Q2 2024 Guardant Health Inc Earnings Call

Speaker Change: Good afternoon. Thank you for attending today's Guardant Health Q2 2024 earnings call.

Tamia: 24 earnings call. My name is Tamia, and I will be your moderator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. If you would like to ask a question, please press star one on your telephone keypad. I would now like to pass the conference over to your host, Zarak Khurshid, Vice President of Investor Relations. You may proceed.

Tomia: My name is Tomia, and I will be your moderator for today's call. All lines will be muted during the presentation portion of the call, with an opportunity for questions and answers at the end. If you would like to ask a question, please press star one on your telephone t-pad.

Tamiya: My name is Tamiya and I will be your moderator for today's call.

Tamiya: All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. If you would like to ask a question, please press star 1 on your telephone keypad. I would now like to pass the conference over to your host, Zarak Khurshid, Vice President of Investor Relations. You may proceed.

Zarak Khurshid: I would not to pass the conference over to your host, Zarak Khurshid, Vice President of Investor Relations. You may proceed.

Zarak Khurshid: Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30.

Zarak Khurshid: Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30th, 2024. 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 differ materially from those anticipated.

Sarek Khurshid: Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30, 2024. 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.

Zarak Khurshid: Thank you for joining me today from Guardant, our Helmy Eltoukhy, Co-CDO, AmirAli Talasaz, Co-CDO, and Michael Bell, Chief Financial Officer.

Zarak Khurshid: Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meeting Federal Securities Laws. These statements involve material risks and uncertainties that could cause actual results or events to differ materially from those anticipated.

Sarek Khurshid: These statements involve material risks and uncertainties that could cause actual results or events.

Zarak Khurshid: 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 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. 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. The information in this conference call is accurate only as of the live broadcast. With that, I would like to turn the call over to Helmy. Thanks, Zarak.

Zarak Khurshid: 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 reconciliation to most directly comparable GAAP financial measures, are available in the press release guarding issue today, as well as in our 10-K and other filings with the SEC.

Sarek Khurshid: to differ materially.

Sarek Khurshid: This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items.

Sarek Khurshid: Additional information regarding material risks and uncertainties, as well as reconciliation to most directly comparable GAAP financial measures, are available in the press release Guardant issued today, as well as in our 10-K and other filings with the SEC.

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

Zarak Khurshid: Thank you, Zarak.

Helmy Eltoukhy: Thanks, Zarak. Good afternoon, and thank you for joining our second quarter 2024 earnings call. We founded Guardant Health with a bold mission to conquer cancer with data. With our comprehensive suite of tests, we are now truly transforming patient lives across the continuum of care. It has always been our belief that the best way to conquer cancer is to catch it in its earliest stages when patients have the best chance of survival.

AmirAli Talasaz: Good afternoon, and thank you for joining our second quarter of 2024 earnings call. We founded Garden Health with a bold mission to conquer cancer with data. With our comprehensive suite of tests, we are now truly transforming patient lives across the continuum of care. It has always been our belief that the best way to conquer cancer is to catch it in its earliest stages when patients have the best chance of survival. We have spent the last decade developing a blood-based test that we believe will launch cancer screening into a whole new era with vastly improved screening rates, earlier cancer detection, and ultimately a significant increase in the number of lives saved.

Helmy: Thanks, Zarak. Good afternoon and thank you for joining our second quarter 2024 earnings call.

Helmy: We founded Guardant Health with a bold mission to conquer cancer with data. With our comprehensive suite of tests, we are now truly transforming patient lives across the continuum of care.

Helmy: It has always been our belief that the best way to conquer cancer is to catch it in its earliest stages when patients have the best chance of survival.

Helmy Eltoukhy: We have spent the last decade developing a blood-based test that we believe will launch cancer screening into a whole new era with vastly improved screening rates, earlier cancer detection, and ultimately, a significant increase in the number of lives saved. We have reached a pivotal moment on this journey, and to commemorate this important milestone, AmirAli will start us off with an update on our screening business.

Helmy: We have spent the last decade developing a blood-based test that we believe will launch cancer screening into a whole new era with vastly improved screening rates, earlier cancer detection, and ultimately, a significant increase in the number of lives saved.

Emerald Lee: We have reached a pivotal moment on this journey, and to commemorate this important milestone, Emerald Lee will start us off with an update on our screening business.

Helmy: We have reached a pivotal moment on this journey, and to commemorate this important milestone, AmirAli will start us off with an update on our screening business.

Emerald Lee: Can I tell me? Starting on slide three, as we announced last week, I'm thrilled to share that FDA has approved our shield blood test for colorectal cancer screening in adults ages 45 and older for an average risk for the disease. Shield is the first blood test to be approved by the FDA as the primary screening option for CRC, meaning healthcare providers can offer our tests in a manner similar to non-invasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for medical coverage.

AmirAli Talasaz: Starting on slide three. As we announced last week, I'm thrilled to share that FDA has approved our SHIELD blood test for colorectal cancer screening in adults ages 45 and older who are at average risk for the disease. Shield is the first blood test to be approved by FDA as a primary screening option for CRC. Many healthcare providers can offer our tests in a manner similar to non-invasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage. This FDA approval of S.H.I.E.L.D. is an incredibly significant milestone in our mission to conquer cancer with data, and more importantly, a huge victory for patients. Moving on to slide four.

Amirali: Thanks, Helmy.

Amirali: Starting on slide 3. As we announced last week, I am thrilled to share that FDA has approved our SHIELD blood test for colorectal cancer screening in adults ages 45 and older who are at average risk for the disease.

Speaker Change: Shield is the first blood test to be approved by FDA as the primary screening option for CRC, meaning healthcare providers can offer our tests in a manner similar to non-invasive methods recommended in screening guidelines.

Speaker Change: Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage. This FDA approval of SHIELD is an incredibly significant milestone in our mission to conquer cancer with data, and more importantly, a huge victory for patients.

Emerald Lee: This FDA approval of Shield is an incredibly significant milestone in our mission to conquer cancer with data and, more importantly, a huge victory for patients. Yes, moving on to slide four, we have deviled the suit of clinical evidence supporting the value of SHIELD. We believe this robust evidence will pave the path for inclusion of SHIELD and guideline recommendations. I highlight a few key publications that exemplify this. The data from our pivotal eclipse study was published in the New England Journal of Medicine and the world's leading peer-reviewed medical journal. A randomized study at Kaiser Permanence demonstrated that when individuals who hadn't completed this fifth wear offered SHIELD, the proportion of screening completed was three times higher.

AmirAli Talasaz: We have developed a suite of clinical evidence supporting the value of SHIELD. We believe this robust evidence will pave the path for the inclusion of shielding guideline recommendations. I highlight a few key publications that illustrate, The data from our Pivotal Eclipse study was published in the New England Journal of Medicine, the world's leading peer-reviewed medical journal.

Speaker Change: Moving on to slide four.

Speaker Change: We have developed a suite of clinical evidence supporting the value of SHIELD.

Speaker Change: We believe this robust evidence will pave the path for inclusion of shielding guideline recommendations.

Speaker Change: I highlight a few key publications that exemplify this.

Speaker Change: The data from our Pivotal Eclipse study was published in the New England Journal of Medicine, the world's leading peer-reviewed medical journal.

AmirAli Talasaz: A randomized study at Kaiser Permanente demonstrated that when individuals who hadn't completed FIT were offered SHIELD, the proportion of screening completed was three times higher. And just last week, we announced that our CanScreen Health Outcome Model was published in the Journal of Medical Economy. This outcome model considers both clinical efficacy and longitudinal adherence when assessing the impact of SHIELD on CRC incidence and mortality rates and confirms the public health importance of blood-based testing.

Speaker Change: A randomized study at Kaiser Permanente demonstrated that when individuals who hadn't completed FIT were offered SHIELD, the proportion of screening completed was three times higher.

Emerald Lee: And just last week, we announced that our can-screen health outcome model was published in the Journal of Medical Economies. This outcome model considers both clinical efficacy and longitudinal adherence, one accessing the impact of SHIELD on CRC incidents and mortality rates, and confirms the public health importance of blood-based testing. Specifically, SHIELD outperforms two guideline-recommended stool-based tests, BIT, and multi-target stool DNA. When considering life-years gain, CRC cases are verited and prevention of CRC deaths. Turning to slide five. Post-FTA approval with first-line indication, with 83% sensitivity and 90% specific testing in detecting CRC, SHIELD now raises the bar required for blood test performance.

Speaker Change: And just last week, we announced that our CanScreen Health Outcome Model was published in the Journal of Medical Economics.

Speaker Change: This outcome model considers both clinical efficacy and longitudinal adherence when assessing the impact of SHIELD on CRC incidence and mortality rates and confirms the public health importance of blood-based testing.

AmirAli Talasaz: Specifically, SHIELD outperforms two guideline-recommended stool-based tests, BIT and multi-target stool DNA, when considering life-year gain, CRC cases averted, and prevention of CRC deaths. TURNING TO SLIDE 5, Post FDA approval with first line indication with 83% sensitivity and 90% specificity in detecting CRC Shield now raises the bar required for blood test performance, and going forward, we believe tests falling below this bar will not be viable. This achievement did not happen overnight and came on the heels of more than a decade of world-class innovation and learnings as the liquid biopsy leader, hundreds of millions of dollars of investment, conducting a 20,000 patient registration study, publishing results in a leading peer-reviewed journal, engaging in a rigorous 16-month review process with Now turning to slide 6.

Speaker Change: Specifically, S.H.I.E.L.D. outperforms two guideline-recommended stool-based tests, BIT and multi-target stool DNA, when considering life-years gain, CRC cases averted, and prevention of CRC deaths.

Speaker Change: Turning to slide 5.

Speaker Change: Post FDA approval with first-line indication with 83% sensitivity and 90% specificity in detecting CRC.

Speaker Change: Shield now raises the bar required for blood test performance, and going forward, we believe tests falling below this bar will not be viable.

Emerald Lee: And going forward, we believe tests falling below this bar will not be viable. This achievement did not happen overnight and came on the SHIELD's own.

Speaker Change: This achievement did not happen overnight and came on the heels of more than a decade of world-class innovation and learnings as the liquid biopsy leader.

Emerald Lee: More than a decade of both-class innovation and learnings as the liquid biopsy leader, hundreds of millions of dollars of investment, conducting a 20,000-patient registration study, publishing results in a leading peer review journal, engaging in a rigorous 16-month review process with FBA and receiving a successful advisory committee panel vote. We believe we have an incredible lead ahead of any other company that are vying to enter this market. Now, turning to slide six. I am proud that we are able to launch this test just a few days after receiving FBA approval. SHIELD IVD is now commercially available, and we have already begun processing samples in our lab.

Speaker Change: Hundreds of millions of dollars of investment, conducting a 20,000 patient registrational study, publishing results in a leading peer review journal, engaging in a rigorous 16-month review process with FDA, and receiving a successful advisory committee panel vote.

Speaker Change: We believe we had an incredible lead ahead of any other company that are vying to enter this market. Now turning to slide 6, I am proud that we were able to launch this test just a few days after receiving FDA approval.

AmirAli Talasaz: I am proud that we were able to launch this test just a few days after receiving FDA approval. Shield IVD is now commercially available, and we have already begun processing samples in our labs. At Guardant, we are committed to educating physicians and patients on the risk-benefit of S.H.I.E.L.D. so that they will be empowered to make informed, shared decisions when selecting a CRC screening option. Moving on to slide seven.

Speaker Change: Shield IVD is now commercially available, and we have already begun processing samples in our lab.

Emerald Lee: At Garnet, we are committed to educating physician patients on the risk-benefit of SHIELD so that they will be empowered to make informed shared decisions when selecting a CRC screening option. Moving on to slide seven. At launch, with a first-line indication, SHIELD is already addressing an enormous opportunity with 120 million average risk individuals between the age of 45 to 84. From this average risk population, 45 million lives are covered by many here. This represents a 15 million annual testing opportunity at a multi-billion dollar market. With Medicare coverage, SHIELD already addresses one of the largest-ever diagnostics opportunities.

Garden: At Guardant, we are committed to educating physicians and patients on the risk-benefit of S.H.I.E.L.D. so that they will be empowered to make informed, shared decisions when selecting a CRC screening option.

AmirAli Talasaz: At launch, with a first-line indication, SHIELD is already addressing an enormous opportunity with 120 million average-risk individuals between the ages of 45 to 84. Furthermore, 45 million lives are covered by Medicare. This represents a $15 million annual testing opportunity in a multi-billion dollar market.

Garden: Moving on to slide 7.

Garden: At launch, with a first-line indication, SHIELD is already addressing an enormous opportunity with 120 million average-risk individuals between the ages of 45 to 84.

Garden: Of this average risk population, 45 million lives are covered by Medicare.

Garden: This represents a $15 million annual testing opportunity and a multi-billion dollar market. With Medicare coverage, S.H.I.E.L.D. already addresses one of the largest ever diagnostics opportunities.

AmirAli Talasaz: With Medicare coverage, S.H.I.E.L.D. already addresses one of the largest ever diagnostic problems. Moving on to slide eight, existing school-based screening methodologies have been around for a decade or more, and still, we have not seen a material change in screening compliance over the last several years. There are 50 million people who remain unscreened.

Emerald Lee: Moving on to slide 8. A resisting stool-based screening methodology is happening around for a decade or more, and still, we have not seen a material change in screening compliance over the last several years. There are 50 million people who remain unscreened, and for those that are screened, the re-screening rate has been poor. Seven out of ten surveyed individuals who have been previously screened for CRC with stool-based tests said they would not choose to screen with stool again. On the other side, unscreened individuals who are surveyed had a strong preference 5-1 for blood over stool. Days of use of a blood test and the ability to screen patients during routine care can change this.

Garden: Moving on to slide 8.

Speaker Change: Existing school-based screening methodologies have been around for a decade or more, and still, we have not seen a material change in screening compliance over the last several years.

AmirAli Talasaz: And for those that are screened, their re-screening rate has been poor. Seven out of 10 surveyed individuals who have been previously screened for CRC with a stool-based test said they would not choose to screen again, which still I guess. On the other side, unscreened individuals who were surveyed had a strong preference 5 to 1 for blood over stool.

Garden: There are 50 million people who remain unscreened, and for those that are screened, their screening rate has been poor.

Speaker Change: Seven out of ten surveyed individuals who have been previously screened for CRC with a stool-based test

Speaker Change: said they would not choose to screen with stool again. On the other side, unscreened individuals who were surveyed had a strong preference 5 to 1 for blood over stool.

AmirAli Talasaz: The ease of use of a blood test and the ability to screen patients during routine care can change this. Blood testing is already entrenched in routine patient care. 87% of people aged 50 and above have seen their doctor during the last 12 months, and 91% of that group have had a blood drop in the last 12 months.

Garden: the use of use of the blolotcess and the ability to the screen patients during routinecare can change this

Emerald Lee: Blood testing is already entrenched into routine patient care. 87% of people aged 50 and above have seen their doctor during the last 12 months, and 91% of that group has had a blood drop in the last 12 months. Our real-world experience with SHIELD-LVT providing over 20,000 tests during the past two years confirms that SHIELD has a clear fit into existing care, with PCPs enthusiastically ordering this test. And when they do, patients complete this. We continue to see an incredibly strong adherence rate of more than 90%. At our Investor Day last fall, we shared our target to exceed 1 million SHIELD tests in 2028.

Speaker Change: Blood testing is already entrenched into routine patient care. 87% of people aged 50 and above have seen their doctor during the last 12 months. And 91% of that group has had a blood drop in the last 12 months.

AmirAli Talasaz: Our real-world experience with SHIELD LVT providing over 20,000 tests over the past two years confirms that SHIELD has a clear fit into existing care, with PCPs enthusiastically ordering these tests, and when they do, patients complete them. We continue to see an incredibly strong adherence rate of more than 90%.

Speaker Change: Our real-world experience with SHIELD LBT providing over 20,000 tests during the past two years confirms that SHIELD has a clear fit.

Garden: into existing care with PCPs enthusiastically ordering this test.

Speaker Change: And when they do, patients complete the test.

Speaker Change: we continueed withstand incredibly strong adcurce rate of more than ninety percent

AmirAli Talasaz: At our Investor Day last fall, we shared our target to exceed 1 million shield tests in 2028. Now, following FDA approval with first-line indication, we are even more confident that we will reach our goal. Moving on to slide nine.

Garden: At our Investor Day last fall, we shared our target to exceed 1 million shield tests in 2028. Now, following FDA approval with first-line indication, we are even more confident that we will reach our goal.

Emerald Lee: Now, following FDA approval with first-line education, we are even more confident that we will reach our goal. Moving on to slide 9, we are very pleased to see that CMS is proactively removing barriers to blood-based CRC screening and acknowledging its unique benefits. Through its recently proposed physician fee schedule, CMS is taking steps to close a loophole and remove patient out-of-pocket cost for follow-up colonoscopy after a positive blood-based test. CMS originally eliminated cost-sharing for the follow-up colonoscopy after a non-invasive sous-based test in its 2023 Physician Fee Schedule. But many years after sous-based test entered the market, we are encouraged by the creek inclusion of blood in the proposed 2025 physician fee schedule.

AmirAli Talasaz: We are very pleased to see that CMS is proactively removing barriers to blood-based CRC screening and acknowledging its unique benefits. Through its recently proposed physician fee schedule, CMS is taking steps to close a loophole and remove patient out-of-pocket costs for follow-up colonoscopies after a positive blood test. CMS originally eliminated cost-sharing for the follow-up colonoscopy after a non-invasive stool-based test in its 2023 Physician Fee Schedule, but many years after stool-based tests entered the market. We are encouraged by the quick inclusion of blood in the proposed 2025 Physician Fee Schedule. We look forward to the finalization of this fee schedule in the fall. Turning to slide 10.

Garden: Moving on to slide 9, we are very pleased to see that CMS is proactively removing barriers to blood-based CRC screening and acknowledging its unique benefits.

Garden: Through its recently proposed physician-feed schedule, CMS is taking steps to close a loophole and remove patient out-of-pocket costs for follow-up colonoscopy after a positive blood-based test.

Garden: CMS originally eliminated cost-sharing for the follow-up colonoscopy after a non-invasive stool-based test in its 2023 Physician Fee Schedule, but many years after stool-based tests entered the market.

Speaker Change: We are encouraged by the quick inclusion of blood in the proposed 2025 Physician Fee Schedule. We look forward to the finalization of this fee schedule in the fall.

Emerald Lee: We look forward to the finalization of this fee schedule in the fall. Turning to slide 10. In midway through 2024, we are well on track with milestones within our screening business and look forward to ramping adoption throughout the remainder of this year. In 2025, we look forward to sharing SHIELD multi-cancer data. Also, we expect to receive ADLG status information. Foundation, ADLT was established to incentivize innovation and support the investment in diagnostic development, all to benefit of patients. It provides new and innovative tests for early, not based on historical precedent, but based on the unique value they bring to bear to health system.

AmirAli Talasaz: Midway through 2024, we are well on track with milestones within our screening business and look forward to ramping adoption throughout the remainder of this year. In 2025, we look forward to sharing SHIELD multi-cancer data. Also, we expect to receive ADLP status as a nation. ADLT was established to incentivize innovation and support the investment in diagnostic development, all to benefit the patient. It provides new and innovative tests per day, not based on historical precedent but on the unique value they bring to bear on health.

Speaker Change: Turning to slide 10.

Speaker Change: Midway through 2024, we are well on track with milestones within our screening business and look forward to ramping adoption throughout the remainder of this year.

Speaker Change: In 2025, we look forward to sharing SHIELD multi-cancer data. Also, we expect to receive ADLT status designations.

Speaker Change: ADLT was established to incentivize innovation and support the investment in diagnostic development, all to benefit of patients.

Speaker Change: It provides new and innovative tests per day, not based on historical precedent, but based on the unique value they bring to bear to health systems.

AmirAli Talasaz: Our pricing strategy is intended to establish a sustainable ASB that recognizes the value of SHIELD, enabling us to build a best-in-class profitable business and also future-proofs shield reimbursement for its expansion to multi-cancerous training. As Helmy said at the start of this call, this is truly a historic moment for Guardant, the liquid biopsy field, and cancer screening. Our team has worked tirelessly to reach this milestone. I'd like to thank them for their hard work during the last 10 years and especially during the last three years to get us here. I would also like to acknowledge and thank the FDA and their review team for their collaboration and partnership. With that, I will now turn the call over to Helmy for an update on therapy selection and MRD.

Emerald Lee: Our pricing strategy is intended to establish a sustainable A at speed that recognizes the value of shield, enables us to build a best-in-class profitable business, and also future-proofed shield reimbursement for its expansion to multi-cancerous craning.

Speaker Change: Our pricing strategy is intended to establish a sustainable ASB that recognizes the value of SHIELD, enables us to build a best-in-class profitable business, and also future-proofs SHIELD reimbursement for its expansion to multi-cancerous screening.

AmirAli Talasaz: As tell me, Tim, at the start of this call, this is truly a historic moment for Guardant, the liquid biopsy and cancerous craning. Our team has worked tirelessly to reach this milestone. I'd like to thank them for their hard work during the last ten years, and especially during the last three years to bring us here.

Speaker Change: As Helmy said at the start of this call, this is truly a historic moment for Guardant.

Helmy: The liquid biopsy field and cancer screening.

Helmy: Our team has worked tirelessly to reach this milestone. I'd like to thank them for their hard work during the last 10 years and especially during the last 3 years to bring us here.

AmirAli Talasaz: I also like to acknowledge and thank the FDA and their review team for their collaboration and partnership.

Helmy: I also like to acknowledge and thank the FDA and their review team for their collaboration and partnership.

Helmy Eltoukhy: With that, I will now turn the call over to Helmy for an update on therapy selection and MRD. Thanks AmirAli, turning this slide 11, while we are excited for the next chapter in screening, we continue to make excellent progress with our oncology business. We have a robust suite of precision oncology products addressing both late and early stage cancers, as well as a current monitor in core cancer survivors.

Helmy: With that, I will now turn the call over to Helmy for an update on therapy selection and MRD.

Helmy Eltoukhy: Turning to slide 11. While we are excited about the next chapter in screening, we continue to make excellent progress with our oncology business. We have a robust suite of precision oncology products addressing both late and early stage cancers, as well as recurrence monitoring for cancer survivors. Now, I would like to share a story highlighting the value our liquid biopsy tests bring to late stage cancer patients. In 2023, a 33-year-old woman went to her doctor after noticing a progressive neck mass during her third pregnancy.

Helmy: Thanks AmirAli. Turning to slide 11.

Helmy: While we are excited for the next chapter in screening, we continue to make excellent progress with our oncology business. We have a robust suite of precision oncology products addressing both late and early stage cancers, as well as recurrence monitoring for cancer survivors.

Helmy Eltoukhy: Now I would like to share a story highlighting the value our liquid biocip tests bring to late stage cancer patients. In 2023, a 33 year old woman went to her doctor after noticing a progressive neck mass during her third pregnancy. She initially received a CGP tissue test to diagnose the cause of the mass, but the test did not identify any actionable biomarkers. The patient then received a Guardant 360 liquid biopsy test, which identified the patient was out positive, and she was diagnosed with thyroid carcinoma. As a result, the patient was put in a lectinist for therapy, and I am very pleased to report that after about a year of being on treatment, the patient no longer has evidence of disease.

Helmy: Now I would like to share a story highlighting the value our liquid biopsy tests bring to late stage cancer patients.

Helmy Eltoukhy: She initially received a CGP tissue test to diagnose the cause of the mask, but the test did not identify any actionable biomarkers. The patient then received a Guardant 360 liquid biopsy test, which revealed that the patient was L-positive, and she was diagnosed with thyroid carcinoma. As a result, the patient was put on a Lexinet for therapy, and I am very pleased to report that after about a year of being on treatment, the patient no longer has evidence of disease. She also successfully gave birth to her third child.

Speaker Change: In 2023, a 33-year-old woman went to her doctor after noticing a progressive neck mask during her third pregnancy. She initially received a CGP tissue test to diagnose the cause of the mask, but the test did not identify any actionable biomarkers.

Speaker Change: The patient then received a Guardant 360 liquid biopsy test, which identified the patient was L-positive and she was diagnosed with thyroid carcinoma.

Speaker Change: As a result, the patient was put in a Lexinet for therapy, and I am very pleased to report that after about a year of being on treatment, the patient no longer has evidence of disease.

Helmy Eltoukhy: She also successfully gave birth to her third child. Given there are minimal side effects to the therapy, she will remain unallecting it for another year, with a Guardant 360 test every three months to monitor. This is just one of many patient stories that highlight the superior ability of Guardant 360 to identify actionable biomarkers and inform cancer care over other approaches.

Speaker Change: She also successfully gave birth to her third child.

Helmy Eltoukhy: Given there are minimal side effects to the therapy, she will remain on Alexinib for another year with a GARDEN360 test every three months to monitor. This is just one of many patient stories that highlight the superior ability of Guardant 360 to identify actionable biomarkers and inform cancer care over other approaches. Turning to slide 13, clinical test volume for the second quarter grew 14% year over year, reaching 49,400 tests with continued progress in Guardant 360 volumes. Reveal also continued to grow strongly, even with our ongoing management of volumes ahead of broader reimbursement. Biopharma volumes were exceptionally strong in the second quarter, growing 56% year-over-year to a record 10,475.

Speaker Change: Given there are minimal side effects to the therapy, she will remain on Alexinib for another year with a Guardant 360 test every three months to monitor.

Speaker Change: This is just one of many patient stories that highlight the superior ability of Guardant 360 to identify actionable biomarkers and inform cancer care over other approaches.

Helmy Eltoukhy: Turning to top line performance in slide 12, we had a robust second quarter with total revenue growing 29% to $177 million. This is driven by another quarter of very strong precision oncology revenue, which increased 33% in the quarter, supported by significant Guardant 360 reimbursement tailwinds, as well as strong growth and volumes, particularly within biopharma. Turning to slide 13, clinical test volume for the second quarter grew 14% year over year, reaching 49,400 tests with continued progress in Guardant 360 volumes.

Speaker Change: Turning to top-line performance in slide 12, we had a robust second quarter with total revenue growing 29% to $177 million.

Speaker Change: This is driven by another quarter of very strong precision oncology revenue, which increased 33% in the quarter, supported by significant Garden 360 reimbursement tailwinds, as well as strong growth in volumes, particularly within biopharma.

Speaker Change: Turning to slide 13, clinical test volume for the second quarter grew 14% year over year, reaching 49,400 tests with continued progress in Guardant 360 volumes.

Helmy Eltoukhy: Reveal all to continue to grow strongly, even with our ongoing management of volumes ahead of broader reimbursement. Department, biopharma volumes were exceptionally strong in the second quarter, growing 56% year-over-year to a record 10,475 tests. We continue to see a lot of excitement for Guardant Infinity, our newest biopharma offering powered by a smart liquid biopsy platform with growing contributions in the second quarter. This is an important leading indicator for future demand for our clinical tests.

Speaker Change: Reveal also continue to grow strongly, even with our ongoing management of volumes ahead of broader reimbursement.

Speaker Change: Biopharma volumes were exceptionally strong in the second quarter, growing 56% year-over-year to a record 10,475 tests.

Helmy Eltoukhy: We continue to see a lot of excitement for Guardant Infinity, our newest biopharma offering powered by our smart liquid biopsy platform, with growing contributions in the second quarter. This is an important leading indicator for future demand for our clinical tests. Moving on to slide 14.

Speaker Change: We continue to see a lot of excitement for Guardant Infinity, our newest biopharma offering powered by our smart liquid biopsy platform, with growing contributions in the second quarter. This is an important leading indicator for future demand for our clinical tests.

Helmy Eltoukhy: Moving on to slide 14. Last week, we launched a major upgrade of Guardant 360 LVT on our smart liquid biopsy platform. Guardant 360 is a leading liquid biopsy test for patients with advanced cancer, and this upgrade gives oncologists a much more complete view of cancer by utilizing novel genomics and epigenomics sequencing technology. With a 10 times larger panel, including 739 genes, the upgraded test covers both currently actionable and emerging biomarkers not available. In addition, the test quantifies tumor burden with 10 times more sensitivity, further extending its specimen class performance. Guardant 360 LVT is covered by Medicare and major private payers for CGP of all advanced solid tumors.

Helmy Eltoukhy: Last week, we launched a major upgrade of Guardant 360 LVT on our smart liquid biopsy platform. Guardant 360 is a leading liquid biopsy test for patients with advanced cancer, and this upgrade gives oncologists a much more complete view of cancer by utilizing novel genomics and epigenomics sequencing technology. With a 10 times larger panel including 739 genes, the upgraded test covers both currently actionable and emerging biomarkers not available in any other liquid biopsy test.

Speaker Change: Moving on to slide 14.

Speaker Change: Last week, we launched a major upgrade of Guardant 360 LVT on our SmartLiquid VibeC platform.

Speaker Change: 360 is a leading liquid biopsy test for patients with advanced cancer, and this upgrade gives oncologists a much more complete view of cancer by utilizing novel genomics and epigenomics sequencing technology.

Speaker Change: With a 10 times larger panel including 739 genes, the upgraded test covers both currently actionable and emerging biomarkers not available in any other liquid biopsy test.

Helmy Eltoukhy: In addition, the test quantifies tumor burden with 10 times more sensitivity, further extending its best-in-class performance. 360 LVT is covered by Medicare and major private payers for CGP of all advanced solid tumors. This upgrade marks the beginning of a new chapter of comprehensive genomic profiling, helping to identify novel targets for the current and next generation of targeted therapies and immunotherapies, unlock new clinical applications, and access genotype and phenotype from the

Speaker Change: In addition, the test quantifies tumor burden with 10 times more sensitivity, further extending its specimen class performance.

Speaker Change: 360 LVT is covered by Medicare and major private payers for CGP of all advanced solid tumors.

Helmy Eltoukhy: This upgrade marks the beginning of a new chapter of comprehensive genomic profiling, helping to identify novel targets for the current and next generation of target therapies and immunotherapies, unlock new clinical applications, and access genotype and phenotype from the blood. We are excited by the ability to better inform cancer care teams about the optimal treatment strategy for their patients and give them more precision treatment options that can help improve their outcomes. Over time, we will quickly add even more exciting first-of-their-kind capabilities to the test.

Speaker Change: This upgrade marks the beginning of a new chapter of comprehensive genomic profiling helping to identify novel targets for the current and next generation of targeted therapies and immunotherapies, unlock new clinical applications, and access genotype and phenotype from the blood.

Helmy Eltoukhy: We are excited by the ability to better inform cancer care teams about the optimal treatment strategy for their patients and give them more precision treatment options that can help improve their outcomes. Over time, we will quickly add even more exciting, first-of-their-kind capabilities to the test.

Speaker Change: We are excited by the ability to better inform cancer care teams about the optimal treatment strategy for their patients and give them more precision treatment options that can help improve their outcomes.

Speaker Change: Over time, we will quickly add even more exciting first-of-their-kind capabilities to the test.

Helmy Eltoukhy: Turning to slide 15, in early June, we introduced an upgraded Guardant 360 tissue next test featuring an expanded panel of 498 clinically relevant actionable biomarkers to identify more treatment options for patients with advanced cancer and further improve best-in-class turnaround time. As a reminder, Tissue Next is differentiated as it leverages our AI power scoring algorithm and is the only tissue CGP test that improves PDO1 detection by over 20% in non-small cell lung cancer. Importantly, the tissue next test is covered by Medicare for all advanced solid tumors. With these two significant upgrades to our portfolio, we are looking forward to continued progress with our therapy selection business for the remainder of 2024 and beyond.

Helmy Eltoukhy: In early June, we introduced an upgraded Guardant 360 Tissue Next Test featuring an expanded panel of 498 clinically relevant actionable biomarkers to identify more treatment options for patients with advanced cancer and further improve best-in-class turnaround. As a reminder, Tissue Next is differentiated as it leverages our AI-powered scoring algorithm and is the only tissue CGP test that improves PD-L1 detection by over 20% in non-small cell lung cancer. Importantly, the Tissue Next test is covered by Medicare for all advanced solid tumors.

Speaker Change: Turning to slide 15, in early June we introduced an upgraded Guardant 360 tissue next test featuring an expanded panel of 498 clinically relevant actionable biomarkers to identify more treatment options for patients with advanced cancer and further improve best-in-class turnaround time.

Speaker Change: As a reminder, Tissue Next is differentiated as it leverages our AI-powered scoring algorithm and is the only tissue CGP test that improves PD-L1 detection by over 20% in non-small cell lung cancer. Importantly, the Tissue Next test is covered by Medicare for all advanced solid tumors.

Helmy Eltoukhy: With these two significant upgrades to our portfolio, we are looking forward to continued progress with our therapy selection business for the remainder of 2024 and beyond. Now, shifting gears to reveal on slide 16, where we are the leader in tissue-free MRG. I'm excited to share that our Cosmos CRC manuscript with data from our Cosmos colon study looking at stage 2 and stage 3 patients was accepted for publication in the peer-reviewed journal Clinical Cancer Research.

Speaker Change: With these two significant upgrades to our portfolio, we are looking forward to continued progress with our therapy selection business for the remainder of 2024 and beyond.

Helmy Eltoukhy: Now shifting gears to reveal on slide 16, but we are the leader in tissue-free MRD.

Speaker Change: Now shifting gears to reveal on slide 16, where we are the leader in tissue-free MRD.

Helmy Eltoukhy: I'm excited to share that our Cosmos CRC manuscript with data from our Cosmos colon study looking at stage two and stage three patients was accepted for publication in the peer-reviewed journal Clinical Cancer Research. This study was also submitted to MOLVS for Medicare reimbursement for the CRC surveillance MRD indication. Cosmos are largest MRD studies to date evaluated CTD detection using a tissue free approach and included 1,900 longitudinal surveillance samples from 342 patients representing a median of six samples per patient. Foundation, all patients in this study were able to undergo evaluation without the need for tissue testing.

Speaker Change: I'm excited to share that our COSMOS CRC manuscript, with data from our COSMOS colon study looking at stage 2 and stage 3 patients, was accepted for publication in the peer-reviewed journal Clinical Cancer Research.

Helmy Eltoukhy: This study was also submitted to MOBI-X for Medicare reimbursement for the CRC surveillance MRD indication. Cosmos, our largest MRD study to date, evaluated CT DNA detection using a tissue-free approach and included 1,900 longitudinal surveillance samples from 342 patients, representing a median of six samples per patient. All patients in this study were able to undergo evaluation without the need for tissue testing.

Speaker Change: This study was also submitted to Moldy X for Medicare reimbursement for the CRC Surveillance MRD Indication.

Speaker Change: Cosmos, our largest MRD study to date, evaluated CT DNA detection using a tissue-free approach and included 1,900 longitudinal surveillance samples from 342 patients, representing a median of 6 samples per patient.

Speaker Change: All patients in this study were able to undergo evaluation without the need for tissue testing.

Helmy Eltoukhy: The study demonstrated 98% specificity with 81% longitudinal sensitivity for occurrence in stage two or higher colon cancer, and more than a five months median lead time for CTD-9 detection to recurrence. This data validates the utility of reveal and predicting recurrence in CRC.

Helmy Eltoukhy: This study demonstrated 98% specificity with 81% longitudinal sensitivity for recurrence in stage 2 or higher colon cancer and more than a 5 month median lead time for CT DNA detection to recurrence. This data validates the utility of REVEAL in predicting recurrence in Sears. Turning to slide 17.

Speaker Change: This study demonstrated 98% specificity with 81% longitudinal sensitivity for recurrence in stage 2 or higher colon cancer and more than a 5 month median lead time for CT DNA detection to recurrence.

Speaker Change: This data validates the utility of REVEAL in predicting recurrence in CRC.

Helmy Eltoukhy: Turning this slide 17, beyond CRC surveillance, we have an extensive pipeline of clinical cohorts for establishing validity and utility for Gardenerville. This will be instrumental in building compelling evidence that not only supports efforts to expand reimbursement, but also has the potential to influence changes in practice guidelines.

Helmy Eltoukhy: Beyond CRC surveillance, we have an extensive pipeline of clinical cohorts for establishing validity and utility for Guardant Reveals. This will be instrumental in building compelling evidence that not only supports efforts to expand reimbursement but also has the potential to influence changes in practice guidelines. Looking ahead to the remainder of the year, we anticipate publications that will support submissions to Medicare for potential coverage in breast cancer. Next year, we have important clinical validity studies for additional cancers such as lung, pancreatic, and gastric.

Speaker Change: Turning to slide 17.

Speaker Change: Beyond CRC surveillance, we have an extensive pipeline of clinical cohorts for establishing validity and utility for Guardant Reveals. This will be instrumental in building compelling evidence that not only supports efforts to expand reimbursement, but also has the potential to influence changes in practice guidelines.

Helmy Eltoukhy: Looking ahead to the remainder of the year, we anticipate publications that will support submissions to Medicare for potential coverage and breast cancer. Next year, we have important clinical validity studies for additional cancers such as lung, pancreatic, and gastric.

Speaker Change: Looking ahead to the remainder of the year, we anticipate publications that will support submissions to Medicare for potential coverage in breast cancer. Next year, we have important clinical validity studies for additional cancers such as lungs, pancreatic, and gastric.

Helmy Eltoukhy: Moving on to slide 18. We are excited by the demand we are seeing in the tissue-free MRD market, and there are multiple near-term inflection opportunities in 2025. As I just discussed, we are making good progress towards CRC surveillance reimbursement, which will improve our ASA. We are also continuing to make very good progress in our COGS reduction initiatives for Revealed. As a reminder, these two milestones will be a significant step towards our long-term goal of achieving greater than 60% gross margins for our MRD business.

Helmy Eltoukhy: Moving on to slide 18, we are excited by the demand we are seeing in the tissue-free MRD market, and there are multiple near-term inflection opportunities in 2025. As I just discussed, we are making good progress towards CRC surveillance reimbursement, which will improve our ASD. We are also continuing to make very good progress in our COGS reduction initiatives for Reveal. As a reminder, these two milestones will be a significant step towards our long-term goal of achieving greater than 60% gross margins for our MRD business. While we are seeing strong growth and strong market appetite for Reveal, we continue to manage volumes to minimize cash burn and will continue to do so until Reveal of gross margin positive, which we anticipate in 2025.

Speaker Change: Moving on to slide 18. We are excited by the demand we are seeing in the tissue-free MRD market, and there are multiple near-term inflection opportunities in 2025.

Speaker Change: As I just discussed, we are making good progress towards CRC surveillance reimbursement, which will improve our ASD. We are also continuing to make very good progress in our COGS reduction initiatives for Revealed.

Speaker Change: As a reminder, these two milestones will be a significant step towards our long-term goal of achieving greater than 60% gross margins for our MRD business.

Helmy Eltoukhy: While we are seeing strong growth and strong market appetite for Reveal, we continue to manage volumes to minimize cash burn and will continue to do so until Reveal is gross margin positive, which we anticipate in 2025. With that, I will now turn the call over to Mike for more detail on our financials. Thanks, Helmy.

Speaker Change: While we are seeing strong growth and strong market appetite for Reveal, we continue to manage volumes to minimize cash burn and will continue to do so until Reveal is gross margin positive, which we anticipate in 2025. With that, I will now turn the call over to Mike for more detail on our financials.

Michael Bell: With that, I will now turn the call over to Mike for more detail on our financials. Thanks, tell me. Turning to slide 19, I'll discuss our revenue results for the three months ended June 30, 2024, and refer to year-over-year growth rates unless otherwise noted. Total revenue grew 29% to $177.2 million, run by precision oncology revenue, which increased 33% to 166.5 million. Precision oncology revenue from clinical tests increased 30% to 130.2 million. Clinical test volume grew to a record 49,400 tests in Q2 2024. Clinical volume growth of 14% was in line with our expectations, which factored in the uptick in volume we experienced in the second quarter of 2023 following the Gardner 360 CDx approval for ESL1.

Mike Bell: Turning to slide 19, I'll discuss our revenue results for the three months ended June 30, 2024, and refer to year-over-year growth rates, unless otherwise noted. Total revenue grew 29% to $177.2 million, driven by Precision Oncology revenue, which increased 33% to $166.5 million. Precision Oncology revenue from clinical tests increased 30% to $130.2 million. Clinical test volume grew to a record 49,400 tests in Q2

Mike: Thanks Helmy

Mike: Turning to slide 19, I'll discuss our revenue results for the three months ended June 30, 2024, and refer to year-over-year growth rates, unless otherwise noted.

Mike: Total revenue grew 29% to $177.2 million, driven by precision oncology revenue, which increased 33% to $166.5 million.

Mike: Precision Oncology Revenue from Clinical Tests increased 30% to $130.2M. Clinical test volume grew to a record 49,400 tests in Q2 2024.

Mike Bell: Clinical volume growth of 14% was in line with our expectations, which factored in the uptick in volume we experienced in the second quarter of 2023, following the Guardant 360 CDX approval for ESL-1. For the second quarter of 2024, we again saw year-over-year volume growth for Guardant 360 in the U.S., increased volume contribution from Japan and the U.K., and strong volume growth for both reveal and tissue neck. For Our biopharma business performed incredibly well in the second quarter, with precision oncology revenue from biopharma tests totalling $36.2 million, increasing 45%. This exceptional growth was fuelled by a record number of tests in the second quarter, 10,475, which was up 56%.

Mike: Clinical volume growth of 14% was in line with our expectations, which factored in the uptick in volume we experienced in the second quarter of 2023 following the Guardant 360 CDX approval for ESL-1.

Michael Bell: For the second quarter of 2024, we again saw year-of-year volume growth for Gardner 360 in the US, increased Gardner 360 volume contribution from Japan and the UK, and strong volume growth for both Reveal and Tissue Next. For the full year 2024, we continue to expect clinical volume growth to be approximately 20%. Our biopharma business performed incredibly well in the second quarter, with precision oncology revenue from biopharma tests to 36.2 million, increasing 45%. This exceptional growth was fueled by a record number of tests in the second quarter, 10,475, which was of 56%. We continue to expect our biopharma business to perform well and have increased our biopharma revenue growth expectation for the full year 2024 to now be in the high teens, compared to our previous expectation of low teens revenue growth.

Speaker Change: For the second quarter of 2024, we again saw year-over-year volume growth for Gardner 360 in the U.S., increased Gardner 360 volume contribution from Japan and the U.K., and strong volume growth for both Reveal and TissueNext.

Speaker Change: For the full year 2024, we continue to expect clinical volume growth to be approximately 20%.

Speaker Change: Our biopharma business performed incredibly well in the second quarter, with precision oncology revenue from biopharma tests tussling $36.2 million, increasing 45%.

Speaker Change: This exceptional growth was fueled by a record number of tests in the second quarter, 10,475, which was up 56%.

Mike Bell: We continue to expect our biopharma business to perform well and have increased our biopharma revenue growth expectation for the full year 2024 to now be in the high teens, compared to our previous expectation of low teens revenue growth. Finally, Development Services and Other Revenue totaled $10.7 million. Turning to Garmin 360 ASPs on slide 20.

Mike: We continue to expect our biopharma business to perform well and have increased our biopharma revenue growth expectation for the full year 2024 to now be in the high teens.

Mike: Compared to our previous expectation of low teens revenue growth.

Michael Bell: Finally, development services another revenue totaled $10.7 million.

Mike: Finally, Development Services and Other Revenue totaled $10.7 million.

Michael Bell: Turning to Garmin 360 ASPs on slide 20. We're very pleased to report that we again saw strong cash collections for Garmin 360 in the second quarter of 2024 through and by continued improvements in both Medical Advantage and commercial reimbursement. These improvements led to a step up in the Garmin 360 ASP range to $2,950 to $3,000. An increase from the range of $2,900 to $2,950 in Q1 2024 and from approximately $2,650 in Q2 2023.

Mike: Turning to Garmin 360 ASPs on slide 20.

Mike Bell: We're very pleased to report that we again saw strong cash collections for Guardant 360 in the second quarter of 2024, driven by continued improvement in both Medicare Advantage and commercial reimbursement. These improvements led to a step up in the Guardant 360 ASP range to $2,950 to $3,000. This is an increase from the range of 2,900 to 2,950 in Q1 2024 and from approximately 2,650 in Q2 2023. These improved trends also give us confidence that the Guardant 360 ASP can remain in this new range for the remainder of 2024.

Speaker Change: We are very pleased to report that we again saw strong cash collections for Garden360 in the second quarter of 2024, driven by continued improvements in both Medicare Advantage and commercial reimbursement.

Mike: These improvements led to a step up in the Guardant 360 ASP range to $2,950 to $3,000.

Mike: An increase from the range of 2,900 to 2,950 in Q1 2024 and from approximately 2,650 in Q2 2023.

Michael Bell: These improved trends also give us confidence that the Garmin 360 ASP can remain in this new range for the remainder of 2024. In Q2 2024, we also had a review upside of approximately $8 million related to cash collected per Garmin 360 test performed in prior periods. This was similar to the upside we recorded in Q1 2024 and reflects the continued tailwind of improved collections.

Mike: These improved trends also give us confidence that the Guardant 360 ASP can remain in this new range for the remainder of 2024.

Mike Bell: In Q2 2024, we also had a revenue upside of approximately $8 million related to cash collected for Guardant 360 tests performed in prior periods. This was similar to the upside we recorded in Q1 2024 and reflects the continued tailwind of improved collections. Although it's early days, we believe we will achieve the long-term ASP targets we presented at our investor day earlier than originally anticipated, which could potentially bring forward our timeline to reach company-wide caseload breaking.

Mike: In Q2 2024, we also had a revenue upside of approximately $8 million related to cash collected per Guardant 360 test performed in prior periods.

Mike: This was similar to the upside we recorded in Q1 2024 and reflects the continued tailwind of improved collections.

Michael Bell: Although it's early days, we believe we will achieve the long-term ASP targets we presented at our investor date earlier than originally anticipated, which could potentially bring forward our timeline to reach company-wide cash flow break-even.

Mike: Although it's early days, we believe we will achieve the long-term ASP targets we presented at our Investor Day earlier than originally anticipated, which could potentially bring forward our timeline to reach company-wide cash flow break-even.

Michael Bell: Moving on to non-GAAP financial measures on slide 21. Our non-GAAP growth margin excluding screening, which reflects our therapy selection and MRD businesses, was 62% in the second quarter of 2024 and was in line with our full year guidance of 61% to 63%. Compared to Q2 2023, non-GAAP growth margin excluding screening decreased to a 62% from 64% due to test and revenue mix.

Mike Bell: Moving on to non-GAAP financial measures, slide 21, our non-GAAP gross margin excluding screening, which reflects our therapy selection and MRD businesses, was 62% in the second quarter of 2024 and was in line with our full year guidance of 61 to 63%. Compared to Q2 2023, Nungap gross margin excluding screening decreased to 62% from 64% due to test and revenue mix. Specifically, in Q2 2024, we saw an increase in the mix of negative gross margin revealing tests in the Precision Oncology revenue line.

Speaker Change: Moving on to non-GAAP financial measures on slide 21.

Mike: Our non-GAP gross margin excluding screening, which reflects our therapy selection and MRD businesses, was 62% in the second quarter of 2024 and was in line with our full year guidance of 61-63%.

Mike: Compared to Q2 2023, Nungap gross margin excluding screening decreased to 62% from 64% due to test and revenue mix.

Michael Bell: Specifically, in Q2 2024, we saw an increase in the mix of negative growth margin reveal test in the precision oncology revenue line. As well as a decrease in the mix of 100% growth margin, milestone, and royalty revenue in the development services, another revenue line.

Speaker Change: Specifically, in Q2 2024, we saw an increase in the mix of negative gross margin reveal tests in the Precision Oncology Revenue line, as well as a decrease in the mix of 100% gross margin milestone royalty revenue in the Development Services and Other Revenue line.

Mike Bell: As well as a decrease in the mix of 100% gross margin milestone and royalty revenue in the development services and other revenue lines. Non-GAP operating expenses were $178.8 million, a reduction of $1.7 million compared to the prior year quarter. This decrease was primarily driven by lower clinical study costs following the completion of Eclipse enrolment in Q3 last year and a decrease in G&A expenses. However, these decreases were offset by an increase in sales and marketing expenses in preparation for the Shield IVD commercial launch and in support of the continued growth of our therapy selection and MRD revenue. We continue to tightly control our operating expenses by leveraging the infrastructure we've built to support all of our businesses and by gating our commercial spend on specific milestones.

Michael Bell: Non-GAAP operating expenses were 178.8 million, a reduction of 1.7 million compared to the prior year quarter. This decrease was primarily driven by lower clinical study costs following the completion of Eclipsome Reulmans in Q3 last year and a decrease in GNA expense. These decreases were offset by an increase in sales and marketing expense in preparation for the Shield-IVD commercial launch and its support of the continued growth of our therapy selection and MRD revenue. We continue to tightly control our operating expenses by leveraging the infrastructure we've built to support all of our businesses and by gating our commercial spend on specific milestones.

Mike: Non-GAP operating expenses were $178.8 million.

Mike: a reduction of one point seven million compared to the prior year quarter this decrease was primarily driven by a lower clinical cityy costs following the completion of ecllistone rollment in q three last year and a decrease in gna expense

Mike: These decreases were offset by an increase in sales and marketing expense in preparation for the Shield IVD commercial launch and in support of the continued growth of our therapy selection and MRD revenue.

Mike: We continue to tightly control our operating expenses by leveraging the infrastructure we've built to support all of our businesses.

Mike: and by gating our commercial spend on specific milestones.

Michael Bell: For the second half of 2024, we expect R&D and GNA expenses to be similar to the first half of the year and expect sales and marketing expense to increase now that we're firmly in those launch phase for Shield, and we'll be ramping up the number of field sales reps to 100 by the end of the year.

Mike Bell: For the second half of 2024, we expect R&D and G&A expenses to be similar to the first half of the year and expect sales and marketing expenses to increase now that we're firmly in the large phase for Shield and we'll be ramping up the number of field sales reps to 100 by the end of the year. As a result of our increased revenue and reduction in operating expenses, our adjusted EBITDA loss was $61.9 million in Q2 2024, a decrease of $23.3 million from $85.2 million in Q2 2023.

Mike: For the second half of 2024, we expect R&D and G&A expenses.

Mike: To be similar to the first half of the year, and expect sales and marketing expense to increase now that we're firmly in those large phase for Shield, and we'll be ramping up the number of field sales reps to 100 by the end of the year.

Michael Bell: As a result of our increased revenue and reduction in operating expenses, our adjusted even with our loss of 61.9 million in Q2 2024, a decrease of 23.3 million from 85.2 million in Q2 2023. Precashler for the second quarter of 2024 was negative 99.1 million dollars compared to negative 100.5 million in Q2 2023. The year of a year change reflects a decrease in operating cash burn and equipment purchases, offset by an increase in the annual bonus payout, which is made in April each year.

Speaker Change: As a result of our increased revenue and reduction in operating expenses, our adjusted EBITDA loss was $61.9 million in Q2 2024, a decrease of $23.3 million from $85.2 million in Q2 2023.

Mike Bell: Pre-cash flow for the second quarter of 2024 was negative $99.1 million compared to negative $100.5 million in Q2 2023. The year-over-year change reflects a decrease in operating cash burn and equipment purchases, offset by an increase in the annual bonus payout, which is made in April each year.

Speaker Change: Pre-cash flow for the second quarter of 2024 was negative $99.1 million, compared to negative $100.5 million in Q2 2023.

Speaker Change: The year-over-year change reflects a decrease in operating cash burn and equipment purchases, offset by an increase in the annual bonus payout, which is made in April each year.

Michael Bell: We ended the second quarter of 2024 with over 1 billion dollars in cash, which we continue to believe is sufficient to enable us to achieve our goal of reaching cash flow break even by 2028 or potentially earlier.

Mike Bell: We ended the second quarter of 2024 with over $1 billion in cash, which we continue to believe is sufficient to enable us to achieve our goal of reaching cash flow break-even by 2028 or potentially earlier. Now turning to our Outlook and Assumptions for the full year 2024 on slide 22. We're pleased to be able to increase our revenue guidance and now expect full year 2024 revenue to be in the range of $690 to $700 million, representing growth of approximately 22 to 24% compared to 2023.

Speaker Change: We ended the second quarter of 2024 with over $1 billion in cash, which we continue to believe is sufficient to enable us to achieve our goal of breaching cash flow break-even by 2028 or potentially earlier.

Michael Bell: Now turning to our outlook in assumptions for the full year 2024 on slide 22. We're pleased to be able to increase our revenue guidance and now expect full year 2024 revenue to be in the range of 690 to 700 million, representing growth of approximately 22 to 24% compared to 2023. This increase reflects the cash collection upside we had in the second quarter. The increase in the garland 360 ASP that we expect for the remainder of the year and the increased full year expectation for our biopharma business.

Speaker Change: Now turning to our Outlook and Assumptions for the full year 2024 on slide 22.

Speaker Change: We're pleased to be able to increase our revenue guidance and now expect full year 2024 revenue to be in the range of $690 to $700 million, representing growth of approximately 22 to 24% compared to 2023.

Mike Bell: This increase reflects the cash collection upside we had in the second quarter, as well as the increase in the Garland 360 ASP that we expect for the remainder of the year and the increased full year expectation for our biopharma business. As a reminder, this review guidance does not include any contribution from Screening. Although we've now successfully launched SHIELD IV, obtained Medicare coverage, and started to receive samples into the lab, it's still very early days, and the Medicare capsule rate has yet to be established.

Speaker Change: This increase reflects the cash collection upside we had in the second quarter, the increase in the Garland 360 ASP that we expect for the remainder of the year, and the increased full year expectation for our biopharma business.

Michael Bell: As a reminder, this revenue guidance does not include any contribution from screening.

Speaker Change: As a reminder, this review guidance does not include any contribution from Screening.

Michael Bell: Although we've now successfully launched SHIELD-IVD, obtained medical coverage, and started to receive thungles into the lab, it's still very early days, and the medical gap full rate has yet to be established. As such, we'll begin to provide screening revenue guidance at a more appropriate time in the future.

Speaker Change: Although we've now successfully launched SHIELD-IVD, obtained Medicare coverage and started to receive samples into the lab, it's still very early days and the Medicare gap fill rate is yet to be established.

Mike Bell: As such, we'll begin to provide screening review guidance at a more appropriate time in the future. We continue to expect non-gap gross margin excluding screening to be in the range of 61 to 63 percent, and Non-Gap Operating Expenses to be in a range of $720 million to $730 million, representing a flat to 1% decline year-over-year. Finally, we continue to expect free cash flow for 2024 will be in the range of negative $275 to $285 million, an improvement of $60 to $70 million compared to 2023, and that our therapy selection business will deliver positive free cash flow for the full year 2024.

Speaker Change: As such, we will begin to provide screening review guidance at a more appropriate time in the future.

Michael Bell: We continue to expect non-GAAP growth margin expedient screening to mean the range of 61 to 63% and non-GAAP operating expenses to mean a range of 720 to 713 million, representing a black to 1% decline year of year. Finally, we continue to expect free cash flow for 2024 will be in the range of negative 275 to 285 million, an improvement of 60 to 70 million compared to 2023, and that our therapy selection business will deliver positive free cash flow for the full year 2024. We also continue to expect the maximum screening cashflow this year to be 175 million.

Speaker Change: We continue to expect non-GAP gross margin excluding screening to be in the range of 61-63%, and non-GAP operating expenses to be in the range of $720-730 million, representing a flat to 1% decline year-over-year.

Speaker Change: Finally, we continue to expect free cash flows for 2024 will be in the range of negative $275 to $285 million.

Speaker Change: an improvement of $60-$70 million compared to 2023 and that our therapy selection business will deliver positive free cash flow for the full year 2024.

Mike Bell: We also continue to expect the maximum screening cash flow this year to be $175 million. Our increased revenue expectation enables us to maintain this free cash flow range while providing us with further flexibility to manage potential working capital fluctuations in the back half of the year, as well as the potential to bring forward capital purchases to accelerate our capacity expansion and automation efforts. Finally, turn to slide 23 to review our catalyst.

Speaker Change: We also continue to expect the maximum screening cash burden this year to be $175 million.

Michael Bell: Our increased revenue expectation enables us to maintain this free cashflow range while providing us with further flexibility to manage potential working capital fluctuations in the back half of the year, as well as the potential to bring forward capital purchases to accelerate our capacity expansion and automation efforts.

Speaker Change: Our increased revenue expectation enables us to maintain this free cash flow range, while providing us with further flexibility to manage potential working capital fluctuations in the back half of the year.

Speaker Change: As well as the potential to bring forward capital purchases to accelerate our capacity expansion and automation efforts.

Michael Bell: Finally, turn to slide 23 to review our capitalists. We've already made significant progress on masters across each of our business areas in the first half of the year.

Mike Bell: We've already made significant progress on milestones across each of our business areas in the first half of the year, and as we look ahead to the rest of 2024, we're very excited by the potential opportunities across therapy selection, MRD, and screening. With that, we'll now open the call to questions.

Speaker Change: finally turns to ide twenty-three to review our catalyst

Speaker Change: We've already made significant progress on milestones across each of our business areas in the first half of the year.

Michael Bell: As we look ahead to the rest of 2024, we're very excited by the potential opportunities across therapy selection, MRD, and screening.

Speaker Change: As we look ahead to the rest of 2024, we are very excited by the potential opportunities across therapy selection, MRD and screening.

Tomia: With that, we'll now open the call to questions. Questions. We will now begin the question and answer session. If you would like to ask a question, please press star followed by one on your telephone keypad. If, for any reason at all, you would like to remove that question, please press star followed by two. Again, to ask a question, please press star one. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking your question.

Unknown Moderator: We will now begin the question and answer session. If you would like to ask a question, please press star followed by one on your telephone keypad. If, for any reason at all, you would like to remove that question, please press star followed by two. Again, to ask a question, please press star one. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking your question. You may proceed.

Speaker Change: With that, we'll now open the call to questions.

Speaker Change: We will now begin the question and answer session.

Speaker Change: if you would like to ask a question please press star followed by one on your telephone keypad

Speaker Change: If for any reason at all you would like to remove that question, please press star followed by 2.

Speaker Change: Again, to ask a question, please press star 1. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking your question. The first comes from Mark Massaro with BTIG. You may proceed.

Mark Massaro: The first comes from Mark Massaro with BTIG; you may proceed. Hey guys, thank you for the questions. The first one is for Helmy. Good to see the Cosmos Study come out and submit for publication. Can you just discuss perhaps what your expectations are on Medicare coverage in the CRC surveillance space. Obviously, Natera has an indication there. They are tumor informed; your blood. Do you think you could do that? I think you can sort of effectively crosswalk to that particular coverage, or do you think you might need a new Medicare coverage decision.

Mark Massaro: Hey guys, thank you for the questions. The first one is for Helmy. Good to see the Cosmos study come out and be submitted for publication. Can you just discuss, perhaps, what your expectations are for Medicare coverage in the CRC surveillance space? Obviously, Natera has an indication there, they are tumor and

Speaker Change: Hey guys, thank you for the questions. The first one is for Helmy.

Speaker Change: Good to see the COSMOS study come out and submit for publication.

Speaker Change: Can you just discuss perhaps what your expectations are on Medicare coverage in the CRC surveillance space?

Speaker Change: obviously the terra has an indication there they are tumor informed your blood do you think you can sort of effectively crosswalk to that particular coverage or do you think you might need a new net new medicare coverage decision

Helmy Eltoukhy: Yeah, no, so we, thanks for the question, Mark. You know, as a reminder, we already do have coverage in the adjuvant setting, for Garden Reveal. And so essentially, the aim of this publication, and this data is to get us the sort of second half of the indication, which is the surveillance setting in terms of testing patients that are further out at multiple time points. Right now we're covered for three time points, if they're within the first, at least if the first is within the first 12 months, of Treatment, and so, yeah, this study was designed essentially with Medicare coverage in mind, and so we're very pleased with the outcome of the study, very pleased with the publication, and it has already been submitted to MLBX, as we said, and prepared remarks, and we believe it qualifies under the current LCD that exists.

Helmy Eltoukhy: Thanks for the question, Mark. As a reminder, we already do have coverage in the adjuvant setting for Garden Reveal. Essentially, the aim of this publication and this data is to get us a second half of the indication, which is a surveillance setting in terms of testing patients that are further out at multiple time points. Right now, we are covered for three time points, at least at the first is within the first 12 months of treatment. This study was designed, essentially, with Medicare coverage in mind. We are very pleased with the outcomes of the study, very pleased with the publication.

Speaker Change: Thanks for the question, Mark. As a reminder, we already do have coverage in the adjuvant setting.

Speaker Change: and Reveal. And so essentially the aim of this publication and this data is to get us the sort of second half of the indication, which is a surveillance setting in terms of testing patients that are further out at multiple time points.

Speaker Change: Right now we're covered for three time points, if they're within the first, at least if the first is within the first 12 months.

Speaker Change: of treatment. And, and, and so yeah, we this study was designed

Speaker Change: essentially.

Speaker Change: with Medicare coverage in mind. And so we're very pleased with the outcome of the study, very pleased with the publication, and it has already been submitted to MLBX as we said in prepared remarks, and we believe it qualifies under the current LCD that exists.

Helmy Eltoukhy: It has already been submitted. We have prepared remarks, and we believe it qualifies under the current LCD that exists.

Mark Massaro: And then I wanted to ask about the potential for ADLT status on Shield. You know, many of the lab tests today that have ADLT status are not for asymptomatic screening tests. So I'm just curious if you think that your ADLT application might follow a similar timeline as some of the other tests that have obtained it, and I'm just curious if you've had any dialogue that could give you a sense for the timing expectation there.

Mark Massaro: And then I wanted to ask about the potential for ADLT status on SHIELD. You know, many of the lab tests today that have ADLT status are not for asymptomatic screening tests. So I'm just curious if you think that your ADLT application might follow a similar timeline as some of the other tests that have obtained it. And I'm just curious if you've had any dialogue that could give you a sense of the timing expectation there.

Speaker Change: And then I wanted to ask about the potential for ADLT status on SHIELD.

Speaker Change: You know, many of the lab tests today that have ADLT status are not for asymptomatic screening tests.

Speaker Change: So I'm just curious if you think that your ADLT application might follow a similar timeline as some of the other tests that have obtained it, and I'm just curious if you've had any dialogue that could give you a sense for the timing expectation there. Thank you.

Helmy Eltoukhy: Thank you. Thank you, Mark. So, in terms of ADLT criteria to get the designation, it's very clear. It's the criteria for that is very clear on that need FDA approval would get the designation. We have to just go through the process together in terms of timeline. Our best estimate is going to be some time within 2025. We'll get our code and get the ADLT status and activates the favorable Medicare pricing enabled by that pay deal.

AmirAli Talasaz: Thank you. Yeah, thank you, Mark. So, enjoy it.

AmirAli Talasaz: Yeah, thank you, Mark. So in terms of ADLT criteria to get the designation, it's very clear. The criteria for that are very clear, unmet need, FDA approval, we get the designation; we have to just go through the process to get our clothes and get the ADLT status, and activates the PrEP. Favorable Medicare pricing enabled by that designation.

Speaker Change: Yeah, thank you, Mark. So in terms of ADLT criterias to get the designation, it's very clear.

Mark: The criteria for that is very clear. Unmet need. FDA approval. We get the designation. We have to just go through the process.

Speaker Change: To get it, in terms of timeline, our best estimate is going to be sometime within 2025.

Speaker Change: We get our code and get the ADLT status and activate the PrEP.

Helmy Eltoukhy: University of Designation.

Speaker Change: Favorable Medicare pricing enabled by that ADLT designation.

Helmy Eltoukhy: Thank you.

Dan Brennan: Thank you. The next question comes from Dan Brennan with TD Cowan. You may proceed.

Daniel Brennan: The next question comes from Dan Brennan with T.D. Callin. You may proceed. Great. Thank you. Thanks for the questions. Congrats on the quarter.

Speaker Change: Thank you. The next question comes from Dan Brennan with TD Cowan. You may proceed.

Dan Brennan: Great, thank you. Thanks for taking the questions. Congratulations on the quarter.

AmirAli Talasaz: Maybe the first one, AmirAli. I think you discussed in the prepared remarks how, given the first mover advantage that you have, which field do you think other blood tests will not be viable if they don't meet your performance? Maybe you could just expand on that a little bit. Are you referring to, I mean, the NCD is obviously 74 and 90. So are you thinking lack of FDA approval, or are you contemplating that you think the first mover is going to afford you this really, you know, unpenetrable kind of position?

AmirAli Talasaz: Maybe the first one. AmirAli, I think you discussed in the prepared remarks how, given the first mover advantage that you have with Chio, do you think other blood tests will not be viable if they don't meet your performance?

Dan Brennan: Great, thank you. Thanks for taking the questions. Congrats on the quarter.

Dan Brennan: Maybe the first one, Amirali, I think you discussed in the prepared remarks.

Dan Brennan: How given the first mover advantage that you have with SHIELD, do you think other blood tests will not be viable?

AmirAli Talasaz: Maybe could you just expand on that a little bit? Are you referring to me? The NCD is obviously 74 and 90. So are you thinking lack of FDA approval, or are you contemplating? I think the first mover is going to afford you this really, you know, unpenetrable kind of position. Because obviously, exact, I think spoke, you know, recently about their own performance. So let they expect on their blood tests, and they're expecting some more performance and possible superiority in AA.

Speaker Change: If they don't meet your performance, maybe could you just expand on that a little bit? Are you referring to, I mean the NCD is obviously 74 and 90, so are you thinking lack of FDA approval? Or are you contemplating, you think the first mover is going to afford you this really, you know,

AmirAli Talasaz: Because obviously XACT, I think, spoke recently about their own performance or what they expect in their blood tests, and they're expecting similar performance and possible superiority in AAs. Maybe just unpack a little bit. This won't be a viable comment and the competitive profile of Shield.

Speaker Change: Unpenetrable kind of position because obviously XACT I think spoke you know recently about their own performance or what they expect on their blood tests and they're expecting similar performance and possible superiority in AAs. Maybe just unpack a little bit this won't be viable comment and the competitive profile of SHIELD

AmirAli Talasaz: Maybe just unpack a little bit. This won't be a viable comment in the competitive profile of SHIELD. Yeah, so interesting. You know, we are hearing in this market a lot of talk versus even a slide of a presentation of a data. But, you know, I think now with our first line indication, FDA approval with the performance of CRC that we have with a long lead time advantage that we have relative to anybody else in this marketplace. I think we believe this performance of CRC would be the barrier in our viable product, in order to get favorable FDA approval.

AmirAli Talasaz: Yeah, so interesting. You know, we are hearing in this market a lot of talk versus just a slide presentation on the data. But you know, now with our first-line indication FDA approval and the performance of CRC, we have a long lead time advantage that we have relative to anybody else in this marketplace. I think we believe this performance of CRC would be the barrier in order to have a viable product, in order to get favorable FDA approval, getting first-line indications similar to us.

Speaker Change: Yeah, so interesting, you know, we are hearing in this market a lot of talk versus even a slide of a presentation of a data, but you know, I think

Speaker Change: Now, with our first-line indication, FDA approval with the performance of CRC that we have, with a long lead time advantage that we have relative to anybody else in this marketplace.

Speaker Change: I think we believe this performance of CRC

Speaker Change: What would be the barrier in order to have a viable product, in order to get favorable FDA approval, getting first-line indications similar to us?

AmirAli Talasaz: I think first line indication similar to us. And then making sure that the test would become fairly successful in the eye of the physician.

AmirAli Talasaz: and then making sure that the test would be commercially successful in the eye of the physician. When you look at all of the pieces that need to fall into place, it's hard for us to sit here and imagine a device with a lower performance would even be able to achieve any of these milestones. But we'll see. I think at some point, the field needs to go from just talking the talk to the reality of what kind of data people have. We are very confident with the position that we are sitting in right now.

Speaker Change: and then making sure that the test would be commercially successful in the eye of the physician when you look at all of the pieces that need to fall into the place.

AmirAli Talasaz: When you look at all of the pieces that need to fall into place, it's hard for us to sit here and imagine a device with a lower performance with even be able to get any of these files from that sheet. So, but we'll see. I think at some point, the field needs to go from just talking the talk to the reality of what kind of data people have. We are very confident with the position that we're sitting right now.

Speaker Change: It's hard for us to sit here and imagine a device with a lower performance would even be able to get any of these milestones achieved. But we'll see, I think, at some point.

Speaker Change: The field needs to go from just talking the talk to the reality of what kind of data people have. We are very confident with the position that we are sitting in right now.

AmirAli Talasaz: Great. Thank you for that.

Dan Brennan: Great, thank you for that. And there may be one more.

Michael Bell: And then maybe one just more tactically just on the screen in the quarter with biopharma. It's a really healthy beat. I think you updated your guidance from low teams to high teams. Can you just speak to kind of what you saw on the quarter that kind of drove the extent of that beat? And their updated guide mic, I think reflects a pretty material, obviously, not going to go 56 percent, but to get the high teams, I think we reflect a pretty steep slowdown on the die care for this. So, anything in common on what's going on in biopharma, what the die care for your guide employees.

Speaker Change: thank you that and maybe one just more tactically just on the strength in the quarter with bile phar it s really healthy beat

Speaker Change: I think you updated your guidance from low teams to high teams. Can you just speak to kind of what you saw in the quarter that kind of drove the extent of that beat?

Mike: and their updated guide, Mike, I think reflects a pretty material, obviously you're not going to go 56%, but to get to high teens, I think will reflect a pretty steep slowdown in the diet care for the SRO. Anything you can comment on what's going on in biopharma and what the diet care for your guide implies. Thank you.

Michael Bell: Thank you.

Puneet Souda: And I'd both charge and Mike, we can fill in the rest. Yeah, a lot of this has to do with infinity, infinity with its sort of epigenomic footprint, with its modularity in terms of being able to do monitoring or comprehensive profiling. We've seen a lot of uptake of that test and that platform by biopharma. And so that I think what you're seeing is the fruits of that investment we've made over the last few years. Other elements are just the scope of our offering, not only the sort of regulatory competency that we have in terms of bringing essentially regulated products to market on behalf of biopharma, such as companion diagnostic products, but also our global reach. We are really seeing a healthy pipeline build up in China right now that I think of high interest to a lot of the major global biopharma companies.

Unknown Executive: And they're both charged. And Mike, you can fill in the rest. Yeah, no, a lot of this has to do with infinity. Infinity with its sort of epigenomics.

Mike: in abe charge in mike we can se in the rest yeah i know a lot of this has to do with infinity

Mike: Infinity, with its sort of epigenomic footprint, with its modularity in terms of being able to do monitoring or comprehensive profiling. We've seen a lot of uptake of that test and that platform by Biopharma. And so that I think what you're seeing is the fruits.

Mike: of that investment we've made over the last few years. Other elements are just the scope of our offering, not only the sort of regulatory competency that we have in terms of bringing essentially regulated products to market on behalf of Biopharma such as companion diagnostic products.

Mike: but also our global reach.

Mike: We are releasing a healthy pipeline build up in China right now that's, I think, of high interest to a lot of the major global biopharma companies. And then I'll let maybe Mike talk about this sort of ramp up.

AmirAli Talasaz: And then I'll let maybe Mike talk about this sort of ramp up. Yeah, you know, we had a we've had a really strong first. I think, you know, we're really pleased to be able to increase our guide for the full year now to go from low teens to high teens. I think as we look in the second half of the year, you know, we still got a strong pipeline. It's a very, it's a very lumpy business, you know, it depends a lot on the timing of the samples that we get through the door. And so we've had, you know, yeah, really strong volume in the first half.

Unknown Executive: Yeah, you know, we've had a really strong first half, I think, you know, we're really pleased to be able to increase our guide for the full year now to go from low teams to high teams. And I think as we look at the second half of the year, you know, we still have a strong pipeline.

Mike: Yeah, you know, we've had a really strong first half. I think, you know, we're really pleased to be able to

Mike: Increase our guide for the full year now to go from low teens to high teens. And I think as we look in the second half of the year, you know, we still got a strong pipeline.

Mike: It's a very lumpy business, you know, it depends a lot on the timing of the samples that we get, we get through the door. And so we've had, you know,

Michael Bell: I wouldn't call it, you know, a real slow down in the second half of the year, but I think we've had a boil in Q2. So we think we'll still have a very strong. But we're strong second half of 2024. And yeah, you know, again, we're really pleased to be able to increase the guidance to high teens revenue growth.

Speaker Change: Yeah, really strong volume in the first half. I wouldn't call it, you know, a real slowdown in the second half of the year, but I think we've had a bolus in in Q2. So we think we'll still have a very strong.

Mike: Very strong second half of 2024. And yeah, you know, again, we're really pleased to be able to increase the guidance to high teens revenue growth.

Michael Bell: Thank you.

Puneet Souda: Thank you. The following comes from Puneet Souda with Learing Partners. You may proceed.

Puneet Souda: The following conference will meet Suda with leering partners. You may proceed. Yeah, hi guys. Thanks for taking my questions and, you know, congrats on the strong beat here. You know, maybe first one for primarily, I mean, look, you know, congrats on the FDA approval, and then you received CMS coverage as well. I mean, you continue to win on things that were generally questioned in the investors' fair. I mean, the first line in FDA approval and then CMS coverage.

Mike: Thank you. The following come from Puneet Souda with Learing Partners. You may proceed.

Puneet Souda: Yeah, hi, guys. Thanks for taking my questions. And, you know, congrats on the strong beat here.

Puneet Souda: Yeah, hi guys. Thanks for taking my questions and, you know, congrats on the strong beat here.

Puneet Souda: You know, maybe first one for Amir Ali, I mean, look, you know, congrats on the FDA approval and then you received CMS coverage as well. I mean, you continue to win on things that were generally questioned in the investors fair. I mean, the first line in FDA approval and then CMS coverage.

AmirAli Talasaz: So I wanted to address something that is coming up more in questions lately. And that's really the cash pay price here: 1495. I assume you're going to pursue that into an ADLT, but just help us understand this is, you know, significantly above the current non-screening, I mean, non-invasive CRC screening products on the market. So what's your rationale behind it? You know, this is what's the rationale behind the elevated pricing?

Speaker Change: I wanted to address something that is coming up more in questions lately, and that's really the cash pay price here.

Speaker Change: 1495. I assume you're going to be pursuing that into an ADLT.

Speaker Change: But just help us understand, this is, you know, significantly above the current non-screening, I mean, non-invasive CRC screening products on the market. So what's your rationale behind it? You know, what's the rationale behind this elevated pricing?

AmirAli Talasaz: I'm going to, so maybe I can share with you the rationale behind our pricing strategy for Shield. You know, first and the most important thing is based on the value. This 1495 in our view, you added quickly reflects the value of shield and marketplace. How just by the health outcome benefits that we're going to see, like we just published our health outcome modeling results, you can see them out of life here again and the value that we're putting on table is calculatable that what's the economy called value of that. Bringing on the screen patient population to the screening table and adding those life years, reducing the cost associated retreating and managing CRC, is going to have tremendous value to the system.

Puneet Souda: You know, maybe the first one for AmirAli, I mean, look, you know, congrats on the FDA approval, and then you received CMS coverage as well. I mean, you continue to win on things that were generally questioned at the investors fair. I mean, the first line in FDA approval and then CMS coverage. So I wanted to address something that has been coming up more in questions lately. And that's really the cash pay price here. 1495.

Speaker Change: Thank you, Puneet. So maybe I can share with you the rationale behind our fighting strategy for SHIELD.

AmirAli Talasaz: I assume you're going to be pursuing that into an ADLT. But just help us understand this is, you know, significantly above the current non-screening, I mean, non-invasive CRC screening products on the market. So what's your rationale behind it? You know, what's the rationale behind this elevated pricing?

Speaker Change: You know, first, and the most important thing is based on the value, this $14.95 in our view, it adequately reflects the value of SHIELD.

AmirAli Talasaz: Thank you, Puneet. So maybe I can share with you the rationale behind our pricing strategy for SHIELD. You know, first, and the most important thing is based on the value, this $14.95, in our view, really adequately reflects the value of SHIELD in the marketplace, Al, just by the health outcome benefits that we are going to see. You just published our health outcome modeling results, you can see the amount of life here, and the value that we are putting on a table is calculable. It's calculable to know what the economic value Bringing the unscreened patient population to the screening table and adding those life years, reducing the cost associated with treating and managing CRC, is going to have tremendous value to the system.

Puneet Souda: In the marketplace, how? Just by the health outcome benefits that we are going to see. If we just publish our health outcome modeling results, you can see the amount of life year gains.

Puneet Souda: And the value that we are putting on a table is calculatable, that what's the economical value of that.

Mike: Bringing unscreened patient population to the screening table and adding those life years, reducing the cost associated with treating and managing CRC.

AmirAli Talasaz: So that's why we think that price is totally justifiable. In fact, the current model shows even more that their one is about ADLT like the ADLT pathway is really put in place as a mechanism to Prize Innovative Tests like SHIELD in a fair way. Based on their value, not necessarily based on the precedent, and that's the way the mechanism works.

AmirAli Talasaz: So that's why we think that price is totally justifiable. In fact, a higher model shows even more that that's not there. The other one is about ADLT, like ADLT pathways really put in place as a mechanism to price, innovative test like shield in a fair way, based on their value, not necessarily based on the precedence, and that's the way the mechanism works, and we would be beneficiary of that pathway which is enacted in law for the exact same purpose.

Speaker Change: is going to have tremendous value to the system. So that's why we think that price is totally justifiable. In fact, the current model shows even more that that's not there.

Speaker Change: The other one is about ADLT. ADLT pathway is really put in place as a mechanism to

Speaker Change: Price Innovative Tests like SHIELD in a fair way, based on their value, not necessarily based on the precedents. And that's the way the mechanism works, and we would be beneficiary of that pathway which is enacted in law for the exact same purpose.

AmirAli Talasaz: And we would be a beneficiary of that pathway, which is enacted in law for the exact same purpose. Look, yes, there are other companies which have multi-billion dollar, you know, kind of a top line, but still, I'm not sure how they're going to get to a profitable business. We have a different mentality. We are going to build a sustainably profitable business here; that's what we are after. And I think maybe the last one I will add is:

AmirAli Talasaz: Now look, yes, our other companies, which with multi-billion dollar, you know, kind of a tough line, still I'm not sure how they're going to get exactly to a profitability business. We have a different mentality; we are going to feel the sustainably profitable business here, that's what we are after. And I think maybe the last thing I add is, you know, maybe a futuristic thing, you know, Shield is a multi-cancerous training test. ADLT Price is not going to get activated now; it's sometime next year, and by the time that that pricing is activated, we expect to have some exciting updates related to the multi-cancer for Shield.

Speaker Change: i look that yes there are other companies to which with multibillion dollar know kind of a top line still i'm not sure how they're going to get exactly to a profitability business we have a different renmentality

Speaker Change: We are going to build a sustainably profitable business here. That's what we are after.

AmirAli Talasaz: You know, maybe a futuristic thing. A, you know, SHIELD is a multi-cancerous screening. ADLT price is not going to get activated now. It's sometime next year. And by the time that that pricing gets activated, we expect to have some exciting updates related to the multi-cancer push. So I think that's the way we were thinking about our pricing strategy, and we think this price is very well justified.

Speaker Change: and i see maybe the last lide add is

Speaker Change: You know, maybe a futuristic thing.

Speaker Change: You know, SHIELD is a multi-tasker screening test.

Speaker Change: ad price is not going to get activated now it's sometime next year and by the time that that pricing is activated

Speaker Change: We expect to have some exciting updates related to multi-cancer for SHIELD.

AmirAli Talasaz: So I think that's the way we're thinking about our pricing strategy, and we think this price is very well justified.

Speaker Change: So, I think that's the way we were thinking about our pricing strategy, and we think this price is very well justified.

AmirAli Talasaz: Got it, that's helpful, and you know, another question is USPSTF. Now that you have FBA and CMS behind you, you know, could you take a step back and give us your thoughts on what's needed in terms of modeling studies, next steps, things that need to happen over the next two years to get shield into USPSPS? Because I think that is still a, you know, a lingering question in the space. Thank you. We are very optimistic about the inclusion of shielding to the guidelines starting from ACS and then USPSTF. We are ahead of the plan that we had in terms of clinical evidence generation to show the value of Shield.

Puneet Souda: Got it. That's helpful. And, you know, another question is, is USPSDF, now that you have SBA and CMS behind you?

Speaker Change: Got it. That's helpful. And, you know, another question is, is USPSTF, now that you have SBA and CMS behind you, you know,

Speaker Change: Could you take a step back and give us your thoughts on what's needed in terms of modeling studies, next steps, things that need to happen over the next two years to get SHIELD into USPSTS, because I think that is still a, you know, a lingering question in this space.

AmirAli Talasaz: We are very optimistic about the inclusion of shielding in the guidelines starting from ACS and then USPSDF. We are ahead of the plan that we had in terms of clinical evidence generation to show the value of SHIELD. This is FDA approval. NEJM, as I mentioned in a previous remark, the randomized prospective study to show the rate of screening in the on-screen patient population would, in fact, go up, Not marginally, but like 3x, and the Unscreened Patient Population. We have randomized studies to support it. We have publications around the reality of adherence to completing blood tests. It's not just a promise; it's been proven.

Speaker Change: thank you

Speaker Change: We are very optimistic about...

Speaker Change: Inclusion of shielding to the guidelines, starting from ACS and then USPSDF.

Speaker Change: We are ahead of the plan that we had in terms of clinical evidence generation to show the value of SHIELD.

AmirAli Talasaz: This is the approval of any JMI mentioned in the pre-part remark. The randomized prospective study to show the rate of screening in on screen patient population within fact would go up, not marginally by like 3x in on screen patient population. We have randomized study to support it. If we have publications around the reality of adherence to completing blood tests, it's not just a promise; it's proven. The outcome models finally got appropriately modeled and published in terms of when you look at longitudinal adherence, really a blood based cancer screening, especially with shield performance and really add significant value to the society.

Speaker Change: This FDA approval, NEJM, I mentioned in the pre-print remark, the randomized prospective study to show the rate of screening in on-screen patient population would in fact would go up, not marginally, by like 3x

Speaker Change: In on-screen patient population, we have randomized studies to support it. We have

Speaker Change: publications around the reality of adherence to completing blood tests. It's not just a promise, it's proven.

AmirAli Talasaz: The outcome models finally got appropriately modeled and published in terms of when you look at longitudinal adherence, really blood-based cancer screening, especially with shield performance, and really add significant value to society. And we are very excited just with the suite of clinical evidence that we have today. I don't think we are missing anything for the package, and some of this was by design. You know, we expect the research plan to get drafted and the review process to get started very soon. And we are ready for it in terms of the evidence that we have in peer-reviewed publications.

Speaker Change: the outcome models finally got appropriate model and publish in terms of when you look at longitutu that our herenance

Speaker Change: Really a blood-based cancer screening, especially with SHIELD performance.

AmirAli Talasaz: And we are very excited just with the suite of clinical evidence that we have today. I don't think we are missing anything for the package; some of this was by the design. You know, we expect the research plan to get drafted and the review process to get started very soon. And we are ready for it in terms of the evidence that we have in peer-reviewed publications. Thank you.

Speaker Change: and really add significant value to the society.

Speaker Change: And we are very excited just with the suite of clinical evidence that we have today. I don't think we are missing anything for the package and some of this was by the design, you know, we expect the research plan to get drafted and the review process to get started very soon.

Speaker Change: And we are ready for it in terms of the evidence that we have in peer-reviewed publications.

Tejas Savant: Thank you. The next question comes from Tejas Savant with Morgan Stanley. Your line is open.

Tejas Salant: The next question comes from Tejas Salant with Morgan Stanley. Your line is open. Hey guys, thanks for taking my question.

Speaker Change: Thank you. The next question comes from Tejas Savant with Morgan Stanley . Your line is open.

Tejas Savant: Hey guys, thanks for taking my question. So maybe I'll start one on the Shield side, and then I have a follow up on Guardant360 as well. So AmirAli, can you just walk us through, you know, in your mind, you know, as you think about the pros and cons of an NGS approach versus a lower COGS PCR based approach, which could enable potentially a lower sort of price point for some of your competitors for their screening assays, blood-based screening assays, that is.

Tejas Salant: So maybe I'll start one with on the shield side, and then I have a follow-up on Guardant 360 as well. So AmirAli, could you just walk us through, you know, as you think about the pros and cons of an NGS approach versus a lower COGS, PCR-based approach, which could enable potential or sort of price point for some of your competitors for their screening assays, blood-based screening assays, that is, how do you think about sort of that choice, and then on a related note, you know, just any thoughts on this exact twin-spanned licensing agreement, the implications of that, it's not necessarily related to Shield, but to the broader sort of portfolio.

Tejas Savant: Hey guys, thanks for taking my question. So maybe I'll start one on the Shield side and then I have a follow-up on Guardant 360 as well. So Amirali, can you just walk us through...

Speaker Change: In your mind, you know, as you think about the pros and cons of an NGS approach versus a lower COGS PCR based approach, which could enable potentially a lower sort of price point for some of your competitors for their screening assays, blood based screening assays, that is. How do you think about sort of that choice?

Tejas Savant: How do you think about sort of that choice? And then, on a related note, you know, just any thoughts on this exact twin-strand licensing agreement, the implications of that, not necessarily related to Shield but to the broader sort of portfolio?

Speaker Change: And then on a related note, you know, just any thoughts on this exact twin strand licensing agreement, the implications of that, not necessarily related to SHIELD, but to the broader sort of portfolio?

AmirAli Talasaz: Yeah, so low cost kind of an old class, you know, 20-year-old technology of PCR solved the problem of cancer screening. If the science was that easy, you know, maybe this problem would have been solved, you know, ages ago. So look, we're looking at thousands of features with our technology. We can just look at the top 10, 20 features that we have, and we can, you know, just tell you what the performance would be. I reached the science was easier, maybe in terms of, then we didn't need 10 years of active research and investment in this area, but this is a hard deal.

AmirAli Talasaz: Yeah, so low cost kind of the old class, you know, 20 year old technology of PCR solves the problem of cancer screening. If the science was that easy, maybe this problem would have been solved ages ago.

Speaker Change: Yeah, so low-cost, kind of the old-class, you know, 20-year-old technology of PCR solved the problem of cancer screening if the science was that easy and

Speaker Change: And maybe this problem would have been solved, you know, ages ago. Now look, we are looking at thousands of features with our technology.

AmirAli Talasaz: Look, we are looking at thousands of features with our technology. We can just look at the top 10-20 features that we have and tell you what the performance would be. I wish the science was easier, maybe in terms of then we didn't need 10 years of active research and investment in this area, but this is a hard field. In terms of pricing, Look, you know, at scale. We mentioned that once we get to, like, about 1 million samples, our cost is going to be $200.

Speaker Change: We can just look at the top 10-20 features that we have and we can figure it out.

Speaker Change: You know just tell you what the performance would be. I wish the science was easier maybe in terms of then we didn't need 10 years of active research and investment in this area, but this is a hard field.

AmirAli Talasaz: In terms of pricing, look, you know, at scale, we mentioned that once we get to like about 1 million samples, our cost is maybe $200, and frankly, a good fraction of that $200, it's not even the cost of lap processing of the sample. It's like, you know, the reality of logistics of getting the kids samples, lot of achievement, bunch of stuff, which is the upfront of many, many different kind of tests versus just the cost of running a sequencing essay. At least in expert hand like us, we know how to have high throughput NGS operation with low cost. We have some of the best automation, you know, gurus who have done high throughput low cost operation.

AmirAli Talasaz: And frankly, a good fraction of that $200. It's not even the cost of lab processing of the sample. It's like, you know, the reality of logistics of getting the kits, samples, blood tubes, shipment, a bunch of stuff, which is the upfront cost of many, many different kinds of tests versus just the cost of running a sequencing assay, at least on the third hand, like us. We know how to have high throughput NGS operations with low cost.

Speaker Change: In terms of pricing,

Speaker Change: Look, you know, at scale...

Speaker Change: We mentioned that once we get to about 1 million samples, our cost is going to be $200, and frankly a good fraction of that $200 is not even the cost of

Speaker Change: lab processing of the sample it's like kind of the reality of logistics of getting the kids samples blotobe shipapment

Speaker Change: bunch of stuff which is the upfront of many many different kind of tests versus just the cost of running a sequencing assay at least in expert hands like us

Speaker Change: We know how to have high-throughput NGS operation with low cost. We have some of the best.

AmirAli Talasaz: We have some of the best. Automation, you know, gurus who have done high-throughput, low-cost operation before, we are NGS experts, so we are very confident with the tech stack that we picked and the, The long term, you know, viability of the technology stack, about TwinStrand actually, you know, I, I cannot comment on it except like you know at the top level for Shield and you know some other products that we have we mentioned that you know the future of some of these products are going to be genomics only so but I don't want to put my legal hat on because I cannot say anything with expert opinion I don't know if anybody else can take that.

Speaker Change: Automation, you know, gurus who have done high throughput, low cost operation before, we are NGS experts. So we are very confident with the tech stack that we picked. And the

AmirAli Talasaz: Before we are NGS experts, so we are very confident with the tech stack that we picked and the, the long term, you know, viability up to technology stack.

Speaker Change: The long term, you know, viability of the technology stack.

AmirAli Talasaz: About twin strand, actually, you know, I cannot comment on it except like not the top level for shield and, you know, some other products that you have mentioned that, you know, the future of some of these products are going to be a genomics only. So, but I don't want to put my legal hat off because I cannot say anything with expert's opinion. I don't know if anybody else can take that. No, I don't think it is more to us.

Speaker Change: AmirAli Talasaz, Michael Bell, Unknown Executive, Helmy Eltoukhy

Speaker Change: it

Speaker Change: I cannot comment on it except like not the top level for Shield and you know some other products that we have. We mentioned that you know the future of some of these products are going to be genomics only so

Speaker Change: But I don't want to put my legal hat on because I cannot say anything with expert opinion. I don't know if anybody else can take that.

Unknown Executive: No, I don't think I have anything more to add. Yeah.

Tejas Savant: Got it. Okay, fair enough.

Speaker Change: yeah

Tejas Salant: Got it. Okay, fair enough. All right, guys.

Speaker Change: No, I don't think anything more to add, yeah.

Tejas Savant: Alright guys, so on G360, Helmy, one for you, I mean, as you look at that sort of, you know, tenfold expansion, are there any sort of gross margin implications from it that we should be thinking about? Do you anticipate a greater shift, perhaps, from this new version of the assay from tissue to liquid? And then, can you share some color on just U.S. volumes, year-over-year; do you see any uptick there, including from, you know, the U.K. Royal Margin Program, or from the U.S. as well, or was it really a U.S.-led uplift this quarter? Thank you.

Tejas Salant: So, on G360, how many? One for you?

Speaker Change: Got it. Okay, fair enough.

Helmy: Alright guys, so on G360, Helmy, one for you, I mean, as you look at that sort of, you know, tenfold expansion, you know, are there any sort of gross margin implications from it that we should be thinking about? Do you envision a greater shift perhaps from this new version of the assay from tissue to liquid? And then can you share some color on just U.S. volumes year over year? Did you see any uptick there, including from, you know, the UK Royal Margin Program or U.S. as well, or was it really a U.S.-led uplift this quarter? Thank you.

Tejas Salant: I mean, as you look at that sort of, you know, tenfold expansion, you know, are there any sort of gross margin implications from it that we should be thinking about? Do you envision a greater shift perhaps from this new version of the essay from tissue to liquid? And then, can you share some color on just US volumes? You're, you're, do you see any uptake there, including from, you know, the, the UK Royal Martin program or US as well? Was it really a US-led uplift this quarter?

Tejas Salant: Thank you.

Tejas Salant: Yeah, so I'll maybe take the sort of 360 sort of a smart liquid biopsy upgrade first, and this something like we're super excited about. Obviously, it's early days right now. We've seen a lot of addition excitement. You can see the leading indicator from bioparma in terms of uptake that has happened. And they are some of the most described. Accriminating the customers out there. And so the fact that we have biomarkers that really no one else can see. I think it's going to help us really accelerate our growth in liquid as well as obviously take share from other products such as the tissue products.

Helmy Eltoukhy: Yeah, so I'll maybe take the sort of 360 sort of smart liquid biopsy upgrade first. This is something that we're super excited about. Obviously, it's early days right now.

Speaker Change: Yeah, so I'll maybe take the sort of...

Speaker Change: um

Speaker Change: 360, sort of a smart liquid biopsy upgrade first.

Speaker Change: This is something that we're super excited about, obviously it's early days right now, we're seeing a lot of physician excitement. You can see the leading indicator from biopharma in terms of uptake.

Helmy Eltoukhy: We're seeing a lot of physician excitement. You can see the leading indicator from biopharma in terms of the uptake that has happened. And they are some of the most discriminating customers out there. And so the fact that we have biomarkers that,

Speaker Change: that has happened. And they are some of the most discriminating customers out there. And so the fact that we have biomarkers that

Speaker Change: really no one else can see I think it's going to help us really accelerate

Speaker Change: Our growth in liquid, as well as obviously take share from other products such as the tissue products. So we're very, very excited about that transition. And then I'll let maybe Mike talk about gross margins.

Michael Bell: So we're very, very excited about that transition, and then I'll let it be Mike talk about those moments. Yeah, on the on the gross gross margin size. Yeah, there's a little bit of a uptake in the cost now with the garden at LVT because of the additional additional features, but you know it's not making I'd say any sort of significant impact on our overall gross margins, and it's well manageable within the, you know, 61 to 63% gross margin range that we've set for.

Unknown Executive: Yeah, on the gross gross margin side, yeah, there's a little bit of an uptick in the cost now for the Guardant LDT because of the additional additional features, but, you know, it's not making any sort of significant impact on our overall gross margins. And it's well manageable within the, you know, 61 to 63% gross margin range that we've set for the business, excluding screening. Yeah, I think that... Tejas, anything else?

Mike: On the gross margin side, yeah, there's a little bit of an uptick in the costs now with the Guardant LDT because of the additional features, but

Mike: You know, it's not making, I'd say, any sort of significant impact on our overall gross margins, and it's well manageable within the, you know, 61 to 63% gross margin range that we've set for the business excluding screening.

Michael Bell: So the business excluding excluding screening. Anything else in the question? Anything else.

Mike: I don't think that answered the question, Tejas. Anything else?

Michael Bell: Thank you. And I guess in terms of. Go ahead, apologies. I just last thing in terms of volumes. I think we're seeing really broad growth both in the US and internationally.

Unknown Executive: Thank you.

Tejas Savant: thank you and i guess in pro come no

Tejas Savant: Go ahead. Apologies.

Unknown Moderator: And just last thing, in terms of volumes, I think we're seeing really broad growth, both in the US and internationally. Thank you. The following comes from Bill Bonillo with Craig Hallam. You may proceed. Hey guys, thanks.

Speaker Change: Go ahead. Apologies.

Speaker Change: And just last thing in terms of volumes, I think we're seeing really broad growth both in the U.S. and internationally.

William Bonello: Thank you. The following comes from Bill Bonillo with Craig Highland. You may proceed.

Bill Bonillo: Thank you. The following comes from Bill Bonillo with Craig Hallam. You may proceed. Hey guys.

Speaker Change: Thank you. The following comes from Bill Bonil with Craig Hallam. You may proceed.

AmirAli Talasaz: Hey guys, thanks a lot for taking my question. Switching back to Shield, a couple of things I'm hoping it might be able to ask, but just first can you talk about sort of where you're at to date with your primary care sales force build and give a little bit of color on your sort of near term marking plans. So we're on track to actually finish the year with 100 sales people higher terrain in the field actively promoting that shield. We made a very good progress in second quarter in fact, and we have bunch of actually new class, which is higher and we are, you know, we just put them in the training class.

Bill Bonil: Hey guys, thanks a lot for taking my question. Switching back to SHIELD.

Bill Bonil: A couple of things I'm hoping I might be able to ask, but just first, can you talk about sort of where you're at to date with your primary care sales force build and give a little bit of color on your sort of near-term marking plans?

AmirAli Talasaz: So we are on track to actually finish the year with 100 salespeople, higher trained in the field, actively promoting SHIELD. We made very good progress in the second quarter, in fact, and we have a bunch of actually new class, which is higher than we just put them in the training class. So I have very high confidence that we are going to have this hundred people by the end of the year. In terms of sharing any specific KPIs and numbers, you know, I can tell you that we are very in the early days of this IBD launch.

Speaker Change: So we are on track to actually finish the year with 100 salespeople hired, trained, in the field, actively promoting SHIELD.

Speaker Change: We made very good progress in the second quarter.

Speaker Change: and we have a bunch of actually in your class which is hired and

AmirAli Talasaz: So I have very high confidence that we are going to have this 100 people by end of the end of the year.

Speaker Change: You know, we just put them in the training class, so I have very high confidence that

Speaker Change: we are going to have this hundred people i had up end up the year in terms of sharing any specific kp and numbers you know i can't tell we are very in early days of this ivd launch

AmirAli Talasaz: In terms of sharing any specific KPIs and numbers, you know, I can't really, you know, we are very in early days of this IVD launch. I'm very pleased with what we see, but again, it's just very few days. We just need to see how it goes, and also we need to wait for this gap to rate by Medicare in order to set any specific items and expectation of what shield can deliver across in terms of top line.

AmirAli Talasaz: I'm very pleased with what we have, But again, it's just a few days. We just need to see how it goes and also we need to wait for this gap fuel rate by Medicare in order to set any specific guidance and expectation of what SHIELD can deliver for us in terms of top line. Yeah, I probably wasn't clear.

Bill Bonil: I am very pleased with what...

Speaker Change: We see, but again, it's just very few days. We just need to see how it goes. And also we need to wait for this gap fill rate by Medicare in order to set any specific guidance and expectation of what SHIELD can deliver for us in terms of top line.

AmirAli Talasaz: Yeah, probably wasn't clear. I was just asking any color around your marketing plans, not your revenue-generating plans. Marketing flat, you know, this is mainly pre-positioned, let kind of ordering. And so, we do a lot of actually direct personal commercialization efforts. Interestingly, this FDA approval got a tremendous amount of media attention, and some interesting facts that we are dealing with is, although it was not funded by Guardant in any material way. Many of our new reps going to new accounts and frankly a good fraction of PCPs have paired about Shield through the media coverage that we got.

Speaker Change: Yeah, I probably wasn't clear. I was just asking any color around your marketing plans, not your revenue generating plans.

Speaker Change: Marketing plans, you know, this is mainly position-led kind of ordering.

Speaker Change: So we do a lot of, actually, direct, personal...

AmirAli Talasaz: I was just asking any color around your marketing plans, not your revenue generating plans. Marketing plans, you know, this is mainly precision, less kind of ordering and, So we do a lot of actually direct personal Commercialization Effort, Interestingly, this FDA approval got a tremendous amount of media attention, and some interesting facts that we are dealing with is, although it was not funded by Guardant in any material way, many of our new reps going to new accounts, and frankly, a good fraction of PCPs have heard about SHIELD through the media coverage that we got.

Speaker Change: Commercialization effort.

Speaker Change: Interestingly, this FDA approval got a tremendous amount of media attention, and some interesting facts that we are dealing with is

Speaker Change: Although it was not funded by Guardant in any material way.

Speaker Change: Many of our new reps going to new accounts and frankly a good fraction of PCPs have heard about Shield through the media coverage that we got. So we are dealing with some kind of interesting phenomena

AmirAli Talasaz: So we are dealing with some kind of interesting phenomena, but, you know, again, it's very early days. We are going to try a few different things in our marketing program to just see which ones are going to scale better. But again, the main... strategy is focused on direct sales force promotion to PCP.

AmirAli Talasaz: So we are dealing with some kind of interesting phenomena.

AmirAli Talasaz: But, you know, again, it's very early days. We are going to try to defend things in our marketing program to just see which ones are going to scale better. But again, the main strategies focused on direct sales force promotion to PCPs. Okay, thanks. That's helpful.

Speaker Change: strategies focused on direct sales force promotion to pcp

Bill Bonillo: Okay, thanks. That's helpful. Thank you. The next question comes from Jack Meehan with Nifron Research. You may proceed. Thank you. Good afternoon.

Jack Meehan: Thank you.

Speaker Change: Okay, thanks. That's helpful.

Jack Meehan: Thank you. The next question comes from Jack Meehan with Nifron Research. Please proceed.

Jack Meehan: The next question comes from Jack Mehan with New Family Search. You may proceed. Thank you. Good afternoon. One to talk about shield for the questions. First one is for Murali. So, you know, this $1,500 cash pay price for the IBD version of the test.

Speaker Change: Thank you. The next question comes from Jack Meehan with Nifron Research. You may proceed.

Jack Meehan: Thank you. Good afternoon.

Jack Meehan: when the talk about shield for the questions first one is for mirali so you know this fifteen hundred dollars cash pay praice through the ivd version the test

AmirAli Talasaz: Can you just talk maybe about the marketing plans when you go into a physician office for the sales team, just how you address concerns around potential for out-of-pocket bills that, you know, non-Medicare covered patients might get. Yeah, sure. So, at high level, we are very upfront and we make sure both physician and patients are well informed when they agree to use this test. So first of all, for patients like 65 and above, obviously the manager beneficiary, they have now good access to this. Many of them zero dollar out of pocket or minimal cost. But, as you mentioned, Jack, when we go to a younger patient population.

Jack Meehan: Can you just talk maybe about the marketing plans when you go into a physician office for the sales team, just how you address concerns around potential for out-of-pocket bills that, you know, non-Medicare covered patients might get?

Jack Meehan: Yeah, sure. So at a high level, we are very upfront, and we make sure both physicians and patients are well informed when they agree to use this test. So first of all, for patients like 65 and above, obviously, the Medicare beneficiary, they do not have good access to this test, many of them with zero dollars out of pocket or minimal cost. But as you mentioned, Jack, when we go to a younger patient population, Access is not as equitable in terms of the financial responsibility for a patient until we go to the guidelines and we are very transparent about it.

Speaker Change: yes sure so at high level we are very upfront and we make sure good trysition patients are willing for when they agree to use this test

AmirAli Talasaz: The fact that access is not as equitable in terms of the financial responsibility for patients till we go to guidelines and we are very transparent about it. The cash paid price of shield out of pocket costs are shared with both physician and patient as I mentioned. Because at garden, we never want to have any surprise by physician and patients down the road. So we are very upfront about it. And we are learning, and we have learned a lot, frankly, through 10 years of commercialization of, you know, with Garden 360. We've revealed toward oncologists; PCPs are a bit different, but there's a lot of learning.

Speaker Change: tofact that the access is not adeeudable in terms of to financial responsibility for our patients till we go to the guidelines and we are very transparent about it

Jack Meehan: The cash rate, price of shield, the out-of-pocket costs are shared with both physician and patient, as I mentioned, because at Guardant, we never want to have any surprise by physician and patients down the road, so we are very upfront about it, and we are learning, and we have learned a lot, frankly, 10 years of commercialization of, you know, with Guardant 360, we've revealed toward oncologists, PCPs are a bit different, but there's a lot of learnings and skill set that we have gathered that we are leveraging in marketing of SHIELD in terms of the financial responsibility. In fact, actually, something interestingly, I look at some of this in a very positive way.

Speaker Change: The cash-paid price of SHIELD out-of-pocket costs are shared with both physician and patient, as I mentioned.

Speaker Change: Because at Guardant, we never want to have any surprise by physicians and patients down the road. So we are very upfront about it. And we are learning, and we have learned a lot, frankly, through

Speaker Change: 10 years of commercialization of, you know,

Speaker Change: with gard entry sixty wee revealed toward oncoleges pcp are a bit different but there is a lot of learning that skill said that we have gathetered that

AmirAli Talasaz: I'm skilled said that we have gathered that we are leveraging in marketing of shield in terms of the financial responsibility. The fact actually something interesting, we, I look at some of this in a very positive way. We expect this dynamic. Bank would help us to get more reversible volume in our mix. And that's really our focus. At this time, we really prefer to just scale the reversible volume for SHO, which are just 65 and above. And some of this out-of-pocket conversation would suffer as they use case in younger patient population. And that's a good thing.

Speaker Change: We are leveraging in marketing of SHIELD in terms of the financial responsibility. In fact, actually, something interestingly, I look at some of this in a very positive way. We expect this dynamic

Jack Meehan: We expect this dynamic to help us to get more reimbursable volume in our bank. And that's really our focus. At this time, we really prefer to just scale the reimbursable volume for SHIELD, which is for patients 65 and above. And some of this out-of-pocket conversation would suppress the use case in younger patient populations.

Speaker Change: would help us to get more reimbursable volume in our mix.

Speaker Change: And that's really our focus. At this time, we really prefer to just scale the reimbursable volume for SHIELD, which are the 65 and above. And some of this out-of-pocket conversation would suppress the use case in younger patient populations.

Daniel Arias: Thank you. The next question comes from Dan. Are you asked what's faithful, you may proceed? Thanks. I think that's thanks for the questions here.

AmirAli Talasaz: Thank you. The next question comes from Dan Arias with Steeple. You may proceed.

Speaker Change: And that's a good thing.

Speaker Change: Thank you. The next question comes from Dan Arias with STFL. You may proceed.

Dan Arias: I think guys, thanks for the questions here. Maybe just one for me to follow up on the sales and marketing side, but more on the clinical oncology piece. Helmy or Mike, how do you see the size of the commercial team evolving there over time? And I don't necessarily ask in the context of OPEX, obviously that's an important part.

Daniel Arias: Maybe just one for me, follow up on the sales and marketing side, but more on the clinical oncology piece. Helmy or Mike, how do you see the size of the commercial team evolving there over time? And I don't necessarily ask in the context of off-backs. Obviously, that's an important part, but I'm thinking more just from the competitive standpoint, as we think about the therapy selection market and the MRD market. And there's just a number of players that are trying to state their claim to business there. Does it become more of a feed on the street game at any point or on any level, just the way that the PCTD market does?

Speaker Change: this

Speaker Change: Thanks for the questions here. Maybe just one for me, follow up on the sales and marketing side, but more on the clinical oncology piece. Helmy or Mike, how do you see the size of the commercial team evolving there over time? And I don't necessarily ask in the context of OPEX. Obviously, that's an important part, but I'm thinking more just from the competitive standpoint.

Speaker Change: As we think about the therapy selection market and the MRD market, and there's a number of players.

Speaker Change: that are trying to state their claim the business there is does it become more of a feed on its three game at any point or any level just the way that the pcteam the market does at popointts letlove to get your thoughts on just how you see the evolution of the sales more effortate

Helmy Eltoukhy: At points, I love to get your thoughts on just how you see the evolution of the Salesforce effort. Yeah, I mean, I think it's always been promotionally sensitive to some extent in terms of the oncology market. I think pharma reps have sort of trained the market in that vein. And diagnostic companies now for the first time are building fairly sizable sales teams in the oncology channel. And I think we're in a very invable position, given where gross margins are, given where the amount of revenue for rep we have right now. And so we typically see the sort of marginal improvement that sales reps can add to our volumes.

Helmy Eltoukhy: Yeah, I mean, I think it's always been promotionally sensitive to some extent in terms of the oncology market. I think pharma reps sort of train the market in that vein. Diagnostic Authorian, Graham J. Yesenia

Speaker Change: Yeah, I mean, I think it's always been promotionally sensitive to some extent in terms of oncology market. I think pharma reps have sort of trained the market in that vein.

Speaker Change: Diagnostic Companies now for the first time are building a fairly sizable sales team in the Oncology Channel and I think we're in a

Speaker Change: I think we're in a very enviable position given where our gross margins are, given where the amount of revenue per rep we have right now and so we typically see the sort of marginal improvement that sales reps can add to our volumes and

Helmy Eltoukhy: And we adjust accordingly in terms of it can help us drive more volume. And we can do it in an efficient way. We'll continue to add reps. But at some point, the market saturates. And that's where we have built out other channels in terms of EMR digital, obviously, and other marketing channels as well, a top-down partnerships. And so it really is a surround sound methodology in terms of how we continue winning share of voice in the market. We have number one share of voice in the market; we've had that for the last few years. And we'll continue to maintain that accordingly.

Speaker Change: We adjust accordingly in terms of it can help us drive more volume and we can do it in an efficient way. We'll continue to add

Speaker Change: Refs, but at some point the market saturates and that's where we have built out other channels in terms of EMR, digital, obviously, and other marketing channels as well, top-down partnerships,

Speaker Change: So it really is a surround sound methodology in terms of how we continue winning share of voice in the market. We have number one share of voice in the market. We've had that for the last few years and we'll continue to maintain that accordingly. I don't know if, Mike, there's anything you want to add.

Helmy Eltoukhy: I don't know if Mike, there's anything around. No, I think not.

Unknown Executive: No, Helmy, I think that covers it.

Helmy Eltoukhy: Is that good?

Mike: No, Helmy, I think that covers it.

Doug Shinkle: Thanks. Thank you.

Dan Arias: Thank you. The following comes from Doug Schenkel with Wolf Research. You may proceed.

Doug Shinkle: The following comes from Doug Shinkle with Wolf Research. You may proceed. Hi, thank you for taking my questions. So a couple on Shield. I was surprised he took such a strong stance on the topic of test viability for emerging competitors. And I think it's a fair point. Like, let's see how the data shakes out. And if it, you know, sounds as good as it's been described when we get to perspective randomized studies.

Speaker Change: Thanks.

Speaker Change: Thank you. The following comes from Doug Schenkel with Wolf Research. You may proceed.

Doug Schenkel: Hey guys, thank you for taking my questions. A couple on SHIELD.

Doug Schenkel: I was surprised you took such a strong stance on the topic of test viability for emerging competitors. And I think it's a fair point. Like, let's see how the data shakes out and if it, you know, sounds as good as it's been described when we get to randomized studies, but Yeah, what what what happens if a test has better sensitivity than 83% blended or what if somebody's you know essentially equivalent blended but has stage one detection that is better than your 55% stage one sensitivity and or better than your 13% advanced adenoma detection ?

Doug Schenkel: Hey guys, thank you for taking my questions.

Doug Schenkel: A couple on SHIELD. I was surprised you took such a strong stance on the topic of test viability for emerging competitors and I think it's a fair point like let's let's see how the data shakes out and

Speaker Change: if it sounds as good is it's been described when we get to perspective randomized studies but what happens if a test has

AmirAli Talasaz: But, you know, what what what happens if a test is a test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability test viability with better sensitivities than 83% blended, or what if somebody's essentially equivalent blended but has stage one detection that is better than your 55% stage one sensitivity, and or better than your 13% advanced out-of-nome detection?

Speaker Change: Better sensitivity than 83% blended, or what if somebody's, you know, essentially equivalent blended but has stage one detection that is better than your 55% stage one sensitivity and or better than your 13% advanced adenoma detection?

Michael Bell: Would that, using the same logic, call into question the viability of shields? So that's my first question, and then why does the increased DSP not change your break even targets? You know, what else changes? Is there an offset in terms of your market penetration assumptions, or your COGS assumptions?

Doug Schenkel: So that's my first question. And then... Why does the increased ASP not change your breakeven targets? You know, what else? Is there an offset in terms of your market penetration assumptions or your COGS assumptions?

Speaker Change: Would that, using the same logic, call into question the viability of S.H.I.E.L.D.? So that's my first question. And then, why does the increased ASP not change your break-even targets? You know, what else changes?

Speaker Change: Is there an offset in terms of your market penetration assumptions or your COGS assumptions?

AmirAli Talasaz: Yeah, so I think for a first point, and thanks, Doug, for asking this important one. So, you know, Viam here has done the biology of cell-free DNA very, very well. You know, the kind of biomarkers that are associated with cell-free DNA, we have studied the science and biology of it very, very well. So I think we can kind of distinguish some science fiction, which doesn't like biology, there's no biology for it versus the reality of what different technologies can do, as long as they are looking at cell-free DNA, kind of biomarkers that again, we know the biology very well.

AmirAli Talasaz: Yeah, so I think for a first point, and thanks, Doug, for asking this important one. So, you know, we understand the biology of cell-free DNA very, very well, the kind of biomarkers that are associated with cell-free DNA. We have studied the science and biology of it very, very well. So I think we can kind of distinguish some science fiction, which doesn't like biology, there's no biology for it versus the reality of what different technologies can do, as long as they are looking at cell-free DNA kind of biomarkers that, again, we know the biology very well.

Speaker Change: Yeah, so I think for a first point, and thanks, Doug, for asking this important one, so, you know, we understand the biology of cell-free DNA very, very well. You know, the kind of biomarkers that are associated with cell-free DNA,

Doug Schenkel: We have studied the science and biology of it very, very well, so I think we can...

Doug Schenkel: kind of distinguish some science fiction which is doesn't like biology there's no biology for it versus the reality of what different technologies can do as long as they are looking at cell-free DNA kind of biomarkers that again we know the biology they will.

AmirAli Talasaz: So, in science, we can never say, you know, it's mission impossible, but I can tell you, like I think some of the scenarios you mentioned cannot happen really in a probabilistic way, like through very, very high probability. So, like, stage 2, 3, 4 is going to be better with cell-free DNA than stage 1, and, you know, performance matrix as long as the team is capable, frankly. You know, that kind of a response care is what cell-free DNA can do with some kind of upgrades that I think we're going to see with our Shield V2, but response care would be similar.

AmirAli Talasaz: So in science, we can never say, you know, it's mission impossible, but I can tell you, like, I think some of the scenarios you mentioned cannot happen in a probabilistic way, like, with a very, very high probability.

Doug Schenkel: So.

Speaker Change: In science, we can never say, you know, it's mission impossible, but I can tell you, like, I think some of the scenarios you mentioned cannot happen, really, in a probabilistic way, like, with very, very high probability.

AmirAli Talasaz: So, like, stage 2, 3, 4 is going to be better with cell-free DNA than stage 1, and, you know, the performance matrix, as long as the team is capable, frankly, that kind of a response curve is what cell-free DNA can do, with some kind of upgrades that I think, hopefully, we are going to see with our SHIELD v2, but the response curve would be similar. AA, I think it's a different topic.

Doug Schenkel: So, like, stage 2, 3, 4 is going to be better with cell-free DNA than stage 1, and, you know, the performance matrix, as long as the team is capable, frankly,

Speaker Change: You know, that kind of a response curve is what cell-free DNA can do with some kind of upgrades that I think hopefully we are going to see with our SHIELD v2, but response curve would be similar.

AmirAli Talasaz: A, A, I think it's a different topic, like, you know, if somebody thinks they can have just a 70% plus or 70 can change CRC, but they can't be take, like materially more AA, we just let them learn some lessons through biology. In terms of, I think, a profitability target, I'm more confident than ever about the targets that we shared in our investor day last fall, a 1,500,000,000 revenue with a $200 clock at a time. But there are some stuff that went better than our base case, like this first line indication is better. The way we are doing the ADLT pricing is, you know, higher than before, but it's still, again, too early for us to, you know, adjust any updates, vacation, frankly.

AmirAli Talasaz: Like, you know, if somebody thinks they can have just 70% plus or 70 and change CRC, but they can detect, like, materially more AA, we just let them learn some lessons through biology. In terms of, I think, profitability targets, I'm more confident than ever about the targets that we shared at our investor day last fall. One million samples, 500 million. Revenue with a $200 card at a time. But there are some things that went better than our base case, like this first line indication is better. The way we are doing the ADLT pricing is, of America, Dr. Ashraf Ghani, Dr. Ashraf Ghani, Dr. Ashraf Ghani,

Speaker Change: AA, I think it's a different topic. Like, you know, if somebody thinks they can have just 70% plus or 70 and change CRC, but they can detect, like, materially more AA,

Speaker Change: We just let them learn some lessons through biology.

Speaker Change: In terms of, I think, a profitability target,

Speaker Change: I'm more confident than ever about the targets that we shared in our investor day last fall.

Speaker Change: so one million sample five hundred million

Speaker Change: revenue with a $200 COGS at a time. But there are some stuff that went better than our base case, like this first line indication is better. The way we are doing the ADLT pricing is

Speaker Change: You know, higher than before.

Doug Schenkel: But it's still, again, too early for us to, you know, adjust any of the expectation, frankly. We cannot get ahead of our skis. We will not get ahead of our skis.

AmirAli Talasaz: We cannot get ahead of our skis; we will not get ahead of our skis. We just need to see how the volume ramp is going to look like, how the payer makes it going to look like as we go through this launch and the first few months after.

Doug Schenkel: We just need to see how the volume ramp is going to look like, how the payer mix is going to look like as we go through this launch and the first few months after. And then maybe we can talk about long-term perspectives with better data.

AmirAli Talasaz: And then maybe we can't talk about long-term perspectives with better data.

Patrick Donnelly: Thank you. The next comes from Patrick Dunnelly with City. We may proceed. Hey guys, thanks for taking the questions. I guess maybe just one on the G360 volume, clinical volume broadly. You know, can you just talk about, I know you talked a little bit about the drivers. It sounds like it was pretty broad-based. You know, is that still, you know, a little bit more of kind of a depth game, given the EMR integrations? Is that the biggest opportunity?

Patrick Donnelly: Thank you. The next comes from Patrick Donnelly with Citi. You may proceed.

Speaker Change: Thank you. The next comes from Patrick Donnelly with Citi. You may proceed.

Patrick Donnelly: Hey guys, thanks for taking the questions. I guess maybe just one on the G360 volume, clinical volume broadly. You know, can you just talk about I know you talked a little bit about the drivers, it sounds like it was pretty broad based, you know, is that still, you know, a little bit more of kind of a depth game given the EMR integrations?

Patrick Donnelly: Hey guys, thanks for taking the questions. Um, I guess maybe just one on the G360 volume, clinical volume broadly.

Patrick Donnelly: Can you just talk about, I know you talked a little bit about the drivers, it sounds like it was pretty broad based. Is that still a little bit more of kind of a depth scan given the EMR integrations?

Michael Bell: And then again, it sounds like still 20% for the year, you know, is the confidence higher on that in terms of potential upside, and as we work our way, you know, relative to three months ago, just curious how you're thinking about the back half and any potential changes to that volume number. Thank you, guys. Yeah, I mean, obviously a lot of the depth at this point, we have, I think something probably close to 90% of U.S. Oncologists have ordered a test from us or a Guardant G60 test, and so it's all about griding deeper into accounts.

Speaker Change: is that the biggest opportunity and then again it it sounds like stillill twenty percent for the year you know is the confidence higher on that in terms of potentionial upside and as we work car wayyou know relative three months ago just curious how you thinkking about the back half and any potential changes to that volume number thank you go

Helmy Eltoukhy: Um, yeah, I mean, obviously, a lot of it is deaf at this point, we have Something probably close to 90% of U.S. oncologists have ordered a test from us or a Guardant 360 test. And so it's all about driving deeper into accounts. And I think as the, You know, I think the patient story kind of showed that, you know, this idea that we can go from a single test per patient to testing patients as their cancer comes back or as they get progressed, I think is one that we're just scratching the surface of in terms of, you know, response monitoring and then obviously,

Speaker Change: Yeah, I mean, obviously, a lot of it is depth at this point. We have

Speaker Change: I think something probably close to 90% of U.S. oncologists have ordered a test from us or a Guardant 360 test. And so it's all about driving deeper into accounts. And I think as the

Michael Bell: And I think, as the, you know, I think this patient story kind of showed that, you know, this idea that we can go from a single point. A single test per patient to testing patients as their cancer comes back, or as they get progressed, I think is one that we're describing the surface of in terms of, you know, response monitoring, and then obviously testing as their, as their cancers come back, and then obviously that's even more so in the MRD setting outside of G360.

Speaker Change: You know, I think the patient story kind of showed that, you know, this idea that we can go from a single test per patient to testing patients as their cancer comes back or as they get progressed, I think is one that we're just crashing the surface of in terms of, you know,

Speaker Change: Response Monitoring, and then obviously...

Speaker Change: testing as the cancers come back. And then obviously that's even more so in the MRD.

Michael Bell: In terms of the contours for the year, we're very excited about the product upgrades we've, you know, had tissue next with, you know, a much, much bigger panel and obviously the smart liquid biopathy upgrade that everyone's been waiting for. I think are going to be a really important catalyst for us this year. You know, for Mike One. Yeah, I think, I think, yeah, we did on the prepared remarks, just, you know, reiterate for the full year expectations of 20% year-of-year clinical volume growth. You know, we know that we had a very difficult comp in Q2 because, in the first half of last year, we had the ESR1 approval for Guardant 360 CDX.

Speaker Change: setting outside of G360.

Speaker Change: In terms of the contours for the year, we're very excited about the product upgrades we've, you know, had. We have Tissue Next with

Speaker Change: Michael Bell, Unknown Executive, Helmy Eltoukhy

Unknown Executive: Yeah, I think I think we did, in the prepared remarks, just, you know, reiterate the full year expectations of 20% year over year clinical volume growth. And, you know, we know that we had a very difficult comp in Q2, because in the first half of last year, we had the ESR1 approval for GARNET360 CDX.

Speaker Change: Yeah, I think, yeah, we did on the prepared remarks just, you know, reiterate for the full year expectations of 20% year-over-year clinical volume growth and, you know, we know that we had a very difficult comp in Q2,

Speaker Change: because

Speaker Change: In the first half of last year we...

Michael Bell: And, you know, that led to a rapid increase in breast volumes when we saw in Q2 of last year a bolus effect. And so we were really pleased with clinical volume growth this quarter. Again, you know, we saw growth in the US on Guardant 360, but also outside in Japan and the UK, but also across Tissue Next and Reveal. And so we're really pleased with Q2, and yes, we look ahead for the full year. We're still very confident on the 20% clinical volume growth for the reasons that we just outlined.

Unknown Executive: And, you know, that led to a rapid increase in breast volumes. And we saw a bolus effect in Q2 of last year. And so we were really pleased with clinical volume growth this quarter. Again, you know, we saw growth in the U.S. on GARNET360 but also outside in Japan and the UK, but also across TissueNext and Reveal. And so we're really pleased with Q2. And yeah, as we look ahead for the full year, we're still very confident in the 20% clinical volume growth for the reasons that we just outlined.

Speaker Change: We had the ESR-1 approval for GARNET360, CDX, and...

Speaker Change: You know that led to a rapid increase in in breast volumes and we saw in Q2 of

Speaker Change: last year.

Speaker Change: Abolas

Speaker Change: effect

Speaker Change: And so we were really pleased with clinical volume growth this quarter.

Speaker Change: Again, you know, we saw growth in the U.S. on Ghana 360, but also outside in Japan and the U.K., but also across Tissue Next and Reveal. And so we're really pleased with Q2, and yeah, as we look ahead for the full year, we're still very confident on the 20%.

Speaker Change: Clinical Volume Growth, for the reasons that Helmy just outlined.

Tycho Peterson: Thank you. The final question comes from Tcho Peterson with Jeffries. You may proceed. Thanks for excusing me in. So really two questions. One on Medicare, specifically Medicare Advantage, right? It's over 50% of Medicare; you know, he discourse matter. The obviously feed into star ratings and reimbursement and, you know, Medicare Advantage plans let someone get a non guideline test. It puts the reimbursement at risk, and it feels like they actively block them until you have USPSTF. So do you agree with that view? And then what's the timeline for, you know, he just scores. I know it took exact about two years.

T. Joe Peterson: Thank you. The final question comes from T. Joe Peterson with Jeffries. You may proceed.

Speaker Change: Thank you. The final question comes from Ticho Peterson with Jeffries. You may proceed.

T. Joe Peterson: Hey, thanks for squeezing me in. So really, two questions, one on Medicare, specifically Medicare Advantage, right? Since it's over 50% of Medicare, you know, HEDIS scores matter. They obviously feed into star ratings and reimbursement. And, you know, if Medicare Advantage plans let someone get a non-guideline test, it puts the reimbursement at risk, and it feels like they actively block them until you have the USPSTF. So do you agree with that view? And then what's the timeline for, you know, HEDIS scores? I know it took exactly about two years.

Ticho Peterson: Thanks for squeezing me in. So really two questions, one on Medicare, specifically Medicare Advantage, right? It's over 50% of Medicare, you know, HEDIS scores matter. They obviously feed into star ratings and reimbursement. And, you know, if Medicare Advantage plans let someone get a non-guideline test, it puts the reimbursement at risk and it feels like they actively block them until you have USPSTF. So do you agree with that view? And then what's the timeline for, you know, HEDIS scores? I know it took exact about two years.

AmirAli Talasaz: And then the second question was just I want to confirm on G360 were the volumes down sequentially into Q clinical ASPs were down sequentially G360 ASPs are up sequentially prayer slides. So that would seem to imply that the G360 volumes are down sequentially, as unpaid tests are obviously driving a lot of the volume. Thanks. Yeah, exactly, actually it's true that Medicare fee-for-service would be likely easier to collect from, and Medicare Advantage plan are supposed to pay us because NCD is brought, no restriction, our label is brought, no restriction. So they're supposed to pay, but as we've seen, sometimes MA plans are notorious for putting some kind of broad blocks and stuff. But we needed to deal with it before too.

T. Joe Peterson: And then the second question was just, I want to confirm on G360, were the volumes down sequentially in 2Q? Clinical ASPs were down sequentially. G360 ASPs are up sequentially, per your slides. So that would seem to imply that G360 volumes are down sequentially as unpaid tests are obviously driving a lot of the volume. Thanks.

Speaker Change: And then the second question was just, I want to confirm on G360, were the volumes down sequentially in 2Q? Clinical ASPs were down sequentially. G360 ASPs were up sequentially per your slides. So that would seem to imply that G360 volumes are down sequentially as unpaid tests are obviously driving a lot of the volume.

Unknown Executive: Yes, actually, it's true that Medicare fee-for-service would be likely easier to collect from and Medicare Advantage plans are supposed to pay us because NCD is broad, with no restriction. Our label is broad, with no restriction.

Speaker Change: Thanks.

Speaker Change: Yes, actually it's true that Medicare Fee-for-Service would be likely easier to collect from, and Medicare Advantage plans are supposed to pay us, because NCD is broad, no restriction, our label is broad, no restriction, so they're supposed to pay.

Unknown Executive: So they're supposed to pay, but sometimes MA plans are notorious for putting some kind of roadblocks and stuff, but we needed to deal with that before too. We have experience working with MedAdvantage plans for both 360 and Reveal, and we've been very successful. We've made great success, and great strides dealing with them, and looking forward to applying those learnings now to shield them.

Bud Haslam: Bud Haslam

Bud Haslam: We've seen sometimes M.A. plans are notorious for putting some kind of roadblocks and stuff, but we needed to deal with it before too.

Michael Bell: We have experience working with Med Advantage plans for both three six-hand review, and we've been very successful event, great success, great strikes, dealing with them, and looking forward to applying those learning style to shield them. Yeah, on the clinical volume, the Guardant 360 volume, the overall on the clinical volume, we saw sequential growth of about 2,500 tests, and yeah, I can confirm Guardant 360 groups sequentially. As did Revere, I left it tissue next, and Guardant 360, yeah, was it through in the US sequentially and outside the US sequentially. And I think there's a comment on ASP as well, you know, Guardant 360 ASP. You know, we've seen the significant tearwind over the last sort of 12, 18 months with the Guardant 360 ASP.

Speaker Change: We have experience working with MedAdvantage plans for both 360 and Reveal, and we've been very successful. We've had great success, great strides, dealing with them, and looking forward to applying those learnings now to shield them.

Mike Bell: Yeah, on the clinical volume, the Guardant 360 volume, yeah, overall on the clinical volume, you know, we saw sequential growth of about 2,500 tests, and yeah, I can confirm Guardant 360 grew sequentially. As did Reveal, as did Tissue Next, and Guardant 360, yeah, it grew in the US sequentially and outside the US sequentially.

Speaker Change: On the clinical volume, the Guardant 360 volume, overall on the clinical volume, we saw sequential growth of about 2,500 tests,

Speaker Change: I can confirm Guardant 360 grew sequentially, as did Reveal, as did Tissue Next, and Guardant 360 grew in the U.S. sequentially and outside the U.S. sequentially. I think there was a comment on ASPs as well, Guardant 360, ASP.

Mike Bell: And I think there's a comment on ASPs as well. You know, Guardant 360 ASP, you know, we've seen a significant tailwind over the last sort of 12, 18 months with the Guardant 360 ASP. So that improved significantly year over year, but they also improved sequentially as well. So we're up now to 2950 to 3000. So I think we're again really pleased with the quarter from a volume perspective year over year and sequentially from an ASP perspective. And so, yeah, for us, it was a very strong second quarter of 2024.

Speaker Change: we've seen a significant taayeror wind

Speaker Change: Over the last sort of 12

Michael Bell: So that improved significantly year-of-year, but now also improved sequentially as well. So we're now to 2950 to 3000. So I think we again, we're really pleased with the quarter from a volume perspective year-of-year and sequentially from an ASP perspective. And so, yeah, for us, it was a very strong second quarter of 2024.

Speaker Change: 18 months with the Guardant 360 ASP so

Speaker Change: That improved significantly year over year, but it also improved sequentially as well.

Speaker Change: 2950 to 3000. So I think we again we're really pleased with the quarter from a volume perspective year-over-year and sequential from an ASP perspective and so yeah for us it was a very strong second quarter of 2024.

Tomia: Thank you.

Unknown Moderator: Thank you. This concludes today's conference call.

Tomia: This concludes today's conference call. Thank you for your participation. You may now disconnect your line.

Speaker Change: Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect your line.

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