Q1 2025 Guardant Health Inc Earnings Call

Okay.

[music].

Operator: Hello everybody and welcome to the Guardant Health Q1 2025 earnings call.

Hello, everybody and welcome to the Garden, how Q1 2025 earnings call My.

Operator: My name is Elliot and I'll be your coordinator today.

Speaker Change: My name is elliott's there'll be a core tonight.

Operator: If you would like to register a question during today's event, please press star 1 on your telephone.

Speaker Change: If you'd like to register a question Jim stage event. Please press star one on your telephone keypad.

Zarak Khurshid: I would now like to hand over to Zarak Khurshid, Vice President of Investor Relations. Please go ahead. Thank you.

Zurich: I would now like to hand over to Zurich <unk> <unk>.

Speaker Change: <unk> President of Investor Relations. Please go ahead.

Speaker Change: Thank you earlier today Guardant health released financial results for the quarter.

Unknown Executive: Earlier today, Guardant Health released financial results for the quarter ended March 31, 2025.

Speaker Change: March 31, 2025, joining me today from garden.

Helmy Eltoukhy: Joining me today from Guardant are Helmy Eltoukhy, Co-CEO, AmirAli Talasaz, Co-CEO, and Mike Bell, Chief Financial Officer.

Speaker Change: Co CEO of Merrill Lynch, <unk> co CEO, and Mike Bell Chief Financial Officer, before we begin I'd like to remind you that during this call management will make forward looking statements within the meaning of federal Securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated this call.

Unknown Executive: Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated.

Unknown Executive: This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures, are available in the press release Guardant issued today, as well as in our 10-K and other filings with the SEC.

Speaker Change: We'll also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items additional information regarding material risks and uncertainties as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures are available in the press release guardant issued today as well as in our 10-K and other.

Speaker Change: Filings with the SEC.

Unknown Executive: Guardant disclaims any intention or obligation to update or revise financial projections in forward-looking statements, whether because of new information, future events, or otherwise, except as required by law.

Speaker Change: <unk> disclaims any intention or obligation to update or revise financial projections and forward looking statements, whether because of new information future events or otherwise except as required by law. The information in this conference call is accurate only as of the live broadcast with that I would like to turn the call over to help me.

Unknown Executive: The information in this conference call is accurate only as of the live broadcast.

Helmy Eltoukhy: With that, I would like to turn the call over to Helmy. Thanks, Zarak.

Speaker Change: Thanks, Derek good afternoon, and thank you for joining our first quarter 2025 earnings call sorry.

Helmy Eltoukhy: Good afternoon, and thank you for joining our first quarter 2045 earnings call. Starting on slide 3, we started the year with strong momentum across our portfolio, fueled by groundbreaking product upgrades introduced in 2024, which leverage our smart liquid biopsy platform, as well as the launch of Shield. We continue to successfully execute our long-term vision to support patients throughout their entire cancer journey, from early detection, monitoring of recurrence, to treatment selection.

Speaker Change: Starting on slide three.

Speaker Change: We started the year with strong momentum across our portfolio fueled by groundbreaking product upgrades introduced in 2024, which leverage our smart liquid biopsy platform as well as the launch of shield.

Speaker Change: We continue to successfully execute on our long term vision to support patients throughout their entire cancer journey from early detection monitoring of recurrence and treatment selection.

Helmy Eltoukhy: By delivering critical insights at every stage of cancer care, we empower clinicians to deliver timely, actionable insights that make a meaningful difference in the lives of patients and their families around the world.

Speaker Change: By delivering critical insights at every stage of cancer care, we empower our clinicians to deliver timely actionable insights that make a meaningful difference in the lives of patients and their families around the world.

Helmy Eltoukhy: As we do each quarter, I would like to start our call today by sharing a powerful story that captures the real-world impact of our Guard and Reveal test and the difference it can make in the lives of those we serve.

Speaker Change: As we do each quarter I would like to start our call today by sharing a powerful story that captures the real world impact of front gardens.

Speaker Change: And the difference it can make in the lives of those we serve.

Helmy Eltoukhy: In September of 2022, a 55-year-old woman was diagnosed with breast cancer and later identified as having a pathogenic BRCA1 variant. She was prescribed neoadjuvant chemotherapy to help shrink the tumor prior to surgery, and a few months later, the cancer was removed successfully. In order to monitor for potential recurrence, her oncologist ordered an initial reveal test shortly after surgery, and six subsequent reveal tests have been performed over the last two years at three to six month intervals.

Speaker Change: In September of 2022, and 55 year old woman was diagnosed with breast cancer and later identified as having a pathogenic bronco one berrien swith prescribed new adjuvant chemotherapy to help shrink the tumor biopsy surgery and a few months later the cancer was removed successfully.

Speaker Change: In order to monitor potential recurrence for oncologist ordered and initial revealed shortly after surgery and six subsequent reveals tests have been performed over the last two years at three to six months intervals.

Helmy Eltoukhy: All six reveal tests have returned negative results, and today the patient is enjoying life with the peace of mind that she remains cancer free.

Speaker Change: Fixed mobile status have returned negative results and today the patient is enjoying life with the peace of mind that Ciena remains cancer free.

Helmy Eltoukhy: Churning the top-line performance on slide four. We had an excellent start to the year with Q1 revenue growing 21% year over year to $203 million. As we discussed last quarter, we are now reporting revenue in a way that more closely aligns with how we run the business, and we believe this new reporting structure will help investors and analysts better understand our rapidly evolving business model. The full revenue lines are oncology, which represents clinical therapy selection and MRD testing revenue. Biopharma and Data, which represents the revenue we generate from our biopharma customers from sample testing, companion diagnostic collaborations, and data services.

Speaker Change: Turning to top line performance on slide four we had an excellent start to the year with Q1 revenue growing 21% year over year to $203 million.

Speaker Change: As we discussed last quarter, we are now reporting revenue in a way that more closely align with how we run the business and we believe this new reporting structure will help investors and analysts better understand our rapidly evolving business. The four revenue lines are oncology, which represents clinical therapy selection.

Speaker Change: MRV testing revenue.

Speaker Change: Biopharma and data, which represents the revenue we generate from our biopharma customers from sample testing companion diagnostic collaborations and data services screening, which represented shield testing revenue and finally licensing another.

Helmy Eltoukhy: Screening, which represents shield testing revenue. And finally, licensing and other. Starting with our oncology business in slide 5, Q1 represented another quarter of strong oncology performance with revenue increasing 20% year-over-year to $151 million. Oncology volumes increased 25% year-over-year to approximately 59,000 tests in the first quarter, with the majority of growth driven by Guardant 360, closely followed by strong contribution from Reveal. Looking more closely at some of the recent highlights within our oncology business on slide six. We experienced continued volume growth across all oncology tests, with notable strength from GARDEN360 volume, which accelerated again in the quarter following the major product upgrades leveraging the Smart Liquid Biopsy platform last year.

Speaker Change: Starting with our oncology business in slide five Q1 represented another quarter of strong oncology performance with revenue, increasing 20% year over year to $151 million.

Speaker Change: Oncology volumes increased 25% year over year to approximately 59000.

Speaker Change: In the first quarter with the majority of growth driven by Garden's <unk> closely followed by strong contribution from reveal.

Looking more closely at some of the recent highlights within our oncology business on slide six.

Speaker Change: We experienced continued volume growth across all of oncology tests with notable strengths from garden, 360 volume, which accelerated again in the quarter. Following the major product upgrades leveraging the smart liquid biopsy platform last year.

Helmy Eltoukhy: In addition to the strengthening product portfolio across both liquid and tissue, we continue to invest in UMR integrations, which are helping to improve depth of ordering for accountants. I'm pleased to share that Guardant 360 ASP improved again this quarter to the range of $3,000 to $3,100, driven by continued improvement in Medicare Advantage and commercial reimbursement. As a reminder, tissue Medicare pricing increased from $3,140 to $3,500 at the start of the year, and we received Medicare coverage through Reveal in the CRC surveillance setting in January. This reimbursement when through Reveal allows us to more aggressively invest in commercial efforts supporting the test, resulting in greater accessibility for patients and enabling oncologists to make more informed therapeutic decisions.

Speaker Change: In addition to the strengthening product portfolio across both liquid and tissue. We continued to invest in EMR integrations, which are helping to improve depth of ordering per account.

Speaker Change: I'm pleased to share that garden uses the ASP improved again this quarter to the range of 3000 to $3100 driven by continued improvement in Medicare advantage and commercial reimbursement.

Speaker Change: As a reminder, tissue Medicare pricing increase from $31 40 to $3500 at the start of the year and we received Medicare coverage reveal in the CRC surveillance that again January this reimbursement wins reveal allows us to more aggressively invest in commercial efforts supporting the test, resulting in greater accessibility for pace.

Speaker Change: <unk> and enabling oncologists to make more informed therapeutic decision.

Helmy Eltoukhy: In the first quarter, a deal was gross margin positive for the first time, driven predominantly by the 50% cost improvement we achieved exiting 2024. We continue to believe this positive gross margin inflection, along with CRC surveillance reimbursement announced in the quarter, will allow us to unlock volume acceleration while meaningfully improving cash burn.

Speaker Change: In the first quarter of deal with gross margin positive for the first time driven predominantly by the 50% cost improvement we achieved exiting 2024, we continue to believe this positive gross margin inflection along with CRC surveillance reimbursement announced in the quarter will allow us to unlock volume acceleration while meaningfully.

Speaker Change: Moving cash burden.

Speaker Change: Moving on to slide seven now I would like to highlight some of our infinity smart liquid biopsy application development work in greater depth, we have been quietly developing powerful real world evidence platform utilizing the nearly 100000 broad genomic and epigenomics profile spanning more than 50 cancer types that.

Helmy Eltoukhy: Now, I would like to highlight some of our Infinity Smart Liquid Biopsy application development work in greater depth. We have been quietly developing powerful real world evidence platform, utilizing the nearly 100,000 broad genomic and epigenomic profiles, spanning more than 50 cancer types that we have assembled. Moreover, most of these profiles have been combined with rich clinical data and when analyzed with our Infinity AI Learning Engine, have enabled the development of the groundbreaking clinical applications we have launched and are continuing to launch this year.

Speaker Change: We have assembled.

Speaker Change: Moreover, most of these profiles have been combined with greater clinical data and when analyzed with our Infinity AI learning engine have enabled the development of the groundbreaking clinical applications. We have launched and are continuing to launch this year.

Helmy Eltoukhy: Specifically, a significant number of the 18 abstracts we are presenting at AACR are highlighting some of these new applications, which enable features such as tumor burden quantitation, tumor subtyping, chip annotation, HRD detection, immunotherapy prediction, and many, many more to come. We believe these applications will soon set a new standard of care in oncology.

Specifically a significant number of the 18 abstracts were presented at ACR are highlighting some of these new applications, which enabled features such as tumor burden quantitation tumor subtyping chip annotation HRD detection immunotherapy prediction and many many more to come we believe these applications will soon.

Speaker Change: We set a new standard of care and oncology.

Helmy Eltoukhy: Moving on to slide 8, we are pleased to announce that we have launched our upgraded tissue test, which is called GARDEN360 tissue. GARDEN360 tissue represents what we believe to be the first of its kind broad multi-omic tissue CGT test to incorporate comprehensive DNA, RNA, AI-powered PD-L1, and broad methylomenality.

Speaker Change: Moving on to slide eight we are pleased to announce that we have launched our upgraded tissue test, which is called garden 360 tissue Garden 60 tissue represents what we believe to be the first of its kind broad multi youll move tissue CGP test to incorporate comprehensive DNA RNA AI powered PDL one.

Speaker Change: And broad met the loom analysis.

Helmy Eltoukhy: This marks the final major product in the oncology portfolio to be upgraded to the Infinity Smart Liquid Biopsy Platform, which will enable our tissue product to leverage and accrue many of the groundbreaking epigenomics-powered features we are launching on Guardant 360 Liquid. In this way, all of our products spanning our liquid and tissue portfolio will work together synergistically to provide a differentiated physician and patient experience across therapy selection and MRD in pursuit of improved clinical outcomes.

Speaker Change: This marks the final major product in oncology portfolio to be upgraded to the infinity smart liquid biopsy platform, which will enable our tissue product to leverage and accrue many of the groundbreaking epigenomics powered futures, we are launching from garden to 60 liquid.

Speaker Change: In this way all of our projects spanning our liquidity portfolio will work together synergistically to provide a differentiated physician and patient experience across therapy selection in MRV in pursuit of improved clinical outcomes.

Speaker Change: Finally, since garden 360 tissue was built from the ground up utilizing our smart liquid biopsy platform. It can provide results with 40% less tissue required than most of our key competitors, enabling some of the lowest industrywide sample requirements for next generation sequencing. We are excited for this next generation of <unk>.

Speaker Change: Tissue CGP.

Helmy Eltoukhy: Now shifting gears to Reveal on slide 9, where we are the leader in tissue-free MRD.

Now shifting gears to reveal on slide nine where we are the leader in tissue <unk> and Marquis we are excited to announce a new breast cancer publication in clinical cancer research highlighting the performance of Gardened revealed importantly, this is the first publication utilizing reveal and our smart liquid biopsy platform with early stage stage II.

Helmy Eltoukhy: We are excited to announce a new breast cancer publication in Clinical Cancer Research, highlighting the performance of Guardant Reveal. Importantly, this is the first publication utilizing Reveal on our smart liquid biopsy platform with early-stage, stage 2-3, triple-negative breast cancer patients. This retrospective study evaluated triple-negative breast cancer patients who were undergoing new-adjuvant chemotherapy. With 83% sensitivity for distant recurrence and 99.5% specificity at the sample level, this data shows that Reveal has the potential to significantly guide both surgical monitoring and therapeutic decisions.

Speaker Change: Three triple negative breast cancer patients. This retrospective study evaluated triple negative breast cancer patients undergoing <unk> chemotherapy with 83% sensitivity for distant recurrence and 99, 5% specificity at this <unk> level. This data shows that reveal is the potential for significant blade guide.

Speaker Change: Post surgical monitoring and therapeutic decisions. This publication is building our data evidenced sports submission for Medicare reimbursement in breast cancer, which is expected this year.

Helmy Eltoukhy: This publication is building our data evidence for submission for Medicare reimbursement in breast cancer, which is expected this year.

Helmy Eltoukhy: Turning to slide 10, beyond CRC and breast, we have an extensive pipeline of clinical cohorts to further support clinical utility and analytical validity for Guardant Reveal.

Speaker Change: Turning to slide 10, Jan CRC and breadth, we have an extensive pipeline of clinical cohorts to further support clinical utility and analytical validity for garden to deal.

Helmy Eltoukhy: We recently submitted data for publications supporting potential Medicare reimbursement for coverage and immuno-oncology therapeutic monitoring, and have a number of ongoing clinical validity studies for additional cancers. We look forward to sharing updates on our progress throughout the year.

Speaker Change: We recently submitted data for publication supporting potential Medicare reimbursement for coverage in immuno oncology therapeutic monitoring and have a number of ongoing clinical validity studies for additional cancers, we look forward to sharing updates on our progress throughout the year.

Helmy Eltoukhy: Turning to slide 11, the oncology business is well-positioned to continue to experience durable growth, benefiting from organic market growth, ASB tailwinds, and continued international expansion. Guardant 360 liquid and Guardant 360 tissue are further benefiting from recently expanded genomic and epigenomic breadth, which are unlocking greater utility and driving share gain. In MRD, a redoubled commercial focus following major cost improvements in Medicare CRC surveillance reimbursement are helping to fuel growth. Guardant Reveal has seen strong uptake in breast cancer already, and we have additional publications of breast data and bio-monitoring data this year that will help to further unlock demand and indications beyond CRC.

Speaker Change: Turning to slide 11, the oncology business is well positioned to continue to experience durable growth benefiting from organic market growth ASB tailwind and continued international expansion gardens, or 50 liquid and garden $360 issue are further benefiting from recently expanded genomic and epigenomics breath, which are unlocking greater utility and <unk>.

Speaker Change: Driving share gain and <unk> redoubled commercial focus following major Cogs improvements in Medicare CRC surveillance reimbursement are helping to fuel growth garden reveal has seen strong uptake in breast cancer already and we have additional publications of breast data in Io monitoring data. This year that will help to further unlock them.

Speaker Change: Men and indications beyond <unk>.

Helmy Eltoukhy: Looking more closely at some of the recent highlights within our biopharma and data business in slide 12, we had another strong quarter for biopharma with first quarter revenue growing 21% year over year. We continue to see an increasing number of biopharma partnerships and growing mix of volume, leveraging methylation analysis from our smart liquid biopsy platform. We recently announced a strategic collaboration agreement with Pfizer, which meaningfully strengthens and expands our long term partnership where Guardant 360 has been a preferred liquid biopsy test in various Pfizer clinical trials. We have also built a robust and growing pipeline of companion diagnostic deals.

Speaker Change: Looking more closely at some of the recent highlights within our Biopharma data business in slide 12, we had another strong quarter for Biopharma with first quarter revenue growing 21% year over year, we continue to see an increasing number of biopharma partnerships and growing mix of volume leveraging methylation analysis from our smart liquid.

Speaker Change: Obviously platform, we recently announced the strategic collaboration agreement with Pfizer, which meaningfully strengthens and expands our long term partnership where garden 360 has been a preferred liquid biopsy test in various by this clinical trials.

Speaker Change: We have also built a robust and growing pipeline of companion diagnostic deals lastly pertaining to our garden inform real world data business, we continue to expand our presence with large pharma partners such as the recently announced Bayer and concert AI collaboration benefiting from the growing interest in our industry, leading methylation knowledge base and.

Helmy Eltoukhy: Lastly, pertaining to our garden-informed real-world data business, we continue to expand our presence with large pharma partners, such as the recently announced Bayer and Concert AI collaboration, benefiting from the growing interest in our industry-leading methylation knowledge base and the expanding richness of our EMR-linked data offerings.

Expanding richness of our EMR early data offering.

AmirAli Talasaz: With that, I will now turn the call over to AmirAli for an update on screening. Thanks Helmy. Moving on to slide 13. We are pleased to see continued strong traction for S.H.I.E.L.D. in the second full quarter of commercial launch. We delivered $5.7 million of shield testing revenue in Q1, driven by approximately 9,000 tests, and exited the corridor with positive momentum. We continue to experience outstanding reception from physicians and patients. The depth of ordering for iCamp continues to be strong, reaffirming the market opportunities, the product market fit, and the differentiated physician and patient experience compared to existing modalities.

Speaker Change: With that I will now turn the call over to <unk> for an update on screening.

Speaker Change: Tanks helped me moving on to slide 13.

Speaker Change: We're pleased to see continued strong traction for shale and the second full quarter of coronary Shlomo.

Speaker Change: We delivered $5 $7 million shift testing revenue in Q1, driven by approximately 9000 deaths.

Speaker Change: It is a coronary positive momentum.

Speaker Change: We continue to experience outstanding reception from physicians and patients.

Speaker Change: The desktop ordering frac count continues to be strong reaffirming the market opportunity the product market fit and a differentiated physician and patient experience compared to existing modalities.

AmirAli Talasaz: We are particularly encouraged by our Salesforce Productivity Ramp.

Speaker Change: We are particularly encouraged by our salesforce productivity ramp turning to slide 14.

AmirAli Talasaz: Turning to slide 14. We were very pleased last month with SHIELD receiving ADLT status, which catalyzed an increase in Medicare price from $920 to $1,495 effective April 1st. ADLT status reinforces the value that SHIELD brings to patients as a more pleasant and convenient option for CRC screening that can help increase the overall screening rate and improve CRC survival outcomes. This more favorable Medicare rate allows us to accelerate the commercial infrastructure buildup to bring SHIELD to a wider audience.

Speaker Change: We were very pleased last month, which shield, receiving a DLT status, which catalyzed by increasing Medicare price from 928 to.

Speaker Change: $1495 effective April one.

Speaker Change: <unk> status reinforcing the value gets shield greenstone PE shops at Moore Plaza and convenient option for CRC screening.

Speaker Change: That helped increase the overall screening rates.

Speaker Change: CRC survival outcomes.

Speaker Change: This more favorable Medicare rate allows us to accelerate the commercial infrastructure build out to be.

Speaker Change: <unk> shield to a wider audience.

AmirAli Talasaz: Turning now to slide 15 to take a closer look at our screening highlights for the first quarter 2025. I'm excited to share that we achieved positive gross margin for shield in the first quarter, much sooner than we had originally anticipated. This was driven by cognitive improvement and a high mix of reimbursable test volume. We receive coverage from the VA Community Care Network, which brings shield access to over 9 million VA beneficiaries with no copay. Importantly, the VA will cover S.H.I.E.L.D. for all eligible individuals between 45 and 84 years old, which marks S.H.I.E.L.D.'s first coverage of patients below the Medicare age.

Speaker Change: Turning now to slide 15 to take a closer look at our screening highlights for our first quarter finding fine you're fine.

Speaker Change: I'm excited to share that we achieved positive gross margin for sale in the first quarter microphone area that we had originally anticipated.

Speaker Change: This was driven by Cogs improvement and a higher mix of Reimbursable test volume.

Speaker Change: He received coverage from the VA community care network, which brings shield access to over 9 million VA beneficiaries with no copay.

Speaker Change: Importantly, the VA will cover shelf for all eligible individuals between 45084 years old, which marks shield's first coverage of Asia B note that Medicare age and last week and I can get.

AmirAli Talasaz: And last week, the American Gastroenterological Association, or AGA, the leading professional organization representing top leaders in the GI space, released a clinical practice update. This update mentioned the potential for S.H.I.E.L.D. to improve adherence to cancer screening and recognized that programmatic screening every three years with this blood test is valuable for currently unscreened individuals. Lastly, a recent Paris poll survey shows that 92% of patients would be more satisfied with their wellness visit if their provider offered an FDA-approved blood test as an option for a CRC screening. and 93% of primary care providers believe patients are less likely to avoid screening if presented with an FDA-approved blood test option.

Speaker Change: <unk> Association or HVA, they're leading professional organization representing top leaders ended Gi space re leased at clinical practice update this update mentioned a potential force shield to improve adherence to cancer screening and recognize that programmatic screening every day.

Speaker Change: Three years with this blood test is valuable for currency on the screen individuals.

Speaker Change: Lastly, a recent Harris poll survey.

Speaker Change: Does that 92% of patients would be more satisfied with their wellness visit keep their provider offer that FDA absolute blood tests as an option for CRC screening.

Speaker Change: And 93% of primary care providers believe patients are less likely to outweigh screening dentists with an FDA approved blood test option.

AmirAli Talasaz: Turning to slide 16. Our goal has always been to identify and catch many cancer types early when they are most treatable. We develop our shield assay as a platform capable of multi-chapter detection or CRC screening is the first indication for our SHIELD test, and we are excited to see SHIELD CRC is gaining strong traction. We are even more excited about expanding the impact of SHIELD beyond single cancer screening.

Speaker Change: Turning to slide 16.

Speaker Change: Our goal has always been to identify and catch many cancer attacks early when they are most treatable.

Speaker Change: We develop our shield I'd say as a platform.

Speaker Change: Couple of multi tax rate detection or mcd.

Speaker Change: CRC screening is the first indication of our shale test and we are excited to see shield CRC is gaining strong traction.

Speaker Change: We are even more excited about expanding the impact of shield beyond single cancer screening.

AmirAli Talasaz: Moving on to slide seven. In early January, we announced SHIELD selection for inclusion in the National Cancer Institute's Vanguard Study. The Vanguard study is a 24,000 patient pilot study to evaluate the use of MCD tests.

Speaker Change: Moving on to slide seven.

Speaker Change: In early January we announced shield selection for inclusion in the National Kathryn.

Speaker Change: <unk> study.

The Vanguard studies of 24000 patient pilot study to evaluate the use of LCD fab.

AmirAli Talasaz: Shield was one of the only two technologies selected through a highly competitive process. And inclusion not only represented validation of our platform by NCI, but we believe establishes Guardant as a leader in the field of MCI. We are pleased that FDA has completed the review of our SHIELD MCD device in their approval of the Investigational Device Exemption, or ID, Supporting the Vanguard Study, which is expected to start in the very near future.

Speaker Change: Shale was one of the only two technologies satellite that is for a highly competitive process and inclusion not only represents a validation of our platform by NCI, but we believe establishes garden leave there and that filled up mcd.

Speaker Change: We are pleased that FDA has completed their review of our shield MCT device in their approval of the investigational device exemption or IDE supporting the Vanguard study, which is expected to start in the very near future.

AmirAli Talasaz: And this week at AACR, we are excited to present the validation performance data from SHIELD-NCD that was the basis for its selection by NCI. Overall sensitivity for 10 cancers was 60%, with 35% sensitivity in stage 1-2 and 84% sensitivity in stage 3-4 cancers at a specificity of 98.5%. While SHIELD can operate at a specificity level of 99.5%, the NCI preferred 98.5% specificity to optimize for early stage cancers. Primary or secondary cancer site of origin or CSO accuracy was 89%. As a reminder, cancer site of origin refers to a prediction made by the test about the likely organ where a cancer signal origin.

Speaker Change: And this week at ACR.

Speaker Change: We're excited to present, the validation performance data from shield NCD that was the basis for its selection by NCI.

Speaker Change: Overall sensitivity for 10 cancers was 60%.

Speaker Change: 35% sensitivity in stage, one two and 84% sensitivity in stage three four cancers.

Speaker Change: Statistically up 98, 5%.

While shield can operate at a specificity of 99, 5% the NCI preferred 98, 5% specificity to optimize for early stage sensitivity.

Speaker Change: Primary or secondary attach or signed up origin, our CSO accuracy was 89%.

Speaker Change: A reminder, cancer side of origin refresh that prediction may find out that about that likely Oregon, where a cancerous technology oriented.

AmirAli Talasaz: CSI accuracy was an important factor in the MCI evaluation process, and our diligence suggests it is critically important to the commercial success of MCD tests. Turning to slide 18 to take a closer look at the data, sensitivity in the six most aggressive cancers with the shortest survival rates, including esophageal, lung, liver, pancreatic, ovarian, and gastric was 74%, ranging from 67% in lung cancer to 96% in esophageal and gastric cancer.

Speaker Change: So that's why I'm curious Jim was an important factor in the Sci evaluation process and our diligence suggests it is critically important to the commercial success of <unk>.

Speaker Change: C D pets.

Speaker Change: Turning to slide 18 to take a closer look at the data sensitivity and a six month <unk> in cancers with the shortened survival rates, including NGL long labor pancreatic ovarian and gastric with 74% ranging from 67 million lung cancer to 96%.

Speaker Change: And as a fish oil and gastric cancers.

AmirAli Talasaz: This test has the opportunity to save many lives. And following the commencement of the NCI Vanguard study this year, multi-cancer detection analysis capabilities of the SHIELD test will be ready to be clinically offered.

Speaker Change: This test is to offer a chance to save many lives and so I'm going to comment stopped NCI vanguard sustain this year multi cancer detection and analysis capabilities of this shale tests will be ready to be clinically offerings. Looking ahead. We are excited about our upcoming milestones in 2020 five.

AmirAli Talasaz: Looking ahead, we are excited about our upcoming milestones in 2025, including the potential inclusion of SHIELD in American Cancer Society or ACS guidelines, SHIELD CRT V2 data, and potentially launching SHIELD V2 later this year.

Speaker Change: Including the potential push out shield and I'm right that Castro society or Acs guidelines she.

Mike: <unk>, two data and potentially launching Shelby two later this year with that I will now turn the call over to Mike for a more detail on our financials.

Mike Bell: With that, I will now turn the call over to Mike for more detail on our finance. Thanks Amirali. Turning to slide 19, I'll now discuss some select financial highlights for the quarter ended March 31st, 2025. I'll refer to year-over-year growth rates, unless otherwise necessary. As previously mentioned, going forward, we'll present new revenue categories. To help with modeling and analysis, we've included supplemental information on our Investor Relations website that breaks our historical 2024 quarterly revenue into the new category. First quarter total revenue grew 21% to $203.5 million and was largely driven by oncology revenue, which grew 20% to $150.6 million.

Mike: Thanks Ronnie.

Mike: Turning to slide 19, I will now discuss some select financial highlights for the quarter ended March 31st 2025.

Mike: I'll refer to year over year growth rates unless otherwise noted.

Mike: As previously mentioned going forward, we will present new revenue categories.

Mike: With modeling that analysis, we have included supplemental information on our Investor Relations website that breaks how historical 2020 for quarterly revenue and to the new categories.

Mike: First quarter total revenue grew 21% to $203 5 million.

Mike: And was largely driven by oncology revenue, which grew 20% to $150 6 million.

Mike Bell: Oncology volume grew 25% to approximately 59,000 tests in Q1, with the majority of unit growth driven by Guardant 3C. closely followed by strong contribution from Reveal. Year-over-year Guardant 360 growth accelerated again in Q1, marking the third consecutive quarter of accelerated growth. Revealed continue to represent our fastest-growing product on a year-over-year basis. Guardant 360 ASP was in the range of $3,000 to $3,100 in the first quarter of 2025, compared to approximately $3,000 in Q4 2024. This increased Guardant 360 AFP was a function of continued improved reimbursement for Medicare Advantage and commercial payments. First Quarter Oncology Revenue also benefited from an asset period upside of approximately $5 million above our normal expected level.

Mike: Oncology volume grew 25% to approximately 69000 tests in Q1 with the majority of the unit growth driven by card and 360 closely followed by strong contribution from mobile.

Mike: Year over year guidance <unk> growth accelerated again in Q1, marking the third consecutive quarter of accelerating growth.

Mike: Reveal continue to represents our fastest growing products on a year over year basis.

Mike: <unk> hundred 60, <unk> ASP was in the range of 3000 to $3100 in the first quarter of 2025.

Mike: Approximately $3000 in Q4 2024.

Mike: This increased government receipts. The HP was a function of continued improved reimbursement for Medicare advantage and commercial payers.

Mike: First quarter oncology revenue also benefited from an asset period upside approximately $5 million above our normal expected level.

Mike Bell: This confers to an $8 million out-of-period upside that we recognize in Q1 2024. Our biopharma and data business performed incredibly well again in the first quarter, with revenue totaling $45.4 million, an increase of 21%. Our biopharma pipeline continues to shape up solidly, driven by Guardant's affinity on our smart liquid biopsy platform, and the recently announced multi-year strategic collaboration with Pfizer further adds to our confidence in both the short-term and long-term benefits. Screening revenue totaled $5.7 million in Q1 2025, generated from the 9,000 SHIELD tests that were reported in the quarter. And finally, licensing and other revenue was $1.9 million, compared to $5.2 million in the prior year period.

Mike: This compares to an $8 million out of period upsides that we recognized in Q1 2024.

Mike: Our biopharma and data business performed incredibly well again in the first quarter with revenues totaling $45 4 million an increase of 21%.

Mike: Our Biopharma pipeline continues to shape up solidly driven by garden's infinity, and our smart liquid biopsy platform and the recently announced strategic collaboration with Pfizer further adds to our confidence in both the short term and long term business screening revenue totaled $5 $7 million in Q1 2025.

Mike: Generated from a 9000 shale tests that we reported in the quarter and finally licensing and other revenue was $1 9 million.

Mike: To $5 2 million in the prior year period.

Mike Bell: Turning to slide 20, we're extremely pleased to be able to report that both Reveal and Shield became gross margin positive in the first quarter of 2025. For Reveal, we saw the full impact of the workflow changes made towards the end of last year, which have resulted in a significant reduction in cost per test. From an average cost of more than $1,000 in 2024, we've achieved a reduction of more than 50%, with the cost per test now less than $500. This, together with an improved revealed CRC ASP of more than $600 following Medicare coverage means that we can now unlock revealed volume acceleration while meaningfully improving cash flow.

Mike: Turning to slide 20.

Mike: We're extremely pleased to be able to report that both reveal and shield became gross margin positive in the first quarter of 2025.

Mike: For reveal we saw the full impact of the workflow changes made towards the end of last year, which have resulted in a significant reduction in cost per test.

Mike: From an average cost of more than $1000. In 2024, we've achieved a reduction of more than 50% with the cost per test now less than $500.

Mike: This together with an improved through Elcic asps.

Mike: $600 following Medicare coverage.

Mike: We can now unlock reveal volume acceleration, while meaningfully improving cash plan.

Mike Bell: For S.H.I.E.L.D., we also saw continued reduction in cost per test, driven by increased volume and by tight cost control and efficiencies across our screening operations. In the first quarter of 2025, shield cost per test was approximately $500. With an ASP of approximately $600, SHIELD is also now gross margin. We expect the gross margin to further expand in Q2, due to the increase in ASP we'll get from ADLT status, which was effective April 1st, and from continued volume-related cost reductions.

Mike: The shield. We also saw continued reduction in cost per test driven by increased volume by tight cost control and efficiencies across our screening operations.

Mike: In the first quarter of 2025 ship cost per test was approximately $500.

Mike: With an ASP of approximately $600 shoot is also not gross margin positive.

Mike: We expect the gross margin to further expand in Q2 due to the increase in ASP will get from <unk> status, which was effective April 1st from continued volume related cost reductions.

Mike Bell: Moving on to slide 21. Our non-gap growth margin of 65% was above our expectations in the first quarter of 2025 and was an improvement compared to 63% in the first quarter of 2024. The strong gross margin is primarily a result of the improved oncology ASPs, as well as the significant reveal in shield culture. Non-GAAP operating expenses were $199.6 million in the first quarter of 2025, an increase of 13% and in line with our expectations. Both NOMGAP, R&D and G&A expenses in the quarter were approximately flat compared to prior year, which reflects the operating leverage that we are achieving throughout the bill.

Mike: Moving on to slide 21.

Mike: Our non-GAAP gross margin of 65% was above our expectations in the past cluster of 2025.

Mike: It is an improvement compared to 63% in the first quarter of 2024.

Mike: The strong gross margin was primarily a result of the improved oncology Isps as well as the significant reveal and shield cost reductions.

Mike: non-GAAP operating expenses were $199 6 million in the first quarter of 2025.

Mike: An increase of 13% and in line with our expectations.

non-GAAP R&D and G&A expenses in the quarter were approximately flat compared to prior year, which reflects the operating leverage we are achieving throughout the business.

Mike Bell: As expected, non-gap sales and marketing expense increased 29% to $94.1 million in the first quarter of 2025. This increase was due to the ongoing screening commercial build-out, as well as continued investment in oncology sales and marketing. The adjusted EBITDA loss was $58.5 million for Q1 2025, an improvement of $2.6 million compared to a loss of $61.1 million in Q1 2024.

As expected non-GAAP sales and marketing expense increased 29% to $94 1 million in the first quarter of trying to 'twenty five.

Mike: This increase was due to the ongoing screening commercial buildup as well as continued investment in oncology sales and marketing.

Mike: Adjusted EBITDA loss was $58 $5 million for Q1, 2025, an improvement of $2 6 million.

Mike: To a loss of $61 1 million in Q1 2024.

Mike Bell: You continue to be focused on cash management and reducing our burden in 2025 versus 2021. Q1 2025 free cash flow burn was $67 million compared to $37 million in the prior year period. The year-over-year increase was entirely due to the timing of the company's annual bonus payout, which this year was made in Q1, and which in previous years has been made in Q2. I just think for this timing difference, free cash flow burn in the quarter decreased year over year. We ended the quarter with approximately $804 million in cash, cash equivalents, and restricted cash.

Mike: You continue to be focused on cash management, and reducing got done in 2025 versus 2024.

Mike: Q1, 2025 free cash flow burn of $67 million.

Mike: 37 million in the prior year period.

Mike: The year over year increase was entirely due to the timing of the company's annual bonus path.

Mike: Which tissue is made in Q1 and which in previous years and has been made in Q2.

Mike: Adjusting for this timing difference free cash flow burn in the quarter decreased year over year.

Mike: We ended the quarter with approximately $804 million in cash cash equivalents and restricted cash.

Mike Bell: We continue to expect that we will reach cash flow breakeven in 2028 with cumulative free cash outflow of $450 to $550 million over the next three years.

Mike: We continue to expect that we will reach cash flow breakeven in 2028 with cumulative free cash outflow of $450 million to $550 million over the next three years.

Mike Bell: Moving to slide 22 for our outlook and assumptions for the full year 2025. We're increasing our full year 2025 revenue to be in the range of $880 to $890 million. We're presenting growth of approximately 19 to 20% compared to 2024, and an increase of $30 million compared to our prior range of $850 to $860 million. We now expect oncology revenue to grow approximately 18% year over year in 2025, compared to our prior guidance of 15%. The increase is based on stronger-than-expected volumes and reimbursement experienced in Q1 2025 and improves Guardant 360 ASPs and oncology volume now projected for the remainder of the year.

Mike: Moving to slide 20.

Mike: For our outlook and assumptions for the full year 2025.

Mike: We're increasing our full year 2025 revenue to be in the range of $880 million to $819 million representing growth of approximately 19% to 20% compared to 2024.

Mike: And an increase of $30 million.

Mike: From a prior range of $850 million to $60 million.

Mike: We now expect oncology revenue to grow approximately 18% year over year in 2025.

Mike: Much of our prior guidance of 15%.

Mike: The increase is based on stronger than expected volumes and reimbursement experienced in Q1 2025.

Mike: Unimproved gone in 360, Isps and oncology volume now projected for the remainder of the year.

Mike Bell: Given the continued positive traction we're seeing from GARN360 LDT on smart liquid biotin the Medica CRC surveillance coverage for Reveal and the recent upgrade to Garmin 360 Tissue. We continue to expect volumes across all oncology products to accelerate in 2025, and we now expect total oncology volume to grow greater than 25%. We expect our biopharma business to perform well throughout 2025 and continue to expect low double-digit growth for biopharma and data revenue. We're raising our full year 2025 shield revenue guidance forecast to $40 to $45 million from our prior guidance of $25 to $30 million.

Mike: Given the continued positive traction were seeing from Gartner 360, <unk> smart liquid biopsy.

Mike: <unk> coverage for rebuild.

Mike: And the recent upgrades to come 360 tissue, we continue to expect volumes across all oncology products accelerates in 2025.

Mike: We now expect total oncology volume to grow greater than 25%.

Mike: We expect our biopharma business to perform well throughout 2025 and continue to expect low double digit growth for Biopharma and data revenue.

Mike: We are raising our full year 2025 shield revenue guidance forecast to $40 million to $45 million.

Mike: From our prior guidance of $25 million to $30 million.

Mike Bell: Approximately $10 million of this increase is the result of obtaining ADLT status for SHIELD, which has increased ASP to approximately $800 per test starting April 1st. The remaining $5 million increase in SHIELD revenue guidance is a result of higher volume, where we now expect 52,000 to 58,000 tests, versus our prior guidance of 45,000 to 58,000. We continue to expect full-year volume to be more back-end loaded due to the time required for recently hired sales reps to ramp product . Without Reveal, She'll Become Engrossed, Margin Positive in Q1 2025. And with the progress we're seeing with Oncology Shield ASPs, we're confident that we can deliver full-year non-gap gross margins in the range of 62% to 63%.

Mike: Approximately $10 million. This increase is a result of obtaining a DLT spaces for shield, which decreased asps to approximately $800 a test starting April 1st.

Mike: The remaining $5 million increase in shield revenue guidance as a result of higher volume.

Mike: We now expect 52000 to 58000 tests versus our prior guidance of 45000 to 50000 tests.

Mike: We continue to expect full year to be more backend loaded due to the time required for our recently hired sales reps to ramp productivity.

Mike: We've done trivial issue of becoming gross margin positive in Q1 2025.

Mike: And with the progress we're seeing with oncology show the NSP.

Mike: We're confident that we can deliver full year non-GAAP gross margins in the range of 62% to 63%.

Mike Bell: We continue to monitor the tariff news closely, and as a reminder, we do not source any of our assay inputs directly from China. We've completed a thorough materials analysis in concert with our third-party vendors, and based on what we know today, any tariff impact is likely to be minimal. Given the higher 2025 shield revenue on the heels of ADLT pricing and increased volume, we plan to reinvest the incremental screening gross profit back into the business to accelerate our commercial infrastructure build out. As a result, we now expect 2025 non-GAAP operating expenses to be in the range of $830 to $840 million, representing a 10 to 11% increase compared to 2024.

Mike: We continue to monitor the tariff news closely.

Mike: As a reminder, we do not sell any of our assay in post directly from China.

Mike: We've completed a thorough materials analysis and concept with our third party vendors and based on what we know today any tariff impact is likely to be minimum.

Mike: Given the higher 2025 shows revenue on the heels of <unk> pricing and increased volume.

Mike: Plan to reinvest the incremental screening gross profit back into the business to accelerate our commercial infrastructure build out.

Mike: As a result, we now expect 2025 non-GAAP operating expenses to be in the range of ancient incentive payment of $40 million, representing a 10%, 11% increase compared to 2024.

Mike Bell: We continue to expect full year R&D and G&A expenses to be relatively flat compared to 2024, with the full year increase in operating expenses coming mainly from investments in sales and marketing activities as we continue to drive top line growth.

Mike: We continue to expect full year, R&D and G&A expenses to be relatively flat compared to 2024.

Mike: For the full year increase in operating expenses coming mainly from investments in sales and marketing activities as we continue to drive topline growth.

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

Mike: Lastly, our commitment to reduction in cash burn each yet just to reach company wide cash flow breakeven in 2028 is unchanged.

Mike: Our full year 2025, we still expect free cash flow to be in the range of $225 million to $235 million.

Mike: An improvement compared to $275 million for 2024.

Mike: We continue to expect our cash burn in 2025 to consist of approximately $20 million related to screening as we scale, our shield business and maximize our first mover advantage.

Mike: Significantly excluding screening we expect the remainder of the business to approximately 25% to $35 million during the year and to reach cash flow breakeven in the fourth quarter of 2025.

Unknown Executive: Finally, turning to slide 23, we've already reached key milestones across each of our business segments, and we continue to have a rich pipeline of catalysts for the remainder of the year.

Mike: Finally, turning to slide 23, we've.

Mike: We've already reached key milestones across each of our business segments and we continue to have a rich pipeline of penalties for the remainder of the year.

Operator: With that, we'll now open the call to questions. Thank you.

Mike: With that we'll now open the call to questions.

Thank you and if you would like to ask a question. Please press star followed by one on your telephone keypad.

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

Operator: If you would like to withdraw your question, please press star followed by two.

Mike: If you would like to withdraw your question. Please press star followed by chicken.

Operator: When preparing to ask a question, please ensure your device is unmuted locally.

Mike: When preparing to ask a question. Please ensure your devices are muted locally.

Mark Massaro: Our first question comes from Mark Massaro with BTIG. Your line is open, please go ahead. Hey, guys, congrats on the quarter. Thanks for taking the questions.

Mark Massaro: Our first question comes from Mark Massaro with <unk>. Your line is open. Please go ahead.

Mark Massaro: Hey, guys congrats on the quarter, thanks for taking the questions.

Helmy Eltoukhy: Maybe the first one for you, Helmy, you know, you've had Garden360 in the market now for I think this is year number 11, and yet you're raising the oncology volume to accelerate to over 25% growth. As this is accelerating, I was wondering if you could help us perhaps rank order what these opportunities are. To what extent is this epic? To what extent is this potentially competitive takeaways? And then to what extent could this be, you know, some boost from attachment to the Garden360 tissue? Yeah, no, thanks for the question, Mark. We're very pleased in terms of the progress we're making.

Speaker Change: Maybe the first one for you help me.

Speaker Change: <unk> had garden $3 60 in the market now for I think this year number 11.

Speaker Change: Yet you're raising the oncology.

Speaker Change: Volume to accelerate to over 25% growth.

Speaker Change: As this is accelerating I was wondering if you could help us perhaps rank order what these.

Speaker Change: Opportunities are to what extent is this epic.

Speaker Change: What extent is this potentially competitive takeaways and then to what extent could this be.

Speaker Change: Some boost from attachment to the garden 360 tissue.

Mark Massaro: Yeah no. Thanks for the question Mark.

Mark Massaro: We're very pleased in terms of the progress, we're making and I was looking at.

Helmy Eltoukhy: I was looking at where we were with 360 over the last couple years. And with the recent smart liquid biopsy upgrade, we're actually seeing some of the strongest growth we've seen in a number of years. This is the third quarter of sequential sort of accelerating growth for that product. And so we, we really know we've achieved product market fit with respect to the sort of liquid biopsy market and therapy selection. So that's going to continue to be a really nice growth driver. Obviously, reveal is growing nicely. We're seeing accelerating growth there for the last two quarters as well.

Mark Massaro: Where we were with 360 over the last couple of years and.

Mark Massaro: With the recent smart liquid biopsy upgrade we're actually seeing some of the strongest growth we've seen in a number of years. This is the third quarter of sequential sort of accelerating growth for that product and so we really know we've achieved product market fit.

Mark Massaro: With respect to the sort of liquid biopsy market and therapy selection. So that's going to continue to be a really nice growth driver. Obviously of reveal is growing nicely, we're seeing accelerating growth there for the last two quarters as well and we're going to really lean into that now that we are gross margin positive on that product and then last but not <unk>.

Helmy Eltoukhy: And we're going to really lean into that now that we're gross margin positive on that product. And then last but not least, you know, this massive upgrade we've done on tissue where we're really taking everything that has worked so well in liquid for us, especially last few quarters and essentially putting all of that into the tissue product. And then everything else you mentioned that increases depth that simplifies the ordering experience in terms of EMR and digital and so on is sort of gravy on top of all of that.

Mark Massaro: Leased.

Mark Massaro: This massive upgrade we've done on tissue, where we're really taking everything that has worked so well in liquid for us, especially the last few quarters and essentially putting all of that into the tissue product.

Mark Massaro: And then everything else you mentioned that increases does that Lady supervise the ordering experience in terms of EMR in digital and so on is sort of gravy on top of all of that.

Helmy Eltoukhy: So it's a really nice setup in twenty five for us and we're really excited for this next chapter. Okay, great.

Mark Massaro: Really nice setup in 'twenty five for us and we're really excited for this next chapter.

Mark Massaro: Okay, Great and then maybe a two parter on the screening business.

AmirAli Talasaz: And then maybe a two parter on the screening business. Nice to see that the RAISE guide. Can you walk us through the components of that? Obviously, you signed VA and Abu Dhabi. I'm curious what you're seeing on the business development side as well. Any other potential similar type systems that you're engaged with? And then as we think about the ASP assumptions of the RAISE guide, it's somewhere in the range per test. Why is that the right number when your ADLT price is $14.95 and you're focusing on the Medicare population? Just curious what that Medicare mix was in Cuba.

Mark Massaro: Nice to see the raise guide.

Mark Massaro: Can you walk us through the components of that obviously, you signed VA in Abu Dhabi I'm curious, what you're seeing on the business development side as well any other potential <unk>.

Mark Massaro: Type systems that you are engaged with and then as we think about the ASP assumptions of the Res guide it's somewhere in the 770 range per test why is that the right number when youre, a DLT prices $40 95, and you're focusing on the Medicare population and just curious what that Medicare mix was in Q1.

AmirAli Talasaz: Yeah, sure.

Mark Massaro: Yeah sure so maybe I'll start on that.

AmirAli Talasaz: So maybe I start on the commercials. I asked Mike to write a comment on the ASB products. So we are very excited and pleased with what we are seeing in terms of the productivity of the reps in the field. And this improved productivity is giving us more confidence that maybe we can achieve more than what we originally anticipated.

Speaker Change: <unk>, sorry, I asked Mike sort of added comment that the Asp's products. So you are.

Speaker Change: Very excited that basically what we are seeing in terms of the products to Etfs have reps in the field.

And that same pro productivity is giving us more confidence that maybe we can achieve more than what you originally anticipated.

Speaker Change: Yeah on that.

Speaker Change: Apple's debut side Q1 for it that was really to get to this set up the program. So if you have to see really how quickly that program is kind of set up we have limited visibility at this time as a result, it caught chance to just add a fraction of that 10000 samples that would be a contract that for this year.

Speaker Change: A big part of our guidance are we ready to guide change that.

Speaker Change: No impact by the upside potential of you are going to have from Abu Dhabi.

Speaker Change: We are very excited about the SBA like there are millions of people at age 45 about 6% or find out also get access to this test.

Speaker Change: It kind of finds against all of our target actually that have kind of more press asking some of the areas that they have more concentration of the SBA families at VA.

Speaker Change: <unk> members to really extend our offerings with them and I ask Mike's effect of ASC.

Speaker Change: On the Asps of course, we received the ADL T stages in Q1 and that goes that goes effective went effective first of April so the Medicare rate went from nine to 20 to 14 95.

Speaker Change: That's going to have.

Speaker Change: A nice positive impact on our ASP for Q1.

Speaker Change: It was just north of $600 and we expect for the remainder of the year Q2, Q4, the ASP to be around $800 to look at an uplift from.

Speaker Change: From the agency.

Mark Massaro: You asked mark around the propulsion, that's Medicare there are basically three elements too.

Speaker Change: To the ISP Theres, obviously the Medicaid.

Speaker Change: FIFA service portion is Medicare advantage, and we're starting to get paid by Medicare advantage payers, but the way that we're sort of recognizing the revenue and the ASP that we're using for that is I would say, it's conservative about that at the moment in this room for that to improve over time as we see the collections come through.

Speaker Change: And then there is there is a portion is a relatively small portion, but there is a portion of commercial pace in that and of course, you're not at the moment, we're getting paid zero. So you put them altogether.

Speaker Change: We expect to ASP.

Speaker Change: For the remainder yet to be about ancient dividend overall getting this a DLP status from the person may flow.

Speaker Change: That's roughly it.

Speaker Change: $10 million increase from our original guidance at the start of the year and that's part of the $30 million of lifting guidance that we've.

Speaker Change: That we've just announced today.

Unknown Executive: Great, thank you.

Speaker Change: Great. Thank you.

Tycho Peterson: We now turn to Tycho Peterson with Jeffreys. Your line is open, please go ahead.

Speaker Change: Now turning to Tycho Peterson with Jefferies. Your line is open. Please go ahead.

Tycho Peterson: Hey, Thanks, maybe just sticking with the guidance team Theres still seems like a lot.

Tycho Peterson: Fully baking in here, but can you give us a sense <unk> hundred 60, <unk> Asps you guided flat previously.

Tycho Peterson: What are you baking in for <unk> hundred 60 tissue next and then reveal adoption in the surveillance setting where do you ultimately think you'll end the year on test per patient.

Mike Bell: I can answer the ASP on Guardant360. At the start of the year, we were guiding to $3,000. We saw a nice uplift in Q1, mainly coming, again, from Medicare Advantage and commercial reimbursement being stronger than expected, and we're in this new range now, $3,000.

Tycho Peterson: Yes.

Tycho Peterson: I can answer that.

Tycho Peterson: The asps on that.

Tycho Peterson: On guidance.

Tycho Peterson: At the start of the year.

Tycho Peterson: We're guiding two to $3000.

Tycho Peterson: We saw a nice uplift in in Q1.

Tycho Peterson: Mainly come in again from Medicare advantage, and commercial reimbursement being stronger than expected and we're in this new range now 3000 to 3100, so we expect that to continue.

Mike Bell: 3100. So, you know, we expect that to continue for the remainder of the year. And so that's, you know, helped us raise our guide, raise our guide again. And for tissue next, you know, current ASP is around $1,700, $1,800. And so we're effectively assuming, you know, similar, a similar rate for the remainder of the year.

Tycho Peterson: For the remainder of the year and so that helps us.

Tycho Peterson: Raise our guide.

Tycho Peterson: That guide again.

Tycho Peterson: And for tissue next.

Tycho Peterson: Current asps.

Tycho Peterson: Is around.

Tycho Peterson: 17, 18 hundreds of dollars.

Tycho Peterson: And so where.

Tycho Peterson: We're effectively assuming gain out similar a similar rate for the remainder of the year and we got a nice lift at the start of the tissue with the Medicare rate going from 31 42 35.

Helmy Eltoukhy: We got a nice uplift at the start of the year for tissue with the Medi-Cal rate going from $3,140 to $3,500. Yeah, I know. I mean, obviously. That's something we're very focused on in terms of increasing the number of tests per patient that you saw from the patient story, you know, there's huge potential there in terms of increasing that. And, you know, it's a it's a metric that's been improving across our portfolio in terms of number of garden tests per patient quarter over quarter. And there's a lot of, I would say, work being done by the teams to make that as simple as possible in terms of the compliance and adherence with each additional test.

Tycho Peterson: Yes.

Tycho Peterson: Obviously.

Speaker Change: That's something we're very focused on in terms of increasing the number of tests per patient that you saw from the patient story.

Speaker Change: Huge potential there in terms of increasing that in.

Speaker Change: It's a.

Speaker Change: Metric that's been improving across our portfolio in terms of the number of garden tests per patient quarter over quarter and there.

Speaker Change: There is a lot of I would say.

Speaker Change: Work being done by the teams to make that as simple as possible in terms of the compliance and adherence with each additional test and so we expect that to see that grow considerably throughout.

Helmy Eltoukhy: And so we expect that to see that grow considerably throughout.

Speaker Change: Throughout the year.

Speaker Change: Okay.

Unknown Executive: Okay, and then follow up on MSED. Obviously, you know, it was a big topic at AACR. Good to see the data from you guys.

Speaker Change: Okay, and then follow up on <unk>, obviously, it was a big topic at ACR good to see the data from you guys.

Helmy Eltoukhy: You know, I guess maybe talk a little bit about roadmap from here, what you need to do to get ready for payer discussions. How, you know, what are you able to do to kind of get them comfortable? Historically, obviously, they balked at multi-cancer. You know, talk about some of the steps you need to take going forward.

Speaker Change: Maybe talk little bit about roadmap from here, what you need to do to get ready for payer discussions.

Speaker Change: What are you able to do to kind of get them comfortable historically, obviously, they bought multi cancer. So talking about some of the steps you need to take going forward.

Helmy Eltoukhy: Yeah, it's a very kind of exciting moment for us. Like, you know, we had this vision that SHIELD would be a multi cancer screening detection kind of a technology, we build it that way. You know, we went through this route of CRC approval for reimbursability pathway and like, you know, approval pathway. I think over time, we are kind of figure out that this SHIELD platform that can detect not only CRC, but that can have some kind of secondary analysis for other cancer type detection, which have very strong product market fit. So we are excited with the data that we showed in AACR, you know, technology works, platform works.

Speaker Change: Yeah, it's a very kind of exciting all.

Speaker Change: All of that for us like caveat. This vision that shield would be a multi cancer screening detection kind of it takes allergy we built it that way.

Speaker Change: We went through this route of CRC approval for Reimbursable achieve pathway unlike approval pathway.

Speaker Change: I think over time, we are trying to figure out that this shield platform that can detect not always CRC, but that can have some kind of secondary analysis for either a cancer attack detection.

Speaker Change: It had a very strong product market fit. So we are excited with the data that we showed at ACR technology works platform works.

Speaker Change: We are doing some additional data generation like I'm excited that we're about 20 to 25000 patients that we tested with shell.

Helmy Eltoukhy: We are doing some additional data generation, like I'm excited that we're about 20-25,000 patients that we tested with SHIELD. Right now we correlated, actually we gathered the clinical outcome of those patients. In real world, did they have, you know, have they been diagnosed with other cancers or not? And we are in the process of now running this algorithm on those patients to see in a cohort of tens of thousands of patients, what are we going to see in terms of sensitivity and specificity? Definitely very exciting days for us. I'm looking forward to having more conversation about this throughout the year.

Speaker Change: Right now we correlate that actually we gather the clinical outcome of op dose patients and real royalty they have.

Speaker Change: They've been diagnosed with either Canada or not and we are in the process of now running this asset algorithm on those patients we see in that cohort of tens of thousands of patient what are we going to see in terms of SaaS specific specificity definitely very exciting days for us and looking forward to having more conversation about this.

Speaker Change: Throughout the year.

Speaker Change: Thank you.

William Bonello: Our next question comes from Bill Bonello with Craig Hallam.

Speaker Change: Our next question comes from Bill Bonello with Craig Hallum. Your line is open. Please go ahead.

William Bonello: Your line is open, please go ahead. Thanks a lot. I wanted to circle back a little bit on the tissue test and the commentary about needing 40% less tissue seemed really important, but maybe just, you know, if you could elaborate a little bit based on, you know, discussions you're having with existing accounts, sort of how you expect this to play out over time. I mean, presumably we're talking about, you know, taking share with, you know, maybe with your existing customers for liquid biopsy who are sending tissue to somebody else. But are there particular cancers where you think the advantages of your new product are going to be most distinctive?

Bill Bonello: Thanks, a lot.

Speaker Change: I wanted to circle back a little bit.

Bill Bonello: Tissue.

Bill Bonello: Yes.

Speaker Change: Commentary that meeting, 40% less tissue seemed really important but maybe just if you could elaborate a little bit based on discussions you're having.

Bill Bonello: With existing accounts.

We expect this to play out over time, I mean, presumably we're talking about taking.

Bill Bonello: Taking share.

Bill Bonello: With maybe with your existing customers.

Bill Bonello: For liquid biopsy, who are sending tissue.

Bill Bonello: To somebody else, but are there.

Speaker Change: Are there particular cancers, where you think the advantages.

Speaker Change: New products are going to be most distinctive do you think it's more that just the ease of working with one provider rather than.

Helmy Eltoukhy: Do you think it's more about just the ease of working with one provider rather than sending tests to multiple providers, maybe the ability to reflex to blood, et cetera?

Speaker Change: Sending tests to multiple providers may be the ability to reflex to blood et cetera.

Helmy Eltoukhy: Just are you sort of expecting to compete there? You answer the question in some ways. You know, we're very excited about this product because we have a lot of customers who love the sort of white glove service that we're able to provide them. And just in terms of the quality of our sales reps, and really the knowledge base we have around our medical affairs team and so on. And many of them have said, if you simply add RNA to your tissue product, we're going to switch to you. And so we did way more than that with this product.

Speaker Change: Are you sorted.

Speaker Change: Expecting to compete there.

Speaker Change: Thank you you answered the question.

Speaker Change: Uh huh.

Speaker Change: We're very excited about this product because we have a lot of customers, who love the sort of white glove service that we're able to provide them just in terms of the quality of our sales reps and really the knowledge base, we have around our medical affairs team and so on.

Speaker Change: Many of them have said, if you simply add RNA adhere tissue product, we're going to switch to you and so we did way more than that with this product we really built from the ground up where we can use very limited sample.

Helmy Eltoukhy: We really built it from the ground up where we can use very limited samples. That continues to be one of the issues that many providers have is, you know, not being able to get sort of actionable results out of the limited tissue biopsy samples. We've been able to sort of solve that issue, but it's well more than that. You know, the fact that we're going deep into epigenomics, it's really the first tissue product that has a broad based methylation backbone to it. And you see really kind of the richness of what we've been able to present at ACR and the fact that all of our products now will work together essentially with these applications all embedded in them.

Speaker Change: Continues to be one of the issue that many providers have as you know.

Speaker Change: Not being able to get sort of actionable results out of the limited tissue biopsy samples. So we've been able to sort of solve that issue, but it's well more than that.

Speaker Change: Sure.

Speaker Change: We're going deep into epigenomics, it's really the first.

Speaker Change: Tissue product that has a broad based methylation backbone to it and you see really kind of the richness of what we've been able to present at ACR and the fact that all of our products now will work together essentially with these applications all embedded in them and this content.

Helmy Eltoukhy: This continuity of information that we believe will provide a lot more actionability than any other product in the market from a clinical outcomes point of view, from a clinical decision making. And that is our North Star. Can we help provide actionable decisions for every patient more so than other tools in the market? And we believe this product absolutely does that. We're very excited by it. We had great reception at ACR in terms of unveiling the specifics around it. And I can tell you our sales team has been chomping at the bit to get access to this to tell the world about it.

Speaker Change: 80 of information that we believe will provide a lot more action ability than any other product in the market from a clinical outcomes wanted to do on the clinical decision, making and that is our north star is can we hope.

Speaker Change: Provide actionable decisions for every patient more so than other tools in the market.

Speaker Change: And we believe this product absolutely those that we're very excited by it and we had great reception at ACR in terms of.

Speaker Change: Unveiling the specifics around it and I can tell you our sales team has been chomping at the bit to get access to this too to tell the world about it.

Helmy Eltoukhy: And ultimately, I mean, is your strategy to try and push for a world in where, you know, doctors are wearing both tissue and blood based testing? Or is that just not a realistic scenario anytime in the next several years? No, I mean, the guidelines are already almost there. We have a growing number of payers who believe in that. When you think about the fact that neither modality is perfect, neither modality has 100% sensitivity, whether it's liquid or tissue. And when you think about that decision that could be so imperative and could be the difference between life and death for a patient, isn't a patient's life worth searching both liquid and tissue for a potential life-saving outcome?

Speaker Change: Sure.

Speaker Change: And ultimately if your strategy to try and push for a world in where.

Speaker Change: Doctors that are ordering food.

Speaker Change: <unk> you Andrew blood based testing or is that just not a realistic scenario anytime in the next several years.

Speaker Change: No I mean, the guidelines are already almost there.

Speaker Change: <unk>.

Speaker Change: Alert and the growing number of payers, who believe in that.

Speaker Change: When you think about the fact that neither modality is perfect. Neither modality is a 100% sensitivity whether its liquid our tissue and when you think about that decision that could be so imperative and could be the difference between life and death for a patient.

Speaker Change: Isn't a patients life worth searching both liquid and tissue.

Helmy Eltoukhy: We think so. I think the guidelines, you know, believe it to be the case. So we believe eventually it will be the standard of care to have both for everything.

Speaker Change: Potential life saving outcome, we think so I think the guidelines you believe to be the case. So we believe eventually it will be the standard of care both for every patient.

Helmy Eltoukhy: Okay, and then just one final one and I'll hop off. But I have to ask, is there any risk at all of sort of cannibalization of the higher priced, you know, blood based tests, just people saying, hey, you know, if we can get tissue, we want to do tissue. And, you know, now, now we can use 40% less tissue, you know, we're more likely to be able to get a result in cancers where we might have just jumped right to blood. No, I mean, the way we look at it is, there's going to be many shots on goal with liquid, whether Screening, MRD or Therapy Selection, and then obviously we're the one company that really has a continuum of testing across the board.

Okay, and then just one final one and I'll hop off but.

Speaker Change: They have to ask is there is there any risk at all some sort of cannibalization of the higher price.

Speaker Change: The blood based tests, just people, saying hey.

Speaker Change: If we can get tissue, we want to do tissue.

Speaker Change: And now we can do is 40% less tissue.

Speaker Change: We're more likely to be able to get a result in cancers, where we might've just jumped right to blood.

Speaker Change: No I mean, the way we look at it is there going to be many shots on goal with liquid whether it's in screening and Marty or therapy selection and.

Speaker Change: And then obviously, we're the one company that really has a continuum of testing across the board. So if we can also provide them what.

Helmy Eltoukhy: So if we can also provide what we believe to be a leading modality and product on the tissue side, we think that ultimately just goes a pipework.

Speaker Change: What we believe to be a leading <unk>.

Speaker Change: Modality in product on the tissue side, we think that ultimately disclose the pie for us.

Unknown Executive: Okay. Hey, thank you guys very much.

Speaker Change: Okay, Hey, Thank you guys very much.

Speaker Change: Thank you.

Operator: As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad now.

Speaker Change: As a reminder, if you would like to ask a question. Please press star one on your telephone keypad now.

Operator: And in order to allow everyone to ask a question, please limit yourself to one question only.

Speaker Change: To allow everyone to ask a question. Please limit yourself to one question. Thank you.

Subhu Nambi: We now turn to Subhu Nambi with Guggenheim Partners. Your line is open, please go ahead.

Speaker Change: <unk> <unk> with Guggenheim Partners. Your line is open. Please go ahead.

AmirAli Talasaz: Hey guys, thank you for taking my questions.

Speaker Change: Hey, guys. Thank you for taking my questions.

AmirAli Talasaz: Amirali, what are the potential drivers or catalysts to drive upside or downside to your shield volume guidance of 52 to 58,000? So in terms of upside, like, you know, if we continue to outperform the productivity of our reps in the field, that could be an upside of what we are assuming right now. The other upside could be the inclusion in the ACS guidelines. Any kind of guideline inclusion definitely has some kind of impact on the commercial adoption of the test. And although we are very optimistic about the timing for that guideline inclusion for some time this year, since we don't know when, we are not assuming that in our volume guidance.

Speaker Change: Immediately what are the potential drivers or catalysts to drive upside or downside to your volume guidance of 52 to 58000.

Speaker Change: So in terms of upside like E Con.

Speaker Change: Continue to outperform the productivity of our reps in the field that could be upside to what we are assuming right now.

Speaker Change: The other offset could be the inclusion in the Acs guidelines any kind of guideline inclusion.

Speaker Change: I'm kind of in fact on that.

Speaker Change: Commercial adoption of the test and although we are.

Speaker Change: I'm very optimistic about the timing for that Guy my anguish that for some time. This year since we don't know when we are not assuming that in our volume guidance.

AmirAli Talasaz: The other potential upside could be on this Abu Dhabi contract. It's kind of a sizable contract. We're just assuming a small fraction of it in our numbers.

Speaker Change: The other potential offset could be at this app has diabetes contracting it's kind of a.

Speaker Change: Size of a contractor I just I assume you get a small fraction of it in our numbers.

AmirAli Talasaz: And lastly, as we talked about it in our preferred remark, there are additional positive gross profit that we are getting because of this sooner than expected ADLT pricing. We are reinvesting it back in building more commercial infrastructure, a lot more kind of reps in the field. We are just going through that process right now. It would help us to have more reps deployed very late this year. It's mainly a 2026 kind of upside for us. But if we can bring the reps and deploy them to the field sooner than the current plan, maybe there would be some upside there.

Speaker Change: Lastly is you know as we're talking about it in our prepared remark. Our addition of positive gross profit.

Speaker Change: Ah you're getting because of this so I expect that a DLT pricing we are reinvesting it back in building more commercial infrastructure a lot you know a lot more kind of reps in the field.

Speaker Change: We are just going through that process right now.

Speaker Change: It would help us to have more reps deployed very late this year, it's mainly a declining 26 kind of upside for us, but if we can bring their reps and deploy them to the field sooner not a current plan, maybe there would be some upside there too.

AmirAli Talasaz: downside I think I feel deep so hard to say. Hopefully there aren't any downsides.

Speaker Change: Downside I think.

Speaker Change: You'll see so far.

Speaker Change: Hard to say.

Speaker Change: Hopefully that aren't any downside connect quickly squeeze a short question how much tissue next is assumed in the guidance.

AmirAli Talasaz: Can I quickly squeeze a short question? How much tissue next is assumed in the guidance? Well, without specifically breaking out, I mean, it's relatively a small portion of the oncology guidance, you know, the main drivers of oncology in that guide are obviously Guardant 360 and Reveal.

Speaker Change: Well without without specifically breaking out.

Speaker Change: Relatively a small.

Speaker Change: A portion of the oncology guidance.

Speaker Change: The main drivers on oncology and that guide, obviously gone in 360 and reveal.

Unknown Executive: Thank you, guys.

Speaker Change: Thank you guys.

Speaker Change: Okay.

Puneet Souda: We now turn to Puneet Souda with Lerink Partners. Your line is open.

Speaker Change: We now turn to Puneet <unk> with Leerink partners. Your line is open. Please go ahead.

Puneet Souda: Please go ahead. Yeah, hi, Amir Ali and the team. Thanks for taking my question, Mike.

Right.

Speaker Change: Yes, hi.

Speaker Change: Hello.

Speaker Change: And the team thanks for taking my question Mike.

AmirAli Talasaz: First one, if I could, on the screening side, you know, Guardant has obviously met all of your products in a unique way. They're working to the top right now.

Speaker Change: First one if I could.

Speaker Change: On the screening side.

Speaker Change: Sure.

Speaker Change: Gardeners.

Speaker Change: Obviously, not all of your products.

Speaker Change: Is in a unique way theyre working to the top right now.

AmirAli Talasaz: But just wanted to understand from the SHIELD side, how are you thinking about, you know, in this multimodal market where you're I would love to know where you're getting the most traction, the type of patients, the type of practices, and now with, you know, ADLT and better margins, how are you thinking about the size of the sales force?

Speaker Change: Now, but just wanted to understand from the shield side.

Speaker Change: How are you thinking about.

Mark Massaro: In this multi modal market, where you would get I would love to know where you're getting the most traction the type of patient the type of practices and now with a DLT and better margins. How are you thinking about the size of the sales force and I have a follow up for me.

AmirAli Talasaz: And I have a follow up for Helmy. Okay, yeah. So, you know, it's definitely exciting days for us. When we look at the market, like we talked about it before, and we are now just experiencing it, like there are a lot of on-screen patient population out there, 50 million on-screen, we are seeing very good traction on the PCPs that we onboarded, the depth of ordering continues to be very favorable, which is an endorsement that there are many on-screen patient practices that we are going to in general, you know, everywhere. So that's actually pretty good.

Speaker Change: <unk>.

Speaker Change: Okay, Yeah. So.

Speaker Change: Yeah.

Speaker Change: That's very exciting days for us when we look at the market like we talked about it before and we are now just experiencing like there are a lot of onscreen patient population out there $50 million on screen.

Seeing very good traction on the PCP is that via onboard that desktop ordering on tends to be very favorable which is an endorsement that there are many honest screen patient and the practices that we are going to general everywhere.

Speaker Change: So that's actually create a good and our steady state in terms of commercial infrastructure conscious to be the same we are planning to get to the 700 grafts.

AmirAli Talasaz: In our steady state in terms of commercial infrastructure continues to be the same, we are planning to get to the 700 rep, you know, at some point. This additional gross profit helps us to accelerate to some extent, like, you know, we are probably are going to have in terms of fully trained, deployed sales force, probably are going to have about 200 people by end of the year. That's where we are targeting and we continue from there. Got it.

Speaker Change: At some point this additional gross profit helps us to access rates to some extent like you know we are probably are going to have in terms of fully trained and deployed sales force probably are going to have about 200 people by end of the year, that's where we are targeting and we constantly are from there.

Speaker Change: Got it and then.

Helmy Eltoukhy: And then on the Reveal side, Helmy, you know, could you talk a little bit about where you're getting the best product fit for Reveal? Because you're coming into this market much later versus some of the tissue-informed tests out there.

Speaker Change: On the reveal side to help me.

Speaker Change: Could you talk a little bit about.

Speaker Change: Where you're getting the best product fit for reveal because youre coming into this market much later versus some of the tissue informed tests out there.

Helmy Eltoukhy: Can you just talk to us in terms of the adoption you're seeing today in CRC surveillance, the way the product could grow in breast, and then beyond that, other indications where tissue might be a little bit challenged? Could you talk to us about that and the sort of growth expectations potentially for Reveal? Thank you. Yeah, we see the product is sort of being adopted in a pretty broad based way. I think there are just the reality is that the anxiety of waiting 3, 4, 5, 6, 7 weeks in the adjuvant setting is just too much to bear for many patients and we believe that our mind 3 times a week is the right way to do it.

Speaker Change: Can you.

Speaker Change: Just talk to us in terms of the adoption you're seeing today.

Speaker Change: In CRC surveillance.

Speaker Change: The way the product could grow in breast and then beyond that other indications where tissue might be a little bit challenged could you talk to us about that and the sort of the growth expectations potentially for reveal thank you.

Speaker Change: We see the product is sort of being adopted in a.

Speaker Change: Pretty broad based way I think there are just.

Speaker Change: The reality is that.

Speaker Change: Then xiety waiting.

Speaker Change: 34567 weeks.

Speaker Change: In the adjuvant setting is just too much to bear for many patients and we believe that our.

Helmy Eltoukhy: Product Profile in terms of the performance and so on is one that I think matches up favorably in that market, in that setting. So yeah, we're seeing a lot of physicians in the adjunct setting start and reveal. We're averaging less than seven days in terms of turnaround time for that product. So it's really exciting to see the operational efficiency the team has kind of built up to. And then clearly in the surveillance setting, you know, as the patient is negative for a year or two, there's a big chance that what comes back may not be the same as what was taken out.

Product profile in terms of the performance and so on is a is one that I.

Speaker Change: I think matches up favorably.

Speaker Change: And that market in that setting so yeah, we're seeing a lot of physicians in the ads and setting prefer.

Speaker Change: Arden to reveal.

Speaker Change: We're averaging less than seven days in terms of turnaround time for the product. So it's really exciting to see the operational efficiency of the team has.

Speaker Change: Kind of a built up too.

Speaker Change: Clearly in the surveillance setting.

Speaker Change: You know as the patient is negative for a year or two.

Speaker Change: A big chance that what comes back may not be the same as what was taken out.

Helmy Eltoukhy: And there's a greater confidence in something that like reveal that can have a much larger catchment in terms of catching a disease that might be slightly different that comes back. And so we're feeling very confident in terms of the trajectory, in terms of the growth that reveal has ahead of it, especially with surveillance reimbursement.

Speaker Change: And there's a there's a.

Speaker Change: Greater confidence and something that like reveal that.

Speaker Change: Have a much larger catchment in terms of catching a disease that might be slightly different that comes back and so we're.

Speaker Change: We're feeling very confident in terms of the.

Speaker Change: Trajectory in terms of the growth that reveal has especially with surveillance reimbursement and then clearly some of the other indications that we.

Unknown Executive: And then, you know, clearly some of the other indications that we're building towards, obviously breast is a huge, huge opportunity and one where having the kind of profile we have in the surveillance setting, I think is really going to be nice. Got it. Okay. Thank you.

Speaker Change: We are building towards obviously breast is a huge huge opportunity and one where having the kind of profile. We haven't been surveillance setting I think is.

Speaker Change: It really going to be nice.

Speaker Change: Okay.

Speaker Change: Okay. Thank you.

Dan Leonard: We now turn to Dan Leonard with UBS. Your line is open, please go ahead. Thank you very much.

Speaker Change: We now turn to Dan Leonard with UBS. Your line is open. Please go ahead.

Speaker Change: Yeah.

Speaker Change: Thank you very much I'll ask a two parter on the tissue launch for starters I'm trying to put some context around the launch and wonder how would you frame your market share today in tissue versus what you view as your long term entitlement in that market. So that's the first part and then the <unk>.

Helmy Eltoukhy: I'll ask a two-parter on the tissue launch. For starters, I'm trying to put some context around the launch and wonder, how would you frame your market share today in tissue versus what you view as your long-term entitlement in that market? So that's the first part. And then the second part, and I'll keep this to one question, are there any ASP implications of the new tissue product? Is there potentially a different Medicare rate than that $3,500 that might be attainable long-term? Thank you.

Speaker Change: <unk> parts and I'll keep this to one question.

Speaker Change: Are there any ASP implications of the new tissue product is there potentially a different Medicare rates in that $3500 that might be attainable long term. Thank you.

Helmy Eltoukhy: Yeah, maybe I'll start with the second one. You know, it's, it's a product that, you know, I think we're eventually going to take through FDA approval, and then we'll have the opportunity to qualify for ADLT status. And I think there's the opportunity to have, you know, higher price at that point, which, you know, we've seen for other products here at the company. I can, I don't want to get into specifics in terms of, you know, market share and where we, you know, think we can be. But certainly, we think we can take, you know, a much greater share of the market than we have today on the tissue side.

Speaker Change: Yeah, maybe I'll start with the second one.

Speaker Change: It's a product that I think we're eventually going to take through FDA approval and then we will have that.

Speaker Change: Opportunity to qualify for <unk> status, and I think there's the opportunity to us.

Speaker Change: Higher price.

Speaker Change: At this point.

Speaker Change: We've seen for other products here at the company.

Speaker Change: I can't I don't want to get into specifics in terms of market share and where we think we can be but certainly we think we can take.

Speaker Change: Much greater share of the market than we have today on the tissue side, we believe a product now that compares favorably in terms of product market fit to a lot of wood to a lot of the products that are on the market today and ultimately that's going to do a lot of good for patients and what do you have that kind of.

Helmy Eltoukhy: We believe a product now that compares favorably in terms of product market fit to a lot of what, to a lot of the products that are on the market today. And ultimately, that's, that's going to do a lot of good for patients. And when you have that kind of profile, I would say there's no ceiling in terms of, you know, where you can reach in the market. So we're we think there's no reason why we can't catch up to where we are on the liquid side over time. Thanks so much.

Speaker Change: Profile.

I would say there's no ceiling in terms of where you can reach in the market. So we think there is no reason why.

Speaker Change: We can catch up to where we are in the liquid side over time.

Speaker Change: Thanks Tommy.

Daniel Brennan: Our next question comes from Dan Brennan with TD Cohen. Your line is open. Please go ahead. Great, thank you. Thanks for the questions.

Speaker Change: Our next question comes from Dan Brennan with TD Cowen. Your line is open. Please go ahead.

Dan Brennan: Great. Thank you and thanks for taking the questions maybe just starting on reveal.

Mike Bell: Maybe just starting on Reveal. Mike, did I hear you say realized price above $600? Sorry, you went through the prepared remarks, so just any color on pricing that you shared there. And then if there is, I know there was a question asked earlier, but any additional color you can provide about just how the first quarter kind of played out in surveillance and kind of what we should think about for the rest of the year in terms of, you know, the accelerant to that business now that you've got the approval. Yeah, I mean, I can I can address that the ASP we said in the in the prepared remarks, and it's in the it's in the index that we also shared that are you know, reveal CRC ASP now is over over $600.

Dan Brennan: Two part Mike did I hear you say realized price of about $600. Sorry, you went through the prepared remarks. So just any any color on pricing that you shared there and then if there is I know there was a question asked earlier, but any any additional color you can provide about.

Dan Brennan: Just how the first quarter kind of played out in surveillance and kind of what we should think about for the rest of the year in terms of the accelerant to that business now that you've got the approval.

Dan Brennan: Yes, I mean, I can that can address the ISP resetting in the prepared remarks.

Dan Brennan: We also shared that reveal.

Dan Brennan: <unk>.

Dan Brennan: ASP now.

Dan Brennan: Over $600.

Helmy Eltoukhy: And of course, you know, that puts reveal now in a gross margin positive position. So it's allowing to push on on the boys and I don't know how. Yeah, no, as I said, I think maybe In response to one of the other questions, we've seen accelerating growth over the last few quarters with a with a reveal and certainly there's a lot of opportunity now in terms of pushing the surveillance testing that we're starting to pursue. So we've been very pleased to the start of the year. It's been really, really nice. And, you know, we believe that it will continue to be our fastest growing product on the oncology side, as it was in Q1 .

Dan Brennan: And of course, you know that puts reveal now and in the gross margin positive position, so it's allowing us to.

Dan Brennan: To push on the volumes and I don't know how many people do you know.

Dan Brennan: As I said I think maybe it.

Dan Brennan: In response to one of the other questions we've seen accelerating growth over the last few quarters, where the where the reveal and certainly there's a lot of opportunity now in terms of pushing the surveillance testing, but we're starting to pursue so we've been very pleased to the start of the year, it's been really been really nice.

Dan Brennan: We believe that it will continue to be our fastest growing product in the oncology side as it was in Q1.

AmirAli Talasaz: Great.

Dan Brennan: Great and then and then maybe merely just coming back to shelter you took the volumes of 7000 or so obviously, the unscreened opportunities pretty massive.

AmirAli Talasaz: And then maybe AmirAli, just kind of back to Shields, you took the volumes up 7,000 or so. Obviously, the unscreened opportunity is pretty massive. I think you're at 55,000 testings here. But can you just, I know, you know, back to Puneet's question, can you spend a little more time? Yeah, I mean, we, as I mentioned, like, we continue to hear a lot of positive feedback from the market on PCP side, like, you know, we are a blood drop modality. So we are going like, you know, in terms of integration of, you know, blood work flows into the practice and stuff, it takes some more energy from us probably than, you know, just dropping off still kitting accounts in terms of activating accounts, but the depth of ordering we are hearing and seeing are very positive.

Dan Brennan: I think there are 55000 test issue, but can you just I know back to <unk> question can you spend a little more time.

Dan Brennan: On just kind of what youre seeing in the field, maybe what's surprising you on the positive anything on the negative.

Dan Brennan: Exactly about the frequency of Doctor visits when they start to see an uptick maybe six or seven times visiting the doctor before they see someone do with taxes.

Dan Brennan: Does the same thing playing on the blood side or just any color you could share in terms of what informs this modest raise and.

Dan Brennan: Kind of how it havent launches going versus expectations.

Dan Brennan: Yeah, I mean, we have.

As I mentioned, how much of your contents, we hear a lot of positive feedback from the market on PCP side like we are a blood draw modality. So we are buying like Kenai in terms of integration and a lot of work those into the practice and stuff. It it takes some more.

Dan Brennan: A more energy from us probably down just dropping.

Dan Brennan: Still kissing that counts.

Dan Brennan: In terms of activating accounts, but the depths award and we are seeing are very positive.

AmirAli Talasaz: I can't, you know, I cannot point to any specific thing that we are hearing that we did not expect it and consider it negative. Maybe if I want to highlight something, but, you know, we knew it, we expected it is, you know, the reality of the importance of quality scores, like, that's important. Once we get into heat of the score, it's going to be a huge catalyst for us, but there is a lot of business for us to mine that we are focused on it and we are growing comfortably so far. I'm very excited of like the rest of this year.

Dan Brennan: I can.

Dan Brennan: I'm not pointing to any specific thing that we are hearing that we did not expect it.

Dan Brennan: Sure it's negative.

Dan Brennan: Maybe if I run out highlight something but we knew it we expect that it is the reality of the importance of quality scores like Thats very important once we get into heater score, it's gonna be a huge catalyst for us, but there is a lot of business for us to mine that'd be our focus on that and we are going after it.

Dan Brennan: So far.

Dan Brennan: I'm very excited about like the rest of this year still very in very very early innings of this I don't want to get ahead of our skews, but so far.

AmirAli Talasaz: Still, we are in very, very early innings of this, right? I don't want to get ahead of our skis, but so far, better than what we thought.

Dan Brennan: The other is on what we will see how it goes.

Unknown Executive: Great, thanks.

Dan Brennan: Great. Thanks.

Rachel Vattenstall: We now turn to Rachel Vattenstall with JP Morgan. Your line is open, please go ahead. Great. Good afternoon. And thanks so much for taking the questions. I wanted to ask another follow up just on SHIELD and some of the volumes that you're seeing. You increased volumes by 2600 sequentially, roughly. So if we apply that same sequential increase for the rest of the year, that really gets us near that low end of the guidance range for SHIELD volumes. So I wanted to dig into a few questions around that. First, as we look specifically to the second quarter, should we see a sequential step up above that 2600 sequential volume increase?

Speaker Change: We now turn to Rachel Boston store with J P. Morgan. Your line is open. Please go ahead.

Rachel Boston: Great. Good afternoon, and thanks, so much for taking the question I wanted to ask another follow up just on shale during some of the volumes that you're seeing increased volumes by 2600 sequentially roughly Tim if we apply that same sequential increase for the rest of the year and that really gets us near that low end of the guidance range for shale volumes, yes, I wanted to dig into a few.

Rachel Boston: Questions around that first as we look specifically to the second quarter should we see a sequential step up that.

Rachel Boston: <unk> thousand 600 sequential volume increase or could they kind of be the same level that you guys saw this quarter and then if we were to get towards that high end <unk> shield volume range at what point in the year, we expect a larger step up in the sequential given what you're seeing in the field so far.

AmirAli Talasaz: Or could it kind of be the same level that you guys saw this quarter? And then if we were to get towards that high end of the SHIELD volume range, at what point in the year would you expect a larger step up in the sequential, given what you're seeing in this field so far?

Rachel Boston: Yeah.

AmirAli Talasaz: Yeah, I think, you know, maybe I reiterate what we mentioned in the pre-program remarks, we continue to expect it to be second half loaded. And the reason for it is there are a bunch of new reps that we have the productivity ramp of those people need to be considered when you're modeling sequential Q over Q growth. And we are continuing to hire so we are going to end the year with more than the year that the number of reps that for instance, we deployed in the field in Q1. So when you consider all this, I think you need to consider that as a result, it should be biased towards second half.

Yes, I think maybe.

Speaker Change: I reiterate what Mary mentioned in the prepared remarks, we continue to expect this would be second half loaded.

Rachel Boston: <unk> and <unk>.

Rachel Boston: For it is there are a bunch of new reps that'd be haptic productivity to wrap up dose people need to reconstitute their buying your modeling sequential Q over Q growth and we are constantly so a higher so we are kind of end of year, where it's more reps than the year that that number of reps that France has to be deployed in the field in Q1.

Rachel Boston: So when you consider all of this I think you need to consider that as a result, it should be.

Rachel Boston: Our bias towards that kind of half grows.

AmirAli Talasaz: Maybe, guys, maybe just digging deeper on that, though, specifically on 2Q, should we be modeling a step up sequentially relative to this 2600 you did in the first quarter? Or at this point, given the reps are still kind of getting deeper ingrained into their territories, should we assume a similar step up to what you had? Yeah, I think maybe what I can comment is like we exited Q1 with just marginally a little bit more reps than the number of reps that we started with Q1. I don't want to get into like, a lot more details of the exact number of reps and what we are saying.

Rachel Boston: Guys, maybe just digging deeper on that though specifically on <unk> should we be modeling a step up sequentially relative to this 2600, you did in the first quarter four at this point given that the rock.

Rachel Boston: So we're still kind of getting deeper ingrained into their characteristics should we assume a similar step up to what you had.

Rachel Boston: Yes, I think maybe that comment like we exited Q1 with just marginally a little bit more reps.

Rachel Boston: Number of reps that we started with Q1 I don't want get into a lot more details of the exact number of reps and what we are saying, but I think you should consider that.

AmirAli Talasaz: But I think you should consider that. And the reality of diagnostics, it takes 12, you know, 12 to 18 months to get to the full productivity. When you add the reps within the first three months, you shouldn't expect anything really six months, maybe, you know, some material contribution. So I think if you consider all this, you're going to get to some reasonable number. Fair enough.

Rachel Boston: The reality of diagnostics it takes 12.

Rachel Boston: 12 to 18 months to get to their full productivity.

Rachel Boston: Their reps within their first three months, we shouldn't expect anything really six months maybe.

Rachel Boston: Some material contribution so I think if your clients either all of this year it kind of gets a song.

Rachel Boston: Reasonable numbers.

Rachel Boston: Fair enough that's it for me thanks.

Unknown Executive: That's it for me. Thanks, guys.

Rachel Boston: Thanks, guys.

Luke Sergott: We now turn to Luke Sergott with Barclays. Your line is open, please go ahead. Hey, thanks for the questions, guys.

Speaker Change: We now turn to look cynical with Barclays. Your line is open. Please go ahead.

Rachel Boston: Hey.

Rachel Boston: Thanks for the questions guys I just wanted to ask about.

Helmy Eltoukhy: I just wanted to ask about the Serena 6 trial with Astra and kind of how that's ramping and how we can think about those volumes as it goes through and You know, as that trial keeps progressing. Yeah, obviously, hasn't gotten approved yet. You know, it's still something that we're waiting for, you know, that the trial is done in terms of enrollment and so on. And I believe some of that data may be may be presented later this year. That's up to our pharma partner. There are timelines. We're not going to comment on that, but it's something we're very excited about in terms of the paradigm that it means in terms of being able to test patients, look for essentially molecular changes in a patient's genotype.

Rachel Boston: Serena six trial with Astra and kind of how that's ramping and how we can think about those volumes as it goes through.

Rachel Boston: Is that trial keeps progressing.

Rachel Boston: Yes.

Rachel Boston: It hasn't.

Rachel Boston: Got an approved yet.

Rachel Boston: It's still.

Rachel Boston: The trials right.

Rachel Boston: Yeah, So we're waiting for that.

Rachel Boston: Trials done in terms of enrollment and so on.

Rachel Boston: And I believe some of the data you know maybe maybe presented later this year that's up to a pharma partner in terms of their timelines. So we're not going to comment on that but.

Rachel Boston: It's something we're very excited about in terms of the paradigm that it means.

Rachel Boston: Being able to test patients look for essentially.

Rachel Boston: Molecular.

Rachel Boston: Changes in Ah patients genotype. We think this is really the way of the future in terms of where many drugs will start being developed are really at the first sign of molecular progression being able to switch therapies and so.

Helmy Eltoukhy: We think this is really the way of the future in terms of where many drugs will start being developed, really the first sign of molecular progression, being able to switch therapies. And so it's something that we're coordinating, I think, very closely on, and we're very excited for in terms of the potential that it means for uptake in terms of liquid biopsy volume, Garden 360 volume in the future. And so, yeah, I would just say maybe stay tuned over the remainder of the year. But yeah, certainly we think it could present some nice upside for testing for liquid biopsy testing and Garden 360 testing.

Rachel Boston: It's something that we're coordinating I think very closely on and we're very excited for in terms of the potential that it means for uptake in terms of our liquid biopsy volume garden to 60 volume in the future and.

Rachel Boston: And so yes, I would just say stay tuned over the remainder of the year.

Rachel Boston: But yeah, certainly we think it could present, some nice upside for testing for liquid biopsy testing and garden to 60 testing in the future.

Operator: Operator, I think we're out of time. Ladies and gentlemen, that concludes our Q&A and today's conference call. With that, thank you for your patience, your participation.

Rachel Boston: Operator.

Rachel Boston: Sure.

Rachel Boston: Uh huh.

Rachel Boston: Yeah.

Speaker Change: Ladies and gentlemen that concludes our Q&A on today's conference call. Thank.

Speaker Change: Thank you for your questions for your participation you may now disconnect your lines.

You may now disconnect your line.

Speaker Change: Okay.

Speaker Change: [music].