Moderna says FDA has been constructive, but delays flu/COVID shot

By Patrick Wingrove and Michael Erman

(Reuters) -Moderna on Thursday pushed back the time frame for likely approval of a combination vaccine meant to protect against both COVID-19 and influenza, but said exchanges with U.S. drug regulators have remained constructive under Health Secretary and vaccine skeptic Robert F. Kennedy Jr.

The U.S. vaccine maker reported first-quarter profit and sales that beat Wall Street estimates, as the company’s cost-cutting efforts offset some of the waning post-pandemic demand for its COVID shot. It said it plans to cut more costs over the next two years.

The company’s shares, which have been battered by declining COVID revenue as well as political concerns spurred by Kennedy’s appointment, fell 3.3% to $27.60 in morning trading. They have lost over 90% of their value since their pandemic-era highs.

"It really has been business as usual," Moderna (NASDAQ:MRNA) President Stephen Hoge said of exchanges with the U.S. FDA during a call to discuss quarterly results.

He said the company has not seen any sign that the review of its next-generation COVID vaccine, which the FDA has targeted to finish by the end of May, will take longer than expected.

"Those assessments have, we believe, been constructive and positive," Hoge said.

Investor concerns about the prospects for new vaccines under the Trump administration have been on the rise following a regulatory delay for Novavax (NASDAQ:NVAX)’s rival COVID-19 vaccine. The FDA had set an approval decision goal of April 1 for the Novavax shot and missed that deadline.

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Jefferies analyst Michael Yee said after the conference call that these concerns about Moderna remained.

"Overall, changes by HHS bring uncertainty for the landscape and investors," he said.

Moderna said on Thursday it now does not expect regulatory approval for its combination flu/COVID-19 shot until 2026, after the FDA said it required late-stage data demonstrating the shot’s efficacy against the flu. Moderna previously said it hoped to launch the vaccine for the autumn respiratory disease season in 2025 or 2026.

DRIVEN BY COST CUTTING

The Cambridge, Massachusetts-based drugmaker said it plans to cut its operating costs by as much as $1.7 billion by 2027. It said it expects operating costs for 2027 to be between $4.7 billion and $5 billion.

Finance chief James Mock said in an interview that Moderna expects costs to fall as it completes several late-stage vaccine trials.

Moderna posted an adjusted loss of $2.52 per share for the quarter, smaller than analysts’ estimates for a loss of $3.14 per share, according to LSEG data. Mock said the smaller-than-expected loss was all driven by cost cutting.

The company brought in $108 million in quarterly revenue, down 35% from last year but slightly ahead of analysts’ expectations of $106.2 million.

The company’s Spikevax COVID shot generated $84 million in sales, while $2 million came from sales of mRESVIA, its RSV vaccine. Analysts had expected sales of $75.67 million and $3.3 million, respectively for Spikevax and mRESVIA.

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Moderna has been banking on revenue from newer mRNA shots to make up for falling sales of its COVID vaccine and less-than-expected uptake of its respiratory syncytial virus vaccine, which sent shares down nearly 60% last year.

Drugmakers have also been grappling with the prospect of sector-specific tariffs, following the Trump administration’s decision to launch a probe into pharmaceutical imports that sets the stage for levies on the industry.

Mock said the tariff policies in place now will have a "very immaterial" impact on Moderna, as all of the company’s drug substance for the U.S. market is made in Massachusetts.

Moderna reiterated its full-year 2025 product sales forecast of $1.5 billion to $2.5 billion, with most expected in the second half of the year. The company had previously said it expected $200 million of its forecast revenue for 2025 to come in during the first half of the year.

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