Novavax raises 2026 revenue outlook, flags Sanofi trial talks and C. diff progress

Novavax said Sanofi confirmed with Novavax they intend to be among the first movers in the combination vaccine segment and that they are in advanced discussions with regulators regarding their Phase 3 COVID-19-Influenza Combination (CIC) trial timing.¹ Initiation of this trial in the U.S. or European Union will trigger a $125 million milestone to Novavax.¹

On manufacturing, technology transfer to Sanofi for Nuvaxovid is expected to be completed in mid-2027, which would trigger a $75 million milestone payment to Novavax.¹ The company also said Sanofi received Fast Track designation from the FDA for its H5 pandemic influenza vaccine candidate (SP0335) utilizing Matrix-M.¹

On its own pipeline, Novavax said it advanced its differentiated C. difficile vaccine candidate into pre-IND interactions with the FDA and initiated GMP manufacturing process, supporting potential clinical entry as early as 2027.¹

Novavax raised its financial outlook. For 2026, Novavax raised its 2026 Revenue Framework and expects to achieve Adjusted Total Revenue to between $235 million and $275 million.¹ On expenses, the company narrowed its guidance, with Combined R&D and SG&A Expenses now expected at $370 million to $410 million, down from a prior range of $380 million to $420 million, while Non-GAAP Combined R&D and SG&A Expenses guidance was maintained at $310 million to $340 million.¹

On cash, the company reported cash, cash equivalents, marketable securities and restricted cash of $724 million as of June 30, 2026, compared to $751 million as of December 31, 2025.¹

Total revenue for the quarter was $57 million, and Novavax attributed the year-over-year change to the prior year's second quarter 2025 total revenue including the benefit of $202 million from the combination of a $175 million milestone earned for the Nuvaxovid U.S. Biologics License Application (BLA) approval and a $27 million Takeda amendment.¹