NASDAQ:GRAL GRAIL Q2 2025 Earnings Report $80.77 +0.82 (+1.03%) Closing price 09/18/2026 04:00 PM EasternExtended Trading$80.96 +0.19 (+0.23%) As of 09/18/2026 07:31 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast GRAIL EPS ResultsActual EPS-$3.18Consensus EPS -$3.14Beat/MissMissed by -$0.04One Year Ago EPSN/AGRAIL Revenue ResultsActual Revenue$35.54 millionExpected Revenue$37.57 millionBeat/MissMissed by -$2.02 millionYoY Revenue GrowthN/AGRAIL Announcement DetailsQuarterQ2 2025Date8/12/2025TimeAfter Market ClosesConference Call DateTuesday, August 12, 2025Conference Call Time4:30PM ETUpcoming EarningsGRAIL's Q3 2026 earnings is estimated for Wednesday, November 11, 2026, based on past reporting schedules, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by GRAIL Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 12, 2025ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: We observed substantially greater cancer detection and a higher positive predictive value in both the Pathfinder 2 and NHS-Galleri registrational studies, with specificity and signal origin accuracy consistent and no serious safety concerns reported. Positive Sentiment: Commercial momentum remains robust, with over 45,000 tests sold in Q2 and more than 370,000 prescriptions since launch, driving US revenues up 21% and repeat testing now over 25% of volume. Positive Sentiment: Financial performance improved as Q2 revenue rose to $35.5 million (+11% YoY), net loss narrowed by 93% to $114 million, and full-year cash burn guidance was lowered to ≤ $310 million, extending the cash runway into 2028. Negative Sentiment: Deployment of a new industrial scale automated testing platform led to increased turnaround times and higher sample reprocessing costs for a small proportion of samples, with remediation efforts now underway. Positive Sentiment: Strategic collaborations expanded access, including adding Rush University System for Health, launching direct prescription via EverlyWell, and integrating Galleri into Quest’s ordering platform, which accounted for 7% of Q2 orders. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallGRAIL Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xThere are 10 speakers on the call. Speaker 700:00:00Today, ladies and gentlemen, and welcome to the GRAIL second quarter 2025 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. Speaker 400:00:18Thanks, Operator, and thanks everyone for joining us today. On the call are Bob Ragusa, our Chief Executive Officer, Aaron Freidin, our Chief Financial Officer, Dr. Joshua Ofman, our President, Sir Harpal Kumar, our President, International Business and Biopharma, and Andy Partridge, our Chief Commercial Officer. We'll be making forward-looking statements on this call based on current expectations. It's our intent that all statements, other than statements of historical fact made during today's call, including statements regarding our anticipated financial results and commercial activity, will be covered by the safe harbor provisions for forward-looking statements contained in Section 27(a) of the Securities Act of 1933 as amended, and Section 21 of the Securities Exchange Act of 1934 as amended. Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. Speaker 400:01:12All 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 in GRAIL's most recent quarterly report on Form 10-Q. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit or loss, which are adjusted to exclude 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. Speaker 500:01:58Thank you. Good afternoon, everyone, and thank you for joining us to review second quarter results. For nearly a decade, GRAIL has made key investments to advance our vision for population scale, multi-cancer early detection, and establish a durable advantage in a growing field. The timeframe to establish evidence in this space is long, and we are setting the evidence bar high. We started population scale clinical studies years ago and now house several years of follow-up data. Our pivotal implementation and clinical utility studies in the intended-use population are beginning to read out, and we are delighted to see results not only confirm earlier studies but actually improve certain performance measures as we evaluate Galleri in larger populations. We plan to submit detailed results from the pre-specified analysis of the first 25,000 patients in our registrational Pathfinder 2 study for a presentation at the ESMO Congress 2025 in October. Speaker 500:03:00As a reminder, we announced positive top-line performance and safety results from this data set in June, namely that we observed substantially greater additional cancer detection and a substantially higher positive predictive value in Pathfinder 2 compared to the first Pathfinder study. Dr. Joshua Ofman will describe these results further shortly. We have been working with advocates and stakeholders to deploy MCED, and we are finding aggressive cancers in real-world commercial settings, many of which are in early stages. Galleri test orders continue to grow at a strong clip, with more than 45,000 Galleri commercial tests sold in the second quarter. As of June 30, more than 370,000 Galleri tests have been prescribed by more than 15,000 healthcare providers since we launched Galleri commercially in 2021. Speaker 500:03:55We continue to drive provider and patient awareness of the MCED opportunity and Galleri's ability to detect cancer earlier when it is more amenable to treatment. GRAIL has established several partnerships with healthcare systems to make Galleri available to patients, and we were very pleased to add Rush University System for Health in July. Rush is one of the largest health systems in the U.S. and the first in the Chicago area market to offer the Galleri test. Additionally, we recently entered into a new collaboration with EverlyWell, a digital health company pioneering in next-generation biomarker intelligence, and Galleri is now available for requests directly on EverlyWell's website via prescription. We remain on track for continued commercial growth in 2025. We are also encouraged by increasing Galleri volume via the Quest Diagnostics Test Ordering Platform at mid-year, which follows Galleri integration into the platform earlier in 2025. Speaker 500:04:58In late 2024, we began the use of a new version of Galleri, for which we are submitting our PMA in commercial channels. This new version incorporates an industrial-scale platform with significant automation intended to enable us to scale more efficiently with future demand. As a result of the scale and complexity of the system, there are certain new processes to sort through with a large-scale rollout. For example, for a small proportion of samples, we've experienced increased turnaround times with higher reprocessing costs. We are now working to implement the fix to this issue. Before I hand it over to Josh, I'd like to notify the group that we will host our 2025 Analyst Day in November. Featured speakers will detail key study results and clinical surveillance findings, frame our upcoming longitudinal clinical utility data, and describe firsthand customer experience with Galleri. Speaker 500:05:54Event details will be announced at a later date. Josh, please go ahead. Operator00:05:59Thanks, Bob, and hello everyone. We've spoken in the past about key performance metrics, features, and capabilities for multi-cancer early detection tests, which are quite different from those for single-cancer screenings. Most critically, any test developer must confirm clinical validation in the intended-use population of asymptomatic adults eligible for screening before they introduce those tests into clinical practice. This critical criterion was the reason that GRAIL did not introduce Galleri into clinical practice until we saw the results from the Pathfinder trial in the screening population. Even tests with strong results in observational case-controlled studies may fail to confirm those results in the actual screening population. Full clinical validation requires demonstration of compelling performance in the intended-use population. It is simply not possible to know the benefits and potential harms of any test before being adequately studied in the intended-use population. Operator00:07:14It is also important to note that any multi-cancer test seeking FDA approval will need to demonstrate this as well. In terms of performance metrics, we've discussed what we consider to be most clinically important for MCEDs: positive predictive value, or PPV, which tells us among positive test results how many cancers are found or how many are actually true positives, and the specificity, critically important, which defines the false positive rate, as well as the cancer detection yield when added to standard of care screening and the ability to localize where in the body a cancer signal is coming from. After hundreds of thousands of commercial tests performed, we've now confirmed how essential it is for any MCED test to report a predicted CSO or cancer signal origin to guide an efficient and effective clinical workup. Operator00:08:18We believe that any other approach, such as relying on whole-body imaging with its radiation exposure, cost, and lack of any performance or safety data, is simply not practicable. Our first clinical implementation study, Pathfinder, which was presented at ESMO in 2022, showed that Galleri more than doubled the number of cancers identified when added to standard of care screening. About half of the MCED-detected cancers were at early stage, and about 70% of the MCED-detected cancers had no recommended screenings at all. The positive predictive value for Galleri in the study population was 43%, which, as you recall, is an order of magnitude higher than leading single-cancer screening tests whose PPVs remain in the single digits. Galleri specificity was 99.5%, and its cancer signal origin accuracy was 88%. Operator00:09:24We have subsequently undertaken Pathfinder 2, similarly designed as a prospective multi-center interventional study of Galleri added to standard of care screening, designed to assess the performance and safety of Galleri in an even larger and more representative intended-use population. As Bob said, we observed a number of very promising results in the pre-specified analysis of the first 25,000 participants enrolled with 12 months follow-up and shared top-line results in June. First, adding Galleri to standard of care screening in Pathfinder 2 demonstrated substantially greater additional cancer detection than that observed in the first Pathfinder study. That is substantially greater than the more than doubling of the overall number of cancers detected when added to standard of care in the first Pathfinder study. Second, data showed a substantially higher positive predictive value than that observed in the first Pathfinder study, which was 43%. Operator00:10:36Third, specificity and CSO accuracy were consistent with that observed in the first Pathfinder study. Finally, there were no serious safety concerns reported in Pathfinder 2. We're enormously pleased with the top-line results from both of our registrational studies, Pathfinder 2 and the NHS Galleri randomized clinical trial. You will recall in May that we completed a review of Galleri test performance results in the intervention arm from the prevalence screening round of the registrational NHS Galleri trial. Data from the prevalence screening round showed a substantially higher positive predictive value than that observed in the first Pathfinder study. Specificity and CSO accuracy were consistent with that observed in the first Pathfinder study, and again, there were no serious safety concerns observed in Pathfinder 2, also consistent with the first Pathfinder study. Operator00:11:40These top-line findings from NHS Galleri and Pathfinder 2 confirm and extend what we already know about our multi-cancer early detection technology. The technology has been validated through many robust studies, including intended-use populations, and through hundreds of thousands of commercial and clinical study test results showing very consistent results. Data presented at the ASCO Annual Meeting 2025 in May included a five-year follow-up analysis of the circulating Self-Read Genome Atlas study, which demonstrated Galleri's preferential detection of aggressive and clinically meaningful cancers. These findings were consistent with earlier analyses assessing the prognostic importance of Galleri's cell-free DNA-based methylation approach. Between case-controlled studies and prospective implementation studies in the intended-use population, we have not seen deterioration in the key performance metrics. Many of you well know this is not always the case. Operator00:12:50Case-controlled performance often doesn't carry over into the real world, yet we saw no deterioration in specificity, positive predictive value, or cancer detection yield. Now we're moving into readouts of much larger registrational studies in the intended-use groups, as well as analyses performed by large health systems who have actual clinical experience with Galleri. We're seeing a body of results with substantially improved PPV figures and substantially higher cancer detection numbers, while other key figures like specificity and cancer signal origin (CSO) accuracy remain consistent. Earlier in GRAIL's development phase of our MCED technology, we deployed a very rigorous, unbiased, and comprehensive discovery approach to identify the effective genomic features for early cancer screening. Out of those approaches evaluated, methylation patterns exhibited the strongest performance for both sensitive and specific cancer signal detection and accurate prediction of the cancer signal origin. Operator00:14:04Adding on other analytes or DNA features did not improve the performance. What we are seeing today from our growing data sets strengthens our conviction in our targeted methylation approach, which is focused on highly informative and low-noise methylation regions known to be informative for cancer. Through hundreds of thousands of samples run in both clinical studies and commercially, we're seeing very strong positive predictive values in cancer detection rates and a highly accurate cancer signal origin prediction, all of which, critically, is achieved at a very low false positive rate of 0.5%, which befits population scale testing. Remember, if another test developer is operating at a lower specificity, a difference in specificity of 99.5% to 98.5% is actually a three times higher false positive rate. That's really important to remember. Operator00:15:10We reported top-line results from Pathfinder 2 in order to preserve detailed results for a major medical meeting, and we hope to present the full data set at ESMO in October. We look forward to discussing detailed results from Pathfinder 2 with you potentially very soon. I'll now hand off to Aaron Freidin for a review of the financials. Speaker 400:15:31Thanks, Josh, and good afternoon, everyone. I'm pleased to present our results for the second quarter. Overall, second quarter results were strong. Revenue for the quarter was $35.5 million, up $3.5 million, or 11% as compared to the second quarter of 2024. Total revenue for the quarter is comprised of $34.4 million of screening revenue and $1.1 million of development services revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research, and therapy development. We see continued demand for our Galleri test and sold more than 45,000 tests in the second quarter. We have historically observed seasonal fluctuations over the course of the year, in particular relatively high volume in the second and fourth quarters and lower in the first and third, and we would expect these seasonal trends to continue. Speaker 400:16:29Repeat test volumes have trended higher over time, including year to date. Today, more than 25% of Galleri's volume is repeat testing. Screening revenue of $34.4 million in the second quarter was up 22% as compared with the second quarter of 2024. U.S. Galleri revenue was $34.2 million, up 21% compared to the second quarter last year. The second quarter has been a strong quarter for U.S. Galleri revenue historically. We were on track relative to our full-year guidance of U.S. Galleri revenue growth between 20% to 30%. As stated last quarter, we do not expect major impacts from tariffs on our current business, as our laboratory is located in the U.S. and a significant majority of our suppliers are located and manufactured in the U.S. Speaker 400:17:19Fastest screening revenue, exclusive of amortization of intangible assets, as a percent of revenue decreased in the second quarter of 2025 compared to the same period in 2024, primarily due to a 6% decrease in ASP and additional sample reprocessing costs, largely offset by the reduction in variable costs of Galleri testing performed on our automated platform. Net loss for the quarter was $114 million, an improvement of 93% as compared to the second quarter of 2024. Net loss in the second quarter includes impairment of Illumina acquisition-related intangible assets of $28 million and stock-based compensation of $14.2 million. While we focus on advancing Galleri, we remain committed to our ongoing work with pharma partners, and we have confidence in the potential application of our technology. Speaker 400:18:08Non-GAAP adjusted gross profit for the second quarter of 2025 was $16.1 million, an increase of $0.1 million, or 1% as compared with the second quarter of 2024. We ended the quarter with a cash position of $606.1 million. In January, we guided that we expect cash burn for the full year 2025 to be no more than $320 million, and we are updating the guidance to cash burn of no more than $310 million for the full year of 2025, which represents a decrease of more than 40% to 2024. Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones. I'll turn it back to Bob for concluding remarks. Speaker 500:18:53Thank you, Aaron. To close, we are highly encouraged by the demand we are seeing today, both for new patients and for returning patients who are repeat testing. Our strategic priorities are seeking FDA approval of Galleri and pursuing broad reimbursement. We are advancing Galleri today toward near-term key clinical and regulatory catalysts to achieve broad access while maintaining our disciplined cost management. We plan to submit for presentation at ESMO in October detailed performance and safety results from the first 25,000 participants enrolled in the pivotal Pathfinder 2 study. This is a registrational data set that will go to the FDA. Soon into 2026, our key milestones are the completion of our modular PMA submission to the FDA in the first half and full clinical utility results from our 140,000 participant NHS Galleri study, which we expect to read out mid-year. Speaker 500:19:51This longitudinal data set will be reviewed by the NHS to determine Galleri's potential deployment within the UK population. As I mentioned earlier, we look forward to seeing many of you at our 2025 Analyst Day in November. With that, we'll turn the call over to Q&A. Operator, please go ahead. Speaker 700:20:09Thank 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 related follow-up today. We will wait a moment for the queue to form. Thank you. Our first question will come from Kyle Mixon with Canaccord Genuity. Your line is open. Please ask your question. Speaker 900:20:44Hi, this is Alex McKinney with another line for Kyle Mixon. Thanks for taking my questions. If we just take a step back here, the first quarter cash burn came in a bit higher than we expected. That's partially due to the bonuses that you have payout in the prior year period in Q1, but that's obviously not repeated in future quarters. We modestly improved the burn target for 2025. Can you just comment on Q2's free cash burn? Given how integral the burn is to your story, can you elaborate on any other dynamics that could impact cash burn in the second half of 2025, whether that be additional R&D, increases to headcount, or any other one-offs? Thanks. Speaker 400:21:24Yeah, Aaron, you want to take that one? Speaker 900:21:27Yeah, happy to. Thanks for the question. I think the first six months, I think it was about $160 million of burn, and it is important for us to, again, as Bob said, manage the business as efficiently as possible. We do see that coming down in the next couple of quarters as you can get into the $310 million and more than guide that we just updated, really driven by any increased volumes in the back half of the year, increased revenue, and also we'll be working on working through some of the getting more volume on our new automated platform. Speaker 400:22:15Yeah, I think maybe just add a little color to that too. One of the things when we did the restructuring, we wanted to make sure that we gave ourselves a lot of flexibility in the go-forward state and, you know, recognizing that MCED being a new field, we undoubtedly face a number of new and interesting challenges. That flexibility was a key element, and I think by doing the restructuring, getting us cash into 2028 has provided that, and I think being able to guide down a little bit to $310 million shows we think we're on track to be able to hit that more aggressive number. Speaker 900:22:57Got it. Thank you for the color. Speaker 700:23:02Our next question will come from Subhu Nabi with Guggenheim. Your line is open. Please ask your question. Speaker 800:23:09Hey, guys. Thank you for taking my question. Just to clarify, do you not need full longitudinal clinical utility data that is expected mid-2026 for PMA submission? One, and then when you say significantly higher PPV in Pathfinder 2, I had a basic question. Are you normalizing for cancer prevalence in both these studies? Just because shouldn't cancer prevalence impact PPV? Speaker 400:23:36Yeah, maybe I'll start off. Thanks for the questions. On the clinical utility question, the FDA, if you go back to their advisory board meeting, they're really going to be looking at benefits, benefits-harms view of the world. They are not going to be looking at clinical utility and typically don't for the approvals. That gets much more into the payer discussion. The payers would more typically look at that, and that's what the NHS Galleri data will provide. Josh, do you maybe want to take the PPV question on Pathfinder 2? Operator00:24:19Sure. On the FDA, they're going to be focused on clinical validation rather than clinical utility, excuse me, clinical validation, not clinical utility. They will, and they've said that in their advisory board, as Bob said. On the PPV, right now we are not normalizing that for the standard population. We're reporting it out within each study's population. As we mentioned earlier, these are much broader, more diverse, and more representative populations than has been studied previously. We're expecting that there will be a more diverse cancer risk in that population and cancer incidence, which may be driving the higher PPV. We will ultimately normalize all of this for cancer incidence and the cancer case mix, which is the distribution of cancers within each population, which is enormously important for performance reporting. We will ultimately do that, but today we're just reporting them within the study population themselves. Speaker 800:25:29Thank you so much for clarifying that. One follow-up, non-secular, based on other prior integrations with more concierge-type testing platforms like Function and Superpower, how long is the typical growth ramp, and do you expect EverlyWell to drive similar volumes? Speaker 400:25:51Yeah, we have seen good consistent performance out of groups like Function and have been very good partners. We anticipate that EverlyWell will add an important dimension to the channel with a whole other outlet given their subscriber base. Maybe Andy, do you want to, Andy Partridge, our Chief Commercial Officer, do you want to add some color to that? Speaker 200:26:16Absolutely. We're definitely anticipating these telemedicine longevity-based platforms like Function Health, like EverlyWell to really give us a tailwind in terms of growth going forward. When we look at EverlyWell, they've had millions of customers order through their platform, and EverlyWell, in terms of the Everly 360 launch that they announced, are offering Galleri as an add-on, and they've emailed hundreds of thousands of their customers about the Galleri multi-cancer early detection test. We're excited to partner with groups like Function Health, like EverlyWell, as they really amplify our education around Galleri and multi-cancer early detection. Speaker 800:27:10Perfect. Thank you, guys. Speaker 700:27:14Our next question will come from Yuko Oku with Morgan Stanley. Your line is open. Please ask your question. Speaker 300:27:38Hello. Thank you for taking my questions. With timelines for PMA submission approaching, could you elaborate on customer support infrastructure in place to help integrate MCED testing in cancer care today? Outside of sales reps, what are areas you intend to bolster as you get closer to the timing of anticipated FDA approval? Speaker 400:28:01Yeah, so the timeline for our PMA submission is first half of next year, 2026. We're anticipating, beyond that for FDA approval, about a one-year process since we believe since this is the first MCED that will go through the FDA. We believe it'll be about a one-year process due to having an advisory board. That puts you out into kind of mid, first half 2027. We've been consistently ramping our customer support, both size as well as capability in line with the growth of the business. We would assume that we would continue to do that. We're obviously looking for efficiencies in the way we deliver that customer support going through that process. In terms of other elements, at that point, we'll be looking at, certainly from a sales and marketing perspective, how much effort we're going to be putting in as well. Speaker 400:29:09Also looking at, from a cost perspective, we expect some step-downs in cost in other areas of the business as we get through those important milestones. Andy, anything you want to add on the customer support side? Speaker 200:29:23Yeah, I think you covered it, Bob. We're really looking at what are those opportunities to expand our customer-facing teams. We're going to do that to capture those growth opportunities. We're also going to continue to keep an eye on expenses, as you outlined, Bob, as we really want to drive to kind of a commercial break-even going forward. Speaker 300:29:49Great. Thank you for that color. If I could squeeze one more in, if I may, could you elaborate on the statistical powering of the NHS Galleri study? What difference is the trial powered to detect on the primary endpoint, a reduction in the incidence of late-stage cancer versus the control arm, and what result will be viewed as meaningful benefit? Speaker 400:30:10Yeah, Harpal, you maybe want to take that one. Speaker 200:30:14Yeah, sure. The study is powered to show a significant reduction in late-stage cancer. The primary endpoint is a reduction in stage three and four cancers. We look first at the 12 cancers that represent about two-thirds of all cancer mortality, and then we go on to look at all cancers from there. We will be looking at that late-stage reduction. We don't have a specific reduction in mind, but the size of the study was set to be able to deliver a statistically significant result in terms of that reduction. We will see what that reduction ends up being. We're interested, obviously, both in reduction of stage three and four cancers, but also stage four cancers because, ultimately, people primarily die of stage four cancers. If we can see significant reductions in those late-stage cancers, we believe this will provide substantial benefit to the population. Speaker 700:31:27Our next question will come from Doug Shinko with Wolfe Research. Your line is open. Please ask your question. Speaker 600:31:33Hi, this is Colleen on for Doug. Thanks for taking our question. As the NHS data reads out next year, we think that could serve as a strong evidence package for other international opportunities with single-payer systems. How are your conversations with territories across the globe looking to deploy Galleri? Also, if international volume grows sufficiently, will you have to do a tech transfer to international labs? Speaker 400:32:02Yes, no, that's a great question. We get a tremendous amount of inbound interest, as you can imagine, from around the globe. With that, we've had numerous conversations. We also believe, as you rightly point out, that in the middle of next year, from an efficiency standpoint and effectiveness standpoint, the middle of next year, when we read out the NHS Galleri study, we think that's going to be a great calling card to really have significant discussions with a lot of countries around the globe, both due to just the sheer size of the study, but also the rigor and reputation of studies done on the NHS. I think that reputational advantage will go a long way as we have those conversations. Harpal, anything you want to add with that? Speaker 200:32:49I think you've largely covered it, Bob. As you said, this is a very large study conducted extremely well in a health system that is very well respected around the world. We fully expect that the results from this study will be and are being observed by countries right across the world. We're getting, as Bob said, a lot of inbound interest from pretty much every country around the world. We expect that the results, middle of next year, will provide us with the data to really turn those conversations into meaningful opportunities as we look forward. As you alluded to, it should give us a substantial growth opportunity as we look forward. Speaker 300:33:36Thank you. Speaker 700:33:39Our last question will come from David Westenberg with Piper Sandler. Your line is open. Please ask your question. David Westenberg with Piper Sandler. Your line is open. Please ask your question. I'm not sure if David is having audio issues. Can you hear us, David? Speaker 100:34:21Hi, this is John on for Dave. Can you hear me? Speaker 400:34:25Yes. Speaker 100:34:32Hi, this is John on for Dave. Can you hear me? Speaker 400:34:35Yes, we can. Speaker 100:34:37Great. Thank you. First off, Quest integrated Galleri into their ordering system earlier this year. It's still early days, but could you give any color on what you're seeing in terms of orders coming through the Quest platform at this point? Any thoughts on what's driving it? Speaker 400:34:57Maybe answer in reverse. Part of integrating with Quest is we've found every time you remove friction from the system, we see an uplift in sales. We believe that Quest and the Quest integration would be able to give that significant friction reduction in the system. What we've seen so far year to date is about 500 healthcare professionals have ordered the Galleri test via the Quest system. In Q2, we saw about 7% of the orders actually came through the Quest platform. We're pretty excited about the uptake on Quest being relatively quick. As we try to onboard more practitioners, some of them can just go in immediately and order the Galleri tests on their Quest integration, while others need to specifically enable the Galleri tests. That enablement typically takes a few weeks to occur. We do anticipate that we'll continue to grow that channel. Speaker 400:36:05Another nice part about it is what we're finding is the Quest providers, people going through that system, tend to be higher prescribers. We look at the ordering depth by prescriber, and they tend to be some of the higher ones. We're seeing that get enabled definitely drives increased volumes. Speaker 100:36:29Great. Thank you. Just a little more broadly, could you give me color on how you interpret the repeat test rate for Galleri? Are you pleased with it? Do you have a target in mind? Any general thoughts on the directional trend for repeat testing? Speaker 400:36:47Sure. First, we're pretty pleased with repeat testing. Last quarter we were at over 20%. This quarter we went to 25%. We've seen a continued step up in repeat testing, which I think is really a testament to both the product as well as the medium. We think a blood-based test is going to have a better adoption capability than some of the other medias. We also think the fact that it compares very favorably to other tests, given that it's not a non-reimbursed test generally, to have repeat test rates above 25% at this stage of the game is something we're pretty happy with. It's also something we're looking to continue to do efforts to make sure we continue to drive that higher. Speaker 100:37:38Great. Thank you. Speaker 700:37:42Thank you. There are no further questions at this time. I will now turn the call back to GRAIL for closing remarks. Speaker 400:37:49I just want to thank everybody for the questions, and I look forward to talking to you at the next call. Speaker 700:37:59Ladies and gentlemen, this concludes the call. You may now disconnect.Read morePowered by Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) GRAIL Earnings HeadlinesGRAIL Risk-Reward Attractive Ahead of FDA Advisory Committee, UBS SaysSeptember 18 at 6:18 PM | finance.yahoo.comRBC Capital initiates coverage of GRAIL at sector performSeptember 18 at 8:14 AM | msn.comHere’s the stock symbol I’ve promisedWhitney Tilson of Stansberry Research has long recommended Berkshire Hathaway as a core retirement holding - but now he believes he's found something better. This under-the-radar company sits at the intersection of America's two most important industries, including AI, pays massive dividends, and attracted a famous money manager who put 60% of his multi-billion-dollar fund into it. Tilson is revealing the name and ticker symbol completely free - no credit card or email required.September 19 at 1:00 AM | Stansberry Research (Ad)RBC Initiates GRAIL at Sector Perform With $84 Price TargetSeptember 17 at 2:47 PM | marketscreener.comMGrail's Galleri Test Has Large Market Potential Amid Adoption Curve Concerns, RBC Capital Markets SaysSeptember 17 at 2:47 PM | finance.yahoo.comUBS Initiates a Buy Rating on GRAIL Inc (GRAL)September 15, 2026 | theglobeandmail.comSee More GRAIL Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like GRAIL? Sign up for Earnings360's daily newsletter to receive timely earnings updates on GRAIL and other key companies, straight to your email. Email Address About GRAILGRAIL (NASDAQ:GRAL) is a healthcare company focused on developing blood-based tests for the early detection of cancer. Its technology uses genomic and epigenomic signals, including patterns of DNA methylation, to identify signals associated with multiple cancer types from a single blood sample. The company’s primary product is Galleri, a prescription blood test designed to screen for signals of more than 50 types of cancer, including cancers that currently lack recommended screening methods. Galleri is intended to complement, not replace, guideline-recommended cancer screenings, and a positive result requires follow-up diagnostic testing to determine whether cancer is present and where it may be located. GRAIL was founded in 2016 as a subsidiary of Illumina and became an independent publicly traded company following its separation from Illumina in 2021. The company is headquartered in Menlo Park, California, and primarily serves the U.S. market. 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There are 10 speakers on the call. Speaker 700:00:00Today, ladies and gentlemen, and welcome to the GRAIL second quarter 2025 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. Speaker 400:00:18Thanks, Operator, and thanks everyone for joining us today. On the call are Bob Ragusa, our Chief Executive Officer, Aaron Freidin, our Chief Financial Officer, Dr. Joshua Ofman, our President, Sir Harpal Kumar, our President, International Business and Biopharma, and Andy Partridge, our Chief Commercial Officer. We'll be making forward-looking statements on this call based on current expectations. It's our intent that all statements, other than statements of historical fact made during today's call, including statements regarding our anticipated financial results and commercial activity, will be covered by the safe harbor provisions for forward-looking statements contained in Section 27(a) of the Securities Act of 1933 as amended, and Section 21 of the Securities Exchange Act of 1934 as amended. Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. Speaker 400:01:12All 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 in GRAIL's most recent quarterly report on Form 10-Q. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit or loss, which are adjusted to exclude 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. Speaker 500:01:58Thank you. Good afternoon, everyone, and thank you for joining us to review second quarter results. For nearly a decade, GRAIL has made key investments to advance our vision for population scale, multi-cancer early detection, and establish a durable advantage in a growing field. The timeframe to establish evidence in this space is long, and we are setting the evidence bar high. We started population scale clinical studies years ago and now house several years of follow-up data. Our pivotal implementation and clinical utility studies in the intended-use population are beginning to read out, and we are delighted to see results not only confirm earlier studies but actually improve certain performance measures as we evaluate Galleri in larger populations. We plan to submit detailed results from the pre-specified analysis of the first 25,000 patients in our registrational Pathfinder 2 study for a presentation at the ESMO Congress 2025 in October. Speaker 500:03:00As a reminder, we announced positive top-line performance and safety results from this data set in June, namely that we observed substantially greater additional cancer detection and a substantially higher positive predictive value in Pathfinder 2 compared to the first Pathfinder study. Dr. Joshua Ofman will describe these results further shortly. We have been working with advocates and stakeholders to deploy MCED, and we are finding aggressive cancers in real-world commercial settings, many of which are in early stages. Galleri test orders continue to grow at a strong clip, with more than 45,000 Galleri commercial tests sold in the second quarter. As of June 30, more than 370,000 Galleri tests have been prescribed by more than 15,000 healthcare providers since we launched Galleri commercially in 2021. Speaker 500:03:55We continue to drive provider and patient awareness of the MCED opportunity and Galleri's ability to detect cancer earlier when it is more amenable to treatment. GRAIL has established several partnerships with healthcare systems to make Galleri available to patients, and we were very pleased to add Rush University System for Health in July. Rush is one of the largest health systems in the U.S. and the first in the Chicago area market to offer the Galleri test. Additionally, we recently entered into a new collaboration with EverlyWell, a digital health company pioneering in next-generation biomarker intelligence, and Galleri is now available for requests directly on EverlyWell's website via prescription. We remain on track for continued commercial growth in 2025. We are also encouraged by increasing Galleri volume via the Quest Diagnostics Test Ordering Platform at mid-year, which follows Galleri integration into the platform earlier in 2025. Speaker 500:04:58In late 2024, we began the use of a new version of Galleri, for which we are submitting our PMA in commercial channels. This new version incorporates an industrial-scale platform with significant automation intended to enable us to scale more efficiently with future demand. As a result of the scale and complexity of the system, there are certain new processes to sort through with a large-scale rollout. For example, for a small proportion of samples, we've experienced increased turnaround times with higher reprocessing costs. We are now working to implement the fix to this issue. Before I hand it over to Josh, I'd like to notify the group that we will host our 2025 Analyst Day in November. Featured speakers will detail key study results and clinical surveillance findings, frame our upcoming longitudinal clinical utility data, and describe firsthand customer experience with Galleri. Speaker 500:05:54Event details will be announced at a later date. Josh, please go ahead. Operator00:05:59Thanks, Bob, and hello everyone. We've spoken in the past about key performance metrics, features, and capabilities for multi-cancer early detection tests, which are quite different from those for single-cancer screenings. Most critically, any test developer must confirm clinical validation in the intended-use population of asymptomatic adults eligible for screening before they introduce those tests into clinical practice. This critical criterion was the reason that GRAIL did not introduce Galleri into clinical practice until we saw the results from the Pathfinder trial in the screening population. Even tests with strong results in observational case-controlled studies may fail to confirm those results in the actual screening population. Full clinical validation requires demonstration of compelling performance in the intended-use population. It is simply not possible to know the benefits and potential harms of any test before being adequately studied in the intended-use population. Operator00:07:14It is also important to note that any multi-cancer test seeking FDA approval will need to demonstrate this as well. In terms of performance metrics, we've discussed what we consider to be most clinically important for MCEDs: positive predictive value, or PPV, which tells us among positive test results how many cancers are found or how many are actually true positives, and the specificity, critically important, which defines the false positive rate, as well as the cancer detection yield when added to standard of care screening and the ability to localize where in the body a cancer signal is coming from. After hundreds of thousands of commercial tests performed, we've now confirmed how essential it is for any MCED test to report a predicted CSO or cancer signal origin to guide an efficient and effective clinical workup. Operator00:08:18We believe that any other approach, such as relying on whole-body imaging with its radiation exposure, cost, and lack of any performance or safety data, is simply not practicable. Our first clinical implementation study, Pathfinder, which was presented at ESMO in 2022, showed that Galleri more than doubled the number of cancers identified when added to standard of care screening. About half of the MCED-detected cancers were at early stage, and about 70% of the MCED-detected cancers had no recommended screenings at all. The positive predictive value for Galleri in the study population was 43%, which, as you recall, is an order of magnitude higher than leading single-cancer screening tests whose PPVs remain in the single digits. Galleri specificity was 99.5%, and its cancer signal origin accuracy was 88%. Operator00:09:24We have subsequently undertaken Pathfinder 2, similarly designed as a prospective multi-center interventional study of Galleri added to standard of care screening, designed to assess the performance and safety of Galleri in an even larger and more representative intended-use population. As Bob said, we observed a number of very promising results in the pre-specified analysis of the first 25,000 participants enrolled with 12 months follow-up and shared top-line results in June. First, adding Galleri to standard of care screening in Pathfinder 2 demonstrated substantially greater additional cancer detection than that observed in the first Pathfinder study. That is substantially greater than the more than doubling of the overall number of cancers detected when added to standard of care in the first Pathfinder study. Second, data showed a substantially higher positive predictive value than that observed in the first Pathfinder study, which was 43%. Operator00:10:36Third, specificity and CSO accuracy were consistent with that observed in the first Pathfinder study. Finally, there were no serious safety concerns reported in Pathfinder 2. We're enormously pleased with the top-line results from both of our registrational studies, Pathfinder 2 and the NHS Galleri randomized clinical trial. You will recall in May that we completed a review of Galleri test performance results in the intervention arm from the prevalence screening round of the registrational NHS Galleri trial. Data from the prevalence screening round showed a substantially higher positive predictive value than that observed in the first Pathfinder study. Specificity and CSO accuracy were consistent with that observed in the first Pathfinder study, and again, there were no serious safety concerns observed in Pathfinder 2, also consistent with the first Pathfinder study. Operator00:11:40These top-line findings from NHS Galleri and Pathfinder 2 confirm and extend what we already know about our multi-cancer early detection technology. The technology has been validated through many robust studies, including intended-use populations, and through hundreds of thousands of commercial and clinical study test results showing very consistent results. Data presented at the ASCO Annual Meeting 2025 in May included a five-year follow-up analysis of the circulating Self-Read Genome Atlas study, which demonstrated Galleri's preferential detection of aggressive and clinically meaningful cancers. These findings were consistent with earlier analyses assessing the prognostic importance of Galleri's cell-free DNA-based methylation approach. Between case-controlled studies and prospective implementation studies in the intended-use population, we have not seen deterioration in the key performance metrics. Many of you well know this is not always the case. Operator00:12:50Case-controlled performance often doesn't carry over into the real world, yet we saw no deterioration in specificity, positive predictive value, or cancer detection yield. Now we're moving into readouts of much larger registrational studies in the intended-use groups, as well as analyses performed by large health systems who have actual clinical experience with Galleri. We're seeing a body of results with substantially improved PPV figures and substantially higher cancer detection numbers, while other key figures like specificity and cancer signal origin (CSO) accuracy remain consistent. Earlier in GRAIL's development phase of our MCED technology, we deployed a very rigorous, unbiased, and comprehensive discovery approach to identify the effective genomic features for early cancer screening. Out of those approaches evaluated, methylation patterns exhibited the strongest performance for both sensitive and specific cancer signal detection and accurate prediction of the cancer signal origin. Operator00:14:04Adding on other analytes or DNA features did not improve the performance. What we are seeing today from our growing data sets strengthens our conviction in our targeted methylation approach, which is focused on highly informative and low-noise methylation regions known to be informative for cancer. Through hundreds of thousands of samples run in both clinical studies and commercially, we're seeing very strong positive predictive values in cancer detection rates and a highly accurate cancer signal origin prediction, all of which, critically, is achieved at a very low false positive rate of 0.5%, which befits population scale testing. Remember, if another test developer is operating at a lower specificity, a difference in specificity of 99.5% to 98.5% is actually a three times higher false positive rate. That's really important to remember. Operator00:15:10We reported top-line results from Pathfinder 2 in order to preserve detailed results for a major medical meeting, and we hope to present the full data set at ESMO in October. We look forward to discussing detailed results from Pathfinder 2 with you potentially very soon. I'll now hand off to Aaron Freidin for a review of the financials. Speaker 400:15:31Thanks, Josh, and good afternoon, everyone. I'm pleased to present our results for the second quarter. Overall, second quarter results were strong. Revenue for the quarter was $35.5 million, up $3.5 million, or 11% as compared to the second quarter of 2024. Total revenue for the quarter is comprised of $34.4 million of screening revenue and $1.1 million of development services revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing, research, and therapy development. We see continued demand for our Galleri test and sold more than 45,000 tests in the second quarter. We have historically observed seasonal fluctuations over the course of the year, in particular relatively high volume in the second and fourth quarters and lower in the first and third, and we would expect these seasonal trends to continue. Speaker 400:16:29Repeat test volumes have trended higher over time, including year to date. Today, more than 25% of Galleri's volume is repeat testing. Screening revenue of $34.4 million in the second quarter was up 22% as compared with the second quarter of 2024. U.S. Galleri revenue was $34.2 million, up 21% compared to the second quarter last year. The second quarter has been a strong quarter for U.S. Galleri revenue historically. We were on track relative to our full-year guidance of U.S. Galleri revenue growth between 20% to 30%. As stated last quarter, we do not expect major impacts from tariffs on our current business, as our laboratory is located in the U.S. and a significant majority of our suppliers are located and manufactured in the U.S. Speaker 400:17:19Fastest screening revenue, exclusive of amortization of intangible assets, as a percent of revenue decreased in the second quarter of 2025 compared to the same period in 2024, primarily due to a 6% decrease in ASP and additional sample reprocessing costs, largely offset by the reduction in variable costs of Galleri testing performed on our automated platform. Net loss for the quarter was $114 million, an improvement of 93% as compared to the second quarter of 2024. Net loss in the second quarter includes impairment of Illumina acquisition-related intangible assets of $28 million and stock-based compensation of $14.2 million. While we focus on advancing Galleri, we remain committed to our ongoing work with pharma partners, and we have confidence in the potential application of our technology. Speaker 400:18:08Non-GAAP adjusted gross profit for the second quarter of 2025 was $16.1 million, an increase of $0.1 million, or 1% as compared with the second quarter of 2024. We ended the quarter with a cash position of $606.1 million. In January, we guided that we expect cash burn for the full year 2025 to be no more than $320 million, and we are updating the guidance to cash burn of no more than $310 million for the full year of 2025, which represents a decrease of more than 40% to 2024. Our cash runway extends into 2028, enabling us to achieve major planned clinical and regulatory milestones. I'll turn it back to Bob for concluding remarks. Speaker 500:18:53Thank you, Aaron. To close, we are highly encouraged by the demand we are seeing today, both for new patients and for returning patients who are repeat testing. Our strategic priorities are seeking FDA approval of Galleri and pursuing broad reimbursement. We are advancing Galleri today toward near-term key clinical and regulatory catalysts to achieve broad access while maintaining our disciplined cost management. We plan to submit for presentation at ESMO in October detailed performance and safety results from the first 25,000 participants enrolled in the pivotal Pathfinder 2 study. This is a registrational data set that will go to the FDA. Soon into 2026, our key milestones are the completion of our modular PMA submission to the FDA in the first half and full clinical utility results from our 140,000 participant NHS Galleri study, which we expect to read out mid-year. Speaker 500:19:51This longitudinal data set will be reviewed by the NHS to determine Galleri's potential deployment within the UK population. As I mentioned earlier, we look forward to seeing many of you at our 2025 Analyst Day in November. With that, we'll turn the call over to Q&A. Operator, please go ahead. Speaker 700:20:09Thank 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 related follow-up today. We will wait a moment for the queue to form. Thank you. Our first question will come from Kyle Mixon with Canaccord Genuity. Your line is open. Please ask your question. Speaker 900:20:44Hi, this is Alex McKinney with another line for Kyle Mixon. Thanks for taking my questions. If we just take a step back here, the first quarter cash burn came in a bit higher than we expected. That's partially due to the bonuses that you have payout in the prior year period in Q1, but that's obviously not repeated in future quarters. We modestly improved the burn target for 2025. Can you just comment on Q2's free cash burn? Given how integral the burn is to your story, can you elaborate on any other dynamics that could impact cash burn in the second half of 2025, whether that be additional R&D, increases to headcount, or any other one-offs? Thanks. Speaker 400:21:24Yeah, Aaron, you want to take that one? Speaker 900:21:27Yeah, happy to. Thanks for the question. I think the first six months, I think it was about $160 million of burn, and it is important for us to, again, as Bob said, manage the business as efficiently as possible. We do see that coming down in the next couple of quarters as you can get into the $310 million and more than guide that we just updated, really driven by any increased volumes in the back half of the year, increased revenue, and also we'll be working on working through some of the getting more volume on our new automated platform. Speaker 400:22:15Yeah, I think maybe just add a little color to that too. One of the things when we did the restructuring, we wanted to make sure that we gave ourselves a lot of flexibility in the go-forward state and, you know, recognizing that MCED being a new field, we undoubtedly face a number of new and interesting challenges. That flexibility was a key element, and I think by doing the restructuring, getting us cash into 2028 has provided that, and I think being able to guide down a little bit to $310 million shows we think we're on track to be able to hit that more aggressive number. Speaker 900:22:57Got it. Thank you for the color. Speaker 700:23:02Our next question will come from Subhu Nabi with Guggenheim. Your line is open. Please ask your question. Speaker 800:23:09Hey, guys. Thank you for taking my question. Just to clarify, do you not need full longitudinal clinical utility data that is expected mid-2026 for PMA submission? One, and then when you say significantly higher PPV in Pathfinder 2, I had a basic question. Are you normalizing for cancer prevalence in both these studies? Just because shouldn't cancer prevalence impact PPV? Speaker 400:23:36Yeah, maybe I'll start off. Thanks for the questions. On the clinical utility question, the FDA, if you go back to their advisory board meeting, they're really going to be looking at benefits, benefits-harms view of the world. They are not going to be looking at clinical utility and typically don't for the approvals. That gets much more into the payer discussion. The payers would more typically look at that, and that's what the NHS Galleri data will provide. Josh, do you maybe want to take the PPV question on Pathfinder 2? Operator00:24:19Sure. On the FDA, they're going to be focused on clinical validation rather than clinical utility, excuse me, clinical validation, not clinical utility. They will, and they've said that in their advisory board, as Bob said. On the PPV, right now we are not normalizing that for the standard population. We're reporting it out within each study's population. As we mentioned earlier, these are much broader, more diverse, and more representative populations than has been studied previously. We're expecting that there will be a more diverse cancer risk in that population and cancer incidence, which may be driving the higher PPV. We will ultimately normalize all of this for cancer incidence and the cancer case mix, which is the distribution of cancers within each population, which is enormously important for performance reporting. We will ultimately do that, but today we're just reporting them within the study population themselves. Speaker 800:25:29Thank you so much for clarifying that. One follow-up, non-secular, based on other prior integrations with more concierge-type testing platforms like Function and Superpower, how long is the typical growth ramp, and do you expect EverlyWell to drive similar volumes? Speaker 400:25:51Yeah, we have seen good consistent performance out of groups like Function and have been very good partners. We anticipate that EverlyWell will add an important dimension to the channel with a whole other outlet given their subscriber base. Maybe Andy, do you want to, Andy Partridge, our Chief Commercial Officer, do you want to add some color to that? Speaker 200:26:16Absolutely. We're definitely anticipating these telemedicine longevity-based platforms like Function Health, like EverlyWell to really give us a tailwind in terms of growth going forward. When we look at EverlyWell, they've had millions of customers order through their platform, and EverlyWell, in terms of the Everly 360 launch that they announced, are offering Galleri as an add-on, and they've emailed hundreds of thousands of their customers about the Galleri multi-cancer early detection test. We're excited to partner with groups like Function Health, like EverlyWell, as they really amplify our education around Galleri and multi-cancer early detection. Speaker 800:27:10Perfect. Thank you, guys. Speaker 700:27:14Our next question will come from Yuko Oku with Morgan Stanley. Your line is open. Please ask your question. Speaker 300:27:38Hello. Thank you for taking my questions. With timelines for PMA submission approaching, could you elaborate on customer support infrastructure in place to help integrate MCED testing in cancer care today? Outside of sales reps, what are areas you intend to bolster as you get closer to the timing of anticipated FDA approval? Speaker 400:28:01Yeah, so the timeline for our PMA submission is first half of next year, 2026. We're anticipating, beyond that for FDA approval, about a one-year process since we believe since this is the first MCED that will go through the FDA. We believe it'll be about a one-year process due to having an advisory board. That puts you out into kind of mid, first half 2027. We've been consistently ramping our customer support, both size as well as capability in line with the growth of the business. We would assume that we would continue to do that. We're obviously looking for efficiencies in the way we deliver that customer support going through that process. In terms of other elements, at that point, we'll be looking at, certainly from a sales and marketing perspective, how much effort we're going to be putting in as well. Speaker 400:29:09Also looking at, from a cost perspective, we expect some step-downs in cost in other areas of the business as we get through those important milestones. Andy, anything you want to add on the customer support side? Speaker 200:29:23Yeah, I think you covered it, Bob. We're really looking at what are those opportunities to expand our customer-facing teams. We're going to do that to capture those growth opportunities. We're also going to continue to keep an eye on expenses, as you outlined, Bob, as we really want to drive to kind of a commercial break-even going forward. Speaker 300:29:49Great. Thank you for that color. If I could squeeze one more in, if I may, could you elaborate on the statistical powering of the NHS Galleri study? What difference is the trial powered to detect on the primary endpoint, a reduction in the incidence of late-stage cancer versus the control arm, and what result will be viewed as meaningful benefit? Speaker 400:30:10Yeah, Harpal, you maybe want to take that one. Speaker 200:30:14Yeah, sure. The study is powered to show a significant reduction in late-stage cancer. The primary endpoint is a reduction in stage three and four cancers. We look first at the 12 cancers that represent about two-thirds of all cancer mortality, and then we go on to look at all cancers from there. We will be looking at that late-stage reduction. We don't have a specific reduction in mind, but the size of the study was set to be able to deliver a statistically significant result in terms of that reduction. We will see what that reduction ends up being. We're interested, obviously, both in reduction of stage three and four cancers, but also stage four cancers because, ultimately, people primarily die of stage four cancers. If we can see significant reductions in those late-stage cancers, we believe this will provide substantial benefit to the population. Speaker 700:31:27Our next question will come from Doug Shinko with Wolfe Research. Your line is open. Please ask your question. Speaker 600:31:33Hi, this is Colleen on for Doug. Thanks for taking our question. As the NHS data reads out next year, we think that could serve as a strong evidence package for other international opportunities with single-payer systems. How are your conversations with territories across the globe looking to deploy Galleri? Also, if international volume grows sufficiently, will you have to do a tech transfer to international labs? Speaker 400:32:02Yes, no, that's a great question. We get a tremendous amount of inbound interest, as you can imagine, from around the globe. With that, we've had numerous conversations. We also believe, as you rightly point out, that in the middle of next year, from an efficiency standpoint and effectiveness standpoint, the middle of next year, when we read out the NHS Galleri study, we think that's going to be a great calling card to really have significant discussions with a lot of countries around the globe, both due to just the sheer size of the study, but also the rigor and reputation of studies done on the NHS. I think that reputational advantage will go a long way as we have those conversations. Harpal, anything you want to add with that? Speaker 200:32:49I think you've largely covered it, Bob. As you said, this is a very large study conducted extremely well in a health system that is very well respected around the world. We fully expect that the results from this study will be and are being observed by countries right across the world. We're getting, as Bob said, a lot of inbound interest from pretty much every country around the world. We expect that the results, middle of next year, will provide us with the data to really turn those conversations into meaningful opportunities as we look forward. As you alluded to, it should give us a substantial growth opportunity as we look forward. Speaker 300:33:36Thank you. Speaker 700:33:39Our last question will come from David Westenberg with Piper Sandler. Your line is open. Please ask your question. David Westenberg with Piper Sandler. Your line is open. Please ask your question. I'm not sure if David is having audio issues. Can you hear us, David? Speaker 100:34:21Hi, this is John on for Dave. Can you hear me? Speaker 400:34:25Yes. Speaker 100:34:32Hi, this is John on for Dave. Can you hear me? Speaker 400:34:35Yes, we can. Speaker 100:34:37Great. Thank you. First off, Quest integrated Galleri into their ordering system earlier this year. It's still early days, but could you give any color on what you're seeing in terms of orders coming through the Quest platform at this point? Any thoughts on what's driving it? Speaker 400:34:57Maybe answer in reverse. Part of integrating with Quest is we've found every time you remove friction from the system, we see an uplift in sales. We believe that Quest and the Quest integration would be able to give that significant friction reduction in the system. What we've seen so far year to date is about 500 healthcare professionals have ordered the Galleri test via the Quest system. In Q2, we saw about 7% of the orders actually came through the Quest platform. We're pretty excited about the uptake on Quest being relatively quick. As we try to onboard more practitioners, some of them can just go in immediately and order the Galleri tests on their Quest integration, while others need to specifically enable the Galleri tests. That enablement typically takes a few weeks to occur. We do anticipate that we'll continue to grow that channel. Speaker 400:36:05Another nice part about it is what we're finding is the Quest providers, people going through that system, tend to be higher prescribers. We look at the ordering depth by prescriber, and they tend to be some of the higher ones. We're seeing that get enabled definitely drives increased volumes. Speaker 100:36:29Great. Thank you. Just a little more broadly, could you give me color on how you interpret the repeat test rate for Galleri? Are you pleased with it? Do you have a target in mind? Any general thoughts on the directional trend for repeat testing? Speaker 400:36:47Sure. First, we're pretty pleased with repeat testing. Last quarter we were at over 20%. This quarter we went to 25%. We've seen a continued step up in repeat testing, which I think is really a testament to both the product as well as the medium. We think a blood-based test is going to have a better adoption capability than some of the other medias. We also think the fact that it compares very favorably to other tests, given that it's not a non-reimbursed test generally, to have repeat test rates above 25% at this stage of the game is something we're pretty happy with. It's also something we're looking to continue to do efforts to make sure we continue to drive that higher. Speaker 100:37:38Great. Thank you. Speaker 700:37:42Thank you. There are no further questions at this time. I will now turn the call back to GRAIL for closing remarks. Speaker 400:37:49I just want to thank everybody for the questions, and I look forward to talking to you at the next call. Speaker 700:37:59Ladies and gentlemen, this concludes the call. You may now disconnect.Read morePowered by