Moderna (MRNA) FY2025 10-K Annual Report
Moderna (MRNA) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Feb 20, 2026. This page provides AI-powered analysis including business overview, management discussion & analysis (MD&A), risk factors, and key financial data such as revenue, net income, gross margin, operating margin, and return on equity (ROE) extracted from XBRL.
Moderna FY2025 10-K Analysis
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
Moderna FY2025 Key Financial MetricsXBRL
Revenue
$1.9B
▼ -39.9% YoY
Net Income
-$2.8B
▲ +20.8% YoY
Operating Margin
-158.1%
▼ -3622bp YoY
Net Margin
-145.2%
▼ -3512bp YoY
ROE
-32.6%
▲ +4bp YoY
Total Assets
$12.3B
▼ -12.8% YoY
EPS (Diluted)
$-7.26
▲ +21.8% YoY
Operating Cash Flow
-$1.9B
▲ +37.6% YoY
Source: XBRL data from Moderna FY2025 10-K filing on SEC EDGAR. All figures in USD.
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