Guardant Health, Inc.

If you would like to ask a question, please press star one on your telephone keypad. I will now to pass the conference over to your host, Zahir Khurshid, VP of Investor Relations. You may proceed.

Thank you. Earlier today, Garden Health released financial results for the quarter and year ended December 31, 2024. Joining me today from Garden are Helmiel Cuky, co-CEO, Amir Ali Talasaz, co-CEO, and Mike Bell. Chief Financial Officer. Before we begin, I'd like to remind you that during this call, management will be making forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures, are available in the press release Garden issued today, as well as in our 10K and other filings with the SEC. Garden 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'd like to turn the call over to Helmiel.

Thanks, Eric. Good afternoon, and thank you for joining our fourth quarter and full year 2024 earnings call. Starting on slide three, 2024 was an outstanding year for Garden. I'm so proud of our team for their hard work and execution and delivering on a number of key milestones across our portfolio. In oncology, we made significant strides in both therapy selection and MRD. We completed a major upgrade of our flagship Garden 360 test onto our new Smart Liquid Biopsy platform, all while generating record revenue, increasing test volumes, and expanding the profitability of our therapy selection business. And we continued growing reveal volumes and generating evidence for our MRD business, positioning us well for an inflection this year. In screening, we received FDA approval and Medicare coverage for SHIELD, our screening blood test for CRC, opening up an enormous market for early detection of cancer. Our team fired on all cylinders in 2024, and I'm even more excited for what to come in 2025 in terms of product innovation, accelerated volume growth, and most importantly, the impact we will have on cancer patients around the world. As we typically do, I would like to start our call today with a story that highlights the importance of our tests and how they can work together synergistically to improve patient outcomes. In 2021, a -year-old woman was diagnosed with triple negative breast cancer. After completing standard of care therapy, she was tested for germline predisposition and was negative. Her oncologist then used imaging to monitor for recurrence. Unfortunately, after some time, imaging identified lung nodules. To get more information on whether or not these nodules were indeed metastatic, her oncologist ordered a non-invasive garden reveal test. The test came back positive for CT DNA and was automatically reflexed to a Garden 360 test. Garden 360 identified a pathogenic BACA1 mutation. The nodules were also confirmed to be metastatic triple negative breast cancer and the patient is being considered for a PARP inhibitor. Garden reveal was crucial in confirming her cancer recurrence and the ability to effortlessly reflex to Garden 360 helped her oncologist move quickly to determine the next steps in her treatment. Turning to top line performance in slide four, we had an excellent finish to the year with a speed four revenue growing 30% year over year to $202 million, bringing our total full year revenue to $739 million, an increase of 31% year over year. Turning to slide five, this performance was driven by incredibly strong clinical revenue, which grew 34% year over year supported by ASP and reimbursement tail lens. Total oncology clinical volumes in the fourth quarter increased 24% year over year, bringing our total clinical volume growth to 20% for the full year 2024. This was largely driven by Garden 360, which saw double digit volume growth in 2024. Turning now to slide six to take a closer look at the reimbursement tail lens supporting therapy selection. We saw significant ASP improvement over the course of the year. At our investor day in September of 2023, we stated our goal was to reach an ASP of $3,000 for Garden 360 by 2028. We achieved this goal roughly four years ahead of target due to a number of reimbursement wins, including the increase of our Garden 360 LBT Medicare rate from $3,500 to $5,000. We also saw significant improvements in both the amounts we have been paid for our tests and the speed at which we have been paid by commercial payers. In addition to wins for Garden 360, tissue Medicare pricing increased from $3,100 to $3,500 effective January 1st of this year, creating another important tail end for our therapy selection business. Looking ahead this year, there are additional opportunities for state biomarker laws and continued commercial coverage expansion to further improve the ASP for our therapy selection products. Moving on to slide seven. Last July, we transitioned our Garden 360 LBT onto our Smart Liquid Biosy platform, representing the most significant upgrade to our flagship Precision Oncology product. The upgraded test called Garden 360 Liquid reinforces Garden 360's leading position in liquid CGP. Garden 360 Liquid expands a number of genes by nearly 10 fold, including all guideline recommended genomic markers for solid tumors and improves the sensitivity for tumor burden detection by a factor of 10. Garden 360 Liquid is resonating incredibly well and is helping to drive greater depth of ordering and increased testing frequency as physicians experience the capabilities of the upgraded platform firsthand. Importantly, we have a rich pipeline of additional features leveraging our smart platform, which we believe will generate a limitless number of differentiated applications. These apps will allow Garden 360 Liquid to help identify more patients for existing therapies that are undetectable by current CGP tests, detect harmful adverse effects of chemotherapy, and provide detailed phenotypic information about the tumor, such as histology, subtypes, and much, much more. Given the positive fraction we are seeing from Garden 360 Liquid, we expect to continue to see an acceleration in Garden 360 volume growth in 2025. Turning to slide eight, with our major product upgrades, growing use cases in both early and late stage settings and opportunities for international expansion, I'm more confident than ever that the therapy selection portion of our oncology business will continue to see very strong growth over the next few years. Now shifting gears to reveal in slide nine, where we are the leader in tissue-free MRD. We were thrilled that Garden's Reveal, which runs in our Smart Liquid Biopsy platform, recently received Medicare coverage for CRC surveillance testing after curative intent treatment for stages one through four. Medicare reimbursement for Reveal is $1,644 per test, consistent with buyer expectations. Utilizing CT DNA testing, the surveillance setting alongside standard of care monitoring, such as CT scans and CA testing, has the potential to identify molecular recurrent of CRC ahead of traditional imaging. Now Reveal will be more widely available for patients and support oncologists in making more informed therapeutic decisions. We are encouraged to see the recent NCCM guideline updates related to MRD. The changes are beginning to reflect what we are seeing in clinical practice and represent an increasing recognition of the value of CT DNA testing and recurrence monitoring. The NCCM guideline updates only further reinforce our view of the effectiveness of the opportunity, as well as of our commercial strategy. Turning to slide 10, beyond CRC surveillance, we have an extensive pipeline of clinical courts to further support validity and utility for garden reveal. We recently submitted data for publications supporting potential Medicare reimbursement for coverage in breast cancer and therapy monitoring. Looking ahead, we have a number of ongoing clinical validity studies for additional cancers, and we look forward to sharing updates on their progress throughout the year. Moving on to slide 11, during the course of 2024, we made critical progress to reduce the cogs for reveal and achieve more than a 50% reduction exiting the year. This reduction will save tens of millions of dollars in 2025 and was largely supported by the transition to our Smart Liquid Biopsy platform. This is an incredible accomplishment and is a testament to our team's ability to execute well. Turning to slide 12, reveal is on track to reach an important inflection point in 2025. As a reminder, despite very strong demand, we had been managing reveal volumes ahead of Medicare reimbursement in order to manage our cash burn. Now with CRC surveillance reimbursement in place, improving ASP and achieving a meaningful reduction to our cogs, making the test gross margin positive, we'll be leveraging a robust commercial channel and oncology to push ahead with the reveal to meet the market demand for a tissue-free MRD test. This long awaited milestone unlocks a key commercial market for us this year, and our team is focused in executing at a high level. Turning to slide 13, we had a very strong year for biopharma with 2024 revenue growing 31% year over year. This was fueled by a growing number of biopharma partnerships now above 180 and the growing mix of our Smart Liquid Biopsy platform, which now represents more than 50% of reported samples in new contracts. Our Smart Liquid Biopsy products offer improved performance as well as key applications such as novel biomarker discovery and signature development. This offering was a major growth catalyst in 2024 and is supporting strategic partnerships with top 20 global biopharma companies. Looking more closely at some of the recent highlights within our biopharma and data business on slide 14. We recently announced a collaboration with Borundur Inderheim to develop a companion diagnostic for the detection of specific mutations in advanced lung cancer, and we have a robust pipeline of other companion diagnostic partnerships positioning us well for this year. Moving on to data, in early January, we announced a collaboration with Concert AI to create a differentiated data as a service platform that integrates comprehensive patient EMR records with both genomic and epigenomic tumor profiling data. This platform augments garden and form with insights from Concert AI's national database of 5.5 million clinical records and our profiling data across more than 60 tumor types. This combined real-world evidence platform will help to accelerate cancer therapy research and development for biopharma partners. Our mission is to conquer cancer with data, and this collaboration brings us one step closer to achieving this goal. With that, I will now turn the call over to Amir Ali for an update on screening.

Thanks, Elmi. Turning to slide 15, our goal has always been to identify and catch many cancer types early when they are most treatable. We developed our SHIELD assay as a platform capable of multi-cancer detection across a range of indications. We selected CRC as our first indication for SHIELD, given it has an established regulatory and reimbursement pathway. We've made incredible progress in 2024 with SHIELD, becoming the first FDA-approved and Medicare-covered blood test for primary CRC screening. Turning to slide 16, up on our FDA approval, SHIELD was covered for 45 million Medicare beneficiaries at average risk of CRC. We are very pleased that SHIELD was recognized as an important new class of CRC screening and received a favorable Medicare price of $920. We recently received a unique PLA code for SHIELD and expect that upon securing a vast diagnostic laboratory test or ADLT status designation for SHIELD, the Medicare rate will increase to an even more favorable price of $1,495. Moving on to slide 17. In early August, just a few days after FDA approval, we were thrilled to launch our SHIELD IVD assay. We are seeing outstanding reception from physicians and patients and are excited that thousands of patients have been screened using our test. We are looking forward to scaling our impact quickly. Our strategy is to focus on the covered patient population to drive a high mix of covered pre-immersible tests. We delivered 4.1 million of SHIELD testing revenue in Q4, driven by a majority of samples coming from covered Medicare beneficiaries. In addition, I'm happy to report that in our first full quarter of launch, we achieved gross margin break even for SHIELD with COGS and ASP of approximately $600. With the current rate of improvement, we are expecting SHIELD to be gross margin positive in its first full year post-launch much sooner than we originally anticipated. This gives us flexibility to reinvest in our commercial infrastructure in 2025 while we maintain our annual screening cash-burn target of 200 million. Turning now to slide 18. While we are focused on our scale-up in the U.S., we are exploring some strategic international interests in our screening platform. Recently, we were excited to announce that the Abu Dhabi Department of Health selected SHIELD to be a part of their screening program. Currently, the overall compliance to colorectal cancer screening in the region with the current screening modalities, including FIT and colonoscopy, is less than 10%. And the majority of colorectal cancers are getting diagnosed at later stages. The introduction of a non-invasive blood test as a more pleasant option may encourage greater participation in screening and boost early detection of CRC. This program, initially in its first year, aims to screen approximately 10,000 patients in Abu Dhabi and the surrounding regions in UAE and may scale to approximately 100,000 annual tests in the later phases. Moving on to slide 19. We recently announced that SHIELD has been selected through a highly competitive process by NIH for the Vanguard Multicancer Detection, or MCD, study. NIH's decision to select SHIELD recognizes GARDEN as a leader in the field of MCD and validates our technology. The MCD test needed to detect the presence of disease across a variety of cancer types with good sensitivity, especially for the detection of early stage cancers, as well as accurately predict the cancer site of origin. We are pleased to announce that the performance data of SHIELD MCD in approximately 800 patients at across 10 cancer tests will be presented in a scientific conference in the second quarter of 2025. Looking ahead, we are excited about our upcoming milestones in 2025, including presentation of our multicancer data, the potential inclusion of SHIELD in American Cancer Society or ACS guidelines, and securing ADLT status, which enables improved ASP. We are also planning to operate our CRC screening test, which SHIELD V2. With that, I will now turn the call over to Mike for more detail on our financial.

Thanks, Mr. Ali. Turning to slide 20, I'll now discuss some select financial highlights for the quarter and year-end of December 31, 2024. I'll refer to -over-year growth rate, unless otherwise noted. Fourth quarter total revenue grew 30% to $202 million, primarily driven by precision oncology revenue, which also increased 30% to $185 million. Precision oncology revenue from clinical tests increased 35% to $146 million. Clinical test volume grew 24% to a record 57,300 tests in Q4, 2024, and was primarily driven by GARN360, which grew sequentially in the mid-single digits. We continue to see very strong uptake of our upgraded GARN360 liquid, which we launched in our Smart Liquid Biosy platform at the start of Q3. We also saw continued strong growth of revealing tissue during the fourth quarter of 2024. GARN360 ASP in the fourth quarter of 2024 was approximately $3,000. As we have seen throughout the year, we also had very strong commercial pair collections in the fourth quarter, which led to an out of period revenue upside of approximately $8 million above our expectations. Once again, our biopharma business performed incredibly well in the fourth quarter, with precision oncology revenue from biopharma tests circling $39 million, increasing 15%. This strong growth was fueled by another record quarter of tests in the fourth quarter, 11,050, which was up 16%. Finally, development services and other revenue totaled $17.2 million in Q4 2024 and includes $4.1 million screening revenue generated from the 6,400 shield tests that we reported in the quarter. For the full year 2024, total revenue grew 31% to $739 million, with growth again being primarily driven by precision oncology revenue, which increased 34% to $688 million. Precision oncology revenue from clinical tests increased 34% to $543 million. Clinical test volume in 2024 was 206,700, which represents growth of 20%. As Henry mentioned, clinical volume growth was largely driven by an increase in GARN and 360 test volume, which grew double digits in 2024. We saw continued strong growth and reveal throughout the year, which despite us managing volumes ahead of medical surveillance reimbursement, was our fastest growing clinical test in 2024. Finally, tissue also grew strongly throughout 2024. Clinical test revenue growth was also driven by significant improvement to our GARN and 360 ASP, which increased from approximately $2,750 in the fourth quarter of 2023 to approximately $3,000 in the second half of 2024. In addition to this tailwind, the significant improvement in reimbursement trends throughout the year led us to collect more cash for our tests than we had previously accrued for, which resulted in out of period revenue upsides throughout the year. For the full year 2024, revenue recorded for tests performed in prior years was approximately $35 million. Of this $35 million, approximately $13 million was consistent with our expectations based on historical experience and payment trends. However, the remaining $22 million was the result of better than expected cash collections, and we view this as a non-recurring out of period revenue upside for 2024. Turning to BioFarma, as mentioned earlier, our BioFarm business performed incredibly well during 2024, with precision oncology revenue from BioFarma tests totaling $145 million, increasing 31%, and BioFarma test volume growing 35% to 40,500 tests during the full year 2024. Finally, development services and other revenues totaled $51.1 million for the full year 2024, and includes $5.1 million of screening revenue generated from SHIELD tests that were reported between the IVD launch at the start of August and the end of the year. Moving on to slide 21, our non-GAAP gross margin continued to be very strong, and was 63% in the fourth quarter of 2024, compared to 61% in the fourth quarter of 2023. We also saw an improvement on an annual basis, with 2024 non-GAAP gross margin of 62%, compared to 61% in 2023. Excluding screening, non-GAAP gross margin of 64% for both the fourth quarter and full year 2024, an improvement from 63% in the prior year period, and above the full year guidance range of 61% to 63% that we provided on our Q3 earnings call. Non-GAAP operating expenses were $250 million in the fourth quarter of 2024, an increase of 17%, and $757 million for the full year 2024, an increase of 4%. Our full year non-GAAP operating expense was above our guidance range of $720 to $730 million due to a couple of one-time items in the fourth quarter of 2024. Firstly, we incurred significant litigation expense related to the November false advertising trial, of which the jury unanimously found in favor of Garden Health on all its claims, and awarded us $293 million. Secondly, in Q4, we increased the full year accrual for the 2024 company bonus plan, in line with the board approved payout level, which reflects a successful year with respect to bonus performance components, such as top and bottom line financial measures, the FDA approval shield, and the launch of new products. As a result of our increased revenue, gross profit, and an operating leverage, both our adjusted EBITDA and free cash flow improved year over year in full year 2024. Adjusted EBITDA loss was $258 million for the full year 2024, an improvement of $86 million compared to a loss of $344 million in 2023. We continue to be focused on cash and materially reduced our burn in 2024. Free cash flow burn of $275 million for the full year 2024, was in line with the guidance we provided on our Q3 earnings call, and represents an improvement of $70 million compared to $345 million in 2023. I'm also pleased to report that our core therapy selection business was free cash flow positive in 2024, and that we successfully managed our cash burn for screening to be in line with our guidance target of approximately $175 million. Turning to the balance sheet on slide 22, we ended the year with approximately $944 million in cash, cash equivalent, restricted cash, and marketable debt securities. Earlier this month, we successfully completed a private convertible debt exchange, where we extended the maturity on $600 million of convertible debt with favorable terms, which we believe helps to mitigate potential balance sheet risk, while at the same time provides greater optionality to optimize our capital structure in the future. The $600 million of new convertible debt is now due in 2031, and comes with a .25% annual coupon, and a 35% conversion premium, which represents a conversion price of $62.22. As a result of the transaction, our total debt was reduced from 1.15 billion to 1.09 billion, of which 491 million is our zero coupon convertible debt, which is due in November, 2027. We also structured a concurrent stock repurchase of $45 million to help mitigate dilution. Following these transactions, our pro forma cash division was approximately $887 million. We continue to expect that we will reach cashflow breakeven in 2028 with cumulative free cash outflow of $450 to $550 million over the next three years. Turning to slide 23, before discussing our outlook and assumptions for 2025, we want to take a moment to preview how we intend to present our revenue going forward. Rather than splitting revenue into precision oncology and development services and other, we're changing the presentation to better reflect our different business lines, and to provide clarity on the performance of SHIELD. As such, for 2025, we'll start to break out revenue into four components, which are shown in the slide with 2023 and 2024 full year numbers. In summary, the new revenue components are oncology, which represents clinical therapy selection and MRD testing revenue, which we previously reported as clinical testing revenue within the precision oncology line. Biofarm and data, which represents the total revenue we generate from our biopharma customers, namely biopharma sample testing revenue that we previously reported in precision oncology, as well as biopharma companion diagnostic and data services revenue that we previously reported as development services. Licensing and other, which was previously reported as other revenue, and finally screening, which will represent SHIELD testing revenue. Moving to slide 24 for our outlook and assumptions for full year 2025. We expect full year 2025 revenue to be in the range of 850 to $860 million, representing growth of approximately 15 to 16% compared to 2024. Excluding the $22 million non-recurring out of period upside in 2024, this range implies total revenue growth of 19 to 20% in 2025. Now breaking down the key assumptions in our revenue guidance. We expect oncology revenue to grow approximately 15% year over year in 2025. Again, excluding the non-recurring out of period upside in 2024, this represents oncology revenue growth of approximately 20%. Given the positive traction we're seeing from our launch of GANON 360 LDT on smart liquid biopsy, our recent Medicare CRC surveillance coverage for reveal, and the upgrades we're making to our tissue test. We expect volumes across all oncology clinical products to accelerate in 2025, and total oncology clinical volume growth to be approximately 25%. We expect our biopharma business to continue to perform well in 2025, and our forecasting low double digit growth for biopharma and data revenue. Finally, although it's still very early into the launch, we want to provide some initial guidance for screening revenue, which we expect to be in the range of 25 to $30 million, driven by 45,000 to 50,000 shield tests. We expect this full year volume to be significantly backend loaded, due to the time it will take to ramp up the productivity of newly hired reps throughout the year. Also, our guidance does not include any ASP impacts from receiving ADLT designation. We continue to expect this to occur in 2025, and we'll update our guidance accordingly at the appropriate time. We've made great progress in reducing our COGs over the last few months, with both review and shields reaching gross margin breakeven. 2025, we're confident that we can deliver full year non-GAAP gross margins in the range of 62 to 63%, despite the impact of changes in product mix that we expect during the year. We expect total non-GAAP operating expenses to be in the range of 815 to $825 million, representing an eight to 9% increase compared to 2024. We'll continue to gain significant operating leverage during 2025, and expect R&D and G&A expenses to be relatively flat compared to 2024, with the increase in operating expense coming mainly from investments in screening sales and marketing, as we continue to ramp up our commercial efforts to shield. Lastly, we continue to be committed to reducing our cash burn each year in order to reach company-wide cash flow breakeven in 2028. For full year 2025, we expect free cash flow burn to be in the range of 225 to $235 million, an improvement compared to 275 million for 2024. Our burn in 2025 will 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 million during the year, and to reach cash flow breakeven in the fourth quarter of 2025. Finally, turning to slide 25, we have a rich pipeline of capitalists across our business segments, and are excited about the opportunities ahead. With that, we will now open the call to questions.

Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star followed by one on your telephone keypad. If for any reason at all, you would like to remove that question, please press star followed by two. Again, to ask a question, please press star one. We ask that you please limit yourself to one question only. The first comes from Punit Suda with Learing Partners. You may proceed.

Yeah, hi, guys. Thanks for taking my question. First one on screening, and I'll try to wrap one on reveal as well. Shield guide of 25 to 30 million was well ahead of us, and I believe the street as well. I appreciate the second half loaded, but could you talk about the Salesforce expansion that you expect is gonna contribute here for the second half? Any other drivers and the feedback that you're getting from the field that gives you confidence in this 30 million on the upper end, and maybe what are you contemplating for the lower end? And on reveal, congrats on the surveillance coverage, but can you square the NCCN? Unfortunately, NCCN recommended against surveillance, so could you balance those two? I know it's still early days of this market. How do you expect the adoption and reveal to go as a result of that? Thank you.

Thank you, Punit. Maybe I start with the shield question, and then I give it to Tommy about reveal. So the question to be very pleased with what we are hearing in the field, physician response, patient response. Now connecting it to our guidance, I make few points. One is, we launched it back in August with 50 reps in the field. We increased it to 100 as we ended the last year, 2024. That's majority of the people we added, they came late, very late in 2024. In fact, it's gonna take them some time to contribute in productivity. As a result, we believe that actually our ramp rate is gonna be more back-ended. The other thing to consider is this is our first full year of launch. So obviously in the launch years, this kind of growth is always, when you look at it just numerically, it's more back-ended too. In terms of total number of reps that we are gonna have, we mentioned our investor, they fall of 23, that we are planning to have about maybe 150 people in the field by end of 2025. Some stuff went better than what we expected, mainly the Medicare pricing. As a result, we will have maybe a little bit more people in the field, but again, a bunch of these newly hired reps are not gonna contribute meaningfully, till like three, six months after their hire date. Maybe I'll leave it like that and give it to

Elmer for review. Hey, Puneet. Yeah, good question. We actually were fairly encouraged when we saw the update in NCCM guidelines. I think on the whole, it's actually a step forward in terms of recognizing the value of CT DNA testing, really in the sort of adjuvant setting. And this is not too dissimilar from the sort of cadence we saw with NCCM guidelines, where it was 360 in terms of liquid biopsy testing. The guidelines tend to be a little bit behind where clinical practices, but I think all in all, we're encouraged in terms of this moving in the right direction. And we're very confident given the utility we see with surveillance testing as a whole, and especially with reveal that we'll get to the right place in the coming years from a guideline perspective.

Thank you. The next question comes from Bill Bonilla with Craig Hellam, Capital Group. You may proceed.

Hey guys, thanks for the call. Another one on SHIELD. I'm just curious if you are having any kinds of preliminary discussions with payers outside of Medicare, commercial payers about SHIELD. I mean, obviously the thinking has been, well, you have to wait on USPSTF and whatnot, but I wasn't sure if there was activity you might be trying to accomplish ahead of that.

Yeah, Bill, we are in very kind of early conversation mainly in terms of having advisory boards, getting some initial feedback from them. We are planning to ramp up some of those engagements after we go into guidelines, and right after ACS guideline inclusion, as we are optimistic hopefully it will happen in 2025, we will ramp up those activities.

Thank you. The next question comes from Ticho Peterson with Jeffries. You may proceed.

Hey, thanks. Couple on SHIELD. So you're guiding for ASPs to move a little bit lower here, 580 at the midpoint versus 625 in the fourth quarter. Is that just Medicare fee for service dynamics or is that Abu Dhabi and maybe subsidized samples? And can you maybe just confirm whether the SHIELD volume guide includes Abu Dhabi? And then any risk to ADLP status? And then lastly, just ACS guidelines. Do you expect that in the second quarter and how do you think about the lift that could come? I assume that's not baked into the guide?

Yeah, so Ticho, thanks for a great question. We are very pleased with the ASP that we printed for Q4. We just don't wanna get ahead of our skis. That was really the first full quarter data that we had. We want to be very thoughtful with the ASPs that we are gonna put in the first full year of the launch. We are continuing to monitor our payer mix that would impact the ASP. I think, again, I emphasize that this bump of ADLP improved Medicare rates is not kind of embedded in our guide. We are gonna get to that point and then look at our payer mix at a time and then revise the guidance accordingly. Based on everything that we know, we are very confident about this ADLP process. We know how it works. It's just a matter of the mechanics of the timing. It's a quarterly process. When exactly it's going to get activated for us, it's something that's not very clear. So we just wanna make sure we de-risk it before we include that offsite to our guidance and our ASP. And I will say very quickly, it's not a dilutive for our ASPs. So without going into more details of it, we are very pleased with the engagement that we have with the Department of Health there.

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

Great, thanks for the questions. I'm gonna focus on reveal. Can you help us think through kind of what's baked in for 25? We show you guys did like 35,000 tests in 24, maybe ramping to like 55 and 25. I know you're not gonna give us specifics, but how do we think about what the impact of surveillance could be? And then B, when you think about the additional indications, breasts and monitoring, could you just give us some color about timelines of when we might hear back on that? Thank you.

Maybe I'll start and maybe Mike wants to fill in some of the sort of cadence there on volumes. But as we said in the prepared remarks, we see acceleration across each of our product lines on oncology in terms of volume growth. And certainly we're very pleased with how the sort of year has started, not just for reveal, but for all our products. That being said, in terms of kind of additional indications, as we said, we submitted data for publication for both breasts and monitoring late last year. And as soon as those are published and accepted in respective journals, we'll be submitting that to Moldex. And so we think sometime second half of this year, the earliest we could see potential indication expansion for reveal.

Yeah, maybe I'll ask, yeah, it's how we mentioned, we expect for reveal volume acceleration. You're right, we're not breaking out the reveal volumes or the volumes across all of the clinical oncology lines. But yeah, we expect reveal is gonna accelerate. It'll take some time. And we think this will be more, again, back-end loaded for the acceleration increase during the year. And that's really because we're just sort of getting the field now ramped up to be very much focused on CRC. So we had our national sales meeting kickoff just two or three weeks ago. The team's very excited and energized to go out and sell reveal CRC. But it's gonna take time for that traction to take hold. But yeah, we're looking very much forward to accelerating the volumes throughout the year.

Thank you. The following question comes from Subu Nimbim with Guggenheim. You may proceed.

Hey guys, thank you for taking my question. Two questions. On SHIELD, the SHIELD COGS productions have already been impressive. Is it fair to assume that you're achieving the SHIELD COGS production via a similar approach like reveal? And what is embedded in the 2025 guide? And for reveal, what ASP is embedded in your guidance with respect to ramp mix? ADLD timing.

Thank you. Yeah, so actually a bunch of R&D activities that we are doing at GARDEN is highly leveraged and especially for the platforms that are based on epigenomics mainly, there is a lot of synergy. So on reveal, which is an LDG product, you guys have seen what we have achieved by reducing the COGS through some of the improvements and technologies that can process improvements that we had. SHIELD is an IBD product, so implementing some of these changes takes a bit longer, but there is a bunch of synergy and cross-learning, cross-deployment that we are doing across both SHIELD and reveal.

Yeah, and maybe I'll take the reveal ASP. Yeah, so of course we were very pleased to get the CRT surveillance Medicare coverage at 1644 starting at the start of the year. So that's gonna have a positive impact on ASP. We ended 2024 with an ASP roughly between $400 and $500, and so we're gonna have an impact, positive impact of the Medicare coverage. There is a big sort of mixed impact in all of reveal because we have CRT surveillance, CRT adjuvant, and then we have breast and lung, and then of course there's Medicare, Medicare advantage in commercial. So there's a lot that we have to sort of deal with from a mixed perspective. But yeah, we would expect the ASP in our guide roughly to increase to something like $600. $600, we haven't included any impact for ADLT in that $600. It's our intention to apply for ADLT rate, and so similar to SHIELD, if and when we get that, we would expect an increase on the Medico rate, and we would change our guidance in line with receiving that.

Thank you. The next comes from Mark Mithara with BTIG. You may proceed.

Hey guys, thanks for the questions. Congrats on a strong 2024. The first one is for you, Helmi. I think about a year ago, there was probably an investor misconception that your G360 business was either saturating or about to go into de-sell, but your prepared comments today, you indicated you plan to accelerate volumes across all your products this year.

So I was

curious if you could just give us some anecdotes about what you're seeing in the field with the upgraded G360 liquid product. And then one for Amirali, I recognize that the majority of your revenue came from Medicare and Q4, but I would be curious about what level of interest you're seeing billed from the non-Medicare population and whether or not you think you'll be well addressed to equip those orders when commercial payer coverage comes in.

Thanks, Mark, appreciate the question. I can tell you at our national sales meeting, obviously been going to them every year, this is probably the most excited I've seen the team given the sort of products we have out there and smart liquid biopsy with 360 and reveal, and then some of the ones that we have upcoming, especially with tissue. And so we are seeing that momentum, we saw that momentum since we launched 360 and smart liquid biopsy, it's been really nice uptake from existing physicians and new physicians alike, and we really haven't even turned on a lot of the exciting features yet. And so we have extremely high confidence just given how this year has started, how the last year ended, that 360 liquid will continue to do well. And there's a lot of room for growth over the next few years in this market. I outlined some of the growth drivers, it's not just sort of increased penetration, it's more applications going in sort of the long tail of tumor types that only really epigenomics can address, some of the new findings we have, as well as where the field is going in terms of testing patients at each progression. And so we are really at the sort of very early innings in terms of where liquid biopsy for therapy cell selection can

grow. And regarding SHIELD, SHIELD on the younger patient or commercial side, our experience during SHIELD LDT, when we didn't have proactive workflow adjustment to really focus on covered patient, we're experiencing that in fact, the 65 and above was a minority of our ordering and payer mix. And our workflow changes actually has worked that now vast, vast majority are volume coming from this covered patient. But totally we have that market feedback and data that once the coverage get expanded and access get expanded to younger patient population. There's a huge demand and opportunity for SHIELD to go to younger patients. Right now though, we are just focused on reimbursable covered case like Medicare and some of, for instance, initiatives that we have internationally in Abu Dhabi. I maybe take this opportunity, there was earlier question, I forgot to answer about what's the level of assumption of contribution of this Abu Dhabi partnership. That program in the first one year, the expectation of the Department of Health there is to test about 10,000 patients. Having said that, since the program need to go through the RAM logistics, we don't know exactly how quickly they're gonna ramp. At this time, we are just assuming a fraction of those patients would get tested by SHIELD till we get more visibility over that ramp.

Thank you. The next question comes from Patrick Donnelly of Citi. You may proceed.

Hey guys, thanks for the questions. Helmy, maybe one on reveal, just I know before the reimbursement, you're holding back a little bit, kind of pursuing the volumes. Can you talk about just the change in strategy, how that will go? I know Mike mentioned maybe a little more of a second app ramp as we go through that. And then a quick one for Amir Ali, just on V2 for SHIELD. Can you talk about the change in strategy and can you just talk through what the expectations there should be on the catalyst that's on V2? Thank you guys.

Yeah, as we have said before, we're sort of limiting in some ways how much we were servicing the demand that was out there from our sales team. And one of the big sort of exciting initiatives we had at our national sales meeting this year was really training on reveal, really getting the sales team sort of motivated and they were very excited in terms of being able to now offer this product a lot more robustly and really accelerate our efforts there. So yeah, there's a lot of room to grow, especially with tissue-free MRD, it's really the surveillance setting where you sort of get most of the juice out of the market where most of the opportunity is. And that's not really been an area that we've been targeting, given the fact we didn't have reimbursement there. And so the team is ready to go and very, very excited for what this means for our oncology business.

Regarding Shield V2, it's actually programmed for us right now, stay tuned. And we are planning to have hopefully to approve on launch of that version of the test by end of the year.

Thank you. The following comes from Dan Arias with Stiefel. You may proceed.

Afternoon guys, thanks. Help me on MRD and maybe just piggybacking up your last comment there. The way that the field is evolving here, as companies increasingly shooting for both tumor informed and tumor naive approaches, as you think about your own portfolio and just the way to best serve the community, how interested are you in that idea and having both? And then just quickly and fairly, I had someone ask for a clarification on Tyco's question, whether Abu Dhabi volumes are considered in the 45 to 50K outlook for test volumes.

Thanks. Yeah, I mean, we ultimately think that tissue-free MRD is gonna be the largest portion of the market. The simplest from a product market fit to use that addresses the 12 million cancer survivors that are more than five years out, out of the 18 million in the market. But that doesn't mean that a tumor informed product would at some point not be part of our portfolio as well. We have to listen to the market, understand what the needs are for customers and we'll continue to do that. We obviously launched Garden360 TissueNext a couple of years ago. We have a major upgrade of that test this year. And so we're gonna continue to listen to the needs of the market and adapt as required.

About Abu Dhabi, so the contract and the program aim is to approximately test 10,000 patients within the first year. Having said that, since we don't have really visibility over how quickly they can ramp it up and if at all they can screen these approximately 10,000 patients or not, at this time we are just assuming a fraction of that. So effectively not a really material part of our guide. It's just a fraction of that 10,000 is included.

Okay, thank you.

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

Hey guys, good evening. So just a quick follow up there on one of Tycho's earlier questions. Is ACS guideline inclusion a second off 25 catalyst for use in Amarali? And then with that Supreme Court case looming here, I know there's offsets via ACS states and the Medicare opportunities obviously insulated from that situation, but what the decisions require any sort of rejigging on your commercial effort on shield or perhaps need, in the past you've talked about this activation energy sort of phenomenon. Will that be sort of a bigger gating factor for you? Will that decision to go against USDSS?

Okay, so maybe I started with ACS about some of this stuff, maybe you need to clarify it a little bit more Teja. So in terms of ACS, we are pleased with the conversation that we continue to have with that team and we are optimistic that they would consider shield in the CRC guidance review that they started working on. So exact timing, we are not sure, but we are confident based on what we know it should be sometime in 2025. In terms of the Supreme case, we are right now focused mainly on Medicare patient population and the covered patient population, which is not gonna get impacted by that case. We are monitoring it actually very closely. It's kind of good for the field, the fact that Trump administration is continuing to kind of be on the opposite side and kind of work against the sexes of that law case, but we'll see what happens. There is a lot of business actually for us on Medicare to mine while we are waiting for building that pathway access for younger patient population in future. I'm not sure if I got the last question. Maybe we just move on.

Thank you. The following comes from Rachel Westenow with JP Morgan. You may proceed.

Perfect, good afternoon and thanks so much for taking the questions. So I wanted to dig into ASP assumptions this year, specifically on G360. So just given the traction that you saw throughout 2024, can you walk us through your assumptions embedded for 2025? What are the levers this year that you can see for continued growth in ASP on that front for poor therapy selection?

Thanks. Yeah, Rachel, it's Mike. I'll take that one. Yeah, no, I think just to reiterate, we had a very, very impressive increase in our ASP and garden 360 in 2024. The main driver at the start of the year was increasing the garden 360 LDG rate from 3,500 to 5,000. And then throughout the year, we saw sort of the Medicare Advantage pull through, bringing them up to that rate. And so yeah, garden 360 ASP went from 2750 at Q423 to $3,000 in the back half of 2024. And also, on top of that, we had these out of period upsides just because we were receiving a lot more cash than we previously accrued for. I think when we look at 2025, definitely the $3,000 ASP we believe is here to stay. And the opportunity for us over the next sort of 12 months and longer is really to focus on the commercial payers and expanding the coverage that we have for garden 360. So we've got very good coverage now. All the national payers cover garden 360, but they don't cover every time that we run the test. So some cover for their LDT version, some for the CDX only and vice versa. And in certain cases, only for certain cancer types like lung or breast, FDA approved indications. And so yeah, that's really gonna be the focus for us to expand coverage over time. What's built into our guidance is really just the $3,000 ASP for garden 360. So if we can accelerate the expansion of the coverage, that'll be upside. If we continue to get any more of these out of period upsides above our expectations, then again, that will be incremental to our guidance. But yeah, we're feeling bullish about what we've got to with our garden 360 ASPs and looking forward.

Thank you. The next question comes from Kyle Nixon with Canaccord. You may proceed.

Hey guys, thanks for the questions. Helmy, could you talk about the contribution from G360 tissue in 2025 and how important that's gonna be longer term in the portfolio, just given that quick standard opportunity, enhance your competitive position, and maybe lengthen the runway for that franchise in G360? And secondly, Mary Lee, could you just clarify the volume of source shield this year in terms of demographics of patients and their insurance? Is that gonna be different from the 24? Thanks.

Yeah, I mean, we've seen, I think, pretty strong growth from our tissue franchise over the last few years since we launched it. But this is gonna be, I think, a significant upgrade for that test. We think it'll be sort of bar none, one of the most competitive offerings in this space from a capabilities point of view and one that is really gonna resonate with physicians. And so, yeah, we are expecting that this is a product that is gonna be a very important pillar for our therapy selection business and a major contributor over the next couple of years. And I think it's really important to, as a sort of pillar of what physicians use when they're seeing a patient really doing both tests upfront and then continuing to sort of monitor the patient with 360 going forward.

And SHIV volume Q4 was vast majority from Medicare beneficiaries. And what we assume in 2025 is still majority of the volume would come from the targeted covered patients, meaning Medicare beneficiaries. So the commercial insurance, like younger patients are minority of our volume.

Thank you. The next question comes from Mason Carraco with Stevens. You may proceed.

Hey, thanks. Sorry if this has been asking jump in between a few tonight, but on the growth you're seeing for G360 in the US, could you just give us some insight into where exactly that incremental growth is coming from? Is it capturing incremental share from competitors? Is it higher utilization in tumor types where penetration was lower? Is it new accounts? Any color there would be helpful.

I would say it's largely from greater depth from existing accounts. As you know, we have majority of US on colleges order Garten 360 today. And so it's a lot more about getting greater depth. So some of it is sort of taking back share from some of the competitors out there, but it's also just greater utilization as well. There's still a lot of physicians that don't test all of their patients with a comprehensive genomic profiling test. And having a test like this that has capabilities that go beyond just a standard genomic test, I think has been exciting, has been resonating with a lot of physicians. And we see a lot more of that to come as we roll out these applications, these apps onto the platform.

Thank you. Our final question comes from Matt Sykes with Golden Facts. You may proceed.

Thanks for taking my questions. Maybe just quickly, Amarali, just on Salesforce expansion for Shield, you talked a little bit earlier in the call about maybe being a little bit bigger than what you originally expected, but a year or two ago, you talked about gating factors that you would consider at any given point in terms of building that out. Could you just maybe kind of walk through what those gating factors today are? Is it ACS guidelines, competitive launches in the future? Just how you're thinking about sizing that investment over this year and maybe in the 26th?

Yeah, everything that we are talking about in terms of Shield investment, gated by continued execution and continuing to believe this brand is gonna have a huge opportunity for us at Garden Health. So that remains constant. The other part, which is constant, it's like what we mentioned now for some time, that our annual net burn is gonna be ring-fenced at around this 200 million. So we are continuing to execute based on that financial discipline. So what's embedded there is continued execution on the commercial showing that the volume is coming. The P&L unit economics makes sense. And the point I made earlier about commercial expansion was just based on the fact that unit economics is more favorable today than what we assumed a year and a half ago. Because of multiple reasons, the main factor, we didn't expect Medicare pricing to be $920 a year and a half ago. And what we are gonna expect with ADLT is gonna be $14.95 versus a year and a half ago. It was lower cash pay price. So this would give us some additional gross profit that we can reinvest in the field in the commercial infrastructure.

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