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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
October 29, 2026
NOVAVAX, INC.
(Exact name of registrant as specified
in charter)
| Delaware |
|
0-26770 |
|
22-2816046 |
|
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer
Identification No.) |
21 Firstfield Road
Gaithersburg, Maryland 20878
(Address of Principal Executive Offices,
including Zip Code)
(240) 268-2000
(Registrant’s telephone number,
including area code)
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General
Instruction A.2. below):
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
| Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which
registered |
| Common Stock, Par Value $0.01 per share |
|
NVAX |
|
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01. Regulation FD Information.
On October 29, 2026, Novavax, Inc. (“Novavax”
or the “Company”) issued a press release announcing the information discussed under Item 8.01 hereof. A copy of the press
release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 7.01 shall
not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly
set forth by specific reference in such a filing.
Item 8.01. Other Events.
On October 28, 2026 Sanofi Pasteur Inc. (“Sanofi”)
dosed the fifth patient in its Phase 3 influenza-COVID-19 combination vaccine trial in the European Union, utilizing the Company’s
COVID-19 component. Dosing of the fifth patient has triggered a $125 million milestone payment from Sanofi under the Company’s
Collaboration and License Agreement with Sanofi. The Company anticipates receipt of payment by the first quarter of 2027.
Cautionary Note Regarding Forward-Looking Statements.
This Current Report on Form 8-K contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be
covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Any statements in the discussion below and elsewhere in this Current Report about expectations, beliefs, plans, objectives, assumptions,
or future events or performance of the Company are not historical facts and are forward-looking statements. Such forward-looking statements
include, without limitation, statements regarding expected milestone payments under the Sanofi agreement. Generally, forward-looking
statements can be identified through the use of words or phrases such as “believe,” “may,” “could,”
“will,” “would,” “possible,” “can,” “estimate,” “continue,” “ongoing,”
“consider,” “anticipate,” “intend,” “seek,” “plan,” “project,”
“expect,” “should,” “would,” “aim,” or “assume,” the negative of these terms,
or other comparable terminology, although not all forward-looking statements contain these words.
Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based only on Novavax’s current beliefs and expectations about the
future of our business, events and trends, and other future conditions. Forward-looking statements involve estimates, assumptions, risks,
and uncertainties that could cause actual results or outcomes to differ materially from those expressed or implied in any forward-looking
statements, and, therefore, you should not place considerable reliance on any such forward-looking statements. Such 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, challenges
or delays in conducting clinical trials or studies for its product candidates; manufacturing, distribution or export delays or challenges;
Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling
Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; the impact of potential legislative, regulatory,
or policy changes under the current presidential administration, including any adverse impact funding for vaccine research and development,
reimbursement for vaccines and their administration, vaccine mandates and recommendations, and public perception of vaccine importance;
uncertainty with respect to pricing, third-party reimbursement and healthcare reform; the impact of any new or changes in interpretations
of existing trade measures, including tariffs, embargoes, sanctions, import restrictions, and export licensing requirements; difficulty
obtaining scarce raw materials and supplies including for its proprietary adjuvant; 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; Novavax's ability to timely deliver doses;
challenges in obtaining commercial adoption and market acceptance of its COVID-19 vaccine or any COVID-19 variant strain containing formulation,
or for its CIC vaccine candidates, stand-alone influenza vaccine candidates or other candidates; 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; challenges related to the demand for vaccinations against COVID-19
or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities; Novavax's expectations as to expenses
and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions;
and other risks and uncertainties identified in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year
ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 26, 2026, as updated by the
information in Part II, Item 1A “Risk Factors” in our subsequent Quarterly Reports on Form 10-Q which may be further detailed
and modified or updated in other documents we file with the SEC from time to time, and are available at www.sec.gov and at www.novavax.com.
You are encouraged to read these filings as they are made.
Novavax cannot guarantee future results, events, level of activity,
performance, or achievement. Any or all of Novavax’s forward-looking statements in this Current Report on Form 8-K may turn out
to be inaccurate or materially different from actual results. Further, any forward-looking statement speaks only as of the date when it
is made, and Novavax undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information,
future events, or otherwise, unless required by law. New factors emerge from time to time, and it is not possible for Novavax to predict
which factors will arise. In addition, Novavax cannot assess the impact of each factor on our business or the extent to which any factor,
or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description |
| 99.1 |
|
Press release, Dated October 29, 2026 |
| 104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL). |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
| |
Novavax, Inc. |
| |
|
|
| Date: October 29, 2026 |
By: |
/s/ Mark J. Casey |
| |
Name: |
Mark J. Casey |
| |
Title: |
Executive Vice President, Chief Legal Officer and Corporate Secretary |
Exhibit 99.1
News & Media
Novavax Earns $125 Million
Milestone as Sanofi Launches Phase 3 Influenza-COVID-19 Combination Vaccine Trial in Europe
October 29, 2026
| · | The global flu and COVID-19
markets have a current combined value that exceeds $10 billion, with significant burden of disease1 |
| · | The combination vaccine candidate evaluated in this trial
pairs Sanofi's leading high-dose flu vaccine with Novavax's differentiated COVID-19 vaccine |
| · | Significant potential value remains in Sanofi partnership
via additional future opportunities for milestones and royalties |
GAITHERSBURG, Md., Oct. 29,
2026 /PRNewswire/ -- Novavax (Nasdaq: NVAX) has earned a $125 million milestone payment with the initiation (fifth patient dosed) of
Sanofi's Phase 3 influenza-COVID-19 combination vaccine trial utilizing Novavax's COVID-19 vaccine, Nuvaxovid™. Sanofi's Phase
3 trial, being conducted in Europe, is assessing the safety and immunogenicity of Nuvaxovid in combination with Sanofi's marketed Efluelda/Fluzone®
High-Dose vaccine in adults aged 60 and older.
"Novavax and Sanofi continue to
successfully execute on the opportunities afforded by our partnership. To date, the partnership has generated over $1 billion in revenue
for Novavax,"2 said John C. Jacobs, President and Chief Executive Officer, Novavax. "Sanofi has stated that they
intend to be one of the first movers in the combination vaccine segment, and Novavax believes this is an important step toward that goal.
We are excited about the value we are building together with our partners."
Under the collaboration and
license agreement, for Nuvaxovid, Novavax is eligible to receive royalties on Sanofi sales and a $75 million milestone payment upon the
successful completion of the manufacturing technology transfer anticipated in mid-2027. Novavax is also eligible to receive an additional
milestone of $225 million upon a U.S. launch of an influenza-COVID-19 combination vaccine following successful completion by Sanofi of
all clinical and regulatory requirements in the U.S. The agreement also includes royalties for any combination products developed by
Sanofi using Nuvaxovid and milestones plus royalties for any new vaccines created by Sanofi utilizing Novavax's Matrix-M®
adjuvant.
About Novavax
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 its Matrix-M
adjuvant and protein-based nanoparticles. The Company's corporate growth strategy is designed to deliver value via three key strategic
pillars: partnering its technology, capital-efficient R&D innovation and a lean and efficient operating model. This includes maximizing
impact through partnerships for its marketed products (Nuvaxovid™, R21/Matrix-M™), Matrix technology and R&D assets.
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 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. Additional clinical studies may be required to support regulatory filings in the U.S. market
for the combined influenza-COVID-19 program. The U.S. may have different regulatory requirements from other markets. 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, 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 Sanofi to pursue planned regulatory pathways; 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, 2025, 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
Naina Zaman
240-410-5353
ir@novavax.com
Media
Yvonne Sprow
240-720-7804
media@novavax.com
References
| 1. | 2025 Flu and COVID-19 global market revenues based on revenue disclosures from the
primary market participants in their SEC filings. |
| 2. | Novavax revenue recognized from upfront payments, milestones, R&D reimbursement
and royalties through 6/30/2026 plus achievement of the $125 million CIC Phase 3 milestone in October 2026. |
SOURCE Novavax, Inc.
