GRAIL (GRAL) Q4 2025 earnings summary

Executive summary

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

• 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 in Q4 2025, strengthening financial flexibility and ending the year with $904.4 million in cash.

• 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.

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

• Development services revenue declined 49% to $8.6 million for the year.

• Q4 net loss was $99.2 million; full-year net loss improved 80% to $408.4 million, including amortization and impairment charges.

• Non-GAAP adjusted gross profit for 2025 was $73.6 million, up 27%; adjusted EBITDA for the year was -$320.6 million, a 34% improvement.

Outlook and guidance

• Reiterated 2026 Galleri sales growth guidance of 22%-32%.

• Projected 2026 cash burn to be no more than $300 million, with cash runway extending into 2030.

• 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.

• Anticipates continued commercial growth through new partnerships and expanded provider engagement.