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spk09: Hello and welcome to the Garden Health third quarter 2022 financial results call. My name is Alex and I'll be coordinating the call today. If you'd like to ask a question at the end of the presentation, you can press star one on your telephone keypad. If you'd like to withdraw your question, you may press star two. I will now hand over to your host, Alex Claiborne, Vice President of Investor Relations. Please go ahead.
spk01: Thank you. Earlier today, Garden Health released financial results for the quarter ended September 30th, 2022. Joining me today from GARDEN are Helmi Eltuki, 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 make forward-looking statements within the meeting Federal Securities Laws. These statements involve mature risks and uncertainties that could cause actual results or events that maturely differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled Forward-Looking Statements in the Pressure Release Garden Issue today. For a more complete list and description, please see the risk factors section of the company's annual report on Form 10-K for the year ended December 31st, 2021, and in its other filings with the Securities and Exchange Commission. This call will also include a discussion of certain financial measures that are not calculated in accordance with GAAP. Reconciliation to the most directly comparable GAAP financial measures may be found in today's earnings release submitted to the FTC. Except as required by law, the guardian disclaims any intention or obligation to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information that is accurate only as of the live broadcast, November 3rd, 2022. With that, I'd like to turn the call over to Helmut.
spk15: Thanks, Alex. Good afternoon, and thank you for joining our third quarter 2022 earnings call. I will begin the call today by providing an update on our progress across oncology. I will then turn the call over to Amir Ali for an update on our screening business, including progress with Eclipse and multi-cancer screening. And finally, Mike will provide a more detailed look at our financials and guidance for 2022. At GARDENED, we are dedicated to helping patients across all stages of cancer live longer and healthier lives with the data provided from our powerful blood tests. In line with this commitment, I would like to start off by sharing an example of how our recently launched SHIELD laboratory-developed test is positively impacting screening for the non-compliant population. Our SHIELD LVT test is off to a fantastic start and has vastly exceeded our expectations. With SHIELD, we have a unique opportunity to impact outcomes at both the practice and health system level. In one primary care practice, over 100 SHIELD tests were completed as of early October. These tests primarily addressed a non-compliant population who for one reason or another, had not completed CRC screening via stool tests or colonoscopy. From these tests so far, five individuals have completed a colonoscopy following a positive SHIELD result. Of these five, four individuals had polyps, including adenomas, and one of the individuals with polyps has been referred for further evaluation for potential cancer diagnosis. We developed SHIELD with the intent to reduce cancer mortality by ensuring more individuals are screened. We are very proud to see that only after a few short months, this is already becoming a reality. With time, we believe SHIELD will be a powerful tool for primary care practices and health systems to boost screening compliance in their communities. Now, turning to our performance in slide three. We ended the third quarter with record revenue of $117 million. up 24% over the prior year quarter. Within this, precision oncology grew by 29%, while development services and other revenue declined by 1%. Moving on to slide four, clinical test volume reached over 32,400 tests, up 42% compared to the prior year quarter. In line with recent quarters, growth was driven by an increase in the number of ordering oncologists and by an increase in the number of oncologists ordering multiple GARDEN products, including Reveal, Response, and TissueNext assays, in addition to GARDEN360. Importantly, we achieved this accelerated growth despite continuing challenges of staffing shortages and lingering access restrictions across a number of practices, the majority of which we had expected to resolve more quickly. Turning to MRD. Shortly after last quarter's earnings call, we launched garden reveal for multi-cancer, adding breast and lung cancers to CRC. Collectively, these three cancers affect 6 million people annually in the United States alone, but obtaining tissue in these settings can be challenging. This makes our tissue-free reveal assay a crucial option, and we are very pleased to be able to extend the benefits of our reveal test to more patients. Following this expansion, We saw significant growth in the number of reveal tests ordered. Finally, following the positive CMS reimbursement we spoke about last quarter, we are pleased to report that our Medicare reimbursement rate for garden reveal for CRC was recently increased from approximately $3,600 to over $4,900. We also made great progress with the build out of our Epic EMR integration capabilities and have the first group of practices expected to be onboarded in Q4. Turning to slide five in biopharma. Volume reached 6,750 samples, a record number of 40% on a year-over-year basis. During Q3, we saw a rapid uptake of our recently launched smart liquid biopsy, Garden Infinity, which is available for research use by biopharma partners. Infinity accounted for more than 10% of our quarterly biopharma volume just months after launch. We're very pleased with this rapid uptake and believe we are just scratching the surface of Infinity's potential, which will be a major area of focus for us heading into 2023. Additionally, we received FDA approval for GARDEN360 CDX as a companion diagnostic for N-HER2 in non-small cell lung cancer patients with activating HER2 mutations. This adds to our ever-growing list of FDA-approved companion diagnostic indications for GARDEN360 CDX. Moving to slide six, I want to take a moment to share a bit more about why we are so excited about Infinity and the capabilities it brings to our customers. We often use the cellular phone analogy to try and put the significant step changes we are delivering into perspective. In 2014, we launched Garden360 as the first comprehensive liquid biopsy, enabling oncologists to genotype their patients' tumors with a simple blood draw rather than a tissue biopsy, a test that is increasingly part of today's standard of care. That was nearly 10 years ago. We are now entering a new age, the age of the epigenome. With our smart liquid biopsy platform, Garden Infinity, we are shining a light on an area of human biology that has been largely dark and underexplored for a variety of technological reasons. Years of research pursuing early cancer detection has enabled us to develop a revolutionary new chemistry and powerful informatics pipeline that enables broad interrogation of the epigenome at very low cost. Indeed, with Infinity, we have achieved a seemingly impossible product form factor with 100 times greater breadth than Garden360 CDX and higher sensitivity at reasonable cost. Furthering the analogy, akin to the smartphone, our Infinity platform opens up countless new potential applications. Examples include predicting drug efficacy, such as from PARP inhibitors and immunotherapies, assessing drug toxicity, and tracking tumor dynamics with greater sensitivity and breadth. The possibilities do not end there. We believe our epigenomic capabilities could lead to countless future applications for liquid biopsy that may one day extend to indications even beyond oncology. We look forward to sharing additional detail with you as we continue to develop these next generation capabilities. I will now turn the call over to Amir Ali to provide an update on our screening program. Thanks, Elmi.
spk12: Starting on slide seven with an update on Eclipse. Since our last training call in early August, we've made great progress on the Eclipse study. We have all been patiently waiting for the results of this study, and I'm pleased to report that we are very close to locking our study database with about 70 CRCs in next few days. This means we are now in the final phases and are on track for this study to redoubt during the fourth quarter. The remaining phase consists primarily of the final steps of QA and QC checks of the clinical and lab dataset, unblinding the database, and data analysis. Pending a successful redoubt, we will submit our final PMA module to FDA which remains on target for Q4 submission. Moving to slide eight and our progress with SHIELD. In May of this year, we launched our SHIELD laboratory-developed test with the ultimate goal of increasing overall compliance to colorectal cancer screening. In the United States, there are about 137 million people between the ages of 45 and 85 and about 120 million of these individuals are at average risk and eligible for CRC screening. The latest estimates show that only around 71 million people are currently screened for CRC. Of this screening group, colonoscopy is the main screening modality, and about 15 million individuals are being screened for CRC using stool tests. While by comparison, 49 million individuals are not getting screened. This unmet need in this segment alone translates to a potential annual opportunity of 16 million tests for SHIELD, assuming a three-year interval testing. Not only we are confident SHIELD can significantly increase screening in the unscreened individuals, but based on our early learning from the market, we believe SHIELD will make a significant impact across the entire eligible screening population. Turning to slide nine and our learnings from SHIELD LDT. By the end of the third quarter, we received more than 8,000 orders from over 600 accounts, far exceeding our expectations. After only five months on the market, The average depth of ordering per month for Shield LDT was over four tests per provider. This is much greater than the depth of ordering for Cologuard after many years being on the market. We are excited by this uptake and believe the promise of blood screening for patients is becoming a reality. The Shield patient adherence continues to be more than 90%. As a reminder, we define patient adherence as the ratio of blood samples received to the total number of tests ordered. By comparison, one out of every three patients that receives a Cologuard kit never completes their tests, even with significant resources spent on patient engagement and navigation programs. These early data point to the power of truly integrating CRC screening into a patient visit and the high unmet need that exists for a screening test that will be completed. Turning to slide 10. We believe there are multiple factors that contribute to the adoption of blood-based CRC screening tests. First is compliance and the unmet need. As I mentioned earlier, 49 million eligible people are currently unscreened, and the overall compliance of CRC screening using available scoping and stool tests has flattened. A new modality of screening is needed to address this huge unmet need. For this unscreened population, the best test is the test that gets done by the patients. Second, is the performance level of the test, which impacts the physician adoption rate. The level of CRC sensitivity in eclipsed trial readout is a key contributing factor. Third is patient access to the test. We believe once our SHIELD test is approved by FDA, the existing Medicare and CD will open up access for millions of individuals and pathways for ACS and USPSTF guideline inclusions. will lead to full access for individuals over time. Fourth is patient preference. We believe patient satisfaction and preference for blood tests over other modalities will act as a major catalyst for its adoption over time. And the final factor is the enhanced utility of blood tests. Over time, blood tests will be upgraded to multi-cancer screening beyond CRC, and this utility booster will further drive adoption of blood-based tests in the longer term. We have covered the unmet need, the impact of CRC screening, and guidelines on access in our recent earning calls. I now want to spend a bit more time on the impact of patient reference. Moving to slide 11. This table is a readout from our survey of 559 individuals, comprised of people who were compliant to screening, as well as those who were never screened. In this survey, we asked individuals to identify their previous screening modality, and if a blood test were available, which modality they would choose next time. These results demonstrated a strong patient preference for blood-based tests. For individuals who were previously screened with a stool test, 7 out of 10 said no to stool tests again and voiced a strong preference for blood over stool testing. For those who had never been screened, the preference for blood relative to stool was almost 5 to 1. Turning to slide 12, our experience with Shaled LDT gives us confidence that the market opportunity for blood screening tests could be higher than our previous forecast. While the performance of the assay in terms of CRC sensitivity will form the starting point for physician adoption, the overall adoption of the CRC screening modality is driven by more than the specification of the assay. Patient preference and physician's ability to complete CRC screening during routine care is proving to be a very compelling value proposition for blood testing relative to other screening modalities. We also believe the adoption of blood-based CRC screening will accelerate and deepen once the test utility goes beyond just CRC and becomes a single screening test for multiple cancers. The additional clinical utility benefit will further give competitive advantage for blood tests relative to a single cancer screening modality. The future competitive landscape between blood and stool tests will be a choice between a patient preferred blood test multi-cancer screening versus single cancer CRC screening using stool. In summary, we believe long-term adoption of SHIELD CRC screening will be boosted by patient preference and multi-cancer screening across the spectrum of assay performance. That said, performance will be a significant competitive differentiator once multiple blood tests come to market i'm excited about the future of shield and the potential impact for many millions of people this test can reduce the cancer mortality in a meaningful way i'm looking forward to get to eclipse readout and continue to build this business with that i will now turn the call over to mike for more details of our financials and outlook for 2022.
spk11: Thanks, Amirali. Turning to slide 13, total revenue for the first quarter of 2022 was $117.4 million, or 24% from $94.8 million in the prior year quarter. Total precision oncology testing revenue for the third quarter was $102.1 million, increasing 29% compared to $79.3 million in the prior year quarter. This increase was driven by year-over-year growth in both clinical and biopharma sample volumes, as well as by improved reimbursement for new products, specifically Tissue Next, which received Medicare coverage in early 2022, and Reveal, which received Medicare coverage for colorectal cancer mid-year and recently received a rate increase from approximately $3,600 to just over $4,900. Precision oncology revenue from clinical tests was $77.8 million, up 27% from $61.3 million for the prior year quarter. Third quarter clinical test volume was $32,400, an increase of 42% from the same period of the prior year, and an increase of approximately $3,100 from the previous quarter. As well as strong Garden360 growth, our new products Reveal, Tissue Next, and Response again contributed to the growth for the quarter. For the third quarter of 2022, the ASP for Garden360 was in the range $2,600 to $2,700, which is consistent with the last few quarters. The blended clinical ASP was in line with our expectation of approximately $2,400 and As we have previously stated, the blended clinical ASP will continue to be influenced by both the volume mix of GARN360 and new products, as well as the reimbursement received for new products. Precision oncology revenue from biopharma tests in the third quarter totaled $24.2 million, up 35% from $17.9 million for the prior year quarter. Biopharma volume was strong, with third quarter samples totaling 6,750 which was up 40% from the prior year quarter. Biopharma sample ASP in the third quarter was approximately $3,600, a slight decline from the prior year period, but in line with the prior quarter. Development services and other revenue in the third quarter totaled $15.4 million, down 1% from the prior year quarter. As we have previously noted, while we continue to see strong demand for our development services, We still expect that our 2022 development services and other revenue will continue to be lower than prior year, as several companion diagnostic projects were successfully completed in 2021 and new projects will take time to ramp up. Gross profit for the third quarter of 2022 was $76.9 million, compared to a gross profit of $64.0 million in the same period of the prior year. Our gross margin percentage continues to be in line with our mid-60s target, being 66% compared to 67% in the prior year quarter. Operating expenses from the third quarter of 2022 were $221.5 million, an increase of 29% compared to the $171.3 million in the third quarter of 2021. Net loss was $162.0 million, or $1.58 per share for the third quarter of 2022, compared to $107.5 million, or $1.06 per share in the third quarter of 2021. Moving on to non-GAAP financial measures on slide 14. Non-GAAP operating expenses exclude stock-based compensation and related employer payroll tax payments. amortization of intangible assets and contingent consideration. Non-GAAP operating expenses for the third quarter of 2022 were $200.5 million, a 48% increase from $135.1 million in the prior year quarter. This increase was driven by the investments made over the past 12 months across both our oncology and screening businesses, primarily in the commercial infrastructure and the continued development of our product pipelines and clinical data. Throughout 2022, we have continued to invest in progressing our strong pipeline of oncology products, as well as in generating clinical data to support their reimbursement. For screening, 2022 investment has been focused on the commercialization of our SHIELD LDT test, completing the data readout from Eclipse, the PMA submission for our CRC device, and the continued development of our multi-cancer screening test. Non-GAAP net loss was $120.8 million, or $1.18 per share for the third quarter of 2022, compared to $70.5 million, or 70 cents per share for the third quarter of 2021. Adjusted EBITDA was a loss of $112.8 million in the third quarter of 2022, compared to a $65.2 million loss in the third quarter of 2021. We defined adjusted EBITDA as non-GAAP net loss adjusted for interest, income tax, depreciation, amortization, and other income and expense. Turning to the balance sheet, we entered the third quarter of 2022 with approximately $1.1 billion in cash, cash equivalents, and marketable debt securities. We continue to be in a fortunate position to have sufficient cash on our balance sheet to fund the business for the foreseeable future. and we will continue to actively manage our capital allocation with a goal to long-term profitability. Now, turning to our revenue outlook for the full year 2022 on slide 15. We are revising our revenue guidance from the previous range of $460 to $470 million to now be in the range of $440 to $450 million. This revised guidance represents growth of approximately 18% to 20% compared to 2021. There are a few notable changes to our guidance since our Q2 earnings call in early August. Firstly, with regards to our clinical volume. While below our previous expectations, we were pleased with both the 42% year-to-year volume growth and the sequential volume growth we saw in the third quarter of 2022, which we view as a strong leading indicator of the trajectory of our business. We still expect to see sequential clinical sample growth in the fourth quarter. However, as Helmy noted, we continue to see challenges with practices still experiencing staffing shortages and lingering access restrictions, the majority of which we had expected to be resolved more quickly. In addition, at the start of the fourth quarter, we also saw an impact on our volumes due to the hurricane in Florida, which is a major region for our business. Given our year-to-date growth at the end of Q3 and the factors just mentioned, we now expect full-year clinical volume growth to be approximately 40%. Although we consider this to be a very strong growth, it is lower than the 45% level that we previously guided. Secondly, reimbursement timing has affected our forecast. Although we received Medicare reimbursement for Tissue Next and Reveal in 2022, our previous guidance had assumed Medicare reimbursement for response and garden 360 CDX reimbursement in Japan during 2022. We now assume reimbursement will come after the year end. At the midpoint of the range, $445 million, our revised guidance assumes full-year biopharma volume growth of approximately 40% compared to 2021, and full-year development services and other revenue of approximately $55 million. Although we have a good line of sight at the end of the year for most of our business, there are still some potential swing items, which include the timing of receipt into our lab of contracted biopharma samples, which could impact our ability to process and recognize revenue by the end of the year, and the timing of revenue recognition related to some of our companion diagnostics project milestones, which are dependent on our partners. While the reduction in our revenue expectation for the year is disappointing to us, we believe our core business is as strong as ever. demonstrated by the approximately 40% year-over-year volume growth of both our clinical and biopharma businesses, despite the challenging backdrop throughout the year. Finally, know that our clinical volume does not include screening volume, and that while we are highly encouraged by the strong reception to the launch of our SHIELD LDT test, we are not expecting significant revenue contributions from it this year. Moving to slide 16. We are continuing to make great strides across our business, obtaining reimbursement for our new products, broadening our product portfolio with our Shield LDT test, and expanding our reach into the cancer screening market. We are aggressively pursuing the best opportunities ahead, and we are confident that we will be a leader in cancer across the continuum of care. At this point, we will now open up the call to questions.
spk09: Thank you. As a reminder, if you'd like to ask a question, you can press star one on your telephone keypad. If you'd like to withdraw your question, you may press star two. Please ensure you're unmuted locally when asking your question. Our first question for today comes from Puneet Sudha from SVB Securities. Puneet, your line is now open.
spk17: Hey, Helmi, Merrilee, thanks for taking the question. First one is really on the timeline and learnings from the Shield launch. You mentioned September-October timeline before, and that was already extended from the summer. So, I mean, I appreciate you're locking in the database now with 70 CRCs, but what is the level of confidence you have at this point to have the data released by September and this to not stretch into Q1? And then on the learning side, from the 8,000 orders that you've received, I mean, it's great to see the 90% adherence rate. But just wondering, what have you learned about the performance of the test in terms of sort of sensitivity, specificity there in the real world setting? I mean, I appreciate this is not an FDA registrational trial, but just wondering what learnings you have on the performance there and have a quick follow up on the guidance.
spk12: Yeah, thank you for your question. So I think first, starting with the Eclipse trial readout, as we mentioned in that last last earning call, we mentioned actually now we are expecting Eclipse trial readout to be Q4. As I mentioned in the prepared remark, in the next very few days, we are basically locking the database. So it's it's going to be Q4 readout. So it's going to be soon. Regarding actually the SHIELD LDT and the 8,000 samples that we got and we continue to be very pleased with the level of actually adoption and the feedback that really we are getting from the marketplace. In terms of the performance, it's very hard since we are not doing registry study to really track the patients. It's very hard to get a sense of the true performance of the test. Anecdotally, we are hearing the stories. We share the patient's story, like, you know, a few patient stories in our prepared remarks. There are a bunch of other anecdotal cases that we have heard from practices, but it's hard to connect those anecdotal positive stories to really the performance of the test. But all in all, just based on the positivity rate that we are seeing in our device in terms of what's getting reported, it's in line with what we think the device should generate so but it's very hard to connect that to CRC sensitivity since the prevalence of CRC is very low.
spk17: Okay got it and then on the 20 million you're lowering your guide by 20 million at the midpoint I mean that is still a sizable you know, Helmy, can you elaborate a little bit on the staffing challenges and other things that you're seeing in the market? And why is this sort of unique to the clinical side? And then, you know, I think the question we didn't frequently get is on the competition side, obviously G360 has been a well-established product in the marketplace as FDA and then reimbursement too. So are you seeing any impact from the larger panels in the market. It's a bit surprising to see, you know, this lowering up the guide. Thank you.
spk16: Yeah, no, thanks. You know, obviously, you know, we set some really high, I think, expectations at the beginning of the year for 50% volume over year over year volume growth. And, you know, we're heading, you know, both 40%. So still fantastic growth, but not what we expected at the beginning of the year. And That's largely just because we expected a snapback from some of the lingering effects of COVID in the second half of the year. And it just hasn't happened as fast as we expected. That being said, when we look at the underlying metrics of the business in terms of number of physicians that are ordering per quarter, depth of ordering, our share in terms of liquid, even how we're doing on the MRD market, I mean, Reveal was a monster quarter for us in terms of, you know, the extension, in terms of breast and lung. We're very pleased, you know, super pumped about, you know, where the business is going. And we're not even getting started in terms of, you know, what we're going to do with some of the technology in 23. And so we feel like we're very well poised in terms of this market and where we are. Obviously, we thought, you know, it would be even more explosive, but you know, 40%, you know, year over year is, you know, still very, very strong growth. And we believe we're growing faster than the market. So we believe we're still taking share and we're a dominant force in the liquid biopsy field.
spk01: Okay. Thanks, Ed. I'll hop back into the queue.
spk09: Thank you. Our next question comes from Jack Meehan of Nephron Research. Jack, your line is now open.
spk04: Thank you. Good afternoon, guys. I wanted to start with a focus on reveal. What was the catalyst for the price increase with Medicare? Were there any other changes in the coverage there? And similar, was there any Medicare reimbursement quarter or back pay that you've received yet?
spk16: Yeah, so we had ongoing discussions with MoldyX around pricing. We believe the pricing didn't quite reflect some of the value and some of the um kind of capabilities of the test and they agreed with us and revised uh pricing so it's the same indication um but just a much better price that we now have and i'll turn it over to to mike for the second part yeah jack on the medicare reimbursement yeah for for reveal for the for the eligible samples um we were able to book revenue this quarter
spk14: And actually, that reimbursement coverage was backdated to the start of the year. So, yeah, this quarter includes that sort of catch-up on those samples year-to-date that have been eligible for reimbursement from Medi-Cal.
spk04: Got it. And, Mike, as a follow-up for you, you know, and Kelmy and Mira Lee kind of referenced, I think you did as well, kind of the challenging environments. Can you just talk about, you know, how you're planning to manage costs as you go into 2023? And is there any color you can share around investment levels on sales and marketing and R&D? Just any color thing about cash burn would be really helpful.
spk14: Yeah, you know, I think, and we've said it sort of on previous calls that, you know, we're managing our OPEX spend, you know, very, very carefully. And I think, you know, with the change in our revenue guidance, actually with the way that we're managing our OPEX in Q3 and what we'll do in Q4, there's no real impact to the bottom line for us with that revenue reduction. So, yeah, you know, we're taking steps. We're looking at everything that we invest in. And, you know, again, we said before, as we go forward, particularly on the screening business, you know, we know that we're going to have to build up a commercial infrastructure as we get closer to FDA approval. And so we're still mindful and taking those milestone-approached increases in OPEX. So it's something, again, we follow very closely and we're managing very tightly. Great.
spk09: Thank you. Thank you. Our next question comes from Matt Sykes of Goldman Sachs. Matt, your line is now open.
spk06: Hi, good afternoon. Thanks for taking my questions. Maybe just on, Mike, your comments around the reimbursement delays impacting guidance in Japan and other places. Do you see that as just sort of a few-month slippage? There's no other issues in there that would cause that to last longer? Is this something that you expect in early 2023?
spk14: um yeah that that that's right you know we were hopeful for both uh for both response and garden um 360 cdx in japan that we'd get reimbursement um well well before the end of of the year but uh it looks like that's getting pushed back into uh into 2023 but there are no fundamental issues where you know we're continuing to have uh dialogue with moldy x with with respect to response And we know there's a lot of work happening in Japan on the reimbursement front. So, you know, both of them we're hopeful for will come, you know, relatively soon in 2023. So it's just a timing impact for us.
spk06: Great. Thanks for that. And then, Amarali, just on slide nine where you had the four tests per provider per month, you said it was above kind of your expectations for what it would be. What were your kind of expectations? What do you think? Where do you think that could potentially go? I know it's obviously very early, but in terms of what your now longer-term expectations are on a test-per-provider basis, what are you thinking?
spk12: So in terms of fact patterns that we knew, we knew what the industry benchmark is in terms of the utility of tests like Cologuard, to some extent like the utility of FIT. When you look at historical trends, even since launch, to my best knowledge and assessment, like almost from beginning till now many years after, the utilization of that test per prescriber per month has been like less than one order a month. We knew that actually the unmet need here is very deep, but industry benchmark is industry benchmark and literally saying like just even less than five months after being in the field with a test which is totally brand new kind of even modality, Still, we don't have even our Eclipse trial readout. We don't have FDA approval. We don't have coverage policies. We are not in any guideline. And literally, even just right off the bat, we are seeing this more than four tests per provider per month. It generates a lot of excitement for us. It's really confirmation of the reality that unmet need is big. And the patients that we are talking about are not the patients which are like in the rural area that they don't have access to anything. It's very hard to get access to them. These are really the patients that the doctors are seeing. And, you know, these prescribers who are ordering our tests, some of them are the same prescribers who are using other kinds of modalities. So we are very excited, but also we don't want to get, you know, too ahead of our skis and we have to monitor to see what happens here. But it's pretty good. Great, thanks.
spk09: Thank you. Our next question comes from Kyle Mixon from Canaccord. Kyle, your line is now open.
spk02: Hey, thanks, guys, for the questions. Just thinking about the cost per shield test and how you get down to that $200 range over time, I know it's been touched on before. I just want to kind of revisit that given it's been something I've gotten questions on recently. So in gardens, clinical costs per test are still currently around like $1,000 per test. The question kind of remains, like, what gives you confidence there's a path there to get to that 50% margin, perhaps $200 in COGS per test on that 500 ASP? And I think that you've said in the past that if, you know, Illumina lowered its NGS costs, if you get down to that $200 per test, I mean, they did lower down to, you know, a price per gig of two bucks for 2023. How does that affect your thoughts on COGS and the market profile of SHIELD over time?
spk12: Yeah, sure. Maybe I'd start on it. Mike, you have some additional comments, please. So, you know, maybe starting just from the sequencing cost. Sequencing cost is a, you know, material part of our bill of material, but not a significant part of our COGS really. So we assume some sequencing cost reduction in our roadmap for the next three years, but not to the level that actually some of the new technologies or even some of the new promises by Illumina is actually generating. kind of new assessment for us. All that would be upside. Really the one that the stuff that we have to do are mainly around process engineering and additional automation to take labor out of our system to a large extent and, you know, amortize our fixed costs over larger volume. You know, without going into a lot of details now that like we kind of ran eclipse samples and commercial samples, Effectively, we are running relatively at high throughput, still not at a half a million sample a year kind of throughput. And our cost structure is not $200 yet, but it's pretty reasonable even at the scale that we are in. So we just need to reach to higher volumes and improve some of our processes by introduction of automation. And I see this pathway for us that we can get to the $200 kind of a cost. and gross margin of at least 60%.
spk14: Yeah, I mean, I think the only other thing I would reiterate, because, Kyle, I think you mentioned relative to Garden 360 cogs, and as Amir Ali mentioned, even with just the Eclipse volume and what we've seen from the LDT launch, our cogs on SHIELD are currently lower than the Garden 360 cogs. So we've made really good progress in such a short time on the cogs on SHIELD.
spk02: Okay, that was great. Thanks, Mike, primarily. Mike, just a question for you. Maybe on next year, so previously this tree was modeling over 30% top line growth for garden in 23. Just given the guy down today and that lower run rate kind of exiting 22, are you guys more comfortable with like a lower growth rate for next year, maybe like in the 20% range? I'm just kind of asking because like in theory, the comp is better for 2023. I'm just wondering like what your thoughts are now, given all these moving pieces and kind of like relatively new tests.
spk14: yeah you know um we don't we don't want to particularly give out uh 2023 uh guidance today um and as helen mentioned you know we're feeling really strong about the fundamentals of of the business uh as we sort of you know go out of the go out of 2022 and we've got 40 year-over-year volume growth on both clinical and biopharma i think you know where we're trending towards this year on total revenue is around about 20 percent year over year, and obviously we'll be starting at a bit of a lower base in Q4. So we're probably at least comfortable with that going into 2023, but our plan obviously will be, as we usually do, giving 2023 four-year revenue guidance when we do our Q4 call in February next year.
spk02: Okay.
spk14: Thanks, Mike.
spk02: Thank you.
spk09: Our next question comes from Mark Massaro from BTIG. Mark, your line is now open.
spk03: Hey, guys. Thanks for the questions. Maybe the first one on Reveal CRC, nice to see the reimbursement rate increase there to 4,900. Can you just confirm that you're still planning to obtain coverage in the surveillance setting? Tell me, I think you said it's for the same indication. And then are you expecting to submit additional information to secure that?
spk16: Yeah. We have a number of studies that we're compiling and they're underway that would go into a sort of subsequent submission to be able to secure that surveillance setting indication.
spk03: Okay. And my second question. Obviously, we're all looking forward to the Eclipse data. I did just want to ask about the market size, and you did. The 120 million average risk individuals earlier this year, you sized it as 110. It's just the difference, including the 85 age cohort from 84, because I don't think there was a huge population increase in the U.S. Just trying to get a sense for why, you know, that TAM seems to have increased from, you know, a few months ago.
spk12: Yeah, so actually, this is Amir. So some of the, you know, as we are going, actually, we are kind of updating our models based on all the latest information. I think one of the important changes that has happened recently is actually introduction of a recommendation of screening in the younger age patient population of 45 to 49. That's a relatively kind of a new addition to the market sizing and you know it's just based on as you go based on that guidance upgrade like what fraction of those for that specific year would be eligible. I think that's one of the main contributors if I recall right based on That generates this delta of 110 versus 120.
spk15: Okay, thank you.
spk09: Thank you. Our next question comes from T. Jess Savant from Morgan Stanley. T. Jess, your line is now open.
spk18: Hi, this is Neil on for data. So starting with Reveal, in light of the pushback seen for one of your peers, do you expect any shift at CMS in regards to evidence requirements for PMA? And has this driven any changes in your approach as you look to expand coverage for CRC and, you know, receive coverage for breast and lung down the road?
spk16: No, I think we have a better understanding now, obviously, with, you know, all the dialogue that we've had. And, you know, bottom line is you need clinical studies, clinical validity studies showing the performance of the test published in peer-reviewed journals. And so that's the bar for really everyone in this space. And it's something that we are committed to and we have underway in terms of the studies for the various indications that we're pursuing.
spk18: Got it. And, you know, you mentioned the headwinds on the clinical side. But in biopharma, are you seeing any delays to clinical trial enrollment or sample treatments, given some of the recent challenges it appears? And there's also been some noise around budgetary concerns for pharma and biotech. Is that a dynamic that you're seeing based on your recent interactions?
spk16: Yeah, you know, I think we've had very strong growth on the biopharma side. But that being said, there have been slowdowns in some of the prospective trials. That's something we continue to monitor. They haven't progressed as fast as I think some of our pharma partners would have liked. And I think it's still TBD in terms of some of the budgetary concerns related to Inflation Reduction Act and so on.
spk18: Great. And then one quick one from me. Would you be able to quantify the catch-up payment you saw for Reveal in the quarter?
spk14: No, we're not breaking that out. I mean, I think, you know, in the past we've talked about not really breaking out our volumes between, you know, Reveal, 360, Tissue, and Response. And so, yeah, we're not going to sort of provide the detail on that catch-up payment.
spk00: Got it. Appreciate the time. Thanks.
spk09: Thank you. Our next question comes from Amy Quyen from J.P. Morgan. Amy, your line is now open.
spk10: Hi. Thank you for taking my question. I have two questions on the show. So first is I appreciate you guys lay out the commercial plan. So I was wondering how do you address the compliant and non-compliant population differently to achieve that goal? And is your current sales force enough to support the revenue ramp? in 2024 once the NCIS guideline is in place.
spk12: Yeah, right now, you know, for the SHIELD LDT, actually the main target for us is just because it's lab-developed tests, it's BFTA approval, like we are kind of positioning and marking the test for unscreened patient population versus really pushing hard on changing the modality of the screening to all the kind of the depth of Ordering that I mentioned is really why we are just promoting for really on-screen patient population. Regarding the size of the sales force, our commercial team is about 100 people now, and we are going to expand it in a milestone-based way. Effectively, as we build ASB, we are going to increase our investment on the commercialization. So as we get actually to FDA approval and de-risking that, We may increase the size of that channel. And as we effectively build ASP on the top line for that business, we would increase our investment on commercialization of the test.
spk10: Great. Thank you. So my second question is on the Eclipse trial. If you can share, like, what does the staging mix look like so far and when we'll have the final information on the staging mix? Because your previous study showed, like, the, you know, 2%, 3% or lower single-digit difference between the early stage 1, 2 sensitivity versus overall. Do you expect to see similar patterns for the colorectal trial? Thank you.
spk12: Yeah, very good question. So our main focus and our trial operation focus was to get to this final analysis of our, you know, top line information to see really what's the sensitivity specificity of CRC and advanced adenomas in the study. So we expect that top line data to include those information. For a fraction of CRCs, actually the patients are staged, but, you know, it's kind of a, lagging information, but we are going to have this information updated by the time that we submit our PMA to FDA since actually we need to include that information in our PMA package. But in order to have the whole staging for everybody, that could take some time.
spk10: Okay, thank you.
spk09: Thank you. Our next question comes from Max Masucci from Cowen. Max, your line is now open.
spk08: Hey, thanks for taking the questions. So first one, the AA detection sensitivity range in the May data release was decently wide, like 11% to 32% based on 51 AA cases. you're able to incorporate the proteomics and impregnatovix components into the final assay, eclipse assay, before locking it down. So number one, it would be great to hear just generally how many total CRC cases you were able to train that final optimized assay on before locking it down. And then number two, there can be heterogeneity, size differences for advanced adenomas. So if you could offer any detail around that. the profile of the types of the AA cases that you've trained the assay on and any steps you've taken to better address the diversity that does exist even in the AA population.
spk12: Yes, you know, in terms of training, it's like our CRC models is kind of now relatively pretty old now. So we included thousands of cases like I think over 5,000, 6,000 cases, I think, on the healthy, normal side. On the CRC and disease side, I think it was like more than 2,000, 2,500 cases, I believe. CRCs across different stages with a heavy focus around stage one, stage two. On advanced adenoma side, you know, getting advanced adenoma cases for really screening patient population before advanced adenoma is removed during the colonoscopy, we had limitations and that's why we, you know, in our training said we had a few hundred cases and, you know, for our LDT validation, we just had 50 cases as part of that validation. So, um, And performance we saw was about that 20% in LDT validation. It's really going to get characterized very nicely as part of Eclipse. We have high percentage of the cases of advanced adenoma, you know, what we expect based on real-world advanced adenoma rates. So it's going to get very accurately actually quantified. But as I mentioned always, from my perspective, the most important thing is really the CRC sensitivity and that's the parameter that you know I'm going to pay a lot more attention when we get to the eclipse trial readout and that's what we're hearing from our physician and different surveys that's really that's the center point of the performance when we report eclipse yeah it makes sense uh final one for me
spk08: I think there was some revealed data presented at an international conference late last month, and we've received some inbounds on the data and some asking questions about the Kaplan-Meier survival curve that was presented. So I just wanted to, you know, ask an open-ended question and just get your perspective and sort of key observations from that recent data readout just so we can round out our perspective.
spk16: Which data readout? I missed the first one.
spk08: In late October at the Japan Society of Clinical Oncology in late October.
spk16: Yeah, I don't know exactly which one that was.
spk08: The COSMOS study.
spk16: The COSMOS, yeah. That's a study that we've been doing for some time on CRC. You know, I think that study, I think we're very pleased with the, you know, output and data. I think there was some confusion around some of the numbers and the abstracts versus what was presented. But, you know, it was pretty much, I think, in line with, you know, data we had seen before. And, you know, I think one of the challenges of any new data sets is just the time it takes to mature in terms of really waiting for some of those patients to, you know, really detect recurrence in the sort of clinical setting. But it's relatively in line with, I think, some of the data we had seen previously.
spk08: Great. Figured it was worth getting some additional perspective. But good stuff. Thanks for taking the questions.
spk09: Thank you. Our next question comes from Andrew Brackman of William Blair. Andrew, your line is now open.
spk07: Good afternoon. This is Griffin. Thanks for the questions. Just first on the lingering access restrictions, I think last quarter you pegged at about 60% pre-pandemic. Is that where we are today? Do you kind of see this as the new normal? I'm just curious what you think kind of drives improvements from here.
spk16: Yeah, that's part of it. But, you know, I think another aspect of it are these sort of shortages that we're seeing in staff levels, you know, the whole sort of travel nurse kind of issues and, you know, the difficulty in terms of staffing some of these hospitals and these practices. And that's just leading to a sort of cap on the sort of growth rate and acceleration that we can see in the near term. But we know that these issues are going to resolve eventually. And so we see them as very much kind of short-term issues and not a reflection on sort of any intrinsic element of our business. In fact, as I mentioned before, our business is really firing on all cylinders from the number of physicians that are engaged, the number of physicians that are ordering, the depth of ordering. So we're very pleased in terms of the progression of the underlying metrics. But, you know, we see this as resolving eventually. And we do think that that sort of 60%, 70% access will probably be there for some time, but we think the staffing shortages should certainly resolve.
spk07: Okay. And one on the OUS opportunities. Could you just talk about how you're thinking about the incremental revenues that those can drive? between Japan, CDX, reimbursement coming soon, you brought out the rest of the MUJV partnership lab in Spain and one coming in the UK. I mean, is it right to think about all these opportunities sort of summing as, you know, meaningful incremental revenues here in the short term?
spk16: Yeah, maybe let Mike, you know, talk about the specifics, but I'll just give you a kind of overview of, you know, how excited we are about the Japan opportunity. I mean, it's a country that we've, really built some very deep partnerships with and hundreds of practices over the last now five years. We have a lab that's open there. We're one of the few international companies that has a physical laboratory presence in the NGS space and comprehensive genomic profiling in Japan. And we're really hoping to get reimbursement very soon there for our regulatory-approved GARDEN360 test. So obviously that's been delayed from where we thought it would initially happen. One of the challenges in Japan is that you can't actually sell in this sort of interim period between regulatory approval and reimbursement. And so we're sort of in this limbo there. But once again, once we get reimbursement, that's a market that's about 40% as large as the U.S. population with reimbursement rates that are as good and better in a single-payer system. fantastic opportunity. We obviously just announced the partnership in China with Atacom. That's a very big opportunity as well. And then we're also making good progress in Europe, as you mentioned. So yeah, we think these will increasingly be larger percentages of our revenue.
spk14: Yeah, yeah, maybe to add. Obviously, Ex-US revenue is below 10% of our total revenue at the moment, so relatively small. But Helmy mentioned the opportunities ahead of us, and we'll start to see the Japan revenue come through next year. In China, that'll start to add to our biopharma revenue line. And then we've got the labs coming online in Europe and starting to generate revenue. So without breaking out the specifics, we feel excited and that revenue can start to contribute next year.
spk00: Okay.
spk09: Thank you. Our next question comes from Patrick Donnelly of Citi. Patrick, your line is now open.
spk05: Hey, guys. Thank you for taking the questions. A lot's been covered. Maybe just a quick follow-up for you, Helmy, just on the staffing shortages. It seems like you're pretty confident those will be relatively near-term. Did you see improvement kind of throughout the quarter and even into October? Just wondering in terms of kind of that volume progression, trying to think through the trajectory as we work our way towards 23, if that's easing at all or kind of still is pretty – pretty heavy and you're just kind of looking forward and assuming it eases as we get into 23. Thanks.
spk16: Yeah, no, I mean, we definitely saw continued improvement. That's why, you know, I think despite kind of where we are and some of the guidance, we are very pleased with the sort of underlying metrics. We obviously had expected, you know, kind of a much greater snapback and resolution of some of these effects that continue to linger. But that being said, Yeah, we continue to see very good growth on almost every line of our business in terms of the core business is growing solidly, certainly Reveal and our tissue products.
spk09: Thank you. Our final question for today comes from Derek De Bruin from Bank of America. Derek, your line is now open.
spk13: Hey, guys. This is Nisar gone for Derek. Thank you for the question. Just a quick one here for me. So I wanted to start off on the delays. Another competitor called out pharma sample delays and trial delays. Can you talk a little bit about how much of an impact it was in the quarter and how trends have been so far in 4Q?
spk14: Yeah, on the biopharma, I don't know if we saw any specific delays to samples in the quarter. And again, you know, we reported really strong year-over-year growth on biopharma samples. I think, you know, I flagged in the prepared remarks that, you know, one of the swing items is going to be the biopharma samples that we get in by the year end. And we need to get those in time to process them and recognize the revenue. And I think, you know, some of those delays we're anticipating. And so, you know, we're looking at that as a sort of a swing item in the sort of two to three million level. But, you know, if the samples don't come in by the end of the year, you know, we're expecting them a little bit later into 2023. So for us, yeah, it's just the timing. rather than a reduction in overall volume on the biopharma business.
spk00: Got it. Thank you. Thank you. This concludes the conference call for today.
spk09: You may now disconnect your lines.
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