Sanofi SA · EURONEXT:SAN
Sanofi SA — Investor Day (December 2021)
49 slides from Sanofi SA's investor day presentation, Dec 1, 2021
Slide 1: Vaccines Investor Event Part 1: Growing current business
Vaccines Investor Event Part 1 Growing current business December 1st, 2021 1
Slide 2: Forward looking statements
Forward looking statements This presentation 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 unde
Slide 3: Vaccines Investor Event | Agenda
Vaccines Investor Event | Agenda Introduction Paul Hudson Chief Executive Officer We Play to Win Thomas Triomphe Head of Vaccines GBU Winning in Influenza Bill Averbeck Head of Influenza Franchise Growing current business All infant protection Kimberly Tutwiler Head of RSV Franchise against RSV Q&A
Slide 4: Introduction
Introduction Paul Hudson Chief Executive Officer 4
Slide 5: Play to Win: Our six-year plan – ahead of schedule
Play to Win: Our six-year plan – ahead of schedule 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
Slide 6: Our key growth drivers are delivering
Our key growth drivers are delivering Dupixent® Vaccines Pipeline Maximize patient benefits Expected mid-to-high single-digit Prioritize and accelerate with ambition to achieve >€10 growth, through differentiated portfolio of potentially billion peak sales across type 2 products, market expansion, t
Slide 7: Constant progress in ESG
Constant progress in ESG Our four-pillar strategy Sustainability scores: Sanofi vs. selected benchmark 100 90 89 88 87 84 86 Sanofi 80 82 76 60 Score 1st quartile Affordable access Vulnerable communities 40 2nd quartile 20 3rd quartile 4th quartile 0 2018 2019 2020 2021 • Innovation management Award
Slide 8: COVID-19 recombinant vaccine program
COVID-19 recombinant vaccine program 1 PHASE 3 SAFETY & EFFICACY TRIAL – Primary vaccine Efficacy Readout Monovalent Enrollment completed(1) By end of Stage 1: 10µg parent strain December 2021 Bivalent Enrollment Stage 2: 5µg parent + 5µg Beta strains started MAY-21 JUL-21 OCT-21 NOV-21 DEC-21 2 BOO
Slide 9: Conclusion
Conclusion PICTURE 9
Slide 10: We Play to Win in Vaccines
We Play to Win in Vaccines Thomas Triomphe Head of Vaccines GBU 10
Slide 11: We Play to Win in Vaccines
We Play to Win in Vaccines Focus on growth Lead with innovation Accelerate efficiency Reinvent how we work • Set to lead in • Building next-generation • Fund mRNA and • Evolutive Vaccines differentiated Influenza mRNA platform innovation through Facilities • Ready to launch • Breaking boundaries for
Slide 12: What we heard from some of you
What we heard from some of you COVID-19 “Is the Flu “Late in the first wave of COVID- Flu franchise 19 vaccines, can booster be an a sitting duck?” opportunity?” “Scrambling to make sure it has Pipeline mRNA skin in the game on mRNA” “Underwhelming Pipeline” 12 Source: Analyst reports
Slide 13: Addressing COVID-19 evolving needs
Addressing COVID-19 evolving needs 2021 2022/2023 2024+ Sanofi Phase III efficacy Newly licensed vaccines to Sanofi offering thermostable read-out expected by complement existing orders booster vaccine, depending on end-of-year • Demand addressed by market demand ~25bn(1) COVID-19 vaccine doses rele
Slide 14: Limited opportunity for Flu / COVID-19 combo as of now
Limited opportunity for Flu / COVID-19 combo as of now Immune response(1) of Fluzone HD maintained Key requirements for a Flu / COVID-19 when co-administered with COVID-19 vaccine combo vaccine Immunogenicity – GMT of influenza HA antibody response Status 600 550 • Immunization Unlikely 500 450 sche
Slide 15: We have everything it takes to win
We have everything it takes to win Best-in-class products Ability to deliver at scale Large-scale manufacturing & R&D strength in Immunology supply capabilities Extensive RWE experience to Unique formulation & demonstrate real-life efficacy combination capabilities Long history of working with key s
Slide 16: Confirming CMD guidance for 2025
Confirming CMD guidance for 2025 Mid-to-high single-digit sales growth(1) Growth drivers • Targeting nirsevimab launch in 2023 RSV • First-in-class to protect all infants • Converting to differentiated Flu in U.S. €5.1bn Influenza • Launch of differentiated Flu in EU 1.7 PPH & • Switch from Pentaxim
Slide 17: Sanofi addressable market to grow significantly
Sanofi addressable market to grow significantly New Frontiers >€2bn Pneumo €8.4bn >10.0 15.0 Pneumo 6.2 6.7 2030 8.0 2020 0.8 2.4 4.4 11.7 7.6 ~€24bn ~€50bn Influenza PPH & Boosters, Travel & Endemic Meningitis RSV New Growth Areas 17 Source: Sanofi internal estimates
Slide 18: Creation of a first-of-its-kind mRNA Center of Excellence
Creation of a first-of-its-kind mRNA Center of Excellence Vision & Ambition Accelerating execution Next generation mRNA vaccines • Significant investment funded through • Leveraging digitalized environment resource reallocation • Leading mRNA vaccine player within 5 years • 400 dedicated employees (
Slide 19: Building an industry leading pipeline
Building an industry leading pipeline Deepen our leadership in existing franchises New Growth Areas Influenza Meningitis RSV Pneumo New frontiers • Fluzone HD • MenB • Nirsevimab • PCV21 • Chlamydia pediatric • MenPenta • RSV toddler • Acne • Influenza QIV mRNA • RSV older adults & respiratory combo
Slide 20: Ambition to more than double sales by end of decade
Ambition to more than double sales by end of decade Win in Influenza More than Continue expansion of recurring business Launch nirsevimab & become the RSV leader Enter large Pneumococcal vaccines market vaccine sales by end of the decade(1) Deliver new mRNA vaccine candidates 20 (1) Vs. 2018, risk a
Slide 21: Vaccines Investor Event | Agenda
Vaccines Investor Event | Agenda Introduction Paul Hudson Chief Executive Officer We Play to Win Thomas Triomphe Head of Vaccines GBU Winning in Influenza Bill Averbeck Head of Influenza Franchise Growing current business All infant protection Kimberly Tutwiler Head of RSV Franchise against RSV Q&A
Slide 22: Winning in Influenza
Winning in Influenza Bill Averbeck Head of Influenza Franchise 22
Slide 23: Why we will win in flu
Why we will win in flu Strong growth of the global influenza market (sales in €bn(1)) +8% CAGR ~15.0 mRNA • Overcoming limitation of current mRNA vaccines platform to deliver Next-Gen Flu vaccines +8% CAGR Differentiated • Raising the bar for Protection Beyond Flu 6.7 vaccines with Fluzone HD and Fl
Slide 24: Pandemic mRNA platforms not ready for seasonal flu
Pandemic mRNA platforms not ready for 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 syringe
Slide 25: Protection against flu infection is not enough
Protection against flu infection is not enough 8x 10x increased risk of stroke increased risk of heart attack 9% experience loss of independence 8x 75% increased risk of pneumonia increased abnormal glycemic events Total flu related healthcare costs in the U.S. estimated at $11bn(1) (1) Direct costs
Slide 26: Protection Beyond Flu is the new minimum standard
Protection Beyond Flu is the new minimum standard Cumulative endpoints required vs. standard dose flu vaccine Protection Beyond Flu • High-quality study design, including Hospitalization RCTs • Multiple seasons of consistent results vs. standard of care • Cardiovascular & pneumonia hospitalization e
Slide 27: Fluzone High-Dose sets the bar for Protection Beyond Flu
Fluzone High-Dose sets the bar for Protection Beyond Flu Incremental hospitalization reduction over standard dose Pneumonia -27.3% hospitalization U.S. savings $4.6bn Cardiorespiratory (1) -17.9% hospitalization Influenza 10-year added value hospitalization -11.7% vs. standard dose flu vaccine All-c
Slide 28: Immunogenicity alone is simply not enough
Immunogenicity alone is simply not enough Immunogenicity Efficacy against infection Protection Beyond Flu Demonstrated consistent improved Demonstrated superior Fluzone High-Dose(1) efficacy vs. SD (rVE: 24%) protection against multiple hospitalization endpoints vs. SD Demonstrated improved Flublok(
Slide 29: It takes Protection Beyond Flu to win
It takes Protection Beyond Flu to win Fluzone HD share of U.S. 65+ years old flu market value, $bn Efficacy against Immunogenicity Protection Beyond Flu infection 1.4 1.0 1.1 0.8 0.7 0.6 0.5 0.4 0.3 0.3 0.3 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Fluzone HD Other Nearly 2 out of 3 vac
Slide 30: Current mRNA safety profile unfit for flu market
Current mRNA safety profile unfit for flu market Adverse events in 65+ years old Grade 3(3) adverse events(4) Moderna Spikevax Fluzone SD(1) Fluzone HD(1) mRNA Covid Dose 2(2) 12.3x 3.5x Pain 24% 36% 83% 13.5% Myalgia 18% 21% 47% 7.7% Headache 14% 17% 46% 2.2% Swelling 6% 9% 11% 1.1% Grade 3 systemi
Slide 31: Pandemic mRNA platforms not ready for seasonal flu
Pandemic mRNA platforms not ready for seasonal flu Differentiated Flu mRNA 1st generation Protection Beyond Flu Proven superior Protection No trial currently running Beyond Flu vs. SD 12.3x more Grade 3 systemic reactions Safety & tolerability Well established vs. HD(1) Fully liquid in pre-filled sy
Slide 32: Winning in the differentiated flu market
Winning in the differentiated flu market Building 2nd Setting a high bar generation mRNA with Fluzone HD and Flublok + platform to deliver Next-Gen Flu vaccines 32
Slide 33: All infant protection against RSV
All infant protection against RSV Kimberly Tutwiler Head of RSV Franchise 33
Slide 34: All infants are at risk of Respiratory Syncytial Virus
All infants are at risk of Respiratory Syncytial Virus High burden of RSV disease for all infants Infant segment to represent 1/3 of total RSV market in 2030(3) 135m 2m 6% 15% 2.5 (31%) RSV market 94% in 2030 85% 4.5 in €bn (56%) 1.0 (13%) Birth cohort(1) RSV hospitalization(2) Healthy full-term inf
Slide 35: Nirsevimab is the only option for All Infant Protection
Nirsevimab is the only option for All Infant Protection Full-term infants Pre-term or Full-term infants Duration of born before at risk infants born in season protection season Covering the entire All Infant nirsevimab RSV season(1) Protection maternal Clinical trials Expected to be Not All Infant i
Slide 36: Three pivotal studies to enable universal RSV immunization
Three pivotal studies to enable universal RSV immunization Study Target population Status MELODY Primary analysis & Healthy full-term and late pre-term infants Pivotal Phase III vs. placebo enrollment for full safety ≥ 35 wGA n=2,990 population completed PHASE IIb Healthy pre-term infants Completed
Slide 37: 3 out of 4 hospitalizations prevented with nirsevimab
3 out of 4 hospitalizations prevented with nirsevimab Incidence, in % placebo nirsevimab (49.6, 87.1) (-8.6, 86.8) (50.3, 89.7) p<0.0001 p=0.0708 p=0.0002 -74.5% 5.0 -77.3% -62.1% 2.7 1.6 1.2 0.6 0.6 RSV-confirmed RSV-confirmed RSV-confirmed medically attended LRTI hospitalizations hospitalizations
Slide 38: Nirsevimab safety profile similar to placebo
Nirsevimab safety profile similar to placebo Subjects (%) with ≥ 1 event Placebo (n=491) Nirsevimab (n=987) Any AE 426 (86.8) 863 (87.4) AE occurring ≤ 1 day postdose(1) 3 (0.6) 18 (1.8) AE occurring ≤ 7 days postdose 63 (12.8) 132 (13.4) AE related to investigational product 7 (1.4) 10 (1.0) AE of
Slide 39: Ready for global launch, starting with 2023 RSV season
Ready for global launch, starting with 2023 RSV season Annual birth Expected Expected Designation Pre-launch activities cohort (m) submission launch season FDA Breakthrough 3.6 Q4 2022 2023 • NITAGs confirmed interest in All Therapy designation Infant Protection to avoid healthcare inequalities EMA
Slide 40: First to deliver All Infant Protection
First to deliver All Infant Protection Recommended Efficacy Administration Cost effectiveness population Universal, targeting all ~75% observed relative One single injection for In line with other recent infants risk reduction of RSV- the entire first season premium priced vaccines • Pre- and full-t
Slide 41: Q&A session | Growing our current business
Q&A session| Growing our current business Thomas Triomphe Bill Averbeck Kimberly Tutwiler Head of Vaccines GBU Head of Influenza Head of RSV Franchise Franchise Thomas Grenier Jon Heinrichs Head of Franchises & Head of R&D RSV Product Strategy Franchise
Slide 42: Appendix
Appendix SANOFI
Slide 43: Immunogenicity alone is not fully predictive of efficacy: cross-trial comparison
Immunogenicity alone is not fully predictive of efficacy: cross-trial comparison Immunogenicity vs. Standard Dose(1) Efficacy against infection vs. Standard Dose(8) GMT H1N1 H3N2 Trial Vaccine Measu- Candidate Compara- Candidate Compara- Against ANY laboratory-confirmed strains Population rement tor
Slide 44: Recommending bodies demand Protection Beyond Flu
Recommending bodies demand Protection Beyond Flu GRADE is a systematic, transparent way “Evidence of relative efficacy / effectiveness and safety is to assess the quality and certainty of better for HD than for the 3 other enhanced vaccines.” clinical evidence STIKO • Based on following factors • In
Slide 45: Fluzone High Dose | Publications
Fluzone High Dose | Publications FIM12 • DiazGranados CA, et al. Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults. N Engl J Med. 2014;371(7):635-645 • DiazGranados CA, et al. Prevention of serious events in adults 65 years of age or older: A comparison between high-dose a
Slide 46: Flublok | Publications
Flublok | Publications PSC 12 • Dunkle LM, Izikson R, Patriarca P, et al; PSC12 Study Team. Efficacy of recombinant influenza vaccine in adults 50 years of age or older. N Engl J Med. 2017;376(25):2427-2436 PSC 4 • Treanor JJ, El Sahly H, King J, et al. Protective efficacy of a trivalent recombinant
Slide 47: CDC modeling estimated highest reduction of LRTIs with an all infant antibody strategy
CDC modeling estimated highest reduction of LRTIs with an all infant antibody strategy Hospitalizations prevented ED visits prevented Outpatient visits prevented Estimated annual MA-LRTIs Estimated annual MA-LRTIs Estimated annual MA-LRTIs 35,000 160,000 450,000 2x 3.5x 3.5x 0 0 0 Maternal Immunizat
Slide 48: Nirsevimab | Publications
Nirsevimab| Publications Phase IIb • Griffin M.P. et al. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med 2020; 383:415-425 Ph II/III • Mankad S.V. et al. Nirsevimab for the prevention of respiratory syncytial virus: safety in infants with congenital heart disease, MEDLE
Slide 49: PPH Primary series set to grow
PPH Primary series set to grow Sanofi standard of care Growth potential estimates Sanofi sales in €bn 2020 global birth cohort (m newborns) ~10% CAGR(1) ~135 2.1 ~5% Hexa acP 14 CAGR(1) Hexa acP(2) Penta acP 10 Switch potential to hexa acP 1.4 1.2 ~15-20m newborns' switch Penta acP potential to hexa