore a healthy through Origimm acquisition validated skin microbiome with strong proof of mechanism data Leveraging antigens from Origimm acquisition, 106 enhanced wi
Slide 108: Therapeutic vaccine addressing multiple pathogenic mechanisms
Therapeutic vaccine addressing multiple pathogenic mechanisms Acne vulgarum: skin dysbiosis Origimm Antigens driven by outgrowth of pathogenic - Expressed on surface of pathogenic C. acnes strains Cutibacterium acnes - Induce opsonophagocytic killing antibodies to reduce bacterial burden C. acnes -
Slide 109: Positive pre-clinical data support move to phase 1/2
Positive pre-clinical data support move to phase 1/2 in 2023 mRNA expression of bacterial antigens induces functional No interference in induced responses with immune responses at least equivalent to recombinant proteins combination of all three mRNAs Antigen 1 Antigen 2 Antigen 3 107 107 100 107 10
Slide 110: Moving at pace to unlock new areas in infectious disease
Moving at pace to unlock new areas in infectious disease Expanding to Addressing Leveraging the right new disease areas unmet needs technological solutions Therapeutic or prophylactic Association of infectious agents with chronic diseases Microbiome 110 Vaccines Investor Event
Slide 111: Conclusion
Conclusion Thomas Triomphe Head of Vaccines GBU
Slide 112: Sanofi drives innovation with BiC/FiC vaccines pipeline
Sanofi drives innovation with BiC/FiC vaccines pipeline 3 New products approved since Vaccines Investor Event in December 2021 Leading-edge mRNA platform to lift our influenza standard mRNA of care and deliver innovation to address unmet needs 6 New vaccine candidates expected in phase 1/2 trial in
Slide 113: On a clear path to generate >€10bn sales by 2030
On a clear path to generate >€10bn sales by 2030 Launch Beyfortus blockbuster and build BiC RSV franchise Continue to win in Influenza Sanofi Vaccines sales Enter Pneumococcal market with PCV blockbuster candidate Sustain growth of established business >€10bn by 20301 Introduce our new mRNA vaccines
Slide 114: Q&A session Part 2
Q&A session Part 2 Thomas Triomphe Thomas Grenier Jean-François Toussaint Saranya Sridhar Head of Vaccines GBU Head of Vaccines F&PS Head of Vaccines R&D Head of Translational Medicine Frank DeRosa Dr William Geisler, MD, MPH Sally Mossman Head of Research for Professor of Medicine & Epidemiology He
Slide 115: Appendices
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Slide 116: Collaborations
Collaborations Name Developed in collaboration with… Beyfortus® AstraZeneca Dupixent® Regeneron itepekimab (IL-33) frexalimab ImmuNext VidPrevtyn® Beta GSK and with funding from Biomedical Advanced Research and Development Authority (BARDA) SP0202 SK Bioscience 116 Vaccines Investor Event
Slide 117: Abbreviations
Abbreviations ACIP Advisory Committee on Immunization Practices HLA Human Lymphocyte Antigen NVT Non-vaccine type AE Adverse Event hMPV Human Metapneumovirus OA Older Adults AI Artificial Intelligence HPV Human Papillomavirus OPK Opsonophagocytic killing BTK Bruton’s Tyrosine Kinase HSBA Human Serum
Slide 118: sanofi
sanofi