By Mariam Sunny and Michael Erman
Feb 13 (Reuters) – Moderna said it is looking for growth overseas after the U.S. FDA refused to review its experimental flu shot and the country’s top health officials have deprioritized vaccination.
The vaccine maker expects to leverage its partnership with governments in the U.K., Canada, and Australia as well as the expansion of its next-generation COVID-19 vaccine to drive growth this year.
Moderna said it sees up to 10% revenue growth in 2026 compared to a year earlier, driven primarily by international market sales.
Moderna shares were up more than 7% in morning trade.
The company said it now expects about 50% of sales to come from the U.S. and the rest from international markets. Last year, the U.S. accounted for about 62% of sales.
This follows the Food and Drug Administration’s refusal earlier this week to review Moderna’s flu vaccine application, claiming its trial design was flawed.
“Sustained regulatory uncertainty threatens U.S. leadership in innovative medicines,” CEO Stephane Bancel said, adding that the current climate could mean transformative therapies from U.S. companies will reach patients overseas before becoming available in the United States.
The company has been counting on its flu vaccine and a future COVID-flu combination shot to help it return to revenue growth.
Vinay Prasad, a COVID-vaccine critic who now serves as the FDA’s top vaccine official, said on Tuesday the company in its clinical trial should have compared the flu vaccine to a higher-dose shot often given to older people, even though that is not available in many countries where Moderna conducted its trial.
The vaccine maker criticized the move, saying the FDA had approved the trial design as adequate when the study was initiated 18 months ago.
TOUGH U.S. LANDSCAPE
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.
“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.
Kennedy, a fierce critic of the mRNA technology used in Moderna’s vaccines, oversaw the Department of Health and Human Services’ cancellation of an mRNA vaccine government contract worth $600 million last year that had been earmarked for developing vaccines against bird flu and other dangerous influenza strains through its biomedical research unit.
Moderna said last month it does not plan to invest in new late-stage vaccine trials because of growing opposition to immunizations from U.S. officials.
The company has been struggling financially as demand for COVID vaccines collapsed in the years following its pandemic windfall. It is working on newer products and cost-saving efforts to return to growth and prove the long-term viability of mRNA technology, which was used in most COVID shots, saving millions of lives.
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.
(Reporting by Mariam Sunny in Bengaluru and Michael Erman in New Jersey; Editing by Shinjini Ganguli and Bill Berkrot)
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