Full Press Release Details
GAITHERSBURG, Md.,Nov. 6, 2025/PRNewswire/ -- Novavax, Inc. (Nasdaq:NVAX) today announced its financial results and operational highlights for the third quarter ended September 30, 2025.
"We have continued the steady transformation of Novavax and are proud of our progress this quarter," said John C. Jacobs, President and Chief Executive Officer, Novavax. "This year we have relaunched the Company with a focus on R&D and partnerships intended to position us well for long-term growth and profitability."
Third Quarter 2025 and Recent Highlights
Key Highlights
Strategic Priority #1: Optimize our Sanofi Partnership
Strategic Priority #2: Enhance Existing Partnerships and Leverage our Technology Platform and Pipeline to Forge Additional Partnerships
Strategic Priority #3: Advanceour Technology Platform and Early-Stage Pipeline
Other Corporate Highlights
Third Quarter 2025 Revenue
Third Quarter 2025 Financial Results
Financial Framework
FullYear 2025 Financial Guidance
Novavax provides Full Year 2025 Financial Guidance for Combined R&D and SG&A Expenses and Non-GAAP Combined R&D and SG&A Expenses and currently expects to achieve the following results:
Full Year 2025
(as of November 6, 2025)
Full Year 2025
(as of August 6, 2025)
Non-GAAP Combined R&D and SG&A Expenses exclude R&D Reimbursements, which are amounts reimbursed by Novavax's license partners. See "Non-GAAP Financial Measures" below. R&D Reimbursements are recorded as revenue under Licensing, Royalties and Other Revenue.
Full Year 2025 Revenue Framework
Novavax transitioned lead commercial responsibility of Nuvaxovid beginning with the 2025-2026 COVID-19 vaccination season to Sanofi for select markets. Since Novavax is reliant on Sanofi's sales forecasts for certain revenue components, these are not included in the Full Year 2025 Revenue Framework. For 2025, Novavax currently expects to achieve Adjusted Total Revenue1of between $1,040 million and $1,060 million.
Full Year 2025
(as of November 6, 2025)
Full Year 2025
(as of August 6, 2025)
Components of Revenue excluded from the Full Year 2025 Revenue Frameworkare described below.
Sanofi Influenza-COVID-19 Combination and Matrix-M Related Milestones
Conference CallNovavax will host its quarterly conference call today at 8:30 a.m. ET. To join the call without operator assistance, you may register and enter your phone number athttps://registrations.events/easyconnect/3585070/rec5O9dY5wckxc0Os/to receive an instant automated call back. You may also dial direct to be entered to the call by an operator. The dial-in numbers for the conference call are (888) 880-3330 (Domestic) or (+1) (646) 357-8766 (International). Participants will be prompted to request to join the Novavax, Inc. call. A replay of the conference call will be available starting at 11:30 a.m. ET on November 6, 2025, until 11:59 p.m. ET on November 13, 2025. To access the replay by telephone, dial (800) 770-2030 (Domestic) or (+1) (609) 800-9909 (International) and use passcode 3585070#.
A webcast of the conference call can also be accessed on the Novavax website atir.novavax.com/events. A replay of the webcast will be available on the Novavax website until December 5, 2025.
About NovavaxNovavax, 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 protein-basednanoparticlesand itsMatrix-Madjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via R&D innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visitnovavax.comandLinkedInfor more information.
Non-GAAP Financial MeasuresThe Company presents the following non-GAAP financial measures in this press release: Non-GAAP Combined R&D andSG&A Expenses, Adjusted Total Revenue and Adjusted Licensing, Royalties and Other Revenue. Non-GAAP financial measures refer to financial information adjusted from financial measures prepared in accordance with accounting principles generally accepted in the United States (GAAP). The Company believes that the presentation of these adjusted financial measures is useful to investors as they provide additional information on comparisons between periods by including certain items that affect overall comparability. The Company uses these non-GAAP financial measures for business planning purposes and to consider underlying trends of its business. 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. Our use of non-GAAP financial measures 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 these revenue forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable effort because the Company is reliant on Sanofi sales forecasts for certain revenue categories, which are not available.
Forward-Looking StatementsThis press release contains forward-looking statements relating to the future ofNovavax, its mission; its corporate strategy and operating plans, objectives and prospects; its value drivers and strategic priorities, its partnerships, including expectations with respect to potential royalties, milestones, and cost reimbursement, and plans for additional potential partnering activities; its expectations regarding manufacturing capacity, timing, production and delivery for its COVID-19 vaccine; the development ofNovavax'sclinical and preclinical product candidates and pipeline advancement opportunities, including with respect to new Matrix formulations; the conduct, timing and potential results from clinical trials, conducted byNovavaxor its partners, and other preclinical andpostmarketingstudies; expectations as to the timing and outcome of future and pending regulatory filings and actions; expected savings from Maryland site consolidation transactions; full year 2025 financial guidance and revenue framework; andNovavax'sfuture financial or business performance.Novavaxcautions 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 or delays in obtaining regulatory authorization or approval for its COVID-19 vaccine, including for future COVID-19 variant strain changes, itsCICvaccine candidate, its stand-alone influenza vaccine candidate or other product candidates;Novavax'sability to successfully and timely manufacture, market, distribute, or deliver its COVID-19 vaccine; challenges related toNovavax'spartnership withSanofi, including collaboration on theNuvaxovidPMC, 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, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for its product candidates, including theNuvaxovidPMC; manufacturing, distribution or export delays or challenges;Novavax'ssubstantial dependence onSIIand Serum Life Sciences Limited for co-formulation and fillingNovavax'sCOVID-19 vaccine and the impact of any delays or disruptions in their operations; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints onNovavax'sability to pursue planned regulatory pathways, alone or with partners; challenges in implementing its global restructuring and cost reduction plan;Novavax'sability 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 itsCICvaccine candidate and stand-alone influenza vaccine candidate or other product candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may requireNovavaxto refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in negotiating, amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19 or influenza; challenges and uncertainty related to regulatory development; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities, including with respect toNovavax's Matrix-Madjuvant;Novavax'sexpectations 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 those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections ofNovavax'sAnnual Report on Form 10-K for the year ended December 31, 2024, 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 atwww.sec.govandwww.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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share information)
December 31,
Contacts:
InvestorsLuis Sanay, CFA240-268-2022[email protected]
MediaYvonne Sprow844-264-8571[email protected]
SOURCE Novavax, Inc.
| $ in millions | Q3 2025 | Q3 2024 | Change | % | |
| Nuvaxovid Sales1 | ($0) | $38 | ($38) | NM | |
| Supply Sales2 | 14 | 3 | 11 | NM | |
| Product Sales | 13 | 41 | (28) | (68 %) | |
| Sanofi3 | 48 | 36 | 12 | 33 % | |
| Takeda | 6 | 5 | 1 | 20 % | |
| Other Partners4 | 2 | 2 | 0 | - | |
| Licensing, Royaltiesand Other Revenue | 57 | 43 | 14 | 33 % | |
| Total Revenue | $70 | $85 | ($15) | (18 %) |
| Notes | |
| 1. | Nuvaxovid Sales reflects product sales where Novavax is the commercial market lead and records revenue related to the sales and distribution of our COVID-19 vaccine. |
| 2. | Supply Sales includes sales of finished product, adjuvant and other supplies from Novavax to our license partners. |
| 3. | Sanofi includes revenue recognized under our license agreement including upfront payments, milestones, royalties and transition services reimbursement. |
| 4. | Other Partners include upfront payments, royalties and milestone revenue under our licensing agreements including Serum Institute and SK bioscience. |
| $ in millions | Full Year 2025(as of November 6, 2025) | Full Year 2025(as of August 6, 2025) |
| Combined R&D and SG&A Expenses | $505 - $535 | $495 - $545 |
| Less: R&D Reimbursements | ($65 - $75) | ($45 - $70) |
| Non-GAAP Combined R&D and SG&AExpenses | $440 - $460 | $450 - $475 |
| $ in millions | Full Year 2025(as of November 6, 2025) | Full Year 2025(as of August 6, 2025) |
| Nuvaxovid Product Sales2 | $610 | $610 |
| Adjusted Supply Sales3 | $35 - $45 | $25 - $40 |
| Adjusted Licensing, Royalties and OtherRevenue4,5,6,7 | $395 - $405 | $365 - $400 |
| Adjusted Total Revenue1 | $1,040 - $1,060 | $1,000 - $1,050 |
| Sanofi Supply Sales | No guidance | No guidance |
| Sanofi Royalties | No guidance | No guidance |
| Sanofi Influenza-COVID-19 Combinationand Matrix-M Milestones | No guidance | No guidance |
| 1. | Adjusted Total Revenue is a non-GAAP financial measure. Adjusted Total Revenue is total revenue excluding Sanofi Supply Sales, Sanofi Royalties and Sanofi Influenza-COVID-19 Combination and Matrix-M related Milestones. See "Non-GAAP Financial Measures" below. |
| 2. | Nuvaxovid Product Sales of $610 million include $603 million in revenue recognized in the first quarter of 2025 from the termination of the Canada and New Zealand Advance Purchase Agreements, plus sales by Novavax in the U.S. and select markets outside the U.S. |
| 3. | $35 million to $45 million in Adjusted Supply Sales associated with collaborations with the Serum Institute on R21/Matrix-M and collaboration partners for COVID-19 vaccine, including Serum, SK bioscience and Takeda. Beginning in 2025, Supply Sales are included in Product Sales. |
| 4. | Adjusted Licensing, Royalties and Other Revenue is a non-GAAP financial measure, Adjusted Licensing, Royalties and Other Revenue is Licensing, Royalties and Other Revenue excluding Sanofi Royalties and Sanofi Influenza-COVID-19 Combination and Matrix-M related milestones. See "Non-GAAP Financial Measures" below. Adjusted Licensing, Royalties and Other Revenue includes $225 million in U.S. BLA & Marketing Authorizations Milestones. Novavax earned a $175 million milestone upon the approval of the COVID-19 U.S. BLA in May 2025 and two separate $25 million milestone payments earned in the fourth quarter of 2025 for the transfer to Sanofi of the Marketing Authorizations for the U.S. and EU markets, respectively. |
| 5. | $65 million to $75 million in R&D Reimbursement. Under the Sanofi co-exclusive licensing agreement (CLA), Novavax is eligible to receive reimbursement for costs incurred related to select R&D and technology transfer activities during the transition performance period that is expected to run through the end of 2026. |
| 6. | $45 million in Other Partner related revenue including royalties and milestones from the Serum Institute on R21/Matrix-M and collaboration partners for COVID-19 vaccine, including Serum, SK bioscience and Takeda. |
| 7. | $60 million amortization related to the $500 million Upfront Payment and the $50 million Database Lock Milestone from Sanofi. Revenue recognition will occur over the performance period through 2026. During 2024, a combined amortization of $440 million was recorded, and $60 million and $50 million are expected for 2025 and 2026, respectively. All remaining milestone payments under the Sanofi CLA will be recorded to revenue in the periods when earned. |
| NOVAVAX, INC. | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(in thousands, except per share information) | |||||||
| Three Months Ended | Nine Months Ended | ||||||
| September 30, | September 30, | ||||||
| 2025 | 2024 | 2025 | 2024 | ||||
| (unaudited) | (unaudited) | ||||||
| Revenue: | |||||||
| Product sales | $ 13,442 | $ 41,528 | $ 645,844 | $ 153,952 | |||
| Licensing, royalties and other | 57,003 | 42,984 | 330,496 | 439,899 | |||
| Total revenue | 70,445 | 84,512 | 976,340 | 593,851 | |||
| Expenses: | |||||||
| Cost of sales | 21,496 | 60,619 | 50,936 | 166,070 | |||
| Research and development | 98,274 | 87,164 | 266,444 | 286,789 | |||
| Selling, general and administrative | 31,655 | 70,747 | 123,357 | 258,843 | |||
| Impairment of assets held for sale | 97,038 | - | 97,038 | - | |||
| Total expenses | 248,463 | 218,530 | 537,775 | 711,702 | |||
| Income (loss) from operations | (178,018) | (134,018) | 438,565 | (117,851) | |||
| Interest expense | (5,482) | (4,236) | (16,723) | (12,490) | |||
| Loss on debt extinguishment | (28,714) | - | (28,714) | - | |||
| Other income, net | 9,178 | 15,922 | 31,136 | 27,307 | |||
| Income (loss) before income taxexpense | (203,036) | (122,332) | 424,264 | (103,034) | |||
| Income tax expense (benefit) | (657) | (1,032) | 1,489 | 3,435 | |||
| Net income (loss) | $ (202,379) | $ (121,300) | $ 422,775 | $ (106,469) | |||
| Net income (loss) per share: | |||||||
| Basic | $ (1.25) | $ (0.76) | $ 2.61 | $ (0.71) | |||
| Diluted | $ (1.25) | $ (0.76) | $ 2.53 | $ (0.71) | |||
| Weighted average number of commonshares outstanding: | |||||||
| Basic | 162,353 | 160,049 | 161,811 | 149,486 | |||
| Diluted | 162,353 | 160,049 | 168,195 | 149,486 |
| SELECTED CONSOLIDATED BALANCE SHEET DATA | |||
| (in thousands) | |||
| September 30,2025 | December 31,2024 | ||
| (unaudited) | |||
| Cash and cash equivalents | $ 268,023 | $ 530,230 | |
| Marketable securities | 494,871 | 392,888 | |
| Total restricted cash | 15,334 | 15,062 | |
| Total current assets | 974,590 | 1,128,942 | |
| Working capital | 544,721 | (25,474) | |
| Total assets | 1,179,889 | 1,560,418 | |
| Convertible notes payable | 243,835 | 169,684 | |
| Total stockholders' deficit | (156,672) | (623,841) |