Core Insights - GRAIL, Inc. reported significant growth in Galleri® test sales, with over 137,000 tests sold in 2024, leading to a 45% year-over-year increase in U.S. Galleri revenue to $108.6 million [1][2] - The company completed study visits for two registrational studies in July 2024, which will support a modular PMA submission planned for the first half of 2026 [1][3] - GRAIL ended 2024 with a cash position of $767 million, extending its financial runway into 2028 [1][5] Financial Performance - Fourth quarter revenue increased by 26% year-over-year to $38.3 million, with Galleri revenue growing by 39% to $31.6 million [2][4] - For the full year, total revenue rose by 35% to $125.6 million, while Galleri revenue increased by 45% to $108.6 million [2][4] - The net loss for the year was $2.0 billion, primarily due to goodwill and intangible asset impairment of $1.4 billion [2][4] Operational Highlights - TRICARE Health Insurance added GRAIL's Galleri test as a covered benefit for patients aged 50 and older with elevated cancer risk, enhancing market access [2][4] - The company executed a restructuring plan in the latter half of 2024 to improve business efficiencies while focusing on commercial growth [3][4] - GRAIL's Galleri test is designed to detect multiple cancer types early through a simple blood draw, targeting cancers that currently lack recommended screening [9][10] Cash Flow and Position - GRAIL's cash, cash equivalents, restricted cash, and short-term marketable securities totaled $766.8 million as of December 31, 2024, indicating a strong liquidity position [5][19] - The company reported a net cash used by operating activities of $577.2 million for the year, with financing activities providing $1.2 billion [22] Future Outlook - GRAIL plans to read out results from its registrational studies in 2025 and 2026, which are critical for future product approvals [3][4] - The integration with Quest Diagnostics is expected to streamline the ordering process for the Galleri test, increasing its availability across the U.S. [10]
GRAIL Reports Fourth Quarter and Full Year 2024 Financial Results