Moderna (MRNA) FY2025 results: revenue $1.9 billion, down 39.9% on the year

Moderna works in mRNA medicine, using a single technology platform to develop vaccines and therapeutics across infectious disease, oncology and rare disease. The filing describes the company as a pioneer and leader in the field. There are three commercial products: the COVID vaccines Spikevax and mNEXSPIKE, and mRESVIA, a vaccine against respiratory syncytial virus for older adults and high-risk adults aged 18 to 59. mNEXSPIKE was launched commercially in the third quarter of 2025 and the company states that it is now the leading product in the United States retail channel.

The COVID vaccines

Spikevax came first. The FDA approved mNEXSPIKE in May 2025 for people 65 and over and for those aged 12 to 64 at high risk of severe COVID-19, and it concentrates the immune response on the domains of the SARS-CoV-2 spike protein that matter for neutralising antibody and T cell responses, using one-fifth of Spikevax's mRNA dose. Phase 3 data shared in April 2025 showed efficacy non-inferior to Spikevax and 13.5 percent relative vaccine efficacy against it in participants 65 and over. Because the virus keeps changing, the company develops variant-specific versions each season, following direction from the FDA, the European Medicines Agency and the World Health Organization. The 2025-2026 formulas of both vaccines target the LP.8.1 variant, and the Spikevax formula has been approved in 40 countries.

The pipeline

In infectious disease, regulatory filings are under review for a seasonal flu and COVID combination candidate in Europe and Canada, and for a seasonal flu candidate in the United States, Europe, Canada and Australia. On the flu candidate, after a Refusal-to-File letter the company met the FDA and submitted an amended biologics licence application with a revised pathway by age, seeking full approval for adults 50 to 64 and accelerated approval for adults 65 and over plus a post-marketing study in older adults; the FDA accepted the application with a goal date of 5 August 2026. A second Northern Hemisphere cohort has completed enrolment in the Phase 3 study of a norovirus candidate. In oncology the lead programme is intismeran autogene, an individualised neoantigen therapy run with Merck alongside Merck's pembrolizumab, with eight Phase 2 and Phase 3 trials under way across multiple tumour types; five-year Phase 2b data announced in January 2026 showed sustained improvement in recurrence-free survival in high-risk melanoma after complete resection. The company is also advancing a cancer antigen therapy designed to elicit T-cell responses against tumour and immunosuppressive cells. In rare disease, a propionic acidemia therapeutic has reached target enrolment in a registrational study and is now partnered with Recordati under a January 2026 collaboration covering the final stages of development and, if approved, global commercialisation.

Manufacturing

Manufacturing supports every stage, from drug substance and drug product for platform research, through material for toxicology studies and early human trials, to Phase 3 supply and commercial production, the last of these done alongside contract manufacturing organisations inside and outside the United States. The in-house campus is the Moderna Technology Center in Norwood, Massachusetts, a multi-building site the company purchased outright in December 2024 and which supplies preclinical research, toxicology, early and late clinical development, and commercial drug substance for vaccines. Construction began at that campus in 2025 for commercial drug product manufacturing and packaging, to give end-to-end capability on one site. A separate facility at Marlborough, Massachusetts was purpose-built for intismeran and began clinical batch supply in September 2025. Production sites have been streamlined into a single global network since 2022.

Selling it

There are commercial subsidiaries in key markets across North America, Europe and the Asia-Pacific region, with local teams where respiratory vaccine use is high, and third-party distributors and commercial alliances in countries without a direct presence. The filing describes the markets for these vaccines as seasonal, with a fragmented end customer base, unpredictable orders and uneven delivery timing, particularly in the United States, which is the largest market, and notes that the private vaccine market involves rebates, discounts and returns. Demand depends on medical need, viral evolution, public health authority recommendations and how motivated people are to vaccinate. Three mRNA manufacturing facilities built and managed by the company in the United Kingdom, Canada and Australia were fully licensed in 2025, and the government of each of those countries has entered a multi-year commitment to buy mRNA products.

From Moderna's annual report on Form 10-K for the year ended 31 December 2025. The filing

Written from the 10-K filed 20 February 2026: read the full 10-K.