Moderna Pops On Fourth-Quarter Report, But Can It Overcome Recent FDA Setbacks?

Moderna (MRNA) stock popped Friday after the company reported better-than-expected fourth-quarter sales and reiterated its guidance for 10% sales growth in 2026.

But the company was mum on the prospects for it to hit break-even in 2028. Earlier this week, the Food and Drug Administration refused to review Moderna’s experimental flu vaccine, saying the company’s study was insufficient. The flu vaccine was expected to be a big contributor to sales.

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“We believe recent U.S. regulatory setbacks for mRNA-1010 (flu vaccine) and potentially mRNA-1083 (combo flu/COVID) could pressure this prior guidance,” William Blair analyst Myles Minter said in a report.

Moderna stock jumped 5.3%, closing at 42.23 on Friday. That followed a 3.5% tumble on Wednesday after the FDA refused to file the flu vaccine.

Better-Than-Expected Quarter For Moderna Stock

During the fourth quarter, Moderna lost $2.11 per share. But analysts expected a steeper $2.55 per-share loss, according to FactSet. Losses also narrowed from $2.91 a share in the year-earlier quarter.

Sales came in at $678 million, sliding 30% from the same three months in 2024. But that still topped the Street’s forecast for a bigger drop to $652.5 million.

In fact, Moderna’s products generated $1.94 billion in full-year sales — more than $100 million above the midpoint of the company’s original 2025 revenue guidance for $1.6 billion to $2 billion. That was driven by stronger-than-anticipated sales of Covid vaccines Spikevax and mNexspike.

For this year, Moderna projects 10% sales growth.

This is “largely due to ex-U.S. vaccine contracting opportunities,” William Blair’s Minter said. “The revenue split is expected to be 50:50 U.S. to International sources.”

That’s better than analysts’ projections for $2.02 billion in sales next year, up just 4%.

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Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.

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