Moderna Reports Q4 2025 Results, Cuts Costs 30% Amid FDA Flu Vaccine Setback

Moderna reported 2025 revenue of $1.9 billion, with Q4 sales of $700 million landing at the high end of guidance. The company reported a statutory loss of $7.26 per share, 8.0% smaller than expected, beating consensus estimates. The U.S. contributed $1.2 billion, or about 62% of full-year revenue, while international markets added $700 million.

The company's net loss narrowed to $2.8 billion from $3.6 billion, with loss per share improving roughly 22% to $7.26. Moderna ended 2025 with $8.1 billion in cash and investments, or $7.6 billion excluding a credit draw. Management expects cash and investments to decline further to $5.5-6.0 billion by the end of 2026.

Operating expenses declined $2.2 billion, or 30%, for the year and 31% lower in Q4 versus last year. Cost of sales dropped 41% to $868 million, R&D fell 31% to $3.1 billion, and SG&A declined 13% to $1.0 billion, beating the original 2025 savings plan by over $1 billion.

A key setback from the earnings call was the U.S. regulator's refusal to file Moderna's seasonal flu vaccine application. The company has requested a follow-up meeting, but the timeline and requirements to resubmit remain unclear, raising questions around U.S. flu market entry. Management expressed concerns about U.S. regulatory unpredictability, warning that approvals could increasingly arrive abroad before the domestic market.

The MNEXT Spike COVID vaccine launch in the U.S. was a bright spot, capturing 24% of the retail market and 34% among adults 65 and older. Approvals in Canada and Australia position the product as the core commercial engine while the broader portfolio develops.

For 2026, management outlined a framework targeting up to 10% revenue growth, driven largely by international markets and a more balanced regional mix. The company expects revenue to be heavily back-half weighted, with roughly 15% in the first half and 85% in the second half. Because of flu uncertainty, the 2026 outlook assumes no U.S. revenue from the standalone flu vaccine or the flu-COVID combo.

Moderna announced two commercial agreements in recent weeks. The company signed an agreement with Recordati for the global commercialization of its propionic acidemia rare disease candidate, currently in a pivotal study. The company also announced a 5-year strategic agreement with the government of Mexico for respiratory vaccine supply.

The company's seasonal flu vaccine is filed and under review in Europe, Canada and Australia. The flu plus COVID combination vaccine is filed and under review in Europe and Canada.

On the pipeline, Moderna highlighted 5-year phase 2 data for its individualized cancer therapy in adjuvant melanoma, showing about a 50% reduction in relapse or death. Multiple late-stage oncology trials plus fully enrolled phase 3 programs in norovirus and propionic acidemia set up a slate of important potential readouts in 2026.

The company is broadening its geographic and product footprint through partnerships and local manufacturing. Local production deals in the U.K., Canada, and Australia are expected to contribute meaningfully from 2026 onward.

Following the latest results, the consensus from 22 analysts is for revenues of $2.05 billion in 2026, implying a 5.3% increase over the past 12 months. The loss per share is expected to ameliorate slightly, reducing to $6.63. The average price target rose 5.4% to $40.90.

Shares of Moderna rose 5.3% on Feb. 13, as investors showed renewed interest in large-cap biotech names. The stock closed at $42.23, near its 52-week low of $29.25. The advance stood out against a choppy broader market, suggesting traders were selectively rotating into healthcare stocks. Moderna triggered a bullish reversal of its long-term downtrend in mid-January, with a breakout above $35.59.

Multiple analysts maintained Hold ratings on the stock following the earnings release. The consensus analyst rating for Moderna is a Hold with an average price target of $32.25.