Moderna reported better-than-expected fourth quarter sales and affirmed revenue growth estimates for 2026 despite soft demand for its COVID-19 vaccine and recent, high-profile pushback from the Food and Drug Administration.
The biotechnology company said Friday it recorded revenue of $678 million over the final three months of last year and $1.9 billion for all of 2025, figures that came at the higher end of a projected forecast from November. U.S. sales more than halved between the third and fourth quarters, but still made up more than 60% of Moderna’s full-year revenue, in part because of the successful launch of the COVID shot mNEXSPIKE and a strong U.S. retail COVID vaccine market.
Moderna reiterated its predicted growth of 10% in 2026, though revenue is expected to come “primarily from international markets,” Chief Financial Officer Jamey Mock said on a call with investors Friday. The guidance accounts for a decline in COVID vaccinations, and assumes no revenue from the company’s influenza or combination COVID-plus-flu shots.
That combo shot, as well as Moderna’s standalone flu vaccine, are under review in international markets. The two were projected to diversify the company’s slate of approved products, but have faced a challenging regulatory environment in the U.S.
Earlier this week, Moderna received a “refuse-to-file” letter for its flu vaccine, mRNA-1010, signed by top FDA official Vinay Prasad. The letter stated the agency would not consider approval because of the comparator Moderna chose to test the shot against in its Phase 3 trial. Moderna said the rationale from the agency was “inconsistent” with prior guidance, and has requested a Type A meeting to discuss the decision.
In an investor call Friday, Moderna president Stephen Hoge said the company does not know how quickly it can move forward with mRNA-1010 in the U.S. until the meeting.
Analysts are wary. In a note to clients Tuesday, RBC Capital Markets analysts Luca Issi and Lisa Walter wrote that they “struggle to see a scenario where current FDA leadership reverses course.” Meanwhile, Mani Foroohar of Leerink Partners sees the FDA letter as reflective of a “maximum pressure” campaign by current leadership at the FDA and Health and Human Services Department.
“We absolutely feel that American seniors should have access to the same innovations” as other markets, Hoge said. When it comes to choosing strains to target for the influenza season, it is “particularly important that technologies like Moderna’s mRNA platform are used to advance new and potentially improved products.”
The company is additionally looking toward trial results for its vaccines against norovirus and melanoma. Foroohar argues the readouts could put the candidates “in focus to diversify the story away from respiratory vaccines.”
Moderna shares were up nearly 9%, to hover around $43.65 apiece, in late morning trading Friday.
