Moderna Pivots to International Markets After FDA Rejects Flu Vaccine Application
Key Insights
Moderna is shifting focus to international markets after the FDA refused to review its experimental flu vaccine (search) application, citing flaws in trial design.
The company forecasts up to 10% revenue growth in 2026 driven primarily by international sales, with U.S. revenue share dropping from 62% to roughly 50%.
Moderna reported fourth-quarter revenue of $678 million, beating Wall Street estimates of $626.1 million, while advancing its oncology pipeline including a skin cancer (search) vaccine with partner Merck (search).
Moderna announced a strategic pivot toward international markets following the U.S. Food and Drug Administration's refusal to review its experimental flu vaccine (search) application, citing flaws in the trial design. The vaccine maker expects to leverage partnerships with governments in the U.K., Canada, and Australia, along with expansion of its next-generation COVID-19 vaccine, to drive growth this year.
The company forecasts up to 10% revenue growth in 2026 compared to last year, driven primarily by international sales. Moderna now expects roughly half its revenue to come from the U.S., down from about 62% last year. Shares rose more than 10% on Friday after initially falling as much as 12% following the FDA's flu shot rejection.
Regulatory Challenges Reshape Strategy
The FDA's refusal earlier this week to review Moderna's flu vaccine (search) application has forced the company to reconsider its U.S.-focused growth strategy. Vinay Prasad, a COVID (search)-vaccine critic who now serves as the FDA's top vaccine official, said the company should have compared the flu vaccine to a higher-dose shot often given to older people in its clinical trial, even though that formulation is not available in many countries where Moderna conducted its trial.
"The company said the FDA had deemed the trial design adequate when the study began 18 months ago," according to the report. CEO Stephane Bancel criticized the regulatory environment, stating that "sustained regulatory uncertainty threatens U.S. leadership in innovative medicines," adding that the current climate could mean transformative therapies from U.S. companies will reach patients overseas before becoming available in the United States.
Policy Changes Impact mRNA Development
Sweeping changes to U.S. vaccine policy under Health Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, have led to reduced vaccine usage and reshaped the regulatory landscape for companies developing new shots. Kennedy, a fierce critic of the mRNA technology used in Moderna's vaccines, oversaw the Department of Health and Human Services' cancellation of a $600 million government contract to develop mRNA vaccines (search) against avian flu (search) and other high-risk strains.
"When expectations and review time lines are unpredictable, companies face greater risk and can hesitate to invest, slowing the development of breakthrough medicines," Bancel said on a call with analysts. Moderna announced last month it would halt new late-stage vaccine investments due to growing opposition from U.S. officials.
Diversification Beyond Vaccines
The company has been counting on its flu vaccine (search) and a future COVID (search)-flu combination shot to help return to revenue growth as demand for COVID vaccines collapsed in the years following the pandemic revenue windfall. Moderna shares have plummeted 90% from 2021 highs.
Moderna is now betting heavily on oncology and rare diseases, advancing individualized cancer vaccines with partner Merck (search) and exploring mRNA therapeutics for metabolic disorders (search). Analysts are awaiting late-stage data, possibly this year, on skin cancer (search) vaccine intismeran autogene. Barclays analysts said a successful outcome from the study could significantly improve sentiment and potentially double the share price.
Financial Performance
Moderna reported fourth-quarter revenue of $678 million, above Wall Street estimates of $626.1 million, based on LSEG data. The company reported a quarterly loss of $2.11 per share, compared with a $2.91 per share loss a year earlier. Barclays analysts noted that while the FDA refusal adds uncertainty to Moderna's U.S. respiratory franchise, COVID (search) vaccine revenue may edge higher overseas in 2026.
The company is working to cut costs and advance new products to return to growth and prove the long-term viability of mRNA technology, which was used in most COVID (search) shots and credited with saving millions of lives during the pandemic.