GRAIL, Inc. (GRAL) FY2025 10-K Annual Report
GRAIL, Inc. (GRAL) 10-K annual report for fiscal year 2025, filed with SEC EDGAR on Mar 12, 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.
GRAIL, Inc. FY2025 10-K Analysis
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)
- • No segment revenue disclosed; primary business focus on Galleri multi-cancer early detection test commercialized in US
- • 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
GRAIL, Inc. FY2025 Key Financial MetricsXBRL
Revenue
$147M
▲ +17.2% YoY
Net Income
-$408M
▲ +79.9% YoY
Operating Margin
-382.0%
▲ +136105bp YoY
Net Margin
-277.5%
▲ +133646bp YoY
ROE
-15.8%
▲ +6513bp YoY
Total Assets
$2.9B
▼ -2.1% YoY
EPS (Diluted)
$-11.11
▲ +82.5% YoY
Operating Cash Flow
-$299M
▲ +48.2% YoY
Source: XBRL data from GRAIL, Inc. FY2025 10-K filing on SEC EDGAR. All figures in USD.
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