NVAX Novavax Inc

 

 

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): June 6, 2024

 

 

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.)

 

700 Quince Orchard 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 Disclosure.

 

On June 6, 2024, the Company provided an update for investors at the 2024 Jefferies Global Healthcare Conference, sharing information relating to certain strategic and business updates (the “Investor Presentation”), which is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated into this Item 7.01 by reference. A copy of the Investor Presentation will also be accessible on the Company’s website at www.novavax.com under “Latest Investor Presentation.”

  

Item 8.01.   Other Items.

 

The U.S. Food and Drug Administration notified the Company that it completed its filing review of the final portion of the Company’s Biologics License Application (“BLA”) for its COVID-19 Vaccine and has set a Prescription Drug User Fee Act (PDUFA) review goal date in April 2025 for the BLA. As a result, the Company is planning for the commercial sales of its COVID-19 Vaccine in the United States during the 2024-2025 season to be under its existing Emergency Use Authorization.

  

Cautionary Note Regarding Forward-Looking Statements.

 

This Current Report on Form 8-K and the Investor Presentation attached as Exhibit 99.1 include forward-looking statements including information relating to the future of the Company, statements related to potential royalties and milestones, its near-term priorities including delivering an updated single-dose vial COVID-19 vaccine for the start of the 2024-2025 vaccination season, initiating a pivotal Phase 3 trial for CIC in the second half of 2024, a possible combination vaccine launch in 2026, reducing rate of spend, managing cash flow and evolving its scale and structure, the amount and impact of the Company’s previously announced global restructuring and cost reduction plan and new cost reduction plan, its operating plans, objectives and prospects, its future financial or business performance, conditions or strategies, its partnerships, including with respect to the launch of R21/Matrix-M Malaria vaccine, the ongoing development of its updated COVID-19 vaccine and COVID-19-Influenza Combination (CIC) investigational vaccine candidate, the scope, timing and outcome of future and pending regulatory filings and actions, the availability of its updated COVID-19 vaccine, the fall 2024 and future global COVID-19 market opportunities, and the timing of delivery and distribution of its vaccine. 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 our current beliefs and expectations about the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, 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, our and Sanofi’s ability to successfully implement its partnership, including the ability to transition key processes and effect technology transfers, Novavax’s and Sanofi’s ability to successfully develop or commercialize any vaccines or vaccine candidates, our ability to successfully and timely manufacture, distribute, or market our updated COVID-19 vaccine including as a single dose vial or pre-filled product presentation for the 2024-2025 vaccination season, our plans to sell our COVID-19 vaccine for the 2024-2025 vaccination season under Emergency Use Authorization; 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; challenges or delays in conducting clinical trials; challenges or delays in obtaining regulatory authorization for our product candidates, including our updated COVID-19 vaccine in time for the 2024-2025 vaccination season in the U.S. and in foreign jurisdictions to meet APA commitments or for future COVID-19 variant strain changes, our COVID-19-Influenza combination vaccine candidate and our stand-alone influenza vaccine candidate; manufacturing, distribution or export delays or challenges; our 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 our COVID-19 vaccine and the impact of any delays or disruptions in their operations on the delivery of customer orders; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, and constraints on our ability to pursue planned regulatory pathways, alone or with partners, in multiple jurisdictions simultaneously, leading to staggered regulatory filings, and potential regulatory actions; the potential for an unfavorable outcome in disputes; challenges in implementing our global restructuring and cost reduction plan; our ability to timely deliver doses; challenges in obtaining commercial adoption and market acceptance of our updated COVID-19 vaccine 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 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on February 28, 2024, and in Part II, Item 1A “Risk Factors” of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 10, 2024, which may be detailed and modified or updated in other documents filed 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.

 

 

We cannot guarantee future results, events, level of activity, performance, or achievement. Any or all of our forward-looking statements in this Current Report on Form 8-K and the Investor Presentation 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 we undertake 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 us to predict which factors will arise. In addition, we 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.

 

The information in Item 7.01 and Item 8.01, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section and shall not be deemed incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as shall be expressly set forth by specific reference in such filing. In addition, the contents of the Company’s website are not incorporated by reference into this Current Report on Form 8-K and you should not consider information provided on the Company’s website to be part of this Current Report on Form 8-K.

 

Item 9.01.   Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description
99.1		Investor Presentation of Novavax, Inc.
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: June 6, 2024	By:	/s/ Mark Casey
	Name:	Mark Casey
	Title:	Executive Vice President, Chief Legal Officer and Corporate Secretary

 

 

 

 

Exhibit 99.1

 

Investor Presentation 1 © 2024 NOVAVAX. All rights reserved. NASDAQ: NVAX | JUNE 2024

2 Cautionary note regarding forward - looking statements © 2024 NOVAVAX. All rights reserved. This presentation includes forward - looking statements . These forward - looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning . These forward - looking statements address various matters including information relating to the future of Novavax and its products, statements related to Novavax’s partnership with Sanofi and receipt of potential royalties and milestones thereunder, its near - term priorities including delivering an updated single - dose pre - filled syringe and unit dose vial COVID - 19 vaccine for the start of the 2024 - 2025 vaccination season, initiating a pivotal Phase 3 trial for CIC and seasonal influenza in the second half of 2024 , a possible combination vaccine and/or seasonal influenza launch in 2026 , reducing rate of spend, managing cash flow and evolving its scale and structure, the amount and impact of Novavax’s previously announced global restructuring and cost reduction plan and new cost reduction plan, its operating plans, objectives and prospects, full year 2024 financial guidance, its future financial or business performance, conditions or strategies, its partnerships, including with respect to the launch of R 21 /Matrix - M Malaria vaccine, the ongoing development of its updated COVID - 19 vaccine and COVID - 19 - Influenza Combination (CIC) and seasonal influenza investigational vaccine candidates, the scope, timing and outcome of future and pending regulatory filings and actions, including Novavax’s expected U . S . Biologics License Application (BLA) submissions for Nuvaxovid, the availability of its updated COVID - 19 vaccine, the fall 2024 and future global COVID - 19 market opportunities, and the timing of delivery and distribution of its vaccine 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 and Sanofi’s ability to successfully implement its partnership, including the ability to transition key processes and effect technology transfers, Novavax’s and Sanofi’s ability to successfully develop or commercialize any vaccines or vaccine candidates, Novavax’s ability to successfully manufacture, distribute, or market its updated COVID - 19 vaccine for the 2024 - 2025 vaccination season ; 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 ; challenges or delays in conducting clinical trials ; our plans to sell our COVID - 19 vaccine for the 2024 - 2025 vaccination season under Emergency Use Authorization ; challenges or delays in obtaining regulatory authorization or policy recommendations for its product candidates, including its updated COVID - 19 vaccine in time for the 2024 - 2025 vaccination season or for future COVID - 19 variant strain changes ; manufacturing, distribution or export delays or challenges ; Novavax’s substantial dependence on Serum Life Sciences Limited for supply of Novavax’s COVID - 19 vaccines and the impact of any delays or disruptions in their operations on the delivery of customer orders and commercial supply to Sanofi ; 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 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 - CoV 2373 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 the risks identified under the heading “Risk Factors” in Novavax' most recent Annual Report on Form 10 - K and subsequent Quarterly Reports on Form 10 - Q, as well as subsequent filings with the Securities and Exchange Commission . Novavax cautions investors not to place considerable reliance on the forward - looking statements contained in this presentation . Investors are encouraged to read Novavax’ filings with the Securities and Exchange Commission, available at www . sec . gov and on our website at www . novavax . com, for a discussion of these and other risks and uncertainties . The forward - looking statements in this presentation speak only as of the date of this presentation, and we undertake no obligation to update or revise any of these 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 . Novavax TM (and all associated logos) is a trademark of Novavax, Inc . Matrix - M TM is a trademark of Novavax AB .

Company Overview SECTION 3 © 2024 NOVAVAX. All rights reserved.

Novavax corporate highlights 4 © 2024 NOVAVAX. All rights reserved. Positioned for long - term value creation through commercialization of proven technology Proprietary Matrix - M TM adjuvant differentiates pipeline Rapidly advancing COVID - 19 - Influenza Combination (CIC) vaccine to Phase 3 Proven p rotein - based technology platform COVID - 19 vaccine positioned to gain share in long - term market Fully integrated commercial - stage biotechnology company

Fully integrated commercial - stage biotechnology company with global presence 5 © 2024 NOVAVAX. All rights reserved. Global HQ & Corporate Offices • R&D and discovery laboratories • Manufacturing operations • Commercial Novavax HQ Novavax HQ Gaithersburg, Maryland Novavax AB Uppsala, Sweden Novavax CZ Bohumil, Czech Republic Serum Institute of India SK bioscience Takeda EU Commercial Operations Zurich, Switzerland APAC Commercial Operations Singapore Novavax AB – Matrix - M adjuvant Novavax CZ – Antigen Novavax Manufacturing North America European Union (EU) Asia - Pacific (APAC) Novavax Commercial Operations Serum Institute of India (SII) SK bioscience Takeda Strategic Partners North America Commercial Operations Gaithersburg, Maryland

Novavax’s proven technology platform 6 © 2024 NOVAVAX. All rights reserved. • Induces broad, robust neutralizing response 2 • Long - lived polyfunctional CD4+ cellular response 2 • Antigen sparing 2 • Large safety database included in approved vaccines 2,3 • Reactogenicity consistent with licensed vaccines 2,3 Matrix - M Adjuvant Technology Performance Characteristics Stimulates the entry of antigen presenting cells (APCs) into the injection site and enhances antigen presentation in local lymph nodes • Highly immunogenic and efficacious 1 • Durable immune responses with reassuring safety profile 1 • Refrigerator - stable • Well - suited for development of combination vaccines • Disease - agnostic and adaptable Recombinant, Protein - based Nanoparticle Vaccine Technology Performance Characteristics Combines the power and speed of genetic engineering to efficiently produce protein - based nanoparticles 1. Dunkle, LM et al., 2022. DOI .; Heath, PT et al ., 2022 . DOI .; Áñez , G et al., 2023. DOI . ; Shinde, V et al., 2020. DOI . ; Shinde, V et al., 2021. DOI . 2. Stertman , L et al., 2023. DOI . 3. Datoo , MS et al., 2022. DOI .

Core vaccine products and pipeline Significant opportunities for future development 7 © 2024 NOVAVAX. All rights reserved. 1. Authorized in select geographies under trade names Novavax COVID - 19 Vaccine, Adjuvanted; Covovax Œ ; and Nuvaxovid Œ , and authorized in the U.S. under trade name, Novavax COVID - 19 Vaccine, Adjuvanted (2023 - 2024 Formula); Ongoing post - authorization Phase 3 strain change trial. 2. Authorized in Ghana, Nigeria, and Burkina Faso; Commercialized by Serum Institute of India; Granted prequalification by the WHO. Disease Product Preclinical Phase 1 Phase 2 Phase 3 Authorized Novavax Coronavirus Novavax COVID - 19 Vaccine 1 COVID / Influenza Combination Vaccine (CIC) Seasonal Influenza Influenza (Older Adults) Partnered Malaria R21/Matrix - M Œ adjuvant 2 Matrix - M Matrix - M Matrix - M Matrix - M Novavax continues to optimize preclinical candidates, including a new approach to H5N1 pandemic bird flu vaccination, and exp and our core technology for novel applications including mucosal vaccination and high - density nanoparticles.

Novavax & Sanofi Collaboration and License Agreement SECTION 8 © 2024 NOVAVAX. All rights reserved. Announced May 10, 2024

Novavax and Sanofi collaboration and licensing agreement summary This agreement is a further validation of our technology platform and provides significant opportunity to drive value creation and benefit global public health 9 © 2024 NOVAVAX. All rights reserved. A multi - billion dollar potential across upfronts, equity investment, milestones and royalties C o - exclusive license to co - commercialize Novavax’s current stand - alone adjuvanted COVID - 19 vaccine worldwide* Sole license to Novavax’s adjuvanted COVID - 19 vaccine for use in combination with Sanofi’s flu vaccines ** Non - exclusive license to use the Matrix - M adjuvant in vaccine products Sanofi made a minority (<5%) equity investment in Novavax jdsfm * Except in countries with existing Advance Purchase Agreements and in India, Japan, and South Korea where Novavax has existing partnership agreements ** Novavax retains the right to develop its own Covid - 19 / Flu combination product using its Covid - 19 and internally developed flu vaccine

Novavax and Sanofi collaboration and licensing agreement summary (2) Upfront payment $500M Equity Investment ~$70M Total Q2 2024 ~$570M US sBLA approval (PFS) $175M US Authorization Transfer (PFS) $25M EMA MAH Transfer (PFS) $25M Pediatric Study Database Lock $50M COVID - 19 manufacturing technology transfer $75M Total $350M Summary of financial terms Q2 Payments Nuvaxovid COVID - 19 (Mono) Product development and approval milestones $350M COVID - 19 Combination Products Equity investment of ~$70M COVID - 19 Products (Mono): Eligible for tiered royalty on net product sales in the high teens to low twenties CIC Products & Other Combination Products: Eligible for tiered royalty on net product sales in the mid single digits to sub teens percentages Eligible for payments of up to ~$1.3 billion via upfront, equity investment and COVID - 19 related milestones plus royalties ~$1,270M Combined 10 © 2024 NOVAVAX. All rights reserved. Royalties

Novavax and Sanofi collaboration and licensing agreement summary (3) Summary of financial terms Candidate selection & clinical milestones (*) $10M Launch & sales milestones $200M New vaccines Matrix - M TM New vaccines with Matrix - M TH : Eligible for royalty on net product sales in the mid single digits Eligible for payments for new vaccine candidate plus royalties 11 © 2024 NOVAVAX. All rights reserved. (*) Sanofi may select the first four of such products without having to pay these milestones Cost Reimbursement Novavax is eligible to be reimbursed by Sanofi for: o Research and development and medical affairs costs related to the COVID Mono Products in accordance with agreed upon plans and budgets o Select technology transfer costs o COVID - 19 commercial supply o Matrix - M and components supply

Near - term Priorities SECTION 12 © 2024 NOVAVAX. All rights reserved.

2024 Near - term priorities jdsfm Priority #1 Prioritize the successful transition to our new partnership with Sanofi 13 1. A portion of which we expect to be reimbursed by Sanofi under the collaboration and licensing agreement © 2024 NOVAVAX. All rights reserved. jdsfm Priority #2 Continue to expand and diversify organic opportunities, and create additional value via our technology platform jdsfm Priority #3 Prepare to initiate an additional cost reduction program to reduce 2025 R&D plus SG&A expenses to below $500M 1 jdsfm Priority #4 Deliver an updated product for the 2024 - 2025 vaccination season

14 © 2024 NOVAVAX. All rights reserved. Well - positioned to deliver a differentiated CIC vaccine and capture significant market opportunity Leverage Proven Technology Platform 1. Protein Receptivity Study (January 2022). 2. IQVIA Demand Study (2023). 3. IPSOS syndicated Awareness, Trial and Usage tracker (From March 2023 to September 2023), HCP monthly pulse (starting in Octob er 2023). • ~25 - 30% of consumers 1 and healthcare professionals 2 surveyed, prefer a protein - based option Growing Awareness of Novavax in the U.S. 44% 46% 72% 80% 0% 20% 40% 60% 80% 100% Mar-23 Jun-23 Oct-23 Jan-24 % HCPs Strong Preference Share for Protein - Based Option • Commercialized COVID - 19 vaccine with demonstrated efficacy and tolerability profile • Matrix - M induces broad antibody response and long - lived cellular response • Quadrivalent influenza vaccine candidate with positive Phase 3 results generated o Potential to be competitive with stand - alone influenza vaccines U.S. HCP - Aided Awareness 3 Priority #2

vs Clinical program has been modified to seek licensure for both CIC and Stand - alone influenza ( tNIV ) in ≥ 60 yo Part B: Stand - alone Influenza (tNIV) Designed to achieve accelerated approval endpoints for both products with no change to timelines tIIV Novavax COVID - 19 + CIC Placebo + tNIV Placebo + tIIV Placebo + vs Phase 3a on track for 2H2024 • Immunologic non - inferiority/superiority study against age - recommended licensed comparators • Adults ≥ 60 yo ; N=4,000 • Reconfirming FDA concurrence with revised program design Lot - to - Lot manufacturing consistency studies 2H 2024 • CIC lot - to - lot in ≥ 60 yo (N=~1,650) • tNIV lot - to - lot study in ≥ 60 yo (N=~1 , 250) Top - line data for decision - making expected 2Q2025 Potential Accelerated Approval filings 2H2025 Potential launch 2026 Phase 3a Study Design Part A: COVID - Influenza - Combination tNIV = Trivalent nanoparticle influenza vaccine tIIV = Trivalent inactivated influenza vaccine 15 © 2024 NOVAVAX. All rights reserved. Priority #2

R&D and SG&A expense trends & 2024 guidance $1.7B Creating a more lean and agile organization • Reduced workforce by 30 % compared to the first quarter of 2023 • Targeting FY 2024 R&D and SG&A expenses of $700 - $ 75 0 million • Preparing to initiate an additional cost reduction program to reduce 2025 R&D plus SG&A expenses to below $500 million, a portion of which we expect to be reimbursed by Sanofi under the agreement • Prioritizing improvements to long - term supply chain efficiency, including exploring sale of CZ manufacturing facility Combined Annual R&D and SG&A Expense $7 25 M $1.2B Midpoint 16 © 2024 NOVAVAX. All rights reserved. ~$1B reduction compared to FY 2022 Midpoint $700M - $ 75 0M Priority #3

Setting the stage for a stronger U.S. commercial performance in 2024+ 2024 - 2025 Vaccination Season Goals Single - dose pre - filled syringe Product Presentation Timing of Product at Distribution Centers Ready to be Shipped Market Access Marketing Efforts 17 © 2024 NOVAVAX. All rights reserved. Targeting August 2024 National and Regional Retail Large IDNs and HMOs EUA for updated strain in PFS pending FDA Authorization Status Retail channel: Focus on 60+ consumer segments Priority #4

COVID - 19 commercial execution in rest of world in 2024+ Europe Australia, New Zealand and Canada 18 © 2024 NOVAVAX. All rights reserved. • Seeing a more normal, non - pandemic consumer demand pattern • Delivering unit - dose presentation • Focusing on key countries driving business : Italy, Spain , France, the U.K., Poland and Germany • U.K. activating private market • Entering commercial market for first - time • Secured NACI recommendation in Canada • Preparing for National Immunization Program and retail model in Australia and New Zealand Priority #4

Financial Guidance and Corporate Milestones SECTION 19 © 2024 NOVAVAX. All rights reserved.

Full year 2024 financial guidance $ in millions FY 2024 Combined Revenue & Sanofi Agreement Payments $970 - $1,170 Total Revenue 1,2 $400 - $600 Initial Sanofi Agreement Payments 3 ~$570 Combined R&D and SG&A $700 - $750 20 © 2024 NOVAVAX. All rights reserved. Total potential contract value for APAs outstanding, as of March 31 , 2024 , w ere over $ 600 m illion related to expected dose deliveries for the second quarter of 2024 through 2026 . This amount excludes deferred revenue associated with the 2023 Canada amendments to forfeit doses . Guidance Notes : Guidance as of May 10 th , 2024. We undertake no obligation to update or revise this guidance in the future. 1. Total Revenue includes product sales, and royalties & other revenue . 2. Full year 2024 guidance reflects APA expected dose delivery schedules of $ 150 million to $ 250 million and non - APA related revenue of $ 25 0 million to $ 35 0 million, subject to updated variant manufacturing and regulatory approvals, from a combination of commercial market product sales plus royalties and other revenue from our partner - related activity . The update to the expected 2024 APA dose delivery schedules reflects the anticipated shift of approximately $ 250 million in contracted doses from 2024 to future periods . 3. Sanofi agreement initial payments include a non - refundable $ 500 million upfront payment to be received within 10 days and an immediate $ 69 million equity investment in Novavax .

Corporate Milestones 21 © 2024 NOVAVAX. All rights reserved. EMA, WHO and U.S. VRBPAC regulatory guidance on COVID - 19 strain selection for fall 2024 (April and June 2024) Announce Novavax and Sanofi collaboration and licensing agreement (May 2024) Fall 2024 COVID - 19 commercial performance Initiate CIC and stand - alone influenza Phase 3 study (2H 2024) CIC Phase 3 results (1H 2025) Acceptance of U.S. COVID - 19 BLA submission (PDUFA date of April 2025)

700 Quince Orchard Road Gaithersburg, MD 20878 United States novavax.com ir@novavax.com © 2024 NOVAVAX. All rights reserved. 22

v3.24.1.1.u2

Cover	Jun. 06, 2024
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Document Type	8-K
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Document Period End Date	Jun. 06, 2024
Entity File Number	0-26770
Entity Registrant Name	NOVAVAX, INC.
Entity Central Index Key	0001000694
Entity Tax Identification Number	22-2816046
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	700 Quince Orchard Road
Entity Address, City or Town	Gaithersburg
Entity Address, State or Province	MD
Entity Address, Postal Zip Code	20878
City Area Code	240
Local Phone Number	268-2000
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Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, Par Value $0.01 per share
Trading Symbol	NVAX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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