GRAIL, Inc. Q1 FY2025 earnings call

Key Points

• Bob Ragusa highlighted progress in multi-cancer early detection, including over 37,000 Galleri tests sold in Q1, rollout of enhanced Galleri, partnerships with Athena Health and Quest Diagnostics, commercial launch in Israel, and the Generation Possible campaign.
• Harpal Kumar shared NHS Galleri trial results: prevalent screening round had higher PPV than PATHFINDER, specificity 99.5%, CSO accuracy 88%, and no serious safety concerns. Results of the 140,000-participant trial expected in mid-2026.
• Joshua Ofman discussed clinical evidence program, Galleri's real-world performance, importance of PPV and specificity, CSO capability, Mayo Clinic study on Galleri, and need for annual screening.
• Aaron Freidin reported Q1 net loss of $106.2 million (improvement vs Q1 2024), non-GAAP adjusted gross profit $14.3 million, cash position $677.9 million, and cash burn guidance for 2025 at no more than $320 million.

In the first quarter of 2025, GRAIL's revenue was $31.8 million, up $5.1 million or 19% compared to Q1 2024. Screening revenue was $29.1 million, with US Galleri revenue at $28.7 million, up 22% year-over-year. Repeat test volumes account for more than 20% of Galleri volume. Galleri has been sold over 37,000 times in Q1, and over 325,000 tests have been prescribed by over 14,000 healthcare providers since 2021.

Forward-Looking Statements

• Anticipate interim data from PATHFINDER 2 study in late 2025 (first 25,000 of 35,000 participants).
• 2026 milestones: modular PMA submission to FDA in H1, final results from NHS Galleri study.
• 2025 guidance: US Galleri revenue growth expected to be 20%-30%, cash burn for 2025 targeted at no more than $320 million.

Risks

• Forward-looking statements are subject to risks and uncertainties; actual results may differ from projections. Refer to GRAIL's SEC filings, including the Risk Factors section in the most recent 10-Q, for details on factors that could cause actual results to differ.

Q: And on the topic of repeat testing, it sounds like that metric remained stable, I think I heard 20% continues. So when you think about repeat testing, what's an acceptable number at this point, do you like 20%? How do you improve the stickiness and that recurring kind of revenue stream? And then how does movement in that number affect your modeling of ASP and customer acquisition cost over the medium term?

A: We're pleased with repeat volumes above 20%, which compares favorably to reimbursed tests. We expect to grow repeat volumes but need more time to determine exact trajectory. A significant repeat base helps with customer acquisition cost modeling, factored into our medium-term projections.