GRAIL, Inc.

Good day, ladies and gentlemen, and welcome to the Grail Fourth 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.

Thank you, Operator, and thank you all for joining us today. On the call are Bob Ragusa, our Chief Executive Officer, Aaron Frieden, our Chief Financial Officer, Josh Hoffman, President, Sir Harpo Kumar, Chief Scientific Officer and President International, and Andy Partridge, Chief Commercial Officer. Before we get underway, 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 GRAIL's most recent quarterly report and upcoming annual report. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit and adjusted EBITDA, which 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.

Good afternoon, everyone, and thank you for joining us to review results for the fourth quarter and full year 2025 and discuss recent business updates. 2025 was a year of significant commercial growth for Grail, and we have shared a number of exciting developments so far in 2026. We issued a press release this afternoon with top-line results from our NHS Gallery trial. We observed a substantial reduction in stage four cancer diagnosis, increased stage one and two detection of deadly cancers, and a four-fold higher cancer detection rate, outcomes that matter for patient care. While there was a trend towards reduction in combined stage three and four, the trial did not meet the primary endpoint of statistically significant reduction. These data show the benefit of multi-cancer screening with Gallery and provide the strongest evidence for the recommended annual screening interval. Our Paul will talk through the top-line NHS Gallery trial results shortly. In our earnings press release, we also noted full results from all 35,000 participants in Pathfinder 2 and were consistent with data presented from the first 25,000 participants presented at ESMO last year. We anticipate presenting full data from both NHS Gallery and Pathfinder 2 in mid-2026. Based on strong results from the NHS Gallery trial and the Pathfinder 2 study, we also announced today that we are moving forward with a planned expansion of our field sales and medical team. We believe this expanded engagement will enable us to continue to drive commercial momentum. To recap quickly on the strong commercial performance for Gallery in 2025, which we shared in January, the U.S. gallery test volume grew 36% to more than 185,000 gallery tests, and U.S. gallery revenue grew by 26%. Our prescriber base is now approximately 17,000 providers, up 30% from prior year. Gallery's growth in 2025 was driven by both breadth and depth of prescribing. We have been in the market with the Gallery test now for more than four years. And from the launch of Gallery through December 31st, we have sold almost a half a million Gallery tests. We remain on track for continued commercial growth in 2026 with new and expanding partnerships, including digital health opportunities and further integration into health systems. We are focused on expanding awareness of multi-cancer early detection and Gallery's important performance and capability differentiation. We anticipate growing patient, provider, and employer conviction in gallery as other performance safety and clinical utility data sets are read out. A few weeks ago, we announced that we completed our PMA submission with the FDA. The PMA marks a critical step forward, making gallery available to more people and advancing early detection to provide a significant public health benefit. The submission represents years of focus, disciplined work to achieve design, development, and validation of gallery and large, diverse screening populations. Josh will share more about our PMA later in this call. Additionally, earlier this month, the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act became federal law. This establishes a Medicare coverage pathway for FDA-approved multi-cancer early detection tests As a leading MSED developer, it is our privilege to stand with legislators, patient advocates, clinicians, and researchers who have championed the cause. I'll now hand it over to Harpal to discuss topline results from the NHS Gallery study.