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MRNA
FY2025 Q4
Improving
Moderna, Inc. earnings call
Buzzberg read
FDA refusal to file on flu vaccine creates uncertainty
Moderna's FY2025 Q4 call highlighted a return to revenue growth in 2026 driven by international partnerships and the successful launch of Mnext Spike, while managing costs. The company faced regulatory headwinds in the US for its flu vaccine but is progressing internationally. Key pipeline catalysts include INT oncology data and norovirus readouts in 2026. FY2025 revenue was $1.9B with a net loss of $2.8B; cash and investments ended at $8.1B.
Buzzberg read FDA refusal to file on flu vaccine creates uncertainty Moderna's FY2025 Q4 call highlighted a return to revenue growth in 2026 driven by international partnerships and the successful launch of Mnext Spike, while managing costs. The company faced regulatory headwinds in the US for its flu vaccine but is progressing internationally. Key pipeline catalysts include INT oncology data and norovirus readouts in 2026. FY2025 revenue was $1.9B with a net loss of $2.8B; cash and investments ended at $8.1B. Read full analysisCollapse analysis
Moderna's FY2025 Q4 call highlighted a return to revenue growth in 2026 driven by international partnerships and the successful launch of Mnext Spike, while managing costs. The company faced regulatory headwinds in the US for its flu vaccine but is progressing internationally. Key pipeline catalysts include INT oncology data and norovirus readouts in 2026. FY2025 revenue was $1.9B with a net loss of $2.8B; cash and investments ended at $8.1B.
- 2026 guidance: up to 10% revenue growth, R&D spend ~$3B, SG&A ~$1B, capex $200-300M, ending cash $5.5-6B.
- Mnext Spike captured 24% US retail market share in 2025 and is a key 2026 growth driver.
- International growth driven by multi-year agreements with UK ($200M order in H1 2026), Canada, Australia, Mexico, Taiwan, and Brazil.
Revenue$0.678BReported
EPS$-2.11Reported
Gross margin33.33%Reported
Free cash flow$0.912BReported
6 grounded callouts
What matters now
The highest-signal changes from the call.
Guidance
Expects 2026 revenue growth of up to 10%
Pipeline
Antismerin phase 3 adjuvant melanoma data expected this year
Show 3 more callouts
Pipeline
Norovirus phase 3 data expected in 2026
Commercial
Mnex Spike captured 24% US retail market share in launch year
Costs
2026 cash costs guided to $4.2 billion
Reported period
Actuals
| Metric | Reported | Change |
|---|---|---|
| Revenue | $0.678B | Reported |
| EPS | $-2.11 | Reported |
| Gross margin | 33.33% | Reported |
| Free cash flow | $0.912B | Reported |
| Capex | $0.039B | Reported |
| Net income | $-0.826B | Reported |
Forward-looking
Forward guidance
| Metric | Period | Range | Midpoint | Status |
|---|---|---|---|---|
| Capex | FY2026 | $0.2B–$0.3B | $0.25B | Initiated |
| Free cash flow | FY2026 | $5.5B–$6B | $5.75B | Initiated |
| Operating margin | FY2026 | $4.9B | $4.9B | Initiated |
AI, capex & demand read
Management read
Measured
Management acknowledged regulatory setbacks but emphasized progress, cost discipline, and multiple growth drivers, striking a balanced and forward-looking tone.
Investment and capacity
Management guided 2026 capital expenditures to $200-300 million, including investment in building fill-finish capacity in Norwood, Massachusetts.
all 6 named companies below
Companiesreturns since call
Customers
Customers
Stéphane Boncel
Mexico is a committed multi-year customer for Moderna's respiratory vaccines, providing demand visibility and international revenue growth.
Evidence
“We also announced earlier this week a five-year strategic agreement with the government of Mexico for respiratory vaccine supply.”
Partners
Partners
Stéphane Boncel
Merck is the co-developer and commercial partner for Moderna's lead individualized cancer therapy (INT). Management's confidence is reinforced by positive five-year data, implying progress toward a potential BLA submission by Merck.
Evidence
“For intramural or individual cancer therapy developed in partnership with Merck, we recently reported positive five-year phase two data in adjuvant melanoma.”
Partners
Stéphane Boncel
Recordati gains global commercialization rights for Moderna's PA candidate, leveraging its rare disease infrastructure; for Recordati, this is a potential new late-stage asset in its portfolio.
Evidence
“First, an agreement with Ricardati for the global commercialization of our proprionic acidemia rare disease candidate, currently in a pivotal study.”
Supply chain
Supply chain
Stephen Hogue
Moderna's flu vaccine (mRNA-1010) was refused filing by the FDA, but is progressing in Europe, Canada, and Australia. The company highlights a potential strain mismatch in the US vs. Northern Hemisphere, positioning its mRNA platform as a solution for better strain matching. — If Moderna secures approvals abroad, it could gain share in international markets while incumbents like Pfizer and GSK are locked into traditional strain selection, leading to a competitive advantage in vaccine efficacy.
Evidence
“In the United States, it is a different strain than is circulating in the rest of the Northern Hemisphere. And there doesn't look like there would be great cross protection.”
Supply chain
Stéphane Boncel
The European respiratory vaccine market (approx. $1.8 billion) is opening up to Moderna in 2027, as a competitor's pandemic contract expires, allowing Moderna to launch multiple products and challenge incumbent players. — This opens a major new market for Moderna, directly competing with established players like Pfizer, GSK, and Sanofi, potentially disrupting their respiratory franchise revenues.
Evidence
“We look forward to significant expansion of our addressable market with the opening of the $1.8 billion European respiratory vaccines market. As a reminder, we have been excluded from this region for several years due to a competitor”
External signals
Supply-chain alpha · 3returns since call
Moderna's flu vaccine (mRNA-1010) was refused filing by the FDA, but is progressing in Europe, Canada, and Australia. The company highlights a potential strain mismatch in the US vs. Northern Hemisphere, positioning its mRNA platform as a solution for better strain matching.
Moderna's COVID vaccine, Mnext Spike, captured 24% of the US retail market in its first season, with 34% among seniors, indicating rapid share gains against Pfizer's Comirnaty.
Evidence
“MNext Bike capturing 24% of the total U.S. retail market and 34% of the retail market among adults age 65 and older.”
The European respiratory vaccine market (approx. $1.8 billion) is opening up to Moderna in 2027, as a competitor's pandemic contract expires, allowing Moderna to launch multiple products and challenge incumbent players.
Evidence
“We look forward to significant expansion of our addressable market with the opening of the $1.8 billion European respiratory vaccines market. As a reminder, we have been excluded from this region for several years due to a competitor pande…”
Methodology & coverage
Management-only analysis. All 6 validated company mentions are shown. Reported actuals and forward guidance are kept separate. Public evidence is limited to eight short attributed quotes. AI-generated analysis can be incomplete or wrong; verify important claims against the original source.