Veracyte, Inc.

Good day, and thank you for standing by. Welcome to the VeriCite Third Quarter 2024 Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone, and you will hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Shayla Gorman, Senior Director of Investor Relations. Shayla, you have the floor.

Good afternoon, everyone, and thank you for joining us today for a discussion of our third quarter 2024 financial results. With me today are Mark Stapley, VeriCite's Chief Executive Officer, and Rebecca Chambers, our Chief Financial Officer. VeriCite issued a press release earlier this afternoon detailing our third quarter 2024 financial results. This release and a business and financial presentation are available in the Investor Relations section of our website at verisite.com. Before we begin, I'd like to remind you that various statements we make during this call will include forward-looking statements as defined under applicable securities laws. Forward-looking statements are subject to risks and uncertainties, and the company can give no assurance they will prove to be correct. Additionally, we are not under any obligation to provide further updates on our business trends or our performance during the quarter. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that VeriCite files with the Securities and Exchange Commission, including VeriCite's most recent forms 10Q and 10K. In addition, this call will include certain non-GAP financial measures. Reconciliation of these measures to the most directly comparable GAP financial measures are included in today's earnings release accessible from the IR section of VeriCite's website. I will now turn the call over to Mark Staffley, VeriCite CEO.

Thank you, Shayla, and thanks everyone for joining us today. Q3 marked another record quarter for VeriCite. I couldn't be more proud of our team and of their hard work on behalf of the patients we serve. Q3 revenue totaled $115.9 million, growing 29% year over year. This was fueled by testing revenue, which grew an incredibly robust 34% compared to the prior year period, driven by strong volume and ASP improvements, both of which continue to outpace our expectations. Q3 represents our ninth consecutive quarter of 25% or greater testing revenue growth, demonstrating clearly the durability of our testing portfolio. Throughout this year, we have shared our confidence that a firm and Decipher will continue to deliver outsized revenue growth over the next number of years, bridging to our long-term strategic growth drivers, and the trends we observed this quarter reinforce that we are on a solid trajectory. Starting with Decipher, we delivered a record 21,250 test during the third quarter, up 36% year over year, with growth across all NCCN localized risk categories. With the updated NCCN guidelines in place, our incredibly productive urology sales force, consisting of around 50 reps, is driving adoption through awareness and education on the test utility and market-leading clinical evidence. Decipher's clinical validity and utility has already been demonstrated in approximately 85 clinical studies, and over 120 additional publications have focused on data from Decipher Grid, our research use-only platform. In the third quarter alone, there were 14 publications, abstracts, and presentations utilizing Decipher prostate or data from Grid. Generating clinical evidence for Decipher remains a top priority for us to drive further guideline inclusion, durable reimbursement, and increased test differentiation in this under-penetrated market. To that end, in early October, new data was presented at AstroAid 2024, the annual meeting of the American Society for Radiation Oncology from the Van Dam trial. Data from this prospective clinical trial shows that the Decipher prostate genomic classifier accurately predicts aggressive prostate cancer among African-American men with early stage disease. This population is over 70% more likely to be diagnosed with prostate cancer, and more than twice as likely to die of the disease compared to -African-American men, according to the American Cancer Society. Despite this, few prospective studies have specifically sought to examine the disease at a genomic level in such patients. The Van Dam findings confirm that use of the genomic test in this population could potentially enable better treatment decisions and outcomes, helping to reduce outcome disparities, something which our industry needs to embrace. Enrolling diverse patients in our clinical trials is key to this effort, and we proactively try and ensure the inclusion of often underrepresented populations, which is something we are passionate about. We'll afford to share more on our philosophy and approach in our ESG report, which we plan to publish later this year. Another important study was recently presented at the ESMO 2024 Congress in Barcelona, where new data from Stampede, a phase three randomized multi-centum, multi-arm clinical trial supported by Cancer Research UK, was shared. This study was focused on the metastatic population, an incidence group that has risen by about 5% each year since 2014. Studies have shown that adding the chemotherapy dositaxel to standard of care androgen deprivation therapy can improve outcomes for some patients with metastatic prostate cancer. However, the benefit varies from patient to patient, and dositaxel can negatively impact quality of life for many patients. Today, physicians can use tumor volume as a blunt tool to identify who will likely benefit from the drug. The Stampede findings demonstrated quite profoundly that Decipher may be a more precise tool to distinguish patients who will receive the greatest benefit from dositaxel and those who won't. This could help patients avoid unnecessary toxicity while helping to determine the best treatment path for those who will benefit the most. This is the first major study highlighting the significant utility of Decipher as the only predictive gene expression biomarker for metastatic patients that could positively impact care and quality of life for men living with advanced disease. With the recently finalized LCD covering Decipher's use in the metastatic setting, we believe we have the only prognostic gene expression test able to address the entire prostate market, including metastatic patients. We are currently underway with the next step of enabling Medicare reimbursement for this additional indication by following the technical assessment process, which we expect will be finalized in late 2024 or early 2025. With sales training planned for Q1, we are excited about metastatic as a potential growth driver for 2025 and beyond, as we expect to see revenue for this indication start to ramp in the back half of next year. With the expansion of Decipher into this broader patient population, as well as significant greenfield opportunity ahead for our test in localized disease, we expect to see continued meaningful growth for the foreseeable future, driven by both market penetration and share expansion. Moving to Affirma, volume growth continues to be impressively strong. During Q3, we delivered close to 15,100 tests, up 12% from the prior year period. Our endocrinology sales force of close to 50 reps has done a tremendous job of driving the durable adoption of Affirma. By sharing the differentiated level of evidence for the performance of the test, alongside the ease of use for physicians, we've made strides in both share and penetration into the long tail of physicians who did not use a molecular diagnostic previously. Also this quarter, the expanded LCD for Affirma went into effect, adding reimbursement for Medicare and Medicare Advantage patients with Bethesda-5 thyroid nodules, or those that are suspicious to cancer. This is an immensely helpful outcome for this patient population, and further supports our continued leadership in the field. While the impact to revenue this quarter was minimal, given the end of July effective date, we expect this to be a moderate ASP tailwind in 2025. Taking into account the momentum we have driven in 2024, as well as the expanded indication, we expect Affirma to continue to demonstrate strong growth of high single digits next year. With unwavering demands for Decipher and Affirma, as well as positively shifting market dynamics, our confidence in delivering robust revenue growth over the course of the near and midterm has never been stronger, and we couldn't be happier with our execution of the first two of our five strategic imperatives, namely to expand Decipher's market size penetration leadership position, and to deliver continued strong Affirma growth. These will, we believe, bridge us through our exciting additional three long-term growth drivers. One, to launch IBD products for patients globally. Two, to serve more of the patient journey through our expansion into minimal residual disease testing, or MRD. And three, to solve new cancer challenges, such as with our novel perceptor nasal swab test for patients identified with a lung nodule. Critically, to balance our investment in innovation as detailed by these five strategic imperatives, we also regularly assess the prioritization of projects to ensure the appropriate level of investment, while also delivering a differentiated financial profile. As a result of this, we made the difficult decision to pause offering the Invisia CLEAR test at the end of this year. While we always aim to put patients first, the low penetration of the test in this uncommon disease category, and the life cycle management it would require, including continued clinical evidence development, led us to conclude that we need to focus on our other imperatives for now. Turning to those innovative long-term growth drivers, I'll share an update on our effort to serve more of the patient journey through MRD and recurrence testing. We are progressing well towards our launch of an MRD test in muscle invasive bladder cancer, or MIBC, in the first half of 2026, including efforts to secure reimbursement through Medicare and readying our laboratory and operational processes. We continue to be very encouraged about the clinical utility of MRD for MIBC, using our whole genome approach. A study recently published in European Urology shows that a WGS-based analysis of cell-free DNA allows for ultra-sensitive CT DNA detection in patients with MIBC. Importantly, the study demonstrated a mean lead time of over four months between detection of clinical recurrence based on the test, compared to radiographic imaging. Such critical time savings have the potential to accelerate time to treatment and improve the current clinical management of patients. We're excited about the opportunities ahead for MRD. As we have said, while patients with MIBC represent our initial intended use population, given our sales channel and the reimbursement pathway, this is not a single product assay, it is a platform. We plan to expand into other indications, and you can assume that would include the ones where we already have a presence. In closing, Q3 was another exceptional quarter, and there is a long runway of opportunity in front of us. We are primed to continue to deliver robust revenue growth in our core business, and we have a number of key catalysts ahead that will expand our care across the patient journey. My sincere thanks to the VeriCyte team for their relentless focus on our mission to serve patients. It is their hard work that sets us apart as we continue to transform cancer care for patients around the world. With that, I will now turn to Rebecca to review our financial results for the third quarter and our updated outlook for the remainder of 2024.

Thanks, Mark. Q3 was another excellent quarter with $115.9 million of revenue, an increase of 29% over the prior year period. We grew total volume to approximately 39,000 tests, a 20% increase over the same period in 2023. Testing revenue during the quarter was $109.5 million, an increase of 34% year over year, driven by decipher and a firmer revenue growth of 48% and 19% respectively. Total testing volume was approximately 36,800 tests. Testing ASP was approximately $2,975, which included approximately $3.5 million of prior period collections. Adjusting for the impact in the quarter, testing ASP would have been approximately $2,875, up 7% compared to the prior year period. As Mark mentioned, we expect to continue to generate strong testing revenue growth in 2025 while absorbing an approximately $6 million headwind given our Invisia portfolio planning decision. Turning to product, third quarter volume was approximately 2,200 tests and revenue was $3.2 million, down 21% year over year as we continue to work through supply challenges. Given we are currently managing demand, our Q4 and 2025 product expectations are muted. Bio Pharma and other revenue was $3.1 million, down 23% year over year. Moving to gross margin and operating expenses, I will highlight our non-GAAP results. Non-GAAP gross margin was 71%, up approximately 130 basis points compared to the prior year period. Testing gross margin was 74%, up approximately 10 basis points compared to the prior year period. Product margin was 44%, up from 39% in the prior year period. Bio Pharmaceutical and other gross margin was 3%, down year over year due to lower fixed cost absorption. Non-GAAP operating expenses were up 11% year over year at $57.6 million. Research and development expense increased by $3.9 million to $16.1 million, given personnel additions from our C2I acquisition and increased costs related to our development projects. Sales and marketing expenses declined by $0.8 million to $20.8 million given the Invisia sales force reduction performed earlier this year, partially offset by hiring across a firm and Decipher. GNA expenses were up $2.8 million to $20.7 million, driven by infrastructure investments and other personnel costs. Moving to profitability metrics, we continued to demonstrate strong results. We recorded GAAP net income of $15.2 million and delivered adjusted EBITDA of $27.3 million, or 24% of revenue. We generated $38 million of cash in the quarter, driven primarily by 30 million of cash from operations and ended Q3 with $274.1 million of cash and cash equivalents. Looking forward, we are excited to raise our 2024 total revenue guidance to $442 million to $445 million from our prior guidance of $432 million to $438 million. This reflects an improvement in our testing business outlook with revenue growth expectations of approximately 28% as compared to the prior guidance of approximately 25% and our original guidance entering this year of 13 to 15%. We are also raising cash guidance and now expect to end 2024 with between $280 million to $285 million in cash, cash equivalents and short-term investments, taking into account approximately $10 to $15 million in milestone payments and capital expenditures forecasted in the fourth quarter. Additionally, with the profitability we've achieved year to date, we now expect full year 2024 adjusted EBITDA margin to be slightly more than 20%. This year has been nothing short of fantastic across our financial metrics. We have delivered incredibly strong testing revenue growth, profitability and cash generation. I look forward to carrying this momentum into 2025 as we work towards our vision of helping cancer patients globally. We'll now turn to the Q&A portion of the call.

Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, you'll need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while I compile the Q&A roster. Our first question comes from Subu Nambi with Guggenheim Securities. Subu, go ahead with your question. Hey guys,

thank you for taking my question. First, the high level question. You join, Mark, you joined their site as CEO three years ago. It had been a tough period for the group. During this period, you have transformed the leadership team and together with that team, you have succeeded in being emblematic of the Diagnostics 2.0 era, driving revenue growth, with solid science, moving towards FCF and margin expansion. As you think about 2025 and beyond, what comes next? Is it more of the same, which of course will be good, or are there other legs to the stool that remains to be unveiled? And then I have a follow-up.

Great, thanks. We appreciate the question and your summary of the last three years. You know, we started with obviously a strong foundation. We put three companies together. We did a lot of portfolio analysis and restructuring during that time and have continued to do so, as you saw us announce in the current quarter. And as you quite rightly mentioned, we rebuilt the leadership team and many of the layers below that, although we still have a lot of the legacy teams of the multiple companies. And so we've really focused a lot on talent and scaling. At that time, we've scaled, for example, our Decipher Lab to be able to handle three times as many, if not more, volume, which has been necessary. And we haven't missed a beat in terms of turnaround time and things like that. So, you know, I credit our team for that. We've brought on exceptional leaders who know what they're doing to add to the talent that we already had, who also knew what they were doing. And we've come a long way since. And, you know, I'm pretty proud of the revenue, continued revenue growth, our ability to deliver our own expectations and the expectations we set. And then really importantly, our opportunity to deliver a financial profile with the adjusted EBITDA that we've been talking about and that we shared on our call today. So that's all very good. As I look forward, and that's all looking backwards, as I look forward into 2025 and beyond, it is a lot of the same. And we stay very much focused on the portfolio of products that are successfully generating the revenue growth and profitability that we're driving today. We'll continue to invest in those three important strategic initiatives that we talk about, that, you know, deliver long-term growth in the future. We acquired a company during that three-year timeframe, C2I, and that forms one of those major initiatives, MRD. And, you know, we're gonna continue to deliver on the same financial profile that we've been talking about all this time. So we're still, I still consider it, we're partway in our long-term journey here. We're not done. There's still a lot to do in the company. And, you know, but we're set up to achieve it.

Perfect. On second, on the decipher volume, that seems to be continuing the trend of strong growth this year on the heels of the NCTN guideline level upgrade. Could you help us understand the underlying adoption growth drivers here? Is it mostly new positions adopting, or is it existing positions who are increasing order volumes or both?

Yeah, let me, great question. Let me start by dealing with the, you know, various categories of growth that we're seeing. When you look at the NCTN risk levels, we are seeing relatively consistent growth across low, intermediate, and high risk. So the biopsy-based part of the business is driving that growth. And we're happy to be able to see that. And it's the NCTN guidelines, really, to address all those risk categories and prognosis in those categories that's really, you know, causing physicians to, existing physicians to double down on decipher and the use of decipher across their entire patient population, which we're seeing more, as well as new physicians coming on to adopt decipher because it is the only test, molecular diagnostic test with a level 1B, RNA-based test with a level 1B. Going forward, of course, we also have the metastatic indication, which adds another 30,000 patients. And as I mentioned in the prepared remarks, we're working on the tech assessment for that and the reimbursement and the launch that will, you know, start to ramp in the end of 2025. And so that, you know, at that point, we get to what ultimately has been our goal. Every patient with prostate cancer should potentially get a molecular diagnostic and decipher as the, you know, market-leading test that they should really be benefiting from.

Perfect, thank you so much,

guys. Yeah, thank you. By the way, I should just mention one other driver, which was, you know, as we've talked about before, getting commercial payers for decipher. And we had a, I think it was Q2, we mentioned it, maybe it was the earliest Q1 that we had a significant one that added a lot of new covered lives. And we're continuing on that. Yeah,

that was as of middle of the first quarter, announced on the first quarter call in Q2. So all of the above.

Yeah, thanks. Sorry, next question.

Our next question comes from Andrew Brackman with William Blair. Andrew, go ahead with your question.

Hi, good afternoon, thanks for taking the questions. Maybe to start here just on testing volume and in particular, how you're thinking about growth there for 2025. I know there's still a couple months left in the year, but super high level. I know law of large numbers is probably at play here, but any other drivers or headwinds or tailwinds that we should be considering and either decipher or affirm next year. Thanks.

Yeah, so Andrew, thanks for that. I'll let Rebecca jump in here too, but we're not, obviously we're not ready to give numbers for 2025 yet. We're still working through our budget and our plan. I gave some color today on a firmer, kind of indicating high single digit growth there, which is more of a revenue point than a volume point. I didn't get into the level of detail for that. Bethesda 5 will start to drive more next year in a firmer, but of course you do have the law of large numbers there. On decipher side, it's back to that metastatic and then continued growth and penetrating the market that coming into this year was only 35% penetrated. Now in 2025, we're gonna be able to serve the entire market, including metastatic, which will, as I mentioned, will help in the back half of next year. We should continue to drive more penetration into that market and more share, especially given the prolific evidence that we have for decipher with hundreds of studies involving the test. And as you saw, I mentioned Stampede and any of you who paid attention to the stuff we talked about at ESMO. Decipher's moving down the care continuum into prediction, prediction of chemotherapy benefit and which patients will benefit and which patients won't benefit. So lots of exciting things to come for decipher and that's why we continue to remain quite excited about our testing growth for not just 25, but beyond and bridging us to the long-term drivers.

Absolutely, just a couple of things to add there, Andrew, and speaking again more on a revenue than a volume basis. We are seeing these market sizes unfortunately grow from an incidence perspective. So we are seeing kind of a low to mid single digit growth rate for both the via firma and decipher markets. Additionally, on a total revenue basis, I called out the $6 million headwind for Invisia. So that's worth considering. And then also in our prepared remarks, we spoke about product revenue being muted for next year. So take that into account and also think about the bio-farma business being one that we have not incrementally invested in. So that could also be plus or minus a bit next year. We aren't necessarily guiding to that today, but it's not something that we're today, it's very, we're investing in. But when you sum all that up, given the dynamics that Mark shared for a firma and decipher, again, we are very confident in our ability of those two tests to bridge us to our long-term growth drivers in 25 and beyond. And we feel very confident about a position entering next year and we're quite excited for it.

Terrific. I'll stick on another financial question, this one on the profitability and cash front. I mean, you've raised your cash projections, or you're finishing end of the year cash projections by about 50 million since the start of the year. I think it was just five months ago where you threw out that 25% adjusted EBITDA margin target and here you post 24%. So what's a reasonable way to think about further leverage in this model going forward? And I guess related to that, how do you sort of intend to deploy cash here over time? Thanks.

Well, the model is, and you're saying it, it is clearly leverageable in the specialty diagnostics channel where I mentioned we've got 50 sales reps roughly and deciphering 50 in a firm and we've added a handful of sales reps during the year because the effectiveness of our sales team is just second to none. I mean, they really are a best in class team in both categories and they're doing an amazing job. So as we grow, we'll continue to see some leverage there on the sales and marketing side. I don't wanna guide to ultimately what the margin will be. I've always said I think a specialty business like ours should be able to generate a sustainable 25% on a manual basis. You will see quarterly fluctuations in that because spending is not linear. And also, the dials that we choose to turn, there are some optionality there, right? We've got three really important projects that I talk about that make up slightly more than half of our 60 million run rate of R&D a year. And we'll continue to invest in those at an appropriate level in order to be able to launch products on a timely basis and generate, importantly, generate the evidence that we need to support those products. We've always said at VeriCite that developing the product is just the beginning of the journey, creating the evidence to support it and drive adoption and ultimately guidelines and of course reimbursement is as important if not more important than the assay itself. And so we'll turn those dials as we need to in order to make sure that we continue to deliver on our growth expectations.

Yeah, and just a comment or two to add into that very thorough comment Mark had. But Andrew, you're correct. We have, when we were at your conference earlier in the year and we put out the 25% target, we were just coming off of 15% quarter. Thanks to a number of different levers that came through over the course of 2024, we're now looking and guiding to 700 basis points of adjusted EBITDA expansion here in 2024, which is quite an astounding feat and we're quite excited about it. That being said, for the reasons that Mark shared, we are thinking about this from a balanced perspective going forward and absolutely are committed to increasing or further differentiating our financial profile, but that's going to come step function. It won't be necessarily a step function change like we saw through 2024, it will be more incremental as we think through the balance between investing for long-term growth and delivering profitability. Additionally, we also had a decent, have had a decent benefit of prior period cash collections this year, which obviously will continuously benefit ASP on an ongoing basis, but those do flow down in any given period at 100%. So just think about that as well on a go-forward basis. Thanks,

Rebecca, and to your question on deployment, no change in our philosophy around deployment. There aren't a lot of really attractive opportunities to deploy cash in our space to grow our business in a way that wouldn't require a significant investment in evidence development over multiple years and we have a lot of that going on ourselves. In fact, we've actually paused some projects that would require us to do that because it's the right thing to do, not just financially, but more importantly, from a resourcing and a focus standpoint. Execution is important and we execute well because we're very focused on, and the whole company is very focused on what we're trying to accomplish. So we would be clearly very diligent in thinking about how to deploy capital, but more importantly, how to deploy our teams, resources, our management attention and focus and the other assets that we have in the company.

Great, Keller,

thanks

so much. You're

welcome.

Our next question comes from Lou Lee of UBS. Lou, go ahead with your question.

Great, thank you so much for taking my questions. I guess like the first one, one or two, going back to the cyber, so you mentioned the metastatic, going to benefit in the second half. Any way that you can kind of like quantify the benefit to it and then do you think that they're going to be, have some like ASP pressure initially just because it takes time to kind of like negotiate with the commercial players?

Yeah, great question. I'll let Rebecca handle the ASP part, but in terms of the metastatic benefit, you should think of it as about 10% of the total market. So about in the US, 300,000 incidents of the year of which about 30,000 are new instances or incidences of metastatic, right? So don't think of it in terms of the prevalent population, but the new incidences. So 30,000 will launch the test. Think of it as two thirds Medicare related. And so that's why the tech assessment and the process we're going through there is so important. And then you're absolutely right. There will be a ramp up of commercial players, but I don't think it creates ASP pressure initially because we will be putting a ramp in the volume of the test as well. So the test will grow, I think the test will grow as we bring on commercial players in the same way you've seen on the localized setting. Our test has grown as we've added more commercial pairs. Yeah,

no, that's exactly right. I completely agree with you. For the Medicare patients, our Medicare Advantage patients, we absolutely should be getting the same ASP as we do on the biopsy and RP side. And then for commercial, we will be billing with the same code. So we expect to get some reimbursement there, but it'll take some period of time to get this under contract for many of the pairs. But not all, some pairs, we do have blanket statements in there that new incremental testing does get paid. So I think it's going to be just like it always is, right? You're gonna grind higher on your ASP over time, just like we've shown our ability to do so with a firm and Decipher. And I don't view metastatic to be any different.

Okay, appreciate that. My second question on the product revenue. It seems like there was an 18% sequential decline. I mean, you mentioned it's a supply chain issues. Do you think it's getting worse in the quarter or it just like taking longer to solve the issue? Just wanted to get a little bit more color on that. Thank you.

Yeah, it is, but some of it's intentional. As Rebecca mentioned, we're managing demand, right? We don't want to see our customers impacted and patients impacted. And so part of what we're doing to mitigate supply chain risk is managing the demand. And so that's why Rebecca set the expectation of a muted go forward growth next year. I actually think about next year as more of a transition year for the product business. We are developing in parallel multiple tests, including Decipher on PCR and Prosignor on NGS and submitted Prosignor on the NCAN and we're also developing NasalSwap. We're gonna be managing through these supply chain challenges and then driving reimbursement country by country for our tests when we're ready to launch. So 2025 don't think of it as the product line is a revenue driver next year. In fact, on the contrary, I would think of it as Rebecca said, muted and hold back expectations there. We've got a lot to do and we wanna make sure we hit the markets right and launch the right test at the right time with the right kind of strength and infrastructure behind it.

Appreciate that. Our next question comes from Tejas Savant with Morgan Stanley. Tejas, go ahead with your question.

Hello, this is Yuko on the call for Tejas. Thank you for taking our questions. On Decipher, you previously talked about running an awareness campaign on back-up reimbursement for metastatic prostate cancer. Given this will be a new population for you and even more broadly for prostate classifiers, how much market building do you think you'll need to do to facilitate adoption of Decipher use in that setting?

There's definitely some, but really the benefit here is it's largely the same customer base. It's the urologists in particular that we're engaging with for the most part. And it starts with training our Salesforce, which we'll be doing early next year. And then the Salesforce will be out there in a measured way, talking to their customers about the metastatic setting, when to use the test, how to use the test, how to interpret the test report, and so on. And so it's more of the same. I don't think there's anything, we'll do some new product market development, but a lot of it is just continuing what we already do for the localized setting.

And from a spend perspective, I wouldn't think about that as a change in inflection of the curve of sales and marketing spend for next year, just to get that out there as well. Agreed.

Got it, that was super helpful, thank you. And then I think you also talked about Bethesda 5 representing 5 to 10% of your total pharma test volume. Is that volume you're already running mostly associated with commercial, or are you also running Medicare volumes as well? I'm trying to understand whether we could see volume uplift in addition to ASD as a result, the LCD.

Yeah, that's a good question, Yoko. I would think about them as obviously related, not perfectly correlated, but related. And the reason why I say that is, I think when it comes down to it, we do run, we do report out some pieces of Bethesda 5 for commercial payers, obviously. On the, in general, it does follow the same mix. And so I think when it comes down to it, we have the benefit potentially on volume side for Bethesda 5 and obviously also on the ASD side. Again, it's around the edges though, so I don't think of it as, I don't wanna, it's an important opportunity to expand our market population. That being said, it's this very small proportion of the population, and therefore, I don't want, it's gonna be kind of a nice tailwind, but not a huge driver. So I think about it as being helpful, but there are so many other things from an execution perspective that the team has in line of sight to, to drive the revenue growth that we shared with regard to our expectations for next year, that's just kind of a rounding error to that.

Yeah, and just to add to that, I think Rebecca's exactly right. The LCD covers the Medicare population, of course, and the Medicare population, it's inverted from the deciphered comparison. It's actually the smallest part of the population in thyroid cancer, so more like roughly a third or so. I may be slightly off there, but it's in that zone. So yeah, that's the new opportunity, the commercial payers, as Rebecca said, some are already there.

Got it, thank you so much.

Yep. Our next question comes from Soonji Nam with Scottish Bank. Soonji, go ahead with your question. Hi, thanks for taking the

questions and congrats on the quarter. Maybe just another one on decipher, great to see differentiated clinical studies there, like such as the STEMP, DEN, DEN, DEN, especially for the metastatic population, and obviously a lot's going on there as well. Just kind of curious, do you need further guideline inclusion there in order to drive growth as well, or do you anticipate additional guideline inclusions there? And then just specifically for the STEMP trial, are there opportunities for deciphered to become like a companion diagnostic of some sort? And also, could that trial translate into adoption in the US market as well?

Yeah, so great questions. I think on the guideline side, if you think about localized, we got a lot of traction without guidelines, and then every time new guidelines came out, the further talked about the positive benefits of decipher, including in the most recent ones, having a table that literally, for localized disease, tells the physician what to do based on the decipher score. Each time that's happened, that's caused a significant improvement and increase in the adoption. And so on the metastatic side, I expect it to follow the same. Guidelines aren't necessary at the beginning, but they're certainly necessary in order to drive the adoption across the entire cohort and to be able to get to 300,000, ultimately, patients across the entire disease spectrum. So we will continue to use evidence like Stampede and others, and Stampede's not the only one, there are others out there that support the use of decipher in a metastatic setting for both prognostic and predictive abilities. And that's such a core part of what we do here at VeriSci, that evidence generation and partnering with others to do that, that we expect that to help us drive guideline inclusion and even more positive guideline inclusion in the future, both localized potentially and metastatic. On your question on a companion diagnostic, sure, as you get into the prediction side, whether it's a companion diagnostic or it's a diagnostic that's used to determine the appropriate treatment without necessarily being on the label TBD, but either way, I think what it does is it drives more and more physicians to recognize that using decipher throughout the patient's care continuum, no matter what level of risk they're dealing with with that patient is beneficial for the patient, is beneficial for them, it gives them more information. The Stampede trial demonstrated that today, using tumor volume is one way to try and figure out what patients to put on a Dostaxil, but this gives you a higher resolution opportunity to figure out which patients are truly gonna benefit and which aren't. And so the more studies that incorporate those kinds of outcomes and results, I think the better adoption and the better inclusion and guidelines.

Do you wanna comment on the usefulness or utility of Stampede in the US setting?

Oh yeah, I missed that part of your question. Thanks, Rebecca. Absolutely, think of decipher as a global, its studies really are very global in nature. In some of the US studies, we've had PIs from Europe involved, and this is one of the reasons why we're so excited about the IBD test, because so many key opinion leaders and physicians outside the US are already aware of decipher, they've been involved in studies. And the same way, I do think the US will look at the, the trials that have been run out of the UK and other European locations as being somewhat compelling. Now, whether we need to run, smaller studies in the US as well is to be determined. We also wanna make sure that we're dealing with all populations, including underrepresented and diverse populations too. And so to the extent we have to supplement studies with additional clinical trials, we will do that. In that part of the R&D spend I talked about, there isn't those three big strategic drivers. Meaningful, a few million dollar, more than a few million dollar proportion of that is continuing sustaining clinical studies to drive deciphering the same, a little bit on a firmer as well.

Got it, that's super helpful. And just a quick follow up, you guys did mention hurricanes. Some of your peers have mentioned that there's kind of an impact in the quarter. Just curious if there were any, and if not, could there be some impact, some delayed impact from your standpoint from any of the, any disruptions if you will, in terms of patient visits and things like that happening kind of at the end of three Q and early four Q?

I think the short answer is no. When you look at the weekly graphs of shipments, you see a small dent in the areas where the hurricanes were impacting. Of course, our hearts and thoughts go out to everybody, whether patients, physicians, and others who were impacted by those natural events. But what we saw was a small dent, but I'd say we've largely recovered from that. And what would you say, Rebecca, that the effect is less than a day's worth? Yeah,

I would say in any given quarter, a day or two in the lab can fall on one side of the quarter or the other. And I kind of put this in that category. Sungji, I'd say it's about a less of a day volume that we saw earlier this month, and nothing really in the third quarter given the areas impacted. Great,

thank you so much. Standby for our next question. Our next question comes from Thomas DeBorsi with Nefron Research. Thomas, go ahead with your question.

Hi, guys. I guess just a couple of cleanup questions here. First one, I guess just on the Nightingale study, and just I think the last update was, maybe potential completion of enrollment at the end of this year or early next year. Just any thoughts there on updated timing?

Yeah, Thomas, we actually stopped guiding to when we would finish the study. The one thing I've learned over the three years I've been doing this is we're better at forecasting revenue than we are at forecasting clinical studies, because so much of it is outside of our control. And then when you add the extra complexity of a lung-based study, which seemed to be impacted more than others in our experience, it just became, we were chasing something that we couldn't pin down close enough. So we stopped guiding to it. We're continuing to enroll. We have close to 100 sites that are enrolling at a reasonable clip. And we'll update you again next when we've completed enrollment.

Okay, then just one other question. Just the 10 to 15 million milestone payment in Q4, adding to cash, just that, just kind of, I guess a biofarm agreement where you hit milestones there or any other context?

Yeah, happy to provide some context to that, Thomas. It's actually more on the expense side than it is on the revenue side. On the expense side, we have a potential milestone payment that we have a high probability as you'll see in the queue tomorrow of paying in the fourth quarter. That's around $5 million. We also have around a similar amount of capex that we expect to spend in the fourth quarter for development projects that are kicking off here at the beginning of 25. And then the remainder is some working capital that we expect to have in the fourth quarter. So I would say it's those three buckets.

Okay, thank you very much. Appreciate it. Thank you.

Stand by for our next question. Our next question comes from Mike Masson with Needham. Mike, go ahead with your question.

Yeah, thanks. So just, you know, you've had some pretty good pricing this year. I was wondering if you could just talk about what's been driving that, to what degree that would be sustainable into next year.

Sure, happy to, Mike. So I would say that pricing has been a journey over the last couple of years as we have looked at, you know, both the original, going back to 2021, the code change from a firma to from GEC to GSC. If you recall in 22, we had a bit of a headwind there. And over the course of 23 and 24, we've cleaned a lot of that up and benefited from prior period collections tied to doing so. So I think that's been one driver, but I think the bigger driver is just the effectiveness of our managed care team and our billing teams. We have effectively, you know, put in place a team here that are rock stars and they're effectively getting, you know, a number of contracts and coverage signed up for both the firma and Decipher. And, you know, every time we think we're kind of reaching the kind of flattening of the curve, if you will, they pull something else out. And so I think as we think about where we are at now, we've made a ton of progress. And, you know, at some point in time, that portion of the curve will have to flatten. And as we look into next year, you know, I don't know if we're ready to say it's going to flatten fully because, you know, prior period collections have been such a big portion of the outperformance of the story, both on a cash and on a margin perspective this year. But, you know, it's something that we're keeping a close eye on and eventually, unless, you know, we'll get to a rate where we've had the points become more incremental and less, you know, step function changes like we've had over the last year or two. So again, I'd like to say a huge thanks to those two teams. They work incredibly well together and they do amazing work. And obviously a big piece of that this year has been the large commercial pair that we got for Decipher in the first quarter that Mark mentioned earlier. So all's well there. And, you know, the goal is to keep on keeping on with regard to the great progress those teams are making.

Okay, great. And then just on the MRD test. So I understand your reluctance to forecast the trial for the nasal swab. But, you know, in this case, you know, I don't think there's a trial. So, you know, can you just talk about when you expect to really launch that and start generating some meaningful revenue?

Yeah, so thanks for that. No, it's not a full trial and clinical utility study. It's the tech assessment process. It's the work that we have to do in our lab to get it ready for launch. We have to run some samples, obviously, to validate and everything else associated with that. And so, you know, we've talked about that being in the first half of 2026. And then it'll ramp from there. But as I mentioned in the opening remarks that I made, the RMRD test initially launched and the bladder indication makes sense for us because of both our channel and that. What I just described is that kind of faster path to reimbursement. But that's not where we're gonna end with MRD. MRD is, it's a platform and we're gonna obviously launch in other indications as well. The fact that it's whole genome is very differentiated and we believe the right long-term structure fits very well with parasites approach to always running, you know, getting more data by running a whole transcript and more whole genome. And I mentioned, you know, some data that was published in European Urology with respect to that test and, you know, the benefit of that test in identifying residual disease earlier than the standard of care imaging might by a meaningful amount. And so, you know, we're looking forward to actually being able to launch that test in many other indications over multiple years. But we'll start with bladder. That'll be our proof of concept if you think about it that way.

Okay, got it, thanks.

Our next question comes from Puneet Suda with LearLink Partners. Puneet, go ahead with your question.

Yeah, hi guys. Thanks for the questions here. So, first one on decipher. I don't know if this was covered in the question earlier. What is the growth rate you were expecting for decipher sort of going forward into 25? I mean, you have NCCN level 1B and I'm just wondering sort of the tailwinds to that, the metastatic side, what could contribute to the volume growth? So just trying to understand what's the right way to think about the growth rate in this business now from, you know, elevated volume level?

Well, Puneet, I think you've mentioned the key things that the tailwinds. I would only add the more, you know, we get commercial payers as well. The NCCN guidelines you mentioned, the metastatic indication, which I was clear in my remarks, really think of that as starting to ramp in the back half of next year and then beyond. And so, yeah, if you think about coming into this year, decipher has really grown a lot better than we anticipated. I would put the NCCN guidelines and commercial payers down as the primary reasons why that revenue growth has been so strong. We're not ready to give a guide for next year yet because we're still working through that. But we did say when you look at decipher and affirmative together, we feel very bullish about our testing growth going forward without giving that number. I did give some guides for affirmative in the high single digits for next year, but they're not ready to do so on the decipher side just yet.

Okay, that's helpful. And then, you know, recently one of the peers saw commercial pressures from a large payer in pharmacogenomics. Obviously, that's a different test than classifier tests that you have for cancer. But can you just maybe elaborate on what you're seeing in the marketplace in terms of from commercial payers? And what portion of your volume today is for pharma and decipher are sort of contracted with the commercials and the level of stability here? Because the key question being that if the payers start looking for savings, they might look to some diagnostic companies.

Thank you. Yeah, it's an excellent question, Phune. And I think, yeah, there's a lot of differences there. And if I understand it correctly, the way I read that decision was based on the lack of evidence that they perceived was available for those tests. And from our standpoint, decipher and pharma have so much evidence, not just the evidence of retrospective perspective in real world that we have for both tests, but studies that are ongoing. It's in guidelines as well, in CCN for decipher. And so there's so much strength for both tests from an evidence standpoint. And in fact, we're having the opposite conversations, which is bringing more payers into contracts. To your question around the split, think of decipher as roughly, call it 60%ish Medicare, a Medicare advantage, and then the rest is commercial. And we've been adding commercial payers. And I think we're over 200 million covered lives. Think of a firmer as being more like a third Medicare. And so commercial is a much bigger proportion on the firmer side. And a firm has been 270 million lives or more for quite some time. And so we're not seeing any pullback from a commercial payers, as I say, on the contrary, we're actually having some success with moving to contracting with more.

Got it, that's helpful. Thanks guys. Thank you.

Our next question comes from Mason Carrico with Stevens. Mason, go ahead with your question.

Hi, this is Ben on for Mason. Thanks for taking the questions today. I was hoping as it relates to your Salesforce, could you help us understand where you see those teams growing over time? And then as you slowly add reps over time, can you remind us how long it typically takes for those reps to be fully productive, really by your standards?

Yeah, great question. And let me take it in three categories, decipher, firmer, and then IBD. You take the decipher side, we've got roughly 50 reps, same in a firmer. And in both cases, I said, we've added a handful of reps in the last year, and I don't see that changing going forward. It's a much more gradual add in terms of the sales team relative to the revenue and volume growth. And in our experience, you have to be very thoughtful about dividing up territories, creating new territories, splitting territories, bringing on new reps. So you have to plan that very, very carefully. Our team does a great job of that. To answer your question, I think it takes about six months really for sales rep typically to get up to speed in their new territory and region. The fact that we haven't had a lot of turnover means we haven't had to do that much, but when we've added new reps, that's typically what we see. So I think six months is a reasonable estimate. On the IBD side, it's a different matter. You're selling to labs in that case. And so, we will be able to ramp country by country. And bear in mind, we already have some sales teams, commercial teams in the country selling pro-signature, but once we launch more menu, we'll be able to ramp country by country as we see our tests become reimbursed in those countries. And so, it's a very thoughtful, gradual thing. It's not like you have to build a lot of commercial capability in the hope that the volume will come. It's actually, you can, in our business, you can pretty much put those two things together and grow the team as you see the revenue opportunity coming.

Okay, great, thank you. And then, sort of diving into IBD, was wondering if you'd be able to provide any update there on those products under development. Are there any timelines that we're sort of able to look towards in the future? Thank you again for taking the questions.

Yeah, no major update. I said earlier, we're developing several products during 2025, and so I think of that as a transition year. Decipher PCR and ProSignor NGS are the first ones that we expect to have ready for launch next year. And then, NasalSwap following that. And so, that's kind of the timelines we've talked about so far. As I said, we're dealing with some, on the ProSignor side, we're dealing with some challenges that's more on the encounter product, but we wanna make sure that the supply chain is fully ready for PCR and NGS when we're ready to launch those tests as well.

Okay.

This concludes the question and answer session. I would now like to turn it back to Mark Stapley for closing remarks.

Thanks very much, Stacey. So, I'm incredibly proud of our execution this quarter with our team delivering outstanding revenue growth of 34% and the adjusted EBITDA margin of 24%. As you can clearly see, we continue to have a -in-class financial profile for a specialty company and a close-in on our previously stated goal of achieving a sustainable 25% adjusted EBITDA margin annually. Additionally, I wanna take this opportunity to announce an important change to my leadership team in that Keith Glegorich has been promoted to SCP Global Operations. Keith's deep expertise managing our clear labs and CP Clear Ops for the last 18 months has enabled us to scale with our growing revenue and we're in an excellent position to meet our future demand. I look forward to his continued contributions as we further build out our organization for scale. I also wanna take this opportunity to thank Rebecca for her outstanding leadership over our clear operations for the last two years in addition to her CFO responsibilities. Finally, I wanna again thank our incredible team of VeriCyte for their tireless work to make a difference in the lives of the patients we serve. We look forward to updating you all again on our 2024 performance and expectations for 2025 in the new year. Thanks.

Thank you. Ladies and gentlemen, this concludes our call today. Thank you for joining us. You may now disconnect.