Moderna (NASDAQ:MRNA) executives highlighted progress on cost reductions, a ramp in international partnerships, and multiple late-stage pipeline milestones during the company’s fourth-quarter 2025 earnings call, while also addressing disappointment with a U.S. Food and Drug Administration refusal-to-file letter for its seasonal influenza vaccine candidate, mRNA-1010.
2025 results: revenue of $1.9 billion and lower operating expenses
Chief Executive Officer Stéphane Bancel said 2025 revenue totaled $1.9 billion, driven by sales of the company’s COVID-19 vaccines Spikevax and mNEXSPIKE. He also emphasized cost progress, noting operating expenses declined by $2.2 billion, or 30%, year over year. Moderna posted a net loss of $2.8 billion for 2025 and ended the year with $8.1 billion in cash and investments.
For the fourth quarter, Moderna reported a net loss of $800 million, compared to a net loss of $1.1 billion in the fourth quarter of 2024. Loss per share was $2.11 versus $2.91 a year earlier. For 2025, loss per share was $7.26 compared to $9.28 in 2024.
Mock detailed full-year expense trends, including a 41% decrease in cost of sales to $868 million, which he attributed primarily to productivity and lower inventory write-downs, contract manufacturing, wind-down costs, and sales volumes. R&D expense declined 31% to $3.1 billion due to investment prioritization and trial execution efficiencies, partially offset by increased investment in norovirus and oncology programs. SG&A expense fell 13% to $1.0 billion.
FDA refusal-to-file on flu program adds uncertainty in the U.S.
Bancel said the company was “disappointed” by the FDA refusal-to-file letter for mRNA-1010 and argued that unpredictability in expectations and timelines can slow investment and delay patient access. President Stephen Hoge said Moderna has requested a Type A meeting with the FDA to clarify a path forward for the flu program in the U.S., describing the process as typically about 30 days.
Hoge added that the company remains pleased its flu filing is under review in Europe, Canada, and Australia, and that the flu plus COVID combination vaccine (mRNA-1083) is under review in Europe and Canada. On the call, Moderna reiterated that 2026 guidance assumes no revenue from either the standalone flu vaccine or the combination flu/COVID vaccine.
In response to investor questions, executives described the data supporting the original U.S. flu submission. Hoge said the mRNA-1010 package included a randomized phase 3 efficacy study of about 41,000 participants that showed “27% superior relative vaccine efficacy” compared to a standard-dose control, and a separate phase 3 immunogenicity and safety study versus Fluzone High Dose that showed statistical superiority on immunogenicity.
Hoge also said more than 50% of participants in the phase 3 efficacy trial were age 65 or older, with more than 20,000 people over 65 enrolled, and that the company had a population “north of 10%” above age 75.
2026 framework: up to 10% revenue growth and cash ending balance of $5.5 billion to $6.0 billion
Mock outlined a 2026 financial framework calling for total revenue growth of up to 10%, driven primarily by international markets. He said the geographic mix is expected to be “well balanced” between the U.S. and ex-U.S. in 2026, a shift from the 2025 split of about 62% U.S. and 38% international. The company expects to begin selling locally manufactured products in the U.K. and Australia in 2026, which Mock described as the largest driver of international growth.
Moderna expects 2026 revenue to remain heavily weighted to the second half of the year—about 15% in the first half and 85% in the second half—reflecting seasonality. Cost of sales is projected at about $900 million, with anticipated gross margin rate improvement from manufacturing efficiencies and volume leverage. R&D is expected to be about $3.0 billion and SG&A about $1.0 billion, both roughly flat to modestly down versus 2025.
Mock said Moderna expects total GAAP operating expenses of $4.9 billion and $4.2 billion of cash costs (excluding stock-based compensation, depreciation, and amortization). Capital expenditures are projected at $200 million to $300 million, including an investment in building fill-finish capacity in the U.S. at the company’s Norwood, Massachusetts site. Moderna expects to end 2026 with $5.5 billion to $6.0 billion in cash and investments, with no additional credit facility draws assumed.
Commercial updates: mNEXSPIKE launch, strategic agreements, and Europe as a 2027 growth driver
Executives said Moderna had three marketed products in 2025: Spikevax, mNEXSPIKE, and mRESVIA (RSV). Hoge said mNEXSPIKE, approved mid-year in 2025 and initially available only in the U.S., captured 24% of the total U.S. retail COVID market and 34% of the retail market among adults age 65 and older. He described retail as the largest U.S. COVID customer segment, representing about three-quarters of the market.
Hoge also discussed multi-year strategic partnerships in the U.K., Canada, and Australia. He said Moderna expects a $200 million U.K. COVID order to be fulfilled in the first half of 2026 for a spring booster campaign, and also anticipates supplying vaccines for the U.K.’s fall campaign, initially for COVID with potential expansion to other respiratory vaccines over time. He said Canada delivered “made in Canada” COVID vaccines in 2025 and that 2026 should reflect the full annualized impact of the agreements in both Canada and Australia.
Looking further ahead, Hoge pointed to a planned expansion opportunity in Europe beginning in 2027, when Moderna expects access to what he called the $1.8 billion European respiratory vaccines market following the expiration in 2026 of a competitor pandemic contract that had excluded Moderna from the region. He said the company expects to launch mNEXSPIKE, the standalone flu vaccine, and the flu/COVID combination vaccine in Europe by the 2027 winter season, alongside already approved mRESVIA and Spikevax.
Moderna also cited recent commercial agreements, including a five-year strategic agreement with the government of Mexico for respiratory vaccine supply, a strategic agreement with Taiwan, and a global commercialization agreement with Recordati for its propionic acidemia (PA) rare disease candidate.
Pipeline: oncology and norovirus milestones, and leadership transition
On the clinical front, Bancel and Hoge highlighted progress for INT, Moderna’s individualized neoantigen therapy developed with Merck. Moderna recently reported positive five-year phase 2 data in adjuvant melanoma, which Hoge characterized as showing approximately a 50% reduction in relapse or death and “real stability” of curves through five years. He said overall survival (OS) curves will be shared at an upcoming medical meeting, without providing additional detail on the call.
Executives said enrollment has been completed in a phase 2 muscle-invasive bladder cancer study, joining fully enrolled late-stage studies in adjuvant melanoma and adjuvant renal cell carcinoma. Hoge said INT has eight phase 2 or phase 3 studies ongoing and noted that key readouts are event-driven, limiting the company’s ability to provide more precise timing beyond expectations that the adjuvant melanoma phase 3 interim analysis will occur in 2026.
In infectious disease, Moderna said its phase 3 norovirus program is fully enrolled and accruing cases toward interim analysis, with executives expressing optimism about the study design, including its placebo-controlled comparator and focus on seropositive older adults. The company also said mNEXSPIKE approvals and launches are expected in additional markets, with targets including Europe, Japan, and Taiwan.
In rare disease, executives said the PA registrational study is fully enrolled and could deliver data in 2026, while a registrational study in methylmalonic acidemia is expected to start in 2026.
Moderna also announced that Dr. David Berman will join as Chief Development Officer on March 2, succeeding Jackie Miller, whom Bancel thanked for her leadership, including during the pandemic.
About Moderna (NASDAQ:MRNA)
Moderna, Inc is a biotechnology company headquartered in Cambridge, Massachusetts, specializing in messenger RNA (mRNA) therapeutics and vaccines. The company’s platform leverages synthetic mRNA to instruct cells to produce proteins that can prevent or treat diseases. Since its founding in 2010, Moderna has advanced from early-stage research into a broad pipeline of vaccine and therapeutic candidates designed to address infectious diseases, rare genetic disorders and chronic illnesses.
Moderna’s flagship product is its mRNA-based COVID-19 vaccine, which was the first of its kind to receive emergency use authorization and later full approval in multiple jurisdictions.
