Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Revenue for Q2 2024 was $32 million, up 43% compared to Q2 2023.
- Total revenue for the first half of 2024 increased by 40% compared to the same period in 2023.
- GRAIL's Galleri test has been prescribed by over 11,000 healthcare providers, with more than 215,000 tests sold.
- Completion of final study visits for 140,000 participants in the NHS-Galleri study and enrollment of 35,000 participants in the PATHFINDER 2 study.
- Corporate restructuring extends cash runway into 2028, providing greater financial flexibility.
Negative Points
- Net loss for Q2 2024 was $1.59 billion, a 721% increase compared to Q2 2023.
- Goodwill and intangible impairment of $1.42 billion significantly impacted financial results.
- Increased general and administrative expenses related to legal and professional services and higher employee compensation.
- Adjusted EBITDA for Q2 2024 was negative $139.4 million, representing an increased loss compared to Q2 2023.
- Reductions in spend and headcount by approximately 30%, impacting various commercial and R&D activities.
Q & A Highlights
Q: What gives you confidence that the current level of investment is enough to commercialize the multi-cancer early detection (MCED) test?
A: Robert Ragusa, CEO: We've carefully reviewed our portfolio and focused on MCED, particularly FDA approval and broad reimbursement. We are confident that our resources are aligned to achieve these goals successfully. The changes primarily affect areas outside of MCED.
Q: How and when will the cost reductions be phased in, and what is the timeline for MRD and DAC investments to return?
A: Robert Ragusa, CEO: The cost reductions will be implemented immediately. We believe our methylation technology is well-suited for MRD and DAC, but we are pausing future developments in these areas to focus on MCED. No timeline has been set for reinvesting in MRD and DAC.
Q: Can you provide more details on where the largest cost savings will come from?
A: Robert Ragusa, CEO: Savings will come from a 30% reduction in headcount and planned requisitions, centralizing our CLIA lab, and reducing R&D in DAC and MRD programs. We are also streamlining our commercial efforts and reducing G&A expenses.
Q: What is the progress update on the Galleri 2.0 launch, and how confident are you in its performance?
A: Robert Ragusa, CEO: We have collected a lot of real-world data, which gives us confidence in the new version of the assay. We expect to complete our FDA filing in the first half of 2026 with data from our registrational studies, including bridging to the new version.
Q: For the REACH study, will the primary endpoint of reducing stage 4 cancers be sufficient for Medicare coverage following FDA clearance?
A: Joshua Ofman, President: The REACH study is a post-approval study with the FDA and will supplement our PMA data. Medicare coverage will depend on legislative authority and a national coverage analysis by CMS. We believe the data will be compelling for CMS to make a coverage determination.
Q: Can symptomatic patients still order the Galleri test with a prescription, and what is the rationale for pausing DAC investments?
A: Robert Ragusa, CEO: Symptomatic patients can still order the Galleri test with a prescription. We have paused DAC investments to focus on MCED, despite strong results from the SYMPLIFY study, due to the level of investment required to bring DAC to market.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
