Moderna (NASDAQ:MRNA) reported a massive full-year loss and revealed a significant regulatory setback in the U.S., as the Food and Drug Administration refused to review its experimental flu vaccine, complicating the biotech’s path to profitability.
The Cambridge, Massachusetts-based company posted a GAAP net loss of $2.8 billion for 2025 on revenue of $1.9 billion.
While the revenue figure landed at the high end of previous guidance, the company continues to grapple with the steep decline in COVID-19 related income.
In response, CEO Stéphane Bancel has overseen an aggressive restructuring, stripping $2.2 billion in annual operating expenses from the business in 2025—surpassing internal targets as the firm aims for cash breakeven by 2028.
However, the spotlight shifted to a regulatory hurdle after the FDA issued a "Refusal-to-File" letter for Moderna’s seasonal influenza vaccine.
The agency reportedly took issue with the trial’s control arm, which utilized a standard-dose vaccine rather than what it deemed the "best-available standard of care."
Moderna has requested a Type A meeting to contest the decision, noting that the vaccine has already been accepted for review in Europe, Canada, and Australia.
Despite the U.S. flu delay, Moderna reiterated its 2026 outlook, targeting revenue growth of up to 10% driven by its seasonal franchise.
The company ended the year with $8.1 billion in cash and investments, a liquidity cushion bolstered by a $600 million draw on a new term loan facility.
Meanwhile, management is betting heavily on a late-stage pipeline that includes a fully enrolled Phase 3 norovirus trial and multiple readouts in oncology and rare diseases expected throughout 2026.
The 2025 results highlight the high-stakes transition Moderna is navigating.
While it successfully launched its third product, the RSV vaccine mRESVIA, and narrowed its 2025 GAAP operating expenses to approximately $5.1 billion, the FDA’s unexpected stance on the flu filing raises questions about the timing of the company's next major revenue catalyst in its home market.