Guardant Health, Inc. (GH) Q3 2024 Earnings Report, Transcript and Summary

Hello, everyone, and welcome to the Guardant Health Q3 2024 Earnings Call. My name is Nadia and I will be coordinating the call today. [Operator Instructions]. I would now hand over to your host, Zarak Khurshid, Vice President of Investor Relations to begin. Zarak, please go ahead.

Thank you. Earlier today, Guardant Health released financial results for the quarter ended September 30, 2024. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO; and Mike Bell, Chief Financial Officer. Before we begin, I'd like to remind you that, during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specific items. Additional information regarding material risks and uncertainties, as well as the non-GAAP reconciliation to the 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. Guardant disclaims any intention or obligation to update or revise financial projections and forward-looking statements whether because of new information, future events or otherwise except as required by law. The information in this conference call is accurate only as of the live broadcast. With that, I would like to turn the call over to Helmy.

Thanks, Zarak. Good afternoon, and thank you for joining our third quarter 2024 earnings call. Starting on Slide 3, 12 years ago, we embarked on our mission to conquer cancer with data. Roughly two years later, we launched into the late-stage cancer market with our first version of Guardant360 in 2014. In 2021, we launched Guardant Reveal for cancer recurrence and monitoring. And this past quarter, on August 1, we were thrilled to launch our first test into the asymptomatic cancer screening market with Shield unlocking an exciting opportunity to potentially impact millions more individuals across the cancer continuum. As is our practice, I would like to start our call off with a story illustrating the important impact our tests can have on improving patients' lives. A woman was initially diagnosed with left breast cancer when she was 50-years-old. With a family history of cancer, she opted for an aggressive treatment and underwent a double mastectomy. A few years later, she began experiencing hip and lower back pain. After a doctor determined the breast cancer had metastasized, a Guardant360 liquid biopsy test was ordered to determine if the metastasis had any actionable biomarkers. An ESR1 mutation was revealed and she was placed on Elacestrant for therapy. The Guardant360 test report also noted a BRCA2 variant which was later confirmed to be a germline mutation after further testing in a specialized lab. As a result, her family underwent genetic testing and her sister was found to carry the same BRCA2 germline mutation but had not experienced a cancer diagnosis to-date. Her sister chose a prophylactic double mastectomy and oophorectomy as treatment and was found to have occult ovarian cancer. This case highlights the remarkable ability of Guardant360 to provide lifesaving information both for patients with symptoms and for those without. Turning to top-line performance in Slide 4. We continued our strong momentum into the third quarter with total revenue growing 34% to a record $191.5 million. This was driven by another quarter of robust precision oncology revenue, which increased 35% in the quarter supported by significant Guardant360 reimbursement tailwinds and broad-based volume growth fueled by our smart liquid biopsy transition. Turning to Slide 5. Clinical test volume for the third quarter grew 21% year-over-year and 7% quarter-over-quarter, reaching 53,100 tests driven by strength across the portfolio. In particular, Guardant360 performed extremely well in Q3 and grew mid-single-digits sequentially. Furthermore, Reveal continues to see strong growth even with our ongoing careful management of volumes ahead of broader reimbursement. As a reminder, our clinical test volume is specific to our oncology tests, which are Guardant360, TissueNext, Response, and Reveal and does not include screening test volumes from Shield. Q3 was another standout quarter for biopharma with volumes up 40% year-over-year to a record 10,500 tests. I will share some more details in our biopharma progress shortly. Looking more closely at some of the recent highlights within our therapy selection business in Slide 6. In late July, we launched our upgraded Guardant360 LVT and smart liquid biopsy, representing the most significant upgrade to our flagship precision oncology product. Guardant360 is the leading liquid biopsy test for patients with advanced cancer, with industry-leading turnaround time and the improved platform positions us for continued robust growth and share gain. The Guardant360 upgrade expands the number of genes by nearly tenfold, includes all guideline recommended genomic markers for solid tumors, improves the sensitivity for tumor burden detection by a factor of 10 and introduces the first feature enabled by our methylation tech stack and therapy selection. As the performance and richness of the Guardant360 LVT product evolves and we continue to generate clinical data and add features, oncologists will gain an unparalleled view of cancer that we believe will quickly become a new standard of care in the clinical management of advanced cancer patients. Due to this compelling upgrade, we are very pleased that we are already seeing an increase in both breadth and depth of accounts and believe this will continue to drive growth as additional capabilities are unlocked over time. In particular, Guardant360 LVT on smart liquid biopsy was the strongest contributor to year-over-year and sequential volume growth in the third quarter. We also saw continuing improvements in Guardant360 ASPs, which reached $3,000 in the third quarter. Last quarter, we shared the upgrade of our TissueNext test to identify more treatment options for patients with advanced cancer. We have seen strong interest in the expanded panel and are excited to share that effective January 1, 2025, Medicare pricing will increase from $3,100 to $3,500. Following these great updates, I'm excited to share that we again generated positive free cash flow in our therapy selection business in the third quarter. We also announced a partnership with Policlinico Gemelli in Rome, a leading European oncology center to implement on-site processing of Guardant360 CDx tests for therapy selection in advanced cancer patients. This will mark one of the first dedicated liquid biopsy testing facilities housed within a hospital system in Italy. This partnership is significant given there are approximately 400,000 new malignant tumor cases recorded annually across Italy. When implemented, oncologists in Italy will be able to access our tests to make more informed treatment decisions for patients with solid tumor cancers. Finally, results from the SCRUM-Japan GOZILA study were recently published in Nature Medicine demonstrating the significant survival benefits of using Guardant360 CDx to test patients with advanced gastrointestinal cancer. Of the 4,037 patients in the study, 24% received personalized targeted treatment based on Guardant360 CDx and this subgroup survived nearly twice as long as those who did not receive Guardant360 match therapy. This study further solidifies the clinical utility of Guardant360 in guiding effective treatment decisions for advanced cancer patients. Turning to our biopharma business on Slide 7. As I mentioned earlier, we had another record quarter of reported biopharma samples growing 40% year-over-year. Biopharma revenue grew 34% year-over-year in the third quarter. We continue to see a lot of excitement for Guardant Infinity, our newest biopharma offering powered by our smart liquid biopsy platform driven by applications such as improved performance, novel biomarker discovery and signature development. Smart liquid biopsy now represents over 50% of reported samples and new contracts. Importantly, this strength in biopharma is driven by our smart liquid biopsy upgrade and we are still in the early innings of this exciting upgrade cycle. We have recently seen an acceleration of our clinical Guardant360 LVT volume, demonstrating how biopharma R&D testing is an important leading indicator for demand of our clinical oncology tests and in turn, clinical patient testing is a driver for increasing biopharma interest. Taken together, these elements create an important virtuous cycle in the precision oncology space. Finally, we are also seeing increased momentum in China with a strong and growing pipeline of samples. Now shifting gears to Reveal on Slide 8, where we are the leader in tissue-free MRD. Last quarter, we shared that data from our COSMOS colon study looking at Stage 2 and Stage 3 patients was published in the peer-reviewed journal Clinical Cancer Research. This study was also submitted to MolDx for Medicare reimbursement for the CRC surveillance MRD indication and review is ongoing. Beyond CRC surveillance, we have an extensive pipeline of clinical cohorts for establishing validity and utility for Guardant Reveal. This will be instrumental in building compelling evidence that not only supports efforts to expand reimbursement but also has potential to influence changes in practice guidelines. Looking ahead to the remainder of the year, we anticipate submissions for publications that will support potential Medicare reimbursement for coverage and breast cancer, next year we have important clinical validity studies for additional cancers such as lung, pancreatic and gastric. Moving on to Slide 9, we are excited by the demand we are seeing in the tissue-free MRD market and there are multiple near-term inflection opportunities in 2025. We continue to make good progress towards CRC surveillance reimbursement which will improve our ASP. We also remain on track on our COGS reduction initiatives for Reveal. As a reminder, these two milestones will be a significant step towards our long-term goal of achieving greater than 60% gross margins for our MRD business. While we are seeing strong growth and strong market appetite for Reveal, we continue to manage volumes to minimize cash burn and will continue to do so until Reveal is gross margin positive, which we anticipate in 2025. Overall, we are seeing tremendous growth and opportunity around Guardant360, TissueNext, and Reveal largely driven by our recent smart liquid biopsy platform transition. As a result of the great progress we have made this year and are continuing to make, we are more confident than ever that our oncology business will continue to see strong growth over the next few years. With that, I will now turn the call over to AmirAli for an update on screening.

Thanks, Helmy. Moving on to Slide 10, as we have previously announced, we are thrilled that FDA has approved our Shield blood test for colorectal cancer screening in adults ages 45 and older who are at average risk for the disease. Shield is the first blood test to be approved by FDA as a primary screening option for CRC and it's also the first blood test for CRC screening that is now covered by Medicare. Turning to Slide 11. Just a few days after FDA approval, we brought Shield IVD to market with a successful launch in August. Our initial strategy is to focus on the covered patient population. This approach will help us to establish a strong foundation for industry-leading long-term scalability and profitability. I'm excited to share that we have had very positive reception and seen strong demand from physicians and patients in the first few months of the test being commercially available. To highlight this positive impact of Shield, I'd like to share an example of a primary care provider in rural South Carolina who had previously been facing challenges keeping patients up to-date with colorectal screening guidelines. With the introduction of Shield blood tests, he has seen his screening rate skyrocket. And in just the last few months alone, four of his patients received positive Shield tests, quickly went through colonoscopy procedures and ultimately were diagnosed with early stage colorectal cancer. In all four of these cases, the disease was cut early enough that these patients only required partial colectomy, avoiding any further treatment and most importantly were able to quickly resume their lives. Turning now to Slide 12, to share some more exciting details on the launch reception. Early post launch volume was ahead of our expectations and we exited the quarter with strong momentum, which we continue to see in the fourth quarter. The majority of our volume is coming from covered patients. We saw robust depth of ordering by prescribing physicians. We continue to see an incredibly strong adherence rate of over 90%, which means over 90% of the patients, completed the blood draw and we are on track to have a trained sales force of over 100 people in the field by end of this year. Moving on to Slide 13, we are very pleased to report that Shield received a Medicare price of $920, recognizing Shield as an important new class of first line CRC screening. This Medicare price makes us more confident that our ASP will be approximately $500 even prior to an advanced diagnostics laboratory test or ADLT designation. We continue to expect to obtain ADLT designation and secure an even more favorable Medicare price of $14.95 in 2025. Turning to Slide 14. CMS has finalized the policy to remove cost sharing for a follow-on colonoscopy after blood-based screening test for Medicare beneficiaries. This ruling proactively removes barriers to blood-based CRC screening and acknowledges its unique benefits to promote access to cancer prevention early detection, particularly for individuals within rural communities and communities of color that are especially impacted by the incidence of CRC. We are encouraged by the quick inclusion of blood in the final 2025 physician fee schedule. This rule will go into effect on January 1, 2025. Moving on to Slide 15, we are proud of our team's execution throughout 2024, starting with publishing our pivotal study results in the New England Journal of Medicine, followed by positive advisory panel voting, receiving FDA approval with the first line screening label, and finally securing a favorable reimbursement rate and successful commercial launch. We look forward to executing our commercial scale up and ramping adoption throughout the remainder of this year. We are excited about our upcoming milestones in 2025 and making Shield one of the most impactful products in the history of diagnostics. We are optimistic about the potential inclusion of Shield in American Cancer Society or ACS guidelines and expect to secure ADLT status which enables improved ASV. We are pleased with the progress on indication expansion for Shield to become a leading multi-cancer detection blood test and expect to present our multi-cancer data. We are also planning to upgrade our CRC screening test with Shield V2. With that, I will now turn the call over to Mike for more detail on our financials.

Thanks, AmirAli. Turning to Slide 16, I'll discuss our financial results for the three months ended September 30, 2024, and refer to year-over-year growth rates unless otherwise noted. Total revenue grew 34% to $191.5 million, primarily driven by precision oncology revenue, which increased 35% to $180.6 million. Precision oncology revenue from clinical tests increased 36% to $141.2 million. Clinical test volume grew to a record 53,100 tests in Q3 2024. Clinical volume growth of 21% was in line with our expectations and was primarily driven by Guardant360. As Helmy mentioned, we have seen very strong uptake of our upgraded Guardant360 LVT, which we launched in our smart liquid biopsy platform at the start of Q3 and which led Guardant360 to grow sequentially in the mid-single-digits. We also saw continued strong growth of Reveal and Tissue during the third quarter of 2024. For the full year 2024, despite the weather impacts we experienced at the end of Q3 and during October, we continue to expect total clinical volume growth to be approximately 20%. Once again, our biopharma business performed incredibly well in the third quarter with precision oncology revenue from biopharma tests totaling $39.4 million, increasing 34%. This exceptional growth was fueled by a record number of tests in the third quarter 10,500, which was up 40%. With good line of sight to the end of the year, we now expect biopharma revenue growth to be in the high-20s for the full year 2024. Finally, development services and other revenue totaled $10.9 million. As a reminder, precision oncology clinical test volume does not include Shield tests and we currently include Shield screening revenue in the development services and other line. We'll start to separately report Shield revenue and volume in the fourth quarter of 2024 as they become material to our numbers. Turning to Guardant360 ASPs on Slide 17. In the third quarter of 2024, we again saw very strong reimbursement and ASP trends for Guardant360. At our Investor Day in September 2022, we stated our goal was to reach an ASP of $3,000 for Guardant360 by 2028. Since our Investor Day, we've received an increase to our Guardant360 LVT Medicare rate from $3,500 to $5,000 and have seen significant improvements in both the amounts we've been paid for our tests and the speed at which we've been paid by commercial payers. As a result, we're very pleased to report that we achieved our long-term Guardant360 ASP goal of $3,000 in Q3 2024, roughly four years ahead of target. Achieving this milestone so quickly is a testament to the strategic and operational excellence of our reimbursement team. In addition, the significant improvement in commercial reimbursement has led us to collect more cash than expected for our tests, which in turn has resulted in active period revenue upsides throughout the year. In Q3 2024, cash collected for Guardant360 test performed in prior periods was $12 million above our expectations. It's worth noting that of this $12 million upside more than half relates to tests performed in the first half of 2024, which illustrates how quickly and consistently we're now being reimbursed for our tests. Going forward, although we don't anticipate similar future out-of-period revenue upsides, we believe our new Guardant360 ASP of $3,000 is sustainable and that we have the opportunity to further improve it over the next few years. Moving on to non-GAAP financial measures on Slide 18, our non-GAAP gross margin excluding cost of screening continues to be very strong and was 65% in the third quarter of 2024. Non-GAAP operating expenses were $187.3 million, an increase of $10 million compared to the prior quarter. This was primarily driven by a planned increase in sales and marketing expense to support the commercial launch and expansion of Shield. The increase was partially offset by savings in R&D expense due to the reduction in ECLIPSE clinical trial spend, which completed enrollment towards the end of 2023. We continue to tightly control our operating expenses by leveraging the infrastructure we've built to support all of our businesses, by focusing our R&D spend on projects that will drive future growth, and by directing our incremental investments towards the sales and marketing line to accelerate revenue across both screening and oncology. As a result of our increased revenue and operating leverage, both our adjusted EBITDA and free cash flow improved year-over-year in Q3 2024. Adjusted EBITDA loss was $56.2 million in Q3 2024, a decrease of $23.5 million from Q3 2023. Free cash flow for the third quarter of 2024 was negative $55.3 million, an improvement of $24.9 million from $80.2 million in Q3 2023. We ended the third quarter of 2024 with approximately $1 billion in cash, which we continue to believe is sufficient to enable us to achieve our goal of reaching cash flow breakeven by 2028. We also believe that achieving a Guardant360 ASP of $3,000 well ahead of our target of 2028, will reduce our total cash burn over the next few years and could help bring forward our cash flow breakeven target date. Now, turning to our outlook and assumptions for the full year 2024 on Slide 19. We're pleased to be able to increase our revenue guidance for the third time this year and now expect full year 2024 revenue to be in the range of $720 million to $725 million, representing growth of approximately 28% to 29% compared to 2023. This compares to our initial revenue guidance of 16% to 19% that we provided in February of this year. This latest increase reflects the further improvement in Guardant360 ASPs, the cash collection upside we had in the third quarter, our higher expectation for full year biopharma revenue and revenue contribution from Shield. We continue to expect non-GAAP gross margin excluding screening to be in the range of 61% to 63% and non-GAAP operating expenses to be in the range of $720 million to $730 million, representing a flat to 1% decline year-over-year. In addition, we now expect free cash flow for 2024 to be in the range of negative $265 million to $275 million, an improvement of $70 million to $80 million compared to 2023 and an improvement compared to our prior expectations of negative $275 million to $285 million. We continue to expect that our therapy selection business will deliver positive free cash flow for the full year 2024 and screening cash burn this year will be approximately $175 million. Finally, while we typically reserve granular out year commentary to our Q4 earnings in February, we would like to share some initial considerations as you think about next year. With the positive traction we're seeing from our launch of Guardant360 LVT on smart liquid biopsy, we expect an acceleration in Guardant360 volume growth in 2025. As a result of this, and continued expected strong growth across both Reveal and TissueNext, we expect oncology clinical volume growth to accelerate above 20% in 2025, even without including contributions from Shield, which we will report separately. Finally, turning to Slide 20, to review our catalysts. We've made significant progress on milestones across each of our business areas this year. As we look ahead to the rest of 2024, we are very excited by the potential opportunities across therapy selection, MRD and screening. With that, we will now open the call to questions.

Thank you. [Operator Instructions]. Our first question goes to Bill Bonello of Craig-Hallum. Bill, please go ahead.

Hey, congratulations on a great quarter guys. Question on the Shield plans sort of two parts on it. One with the initial Medicare pricing even before ADLT looking pretty strong, I'm curious if that makes you think differently at all about how aggressive you might be sort of early on in terms of your sales and marketing efforts. And then, the second part of that is just conventional wisdom is obviously that you need USPSTF recommendations to secure commercial reimbursement. I'm just curious if to what degree you think that's the case universally or if you've had conversations at all where people with payers where you think you might actually be able to secure reimbursement even without that.

Thanks, Bill, for the question. So I want to reiterate our commitment that we made that we under all kind of scenarios, the level of investments that we are going to have for Shield in terms of the spend would be around that maximum $200 million for the following years and this year $175 million, as you see, but in our reiterated guidance. And even that level of investment is assuming we are going to meet the milestones, the business milestones that we are going to have. I'm very pleased about 2024 and many milestones that we have achieved. But we are still in the early innings, very, very early innings of commercialization. We need to continue to monitor our volume ramp and meeting revenue milestones that we have to continue that level of investment. But obviously, I'm very pleased with this Medicare pricing that we got. It gives us a lot of opportunity. When you think about now, our ASV is approximately $500 and effectively even before ADLT, we can get to reasonable actually gross margin for this test very soon as the volume starts to scale as we go to 2025. So we are very, very pleased with where we are sitting. But it doesn't mean that should be positive developments is going to change our financial discipline of the level of investment. In terms of USPSTF, yes, we continue to look at USPSTF as a major milestone for us that would enable a lot of commercial accessibility for the patient on the younger side in a 45 to 64. Having said that, this segment of the market, which is now covered today, is very deep. We have a lot of business to mine while we are waiting for guideline inclusion and USPSTF. There is a very -- this is a very deep market. So it's not that we are going to be just waiting for that guideline. There's a lot of business to mine here, especially now that we have. We are going to have a healthy gross margin in near future. And also keep in mind there is American Cancer Society guidelines and some of the impact that that guideline inclusion could have on select state based on state level mandates that they have.

Thank you. The next question goes to Mark Massaro of BTIG. Mark, please go ahead.

Hey guys, thanks for the questions. Congrats on the quarter. I think some of us were hoping to perhaps hear how Shield is doing in the field. I think most people thought somewhere in the low to mid-thousands of tests. I know, I think I heard you say you plan to report that out next quarter. But maybe AmirAli, can you just give us a sense any metrics like ordering providers or just feedback that you're hearing in the field? I think that would be helpful. And then, a question for Mike, about the Shield target for $500 million plus by 2028, on a million tests. This is at your Analyst Day assumes assumed a price of $500 million plus. Your Medicare prices are is already set at $920 and may go up to $1,500. So just making sure you guys likely see some upside to that initial target that you provided at the Analyst Day.

Yes, sure, Mark. Thanks for the good question. So we are not breaking out like Shield volume at this time. So I can tell you we are very pleased with the progress. The initial volume post launch is ahead of our expectation. We are now three months into it. We had a good couple of months last quarter, exited last quarter with good momentum and that momentum continues to build in this quarter for us. We had a good October but still 3Q was not a full quarter for us. It's too early to break it up. But based on the traction that we are seeing, we do fully intend to report the volume and revenue contribution of Shield in our Q4 numbers and Q4 call, so looking forward to sharing more details at the time. The market feedback as we expected actually has been very positive. The target primary care physician that we are going after are very enthusiastic about adding this option to patients and giving them the choice. As I mentioned in the prepared remarks like the depth of ordering is very healthy for us for this blood test, which frankly is just an endorsement of how deep this market is more than our commercial execution. I'm proud of what we've done but the reality is this market of unscreened patient population and the people who are ready for rescreening is a very, very deep market. So we are seeing -- actually we are seeing very strong depth of ordering at this time too. I'm looking forward to sharing more details in our Q4 results.

Yes. And Mark, on your comments on our Investor Day target, yes, we set the target of in 2028 to be Shield revenue of $500 million with a million tests, and so yes, implying an ASP of $500. I think since our Investor Day, quite a few things have gone positively for us versus the assumptions we had. I mean firstly, I think the ASP I'm getting this Medicare rate of $920 now we already have ASPs around the $500 mark. When we get the ADLT rate then it's going to depend on the payer mix. But I think we're confident we can increase the ASP above $500. So that's one thing. I think the other two assumptions that we had at that Investor Day was one, that we were assuming nothing more akin to a second line label. And of course, that's gone in our favor now and we have a first line label. And then, secondly, we assumed that competition would be on the market about approximately a year after we launched. And I think now we look at where potential competition is it's probably at least 2.5 years to be on the market after our launch back in August. So I think things are going very well for us. We don't want to sit here today and give out some new long-term guidance. But I think that $500 million and 1 million tests we're feeling very confident about.

Thank you. The next question goes to Subbu Nambi of Guggenheim. Subbu, please go ahead.

Hey guys, thank you for taking my question. Our recent KOL checks indicate that therapy selection TAM may be larger than what we previously anticipated. Even during your IPO, the 700,000 late-stage metastatic solid tumor patients for a test like Guardant360. And given repeat testing opportunity, could you comment on what you see as the TAM in maybe the number of tests for Guardant360 and with respect to repeat ordering for the same patient?

Yes, no, thank you for the question. It's something that I think we outlined and break up at our Investor Day last year is essentially that, right now the market in therapy selection has been focused on what we call zero to one, just getting patients to one test per patient for a lifetime. And you see that now there are first-line, second-line, third-line therapies. There needs to be adaptive management of patients as their therapies stop working and they get cycled to a new therapy. And so yes, we see the market growing by orders of magnitude. We can see a future where patients are getting three, four, five therapy selection tests over their lifetime, which obviously grows the market considerably. And that's why I think we're very excited about the future that is before us. We're seeing with our biopharma partners that they're testing their patients multiple times or testing samples multiple times for some of these new drugs. And just like we've seen, we saw record biopharma volume over the last few quarters in a space where people were struggling with biopharma. We are an outlier there. And now that's translating to the clinical side and I think you're going to see that further translate to further momentum in clinical testing. So, yes, we see this as a really important growth driver that frankly only liquid biopsy can really hit because you can take tissue biopsies multiple times from patients in an easy way. And this is really where having what we consider to be the best performing and I think really sort of most complete liquid biopsy on the market with our new upgraded panel puts us in full position to capture that market.

Thank you. The next question goes to Tycho Peterson of Jefferies. Tycho, please go ahead.

Hey, thanks. On the back of COSMOS, I'm just wondering if you can help us size potential upside from Reveal surveillance coverage next year. I know you talked at September conference of about 12 million or 15 million potential patients being cancer survivors, but what could it do next year? Any more framework you can put around ASP? You obviously have talked about the $2,000 ASP when you're paid by Medicare, but how do we think about ASPs next year? And then did you give a G360 number? I know last quarter was $2,500. Can you give us the number there? And are you reiterating your 20% target for the year?

Yes, I mean, I can maybe take the 20% target for next year, Tycho. So one, we -- yes, we were reiterated just on the call then that 20% clinical volume growth. We still expect that for this year. And we've seen an acceleration in Guardant360 volume growth, particularly driven by the LVT. And so as we go into 2025, we talked about volume acceleration with Guardant360. But then also we're seeing good traction with TissueNext and Reveal as well and driving Reveal acceleration and we've said this many times is going to be focused or driven by the fact that we get additional reimbursements on the CRC surveillance side and that we bring our cost per test down. So we move Reveal from being a negative gross margin to positive gross margin. So we're making good traction on all of those things. And so as we go into 2025, assuming we get the CRC surveillance reimbursement from all the X, I think we'll have an uptick to our ASP. It's a bit difficult to quantify that uptick yet. It's going to depend on the reimbursement rate that we get from Medicare. But yes, we'll have an uptick in the volume. And again, with gross margins being positive, it's going to allow us to put the foot on the accelerator and push Reveal to significantly accelerate next year.

Thank you. The next question goes to Puneet Souda of Leerink Partners. Puneet, please go ahead.

Yes. Hi, AmirAli, Helmy, thanks for taking my question, and Mike. It's great to see the Medicare at $920 for Shield and it'll be material in fourth quarter. I mean, a bigger question here is that you're ahead of any other liquid biopsy CRC screening test in the market. A competitor could potentially emerge in 2026, but I think you're going to have V2 data before that. So could you please provide a timing on that V2 data and also what is your assumption of market penetration for Shield CRC now since having this in the market since August? Thank you.

Yes. Thanks, Puneet. So in terms of Shield V2, we continue to expect having that data and if data is positive, potentially upgrade our Shield so that V2 in 2025. So we are making progress there. In terms of market share today, our blood test, we are just two months into it. So we don't have really any material market share in terms of CRC screening yet. In terms of our kind of long-term projection, what we shared in last fall in the Investor Day, that assumption that 1 million at the time, we assume we are going to have 60% market share in blood-based CRC screening at a time. And as Mike mentioned earlier, we assumed there would be more progress by some of our competition than what we have observed. So -- but we'll see how the market would shape out. We don't expect to see any other competing tests to get FDA approval and Medicare reimbursement for at least the next two years, not 2.5 years, so very good shape.

Thank you. The next question goes to Kyle Mikson of Canaccord. Kyle, please go ahead.

Hey, thanks for taking the question. Congrats on the quarter. For Mike, the growth implied by the updated guidance is 20% to 29% over 2023. That compares 16% to 19% in the initial guide for 2024. How much of that 11 percentage point delta in growth has been from these like prior period collections and the Medicare pricing updates for G360, like essentially what's the core revenue growth? And quickly for AmirAli, Shield has been available as an LDT since May of 2022. How many of those early patients have retaken the test? Where are those reordering rates looking like so far? What are your expectations? Thanks.

Yes. Kyle, from the sort of prior period cash upsides that we've had, we reported $8 million in Q1 and then $8 million in Q2 and then $12 million, so $28 million in total. But of that, of that $28 million, $8 million of that is within 2024, so coming from Q1 and Q2. So effectively from these out of period upside, it's roughly around $20 million. So the other obviously drivers of growth have been on the clinical volume side, primarily that's Guardant360 volume growth. It's been increased to the Guardant360 ASP. We reiterated again that that's now at $3,000. And then of course, the incredible performance that we've seen in the biopharma business. So growth drivers really across all of the business on top of the additional sort of $20 million that we've got from prior year upsides.

Regarding reordering rate cloud like as you mentioned, we launched the LDT in May of 2022, so and our recommended intervals every three years. So we haven't reached to that time window for to see what fraction of those patients would get retested. That would be probably something toward like later part of next year that maybe we can have some data.

Thank you. The next question goes to Tejas Savant of Morgan Stanley. Tejas, please go ahead.

Hey guys, good evening. Maybe I'll start with one on G360 and then one on screening. So Mike, one for you on that growth rate in clinical volume next year exceeding 20%. You've got the smart LB upgrade, you've got the ESR1 dynamics now sort of squarely behind you. You called out a little bit of weather impact as well, weighing down recent volume. And you've got the surveillance reimbursement for Reveal coming through, which should have volume in the back half of next year, right? So any sort of finer point you can put on how much the quantum of the acceleration versus that 20% floor for next year. And then on the Shield side of things, AmirAli, can you share some lessons on what you've learned in terms of the initial lab setup and the ordering process for these new accounts that have come on board post-August? And have you had any pushback from health systems, et cetera, around quality scores? Just trying to get a sense for what that could mean for the Shield volume ramp into 2025, as we try and benchmark it versus the early days of stool based testing.

Yes, I'll take the first one on the volume, Tejas. Yes, I think you laid out, what we've seen in 2024 with the difficult ESR1 comps with weather impacts. But we're still on track to be approximately 20% growth this year. And yes, we're very, very confident that that clinical volume growth will accelerate in 2025 above 20%. And again, I laid out in the prepared remarks but that's going to be driven by growth across all the products on the oncology side. So yes, Guardant360 again, we're seeing really good traction with the LDT and smart liquid biopsy upgrade. So we know that that volume is going to going to accelerate going into 2025. Again TissueNext we had an upgraded product launch just recently and we've seen nice traction there. And so that growth is accelerating. And yet, again you laid out the upside that we can have on Reveal once we can start to accelerate the volumes and at some point in 2025. So I think we don't want to be more specific than accelerating above 20%. But I think we sat here very confident across all the products on the oncology side of the business.

Earning shared work front experience since August 1, definitely just being in market as LDT, those kind of experimentation, getting feedback from market. We really incorporated a lot of those learnings in this successful launch in terms of digital solutions that we have workflows that we have connection to blood draw services that we have even on EMR integration, still it's very, very early days, but about 15% of our orders even these days are coming from the accounts that we have full EMR integration. We are in very early innings of it. But I'm very pleased with this strong foundation that we built to support this strong launch. In terms of quality score, that's very relevant. That's very relevant parameter. As part of our targeting, we are kind of not going a lot after the health system accounts or the ones that have higher sensitivity around quality score. We continue to believe actually Shield testing has potential to even improve quality score without inclusion of blood-based CRC screening as a modality-based on the fact that unscreened patients come around the table and then a fraction of them go through colonoscopy after getting the blood data. But we are kind of not targeting those accounts, which have high sensitivity toward quality matrix till we get to the guidelines and either scores gets adjusted. But that's a very material parameter in terms of the adoption of this test over time.

Thank you. The next question goes to Dan Brennan of TD Cowen. Dan, please go ahead.

Great. Thank you. Thanks for the questions. Maybe I'll discuss on Reveal, could you provide any color on the contribution in the quarter and kind of what's assumed in 4Q? For COSMOS, I think you submitted maybe three or four months ago. Could you give any color on how the process is going kind of when you expect to hear back? And then, I know you put in the slide, the breast publication I think is expected before year end. Could you just provide some more color in terms of the indication and what would that portend for a MolDx filing? Thanks.

Maybe I'll take the second half, and Mike take the first. Yes, in terms of the process around reimbursement for the CRC surveillance indication, we're making good progress business. Couple of back forth some clarification of data but -- yes, and we're still hopeful that sometime early next year we should be able to get over the finish line. We've made good progress with the breast data. We expect to submit that soon for publications and then it'll depend on how fast it sort of comes out and gets accepted by the relevant journal. But yes, we think next year should be a very important year for us in terms of getting really the two largest indications in MRD breast and CRC under our belts. And then obviously that coupled with the major COGS reduction initiative that we have should put us in good shape.

Yes. Maybe on the Reveal, Dan, we're not breaking out the volumes or the revenue contribution for Reveal. I can tell you that in -- of the sequential growth, the biggest driver of that sequential growth and the majority of the sequential growth was from Guardant360. But coming to second place though was Reveal, so it's still growing very nicely even though we're managing those volumes. And so we saw nice year-over-year growth for Reveal and nice sequential growth. So it's going well. And again, we're really looking forward to 2025 being a pivotal year for Reveal.

Thank you. The next question goes to Dan Arias of Stifel. Dan, please go ahead.

Hi guys, thanks for your questions. Mike, on the acceleration that you're talking about for clinical volumes next year, how much are you attributing to international growth, Japan and UK, what's the contribution like there? And then to your point on just Reveal, I guess, a clarification maybe, does that acceleration depend on getting surveillance on Board as reimbursed by a particular date? Do you have less confidence in it if that process gets dragged out a bit into 2025?

Yes. Dan, yes, I would say again the main growth driver as we see the acceleration next year is still going to be Guardant360 in the U.S. and again, that's where we see the main traction with Guardant360 LVT on smart liquid biopsy. International, it's still a relatively low percentage of our overall volume. So I think we still expect to see growth internationally and particularly in Europe and the UK, but really it's going to be dwarfed by what we see in the U.S. And for Reveal, yes, I think again we're seeing good growth, we're managing that growth on Reveal, where we're making really good progress on reducing the cost per test for Reveal. So we're -- we hope that that can be implemented and put in place relatively -- in the relatively near future. So even without CRC surveillance reimbursement, I think we'll be at a place where our cost per test of Reveal is at the low end that we can start to push on our Reveal and accelerate volumes even without a CRC surveillance reimbursement. And when that comes, then obviously, we'll move to being gross margin positive and we can really push a lot harder. So I think, yes, regardless of the CRC surveillance reimbursement, I think we still expect to see an acceleration in Reveal. But that, that reimbursement is going to allow us to just really push a lot harder.

Thank you. The next question goes to Eve Burstein of Bernstein Research. Eve, please go ahead.

Hi there, thanks so much for taking the question. Maybe just following-up actually on that international question. You said big drivers for G360 will be in the U.S. and then primarily in Europe. And in late October, a news source indicated that you actually shutdown your Shonan Research Center in Japan before launch [indiscernible] and they attributed it to slow uptake of G360 in Japan specifically. So is that a fair characterization of why you shut that down. And can you add more color on the commercial traction that you are seeing in Japan and what your expectations are for G360 there in the short and then medium-term?

Yes. I mean, the lab closure we had there it was a really had no relationship to sort of any our progress in Japan. It was just something that we had thought would make sense a number of years ago, especially when we had the sort of SoftBank JV. And it's not something that made sense at this point going forward. And so we took the opportunity to really cut some costs over there. That being said, the ramp has been a little bit slower than we expected in Japan, but that has mostly to do with the way that reimbursement works there and the fact that essentially these therapy selection tests are only reimbursed once per lifetime, regardless if it's tissue or liquid. And so tissue has more of a role there in terms of preferences right now. But we're very encouraged by some of the new programs we have there. And we think over time, we can start sort of moving forward and displacing some of the tissue volume that's there in Japan. So I think still going reasonably well. Just, it'll just take a little bit more time given the structural nature of the market there in Japan.

Thank you. The next question goes to Doug Schenkel of Wolfe Research. Doug, please go ahead.

Hey, good afternoon, guys. A quick one on guidance and then I want to just try to do some Shield math and see if you'll bless it. On guidance, you increased full year guidance, as you know, at the revenue line by almost $20 million. That's at the midpoint. Just wondered if you'd talk through the bridge. Is this essentially just the Q3 beat or is there more to it than that? Because if it's just the Q3 beat, I'm wondering if that really doesn't capture Shield momentum, G360 momentum with the new version and ASP bump, not to mention trends on more rapid collections. It just seems like the error bars might skew to the upside there. So I just want to see if you'll comment on that. And then on Shield, I'm going to take a shot at this. Development service gross margin was about 22%. That's about 40 points below trend. So that suggests COGS in that category were maybe $4 million higher than you would have expected pre-Shield. So if we assume COGS per test of like $600 to $700, which is higher than your goal, but given the early stage of the ramp seems reasonable. It seems like you probably did 5,000 to 6,000 tests in the quarter, any flaw in the logic that you'd point out? Thank you.

Yes, Doug, I think there's a few factors in us increasing our guidance. And so previously with $690 to $700 and now it's $720 to $725. So, yes, something like a $27 million step-up at the mid-point. There's a few things in that. One of them, of course, is the cash upside from outer period payments that we saw and that I talked about in the prepared remarks. The other is Guardant360 ASPs and they've gone up consistently throughout the year and now they're at $3,000. So we've got an uplift on the Guardant360 ASP. And then biopharma revenue, previously we were guiding to sort of high-teens revenue growth. Now, we're guiding to high-20s revenue growth. So they're the real drivers. Of course, on top of that, we start now to have some revenue contribution from Shield, so that's also included that. The one thing that stayed consistent over the last few quarters has been our projection of clinical volumes being at 20%. And again we reiterated that we're expecting to come in at with approximately 20% clinical volume growth. So that's where we are with that. I think, yes, on your trying to back into sort of some of the Shield volumes, I think some of that's a bit off. One thing that we can talk about or want to talk about is the cost per test and so, prior to the launch, that cost per test was over $1,000. And a lot of that built into the cost was the fixed cost. And so as we've gone into launch now, as we've started to see traction with the volume, we've seen that cost per test come down pretty rapidly. So now, it's below $1,000 and we expect that to continue to reduce over the next few quarters. And again, we've set this target for, to be gross margin neutral, gross margin positive, when we get the ADLT rate. And so I think we're well on track with the cost reduction on Shield together.

Thank you. That's all the questions that we have time for today. This now concludes today's call. Thank you all for joining. You may now disconnect your lines.