Day two of the Raymond James Institutional Investor Conference. I'm Andrew Cooper. I cover diagnostics here for us, and I'm happy to be joined by the team from Veracyte. We've got Marc Stapley, CEO, who's gonna kick us off with a presentation. If we have a little bit of time at the end, we might do a little Q&A. With that, I'll pass it over to you, Marc.
Thanks, Andrew. Good morning. Thanks everyone for joining us today. We're very pleased to be here at the Raymond James Investor Conference. Before I get into the presentation, please do note our Safe Harbor statement. This can also be found on our website, www.veracyte.com. At Veracyte, we are focused on fundamentally enhancing our collective understanding of cancer and changing the way it is treated through the power of advanced molecular diagnostics. By enabling deep research and delivering actionable clinical insights at the most critical moments, we empower physicians to make more confident decisions, improving outcomes for their patients. Somewhat uniquely, our mission extends beyond just the U.S. as we are focused on reaching patients all around the world with our suite of tests. To deliver on this mission, we've undertaken a platform approach across Veracyte.
Our fundamental belief is that more data drives deeper insights, which strengthens evidence, which expands clinical utility, which in turn will drive greater adoption and an ability to serve even more patients. We intentionally generate more data than we need for each test in order to answer the clinical question at hand and fuel research with our whole transcriptome and our whole genome-based assays. This novel approach results in a data-driven flywheel effect, which allows us to extend our impact across indications and geographies to deliver durable long-term growth, and I'll get into that a little bit more shortly. Today, we actually have an expanding portfolio of tests, with tests spanning breast, prostate, bladder, and thyroid cancers, focused on serving patients who've been diagnosed with cancer or those who have or are suspected of having cancer.
In addition to serving all these multiple indications, we also aim to serve patients across the care continuum from risk assessment to diagnosis, prognosis, treatment, guidance, and ultimately recurrence monitoring. Our urology tests are actually the best example today of our breadth of coverage across the care continuum. As we deliver upon our strategic growth drivers in coming years, we'll add more indications across the continuum of care, thereby extending our reach and deepening our impact. Historically, we have delivered exceptionally strong growth with a significant and sustainable inflection in the business in 2021 as we added our urology portfolio, expanding our impact on patients while building a highly durable financial profile. Our platform is driving meaningful clinical adoption with more than 800,000 patients served to date.
This has been achieved on the back of more than 600 publications supporting the clinical utility of our tests. I couldn't be more proud of our performance in 2025. We delivered $517 million of revenue driven by 18% testing revenue growth led by the continued strength of our core Afirma and Decipher franchises. In addition to our strong revenue and volume growth, we executed against every one of the key milestones we set for 2025. We drove continued penetration and share gains. We launched Decipher for metastatic patients, expanding our presence in advanced disease. We generated meaningful new clinical evidence across endocrinology and urology. We advanced our pipeline with positive Prosigna outcomes data from the OPTIMA prelim study, submitted the technical assessment for TrueMRD. Completed enrollment for our NIGHTINGALE lung cancer study.
Together, these accomplishments position us well for multiple product launches beginning in 2026. Importantly, we achieved this while delivering industry-leading profitability and cash generation. Adjusted EBITDA margin exceeded 27% in 2025, not only reaching but surpassing our 25% target more than a one year ahead of plan. We also completed key operational priorities, including the restructuring of Veracyte SAS and the full transition of our Afirma volume to the scalable lower cost v2 transcriptome platform, improving our operational efficiency in launching new transcriptome-based tests. These actions support the sustainability of our financial profile as we continue to invest in growth. I'm incredibly proud of our team for their relentless focus on execution and innovation, which enabled us to deliver an exceptional year for Veracyte and reach more patients than ever before. Now taking a look at our Decipher test.
A prostate cancer diagnosis can be overwhelming for patients, raising difficult questions about what treatment they need and what comes next. Decipher helps bring clarity during this uncertain time by providing genomic insight into the biology of a patient's cancer. By better understanding an individual's risk, clinicians can help patients avoid unnecessary treatment and ensure more intensive therapy is used when it can make a meaningful difference. Decipher is the leading diagnostic test for prostate cancer prognosis and prediction, and is the only such test that can provide insights for all patients with prostate cancer, from low risk to high risk and metastatic.
With broad reimbursement across approximately 215 million covered lives, it is increasingly being adopted by physicians, as demonstrated by a consistently higher order rate per physician. In addition to increased utilization, we're also expanding our reach as the number of ordering physicians grew over 15% in 2025. This scale has resulted in more than 300,000 prostate cancer patients being tested with Decipher to date, over 100,000 of whom were tested in 2025 alone. Prostate cancer remains a large and growing clinical challenge, with approximately 334,000 patients diagnosed annually in the US, and sadly, that number is growing each year.
While adoption has accelerated, there are still so many patients in the U.S. and even more outside the U.S. who are not getting access to Decipher and therefore not benefiting from the insights that our test provides. That needs to change. We estimate that as of the end of 2025, Decipher was only about 33% penetrated. There is plenty of opportunity ahead to continue to reach even more prostate cancer patients. As we've expanded our market penetration and benefited from favorable share gains, Decipher has delivered explosive growth over the last few years. The fourth quarter marked our 15th consecutive quarter of greater than 20% volume growth, and we've delivered a three-year revenue growth CAGR of over 37%.
We're proud that Decipher is recognized as the only gene expression test with high quality evidence in NCCN guidelines, which has helped catalyze this growth. To achieve this, we have consistently enabled an ever-growing body of clinical evidence demonstrating Decipher's role in guiding cancer. There are now more than 100 publications on the utility and validity of Decipher across the prostate cancer risk spectrum, with an additional 100 publications leveraging our research use-only GRID data. Due to the flywheel effect I was talking about earlier, this body of evidence will only continue to grow. We're seeing strong momentum in bladder cancer as well, with five abstracts highlighting Decipher Bladder at ASCO GU. Our Decipher Bladder classifier and associated research use-only GRID data is increasingly being integrated into studies that aim to help researchers identify critical signatures to guide the future of bladder cancer treatment.
As the field transitions towards more biologically informed evaluation of novel treatment strategies in bladder cancer, we plan to continue investing in this indication to drive future growth in urology. Looking ahead, we're confident in Decipher's ability to sustain strong double-digit growth in 2026 and beyond, supported by several key drivers. As grid-enabled research establishes clinical utility for new prostate signatures, we plan to expand our clinical reporting to incorporate these insights. Our first examples are three new predictive signatures, PORTOS, PTEN, and PAM50, that are now widely recognized by key opinion leaders as having utility based on recent publications. Patients with higher PORTOS scores have been shown to benefit from higher doses of radiation in both post-biopsy and post-RP salvage settings. PTEN, used alongside the Decipher score, showed promise in the STAMPEDE study for identifying which metastatic patients would benefit from adding chemotherapy.
The BALANCE trial, whose results were presented at ASTRO last fall, found that the PAM50 molecular signature confidently predicts which patients with recurrent prostate cancer may benefit from hormone therapy with apalutamide in addition to salvage radiation therapy. We're working to add these molecular features to the Decipher report as optional insights, providing additional information for men with high-risk biopsy and RP disease, including those with biochemical recurrence. As a reminder, this patient population has been underserved to date, a trend that we've been focused on improving with augmented clinical evidence supporting Decipher in advanced disease, where its predictive power has been shown to improve patient outcomes. This focus, paired with the launch of Decipher Metastatic, has led to another quarter of more than 30% growth in the combined high-risk and metastatic categories, and we believe there remains significant opportunity to expand Decipher's use in advanced disease.
Additionally, we view digital pathology and AI-powered analysis as complementary to molecular analysis with the potential for additional data points to provide a more comprehensive assessment of tumor histology. To support further research, we made our digital pathology services and associated AI models available to collaborators last year and have implemented slide scanning as a standard production workflow. We have now scanned over 210,000 slides from over 150,000 patients with outcomes data, representing the majority of our historical database on Decipher. We plan to leverage this extensive database in combination with whole transcriptomes in an expanding number of collaborations with top academic centers to understand the complementary nature of these two data types in order to continue to evolve our clinical offerings.
It is clear that Decipher is increasingly becoming the standard of care in prostate cancer with a long runway of durable growth ahead. Now turning to our Afirma test. An indeterminate thyroid nodule diagnosis often leaves patients uncertain about whether surgery is needed. Afirma delivers molecular insights that help clarify risk and guide more confident decisions, allowing many to safely avoid surgery. In fact, among the 400,000 patients tested so far, we believe that over 60% of these patients were spared an unnecessary surgery through the utility of our test, Afirma. Afirma now has over 280 million covered lives and over 150 publications to date. Afirma is currently 38% penetrated into the Bethesda III to VI category, which are patients whose thyroid nodule has been deemed indeterminate, suspicious or malignant.
There remains meaningful opportunity for further share gains and incremental penetration to drive continued growth. We were pleased to see 11% volume growth for Afirma in 2025, as throughout the year we experienced a steady pipeline of new account wins and increased utilization per account. Growth was further driven by the expanded LCD that now includes reimbursement for Medicare for the Bethesda V population, with such volume growing 16% in 2025. Lastly, as I previously mentioned, we finalized the move over to our new transcriptome during the fourth quarter. While this benefits our scalability and cost profile, I'm even more excited about the patient impact. Historically, there have been cases where we were not able to provide an Afirma result due to low RNA quality or quantity. With the v2 transcriptome, we're able to confidently call even more results.
Our research-use-only GRID tool, which was launched in 2024, continues to strengthen Afirma's leadership and drive ongoing adoption. By aggregating large-scale, high-quality molecular and clinical data from patients tested with Afirma, GRID enables ongoing research and supports a generation of new clinical evidence. We've seen a meaningful increase in Afirma related publications in 2025, with the majority driven by GRID. This growing body of evidence helps maintain Afirma's role as the standard of care in thyroid diagnostics. Now moving to our growth drivers. The foundation we built through the Veracyte diagnostic platform supports a clear phased expansion strategy anchored by a focused set of drivers contributing to near-term, mid-term, and long-term growth.
The first phase is the ongoing durable expansion in our core business, Decipher and Afirma, which we've just covered, which we believe will support double-digit revenue growth for the foreseeable future. The second phase of growth is commencing this year with two exciting new product launches by the summer. First, the launch of our inaugural MRD product, TrueMRD, which will be in the muscle invasive bladder cancer indication. Second, the launch of Prosigna as an LDT for the U.S. market. With our entrance into MRD, we will expand our reach further across the cancer care continuum, with Prosigna, we will be able to serve patients in the U.S. who face a breast cancer diagno. The third phase diagnosis of growth represents our longer term commitments, including geographic expansion through our IVD strategy and addressing new cancer challenges with tests like our nasal swab for lung cancer.
I'm excited to share more detail on each of these initiatives today. Starting with Prosigna, which answers critical questions that breast cancer patients have following diagnosis, such as what kind of breast cancer they have, what treatment is needed, and the risk of cancer returning. Prosigna is based on the well-established and scientifically validated PAM50 signature, providing physicians and patients with deeper insight into the biological classification of their cancer and the risk of recurrence to help inform treatment decisions. The opportunity in the U.S. is significant. With over 300,000 patients diagnosed with breast cancer each year, approximately 225,000 of these patients have early stage hormone receptor-positive disease and would be eligible for Prosigna testing. Given this tremendous opportunity, we plan to launch Prosigna as an LDT in mid 2026 on our new v2 transcriptome, which I just discussed.
We believe upcoming clinical data will be an important driver of adoption. One key milestone in May 2025 was the presentation of the clinical outcomes data from the 10-year OPTIMA prelim study. This study suggested that Prosigna had higher prognostic accuracy in high-risk patients compared to the test that was initially used to assign patients to treatment groups. We were encouraged by the preliminary results and look forward to seeing the readout of the full OPTIMA trial, which we expect will be presented by the study's principal investigators at ASCO in June. In addition, we continue to work on driving further clinical evidence for the test. Now moving on to MRD and surveillance testing.
After completing initial treatment, a new set of difficult questions often emerges for patients, such as whether they can be monitored through surveillance or require additional therapy if the cancer is returning or spreading, and whether treatments such as chemotherapy will provide meaningful benefit. Our MRD approach is differentiated in that it is whole genome every step of the way, from the initial baseline sequencing to the sequencing of serial testing samples, all whole genome. We believe this data-rich approach is not only sufficient, but necessary to provide the right level of information to patients who are at risk of recurrence, and importantly, to further our collective understanding of cancer. This follows our fundamental belief, again, that more data drives more insights, more clinical evidence, more payer coverage, and therefore more durable adoption, as discussed earlier. We've made good progress in advancing our TrueMRD platform.
We plan to launch our first indication, muscle invasive bladder cancer, as I mentioned, in the first half of this year with reimbursement. We will leverage our strong Decipher brand and channel, which we believe reaches approximately 70% of MIBC patients who are seen in the urology and radiation oncology setting. Beyond MIBC, our platform's extensible into many other cancers, and we plan to launch additional indications annually going forward. We're building a strong and growing body of clinical evidence around TrueMRD. Multiple studies have already been completed across bladder, colorectal, and lung cancer, as well as other indications, and we have a deep pipeline of additional studies underway. Today, that includes 10 studies in testing or analysis, 13 in contracting, and 17 in active planning, spanning MIBC as well as non-muscle invasive bladder cancer, breast, lung, colorectal, and immunotherapy treatment response.
With strong engagement from leading institutions and encouraging early results, we believe that TrueMRD's differentiated approach positions us well to capture meaningful share in the MRD market. Turning now to geographic expansion. We are passionate about ensuring our tests are available to patients outside the U.S. In Europe, there are approximately 270,000 patients diagnosed with HR-positive breast cancer each year. Prosigna is already available to these patients on the nCounter platform. To further expand the reach of the test, we are developing Prosigna as an IVD on next-gen sequencing, NGS. Similarly, more than 450,000 patients are diagnosed with prostate cancer in Europe each year and do not have access to a test like Decipher. To address this need, we're developing Decipher as an IVD on qPCR technology to serve this patient population.
Our next step in this IVD process is receiving our oncology IVDR certification for our Prosigna test on nCounter, which we anticipate will occur sometime this year. We need to complete development for Prosigna on NGS and Decipher on qPCR and submit for IVDR certification for these tests. Prosigna is our priority, given the expected OPTIMA readout this summer and the fact that it is already reimbursed in many countries. We will plan to launch Decipher, where we will need to go country by country to get KOL acceptance and reimbursement. Serving patients around the world is central to our mission, and we look forward to bringing these and other IVD tests to market in the coming years. Moving on now to our final growth driver of solving new cancer challenges with innovative products like our Percepta nasal swab.
Lung cancer is the leading cause of cancer-related deaths worldwide. Each year, there are 1.6 million incidental lung nodules detected and approximately 15 million people who should be getting screened. This represents a massive and underserved market where effective early risk stratification is critical. For patients with an identified lung nodule, determining whether invasive or surgical management is appropriate is a difficult question. We believe a non-invasive test like Percepta can play an important role by helping classify risk earlier and guiding more appropriate patient management. We made important progress on this initiative last year, completing enrollment in our NIGHTINGALE Study. Looking ahead, we will conduct follow-up and data analysis, which we hope we will lead to publication and ultimately reimbursement. Taking a closer look at our recent performance, we believe we have a best-in-class financial profile delivering strong revenue growth and profitability.
Our core testing business grew 18% in 2025, exceeding our expectations coming into the year. For the full year, our Adjusted EBITDA margin was 27.6%, ahead of our target of 25%, which was achieved more than a year ahead of our projections. We increased our cash balance by more than $120 million over the course of the year, and these results give us the flexibility to invest in our growth drivers and are a testament to our differentiated financial profile. I couldn't be more proud of our team and our accomplishments. I'd like to thank all of my colleagues at Veracyte for their hard work and focus on our patients. Turning to our outlook for 2026, we expect to deliver total revenue in the range of $570 million-$582 million.
This is driven by testing revenue from our core business of $560 million-$570 million or 14%-16% growth. It excludes new test introductions. We expect to organically maintain our industry-leading 25% Adjusted EBITDA margin in 2026 and beyond. Even more importantly, it is likely that in 2026 we will hit a very key milestone, serving our 1 millionth patient. This demonstrates clearly the impact that Veracyte is having on so many people dealing with cancer and their families. I couldn't be more proud of that. In closing, I'm thrilled with our progress over the course of 2025. We delivered on our product goals, improved our financial profile, and ended the year with strong momentum across our development programs and commercial tests.
We look forward to steadily executing against our rich pipeline of catalysts, including multiple product launches this year alone, which will further fuel our growth for years to come. Above all, we remain deeply committed to our mission of transforming cancer care and improving patient lives all over the world. Thank you.
We've got a few minutes if you want to do a little bit of Q&A.
Yeah.
I'll maybe just sit up here I think since you have the podium mic. Maybe first just Decipher. I guess the thing I kind of grapple with is penetration continues to climb. You know, you grew, what, 27% in 2025. Why shouldn't we think that going from, call it 40, you know, 20%-40% penetration to 60% happens a lot faster than 20-40, especially when you have PORTOS and PAM50 and things that you're rolling out? Like, what is the limiting factor on driving that penetration a lot closer to?
Mm.
kinda true standard of care and every patient getting it?
Yeah, that's a great question. I mean, obviously when you launch a new test in a market, as we did with Decipher many years ago, the market was somewhat used to, albeit low penetrated, somewhat used to, molecular diagnostics, you know, obviously, you get those early adopters, and then you get the fast followers, and then you continue to expand. As I mentioned, you know, we've been adding new physicians, and we've been expanding the use across the care continuum within those existing accounts. We also recently launched Metastatic, you know, that's starting to catalyze more growth, as I mentioned, that 30% growth in high risk and metastatic. Now, you know, now you're dealing with the less penetrated low and high-risk parts of the care continuum.
There's still more growth opportunity in RP. You know, each While there's a tremendous amount of tailwinds, which there are, the only real headwind is, you know, as you continue to penetrate any market, you know, it's, it's a little bit harder to, to push into the next, the next phase of that. We've been able to beat that consistently, by growing our volumes, tremendously each year when you look at year-over-year volume growth, because of the evidence, the strong evidence in the NCCN guidelines behind Decipher.
While, you know, those new molecular features, the NCCN guidelines, the breadth of evidence are all very strong tailwinds for us, you know, I think it's important to, you know, drive to that larger penetration in a, you know, in a steady way, and our projections suggest that.
Great. Maybe just quickly on sort of the digital pathology and AI side because I think it's pretty topical. You've got players out there just on one side or the other at this point in terms of there's some AI tools that are sorta standalone. You've got a competitor who is trying to launch a combined genomic and digital pathology tool later this year. What's your kinda thought today knowing that you're still sort of in the process of figuring out maybe how these best fit together, but, you know, would love your view as you sit there today and kinda what helps you make those decisions when you are starting to commercialize a digital pathology tool?
Yeah, it's a great question. Let's talk about what we already know, right? We already know that these methods, digital pathology-based AI, which is really looking at the phenotype of the biology and then molecular diagnostics, which is looking at the underlying biology itself. We already know that they are measuring different biological effects, that they are complementary, and that they conflict in some way. I mean, I think we saw in some recent studies like a 30% discordance rate. You know, when you have an established product like Decipher, which is being significantly recognized as a standard of care in at least a third of cases here, as you can see by the penetration, then physicians lean on that raft of evidence we have behind Decipher.
Our belief is for digital pathology to really have its place in diagnostics, it needs to have similar levels of evidence generated over many years, both, you know, retrospective and prospective, and that needs to happen. We're fueling that research by scanning so many samples, let's say 210,000, and then we're letting the community figure out where the test has utility with AI and where it doesn't. The worst thing that can be done is launching, you know, something when it's not fully vetted out in that way and so we're not gonna do that. As you think about it, the way I think about it is, you know, digital pathology in a molecular diagnostic is another molecular it's a feature, right?
That feature could be added to our test when the time is right. That just, you know, that is just something we will do like we would do with PORTOS PTEN and PAM50.
Perfect. With just about 1 minute left here, maybe I'll jump to the classic ending question of what do you think the street kinda misses, what do you wanna leave, you know, investors with, in terms of what you think is most underappreciated?
Yeah, it's great. I think couple of things. Actually, I'll say three things. Number one is our core business growth, right? We've been asked the opposite question that you asked earlier about how do you even accelerate the penetration faster, which is why do you think Decipher's gonna continue to grow? And I think we've demonstrated over the last five years that it does and it will, and we feel confident about that. And Afirma's got tremendous legs, as you can see. And again, only 38% penetrated into that market. There's plenty of opportunity for Afirma. The core business growth shouldn't be underestimated, in particular its durability. The second is the pipeline. You know, I don't think we're getting much credit for Prosigna as an LDT or for MRD, TrueMRD.
MRD, TrueMRD is a crowded marketplace, but I've also already talked about what's differentiated with our test. Don't underestimate that data-driven strategy. It's paid off, and it's worked well in Decipher. It's doing well in Afirma, and it's gonna help in MRD. I'd say thirdly, the unique financial profile. I mean, you saw it in our, you know, hitting our EBITDA target one year ahead. We are very strong, very well-positioned for continued growth, organic and inorganic.
Perfect. Well, a lot more to get into in the breakout in Amaranth I. Appreciate the time. We'll see you downstairs.
Thank you. Appreciate it. Thanks, everyone.