Business
Novavax Reports First Quarter 2025 Financial Results and Operational Highlights
FDA feedback on COVID-19 BLA suggests pathway to approval upon alignment on study parameters for the postmarketing commitment requested by FDASHIELD-Utah
About this update from Novavax, Inc.
[{"type":"text","content":"FDA feedback on COVID-19 BLA suggests pathway to approval upon alignment on study parameters for the postmarketing commitment requested by FDASHIELD-Utah study demonstrates that Nuvaxovid® resulted in fewer and less severe reactogenicity symptoms when compared to marketed mRNA vaccine; Nuvaxovid recipients experienced approximately 39% fewer symptoms on averageData presented at World Vaccine Congress showcases Matrix-M® utility when co-administered with a broad array of vaccine platforms and diseasesStrengthened partnership with Takeda in Japan, the third largest pharmaceutical market, with significant improvement in financial termsRaises full year 2025 revenue framework to between $975 million and $1,025 million Reiterates full year 2025 financial guidance for combined R&D and SG&A expenses of between $475 million and $525 millionRecorded total revenue of $667 million in the first quarter of 2025Company to host conference call today at 8:30 a.m. ETGAITHERSBURG, Md., May 8, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced its financial results and operational highlights for the first quarter ended March 31, 2025.\n\"I am pleased with the progress we have made in the first quarter on our corporate growth strategy,\" said John C. Jacobs, President and Chief Executive Officer, Novavax. \"We remain focused on creating shareholder value as we advance our three priorities for the year – optimizing our partnership with Sanofi, advancing new and existing partnership opportunities and continuing the development of our early-stage organic pipeline.\" \nFirst Quarter 2025 and Recent Highlights\nStrategic Priority #1: Sanofi Partnership\nCOVID-19 Biologics License Application (BLA) under review by the U.S. Food and Drug Administration (FDA). In April 2025, we received an information request for a postmarketing commitment (PMC) for a clinical trial. Discussions with the FDA regarding our proposed study design are ongoing and we believe our BLA is approvable upon alignment on the details of the PMC.Achievement of BLA approval triggers a $175 million milestone payment from Sanofi.Transfers of marketing authorization to Sanofi for U.S. and European Union (EU) markets, assuming approvals in each jurisdiction, are expected in Q4 2025 and trigger an additional $50 million in combined milestones from Sanofi.Strategic Priority #2: L...