Play to Win
JP Morgan Healthcare Conference
January 12, 2021
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Forward looking statementsThis 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 underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
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Agenda
‘Play to Win’ update Paul Hudson Chief Executive Officer
Driving digital strategy Arnaud Robert Chief Digital Officer
Q&A session
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Acquisition(1) of Kymab a perfect fit to Sanofi’s I&I portfolio
(1) Subject to regulatory approval and other customary closing conditions
Antigen presenting
cell
Lymphoid cell
Oth
er s
igna
ls
OX40L
OX40
TeffTmem
B cells
Treg
Anti-inflammatory
KY1005
Pro-inflammatory
Pro-inflammatory
Kymab pipeline adds oncology asset KY1044, an ICOS agonist in Phase 1/2
Lead asset KY1005 targets OX40L, a key regulator of the
immune system
Potential first-in-classtreatment for range of
immune-mediated diseases
Opportunity to enhance efficacyover available therapies in
suboptimal responders
Promising Phase 2a results in atopic dermatitis with KY1005
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Sanofi transformation: 2020 progress in figures
MS: Multiple Sclerosis; I&I: Inflammation & Immunology; HAs: healthcare authorities; BOI: business operating income; Dupixent® is in collaboration with Regeneron(1) Dupixent (COPD, Chronic Inducible Urticaria-Cold, Chronic Sinusitis w/o NP, Allergic Fungal Rhinsosinusitis), itepekimab (COPD – 2x), tolebrutinib (RRMS -2x, SPMS, PPMS),
rilzabrutinib (ITP), amcenestrant (1L BC),(2) In adolescents and adults
Growth
Pipeline
Efficiency
• Dupixent® sales annualizing at >€3.5bn• Differentiated flu vaccines growing 67% in Q3• >60% volume growth in China VBP products
• 12 Phase 3 studies initiated(1) in core areas of I&I and oncology• 7 upcoming pivotal read-outs on track • Fitusiran protocol updated; 3 clinical trials(2) to resume dosing
• 9.6%: BOI 9M growth at CER
• ~€1bn of savings achieved in H1• 2022: planned IPO for API company spin-off
Culture • Top 200 leaders: Culture of accountability fully embraced• 2021: Digital changing from a cost center to a business partner
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Dupixent®: $1bn sales in Q3 2020
AD: moderate to severe atopic dermatitis; EoE eosinophil esophagitis(1) IQVIA Patient insights; Sep 18, 2020(2) For the treatment of moderate to severe atopic dermatitis in children ages 6-11 whose
disease is not adequately controlled
(3) BrandImpact; Aug 2020(4) Spherix Global Insights, Wave 10, Dermatology; Sep 23, 2020(5) Represents Q3 2019 to Q3 2020
• >200K patients on Dupixent® worldwide
• Expect strong continued momentum fueled byglobal rollout across indications
• Q3: In the US, NBRx nearing pre-COVID levels(1)
• Strong uptake for AD in ages 6-11 years in the U.S.(2)
• In-office patient visits with dermatologists and allergists at ~80%(3,4) pre-COVID levels
Global Dupixent® quarterly sales (€m)
455545 613
697 725
115
134163
161193
679570
Q1
918
Q3
858776
Q2Q4 Q3
2019 2020
U.S.(+68%)(5)
Ex-U.S.(+72%)(5)
On track to achieve >€10bn peak sales ambition
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Eight new Type 2 inflammatory indications for Dupixent®
being pursued
National Reimbursement Drug List.
Source: epidemiology data primarily from Sanofi Real World Evidence platformCOPD: chronic obstructive pulmonary disease; NP: nasal polyposis; NRDL:
(1) Investigational program not yet reviewed by any regulatory authority(2) Not included in >€10 billion ambition due to heterogeneity of disease(3) Accessible population definition combines reimbursed, affordability and changes in
clinical practice. Estimates are primarily derived from Sanofi Real World Evidence platform
Dermatology Respiratory Other Type 2 indications
EosinophilicEsophagitis(1)2022e 48k
U.S. biologics eligible population
Expected U.S. submission date
U.S. biologics eligible population
U.S. biologics eligible population
Prurigo Nodularis(1)
Chronic Spontaneous Urticaria(1)
Chronic Inducible Urticaria-Cold(1)
2021e
2022e
2022e
74k
308k
25k
Expected U.S. submission date
Bullous Pemphigoid(1)2023e+ 27k
Type 2COPD(1, 2)
Chronic Sinusitis without NP(1)
2023e+
2023e+
300k
130k
Expected U.S. submission date
Allergic Fungal Rhinosinusitis(1)2023e+ 11k China
150k
NRDL accessible population(3)
AD in >18 yoMarch 2021
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Vaccines: mid-to-high single-digit growth(1) objective driven by three core franchises & RSV
Growth rates at CER; EC: European Commission; PPH: Polio, Pertussis, Hib vaccines; VCR: vaccination coverage rate; RSV: respiratory syncytial virus(1) Sales CAGR from 2018 base to 2025 (2) Known as EflueldaTM in some western European markets (3) Known as Flublok® in the U.S.
7.1%
41.2%
8.8%
11.1%PPH
31.8%
Travel and others
Influenza
Adult Boosters
Meningitis
9M 2020 sales in % of total sales
€735m
€1,065m+53%
Q3 2019 Q3 2020
€615m+67%
€440m+37%
Differentiatedflu
RegularQIV flu
€3.9bn (+5.9%)
On track for a record flu season in 2020 PPH & Adult Boosters
• Hexaxim® and Vaxelis®
• Booster acceleration
Nirsevimab (RSV)• Potential 1st prophylaxis for all infants
Influenza• Fluzone® HD QIV(2) global launch • Supemtek®(3) launch in Europe• Pipeline
Meningitis• Men ACWY expansion• MenQuadfi® launch in Europe
Growth drivers
Sanofi Pasteur’s comprehensive set of technologies to deliver new vaccine solutions
VaccineDNA/mRNA
VaccineInactivated
(killed)
VaccineLive
Attenuated
VaccineVirus-likeParticles
VaccineGlyco-
conjugate
VaccineViral/Bacterial
vector
VaccineMonoclonalAntibodies
VaccineSubunit
• Proof of concept of the mRNA platform established• Provides opportunities for future target application• Promising in terms of ease of manufacture, adaptability to various
targets and biological delivery
• Sanofi is well positioned with TranslateBio partnership• 2 new mRNA clinical programs to start in 2021• Thermostable formulation development ongoing
• Complex vaccines expected to require non-mRNA platforms or a combination• Whole virus, polysaccharide, multivalent proteins
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Oncology: anchor assets across four core disease areas with emerging early-stage pipeline
(1) Launched in advanced cutaneous squamous-cell carcinoma (2) In collaboration with Regeneron
(3) In collaboration with Revolution Medicine(4) In collaboration with BioNTech
Marketed Late-stage
Multiple Myeloma& other blood cancers • Sarclisa® • TGFb
• CD123-CD3
• SHP2i(3)
• THOR-707
• Cytokine mRNA(4)
• CD38-CD28-CD3
• CD38 ADCC
Skin cancer • Libtayo®
Lung cancer • Libtayo®
• CEACAM-5
Breast cancer& other hormone positive cancers
• Amcenestrant
(1,2)
Small molecules
Monoclonal antibodies
Bi-specific antibodies
Tri-specific antibodies
Nanobodies
Antibody Drug Conjugates
Synthorins
Assets in Phase 1/2
Anchor Assets
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Tolebrutinib: brain-penetrant BTKi with best-in-disease potential across the full MS spectrum
BTKi: Bruton Kinase Inhibitor; MS: multiple sclerosis NR: non-relapsing DMT: disease modifying therapy; Tolebrutinib is an asset under investigation, not approved by regulators.(1)KMR Group and Centre for Medicines Research (CMR) International 2013-2018 benchmarking data for neurology indications; (2) Tolebrutinib: estimate cycle times; (3) Brown J et al. JAMA. 2019;321(2):175-187; (4) Ocrevus Summary of Product Characteristics
Phase 1 and 2 performed 1 year faster than benchmarks
Tolebrutinib: 2.9 yearsBenchmark: 3.9 - 5.9 years(1)
Tolebrutinib: Expected 3.5 years(2)
Benchmark: 3.9 - 5.2 years(1)
Phase 2 results to
Phase 3 first patient
Four MS Phase 3 trials open and recruiting
Beating industry cycle times to address key unmet needs in MS
4 months
N = 900 + 900
Disability accumulates
despite treatment(3)
Relapsing
N = 990
Only one DMT, not approved for all
patients(4)
Primary Progressive
N = 1290
No approved DMTs for NR-SPMS
NR-Secondary Progressive
First expected submission H1 2024e H1 2025e H1 2025e
Estimated enrollment
Current unmet need
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Sanofi's digital priorities support Play to Win and will allow us to reinvest in science through efficiencies and growth
Focus on growth Lead with innovation Accelerate efficiency Reinvent how we work
Scale e-commerce
Digital HCP engagement Optimize + accelerate R&D using data
Patient experiences
Digital manufacturing
Operational excellence
Employee experiences
Data democratization
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Digital's new ways of working are purposeful and will accelerate the company's cultural change
New digital cultureto address our challenges
and propel us forward
Agile
Digital as abusiness partner
Build thefoundation
Focus onstrategic initiatives
Insourcingcapabilities
Operationalexcellence
CHC R&D
Our digital journey has started, with big ambitions for the next 2 years
New leadership team
I.A.
2020 achievements
Prioritized projects
Decreased external spend
Digital product launches
2021-2022 focus
Specialty Care General MedicineIncrease patient engagement and digital marketing
Better profitabilityvia new digital
engagement model
Plant digitization & data-driven inventory
management
Increase sales & improve ROI using
digital & data
Accelerate R&D through data & digital
experiences
VaccineScale e-commerce
and digitize I.A.
Illustrative data
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Play to Win: Our six-year plan – ahead of schedule
• Refocus with decisive actions• Growth through winning assets• Margin expansion
• Transformative launches• Agile and efficient resource deployment• Leading R&D productivity
2020-2022 2023-2025+
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Q&A session
Paul HudsonChief Executive Officer
John ReedR&D
Bill SiboldSpecialty Care
Jean-Baptiste de ChatillonChief Financial Officer
Arnaud RobertDigital
Thomas TriompheVaccines
Dietmar BergerDevelopment Head, CMO