GRAL GRAIL, Inc.
FY2025 10-K
GRAIL, Inc. (GRAL) filed its fiscal year 2025 10-K annual report with the SEC on Mar 12, 2026. This page provides AI-powered analysis of the filing, including business overview, management discussion, risk factors, and key financial metrics from XBRL data.
AI Filing AnalysisFY2025 10-K
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
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)
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
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