Aug 6, 08:02 PM

Novavax Raises 2025 Revenue Outlook After FDA Nod, $175 Million Sanofi Boost

Novavax reported second-quarter revenue of $239 million, more than 50 % above Wall Street expectations, and swung to net income of $106.5 million. The performance was driven chiefly by a $175 million milestone payment from Sanofi that followed U.S. regulatory clearance of Nuvaxovid, the only recombinant protein-based, non-mRNA COVID-19 vaccine available in the country. The U.S. Food and Drug Administration granted biologics licence approval for Nuvaxovid in May, covering adults aged 65 and older as well as at-risk adolescents and adults. Under the firms’ co-exclusive agreement, Sanofi assumes lead commercial responsibility for the 2025-26 season and will reimburse about 70 % of a $70-90 million post-marketing safety study. Novavax has already transferred U.S. commercial leadership and expects additional $50 million milestones when marketing authorisations are handed over in the United States and European Union later this year. Buoyed by the FDA decision and the Sanofi payment, Novavax raised its 2025 adjusted revenue outlook to $1.0-1.05 billion from a previous $975 million–$1.025 billion range. Management cited continued demand for Nuvaxovid, progress on early-stage partnerships and encouraging Phase 3 immunogenicity data for its COVID-19-influenza combination and stand-alone influenza vaccines. The Maryland-based company ended June with $628 million in cash and said current resources, together with milestone inflows, will fund operations through the next several clinical and regulatory milestones.