GRAIL Reports First Quarter 2025 Financial Results

GRAIL, Inc., a healthcare company focused on early cancer detection, has released its financial results for the first quarter of 2025. The company reported significant growth in revenue and improvements in key financial metrics, despite continuing net losses.

Financial Highlights

For the first quarter of 2025, GRAIL reported total revenue of $31.8 million, marking a 19% increase year-over-year. The company's U.S. Galleri revenue grew by 22% to $28.7 million. Despite these gains, GRAIL posted a net loss of $106.2 million, which includes $34.6 million in amortization of Illumina acquisition-related intangible items. The gross loss for the quarter was $19.9 million, while the adjusted gross profit stood at $14.3 million. Adjusted EBITDA improved by 35% to $(98.7) million.

Business and Operational Highlights

GRAIL completed over 37,000 Galleri tests in the first quarter of 2025, reflecting strong commercial growth. The company also streamlined the test ordering process and increased test access. Additionally, GRAIL announced positive top-line results from the prevalent screening round of the NHS-Galleri trial, showing higher positive predictive value (PPV) compared to previous studies.

Strategic Initiatives and Corporate Developments

GRAIL highlighted several strategic initiatives, including a partnership with athenahealth to integrate Galleri test ordering into AthenaCoordinator Core, enhancing access for over 160,000 U.S. providers. The company also launched the "Generation Possible" educational initiative with actress Kate Walsh to raise awareness of multi-cancer early detection (MCED) testing.

Management's Perspective

Bob Ragusa, CEO of GRAIL, expressed satisfaction with the company's commercial growth and operational improvements. He emphasized the focus on developing the market for population-scale multi-cancer early detection and advancing Galleri to unlock broad access and cost efficiency.

Future Outlook

GRAIL plans to share registrational data from the PATHFINDER 2 study later this year and expects final results from the NHS-Galleri trial in mid-2026. The company aims to submit data from the prevalent screening round of the NHS-Galleri trial as part of its premarket approval application in the first half of 2026.

SEC Filing: GRAIL, Inc. [ GRAL ] - 8-K - May. 13, 2025