GRAIL, Inc. (GRAL) Earnings

Management highlights

- 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 Q1, up 50% year over year. - Made strides to enhance provider and patient awareness of MSED, growing partnerships with health systems. - Saw growing deployment of gallery in leading systems like Dana - Farber, Rush, etc. - Completed FDA PMA submission, accepted by FDA for review. - Planned expansion of field sales and medical teams, majority to be onboarded and trained by mid - year. - Looking forward to data presentations at ASCO for NHS gallery trial and Pathfinder 2 study. - Announced integration with Epic electronic health record platform for easier ordering and result management.

Guidance

- Reiterated guidance with a 10% range, not updating it. - Growth expected between 22% and 32% on the revenue side for the year. - Factors like Salesforce expansion, ASCO data, and digital health partner uptake will influence growth. - ASPs expected to have relatively modest decline continuing other than mix - driven changes.

Segment performance

In the first quarter, gallery screening revenue was $39.8 million, a 37% increase year over year. Tests sold were over 56,000, a 50% volume increase year over year. Screening revenue contributed a significant portion to total revenue. Adjusted gross profit for the first quarter of 2026 was $19.7 million, an increase of $5.4 million or 38% compared to the first quarter of 2025. Adjusted EBITDA was negative $79.9 million, an improvement of $18.8 million or 19% compared to the first quarter of 2025.

Risks & headwinds

- Forward - looking statements subject to risks and uncertainties where actual events or results may differ materially. - Competitor advertising in the MSED space could be a potential competitive threat. - Uncertainty regarding FDA adcom convening and focus if it does. - Uncertainty around the pace of uptake of new digital health partners.

Analyst Q&A

• Q: Given Gallery has breakthrough device status and would be a Class III device, do you expect Gallery to be eligible for the rapid pathway or does the 2029 start date specified in the MSED bill negate this opportunity?

  A: We've looked at RAPID, it's a framework without much detail yet. On a high level, our test's characteristics like breakthrough designation and drive for FDA approval put us in what the act is intended for. We're hopeful we'll be eligible when details unfold.

• Q: How much growth from partnerships like Function Health and HINTS and HARS are factored in your guidance for gallery growth in 2026?

  A: We'll have to see just how fast the uptake of those goes.

• Q: Can you talk about the feedback from stakeholders since the NHS Gallery reveal?

  A: We've seen strong growth through Q1. The NHS Gallery data release led to questions from customers, etc. Once ASCO data comes out, there'll be interest for us to walk customers through detailed data and we plan to train sales force immediately after ASCO.

• Q: How should we expect ASPs to trend for the rest of the year?

  A: We have planned price reductions over time. With new scalable platform, we can bring pricing down while maintaining strong margins. Relatively modest decline expected continuing other than mix - driven changes.

• Q: Any plans on the advertising side to make sure you're getting brand recognition with consumers?

  A: We've been doing a bit more in social media channels. Competitors' advertising in the MSED space brings awareness, we'll probably increase marketing spend a bit through social media but not to the level of some other competitors.

• Q: Can you provide any color on how many reps are currently in the field and about the productivity of newly hired reps?

  A: We're expanding territories from about 90 to 120. Majority of newly hired reps will be onboarded and trained around mid - year.

• Q: Based on your conversations with the FDA post - final PMA module submission, what's your read on whether the FDA will convene an adcom?

  A: We submitted the final module of our PMA earlier this year, FDA is in ongoing iterative review. Guidance on timing is 180 days without adcom and about 320 days with. We can't comment yet on whether an adcom will be convened or its focus if it is.

• Q: Can you give any additional color to why there might be conservatism in guidance given you came in at 37% in Q1?

  A: It's early in the year, there are factors like FDA filing, Salesforce expansion, ASCO data, and digital health partner uptake to consider. We kept guidance the same and will update again after Q2.

• Q: How should we think about mix between hospital and DTC channels in 2027 and beyond?

  A: Too early to give guidance as it's driven by FDA approval.

• Q: Just wanted to hear about, you know, I assume it's kind of a Priyasko preview, but, you know, we're going to get NHS Gallery and Pathfinder full data. You know, is this group of the eventual customers, are they kind of conducive to these slices? You know, do they understand, you know, the superior sensitivity of gallery or specificity?

  A: Our customers are fairly well versed in gallery performance. We think the performance aspects are well understood by many customers but there's still a lot of education yet to be done.

• Q: What does the business kind of look like post ASCO, pre - FDA approval? How do you think about managing the pedal and maybe how does FDA approval impact the business?

  A: We'll have to see the impact of FDA approval. Fortunately, we've got the fundraising to intercept inflection point if it shows up.