Novavax Reports Second Quarter 2025 Financial Results and Operational Highlights

• Total revenue of $239 million in the second quarter of 2025
• Received FDA BLA approval for Nuvaxovid™, the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the U.S.; approval triggered $175 million milestone payment from Sanofi
• Completed transition of Nuvaxovid™ commercial leadership in the U.S. to Sanofi for the 2025-2026 COVID-19 vaccination season 
• COVID-19-Influenza-Combination and stand-alone influenza vaccine candidates showed robust immune responses in initial cohort of a Phase 3 trial with new T-cell response data in both Novavax vaccine candidates numerically higher than in the comparator Fluzone HD arm
• Updated Full Year 2025 Revenue Framework and Financial Guidance 
• Company to host conference call today at 8:30 a.m. ET

GAITHERSBURG, Md., Aug. 6, 2025 /PRNewswire/ — Novavax, Inc. (NASDAQ:NVAX) today announced its financial results and operational highlights for the second quarter ended June 30, 2025.

“This quarter we continued to progress our growth strategy with key achievements including BLA approval for our COVID-19 vaccine, positive data from our COVID-19-Influenza-Combination and stand-alone influenza programs, advancement of our early-stage pipeline, and progression of our partnership strategy,” said John C. Jacobs, President and Chief Executive Officer, Novavax. “We look forward to continuing to build on this foundation into the second half of the year.”

Second Quarter 2025 and Recent Highlights

Strategic Priority #1: Sanofi Partnership

• In May 2025, the U.S. Food and Drug Administration (FDA) approved the Nuvaxovid™ Biologics License Application (BLA) for prevention of COVID-19 in adults 65 years and older and individuals aged 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
  • BLA approval triggered a $175 million milestone payment from Sanofi.
• Completed transition of Nuvaxovid commercial leadership in the U.S. to Sanofi for the 2025-2026 COVID-19 vaccination season.
• Transfers of marketing authorization to Sanofi for U.S. and European Union (EU) markets are expected in the fourth quarter of 2025 which will trigger an additional $50 million in combined milestones from Sanofi.

Strategic Priority #2: Enhance Existing Partnerships and Leverage our Technology Platform and Pipeline to Forge Additional Partnerships

• In June 2025, the company reported initial cohort data for the Phase 3 trial for its COVID-19-Influenza–Combination (CIC) and stand-alone seasonal influenza vaccine candidates, showing robust immune responses for both candidates. This descriptive data set will help inform a potential future registrational Phase 3 program. Novavax intends to partner these programs and this trial reflects the completion of material investment by Novavax. Discussions are ongoing with potential partners for these late-stage assets.
  • New T-cell response data in both CIC and stand-alone influenza vaccine candidates were numerically higher than the Fluzone HD comparator arm indicating the potential for an increased duration of protection.
• In May 2025, Novavax and Takeda Pharmaceuticals announced significantly improved terms for their partnership to support ongoing commercialization of Nuvaxovid in Japan. Takeda filed for approval of the updated Nuvaxovid vaccine in June and is on track to be on the market for the fall respiratory season in Japan.
• R21/Matrix-M^®, a malaria vaccine developed in partnership with Serum Institute of India and Oxford University, continued to make meaningful progress in addressing the urgent and unmet needs of malaria-endemic regions with 20 million doses sold since launch in mid-2024.
• In the first quarter of 2025, Novavax announced material transfer agreements with three pharmaceutical companies to explore the utility of Matrix-M in their portfolios. These arrangements have led to discussions with potential business partners to develop new vaccines and improve existing vaccines.

Strategic Priority #3: Advance our Technology Platform and Early-stage Pipeline

• In July 2025, the Company announced preclinical data demonstrating that Novavax’s H5N1 avian pandemic influenza vaccine candidate induced robust immune responses by either single or two-dose intranasal or intramuscular administration in primed non-human primates. The results were published in Nature Communications.
• Continued advancement of early-stage preclinical research for H5N1 avian pandemic influenza, respiratory syncytial virus combinations, varicella-zoster virus (shingles) and Clostridioides difficile colitis vaccine candidates.
• Generated preliminary positive data using Matrix-M with an oncology vaccine candidate with potential future application across several tumor types.
• Continued work on new potential Matrix formulations intended to improve upon and expand the utility of Matrix-M.

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 upfronts, royalties and milestone revenue under our licensing agreements including Serum Institute and SK bioscience.

Second Quarter 2025 Financial Results

• Total revenue for the second quarter of 2025 was $239 million, compared to $415 million in the same period in 2024. Licensing, Royalties and Other Revenue of $229 million in the second quarter of 2025 includes a $175 million milestone earned related to the Nuvaxovid BLA approval.
  
  
• Cost of sales for the second quarter of 2025 was $15 million, compared to $46 million in the same period in 2024.
  
  
• Research and development (R&D) expenses for the second quarter of 2025 were $79 million, compared to $107 million in the same period in 2024. The decrease was primarily due to reductions in overall expenditures related to COVID-19 vaccine development and the elimination of the related commercial manufacturing network infrastructure.
  
  
• Selling, general and administrative (SG&A) expenses for the second quarter of 2025 were $44 million, compared to $101 million for the same period in 2024. The 57% decrease was primarily due to the transition of lead commercial activities to Sanofi and the elimination of commercial infrastructure plus ongoing general administrative cost reduction efforts. 
  
  
• Net income for the second quarter of 2025 was $107 million, compared to net income of $162 million in the same period in 2024.
  
  
• Cash, cash equivalents, marketable securities and restricted cash (Cash) were $628 million as of June 30, 2025, compared to $938 million as of December 31, 2024. Receipt of the $175 million milestone earned in the second quarter of 2025 related to the Nuvaxovid BLA approval is expected in the third quarter of 2025.

Financial Framework

Nuvaxovid Postmarketing Commitment Study

As previously announced, in May 2025, our BLA for Nuvaxovid received U.S. FDA approval and with that approval came an FDA request to complete a postmarketing commitment (PMC) study. The PMC is anticipated to occur during 2025 and 2026 and cost between $70 million to $90 million to complete. Novavax will conduct this study on behalf of Sanofi and Novavax will be reimbursed approximately $55 million (at midpoint) or 70% of total costs. The Novavax cost share of approximately $25 million (at midpoint) has been absorbed within the Company’s existing combined R&D and SG&A expense targets and is capped under the agreement at the currently agreed upon costs estimates.

For Full Year 2025, this is expected to result in a $20 million increase to Adjusted Licensing, Royalties and Other Revenue, where Novavax records partner cost reimbursement as revenue, and an equal $20 million increase to combined R&D and SG&A expenses.   

Full Year 2025 Financial Guidance

Novavax provides updated Full Year 2025 Financial Guidance for combined R&D and SG&A expenses and currently expects to achieve the following results:

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