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The call conveyed strong commercial momentum and meaningful clinical and regulatory progress: test volumes grew 50% YoY, screening revenue rose 37% YoY, adjusted gross profit improved 38% YoY, PMA was accepted, and large trial datasets and upcoming ASCO readouts support the evidence base. At the same time, the NHS-Galleri primary combined endpoint was not met, ASP pressure and continued operating losses persist, media scrutiny and competitive activity create near-term headwinds, and regulatory/timing uncertainties (including possible FDA AdCom and CMS coverage) remain. Overall, positives around volume growth, margins improvement, cash runway, partnerships and regulatory progress outweigh the challenges, but the company still faces execution and perception risks that will need to be addressed in coming quarters.
Management reiterated 2026 revenue guidance of 22%–32% growth (a 10‑point range) despite a strong Q1 print—Q1 revenue $40.8M (+28% YoY) including $39.8M screening revenue (+37% YoY) on >56,000 Galleri tests (+50% YoY)—and explained the conservatism by pointing to uncertain uptake from new digital partners (e.g., Function, Hims & Hers), timing of the sales‑force expansion (territories rising from ~90 to 120, majority of new reps to be onboarded by midyear), Epic Aura integration rollout to ~450 eligible health systems (go‑live beginning in Q3), and regulatory/coverage timing. Q1 financials included adjusted gross profit $19.7M (+38% YoY), adjusted EBITDA -$79.9M (improved $18.8M, +19% YoY), net loss $93.2M (12% improvement) and cash of $823.1M; operational metrics cited ~1,300 new prescribers in Q1, ~2,000 providers using Quest/Athena electronic ordering (driving >30,000 tests via those integrations), self‑pay representing ~2/3+ of volume, and an expectation of only modest further ASP declines (with mix effects possible); the company said it will reevaluate guidance after Q2.
Galleri tests sold: >56,000 in Q1 2026, a 50% year-over-year increase. Galleri screening revenue: $39.8M, up 37% year-over-year. Total revenue: $40.8M, up 28% year-over-year (includes $1.0M development services).
Non-GAAP adjusted gross profit of $19.7M in Q1 2026, an increase of $5.4M or 38% year-over-year. Margin improvement driven by fixed cost leverage from higher volumes and reduced sample reprocessing costs.
Adjusted EBITDA was negative $79.9M, an improvement of $18.8M or 19% year-over-year. Cash balance of $823.1M at quarter end, providing multi-year runway to pursue milestones and commercialization.
FDA PMA submission for Galleri was accepted for review (PMA includes ~25,000 PATHFINDER 2 participants with 1-year follow-up and the prevalence round of NHS-Galleri, plus a bridging analysis). Company notes ongoing iterative review and constructive interactions with FDA.
More than 174,000 individuals included in studies supporting the PMA; PATHFINDER 2 (35,000 participants) and NHS-Galleri (140,000 participants) full results to be presented at ASCO. Commercial and study testing yields consistent results across hundreds of thousands of tests.
NHS-Galleri topline: increase in detection of Stage I/II deadly cancers and a fourfold higher cancer detection rate compared to standard of care screening alone; meaningful reductions observed in Stage IV diagnoses and emergency presentations of cancer.
Expanded partnerships with major health systems (Dana-Farber, Cleveland Clinic, Duke, OHSU, Rush, Intermountain), digital-health partners (Function Health, Hims & Hers, WHOOP, Everlywell) and employers. Integrations with Quest and Athena have enabled ~2,000 providers to order via those platforms, yielding >30,000 tests through those integrations; Epic Aura integration announced (targeting ~450 Epic health systems eligible) to streamline ordering and results in EHRs.
Planned expansion of field sales and medical teams to increase territories from ~90 to 120; majority of new sales personnel expected to be onboarded and trained by midyear to drive further commercial momentum.
Good day, ladies and gentlemen, and welcome to the GRAIL First Quarter 2026 Earnings Call. [Operator Instructions] 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; Aaron Freidin, our Chief Financial Officer; Josh Ofman, President; Sir Harpal Kumar, Chief Scientific Officer and President, International; and Andy 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 Factors 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, i...