Q2 2026 GRAIL Inc Earnings Call

August 5, 2026

Operator: Good day, ladies and gentlemen, and welcome to the GRAIL Q2 2026 earnings call. At this time, all participants are in 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 #1: Good day, ladies and gentlemen, and welcome to the GRAIL second quarter 2026 earnings call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session.

Speaker #1: Please be advised that this conference call is being recorded. GRAIL Investor Relations, please begin.

Speaker #2: Thank you. And thank you all for joining us today. On the call are Josh Ofman, our Chief Executive Officer, Aaron Freidin, Chief Financial Officer, Sir Harpal Kumar, Chief Scientific Officer, and President Global Clinical and Medical Affairs, and Andy Partridge, Chief Growth Officer.

[Company Representative] (GRAIL): Thank you, thank you all for joining us today. On the call are Josh Ofman, our Chief Executive Officer, Aaron Freidin, Chief Financial Officer, Sir Harpal Kumar, Chief Scientific Officer and President, Global Clinical and Medical Affairs, and Andy Partridge, Chief Growth 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, GRAIL assumes no obligation to update these statements.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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 Securities and Exchange Commission.

[Company Representative] (GRAIL): 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 Securities and Exchange Commission, including the Risk Factors section in GRAIL's most recent annual report on Form 10-K and the quarterly report on Form 10-Q we plan to file for Q2 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 available on our website. With that, we turn to Josh.

Speaker #2: Including the risk factor section in GRAIL's most recent annual report on Form 10-K and the quarterly report on Form 10-Q. We plan to file for the second quarter of 2026.

Speaker #2: This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit and adjusted EBITDA, which exclude certain specified items.

Speaker #2: 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 available on our website.

Speaker #2: With that, we turn to Josh.

Speaker #3: Thank you. Good afternoon, everybody, and thanks for joining us to review the results of the second quarter 2026 and discuss recent business updates. GRAIL continues to execute across our clinical and commercial priorities.

Josh Ofman: Thank you. Good afternoon, everybody, thanks for joining us to review the results of Q2 2026 and discuss recent business updates. GRAIL continues to execute across our clinical and commercial priorities. We launched the Galleri test in 2021 after our approximate 6,000 participant interventional Pathfinder study, which was conducted under an FDA-approved investigational device exemption and read out and demonstrated strong performance and safety in a screening population. For several years, Pathfinder was the only interventional study that clearly demonstrated the benefits and evaluated the potential harms of deploying an MCED test in the intended use population. Since then, we've read out two additional large studies. Our 35,000 participant Pathfinder 2 study in North America and the groundbreaking 140,000 participant NHS-Galleri trial in England, which included three annual tests.

Speaker #3: We launched the gallery test in 2021 after our approximate 6,000 participant interventional Pathfinder study. Which was conducted under an FDA-approved investigational device exemption and read out and demonstrated strong performance and safety in a screening population.

Speaker #3: For several years, Pathfinder was the only interventional study that clearly demonstrated the benefits and evaluated the potential harms of deploying an MSED test in the intended-use population.

Speaker #3: Since then, we've read out two additional large studies: our 35,000-participant Pathfinder 2 study in North America, and the groundbreaking 140,000-participant NHS Galleri trial in England—which included three annual tests. We recently presented detailed performance, safety, and clinical utility results from these studies at the 2026 American Society of Clinical Oncology Annual Meeting.

Josh Ofman: We recently presented detailed performance, safety, and clinical utility results from these studies at the 2026 American Society of Clinical Oncology annual meeting. They are currently under review for publication, further establishing Galleri as the only MCED with extensive clinical validation from interventional studies. These data in the asymptomatic screening population are critical for physicians and patients to understand test performance as case-controlled studies can fail to replicate performance when tests are rolled out in an intended use population. We are extremely proud of the unparalleled performance demonstrated in these studies in the screening population. We are focused on driving to FDA approval and subsequent Medicare and commercial reimbursement. Galleri test performance is highly differentiated, with a false positive rate of less than 0.5%, resulting in at least three to six times fewer false positives than other MCED tests in development.

Speaker #3: And they are currently under review for publication. Further establishing gallery as the only MSED with extensive clinical validation from interventional studies. These data in the asymptomatic screening population are critical for physicians and patients to understand test performance, as case-controlled studies can fail to replicate performance when tests are rolled out in an intended-use population.

Speaker #3: We're extremely proud of the unparalleled performance demonstrated in these studies in the screening population, and we're focused on driving to FDA approval and subsequent Medicare and commercial reimbursement.

Speaker #3: Gallery test performance is highly differentiated, with the false positive rate of less than 0.5% resulting in at least 3 to 6 times fewer false positives than other MSED tests in development.

Speaker #3: Our technology at GRAIL was designed specifically for population-scale MSED screening. Our extensive research, published in top-tier journals, concluded that methylation holds the highest biological information density.

Josh Ofman: Our technology at GRAIL was designed specifically for population scale MCED screening. Our extensive research, published in top-tier journals, concluded that methylation holds the highest biological information density, which is why GRAIL's proprietary methylation platform, the largest of its kind, is uniquely capable of delivering high accuracy detection and precise localization. We have published, to our knowledge, the largest head-to-head genomic feature comparison study in the entire field. We showed that combining other approaches considered did not improve performance over our proprietary methylation technology. Adding these other features only introduced additional complexity, cost, and biological noise. The field is increasingly moving to methylation as the technology of choice, further validating our approach. Today in the market with Galleri, we continue to expand access through new and existing partnerships. We are accelerating our international expansion activities.

Speaker #3: Which is why GRAIL's proprietary methylation platform, the largest of its kind, is uniquely capable of delivering high-accuracy detection and precise localization. We have published, to our knowledge, the largest head-to-head genomic feature comparison study in the entire field.

Speaker #3: And we showed that combining other approaches, considered, did not improve performance over our proprietary methylation technology. Adding these other features only introduced additional complexity, cost, and biological noise.

Speaker #3: And the field is increasingly moving to methylation as the technology of choice. Further validating our approach. Today in the market with gallery, we continue to expand access through new and existing partnerships.

Speaker #3: And we are accelerating our international expansion activities. Related to that, in the second quarter, we completed the previously announced 110 million dollar financing with Samsung.

Josh Ofman: Related to that, in Q2, we completed the previously announced $110 million financing with Samsung. Alongside that closing, we began work with Samsung C&T Corporation on our strategic collaboration. As a reminder, we and Samsung C&T Corporation will work together to commercialize the Galleri test in South Korea with the potential to expand into additional Asian markets, including Japan and Singapore. The $110 million investment in GRAIL represents a long-term investment to support our growth and international goals. We were very pleased to complete this financing. We look forward to moving forward with Samsung to introduce our MCED technology to patients throughout Asia. In the US, we continue to see growing physician adoption of the Galleri test. We sold over 61,000 Galleri tests in Q2, a 35% increase in volume year over year.

Speaker #3: Alongside that closing, we began work with Samsung C&T Corporation on our strategic collaboration. As a reminder, we and Samsung C&T Corporation will work together to commercialize the Galleri test in South Korea, with the potential to expand into additional Asian markets, including Japan and Singapore.

Speaker #3: The 110 million dollar investment in GRAIL represents a long-term investment to support our growth and international goals. We were very pleased to complete this financing, and we look forward to moving forward with Samsung to introduce our MSED technology to patients throughout Asia.

Speaker #3: In the U.S., we continue to see growing physician adoption of the Galleri test. We sold over 61,000 Galleri tests in the second quarter—a 35% increase in volume year over year.

Speaker #3: Total gallery screening revenue was $42.6 million, up 24% over the year prior. For the first half of 2026, we saw gallery test revenue growth of 30% year over year, to more than $80 million, and gallery test volume growth of 42%, to more than 117,000 tests.

Josh Ofman: Total Galleri screening revenue was $42.6 million, up 24% over the year prior. For H1 2026, we saw Galleri test revenue growth of 30% year over year to more than $80 million. Galleri test volume growth of 42% to more than 117,000 tests. We announced early in 2026 the planned expansion of our field sales and medical teams based on the positive performance and clinical utility results observed in our PATHFINDER 2 and NHS-Galleri trials. This expansion was substantially complete at the end of Q2. New personnel have been onboarded and trained and are now in the field. Initial feedback from sales force engagements with physicians since ASCO has been really positive. Last month, we announced a collaboration with Priority Health to enable its employer groups to add the Galleri test to their existing screening coverage.

Speaker #3: We announced early in 2026 the planned expansion of our field sales and medical teams based on the positive performance and clinical utility results observed in our Pathfinder 2 and NHS gallery trials.

Speaker #3: This expansion was substantially complete at the end of the second quarter. New personnel have been onboarded and trained, and are now in the field, and initial feedback from Salesforce engagements with physicians since ASCO has been really positive.

Speaker #3: Last month, we announced a collaboration with Priority Health to enable its employer groups to add the gallery test to their existing screening coverage. Priority Health is a nationally recognized nonprofit health plan with more than $1.4 million members in Michigan and nearby states.

Josh Ofman: Priority Health is a nationally recognized nonprofit health plan with more than 1.4 million members in Michigan and nearby states. Priority Health launched coverage for Galleri within certain plans in 2025, and our collaboration announced in July marks a promising expansion of this partnership. Moving to our clinical evidence base. We recently shared strong clinical utility performance and safety results from our NHS-Galleri trial and PATHFINDER 2 studies at the recent ASCO annual meeting in May. Although the primary endpoint for the NHS-Galleri trial of a combined reduction of stage III and IV cancers was not met, we believe the other results of this study demonstrated very strong performance, safety, and utility. Across both studies, adding Galleri to standard of care increased the cancer detection rate by four to 6.5 times.

Speaker #3: Priority Health launched coverage for gallery within certain plans in 2025, and our collaboration announced in July marks a promising expansion of this partnership. Moving to our clinical evidence base, we recently shared strong clinical utility performance and safety results from our NHS gallery trial and Pathfinder 2 studies at the recent ASCO annual meeting in May.

Speaker #3: Although the primary endpoint for the NHS gallery trial of a combined reduction of stage 3 and 4 cancers was not met, we believe the other results of the study demonstrated very strong performance, safety, and utility.

Speaker #3: Across both studies, adding Galleri to standard of care increased the cancer detection rate by 4 to 6.5 times. The Galleri test demonstrated very consistent performance, with a false positive rate of less than 0.5% and positive predictive values ranging from 50% to 60%.

Josh Ofman: The Galleri test demonstrated very consistent performance, with a false positive rate of less than 0.5% and positive predictive values ranging from 50% to 60%. Galleri also demonstrated high accuracy in predicting cancer signal origin, enabling efficient and patient-centered diagnostic evaluations. Today, standard of care screening finds only about 14% of cancers in the US and about 6% of cancers in the UK. By adding Galleri, we estimate that those figures can increase to 50% or more, and indeed, in PATHFINDER 2, this number was 60%. This represents a substantial improvement that expands detection of clinically meaningful cancers that otherwise lack recommended screening. Across these two studies, approximately 40% to 50% of the Galleri-detected cancers were found at stages I and II, and approximately 70% were found at stages I through III.

Speaker #3: Gallery also demonstrated high accuracy in predicting cancer signal of origin, enabling efficient and patient-centered diagnostic evaluations. Today, standard of care screening finds only about 14% of cancers in the U.S.

Speaker #3: and about 6% of cancers in the U.K. By adding Galleri, we estimate that those figures can increase to 50% or more, and indeed in PATHFINDER 2, this number was 60%.

Speaker #3: This represents a substantial improvement that expands detection of clinically meaningful cancers that otherwise lack recommended screening. Across these two studies, approximately 40 to 50 percent of the gallery detected cancers were found at stages 1 and 2, and approximately 70% were found at stages 1 through 3.

Speaker #3: Remarkably, in the NHS gallery study, gallery detected 366 stage 1 and 2 cancers, many more than the 290 cancers detected at any stage by the entirety of the U.K.'s standard of care screening program in the control arm.

Josh Ofman: Remarkably, in the NHS-Galleri study, Galleri detected 366 stage I and II cancers, many more than the 290 cancers detected at any stage by the entirety of the UK's standard of care screening program in the control arm. This is truly remarkable. The promise of multi-cancer early detection is not just in finding cancer, but in finding it early enough to open the door to curative treatment options for as many people as possible. What is clear across these groundbreaking trials is that the Galleri test detects a large number of asymptomatic cancers in stages I through III, the majority of which have the opportunity for curative intent treatments. Together, these findings underscore the consistency and actionability of the Galleri test results and demonstrate that adding Galleri to standard of care screening has the potential to improve the effectiveness and efficiency of our current national screening program.

Speaker #3: This is truly remarkable. The promise of multi-cancer early detection is not just in finding cancer, but in finding it early enough to open the door to curative treatment options for as many people as possible.

Speaker #3: What is clear across these groundbreaking trials is that the gallery test detects a large number of asymptomatic cancers in stages 1 through 3, the majority of which have the opportunity for curative intent treatments.

Speaker #3: Together, these findings underscore the consistency and actionability of the gallery test results and demonstrate that adding gallery to standard of care screening has the potential to improve the effectiveness and efficiency of our current national screening program.

Speaker #3: This is critical for providers, regulators, and payers, as they evaluate the clinical and economic value of gallery, alongside standard of care screening. These data support the potential of MSED screening at population scale to identify cancers at earlier stages when treatments are more effective and are potentially curative.

Josh Ofman: This is critical for providers, regulators, and payers as they evaluate the clinical and economic value of Galleri alongside standard of care screening. These data support the potential of MCED screening at population scale to identify cancers at earlier stages when treatments are more effective and are potentially curative. Turning now to our regulatory process. We submitted our pre-market approval application to the FDA in early 2026, and we remain in an ongoing iterative review process. We are very confident in the data package that's been submitted. Galleri's performance has been validated and replicated in multiple rigorous intended use population-level studies. We have consistently shown that Galleri can detect asymptomatic cancers well over and above the standard of care. The evidence clearly demonstrates that Galleri can be useful and safe when implemented at scale.

Speaker #3: Turning now to our regulatory process, we submitted our pre-market approval application to the FDA in early 2026, and we remain in an ongoing, iterative review process.

Speaker #3: We are very confident in the data package that's been submitted. Galleri's performance has been validated and replicated in multiple rigorous intended-use, population-level studies. We have consistently shown that Galleri can detect asymptomatic cancers well over and above the standard of care, and the evidence clearly demonstrates that Galleri can be useful and safe when implemented at scale.

Speaker #3: Our PMA for Galleri is focused on test performance and safety results from the first approximately 25,000 participants in the PATHFINDER 2 study, with one-year follow-up, and the prevalence screening round, which is the first year of the NHS Galleri trial.

Josh Ofman: Our 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 for the first year of the NHS-Galleri trial. The submission also includes a bridging analysis to compare performance of the version of Galleri used in these clinical studies to the updated version that has been submitted to the FDA for pre-market approval. As Galleri is a first-of-its-kind technology and multi-cancer early detection represents a potential paradigm shift in cancer screening, we do expect the FDA to convene an advisory committee for Galleri in the fall. The FDA will announce specific timing of an advisory committee. Turning now to the evolving market environment. As additional MCED tests have launched, a few things are very critical to mention.

Speaker #3: The submission also includes a bridging analysis to compare the performance of the version of Galleri used in these clinical studies to the updated version that has been submitted to the FDA for pre-market approval.

Speaker #3: As gallery is a first-of-its-kind technology, and multi-cancer early detection represents a potential paradigm shift in cancer screening, we do expect the FDA to convene an advisory committee for gallery in the fall.

Speaker #3: The FDA will announce specific timing of an advisory committee. Turning now to the evolving market environment, as additional MSED tests have launched, a few things are very critical to mention.

Speaker #3: Other MSED products have been introduced based only on observational, case-controlled data, and have yet to evaluate the benefits and harms in an actual screening population.

Josh Ofman: Other MCED products have been introduced based only on observational case control data and have yet to evaluate the benefits and harms in an actual screening population. First, that means it is unknown how the purported benefits of these tests shown in case control data will translate, if at all, into performance when deployed into an asymptomatic screening population. Without interventional studies, it's not clear whether the diagnostic pathways and procedures have been developed to support physicians and patients after a positive test. Second, MCED tests with high false positive rates may expose patients to significant risks of radiation exposure and invasive diagnostic tests, which carry potential for complications and increased morbidity. Until these tests have been robustly studied and validated in the intended use screening population, they represent an unknown benefit risk profile and should be considered experimental screening tests at this stage.

Speaker #3: First, that means it is unknown how the purported benefits of these tests, shown in case-controlled data, will translate, if at all, into performance when deployed in an asymptomatic screening population.

Speaker #3: And without interventional studies, it's not clear whether the diagnostic pathways and procedures have been developed to support physicians and patients after a positive test.

Speaker #3: Second, MSED tests with high false positive rates may expose patients to significant risks of radiation exposure and invasive diagnostic tests, which carry potential for complications and increased morbidity.

Speaker #3: Until these tests have been robustly studied and validated in the intended-use screening population, they represent an unknown benefit-risk profile and should be considered experimental screening tests at this stage.

Speaker #3: When we launch gallery, we deliberately chose to do so only after reporting results from a prospective interventional study under an FDA-approved investigational device exemption in the screening population.

Josh Ofman: When we launched Galleri, we deliberately chose to do so only after reporting results from a prospective interventional study under an FDA-approved investigational device exemption in the screening population. We believe that patients deserve and the field demands this level of robust evidence because the true litmus test of test performance, both benefits and harms, is demonstration in interventional clinical studies in the actual intended use population. Now, why do I say this? This is because case control data will not always replicate in interventional studies. For example, after very strong performance for the CancerSEEK assay was observed in a case-controlled study published in a top-tier journal, Science, the DETECT-A study failed to replicate performance and safety in an interventional study. As you know, this test is currently not available or on the market. Beyond study rigor, Galleri test characteristics stand apart in the field.

Speaker #3: We believe that patients deserve and the field demands this level of robust evidence because the true litmus test of test performance, both benefits and harms, is demonstration in interventional clinical studies in the actual intended-use population.

Speaker #3: Now, why do I say this? This is because case-controlled data will not always replicate in interventional studies. For example, after very strong performance for the CancerSEEK assay was observed in a case-controlled study published in the top-tier journal Science, the DETECT-A study failed to replicate performance and safety in an interventional study.

Speaker #3: And as you know, this test is currently not available or on the market. Beyond study rigor, Galleri test characteristics stand apart in the field.

Speaker #3: Based on data from observational studies that are case-controlled, experimental MSED tests are operating at a 3 to 5 times higher false positive rate. They detect a smaller number of cancer types, and some have no ability to predict a cancer signal origin, which we believe is necessary for the safety and performance of any MSED test.

Josh Ofman: Based on data from observational studies that are case-controlled, experimental MCED tests are operating at a three to five times higher false positive rate. They detect a smaller number of cancer types and some have no ability to predict a cancer signal origin, which we believe is necessary for safety and performance of any MCED test. In a field where hope and hype can easily collide, GRAIL is defined by rigorous science and validated by the most extensive evidence base. We believe we chose the right biological signature of cancer after unbiased comparisons. We have built the most advanced proprietary technology to interpret that signal, and we have proved its performance in the real world on an unprecedented scale. I'll now hand off to Aaron for a review of our second quarter financials.

Speaker #3: In a field where hope and hype can easily collide, GRAIL is defined by rigorous science and validated by the most extensive evidence base. We believe we chose the right biological signature of cancer after unbiased comparisons; we have built the most advanced proprietary technology to interpret that signal; and we have proved its performance in the real world on an unprecedented scale.

Speaker #3: I'll now hand off to Aaron for a review of our second quarter financials.

Speaker #1: Thanks, Josh. And good afternoon, everyone. Second quarter results were strong, with revenue of $44.7 million. Up 9.1 million. Or 26% as compared to the second quarter of 2025.

Aaron Freidin: Thanks, Josh, and good afternoon, everyone. Second quarter results were strong with revenue of $44.7 million, up $9.1 million or 26% as compared to the second quarter of 2025. Total revenue for the second quarter consisted of $42.6 million of screening revenue and $2 million of development services revenue. Screening revenue was up 24% as compared with the second quarter 2025, with test volumes of more than 61,000, an increase of 35% over the second quarter of 2025. Net loss for the quarter was -$110.2 million, a decrease of 3% as compared to the second quarter of 2025. Non-GAAP adjusted gross profit for the second quarter was $21.6 million, an increase of $5.4 million or 34% as compared with the second quarter of 2025.

Speaker #1: Total revenue for the second quarter consisted of $42.6 million of screening revenue and $2 million of development services revenue. Screening revenue was up 24% as compared with the second quarter 2025, with test volumes of more than 61,000 and increase of 35% over the second quarter of 2025.

Speaker #1: Net loss for the quarter was $110.2 million, a decrease of 3% as compared to the second quarter of 2025. Non-GAAP adjusted gross profit for the second quarter was $21.6 million.

Speaker #1: An increase of $5.4 million, or 34%, as compared with the second quarter of 2025. The primary drivers of the increased gross margin were improved fixed-cost leverage from higher volumes and a decrease in sample reprocessing costs.

Aaron Freidin: Primary drivers of the increased gross margin were improved fixed cost leverage from higher volumes and a decrease in sample reprocessing costs, partially offset by a decrease in ASP. Adjusted EBITDA for the second quarter was -$90.3 million, an increase in adjusted EBITDA loss of $11.9 million or 15% as compared to the second quarter of 2025. We ended the second quarter with a cash position of $861.6 million, which includes the $110 million strategic investment by Samsung, which closed in June. Our cash balance today provides us with financial flexibility as we advance key priorities, including securing regulatory approval and reimbursement for Galleri in the United States. Back to you, Josh.

Speaker #1: Partially offset by a decrease in ASP. Adjusted EBITDA for the second quarter was negative 90.3 million. An increase in adjusted EBITDA loss of 11.9 million.

Speaker #1: Or 15% as compared to the second quarter of 2025. We ended the second quarter with a cash position of $861.6 million. Which includes the $110 million strategic investment by Samsung, which closed in June.

Speaker #1: Our cash balance today provides us with financial flexibility as we advance key priorities including securing regulatory approval and reimbursement for gallery in the United States.

Speaker #1: Back to you, Josh.

Speaker #2: Thank you, Aaron. We're really pleased with the continued growth for gallery and the progress we're making towards FDA approval and broad-based access. And we anticipate continued progress over the next year.

Josh Ofman: Thank you, Aaron. We're really pleased with the continued growth for Galleri and the progress we're making towards FDA approval and broad-based access. We anticipate continued progress over the next year. With ASCO behind us, our expanded field teams are now fully equipped to educate clinicians about our groundbreaking trial results and continue market development. Initial feedback from the field has been really positive. We look forward to potential FDA approval of Galleri, expanding distributor partnerships internationally, progressing R&D on Galleri improvements and cost of goods reduction, and publication of the NHS-Galleri and PATHFINDER 2 studies, as well as additional analyses from our extensive clinical program. Operator, we can now go to Q&A.

Speaker #2: With ASCO behind us, our expanded field teams are now fully equipped to educate clinicians about our groundbreaking trial results and continue market development. Initial feedback from the field has been really positive.

Speaker #2: We look forward to potential FDA approval of gallery. Expanding distributor partnerships internationally; progressing R&D on gallery improvements and cost of goods reduction; and publication of the NHS Gallery and Pathfinder 2 studies as well as additional analyses from our extensive clinical program.

Speaker #2: Operator, we can now go to Q&A.

Speaker #3: 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.

Operator: 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 related follow-up today. We'll wait one moment to allow the queue to form. Our first question will come from Subbu Nambi with Guggenheim. Please unmute your line and ask your question.

Speaker #3: 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.

Speaker #3: As a reminder, we are allowing analysts one question and one related follow-up today. We'll wait one moment to allow the queue to form. Our first question will come from Sugu Nambi with Guggenheim.

Speaker #3: Please unmute your line and ask your question.

Speaker #4: Hey, team. Thank you for taking my question. As you would anticipate an FDA outcome in the fall, where do you think the FDA will focus on?

Subbu Nambi: Hey, team. Thank you for taking my question. As you anticipate an FDA AdCom in the fall, where do you think the FDA will focus on? What type of questions, how are you preparing for those questions?

Speaker #4: What type of questions and how are you preparing for those questions?

Josh Ofman: Hi, Subbu. Thank you for the question. We are obviously getting ready and preparing internally. We don't know the nature of any of that information at this time. Obviously, we'll be informed about that as the time approaches. We're waiting to hear something from the FDA as it relates to timing.

Speaker #5: Hi, Sugu. Thank you for the question. We are obviously getting ready and preparing internally. We don't know the nature of any of that information at this time.

Speaker #5: But we should obviously will be informed about that as the time approaches. We're waiting to hear something from the FDA as it relates to timing.

Speaker #4: Okay. That's helpful. And then given all the leadership changes at the FDA and the delays we have seen recently when it comes to finding the right panelists for ADCOMs, is there a risk this meeting pushes into next year at all?

Subbu Nambi: Okay. That's helpful. Given all the leadership changes at the FDA and the delays we have seen recently when it comes to finding the right panelists for AdComs, is there a risk this meeting pushes into next year at all? I know it's an unfair question.

Speaker #4: I know it's an unfair question.

Speaker #5: Well, it's fine. We don't know the answer to that question. We know that the division that we're working with has been fairly stable at the FDA, which has been very positive and productive.

Josh Ofman: Well, it's fine. We don't know the answer to that question. We know that the division that we're working with has been fairly stable at the FDA, which has been very positive and productive, and we continue our iterative review with them. I couldn't really comment on their ability to find experts.

Speaker #5: And we continue our iterative review with them. But I couldn't really comment on their ability to find experts.

Speaker #4: Okay. Can I squeeze one more? Would you expect CMS to wait for an FDA approval before better defining the NCD criteria for an MSET test?

Subbu Nambi: Okay. Can I squeeze one more, though? Would you expect CMS to wait for an FDA approval before better defining the NCD criteria for an MCED test?

Speaker #5: You know, again, it's a good question. I'd be speculating if I tried to answer it. We do know that CMS's coverage authority is only for FDA-approved products.

Josh Ofman: Again, it's a good question. I'd be speculating if I tried to answer it. We do know that CMS's coverage authority is only for FDA-approved products. Our assumption has been that they would only undertake a national coverage analysis upon an FDA approval. Whether they're going to set specific coverage criteria is unknown.

Speaker #5: So our assumption has been that they would only undertake a national coverage analysis upon an FDA approval. Whether they're going to set specific coverage criteria is unknown.

Subbu Nambi: Fair. Thank you so much, guys.

Speaker #4: Fair. Thank you so much, guys.

Speaker #3: Our next question will come from Kyle Mixon with Canaccord Genuity. Please unmute your line and ask your question.

Operator: Our next question will come from Kyle Mikson with Canaccord Genuity. Please unmute your line and ask your question.

Speaker #6: Hey, guys. Thanks for the questions. Congrats on the strong quarter. Yeah, following up on Sugu's questions about FDA. So maybe, Josh, wasn't clear to me what the specific communication with the FDA was for you to now anticipate the meeting ADCOM to be in the fall.

Kyle Mikson: Hey, guys. Thanks for the questions. Congrats on a strong quarter. Yeah, following up on Subbu Nambi's questions about FDA. Maybe Josh Ofman, it wasn't clear to me what the specific communication with the FDA was for you to now anticipate the meeting AdCom to be in the fall. If you could talk about that would be helpful. Additionally, in the past you've talked about an early 2027 sort of approval timeline. Let's say this is mid-fall or something, how would that affect your new timeline for FDA approval? Thank you.

Speaker #6: So if you could talk about that, that would be helpful. And then, additionally, in the past, you've talked about an early 2027 sort of approval timeline.

Speaker #6: Let's say this is mid-fall, or is there a new timeline for FDA approval? Thank you.

Speaker #5: No, thanks for the question, Kyle. We have long stated publicly that we would anticipate that a groundbreaking technology like an MSET test, like gallery, that is really changing the potential cancer screening paradigm would get an advisory panel.

Josh Ofman: No, thanks for the question, Kyle Mikson. We have long stated publicly that we would anticipate that a groundbreaking technology like an MCED test, like Galleri, that is really changing the potential cancer screening paradigm would get an advisory panel, and we continue to believe that. There's no specific information that has been made public yet from the FDA about that, we certainly are anticipating that an AdCom would occur. The timing of it has not been made public yet, that is still to come, our current anticipation for potential approval as it relates to timing remains unchanged. We would expect it to occur in the first part of 2027.

Speaker #5: And we continue to believe that. There's no specific information that's been made public yet from the FDA about that. But we certainly are anticipating that an ADCOM would occur.

Speaker #5: The timing of it, it is not has not been made public yet. That's still to come. And our current anticipation for a potential approval as it relates to timing remains unchanged.

Speaker #5: We would expect it to occur in the first part of 2027.

Speaker #6: Perfect. Thanks for that. And then on competition, you called that out. That's interesting. It doesn't seem like there's been a volume impact, but how has that impacting your pricing?

Kyle Mikson: Perfect. Thanks for that. On competition, you called that is interesting. It doesn't seem like there has been a volume impact, how is that impacting your pricing? It looks like ASP in the quarter was $700 or something around there. On that note, I think USPSTF is meeting later this month. Could they possibly talk about MCED at that meeting, or how do you think that progresses given it is more noise in the marketplace with some of these other entrants recently?

Speaker #6: It looks like ASP for the quarter was $700 or something around there. And then, kind of on that note, I think USPSTF is meeting later this month.

Speaker #6: Could they possibly talk about MSET at that meeting? How do you think that progresses given it's more noise in the marketplace with some of these other entrants

Speaker #5: Yeah, it's a fair question. Let me take your second question, and then I'll have Andy address here first. As it relates to the USPSDF, I think there's just a lot that's unknown right now about the USPSDF.

Josh Ofman: Yeah, it is a fair question. Let me take your second question, I will have Andy Partridge address your first. As it relates to the USPSTF, I think there is just a lot that is unknown right now about the USPSTF. It is unknown what its composition is going to be, what its focus will be. I think before there is an FDA-approved product on the market, it is, in my mind, less likely that they are going to take MCEDs up, irrespective of the amount of noise that is in the market or not. There is just a lot unknown about the USPSTF, it is mandated at this time. Your first question, which was about the impact of competition on our pricing, I am going to let Andy Partridge discuss that.

Speaker #5: It's unknown what its composition is going to be, what its focus will be. And I think without—before there's an FDA-approved product on the market, it's, in my mind, less likely that they're going to take MSET up.

Speaker #5: Irrespective of the amount of noise that's in the market or not. But there's just a lot of unknown about the USPSDF and its mandate at this time.

Speaker #5: Your first question, which was about the impact of competition on our pricing, I'm going to let Andy discuss that.

Speaker #2: Yeah, I think the I guess, first of all, the ISP decrease in second quarter 26 was the result of both expansion of digital health volume and also lower employer pricing which was planned that reduced employer pricing has come along with the benefit of strengthened partnerships with those employers such as specific marketing commitments and blood draw events.

Andy Partridge: Yeah. I think, first of all, the ASP decrease in Q2 2026 was the result of both expansion of digital health volume and also lower employer pricing, which was planned. That reduced employer pricing has come along with the benefit of strengthened partnerships with those employers, such as specific marketing commitments and blood draw events. In terms of competition, there's definitely been some active competition that we've seen that has been stepped up, as I'm sure you've also seen. It has been causing some customer confusion in the market, given, as Josh outlined earlier, these what we would call experimental MCEDs do not have data in the screening population. Many of their performance characteristics are unknown to those prescribing physicians. They also have higher false positive rates.

Speaker #2: In terms of competition, there's definitely been some active competition that we've seen that has been stepped up as I'm sure you've also seen. It has been causing some customer confusion.

Speaker #2: In the market, given as Josh outlined earlier, these what we would call experimental MSETs do not have data in the screening population. So many of their performance characteristics are unknown to those prescribing physicians.

Speaker #2: They also have higher false positive rates. So what we're seeing with physicians that have experimented with some of these MSETs is quite a bit of confusion due to these higher false positive rates and unclear performance characteristics.

Andy Partridge: What we're seeing with physicians that have experimented with some of these MCEDs is quite a bit of confusion due to these higher false positive rates and unclear performance characteristics. That's something that our sales team are following up with those customers to reinforce Galleri's extensive clinical program that we conducted and the clinical results that we've presented and published. As Josh said, the initial reactions from these conversations where we followed up with our customers with the data that was presented at ASCO for both PATHFINDER 2 and NHS-Galleri has been very promising and very favorably received.

Speaker #2: That's something that our sales team are following up with those customers. To reinforce galleries, extensive clinical program that we've conducted, and the clinical results that we've presented and published.

Speaker #2: And as Josh said, the initial reactions from these conversations where we followed up with our customers with the data that was presented at ASCO for both Pathfinder 2 and NHS Gallery has been very promising and very favorably received.

Speaker #5: I think that's great, Andy. I would just add one other thing: the noise that's been interjected into the market. We expect, and our anticipation is, that we will have an FDA approval.

Josh Ofman: I think that's great, Andy. I would just add one other thing. The noise that's been interjected into the market, we expect that our anticipation is that we will have an FDA approval, and that will create a bifurcation in the market and clear up a lot of that noise. We expect the market really to evolve one side with Galleri as a well-validated and potentially FDA-approved MCED, and then the other side of the market with the other MCEDs that are still, quite frankly, in development with unknown risk-benefit profiles in the intended use population. They'd be considered very experimental. We see that bifurcation coming, and we look forward to executing upon it.

Speaker #5: And that will create a bifurcation in the market and clear up a lot of that noise. We expect the market really to evolve. One side with gallery as a well-validated and potentially FDA-approved MSET, and then the other side of the market with the other MSETs that are still, quite frankly, in development with unknown risk-benefit profiles and the intended-use population.

Speaker #5: And so they'd be considered very experimental. So we see that bifurcation coming. And we look forward to executing upon it.

Speaker #6: Our next question will come from Bradley Bowers with Mizuho. Please unmute your line, and ask your question.

Operator: Our next question will come from Bradley Bowers with Mizuho. Please unmute your line and ask your question.

Speaker #7: Hey, thank you for taking my questions. Maybe just wanted to click on the Salesforce expansion. Obviously, a pull forward of some of the costs just wanted to hear about why the timing is right.

Bradley Bowers: Hey, thank you for taking my questions. Maybe just wanted to click on the sales force expansion, obviously a pull forward of some of the costs. Just wanted to hear about why the timing is right. Seemingly, the first part of 2027 timeline seems coincident with expected productivity ramp. Also just wanted to hear about if you knew about the AdCom scenario from the FDA, when you allocated this size and if this is the max sales force you expect.

Speaker #7: Seemingly, the first part of the 2027 timeline seems coincident with the expected productivity ramp, but I also just wanted to hear about if you knew about the ADCOM scenario from the FDA—kind of when you allocated this size, and if this is kind of the max Salesforce you expect.

Speaker #2: Yeah, we pulled forward the Salesforce expansion really on the back of the NHS Gallery and Pathfinder 2 data that we announced earlier in the year, given how excited we were with both sets of that data.

Andy Partridge: Yeah. We pulled forward the sales force expansion really on the back of the NHS-Galleri and PATHFINDER 2 data that we announced earlier in the year, given how excited we were with both sets of that data. That sales force expansion is essentially complete now. Those sales members are now in the field. We expect to see the true benefit of that additional sales force horsepower as we go through the rest of the year. The other reason that we did this is to have those new salespeople in territory, all trained, so that they can truly meet the moment of FDA approval, as Josh outlined, as this is going to be a landmark event for GRAIL, really establishing Galleri as the gold standard MCED.

Speaker #2: That Salesforce expansion is essentially complete now. Those sales members are now in the field. We expect to see the true benefit of that additional Salesforce horsepower as we go through the rest of the year.

Speaker #2: And the other reason that we did this is to have those new salespeople in territory, all trained, so that they can truly meet the moment of FDA approval, as Josh outlined, as this is going to be a landmark event for GRAIL, really establishing gallery as the gold standard MSET.

Speaker #7: Got it. And just real quick, would you give a number just because of competitors that we do know a lot of them, and then just actually totally switching gears, on the panel, do you think this would make it maybe easier or harder for the incremental MSET test, asking just because the government initiative right now seems to be just trying to ease the pathway towards getting MSET tests adding more to the market?

Bradley Bowers: Got it. Just real quick, would you give a number just because with competitors, we do know a lot of them. Just actually totally switching gears. On the panel, do you think this would make it maybe easier or harder for the incremental MCED test? Asking just because the government initiative right now seems to be just trying to ease the pathway towards getting MCED tests, adding more to the market. Obviously the panel would be differentiated. Wanted to hear if you think it would be a competitive advantage, an extra barrier to entry, or if it might have the adverse effect of making it easier for other MCEDs down the line. Thank you for the questions.

Speaker #7: But obviously, the panel would be kind of differentiated. So wanted to hear if you think it would be kind of a competitive advantage kind of an extra barrier to entry, or if it might have the adverse effect of making it easier for other MSETs down the line.

Speaker #7: Thank you for the questions.

Speaker #5: Just to clarify, when you say a panel, do you mean an advisory committee panel or which panel?

Josh Ofman: Just to clarify, when you say a panel, do you mean an advisory committee panel or which panel?

Bradley Bowers: Sorry, the AdCom. I apologize. Yes, this fall, the meeting this fall.

Speaker #7: Sorry, the ADCOM. I apologize. Yes, this fall, the meeting this fall.

Speaker #5: Yeah, no, an ADCOM. Look, the reason we expect an ADCOM is because typically, when the FDA reviews a kind of groundbreaking pioneering type of technology, particularly one that could have this kind of impact on public health, that is really paradigm-changing.

Josh Ofman: Yeah. No, an AdCom. Look, the reason we expect an AdCom is because typically when the FDA reviews a kind of groundbreaking pioneering type of technology, particularly one that can have this kind of impact on public health that is really paradigm-changing, they typically hold an AdCom because they want to get advice from other experts. The AdCom will be completely about Galleri. It will not be about the field of MCEDs. It won't be about other MCEDs. It'll be just about our data package that we've submitted to the FDA. We don't really view it as a competitive advantage or disadvantage. We view it as part of the FDA approval process for a groundbreaking technology like Galleri. To your further question, I don't think that that has necessarily any bearing on whether there will be AdComs for future MCEDs.

Speaker #5: They typically hold an ADCOM because they want to get advice from other experts. The ADCOM will be completely about gallery. It will not be about the field of MSETs.

Speaker #5: It won't be about other MSETs. It'll be just about our data package that we submitted to the FDA. So we don't really view it as a competitive advantage or disadvantage.

Speaker #5: We view it as part of the FDA approval process for a groundbreaking technology like gallery. And to your further question, I don't think that that has necessarily any bearing on whether there will be ADCOMs for future MSETs.

Speaker #5: And I don't see any MSETs right now, even on the horizon. I'm doing registrational trials or anything like that. So it's really hard to say.

Josh Ofman: I don't see any MCEDs right now, even on the horizon, doing registrational trials or anything like that. It's really hard to say.

Speaker #2: Yeah, I think just building on Josh's point, what the ADCOM and the FDA approval are going to do is establish that approval bar for future MSETs.

Andy Partridge: Yeah, and I think just building on Josh's point, what the AdCom and the FDA approval is going to do is establish that approval bar for future MCEDs. That's why we're excited for this panel and for the anticipated FDA approval, that it is going to set that bar for future MCEDs coming forward.

Speaker #2: And that's why we're excited for this panel, and for the anticipated FDA approval, that it is going to set that bar for future MSETs coming forward.

Speaker #6: Our next question will come from Dan Brennan from TD Cohen. Please unmute your line and ask your question.

Operator: Our next question will come from Dan Brennan from TD Cowen. Please unmute your line and ask your question.

Speaker #7: Great, thanks. Congrats on the quarter. Thanks for the questions. Maybe just one more on the panel since it's obviously the topic to George. So Josh, you sounded pretty definitive that there'll be a panel, the FDA will alert us when kind of when the time is right.

Dan Brennan: Great. Thanks. Congrats on the quarter. Thanks for the questions. Maybe just one more on the panel since it's obviously the topic du jour. Josh, you sounded pretty definitive that there'll be a panel. The FDA will alert us when the time is right. Can you just share any color like, does that mean like an outright decision popping up one day is off the table? Just what's the level of the discussions that you have with FDA under these types of processes and just anything you can share on that front would be helpful.

Speaker #7: Can you just share any color, like so does that mean like an outright decision popping up one day? Is it off the table? Just what's the level of the discussions that you have with FDA under these types of processes and just anything you can share on that front will be helpful.

Speaker #5: Yeah, there's not a lot we can share until the FDA decides to make a public pronouncement one way or the other. But from the very outset, we have been anticipating an ADCOM.

Josh Ofman: Yeah. There's not a lot we can share until the FDA decides to make a public pronouncement one way or the other. From the very outset, we have been anticipating an AdCom. We've stated that numerous times. We don't see any reason why that wouldn't be the case. Really it's just our own internal preparation at this point until the FDA decides to make a public pronouncement. We're prepared for one. We continue to prepare. We feel very confident about the evidence package that we've submitted to the FDA. We've been in a very productive, iterative review process, and going through all the relevant steps of inspections and other things that you would expect going into a PMA. Things are progressing well and we look forward to hearing more from the FDA.

Speaker #5: We've stated that numerous times. We don't see any reason why that wouldn't be the case. And so really, it's just our own internal preparation at this point until the FDA decides to make a public pronouncement.

Speaker #5: But we're prepared for one. We continue to prepare. We feel very confident about the evidence package that we've submitted to the FDA. We've been in a very productive, iterative review process.

Speaker #5: And going through all the relevant steps of inspections and other things that you would expect going into a PMA. So things are progressing well.

Speaker #5: And we look forward to hearing more from the FDA.

Speaker #7: Great, thank you. Is there anything you can share about the back and forth in terms of obviously, you can't get into specifics, but I'm sure there's a certain cadence to questions and responses all.

Dan Brennan: Great. Thank you. Is there anything you can share about the back and forth, like in terms of, obviously you can't get into specifics, I'm not sure how you might categorize those. If there's anything you could share on that front.

Speaker #7: But I'm not sure how you might categorize those if there's anything you could share on that front.

Speaker #5: You know, not really. I mean, it's pretty typical. There have been a series of questions. We've responded. There have been a series of inspections.

Josh Ofman: Not really. It's pretty typical. There have been a series of questions. We've responded. There have been a series of inspections. We've performed through those. It's just a very standard process. Not much I can really share.

Speaker #5: We've performed through those. And so it's just a very standard process, not much I can really share.

Speaker #7: Okay. How about the marketing, since ASCO, I know that you guys were kind of held back a bit from being out in the field.

Dan Brennan: Okay. How about the marketing since ASCO? I know that you guys were kind of held back a bit from being out in the field since the NHS-Galleri headline was out. You wanted to wait until you presented the full data set at ASCO. Now that that was out, can you just share any color about what the plan has been in the last six weeks or so, or eight weeks, excuse me. What have you guys done? How many customers have you hit? What's been the response? Anything on that front to kind of provide color on?

Speaker #7: Since then, the gallery headline was out, but you wanted to wait until you presented the full data set at ASCO. Now that that is out, can you just share any color about what the plan has been in the last six weeks or so—or eight weeks, excuse me—and what you guys have done?

Speaker #7: How many customers have you hit? What's been the response? Anything on that front to kind of provide color on?

Speaker #2: Yeah, we're trying to all of the salesforce, the week after the ASCO meeting. So we plan to do that. We're also trying to all of our new salesforce that we brought on board in terms of the salesforce expansion and our sales teams have been out there.

Andy Partridge: Yeah. We trained all of the sales force the week after the ASCO meeting. We planned to do that. We also trained all of our new sales force that we brought on board in terms of the sales force expansion. Yeah, our sales teams have been out there talking to customers, both healthcare providers and to employer customers. The reaction has been very favorable from customers as we've explained to them both the PATHFINDER 2 data and the NHS-Galleri data, really establishing that Galleri is the only MCED proven to reduce Stage 4 diagnoses. Physicians have reacted very favorably to that. Really, this has been the promise of Galleri all along, to increase early-stage detection and reduce late-stage detection, enabling more patients to receive curative intent therapy. Yeah, everything very promising up until this point.

Speaker #2: Talking to customers — both healthcare providers and employer customers — the reaction has been very favorable. As we've explained to them, both the PATHFINDER 2 data and the NHS GALLERI data really establish that Galleri is the only MCED proven to reduce stage IV diagnoses, and physicians have reacted very favorably to that.

Speaker #2: And really, this has been the promise of gallery all along to increase early stage detection, and reduce late stage detection. Enabling more patients to receive curative intent therapy.

Speaker #2: So yeah, everything very promising up until this point.

Speaker #5: Yeah, I was in the field recently as well speaking with clinicians and practicing providers. And when they hear the results of the study, like we found gallery found more early stage one and two cancers in the NHS trial than the entire number of cancers found by the UK's National Screening Program, it's pretty remarkable.

Josh Ofman: Yeah, I was in the field recently as well speaking with clinicians and practicing providers. When they hear the results of the study, like Galleri found more early Stage 1 and 2 cancers in the NHS trial than the entire number of cancers found by the UK's National Screening Program, it's pretty remarkable, and I think it has quite an impact. We also found that there was a dramatic increase in the Stage 1 and 2 screen-detected cancers in the Galleri arm compared to the control arm in NHS-Galleri. Of course, there was a six and a half-fold increase in the overall cancer detection rate in PATHFINDER 2 when added to standard of care. When you talk to doctors about those kinds of numbers, you get a very positive reaction.

Speaker #5: And I think it has quite an impact we also found that there was a dramatic increase in the stage one and two screen detected cancers in the gallery arm compared to the control arm in NHS gallery.

Speaker #5: And then, of course, there was the six and a half-fold increase in the overall cancer detection rate in Pathfinder 2 when added to standard of care.

Speaker #5: And so when you talk to doctors about those kinds of numbers, you get a very positive reaction. And Andy's point is I want to underscore it.

Josh Ofman: Andy’s point is, I want to underscore it, the whole purpose of screening for cancer is to give individuals an opportunity to find cancer in stages that have curative intent opportunities. In PATHFINDER 2, for example, the vast majority of Galleri-detected cancers received curative intent treatment.

Speaker #5: The whole purpose of screening for cancer is to give individuals an opportunity to find cancer in stages that have curative intent opportunities. And in Pathfinder 2, for example, the vast majority of gallery detected cancers received curative intent treatment.

Speaker #7: Great. And maybe just I'll say two more in. Publication, just latest thoughts there, timing, when we might expect the data to be in a leading journal?

Dan Brennan: Great. Maybe just I’ll sneak two more in. Publication, just latest thoughts there, timing, when we might expect the data to be in a leading journal?

Harpal Kumar: Harpal. Yeah. Harpal here. Thanks, Dan. We have submitted publications both on PATHFINDER 2 and NHS-Galleri. Those have been in active review at top-tier journals, and those review processes are going well, and they’re going quickly. We are hopeful of publication in the near future.

Speaker #2: Yeah, Harpal here. Thanks, Dan. So we're we have submitted publications both on Pathfinder 2 and NHS gallery. Those have been in active review at top-tier journals.

Speaker #2: And those review processes are going well. And they're going quickly. And so we are hopeful of publication in the near future.

Dan Brennan: Great. Assuming FDA approval comes at some point this fall or early next year, obviously Medicare will have to follow the decision there. In the interim, what type of impact will FDA approval, do you think, have upon either could some payers adopt then? Will maybe self-insured plans look to do anything, volumes? Just what’s the meaning of FDA approval, do you think, on the business, say, like in that 12-month period between that decision and when the Medicare decision comes?

Speaker #7: Great. And then maybe just—so, assuming FDA approval comes at some point this fall or early next year, obviously Medicare will have to follow the decision there.

Speaker #7: But in the interim, what type of impact will FDA approval do you think have upon either could some payers adopt then will maybe self-insured plans look to do anything, volumes, just what's the meaning of FDA approval do you think on the business, say, like in that 12-month period between that decision and when the Medicare decision comes?

Speaker #2: Yeah, thanks for the question. So yeah, FDA approval is really the gate that a lot of payers have been waiting for to really dig into gallery and serious conversations.

Andy Partridge: Yeah. Thanks for the question. FDA approval is really the gate that a lot of payers have been waiting for to really dig into Galleri in serious conversations. We're looking forward to that. Also, many employers have told us that they're waiting for FDA approval as well. That's going to put a wind at our backs with both employers and with payers going forward. Of course, healthcare providers. Josh and I have talked about the confusion that's being caused by experimental MCEDs promoting their unproven tests. An FDA approval is going to give providers the confidence that Galleri is the gold standard MSAT. We feel that that's also going to give our sales teams a lot of confidence going forward in terms of their sales efforts to provider clinics.

Speaker #2: So we're looking forward to that. Also, many employers have told us that they're waiting for FDA approval as well. So that's going to put a window that backs with both employers and with payers going forward.

Speaker #2: And then, of course, healthcare providers Josh and I have talked about the confusion that's being caused by experimental MSETs promoting their unproven tests. FDA approval is going to give providers the confidence that gallery is the gold standard.

Speaker #2: MSET, so we feel that that's also going to give our sales teams a lot of confidence going forward in terms of their sales efforts to provide a clinics.

Speaker #7: Terrific. Thank you all.

Dan Brennan: Terrific. Thank you all.

Speaker #1: Our next question will come from David Westenberg from Piper Sandler. Please unmute your line and ask a question.

Operator: Our next question will come from David Westenberg from Piper Sandler. Please unmute your line and ask a question.

Speaker #3: Hey guys, it's Karan Patel on for David Westenberg. And I'll maybe shift gears here. If you could speak to the Illumina royalty resuming sometime in Q4, how could we think about margins for Q4 and then specifically for full year 27?

Tarun Patel: Hey, guys, it's Tarun Patel on for David Westenberg, and I'll maybe shift gears here. If you could speak to the Illumina royalty resuming sometime in Q4, how can we think about margins for Q4 and then specifically for full year 2027?

Speaker #2: Yeah, Sarah, so that royalty will kick in toward the end of Q4, so it's not going to have an impact on Q4 in any meaningful way.

Aaron Freidin: Yeah, Tarun. That royalty will kick in toward the end of Q4, so it's not going to have an impact on Q4 in any meaningful way. We've been disclosing what that royalty would be every quarter so far in the financials, so you can see what that would have been if we had been paying it. We've disclosed in the financials it's 7% to 9%, 7% royalty, I believe. You can do your modeling to see what the impact would be based off of the volumes that you're expecting in the Ice piece.

Speaker #2: And we've been disclosing what that royalty would be every quarter. So far, our the financials so you can see what that would have been.

Speaker #2: If we had been paying it. We've disclosed in the financials it's a 7 to 9% 7% royalty, I believe. And you can do your modeling to see what the impact would be based off of the volumes that you're expecting in the ASPs.

Speaker #3: Understood. Thank you. So, minimal for Q. Got it.

Tarun Patel: Understood. Thank you. Minimal for Q. Got it.

Speaker #2: Yep.

Josh Ofman: Yep.

Speaker #1: Our next question will come from Callum Tishmarsh from Morgan Stanley. Please unmute your line and ask your question.

Operator: Our next question will come from Calum Titchmarsh from Morgan Stanley. Please unmute your line and ask your question.

Speaker #4: Yeah, great. Thanks for taking the question, guys. Sorry again to move back to the outcome. I was just reading through the transcript from the Q4 call back in February.

Calum Titchmarsh: Yeah, great. Thanks for taking the question, guys. Sorry again to move back to the AdCom. I was just reading through the transcript from the Q4 call back in February, the message did seem to be that you were prepping for an AdCom, but one likely wasn't necessary. I'm still just trying to unpackage what perhaps has changed, maybe from the questions that you've had from the FDA, to the tone that you've given today. I realize you can't perhaps go into too many of the specifics, but just some guidance would be helpful.

Speaker #4: And the message did seem to be that you were prepping for an outcome, but one likely wasn't necessary. So, I'm still just trying to unpack what perhaps has changed, maybe from the questions that you've had from the FDA to the tone that you've given today.

Speaker #4: And I realize you can't perhaps go into too many of the specifics, but just some guidance would be helpful.

Speaker #2: Sure. That's fair question. There's nothing that's changed in our minds or in our point of view about the FDA outcome. I'm not sure what you're reading into prior comments.

Josh Ofman: Sure. That's a fair question. There's nothing that's changed in our minds or in our point of view about the FDA AdCom. I'm not sure what you're reading into prior comments. We've been very consistent saying that we are expecting that there will be an AdCom, and we still expect that, and we're fully prepared for that. In fact, we look forward to the opportunity to really discuss this data package, which is unprecedented in performance and scale, with the AdCom.

Speaker #2: We've been very consistent saying that we are expecting that there will be an outcome. And we still expect that. And we're fully prepared for that.

Speaker #2: In fact, we look forward to the opportunity to really discuss this data package, which is unprecedented in performance and scale with the outcome.

Speaker #4: Okay. Fair enough. And then some pretty sizable financing completed with Samsung in the quarter. Can you maybe just speak to the level of engagement there and how we should be thinking about the regulatory and commercial timelines in South Korea, Japan, and Singapore?

Calum Titchmarsh: Okay. Fair enough. Some pretty sizable financing completed with Samsung in the quarter. Can you maybe just speak to the level of engagement there and how we should be thinking about the regulatory and commercial timelines in South Korea, Japan, and Singapore? Thank you.

Speaker #4: Thank you.

Speaker #2: Yeah, it's Aaron again. We closed that toward the end of the quarter, and we're just kicking off those discussions now around distribution in the near term, and then any sort of longer-term strategic engagement.

Aaron Freidin: It's Aaron again. We closed that toward the end of the quarter, and we're just kicking off those discussions now around distribution in the near term and then any sort of longer-term strategic engagement. As you recall, we were under CFIUS review during that period, and we weren't engaging with each other as such. We'll be able to provide more color on that as we move through the year.

Speaker #2: As you recall, we were under Cepheus review during that period, and we weren't engaging with each other as such. So, we'll be able to provide more color on that as we move through the year.

Speaker #1: Our last question will come from Robert Bamberger with Baird. Please unmute your line and ask your question.

Operator: Our last question will come from Robert Bamberger with Baird. Please unmute your line and ask your question.

Speaker #4: Hi guys, this is Josh on for Robbie. Thanks for taking my question. And I guess first, another solid quarter for gallery here. What was the primary growth driver in the quarter?

[Analyst] (Baird): Hi, guys. This is Josh on for Robbie. Thanks for taking my question. I guess first, another solid quarter for Galleri here. What was the primary growth driver in the quarter? Was this more on new physician adds or improving order rates among existing physicians? Thanks.

Speaker #4: Was this more on new physician ads or improving order rates among existing physicians? Thanks.

Speaker #2: Self-pay remains the majority of Gallery's volume, but counting through about 70% of sales, we see that most of the volume is coming from brick-and-mortar physicians.

Andy Partridge: Thanks. Self-pay remains the majority of Galleri's volume, accounting for about 70% of sales. We see that most of the volume's coming from brick-and-mortar physicians, and we added, again, about 1,000 new ordering providers in Q2. Depth of prescribing continues to increase over time. Electronic order integrations with Quest and Athena are also both bringing on new prescribers themselves and helping increase the depth of prescribing as well, given we don't just want to have the best-performing tests and the gold standard, MSK. We also want to have the easiest tests for prescribers to prescribe to their patients. We also continue to see very strong growth in our digital health business from both new and existing digital health partners. We're seeing continued expansion in employers that are offering the test and also expansion in some new digital health partners.

Speaker #2: And we added again about 1,000 new ordering providers in Q2. Depth of prescribing continues to increase over time. And our electronic order integrations with Quest and Athena are also both bringing on new prescribers themselves.

Speaker #2: And helping increase the depth of prescribing as well, given we don't just want to have the best performing test and the gold standard MSET.

Speaker #2: We also want to have the easiest test for prescribers to order for their patients. We continue to see very strong growth in our digital health business from both new and existing digital health partners.

Speaker #2: We've seen continued expansion in employers that are offering the test and also expansion in some new digital health partners. And also as we announced expansion in our payer partnerships with Priority Health now joining a number of other ASO payers who have decided to offer the gallery test to their employer-based customers.

Andy Partridge: Also as we announce expansion in our payer partnerships with Priority Health now joining a number of other ASO payers who have decided to offer the Galleri test to their employer base of customers.

Speaker #4: Great. And was just wondering too with the NHS, how have discussions here gone around expanded gallery studies or future collaborations? Do you have any concerns around the ongoing NHS reform?

[Analyst] (Baird): Great. Was just wondering, too, with the NHS, have discussions here gone around expanded Galleri studies or future collaborations? Do you have any concerns around the ongoing NHS reform? How is that impacting Galleri and diagnostic aid for cancer conversations? Thanks.

Speaker #4: How has that impacted Galleri and diagnostic aid for cancer conversations? Thanks.

Speaker #2: Yeah, thank you for the question, Josh. So look, the there's no getting around the fact that the fundamental changes in the sort of organizational structure and governance for NHS services in the UK is causing some hiatus in decision-making and what those future structures will look like.

Harpal Kumar: Yeah. Thanks for the question, Josh. Look, there's no getting around the fact that the fundamental changes in the sort of organizational structure and governance for NHS services in the UK is causing some hiatus in decision-making and what those future structures will look like. There's still an enormous amount of uncertainty around that and quite a lot of organizational upheaval that's flowing from that. What I will say is that as we have talked to the leading clinicians in the NHS and indeed clinicians more generally in the UK, the overwhelming reaction is one of positivity about the results. Really, as Andy has described for the US, we're seeing a great deal of enthusiasm around the stage 4 reduction and some of the other metrics that we've talked about, but particularly the stage 4 reduction and the opportunity that promises to really transform cancer outcomes.

Speaker #2: And there's still an enormous amount of uncertainty around that. And quite a lot of organizational upheaval that's flowing from that. What I will say is that as we have talked to the leading clinicians in the NHS and indeed clinicians more generally in the UK, the overwhelming reaction is one of positivity about the results.

Speaker #2: Really, as Andy has described for the US, we're seeing a great deal of enthusiasm around the stage four reduction and some of the other metrics that we've talked about.

Speaker #2: But particularly the stage four reduction and the opportunity that promises to really transform cancer outcomes. So look, as we get through this as I say, this organizational upheaval with the NHS, I would anticipate those conversations will translate into defining hopefully a meaningful way forward.

Andy Partridge: Look, as we get through this, as I say, this organizational upheaval with the NHS, I anticipate those conversations will translate into defining, hopefully, a meaningful way forward.

Operator: Thank you. There are no further questions at this time. Ladies and gentlemen, this concludes the call. You may now disconnect.

Q2 2026 GRAIL Inc Earnings Call

Request DemoDemo

GRAIL

Earnings