GRAIL Q1 Earnings Call Highlights

Key Points

• Commercial momentum: GRAIL sold more than 56,000 Galleri tests in Q1 (up 50% YoY) and generated $39.8M in screening revenue, while integrations with partners like Quest, athenahealth and Epic are rolling out and have driven ~30,000 tests via ~2,000 providers to date.
• Clinical and regulatory update: The FDA has accepted GRAIL’s PMA submission (based on PATHFINDER 2 and NHS‑Galleri data); NHS‑Galleri missed its combined stage 3+4 endpoint but showed reductions in stage 4 diagnoses and other clinical utility signals, with 140,000‑patient NHS and 35,000‑patient PATHFINDER 2 data due at ASCO later this month.
• Financial position and outlook: Q1 revenue was $40.8M (up 28% YoY) with a net loss of $93.2M (improved 12% YoY) and cash of $823.1M; management reiterated guidance while citing upcoming ASCO data, sales expansion and partner rollouts as near‑term catalysts.

GRAIL NASDAQ: GRAL reported first-quarter fiscal 2026 results highlighting higher test volumes and screening revenue growth, alongside updates on its FDA premarket approval (PMA) review and upcoming clinical data presentations. Executives also discussed commercial partnerships, electronic health record integrations, and how recent NHS-Galleri trial headlines have shaped stakeholder questions ahead of additional data disclosures at ASCO later this month.

Commercial momentum and test volume growth

Chief Executive Officer Bob Ragusa said the company saw “continued strong commercial momentum with expanding physician adoption, increasing engagement across health systems, and growth in test volumes.” GRAIL sold more than 56,000 Galleri tests during the quarter, a 50% increase year-over-year, and generated $39.8 million in Galleri screening revenue, up 37% from the prior year.

Ragusa pointed to growing deployment within major health systems, citing Dana-Farber, Rush, Oregon Health & Science University, Cleveland Clinic, and Duke. He also said health systems including Community Health and Intermountain have invested in new or expanded employee benefit coverage for Galleri.

GRAIL said it continues to deepen relationships with digital health partners and added new partners, including WHOOP. Management also discussed expanding employer relationships as experience with Galleri grows.

Integrations with Epic, Quest, and athenahealth

Ragusa said GRAIL has invested in improving ease of access through integrations, referencing its previously announced partnership with Quest and a recently announced collaboration with Epic’s electronic health record platform. He said integration through Epic Aura is intended to allow health systems to order Galleri at the point of care, receive structured results, and manage follow-up within existing workflows, with standardized implementation and faster onboarding. Ragusa said integrations are beginning now.

In the Q&A, Chief Commercial Officer Andy Partridge provided adoption metrics for existing integrations. Partridge said about 2,000 healthcare providers have ordered through the Quest or athenahealth integrations, resulting in more than 30,000 tests deployed via those integrations since launch.

On Epic, Partridge said GRAIL is targeting roughly 450 health systems eligible for the integration—describing these as large systems—and that the company is currently completing technical build and go-to-market readiness. He said customers are expected to go live on Epic in the third quarter, and the sales team is profiling customers to assess their readiness and timing.

Clinical and regulatory updates ahead of ASCO

Ragusa reiterated that GRAIL’s FDA PMA submission for Galleri has been accepted for review. He said the PMA 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 of the NHS-Galleri trial. He also said the submission includes a bridging analysis comparing the version used in clinical trials with the updated version submitted for approval.

President Josh Ofman said more than 174,000 individuals are included in studies supporting the PMA submission and that the company has built what it believes is the “largest linked clinical and genomic data set in the field,” which has been used to drive test improvements.

Ofman summarized two analyses presented at the American Association for Cancer Research meeting in April:

• Emergency department involvement and outcomes: Ofman said emergency department involvement in a cancer diagnosis was associated with a significant fraction of overall mortality in the Medicare population and remained a strong independent predictor of mortality after adjusting for several factors.
• Mammography adherence after MCED testing: Ofman said women who received a negative MCED result maintained high adherence to guideline-recommended mammography, with greater than 80% undergoing screening in the 24 months after MCED testing, similar to the 24 months prior.

On the NHS-Galleri trial, Ofman said it was the first randomized trial to demonstrate a “population-scale stage shift” for a multi-cancer early detection test, but that the combined endpoint of stage 3 and 4 reduction over three screening rounds was not met. He said the trial observed an increase in stage 3 cancers detected and a decrease in stage 4 cancers detected, which “ended up canceling one another out” in the combined endpoint.

Despite not achieving statistical significance on the primary endpoint, Ofman said the trial demonstrated several clinical utility findings, including increased detection of stage 1 and 2 “deadly cancers,” a four-fold higher cancer detection rate compared with standard-of-care screening alone, reductions in stage 4 diagnoses, and reductions in emergency presentations of cancer. He emphasized that reducing stage 4 diagnoses is meaningful due to the survival differences between stage 3 and stage 4 for many cancers.

Management said it expects to present data from the 140,000-participant NHS-Galleri trial and the 35,000-participant PATHFINDER 2 study at the 2026 American Society of Clinical Oncology annual meeting later this month. Ragusa said the company plans to hold an analyst call on Sunday evening, May 31, following the ASCO data presentations.

Asked about whether the FDA will convene an advisory committee, Ofman said the company is in an iterative review process and it is unknown at this time whether an advisory committee will be held or what its focus would be. He cited FDA timing guidance of typically 180 days from submission without an advisory committee and about 320 days with one.

Financial results: revenue growth and narrowing loss

Chief Financial Officer Aaron Frieden said first-quarter revenue was $40.8 million, up 28% year-over-year, consisting of $39.8 million in screening revenue and $1.0 million in development service revenue. Net loss was $93.2 million, an improvement of 12% compared with the first quarter of 2025.

Frieden reported non-GAAP adjusted gross profit of $19.7 million, up 38% year-over-year, driven by improved fixed cost leverage from higher volumes and lower sample reprocessing costs, partially offset by a decrease in average selling price (ASP). Adjusted EBITDA was negative $79.9 million, improving 19% year-over-year.

GRAIL ended the quarter with $823.1 million in cash. Frieden said the cash position provides “financial flexibility to navigate growth over the next several years.”

On guidance, Frieden said the company reiterated its existing outlook and did not update it. In response to questions on why guidance was not raised despite first-quarter growth, Ragusa pointed to the early point in the year, upcoming catalysts including ASCO, the sales force expansion, digital health partner rollout timing, and competitive dynamics.

Pricing, sales force expansion, and stakeholder feedback

Management addressed ASP trends, with Ragusa saying the company has planned for price reductions over time as it scales Galleri. He said the company began leaning into observed price elasticity in 2025 and expanded discounting programs, with much of that occurring in 2025 as new pricing structures were established by channel. For 2026, he said GRAIL expects “relatively modest declines” aside from mix-driven changes.

On commercial execution, Ragusa said the company announced an expansion of field sales and medical teams, expecting the majority of new sales personnel to be onboarded and trained by mid-year. Partridge provided additional detail, saying the provider channel expansion increases territories from about 90 to 120, and that GRAIL does not expect to return to pre-spin Illumina levels for the sales team.

Partridge also discussed customer engagement after the release of NHS-Galleri top-line data, saying media coverage—including negative coverage—has led to questions from healthcare providers, employers, and patients. He said it has been difficult to address every question before full data are presented, and that the company plans to train its sales force immediately after ASCO to support customer follow-up.

In another discussion of sentiment, Ragusa said the reduction in stage 4 cancers “is one of the things that’s really resonating” with primary care physicians and oncologists, adding that oncologists’ attention has increased as they recognize the significance of the stage 4 reduction.

Ragusa also acknowledged competitive advertising in the MCED space, saying it has increased awareness and created “tailwinds” in educating the market, though he also characterized it as a potential competitive threat. He said GRAIL expects marketing spend to increase somewhat in social media channels, but “probably not to the level” of some competitors.

The call also marked a leadership transition, with Ofman noting Ragusa’s planned retirement at the end of the month and praising his role in GRAIL’s progress over the past five years. Ragusa said leading the company has been “the greatest honor” of his career and said he is “pleased to pass the reins shortly to Josh.”

About GRAIL NASDAQ: GRAL

GRAIL, Inc NASDAQ: GRAL is a biotechnology company dedicated to the early detection of cancer through a multi-cancer blood test. Leveraging advances in next-generation sequencing, cell-free DNA (cfDNA) analysis and machine learning, GRAIL has developed the Galleri™ test, which aims to identify more than 50 types of cancer at their earliest stages. The company's platform analyzes methylation patterns in circulating tumor DNA to pinpoint tumor presence and tissue of origin, enabling physicians to pursue timely diagnostic follow-up.

Founded in 2016 as a spin-out from Illumina, GRAIL established its headquarters in Menlo Park, California, with additional research and operations centers in the United Kingdom.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.