Grail, Inc.(US:GRAL)2025-08-12 21:30Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $35.5 million, an increase of $3.5 million or 11% compared to Q2 2024 [22] - Screening revenue was $34.4 million, up 22% compared to the same period in 2024 [24] - Net loss for the quarter was $114 million, an improvement of 93% compared to Q2 2024 [26] - Non-GAAP adjusted gross profit for Q2 2025 was $16.1 million, an increase of $100,000 or 1% compared to Q2 2024 [26] - Cash position at the end of the quarter was $606.1 million, with updated guidance for cash burn in 2025 reduced to no more than $310 million [26] Business Line Data and Key Metrics Changes - More than 45,000 Gallery tests were sold in Q2 2025, with over 370,000 tests prescribed since the commercial launch in 2021 [7][22] - U.S. Gallery revenue was $34.2 million, up 21% compared to Q2 2024, with expectations of 20% to 30% growth for the full year [24][25] - Repeat test volumes have trended higher, with over 25% of Gallery's volume being repeat testing [23] Market Data and Key Metrics Changes - The company has established partnerships with healthcare systems, including Rush University System for Health, to increase availability of the Gallery test [7] - Integration of Gallery into the Quest diagnostic test ordering platform has shown promising growth, with 7% of orders coming through this platform in Q2 [61] Company Strategy and Development Direction - The company is focused on seeking FDA approval for Gallery and pursuing broad reimbursement [28] - Plans to submit detailed results from the Pathfinder two study for presentation at the ESMO Congress in October 2025 [28] - The company aims to achieve major clinical and regulatory milestones, with cash runway extending into 2028 [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for Gallery, both from new and returning patients [28] - The company is encouraged by the performance metrics from the Pathfinder studies, indicating improved cancer detection rates and positive predictive values [14][17] - Management highlighted the importance of clinical validation in the intended use population for the success of multi-cancer early detection tests [12][42] Other Important Information - The company is working to address increased turnaround times and higher reprocessing costs associated with the new version of Gallery [9] - The upcoming Analyst Day in November 2025 will feature key study results and clinical findings [9][28] Q&A Session Summary Question: Can you comment on Q2 free cash burn and dynamics impacting cash burn in the second half of 2025? - Management indicated that cash burn for the first half was about $160 million and expects it to decrease in the second half due to increased revenue and volume [34][35] Question: Do you need full longitudinal clinical utility data for PMA submission? - Management clarified that the FDA focuses on clinical validation rather than clinical utility for approvals [41][42] Question: How is the integration with Quest performing? - Management reported that about 500 healthcare professionals have ordered the Gallery test via Quest, with a 7% order rate through this platform in Q2 [61] Question: What are the expectations for repeat testing rates? - Management expressed satisfaction with the increase in repeat testing rates, which rose to over 25% in Q2 [65]