- Novavax continues to progress Sanofi agreement by achieving
first milestone, with additional milestones and ongoing tiered
royalties to come, solidifying a strong model for future
partnerships
- Novavax's COVID-19 vaccine included in Sanofi's two
combination vaccine candidates for prevention of influenza and
COVID-19, for which Phase 1/2 trials were initiated and Fast
Track designation recently granted in the U.S.
GAITHERSBURG, Md., Dec. 13,
2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a
global company advancing protein-based vaccines with its Matrix-M™
adjuvant, today announced progress in Q4 2024 advancing its
corporate growth strategy through its partnership with Sanofi. The
Company has achieved a milestone associated with its Phase 2/3
clinical trial for its COVID-19 vaccine in children,
triggering the first $50 million
milestone payment from Sanofi.
"Novavax is steadily advancing our new corporate growth
strategy. By achieving this milestone in our collaboration
agreement with Sanofi, as well as the upcoming sale of our
Czech Republic manufacturing site,
we are strengthening our balance sheet as well as delivering
significant cost reductions," said John C.
Jacobs, President and Chief Executive Officer, Novavax. "In
addition, Sanofi recently announced it received U.S. FDA Fast Track
designation for two vaccine candidates combining our proven
COVID-19 vaccine with its market-leading influenza vaccines. These
assets have progressed to Phase 1/2 clinical trials, with the
potential for future Novavax milestone payments and royalties, if
successful."
The $50 million milestone is the
first following the initial upfront payment at signing of the
agreement with Sanofi in May
2024. Following this payment, there are additional potential
milestones of up to $300 million
related to Novavax's partnered COVID-19 vaccine that will be
recognized in the periods when earned. In addition to milestones
for the stand-alone COVID-19 vaccine, the agreement also includes
combination products developed by Sanofi including Novavax's
COVID-19 vaccine, which present a potential opportunity of up to an
additional $350 million for Novavax
in future milestones. In addition, both stand-alone COVID-19 sales
and potential sales of any Sanofi combination products would net
Novavax ongoing tiered royalties. 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.
Novavax's corporate growth strategy includes efforts to pursue
additional partnerships for its late-stage and early-stage Research
and Development assets and Matrix-M adjuvant alone. This growth
strategy should position the Company for ongoing value creation as
additional partnerships are secured under a similar contractual
framework.
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, Md., U.S., offers a
differentiated vaccine platform that combines a recombinant protein
approach, innovative nanoparticle technology and Novavax's patented
Matrix-M adjuvant to enhance the immune response. The Company's
portfolio includes its COVID-19 vaccine and its pipeline includes
its COVID-19-Influenza Combination and stand-alone influenza
vaccine candidates. In addition, Novavax's adjuvant is included in
the University of Oxford and Serum
Institute of India's R21/Matrix-M
malaria vaccine. Please
visit novavax.com and LinkedIn for more
information.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and prospects, the
possible achievement of additional milestones or receive royalties,
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, Novavax's ability to successfully and timely
manufacture, market, distribute, or deliver its updated 2024-2025
formula COVID-19 vaccine and the impact of its not having received
a BLA from the FDA for the 2024-2025 vaccination season; 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 a JN.1 protein-based COVID-19 vaccine or 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, 2023, 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 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.
Contacts:
Investors
Luis Sanay, CFA
240-268-2022
ir@novavax.com
Media
Giovanna Chandler
240-720-7804
media@novavax.com
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SOURCE Novavax, Inc.