5/13/2025

speaker
Operator
Conference Operator

Good day, ladies and gentlemen, and welcome to the Grail First Quarter 2025 Earnings Call. At this time, all participants are in 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.

speaker
Grail Investor Relations
Investor Relations

Thanks, operator, and thanks, everyone, for joining us today. On today's call are Bob Ragusa, Grail's Chief Executive Officer, Aaron Frieden, Chief Financial Officer, Dr. Joshua Offman, President, Sir Harpal Kumar, President, International Business and Bound Pharma, and Andy Partridge, Chief Commercial Officer. We'll be making forward-looking statements on this call based on current expectations. It's our intent that all statements, other than statements of historical fact made during today's call, including statements regarding our anticipated financial results and commercial activity, will be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933 as amended and Section 21 of the Securities Exchange Act of 1934 as amended. 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 in GRAIL's most recent quarterly report on Form 10-Q. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit or loss, which are adjusted to exclude 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.

speaker
Bob Ragusa
Chief Executive Officer

Thank you. Good afternoon, everyone, and thank you for joining us to review first quarter results. We're making progress toward our vision of population-scale multi-cancer early detection and our main focus on developing the market. We plan to continue advancing Gallery through several key clinical and regulatory milestones that will help unlock broad access while maintaining our disciplined cost management. We are very pleased this afternoon to share positive top-line results from the prevalent round of screening in the 140,000 participant NHS Gallery trial. NHS Gallery is one of our two registrational studies, and as Harpal will describe shortly, these results continue to demonstrate strong Gallery performance in detecting multiple types of cancers with very low false positive rates. I'll take a moment to review key achievements in the first quarter before turning it over to Harpal. Then Josh will provide a medical and scientific update and Aaron will cover the financials. We are building on our unique position as the first mover in the multi-cancer early detection field with the only commercially available clinically validated MSED test that has shown the ability to detect many types of cancer. Grail has sold more than 37,000 Gallery tests in the first quarter, and as of March 31st, more than 325,000 Gallery tests have been prescribed by more than 14,000 healthcare providers since we launched Gallery commercially in 2021. We continue to drive provider and patient awareness of the MSED opportunity and Gallery's ability to detect cancer early when it is more amenable to treatment. And importantly, we are generating real-world evidence as our leading health systems and physician practices who have offered MSED as early gallery adopters. We are proud of the demonstrated impact Gallery is having on patients' lives today, and I'm excited about our technology's potential to affect how and when we find cancer on a broad scale. We have made significant investments over time to optimize our technology and laboratory infrastructure. and we began the rollout of an enhanced version of the Gallery test in the fourth quarter of last year. The workflow integrates a significant level of automation, among other efficiencies, to help support volume at scale and help achieve reductions in costs over time. Among recent business highlights, we announced yesterday a new partnership with Athena Health intended to further streamline the Gallery test ordering process. Gallery's integration within Athena Health's EHR platform, Athena Coordinated Core, can provide a more seamless ordering process for over 160,000 US providers. Additionally, Gallery test results will be returned directly in the EHR. We remain on track for continued commercial growth in 2025 with expected volume growth from TRICARE coverage and Gallery's integration with the Quest Diagnostics ordering system. Additionally, we have commercially launched in Israel in partnership with Oncotest, which has a strong record in genomic test distribution. We are pleased to see the initial test orders within that region. Finally, we are initiated a new educational campaign called Generation Possible. Generation Possible's goal is to build public awareness of multi-cancer early detection. And we have partnered with Kate Walsh as a spokesperson to help further the message. The campaign underscores at the patient level, the importance of taking control over your health with the option to screen for many of the deadliest cancers before symptoms appear. More information about Generation Possible is available at genpossible.com. And with that, I'll turn it over to Harpal.

Disclaimer

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