Moderna’s plans to reach breakeven by 2028 have been disrupted after the U.S. Food and Drug Administration (FDA) declined to review its application for the influenza vaccine mRNA-1010, executives said during the company’s fourth quarter earnings call.
Chief Financial Officer Jamey Mock acknowledged that investors are concerned about the company’s financial outlook following what he described as a “fresh and fluid situation.” Mock stated, “I recognize that it’s on investors’ minds. This is a bit of a fresh and fluid situation, and without understanding the resolution of what is next for our flu product, it’s a little bit difficult to comment at this time.”
Despite uncertainty around its flu vaccine in the U.S., Moderna expects 10% topline revenue growth in 2026, driven largely by contracts outside of the country. Mock also highlighted that ten products in Moderna’s pipeline could start generating revenue over the coming years. “We have 10 large shots on goal to increase revenue over the coming years, all with a wide range of potential outcomes,” he said.
The FDA recently issued a Refusal-to-File letter regarding mRNA-1010, an unusual move that led to a decline in Moderna shares earlier in the week. The letter was signed by Vinay Prasad, chief of the FDA's Center for Biologics Evaluation and Research (CBER), who reportedly overruled other regulators.
During the call, Moderna President Stephen Hoge confirmed that CBER would oversee regulatory review for another key candidate: personalized cancer vaccine intismeran autogene (INT), which is being developed with Merck. Hoge noted that other offices would be involved due to INT's significance as an oncology therapy but described interactions so far as “highly productive engagement.”
Merck remains responsible for running INT’s Phase 3 trial in melanoma under their existing partnership agreement. If successful, Merck will handle any subsequent biologics license application.
Moderna CEO Stéphane Bancel expressed disappointment with the FDA decision and emphasized broader challenges posed by unpredictable regulatory timelines. “The current uncertainty in the U.S. FDA regulatory environment creates real challenges for businesses, patients and the broader innovation ecosystem,” Bancel said during his prepared remarks. “When expectations and review timelines are unpredictable, companies face greater risk and can hesitate to invest, slowing the development of breakthrough medicines.”
Bancel added that such roadblocks may lead companies like Moderna to prioritize regulatory filings outside of the United States.
With its U.S. plans delayed, Moderna intends to refile mRNA-1010 pending further feedback from regulators but is now focusing on markets including Europe, Canada, and Australia where applications are already underway or approvals could arrive by year-end. Executives expect revenues from these regions could begin contributing during the 2027–2028 seasonal flu season.
Additionally, Moderna has submitted its combination flu-COVID vaccine mRNA-1083 in Europe and Canada while waiting for clarity from U.S. regulators; both vaccines may be approved internationally before advancing domestically.
Hoge noted that Pfizer and BioNTech had previously locked up European COVID-19 vaccine supply through their Comirnaty contract—set to expire this year—potentially allowing Moderna's second-generation COVID shot mNEXSPIKE entry into those markets alongside new respiratory disease products.
Despite ongoing regulatory issues, Moderna reported quarterly revenues above analyst expectations at $645 million—primarily from COVID vaccines Spikevax and mNEXSPIKE—and full-year revenue of $1.94 billion.
However, losses continue: The company posted a net loss of $826 million for Q4 (less than analysts predicted) and $2.8 billion for all of last year. To address these losses, Bancel said cost-cutting efforts are underway across operations using artificial intelligence tools.
