Sanofi Form 6-K Due: May 31
Sanofi forward-looking statements
This 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 potentials of the product, or regarding the potential future revenues of 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 these 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 Sanofi’s control. , which could cause actual results and developments to differ materially from those expressed, implied or projected by the forward-looking information and statements. These risks and uncertainties include, among others, unexpected regulatory actions or delays, or government regulation generally, which could affect the availability or commercial potential of the product, the product’s failure to achieve commercial success, 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[feminine] will have on us, our customers, suppliers, vendors and other business partners, and the financial condition of each of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19[feminine] on any of these elements could also have a negative impact on us. This situation is changing rapidly and additional impacts may arise that we are not currently aware of and may exacerbate other previously identified risks. Risks and uncertainties also include uncertainties discussed or identified in public filings with the SEC and AMF by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements”. in Sanofi’s annual report on the form 20-F for the year ended December 31, 2021. Except as required by applicable law, Sanofi undertakes no obligation to update or revise any forward-looking information or statements.
Regeneron Forward-Looking Statements and Use of Digital Media
This press release contains 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. of these forward-looking statements. research statements. Words such as “anticipate”, “expect”, “intend”, “plan”, “believe”, “seek”, “estimate”, variations of these words and similar expressions are intended to identify these forward-looking statements, although not all forward-looking statements contain these identifying words. These statements relate to, and such risks and uncertainties include, but are not limited to, the impact of SARS-CoV-2 (the virus that caused the COVID-19[feminine] pandemic) on the operations of Regeneron and its employees, collaborators, suppliers and other third parties upon which Regeneron relies, the ability of Regeneron and its collaborators to continue to conduct research and clinical programs, the ability of Regeneron to manage its supply chain, net sales of products marketed or otherwise marketed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron Products”) and the global economy; the nature, timing, possible success and therapeutic applications of Regeneron’s products and product candidates developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s product candidates”) and research programs and ongoing or planned clinics, including but not limited to Dupixent® (dupilumab) for the treatment of nodular prurigo; the likelihood, timing and scope of eventual regulatory approval and commercial launch of Regeneron’s product candidates and new indications for Regeneron’s products, such as Dupixent for the treatment of prurigo nodularis (including approval by the United States Food and Drug Administration based on the Biologics Supplement License Application discussed in this press release), pediatric atopic dermatitis, atopic dermatitis of the hands and feet, chronic obstructive pulmonary disease with signs of inflammation of type 2, pediatric eosinophilic esophagitis, bullous pemphigoid, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic inducible urticaria – common cold, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and other potential indications; uncertainty regarding the use, market acceptance and commercial success of Regeneron’s products (such as Dupixent) and Regeneron’s product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandatory or voluntary), including studies discussed or referenced in this press release, any of the foregoing or any potential regulatory approval of Regeneron’s products (such as Dupixent) and Regeneron’s product candidates. Regenerate; the ability of Regeneron’s collaborators, licensees, suppliers or other third parties (as applicable) to perform the manufacturing, filling, finishing, packaging, labeling, distribution and other steps related to the products of Regeneron and Regeneron’s product candidates; Regeneron’s ability 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 related to the use of Regeneron’s products and product candidates of Regeneron in clinical trials; decisions of governmental regulatory and administrative authorities that may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron Products and Regeneron Product Candidates, including, without limitation, Dupixent; ongoing regulatory obligations and oversight impacting Regeneron’s products, research and clinical programs and operations, including those relating to patient privacy; the availability and extent of reimbursement for Regeneron’s products from third-party payers, including private healthcare and insurance programs, health maintenance organizations, drug 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 or more cost-effective than Regeneron’s products and Regeneron’s product candidates; the extent to which the results of research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to the advancement of product candidates into clinical trials, applications therapeutics or regulatory approval; unforeseen expenses; product development, production and selling costs; Regeneron’s ability to meet any of its financial projections or guidance and changes to assumptions underlying such projections or guidance; the possibility that any license, collaboration or supply agreement, including Regeneron’s agreements with Sanofi, Bayer and Teva Pharmaceutical Industries Ltd. (or their respective affiliates, as applicable) be canceled or terminated; and risks associated with the intellectual property of other parties and pending or future litigation relating thereto (including, without limitation, patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection, Dupixent, Praluent® (alirocumab), and REGEN-VOC® (casirivimab and imdevimab)), other litigation and other government proceedings and investigations relating to the Company and/or its operations, the ultimate outcome of such proceedings and investigations, and the impact any of the above may have on business, outlook, results of operations and financial condition. A more complete description of these and other material risks may be found in Regeneron’s filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2021 and its Form 10-Q for the quarterly period ended March 31, 2022. All 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 undertakes no obligation to update (publicly or otherwise) any forward-looking statements, including, without limitation, any financial projections or guidance, whether as a result of new information, future events or otherwise. .
Regeneron uses its media and investor relations website and social media to post material information about the Company, including information that may be considered material to investors. Financial and other information about Regeneron is published regularly and can be accessed on Regeneron’s Media and Investor Relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com /regenerate).