GRAIL Q1 2026 Earnings Call - Galleri Volume Surges 50% Amid Epic Integration and ASCO Data Anticipation

Andy Partridge, Chief Commercial Officer, GRAIL1: Good day, ladies and gentlemen, welcome to the GRAIL First Quarter 2026 earnings call. At this time, all participants are in a 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.

GRAIL Investor Relations, Investor Relations, GRAIL: Thank you, 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 Ofman, President, 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 Factor 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 1st 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 most directly comparable GAAP financial measures are available in the press release issued today, which is posted to our website. With that, we turn to Bob.

Bob Ragusa, Chief Executive Officer, GRAIL: 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 MCED. 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, and Cleveland Clinic and Duke. We are seeing major health systems, including Community Health and 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 the ease of access through our previously announced partnership 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 HCPs 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 prevalent screening round only of the NHS-Galleri trial. The submission also includes a bridging analysis to compare performance of the version Galleri used in the clinical trials to the updated version that has been submitted to the FDA for pre-market 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 mid-year. We believe this expansion will enable us to continue to drive commercial momentum. Finally, we’re looking forward to the upcoming data presentations for a 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 31st. Stay tuned for details on the analyst call in the coming weeks. With that, I’ll ask Joshua Ofman to provide an update on our clinical programs.

Josh Ofman, President, GRAIL: 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. 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’ve already been able to use these data to drive test improvements and will continue to do that over time. Our teams have continued to present evidence demonstrating Galleri’s performance at renowned medical conferences, including 2 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 MCED 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 3 and 4 reduction over three rounds of screening. What was observed in the trial was an increase in stage 3 cancers detected and a decrease in stage 4 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 1 and 2 deadly cancers and a 4-fold 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 4 cancer diagnoses 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 4 diagnoses is incredibly meaningful because there is a large survival cliff between stage 3 and stage 4 for many types of cancer. Many stage 3 cancers can now be treated with curative intent, and finding these cancers at stage 3 rather than stage 4 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 diagnosis 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 in 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’re 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.

Aaron Frieden, Chief Financial Officer, GRAIL: 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 revenues 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 ASP. 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.

Josh Ofman, President, GRAIL: 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 5 years. Our spin-out from Illumina, our commercial expansion, the scaling of our N.C. 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.

Bob Ragusa, Chief Executive Officer, GRAIL: 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 a 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’s played a central role in driving GRAIL’s strategy and execution over the past seven years. Operator, we can go to Q&A.

Andy Partridge, Chief Commercial Officer, GRAIL1: Thank you. At this time, if you would like to ask a question, please click on the Raise Hand button, which can be found on the black bar at the bottom of your screen. You may remove yourself from the queue at any time by lowering your hand. When it is your turn, you will hear your name called and receive a prompt to unmute. As a reminder, we are allowing analysts one question and one relevant follow-up today. We will wait one moment to allow the queue to form. Thank you. Our first question will come from Subbu Nambi with Guggenheim. Your line is open. Please ask your question.

Andy Partridge, Chief Commercial Officer, GRAIL2: Thank you for taking my question, great print. The FDA and CMS recently established their rapid pathway in which CMS will propose the NCD for Class 2, 3 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 3 device, do you expect Galleri to be eligible for the rapid pathway, or does the 2029 start date specified in the NSAID bill negate this opportunity? Sorry for the long question.

Bob Ragusa, Chief Executive Officer, GRAIL: Thanks, Subbu, for the question. You know, we’ve looked at rapid, right now it’s kind of just a framework without a lot, you know, a lot of detail. You know, at a high level, it does look like, you know, the characteristics of our tests, you know, breakthrough designation, the fact that we’re driving for FDA approval, does put us, you know, in what the act is intended for. We’re hopeful that, you know, when the details come out, we will, you know, find ourselves, you know, being, you know, very much eligible for that. We do have to wait to see how the details unfold for that particular piece of legislation. Josh, I don’t know, any other comments on that?

Josh Ofman, President, GRAIL: No, I mean, it’s an important piece of regulation, and it’s very encouraging. I mean, I think for years now, the government has been trying to shorten the gap between FDA approval and CMS coverage. This is something the administration has been prioritizing. It’s great to see. I think to Bob’s earlier point, everything that we’ve done from, you know, seeking FDA approval, having a breakthrough device designation, conducting an IDE that was reviewed by the FDA and CMS, should comport with what this regulation is intending to do. We’re looking forward to seeing the details and the regulation itself.

Andy Partridge, Chief Commercial Officer, GRAIL2: Perfect. How much growth from partnerships like Function Health and Hims & Hers are factored in your guidance for Galleri growth in 2026? Maybe I missed this, but given the beat, are you raising guidance? I’m hopping through multiple earnings, so pardon my question here.

Bob Ragusa, Chief Executive Officer, GRAIL: Aaron, you wanna take that one?

Aaron Frieden, Chief Financial Officer, GRAIL: Yeah. Your first question, Subbu, nice to talk to you. You know, we’ve got our guidance, which, you know, we’re reiterating still the same guidance, not updating it. You got a 10% range there. You know, one of the reasons for that is to really learn and see how the uptake works in the digital health space. Some of those partners like Function we’ve got more experience with. You know, with Hims & Hers and some of these other new agreements that we’ve signed, you know, as they implement, we’ll see what uptake is like. You know, depending on how they implement it can go quickly, sometimes it doesn’t.

Andy Partridge, Chief Commercial Officer, GRAIL2: Got it. Thank you so much, guys.

Andy Partridge, Chief Commercial Officer, GRAIL1: Your next question will come from Kyle Mikson with Canaccord Genuity. Please unmute your audio and ask your question.

Andy Partridge, Chief Commercial Officer, GRAIL0: Hey, guys. Thanks for the questions after addressing the quarter. First one, just a bigger picture question. It’s been a few months since the NHS-Galleri reveal. Can you talk about the feedback from stakeholders since then? You know, very exciting to have the ASCO, you know, presentations pretty soon here. Do you expect to have a material change in opinions following those abstracts and perhaps the call with the investors as well?

Bob Ragusa, Chief Executive Officer, GRAIL: Sure. First piece on the NHS. We obviously, you know, we had a strong quarter. We were able to grow volumes by 50% and revenues by 37% in the screening part of the business. You know, we clearly saw a current strength. Andy, maybe, you know, jump over to you to talk about, you know, the customer response to the NHS Galleri.

Andy Partridge, Chief Commercial Officer, GRAIL: Yeah. Thanks, Bob. Thanks for the question. As Bob said, we’ve seen strong growth through Q1, kind of year-over-year, and that growth’s been across brick-and-mortar providers, digital health, and employers. Drilling specifically into healthcare providers, we’ve seen a significant expansion of new ordering healthcare providers in Q1 with about 1,300 new prescribers to Galleri that we saw in the quarter. We’ve also added important new customers across our employer business, health systems, as Bob mentioned, you know, Cleveland Clinic, Duke, OHSU, all kind of came on board to incorporate Galleri with agreements in Q1, and also added new digital health customers in Q1. All of this in the midst of the NHS-Galleri data being released.

I think specifically to the NHS-Galleri data, that media coverage and some of the negative media coverage that was generated has led to questions from customers, you know, healthcare providers, employers, and also from patients. As the data from the study has not yet been presented, it’s been difficult for our teams to answer every single patient or provider question related to the study. Therefore, once the data comes out at ASCO, there’s definitely gonna be interest from customers for us to walk them through that detailed data, and we’ve got plans to train all of our sales force immediately after ASCO on that data so they can follow up with customers. As Aaron highlighted, we’re confident in our growth prospects, and indeed we’re finalizing our sales force expansion efforts.

Andy Partridge, Chief Commercial Officer, GRAIL0: Yeah. Wow, that was great. Thanks, guys, so much. I guess my final question or second question is gonna be about expansion opportunities, kind of in the near term here. You got the Epic EHR integration. I think planning for that began when that was basically announced in April or so. I know you have the Quest portal, you have Athena. Like, based on your experience with those platforms in the last year or so, you know, can you just talk about your enthusiasm of what Epic could do for you? You know, expansion plans to Oracle, Cerner, things like that.

Just on the Salesforce expansion as well, I mean, are you looking at, like, pretty healthy tailwinds in second half due to things like, you know, Epic and Salesforce expansion as well?

Bob Ragusa, Chief Executive Officer, GRAIL: Yeah. If you think about, maybe cover the first part, you know, the Epic expansion, that’s something we’ve been looking to do for a period of time. We’re really excited about announcing that. We know that, you know, that is, you know, a huge part of the kind of easy button within health systems to be able to have, you know, the Galleri test within their normal workflow, both from the ordering side as well as the test results coming in. It really just fits into the entire workflow of a physician, so it makes it much more likely to be able to be integrated into a health system. You know, that implementation is starting now, and really in the second half of the year we’ll start to see some integrations into actual health systems there.

You know, look for that to build over the, over the second half of the year. You know, Andy, maybe some discussion on the, you know, Quest side, what we’re seeing there, as well as the Salesforce expansion.

Andy Partridge, Chief Commercial Officer, GRAIL: Sure. With both Quest and Athena, we’re seeing continued adoption of electronic ordering with Athena and Quest. Indeed, we’ve got about 2,000 healthcare providers now who have ordered through either the Quest or Athena integration, which has led to over 30,000 tests being deployed through either the Quest or Athena integration since we launched both of those integrations. We’re very excited about the continued use of Quest and Athena by our customers. As Bob said, it really does provide that easy button for them. With Epic now launching on top of that, it provides another kinda easy button for, as we announced in our press release, 450 health systems, and those are the big health systems across the U.S.

Essentially any health system that was on the Epic system in November 2020 or later is gonna be eligible for our Epic or integration. In terms of the Salesforce, you know, we’re gonna have completed that expansion by the middle of the year. With the ASCO and data coming out for both NHS-Galleri and PATHFINDER 2, and potentially an FDA approval at some point, you know, later this year or early next year, that’s gonna give the sales force a lot of wind at their back to continue the momentum that we’ve seen with Galleri that we’re reporting today.

Andy Partridge, Chief Commercial Officer, GRAIL0: Okay. Yeah. Very helpful, guys. Appreciate it.

Andy Partridge, Chief Commercial Officer, GRAIL1: Your next question will come from Daniel Brennan with TD Cowen. Your line is open. Please ask your question.

Daniel Brennan, Analyst, TD Cowen: Great. Thank you. Thanks for the question. Maybe just starting off, I know there’s a question already about the feedback so far since the NHS Galleri data are out, but maybe can you just share a little bit more on that? We’ll, we’ll learn obviously a lot more at ASCO, but I’m just wondering with that 20% plus stage 4 shift, kind of what the feedback’s been from oncologists and any particular cancers where oncologists or experts are feeling most optimistic about that shift?

Bob Ragusa, Chief Executive Officer, GRAIL: You know, with this respect to the, you know, reduction in stage 4, the 20%+ reduction in stage 4 in particular, you know, that is one of the things that’s really resonating with both primary care physicians as well as with oncologists. I would say over the last, you know, since that data has been released, we’ve seen more favorable things from oncologists who truly understand just how important, you know, that reduction is. You know, I think over the last 5 years with Galleri being out in the market, we’ve seen good understanding from primary care physicians and, you know, but the oncologist community has probably lagged behind in their understanding ’cause they’re not frontline users of it. I think that particular piece really caught their attention quite well.

I think that piece in particular is resonating really nicely. Josh.

Daniel Brennan, Analyst, TD Cowen: Oh.

Bob Ragusa, Chief Executive Officer, GRAIL: No.

Daniel Brennan, Analyst, TD Cowen: No, go ahead. Okay, great. Then maybe just in terms of, you know, the guidance range for the year, I know there’s a couple questions asked about like the buckets and the drivers there, but, you know, could you help like zoom out a little bit and just give a little bit more color about, you know, between, you know, health systems, concierge medicine, direct-to-PCP? Kinda where are you guys seeing like the most traction right now? You know, how do you think about, you know, the rest of the year in terms of the guide? Does it remain in those buckets, or does anything change on that front? Thank you.

Bob Ragusa, Chief Executive Officer, GRAIL: Yeah, maybe I can give a little bit, and then I’ll pass it over to Aaron and Andy. They give some more color. You know, the self-pay piece remains the majority of Galleri’s volume, you know, accounting for kind of 2/3 plus of the volume. You know, in terms of volume growth, you know, the brick-and-mortar physicians continue to be grow strong. You know, clearly, as we talked about our integrations with Quest and athenahealth, that, you know, helped add new providers and reduce order friction. You know, going forward, we do see the Salesforce expansion continuing to drive extra volume. You know, digital health continues to provide a great opportunity in the self-pay market.

You know, here we have access to people who are used to being in the self-pay market. That’s continued to, you know, do quite well with, you know, partners like Function Health and Everlywell. Then we have, you know, the new partnership coming on with Hims and then WHOOP that we just announced. As Aaron mentioned, we’ll have to see, you know, just how fast the uptake of those goes. But I think that gives you some sense. Aaron, anything to add on the color on the guide?

Aaron Frieden, Chief Financial Officer, GRAIL: No. I mean, I think it’s Bob’s covered it. You know, we’ll track to see how the quarters go and look at it again next quarter.

Daniel Brennan, Analyst, TD Cowen: Okay, great. Thank you.

Andy Partridge, Chief Commercial Officer, GRAIL1: Your next question will come from Catherine Schulte with Baird. Your line is open. Please ask your question.

Catherine Schulte, Analyst, Baird: Hi, thanks for the questions. maybe first on guidance. You know, I think ASPs stepped down sequentially. How should we expect those to trend for the rest of the year? Just curious on kind of volume versus ASP assumptions in your reiterated guide. Any color on how we should be thinking about second quarter revenue?

Bob Ragusa, Chief Executive Officer, GRAIL: Yeah. Maybe I’ll hit the ASP piece. You know, if you recall, you know, our vision all along has been, you know, to operate Galleri at population scale. You know, we have planned for price reductions over time. As we talked about, we made significant investments in our new scalable platform and, you know, have rolled that out, you know, throughout from late 2024, you know, all the way through 2025 into this year. With that gives us the ability to bring pricing down while maintaining, you know, strong margins. In 2025, we really began to lean into the price elasticity that we see in the market. We’re finding success by expanding some of our discounting programs.

Much of that happened already in 2025, and so you’re seeing kind of the kinda decline as we set up new pricing structures within each of the channels. You know, within 2026, we would only expect, you know, relatively modest declines to continue other than things driven purely by mix. As the mix of the various channels, you know, changes throughout the quarters, you know, you might see price increase or decrease or on ASP based on that, but that’s really gonna be a mix issue, you know, with an overlay of maybe a slight, you know, slight decline in ASP per channel.

Catherine Schulte, Analyst, Baird: Okay. Anything on 2Q?

Bob Ragusa, Chief Executive Officer, GRAIL: No. I mean, again, we expect our growth for the year to be between 22% and 32% on the revenue side.

Catherine Schulte, Analyst, Baird: Okay. The last question for me. We’ve seen some competitors increasing their DTC advertising. We had one announce a celebrity spokesperson a couple weeks ago. I know you’ve talked about, you know, the Salesforce expansion, but any plans you have on the advertising side to make sure you’re getting brand recognition with consumers?

Bob Ragusa, Chief Executive Officer, GRAIL: You know, we have been doing a little bit more certainly in the social media channels and things to, you know, get the message out. You know, one of the things we’ve actually found is, you know, the competitors by competitors, you know, advertising the MCED space, that’s actually brought a lot more awareness for MCED. You know, we’re actually seeing, you know, while it’s obviously a competitive, you know, potential competitive threat, we’re actually seeing a fair amount of tailwinds from that as people would get, you know, more and more acclimated to, you know, the whole MCED space. They get more knowledge about the MCED space. When, you know, our sales team can go in and describe our product to someone who’s now aware and interested, we usually end up doing very well there.

You know, so far, you know, largely a headwind. Those will continue to and probably increase our marketing spend a little bit to be able to get more message out there through social media and things. You know, probably not to the level that some of the other competitors are putting out there.

Catherine Schulte, Analyst, Baird: Thank you.

Andy Partridge, Chief Commercial Officer, GRAIL1: Your next question will come from Doug Schenkel with Wolfe Research.

Colleen, Analyst, Wolfe Research: Hi, this is Colleen on for Doug. Thanks for the question. A bit of a follow-up from Kyle’s question on sales force expansion. Can you provide any color on how many reps are currently in the field? Is it fair to assume you’re back up to levels prior to the Illumina spin? Then finally on this one, how long do you expect it to take the newly hired reps to get to full productivity?

Bob Ragusa, Chief Executive Officer, GRAIL: Andy, you wanna take that one?

Andy Partridge, Chief Commercial Officer, GRAIL: Yeah. We’re not gonna get back to Illumina levels in terms of sales team in the field. The expansion of the sales force is in the provider channel, we’re expanding territories from about 90 territories up to 120 territories. In terms of, you know, productivity of that team, we’re gonna have the majority of that team onboarded and then trained around the middle of the year.

Colleen, Analyst, Wolfe Research: All right, thank you so much. Then just 1 on the FDA approval process for Galleri. Based on your conversations with the FDA post final PMA module submission, what’s your read on whether the FDA will convene an AdCom? Our sense is that based on the timing, we should be hearing about that soon. If an AdCom is called, what do you think the key areas of focus will be, given the FDA already met at the end of 2023 to discuss MCED?

Bob Ragusa, Chief Executive Officer, GRAIL: Yeah, Josh, you wanna weigh in on that?

Josh Ofman, President, GRAIL: Sure. You know, as you mentioned, good question. As you mentioned, you know, we did submit the final module of our PMA earlier this year. The FDA had accepted that file. We are in an ongoing iterative review process right now. You know, the FDA guidance on timing is typically 180 days from submission without an advisory committee, and about 320 days with an advisory committee. We’d be speculating right now about whether there will or won’t be an advisory committee. We can’t really comment on that right now. We’ve been very active in supporting the FDA’s review, discussions have been very constructive, but it’s unknown right now whether the FDA will hold an advisory board, and if they do, what the focus of that advisory board will be.

As soon as we learn more, if we can share that, we will. That’s kind of where we are right now. We’re in the middle of a very iterative review process.

Andy Partridge, Chief Commercial Officer, GRAIL1: Your next question will come from David Westenberg with Piper Sandler. Your line is open, please ask your question.

David Westenberg, Analyst, Piper Sandler: Thank you very much. I just wanna hit on the topic of the 22%-32% guidance. You know, you obviously came in at 37%. Can you talk about I know you didn’t want to answer the seasonality question, but can you give any additional color to why there might be some of the conservatism? Whether it be, like, maybe you saw really good seasonality. Is there channel mix? Is there ASPs that would make it come in below what you came in at Q1?

Bob Ragusa, Chief Executive Officer, GRAIL: I’ll start and then have Aaron.

Awesome. Of course.

maybe add something. I think first part is, you know, it’s just early in the year. You know, obviously this is a pretty important year for us with our FDA filing. You know, we have a number of factors out there. We have the sales force expansion. We have ASCO coming up at the end of this month. There’s, you know, a number of catalysts out there that we’re looking to see how they go. You know, as we mentioned earlier, we have the, you know, number of digital health partners that, you know, we’ve signed, but now it’s a matter of seeing how fast the, you know, the uptake can go with them, how aggressive they, you know, they are in the market.

As well as, you know, it was also mentioned, you know, just, you know, some of the competitive pressures out there. In that whole mix, we kept guidance the same. As Aaron mentioned, you know, we would update again, you know, look to see if there’s anything new to report out at the end of, you know, after Q2. Go, Aaron.

Aaron Frieden, Chief Financial Officer, GRAIL: Got it.

Bob nailed it again.

David Westenberg, Analyst, Piper Sandler: All right. Maybe I’m just gonna move on to the Epic integration. You announced that the integration is gonna be expected by the end of the year. How many health systems are you currently in active discussion with, and what’s your expectation for winning testing in that other, you know, not DTC channel in the back half of the year? Can that, you know, flow through for 2027? Can that start to be the bigger channel, or am I too early on that?

Bob Ragusa, Chief Executive Officer, GRAIL: Andy, you wanna give some color on that one?

Andy Partridge, Chief Commercial Officer, GRAIL: Yeah. In terms of Epic, there’s about 450 health systems that we’re targeting for the Epic integration. As I said earlier, it’s essentially any health system that is on the November 2020 or later version of Epic that’s gonna be eligible for this integration. When I say 450 health systems, one health system would be HCA, one health system would be Mayo. These are big, big health systems. We’re currently in the process of the technical build and go to market readiness. You know, building the tests and production environments in AWS. All that kind of technical work’s being done right now. As Bob said earlier, we would actually get customers live on Epic in Q3.

The sales team currently are profiling customers to assess their, yeah, excitement and conviction around when they wanna go live on the Epic platform. We’re currently assessing exactly what that list is going to look like. I don’t have a specific answer for you right now. I can tell you there is a lot of excitement with our current, you know, health system adopters in terms of the Epic order integration. Could you repeat the last part of your question ’cause I didn’t quite catch it?

David Westenberg, Analyst, Piper Sandler: Oh, I was just thinking about how we should think about mix between hospital and DTC channels in 2027 and beyond.

Andy Partridge, Chief Commercial Officer, GRAIL: I think that’s too early for us to give any guidance. A lot of that’s going to be driven by when we get the FDA approval. I think it’s a little early to comment on that. You know, I think Epic itself is going to, you know, give us a tailwind in terms of health system integrations. The demand itself we have to create. A health system needs to want to adopt Galleri. Epic is the easy button for them that improves the provider experience by streamlining Galleri ordering, resulting, and follow-up. Yeah, as I said, health systems are very excited about Epic order integration with Galleri. That’s going to sit alongside our athena and Quest electronic order integrations as well.

David Westenberg, Analyst, Piper Sandler: Thank you for taking my questions.

Andy Partridge, Chief Commercial Officer, GRAIL1: The last question will come from Bradley Bowers with Mizuho.

Bradley Bowers, Analyst, Mizuho: Sorry about that, I was muted. Thanks. Just want to maybe get into something we’ve talked about a little differently. You know, just wanted to hear about, you know, I assume it’s kind of a pre-ASCO preview, but, you know, we’re gonna get NHS-Galleri and PATHFINDER full data. You know, it might require, you know, some of the slices, you know, that we’ve seen before, performance in deadly cancers or, you know, hard to detect or those without a paradigm. You know, is this group, you know, of the eventual customers, are they kind of conducive to these slices? You know, do they understand, you know, the superior sensitivity of Galleri or specificity? You know, also that kind of leads into how competitor dynamics have been. You know, we’re about 6 months with other tests on the market.

Bob Ragusa, Chief Executive Officer, GRAIL: Joshua?

Josh Ofman, President, GRAIL: Yeah, no, it’s a great question. I think that it’s fair to say that our customers, you know, are fairly well-versed in the performance of Galleri. You know, Galleri performance has been demonstrated in multiple large studies now. Okay, from case control studies to interventional studies and intended use PATHFINDER, you know, the PATHFINDER study, PATHFINDER 2. Now they’re gonna see the full data set from NHS-Galleri. As it relates to performance, you know, we think the customers absolutely understand, you know, the very high specificity, the safety profile of Galleri, its ability to detect where in the body a cancer signal comes from with very high accuracy.

It’s very strong episode sensitivity in the deadly cancers, and the dramatically improved cancer detection rate that we saw in PATHFINDER 2 relative to when added to standard of care screening and what we reported out in our press release around NHS-Galleri. We think that is very well understood by many customers, but there’s still a lot of education yet to be done. Obviously, the primary care community is enormous in the U.S., and ASCO will be a big opportunity for us to share a more, a deeper look at the NHS-Galleri trial in all of its glory. We’re very much looking forward to that.

Bradley Bowers, Analyst, Mizuho: That’s great. You know, very excited for that. Just maybe to touch on that, you know, what does the business kinda look like post ASCO, pre-FDA approval? You know, we’ll pretty much have the totality of the big data sets, but that kinda gets into, you know, uses of cash, you know, and timing of the sales force ramp, you know. How do you think about maybe managing the pedal, and maybe how does FDA approval, you know, impact the business? Is it like turning on a faucet, or is it kind of a slower build? Thank you.

Bob Ragusa, Chief Executive Officer, GRAIL: No, that’s one of the things we’re gonna have to see is the, you know, impact of FDA approval. You know, certainly our early, you know, early research would suggest it’s gonna providers and patients are both gonna view that very favorably. It’s early days to exactly predict, you know, what the impact of that is gonna be.

Josh Ofman, President, GRAIL: Yeah, I mean, I’d just add, I mean, fortunately with the fundraising we did last year, you know, we’ve got the opportunity to, you know, intercept that inflection point if and when it shows up. I think we’re well-situated.

Bradley Bowers, Analyst, Mizuho: Understood. Thank you.

Andy Partridge, Chief Commercial Officer, GRAIL1: Thank you. There are no further questions at this time. I will now turn the call back to GRAIL for closing remarks.

Bob Ragusa, Chief Executive Officer, GRAIL: 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.