This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

GRAIL, Inc.
5/5/2026
Good day, ladies and gentlemen, and welcome to the Grail First Quarter 2026 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that this conference call is being recorded. Grail Investor Relations, please begin.
Thank you, and thank you all for joining us today. On the call are Bob Ragusa, our chief executive officer, Aroden Frieden, our chief financial officer, Josh Hoffman, president, Sir Halper Kumar, chief scientific officer and president international, and Eddie Partridge, chief commercial officer. I'll remind you that we'll be making forward-looking statements based on current expectations. It's our intent that all statements, other than statements of historical fact, including statements regarding our anticipated financial results and commercial activity, will be covered by the safe harbor provisions for forward-looking statements under federal securities laws. Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon currently available information, and GRAIL assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that GRAIL files with the SEC, including the risk factor section on GRAIL's most recent annual report on Form 10-K and the quarterly report on Form 10-Q, which we plan to file for the first quarter of 2026. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit and adjusted EBITDA, which excludes certain specified items. Our non-GAAP financial measures are intended to supplement your understanding of Grail's financials. Reconciliations of the non-GAAP measures to most directly comparable GAAP financial measures are available in the press release issued today, which is posted to our website. And with that, we turn to Bob.
Good afternoon, everyone, and thank you for joining us to review first quarter results. I will take a moment to highlight recent achievements before turning it over to Josh for an update on our clinical programs and recent and upcoming data, then over to Aaron to cover financials. This quarter, we saw continued strong commercial momentum with expanding physician adoption, increasing engagement across health systems, and growth in test volumes. Rails sold over 56,000 gallery tests in the first quarter, a 50% increase in volume year over year. Total gallery screening revenue was $39.8 million, up 37% over the prior year. We are making important strides to enhance provider and patient awareness of MSED. We continue to grow our partnerships with health systems, which educate physicians and engage the community. We are seeing growing deployment of gallery and leading systems, including Dana-Farber, Rush, OHSU, and Cleveland Clinic and Duke. We are seeing major health systems, including community health and Intermountain, investing in new and expanded employee benefit coverage of gallery. We are continuing to deepen our work with existing digital health partners, which enable outreach to curated memberships. We've also recently added additional partners such as WHOOP. Also, our employee relationships continue to expand as experience with Gallery grows. We've invested in the ease of access through our previously announced partnerships with Quest to integrate into their ordering systems and our recently announced collaboration with the Epic electronic health record platform. Integration through Epic Aura will allow health systems and their HCPs to order the gallery tests directly at the point of care, receive structured results, and manage patient follow-up within their existing native EHR and with their existing clinical workflows. Integration will provide standardized implementation and quicker onboarding for health systems adopting gallery. Integrations are beginning now. In January, we announced that we completed our FDA PMA submission, which has been accepted by the FDA for review. The PMA for gallery is focused on test performance and safety results from the first approximately 25,000 participants in the Pathfinder 2 study with one-year follow-up and the prevalent screening round only at the NHS gallery trial. The submission also includes a bridging analysis to compare performance of the version gallery used in the clinical trials to the updated version that has been submitted to the FDA for pre-market approval. We announced in February our planned expansion of the field sales and medical teams. We expect the majority of the new sales personnel will be onboarded and trained by mid-year. We believe this expansion will enable us to continue to drive commercial momentum. Finally, we're looking forward to the upcoming data presentations for 140,000 participant NHS gallery trial and the 35,000 participant Pathfinder 2 study. at the 2026 American Society of Clinical Oncology annual meeting later this month. We're excited to share data from the studies and begin to incorporate the learnings in our educational and sales initiatives. Following our data presentations at ASCO, we are planning to hold an analyst call on Sunday evening, May 31st. Stay tuned for details on the analyst call in the coming weeks. And with that, I'll ask Josh to provide an update on our clinical programs.
You're reading a preview of the GRAL Q1 2026 earnings call.
Free account.