Short answer
GRAIL, Inc. (GRAL) filed its fiscal 2025 10-K annual report with the SEC on Mar 12, 2026. It reported revenue of $147M (+17.2% year over year) and net income of −$408M.
- Top risk flagged: Regulatory risk from Illumina Supply Agreement royalties commencing December 24, 2026, potentially increasing costs and impacting margins
FY2025 key financial metrics · XBRL
- Revenue
- $147M
- +17.2% YoY
- Net income
- −$408M
- +79.9% YoY
- Operating margin
- -382.0%
- +1361.1 pp YoY
- EPS (diluted)
- −$11.11
- +82.5% YoY
- ROE
- -15.8%
- +65.1 pp YoY
- Operating cash flow
- −$299M
- +48.2% YoY
Source: XBRL data from the GRAIL, Inc. (GRAL) FY2025 10-K on SEC EDGAR. USD.
GRAIL, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business: Commercial-stage healthcare company focused on multi-cancer early detection (MCED) via Galleri blood-based screening test
- New emphasis: 2026 PMA submission to FDA based on PATHFINDER 2 and NHS-Galleri Trial data; Medicare coverage pathway established under new federal law
- Strategic shift: Scaling commercial operations with automated Galleri version launched late 2024; expanding international presence in Israel, Canada, South Korea
- Notable metric: Over 475,000 Galleri tests sold by end of 2025, processing >800,000 total tests across clinical and commercial programs
- Distinctive fact: NHS-Galleri Trial results in 140,000+ participants showed >20% stage 4 cancer diagnosis reduction despite missing primary endpoint, informing ongoing UK NHS evaluation
Management Discussion & Analysis
- Revenue not explicitly stated; commercial Galleri tests sold: 475,000 through 2025, including 185,000 in 2025
- Net losses $408.4M (2025) vs $2.0B (2024) vs $1.5B (2023); Adjusted EBITDA $(320.6)M (2025) vs $(483.5)M (2024)
- Equity raises: $311.3M net from $325M PIPE in Oct 2025; $107.5M net from ATM program shares in 2025; $110M equity investment from Samsung pending
- Management expects continued operating losses due to R&D and commercialization investment; FDA PMA submission ongoing with trial results supporting product performance
Risk Factors
- Regulatory risk from Illumina Supply Agreement royalties commencing December 24, 2026, potentially increasing costs and impacting margins
- U.S. market concentration with majority Galleri sales domestically, risk from limited broad reimbursement and pricing pressure from discounts and rebates
- Operational risk from scaled platform leveraged by demand growth, but reduced investment in DAC and other product development beyond Galleri
- Competitive risk from need to drive Galleri awareness post-positive study results, facing market competition in cancer screening tests
- Financial risk from goodwill and intangible assets impairment review triggered by valuation changes since Illumina acquisition and pushdown accounting adjustments
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