Release Date: February 20, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• GRAIL Inc (NASDAQ:GRAL) reported a 26% increase in revenue for Q4 2024, reaching $38.3 million compared to Q4 2023.
• The company achieved a 45% year-over-year growth in US gallery revenue, selling over 137,000 gallery tests.
• GRAIL Inc (NASDAQ:GRAL) successfully integrated its test ordering system with Quest Diagnostics, facilitating easier access for physicians and patients.
• The US military's TriCare Health Insurance Program added the gallery test as a covered benefit for eligible patients, expanding potential market reach.
• The company has extended its cash runway into 2028, providing financial stability to achieve major milestones, including FDA submissions.

Negative Points

• GRAIL Inc (NASDAQ:GRAL) reported a net loss of $97.1 million for Q4 2024, although this was an improvement from the previous year.
• The full-year net loss increased by 38% to $2 billion, primarily due to goodwill and intangible asset impairments.
• Development services revenue decreased by 13% in Q4 2024 compared to the same period in 2023.
• The company faces uncertainty related to the timing and approval of the MCED legislation, which could impact future reimbursement rates.
• There is no immediate impact from recent AI and cancer detection initiatives, indicating potential long-term rather than short-term benefits.

Q & A Highlights

• Warning! GuruFocus has detected 2 Warning Signs with GRAL.

Q: Can you provide more details on how the lower cost of goods sold (COGS) for the new Gallery test impacts pricing flexibility and demand elasticity? A: (Josh Hoffman, President) The new version of the Gallery test allows us to run four times the number of samples due to a more focused panel, leading to a reduction in COGS. While this provides a platform for scalability and long-term cost structure, we haven't yet tested price elasticity. The focus is on future-proofing for population-scale pricing and margins. (Bob, CEO) We haven't seen immediate elasticity effects, but the updates are designed to support long-term growth and cost efficiency.

Q: What is the status of the MCED legislation, and how does it impact your operations? A: (Bob, CEO) The reintroduction of the MCED bill has strong bipartisan and bicameral support. We are encouraged by the momentum and stakeholder advocacy. The legislation is being considered for inclusion in upcoming spending bills or reconciliation processes. (Josh Hoffman, President) We remain hopeful for its passage, which would support our efforts in early cancer detection.

Q: How does the recent collaboration with Quest Diagnostics and the Tricare news impact your 2025 guidance? A: (Aaron Frieden, CFO) Both the Quest Diagnostics collaboration and Tricare coverage are exciting developments. Quest will facilitate easier test ordering, and Tricare has added the Gallery test as a covered benefit. These opportunities were considered in our 2025 guidance, and there is no change to our projections at this time.

Q: What are the expectations for the Pathfinder 2 study, and what are the key endpoints? A: (Josh Hoffman, President) Pathfinder 2 is a U.S. study evaluating the safety and performance of the Gallery test in adults over 50 with elevated cancer risk. Key endpoints include test performance measures like specificity, sensitivity, and predictive values, as well as safety measures related to diagnostic workups. The study results will be part of our FDA submission in the first half of 2026.

Q: How does the potential delay or acceleration of FDA submission impact your cash burn and financial planning? A: (Aaron Frieden, CFO) Our plans for FDA PMA submission are set for the first half of 2026, with a cash runway extending into 2028. We have built in flexibility to accommodate potential delays, ensuring financial stability. (Bob, CEO) The restructuring and cash management strategies provide a buffer to handle any timeline changes.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.