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Veracyte, Inc.
5/5/2026
Good day and thank you for standing by. Welcome to Verisight first quarter 2026 financial results webcast 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. You will then 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, Kelly Gurra, Director of Investor Relations.
Good afternoon, everyone, and thank you for joining us today to review Verisight's first quarter 2026 financial results. Joining me on the call are Mark Stapley, our Chief Executive Officer, and Rebecca Chambers, our Chief Financial Officer. Dr. John Light, our chief commercial officer, will also be available for Q&A. Earlier this afternoon, we issued a press release detailing our first quarter financial results, and we posted an accompanying presentation in the investor section of our website. Before we begin, I'd like to remind you that 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 VeriSight files with the Securities and Exchange Commission, including the most recent forms 10-Q and 10-K. In addition, this call will include certain non-GAAP financial measures, Reconciliation of these measures to the most directly comparable DAP financial measures are included in today's earnings release accessible from the investor's section of Verisight's website. I'm also pleased to highlight Verisight's newly redesigned website, which makes it easier to access information on our test portfolio, including a publication search tool to help navigate our extensive and growing clinical evidence base. I will now turn the call over to Mark Stapley, Verisight's CEO.
Thank you, Kelly, and thank you all for joining us today. We had an excellent start to 2026. In the first quarter, we delivered strong double-digit revenue and volume growth, exceeded our profitability expectations, and continued advancing key catalysts that position us well for long-term growth. This quarter highlights years of disciplined execution that have transformed VeriSight into a stronger, more focused, scalable company. Five years ago, we set out to make Decipher a commercial success, grow our core franchises, expand operations, enhance clinical evidence, and build a strong pipeline. We revitalized the firma, made Decipher the top prostate cancer gene expression test, increased lab capacity threefold, improved turnaround time and the no result rate, and surpassed the 25% adjusted EBITDA margin. Today, Verisight is a diversified, profitable company with a unique platform, multiple growth drivers, expanding clinical evidence, and strong clinician relationships, all achieved through consistent strategic execution. Now, we believe we're approaching an inflection point that will shape the next five years for VeriCyte. We're on the cusp of our two most significant product launches since Afirma. First, Prosigna LDT, supported by the Optima trial with a key presentation at ASCO in June, and second, TruMRD, launching initially in muscle-invasive bladder cancer. Together, these launches will expand our addressable market, extend our platform into new clinical settings, and position us for what we expect will be an even more transformative next five years for Verisight and the industry. I will spend time discussing both of these growth catalysts shortly, but first, turning to our core business. Starting with Decipher. Since our acquisition in early 2021, the business has delivered consistent growth of more than 20% quarter after quarter. That momentum continued in the first quarter as we delivered approximately 28,000 tests, representing 24% year-over-year volume growth. This strong performance was driven by continued expansion in ordering providers and orders per physician, and it reflects Decipher's differentiated position as the only gene expression test supported by high-quality clinical evidence and inclusion in NCCN guidelines, advantages that continue to drive adoption across the full spectrum of prostate cancer risk. Over the last few quarters, we've seen particularly strong traction in advanced disease, where we believe there remains significant opportunity for Decipher. In the first quarter, we delivered nearly 30% growth across high-risk categories, including radical prostatectomy, biochemical recurrence, and metastatic disease. As we see more evidence supporting the use of Decipher in patients with advanced disease, we expect to see continued growth over time. We're excited about upcoming results from the ENZOMET phase three trial, which will assess Decipher's ability to identify metastatic patients who benefit from triplet therapy. Those data will be featured in an oral presentation at ASCO later this month. ENZOMET is one part of a broader evidence pipeline that continues to advance. Four phase three trials evaluating Decipher prostate in treatment intensification and de-intensification have now completed enrollment, including the guidance trial. which reached that milestone in the first quarter meaningfully ahead of schedule. Guidance includes more than 2,000 patients and is designed to evaluate how the Decipher score can function as an integral biomarker to guide treatment decisions for men with unfavorable intermediate-risk prostate cancer. PREDICT-RT has a similar goal in high-risk disease. These studies move beyond prognostic validation to prospectively demonstrate real-world clinical utility in forming treatment choices We believe they can support high-level evidence standards for guideline and coverage. While advanced disease is a compelling growth factor, we also continue to see physicians leveraging Decipher in the low-risk setting. Since launch, we've delivered results for more than 80,000 patients in this population, creating a substantial real-world evidence database that continues to inform clinical utility. We believe there is a long runway to expand Decipher's role in active surveillance, supported by a growing body of evidence. Recent data published in European Neurology Oncology demonstrated this site's ability to stratify risk among patients undergoing active surveillance. And we were encouraged to see enrollment completed in G-major, a large prospective phase three randomized study evaluating how gene expression classifiers can inform active surveillance decisions. Taken together, these achievements and our robust pipeline of ongoing studies reflect more than a decade of sustained investment in evidence generation, and position us for a steady cadence of high-quality data readouts over the coming years. As our evidence base expands, we're also enhancing our clinical offerings. Through evidence generated using our Decipher Grid research use-only database, we're incorporating additional predictive biomarkers, including PAM50, Orthos, and PTEN. Over time, we plan to add select biomarkers to the Decipher clinical report to further support informed decision-making in high-risk and advanced prostate disease. We are also advancing complementary initiatives in digital pathology and AI-powered analysis, which we view as complementary to molecular profiling. As previously shared, we've been scanning our Decipher database and are close to digitizing all historical slides for U.S. patients, more than 350,000 images. We plan to leverage this extensive dataset together with whole transcriptome data in collaborations with leading academic centers to better define where these technologies can add value in clinical practice. Across recent urology conferences, we have seen the field shifting toward biology-driven treatment strategies for bladder cancer, with Decipher Bladder emerging as a natural extension of our platform. This momentum will be on display at the upcoming AUA annual meeting. where six studies will be presented highlighting our Decipher Bladder portfolio's ability to advance personalized care in bladder cancer, including insights generated from our grid research use-only database. These presentations build on the strong Decipher Bladder data shared at ASCO-GU and support the early but growing adoption we're seeing in the field. Overall, we're very pleased with Decipher's start to the year. We believe the franchise is well-positioned with unmatched scale, depth of evidence, and commercial reach in urology, With only one in three men with prostate cancer in the U.S. currently benefiting from the insights that Decipher offers against the spectrum of disease, we believe it can continue to be a durable, long-term growth engine, and we see meaningful extensibility into bladder disease as an incremental growth driver in the coming years. Turning to Affirma, we delivered approximately 17,200 tests in the first quarter, representing 12% year-over-year volume growth. This reflects both solid demand across our customer base and strong execution on operational initiatives that improve patient access to actionable results. As we've discussed previously, we completed the full transition to our V2 transcriptome workflow in the fourth quarter, establishing a more scalable and cost-effective platform. Importantly, this transition has also enhanced our ability to deliver definitive results for a broader set of patients, including historically challenging low-input RNA samples. That momentum continued in Q1, with our no result rate improving both sequentially and year over year. As a result, more patients and physicians received actionable affirming results to guide clinical decision making, contributing approximately 400 basis points to our volume growth in the quarter. Encouragingly, we saw healthy new account wins, increased utilization, and a high number of ordering providers in the quarter, reflecting strong engagement and the effectiveness of our strategy. We remain focused on expanding the already robust clinical evidence foundation supporting Afirma. Through our Afirma grid research use only database, we continue to generate a steady cadence of new data and incorporate additional molecular signatures into the latest version of grid. We believe this growing data set increasingly reinforces the Afirma grid as a critical research use only tool to advance the understanding of thyroid nodules and thyroid cancer. Importantly, our commitment to evidence-backed research translates into real-world clinical and economic impact. A recent independent study analyzing Medicare payment data from 2016 to 2023 found that increased adoption of Afirma was associated with a meaningful reduction in thyroid surgery rates among Medicare beneficiaries. These findings highlight how Afirma test results help physicians more confidently rule out surgery when it isn't warranted, supporting better-informed treatment decisions, reducing overall healthcare costs, and helping patients avoid unnecessary surgery and its long-term consequences. The study also reinforced Affirma's position as the leading molecular test for indeterminate thyroid nodules. Taken together, Affirma's improving operational performance, expanding clinical evidence, and demonstrated real-world impact give us confidence in the franchise's ability to sustain healthy growth in 2026 and beyond. We believe our Affirma test remains well positioned to deliver value for patients, physicians, and payers while serving as a stable and durable growth engine within our portfolio. Building on the momentum across our core franchises, Procigna LDT represents one of two major upcoming product launches that we believe marks an important next phase of growth. Procigna is built on the well-established and scientifically validated PAN 50 signature and provides deeper insights into the biological classification of breast cancer. By reporting the risk of recurrence using intrinsic subtype and proliferation scores to get the 10-year probability of distant recurrence, Procigna is designed to inform treatment decisions at a critical point in a patient's care journey. We see a significant opportunity in the U.S. market where approximately 225,000 breast cancer patients are diagnosed annually with early stage hormone receptor positive disease and are eligible for pro-sigma testing. This is a large clinically meaningful population where improved biological insight has the potential to enhance outcomes and help avoid unnecessary treatment. Clinical evidence will be a key driver of adoption, as it always is. We look forward to the upcoming presentation results from Optima, a large phase three randomized prospective trial enrolling approximately 4,500 patients. I'm pleased to share that this presentation has now been confirmed on the agenda for ASCO later this month. If positive, we believe these results could be practice changing and further strengthen Procigna's already robust clinical foundation. And beyond Optima, there are additional studies underway that we expect will continue to expand the evidence base and support share gains over time. We remain on track to commercially launch Procigna LDT by mid-year. In preparation, we're scaling our commercial and medical science liaison teams and deepening engagement with key opinion leaders. Our second major upcoming launch is TrueMRD, a whole genome sequence-based MRD platform and a key step in expanding into minimal residual disease. We remain on track to launch TrueMRD in MIBC by the end of the second quarter and plan to leverage the strength of the Decipher brand and our established commercial channels in urology and radiation oncology where we believe 70% of patients with MIB see a theme. Our initial focus will be on recurrence monitoring in patients who have completed curative intent therapy, representing the majority of patients treated in this setting. We believe the initial true MRD test launch addresses a significant unmet clinical need and represents an important proof point for our broader platform as we enter the large and growing MRD market. Early data and strong engagement from leading academic institutions reinforce our confidence that our TrueMRD platform's differentiated whole genome approach positions us well to drive adoption and capture meaningful share over time. The TrueMRD platform is highly scalable with applications well beyond bladder cancer. We're building an expanding body of clinical evidence with several studies completed across bladder, colorectal, and lung cancer, as well as additional indications. Our pipeline continues to grow with more than 10 studies currently in testing or analysis, 12 in contracting, and 29 in active planning spanning muscle invasive and non-muscle invasive bladder cancer, breast, lung, colorectal, prostate, and kidney cancer, as well as immunotherapy treatment response. We're also seeing growing external validation of this approach. At the recent American Association for Cancer Research annual meeting in San Diego, We hosted a spotlight theater focused on the clinical utility of the TrueMRD platform for tumor-informed ctDNA analysis. The session was well attended, underscoring the strong and growing interest in our differentiated approach to MRD. Investigators presented previously shared data from multiple large clinical trials, including Tombola, Umbrella, and Neoblast. As a reminder, Neoblast is the first prospective interventional study utilizing TrueMRD results and is designed to assess the feasibility of active surveillance in bladder cancer patients with negative CT DNA. As we expand our portfolio and advance our pipeline, we're also investing in the leadership and organizational capabilities required to support our next phase of growth. I'm pleased to welcome Dr. Kevin Haas, who recently joined Verisight as our Chief Development and Technology Officer. Kevin brings deep expertise in product innovation, development, and software. with a strong track record of translating complex science into clinically impactful solutions. His leadership will be instrumental as we continue to advance our product roadmap and extend our reach to more clinicians and patients globally. I'd also like to welcome Tracy Ward, our new Chief Human Resources Officer, who will play an important role as we scale the organization in helping us to grow our culture and people, key ingredients to our success. In closing, We believe Verisight is well-positioned with a long runway to deliver durable double-digit growth through execution of our long-term strategy. None of this would be possible without the execution of our team, and I'm proud of what they've accomplished as we reach more patients than ever before. With that, I'll now turn the call over to Rebecca to review our first call of financial results and walk you through our outlook for 2026.
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