GRAIL, Inc. Releases Robust Q4 and Full Year 2025 Financial Results: Key Developments for Investors

Executive Summary

• Record Sales: Over 185,000 Galleri® multi-cancer early detection (MCED) tests sold in 2025, with U.S. Galleri revenue up 26% year-over-year.
• Financial Growth: Total annual revenue rose 17% to \$147.2 million; U.S. Galleri revenue reached \$136.8 million.
• Cash Position: GRAIL ended 2025 with a strong liquidity position, holding \$904.4 million in cash, cash equivalents, and short-term securities.
• Regulatory Milestones: Completed Galleri’s Premarket Approval (PMA) submission to the FDA in January 2026.
• Clinical Data: Announced topline results from the NHS-Galleri trial and completed analysis of the full 35,000-participant PATHFINDER 2 study.
• Legislative Breakthrough: The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act became law, establishing a new pathway for Medicare coverage of MCED tests.
• Expanded Digital Access: Galleri now available through major digital health platforms including Hims & Hers, Function Health, and Everlywell.

Financial Performance in Detail

Fourth Quarter 2025 Highlights

• Total Revenue: \$43.6 million, up 14% year-over-year.
• U.S. Galleri Revenue: \$41.3 million, up 31% year-over-year.
• Net Loss: \$(99.2) million, which includes \$34.6 million in Illumina acquisition-related amortization.
• Gross Loss: \$(11.1) million, improved by 30% from the prior year.
• Non-GAAP Adjusted Gross Profit: \$23.1 million, up 29%.
• Non-GAAP Adjusted EBITDA: \$(71.8) million, a 15% improvement.

Full Year 2025 Highlights

• Total Revenue: \$147.2 million, up 17% year-over-year.
• U.S. Galleri Revenue: \$136.8 million, up 26%.
• Net Loss: \$(408.4) million, including \$138.3 million in amortization and \$28 million in intangible asset impairment.
• Gross Loss: \$(62.6) million, improved by 20%.
• Non-GAAP Adjusted Gross Profit: \$73.6 million, up 27%.
• Non-GAAP Adjusted EBITDA: \$(320.6) million, a 34% improvement year-over-year.

Balance Sheet Strength

• Cash, Cash Equivalents, Short-Term Marketable Securities: \$904.4 million as of December 31, 2025.
• Shareholders’ Equity: \$2.58 billion.
• Total Assets: \$2.92 billion.

Key Business and Regulatory Developments

• NHS-Galleri Trial Results: The landmark, randomized, controlled trial in England’s National Health Service (NHS) with 142,000 participants showed:
  • Substantial reduction in Stage IV cancer diagnoses with Galleri added to standard screening.
  • Increased Stage I and II detection of deadly cancers.
  • Four-fold higher cancer detection rate compared to standard of care alone.
  • However, primary endpoint of statistically significant reduction in combined Stage III & IV diagnoses was not met—may be a point of investor concern and should be monitored for regulatory or reimbursement impacts.
• PATHFINDER 2 Study: Completed analysis of the full 35,000-participant study, with performance consistent with prior interim analyses and a strong safety profile.
• Regulatory Submission: Final module of Galleri’s PMA application submitted to the FDA in January 2026, based on data from PATHFINDER 2 and the NHS-Galleri trial.
• Legislation: The Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act became federal law, providing a clear pathway for Medicare coverage of MCED tests—a major addressable market expansion for GRAIL.
• Strategic Partnerships: Expanded Galleri access through digital health partners (Hims & Hers, Function Health, Everlywell), supporting revenue scale-up and broader adoption.
• Capital Raise: Raised over \$435 million in late 2025, supporting operations and commercialization into 2030.

Product and Market Update

• Galleri® Test: Detects over 50 types of cancer via a blood test before symptoms appear. Demonstrated to increase cancer detection seven-fold when added to recommended screenings, and has the lowest false positive rate among MCED tests on the market. Requires prescription and is recommended for adults 50+ or at elevated risk.
• Regulatory Status: Not yet FDA-approved, but PMA submission is under review. Lab is CLIA-certified and CAP-accredited.

Investor Considerations & Potential Share Price Movers

• Strong Revenue and Cash Position: Topline and cash results demonstrate continued commercial momentum and provide a runway for further growth, supporting investment and R&D.
• Regulatory and Reimbursement Milestones: FDA approval of Galleri and Medicare coverage could rapidly expand the addressable market and accelerate revenue growth.
• Key Risks: The NHS-Galleri trial did not meet its primary endpoint, which may affect payer and regulatory decisions. Investors should monitor FDA review progress and reimbursement developments closely.
• Pipeline and Data Catalysts: Detailed results from PATHFINDER 2 and the NHS-Galleri trial are expected to be presented at a major conference in mid-2026.
• Ongoing Partnerships: Expansion into digital health platforms may create new revenue streams and further broaden access.

Upcoming Catalysts

• FDA decision on Galleri PMA submission.
• Full data presentations from major clinical studies in mid-2026.
• Updates on Medicare reimbursement implementation and commercial partnerships.

Conference Call

GRAIL will host its Q4 and FY2025 conference call and webcast on February 19, 2026 at 2:00 p.m. PT / 5:00 p.m. ET. The webcast replay will be available for 30 days on the GRAIL investor relations website.

Disclaimer

This article is for informational purposes only and does not constitute investment advice. Investors should conduct their own due diligence and consult with a qualified financial advisor before making any investment decisions. The information provided is based on company filings and press releases and may include forward-looking statements subject to risks and uncertainties, including clinical trial results, regulatory decisions, reimbursement coverage, and market adoption. Actual results may differ materially from those indicated. The author and publisher assume no responsibility for any actions taken based on the information contained herein.

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