Conference Transcript - VCYT 2026-06-02

Andrew Brackman, Analyst — William Blair

joining us here on the afternoon session of the first day of the William Blair Growth Stock Conference. If you don't know me, my name is Andrew Brackman. I cover diagnostics for the firm along with my team who's seated down here in the front row. We're very happy to have the team from Verisite joining us here today. We have CEO Mark Stapley, Chief Commercial Officer John Light, and Chief Financial Officer Rebecca Chambers. They're going to go through a presentation. We might have time for one or two questions in the room and then and we'll head to the breakout afterwards. Lastly, for a full list of research disclosures, please visit williamblair.com. That, I'll turn it over to Mark.

Marc Stapley, CEO

Thanks, Andrew, really appreciate it. Okay, it's a pleasure to be here today. So we look forward to updating you on our business with some really important and exciting updates over the last week or so. But before I get into any of that, I do wanna remind people about our forward-looking statement, which can be found on our website at www.verisite.com. So let's get into the main presentation today. So at VeriSight we have this really important mission to transform cancer care for patients all over the world and improve how patients are treated through the power of advanced genomic information and molecular diagnostics. We think about the critical decision points where patients are facing a diagnosis, a prognosis or a treatment decision or they've been treated and how we can help those patients and their physicians provide better insights and importantly our vision extends beyond just the US and we you know we plan to bring our differentiated portfolio to to the patients all over the world. I'm very pleased with the progress we've been making if you look at the last few years we've delivered exceptionally strong growth since the inflection in 2021 when we added our urology portfolio to Verisight. As you can see here we have served over 900,000 patients to date with our tests leveraging more than 600 publications. You're going to hear me come back to this evidence set quite frequently because those publications that evidence is what fuels the adoption of our tests and I can explain that a little bit more as we go through here. Last year was a great end to 2025 as we we delivered $517 million in revenue with 18% testing revenue growth. And that was driven by the continued strength of our Affirma and Decipher franchise. And this momentum carried nicely into the first quarter where we had an exceptionally strong start to the year. But I actually believe we're now what I call an inflection point for the company, but also for the industry in many ways as we launch not one but two really important new tests. So firstly, our ProCigna test, which is launching on Monday in the US on our existing whole transcriptome platform, will build out our global breast cancer franchise, and I'll talk about that a little bit more today, and our True MRD test for muscle-invasive bladder cancer as well that we already have launched. So with ProCigna and True MRD adding to our extensive portfolio, I think we've actually now got one of the most, you know, broadest portfolios in the diagnostics industry and we're not planning to stop there. As we build out indications in the care continuum we intend to go even further and further deepen our impact for patients. But let's deep dive on our products and I'm actually gonna normally we would talk about Decipher and Affirma our core franchise. I want to start by talking about our two new products first given the exciting news that we've had over the last week or so. So patients dealing with breast cancer face some really important questions. You know, what type of treatment do I need? Do I need chemotherapy? What is my prognosis? And ProSignal already answers a lot of those questions today. But over the weekend, really important results came out from the OPTIMIST trial and were presented at the ASCO annual meeting here in Chicago. And this represents a major milestone in the treatment of patients. We're calling this a milestone that is delivering practice-changing evidence for the physicians treating those patients. The trial optimum, which is, by the way, a beautifully designed, elegant study, met its primary endpoint of non-inferiority, and the conclusion of that, the headline conclusion of that is as follows. More than two-thirds of high-risk, node-positive patients dealing with breast cancer can now safely be spared chemotherapy, where, you know, under standard of care or existing guidelines, they would have received chemotherapy. So I'll say that again. More than two-thirds of patients are able to safely avoid chemotherapy. And that is a significant result. Importantly, differentiatingly for us, that study included pre-menopausal patients as well as patients with significant nodal activity up to nine nodes. And so this data demonstrates what we like to say that molecular biology, not clinical factors alone should guide chemotherapy decisions. The OPTIMA study provides level 1a prospective evidence which is important because that is ultimately what will drive guidelines. That high level of evidence is what guideline setting bodies are looking for and so knowing that with that level of evidence you can safely guide the de-escalation amongst these patient populations we believe that over time those guidelines will include prosigna across all risk categories for test-directed chemotherapy decisions. Importantly as well about a year ago or so at the 2025 ESMO breast cancer conference the Optima prelim data came out which was the precursor to the Optima study I just mentioned to you and what that demonstrated is more than 22% of patients or roughly one in five that were identified as high risk of recurrence using ProSigna after they had initially been classified as low risk. So those patients would have been spared chemotherapy incorrectly and would have had adverse outcomes. And so when you look at the combination of that Optima prelim data as well as the Optima main data, you can see that ProSigna has a lot of clinical utility in this population. This data from Optima, these two sets, adds to an extensive wall of evidence for ProCigna which has been building over time. ProCigna is based on this PAM50 genomic classifier which is well known in the research community. It's a well-validated framework and there are over 150 publications today showing that ProCigna delivers greater prognostic accuracy than other genomic assays particularly in you know that long-term cancer recurrence window and also and importantly through the ongoing use of GRID which you'll hear me mention over and over again, will continue to fuel a steady pipeline of additional studies that we expect will further reinforce why ProCigna is the test that stands apart. Now let's go back to that population and just talk about where the ProCigna test starting when it's available on Monday can be utilized by physicians on the back of all of that data supported and supplemented by the incredible Optima data. There are approximately 225,000 patients diagnosed annually in the US with early stage hormone receptor receptor process excuse me early stage hormone receptor positive breast cancer ER positive HER2 negative we address that entire population importantly so while we have distinction in the premenopausal and the high-risk you know node involvement patients we address the entire 225,000 population given that that raft of evidence I just shared with you so we expect that the physician interest in ProCigna is going to be quite high. We're already starting to hear those signals from physicians who saw the ASCO, the Optima Data ASCO over the weekend, and this will help ProCigna address what could potentially be a $700 million addressable market for breast cancer. As I mentioned, we're launching ProCigna as an LDT on Monday the 8th, and importantly, so I'll come back to this in a moment, that is being launched on our existing new V2 transcriptome that we brought up to full scale in our lab in Q4 last year. So that's ProCigna and breast. Moving on to MRD and surveillance testing. You know when patients with bladder cancer are being treated they have a similar set of questions. Has my cancer recurred? What treatment should I consider etc. Our MRD approach to that to the surveillance of those patients post-treatment is different than others. It is a whole genome every step of the way and I want to really punctuate why that's important. There are other companies that do whole genome MRD testing with the initial sample. What we do at Verisite that is distinct is we do a whole genome on every surveillance sample thereafter. And we think that's important because that adds to our data-rich strategy and data approach that I'm going to come back to again and again during this presentation. So we're tracking the variants across the entire genome every step of the way and that we think is essential to detecting recurrence but also helping to drive research and understanding the biology of the disease. In May we received Medicare coverage for our true MRD muscle invasive bladder cancer test. Bladder cancer is a significant unmet need. Approximately 85,000 patients are diagnosed every year and MIBC is about a quarter of the cases and unfortunately for these patients it's associated with a substantially high risk of recurrence up to half of MIBC patients experience recurrence within two years of initial treatment so surveillance today is largely relying on imaging and with our MRD test we are able to detect recurrence much sooner than imaging we're now accepting orders for true MRD in muscle invasive bladder cancer which is the first and we believe only commercially available, truly whole genome MRD test to come to market. What's great about the muscle invasive bladder cancer launch for us is we're launching this test into an existing channel. So as I think you will know, we have a rich urology franchise dealing with our decipher prostate and our decipher bladder cancer classifier. Through that channel, we believe we reach approximately 70% of muscle invasive bladder cancer patients who are seen in that radiation oncology urology setting. The true MRD test is highly scalable you know it's while we're launching a muscle-invasive bladder cancer this test is a platform that can be applied across multiple indications and our pipelines continuing to grow we've got 10 studies in testing or analysis 12 in contracting and 29 in active planning so you know we're covering through those studies muscle invasive bladder cancer, breast, lung, colorectal, prostate, and kidney cancer, as well as immunotherapy treatment response. So we believe true MRD's differentiated approach will allow us to capture share in this very important but crowded MRD market. So those are the two new products that we've just launched with very strong evidence behind them. Now let's move to our core decipher testing business and then I'll talk about affirma. So as we all know a prostate cancer diagnostic diagnosis can be very overwhelming for patients and they have a lot of questions again what's my prognosis, what's the risk of recurrence, do I need chemotherapy and so on. Deciphers are the leading diagnostic test for prostate cancer prognosis and prediction and it's the only test that can address prostate cancer patients across the entire risk spectrum from low risk, intermediate high, very high risk to metastatic now since we launched our metastatic last year. Whether the sample is taken by biopsy or radical prostatectomy, we can address the entire market which is significant. We've got about 215 million covered lives. We are seeing a higher order rate per physician and the number of ordering physicians grew over 15% in 2025. So both you know we're expanding within our current customer base and we're growing our customer base. So this increase in scale has resulted in approximately 400,000 prostate cancer patients being tested with Decipher so far to date and over a hundred thousand of those were tested in 2025 alone. It's a large and growing clinical challenge unfortunately with approximately 334,000 patients diagnosed each year in the US and that incidence rate is growing around six percent. As at the end of 2025 our estimation is that Decipher was penetrated in about 33 percent of the US market leaving substantial opportunity for continued growth. Decipher has delivered strong durable growth every quarter since acquisition. If you look at this chart you can see how far we've come. Decipher has grown seen volume growth of more than 20 percent each quarter and again that goes back to what I talked about earlier, continued market penetration and favorable gains in share. This has been really supported by Decipher's strong evidence position which has led to it being the only test with NCCN level 1 guidelines and recommended. So to achieve this is a similar story to what you heard me just talk about. Evidence is a fuel that drives adoption. There are now more than 120 publications on the clinical utility and validity of Decipher across the entire prostate cancer risk spectrum and more than 100 publications as well in addition leveraging our research use only grid and then in fact we've added to this evidence or the community I should say has continued to add to this evidence with just coming out of ASCO great results from the phase 3 Enzomet trial were presented and that adds even more important evidence in that metastatic population helping to determine which patients are likely to benefit from adding chemotherapy to standard doublet hormone therapy, i.e. triplet therapy, and which patients will not. The findings provide level 1b evidence, and they found that patients with below a certain score did not benefit, and patients above did benefit from the addition of chemotherapy, and that's important evidence for these patients and physicians who are dealing with them. Approximately 30,000 patients are diagnosed with metastatic prostate cancer each year and so the you know this this Enzomet study really adds to previous high-risk and metastatic studies including Stampede and Chartered and is continuing to build the the evidence for Decipher's use in that higher risk population. Looking ahead we remain confident in Decipher's ability to continue to sustain strong double-digit growth in this year 2026 and beyond and there are a few key key growth drivers for that. So firstly we see lots of opportunity to drive adoption across the full spectrum of cancer risk supported by multiple phase three trials like the one I just talked about in both low and high risk disease and there's significant room to continue to penetrate you know the either side of that spectrum low risk and high risk as well as continuing in the intermediate risk setting. Second we're expanding the decipher report I think you know many of you are aware and for those of you who aren't the grid and I'll talk about it again some more drives research which drives the discovery of novel biomarkers some good examples in prostate cancer care include portos p10 and pam50 all of which have been demonstrated to have utility and so we we add those to to the to the report to decipher thirdly building our digital pathology database we're hearing a lot about digital pathology in AI. We believe that there is an opportunity to do research using those images alongside molecular biology. They measure different things. And we've now scanned over 365,000 images for AI-powered research and making that available with our whole transcriptome to physicians who want to do that research and advance the science around DPAI.

John Light, Other

And fourth, we're also focused on deciphered bladder.

Marc Stapley, CEO

We have this urologic channel and adding bladder, we already have a classifier, I already talked about our MRD test, so we're supporting new abstracts, there's a growing number of abstracts at recent conferences highlighting that test ability to advance personalized care for those patients as well. And that's an important point because that starts to really build out the care continuum for us in that particular indication of bladder cancer. So it's clear that Decipher is increasingly becoming the standard of care in your urologic cancers and with a long runway of durable growth ahead. And then finally turning to Affirma. An indeterminate thyroid nodule again raises a lot of questions for patients around what treatment should they consider, should they have their surgery and so on. And our Affirma test has guided physicians and patients to make even more confident decisions. In fact more than 400,000 patients have been tested to date with Affirma and we believe that over 60% of these patients were spared an unnecessary surgery through the utility of our test which is I think an incredibly important metric. As at the end of the year Affirma had over 280 million covered lives and over 150 publications. If you look at the market there are 180,000 patients a year and Affirma was penetrated we believe about 38% into that patient population at the end of last year and we're continuing to gain share. If you look at the growth of Affirma so far we had 11% volume growth in 2025 for a test that as you can see has been on the market for over well over a decade and that continued actually into the first quarter where we saw volume growth of 12% Importantly, and I mentioned this briefly earlier, in the fourth quarter, we transitioned fully to our new transcriptome, and that had a lot of benefits, including, you know, helping with our scalability and costs, but in addition, it also had an important patient benefit. Historically, there were some samples where there just wasn't enough RNA or enough good quality RNA that we were able to report out a result for those patients, and through this new transcriptome we've been able to improve that significantly and now report results for even more patients which has had an impact a very important impact on those patients and our customers but also helps enhance our revenues and cost profile and margin as well and a similar story you'll hear this is the fourth time now I've talked about this the evidence driving the adoption and in fact one of the things we did was we launched grid for a firma in 2024. And you can see from this chart very clearly how that has helped drive additional research and a greater understanding of thyroid cancer. And the majority of these publications or these studies are driven by grid. And so that data-driven strategy that has been an underpinning of our company, you can see it playing out here. In fact, let me close the product section by just talking about that a little bit more. So we have two distinct platforms within Verisight, distinct but very much interacting. We have a whole transcriptome which is where our Affirma and ProCigna are currently on the latest version of that and we also run a whole transcriptome on a different platform for Decipher and we have a whole genome for our true MRD platform. And so we look at every single biomarker, we have it available in that space and then we put it into our research use only grid and make that available for physicians and investigators to do more research that results in those new biomarkers being discovered like i talked about earlier with portos p10 and so on and then that feeds back into the clinical you know offering potentially once it's been proven out and and you know you'll see that continue to grow over time as we just drive an increased understanding of prostate breast bladder and thyroid cancer. So let's move now to the financials and give you a little bit of an update there. So this this evidence-driven approach has resulted in a very strong well best-in-class we believe financial profile for the company. You can see the revenue growth where our core testing business grew 18% in 2025 and you can also see the profitability that we've been able to accomplish by our very robust and disciplined portfolio management. Our adjusted EBITDA margin last year was 27.6% well ahead of our targeted 25% which was achieved more than a year ahead of when we thought we would achieve it and importantly we increased our cash balance by more than 120 million and now have more than 439 million dollars in cash and cash equivalents which gives us incredible flexibility to invest not only in our organic business but also more broadly as well. Turning to our outlook for next year for 2026, I should say the year we're in, we expect to deliver total revenue in the range of 582 to 592 million dollars with testing revenue of 570 to 580 which is 16 to 18 percent growth and that by the way importantly doesn't include any contribution from those two new tests, ProSignor and TrueMRD. We also expect to deliver more than 26% adjusted EBITDA margin. So in closing, I couldn't be more proud of what our team has accomplished to date. When you look at our 2026 goals, we are significantly through those with a few more left to do and well on our way to achieving our 2027 and beyond goals. And that's why I say I believe we're at an inflection point. With the launch of ProSignor, LDT and TrueMRD, two of the most significant new products in the history of Verocyte and creating meaningful opportunities for expansion in breast, bladder and other cancers alongside the continued double-digit expansion in our prostate and thyroid businesses combined. We're deeply committed to our mission of transforming cancer care and improving the lives of patients around the world and I think that's going to be reflected in one of our most important milestones if you just take our guidance alone and extrapolate out, we are likely to serve our one millionth patient towards the end of this year. So that is an exciting milestone. Thank you very much for your time, and I'll wrap it up there.

Andrew Brackman, Analyst — William Blair

Thanks, Mark. We'll do maybe a couple questions. Maybe we can start on ProCigna and just double click on that. Why is this practice changing? Yeah, I mean, it's practice changing because

Marc Stapley, CEO

of that really important outcome that I repeated, and I'll say it again, more than two-thirds of patients who are potentially getting chemotherapy can safely avoid chemotherapy and you know that matters across the entire patient population but but especially when you start talking about those you know those premenopausal patients and their life-changing effects of chemotherapy and and if they don't see a benefit from it you you can avoid that for them and that couldn't be more practice changing in my mind I don't know if you want to add anything to that

John Light, Other

I'll just add the clinical trial design itself was pretty progressive in a sense that it addressed many of the questions that had been left lingering in the industry it showed the true benefit of ovarian suppression versus chemotherapy and so from past trials where ovarian suppression hadn't been mandated it was clear that the benefit that premenopausal women were getting from was actually chemo being used to shut down ovarian function, which can be done with other drugs in a far less damaging and toxic manner. The dropout rate associated with this trial, which means how many patients abandoned the trial, was right around 2% versus 20% for the predecessor, which avoids many of the potential biases in final results. And then ultimately, this is the latest demonstration of the performance of this test across the broadest segment of the indication, meaning patients from node zero through nine nodes, pre- and post-menopausal, women from age 40 upwards, using the latest of drugs so that we can have the most updated pharmacology serving in the background of these results. As such, I think I share the feelings of my colleagues as well as the key opinion leaders who were presented this data prior to the presentation. Following the presentation, the conversations we've had, I agree, this is fundamentally practice changing.

Andrew Brackman, Analyst — William Blair

Yeah, maybe if we could just sort of dovetail off of that, this being applicable, no negative and no positive disease. If you had to sort of think about how do you sort of go after this market, is there one of those areas that you say this is going to be the initial area of adoption, then you expand, or is it truly broad?

Marc Stapley, CEO

Yeah, and I'm glad you brought that up. But I mean, I actually, while we have this differentiation in several of those quadrants of that market, I don't think of it as a beachhead approach. I think of it as because ProCigna has such strong evidence and always has had for the majority of that population anyway and now adds predictive through Optima, that we address that entire market. I think you're gonna see some physicians who wanna use ProCigna in the prognostic setting for no negative patients. And I think you're also gonna see some who start with it in those couple of distinct areas.

Andrew Brackman, Analyst — William Blair

Maybe if we could just transition to the news around the cipher with the evidence across. For this metastatic indication in particular, what do these data results sort of, how do they allow you to even?

John Light, Other

Yeah, so the practice of managing prostate cancer from localized disease through now metastatic disease is evolving very, very quickly, becoming far more complex than it had been. And in this latest incarnation, the questions facing clinicians were, is there a benefit to the addition of an ARPI to patients already being managed with an androgen depleting therapy as well as a taxol-based therapy like docetaxel? The answer, to be brief, is that it benefits only a few. and these can be identified by patients tested by Decipher who score 0.85 or higher on our risk score. So what's evolving is that the therapies are becoming complex, there's lots of heterogeneity in terms of who responds versus who doesn't respond, and the response by clinicians and the science is that we need to drive a biomarker driven approach to assign

Andrew Brackman, Analyst — William Blair

these patients to therapy. Maybe last one here and then we'll be the breakout, but Maybe one for Rebecca. Expanding indication. How do you manage this from a problem?

Rebecca Chambers, CFO

Well, we're in a very fortunate position in that we have incredibly strong gross margins and ASP as a result of the great work that the managed care team has done and the operations team has done. And so we actually have a number of levers in terms of ensuring that we can work towards that 25% adjusted EBITDA target on an annual basis. In any given quarter, it may fluctuate, but the v2 transcriptome is a great example as is the shutdown of france last year both of those provided you know significant incremental investment for us to get the prosigna launch ready to go get the order to cash ready to go hire the sales team etc similarly get mrd in order to cash from rd ready to go so i feel like we take a proactive approach we budget to that 25 um if fun things come in better than in any given period we try and invest there are a number of projects that we have that we can continue to invest in while maintaining that 25 percent adjusted EBITDA target that could be incremental to growth in the near term are more than we actually can fund and execute in any given period and so we have a long tail of high ROI projects that we want to execute upon and if we were to not be able to maintain that 25 percent target in any given year by doing a project that we would explain what the project was why we were making that decision what the duration of the decision was and what the return would be so you know i you can't promise 25 percent just leave it off forever but i feel like we're in a very good position to meet our guide which was increased after the first quarter to be 26 percent um and then budget at that 25 rate on a go forward basis and execute accordingly great uh i think we'll stop there

Andrew Brackman, Analyst — William Blair

the breakout will be in Burnham A. Thank you. Thank you.