JP Morgan Healthcare Conference - Sanofi

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Play to Win JP Morgan Healthcare Conference January 12, 2021

Transcript of JP Morgan Healthcare Conference - Sanofi

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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

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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

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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

Powered by aily.labs

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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