Moderna (MRNA) FY2025 10-K Annual Report

Filed: Feb 20, 2026
Health Care
Biological Products, (No Diagnostic Substances)SEC EDGAR

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 Metrics
XBRL

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.

Get deeper insights on Moderna

Access full AI analysis, insider trading data, fund holdings, and cross-signal detection on SignalX.