Sanofi Sa · EURONEXT:SAN
Sanofi Sa — Investor Day (December 2019)
111 slides from Sanofi Sa's investor day presentation, Dec 10, 2019
Slide 1: Capital Markets Day: Play to Win
Capital Markets Day Play to Win December 10, 2019
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 under
Slide 3: Additional information
Additional information The tender offer for the outstanding shares of Synthorx common stock (“Synthorx”) referenced in this communication has not yet commenced. This communication is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of
Slide 4: Agenda
Agenda Strategic outlook Paul Hudson Chief Executive Officer Margin expansion Jean-Baptiste de Chatillon EVP, Chief Financial Officer Lead with innovation John Reed EVP, Global Head of R&D Q&A Sanofi Executive Committee Breakout sessions 4
Slide 5: Strategic outlook
Strategic outlook Paul Hudson Chief Executive Officer 5
Slide 6: We hear you
We hear you Select analyst quotes, 2014-2019 Focus “Don’t even know where to look” Execution “Did you say execution issues?” Pipeline “The pipeline remains underwhelming” Growth “The long wait for growth” 6
Slide 7: We see opportunities
We see opportunities Untapped potential Predictable, long-term in core assets franchises in portfolio Promising science and prioritized bets World-class and with the potential to change patient’s lives engaged talent 7
Slide 8: Our six-year plan
Our six-year plan 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 8
Slide 9: Play to win
Play to win Focus Lead with Accelerate Reinvent how on growth innovation efficiency we work Portfolio prioritization Bring transformative Decisive actions to Empowerment and to strengthen profile therapies to patients expand margins accountability 9
Slide 10: Our key growth drivers
Our key growth drivers Dupixent® Vaccines Pipeline Maximize patient benefits Expected mid-to-high single- Prioritize and accelerate with ambition to achieve digit growth(1), through portfolio of potentially >€10 billion peak sales differentiated products, transformative therapies across type 2 infla
Slide 11: Dupixent targets a central pathway in T2 inflammation
Dupixent® targets a central pathway in T2 inflammation Type 1 inflammation Type 2 inflammation Primary immune cells Th1 ILC1 NK Th2 ILC2 Key cytokines IL-17 IFNγ IL-6 IL-4 IL-5 IL-12 IL-2 TNF IL-13 Example associated diseases Autoimmune diseases Type 2 inflammatory diseases • Rheumatoid Arthritis •
Slide 12: Dupixent has major growth potential in Atopic Dermatitis
Dupixent® has major growth potential in Atopic Dermatitis Ambition to become leading biologic Opportunity to increase uptake and expand with dermatologists to pediatric segments U.S. monthly NBRx at dermatologists(1) U.S. population by age group (patients in ‘000, approximate)(2) (3) 5,000 Approved
Slide 13: Dupixent driving market expansion in Asthma
Dupixent® driving market expansion in Asthma Best uptake among biologics Expanding biologics market, gaining share Cumulative NBRx in Asthma (monthly, all channels)(1) and seeking pediatric indication U.S. population by age group (patients in ‘000, approximate)(2) Adults/ 10,836 6-11Y(6) 12-17Y Dupi
Slide 14: Dupixent: Significant potential in adjacent indications
Dupixent®: Significant potential in adjacent indications Dermatology Respiratory Other Type 2 indications Expected U.S. U.S. biologics Expected U.S. U.S. biologics Expected U.S. U.S. biologics submission date eligible population submission date eligible population submission date eligible population
Slide 15: Vaccines: Strong growth driven by core franchises & RSV
Vaccines: Strong growth driven by 3 core franchises & RSV Expected Mid-to-high single-digit sales growth(1) • Launch first prophylaxis against RSV(2) RSV for all infants RSV • Global Hexaxim® expansion PPH & Boosters • Vaxelis® U.S. introduction €5.1bn • Boosters acceleration PPH & • Fluzone® HD QIV
Slide 16: Accelerate portfolio of potential transformative therapies
Accelerate portfolio of potential transformative therapies Ambition Planned submission(1) fitusiran 2021e Delivering on new patient dynamics - convenience & BIVV001(2) 2022e SERD (‘859) Master switch for endocrine signaling in HR+ breast cancer 2021e venglustat Leveraging LSD biology in multiple rar
Slide 17: Hemophilia: Patient experience drives choice
Hemophilia: Patient experience drives choice Target profiles vs. marketed products Market research Convenience (dose frequency) Illustrative patients switched to emicizumab Monthly ~75% due to convenience (less frequent q4w fitusiran(2) dosing, SC administration)(6) q2w emicizumab(1) BIVV001(3) emic
Slide 18: SERD ('859): Potential to improve treatment of HR+ BC
SERD ('859): Potential to improve the treatment of HR+ BC BC subtypes(1) Patients treated with HR+/HER2-BC (U.S., 2018)(2) 172k TNBC SERD ('859): ~15% potentially superior HER2+ ~15% endocrine backbone ~70% • Potent, broad estrogen 23k 17k 18k receptor degrader(5) HR+/HER2- • PoC achieved(4) Early B
Slide 19: Venglustat: Leveraging LSD biology in multiple rare diseases
Venglustat: Leveraging LSD biology in multiple rare diseases GCS inhibition to potentially treat 3 types of disease LSD Ciliopathies Synucleinopathies Gaucher GM2 Clinical program type 3 gangliosidoses Fabry ADPKD GBA-PD Parkinson's(1) Illustrative number of patients U.S. diagnosed patient populatio
Slide 20: Nirsevimab: Goal to be cost-effective RSV prophylaxis
Nirsevimab: Goal to be cost-effective RSV prophylaxis for all infants 98% of infants still at risk High disease burden U.S. RSV-related U.S. births(1) infant hospitalizations(2) ~4m ~20k • High medical care costs from RSV-related LRTI ($4.2bn(4)) • Congested ER / ICU during RSV seasons Full-term 83%
Slide 21: BTKi ('168): Potential first DMT to address MS drivers
BTKi ('168): Potential to be first DMT to address MS drivers in the brain Current paradigm BTKi (’168) Periphery & central Periphery CNS exposure confirmed in High unmet needs Blood Blood CNS phase 1 (BBB crossing) • Vast majority of MS patients still Microglia Adaptive & innate immunity accumulate
Slide 22: Synthorx acquisition aligned with R&D strategy
Synthorx acquisition(1) perfectly aligned with R&D strategy • Clinical stage biotechnology company Company overview • Founded in 2014, headquartered in San Diego, CA • Listed on NASDAQ under ticker symbol THOR since December 2018 • THOR-707 “not‐alpha” IL‐2 Synthorin for solid tumors in Phase 1/2 Le
Slide 23: Targeting 30% BOI margin by 2022
Targeting 30% BOI margin by 2022 Sanofi expected BOI margin evolution Expected margin drivers, >32% Peer 2019-2022 average(1) • Sales growth 30% • Improved mix 28% + • Smart spending • Resource reallocation 27% 26% • Operational excellence • Launch costs … - • Accelerate pipeline 2016 2017 2018 2022
Slide 24: Diabetes & cardiovascular cashflow to be maximized
Diabetes & cardiovascular cashflow to be maximized in mature markets Declining DCV sales(1) Immediate decisions(3) • Discontinue DCV research Diabetes and cardiovascular • Optimize commercial model €4.1bn, -14% • No launch of efpeglenatide(2) • Restructure Onduo JV • Praluent® resources right-sized
Slide 25: New Global Business Unit organization
New Global Business Unit organization to support strategy 3 core GBUs(3) with focus on prioritized portfolio Standalone(3) Specialty Care(1) General Medicines(1) Vaccines Consumer Healthcare Immunology Diabetes Influenza vaccines Allergy, Cough & Cold RD / RBD Cardiovascular PPH, Boosters Pain Neuro
Slide 26: Consumer healthcare – unlocking value
Consumer healthcare – unlocking value Mid-term objective Sanofi CHC value drivers ✔ Rx-to-OTC switch growth opportunities • Cialis® unique product profile in erectile dysfunction • Tamiflu® for influenza prevention and care in the U.S. Beat market ✔ CHC digital transformation growth(1) • Precision m
Slide 27: China: Repositioning for new period of growth
China: Repositioning for new period of growth Driving volume expansion in Major growth opportunity with Established Products & Diabetes Specialty and Vaccines • >60% volume growth in 2020 expected due to • Dupixent® expected launch in Q4 2020, offering VBP bidding wins of Plavix® and Co-Aprovel® the
Slide 28: Empowerment and accountability
Empowerment and accountability Culture of Global to local Fully empowered New ways accountability model GBUs of working Top ~200 leaders Empowering and End-to-end Allocate time to higher to be incentivized focusing people responsibility from R&D value activities, on TSR locally to commercialization
Slide 29: Driving innovation and growth with strategic choices
Driving innovation and growth with strategic choices Core drivers Growth enablers Maximize cash flow Standalone Therapeutic areas Immunology Established Products Diabetes(1) Consumer Healthcare Vaccines Key Emerging Markets Cardiovascular(1) RD / RBD Rheumatoid Arthritis Neurology Oncology Geographi
Slide 30: Sanofi's value proposition to society
Sanofi’s value proposition to society Sanofi is committed to innovation and access. We are helping patients and communities to achieve better health outcomes, through large-scale prevention and transformative medicines. 30
Slide 31: Margin expansion
Margin expansion Jean-Baptiste de Chatillon EVP, Chief Financial Officer 31
Slide 32: Strategic choices expected to drive margin expansion
Strategic choices expected to drive margin expansion • De-prioritize non-strategic areas • Implement smart spending • Increase footprint efficiency To fund top line Targeting Margin 30% BOI growth expansion margin by 2022 • Expand Dupixent® franchise • Achieve mid-to-high single-digit growth in Vacc
Slide 33: €2 billion savings expected by 2022
€2 billion savings expected by 2022 to fund growth and drive margin expansion Smart Operational Priorities spending excellence Limited spend on Reduce demand, right-size Improve manufacturing de-prioritized businesses specifications and negotiate efficiency and prices organizational productivity €0.
Slide 34: We are off to a good start in delivering efficiencies
We are off to a good start in delivering efficiencies Operating expense growth YoY at CER(1) 4.8% €600M 2019 expected savings(2) -0.7% Average 2014-2018 YTD Sept. 2019 (1) Operating expense (Opex): Research & Development (R&D) and Selling, General and Administration expenses (SG&A) 34 (2) Savings be
Slide 35: A change of mindset
A change of mindset Digitize Empower Deploy Right-size work space employees e-learning organization Support functions -18% Travel expenses(1) -36% Consulting fees(1) -15% Training costs(1) -8% headcount(3) Financial delegation >11K Zoom(2) meetings/day 2x increased 10x Digital training -6% Real esta
Slide 36: Smart spending: €1.0 Billion savings expected by 2022
Smart spending: €1.0 Billion savings expected by 2022 Spending Procurement savings Expected Ambition €1.0Bn(1) Demand management €14.6Bn Specifications spend in design 2018 €300M Price negotiations 2019 2022 (1) Savings expected by 2022 versus 2019 36
Slide 37: Operational excellence in Manufacturing
Operational excellence in Manufacturing CMC digitalization acceleration(1): aims at reducing lead time by 6 months and delivering 9 launches Factory of Shift to 2nd generation processes(2): 6 'lighthouse’ digital sites(3): decrease of plant the future cycle time by 20% Sanofi Top decile(4) performan
Slide 38: Streamline Established Products portfolio
Streamline Established Products portfolio Number of product families ~300 ~-65% • Driving simplicity and agility • Improving gross margin ratio ~100 Long tail • Greater commercial focus on top products • ~€1.5bn cash proceeds expected in 2019-2025 2018 2025e 38
Slide 39: Objective to increase Free Cash Flow by ~50% by 2022
Objective to increase Free Cash Flow(1) by ~50% by 2022(2) Free Cash Flow(1) evolution • Grow net sales €4.1bn(1) • Improve working capital • Prioritize investments • Expand margin 2018 2019e 2022e Illustrative (1) Free Cash Flow definition in Financial appendices (2) From 2018 base, at current exch
Slide 40: Capital allocation
Capital allocation Operating cash flow 1 Organic investment Vaccines 2 M&A / Business development General CHC Medicines Specialty Care 3 Growing dividend Optionality: Regeneron stake(1) and asset disposals 4 Anti-dilutive share buybacks (1) Post lock-up 40
Slide 41: Key messages
Key messages €2bn savings expected by 2022 to fund growth and drive margin expansion BOI margin expected to reach 30% by 2022 with ambition of >32% by 2025 Ambition to increase Free Cash Flow(1) by ~50% by 2022 Focused capital allocation and growing dividend BOI: Business Operating Income 41 (1) Fre
Slide 42: Lead with innovation
Lead with innovation John Reed EVP, Global Head of R&D 42
Slide 43: Next chapter for Sanofi R&D
Next chapter for Sanofi R&D Vision Strategy Long-term objectives(1) • An industry innovation leader • Allocate resources to • >80% first- or best-in-class bringing transformative priority therapeutic areas • ~70% biologics therapies to patients • Leverage multiple • ~70% internally driven(2) therape
Slide 44: Potential transformative therapies
Potential transformative therapies Ambition Planned initial submission(5) Dupixent®(1) Maximize patient benefit across type 2 inflammatory diseases Launched Fitusiran & Delivering on new patient dynamics – convenience 2021e/2022e BIVV001(2) SERD (‘859) Master switch for endocrine signaling in HR+ br
Slide 45: Priority assets fit with long-term R&D objectives
Priority assets fit with our long-term R&D objectives Potential first- Biologic Internally driven(1) or best-in-class Dupixent®(2) ✔ ✔ fitusiran ✔ ✔ BIVV001(3) ✔ ✔ ✔ SERD (‘859) ✔ ✔ venglustat ✔ ✔ nirsevimab(4) ✔ ✔ BTKi (‘168)(5) ✔ ✔ (1) This includes assets discovered internally or wholly owned thr
Slide 46: Dupixent: IL-4 & IL-13, central drivers of T2 inflammation
Dupixent®(1): IL-4 & IL-13, central drivers of T2 inflammation Th2 differentiation Barrier • Atopic Dermatitis Barrier dysfunction • Asthma • CRSwNP IL-4 IgE production • Bullous Pemphigoid Th2 cell Microbiome alterations • Prurigo Nodularis Inhibits Allergens, • Chronic Spontaneous Urticaria Parasi
Slide 47: Dupixent: Greater specificity enabling safe profile
Dupixent®(1): Greater specificity enabling safe profile IL-4 IL-13 IL-2, IL-7, IL-3, IL-5, EPO, TPO, IL-6, IL-11, IL-12 & IL-10 IL-19, IL-20, IFNα & IFNγ IL-9, IL-15 & GM-CSF G-CSF, GH, LIF & OSM IL-23 & IL-22 IFNβ & IL-21 & leptin JAK2 JAK2 JAK1 JAK3 JAK1 JAK3 JAK1 JAK2 JAK2 JAK1 JAK2 JAK1 JAK1 JAK
Slide 48: Dupixent: Safety supports pediatrics expansion
Dupixent®(1): Safety supports pediatrics expansion Robust safety(2) Expanding to pediatrics Target regulatory submission 9,300+ patients Studied across 23 clinical programs AD 6-11 years 2019e 6,500+ patients Breakthrough designation Treated >1year Clinical trials 76-week long-term safety data AD <6
Slide 49: Dupixent: Expanding into adjacent Type 2 indications
Dupixent®(1): Expanding into adjacent Type 2 indications Prurigo Chronic Spontaneous Bullous Nodularis Urticaria Pemphigoid Biologic eligible Biologic eligible Biologic eligible Dermatology 74k (U.S.)(2) 308k (U.S.)(3) 27k (U.S.)(4) Submission Submission Submission 2021e 2022e 2022e Before After Bef
Slide 50: Hemophilia: Patient experience drives choice
Hemophilia: Patient experience drives choice Target profiles vs. marketed products Different patients, different needs Convenience (dose frequency) Illustrative • Patients choosing SC monthly dosing (convenience) Monthly q4w fitusiran(4) • Fitusiran aiming for ABR<1 • Feasible with emicizumab only a
Slide 51: Fitusiran: Potential first high-efficacy monthly therapy
Fitusiran: Potential first high-efficacy monthly therapy emicizumab fitusiran Hemophilia A patients All Hemophilia patients Patients With & without inhibitors • Hemophilia A & B • With & without inhibitors q4w q2w q1w q4w q2w q1w Efficacy (ABR)1 0.60 0.97 n/a n/a 2.10 1.60 Safety Profile evolving: t
Slide 52: Fitusiran: >70% enrollment achieved in ATLAS Ph3
Fitusiran: >70% enrollment achieved in ATLAS Ph3 program • Adults & adolescents with hem A or B with inhibitors 9 months • On-demand bypassing agents • N ~50 • Adults & adolescents with hem A or B Endpoints without inhibitors 9 months • ABR (spontaneous/joint) • On-demand factor replacement • QoL •
Slide 53: BIVV001: Potential to allow more active lifestyle
BIVV001: Potential to allow more active lifestyle FVIII activity (%), logarithmic scale Only treatment to allow ~3.5 days … and >5 days of of near-normal coagulation… FVIII activity >20% Near-normal (>40% FVIII activity) 100 comparable to non- BIVV001(1) hemophilia sufferers 40 20 Mild 10 (5-40% FVI
Slide 54: BIVV001: Registration study initiated
BIVV001: Registration study initiated Phase 3 study in previously treated patients ⩾ 12 years (n=150) Prior FVIII regimen Arm A • Primary endpoint: ABR in Arm A(1) Prophylaxis Weekly prophylaxis • Novel endpoints include joint health via ultrasound (n=124) and physical activity monitoring Arm B • Do
Slide 55: SERD ('859): Aiming for new standard of care in HR+ BC
SERD ('859): Aiming for new standard of care in HR+ BC MoA: completely shutting down In vitro activity similar to fulvestrant(1) estrogen signaling but orally administered Preclinical data E2 (estradiol) MCF7 MDAMB134VI SUM44PE Control Fulvestrant shortfalls • Less effective in vivo due X Selective
Slide 56: SERD ('859): Early data supporting best-in-class ambition
SERD ('859): Early data supporting best-in-class ambition Full ER degradation(1) Lesion signals blocked(2) Promising Ph1 results(3) Before treatment After treatment FES-PET baseline Day 14 • Promising early efficacy • Favorable safety and tolerability • No related Grade 3 events • No bradycardia • N
Slide 57: SERD ('859): Potential to move quickly to early lines
SERD ('859): Potential to move quickly to early lines 2019 2020 2021 2022 2023 2024 2025 Target submission 3L / 2L mono H2 2021 1L combo CDK4/6i H1 2024 H2 2023 if accelerated submission 2L combo Pi3Ki H2 2024 H2 2023 if accelerated submission Early BC H2 2026 H1 2024 if accelerated submission Explo
Slide 58: Nirsevimab: Aiming for cost-effective RSV prophylaxis
Nirsevimab(1): Aiming for cost-effective RSV prophylaxis Strong risk reduction in healthy Flexible dosing to cover all infants pre-term infants 29-35 weeks during their first RSV season Phase 2b data (n=1,453)(2) • Single injection • Administration independent of gestational age • At birth for born-
Slide 59: Nirsevimab: Addressing shortfall of active immunization
Nirsevimab(1): Addressing shortfall of active immunization Passive ‘immunization’ with nirsevimab Antibody titer Active immunization approach(3) RSV hospitalizations(2) RSV hospitalizations Protective Ab titer in infants 0 1 2 3 4 5 6 7 8 9 10 11 12 Age (months) Passive ‘immunization’ is the only ap
Slide 60: Nirsevimab: Submission expected by 2023
Nirsevimab(1): Submission expected by 2023 MELODY MEDLEY Phase Phase 3 Phase 2/3 Endpoint Safety and efficacy Safety Target submission: Control Placebo palivizumab 2023e >35wk healthy infants High-risk infants Patients (n=3,000) (n=1,500) Study end(2) 2023e 2021e (1) In collaboration with AstraZenec
Slide 61: Venglustat: Leveraging LSD biology in multiple rare diseases
Venglustat: Leveraging LSD biology in multiple rare diseases and beyond Venglustat Associated diseases GCS LSDs Ciliopathies Synucleinopathies Gaucher disease type 3 ADPKD GBA-PD GlcCer (GL-1) GBA mutation, with deficiency in GL- Lysosomal GL-1 accumulation GCS activity driving high GL-1 1 breakdown
Slide 62: Venglustat: Mechanism already validated in LSDs
Venglustat: Mechanism already validated in LSDs Gaucher disease type 3 Fabry disease • Potential first-in-class neurologic GD-3 treatment • Potential best-in-class oral therapy option(2) • ~300 diagnosed patients in U.S., Europe & Japan • ~10,000 diagnosed patients in U.S., Europe & Japan Mean chang
Slide 63: Venglustat: Transformative potential in ADPKD
Venglustat: Transformative potential in ADPKD High unmet need Robust pre-clinical data in validated animal model(2) • ~340,000 patients in U.S., Europe Human PKD Mouse PKD Kidney volume (MRI, live animals) & Japan, ~37% rapidly progressing(1) Kidney GlcCer (AU x 107 ) Volume (mm3) • Significant tole
Slide 64: Venglustat: STAGED-PKD potential submission by 2022e
Venglustat: STAGED-PKD – potential submission by 2022e Q1 H1 H2 2019 2022e 2023e Ph.3 start Potential accelerated Full submission submission (U.S.) (all regions) Patients selection Placebo (n=80) Placebo (n=160) • Class 1C-E(1) Low dose (n=80) Dose(2) (n=160) • eGFR 45-90 ml/min • Age 18-50 High dos
Slide 65: Venglustat: Potential first DMT for genetic Parkinson's
Venglustat: Potential first DMT for genetically defined Parkinson’s disease subpopulation GSL accumulation in Synucleinopathies GSL-1 reduction in plasma and CSF Mean % change in CSF GL-1 at week 4 across doses(1) GCS inhibition GSL accumulation (lysosome dysfunction) 10 6.9 0 GBA mutations Neuronal
Slide 66: BTKi ('168): MS patients still accumulate disability
BTKi ('168)(1): MS patients still accumulate disability EDSS worsening over time(2) SPMS conversion over time(4) Average EDSS score Proportion converting 5.5 1.0 Two natural history cohorts 5.0 0.8 4.5 0.6 4.0 Treated cohort 0.4 3.5 3.0 0.2 0 0.0 5 10 10 20 30 40 50 60 Time since eligible for treatm
Slide 67: BTKi ('168): Best-in-class potential in DMT segment
BTKi ('168)(1): Best-in-class potential in DMT segment Phase 1 results(2) Competitive profile(3) Rapid and durable BTK occupancy % BTK occupancy ocrelizumab evobrutinib BTKi ('168) B1: 7.5mg 100 80 B2: 15mg CNS inflammation ✔ 60 B3: 30mg 40 B4: 60mg Efficacy 20 Microglia 0 (innate immunity) ✔ 0 1 2
Slide 68: BTKi ('168): Ready to launch trials across full MS spectrum
BTKi ('168)(1): Ready to launch trials across full MS spectrum • Relapsing multiple sclerosis (RMS) • Target submission: H1 2024e Q1 2020e • Primary progressive multiple sclerosis (PPMS) PoCC • Target submission: H1 2025e • Secondary progressive multiple sclerosis (SPMS) • Target submission: H1 2025
Slide 69: Expected next steps for potentially transformative assets
Expected next steps for potentially transformative assets Upcoming milestones Next steps Acceleration potential Earlier submission for inhibitor fitusiran – Hem A/B 1H-21 Pivotal results 2H-21 Submission population, potential priority review Dec '19 Phase 3 initiation 2H-21 Pivotal results BIVV001 –
Slide 70: Synthorx promising assets synergistic with Sanofi pipeline
Synthorx promising assets synergistic with Sanofi pipeline Lead asset THOR-707, ✓ ✓ IL-2 potential foundation of IO-IO very promising IL-2 combinations (i.e. PD-1, CD-38) First-ever Expanded Platform of Synthorins in Genetic Alphabet Advancing preclinical IL-15 ✓ platform ✓ oncology and immunology a
Slide 71: Dual Strategy for THOR-707: Exploit T and NK cell
Dual Strategy for THOR-707: Exploit T and NK cell PD1 T Cell NK Cell Engagers CEMIPLIMAB(1) Engagers (more T cell NK cell (less toxic) validated) IL-2 (non-a) MHC I + MHC I - THOR-707 ISATUXIMAB (ADCC) Cancer cell Myeloma (solid tumors) cell MHC: Major Histocompatibility Complex; ADCC: Antibody-Depe
Slide 72: Recent accomplishments from our late-stage pipeline
Recent accomplishments from our late-stage pipeline Ambition Differentiated CD-38 in relapsed Sarclisa® refractory multiple myeloma Pending FDA decision First-in-class treatment for CAD Presented positive Ph3 results in Sutimlimab New SOC for refractory ITP CAD and PoCC in ITP at ASH 2019 Pivotal to
Slide 73: Sutimlimab pivotal data presented at ASH
Sutimlimab pivotal data presented at ASH Serious autoimmune hemolytic anemia Rapid, sustained hemolysis resolution and QoL benefit (n=22)(2) • Diagnosed patients: ~10,000 in U.S., EU5, JP(1) Marker of hemolysis Marker of QoL Mean Hb Mean bilirubin Mean FACIT-Fatigue • Chronic hemolytic anemia, indep
Slide 74: Key messages
Key messages Continuing transformation of Sanofi R&D Resources allocated to priority areas Focus on transformative therapies (T2 biology and priority assets) Execute to secure accelerated time to market 74
Slide 75: Capital Markets Day: Financial appendices
Capital Markets Day Financial appendices December 10, 2019
Slide 76: Definitions
Definitions Free Cash Flow Free Cash Flow is a non-GAAP financial performance indicator which is reviewed by our management, and which we believe provides useful information to measure the net cash generated from the Company’s operations that is available for strategic investments 1 (net of divestme
Slide 77: Accounting of Antibody License and Collaboration Agreement with Regeneron
Sanofi accounting of Antibody License and Collaboration Agreement with Regeneron(1) U.S. Ex-U.S. Net sales Sanofi consolidates worldwide net sales Cost of sales Sanofi consolidates worldwide cost of sales Development costs funded upfront by Sanofi until first positive Phase 3; subsequent costs funde
Slide 78: Libtayo accounting pursuant to immuno-oncology global collaboration
Sanofi Libtayo® accounting pursuant to immuno-oncology global collaboration(1,2) U.S. Ex-U.S. Net sales Consolidated by Regeneron Consolidated by Sanofi Cost of sales Consolidated by Regeneron Consolidated by Sanofi R&D expenses Sanofi reimburses 50% of development expenses incurred during quarter(3
Slide 79: Sanofi's ownership of Regeneron
Sanofi’s ownership of Regeneron Ownership of • As of December 31, 2018 Sanofi owned 21.7% of Regeneron pursuant to the investor Regeneron agreement signed in 2007 and amended in January 2014 Accounting of • Sanofi’s share of Regeneron’s profit / losses are presented on the Income Statement within Ow
Slide 80: Synthorx acquisition bringing significant value creation potential
Synthorx acquisition(1) bringing significant value creation potential Acquisition • Synthorx shareholders to receive $68 per share in cash Price • Values Synthorx at approximately $2.5 billion on a fully diluted basis • Expected to be slightly dilutive to Business EPS in 2020 and 2021(2) Financials
Slide 81: Capital Markets Day: R&D appendices
Capital Markets Day R&D appendices December 10, 2019
Slide 82: Dupixent: Development plan for adjacent indications
Dupixent®(1): Development plan for adjacent indications Indication Unmet need Study start # patients Outcome measures Expected read-out Improvement in worst Prurigo Nodularis No approved therapy Dec-19 150 + 150(2) Mid-2021 itch NRS Dermatology Chronic Spontaneous Additional treatment Dec-19 80 + 1
Slide 83: Expected upcoming milestones
Expected upcoming milestones Priority assets Other H1 H2 2020 2020 2021 2022 BTKi ('168)(1) Dupixent®(2) venglustat Dupixent®(2) PoCC in RMS | Q1 AD adult China approval | Q3 PoCC in GBA-PD | Q1 Pivotal results in AD 6m-5yo| H1 venglustat SERD (‘859) fitusiran Libtayo®(2) PoCC in GD 3 | Q1 PoCC in m
Slide 84: Oncology pipeline potential to drive growth
Oncology pipeline potential to drive growth Skin Multiple Myeloma/ Breast, Ovarian or Cervical Lung Leukemia Clinical 2019 • Cemiplimab (ph3) • Isatuximab (ph3) • Cemiplimab (ph3) • Cemiplimab (ph3) • Cytokine mRNA (ph1) • BCMA-CD3 (ph1) • SERD (ph1) • CEACAM5-DM4 (ph1/2) • TGFβ (ph1) • CD123-CD3 (p
Slide 85: Sarclisa: Large opportunity for differentiated 2nd in class
Sarclisa®: Large opportunity for differentiated 2nd in class Limited penetration in early lines <20% of U.S. patients in 1-2L exposed to Darzalex® or Pd Penetration by line (U.S.)(1) Patients in 1-2L, k (U.S.)(1) 42.3 -5.1 Darzalex® Pd 12% -2.2 5% 35.0 1L 5% 2% 100% 2L 23% 11% 83% 3L 28% 30% MM pati
Slide 86: Sarclisa: Expanding from late lines to early lines
Sarclisa®: Expanding from late lines to early lines U.S. & EU5(1) Number of patients (k) x average ~850 ~2,700 months of treatment by line ~900 ~$11bn market today ~750 ~150 ~50 4L 3L 2L 1L Ti 1L Te Total Current 1.3 3.4 6.0 2.6 1.4 14.7 market, $bn Studies ICARIA IKEMA IMROZ GMMG EMN Sarclisa® is u
Slide 87: Venglustat: >240 patients enrolled in MOVES-PD
Venglustat: >240 patients enrolled in MOVES-PD Q1 H1 H2 H2 2017 2021e 2021e 2025e Ph2 launch Ph2 PoCC Ph3 start Full submission Phase 2: MOVES-PD >240 patients with early- MOVES-PD (ACT14820) MOVES-PD extension stage PD and GBA mutation (vs. placebo) Phase 3 Phase 3 extension ~20% of idiopathic PD p
Slide 88: Sutimlimab: Potentially new SOC for refractory ITP
Sutimlimab: Potentially new SOC for refractory ITP patients Significant unmet need for stable or Rapid and sustained platelet count increased platelet counts increase in Phase 1(2) U.S., EU5, Japan patients(1) Mean platelet count (x 109/L) Diagnosed adult ITP 250 ~142K First Dose Washout Patients 20
Slide 89: Olipudase alfa: Potential first and only therapy for ASMD
Olipudase alfa: Potential first and only therapy for ASMD High unmet medical need Pivotal top line results Jan 2020 Ultra-rare progressive genetic disorder Promising phase 1 results(2) • Results from a deficient activity of the enzyme acid sphingomyelinase, which is found in lysosomes and is +24% -1
Slide 90: Avalglucosidase alfa: Investigational ERT for Pompe Disease
Avalglucosidase alfa: Investigational ERT for Pompe Disease Progressive, often fatal myopathy Promising pre-clinical(3) & PoC data(4) Pompe disease: rare, inherited and often fatal • rhGAA conjugated with bisM6p residues lysosomal storage and neuromuscular disorder • Engineered to increase cellular
Slide 91: Capital Markets Day: Vaccines
Capital Markets Day Vaccines December 10, 2019
Slide 92: Our key growth drivers
Our key growth drivers Dupixent® Vaccines Pipeline Maximize patient benefits Expected mid-to-high single- Prioritize and accelerate with ambition to achieve digit growth(1), through portfolio of potentially >€10 billion peak sales differentiated products, transformative therapies across type 2 infla
Slide 93: Vaccines: Strong growth driven by core franchises & RSV
Vaccines: Strong growth driven by 3 core franchises & RSV Expected Mid-to-high single-digit sales growth(1) • Launch first prophylaxis against RSV(2) RSV for all infants RSV • Global Hexaxim® expansion PPH & Boosters • Vaxelis® U.S. introduction €5.1bn • Boosters acceleration PPH & • Fluzone® HD QIV
Slide 94: PPH / Boosters: Worldwide pediatric combinations leader
PPH / Boosters: Worldwide pediatric combinations leader Large potential in both primary & booster vaccination Boosters increased penetration Geographic expansion Vaxelis® Hexavalent launch in U.S. market leader 2021e PPH: Polio Pertussis Hib combination vaccines 94 Primary vaccination market estimat
Slide 95: Influenza: Growth driven by differentiated vaccines
Influenza: Growth driven by differentiated vaccines Age groups Historical vaccines Driving upgrading with new launches Only vaccine with proven superior 65+ yo HD TIV HD QIV efficacy above 65+ yo(1) 1st recombinant providing 50-64 yo SD TIV / SD QIV Flublok® QIV better protection than standard dose
Slide 96: Fluzone High-Dose: Superior efficacy in landmark trial
Fluzone® High-Dose: Superior efficacy in landmark trial Pivotal efficacy trial results, age 65+ Fluzone® Fluzone® Superior Relative Efficacy: %95 CI Vaccine High-Dose (standard dose) Vaccine Primary Endpoint(1) Secondary Endpoint(2) associated with protocol- associated with modified CDC- Subjects Su
Slide 97: Fluzone High-Dose reduces cardio-respiratory hospitalizations
Fluzone® High-Dose reduces cardio-respiratory hospitalizations Relative vaccine effectiveness(1) of Fluzone® High-Dose vs standard dose vaccine: Cardio-respiratory hospitalizations 30 25 20 19% 19% 17% 17% 18% 18% 15 10 5 0 2010-2011 2011-2012 2012-2013 2013-2014 2014-2015 Longitudinal 5 season anal
Slide 98: Flublok: 1st recombinant flu vaccine with better efficacy in 50+
Flublok®: 1st recombinant flu vaccine showing better efficacy in adults 50+ Pivotal efficacy trial results, age 50+ Fluarix® Relative Efficacy: %95 CI Flublok® Vaccine Vaccine (standard dose) Primary Endpoint Secondary Endpoint Subjects Subjects PCR confirmed + protocol- Culture confirmed + protocol
Slide 99: Innovative prospective real world data generation
Innovative prospective real world data generation Sanofi Pasteur is pursuing leading-edge, innovative real world data to reinforce value of our differentiated flu vaccines & support clinical decision making Randomized trial in Comparative clinical study: Finnish National Registry Kaiser Permanente 6
Slide 100: Meningitis: Strong MenQuadfi results
Meningitis(1): Strong MenQuadfi™ results MenQuadfi™: Better MET50: Adolescents achieving immunogenicity profile(2) seroprotection hSBA titers ≥1:8 at D30(4) Pivotal trial results • Pivotal trials completed for first submissions in the U.S., EU and international regions • All primary objectives met S
Slide 101: Meningitis: Expanding in new age groups & geographies
Meningitis(1) : Expanding in new age groups & geographies Current Menactra® (9 months – 55 years in U.S. and international) MenQuadfiTM (6 weeks+ in U.S., EU and international) • Broader age indications from infants(2) to elderly Future • Geographic expansion, both in mature & emerging markets • Uni
Slide 102: Accelerating innovation in Vaccines
Accelerating innovation in Vaccines Investing in Novel Vaccines New technology platforms • RSV mAbs & vaccines • mRNA technology partnership • PCV • Adjuvants portfolio • MenB & MenPenta • Recombinant & cell-culture flu platform • 15 new targets, including Next-Gen Flu RSV: Respiratory Syncytial Vir
Slide 103: Nirsevimab: Goal to be cost-effective RSV prophylaxis
Nirsevimab: Goal to be cost-effective RSV prophylaxis for all infants 98% of infants currently not eligible High disease burden U.S. RSV-related infant hospitalizations U.S. births; ~4m ~20k • High medical care costs from RSV-related LRTI ($4.2bn(2)) • Congested ER / ICU during RSV seasons Full-term
Slide 104: Nirsevimab: Aiming for cost-effective RSV prophylaxis
Nirsevimab(1): Aiming for cost-effective RSV prophylaxis Strong risk reduction in healthy Flexible dosing to cover all infants pre-term infants 29-35 weeks during their first RSV season Phase 2b data (n=1,453)(2) • Single injection • Administration independent of gestational age • At birth for born-
Slide 105: Nirsevimab: Addressing shortfall of active immunization
Nirsevimab(1): Addressing shortfall of active immunization Passive ‘immunization’ with nirsevimab Antibody titer Active immunization approach(3) RSV hospitalizations(2) RSV hospitalizations Protective Ab titer in infants 0 1 2 3 4 5 6 7 8 9 10 11 12 Age (months) Passive ‘immunization’ is the only ap
Slide 106: Nirsevimab: Submission expected by 2023
Nirsevimab(1): Submission expected by 2023 MELODY MEDLEY Phase Phase 3 Phase 2/3 Endpoint Safety and efficacy Safety Target submission: Control Placebo palivizumab 2023e >35wk healthy infants High-risk infants Patients (n=3,000) (n=1,500) Study end(2) 2023e 2021e (1) In collaboration with AstraZenec
Slide 107: Capital Markets Day: General Medicines and CHC
Capital Markets Day General Medicines and CHC December 10, 2019
Slide 108: China: Building our Specialty franchises
China: Building our Specialty franchises Our portfolio today 25+ launches by 2025 & beyond EP & Cardio CKD Diabetes I&I Oncology RD / RBD MS BTKi MM Specialty Sarclisa® Care SERD BIVV001 Fitusiran Vaccines RSV mAb Expected launches EP: Established Products; I&I: Inflammation & Immunology; RD: Rare D
Slide 109: Game-changing first-in-category switch opportunities
Game-changing first-in-category switch opportunities Disruptive growth tapping into new CHC • Rx-to-OTC switches are an engine of growth in large U.S. market categories • Sanofi has proven global switch expertise (Allegra®, Nasacort®, Xyzal®) • Evolving regulatory environment favorable, discussions
Slide 110: Capital Markets Day: Play to Win
Capital Markets Day Play to Win December 10, 2019 Illustration of an Interleukin 4 (pink) binding to its receptor (dark and light blue). Getty Images – Juan Gaertner
Slide 111: For further information please contact
For further information please contact: Investor Relations Paris Tel: +33 1 53 77 45 45 Bridgewater Tel: +1 908 981 5560 Email: IR@sanofi.com Media Relations Tel: +33 1 53 77 46 46 Email: MR@sanofi.com www.sanofi.com 54, rue de la Boétie – 75008 Paris - FRANCE