GAITHERSBURG, Md. and GENEVA, Feb. 22,
2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX)
and Gavi, the Vaccine Alliance (Gavi) today announced
they have reached a settlement related to the 2021 Advance Purchase
Agreement (APA) for Novavax's prototype COVID-19 vaccine
(NVX-CoV2373). This agreement brings the pending arbitration
related to the APA to a close.
"Novavax is pleased to have reached this agreement with Gavi as
it gives us the ability to continue to work together toward our
shared mission of ensuring equitable access to safe and effective
vaccines," said John C. Jacobs,
President and Chief Executive Officer, Novavax. "We look forward to
a long-term partnership with Gavi to provide continued access to
our protein-based non-mRNA COVID-19 vaccine."
"Gavi welcomes this agreement, which allows us to maintain focus
on our core programmatic goals, including providing access to
COVID-19 vaccines for vulnerable people in lower income countries.
It is good for global immunisation, for countries and for healthy
manufacturing markets," said David
Marlow, Chief Executive Officer (ad int) of Gavi, the
Vaccine Alliance.
With the goal of furthering a joint commitment to public health,
Novavax and Gavi have agreed to terms that will prioritize Gavi's
and Novavax's shared mission to save lives and protect people's
health by increasing equitable and sustainable use of vaccines.
Under the terms, Novavax has made an initial payment of
$75 million to Gavi and has agreed to
make deferred payments of $80 million
annually through December 31, 2028,
which are due in quarterly installments and total up to
$400 million. Novavax's annual cash
obligation would be offset or reduced pursuant to an $80 million annual vaccine credit, which may be
used for qualifying sales of any of the Company's vaccines funded
by Gavi for supply to low-income and lower-middle income countries.
Use of the annual vaccine credit for qualifying sales would reduce
Novavax's annual cash obligation. In addition to the annual
obligation, Novavax will provide an additional vaccine credit of up
to $225 million, should there be
additional demand, which can be applied towards qualifying dose
purchases of any of the Company's vaccines in such countries
throughout the five-year term.
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 a
vaccine for COVID-19 and influenza combined. 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.
About Gavi, the Vaccine Alliance
Gavi, the Vaccine
Alliance is a public-private partnership that helps vaccinate more
than half the world's children against some of the world's
deadliest diseases. The Vaccine Alliance brings together developing
country and donor governments, the World Health Organization,
UNICEF, the World Bank, the vaccine industry, technical agencies,
civil society, the Bill & Melinda Gates Foundation and other
private sector partners. View the full list of donor governments
and other leading organisations that fund Gavi's work here.
Since its inception in 2000, Gavi has helped to immunise a whole
generation – over 1 billion children – and prevented more than 17.3
million future deaths, helping to halve child mortality in 78
lower-income countries. Gavi also plays a key role in improving
global health security by supporting health systems as well as
funding global stockpiles for Ebola, cholera, meningococcal and
yellow fever vaccines. After two decades of progress, Gavi is now
focused on protecting the next generation, above all the zero-dose
children who have not received even a single vaccine shot. The
Vaccine Alliance employs innovative finance and the latest
technology – from drones to biometrics – to save lives, prevent
outbreaks before they can spread and help countries on the road to
self-sufficiency. Learn more at www.gavi.org and connect with
us on Facebook and Twitter.
Forward-Looking Statements
Statements herein relating
to the future of Novavax, its operating plans and prospects, its
mission, its coordination with Gavi, and the occurrence and timing
of certain payments to Gavi 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 manufacture,
distribute, or market its updated COVID-19 vaccine, challenges
satisfying, alone or together with partners, various safety,
efficacy, and product characterization requirements, including
those related to process qualification, assay validation and
stability testing, necessary to satisfy applicable regulatory
authorities; difficulty obtaining scarce raw materials and
supplies; resource constraints, including human capital and
manufacturing capacity, and constraints on Novavax's ability to
pursue planned regulatory pathways, alone or with partners, in
multiple jurisdictions simultaneously, leading to staggered
regulatory filings and potential regulatory actions; challenges or
delays in conducting clinical trials; challenges or delays in
obtaining regulatory authorization for its product candidates,
including for future COVID-19 variant strain changes;
manufacturing, distribution or export delays or challenges;
Novavax's significant dependence on Serum Institute of India Pvt.
Ltd. and Serum Life Sciences Limited for co-formulation and filling
and PCI Pharma Services for finishing Novavax's COVID-19 vaccines
and the impact of any delays or disruptions in their operations on
the delivery of customer orders; challenges in implementing its
global restructuring and cost reduction plan; Novavax's ability to
timely deliver doses; challenges in obtaining commercial adoption
and market acceptance of its updated COVID-19 vaccine, NVX-CoV2373
or any COVID-19 variant strain-containing formulation; challenges
meeting contractual requirements under agreements with multiple
commercial, governmental, and other entities including requirements
to deliver doses that may require Novavax to refund portions of
upfront and other payments previously received or result in reduced
future payments pursuant to such agreements; challenges related to
the seasonality of vaccinations against COVID-19; 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, 2022 and
subsequent Quarterly Reports on Form 10-Q, as filed with the
Securities and Exchange Commission (SEC). Novavax cautions
investors not to place considerable reliance on forward-looking
statements contained in this press release. Novavax encourages you
to read its 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. Novavax's
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
Erika Schultz
240-268-2022
ir@novavax.com
Media
Ali Chartan, Novavax
240-720-7804
media@novavax.com
Meg Sharafudeen, Gavi
+41 79 711 55 54
msharafudeen@gavi.org
Annette Wangong'u, Gavi
awangongu@gavi.org
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SOURCE NOVAVAX, INC