GRAIL (GRAL) Q2 2025 Earnings Call August 12, 2025 04:30 PM ET Speaker0Good day, ladies and gentlemen, and welcome to the GRAIL Second Quarter twenty twenty five Earnings Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. GRAIL Investor Relations, please begin.Speaker1Thanks, operator, and thanks, everyone, for joining us today. On the call are Bob Ragusa ...

Core Insights - GRAIL, Inc. announced positive top-line performance and safety results from the PATHFINDER 2 study, which involved 25,578 participants and aimed to evaluate the Galleri multi-cancer early detection test [1][5] Group 1: Study Results - The PATHFINDER 2 study demonstrated that adding Galleri to standard cancer screening significantly increased cancer detection rates compared to the previous PATHFINDER study [2] - In the PATHFINDER study, Galleri had a positive predictive value (PPV) of 43%, specificity of 99.5%, and cancer signal origin (CSO) accuracy of 88%. The PATHFINDER 2 study showed a substantially higher PPV while maintaining consistent CSO accuracy and specificity [3] Group 2: Safety and Regulatory Aspects - No serious safety concerns were reported in the PATHFINDER 2 study, indicating a favorable safety profile for the Galleri test [4] - GRAIL plans to submit the PATHFINDER 2 study results to the U.S. FDA as part of the Galleri premarket approval application, which is currently in process under a Breakthrough Device Designation [5][6] Group 3: Future Directions - Detailed results from the PATHFINDER 2 study are expected to be presented at a leading international oncology meeting later this year [6] - The study aims to evaluate the Galleri test's performance across various measures, including PPV, negative predictive value (NPV), sensitivity, specificity, and CSO prediction accuracy [7]

Core Viewpoint - Quest Diagnostics has announced a collaboration with The University of Texas MD Anderson Cancer Center to develop a blood test aimed at improving cancer risk assessment and screening for individuals at elevated risk [1][2]. Group 1: Collaboration and Test Development - Quest Diagnostics will develop and validate a laboratory-developed blood test based on circulating protein biomarkers linked to high cancer risk, including cancers such as colorectal, lung, breast, pancreatic, ovarian, liver, prostate, esophageal, and stomach [2]. - The test will utilize technology and intellectual property from the Multi-Cancer Stratification Test (MCaST), developed by Dr. Samir Hanash and his team at MD Anderson, which is based on extensive clinical research involving tens of thousands of individuals [2]. - If the test validation is successful, Quest may commercialize the test, aiming for availability to providers in North America by 2026 [3]. Group 2: Test Purpose and Market Need - The future test is intended to supplement conventional screening methods by providing insights that help identify patients who would benefit from appropriate cancer screenings, addressing the limitations of current methods that often target a limited number of cancers [4]. - Current screening methods can be invasive, inconvenient, or costly, leading to a significant number of patients skipping preventive screenings; only 51% of U.S. adults reported having a routine medical appointment or cancer screening in the last year [5][6]. - Quest aims to create a simple and affordable blood test to identify risks for various cancers, potentially encouraging patients to pursue preventive screenings and early medical assessments [6].

Financial Data and Key Metrics Changes - First quarter revenue reached $31.8 million, an increase of $5.1 million or 19% compared to the first quarter of 2024 [26] - Screening revenue was $29.1 million, up 24% year-over-year, while development service revenue was $2.7 million [27] - Net loss for the quarter was $106.2 million, an improvement of 51% compared to the same quarter last year [29] - Non-GAAP adjusted gross profit was $14.3 million, a 19% increase from the previous year [29] - Cash position at the end of the quarter was $677.9 million, with a projected cash burn of no more than $320 million for the full year 2025 [29][30] Business Line Data and Key Metrics Changes - The company sold over 37,000 Gallery tests in the first quarter, with repeat test volumes exceeding 20% [27][28] - The rollout of an enhanced version of the Gallery test began in Q4 of the previous year, aimed at improving scalability and reducing costs [9] Market Data and Key Metrics Changes - The company has prescribed over 325,000 Gallery tests since its commercial launch in 2021, with more than 14,000 healthcare providers involved [8] - The integration of Gallery within athenahealth's EHR platform is expected to streamline the ordering process for over 60,000 US providers [9] Company Strategy and Development Direction - The company aims to advance its Gallery test through key clinical and regulatory milestones to unlock broader access [5] - A new educational campaign called "Generation Possible" has been launched to raise public awareness about multi-cancer early detection [10] - The company is focused on maintaining disciplined cost management while pursuing commercial growth in 2025 [5][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for the Gallery test and the progress towards FDA approval and broad reimbursement [31] - The company is on track for continued commercial growth, with expected volume growth from TRICARE coverage and integration with Quest Diagnostics [9][31] - Management highlighted the importance of annual screening with the Gallery test to reduce the risk of late-stage cancer diagnosis [21] Other Important Information - The NHS Gallery trial is the largest randomized controlled trial of any multi-cancer early detection test, with results expected in mid-2026 [14][15] - The company plans to submit data from the NHS Gallery trial and other studies as part of its premarket approval application in the first half of 2026 [25] Q&A Session Summary Question: Can you quantify the short-term variable cost improvements from the new version of Gallery? - Management indicated that margins are expected to improve over the year as the transition to the new version is completed [35] Question: How have Quest and TRICARE approvals played out in Q1? - Management noted early positive ordering trends from Quest providers and ongoing work with TRICARE contractors [36][37] Question: What is the cash burn trajectory for the remainder of the year? - The company reported a cash burn of just under $90 million in Q1, with expectations to remain within the $320 million target for the year [42][43] Question: How does the NHS Gallery data impact future readouts? - Management emphasized that the first round of screening results may differ from subsequent rounds, with final results expected in mid-2026 [50] Question: What is the rationale behind not raising additional funds at this time? - Management believes that achieving key milestones will derisk the business and create value, thus justifying the decision to wait [61][62]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $31.8 million, an increase of $5.1 million or 19% compared to Q1 2024 [26] - Screening revenue was $29.1 million, up 24% year-over-year, while development service revenue was $2.7 million [27] - Net loss for the quarter was $106.2 million, an improvement of 51% compared to Q1 2024 [29] - Non-GAAP adjusted gross profit for Q1 2025 was $14.3 million, an increase of $2.3 million or 19% year-over-year [29] - Cash position at the end of the quarter was $677.9 million, with a projected cash burn of no more than $320 million for the full year 2025 [29][30] Business Line Data and Key Metrics Changes - More than 37,000 Gallery tests were sold in Q1 2025, with repeat test volumes increasing over time, now accounting for over 20% of total volume [26][27] - The company has prescribed over 325,000 Gallery tests since its commercial launch in 2021 [7] Market Data and Key Metrics Changes - The company has launched Gallery commercially in Israel in partnership with OncoTest, with initial test orders being received [9] - The integration of Gallery within athenahealth's EHR platform is expected to streamline the ordering process for over 60,000 US providers [8] Company Strategy and Development Direction - The company aims to advance Gallery through key clinical and regulatory milestones to unlock broad access while managing costs [5] - A new educational campaign called "Generation Possible" has been initiated to raise public awareness of multi-cancer early detection [9] - The company is focused on achieving FDA approval for Gallery and pursuing broad reimbursement [31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for Gallery and the progress towards major milestones, including TRICARE coverage and integration with Quest Diagnostics [31] - The company expects to share interim data from the PATHFINDER II study in late 2025 and complete its PMA submission to the FDA in the first half of 2026 [31] Other Important Information - The NHS Gallery trial is the largest randomized controlled trial of any multi-cancer early detection test, with results expected in mid-2026 [12][14] - The company has made significant investments to optimize technology and laboratory infrastructure, including the rollout of an enhanced version of the Gallery test [7] Q&A Session Summary Question: Can you quantify the expected short-term variable cost improvements from the new version of Gallery? - Management indicated that margins are expected to improve over the year as they transition to the new version [35][36] Question: How is the cash burn tracking towards the $320 million target? - The company burned just under $90 million in Q1, with expectations that cash burn will align with the target as margins improve [42][44] Question: What is the rationale behind not raising money to derisk the outlook? - Management believes that achieving major milestones will create value and that they have sufficient cash runway to reach these goals [62][66] Question: How are recent conversations with NHS progressing regarding Gallery commercialization? - Management stated they are in constant dialogue with NHS and that decisions on commercialization will wait for final results from the study [70][72]