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 regarding
the marketing and other potential of the product, or regarding
potential future revenues from the product. 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, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
litigation, and volatile economic and market conditions, 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,
2020. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements. Regeneron Forward-Looking
Statements and Use of Digital Media This press release
includes forward-looking statements that involve risks and
uncertainties relating to future events and the future performance
of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"),
and actual events or results may differ materially from these
forward-looking statements. Words such as "anticipate," "expect,"
"intend," "plan," "believe," "seek," "estimate," variations of such
words, and similar expressions are intended to identify such
forward-looking statements, although not all forward-looking
statements contain these identifying words. These statements
concern, and these risks and uncertainties include, among others,
the impact of SARS-CoV-2 (the virus that has caused the COVID-19
pandemic) on Regeneron's business and its employees, collaborators,
and suppliers and other third parties on which Regeneron relies,
Regeneron's and its collaborators' ability to continue to conduct
research and clinical programs, Regeneron's ability to manage its
supply chain, net product sales of products marketed or otherwise
commercialized by Regeneron and/or its collaborators (collectively,
"Regeneron's Products"), and the global economy; the nature,
timing, and possible success and therapeutic applications of
Regeneron's Products and product candidates being developed by
Regeneron and/or its collaborators (collectively, “Regeneron’s
Product Candidates”) and research and clinical programs now
underway or planned, including without limitation Dupixent®
(dupilumab) for the treatment of adults with moderate-to-severe
atopic dermatitis; the likelihood, timing, and scope of possible
regulatory approval and commercial launch of Regeneron's Product
Candidates and new indications for Regeneron's Products, such as
Dupixent for the treatment of pediatric asthma, chronic obstructive
pulmonary disease with evidence of type 2 inflammation, pediatric
atopic dermatitis, eosinophilic esophagitis, bullous pemphigoid,
prurigo nodularis, chronic spontaneous urticaria, chronic inducible
urticaria-cold, chronic rhinosinusitis without nasal polyposis,
allergic fungal rhinosinusitis, allergic bronchopulmonary
aspergillosis, peanut allergy, and other potential indications;
uncertainty of the utilization, market acceptance, and commercial
success of Regeneron's Products and Regeneron’s Product Candidates
and the impact of studies (whether conducted by Regeneron or others
and whether mandated or voluntary), including the study discussed
in this press release, on any of the foregoing or any potential
regulatory approval of Regeneron's Products and Regeneron’s Product
Candidates; the ability of Regeneron's collaborators, suppliers, or
other third parties (as applicable) to perform manufacturing,
filling, finishing, packaging, labeling, distribution, and other
steps related to Regeneron's Products and Regeneron’s Product
Candidates; the ability of Regeneron to manage supply chains for
multiple products and product candidates; safety issues resulting
from the administration of Regeneron's Products (such as Dupixent)
and Regeneron’s Product Candidates in patients, including serious
complications or side effects in connection with the use of
Regeneron's Products and Regeneron’s Product Candidates in clinical
trials; determinations by regulatory and administrative
governmental authorities which may delay or restrict Regeneron's
ability to continue to develop or commercialize Regeneron's
Products and Regeneron’s Product Candidates, including without
limitation Dupixent; ongoing regulatory obligations and oversight
impacting Regeneron's Products, research and clinical programs, and
business, including those relating to patient privacy; the
availability and extent of reimbursement of Regeneron's Products
from third-party payers, including private payer healthcare and
insurance programs, health maintenance organizations, pharmacy
benefit management companies, and government programs such as
Medicare and Medicaid; coverage and reimbursement determinations by
such payers and new policies and procedures adopted by such payers;
competing drugs and product candidates that may be superior to, or
more cost effective than, Regeneron's Products and Regeneron’s
Product Candidates; the extent to which the results from the
research and development programs conducted by Regeneron and/or its
collaborators may be replicated in other studies and/or lead to
advancement of product candidates to clinical trials, therapeutic
applications, or regulatory approval; unanticipated expenses; the
costs of developing, producing, and selling products; the ability
of Regeneron to meet any of its financial projections or guidance
and changes to the assumptions underlying those projections or
guidance; the potential for any license, collaboration, or supply
agreement, including Regeneron's agreements with Sanofi, Bayer, and
Teva Pharmaceutical Industries Ltd. (or their respective affiliated
companies, as applicable), to be cancelled or terminated; and risks
associated with intellectual property of other parties and pending
or future litigation relating thereto (including without limitation
the patent litigation and other related proceedings relating to
EYLEA® (aflibercept) Injection, Dupixent, Praluent® (alirocumab),
and REGEN-COVTM (casirivimab and imdevimab)), other litigation and
other proceedings and government investigations relating to the
Company and/or its operations, the ultimate outcome of any such
proceedings and investigations, and the impact any of the foregoing
may have on Regeneron's business, prospects, operating results, and
financial condition. A more complete description of these and other
material risks can be found in Regeneron's filings with the U.S.
Securities and Exchange Commission, including its Form 10-K for the
year ended December 31, 2020 and its Form 10-Q for the quarterly
period ended March 31, 2021. Any forward-looking statements are
made based on management's current beliefs and judgment, and the
reader is cautioned not to rely on any forward-looking statements
made by Regeneron. Regeneron does not undertake any obligation to
update (publicly or otherwise) any forward-looking statement,
including without limitation any financial projection or guidance,
whether as a result of new information, future events, or
otherwise. Regeneron uses its media and investor relations
website and social media outlets to publish important information
about the Company, including information that may be deemed
material to investors. Financial and other information about
Regeneron is routinely posted and is accessible on Regeneron's
media and investor relations website
(http://newsroom.regeneron.com) and its Twitter feed
(http://twitter.com/regeneron). |