Novavax secures FDA approval for COVID-19 vaccine

GAITHERSBURG, MD – Novavax Inc. (NASDAQ:NVAX), currently trading at $6.73 and showing strong financial health according to InvestingPro metrics, announced on Monday that the U.S. Food and Drug Administration (FDA) has approved its Biologics License Application for Nuvaxovid™. This approval allows for the active immunization to prevent COVID-19 in adults aged 65 and older, as well as individuals aged 12 through 64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

The FDA approval, dated May 16, 2025, has triggered a $175 million milestone payment from Sanofi (NASDAQ:SNY) Pasteur Inc. under the Collaboration and License Agreement signed in May 2024. This payment will further strengthen Novavax’s already solid balance sheet, with InvestingPro data showing the company holds more cash than debt and maintains a healthy current ratio of 2.06. Furthermore, the FDA has requested a new Phase 4 trial to evaluate the vaccine’s efficacy and safety in a broader age group without high-risk conditions.

In its first-quarter earnings call for 2025, Novavax provided multi-year guidance, including the potential impact of funding the postmarketing commitment (PMC) associated with the FDA’s request. The company reiterated its expectation to achieve R&D plus SG&A expenses for the full year 2025 of between $475 and $525 million. For 2026 and 2027, it expects to reduce these expenses to approximately $350 million and $250 million, respectively. The financial guidance will reflect GAAP R&D and SG&A expenses or Non-GAAP R&D and SG&A, depending on whether Sanofi or Novavax leads the PMC trial and incurs its expenses.

Novavax is preparing for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in the U.S. in the Fall, in partnership with Sanofi, pending strain recommendation at the FDA Vaccines and Related Biological Products Advisory Committee meeting scheduled for May 22, 2025.

The company’s forward-looking statements include expectations about vaccine efficacy, safety, and utilization, as well as achieving further milestones under the Sanofi agreement. With a robust gross profit margin of 58.37% and analysts predicting continued profitability, Novavax appears well-positioned despite trading below its InvestingPro Fair Value. These statements are subject to various risks and uncertainties, including regulatory challenges, supply constraints, and the outcomes of clinical trials. For deeper insights into Novavax’s financial health and growth potential, investors can access comprehensive analysis through InvestingPro’s detailed research reports, available for over 1,400 US stocks.

This news is based on a press release statement and the information provided in the Form 8-K filed with the Securities and Exchange Commission.

In other recent news, Novavax Inc. reported strong financial results for the first quarter of 2025, significantly exceeding market expectations. The company announced earnings per share of $2.93, surpassing the anticipated loss of $0.43, and reported revenue of $667 million, which was well above the expected $251.8 million. This financial performance marks a substantial increase from the $94 million in revenue reported in the same quarter of the previous year. Additionally, Novavax received approval from the U.S. Food and Drug Administration for its Biologics License Application for the Nuvaxovid COVID-19 vaccine, allowing its use in high-risk groups. This approval triggered a $175 million milestone payment from Sanofi, a key partner in the vaccine’s commercialization efforts. Analysts have noted the significance of the FDA’s approval, highlighting the potential for Novavax to capture a unique segment of the vaccine market with its non-mRNA option. Furthermore, the company is preparing for the commercial release of the 2025-2026 COVID-19 vaccine formula in the U.S., pending further FDA recommendations. Novavax has also raised its 2025 revenue guidance to a range of $975-$1,025 million, reflecting confidence in its strategic direction and growth prospects.

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