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spk13: Hello everyone and welcome to the Garden Health First Quarter 2022 Financial Results Call. My name is Charlie and I'll be coordinating the call today. You'll have the opportunity to ask a question at the end of the presentation. If you'd like to register a question, please press star followed by one on your telephone keypad. Please note that we'll only be taking one question and one follow up from each person. I'll now hand over to your host, Alex Kleban, Vice President of Investor Relations to begin. Alex, please go ahead.
spk12: Thank you. Earlier today, Garden Health released financial results. The quarter ended March 31st, 2022. Joining me today from Garden are Helmy Atsuki, Co-CEO, Amir Ali Talasas, 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 of Federal Security's Law Office. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled Forward-Looking Statements in the Press 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 31, 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. Reconciliations and most directed comparable gap financial measure may be found in today's earnings release submitted to the SEC. Except as required by law, the Guard displays 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 comment's call contains a time-sensitive information and is accurate only as of the live broadcast May 5, 2022. With that, I'll let you turn the call over to Helmy.
spk08: Thanks, Alex. Good afternoon, and thank you for joining our first quarter 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 Amira Ali for an update on our screening program. And finally, Mike will provide a more detailed look at our financials. At Garden, we are dedicated to helping patients across all stages of cancer live longer and healthier lives with the data provided from our powerful blood test. In line with this commitment, I would like to start off with a patient story. In 2018, a 54-year-old man was diagnosed with rectal cancer and had a successful surgery to remove his cancer. About three and a half years after surgery, during a regular checkup, his oncologist ordered a garden reveal test, which detected ctDNA, signaling he had a high likelihood of disease recurrence. Because of this result, his oncologist decided to monitor him more closely, and within a few weeks, determined he had a clinical recurrence. His oncologist then ordered a GARDEN360 test, which revealed he had a number of alterations, including HER2 amplification. Given this information, the patient had a number of potential first-line treatment options targeting the HER2 amplification. He was able to start treatment immediately, and I'm happy to report that he's doing well. This is a great illustration of how the garden portfolio of products is increasingly working hand-in-hand to help inform patient treatment across the continuum of care. Now, turning to our performance in slide three, we ended the first quarter with revenue of $96 million, up 22% over the prior year quarter. Our team delivered strong clinical test volumes, reaching 27,100 tests, an increase of 47% from the prior year quarter. This was composed of a somewhat slow start in January and February due to the Omicron surge, followed by a very solid finish to the quarter in March, setting us up very nicely for the second quarter and a very strong ramp for the rest of the year. Moving on to slide four. I'm proud of our team's work to establish Garten as the leader in liquid biopsy for high performance test results and excellent customer service. Since the launch of our first product, Garden360, we have been focused on building relationships with a growing number of oncologists. We now have more than 11,000 ordering oncologists, and within this group, we are seeing our core base of customers ordering more tests and using more garden products each quarter. This is evidence of the depth we are building into these accounts, and that drives adoption of CGP and unlocks more of the TAM over time. This, in turn, allows us to expand our portfolio and field team, which positions us for long-term sustainable growth. We believe there is ample opportunity to continue growing, both in terms of comprehensive genomic profiling and liquid biopsy share. Last month, we announced a partnership with Epic, a widely used comprehensive electronic health record system in the United States, to integrate our broad portfolio of cancer tests and enable our tests to be available to over 250 million individuals with a patient record. This integration will make it easier for health systems, community healthcare providers, and retail health clinics to make our blood tests part of routine clinical care by providing direct ordering access and results delivery. We are proud of our team that is delivering on this initiative in a very condensed timeline, leveraging know-how and lessons learned from across the sector. This is just the first of a number of partnerships that we are exploring to better integrate our products into clinicians' workflows that will include additional EMR systems, among other tools. We are also making progress in the reimbursement front. In early March, we received Medicare coverage for our Garden360 Tissue Next test under the Moldex LCD. We are already seeing that reimbursement of our tissue products accelerating the positive trends we have been seeing of increased depth of ordering per account, as now more and more oncologists are ordering multiple products from Gardens. And as a result, this is deepening our touch points and amplifying our overall brand awareness in the market. Looking more closely at recurrence monitoring on slide five, we continue to be excited by the positive response to our reveal assay, especially given where we are in the product cycle. The MRD space is still in the very early ending, and we continue to hold this singularly unique space as the only commercially available blood-only solution, despite a whole host of tissue-dependent entrants. We are very pleased so far with our progress since launch and the traction we are getting in MRD. With our unique blood-only assay, we believe we are on track and have all of the product and commercial elements necessary to be the leader in MRD. Specifically, we continue to see strong quarter-over-quarter growth and are very pleased with our launch trajectory with respect to the competitive landscape and our previous product launches. We expect to have a series of future tailwinds, including indication expansion, reimbursement, and clinical utility data arriving that sets us up well for long-term growth. Turning to slide six, outside of the United States, we are continuing to broaden our reach to deliver a new paradigm of cancer care around the world. In mid-March, we were excited to announce that the Japanese Ministry of Health, Labor, and Welfare approved the use of GARDEN360 CDX in patients with advanced solid cancers. The GARDEN360 CDX test was also granted approval as a companion diagnostic to identify patients with microsatellite instability high solid tumors who may benefit from Keytruda and patients with MSI high advanced colorectal cancer who may benefit from Updevo. This regulatory approval has taken on added significance as CRC is the most commonly diagnosed cancer in Japan, and this is globally the first liquid biopsy approval for IO therapy. This follows prior regulatory approval for GARDEN360 CDX from the Ministry of Health and Labor and Welfare in December of 2021 as a companion diagnostic for identifying patients with metastatic non-small cell lung cancer who may benefit from treatment with Lomacris. Following this approval, we are now working to securing public reimbursement by the end of 2022. Japan represents a very large market opportunity with about 400,000 late-stage patients compared to 700,000 in the United States and similar reimbursement rates for CGP. We are now in the process of building a commercial footprint to serve this enormous opportunity. We are also moving to quickly establish our footprint in the European market, as we are seeing early traction with hospitals and doctors with programs in the United Kingdom and Spain. In fact, this month our laboratory, in partnership with Valdebron in Spain, will launch and be officially operational. We look forward to being able to provide local access to Garden360 in the region, ensuring that no cancer patient globally is left behind. Moving on to Biopharma on slide seven. We delivered 5,100 tests in the first quarter, representing growth of 45% year over year. We ended the quarter with more than 110 active partnerships, reflecting a growing and diverse set of customers. The breadth of our product offering, strong customer service, and our clinical market leadership makes us an attractive partner. We have a healthy pipeline of discussions and expect the number of customers to continue to grow over the course of the year. We are also seeing growing interest for our Garden Inform offering, further driving our mission of being a partner of choice for Biopharma. We have now signed several deals for Garden Inform, spanning applications from translational oncology to clinical development and study planning, and have seen strong growth in the number of partners and customers we are talking to with regards to this platform. Turning to slide eight, Earlier this year, I shared our vision for our smart liquid biopsy platform. We continue to make excellent progress towards this launch and are seeing strong initial interest from our biopharma partners. We are encouraged by their early feedback and excitement on its capabilities that are profoundly more rich than any liquid biopsy oncology products in the market today. Diving a bit deeper into the platform, what defines all the diverse cell types in our body is not the genetic sequence information itself, but everything beyond that, such as epigenetics and other markers. We expect this product to redefine drug development and enabling, for the first time, a greatly expanded view into this underlying tumor biology, to which the field in general has been largely blind due to a lack of available tools. It's still early days, but we are beginning to witness firsthand the power that deep multimodal interrogation of cancer pathways will have on development of next-generation precision medicines and are very excited for the countless applications possible from this new platform. We look forward to sharing more about this next chapter of our smart liquid biopsy platform at an investor day planned for the fall of this year. Before turning the call over to Amir Ali, I would like to take a moment to talk about what drives us at Gardens. One of our most important values is participation first. Everything we do has to be led by that North Star. Another core value is Blade the Trail. With the momentous launch of our screening test shield a few days ago, we've now spent almost a decade putting these values into practice to make blood-based cancer testing across the entire continuum of cancer care a reality. We've made countless difficult decisions along the way, all to develop the right technology and product market fit to bring our vision to fruition. We learned along the way that as a company, when you blaze a trail, you have to constantly innovate and disrupt to deliver progress, often displacing incumbent technologies and companies, like we did with Garden360 eight years ago, GardenReveal last year, and this week with Shield. This generates excitement and attracts new investment to propel more innovation. We've seen this in the form of billions of dollars in capital invested by financial markets and competitors into blood-based testing. Disruption also triggers vocal reactions at times. All of this is evidence that we are very much on the right track and leading the nascent industry. I am very proud of our team, our products, and this exciting next chapter of Garden Health. I will now turn the call over to Amir Ali to provide an update on our screening program. Thanks, Helmi.
spk04: Turning to slide nine. At Gartner, we've always believed that a blood-based screening test during wellness checkups has the potential to shield patients from cancer. We've been on a 10-year journey to bring a high-performing blood-based screening test to the market that can save millions of lives worldwide. For colorectal cancer, our core belief is that ease of the blood-based test combined with a high level of early stage detection is the key to improving screening compliance and making our vision a reality. This has the potential to improve health equity and access to screening for underserved populations. I'm so excited to announce that we are now officially on the market with our LDT test and only a short distance away from showing pivotal results in Eclipse and filing for FDA approval. Starting with our SHIELD LDT test launched this past Monday on slide 10. This is truly a seminal moment for the garden and the availability of the SHIELD test represents a major milestone in our commitments to transform cancer screening. We have developed highly sensitive technology to detect early stage cancers with a simple blood draw. We are pleased to report the following performance metrics. Overall sensitivity of CRC detection of 91% at specificity of 92%. Specificity of 94% in screen negative normals, which excludes early adenomas. Early stage sensitivity of 94%, stage 1 sensitivity of 90, and stage 2 sensitivity of 97%, and advanced adenoma detection of 20%. The clinical performance of the SHIELD assay was validated using a set of 309 patient samples, including 92 with CRC, 51 with advanced adenomas, and 166 normal cases. CRC patient samples were accurate across six unique cohorts collected in the US, Canada, and the EU. And samples with advanced adenoma and normal cases were collected in the US, mainly from the same colonoscopy sites participating in the Eclipse trial. Subjects were balanced by age, a mean of 64 years old, and gender. If the Eclipse readout is close to our LDT performance, we are confident that SHIELD will become the leading non-invasive CRC screening methodology. Turning to slide 11, the recent LDT validation results are shown together with prior studies that we have recorded in past conferences. This demonstrated for the stability of overall sensitivity, early stage performance, and specificity. Moving on to slide 12, one notable item is the assay's performance in advanced adenoma detection. This is the result of a new R&D pipeline that was ramped up over the past year using a proteomics approach. It has yielded solid results in providing advanced adenoma detection and also adds a slight boost to early-stage CRC sensitivity. we were able to include this upgraded technology into the assay we are using for Eclipse. We believe our SHIELD blood test has the potential to be much more effective in reducing CRC mortality and adding more life years gain than any other stool-based screening test. Throughout the history of GARDENS, we have dealt with several skeptics who claim that blood tests cannot add value in oncology. And every time, they have been proven wrong, and liquid biopsy shows it can in fact transform precision oncology. Current recommendation of USPSDF on CRC screening strategies are based on models that assume 100% adherence. We've seen studies with real-world evidence showing much lower adherence rate for school-based tests versus blood-based tests. In a peer-reviewed publication shown in slide 13 from Harvard Medical School in 2019, the effectiveness of different CRC screening tests were modeled under the assumption of 100% adherence rate and compared to reported real-world adherence rates in this publication. On the left-hand side in this chart, assuming 100% adherence, 5th DNA with 3-year interval and 6th with 1-year interval, averted 42 to 45 CRC cases and 25 to 26 CRC deaths. Clonoscopy, 46 cases and 26 deaths, and Step 9 with 3-year interval, 35 cases and 23 deaths per 1,000 individuals. The right-hand side is assuming reported real-world adherence. SEP9 averted 30 CRC cases and 19 CRC deaths. Clonoscopy, 34 cases and 20 deaths. FIT DNA and FIT, 16 to 25 cases and 10 to 16 deaths per 1,000 individuals. It's interesting to note that SEP9 demonstrated superiority in adherence-adjusted effectiveness despite its low performance of 68% CRC sensitivity, 22% mass adenoma sensitivity, with only 80% specificity. The key takeaway here is that with real-world adherence levels, stool-based testing would need almost perfect performance to match the effectiveness or clinical benefit of blood-based tests. Therefore, we believe our SHIELD blood tests has the potential to have a higher benefit assessment by USPSDF than any other stool-based screening test. Turning to our Eclipse trial on slide 14. The patient journey in Eclipse is broken into multiple stage gates. On our last learning stall, we shared our progress with patient enrollment and collecting colonoscopy and pathology reports to reach our target number of confirmed CRCs. We have designed a study to receive a certain level of positive CRC reports, and we are still waiting on a number of those to come in. At this point in time, delivery of pathology reports from the centralized pathology review board has been slower than we expected. We are doing everything we possibly can to accelerate this as quickly as possible. We now expect the readout for Eclipse to be in the second half of the year, with the September-October timeframe as the likely case. We have already started our modular submission to FDA and are planning to submit our PMA application by end of the year, ending successful eclipse readout. We believe we will be the first to have a blood-based cancer screening test with Medicare coverage and FDA approval. We have the opportunity to secure ADLT status for this test, and with TAMA, we are confident that we will be able to secure Medicare pricing of over $500. We are clearly operating in a very different environment than eight years ago, and I'm confident about our pricing strategy. We expect this test to reach favorable long-term gross margins of around 60%. Through sales and marketing efficiencies powered by higher adherence and patient-free press for blood testing, we believe we can be a profitable company within a couple of years following USPSTF guideline inclusion. Moving on to slide 15, colorectal cancer screening is just the start of this journey. We will soon expand into multi-cancer screening, including lung, pancreas, and others, where we believe cancer screening can save lives. Recently, at the American Association for Cancer Research Annual Meeting, we presented new data demonstrating the ability of our next-generation SHIELD multi-cancer assay to accurately detect early-stage cancers. This assay is designed to analyze approximately 20,000 epigenomic biomarkers that are informative for detection of a wide range of solid tumors in a single blood test. The data for four cancer tests were demonstrated as examples for the rectal, lung, pancreatic, and bladder. In addition, the blood test identified the tumor tissue of origin with high accuracy. By adding new indications to our blood test, the test benefit and the resulting life-year gain should further improve. Once commercially available, this indication expansion will be a major catalyst for our SHIELD assay. We believe SHIELD will be the patient's preferred CRC screening method at launch, and that indication expansion will even further accelerate adoption relative to stool-based tests, completely transforming the screening market from what it is today. With that, I will now turn the call over to Mikey. for more details on our financials on Outlook for 2022. Thanks, Amir Ali. Turning to slide 16, total revenue for the first quarter of 2022 was $96.1 million, up 22% from $78.7 million in the prior year quarter. Total precision oncology testing revenue for the first quarter was $84.1 million,
spk02: This increase was driven by strong year-over-year growth in both clinical and biopharm sample volumes. Precision oncology revenue from clinical tests was $66.0 million, up 32% from $49.8 million for the prior year quarter. First quarter clinical test volume was 27,100, which is an increase of 47% from the same period of the prior year. After the COVID peak at the start of real, tissue, and extra response, and we expect volume from these products to continue to increase as we progress throughout the year. For the first quarter of 2022, the ASP for Gardner 360 was in the 2600 to 2700 range, which is consistent with the last few quarters, and the blended clinical ASP was approximately 2450. While we expect Gardner 360 ASP to be stable in 2022, the blended clinical ASP will continue to be impacted as reimbursement of new products will take time to ramp up. We were very pleased in the first quarter to receive Medicare reimbursement for Tissue Next at $2,920, but as a reminder, we don't expect our new products to start to significantly contribute to revenue until they receive Medicare and private payer reimbursement. Precision oncology revenue from biopharma tests in the first quarter totaled $18.1 million, up 30% from $13.9 million for the prior year quarter. Biopharma volume was strong, with first quarter samples totaling 5,100, which was up 45% from the prior year quarter. Note that volume was 23% lower than the fourth quarter of 2021 due to the positive seasonality in the biopharma business that we encountered towards the end of each calendar year. Biopharma sample A has been the first quarter, was approximately $3,600, down 10% from the prior year period. in line with the fourth quarter of 2021 due to a similar product mix. Development services and other revenue in the first quarter totaled $12.0 million, down 20% from the prior year quarter. Compared to the fourth quarter of 2021, development services and other revenue was down 38%, primarily because fourth quarter 2021 revenue included royalties for the eight-month period from May to December, whereas first quarter 2022 revenue included royalties from the three-month period, January to March 2022. For the remainder of 2022, we will continue to recognize royalties on a quarterly basis. As we have previously highlighted, while we continue to see strong demand for our development services, several companion diagnostic projects were successfully completed in the second half of 2021. And as such, we expect that our quarterly development services revenue will be lower than prior year for the next few quarters as new projects take time to ramp up. Gross profit for the first quarter of 2022 was $64.1 million compared to a gross profit of $49.9 million in the same period of the prior year. Gross margin in the first quarter was 67% compared to 63% in the prior year quarter. The change in gross margin is primarily due to development in the first quarter of 2022. Operating expenses for the first quarter of 2022 were $187.5 million, an increase of 19% compared to $157.8 million in the first quarter of 2021. Non-GAAP operating expenses exclude stock-based compensation and related employer payroll tax payments, acquisition-related expenses, amortization of intangible assets, and contingent considerations. Non-GAAP operating expenses for the first quarter of 2022 were $158.7 million, a 58% increase from the $100.7 million in the prior year quarter. This increase was driven by the significant investments made over the past 12 months in our commercial infrastructure and in the continued development of our product pipeline. we will continue 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 will be focused on the commercial launch 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. Net loss $123.2 million or $1.21 per share for the first quarter of 2022 compared to $109.7 million or $1.09 per share in the first quarter of 2021. Non-GAAP net loss was $93.2 million or $0.91 per share for the first quarter of 2022 compared to $49.4 million or $0.49 Adjusted EBITDA was a loss of $86.6 million in the first quarter of 2022, compared to a $45.4 million loss in the first quarter of 2021. We define adjusted EBITDA as non-GAAP securities. We feel we have a strong cash balance that can support our ongoing operations for the foreseeable future and which gives us flexibility to continue to invest in our business to drive robust future growth. As a reminder, we previously shared our decision to Now turning to our revenue outlook for the full year 2022 on slide 17. We continue to expect revenue to be between 460 and 470 million dollars representing growth of approximately 24 percent over 2021 at the midpoint. As a reminder embedded in this guidance range are a few key assumptions. First we expect clinical oncology sample volume for the full year 2022 to grow by more than grow by at least 30%. As a result, we expect precision oncology testing revenue to grow more than 35% over the prior year, with higher growth expectations for the second half of the year versus the first half due to the reduced impact from COVID and improved reimbursement of new clinical products. Second, we expect development services and other revenue to be approximately $50 million for 2022. Finally, while we are excited about the launch of our Shield LDT test, we are not expecting significant revenue contributions from it this year. We are continuing to make great strides across our business, 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.
spk15: At this point, we will now open it up to questions. Thank you.
spk13: If you'd like to ask a question, please press star followed by 1 on your telephone keypad now. If you'd like to withdraw your question, please press star followed by 2. When preparing to ask your question, please ensure your lines are muted locally. Please note that we'll only be taking one question and one follow-up from each person. Our first question comes from Puneet Sudha of SVB Securities. Puneet, your line is now open.
spk18: Okay, great. Thanks, guys. Thanks for taking the question. So first one, primarily on the stage one and two performance for Shield CRC screening, that was remarkable at sort of the 90 and 97% that you had, obviously well ahead of anyone that, I mean, anyone was expecting sort of that number. And, you know, if I look at that performance, I mean, do you expect, the main question from investors at this point is really, do you expect that data to hold up in the Eclipse trial? I know it's sort of hard to speculate and you've given a number of points around validation study and cohorts and some of the samples from the Eclipse side, but does this give you enough confidence that the performance on the sensitivity side is going to hold?
spk04: Thank you, Puneet. Obviously, we are very excited with this Shield LDT launch and you know, the fact that performance across independent cohorts, some of the samples actually we are running obviously for the first time, and especially for these sample sets, you know, on the CRC side, the samples came from United States, Canada, Europe, the data is holding up on the early stage. We continue to see reproducibility on the assay over time, over different reagent batches, all the things that basically could contribute into technical variation of the assay. We are very pleased with that. And on the specificity side, the samples are even much, much, much closer to actually what we expect in Eclipse. As I mentioned, In fact, some of the samples came from many sites who majority of them are contributing, in fact, in the Eclipse trial. So in terms of expectations, still the same that I always mention. I think so far what we've seen on the early stage side, you know, high 80s, low 90s, and now we'll see what Eclipse is going to have for us. On the specificity side, samples are much, much closer to really intended use statement now. So I think we have a very good understanding of specificity at this time.
spk18: Okay, that's great. And just to follow up on that, thanks for really clarifying the modeling and the questions that have been raised around sort of the USPSTF and potential coverage after USPSTF. But just to boil down that modeling study that you showed, I mean, is it safe to say if the sensitivity of liquid biopsy is strong, obviously the ease of use of a simple blood draw is strong, and the sort of the performance that you're seeing at sort of the 90% sensitivity, 92% specificities, that even at 20% advanced adenoma data, and I appreciate that that had some more larger confidence interval around it, But even with the large confidence interval, as long as USPSTF is modeling it and including the adherence adjusted, that you have no doubt that this would be covered by commercial payers. I just want to be clear on that point. Thank you.
spk04: So our current understanding based on, you know, everything that we look at, in fact, actually it's interesting. You look at 2021 USPSTF, some of the, you know, writings from that, the committees, but, you know, you know, it's the awareness is there that adherence is obviously a parameter. It has not been, you know, always in, you know, fit and, you know, you know, whole of our kind of models. It's been, you know, I assume adherence is like a hundred percent, but they know that an event they reference based on real world experience, obviously adherence is not a hundred percent. We wouldn't have the issues we are dealing with. Probably you don't need any blood tests. You know, there were not issues with patient preference and adherence so that's why everybody is well aware of this and now uh you know we we need to do our work to make sure we continue to you know publish papers on the modeling and show the importance of adherence which is the reality of the business we are running you know that's the way to save lives to make sure patients would comply and adhere to these kind of tests year after year in terms of like the know if every three years for instance they need to do the test they need to test on us the impact of it with a life year again would go down so uh it's notable that it's not that we need for sure to have you know adherence in the model in order to show positive uh life year kind of gain and contribution in this field like all these kind of tests with the performances that we are talking about based on our assessment and over time you're going to show our understanding of models you know over time in different conferences that we are going to talk to you guys you know they are close by when you add actually adherence i think the delta becomes significant based on our understanding that it's almost like school-based that need to detect everything in order to with these lack of compliance and adherence to really have similar kind of life game contribution to patient population. That's our current understanding at this time.
spk13: Perfect. Our next question comes from Dan Arias of CIFL. Dan, your line is now open.
spk17: Yeah, hi, guys. Thanks for the question. Merely, just to maybe follow up on that, can you just kind of recrystallize what you said clarify whether you think that real-world adherence will be considered as the USPS-TF guideline consideration, and that you think that that is what will drive a three-year interval for the test rather than a one-year?
spk04: Yeah, sure. You know, these models actually is parameters that goes into models. Actually, they are kind of public information. You can just solve those modelings, in fact, and kind of see what goes into it. Adherence is a parameter there. And, you know, it's been noted that so far when they looked at school-based tests, since in all of them in terms of adherence, they have similar ballpark kind of issues. That's our kind of, at least, assumption why they haven't really looked at the adherence in a meaningful way. You know, everything just model went simple like 100%. Versus when we are talking about a new mode of screening that, you know, it's the main that, hey, this is a patient-referred blood-based test with the potential for much higher adherence, much higher compliance, obviously that needs to be a factor. And for sure it's a parameter in the models, but so far it's been used just as a kind of a placeholder 100%. And as I mentioned, if you look at 2021 write-ups, they say even that, you know, renal adherence is not 100% based on some real-world evidence. they've done, they went with that single assumption.
spk17: Yeah, okay. And then can you maybe expand a little bit on cost and the COGS associated with SHIELD and then how that aligns with the economics of testing either on an annual basis or a three-year basis? And then, you know, along those lines, the extent to which you just think you achieve price competitiveness with some of the other tests that are on the market. Thank you.
spk04: Yeah, we are confident about our pricing strategy that, you know, it's clear based on NCD, obviously, that, you know, it's going to be three-year pricing. You know, we, after FDA approval, you know, we are going to be qualified. You know, we expect we are going to be qualified as ADLT post-FDA approval. And, you know, the pricing advantages that you get with ADLT and, you know, the way the pricing gets set up, I think that's a great upside for our site. And then the Medicare pricing historically in diagnostics has been an early indicator of some of the conversation with private payers in terms of price anchoring for some of the private payers. And there are a bunch of stories around that and how the Medicare pricing helped with those negotiations. And in fact, some private payers who kind of had pricing issues there are stories of how companies actually handled it. So I think this favorable PMA, PMA, HAPA kind of rate, which is going to come as a result of ADLT for this test, hopefully successful FDA, would really set the top line. But if you go with the assumption that our long-term RASP is going to be just $500, we are building this assay and our operation in such a way that with ASB of $500, we are going to have 60% plus gross margin. And we know that's possible. In fact, the way chemistry works, the way process engineering and investments we've done so far would show us that at scale, we can get to those COGS points. And we are going to help TPNL with 60% margin, even if you just go with $500 pricing.
spk15: Perfect.
spk13: Our next question comes from Jack Meehan of Nephron Research. Jack, your line is now open.
spk11: Thank you. Good afternoon. Wanted to move over to the oncology side of the business, start with Garnt Reveal. I was wondering if you could provide an update, just how the discussions are going with Moldiacs around potential reimbursement for that test?
spk08: Yeah, I mean, we've asked, we've essentially submitted everything that they've, you know, requested, and we're just waiting right now on kind of their feedback on that information. So, nothing there to, nothing new to report at this point. Okay.
spk11: And, you know, if I look, so the 27,100 clinical tests in the quarter, you know, I just kind of triangulate based on the ASP commentary Mike laid out, it seems like you had about 2000 or so all other tests beyond GARN 360 in the quarter. Is there any way you can just provide a little bit of color, you know, around, you know, like what's the largest within there between reveal tissue next or response and, you know, then off that, how does the reimbursement work for tissue next? Have you started getting paid for that yet?
spk02: Yeah, I think, firstly, on Tissue Next reimbursement, yeah, we received the positive coverage in Q1, so I think we'll expect to be able to recognize revenue from the Medicare side of things in Q2 going forward. And then, you know, for the volume, I think, Your numbers probably are a little bit short on the new products. I think we've seen really good traction across the board. Without breaking them out, I think it's fair to say that Garden Reveal is really ahead on those new products, and that's because it's been on the market for just over a year now. The other products were launched in the middle of last year. But again, we've seen really solid traction. We're really pleased with the volume, both on the core Garden 360 business
spk13: um but also yeah with the new products and so really strong year-over-year growth that we've seen on the volume thank you mike thank you our next question comes from tejas savant of morgan stanley tejas your line is now open hey guys this is edmund on for teachers thank you for taking the questions um the first question
spk07: On the new version of the SHIELD test, it requires less depth of sequencing, and obviously the price of sequencing per GB has gone down with the emerging players and Illumina's new chemistry. So I was wondering, to what degree will these two factors, the less depth of sequencing and the lower price of sequencing per GB, to what degree will that provide an offset to the margins for this product?
spk04: So in terms of our roadmap to get to that $200 price that I mentioned at scale, in fact, That's based on the current economics of sequencing dollars. You know, the sequencing part is a material part of our field of material, but not a big part of our COGS, in fact. That's why, like, what we need to deliver on that, you know, it's not a future activity. A bunch of stuff already happened, but we need to continue making progress is, in fact, on process engineering and automation versus reliance on new chemistry that would disrupt sequencing pricing to get to that cost if you know what you're doing in the field of ngs and you have some level of food experience that i'm happy with the type of caliber talent we have at garden uh sequencing can be run actually very efficiently in terms of the total cox planning so i imagine in fact future surviving actually screening tests would Majority of them would, in fact, heavily rely on NGS. And in fact, they could keep their COGS really under control in this market. So in short, definitely any single dollar saving for further sequencing cost reduction, we would take it in terms of gross margin improvement. But it's not that we need it in order to get to 60% margin at scale.
spk07: Got it. Thank you for that. And then a follow-up question. With the EPIC agreement, it's good to hear that the integration is going well, but how are you expecting this to impact ordering patterns? And specifically, with the inclusion of SHIELD, does this change expectations about its revenue contributions ahead of the FDA approval?
spk04: Do you want to start with the impact of that phase?
spk08: Yeah, I can start. We're very excited about this partnership. We think it's going to be a big boost to certainly our oncology portfolio as well as Shield down the line. Increasingly, as these tests become standard of care, being able to integrate in Epic and really have that ease of ordering, really removing sort of barriers and friction in terms of that process is going to be a big boost and a big catalyst for volume for years to come. Epic is one of a number of partnerships that we're exploring right now. And so we see a future where all of our products are very highly accessible across the electronic health record ecosystem. And then I'll let Nirali comment on kind of impact on CHILI.
spk04: Yeah, definitely. We are very excited about all the advantages in terms of workflow advantages when you're dealing with an EHR-EMR, which has such a high, relatively high penetration in our install base. And on the screening side, definitely we are heavy on electronic ordering even today based on LDT launch that we have a bunch of those stuff are operational which we're excited and we're excited that this EHR kind of connection would further make our customers happy in terms of ease of ordering in terms of revenue contribution you know I just refer back to what Mike mentioned that You know, mainly because of low ASPs before FDA approval, we don't expect material revenue contribution of SHIELD this year. But, you know, we are just very few days post-LDT launch, and we are pleased with what's happening just in a matter of few days.
spk07: Great. Thank you very much.
spk13: Thank you. Our next question comes from Derek DeBruin of Bank of America. Derek, your line is now open.
spk06: Hey, thank you. Thank you for taking the question. A follow-up on the last one, just on your commercialization plans and how you're going to roll this out, and also just to compare your plans based upon there's obviously another multi-cancer detection test that's out there as an LDT right now, and you sort of look at their approach on doing concierge and going after that. Could you just sort of talk about what your commercialization plans are, how you're going to do it, and sort of like what the costs are going to be and how much Salesforce you need? I think that's where we're getting a lot of questions from investors is just, you know, once you sort of be on the data, how do you get the commercial rollout and the costs associated with it?
spk04: Yeah, sure. Actually, AtGuard and our commitment is to make sure patient at all classes would get access to our shield product and definitely the business impact of it is we are after unlocking this 20 billion CRC screening market opportunity and the expansion that multi-cancer indication would give on top of that in order to really unlock that 20 billion opportunity and go after that 110 million, 120 million kind of patient population who are eligible for CRC screening, you need to have a path for reimbursement, guideline inclusion, and that's the path that we are taking. As a result, our commercial plan is very different than some players who are just generating access for their test. For a highly privileged individual who can just do self-pay, We have issues with it and we don't believe that's the path to unlock $20 billion opportunity. The number of patients who go into that category is obviously a tiny fraction of this 110 million. Now, in terms of commercial strategy behind this is obviously we are heavily engaging primary care physician, key hospital systems, and employers. we are in an LDT launch phase with about 100 people commercial team all in. And over time, we would expand it at scale to about like 700 people as we get closer and closer to the USPSDF guideline inclusion. So you can expect over time in a system, in a thoughtful way we would scale, obviously based on some of the additional information that we get in terms of getting closer to the FDA approval, getting closer to the USPSDF. Our plan is to have that in-house 700 to 400 commercial team. The way that this PNL is going to look different than I think maybe stool-based PNL is, you know, look, the patient preferences this blood testing, the adherence we expect to be much higher than stool-based testing. As a result, SNM efficiency per sample would be much, much higher. Now, combine this with 60% gross margin at least, even with ASD of 500, we think we are going to have a profitable garden a year or two right after USPSDF inclusion, guideline inclusion.
spk06: Great. Thanks for that. And just my follow-up question to this is, can you clarify why you pushed out the readout for Eclipse? Is it a pathology backlog, or... because you haven't hit enough CRC cases and need to enroll more patients? Could you just a little bit clarify that? I've got some investors that want a little bit more of an expansion on that. Thank you.
spk04: Thanks for asking that because there are a lot of stuff that's going well, execution, this excitement around it. I have to say, it's not great. We are waiting for this Eclipse readout to come out. I think it's going to be a defining moment for patients, for the whole industry. We work on this thing for years now. we are waiting for this thing to happen and we are doing our best to make sure we get to that point sooner than later. Now, in terms of the main contributing factors, like still we are waiting for, like, unfortunately the details of this trial operation is complicated and, you know, there is central pathology review that needs to look at all disease cases that we are finding in the colonoscopy cases. And there is still a few thousand cases in the backlog of that review that needs to happen. So based on the number of CRCs we found, the reports that we got, the backlog of that centralized pathology, and a bunch of stuff that we are doing to increase the productivity, but for such a regulated study that still that singular centralized pathology review is very important. Now we expect the readout to be second half. And the best guess is around September or October time frame. But we think now instead of mid-year, it's going to be sometime after. We are waiting for it. We are doing the best. Our team is on it. We are doing the best that we can. We are waiting for this thing to come. And we just need to now wait a little bit
spk15: Thank you.
spk13: Our next question comes from Kyle Mixon of Canaccord. Kyle, your line is now open.
spk03: Hey, thanks for taking the question. Congrats on the quarter. So just similar to the question before, just wanted to know if you could kind of walk through your confidence level that the AA sensitivity, the 20% from the sample on Monday, is that reproducible? Just given, you know, other screening products have seen degradation of over 15 percentage points, and so it's obviously going to be a big swing factor for FDA and so forth. And so just wanted to get your sense there. Thanks. That's all from me.
spk04: Yeah, sure. So, you know, the nature of my advice, you know, and that's the reason, you know, we have much lower number of samples for training and for this validation, much lower number of samples. It's like advanced adenoma cases need to come from colonoscopy session effectively, right? So the people who go to colonoscopy, so in fact, a fraction of these advanced adenomas are for the patient who are going like obviously through colonoscopy and we are getting blood sample from their colonoscopy. So in terms of really the clinical indication, I mean, it could not be like closer than this, terms of Eclipse. In terms of variation, I think it's just the confidence interval around this 20%. We have 51 advanced adenoma data that we are seeing like about 20% sensitivity. So when you look at the confidence interval around it, that's just the statistical variation. And obviously, Eclipse is going to quantify the exact sensitivity since we have already identified over 1,000 plus kind of advanced adenomas. We are going to have a like a very fine-tuned. So that confidence interval, we showed it in our LDT press release. I hope I'm not misquoting, but that confidence interval is from, I think, 12% to 32% when you go from 20% out of 51. But that's the issue of low-end. We just need higher-end advanced adenoma to figure out. In terms of degradation, I mean, these are coming from screening sites, effectively. same kind of advanced data analysis to a large extent.
spk15: Perfect.
spk13: Our next question comes from Mark Massaro of BTIG. Mark, your line is now open.
spk05: Hey, guys. Thanks for the question. There seems to be some sufficient confusion out there in the marketplace, but I wanted to just maybe get to the basics. You know, there was that CMS memo, January 2021, that specified that CMS would cover any blood-based test at sensitivity and specificity of 74 and 90, but it also cited a test interval of once every three years. So I guess, I know that's a CMS question, but do you have any doubt or material doubt that you can't obtain a once every three-year interval from CMS?
spk04: We don't have doubt about it based on everything that we know. So I think NCD is NCD. In fact, we know what's the bar of changing NCD. Is that like these stuff changing NCD? That's why typically CMS and CAG do not publish NCDs. The bar of changing NCD is, in fact, very high. So NCD language is very clear. I think one thing that maybe, you know, maybe I take this opportunity that maybe there is not also high awareness around it. Like, the way CMS looks at it, like, specificity of 90%, our understanding, in fact, is, like, they want to make sure the specificity is better than Cologuard, and that 90% is coming from 89.8% from Cologuard study when you exclude advanced adenomas. So, effectively, when you just look at specificity in completely negative samples. So when we are talking about our specificity numbers, like for instance, in this LDT, like it's not that 92% for LDT that includes some early adenomas. It's like when you exclude that. So in fact, that 90%, you know, the FDA or the final readout of Eclipse, let's say could be in fact a little bit lower, but the bar of 90% is that. So, and we feel based on the threshold that we set Hopefully we are going to get their everyday clips trial easily, but time will tell.
spk05: Great. I recently put out a survey where 75% of docs indicated that they were likely to order a new blood-based test even if it was not recommended by USPSTF. So I guess I would be curious if you think that that's reasonable relative to some of the survey work you've done. you know, there's been a lot of pushback about your 20% AA sensitivity. Can you walk us through how you think you can gain uptake? Notably, it seems like AA is not at the front in mind of many primary care physicians. It seems like it's FDA approval and overall sensitivity and specificity. But help us think about how you can get to a $500 price and get into USPSTF even if your AA is not above what Coal Guard is.
spk04: Yeah. So, actually, I think those may be untacted. They were maybe a few things at the same time. So, in terms of the PCP, you know, we talked about our market research, you know, and, you know, clear top thing for them is CRC performance, advanced adenomas still in terms of awareness of differentiation of different products. I think in mid to longer term, that could be a parameter, but those are research-based and we're just very few days into the market. I tell you what we are hearing today in very, very early days is in fact strong confirmation of what we've said so far. But again, this is just a three-day commercial activity, and maybe we can have the same conversation three to six months from today. We cannot be more pleased with actually what we are hearing from the market and confirmation of what we think would really drive the adoption of blood-based tests and how much market is waiting for such tests to come to the markets. That's the reality. In terms of the requirement for USPSC, if I try to cover it in the pre-per remarks, but the most important thing, they look at three things. One is clinical evidence. That's why we are doing Eclipse. Second, they look at benefits and harm. Lack of compliance is on top of many people's minds. So it's something that it's not that it's a high bar of education or awareness around that. Adherence, there is a good understanding. In fact, I mentioned it's a parameter in the modeling. So Based on our exercise that hopefully in the near future we can show the way the models are working in our hand based on what we've seen so far, you know, we are going to have a very positive life here again offered with liquid testing. We are in the ballpark of, you know, other tests, reasonable ballpark. And then when you include adherence, I think it's not even close. And I doubt if you're making mistakes. When you incorporate adherence, actually, the blood-based test shines very strongly with what we are talking about. So that's our current understanding of USPSDF. I think CMS and FDA recovered it before. The bars are kind of relatively very clear in terms of requirements and the precedents. And like the primary endpoint of our FDA studies, you can look at our clinical trial graph. It's all around CRC performance and advanced adenomyosis secondary binding in Eclipse trial. But we are excited with this performance that we've shown so far. That's why we even upgraded our assay with this latest and greatest asset that we have on the research side. And now we see what Eclipse is going to show us.
spk05: Thank you.
spk13: Our next question comes from Max Masucci of Cowen. Max, your line is now open.
spk14: Hi, thanks for taking the questions. Just a quick follow-up on Mark's question. I think the NCD states that it will provide coverage, you know, for any qualifying test, you know, either once every three years or at the interval designated in the FDA label if the FDA indicates a specific test interval. So just curious if you're expecting the FDA to recommend a specific interval when they rule on the Eclipse data, and if they do, you know, how that recommendation would play into USPSTF's eventual ruling on the test interval as well.
spk04: You know, based on actually what I know with the FDA, in the labeling kind of indication, interval testing so you know this is not our expectation in terms of like you know like for you know the experiences we have with other products like they don't get into interval testing of when or how or how often used let's say garden 360 cdx those conversations never even came up it's all around safety and efficacy of the treatment and now how often to use it there are some other elements including health economy kind of argument that comes to the picture and you know the added benefit of those tests your test relative to other tests listen you know the way we are looking in the mainstream is people know that lack of compliance is a major issue and people are noticing blood-based cancer screening can as a potential for tremendous population health benefits So people out there in mainstream are trying to help instead of trying to make sure blood-based screening test is not going to be something that the US citizen would get access to. So in fact, many stakeholders, like just look at this NCD, I'm not sure if ever has done to have a finalized NCD before anybody even qualifies for it. So I think there are many efforts in the field, in the mainstream, to make sure patients would get access to these live changing diagnostics, and we are very excited with that.
spk14: Got it. You know, USPSDF, obviously assuming 100% adherence in some of the models that support the recommendations, but they clearly acknowledge the importance of adherence in the real world. So if you're looking across healthcare advocacy groups, guideline bodies, regulators, reimbursement decision makers, which of those parties do you expect to be the biggest advocate for the use of adherence-adjusted modeling, especially when they're determining the role that your test could play in underserved populations and other individuals that are in lower-income areas.
spk04: I mean, it's our relationship, and we are excited with our partnership with multiple patient advocacy groups in this front. This is something that, again, like the whole mainstream and ecosystem is trying to Make sure, in fact, such game-changing, life-saving tests get out there successfully, and we can really increase compliance rates well over 80% with these kinds of devices, but high-sensitivity, high-performing devices, not just devices that the only thing they can do is late-stage detection, so it needs to be a right device, too. I think everybody on the mainstream and stakeholders and influencers are In alignment, there are some former USPSTF members that are in our advisory board. We are kind of discussing with them, brainstorming with them about strategy. And, you know, it's also on the top of the mind, I kind of make sense to them that obviously, you know, hey, you know, you have a good life here kind of again in terms of impact. And when you consider the reality of the problem today, which is the problem of compliance, problem of adherence, you know, when you incorporate those, like the model would clearly show you why blood can add value in a very tremendous way. So, because we have lack of adherence and lack of compliance. But it's not that that's the only way to get positive life-year gains shown in the model. But once you include it, you know, the delta, it goes in our blood favor in a very big way. Based on what we've done, the modeling so far, that hopefully in the near future, we will talk about it.
spk13: Thank you. Our next question comes from Patrick Donnelly of Citi. Patrick, your line is now open.
spk09: Hey, guys. Thanks for taking the questions. I'll just keep it to one. I know we're running a little late. Amir Ali, maybe just on the eclipse delay, just following up on the earlier question, just to be clear, it sounds like it's just kind of the review running long. You guys are still confident the sample size is correct? And then on the back of that, you know, how quickly can you turn the PMA submission around? It sounds like you're still confident that happens in 22, so the timeline on the FDA side doesn't sound like it's slipping. Just wanted to confirm that and, again, confidence level and the ability to turn that around relatively quickly. Thank you.
spk04: Yeah, so maybe I start from the last part of your question, and, you know, based on our planning, actually, we still believe we can submit our PMA package to agency this year. You know, there are a bunch of analytical clinical validation that stuff needs to happen and based on the reality of what's happening on the clinical side, you know, the project planning gets adjusted in terms of the kind of sequence of experimentation and so forth. So we feel that this year we can submit our final module or our PMA to agency. As I mentioned, we started the modular submission already. So if we are know the reviews started in fact for us for some of our early modules and in terms of the the timeline delay this is you know there are many things that we are executing great and this is something that you know obviously not good to see you know this is this is not something we are happy you know about you know obviously there are some stuff which is we are doing our best to increase the you know the what's happening in the centralized review board, which is outside GARDA, and the way to be to really go through this backlog sooner than later, but these are the details of complicated trial operation, and we are doing our best. We are on it to minimize this timeline delay. We need to get to our CRC number, the CRC number that we have in mind for this study to be powered, and we are still few more to go. So we are few more to go and we have to go through this backlog and then we see. So yeah, many things we are executing very nicely and I'm very excited, but this is something that really it's not good. But we are on it and we are doing our best to rectify and get this data as soon as possible. I think all of us are waiting for this for so long.
spk13: Thank you. Our next question comes from Julia King of JP Morgan. Julia, your line is now open.
spk01: Hi, good afternoon. So maybe just a quick follow-up on SHIELD. I know you made a very clear point about the importance of compliance in terms of guideline reviews. How much importance do you think USPSTF will put on AA performance? and i assume that you know you talked about using an improved version of the assay for this you know latest study so i assume there are additional levers you can pull to further enhance the aa performance as well just you know wondering if you can get any color in terms of the theoretical you know how much theoretical improvement potential there is for a performance yeah so actually we
spk04: We are pleased with where we are in terms of the current region of the test. CRC, like we worked on it all along, like many samples, like the performance, like even close to even what we've seen so far, gets validated with Eclipse, with the advanced adenoma performance that we've shown. We believe we are going to have a leading, you know, test for colorectal cancer screening in terms of number of cases that in long term are going to be ordered, we think our test would be the preferred and leading assay. Having said that, you know, is this the best? And there is no way to kind of improve the test in terms of advanced adenoma performance. I cannot make that claim. In fact, I tap into Garden360 experience like the way the test was eight years ago versus today. There are a bunch of performance improvement. One advantage of having multi-cube, you know, sample collection from Eclipse is around test versioning and potential upgrades, but I, you know, we think what we've seen with LDT, if it gets confirmed with Eclipse, we are kind of in a very good shape. In terms of USPSTF, so it's a complicated multi-factor model. CRC sensitivity plays a role. You know, the advanced adenoma detection plays a role. Even early stage adenomas in terms of detection play a role there. Adherence and compliance and follow-on kind of played a role, and I think we talked about it. So once you add the adherence, like I think blood-based tests, we believe it's going to have much higher even life here again, safe versus any stool test out there.
spk15: Our penultimate question comes from Matthew Sykes of Goldman Sachs.
spk13: Matthew, your line is now open.
spk16: Hey guys, this is Dave on for Matt. Congrats again on the Shield launch. Can you give us an idea of the order of magnitude of Shield volume you expect next year? Looks like the one multi-cancer screening test in the market is expecting around 80 or 100,000 tests in its full year.
spk04: So maybe actually give us some time for the next year guidance, I can tell you that actually what you're seeing in the very few days of this March is actually a lot more than what we expected so. But we have to see like you know, even based on what we see looks like there's been bunch of underestimation of what's the input, even with this such a limited commercial team so but we are not ready at this time to talk about. Next year guidance for sample volume on SHIELD. This is very new for us, so we need to understand this better. But so far, so good, I can say. We will keep you posted.
spk16: Got it. Thanks. And can you tell us a little more about how you arrived at the $900 cash pay price?
spk04: yes so you know obviously we talked about the value of the test and for the people who are going to actually offer some cash pay this we need to establish a list pricing and this cash pricing would be something which is going to be important in terms of the track record of payment for us when we go to the adlt and pricing for adlt post fda approval so we are setting some groundwork for So please stay tuned.
spk16: Great. Thanks, guys.
spk13: And our final question comes from Brian Weinstein of William Blair. Brian, your line is now open.
spk00: Hey, guys. Thanks for taking the question. I was just going to ask you about that pricing question as well. It is a substantial premium to CovoGarden. I just was thinking through that. And thinking through with the ADLT, obviously, we'll get reviewed on that pricing based off of what you're seeing on the private side. Do you expect that you will be able to contract with private payers ahead of inclusion in quality metrics? And then I'll just ask the second one right now, just because it's a short one in the name of time. Do you guys expect that there will be any kind of FDA panel review for this, given this is kind of a a new class, and we're going to have, I think, three or more that will be coming within kind of a short period of time. Thanks.
spk04: Maybe again I start from the last part of your question, Brian. So in terms of panel review, the FDA decision on what they want to do, but I don't agree three, four devices will come at the same time. In fact, what we know, we are going to be at least quarters away from anybody else trying to submit their package. So just the notion that there would be multiple submission at the same time and joint review, you know, even for 360 CDX that we got approval with foundation one liquid, like a month away from each other, I didn't experience that kind of notion of parallel review for a brand new liquid biopsy for treatment selection by agency. So we cannot comment on a bunch of, I think maybe to some extent, random statements that's coming to our market from different angles. So in terms of actually reimbursement expectation, you know, it's the reality is FDA would enable CMS coverage, Medicare coverage shortly after, obviously, it would be able to ask for Medicare Advantage coverage. There's always some early payers that actually would jump on it post-Medicare. There is, I think, some payers that would jump on it post-potential ACS guideline inclusion. But in reality, the default expectation would be many of the private payers would jump on this sheet right after USPSTF guideline inclusion. So that's our expectation at this time.
spk15: Great. Thank you. At this time we have no current questions and therefore this concludes today's call.
spk13: Thank you all for joining. You may now disconnect your lines.
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