GRAIL, Inc. (NASDAQ: GRAL) reported fourth‑quarter and full‑year 2025 financial results on February 19, 2026. Revenue rose 14% year‑over‑year to $43.6 million, beating the consensus estimate of $41.92 million. The company posted a GAAP earnings loss of $2.44 per share, a $0.22 improvement over the $3.18 estimate, and a net loss of $99.2 million for the quarter and $408.4 million for the year.
U.S. Galleri revenue, the company’s core product, grew 31% to $41.3 million, accounting for 95% of total revenue. Screening revenue of $42.3 million and development‑services revenue of $1.3 million made up the remaining $1.9 million. Full‑year U.S. Galleri revenue reached $136.8 million, up 26% from $107.5 million in 2024, while full‑year screening revenue totaled $138.6 million and development‑services revenue fell 49% to $8.6 million.
Gross loss for the quarter was $11.1 million, but adjusted gross profit climbed to $23.1 million, reflecting a 29% increase in adjusted gross margin driven by a higher mix of Galleri volume and scale efficiencies. The company recorded $34.6 million in amortization of Illumina‑related intangible assets and a $28 million impairment of goodwill and other intangible assets, which contributed to the net loss. Full‑year gross loss was $62.6 million and adjusted gross profit was $73.6 million.
Operating cash outflow for the quarter was $63.2 million, a 32% improvement from the $96.5 million outflow in Q4 2024, and nine‑month cash used in operating activities fell to $235 million from $484 million in 2024. The company ended the quarter with $904.4 million in cash, cash equivalents, and short‑term marketable securities, giving it a runway that management says extends into 2030.
CEO Bob Ragusa said, "2025 was a year of significant commercial growth for GRAIL, and we're excited by the building momentum for multi‑cancer early detection. In the fall, we presented positive results from the first ~25,000 participants in the PATHFINDER 2 study, and we subsequently raised more than $435 million, which provides financial flexibility as we continue to drive towards broad access for Galleri." He added that the company completed Galleri’s PMA submission to the FDA in January and will present NHS‑Galleri trial results at the upcoming ASCO 2026 meeting. Management reiterated its 2026 guidance of 22%‑32% sales growth and a cash burn of $300 million or less.
Investors reacted negatively, focusing on the NHS‑Galleri trial’s failure to meet its primary endpoint of a statistically significant reduction in combined Stage III and Stage IV cancers, which could impact FDA approval and Medicare coverage. The trial miss has tempered enthusiasm for the company’s strong revenue growth and narrowed loss.
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