Moderna, Inc. Q4 FY2025 earnings call

• 2025 revenue was $1.9 billion, driven by Spikevax, MNEXT Spike, and Emresvia. Operating expenses were down 30% for the year.
• Commercially, MNEXT Spike had an excellent launch in the U.S. Announced agreements with Recordati for rare disease candidates and with Mexico for respiratory vaccine supply. Two products under regulatory review: seasonal flu vaccine in Europe, Canada, Australia and flu plus COVID combination vaccine in Europe and Canada.
• Pipeline progress: INT cancer therapy had positive five-year phase 2 data in adjuvant melanoma, enrollment completed in phase 2 studies in muscle invasive bladder cancer, etc. Cancer antigen therapy mRNA-4259 had positive phase 1b data and moved to phase 2. Norovirus program fully enrolled, PA program fully enrolled in registration study. New Chief Development Officer Dr. David Berman joined on March 2.

In 2025, revenues were $1,900,000,000, driven by sales of COVID vaccine Spikevax and MNEXT Spike. For the fourth quarter, total revenue was $700,000,000, with $300,000,000 in the U.S. and $400,000,000 from international markets. For the full year, total revenue was $1,900,000,000, with U.S. revenue totaling $1,200,000,000 and international revenue $700,000,000. MNEXT Spike was approved in the U.S. in 2025 and became the leading product in the U.S. quickly. Cost of sales in 2025 was $868,000,000, a 41% decrease compared to 2024. R&D expenses were $3,100,000,000, a 31% decrease. SG&A expenses were $1,000,000,000, a 13% decrease.

• Expect total revenue growth of up to 10% in 2026, primarily from international markets. Will start selling locally manufactured products in U.K. and Australia in 2026. Revenue guidance factors in potential declines in COVID vaccination rates and no revenue from flu vaccine or flu COVID combination vaccine. Revenue weighted to second half of 2026. Cost of sales projected at $900,000,000, expecting gross margin rate improvement. R&D expenses anticipated to be approximately $3,000,000,000. SG&A expenses expected to be $1,000,000,000, flat vs prior year.

The FDA refusal to file letter on our flu program mRNA-1010 creates uncertainty in the U.S. FDA regulatory environment. This can lead to challenges for businesses, patients, and the innovation ecosystem, potentially delaying the development of breakthrough medicines, delaying patient access, and increasing healthcare costs. Sustained regulatory uncertainty may also result in transformative medicine developed by U.S. companies becoming available outside the U.S. before reaching American patients.

Q: Terence Flynn with Morgan Stanley asked about the implications of the flu RTF on 2028 cash flow breakeven guidance and timing of the Type A meeting for INT program adjuvant melanoma data timing.

A: Stephen Hoge said they are pleased with flu file progress internationally, but for the U.S. flu vaccine, need to engage in Type A meeting to understand next steps. James Mock said it's too early to comment on cash flow breakeven guidance implications due to fluid situation. Stephen Hoge said INT adjuvant melanoma study is event-driven and depends on event accrual, and they are confident of data readout this year but it's event-driven Q: Salveen Richter with Goldman Sachs asked about the flu and COVID combination vaccine refiling and INT program histology success probability A: Stephen Hoge said they hope for flu COVID combination product approval in Europe this year, and for U.S. refiling depends on Type A meeting feedback. On INT, he said phase 3 adjuvant melanoma has highest probability of success based on current data readout Q: Eliana Merle with Barclays asked about European COVID vaccination market, flu COVID combination vaccine approval pathway, and flu strain selection A: Stephen Hoge said MNEXT Spike has strong profile for European COVID market, pricing not yet issued but market expected to be larger. Flu COVID combination vaccine progressing in international reviews, and there's discussion on better strain matching for flu vaccines to meet regional needs Q: Tyler Van Buren with TD Cowen asked about higher-than-expected cash balance at year-end and levers to lower cash costs A: James Mock said revenue came in close to guidance, cash costs beat guidance, took $600,000,000 initial draw from credit facility, capital expenditures were $100,000,000 less than forecast, and working capital performance was terrific driving the cash balance Q: Michael Yee with UBS asked about INT phase 3 melanoma study interim analysis and norovirus study confidence A: Stephen Hoge said INT phase 3 melanoma study will have interim analysis this year looking at relapse-free survival, and norovirus study is case-driven with different composition and population approach, expected to see results this year Q: Luca Issi with RBC Capital Markets asked about INT OS data and INT trial design feedback A: James Mock said INT phase 3 melanoma study will present OS curves at upcoming medical meeting. Stephen Hoge said INT trial design was followed and there were productive dialogues with regulators, and INT BLA submission will be from Merck Q: Courtney Breen with Bernstein asked about flu phase 3 study patient age and INT trial design feedback and FDA group for INT A: Stephen Hoge said more than 50% of flu phase 3 study population were 65 or older, and INT trial design had productive dialogues with regulators, and INT BLA submission is from Merck with CBER involved Q: Alex Rinnehan with Bank of America asked about INT RCC phase 2 and comparator arm A: James Mock said INT phase 2 RCC study is powered and if sees dramatic benefit could be registrational, and it depends on data and what the standard of care evolves to, including belzutifan Q: Cory Kasimov with Evercore asked about INT adjuvant melanoma use across PD-1, PD-L1 class and regimen selection impact A: Stephen Hoge said INT adjuvant melanoma label could apply broadly to other PD-1, PD-L1s, and INT would be in a category of its own regardless of PD-1 antibody use method