GRAIL, Inc. Q1 FY2026 Earnings Call

Good day, ladies and gentlemen, and welcome to the GRAIL First Quarter 2026 Earnings Call. 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, including adjusted gross profit and adjusted EBITDA, which excludes 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 the 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 first quarter results. I will take a moment to highlight recent achievements before turning it over to Josh for an update on our clinical programs and recent and upcoming data, then over to Aaron to cover financials. This quarter, we saw continued strong commercial momentum with expanding physician adoption, increasing engagement across health systems and growth in test volumes. GRAIL sold over 56,000 Galleri tests in the first quarter, a 50% increase in volume year-over-year. Total Galleri screening revenue was $39.8 million, up 37% over the prior year. We are making important strides to enhance provider and patient awareness of multi-cancer early detection. We continue to grow our partnerships with health systems, which educate physicians and engage the community. We are seeing growing deployment of Galleri in leading systems, including Dana-Farber, Rush, OHSU, Cleveland Clinic and Duke. We are seeing major health systems, including Community Health at Intermountain, investing in new and expanded employee benefit coverage of Galleri. We are continuing to deepen our work with existing digital health partners, which enable outreach to curated memberships. We have also recently added additional partners such as WHOOP. Also, our employer relationships continue to expand as experience with Galleri grows. We've invested in ease of access through our previously announced partnerships with Quest to integrate into their ordering systems and our recently announced collaboration with the Epic electronic health record platform. Integration through Epic Aura will allow health systems and their healthcare providers to order the Galleri test directly at the point of care, receive structured results and manage patient follow-up within their existing native EHR and with their existing clinical workflows. Integration will provide standardized implementation and quicker onboarding for health systems adopting Galleri. Integrations are beginning now. In January, we announced that we completed our FDA PMA submission, which has been accepted by the FDA for review. The PMA for Galleri is focused on test performance and safety results from the first approximately 25,000 participants in the PATHFINDER 2 study with 1-year follow-up and the prevalence screening round only of the NHS-Galleri trial. The submission also includes a bridging analysis to compare performance of the version of Galleri used in the clinical trials to the updated version that has been submitted to the FDA for premarket approval. We announced in February our planned expansion of the field sales and medical teams. We expect the majority of the new sales personnel will be onboarded and trained by midyear. We believe this expansion will enable us to continue to drive commercial momentum. Finally, we're looking forward to the upcoming data presentations for our 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. We're excited to share data from the studies and begin to incorporate the learnings in our educational and sales initiatives. Following our data presentations at ASCO, we are planning to hold an analyst call on Sunday evening, May 31. Stay tuned for details on the analyst call in the coming weeks. And with that, I'll ask Josh to provide an update on our clinical programs.

Thanks, Bob. At GRAIL, we're very excited about the comprehensive data we've been generating to demonstrate the value proposition for Galleri. This technology has been validated through robust studies, including those in intended-use populations. More than 174,000 individuals are included in studies supporting our PMA submission to the FDA, and we're seeing consistent results through hundreds of thousands of commercial and clinical study tests. Through our studies and commercial testing, we've built what we believe is the largest linked clinical and genomic data set in the field. We have already been able to use these data to drive test improvements, and we'll continue to do that over time. Our teams have continued to present evidence demonstrating Galleri's performance at renowned medical conferences, including two new analyses at the American Association for Cancer Research Annual Meeting in April. The first assessed the association between emergency department involvement in the diagnosis of cancer and overall survival across different cancer types in the Medicare population. Emergency department involvement was associated with a significant fraction of overall mortality in patients with cancer. Emergency department involvement in diagnosis remained a strong independent predictor of mortality after adjusting for sociodemographics, comorbidities and stage of diagnosis. A second study evaluated adherence to mammography screening before and after multi-cancer early detection testing. Women who received a negative MCED result maintained their high adherence to guideline-recommended mammography, with greater than 80% undergoing screening in the 24 months after MCED testing, similar rates in the 24 months before testing. As a reminder, Galleri is intended to be used alongside existing standard of care single cancer screening tests, and these findings suggest that MCED testing will not negatively impact participation in guideline-recommended cancer screening. Earlier this year, we released top-line data from the NHS-Galleri trial, which is the first randomized trial to demonstrate population-scale stage shift for a multi-cancer early detection test. Working with the NHS, we agreed to a combined endpoint of Stage III and IV reduction over three rounds of screening. What was observed in the trial was an increase in Stage III cancers detected and a decrease in Stage IV cancers detected, which ended up canceling one another out in this combined endpoint. While we did not achieve a statistically significant reduction in this combined primary endpoint, we did demonstrate a number of strong clinical utility findings. We observed an increase in the detection of Stage I and II deadly cancers and a fourfold higher cancer detection rate compared to standard of care screening alone. These findings indicate we were able to find deadly cancers that we are not screening for and also find cancers that we've been missing with standard of care screening. We also observed meaningful reductions in Stage IV cancer diagnosis and in the emergency presentation of cancer. These findings suggest that with multiple rounds of screening, we may be able to identify some of the most lethal cancers earlier. Reducing Stage IV diagnoses is incredibly meaningful because there is a large survival cliff between Stage III and Stage IV for many types of cancer. Many Stage III cancers can now be treated with curative intent and finding these cancers at Stage III rather than Stage IV can make a meaningful difference in a patient's treatment experience and outcomes. The reduction in emergency presentation reflects a similar opportunity to improve the patient experience, their care and their outcomes. Cancers presenting in the emergency room represent 20% of cancer diagnoses in the U.K. and similar numbers in the U.S., and these cases are among the costliest and those associated with some of the poorest outcomes. We believe that both the increase in overall and early cancer detection and the decrease in metastatic and emergency presentation of cancer are important and relevant to providers and payers in evaluating the clinical and economic value of Galleri as a complement to standard of care screening. We are really looking forward to presenting these data plus the results from all 35,000 participants from our PATHFINDER 2 study at ASCO in just a few weeks. I'll hand off now to Aaron for a review of our financials.

Thanks, Josh, and good afternoon, everyone. I'm pleased to present our results for the first quarter. First quarter results were strong with revenue of $40.8 million, up $8.9 million or 28% as compared to the first quarter of 2025. Total revenue for the quarter consisted of $39.8 million of screening revenue and $1 million of development service revenue. Screening revenue was up 37% as compared with the first quarter of 2025 with test volumes of more than 56,000 tests, an increase of 50% over Q1 of last year. Net loss for the quarter was $93.2 million, an improvement of 12% as compared to the first quarter of 2025. Non-GAAP adjusted gross profit for the first quarter of 2026 was $19.7 million, an increase of $5.4 million or 38% as compared with the first quarter of 2025. Primary drivers of the increased gross margin were improved fixed cost leverage due to the increase in volumes and a decrease in sample reprocessing costs, partially offset by a decrease in average selling price. Adjusted EBITDA for the first quarter of 2026 was negative $79.9 million, representing an improvement of $18.8 million or 19% as compared to the first quarter of 2025. We ended the quarter with a cash position of $823.1 million, providing us with the financial flexibility to navigate growth over the next several years as we pursue key milestones toward broad access to our multi-cancer early detection technology. Back to you, Josh.

Thanks, Aaron. Bob, before your retirement at the end of this month, I want to take a moment to acknowledge the tremendous contributions you've made as CEO of GRAIL. All of us at GRAIL and everyone joining today's call who follows our story can appreciate the incredible progress you've led our teams through over the last five years: our spinout from Illumina, our commercial expansion and the scaling of our North Carolina laboratory operations. As a result, GRAIL has a strong operational and financial foundation to advance multi-cancer early detection at scale and is well positioned for long-term growth. Bob, on behalf of all of our teams at GRAIL, thank you.

Thanks very much, Josh. Leading GRAIL and working alongside this extraordinary team has been the greatest honor of my four decades in healthcare. We are addressing one of the most urgent healthcare challenges of our time, and I am extremely proud of our pioneering work. I'd also like to express my sincere thanks to each GRAIL employee. Every achievement we've made has been the result of the ideas and actions spurred by the great people across this company and driven by a commitment to a singular goal. Our vision is population-scale, multi-cancer early detection, and we're making real advances each year. I'm pleased to pass the reins shortly to Josh, who has played a central role in driving GRAIL's strategy and execution over the past seven years. Operator, we can go to Q&A.

Our first question will come from Subbu Nambi with Guggenheim.

And great print. The FDA and CMS recently established a rapid pathway in which CMS will propose the national coverage determination for Class II and III breakthrough devices on the same day that the FDA provides market authorization. Given Galleri has the breakthrough device status and would be expected to be a Class III device, do you expect Galleri to be eligible for the rapid pathway? Or does the 2029 start date specified in the MCED bill negate this opportunity? Sorry for the long question.

Thanks, Subbu, for the question. We've looked at the rapid pathway and at a high level it does look like the characteristics of our test, the breakthrough designation and the fact that we're driving for FDA approval align with what the act is intended for. So we're hopeful that when the details come out, we will be eligible for that. But we do have to wait and see how the details unfold for that particular piece of legislation. Josh, any other comments on that?

No additional comments beyond what Bob said. It is an important piece of regulation, and it's encouraging. For years, the government has been trying to shorten the gap between FDA approval and CMS coverage. This is something the administration has been prioritizing. Everything that we've done—from seeking FDA approval, having a breakthrough device designation, and conducting an IDE that was reviewed by the FDA and CMS—should comport with what this regulation intends to do. We're looking forward to seeing the details and the regulation itself.

Perfect. And how much growth from partnerships like Function Health and Hims & Hers are factored in your guidance for Galleri growth in 2026? And then maybe I missed this, but given the beat, are you raising guidance? I'm hopping through multiple earnings, so pardon my question here.

Aaron, do you want to take that one?

Yes. So on your first question, Subbu, nice to talk to you. We are reiterating our guidance; we are not updating it today. You should note a 10% range in our guidance to allow for variability. One reason for that is to learn and see how uptake works in the digital health space. Some of those partners like Function we've had more experience with. Hims & Hers and some of these other new agreements are now implementing, and we'll see what uptake is like. Depending on how they implement, it can go quickly or more slowly.

Your next question will come from Kyle Mikson with Canaccord Genuity.

Congrats on the quarter. First, it's been a few months since the NHS-Galleri reveal. Can you talk about the feedback from stakeholders since then? And with ASCO presentations soon, do you expect opinions to materially change following those abstracts and the analyst call?

Sure. First, on NHS-Galleri: we had a strong quarter overall, growing volumes by 50% and screening revenue by 37% year-over-year, so we saw current strength. Andy, I'll ask you to address customer response to NHS-Galleri.

Thanks, Bob. As Bob said, we've seen strong growth in Q1 year-over-year across brick-and-mortar providers, digital health and employers. Specifically, we've seen a significant expansion of new ordering healthcare providers in Q1 with about 1,300 new prescribers writing Galleri orders in the quarter. We've also added important new customers across our employer business and health systems—Cleveland Clinic, Duke and OHSU came on board with agreements in Q1—and added new digital health customers in Q1, all while the NHS-Galleri data was released. The media coverage, including some negative coverage, generated questions from customers, healthcare providers, employers and patients. Because the data from the study has not yet been presented in full, it's been difficult for our teams to answer every question related to the study. Once the data is presented at ASCO, there will be significant interest from customers for us to walk them through the detailed data, and we plan to train our entire sales force immediately after ASCO so they can follow up with customers. As Aaron highlighted, we're confident in our growth prospects and are finalizing our sales force expansion efforts.

Thanks. My final question is on expansion opportunities. You announced Epic EHR integration. Based on your experience with Quest and Athena, can you talk about your expectations for what Epic could do and plans for Oracle or Cerner? Also, do you expect healthy tailwinds in the second half from Epic and the sales force expansion?

If you think about Epic integration, it's something we've wanted to pursue for some time. We're excited about announcing it. Epic provides an easy button within health systems to have Galleri integrated into normal physician workflows for ordering and results. This makes it much more likely to be adopted by health systems. Implementation is starting now, and in the second half of the year we'll start to see integrations into actual health systems. We expect that to build over the second half of the year. Andy, any discussion on Quest and the sales force expansion?

Sure. With both Quest and Athena, we're seeing continued adoption of electronic ordering. We have about 2,000 healthcare providers who have ordered through either the Quest or Athena integration, which has led to over 30,000 tests being deployed through those integrations since we launched them. We're excited about continued use of Quest and Athena by our customers. Epic now launching provides another easy button; as announced, it covers 450 health systems, primarily large systems. Any health system on the Epic system from November 2020 or later will be eligible for our Epic integration. In terms of the sales force, we'll have completed the expansion by midyear. With the ASCO data coming out for NHS-Galleri and PATHFINDER 2, and potentially an FDA approval at some point later this year or early next year, we believe the sales force will have strong momentum to continue the growth we've reported today.

Your next question will come from Dan Brennan with TD Cowen.

Maybe starting with feedback since the NHS-Galleri data release: with that 20% plus Stage IV shift, what has the feedback been from oncologists? Any particular cancers where oncologists are especially optimistic about that shift?

Regarding the reduction in Stage IV—over 20%—that metric is resonating with both primary care physicians and oncologists. Since the data release, we've seen more favorable responses from oncologists who understand how important that reduction is. Over five years with Galleri in the market, primary care physicians have understood the value well; the oncologist community has lagged in understanding because they are not frontline users, but this particular piece has caught their attention. Josh, anything to add?

Yes.

Okay, great. For the guidance range, can you give more color about which channels are driving growth? Between health systems, concierge medicine and direct-to-consumer, where are you seeing the most traction now? Does your guidance assume similar bucket growth, or has anything changed?

I can give some color and then pass to Aaron and Andy. The self-pay channel remains the majority of Galleri volume, accounting for more than two-thirds of volume. Brick-and-mortar physicians continue to be strong, and integrations with Quest and Athenahealth have helped add new providers and reduce ordering friction. Sales force expansion should continue to drive additional volume. Digital health continues to be a strong opportunity in the self-pay market, reaching people used to paying out-of-pocket. Partners like Function Health and Everlywell have done well, and we have the new partnerships with Hims and WHOOP announced. As Aaron mentioned earlier, we'll have to see how quickly uptake occurs with those partners. That gives you a sense of the channel mix. Aaron, anything to add on guidance color?

No, Bob covered it. We'll track how the quarters progress and revisit guidance next quarter as appropriate.

Your next question will come from Catherine Schulte with Baird.

Maybe first on guidance: I see ASPs stepped down sequentially. How should we expect ASPs to trend for the rest of the year? Curious on volume versus ASP assumptions in your reiterated guide. Also, any color on how we should think about second quarter revenue?

On ASPs: our vision has been to operate Galleri at population scale, and we plan price reductions over time. We've made significant investments in our scalable platform rolled out from late 2024 through 2025 into this year, which allows us to bring pricing down while maintaining strong margins. In 2025, we began to lean into price elasticity in the market and expanded some of our discounting programs. Much of that happened in 2025, so you're seeing declines as we set new pricing structures within each channel. In 2026, we would expect only a relatively modest decline, other than changes driven purely by channel mix. As the mix of channels changes across quarters, you may see ASP increases or decreases based on mix, with maybe a slight decline per channel over time.

Anything to say about second quarter?

We expect our revenue growth for the year to be between 22% and 32%.

Last question: competitors have increased direct-to-consumer advertising, including a celebrity spokesperson announced recently. Any plans on advertising to increase brand recognition with consumers?

We have increased activity in social media channels to get our message out. Interestingly, competitors' advertising has helped raise awareness of the MCED category, which has been a tailwind—when someone becomes aware of MCED and our sales team explains our product, we often do well. We may increase marketing spend modestly to amplify our message through social media, but likely not to the level some competitors are spending.

Your next question will come from Doug Schenkel with Wolfe Research.

This is Colleen on for Doug. A follow-up on sales force expansion: how many reps are currently in the field? Is it fair to assume you're back up to levels prior to the Illumina spin? And how long do you expect newly hired reps to reach full productivity?

Andy, do you want to take that one?

We are not returning to Illumina-era sales team levels. The expansion is focused on the provider channel, increasing territories from about 90 to 120. The majority of the new team will be onboarded and trained around the middle of the year. We expect ramp timing to follow our standard onboarding and training cadence, with productivity improving after midyear.

Thanks. One more on the FDA approval process: based on conversations with the FDA after your final PMA submission, what's your read on whether the FDA will convene an advisory committee? If an advisory committee is called, what do you think the key areas of focus will be, given FDA previously met in late 2023 to discuss MCED?

Josh, do you want to weigh in?

Good question. We submitted the final module of our PMA earlier this year, and the FDA accepted the file. We're in an ongoing, iterative review process. FDA guidance on timing is typically 180 days from submission without an advisory committee and about 320 days with an advisory committee. We would be speculating about whether an advisory committee will be held, so we can't comment definitively. Discussions with the FDA have been constructive, and we are actively supporting the review. If we learn more that we can share, we will.

Your next question will come from David Westenberg with Piper Sandler.

You came in at 37% growth in Q1 but maintained 22% to 32% guidance for the year. Can you give color on the conservatism in the guide? Was Q1 seasonally strong, or are there channel mix or ASP considerations that support the more cautious guide?

It's early in the year and this is an important year for us with the FDA review. We have several factors to watch: the sales force expansion, ASCO data, potential timing of FDA approval and the rollout and uptake speed from digital health partners. We also see competitive dynamics. Given those variables, we maintained guidance to allow flexibility. We'll revisit guidance after the second quarter when we have more clarity.

On Epic integration: how many health systems are you currently in active discussion with? What's your expectation for wins in the hospital channel in the back half of the year? Could that flow through meaningfully in 2027?

Andy, do you want to respond?

There are about 450 health systems we're targeting for the Epic integration. Those are large systems—examples include HCA and Mayo. We're in the process of technical build and go-to-market readiness, building test and production environments in AWS. We expect customers to go live on Epic in Q3. The sales team is profiling customers to assess their readiness to go live and their interest level. I don't have a specific list today, but there's a lot of excitement among our current health system adopters about Epic Aura integration. Regarding channel mix beyond 2026, it's too early to forecast. Much will depend on timing of FDA approval and health system demand, but Epic should provide a tailwind for integrations alongside Athena and Quest.

Our last question will come from Bradley Bowers with Mizuho.

On a pre-ASCO preview: we'll get full NHS-Galleri and PATHFINDER data at ASCO. Are your customers receptive to the slices—performance in deadly cancers, hard-to-detect cancers, or those without existing screening paradigms? Do they understand Galleri's sensitivity and specificity? Also, competitors have been in market about six months—how are dynamics evolving?

Josh, do you want to address this?

Great question. Our customers are fairly well versed in Galleri performance, demonstrated across multiple large studies including case-control studies, PATHFINDER, PATHFINDER 2 and now NHS-Galleri. Customers understand Galleri's high specificity, safety profile, ability to localize a cancer signal with high accuracy and its strong episode sensitivity for deadly cancers. They recognize the dramatically improved cancer detection rate we observed in PATHFINDER 2 and what we reported for NHS-Galleri. That said, substantial education remains necessary because the primary care community is large. ASCO will be a major opportunity to present the complete NHS-Galleri dataset, and we're looking forward to that deeper engagement.

Thanks. Post-ASCO and pre-FDA approval, you'll have the totality of big data sets. How do you think about managing cash, the timing of the sales force ramp and the potential impact of FDA approval—will approval be an immediate accelerator or a slower build?

We'll need to observe the impact of FDA approval. Early research suggests providers and patients will view approval favorably, but it's too early to predict the exact magnitude or timing of adoption shifts.

I'll add that, thanks to fundraising last year, we have the capital runway to invest through any inflection point if and when it occurs. We're well positioned operationally and financially.

There are no further questions at this time. I will now turn the call back to GRAIL for closing remarks.

Well, thank you, everyone, for joining today's call. We appreciate the time and your questions, and we look forward to seeing many of you at the upcoming ASCO show.