Novavax and Sanofi Announce Co-Exclusive Licensing Agreement to Co-Commercial COVID-19 Vaccine and Develop Novel Combination Influenza and COVID-19 Vaccines

• The agreement provides individuals with broader access to a protein-based, non-mRNA adjuvanted COVID-19 vaccine through a combined commercial force, starting in 2025.
• Provides Novavax with liquidity and equity investment totaling approximately $1.2 billion (initial payment of 500 million dollars and until 700 million dollars in additional stages of development, regulation and launch), plus tiered royalties
• Novavax is entitled to additional launch and sales opportunities of up to 200 million dollarsplus single-digit royalties, for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax’s Matrix-M™ adjuvant technology
• Accelerates the potential for development of a new COVID-19-flu combination product based on authorized vaccines with demonstrated efficacy and tolerability, potentially providing individuals with improved convenience and protection.

GAITHERSBURG, Maryland., May 10, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M^™ adjuvant, entered into a co-exclusive licensing agreement with Sanofi (Nasdaq: SNY).

Terms of the agreement include: a co-exclusive license to co-market Novavax’s standalone adjuvanted COVID-19 vaccine globally (except in countries with existing advance purchase agreements and in India, Japan And South Korea where Novavax has existing partnership agreements); an exclusive license to Novavax’s adjuvanted COVID-19 vaccine for use in combination with Sanofi’s influenza vaccines, while Novavax retains the right and develops its own COVID-19-flu combination vaccine candidate; a non-exclusive license to use Novavax’s adjuvanted COVID-19 vaccine in combination with non-influenza vaccines; and a non-exclusive license to use Matrix-M adjuvant in vaccine products. In addition, Sanofi will take a minority stake (<5%) in Novavax.

“As hospitalization rates for influenza and COVID-19 now closely mirror each other, we have the opportunity to develop non-mRNA combination vaccines for influenza and COVID-19, providing patients with both convenience increased and protection against two serious respiratory viruses,” said Jean-François Toussaint, global head of vaccine R&D, Sanofi. “We are excited about the prospect of combining Novavax’s adjuvanted COVID-19 vaccine, which has shown high efficacy and favorable tolerability, with our rich portfolio of differentiated influenza vaccines that have demonstrated superior protection against influenza and its serious complications. Improved tolerability and thermostability, without compromising efficacy, is what regulators, recommending bodies and patients will demand.

“This collaboration is important for Novavax and for global public health. Our new partnership combines Novavax’s proprietary recombinant protein and nanoparticle technologies, Matrix™ adjuvant and R&D expertise with Sanofi’s world-class leadership in the launch and commercialization of innovative vaccines, together we can expand access to both our COVID-19 vaccine and our adjuvant to ensure that more people can benefit from the protection that vaccines provide. can offer,” said John C. Jacobs, President and CEO, Novavax. “Novavax is now in a stronger position to refocus our efforts on leveraging our technology platform and novel adjuvant in R&D and expanding our pipeline to help advance our mission of developing vaccines lifesaving tools in the fight against infectious diseases. »

Under the terms of the license agreement:

• Novavax will receive an upfront payment of 500 million dollars and until 700 million dollars in the development, regulatory and launch stages, up to $1.2 billion in total.
• Beginning in 2025, Sanofi will record sales of Novavax’s adjuvanted COVID-19 vaccine and cover certain R&D, regulatory and commercial expenses.
• Novavax will receive double-digit tiered royalties on Sanofi’s sales of COVID-19 vaccines and combination influenza and COVID-19 vaccines.
• Sanofi will be solely responsible for the development and commercialization of any new combination influenza and COVID-19 vaccines containing a Sanofi influenza vaccine.
• Outside of the collaboration, each party may develop and market its own COVID-19-Influenza combination vaccines and adjuvanted products at its own expense.
• Novavax is entitled to additional launch and sales opportunities of up to 200 million dollarsplus single-digit royalties for each additional Sanofi vaccine product developed under a non-exclusive license with Novavax’s Matrix-M adjuvant technology.
• In addition, Sanofi will take a minority stake (<5%) in Novavax.

PJT Partners acts as exclusive financial advisor to Novavax. Ropes & Gray LLP acts as legal advisor.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Maryland., USA, offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax’s patented Matrix-M adjuvant to enhance immune response. The Company’s portfolio includes its COVID-19 vaccine and its pipeline includes its combination COVID-19 influenza and stand-alone influenza vaccine candidates. Additionally, Novavax adjuvant is included in the University of Oxford and the Serum Institute of India Malaria vaccine R21/Matrix-M™. Please visit novavax.com and LinkedIn for more information.

About Sanofi
We are an innovative global healthcare company, driven by a single purpose: we pursue the miracles of science to improve people’s lives. Our team, across the globe, is dedicated to transforming the practice of medicine by striving to turn the impossible into the possible. We bring life-changing treatment options and life-saving vaccine protection to millions of people around the world, while placing sustainability and social responsibility at the center of our ambitions.

Forward-looking statements
Statements below regarding improved access to a non-mRNA protein-based adjuvant-free COVID-19 vaccine from 2025, the development of COVID-19 combination vaccines (including COVID-19 combination vaccines) 19 and influenza), the launch of a phase 3 trial for Novavax’s COVID-19 vaccine. -Combined influenza vaccine candidate in the second half of 2024, future vaccines manufactured with Novavax’s exclusive Matrix-M^TM adjuvant, potential royalties and milestones, the future of Novavax and its mission 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, but are not limited to, the ability of Novavax and Sanofi to successfully implement their partnership, including the ability to transition key processes and effect technology transfers; Novavax’s ability to successfully and timely manufacture, distribute or market its updated COVID-19 vaccine, including in single-dose vial or pre-filled syringe product presentation for the 2024-2025 vaccination season; challenges satisfying, alone or with partners, various safety, efficacy and product characterization requirements, including those related to process qualification, test validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials; challenges or delays in obtaining regulatory authorization for its product candidates, including its updated COVID-19 vaccine in time for the 2024-2025 vaccination season or for future changes in COVID-19 variant strains 19, its combined COVID-19-Influenza vaccine candidate and its stand-alone flu vaccine candidate; delays or difficulties in manufacturing, distribution or export; Novavax’s substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling and PCI Pharma Services for finishing of Novavax’s COVID-19 vaccine and the impact of any delays or interruptions in their operations on the delivery of customer orders; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, constraints on Novavax’s ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggering of regulatory filings and potential regulatory actions; challenges related to the implementation of its global restructuring and cost reduction plan; Novavax’s ability to deliver doses in a timely manner; difficulties encountered in achieving commercial adoption and market acceptance of its updated COVID-19 vaccine or any formulation containing a variant strain of COVID-19; difficulties in meeting contractual requirements under agreements with multiple commercial, governmental and other entities, including dose delivery requirements that may require Novavax to repay a portion of upfront and other payments previously received or result in a reduction future payments pursuant to such agreements; challenges related to the seasonality of COVID-19 vaccinations; and 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 then-ended fiscal year. December 31, 2023 as filed with the Securities and Exchange Commission (SEC). We caution investors not to place significant reliance on the forward-looking statements contained in this press release. We encourage you to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements contained in this press release speak only as of the date hereof, and we undertake no obligation to update or revise these statements. Our business is subject to significant risks and uncertainties, including those discussed above. Investors, potential investors and others should pay particular attention to these risks and uncertainties.

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SOURCE NOVAVAX, INC.