Press Release: Sanofi Pipeline Transformation to Accelerate Growth
Driven by Record Number of Potential Blockbuster Launches, Paving
the Way to Industry Leadership in Immunology
R&D Day
Sanofi Pipeline Transformation to Accelerate
Growth Driven by Record Number of Potential Blockbuster Launches,
Paving the Way to Industry Leadership in Immunology
- Details strong pipeline including
Sanofi’s record 12 blockbuster opportunities under clinical
evaluation: 9 innovative medicines and vaccines with €2 to 5
billion peak sales potential, and 3 ‘pipeline-in-a-product’ assets
with a potential of over €5 billion peak sales
- Strategic transformation through
R&D features potential multi-indication assets such as
amlitelimab, frexalimab and the oral TNFR1si intended to address
unmet patient needs in markets with low penetration of advanced
therapies
- Enhanced R&D focus aims to
deliver a 50% increase in Phase 3 trials in 2024 and 2025 as well
as 25 mid- to late-stage read-outs over the next 2 years
- Ambition to become an immunology
powerhouse driven by recent and future launched pharma assets,
generating over €10 billion in annual sales by 2030, in addition to
the strong growth of Dupixent and Vaccines
Paris, December 6, 2023. Today
Sanofi is hosting an Investor R&D Event in New York providing
updates and insight into its innovative pipeline and new growth
drivers.
Focusing on its unprecedented portfolio of
12 new molecular entities with blockbuster
potential, including multiple late-stage assets, the
company will be prioritizing development and leveraging its
leadership in immunology across all other therapeutic areas. Sanofi
will also share its ambitions to break efficacy ceilings and expand
into new indications, generating a steady flow of predominantly
wholly-owned new assets.
The company will continue to serve more patients
with a combination of strong growth from existing assets and a
steady stream of potential blockbuster launches:
- Pharma assets -
Recently launched and future pharma assets are expected to generate
over €10 billion of annual sales by 2030, driven by late-stage
pipeline assets such as amlitelimab, frexalimab, itepekimab, and
tolebrutinib, as well as recently launched products including
ALTUVIIIO®, Sarclisa®, and Tzield®.
- Dupixent® -
Expected to continue its strong performance and to deliver a low
double-digit net sales growth CAGR from 2023 to 2030, supported by
expected new indications such as chronic obstructive pulmonary
disease (COPD) as well as greater penetration in approved
indications.
- Vaccines - Sanofi
reiterates its expectation to generate over €10 billion of annual
sales by 2030, including the recent launch of Beyfortus®.
Sanofi’s R&D will lead to a 50%
increase in the number of Phase 3 studies between 2023 and
2025, creating the greatest pipeline momentum in Sanofi’s history.
The company’s commitment to R&D will also support an expected
25 mid- to late-stage read-outs and up to 19 regulatory
submissions for its pharma assets in the next two
years.
Houman Ashrafian, Head of Research and Development, Sanofi
“Today we show how our decision to strategically
increase our focus on R&D will unlock our pipeline’s full
potential as we prioritize potential first- or best-in-class assets
to deliver innovative medicines to patients. With an unprecedented
number of potential blockbuster assets in our pipeline, we will
showcase how we become a development-driven, tech-powered biopharma
company, committed to serving patients and accelerating growth. We
are in a privileged position today with many very promising assets
in mid- and late-stage development. We believe in our capacity to
improve outcomes for patients globally, while bringing innovative
new medicines to market and strengthening our leadership in
immunology and neuro-inflammation.”
Paul Hudson, Chief Executive Officer, Sanofi
“Building on our successful recent launches, we
are making decisive choices to deliver breakthrough medicines and
long-term value for all of our stakeholders. We are confident in
our current product portfolio and the strength of our pipeline to
deliver sustainable growth through 2030 and beyond. I could not be
prouder of the progress we have made over the past three years, and
I am looking forward to sharing further updates as our key assets
pass new milestones toward their market launch and as we turn
Sanofi into an immunology powerhouse.”
Highlighted key programs
Sanofi shares insights into the development
status and target indications of its pipeline of 12 potential
blockbuster assets in immunology and vaccines. This includes its
three ‘pipeline-in-a-product’ assets, amlitelimab, frexalimab and
SAR441566 (Oral TNFR1si), each with a peak sales potential of over
€5 billion, as well as treatments for multiple sclerosis
(tolebrutinib), asthma (lunsekimig, rilzabrutinib), inflamatory
bowel disease (Anti-TL1A), atopic dermatitis (IRAK4 degrader), and
COPD (itepekimab). Additional potential blockbusters include
vaccines against acne, extraintestinal pathogenic E. coli, and RSV
in older adults.
The company also demonstrates strong proof
points of its progress in increasing R&D productivity, notably
by continuously evolving its R&D engine, unlocking the power of
its data and leveraging AI at scale to inform portfolio decisions.
Additionally, Sanofi presents the actions taken to reflect the
group’s sustainability roadmap across its development pipeline.
Speakers, Webcast and Materials
Speakers at the event include over a dozen
members of the Sanofi leadership and R&D teams, including CEO
Paul Hudson and Head of R&D Houman Ashrafian. Investors will
also hear physicians’ perspectives on multiple sclerosis (MS) and
chronic obstructive pulmonary disease (COPD), two major development
areas for Sanofi.
A live webcast of the R&D Day presentations
will start at 8:30 a.m. U.S. Eastern Time (2:30 p.m. Paris time)
and supporting slide materials will be available on Sanofi’s
investor relations website at 7:30 a.m. U.S. Eastern Time (1:30
p.m. Paris time). The webcast will conclude at 12:45 p.m. U.S.
Eastern Time (6:45 p.m. Paris time). A replay of the live webcast
will be available after the event.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
Media RelationsSandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.comSally
Bain | + 1 617 834 6026
| sally.bain@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.comEvan Berland | +1
215 432 0234 | evan.berland@sanofi.comNicolas
Obrist | + 33 6 77 21 27 55
| nicolas.obrist@sanofi.com
Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69 36 93 |
arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comTarik Elgoutni| + 1 617
710 3587 | tarik.elgoutni@sanofi.comNathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
Sanofi Forward-Looking
StatementsThis press release 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 pandemics or other
global crises may 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. 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,
2022. 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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