Short answer
Moderna (MRNA) filed its fiscal 2025 10-K annual report with the SEC on Feb 20, 2026. It reported revenue of $1.9B (−39.9% year over year) and net income of −$2.8B.
- Top risk flagged: Regulatory risk: FDA refusal-to-file letter on seasonal flu vaccine mRNA-1010; amended BLA accepted with PDUFA date August 5, 2026
FY2025 key financial metrics · XBRL
- Revenue
- $1.9B
- −39.9% YoY
- Net income
- −$2.8B
- +20.8% YoY
- Operating margin
- -158.1%
- −36.2 pp YoY
- EPS (diluted)
- −$7.26
- +21.8% YoY
- ROE
- -32.6%
- +0.0 pp YoY
- Operating cash flow
- −$1.9B
- +37.6% YoY
Source: XBRL data from the Moderna (MRNA) FY2025 10-K on SEC EDGAR. USD.
Moderna FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Development and commercialization of mRNA-based vaccines and therapeutics across infectious diseases, oncology, and rare diseases
- New product: Launch of mNEXSPIKE COVID vaccine in Q3 2025, now leading US retail product; ongoing filings for flu+COVID and flu-only vaccines in multiple regions
- Strategic shift: Geographic expansion with three new Moderna-managed manufacturing sites in UK, Canada, Australia; partnership with Recordati for rare disease mRNA-3927 development
- Quantitative metric: 2025 revenue $1.9B, primarily from COVID vaccines; eight Phase 2/3 oncology trials on intismeran autogene in collaboration with Merck underway
- Noteworthy fact: First FDA acceptance of amended BLA for seasonal flu vaccine (mRNA-1010) with PDUFA date August 5, 2026, after Type A meeting and revised regulatory pathway
Management Discussion & Analysis
- Revenue $1.944B, down 40% YoY ($3.236B in 2024); net product sales $1.818B, down 42% YoY ($3.109B in 2024) due to lower COVID vaccine demand
- Operating loss $3.074B vs $3.945B; cost of sales $868M (48% of net product sales) vs $1.464B (47%); R&D $3.132B down 31%, SG&A $1.018B down 13%
- Best segment: Other revenue stable at $126M; worst segment: Net product sales down $1.29B driven by COVID vaccine decline
- Net cash used in operations $1.873B (improved from $3.004B); capex $192M; financing proceeds $593M including $578M credit facility draw; cash & investments $8.135B down 15%
- Management expects product sales growth in 2026 from strategic partnerships and mNEXSPIKE uptake; anticipates modest R&D reductions and stable SG&A; identifies COVID market decline as ongoing risk
Risk Factors
- Regulatory risk: FDA refusal-to-file letter on seasonal flu vaccine mRNA-1010; amended BLA accepted with PDUFA date August 5, 2026
- Geopolitical risk: COVID and RSV vaccine manufacturing now onshored in US, Australia, UK, and Canada under government agreements for local supply and pandemic preparedness
- Operational risk: mRNA-1010 flu vaccine regulatory review delays following FDA Type A meeting and need for additional study in older adults
- Competitive risk: Collaboration with Merck on intismeran autogene (mRNA-4157) immunotherapy facing competition from other checkpoint inhibitors like KEYTRUDA
- Financial risk: $1.5 billion five-year credit facility entered November 2025, including $600 million funded initial term loan, adding leverage and interest expense burden
Generated from the filing text; verify against the original. How to read a 10-K
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