GRAIL Reports $2.027 Billion Net Loss and 35% Revenue Growth for Fiscal Year 2024

GRAIL, Inc. reported a net loss of $2.027 billion for the fiscal year ended December 31, 2024, compared to a net loss of $1.466 billion in fiscal year 2023. Total revenue increased by 35% to $125.6 million, driven primarily by a 45% increase in screening revenue to $108.6 million, resulting from a 46% rise in Galleri test sales volume, partially offset by a 1% decrease in average selling price. Development services revenue decreased by 6% to $17.0 million. The increase in revenue was partially offset by a 44% increase in total costs and operating expenses, reaching $2.315 billion, largely due to a significant increase in goodwill and intangible assets impairment charges.

Significant changes compared to the previous fiscal year included a substantial increase in goodwill and intangible assets impairment charges ($1.421 billion in 2024 versus $718.5 million in 2023), reflecting changes in the forecast of GRAIL's value and valuation methods. Research and development expenses decreased by 5% to $322.4 million, while general and administrative expenses increased by 7% to $213.9 million, primarily due to divestiture-related advisory costs associated with the spin-off from Illumina. Interest income increased significantly to $26.7 million due to increased interest earned on money market funds and short-term marketable securities.

Strategic developments included the completion of the spin-off from Illumina on June 24, 2024, resulting in GRAIL becoming an independent, publicly traded company. Illumina retained a 14.5% ownership stake. The company also implemented a restructuring plan in August 2024, reducing its headcount by approximately 30% and resulting in $18.3 million in restructuring charges. The plan aims to focus resources on the core MCED business and reduce operating expenses by approximately $120 million annually. The company launched Galleri in Israel in December 2024 using a distributor model.

As of December 31, 2024, GRAIL had sold over 290,000 commercial Galleri tests, with over 137,000 sold in 2024. The company established commercial partnerships with leading healthcare systems, employers, payors, and life insurance providers. GRAIL's employee headcount was approximately 1,000 as of December 31, 2024. The company is pursuing FDA approval for Galleri, aiming for a PMA submission in the first half of 2026, and is working with stakeholders to advance reimbursement and coverage. The company also highlighted its ongoing clinical studies involving over 385,000 participants.

GRAIL anticipates continued operating losses for the next several years due to ongoing investments in research and development and commercialization efforts. The company's outlook is contingent upon several factors, including securing FDA approval and broader reimbursement for Galleri, successful international expansion, continued market development for MCED testing, and the ability to increase demand for its products. The company's financial performance is heavily reliant on Galleri sales, and its future success depends on achieving market acceptance and securing adequate coverage and reimbursement from third-party payors.