Regeneron Announces New Investment in Manufacturing of its Industry-Leading Biologic Medicines

New manufacturing and supply agreement with FUJIFILM Diosynth Biotechnologies in North Carolina will enable additional production of Regeneron's biologic medicines and support high-paying jobs in the region

Regeneron's ongoing and planned investments in New York and North Carolina infrastructure and manufacturing expected to total more than $7 billion

TARRYTOWN, N.Y., April 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) today announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotechnologies ("Fujifilm") to manufacture and supply bulk drug product of Regeneron's commercial biologic medicines at their Holly Springs, North Carolina, campus. Regeneron, already one of the largest manufacturers of biologics in the world, will nearly double its U.S. large-scale manufacturing capacity by accessing Fujifilm's new state-of-the-art biopharmaceutical facility. With technology transfer beginning immediately and a ten-year term, the total investment is estimated to exceed $3 billion.

"Regeneron is an American success story, with over 80 percent of our workforce and assets in the U.S. and all of our FDA-approved medicines invented in our New York laboratories. Our innovative approach has filled our commercial and clinical pipeline with important new medicines and driven a need for even more manufacturing capacity to fulfill the promise of our science," said Leonard Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We are meeting this need through increased investment in New York and North Carolina. We are proud to advance biotech innovation, which directly improves the health of people around the globe, while generating economic growth and high-paying jobs for America itself."

This new investment underscores Regeneron's commitment to deliver innovative medicines to patients. Regeneron continues to invest heavily in its New York State operations, where an approximately $3.6 billion expansion of its Tarrytown campus is underway, creating 1,000 full-time, high-skill jobs and expanding research, preclinical manufacturing and support facilities. In addition, the company is constructing a brand new, state-of-the-art fill/finish manufacturing facility in Rensselaer, New York, and has acquired an over 1 million-square foot property in Saratoga Springs, New York, for production support activities and, potentially, additional manufacturing capacity.

"At Regeneron, we have the privilege of making some of the best and most innovative therapeutics in the industry, and we are acutely aware of our impact on people's lives as we work to help treat or even cure devastating diseases," said Daniel Van Plew, Executive Vice President and General Manager, Industrial Operations and Product Supply at Regeneron. "We take our role seriously, and our decision to work with Fujifilm reflects our belief that they will meet our high standards and grow with us. We are excited about this unique relationship, and we are already working to bring capacity online at Fujifilm's biologics manufacturing facility in Holly Springs, North Carolina."

"Partnering with Regeneron, a global leader in biotechnology and scientific innovation, is a true honor for us, as we bring together our exceptional teams and shared vision to make transformative medicine accessible to patients," said Lars Petersen, President and Chief Executive Officer of FUJIFILM Diosynth Biotechnologies. "We are honored that Regeneron has the trust and confidence in our teams' ability to deliver capacity faster, ensuring continuity of supply for patients in need."

In the past five years, Regeneron has added more than 7,000 jobs, the majority of which are high-paying R&D and manufacturing jobs based in the United States.

About Regeneron

Regeneron (NASDAQ:REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite^®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X.

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 ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable), including Fujifilm Diosynth Biotechnologies North Carolina, Inc. ("Fujifilm"), to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates"); the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable) as well as the manufacturing and supply agreement with Fujifilm discussed in this press release, to be cancelled or terminated; whether the technology transfer contemplated by the manufacturing and supply agreement with Fujifilm referenced in this press release will be achieved in the expected timeframe or at all; the ability of Regeneron to manage supply chains for multiple products and product candidates; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and Regeneron's Product Candidates and research and clinical programs now underway or planned; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products; 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) on any of the foregoing; safety issues resulting from the administration of Regeneron's Products 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; 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; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees 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 impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), 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 2 mg), 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, 2024. 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 (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

Contacts: Media Relations Alexandra Bowie [email protected]

Investor Relations Ryan Crowe [email protected]