Moderna, Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 13 February 2026: press release. Guidance figures: 3 new, 1 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Q4 revenue fell 30% year over year: Fourth-quarter revenue was $678 million, down 30% from the prior-year quarter, mainly on lower COVID vaccine sales volume. The company said revenue was on the higher end of its prior expectations. Source
• Full-year revenue fell 40%: Full-year 2025 revenue was $1.9 billion, down 40%. The majority came from COVID vaccine sales. Source
• R&D spending fell 31%: Full-year R&D was $3.1 billion, down 31%, driven by lower clinical and manufacturing costs after the wind-down of large Phase 3 respiratory programs. Norovirus and oncology spending partly offset the decline. Source
• Operating cost cuts exceed target: Management said annual operating expenses were lowered by about $2.2 billion, which it described as surpassing its cost-reduction targets. Source
• Year-end cash $8.1 billion: Cash, cash equivalents and investments at December 31, 2025 were $8.1 billion, compared with $9.5 billion a year earlier. Source
• Intismeran melanoma data showed 49% reduction: Five-year Phase 2b adjuvant melanoma data showed the combination reduced risk of recurrence or death by 49% versus KEYTRUDA alone. Source

“In 2025, we sharpened our commercial execution, launched our third product and brought online three international manufacturing sites, while advancing our mRNA pipeline.”

Stéphane Bancel, Chief Executive Officer of Moderna

Guidance

What changed from last quarter

• Guidance kept: Management reiterated its plan for up to 10% revenue growth and GAAP operating expense reductions in 2026. Source
• New guidance: This release gives 2026 capital expenditure and year-end cash ranges. The January update had given only operating expense figures for 2026. Source
• New: The U.S. FDA issued a Refusal-to-File letter for the mRNA-1010 flu vaccine. The January update had said U.S. submissions were completed. Source
• New: The company announced a strategic collaboration with Recordati to commercialize its propionic acidemia candidate globally. Source
• New: The company announced long-term respiratory vaccine agreements with Mexico and Taiwan. Source
• New: David Berman, M.D., Ph.D. was appointed Chief Development Officer, effective March 2, 2026. Source

Results and growth drivers

• Q4 revenue fell 30% year over year: Fourth-quarter revenue was $678 million, down 30% from the prior-year quarter, mainly on lower COVID vaccine sales volume. The company said revenue was on the higher end of its prior expectations. Source
• Full-year revenue fell 40%: Full-year 2025 revenue was $1.9 billion, down 40%. The majority came from COVID vaccine sales. Source
• Net loss narrowed from prior year: Q4 net loss was $826 million, against $1.1 billion a year earlier. Full-year net loss was $2.8 billion against $3.6 billion. Q4 loss per share was $2.11. Source

Segments and regions

• Full-year U.S. and international revenue: Full-year 2025 U.S. revenue was $1.2 billion and international revenue was $745 million. The year-over-year decrease reflected lower COVID vaccine sales volume across all regions. Source
• Q4 product sales split by region: Fourth-quarter product sales were $264 million in the U.S. and $381 million in international markets. Source
• Other revenue sources defined: Other revenue was $126 million for 2025. It includes grant, collaboration, licensing and royalty, and stand-ready manufacturing revenue. Source

“We look forward to delivering multiple potential product approvals and late-stage clinical readouts, while driving continued innovation across our mRNA platform.”

Stéphane Bancel, Chief Executive Officer of Moderna

Products and regulatory filings

• Three approved products entering year: The company enters 2026 with three approved products: Spikevax, mNEXSPIKE and mRESVIA. Source
• Flu-COVID combination still under review: The mRNA-1083 combination vaccine filing is under review in Europe and Canada. The company is awaiting further U.S. FDA guidance on refiling. Source
• Flu vaccine filings under review abroad: Regulatory filings for the mRNA-1010 flu vaccine are under review in Europe, Canada and Australia. Source

Operating expenses

• R&D spending fell 31%: Full-year R&D was $3.1 billion, down 31%, driven by lower clinical and manufacturing costs after the wind-down of large Phase 3 respiratory programs. Norovirus and oncology spending partly offset the decline. Source
• SG&A fell 13% for the year: Full-year SG&A was $1.0 billion, down 13%, mainly from lower consulting and external services spending. Source
• Operating cost cuts exceed target: Management said annual operating expenses were lowered by about $2.2 billion, which it described as surpassing its cost-reduction targets. Source

Cost of sales and tax

• Full-year cost of sales fell 41%: Cost of sales fell 41% for the year, driven by manufacturing productivity, operational efficiencies, lower inventory write-downs and lower contract manufacturing wind-down costs. Source
• Write-downs and royalties in cost of sales: Full-year cost of sales included $88 million of third-party royalties and $291 million of inventory write-downs. Q4 cost of sales included $144 million of write-downs. Source
• Tax provisions not material: Income tax provisions were not material in either period, because a global valuation allowance covers most deferred tax assets. Source

Demand and the 2026 plan

• 2026 growth tied to mNEXSPIKE and partners: Management said the company is poised for up to 10% revenue growth in 2026 through mNEXSPIKE expansion and international strategic partnerships. Source
• U.S. environment described as challenging: Management said the company entered the new year despite a continued challenging environment in the U.S. Source
• Growth through geographic expansion: The company's stated strategy is growth through geographic expansion and new product launches. Source

Cash and capital

• Year-end cash $8.1 billion: Cash, cash equivalents and investments at December 31, 2025 were $8.1 billion, compared with $9.5 billion a year earlier. Source
• $600 million credit facility draw: The year-end balance included an initial $600 million draw on the company's $1.5 billion credit facility. Source
• Cash decline driven by operating losses: The year-over-year cash decrease was driven mainly by operating losses from continued R&D investment and pipeline advancement. Source

Pipeline, rare disease and corporate

• Intismeran melanoma data showed 49% reduction: Five-year Phase 2b adjuvant melanoma data showed the combination reduced risk of recurrence or death by 49% versus KEYTRUDA alone. Source
• Eight intismeran trials underway: The company is advancing intismeran with Merck, with eight Phase 2 and Phase 3 trials underway across several tumor types. Source
• Propionic acidemia enrollment reached target: The propionic acidemia candidate mRNA-3927 is in a registrational study, and target enrollment has been reached. Source
• Methylmalonic acidemia program selected by FDA: The FDA selected the mRNA-3705 methylmalonic acidemia program for its START rare disease pilot program. Source
• Analyst Day held in November: The company hosted an Analyst Day on November 20, 2025, covering pipeline progress and business strategy. Source

Coming up, as management said on 13 February 2026

• Phase 3 melanoma data possible in 2026: Management expects Phase 3 adjuvant melanoma data for intismeran potentially in 2026. Source
• Flu vaccine approvals may begin 2026: Potential approvals for the mRNA-1010 flu vaccine in Europe, Canada and Australia are expected to begin in 2026. Source
• Phase 2 mRNA-4359 readout possible 2026: The company expects a potential Phase 2 data readout for mRNA-4359 in 2026. Source
• Propionic acidemia readout possible 2026: Management expects a potential data readout for the propionic acidemia candidate in 2026. Source
• Methylmalonic acidemia registrational study: A registrational study for the mRNA-3705 methylmalonic acidemia program is expected to begin in 2026. Source
• Norovirus readout expected 2026: The norovirus Phase 3 study is fully enrolled for a second Northern Hemisphere season, with a readout expected in 2026 subject to case accruals. Source
• Annual shareholder meeting May 6: The Annual Meeting of Shareholders is scheduled for Wednesday, May 6, 2026, at 8:00 a.m. ET. Source
• Analyst Day on November 12: The company lists its 2026 Analyst Day for November 12. Source

Figures management reported

Risks management discussed

• Regulatory: The U.S. FDA issued a Refusal-to-File letter for the mRNA-1010 flu vaccine, and the company is seeking a Type A meeting on the path forward. Source
• Demand: Management referred to a continued challenging environment in the U.S. market. Source
• External: The norovirus readout timing depends on case accruals during the 2025-2026 season. Source
• Financial: The company's cash balance fell in 2025 because operating losses continued alongside R&D investment. Source

Earlier plans management reported on

• Not stated: Management reiterated this 2026 plan in the release. Source
• Ahead: Management said the reduction of about $2.2 billion significantly surpassed its cost-reduction targets. Source
• Not stated: Management and Merck announced positive five-year Phase 2b adjuvant melanoma data; the January update had expected this data in early 2026. Source

Other quarters

• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q3 FY2025 results
• Q2 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.