REGN Regeneron Pharmaceuticals Inc

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a strategic collaboration with Truveta, Inc. and its collective of U.S. health systems to advance innovation and data-driven discovery across the life sciences, public health and healthcare delivery ecosystem. Regeneron will provide a strategic investment of $119.5 million as part of Truveta’s Series C financing round and collaborate with Truveta to launch the Truveta Genome Project. This project will extend Regeneron’s world-leading DNA sequence-linked healthcare database with an ambitious new effort to sequence up to ten million additional de-identified patient volunteers, all with linked electronic health records (EHRs). This novel resource is designed to unlock profound insights into how genetics impact health and has the potential to ultimately lead to new genetic-based therapies and optimized healthcare services.

"The scale and diversity of the Truveta Genome Project will enable us to explore the complex interplay between genetics and health in unprecedented detail,” said Aris Baras, M.D., Senior Vice President at Regeneron and Head of Regeneron Genetics Center (RGC). “With nearly three million exomes sequenced in our RGC database to date, Regeneron scientists have already identified dozens of genetic-based drug targets for a wide range of conditions – including chronic liver disease, obesity, cancer and neurodegenerative conditions – that have led to multiple clinical-stage medicines. As we continue to scale our genomics initiatives, we seek more targets and medicines, while expanding the potential impact of our research to optimize clinical trials and personalize healthcare delivery."

To enable the project, RGC will sequence the exomes and conduct genotyping and imputation of up to ten million de-identified consented volunteers using biospecimens provided by Truveta health system members across the nation. This genotypic data will be added to Truveta's unprecedented complete and timely de-identified medical database, representing more than 120 million patients across 30 health systems. The integration of these datasets is expected to yield actionable insights that have the potential to transform drug development, healthcare delivery and population health management.

“Nations have spent decades and billions of dollars to try and uncover the mysteries of biology to advance healthcare,” said Terry Myerson, Chief Executive Officer and co-founder of Truveta. “Just like volunteering to be an organ donor on your driver’s license is a simple act of service with a profound impact, the Truveta Genome Project enables each of us to anonymously contribute to dramatically accelerate progress in discovering the science of humanity, improving the health of our families and communities, and lowering the cost of care. Discoveries from smaller datasets have led to important new approaches to help prevent heart disease and restore hearing in children with certain forms of congenital deafness – it is so exciting to envision where a complete representative genomic dataset will guide us.”

Illumina, Inc., a long-standing RGC partner and a global leader in DNA sequencing and array-based technologies, will also invest $20 million in Truveta’s Series C financing round in support of the Truveta Genome Project.

"Population scale omics initiatives like this hold incredible promise to accelerate new discoveries, improve human health, and advance healthcare equity for all communities. We are excited to bring our world-class sequencing technology to this important endeavor," said Jakob Wedel, Chief Strategy and Corporate Development Officer, Illumina.

RGC will have exclusive rights to perform all research-related sequencing on samples collected under the collaboration, in addition to access to the de-identified EHR data provided by each of the consented study participants. Additionally, Regeneron and Truveta plan to partner to utilize this data in the development of next-generation solutions for healthcare delivery and population health management.

“Big Data – combined with human ingenuity – is the key to driving next-generation scientific advancements. For nearly four decades, Regeneron has discovered and developed groundbreaking medicines that address the underlying causes of disease, and this next frontier of medicine will continue to be driven by innovative application of data,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer of Regeneron. “By combining Regeneron’s expertise in genetics and drug development with Truveta's extensive phenotypic data and collaboration of leading U.S. health systems, we hope to create the ‘Big Data’ that will empower the next generation of drug discovery, as well as enable new approaches to healthcare analytics and healthcare management.”

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.

About the Regeneron Genetics CenterRegeneron Genetics Center® (RGC™) is a genomic research initiative and a wholly owned subsidiary of Regeneron. For over a decade, we have harnessed the power of human genetics to discover important new medicines, validate existing research programs and optimize clinical trials. We tap into our growing database of more than 2.6 million sequenced exomes and de-identified health information using proprietary data analytics, technology and human ingenuity to make meaningful biological discoveries at speed and scale. Our high-touch integrated model focuses on working closely with our collaborators to build a dataset with meaningful cohorts. We use innovative technologies, such as machine learning, to sequence exomes, align with health information and perform large-scale analyses to make meaningful associations between genes and diseases. We apply our insights to guide Regeneron’s broader drug discovery and development efforts.

Forward-Looking Statements and Use of Digital MediaThis 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 nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”), product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”), research and clinical programs now underway or planned, and the use of human genetics in Regeneron's research programs; the likelihood, timing, and scope of achieving any of the anticipated milestones discussed or referenced in this press release, including the launch of the Truveta Genome Project and any related research programs; the extent to which the results from research and development programs conducted by Regeneron and/or its collaborators or licensees (such as those that may result from Regeneron’s collaboration with Truveta, Inc. and the Truveta Genome Project discussed in this press release) may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; 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; the ability of Regeneron’s collaborators, licensees, 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 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; 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 (including biosimilar versions of Regeneron’s Products); 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 and Bayer (or their respective affiliated companies, as applicable), as well as the collaboration with Truveta, Inc. discussed in this press release, to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; 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), other 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), 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, 2023 and its Form 10-Q for the quarterly period ended September 30, 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        Ella CampbellTel: +1 914-572-4003ella.campbell@regeneron.com

Investor RelationsMark HudsonTel: +1 914-847-3483mark.hudson@regeneron.com