Q2 2025 Guardant Health Inc Earnings Call

Helmy Eltoukhy: Good afternoon, and thank you for attending the Guardant Health Q2 2025 earnings conference call. My name is Jay Son, and I'll be the moderator today. All lines will be muted during the presentation portion of the call, with an opportunity for questions and answers at the end. I would now like to pass the conference over to your host, Zarak Khurshid.

Good afternoon and thank you for attending the garden Health, Q2 2025 earnings conference. Call my name is Jason, and I'll be the moderator today. All lines will be muted during the presentation portion of the call and opportunity for questions and answers at the end.

I would now like to pass the conference over to your host, Zarak Khurshid.

Zarak Khurshid: Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30, 2025. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO, AmirAli Talasaz, Co-CEO, and Michael Bell, Chief Financial Officer. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainty that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures, is available in the press release Guardant issued today, as well as in our 10-K and other filings with the SEC.

Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30, 2025. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO; and Mike Bell, Chief Financial Officer. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation to the most directly comparable GAAP financial measures, are available in the press release.

Zarak Khurshid: Guardant disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. The information in this conference call is accurate only as it's a live broadcast. With that, I would like to turn the live call over to Helmy.

Helmy Eltoukhy: Thanks, Zarak. Good afternoon, and thank you for joining our second quarter 2025 earnings call. Starting on slide three, Q2 marked another exceptional quarter for Guardant. We continued to build the momentum across oncology, biopharma, and screening business lines, including accelerating therapy selection and MRD volume growth, record biopharma sales, and quickly scaling shield volumes and revenues. Product innovation built on smart liquid biopsy, combined with strong commercial execution, were integral to the strong performance in the second quarter. I'll walk through some of the key highlights of the quarter in just a moment. But first, as always, I would like to start with a powerful story that demonstrates the impact our tests can have on patients around the world. Last August, a 46-year-old woman was diagnosed with stage III endometrial carcinoma.

Police Garden issued today, as well as in our 10-K and other filings with the SEC, disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. The information in this conference call is accurate only as of the live broadcast. With that, I would like to turn the live call over to Helmy Eltoukhy.

Thanks Eric, good afternoon and thank you for joining us. Our second quarter 2025 earnings call.

Starting on slide 3, Q2 marked another exceptional quarter for Gardens. We continue to build momentum across our oncology, biofarma, and cleaning business lines, including accelerating therapy selection and MRD volume growth records, biofarma sales, and quickly scaling Shield volumes and revenues.

Product innovation, built on smart liquid biopsy combined with strong commercial execution, was integral to the strong performance in the second quarter.

I'll walk through some of the key highlights of the quarter in just a moment. But first, as always, I would like to start with a powerful story that demonstrates the impact our tests can have on patients around the world.

Helmy Eltoukhy: Once it became clear that her cancer was progressing, her oncologist ordered a Guardant 360 tissue test to help identify potential treatment options beyond the standard of care. Guardant 360 tissue had just gone through a major upgrade to incorporate comprehensive DNA and RNA, and the oncologist ordered both results. The test identified a RET fusion, an actionable biomarker that made her eligible for a targeted therapy she likely would not have received based on her initial diagnosis alone. I am glad to be able to share that she has responded positively to this treatment and is doing well today. This case is a powerful example of how comprehensive molecular profiling through our recently upgraded Guardant 360 tissue test can help guide treatment decisions and improve patient outcomes.

Last August, the 46 year old woman was diagnosed with stage 3 endometrial carcinoma. Once it became clear that her cancer was progressing from colleges ordered to Garden, 360 tissue tests to help identify potential treatment options beyond the standard of care.

Garden 360 tissue had just gone through a major upgrade to incorporate comprehensive DNA and RNA, and oncologists ordered both results.

The tests identified a red fusion in an actionable biomarker that made her eligible for a targeted therapy. She likely would not have received it based on her initial diagnosis alone. I'm glad to be able to share that she has responded positively to this treatment and is doing well today.

Helmy Eltoukhy: Turning to top-line performance on slide four, Q2 revenue grew 31% year over year to $232 million, with strong performance across our oncology, screening, and biopharma and data businesses. Starting with our oncology business on slide five, roughly half of the overall year-over-year revenue growth in Q2 came from the oncology business, with revenue increasing 22% to $159 million. Oncology volumes increased 30% year over year to approximately 64,000 tests in the second quarter, with the majority of growth driven by Guardant 360 liquid, again closely followed by a strong contribution from Reveal. Looking more closely at some of the recent highlights within our oncology business on slide six, we saw continued volume growth across all oncology tests this quarter, with particularly strong performance from Guardant 360 liquid, where year-over-year growth accelerated for the fourth consecutive quarter and was over 20% in Q2.

This case is a powerful example of how comprehensive microprofiling through our recently upgraded Garden 360 tissue tests can help guide treatment decisions and improve patient outcomes.

Turning to Topline performance and slide 4 q, 2 Revenue, grew 31% year-over-year to 232 million with strong performance across our oncology, screening, and biofarma, and data businesses.

Starting with our oncology business and slide 5, roughly half of the overall year-over-year Revenue growth in Q2 came from oncology business with Revenue, increasing 22% to 159 million oncology volumes increased 30% year-over-year to approximately 64,000 tests in the second quarter with the majority of growth driven by Gardens 360 liquid. Again closely followed by a strong contribution from RE

Helmy Eltoukhy: We continue to believe that the steady cadence of new app introductions powered by smart liquid biopsy has been instrumental to the accelerating growth profile of Guardant 360 liquid. In late May, as part of the lead-up to ASCO 2025, we introduced 11 groundbreaking smart liquid biopsy applications for Guardant 360 liquid, significantly expanding the clinical utility and further extending our technical leadership in the liquid CGP market. I'll walk through some of these applications in more detail shortly. Guardant 360 tissue continues to be our second fastest growing oncology product and is even better positioned today to accelerate following the major upgrade in April, which we believe makes it a best-in-class product.

Looking more closely at some of the recent highlights within our oncology business on slide 6. We saw continued volume growth across all oncology test. This quarter with particularly strong performance from garden. 360 liquid where year-over-year growth accelerated for the fourth consecutive quarter and was over 20%. In Q2 we continue to believe that the steady Cadence of new app introductions powered by smart liquid biopsy has been instrumental to the accelerating growth profile of garden 360 liquids.

Ending the clinical utility and further extending our technical leadership. In the liquid CGP market, I'll walk through some of these applications in more detail shortly.

Helmy Eltoukhy: As a reminder, the recent improvements expand the panel to include RNA and broad methylome analysis powered by our smart liquid biopsy platform and enable readouts with 40% less slides than the industry norm, which we believe is an important differentiator. We are also excited to report for the first time that Guardant 360 tissue ASP was approximately $2,000 in Q2, achieving our 2028 target three years ahead of schedule. For Reveal, we made great progress with data generation and publications. We recently submitted our Reveal breast cancer data package to MOLDIX for Medicare reimbursement, and the first publication of immuno-oncology therapy monitoring data on Reveal was published this week. In May, we continue to augment our offering with the launches of Guardant hereditary cancer testing and a suite of immunohistochemistry or IHC tests.

Garden 360 tissue continues to be our second fastest growing oncology product and is even better positioned today to accelerate following the major upgrade in April, which we believe make it at best-in-class product,

As a reminder, the recent improvements expand the panel to include RNA and broad methylone analysis, powered by our smart liquid biopsy platform, and enable readouts with 40% fewer slides than the industry norm, which we believe is an important differentiator.

We are also excited to report for the first time the garden 360. ASP was in Q2 achieving our 2028 Target 3 years ahead of schedule.

For reveal, we made great progress with data generation and Publications. We recently submitted our revealed breast cancer data package to molds, for Medicare reimbursement. And the first publication of immuno oncology therapy monitoring data. Under reveal was published this week.

Helmy Eltoukhy: These additions bring us closer to becoming a one-stop shop for oncologists, providing insights across the patient journey. Turning to slide seven, at the annual ASCO meeting in early June, results from the landmark Serena VI trial sponsored by AstraZeneca were featured in a high-profile plenary session. This was the first pivotal trial to use a ctDNA-guided approach to detect and treat emerging resistance in first-line therapy ahead of disease progression in breast cancer. Guardant 360 was the exclusive companion liquid biopsy used in the trial for this monitoring application. Feedback from KOLs during and after ASCO was incredibly positive, and we look forward to chemosestran potentially becoming a new option for breast cancer patients. This important new paradigm involving frequent Guardant 360 testing in order to quickly detect the emergence of resistance mutations has the potential to change clinical practice and improve outcomes for patients with advanced breast cancer.

In May, we continued to augment our offering with the launches of garden hereditary cancer testing and a suite of amino histochemistry, or IHC tests.

These additions, bring us closer to becoming a 1-stop shop for oncologists providing insights across the patient Journey.

Turning the slide 7 at the annual ASCO meeting in early. June results from the landmarks Arena 6 trial, or sponsored by astragin, were featured in a high-profile plenary session

This was the first pivotal trial to use a ctDNA-guided approach to detect and treat emerging resistance. In first-line therapy, ahead of disease progression in breast cancer, Guardant 360 was an exclusive companion. A liquid biopsy was used in the trial for this monitoring application.

Feedback from K. Wells during and after ASCO was incredibly positive, and we look forward to chemistry and potentially becoming a new option for breast cancer patients.

Helmy Eltoukhy: With a prevalence pool of approximately 40,000 patients in the US, this new application of Guardant 360 has the potential to drive significant incremental Guardant 360 revenue in 2026 and beyond. Moving on to slide eight, we have built a powerful real-world evidence platform utilizing over 100,000 genomic and broad epigenomic profiles across more than 50 cancer types. By combining the multi-omic profiling capabilities of our Infinity platform with the analytical power of our Infinity AI learning engine, we are driving the development of first-of-the-kind clinical applications that are setting a new standard in precision oncology. Turning to slide nine, since July of last year, Guardant 360 has delivered accelerating growth each quarter, fueled by our Guardant Infinity smart liquid biopsy platform. In Q2 alone, we launched nearly a dozen groundbreaking new apps, greatly expanding the utility of Guardant 360 liquid.

This important new paradigm involving frequent Garden. 360 testing in order to quickly detect the emergence of resistance, mutations has potential to change clinical practice and improve outcomes for patients with Advanced Breast Cancer.

With a prevalence pool of approximately 40,000 patients in the US. This new application of garden 360 as a potential to drive significant incremental Garden, 360 Revenue, in 2026 and Beyond.

Moving on to slide 8, we have built a powerful real world evidence platform utilizing over 100,000 genomic and Broad epigenomic profiles across more than 50 cancer types.

By combining the multi-omic profiling capabilities of our Infiniti platform with the analytical power of our Infiniti AI learning engine. We are driving the development of first of their kind, clinical applications that are setting a new standard and precision oncology.

Helmy Eltoukhy: The latest wave of new apps includes complementary genomic features, which add an even higher resolution view of tumor biology, helping healthcare providers to make smarter, more personalized treatment decisions, even when tissue isn't available for analysis. Among the many newly launched applications are cancer subtype classification using tumor-specific methylation signatures to complement and enhance standard testing methods, cancer site of origin identification when the primary site is unknown, guiding better diagnosis and therapy, advanced negative prediction to confidently identify wildcat patients, and pharmacogenomic profiling to identify genetic variations that impact the safety and efficacy of commonly used anti-cancer therapies. Now shifting gears to Reveal on slide 10, where we are the leader in tissue-free MRD. Over the last few months, we have continued to generate and publish compelling data on Reveal across a number of cancer types.

Turning to slide 9, since July of last year, Guardant Health has delivered accelerating growth, each quarter fueled by our Guardant Infinity smart liquid biopsy platform. In Q2 alone, we launched nearly a dozen groundbreaking new apps, greatly expanding the utility of Guardant 360 liquid.

The latest wave of new apps include complimentary genomic features which add an even higher resolution view of tumor biology helping Healthcare Providers. To make smarter more personalized treatment decisions even when tissue isn't available for analysis.

Among the many newly launched, applications are cancer. Subtype classification, using tumor specific methylation signatures to complement and enhance standard testing methods.

Cancer site of origin identification, when the primary site is unknown, guiding better diagnosis and therapy.

Advanced negative prediction to confidently identify wild-type patients and pharmacogenomic profiling to identify genetic variations that impact the safety and efficacy of commonly used anti-cancer therapies.

Helmy Eltoukhy: As I mentioned earlier, the Reveal breast reimbursement submission has been made to MOLDIX, and the IO monitoring study just published will support reimbursement submission for this application in the near future. Starting with slide 11, we were excited to announce a new breast cancer publication in ESMO Open, highlighting the performance of Reveal. This retrospective study evaluated 95 patients who were diagnosed with early-stage ER-positive, HER2-negative, or triple-negative breast cancer undergoing chemotherapy prior to surgery. Notably, nearly 40% of patients had minimal or no residual tumor following neoadjuvant chemotherapy, demonstrating the value of Reveal's tissue-free approach. Reveal showed strong performance with 100% sensitivity for distance recurrence in patients with ER-positive, HER2-negative breast cancer, 100% specificity, and 100% positive predictive value for relapse, and an overall sensitivity of 71%.

Power shifting gears to reveal Slide 10, where we are the leader in tissue-free MRD. Over the last few months, we have continued to generate and publish compelling data and reveal across a number of cancer types. As I mentioned earlier, the revealed breast reimbursement submission has been made to Molda X, and the IO monitoring study just published will support reimbursement submission for this application in the near future.

Starting with slide 11, we are excited to announce a new breast cancer publication in asthma. Highlighting the performance of Reveal, this retrospective study evaluated 95 patients who were diagnosed with early-stage ER positive, HER2 negative, or triple negative breast cancer undergoing chemotherapy prior to surgery. Notably, nearly 40% of patients had minimal or no residual tumor following neoadjuvant chemotherapy, demonstrating the value of Reveal's tissue-free approach.

Helmy Eltoukhy: These results, combined with the data recently published in clinical cancer research, further validate Reveal's potential to transform neoadjuvant and post-treatment surveillance strategies with the ultimate goal of improving patient outcomes. Moving on to slide 12, I'm proud to share the Radiohead Reveal immuno-oncology monitoring study, which involves 521 stage IV pan cancer patients treated with standard-of-care immunotherapy, was published in Cancer Research Communications, a journal of the American Association of Cancer Research. This study demonstrated that any decrease in Reveal tumor fraction signal in the study was significantly associated with improved patient outcomes. Additionally, Reveal identified non-responders more than three months and as many as five months before disease progression was visible on standard imaging. Turning to slide 13, at this year's ASCO annual meeting, data from the largest study to date using ctDNA in stage III colon cancer further validated the clinical utility of Reveal.

100% specificity and 100% positive predictive value for relapse, and an overall sensitivity of 71%. These results combined, with the data recently, published in clinical cancer research, further validate reveals potential to transform Neo agim and post-treatment surveillance strategies with the ultimate goal of improving, patient outcomes.

Moving on to slide 12, I am proud to share the radio head revealing immuno-oncology monitoring study, which involved 521 stage 4 pan cancer. Patients treated with standard of care. Am therapy was published in cancer research Communications, a journal of American Association of cancer research.

This study demonstrated that any decrease in revealed tumor fraction signal in the study was significantly associated with improved patient outcomes. Additionally, this reveal identified non-responders more than 3 months and as many as 5 months before disease progression was visible and standard imaging.

Helmy Eltoukhy: This phase III study involved over 2,000 patients evaluated with a median follow-up of 6.1 years, showed that ctDNA detected after surgery and before chemotherapy is a powerful predictor of recurrence and survival. Among patients with detectable ctDNA, 63% experienced recurrence within three years, compared to just 15% of those without detectable ctDNA. These findings strongly support the routine use of Guardant Reveal to stratify patients by risk, inform adjuvant therapy decisions, and ultimately improve outcomes. We have made strong progress over the last few months in MRD. Reveal volume growth accelerated in the second quarter on a year-over-year basis, consistent with our expectations, and we continue to have an extensive pipeline of clinical cohorts to further support clinical utility and analytical validity for Reveal. Turning now to slide 14, our oncology business is well positioned for durable growth, supported by continued CGP penetration, favorable ASP dynamics, and international expansion.

Turning to slide 13 at this year's ASCO annual meeting, dated from the largest 72 days using ctDNA in stage 3 colon cancer, further validated the clinical utility of Reveal. This Phase 3 study involved over 2,000 patients, evaluated with a median follow-up of 6.1 years, and showed that ctDNA detected after surgery and before chemotherapy is a powerful predictor of recurrence and survival.

Among patients with detectable ctDNA, 63% experienced recurrence within 3 years compared to just 15% of those without detectable ctDNA.

These findings strongly support the routine use of Guardant Reveal to stratify patients by risk, inform adjuvant therapy decisions, and ultimately improve outcomes.

We have made strong progress over the last few months in MRD Reveal. Volume growth accelerated in the second quarter on a year-over-year basis, consistent with our expectations, and we continue to have an extensive pipeline of clinical cohorts to further support clinical utility and analytical validity for Reveal.

Helmy Eltoukhy: Guardant 360 liquid and Guardant 360 tissue are seeing increased adoption, driven by the recently expanded genomic and epigenomic breadth of our platform, which is unlocking greater clinical utility and driving share gains. With our redoubled commercial focus on Reveal following major COGS improvements and Medicare CRC surveillance reimbursement earlier this year, the business is primed for strong growth in MRD. Looking more closely at some of the recent highlights within our biopharma and data business on slide 15, we delivered a record quarter for our biopharma business, achieving all-time highs in both volume and revenue, with second-quarter revenue growing 28% year over year. We continue to deepen our relationship with large pharma and signed two new companion diagnostic deals in Q2. We continue to have a robust and growing pipeline of partnerships, and near-term revenue visibility remains high.

Turning now to slide 14, our oncology business is well positioned for durable growth, supported by continued CGP penetration, favorable ASP dynamics, and international expansion.

Gardens 360 liquid and garden. 360 tissue are seeing increased adoption driven by the recently expanded genomic and epigenomic breadth of our platform, which is unlocking greater clinical utility and driving share games.

With our redouble commercial Focus Center revealed following major cogs improvements, and Medicare CRC surveillance reimbursement earlier this year. The business is primed for strong growth in mrd.

Looking more closely at some of the recent highlights within our biofarma and Data Business and side 15. We delivered a record quarter for our biofarma business, achieving all-time highs in both volume and revenue of second quarter, Revenue growing 28% year-over-year.

Helmy Eltoukhy: Of note, our biopharma volume mix continues to skew towards methylation analysis on Infinity, powered by our smart liquid biopsy platform. With that, I will now turn the call over to Amir Ali for an update on screening.

We continue to deepen our relationship with large pharma and signed 2 new companion diagnostic deals. In Q2, we continue to have a robust and growing pipeline of partnerships, and near-term revenue visibility remains high.

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AmirAli Talasaz: Thanks, Helmy. Moving on to slide 16, we delivered $15 million of shield testing revenue in Q2, driven by approximately 16,000 tests. We are pleased to see continued strong traction for shield in the third full quarter of commercial launch. Shield continues to generate strong enthusiasm from both patients and physicians, with high adherence rates that continue to be over 90%, meaning we receive blood samples for more than 90% of ordered cases. This demonstrates the simplicity of shield as a routine blood test for CRC screening that can be implemented into standard PCP care. We also continue to observe strong depth of ordering per physician. Moreover, we've been encouraged with the momentum in sales rep productivity in the field, although it's still early days in our commercial journey, and the average tenure of our sales reps is less than eight months.

With that, I will now turn the call over to Amir Ali for an update on screening.

Revenue in Q2 3 pin by approximately 16,000 tests.

We are pleased to see continuous strong traction for a shield in the third full quarter of commercial launch.

We still continue to see strong enthusiasm from both patients and physicians, with high adherence rates that remain over 90%. This means we received blood samples for more than 90% of ordered cases.

Lifting monstrous the Simplicity of Shield as a routine blood test for CRC screening that can be implemented into standard PCV care.

We also continue to observe strong depth of ordering per physician.

AmirAli Talasaz: Given our performance this quarter across revenue, volume, and gross margin, we are further accelerating the build-out of our commercial infrastructure and now expect to surpass 250 sales reps by year-end to support this growth as we go to 2026. Moving on to slide 17, in late May, we were very encouraged to see National Comprehensive Cancer Network, or NCCN, update its CRC screening guidelines to include shield. The new NCCN guidelines place shield in category 2A, which is the same category recommendation as the other first-line screening modalities. This represents the first national guideline recommendation for shield and, in our view, paved the way for improved commercial coverage and patient access. This also supports our confidence that shield will be included in other national CRC screening guidelines in the future. Now, turning to slide 18 to take a closer look at screening highlights for the second quarter of 2025.

Moreover, we've been encouraged with the momentum in sales rep productivity in the field, although it's still early days in our commercial journey and the average, 10 year of our sales, reps is less than 8 months.

Even with our performance this quarter across revenue volume and gross margin, we are further accelerating the buildout of our commercial infrastructure and now expect to surpass 250 sales reps by year-end to support this growth as we go into 2026.

Moving on to slide 17 in late. May, we are very encouraged to see National Comprehensive Cancer Network for nccn, updated CRC screening guidelines to include Shield.

Which is the same category recommendation as the other First Line Screening modalities. This represent the first national guideline recommendation for Shields and in our view paved the way for improved commercial coverage and patient access. This also supports our confidence that she will be included in other National CRC screening guidelines in the future.

AmirAli Talasaz: Starting with shield CRC, as I mentioned earlier, we are very pleased with the high patient adherence, strong depth of ordering per physician, and the productivity of our reps in the field. We are also very excited to see shield is now a guideline-recommended screening test by the NCCN. Along with this strong momentum, shield was recently named a winner of Fast Company's 2025 World Changing Idea Awards, an award that recognizes innovative companies and projects addressing the world's most urgent challenges. Beyond CRC, we made meaningful progress with shield multicancer detection (MCD) in the second quarter. As a reminder, we presented the clinical validation of shield MCD tests at ACR and ASCO this year. This momentum continued when shield MCD received breakthrough device designation from the FDA, making it an important milestone for us.

Now, turning to slide 18 to take a closer look at screening highlights for the second quarter 2025.

Starting with Shield CRC, as I mentioned earlier, we are very pleased with the high patient, adherence drawing, thats of ordering for physician, and the productivity of our reps in the field.

We are also very excited to see Shield is now a guideline recommended screening test by the mccn.

Along with this strong momentum, Shield was recently named a winner of fast companies, 2025 world, changing idea, Awards and award that recognizes Innovative companies and projects addressing the world's most urgent challenges.

Beyond CRC, we made meaningful progress with Shield multi-cancer detection and CD in the second quarter.

As a reminder, we presented the clinical validation of shield and CD test at ACR and ASCO this year.

AmirAli Talasaz: Moving on to slide 21, as a reminder, our goal has always been to detect cancer early when it's most treatable. We developed our shield assay as a platform capable of multicancer detection, with CRC screening representing just the first indication for shield, given it has an established regulatory and reimbursement pathway. While we are encouraged by the strong traction we are seeing for shield CRC, we are even more excited about broadening the impact of shield across multiple cancer types. Moving on to slide 22, in early January, we announced shield selection for inclusion in the National Cancer Institute's Vanguard study, which is a 24,000-patient pilot study to evaluate the use of MCD tests. As a reminder, shield was one of only two technologies selected through a highly competitive process.

This momentum continued when shield and CD received breakthrough device designation from the FDA making an important milestone for us.

Moving on to slide 21.

as a reminder, our goal has always been to detect cancer early when it's most treatable, we develop our Shield, assay as a platform

Capable of multi-cancer detection with CRC screening representing. Just the first indication for shield. Given it has an established Regulatory and reimbursement pathway.

While we are encouraged by the strong traction, we are seeing for shield CRC. We are even more excited about broadening the impact of Shield across multiple cancer types.

Moving on to slide, 22.

In early January, we announced Shield selection for inclusion in the National Cancer Institute's Vanguard study, which is a 24,000-patient pilot study to evaluate the use of NCD tests.

AmirAli Talasaz: We are pleased to share the comments of NCI Vanguard study just a few weeks ago, and we have already started delivering MCD results to physicians and their patients through this trial. The initiation of this study establishes the clinical and operational readiness for shield MCD and marks an important milestone for the shield platform. We are looking forward to broadening access to shield MCD beyond the scope of the Vanguard study in the near future. Looking ahead, shield V2 continues to be a very active program for us, and we remain confident about the potential inclusion of shield in the American Cancer Society or ACS guidelines. With that, I will now turn the call over to Mike for more detail on our financials.

As a reminder Shield was 1 of only 2 Technologies selected through a climate competitive process.

We are pleased to share the comments of NCI, Vanguard stages a few weeks ago and we have already started, delivering MCD results to Physicians and their patients through this trial.

The initiation of this study establishes, the clinical and operational Readiness for shield and CD.

And marks an important milestone for the Shield platform.

We are looking forward to broadening access to Shield and MCD beyond the scope of the Vanguard study in the near future.

Looking at Shield, V2 continues to be a very active program for us, and we remain confident about the potential inclusion of Shield in the American Cancer Society guidelines.

Michael Bell: Thanks, Amir Ali. Turning to slide 23, I'll now discuss some select financial highlights for the quarter ended June 30, 2025. I'll refer to year-over-year growth rates unless otherwise noted. Second quarter total revenue grew 31% to $232.1 million, driven by strong performance across all our key revenue lines: oncology, biopharma and data, and screening. Starting with our oncology business, oncology revenue grew 22% to $158.7 million, primarily driven by another quarter of accelerated volume growth. As a reminder, oncology volume consists of our Guardant 360 liquid and tissue therapy selection tests and our Reveal and response monitoring tests. Oncology volume grew 30% to approximately 64,000 tests in Q2, with the majority of growth driven by Guardant 360 liquid, closely followed by strong contribution from Reveal. Guardant 360 liquid year-over-year volume growth accelerated for the fourth consecutive quarter and was over 20% in Q2.

With that, I will now turn the call over to Mike for more detail on our financials.

Thanks amirali.

Turning to slide 23, I'll now discuss some select financial highlights for the quarter ended June 30th 2025.

I'll refer to Europe via growth rates, unless otherwise, noted.

Second quarter total revenue. Grew 31% to 232.1 million during by strong performance across. All our key Revenue lines oncology by farmer and data and screening.

Starting with our oncology business.

Oncology revenue grew 22% to $158.7 million, primarily driven by another quarter of accelerated volume growth.

As a reminder, oncology volume consists of our Garment 360 liquid and tissue therapy selection tests, and our Reveal and Response monitoring tests.

Oncology volume grew 30% to approximately 64,000 tests due to the majority of growth being driven by Garden 360 liquid, closely followed by a strong contribution from Reveal.

Michael Bell: Reveal year-over-year volume growth also accelerated in Q2 and continues to be our fastest growing oncology product. We also continue to see strong oncology ASPs in Q2. Guardant 360 liquid ASP was in the range of $3,000 to $3,100 in the second quarter of 2025, in line with the prior quarter. Guardant 360 tissue ASP increased to approximately $2,000 in Q2, which means that we have reached our 2028 tissue ASP target three years ahead of schedule. This has been driven by the increase in Medicare pricing from $3,140 to $3,500 at the start of the year, good progress with commercial players, and incremental reimbursement related to the recently launched tissue RNA feature. We've been very encouraged by the attachment of RNA to our Guardant 360 tissue test, and we want to highlight that we do not count tissue RNA separately from Guardant 360 tissue in our reported volumes.

Planet 360, liquid year-over-year, volume growth accelerated for fourth consecutive quarter and was over 20% in Q2.

Reveal year-over-year volume growth. Also accelerated in Q2 and continues to be our fastest growing on calls your product.

We also continue to see strong oncology aspects in Q2.

Garden 360 liquid ASP was in the range of $3,000 to $3,100 in the second quarter of 2025, in line with the prior quarter.

Garden. 360 tissue ASP increased to approximately $2,000 in Q2.

Which means that we have reached our 2028 tissue. ASP Target 3 years ahead of schedule.

Driven by the increase in Medicare pricing from $3,140 to $3,500 at the start of the year.

Good progress with commercial payers and incremental reimbursement related to the recently. Launched tissue RNA feature

We've been very encouraged by the attachment of RNA to our Garnet 360 tissue test.

Michael Bell: Reveal ASP continues to be in the range of $600 to $700 following Medicare CRC surveillance coverage earlier in the year. Out-of-period revenue was consistent with normal expected levels in Q2 and did not provide a material upside in the quarter. Finally, note that we do not include Guardant's hereditary cancer testing or IHC volumes in our reported volumes, and we expect minimal revenue contribution from these new offerings throughout 2025. Our biopharma and data business performed incredibly well again in the second quarter, with record revenue totaling $56 million, an increase of 28%. Our biopharma pipeline continues to shape up solidly, driven by Guardant Infinity and additional companion diagnostic partnerships signed in the quarter, all of which add to our confidence in both the short-term and long-term business.

And we want to highlight that we do not count tissue RNA separately from Garnet 360 tissue in our reported volumes.

Reveal ASP continues to be in the range of 600 to 700 following Medicare. CSC 7s coverage earlier in the year.

As a period, revenue was consistent with normal expected levels in Q2 and did not provide a material upside in the quarter.

Finally know that we do not include Garden, hereditary cancer testing or IHC volumes. In our reported volumes and we expect minimal Revenue contributions from these new offerings throughout 2025.

Our bio farmer and data business performed incredibly well again in the second quarter, with record revenue of $1,056 million and an increase of 28%.

Our biofarma pipeline continues to shape up, solidly driven by Gardens infinity and additional companion, diagnostic Partnerships signed in the quarter.

Michael Bell: Finally, we continue to see increasing revenue contribution from shield, with screening revenue totaling $14.8 million in Q2, generated from the 16,000 shield tests that we reported in the quarter. Turning to slide 24, we're extremely pleased to report that we're making great progress with shield non-GAAP gross margins, which increased to 48% in Q2 compared to 18% in Q1 2025 and 2% in Q4 2024. This was driven by continued improvements in both ASP and COGS. Shield ASP was over $900 in Q2, which represents a significant increase over the ASP of approximately $600 in Q1. The main drivers of ASP improvement were the increase to our Medicare rate from $920 to $1,495 following the receipt of ADLT status, which became effective on April 1, and the continued high mix of reimbursable test volume.

All of which you had to our confidence in both the short term and long term business.

Finally, we continue to see increasing revenue contribution from Shields, with screening revenue totaling $14.8 million in Q2 generated from the 16,000 Shield tests that we reported in the quarter.

Turning to slide 24.

We're extremely pleased to report that we're making great progress with Shield non-gaap gross margins, which increase the 48% in Q2 compared to 18% in q1, 2025, and 2% in Q4 2024.

This was driven by continued improvements in both ASP and COGS.

Shield ASP was over 900 in Q2, which represents a significant increase over the ASP of approximately 600 in q1.

Michael Bell: It should also be noted that the shield ASP reflects the strong reimbursement that we are receiving from Medicare Advantage payers. Equally pleasing is that shield non-GAAP CROSPR tests further reduced in Q2 and is now less than $500. Its continued improvement is driven by increased shield volume and the excellent performance of our operations team in maintaining rigorous cost controls and driving efficiency gains. Similar to last quarter, we plan to reinvest the incremental shield gross profit we generate back into the sales and marketing line to accelerate the screening commercial infrastructure build-out. We continue to be very proud of the financial profile that shield has demonstrated in such a short period of time. Turning to slide 25, our non-GAAP gross profit was $153.8 million, an increase of $47 million, or 44% year over year.

The main drivers of ASP improvement were the increase to our Medicare rate from $920 to $1,495 following the receipt of ADLT status, which became effective on April 1, and the continued high mix of reimbursable test volume.

You should also note that the shield, ASP, reflects the strong reimbursement that we are receiving from Medicare Advantage payers.

Equally pleasing: is that Shields non-GAAP Costa tests, further reducing G2 and is now less than $500?

This continued improvement is driven by increased Shield volume and the excellent performance of our operations team in maintaining rigorous cost controls and driving efficiency gains.

Similar to last quarter, we plan to reinvest the incremental Shield gross profit we generate back into the sales and marketing line to accelerate the screen and measure infrastructure build-out.

We continue to be very proud of the financial profile that she is a demonstrated in such a short period of time.

Sending to slide 25.

Michael Bell: Our non-GAAP gross margin of 66% was above our expectations in the second quarter of 2025 and was a significant improvement compared to 60% in the second quarter of '24. The improvement in gross margin is primarily a result of improved oncology ASPs, as well as the significant turnaround in gross margins for Reveal and shield, which were both gross margin negative in Q2 2024 and which are now both gross margin positive. As we noted last quarter, Reveal CROSPR test has reduced from over $1,000 in 2024 to less than $500 in 2025. Non-GAAP operating expenses were $215,3 million in the second quarter of 2025, an increase of 20% and in line with our expectations. Both non-GAAP R&D and GNA expenses in the quarter were approximately slapped compared to prior years, which reflects the operating leverage that we're achieving throughout the business.

Our non-GAAP gross profit was $153.8 million, an increase of $47 million, or 444%, year-over-year.

Growth margin of 66% was above our expectations, in the second quarter of 2025 and was a significant Improvement compared to 60% in the second quarter of 24.

The improvement in gross margin is primarily the result of improved oncology ASP as well as the significant turnaround in gross margins for revealing Shields, which were both negative in Q2 2024 and are now both gross margin positive.

As we noted, last quarter revealed that the cost per test has reduced from over $1,000 in 2024 to less than $500 in 2025.

non-gaap operating expenses were 215.3 million in the second quarter of 2025, an increase of 20% and in line with our expectations

Michael Bell: Non-GAAP sales and marketing expense increased 45% to $107.8 million in the second quarter of 2025. This increase was due to the ongoing screening commercial build-out, as well as continued investment in oncology sales and marketing. Adjusted EBITDA loss was $51.9 million for Q2 2025, an improvement of $10 million compared to a loss of $61.9 million in Q2 2024. We continue to be focused on cash management and reducing our burn in 2025 versus 2024. Q2 2025 free cash flow burn was $65.9 million compared to $99.1 million in the prior year period. We ended the quarter with approximately $735 million in cash, cash equivalent, and restricted cash.

Both non-gaap R&D and GNA expenses in the quarter were approximately slapped compared to Prior year, which reflects the operating leverage that were achieving throughout the business.

Non-GAAP sales and marketing expenses increased 45% to $107.8 million in the second quarter of 2025.

This increase was due to the ongoing screening commercial buildout, as well as continued investment, in oncology sales and marketing.

I just did a bit. I lost was 61.9 Million for Q2 20225.

An improvement of 10 million compared to a loss of 61.9 million in Q2 2024.

Up in 2025, just his 2024.

Michael Bell: Moving to slide 26 for our outlook and assumptions for the full year 2025, we're increasing our full year 2025 revenue guidance for the second time this year to be in the range of $915 to $925 million, representing growth of approximately 24% to 25% compared to 2024, and an increase of $35 million compared to our prior range of $880 to $890 million. We now expect oncology revenue to grow approximately 20% year over year in 2025 compared to our prior guidance of 18%. The increase is based on stronger than expected Guardant 360 liquid and Reveal volumes in Q2 2025, as well as higher oncology volume now projected for the remainder of the year. For the full year 2025, we now expect total oncology volume to grow greater than 27% versus our prior expectation of greater than 25%.

Q2 2025 free cash flow burn was 65.9 Million compared to 99.1 million in the prior period. We ended the quarter with approximately 735 million in cash, cash equivalents and restricted cash.

Moving to slide 26 for our Outlook and assumptions for the full year 2025.

We're increasing our full-year 2025 revenue guidance for the second time this year.

To be in the range of 915 to 925 million representing growth of approximately 24 to 25%, compared to 2024 and an increase of 35 million compared, to our prior range of 880 to 890 million.

We now expect on calls your revenue to grow approximately 20% year-over-year in 2025 compared to our prior guidance of 18%.

The increase is based on stronger than expected guidance regarding 360 liquid and Reveal volumes in Q2 2025.

As well as higher oncology volume. Now projected for the remainder of the year,

Michael Bell: We continue to expect our biopharma and data business to perform well throughout 2025 and now expect mid-teens revenue growth compared to our prior expectation of low double-digit growth. We're also raising our full year 2025 shield revenue guidance again this quarter to $55 to $60 million from our prior guidance of $40 to $45 million. This increase is largely driven by a higher volume, where we now expect 68 to 73,000 tests versus our prior guidance of 52 to 58,000 tests. Our shield revenue guidance assumes an ASP of approximately $800 for the second half of 2025, slightly lower than our Q2 ASP, as we anticipate potential changes to the mix of Medicare and commercial pay tests as we scale the business.

For the full year 2025, we now expect total on-call volume to grow greater than 27%. This is an increase from our prior expectation of greater than 25%.

We continue to expect our biofarma and Data Business, to perform welfare 2025 and now expect mid teens Revenue growth compared to our prior expectation of low double digit growth.

We're also raising our full year 2025 Shields Revenue guidance. Again this quarter to 55 to 60 million dollars from our prior guidance of 40 to 45 million

This increase is largely driven by higher volume, where we now expect 68,000 to 73,000 tests. This is our prior guidance of 52,000 to 58,000 tests.

Michael Bell: With the significant improvement to gross margins that we've generated during the first half of the year, we're raising our full year non-GAAP gross margin guidance to be in the range of 63% to 64% compared to the previous range of 62% to 63%. As we've previously outlined, we plan to reinvest any incremental screening gross profit we generate throughout the year back into the business to accelerate our commercial infrastructure build-out. As a result of improved shield volume and gross margin, we're increasing our sales and marketing efforts and now expect 2025 non-GAAP operating expenses to be in the range of $840 to $850 million, representing an 11% to 12% increase compared to 2024. We continue to expect full year non-GAAP R&D and GNA expenses to be relatively flat compared to 2024.

Our Shields Revenue guidance. As soon as an asp of approximately 800 for the second half of 2025 slightly lower than our Q2 ASP. As we anticipate potential changes to the mix of Medicare and Commercial pay tests as we scale the business,

with the significant improvements to gross margins, that we've generated during the first half of the year.

We're raising our full year non-gaap gross margin guidance. To be in the range of 63 to 64% compared to the previous range of 62 to 63%.

As we've previously outlined, we plan to reinvest any incremental screening growth profit regenerate throughout the year back into the business to accelerate our commercial infrastructure build out.

As a result of improved Shield, volume and gross margin. We're increasing our sales and marketing methods and now expect 2025 non-gaap operating expenses to be in the range of 840 to 850 million representing an 11 to 12% increase compared to 2024,

Michael Bell: Lastly, our commitment to cash flow reduction each year in order to reach company-wide cash flow break even in 2028 is unchanged. For full year 2025, we still expect free cash flow burn to be in the range of $225 to $235 million, an improvement compared to $275 million for 2024. We continue to expect our cash burn in 2025 to consist of approximately $200 million related to screening as we scale our shield business and maximize our first mover advantage. Significantly, excluding screening, we continue to expect the remainder of the business to burn approximately $25 to $35 million during the year and to reach free cash flow break even in the fourth quarter of 2025.

We can seemingly expect full-year non-GAAP R&D and G&A expenses to be relatively flat compared to 2024.

Lastly, our commitment to cash burn reduction each year in order to reach companywide cash flow break-even, even in 2028, is unchanged.

For full year 2025, we still expect free cash flow burn between the range of 225 to 235 million and Improvement compared to 275 million for 2024.

We continue to expect our cash burn in 2025 to consist of approximately $200 million related to screening, as we scale our Shield business and maximize our first-mover advantage.

Significantly excluding screening. We continue to expect the remainder of the business to burn approximately, 25 to 35 million dollars during the year.

Michael Bell: Moving on to slide 27, at the start of the year, we outlined an ambitious pipeline of catalysts, and it's a testament to our team's strong execution that we've delivered on nearly all of them just halfway through the year. And finally, turning to slide 28, we'll be hosting an Investor Day on Wednesday, September the 24th, in New York City. We look forward to sharing a deeper dive across our business. Please reach out to investors@guardanthealth.com for more information. With that, we'll now open the call to questions.

And to reach free cash, flow break even in the fourth quarter of 2025.

Moving on to slide 27.

At the start of the year, we outlined an ambitious pipeline of catalysts and it's a testament to our team's strong execution that we've delivered on nearly all of them. Just halfway through the year.

And finally, turning to slide 28.

Will be hosting an investor day on Wednesday. September. The 24th in New York City.

We look forward to sharing a deeper dive across our business.

Please reach out to investors at GuardantHealth.com for more information. We'll now open the call to questions.

Jay Son: If you would like to ask a question, please press star followed by one on your telephone keypad. We are limiting questions to just one question per person. Our first question is from Mark Lazzaro from BTIG. Your line is now open.

If you would like to ask a question, please press star, followed by 1 on your telephone keypad.

Oh, we are limiting questions to just one question per person.

Our first question is from Mark Masaro from BTIG. Your line is now open.

Mark Massaro: Hey, guys. Congratulations on the strong beaten raise. Helmy, the first one's for you. You know, clearly you guys are doing a really great job in G360 liquid, and you've raised the volume guidance for the year. You talked about Serena VI, and what I'm curious about is, did you see any benefit from the New England Journal publication, perhaps in Q2? And can you give us a sense for the likelihood that you can continue to drive the interval of testing in 360 in breast cancer?

Help me the first 1's for you. Um, you know, clearly, you guys are doing a really great job in g360. Liquid and you've raised the volume guidance for the year. Uh, you talked, about Serena, 6, and I'm what I'm curious about is, did you see any benefit from the New England Journal? Publication, perhaps in Q2 and can you give us a sense for, uh, the likelihood that you can continue to drive? Uh, the the interval of testing in in 3606 in 360 in breast cancer?

Helmy Eltoukhy: Yeah, no, thanks for the question. Yeah, we're happy with the quarter, obviously, and you know, happy with the performance of our core business. I think, as we've said, you know, this quarter we saw something like over 20% growth for G360, which is just fantastic, you know, to see this kind of growth, you know, a product that has been in the market for so long. And I think what we're seeing right now is really, I think, a testament to, you know, the product market fit we've achieved with our Infinity smart liquid biopsy platform. And I think there's a lot more juice to squeeze. You know, if there was Serena VI impact, it was very minimal. This quarter, we think we see the majority of that, you know, once and if the drug is finally approved.

Yeah, no. Thanks for the question. Yeah. Happy with the quarter obviously and, um, you know, happy with the performance of our Core Business. Uh, I think, as we've said, you know, this this quarter, we saw something like, you know, over 20% growth for G36 to you, which is just fantastic. Uh, you know, to see this kind of growth

No product, that's been in the market for so long. And I think, um, what we're seeing right now is really, I think a testament

Helmy Eltoukhy: And we obviously are very excited about that in terms of the potential for adding significantly more testing opportunities to the liquid biopsy space. But I think this is really, I think, you know, shows kind of, you know, how big the CGP liquid biopsy market is. I think we're still in the early innings of converting users to essentially just one test or to their first test from a liquid biopsy space. But we have so much room to run, I think, so many years of growth ahead of us as we start getting this sort of monitoring paradigm really, you know, kind of fully realized by the market.

To, um, you know, the product Market fit, we've achieved with our Infinity smart, liquid biopsy platform and I think I think there's a lot more juice to squeeze. I don't you know if there was Serena 6 impact, it was very minimal this quarter. We think we see the majority of that uh you know once and if the the drug is is finally approved and we um obviously have a very excited about that in terms of the potential um for adding uh sign.

Significantly more testing opportunities to the liquid spice liquid biopsy space. But I think this is really, I think um, you know, shows kind of, you know, how big the cgp liquid biopsy Market is. Um, I think we're still in the early Innings of converting users, to essentially, just 1 test or to the first test from a liquid biopsy space, but we have so much room to run. Uh, I think so many years of growth, uh, ahead of us as we start getting this sort of monitoring Paradigm. Really, uh, uh,

You know, kind of fully uh, realized by the market.

Jay Son: Our next question is from Kunne Soto with WeRank. Your line is now open.

Mark Massaro: Yeah, hi, guys. Thanks for the questions here, and congrats on a really strong quarter. If you don't mind, I'll try to squeeze my questions into one. First, shield growth is obviously very impressive. Can you talk a little bit about what's driving that, primarily PCPs among the PCP practices? Is it NCCN? Is it the ramp in the sales force? And wondering if you can give, you know, sort of an ASP number. It seems to be higher than the 800 that you had projected. So wondering where that's going to land. And around shield, if I may also ask, shield V2 is a big focus for investors. We were hoping for data by now. Any updates on that data? And I'll pause there. I have more questions, but I'll follow up with Helmy later.

Our next question is from who needs soda? Because we drink your, your line is now open.

Yeah, hi guys. Um, thanks for the questions here and, um, congrats on a really strong quarter. Um, uh, if you don't mind, I'll try to squeeze my questions into 1. Um, uh, first shield growth is, um, obviously very impressive, can you talk a little bit about what's driving that amaril a pcps? Among the PCB practices that is? Is it nccn, is it the ramp in the, in the sales force? Um, and wondering if you can give, um, you know, the sort of an asp number, it seems to be higher than the 800 that you had projected. Uh, so wondering where where that's going to land and um, around

Shield if I may also ask um Shield V2 is a big Focus for investors. Um we were hoping for a data by now any updates on that data and I'll pause there I have more questions but um um I'll follow up with tell me later.

AmirAli Talasaz: Okay, thanks very much for good questions. So, you know, we are very excited with the shield commercial performance. You know, we are continuing to see a very strong pull by market. You know, when physicians are becoming aware of this test and they're getting access to this test as we are scaling up our footprint in that field in terms of reps, we are seeing a very strong demand. And I think this beaten raise is really an endorsement of a higher productivity that we are seeing in this newly formed sales team that we have kind of assembled. And we are very excited about it and looking forward to see what we can do in the second half of the year. Maybe I go to shield V2 and then I give it to Mike to talk about ASP.

Okay, thanks. Alright for good questions. So, uh, you know, we are very excited with the shield commercial performance, you know, we are continuing to see a very strong tool by market, you know, when Physicians are becoming aware of this test.

And they're getting access to this test as we are scaling up our um, footprint in the field. In terms of reps,

Uh, we are seeing a very strong demand and I think this beat and raise is really uh, an endorsement of a higher productivity that we are seeing in this newly formed sales team that we have kind of a sandal and we are very excited about it. I'm looking forward to seeing what we can do in second half of the year.

AmirAli Talasaz: You know, as I mentioned in the prepared remark, V2 is a very active program for us. A lot of work has gone into it and still it's ongoing, and we'll see what happens.

Maybe I go to Shield V2 and then I give it to Mike to talk about ASV. Yeah. As I mentioned the uh prep program, marked me to is a very active program for us. A lot of work has gone into it and still it's ongoing and uh, we'll see what happens.

Michael Bell: Yeah, and yes, I can add on the ASP side we saw a really good uplift in shield ASP in the quarter. We went from in Q1, ASP was just over $600, and in Q2 that increased to over $900. And the main driver there obviously was that the ADLT status became effective on the 1st of April, so our Medicare rate increased from $920 to $1,495. And you know, we're also seeing very strong Medicare Advantage reimbursement that's coming through now from pretty much all of the payers. And so that's helping to really stabilize that ASP. I think when we look at the back half of the year and we said it in the prepared remarks, you know, we'd expect our ASP for the next six months to be around $800. And so that would be slightly lower than Q2. And really, that's a function of the mix.

Like yeah. And uh, uh yes. I I can add on the, on the ASP. So we saw a really good uplift in Shield. ASP in the quarter, we went from in q1.

Michael Bell: As we continue to scale, we think we'll see more of the mix move from Medicare and Medicare Advantage onto commercial. So we're just allowing for that over the next six months. But yeah, I think the ASP story on shield has been really positive for us this quarter.

Uh, very strong Medicare Advantage reimbursement, that that's coming through. Now from pretty much all of the payers. And so that's helping to, to Really stabilize that that ASP. I think, when we look at the, the back half of the of the year and we said it in the prepared remarks, you know, we'd expect our ASP for the next 6 months to be around 800 and so, that would be a slightly lower than Q2 and really, that's a function of of the mix. Um, as we as we continue to scale, we think we'll see more of the mix. Um, move from Medicare Medicare.

We just allowing for that, uh, over the next 6 months. But yeah, I think, uh, ASP story on on Shield has been really positive for us to squat.

Jay Son: Our next question is from Dan Brennan with TD Cowan. Her line is now open.

Our next question is from Dan, Brennan with TD coward. Caroline is now

Dan Brennan: Great, thank you. Thanks for the question. Maybe just one on G360 since doing so well and it's your biggest business. Just could you give a little color in terms of kind of where the growth is coming from? Do you feel that you know you're seeing better penetration maybe locally or big AMCs? Do you feel like it's more just penetration in the existing market, or do you feel like maybe you're taking share? And then, you know, the other factor is, you know, Helmy, you discussed a lot of the benefits of smart liquid biopsy in terms of the performance. Is that resonating at the oncologist level? Is that really a sale into the hospital administrator? Just trying to unpack a little bit your growth versus maybe the other players in the broader market. Thank you.

Great, thank you. Uh, thanks for the question. Maybe just 1 on 2360 since

Doing so well, that's your biggest business. Just, um, could you give a little color uh, in terms of kind of where the growth is coming from?

you feel that um, you know, you're seeing better penetration maybe locally or big AMC's

Do you feel like it's more just penetration of the existing Market, or do you feel like maybe you're taking share? And then, um, you know, the other factor is you know how many you discuss a lot of the benefits of smart liquid biopsy. Um, in terms of the performance, um, is that resonating at the oncologist level? Is that really a sail into the hospital administrator just trying to just trying to unpack a little bit, your growth versus maybe the other players and the broader Market. Thank you.

Helmy Eltoukhy: Yeah, no, that's a great question. When we dissect the numbers, it really is a broad-based growth. We're seeing more oncologists than ever before ordering every single month. So that continues to grow pretty dramatically over the last few quarters since we launched a smart liquid biopsy. We're seeing higher depth. So in those same accounts, we're seeing a much higher average of a number of 360 tests per month. And so that's really exciting. So we know that is coming from just the increased utilization of the tests. We're growing the sort of market and use cases of liquid biopsy, but also significant share gains as well, which is great to see. And I think, as I alluded to before, we have a test that truly has achieved much greater product-market fit than anything out there.

Yeah, no, that's a great question. Um, when we, when we dice set the the numbers, um, it really is a broad-based growth. We're seeing, um, more oncologists, um, than ever before ordering every single month, so that continues to grow, um, pretty dramatically over the last, um, few quarters since we launched a smart little biopsy. Um, we're seeing higher depths so in those same accounts, um, we're seeing a much higher average of number of 360 tests per month,

Um, and so, that's really exciting. So we know that is coming from just the increased utilization of the tests, we're growing, uh, you know, the sort of market and use cases of liquid biopsy. Um, but also, um, you know, significant share gains as well which is, which is great to see. And I think as I alluded to before,

Helmy Eltoukhy: And when I talk about these features, these features are really resonating at the oncologist level. I was at ASCO. I can tell you that many of the key opinion leaders we work with, many academic center oncologists are really, really excited about these features. But these features resonate at the community level as well. The fact that we can do what sometimes tissue can't, the fact that we can see how the tumor is evolving, a subtype of it, which has serious implications in terms of treatment decisions. We can see those patients who maybe may qualify for certain drugs that many other tests out there can, from immunotherapies to PARP inhibitors. And this is just the beginning in terms of what we're able to do.

Um, we have a test that that truly has achieved, um, much greater product Market fit than anything, uh, out there. And, and when we talk about these features, these features uh, are really resonating in the oncologist level there. I was at ASCO, um, I can tell you that, um, you know, many of the key opinion leaders, we work with many academic. Uh, syndrome colleges are

Helmy Eltoukhy: I can tell you the pipeline we have of new applications and new apps that we're going to launch over the coming quarters is probably even more exciting than what we've launched today. So there's many things I think, if I told you we could do three years ago, most oncologists, most scientists would have said it's science fiction. And that is really, I think, the power of this platform in terms of what we can do. And you're starting to see it in the numbers on both the biopharma side and now the clinical side.

really, really excited about these features. But these features resonate, um, at the community level as well. The the fact that we can do what sometimes tissue, um, can, um, the fact that we can see, you know, how the tumor is evolving from a subtype, what a view which has um, serious implications in terms of treatment decisions, we can see, uh, those patients who, um, maybe uh may qualify for certain drugs that many other tests out there can from amother to um, parp Inhibitors. Um, and and this is just the beginning, in terms of what we're able to do. I can tell you the, the pipeline we have of um, new applications and new apps that we're going to launch over the coming quarters, um, is probably even more exciting than what we've launched today. So there's many, many things, I think, as I told you we could do 3 years ago. Um, most oncologists most scientists would have said is science fiction and and that is

Is really I think, um, that the power of this platform in terms of what they can do, um, and it's and and you're, you're starting to see the numbers on both the bio Pharma side. And now the clinical side,

Jay Son: Our next question is from Taichou Peterson with Jeffries. Your line is now open.

Dan Brennan: Hey, thanks. On shield, you know, congrats on the Vanguard enrollment. I'm just wondering if you can walk through kind of next steps to getting shield marketed as an M-SED test. Do you have to wait for data from the ongoing lung study or an interim Vanguard readout? How do you feel about inducement concerns? That seems to be a bit of a debate in the investment community. And then, can you maybe just talk to your view on the risk around USPSTF? Obviously, you know, if the whole panel gets replaced, that could throw a monkey wrench in things. Thanks.

Our next question is from taicho Peterson. What's your first your line is now

Hey, thanks. Um, on Shield, you know, congrats on the Vanguard enrollment. I just wondering if you can walk through kind of next steps to getting Shield marketed, you know, as a maid test. Do you have to wait for data from the ongoing Lung Study or an interim Vanguard readout? Um, how do you feel about inducement concerns that seem to be a bit of a debate in the investment community? And then can you maybe just talk to your view on the risk around USPSTF? Obviously, you know, if the whole panel gets replaced, that could throw a monkey wrench in things. Thanks.

AmirAli Talasaz: Yeah, so technically, we are very excited with this progress we had on the R&D side. Now, M-SED is clinically validated. Since it's clinically validated, we are not waiting for any other tests for tests to be a clinical grade test. We spent some energy and effort to make it operationally ready for patient testing. And you know, now that we have started the Vanguard study, you know, labs are running these samples. We are reporting out these clinical reports for patient management within the Vanguard. So from those aspects, we are actually ready. It's not that we are waiting for any kind of pivotal study readout to come before we take any action on broadening access for shield M-SED. As I mentioned in the prepared remark, hopefully, we can have some conversation about it in the near future. And stay tuned about it.

Now and said is clinically validated. So it's clinically validated, we are not waiting for any other tests for tests to be a clinical grade test. Its we spend some energy and effort to make you the operationally ready for patient testing.

And you know, now that we are started the Vanguard study you know lab or running these samples, we are reporting out these clinical reports for patient management within the Vanguard. Uh so from those aspects we are actually uh ready. It's not that we are waiting for any kind of pivotal study, read out to come before we take any action on broadening access for shield mset.

As I mentioned in the preferred remark, uh, hopefully we can have some conversation about it in the near future.

AmirAli Talasaz: In terms of some of the, I think, the matters you mentioned, we are very aware of the laws. We are here to help the patients. Never we are going to do something which is against the laws. And I think the way I read about it is the tremendous opportunity that we have with shield that excites us. I think just over time would increase. USPSTF, very quickly, we are monitoring the situation very closely. Yes, it looks like the whole panel appears to be getting to the process to get replaced.

And stay tuned about it in terms of some of the, I think, the matters. You mentioned we are very aware of the laws. We are here to help the patients.

Whenever we are going to do something that is against the laws.

and uh,

I think.

The way I read about it is the tremendous opportunities that we have with shields that excites us. I think, just over time would increase us CFC have very quickly, we are monitoring the situation very closely.

AmirAli Talasaz: It looks like since that we had with our shield in the market right now with a very healthy gross margin and a very big green field, which is in front of us, we had a lot of actually opportunity in front of us to mine, build this business while we are waiting for task force guideline inclusion.

Uh yes, looks like the whole panel appears to be to get into the process to get replaced.

Uh, the good success that we had with our shield in the market right now, with a very healthy gross margin and it's very big green field which is in front of us. We have a lot of actually opportunity in front of us to mine.

Built this business while we are waiting for tasos. Task force, guideline inclusion.

Jay Son: Our next question is from Subhu Nambi with Google. Your line is now open.

Our next question is from tugu, Konami with good time. Your line is now open.

Rachel Vatnsdal: Hey, guys. Thank you for taking my question. You had recently said that Reveal was at approximately 1.7 tests per patient. How much do you expect the CRC surveillance reimbursement to drive this number upwards in the near term in 2026? And then in the long run, what do you think this number could look like? And I noticed in the Kafka slide, you don't have Reveal ADLT listed. I don't think that was on the slide before, but I'm curious if you have any updates there. Thank you.

Helmy Eltoukhy: Yeah, no, good questions. You know, we're already seeing it drive higher with some of the progress we've made. We're seeing not only great traction, as we've said, Reveal is our fastest growing product on the oncology side. We're the only second to shield across the company. And so we're really excited about the progress we've made. We're seeing acceleration there. Really good traction with new patient starts, but even more so with subsequent draws to where we hadn't been pushing quite as much. Now that we've turned a lot of that machinery on, really sort of been exciting to see how much we can start to lean into that and really drive that volume. So yeah, I mean, I think the next few quarters and certainly into '26, we have high expectations for Reveal.

Hey guys, thank you for taking my question. Um, you had recently said that reveal was at approximately 1.7 tests for patient. How much do you expect the CRC surveillance reimbursement to drive this number upwards in the near term in 2026? Um, and then in the long run, what do you think? This number could look like and I noticed in the Catalyst slide you don't have reveal adlt listed. I don't think that was on the slide before but I'm curious, if you have any updates there, thank you.

Yeah, no good questions. Um, you know, we're already seeing a, a drive drive higher, um, with some of the progress we've made, we've seen not only a great traction, as we've said, reveal as our fastest growing product comes oncology side, um, for the only second to the shields across the company.

And uh, so we're, we're really excited about the progress we've made. We're seeing acceleration there. Um, really good traction with new patient starts, but even more. So with a subsequent, uh, drawers, which is, you know, where we hadn't been pushing quite as much, but

now that we've turned a lot of of that Machinery on um a really, you know, really uh sort of a

Helmy Eltoukhy: And we can certainly get that number, I think, up significantly in terms of the number of tests per patient. In terms of ADLT, you know, that was never on the milestone chart there, but it's certainly something we've submitted for, and we are waiting for a decision, basically. Hopefully, over the next quarter or so, we'll know the resolution. I think we're, you know, I think we're very positive. We know that, you know, the test qualifies for ADLT, so hopefully, it'll come back as a positive.

It's been exciting to see how much we can start to lean into that and, and really, uh, drive that that volume. So yeah, I mean I think uh, next few quarters and certainly into into 26. We um, have high expectations uh, for um reveals and uh we can certainly get that number I think up significantly and try.

A number of tests for patients.

In terms of adlt um, you know, that was never on the Milestone chart there. Um, but it's certainly something we've submitted for and

Uh, we are waiting for a decision basically, hopefully over the next quarter or so it will will know the resolution. I think we're, you know, I think we're, uh, very positive. We, we know that, you know, the test, qualifies for adlt so, um, you know, hopefully it'll come back as a budget.

Jay Son: Our next question is from Kyle Mixon with Canaccord. Your line is now open.

Mark Massaro: Hey, guys. Thanks for the questions. Congrats on a great quarter. Helmy, you know, why are you confident that Reveal Medicare reimbursement for breast is going to be obtained faster than CRC, including surveillance for colon, that took a while? And then second, for Amir Ali, you know, NTCA inclusion was nice, but is that having an impact on shield volumes, or do we need ACS and USPSTF? And then on the point of USPSTF from earlier, you know, if the panel's replaced with people that, you know, clinicians don't really trust, is this going to make that milestone for you guys maybe less important? Thanks.

Our next question is from Kyle. Mixon with canaccord, your line is now open.

Hey guys, thanks for the questions. Congrats on the great quarter. Um, help me, you know why you confident that reveal Medicare reimbursement for breast is going to be obtained faster than TRC including surveillance that you know for colon that took a while and then second for a merely, um, you know, entity and inclusion was nice but is not having an impact on Shield volumes or do we need ACS and us csts. And then on the on the point of USPS to have from earlier, you know we have the panels replaced with people that you know Clinic clinicians don't really trust. Is this going to make that milestone for you guys? It's maybe less important. Thanks.

Helmy Eltoukhy: I love the questions. In terms of Reveal Medicare coverage, you know, the second time we got for CRC surveillance was actually pretty quick. I think it was just, you know, I think something like four or five months, which, you know, as fast as it really comes from submission to sort of coverage. So yeah, I mean, obviously, the first time we went through the process, it took a little bit longer. The second time, much, much faster. So I think we have a better sense for what is required from a Medicare point of view. Obviously, it's always up to their discretion in terms of what passes the bar or not. But clearly, having gone through the process multiple times now, we have a better sense of what is required. And so yeah, we have pretty high confidence around breast.

Helmy Eltoukhy: We have good confidence around IO in terms of, you know, when we finally submit that to MOLDIX. And we're making good progress in other cohorts as well with the Reveals. And so it's an exciting pipeline for us.

To reveal Medicare coverage. Um, you know, for the the second time we got for CRC surveillance was actually pretty quick. I think it was just, you know, I think something like 4 or 5, you know, months which you know as fast as it really comes and from a submission to, um, to sort of coverage. So yeah, I mean, obviously, the the first time we, we went through the process, it took a little bit longer a second time much much faster. So I think, uh, we have a better sense for what is required from a Medicare point of view. Um, obviously it's always up to their discretion in terms of what passes the bar or not. But, um, clearly having gone through the process multiple times. Now, um, we have a better sense of what is required. And so, yeah, we, we have pretty high confidence around fresh. We have a good confidence around IO. Um, in terms of, you know, when we finally submit

To to, to mold the accent and we're making good progress on other cohorts as well, um, with the reveals. And so it's an exciting pipeline for us.

AmirAli Talasaz: Regarding NCCN guideline, you know, definitely, it was a surprise great milestone for us. You know, how much of it is impacting our volume, like within this very strong ramp that we are experiencing, it's very hard for us to kind of, you know, mark out the impact of each one of these kind of catalysts for us. But NCCN, again, it's the voice of expert oncologists at the end. So we are very excited with it. And we are also continuing to be very confident about inclusion by other guidelines, including ACS and USPSTF. I think some of this stuff is just common sense. You detect almost all stage II and above CRCs. You can cure or have very long-term survival even if you detect CRC at stage II. You want patients to be unscreened and, you know, do not detect their cancer.

Regarding and see Sam guideline, you know. Definitely it was a, a surprise great milestone for us. You know, how much of it is impacting our volume. Like, within this very strong ramps that we are experiencing, it's very hard for us to kind of, you know, um,

AmirAli Talasaz: I think some of this stuff is just common sense. But over time, we are going to figure it out. And we were very confident, and we remain very confident about guideline inclusion.

Our house, the impact of each 1 of these kind of catalyst for us. But I'm saying again, it's the voice of expert oncologist at the end. So, um, we are very excited with it and uh, are also continue to be very confident about inclusion by other guidelines, including ACS and USPS. Yes, I think some of these stuff is just common sense, you detect, almost all stage 2 and above crc's. You can cure or have very long-term survival, even if you detect CRC at stage 2, b, 1 patient to be on the screen. And, you know, uh, do not detect their cancer. I think some of these stuff is just common sense, but over time we are going to figure it out. But and we what we were very confident and we remain very confident about guideline inclusion.

Jay Son: Our next question is from Dan Arias with Steve Hoff. Your line is now open.

Our next question is from Dan Arias with C4. Your line is now open.

Mark Massaro: And guys, thank you. Amir Ali, you were sufficiently vague on that answer to V2 data timing. Is everything squared away on your end, and it's just a matter of when you decide to pull back the curtain on the results, or are there still things that are being worked on there? Sorry to ask again, but hot topic to say the least.

And guys, thank you. I'm nearly, you were sufficiently vague on that. Answer to V2 data timing is is is everything squared away on your end and it's just a matter of when you decide to pull back the curtain on the results or they're still things that are being worked on their,

AmirAli Talasaz: No problem. I understand. So you're not putting a fine point on the exact timing of the V2 data. But you know, as I mentioned, it's a very active program. A lot of work has gone into it. A lot of work is going into it as we speak. And we'll see. Like, you know, on the other side, we do not feel rushed to get to this. And some of it is really because of commercial success we are seeing by the currently approved product, the V1. It gives us the opportunity to balance some of our R&D initiatives. Like, you know, we pulled forward this M-SET clinical validation, bringing the lab and operation up for patient reporting, which can open up opportunities for us in the near future down the road. And we'll see when we can wrap up this V2. Still, we are working on it.

Sorry to ask again, but Hot Topic to say the least.

No problem. I understand. So uh, we are not putting a fine point on the exact timing of the V2 data, but you know, as I mentioned it's it's very active program. A lot of work has gone into it. It's a lot of work is going into it as we speak.

And, uh, we'll see like, uh, you know, on the other side. We do not feel rushed to get to this and solve it. It is really because of Commerce, like this we are seeing to be by the currently approved products. The V1 gives us the opportunity to balance some of our R&D initiatives. Like, you know, we pulled forward this amset clinical validation, bringing the lab and operation up for patient reporting, which can open up opportunities for us in the near future down the road. And, um, we'll see when we can wrap up this week, too. Still, we are working on it.

Jay Son: Our next question is from Patrick Donnelly with Sydney. Your line is now open.

Our next question is from Patrick Donnelly with City Line is now open.

Dan Brennan: Hey, guys. Thanks for taking the question. Maybe one just on the profitability side. You know, nice to see the gross margins continue to creep higher with the profitability side. You know, as you guys have advertised, the last couple of quarters is going to continue to invest that on the sales and marketing side. I mean, Mike, does that speak to just your confidence in the path to real profitability here in the out years? You know, the fact that you are willing to continue to reinvest rather than chase near-term profitability. Can you just talk about the confidence in the balance sheet and, again, that path to profitability as you reinvest some of these profit dollars? Thanks.

Hey guys, thanks for taking the questions. Um maybe you want to do some of the profitability side you know nice to see the gross margins continue to creep higher with with the profitability side. You know as you guys have advertised the last couple quarters going to continue to invest that on the sales and marketing side. I mean Mike does that speak to to your confidence?

In in the path, to real profitability here in in the out years, you know, the fact that you are willing to continue to reinvest rather than Chase near-term profitability. Can you just talk about the confidence and the balance sheet? And again that passed the profitability as you as you reinvest some of these uh profit dollars? Thanks.

Michael Bell: Yeah, Patrick. I mean, I think at a high level, you know, at our last Investor Day, two years ago, we set this path to profitability of 2028. And we said from then 2023, you know, we would be reducing our cash burn every year. And so, you know, so far, we're well on track, well on track with that. Things are going very well. And we remain very confident that we can get to break even in 2028. On the screening side, you know, we sort of repeatedly said over the next couple of years, we'll manage the burn to something like $200 million. And we'll be very thoughtful about reinvesting any additional gross profit back into the sales and margin line. And I think we're ahead of track bar, gross profit very strongly in Q1 and Q2. It's 48% gross margins.

um yeah Patrick I mean I think I think at a high level

Must invest today. Uh,

2 years ago, we set this path to

Uh, of 2028. And we said from from then 2023, you know, we would be reducing our cash burn every year. And so, uh, you know, so far we're we're well on track. We're on track with that things are going, things are going very well.

Michael Bell: And so we're reinvesting that, but that's not increasing our overall burn of the target that we set at the start of the year. And so I think we're managing that very well. And it's giving us this 200 million burn. It's giving us everything that we need to really scale that commercial infrastructure as quickly as we can. And if you exclude screening, actually, we're making fantastic progress. You know, we said earlier on in the year that excluding screening, the rest of the business is on track to be break even before the end of the year. And that's still the case. And I think, you know, with the traction that we continue to see on ASPs, better than expected gross margins, we feel really confident on that.

To, uh, to break even uh, in 2028 on the, on the screening side, you know? Um, we sort of repeatedly said over the next couple of years. We, we'll manage the burn to something like 200 million dollars and we'll be very thoughtful about reinvesting. The, any additional gross profit back into the sales and marketing line. And I think we're we're ahead of track bar of gross profit very strongly in queue and Q2 it's 48%, gross margins. And so we're reinvesting that. But that's not increasing our overall burn of the Target that we set at the start of the year. And so I think we're managing that very well and it's giving us

Michael Bell: So I think from a balance sheet perspective, path to profitability, yeah, we're still confident and on track to what we stated in the past.

Uh, this 200 million burn is giving us, you know, everything that we need to really scale that commercial infrastructure as as as quickly as we can, and if you exclude screening actually, we're making fantastic progress. You know, we said earlier on, in the year that excluding screening, the rest of the business is on track to be, um, break even before the end of the year. And, uh, and that's still the case. And I think, you know, with the traction that we continue to see on asps, uh, better than expected, gross, margins. We feel really confident on that. So, I think from a, from a balance sheet perspective,

After profitability. Um, yeah, we're, we're still confident and on track to what we stated in the past.

Jay Son: Our next question is from Rachel Bedstall with JPMorgan. Your line is now open.

Our next question is from Rachel badawest with JP Morgan?

Rachel Vatnsdal: Perfect. Good afternoon. Thanks so much for taking the questions. I wanted to press on shield V2 a little bit more, but more so around the timelines associated with it. So you previously had talked about hoping to get that launched by year-end, not really committing to timelines in terms of when we'll see that data. But just given we don't have it yet, can you walk us through your updated assumptions on how long do you think it will take for FDA to review once they do have the data? And are you still on track to launch that by year-end at this point?

Airlines. No perfect. Good afternoon.

Good afternoon. Thanks so much for taking the questions. I wanted to press on Shield V2 a little bit more but more so around the timelines associated with it. So you previously had talked about hoping to get that launched by year, end. Not really committing to timelines in terms of when we'll see that data but just giving we don't have it yet. Can you walk us through your updated assumptions on? How long do you think it will take for FDA to review? Once they do have the data? And are you still on track to launch that by year end at this point?

AmirAli Talasaz: Yeah, so I'm not sure how much I can add. But in terms of, yeah, the timelines for FDA approval and launch, obviously, it's a function of when we get to the readout and how long it would take FDA to review our package. So we're pleased with a bunch of conversations we had with the agency in terms of what they're going to look at and how they're going to look at now, how long it's going to take to go through that review process. We have to see how long their process would take. But yeah, but maybe in terms of end of the year, maybe that's fair. Maybe we are delayed a little bit. But you know, as I mentioned, I don't feel rushed to get to that milestone.

Yeah. So I'm not sure how much I I can. Um, add. But in terms of, yeah, the timelines for FDA approval and launch. Obviously, it's a function of, uh, when we get to the readout and how long it would take FDA to review our package. So, if pleased with bunch of conversations, we had with agency in terms of what, um,

Erica Lukat: How dare I look at now? How long is it going to take to go through that review process? We have to see how long their process would take. Um,

AmirAli Talasaz: And you know, it was important for us to balance some of our R&D activities between V2 and M-SET. And I'm very pleased with where we are today. And we are working on it very extensively. A lot of work is happening. So, but maybe it's a little bit delayed. Yeah.

But yeah, but maybe in terms of end of the year maybe that's fair, maybe we are delayed a little bit but you know, as I mentioned I I don't feel rushed to get to that Milestone. And you know, it was important for us to balance some of our R&D activities between V2 and mset. And I'm very pleased with where we are today and we are working on it very, uh,

Extensively a lot of work is happening. So, but maybe it's a little bit delayed. Yeah.

Jay Son: Our next question is from Eve Bernstein with Bernstein Research. Her line is now open.

Our next question is from Eve Bernstein with Bernstein research.

The line is to help.

Rachel Vatnsdal: Great. Thanks so much for taking the questions. A couple on shield. So now that shield has had ADLT status for four months, you're through a chunk of the time that you have to get private payers to contract with you. So first, can you give us some color on how those conversations are progressing? I imagine that many private payers don't want to reimburse a test that won't get them quality credit yet. So how are you handling that? Second, do you expect to contract with private payers at or close to the ADLT rate? Or is the 920 rate more reasonable, or do you expect it to be below that? And then third, you've given us a guide to ASP of $800 bucks for the rest of the year. But how should we think about what happens to ASP next year?

Great. Thanks so much for taking the questions. Um,

Uh a couple on Shield. So now that Shield has had adlp status for 4 months here, through a chunk of the time that you have to get private payers to contract with you. Um so first can you give us some color on how those conversations are progressing? I imagine that many private payers. Don't want to reimburse the tests that won't get them quality credit yet. So how are you handling that? Um, second, do you expect a contract with private payers at or close to the adlt rate or is the, you know,

20 rate more reasonable, or do you expect it to be below that?

Rachel Vatnsdal: Could it actually decrease pretty meaningfully as that rate resets and as the payer mix shifts up a bit?

And then third, uh, you've given us a guide to ASP of 800 bucks for the rest of the year. But how should we think about what happens to ASP next year? Could it actually decrease pretty meaningfully as that rate, resets? And as the payer mix shifts up a bit,

AmirAli Talasaz: Yes, in terms of conversation with private payers, we've been in touch with them. And you know, even after NCCN guidelines, we've been in touch with the fraction of commercial payers that we think maybe they would be early adopters. We'll see what happens. We are not counting on any major coverage before getting into ACS and USPSTF guidelines. So we'll see how it goes. In terms of expectation for ADLT rate, based on the collections that we are having from Medicare Advantage, we are very confident of keeping our ADLT as what it is today as we go to the next reporting cycle, which is going to start from January of '26 till December of '27. So that $1,495, we are very confident it would remain the same. In terms of ASP, I think it's going to be a function of the payer mix.

That's in terms of conversation with private payers. We've been in touch with them, and you know, even after NCCN guidelines, we've been in touch with the fraction of commercial peers that we think maybe they would be early adopters. We'll see what happens. We are not counting on any major coverage before getting into ACS and USPS guidelines, so we'll see how it goes.

We are very confident in keeping our ADLT as what it is today as we go to the next reporting cycle, which is going to start from January of 2016 until December of 2017.

So that 1495.

We are very confident, it would remain the same.

AmirAli Talasaz: I think still we are in the early innings of this commercial execution. We are pleased with how the payer mix is landing at this time, but we are going to monitor it. And then we would set expectations for ASP as we get closer to 2026.

In terms of ASB, I think it's going to be a function of the payer mix. I think still, we are in the early Innings of this commercial execution. We are pleased with how the payer mixes landing at this time. But we are going to monitor it and then we would set expectation for ASP. As we get closer to 2026

Jay Son: Our next question is from Bill Bonello with Craig Hellum. Your line is now open.

Mark Massaro: Hey, guys. Thanks a lot for taking the question. I guess this one is for Helmy, maybe more big picture. You know, thinking about the traction that you've gotten with Guardant 360 liquid and the paradigm shift from years ago, sort of tissue first to the big ramp you've had and the evolution towards people being willing to consider liquid first or looking at doing both. I'm just kind of curious how you might extrapolate that experience to Reveal and sort of this notion that seems to be out there that, gosh, you know, there's some superiority to tumor-informed. And you know, tissue or tumor naive is fine if you can't get a tissue, but you know, otherwise, you want to do tumor-informed. You know, could you see sort of a similar evolution?

Our next question is from bill bonello with Craig, hello. Your line is now open.

Hey guys, thanks a lot for taking the question I guess this 1 is is for helming. Um maybe more big picture. Um

You're thinking about the traction that you've gotten, uh, with, you know, Garden 360 liquid. Uh, and the, you know, paradigm shift from, you know, years ago, uh, sort of tissue for us to you know the big ramp you've had and the evolution towards people being you know, willing to consider liquid burst or

Mark Massaro: Are you hearing anything from physicians, KOLs in particular now that leads you to believe that will happen?

You know, looking at at doing both, I'm just kind of curious how you might extrapolate that experience, uh, to reveal and, you know, sort of this, this notion that seems to be out there that gosh, you know, there's some superiority to tumor informed and you know, like, you know, tissue or tumor naive is fine. If if you can't get a tissue but you know, otherwise you want to do uh tumor informed, you know, could could you see sort of a similar Evolution? Are you hearing anything from Physicians Kos in particular? Now that that leads you to believe that will happen?

Helmy Eltoukhy: Yeah, no, that's a great question. I think that maybe one of the sort of underappreciated aspects of our Infinity platform, the sort of smart liquid biopsy ecosystem, is that many of these apps that we're populating on 360 liquid will eventually make their way to 360 tissue and even Reveal where appropriate. And so when you think of, you know, where Reveal could be, it's going to look like a very different sort of product than any tumor-informed product out there that is just looking for sort of, you know, passenger mutations or a number of mutations that may not be actionable. And we're actually seeing the biology that is there in that individual, things like, you know, the subtype, how that's evolving, the, you know, potentially even toxicity from some of the adjuvant therapy that they're being exposed to.

Yeah, no, that's that's a great question. Um, I I think the maybe 1 of the sort of underappreciated aspects of our Infinity platform, the sort of smart liquid biopsy. Ecosystem is that many of these apps that we're populating on 360 liquid.

Um, will eventually make their way to 360 tissue and even reveal where appropriate. And so when you think of, you know, where are you going to be?

Helmy Eltoukhy: It really opens up a different space, which is why we've said that, you know, the MRD market will likely have two aspects to it. There'll be a tumor-informed sort of market that some physicians would like to use. And there's going to be, I think, a pretty massive tissue-free aspect to it and market to it. Just like there is in comprehensive genomic profiling, there's two big markets there. And I would argue that the liquid market in CGP, I think few would argue, is ultimately going to be massively bigger than the tissue market. And we potentially see the same dynamic shaping up on the MRD side.

It's going to look like a very different sort of product than any tumor informed product out there. That is just looking for sort of, you know, passenger mutations or number of mutations that may not be actionable. And we're actually seeing the biology that is there, and that individual things like, you know, the subtype how that's evolving the, you know, potentially even toxicity from the sum of the Aspen therapy that they're being exposed to it really opens up a different space which is why we've said that, you know, the mrd market will will likely have 2, um, aspects to it. There there will be a tumor informed um, sort of Market that some Physicians um, would like to use.

And there's going to be a, I think a pretty massive issue free, uh, aspect to it and Market to it just like there is in, uh, in in comprehensive genomic profiling. There's there's 2 big markets there. And I would argue that the liquid Market in, uh, cgp. I think few would argue, um, is ultimately going to be massively bigger, uh, than, than the tissue market. And we potentially see the same Dynamic shaping up on the mrd side.

Jay Son: Our next question is from Yoko Oku with Morgan Stanley. Your line is now open.

Our next question is from Yoko Oku with Morgan Stanley.

Rachel Vatnsdal: Hello. Thank you for taking my question. The recent Serena VI readout provides a compelling argument to monitor emergence of ESR mutation for treatment with Temizastin. What do you think may be the split at steady state to monitor emergence of ESR1 mutation between comprehensive panel like G360 versus hotspot tests? And also, with cuts to Medicaid, what is your view on the impact to cancer testing more broadly?

The Line is now open.

Hello. Thank you for taking my question. The reason Serena 6 readout provides a compelling argument to monitor the emergence of ESR1 mutation for treatment with CIRS. What do you think may be the split at steady state to monitor the emergence of ESR1 mutation between a comprehensive panel like G360 versus a hotspot test?

And also with with cuts to Medicaid, what is your view on the impact to cancer? Testing more, broadly,

Helmy Eltoukhy: Yeah, so we really see this as a beachhead for a new paradigm in essentially oncology that will ultimately be the paradigm that I think all patients are monitored.And

Helmy Eltoukhy: treated within. And the point is, you know, ESR-1 is the first of what we think will be many opportunities to switch therapies dynamically. Really, this idea of adaptive management of disease. And, you know, the chemisestrant example, you know, we are the enrolling assay. We will be, you know, if it gets approved, the official CDX for that, at least in the United States. And so, you know, I think we have a very good chance of not only opening the door in this new paradigm, but capitalizing on the majority of the opportunity and volume that would be there in the first couple of years. So we see it as, I think, a very significant upside opportunity on G360 volumes in the future.

Paradigm that I think all patients are um, monitored and and treated with and and the point is, you know, yes or 1 is, is the first of what we think will be many opportunities to switch therapies dynamically. Really this idea of adaptive management of disease.

And, um, and, and you know the chemistry.

Zarak Khurshid: One more question, please, operator.

Um, example, you know, we we are the enrolling assay, we we will be, you know, if, if it gets approved, the official CD expert for that at least in the United States and, and, and so, you know, I think we have a very good chance of, um, not only opening the door in this new paradigm, but capitalizing on the majority of the opportunity and volume that would be there in the first couple of years. Um, so we we see it. As I think a very significant upside opportunity on um, g360 volumes in the future.

1 more question, please operator.

AmirAli Talasaz: Our last question is from Luke Siergott with Barclays. Your line is now open. This is Salem Salem on for Luke. Thanks for squeezing us in here. Just kind of piggybacking off of the question before, I guess, on Medicaid, could you give us an update on what your exposure is to those volumes, if possible, by tests, which I realize is a tall order? And if not, kind of ballpark numbers, just given the expected fallout of the big beautiful bill. And what do you kind of expect on pacing of any potential headwinds this year or next year? Thank you.

Our last question is from Luke. Sgot with Barclays, your line is now open.

This is Salem salmon for Luke. Thanks for squeezing Us in here. Uh, just kind of piggybacking off of, um, question before, uh, I guess on Medicaid. Could you give us an update on what your exposure is to those volumes if possible by tests which, you know, I realize is a tall order and if not kind of ballpark numbers,

Uh, just given the the expected, Fallout of the big, beautiful Bill and, uh, what do you kind of expect on pacing of any potential headwinds this year, or, uh, next year. Thank you.

Michael Bell: Yeah, I can take that one. I mean, very simply, Medicaid volume is very, very minimal in our overall volume across all products, and even less so on the revenue side. So, you know, any impact overall to Medicaid isn't really going to have any impact on our overall volume or revenue.

Yeah, I I can say that 1 very simply Medicaid for you is very, very minimal in our in our overall volume across across all products and, and even even less. So on uh, on the revenue side. Um, so you know, any any impact overall to Medicaid isn't isn't really going to have any impact on how

on our own volume or our, our Revenue,

AmirAli Talasaz: That concludes the conference call. Thank you for your participation. Enjoy the rest of your day.

That concludes the conference call. Thank you for your participation. Enjoy the rest of your day.