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Moderna Expands Cost-Cutting Program By Up To $1.7 Billion, FDA Approval For Flu/COVID-19 Combo Shot Delayed Into 2026

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Moderna Expands Cost-Cutting Program By Up To $1.7 Billion, FDA Approval For Flu/COVID-19 Combo Shot Delayed Into 2026

Moderna Inc. (NASDAQ:MRNA) reported on Thursday a first-quarter EPS loss of $(2.52), missing the consensus of $(3.12), down from an EPS loss of $(3.07) a year ago.

The COVID-19 vaccine maker reported quarterly sales of $108 million, down from $167 billion a year ago, beating the consensus of $106.20 million.

The decline was primarily driven by lower net product sales, which totaled $86 million in the quarter.

The reduction in product sales reflects lower vaccination rates compared to the same period last year and the continued normalization of COVID-19 into a seasonal commercial market, with demand expected to be concentrated in the second half of the year.

Also Read: Trump-Era FDA Appointees Request New Trials For Novavax COVID Vaccine, Reportedly Delaying Approval Timeline

The company reported $84 million in Spikevax sales in the first quarter of 2025, including $29 million in the U.S. and $55 million in international sales.

The company reported $2 million in mRESVIA sales in the first quarter of 2025. Moderna’s RSV vaccine for adults 60 and older was recently approved in Australia, Switzerland, Taiwan and the U.K.

The cost of sales for the fourth quarter of 2024 was $739 million, which included third-party royalties of $45 million, inventory write-downs of $193 million, and wind-down costs of $259 million, including a non-cash charge of $238 million related to the termination of a contract manufacturing agreement.

Guidance: Moderna has reiterated its 2025 revenue outlook of $1.5 billion to $2.5 billion, compared to a consensus of $2.14 billion. Moderna expects revenue of approximately $0.2 billion in the first half of the year, reflecting the seasonality of its respiratory business.

Moderna expanded its cost efficiency and prioritization programs and expects estimated GAAP operating costs of $5.4 to $5.7 billion in 2026, a reduction from the company’s previous estimate of $5.9 billion.

The company is announcing a new 2027 GAAP operating cost estimate of $4.7 to $5 billion, reducing estimated operating costs by $1.4 to $1.7 billion by 2027 compared to its 2025 estimate.

Moderna shared Phase 3 immunogenicity data for its flu/COVID combination vaccine (mRNA-1083) for adults aged 50 and older at its 2024 R&D Day event. 

The company submitted mRNA-1083 for regulatory approval in older adults in 2024. Based on FDA feedback confirming the need for Phase 3 flu efficacy data, Moderna expects an extended review timeline and is now targeting approval in 2026.

Moderna has deprioritized its flu/COVID combination vaccine (mRNA-1083) for adults aged 18-49.

MRNA Price Action: Moderna stock was down 4.52% at $27.25 at publication on Thursday.

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