Full Press Release Details
to Deliver on Sanofi Partnership, Completing Nuvaxovid EU Marketing Authorization Transfer and Triggering $25 Million
Md., October 7, 2025 - Novavax, Inc. (Nasdaq: NVAX) has completed the transfer of the marketing authorization for its COVID-19
vaccine, Nuvaxovid to Sanofi, in the European Union (EU) enabling Sanofi to take full responsibility for commercial and regulatory
activities in the EU. The transfer triggered a milestone payment of $25 million to Novavax and further progresses the collaboration and
license agreement (CLA) between both companies.
to steadily advance our corporate growth strategy while delivering on our partnership agreement," said John C. Jacobs, President
and Chief Executive Officer, Novavax. "The successful transfer of our EU marketing authorization to Sanofi is yet another step
forward in ensuring global access to our protein-based, non-mRNA COVID-19 vaccine."
to receive additional future milestones and royalties under the CLA related to Nuvaxovid, combination products developed by Sanofi using
Nuvaxovid and new vaccines created by Sanofi utilizing Novavax's Matrix-M adjuvant.
Novavax is eligible to receive an additional $25 million milestone for the marketing authorization transfer in the U.S. and a $75 million
milestone payment upon the completion of the technology transfer of the Company's manufacturing process for the COVID-19 vaccine
to Sanofi. For combination products developed by Sanofi which include Novavax's COVID-19 vaccine (and Matrix-M), Novavax is eligible
to receive up to an additional $350 million in future milestones. Novavax is eligible for ongoing tiered royalties from sales of both
stand-alone COVID-19 and any Sanofi combination products. Further, Novavax is eligible to receive up to $200 million for the first four
products created by Sanofi utilizing its Matrix-M adjuvant, and up to $210 million in milestone payments for each product including Matrix-M
thereafter, plus ongoing royalties for all Sanofi products utilizing Matrix-M.
VACCINE AUTHORIZATION
vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 65 years of age and older, or 12 years
through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
reported (>10%) solicited adverse reactions were injection site tenderness, injection site pain, injection site redness, headache,
muscle pain, fatigue, malaise, joint pain, fever and nausea/vomiting.
adverse reactions, contact Novavax, Inc. at 1-844-668-2829 or the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or
Novavax, Inc. (Nasdaq:
NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology
platform, including protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing
partnerships and expand access to its proven technology platform via research and development innovation, organic portfolio expansion
in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit novavax.com
and LinkedIn for more information.
relating to the future of Novavax, its operating plans and prospects, the possible achievement of additional milestones or receipt of
milestone payments or royalties under the CLA, future marketing initiatives and the potential development and commercialization of Sanofi
combination products, and efforts to pursue additional partnerships, are forward-looking statements. Novavax cautions that these forward-looking
statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed
or implied by such statements. These risks and uncertainties include, without limitation, challenges related to Novavax's partnership
with Sanofi and in pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety,
efficacy and product characterization requirements, including those related to process qualification and assay validation, necessary
to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including
human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining
regulatory authorization for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution
or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and
the impact of any delays or disruptions in their operations on the delivery of customer orders; and those other risk factors identified
in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations"
sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q,
as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking
statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov
and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press
release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business
is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should
give careful consideration to these risks and uncertainties.