JP Morgan Healthcare Conference - Play to Win January 12, 2021
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JP Morgan
Healthcare Conference
Play to Win
January 12, 2021
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
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.
2
Agenda
‘Play to Win’ update Paul Hudson Chief Executive Officer
Driving digital strategy Arnaud Robert Chief Digital Officer
Q&A session
3
Acquisition(1) of Kymab a perfect fit to Sanofi’s I&I portfolio
Lead asset KY1005 targets Antigen
Promising Phase 2a results in
OX40L, a key regulator of the presenting atopic dermatitis with KY1005
cell
immune system
Other signals
OX40L
OX40 KY1005
Lymphoid
cell
Potential first-in-class Opportunity to enhance efficacy
treatment for range of Teff B over available therapies in
immune-mediated diseases Tmem cells suboptimal responders
Pro- Pro-
Treg
inflammatory inflammatory
Anti-inflammatory
Kymab pipeline adds oncology asset KY1044,
an ICOS agonist in Phase 1/2
(1) Subject to regulatory approval and other customary closing conditions 4
Sanofi transformation: 2020 progress in figures
• Dupixent® sales annualizing at >€3.5bn
Growth • 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
Pipeline • 7 upcoming pivotal read-outs on track
• Fitusiran protocol updated; 3 clinical trials(2) to resume dosing
• 9.6%: BOI 9M growth at CER
Efficiency • ~€1bn of savings achieved in H1
• 2022: planned IPO for API company spin-off
• Top 200 leaders: Culture of accountability fully embraced
Culture
• 2021: Digital changing from a cost center to a business partner
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),
5
(2) In adolescents and adults
Dupixent®: $1bn sales in Q3 2020
Global Dupixent® quarterly sales (€m)
• >200K patients on Dupixent® worldwide
918
858
• Expect strong continued momentum fueled by Ex-U.S.
776 193
global rollout across indications 679
161 (+72%)(5)
163
570 134
• Q3: In the US, NBRx nearing pre-COVID levels(1)
115
• Strong uptake for AD in ages 6-11 years in the U.S.(2) U.S.
697 725
• In-office patient visits with dermatologists and allergists 613 (+68%)(5)
545
455
at ~80%(3,4) pre-COVID levels
Q3 Q4 Q1 Q2 Q3
2019 2020
On track to achieve >€10bn peak sales ambition
AD: moderate to severe atopic dermatitis; EoE eosinophil esophagitis (3) BrandImpact; Aug 2020
(1) IQVIA Patient insights; Sep 18, 2020 (4) Spherix Global Insights, Wave 10, Dermatology; Sep 23, 2020
(2) For the treatment of moderate to severe atopic dermatitis in children ages 6-11 whose (5) Represents Q3 2019 to Q3 2020
6
disease is not adequately controlled
Eight new Type 2 inflammatory indications for Dupixent®
being pursued
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
Eosinophilic
Prurigo Type 2 2022e 48k
2021e 74k 2023e+ 300k Esophagitis(1)
Nodularis(1) COPD(1, 2)
Chronic Chronic
2022e Spontaneous 308k 2023e+ Sinusitis 130k
Urticaria(1) without NP(1)
Chronic
2022e Inducible 25k 2023e+
Allergic Fungal
11k China
Rhinosinusitis(1)
Urticaria-Cold(1) NRDL accessible
population(3)
Bullous
2023e+ 27k March
Pemphigoid(1) AD in >18 yo 150k
2021
Source: epidemiology data primarily from Sanofi Real World Evidence platform (1) Investigational program not yet reviewed by any regulatory authority
COPD: chronic obstructive pulmonary disease; NP: nasal polyposis; NRDL: National (2) Not included in >€10 billion ambition due to heterogeneity of disease
Reimbursement Drug List. (3) Accessible population definition combines reimbursed, affordability and changes in
clinical practice. Estimates are primarily derived from Sanofi Real World Evidence
7
platform
Vaccines: mid-to-high single-digit growth(1) objective
driven by three core franchises & RSV
9M 2020 sales in % On track for a record Growth drivers
of total sales flu season in 2020
PPH & Adult Boosters
• Hexaxim® and Vaxelis®
• Booster acceleration
Travel and others €1,065m Influenza
Adult Boosters +53%
7.1% • Fluzone® HD QIV(2) global launch
8.8% • Supemtek®(3) launch in Europe
Meningitis PPH €615m • Pipeline
11.1% €3.9bn
41.2% €735m +67% Differentiated
flu
(+5.9%) Meningitis
• Men ACWY expansion
• MenQuadfi® launch in Europe
Influenza 31.8% €440m Regular
+37% QIV flu Nirsevimab (RSV)
• Potential 1st prophylaxis for all infants
Q3 2019 Q3 2020
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.
8Sanofi Pasteur’s comprehensive set of technologies to
deliver new vaccine solutions
• Proof of concept of the mRNA platform established
• Provides opportunities for future target application Vaccine Vaccine Vaccine
• Promising in terms of ease of manufacture, adaptability to various DNA/mRNA Monoclonal Subunit
Antibodies
targets and biological delivery
• Sanofi is well positioned with TranslateBio partnership
Vaccine Vaccine
• 2 new mRNA clinical programs to start in 2021 Inactivated Live
(killed) Attenuated
• Thermostable formulation development ongoing
• Complex vaccines expected to require non-mRNA platforms
or a combination Vaccine Vaccine Vaccine
Virus-like Glyco- Viral/Bacterial
• Whole virus, polysaccharide, multivalent proteins Particles conjugate vector
9Oncology: anchor assets across four core disease areas
with emerging early-stage pipeline
Anchor Assets
Assets in
Marketed Late-stage
Phase 1/2
Small molecules
Multiple Myeloma • TGFb
• Sarclisa®
& other blood cancers Monoclonal
antibodies
• CD123-CD3
(1,2)
Skin cancer • Libtayo® • SHP2i(3) Bi-specific
antibodies
• THOR-707
Tri-specific
• Libtayo® antibodies
Lung cancer • Cytokine mRNA(4)
• CEACAM-5 Nanobodies
• CD38-CD28-CD3
Breast cancer
& other hormone • Amcenestrant • CD38 ADCC
positive cancers Antibody Drug
Conjugates
Synthorins
(1) Launched in advanced cutaneous squamous-cell carcinoma (3) In collaboration with Revolution Medicine
10
(2) In collaboration with Regeneron (4) In collaboration with BioNTechTolebrutinib: brain-penetrant BTKi with best-in-disease
potential across the full MS spectrum
Phase 2
Phase 1 and 2 performed results to
1 year faster than benchmarks Phase 3 first Four MS Phase 3 trials open and recruiting
patient
Tolebrutinib: 2.9 years 4 months Tolebrutinib: Expected 3.5 years(2)
Benchmark: 3.9 - 5.9 years(1) Benchmark: 3.9 - 5.2 years(1)
Primary NR-Secondary
Relapsing
Progressive Progressive
Disability
Only one DMT, not No approved
Current accumulates
unmet need approved for all DMTs for
despite
patients(4) NR-SPMS
treatment(3)
Estimated N = 900 + 900 N = 990 N = 1290
enrollment
First expected
submission H1 2024e H1 2025e H1 2025e
Beating industry cycle times to address key unmet needs in MS
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. 11
JAMA. 2019;321(2):175-187; (4) Ocrevus Summary of Product CharacteristicsSanofi'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
Optimize + accelerate
Digital HCP engagement Digital manufacturing Employee experiences
R&D using data
Scale e-commerce Patient experiences Operational excellence Data democratization
12Digital's new ways of working are purposeful and will
accelerate the company's cultural change
Digital as a Focus on
business partner strategic initiatives
Operational New digital culture Build the
excellence to address our challenges foundation
and propel us forward
Insourcing Agile
capabilities
13Our digital journey has started, with big ambitions for the
next 2 years
2020 achievements 2021-2022 focus
Illustrative
data
Specialty Care General Medicine
Increase patient Better profitability
New leadership team
engagement and via new digital
digital marketing engagement model
Prioritized projects
Vaccine I.A.
Scale e-commerce Plant digitization &
Decreased external spend
and digitize I.A. data-driven inventory
management
Digital product launches
Powered by aily.labs
CHC R&D
Increase sales & Accelerate R&D
improve ROI using through data & digital
digital & data experiences
14Play 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
15Q&A session
Paul Hudson Jean-Baptiste de Chatillon
Chief Executive Officer Chief Financial Officer
John Reed Arnaud Robert
R&D Digital
Bill Sibold Thomas Triomphe
Specialty Care Vaccines
Dietmar Berger
Development Head, CMO
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