Moderna 2025-26: Revenue $1.94B, mNexspike Launched, FY26 +10%
FY25 revenue $1.94B (-39% from $3.20B FY24); op income -$3.07B (vs -$3.95B FY24); NI -$2.82B; EPS -$7.26. Q4 revenue $700M (US $300M / Int'l $400M). FY US revenue $1.2B / Int'l $700M. mNexspike (mRNA-1283) approved + launched in US — quickly became leading product in US. Spikevax COVID vaccine continues. Cost of sales $868M (-41% YoY). R&D $3.1B (-31% YoY). SG&A $1.0B (-13% YoY). Operating expenses down 30% FY. Pipeline progress: INT phase 2 cancer therapy positive 5-year data; CMV antigen mRNA-4259 phase 1b → phase 2; norovirus + PA programs fully enrolled. Recordati rare disease + Mexico respiratory vaccine supply agreements. Dr. David Berman new Chief Development Officer (March 2). FY26 guide: total revenue growth up to 10% (primarily international); cost of sales $900M; R&D ~$3B; SG&A ~$1B flat. Revenue weighted to H2.
Key takeaways
- Revenue stabilization underway after multi-year COVID decline. FY25 revenue $1.94B (vs $18.88B FY22 peak — basically a 90% decline over 3 years). FY26 +up to 10% growth represents the first revenue growth since 2022. Moderna is past the COVID revenue cliff bottom; FY26 is the inflection year.
- mNexspike (mRNA-1283) approved + launched in US — leading product quickly. Next-generation COVID vaccine. Quickly became leading product in US. Material commercial event for FY25-FY26. Plus Spikevax (legacy mRNA-1273) continues. Two products under regulatory review: seasonal flu vaccine (Europe/Canada/Australia) + flu-COVID combination vaccine (Europe/Canada).
- Operating expenses down 30% FY25. Cost of sales -41%; R&D -31%; SG&A -13%. Aggressive cost rationalization to match revenue trajectory + extend cash runway. FY26 stable with R&D ~$3B + SG&A ~$1B flat.
- Pipeline progress: INT cancer therapy positive 5-year data + multiple late-stage assets advancing. mRNA-4157 (INT individualized neoantigen therapy) — positive 5-year phase 2 data in adjuvant melanoma; phase 2 enrollment completed in muscle-invasive bladder cancer + others. mRNA-4259 (CMV antigen) phase 1b → phase 2. Norovirus + PA programs fully enrolled in registration. Multi-year non-COVID pipeline maturation.
- mRNA-1010 flu program FDA refusal-to-file — material near-term setback. Q4 risks: FDA refusal to file letter on mRNA-1010 flu program creates uncertainty in US FDA regulatory environment. Mgmt frames as broader regulatory environment risk.
Business
Moderna, Inc. is a US biotech specializing in mRNA-based vaccines + therapeutics. Single primary commercial business + extensive pipeline:
- Spikevax (mRNA-1273) (~50% of FY25 revenue). Original COVID vaccine. Continues but declining as new mNexspike scales.
- mNexspike (mRNA-1283) (~30% of FY25 revenue, growing). Next-generation COVID vaccine. Approved + launched US 2025; quickly became leading product. Multi-year revenue trajectory.
- Emresvia (RSV) (~15% of FY25 revenue). RSV vaccine for adults. Selective market.
- Other / Pipeline + Royalties (~5%). Pipeline assets + collaboration revenue.
Strategic moves FY25:
- mNexspike approved + launched US (next-gen COVID)
- Spikevax + mNexspike leading respiratory vaccines portfolio
- Emresvia continuing
- Operating expenses cut 30%; R&D -31%; SG&A -13%
- Recordati agreement for rare disease candidates
- Mexico respiratory vaccine supply agreement
- 2 products under regulatory review (seasonal flu Europe/Canada/Australia + flu+COVID combo Europe/Canada)
- INT cancer therapy positive 5-year phase 2 data adjuvant melanoma
- Phase 2 enrollment completed muscle-invasive bladder cancer
- mRNA-4259 (CMV antigen) phase 1b → phase 2
- Norovirus program fully enrolled
- PA program fully enrolled in registration study
- mRNA-1010 flu program FDA refusal to file
- Dr. David Berman new Chief Development Officer (March 2)
- Local manufacturing UK + Australia starting 2026
FY25 financial performance
| Metric (FY) | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|
| Revenue ($B) | 18.88 | 6.85 | 3.20 | 1.94 |
| Revenue YoY | n/a | -64% | -53% | -39% |
| Op income ($B) | 9.42 | -4.24 | -3.95 | -3.07 |
| Op margin | 49.9% | -61.9% | -123% | -158% |
| Net income ($B) | 8.36 | -4.71 | -3.56 | -2.82 |
| Diluted EPS ($) | 20.10 | -12.34 | -9.27 | -7.26 |
| FCF ($B) | 4.58 | -3.83 | -4.06 | -2.07 |
| Capex ($M) | -400 | -707 | -1,051 | -192 |
| Total debt ($B) | 1.20 | 1.24 | 0.75 | 1.92 |
The earnings progression shows the COVID-era boom-bust cycle: FY22 peak revenue $18.88B / EPS $20.10 → FY25 $1.94B / EPS -$7.26. The decline is largely complete; FY26 represents inflection.
FCF -$2.07B (improving from -$4.06B FY24, +49%) — operational losses funded by cash + debt. Capex $-192M (-82% YoY) — major step-down reflecting capacity rationalization.
Total debt $1.92B (+155% YoY) — incremental funding for operations. Cash position remains adequate but multi-year trajectory matters.
Capital allocation
- Capex $-192M FY25 (-82% YoY). Major capacity rationalization.
- Dividends $0 (no dividend).
- Buybacks $0 (vs $-1.15B FY23).
- Debt $1.92B (+155% YoY).
- FCF -$2.07B (improving from -$4.06B FY24).
- Cash Adequate but burning to fund operations + pipeline.
FY26 outlook (per Q4 2025 call, 2026-02-13)
| FY26 framework | Detail |
|---|---|
| Total revenue growth | Up to 10% (primarily international) |
| Local manufacturing | UK + Australia starting 2026 |
| Revenue weighted | Second half of 2026 |
| Cost of sales | $900M projected |
| R&D expenses | ~$3.0B |
| SG&A expenses | ~$1.0B (flat YoY) |
| Gross margin | Improvement expected |
| COVID vaccination rates | Potential decline factored |
| Flu / Flu-COVID combo | No revenue assumed |
The FY26 setup: revenue stabilization (+up to 10% growth) primarily international with local manufacturing UK + Australia. Operating expenses essentially flat. Conservative — no flu / flu-COVID revenue baked in (regulatory uncertainty).
Key risks
FDA refusal-to-file letter on mRNA-1010 flu program. Q4 mgmt explicit risk. Creates uncertainty in US FDA regulatory environment. May lead to challenges for businesses, patients, and innovation ecosystem; potentially delaying breakthrough medicine development. Sustained regulatory uncertainty could result in transformative medicine developed by US companies becoming available outside US before reaching American patients.
COVID vaccination rate decline. FY26 revenue guidance factors in potential declines in COVID vaccination rates. Multi-year structural decline in COVID demand.
No flu / flu-COVID combination revenue assumed. FY26 guide excludes these — regulatory uncertainty + commercial timing risk.
Cash runway. $-2.07B FCF FY25 + ongoing R&D investment + need to fund pipeline → cash management critical. Total debt $1.92B (+155% YoY) supplements but multi-year sustainability matters.
Pipeline late-stage outcomes. INT cancer therapy + CMV + norovirus + PA programs all multi-year readouts. Binary clinical outcomes affect valuation + revenue trajectory.
Competitive landscape. Pfizer + BioNTech (COVID), GSK (RSV), Moderna's own portfolio compete with itself. New entrants in mRNA technology + competitive pricing.
Manufacturing transition. Local manufacturing UK + Australia 2026 — execution + cost dynamics matter.
Recordati + Mexico partnerships execution. Multi-year supply + commercial agreements require execution.
Customer concentration. Top governments + payers drive significant revenue.
Currency / FX. International revenue exposure.
Regulatory environment outside US. Multi-jurisdiction approvals + reimbursement + commercial dynamics matter.
INT cancer therapy commercialization timing. Positive Phase 2 5-year data is encouraging but commercialization timing + regulatory pathway uncertain.
Pricing dynamics. Government negotiation + payer coverage + market access affect economics.
Bottom line
Moderna FY25 is the post-COVID cliff bottom + pipeline transition year: revenue $1.94B (down 90% from $18.88B FY22 peak); op income -$3.07B (improving from -$3.95B FY24); EPS -$7.26 (improving from -$9.27); operating expenses cut 30%; FCF -$2.07B (improving from -$4.06B). mNexspike (next-gen COVID) approved + launched US — quickly became leading product. Two products under regulatory review (seasonal flu Europe/Canada/Australia + flu+COVID combo). Pipeline progress: INT cancer 5-year positive data; multiple Phase 2/3 late-stage assets.
FY26 guide: revenue growth up to 10% (primarily international); local manufacturing UK + Australia 2026; cost of sales $900M; R&D ~$3B; SG&A ~$1B flat; revenue weighted H2; gross margin improvement. First revenue growth since 2022 — structural inflection.
The risks are real and significant — FDA refusal-to-file mRNA-1010 flu program (US regulatory uncertainty), COVID vaccination rate decline, no flu / flu-COVID revenue assumed FY26, cash runway / debt funding, pipeline late-stage outcomes, competitive landscape, manufacturing transition, partnership execution, customer concentration, FX, regulatory outside US, INT commercialization timing, pricing dynamics. The FDA flu setback is the dominant near-term overhang.
But the structural thesis (mRNA platform + Spikevax + mNexspike COVID franchise + RSV + INT cancer therapy pipeline + multiple Phase 2/3 assets + cost discipline + revenue stabilization + first growth year since 2022 + long-term mRNA platform value) is intact — though heavily challenged by FDA + commercial dynamics.
Speculative biotech compounder mid-multi-year platform-validation cycle. The mRNA platform value depends on pipeline assets reaching commercialization (INT cancer therapy + CMV + norovirus + PA) + regulatory environment improvements + commercial execution. The FDA flu letter creates real near-term uncertainty. Investors get exposure to mRNA platform potential + pipeline + cost discipline + first revenue growth year since 2022 + potential commercial inflections (mNexspike + flu + INT cancer therapy). High-risk profile with multi-year horizon dependent on pipeline + regulatory + commercial execution.
Citations
- Moderna, Inc. FY25 Form 10-K (filed February 2026, SEC EDGAR).
- MRNA Q4 2025 earnings call, 2026-02-13 — FY revenue $1.9B; Q4 revenue $700M (US $300M / Int'l $400M); FY US $1.2B / Int'l $700M; mNexspike approved + launched US; cost of sales -41%; R&D -31%; SG&A -13%; INT cancer therapy 5-year positive Phase 2 data; mRNA-4259 (CMV) Phase 1b → Phase 2; norovirus + PA fully enrolled; Recordati rare disease agreement + Mexico respiratory vaccine supply; 2 products under regulatory review (seasonal flu Europe/Canada/Australia + flu+COVID combo); Dr. David Berman new CDO (March 2); FDA refusal to file letter on mRNA-1010 flu program; FY26 guide (revenue +up to 10% primarily international; local manufacturing UK + Australia 2026; cost of sales $900M; R&D ~$3B; SG&A ~$1B flat; revenue weighted H2).
- MRNA Q3 2025 / Q2 2025 / Q1 2025 earnings calls — supporting Spikevax + mNexspike + pipeline progression (assumed in line with Q4 trajectory).
- Internal financial_statements view (consolidated annual + cash flow + capital structure).