Moderna reported fourth quarter and fiscal year 2024 financial results on February 14, 2025, revealing the biopharmaceutical company's ongoing transition from pandemic-era operations to a more diversified mRNA medicine portfolio amid challenging market conditions.
Financial Performance and Outlook
For the fourth quarter of 2024, Moderna reported revenues of $1.0 billion and a GAAP net loss of $1.1 billion, or $2.91 per share. Full-year revenues totaled $3.2 billion, with a GAAP net loss of $3.6 billion, or $9.28 per diluted share.
"We have made progress in 2024 across our late-stage pipeline and cost reduction efforts. Our team successfully filed three Biologics License Applications in the final months of the year and reduced our costs by 27 percent compared to 2023," said Stéphane Bancel, Chief Executive Officer of Moderna.
The company's COVID-19 vaccine, Spikevax, generated $3.1 billion in sales for the full year, while its recently approved RSV vaccine, mRESVIA, contributed $25 million. Cash, cash equivalents, and investments stood at $9.5 billion as of December 31, 2024, down from $13.3 billion at the end of 2023.
Looking ahead to 2025, Moderna expects revenue between $1.5 billion and $2.5 billion, with approximately $0.2 billion coming in the first half of the year due to the seasonality of its respiratory business. The company projects a year-end cash balance of approximately $6 billion.
Strategic Cost Reductions
Moderna has implemented significant cost-cutting measures across its operations. Research and development expenses decreased by 6% to $4.5 billion in 2024, while selling, general, and administrative expenses fell by 24% to $1.2 billion.
"In 2025, we remain focused on driving sales, delivering up to 10 product approvals through 2027, and expanding cost efficiencies across our business. By the end of 2025, we aim to remove nearly $1 billion in costs," Bancel stated during the earnings announcement.
The company's cost of sales for 2024 was $1.5 billion, or 47% of net product sales, representing a $3.2 billion decrease compared to 2023. This improvement reflects the impact of manufacturing resizing initiatives launched in 2023.
Pipeline Progress and Regulatory Submissions
Moderna has made substantial progress with its late-stage pipeline, submitting three investigational mRNA products for regulatory approval:
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Next-generation COVID-19 vaccine (mRNA-1283): The FDA has accepted Moderna's Biologics License Application and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 31, 2025.
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RSV vaccine for high-risk adults aged 18-59 (mRNA-1345): Following positive Phase 3 data, the FDA has accepted the BLA with a PDUFA goal date of June 12, 2025. The vaccine is already approved for adults aged 60 and older.
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Flu/COVID combination vaccine (mRNA-1083): Moderna has filed for regulatory approval based on positive Phase 3 immunogenicity data for adults aged 50 years and older.
Additionally, several other programs are advancing through clinical development:
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Seasonal flu vaccine (mRNA-1010): A two-season Phase 3 efficacy study is ongoing, with potential readout dependent on case accrual.
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Cytomegalovirus (CMV) vaccine (mRNA-1647): The pivotal Phase 3 study is fully enrolled and accruing cases, with efficacy data anticipated in 2025.
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Norovirus vaccine (mRNA-1403): A two-season Phase 3 study is fully enrolled in the Northern Hemisphere, though currently on FDA clinical hold following a single adverse event report.
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Individualized Neoantigen Therapy (INT) (mRNA-4157): In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled, with additional studies for non-small cell lung cancer, bladder cancer, and renal cell carcinoma ongoing.
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Rare disease therapeutics: Programs for propionic acidemia (mRNA-3927) and methylmalonic acidemia (mRNA-3705) continue to advance, with registrational studies underway or planned for 2025.
Market Position and Recognition
Despite financial challenges, Moderna continues to receive recognition for its workplace culture, topping BioSpace's Best Places to Work in Biopharma ranking for the fourth consecutive year.
The company has also secured a framework agreement with the European Union, Norway, and North Macedonia that provides 17 participating countries a framework for tendering for Moderna's mRNA COVID-19 vaccine for up to four years.
"With strong momentum in our late-stage pipeline, we anticipate multiple approvals starting this year, along with key Phase 3 readouts that will support our long-term growth," Bancel concluded.
Moderna's strategic focus on respiratory vaccines, rare diseases, oncology, and latent viruses positions the company to potentially deliver up to 10 product approvals through 2027, as it navigates the transition from its pandemic-era business model to a more diversified portfolio of mRNA medicines.
