GRAIL (GRAL) Q4 2025 earnings summary

Executive summary

• Achieved significant commercial growth in 2025, with Galleri test volumes up 36% and over 185,000 tests sold, driving U.S. Galleri revenue up 26% to $136.8 million.

• Released top-line results from the NHS-Galleri trial, showing a substantial reduction in Stage IV cancer diagnoses and increased early-stage detection, though the primary endpoint was not met.

• Completed PMA submission to the FDA for Galleri and shared topline results from the PATHFINDER 2 study.

• Raised over $435 million, strengthening financial flexibility and maintaining a strong cash position into 2030.

• Announced expansion of field sales and medical teams and expanded Galleri access through digital health platforms.

Financial highlights

• Q4 2025 revenue was $43.6 million, up 14% from Q4 2024; full-year revenue reached $147.2 million, up 17% year-over-year.

• Screening revenue for 2025 was $138.6 million, up 28% over 2024; U.S. Galleri revenue was $136.8 million, up 26%.

• Net loss for Q4 2025 was $99.2 million; full-year net loss was $408.4 million, including $138.3 million amortization and $28.0 million impairment.

• Non-GAAP adjusted gross profit for 2025 was $73.6 million, up 27% year-over-year.

• Ended 2025 with $904.4 million in cash, cash equivalents, and short-term marketable securities.

Outlook and guidance

• Reiterated 2026 Galleri sales growth guidance of 22%-32% and cash burn not exceeding $300 million.

• Cash runway extends into 2030, supporting long-term growth and milestone achievement.

• Long-term gross margin target remains 50%-60% at scale.

• On track for continued commercial growth in 2026, with new and expanding digital health partnerships and further integration into health systems.

• Detailed results from PATHFINDER 2 and NHS-Galleri trials expected to be presented in mid-2026.