0001000694-23-000039.txt : 20230509 0001000694-23-000039.hdr.sgml : 20230509 20230509075902 ACCESSION NUMBER: 0001000694-23-000039 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20230509 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Cost Associated with Exit or Disposal Activities ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230509 DATE AS OF CHANGE: 20230509 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVAVAX INC CENTRAL INDEX KEY: 0001000694 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 222816046 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26770 FILM NUMBER: 23900037 BUSINESS ADDRESS: STREET 1: 21 FIRSTFIELD ROAD CITY: GAITHERSBURG STATE: MD ZIP: 20878 BUSINESS PHONE: 240-268-2000 MAIL ADDRESS: STREET 1: 21 FIRSTFIELD ROAD CITY: GAITHERSBURG STATE: MD ZIP: 20878 8-K 1 nvax-20230509.htm 8-K nvax-20230509
FALSE000100069400010006942023-05-092023-05-09

 
 
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): May 9, 2023
 
 
 
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 2.02. Results of Operations and Financial Condition.
 
First Quarter Financial Results
 
On May 9, 2023, Novavax, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the quarter ended March 31, 2023. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.


Item 2.05. Costs Associated with Exit or Disposal Activities.

As previously announced, a near-term priority for the Company includes reducing its annual combined research and development and selling, general and administrative spend. In connection with those plans, on May 8, 2023, the Board of Directors of the Company approved an approximately 25% reduction of its global workforce, comprised of an approximately 20% reduction in the Company’s full-time employees and the remainder comprised of contractors and consultants. The Company expects the full annual impact of the cost savings to be realized in 2024 and approximately half of the annual impact, excluding one-time charges, to be realized in 2023 due to timing of implementing the measures, and the applicable laws, regulations, and other factors in the jurisdictions in which it operates. The Company is expected to record a charge of approximately $10 million to $15 million related one-time employee severance and benefit costs, the majority of which is expected to be incurred in the second quarter of 2023 and it is evaluating the anticipated cost related to the consolidation of facilities and infrastructure.


Item 7.01. Regulation FD Disclosure.

On May 9, 2023, the Company issued a press release announcing results of the Company’s Phase 2 clinical trial for combination COVID-influenza, standalone influenza, and high-dose COVID vaccines. A copy of this press release is attached as Exhibit 99.2 to this Current Report on Form 8-K.

The information in Items 2.02, 7.01 and 9.01 of this Form 8-K (including Exhibits 99.1 and 99.2) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act except as expressly set forth by specific reference in such a filing.

This Current Report on Form 8-K includes forward-looking statements including the Company’s priorities, the size and timing of the Company’s workforce reduction, the amount and timing of the charges and cash expenditures resulting from the workforce reduction, and the expected timing and impact of cost savings from the global restructuring and cost reduction plan.  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 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, among others, that the workforce reduction may be larger than currently anticipated, the Company may incur additional costs not currently contemplated, and other risks and uncertainties are identified under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in any subsequent filings with the Securities and Exchange Commission. Further, any forward-looking statement speaks only as of the date when it is made, and the Company 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 the Company to predict which factors will arise. In addition, the Company 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.



 



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: May 9, 2023
By:/s/ John A. Herrmann III
 Name:John A. Herrmann III
 Title:Executive Vice President, Chief Legal Officer and Corporate Secretary
 

 EX-99.1 2 a1q23earningspressrelease_.htm EX-99.1 Document


image_0.jpg
Novavax Reports First Quarter 2023 Financial Results and Operational Highlights

•Announced global restructuring and cost reduction initiative with expected 2024 full-year R&D and SG&A reduction of approximately 40% to 50% vs 2022
•Provided full year 2023 total revenue guidance of between $1.4 and $1.6 billion
•First quarter revenue reflects shift to seasonal demand pattern; on-track to deliver updated COVID vaccine for Fall season
•Announced positive Phase 2 topline results for COVID-Influenza Combination, standalone influenza, and high dose COVID vaccine candidates
•Company to host conference call today at 8:30 a.m. ET

GAITHERSBURG, Md., May 9, 2023 – Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced its financial results and operational highlights for the first quarter ended March 31, 2023.

“Today we outlined significant measures intended to reduce spend, extend our cash runway, and operate more efficiently. Combined with our focus on revenue generation from Nuvaxovid™ and management of our current liabilities, these measures should strengthen our cash position and our potential for the long-term growth and stability of Novavax,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “We also made significant progress on our other key priorities, including our efforts to deliver an updated COVID vaccine for the Fall season. And, today we announced positive Phase 2 data that we believe supports the further development of our combination COVID-influenza, standalone influenza, and high-dose COVID vaccines.

Reducing our workforce has been a difficult decision, but we believe it was necessary to better align our infrastructure and scale to the endemic COVID opportunity,” continued Mr. Jacobs. “Though we still have substantial challenges ahead of us in 2023, we are encouraged by the progress we have made in the last quarter and are determined to continue executing on our top priorities.”

First Quarter 2023 and Recent Highlights

During the quarter, the company has made progress delivering on the three near-term priorities laid out during its fourth quarter 2022 earnings call.

Priority #1: Deliver an Updated, Competitive COVID Vaccine for the Upcoming 2023 Fall Vaccination Season

Novavax remains focused on our top priority of delivering an updated, competitive COVID vaccine consistent with public health recommendations for the 2023 Fall vaccination season.

•Ongoing discussions with global regulators on strain selection guidance and advancement of commercial preparedness for Fall 2023
1


oInvited to join the U.S. Food and Drug Administration’s Technology Working Group to evaluate emerging variants in preparation for strain selection at the June VRBPAC meeting
oOngoing development of variant strains “at risk” to support regulatory and commercial readiness
oModified U.S. government agreement for up to 1.5 million additional doses of Novavax’s COVID vaccine for delivery in 2023, with initial delivery supplied in five-dose vials in the first quarter of 2023

•Continued expansion of Nuvaxovid label to enable broader uptake in the long-term commercial market

•Completed enrollment and on track to receive topline results mid-2023 for Part 2 of Phase 3 strain change study, which is a regulatory prerequisite for updating our 2023-2024 vaccine composition

•Expect to file U.S. Biologics License Application in second half of 2023

Priority #2: Reduce our Rate of Spend, Manage our Cash Flow and Evolve our Scale & Structure
Novavax is focused on significantly reducing our expenses while retaining the key capabilities needed to execute our operating plans.
•Announced a global restructuring and cost reduction plan, which is expected to reduce our annual combined 2024 R&D and SG&A expenses by approximately 40% to 50% versus 2022
oIncludes consolidation of facilities and infrastructure and approximately 25% reduction in global workforce
o2023 R&D and SG&A expense reduction expected to be 20% to 25% versus 2022, based on timing of implementation, local laws and regulations and other factors, as adjusted to exclude one-time charges

Priority #3: Leverage our Technology Platform, our Capabilities and our Portfolio of Assets to Drive Additional Value Beyond Nuvaxovid Alone

Novavax continues to leverage our pipeline and technology with the intent of delivering long-term growth and protecting global health.
•Announced positive Phase 2 COVID-Influenza Combination (CIC) vaccine, standalone influenza, and high-dose COVID vaccine data, which evaluated safety and immunogenicity of different formulations
oAll three vaccine candidates were well-tolerated, demonstrated a reassuring preliminary safety profile, and had reactogenicity comparable to authorized comparators
oPreliminary topline immune responses for all three vaccine candidates were robust
oAdditional details found here

•Serum Institute of India has received authorizations in Ghana and Nigeria for R21/Matrix-M adjuvanted malaria vaccine
oVaccine was developed by Jenner Institute, University of Oxford, and formulated with our proprietary Matrix-M adjuvant

2


First Quarter 2023 Financial Results

•Total revenue: Due to an emerging seasonal demand pattern for COVID vaccines, total revenue for the first quarter of 2023 was $81 million compared to $704 million in the same period in 2022. First quarter 2023 product sales include a $65 million revenue reversal associated with doses delivered in 2022 that are scheduled for future replacement.

•Cost of sales for the first quarter of 2023 were $34 million, compared to $15 million in the same period in 2022. This includes $20 million related to excess, obsolete, or expired inventory and losses on firm purchase commitments.

•Research and development expenses (R&D) for the first quarter of 2023 were $247 million, compared to $383 million in the same period in 2022. The decrease was primarily due to a reduction in clinical and manufacturing spend.

•Selling, general and administrative expenses (SG&A) for the first quarter of 2023 were $113 million, compared to $96 million for the same period in 2022. The increase is related to expansion of our commercial sales operations in Europe and commercial investment in preparation for the Fall 2023 vaccination campaign, partially offset by certain cost containment measures to reduce our operating spend.

•Net loss for the first quarter 2023 was $294 million, compared to a net income of $203 million in the same period in 2022.

•Cash, cash equivalents, and restricted cash were $637 million as of March 31, 2023, compared to $1.3 billion as of December 31, 2022. During the first quarter of 2023 Novavax reduced its outstanding current liabilities by $541 million, including funding the maturity of the $325 million convertible debt in January 2023.

Financial Framework and Guidance

Full Year 2023 Guidance

RevenueFull Year 2023 Guidance
Total Revenue1
Between $1.4 billion and $1.6 billion
Grant Revenue
Between $340 million and $360 million
Product Sales2
Between $1.06 billion and $1.24 billion

•Combined R&D and SG&A expenses of between $1.3 billion and $1.4 billion, as adjusted to exclude one-time restructuring costs3
•Secured a $100 million payment in the second quarter of 2023 related to a negotiated APA to reduce a portion of committed dose deliveries. This payment is excluded from full year 2023 sales guidance

1.Total revenue includes Product Sales, Grants and Royalties/Other
2.APAs based on 2023 committed dose delivery schedules of approximately $800 million and U.S. market sales, subject to updated variant manufacturing and regulatory approvals
3.Novavax expects to record a restructuring charge of $10 million to $15 million related to employee severance and benefit costs, the majority of which are expected to be incurred in the second quarter
3


of 2023, and is evaluating the anticipated cost related to the consolidation of facilities and infrastructure

Full year 2023 R&D expense guidance excludes the potential costs associated with a Phase 3 Flu/CIC program. We plan to evaluate our positive Phase 2 Flu/CIC results announced today to frame our options to advance and finance this program via strategic collaborations and/or available financing alternatives.

2023 Liability Management

•Reduced outstanding current liabilities in the first quarter of 2023 by $541 million, including funding the maturity of the $325 million convertible debt in January 2023
•During April 2023, addressed additional liabilities totaling $140 million, including a $27 million payment to resolve the Par arbitration and a $113 million payment to the UK government per the terms of our APA

Conference Call

Novavax will host its quarterly conference call today at 8:30 a.m. ET. The dial-in numbers for the conference call are (877) 883-0383 (Domestic) or (412) 902-6506 (International). Participants will be prompted to request to join the Novavax, Inc. call. The passcode entry number is 3370620. A replay of the conference call will be available starting at 11:30 a.m. ET on May 9, 2023 until 11:59 p.m. ET on May 16, 2023. To access the replay by telephone, dial (877) 344-7529 (Domestic) or (412) 317-0088 (International) and use passcode 1969560.

A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until August 7, 2023.

Trade Name in the U.S.

The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to 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. Focused on the world’s most urgent health challenges, Novavax is currently evaluating vaccines for COVID, influenza, and COVID and influenza combined. Please visit novavax.com and LinkedIn for more information.

Use of Non-GAAP Measures

The Company has used a non-GAAP financial measure in this press release, which is R&D and SG&A expense, as adjusted to exclude one-time restructuring costs including a restructuring charge of $10 million to $15 million related to employee severance and benefit costs. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally
4


accepted in the United States (GAAP). The Company believes that the presentation of this adjusted financial measure is useful to investors as it provides additional information on comparisons between periods by excluding certain items that affect overall comparability. The Company uses this non-GAAP financial measure for business planning purposes and to consider underlying trends of its business, and believes presenting this measure also provides useful information to investors and others for understanding and evaluating trends in the Company’s expenses in the same manner as the Company’s management. Non-GAAP financial measures should be considered in addition to, and not as an alternative for, the Company’s reported results prepared in accordance with GAAP. The use of this non-GAAP financial measure may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. The company is unable to reconcile this forward-looking non-GAAP financial measure to the most directly comparable GAAP measure without unreasonable efforts because the company is currently unable to predict with a reasonable degree of certainty the type and extent of the anticipated costs related to the consolidation of facilities and infrastructure that would be expected to impact GAAP measure for the period but would not impact the non-GAAP measure.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its near term priorities including delivering an updated, competitive COVID vaccine for the 2023 Fall vaccination season, reducing spend, extending its cash runway and operating efficiently, the amount and impact of Novavax’s global restructuring and cost reduction plan, its operating plans, objectives and prospects full year 2023 financial guidance, its future financial or business performance, conditions or strategies, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including Part 2 of the Phase3 strain change study, the CIC investigational vaccine candidate, the scope, timing and outcome of future and pending regulatory filings and actions, including expected U.S. Biologics License Application filing in second half of 2023, future deliveries under APAs and Novavax’s ability to advance and finance a Phase 3 Flu/CIC program via strategic collaborations and / or financing alternatives 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, 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; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; manufacturing delays or challenges, including as a result of the timing of the anticipated regulatory requirements for the Fall 2023 vaccination season; the loss of future funding from the U.S. government; the potential for an unfavorable outcome in disputes, including the pending arbitration with Gavi; challenges in implementing our global restructuring and cost reduction plan; challenges in obtaining commercial adoption of NVX-CoV2373 or a COVID variant strain-containing formulation; 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, 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,
5


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.

6



NOVAVAX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)

Three Months Ended
March 31,
20232022
(unaudited)
Revenue:
Product sales$ (7,457)$ 585,628
Grants87,37999,301
Royalties and other1,02919,042
Total revenue80,951703,971
Expenses:
Cost of sales34,08615,204
Research and development247,101383,483
Selling, general and administrative112,53295,992
Total expenses393,719494,679
Income (loss) from operations(312,768)209,292
Interest expense(4,316)(4,876)
Other income (expense)24,3621,654
Income (loss) before income tax expense(292,722)206,070
Income tax expense (benefit)1,1832,662
Net income (loss)$ (293,905)$ 203,408

Net income (loss) per share
Basic$ (3.41)$      2.66
Diluted$ (3.41)$ 2.56
Weighted average number of common shares outstanding
  Basic

86,158

                  76,457
Diluted86,15880,711

7


SELECTED CONSOLIDATED BALANCE SHEET DATA
(in thousands)


March 31,
2023
December 31,
2022


Cash and cash equivalents
$     624,950
$     1,336,883
Total restricted cash
11,99311,962
Total current assets
971,0281,703,391
Working capital    
(947,830)(756,553)
Total assets
1,542,6992,258,679
Convertible notes payable*
491,347
Total stockholders’ equity (deficit)
(634,078)

*Included in noncurrent liabilities as of March 31, 2023 and current and non-current liabilities as of December 31, 2022.








Contacts:
Investors
Erika Schultz | 240-268-2022
ir@novavax.com

Media
Ali Chartan | 240-720-7804
media@novavax.com


8

 EX-99.2 3 cicpressrelease_final.htm EX-99.2 Document

Positive Phase 2 Topline Results Show Novavax's COVID-Influenza Combination, Stand-alone Influenza and High-dose COVID Vaccines Demonstrate Robust Immune Responses

•This Phase 2 trial is evaluating three vaccine candidates: COVID-Influenza Combination, stand-alone influenza and high-dose COVID
•Preliminary topline immune responses for all three vaccine candidates were robust versus authorized comparators
•For the stand-alone influenza vaccine candidate, HAI responses were 31 to 56% higher for all four influenza strains compared to Fluad®, and were 44 to 89% higher for A strains compared to Fluzone HD®
•For the COVID-Influenza Combination vaccine candidate, anti-S IgG and neutralization responses achieved levels seen in Phase 3 trial with Novavax’s prototype vaccine, with HAI responses generally consistent with Fluad® and Fluzone HD®
•All three vaccine candidates were well-tolerated and demonstrated a reassuring preliminary safety profile, with reactogenicity comparable to authorized comparators
•These Phase 2 results support continued development for all three vaccine candidates

GAITHERSBURG, Md., May 9, 2023 – Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, today announced that its COVID-Influenza Combination (CIC), stand-alone influenza and high-dose COVID vaccine candidates all showed a reassuring preliminary safety profile as well as comparable reactogenicity to individual Novavax influenza and COVID vaccine candidates or authorized influenza vaccine comparators. Additionally, all three vaccines demonstrated preliminary robust immune responses.

The primary endpoint evaluated the safety of different formulations of the CIC vaccine candidate and the quadrivalent influenza vaccine candidate compared to Fluad®* and Fluzone High-Dose Quadrivalent®** (Fluzone HD), as well as a high-dose COVID vaccine candidate in adults aged 50 through 80. All three vaccine candidates contained Novavax’s patented Matrix-M adjuvant and showed reassuring preliminary safety profiles and reactogenicity that was comparable to Fluad and Fluzone HD. The reactogenicity profile remained consistent as the adjuvant or antigen dose was increased.

In all groups there were no adverse events (AE) of special interest, no potentially immune mediated medical conditions and no treatment-related serious AEs. Unsolicited AEs occurred in 25% or fewer of any group and were consistent with diagnoses in the older adult population. Local and systemic symptoms were mostly mild and moderate and occurred at rates comparable to Fluad and Fluzone HD.

“The reactogenicity results support our previous observations that this technology is well suited for combination vaccines because large amounts of antigen can be incorporated without impacting tolerability,” said Filip Dubovsky President, Research and Development, Novavax. “The immune responses we observed were robust, and the data we have shared today significantly increase the probability of Phase 3 success.”

The CIC vaccine candidate achieved both immunoglobulin G (IgG) and neutralizing levels comparable to Novavax’s prototype COVID vaccine (NVX-CoV2373). In addition, several of the combination formulations achieved responses to both SARS-CoV-2 and to the four homologous influenza strains that were comparable to the reference comparators, supporting their prioritization for advanced development.



The stand-alone influenza vaccine candidate achieved statistically significant hemagglutination inhibition (HAI) antibody responses 31 to 56% higher for all four strains compared to Fluad. Titers were 44 (H1N1) to 89% (H3N2) higher for A strains and statistically non-inferior for B-strains compared to Fluzone HD.

The highest dose stand-alone COVID vaccine candidate achieved statistically significant anti-S IgG and neutralization responses approximately 30% higher than Novavax’s prototype COVID vaccine while maintaining comparable safety and reactogenicity to currently authorized dose level of Nuvaxovid.

“Today’s positive data are encouraging and further validate the value of our technology platform and its potential to improve global public health,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “This is an important milestone in our journey to create additional value and diversify our portfolio of vaccines.”

About the Phase 2 Trial for CIC, Stand-alone Influenza and High-Dose COVID Vaccine Candidates
The Phase 2 Trial is a dose-confirming, randomized, observer-blinded trial evaluating the safety and effectiveness (immunogenicity) of different formulations of the CIC and influenza vaccine candidates, and higher doses of Novavax’s COVID vaccine in adults aged 50 through 80. The trial is assessing a CIC vaccine candidate comprised of Novavax's recombinant protein-based COVID vaccine, quadrivalent influenza vaccine candidate and patented saponin-based Matrix-M adjuvant. Primary and secondary objectives of the study are to assess the safety, tolerability and immune responses to various formulations of the CIC, influenza and high-dose COVID vaccine candidates. The Phase 2 dose-confirmation trial is being conducted in two parts.

About NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax’s Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels. 

About Matrix-M™ Adjuvant
When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader, and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.

About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to 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. Focused on the world’s most urgent health challenges, Novavax is currently evaluating vaccines for COVID, influenza, and COVID and influenza combined. Please visit novavax.com and LinkedIn for more information.

2

Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, the CIC, the high-dose COVID vaccine candidates, the quadrivalent influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax's plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax's global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the evolving COVID pandemic, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety intended utilization, and the expected administration of NVX-CoV2373 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, 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; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; 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, 2021 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.

*Fluad® is a registered trademark of Seqirus UK Limited
**Fluzone High-Dose Quadrivalent®* is a registered trademark of Sanofi Pasteur Inc.

Contacts:
Investors
Erika Schultz
240-268-2022
ir@novavax.com

Media
Ali Chartan
240-720-7804
media@novavax.com
3
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Cover Page
May 09, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date May 09, 2023
Entity Registrant Name NOVAVAX, INC
Entity Incorporation, State or Country Code DE
Entity File Number 0-26770
Entity Tax Identification Number 22-2816046
Entity Address, Address Line One 21 Firstfield 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
Written Communications false
Soliciting Material false
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
Amendment Flag false
Entity Central Index Key 0001000694
XML 9 nvax-20230509_htm.xml IDEA: XBRL DOCUMENT 0001000694 2023-05-09 2023-05-09 false 0001000694 8-K 2023-05-09 NOVAVAX, INC DE 0-26770 22-2816046 21 Firstfield Road Gaithersburg MD 20878 (240) 268-2000 false false false false Common Stock, Par Value $0.01 per share NVAX NASDAQ false EXCEL 10 Financial_Report.xlsx IDEA: XBRL DOCUMENT begin 644 Financial_Report.xlsx M4$L#!!0 ( & _J58'04UB@0 +$ 0 9&]C4')O<',O87!P+GAM M;$V./0L",1!$_\IQO;=!P4)B0-!2L+(/>QLOD&1#LD)^OCG!CVX>;QA&WPIG M*N*I#BV&5(_C(I(/ !47BK9.7:=N')=HI6-Y #OGDK7A.YNJQ<&4GPZ4A!0W_J=0U[R;UEA_6\#MI7E!+ P04 M " !@/ZE6%6R(Q.X K @ $0 &1O8U!R;W!S+V-O&ULS9+! 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