Veracyte 2026 Q2 Earnings Call

Please go ahead. Good afternoon, everyone, and thank you for joining us today to review Veracyte's second quarter 2026 financial results.

Joining me on the call are Marc 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 second quarter financial results. We posted an accompanying presentation in the Investors 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. The company can give no assurance that they will prove to be correct. The company undertakes no obligation to update any forward-looking statements except as required by law.

To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Veracyte files with the Securities and Exchange Commission, including the most recent Forms 10-Q and 10-K. This call will include certain non-GAAP financial measures. Reconciliations of these measures to the most directly comparable GAAP financial measures are included in today's earnings release, accessible from the Investors section of Veracyte's website. I will now turn the call over to Marc Stapley, Veracyte's CEO.

Thank you, Kelly, and thank you all for joining us today. Q2 was a milestone quarter for Veracyte as we launched Prosigna LDT and TrueMRD, catalyzing two of our key growth opportunities and meaningfully expanding our portfolio. We advanced the clinical evidence supporting Prosigna, Decipher, and Afirma while delivering another quarter of double-digit growth and industry-leading profitability. These achievements reflect years of investment in our platform, the growing body of evidence supporting our tests, and our differentiated commercial capabilities. They enhance our ability to reach and positively impact more patients. Today, our portfolio helps guide patient care across multiple cancer types and increasingly across the cancer care continuum, from risk assessment through recurrence monitoring. As we continue to expand that impact, we are approaching one of the most meaningful milestones in our company's history, serving our one millionth patient.

The recent launches of Prosigna LDT and TrueMRD for muscle-invasive bladder cancer, or MIBC, represent the culmination of years of hard work. To say I'm proud of these accomplishments and of our team for delivering them would be an understatement. I want to thank our employees and external collaborators whose expertise and partnership made these outcomes possible. I'm also grateful to the physicians who have worked with us to advance cancer care and to the many thousands of patients whose participation in research helped make these innovations possible. Since launching the Prosigna test in the U.S. following the presentation of the practice-changing OPTIMA trial results at ASCO, we've seen tremendous enthusiasm from both physicians and patients. Prosigna helps guide treatment decisions at a pivotal point in the breast cancer care journey by quantifying the risk of recurrence up to 10 years and providing a likelihood of chemotherapy benefit.

Backed by the most rigorous clinical trial demonstration to date, Prosigna achieves this by providing intrinsic subtyping classification information from the well-validated, well-published PAM50 signature that highlights the underlying biology driving the patient's cancer. This helps identify patients who can benefit from chemotherapy and those who may be able to safely avoid it. Prosigna is foundational to our breast cancer franchise and represents one of the most significant product launches in Veracyte's history. As a reminder, OPTIMA is an independent prospective phase III randomized trial that enrolled more than 4,400 high-risk early-stage breast cancer patients. The study met its primary endpoint and demonstrated that more than two-thirds of clinically high-risk patients may safely avoid chemotherapy without compromising outcomes. Importantly, this includes premenopausal women and patients with up to nine positive lymph nodes.

The OPTIMA results also generated significant media attention, making OPTIMA and Prosigna the most covered diagnostic story at ASCO. Looking ahead, publication in a leading peer-review journal will represent another important milestone, further validating this level 1A prospective evidence supporting Prosigna and its potential inclusion in future clinical guidelines. We see a significant opportunity to expand access to Prosigna in the U.S., where approximately 225,000 patients are diagnosed with ER-positive, HER2-negative breast cancer each year. We believe many of these patients may benefit from the clinically validated insights Prosigna provides to help inform treatment decisions. With OPTIMA, Prosigna has the only clinically validated evidence for premenopausal women and patients with higher nodal involvement. This expands and strengthens the clinical utility already demonstrated in many prior studies, including as a prognostic test for node-negative patients.

There are 157 publications to date featuring Prosigna and more than 1,200 publications featuring the PAM50 classifier on which the test was built. In the near term, we are focused on educating key opinion leaders and driving adoption in high volume centers. While menopausal status and nodal involvement may present the catalyst for the initial conversation, we believe healthcare providers will choose a test they can use with confidence across all ER-positive, HER2-negative patients, rather than stratifying their use based on these differentiating factors alone. We have been thrilled by the quality and breadth of engagement since launch, which gives us confidence our commercial strategy is on point. We are now actively engaged with more than 100 institutions that help shape standards of care in breast cancer, including nationally recognized academic cancer centers, large integrated health systems, and regional oncology networks.

Many of these organizations are evaluating broad adoption of Prosigna across their breast cancer programs, and in some cases have expressed interest in using Prosigna for all hormone receptor-positive patients that they treat. Based on this strong engagement, the growing activity on our ordering platform and our customers' desire to start incorporating Prosigna into existing practice management workflows, we are expanding our sales force ahead of our original plan to capture the demand we are seeing. We are making progress on reimbursement and continue to have constructive discussions with MolDX regarding Medicare coverage. We are encouraged by the engagement to date and look forward to providing updates as those discussions progress. I couldn't be more excited about the momentum we have seen since launch.

While early, the response from patients, clinicians, key opinion leaders, and the broader oncology community reinforces our conviction that Prosigna can become a meaningful growth driver for Veracyte and even more importantly, improve quality of life for the hundreds of thousands of patients dealing with breast cancer. Turning now to MRD. We launched our first test on our TrueMRD platform in June after securing Medicare reimbursement for recurrence monitoring in patients with MIBC following radical cystectomy. The TrueMRD monitoring test for MIBC represents the first commercial application of our MRD platform and our entry into this rapidly growing market. Importantly, our whole genome approach to MRD is extensible well beyond bladder cancer, with the potential to support multiple tumor types and clinical applications over time.

TrueMRD for MIBC is the first and only commercially available MRD test to utilize whole genome sequencing for not just the landmark test, but also through longitudinal monitoring with all subsequent liquid biopsy surveillance tests. We believe this is a meaningful differentiator, offering a broader view of tumor biology and the ability to track tumor evolution over time. Capabilities we expect will become increasingly important as oncology research and testing advances. More broadly, we believe Veracyte is uniquely positioned to serve patients across the bladder cancer continuum. Today, Decipher Bladder helps physicians risk stratify patients, and with TrueMRD for MIBC, we are adding recurrence monitoring at another critical point in the patient journey. Over time, we expect continued evidence generation, product enhancements, and portfolio expansion to further strengthen our position in bladder cancer management.

We are leveraging the strong brand we have built through Decipher and our long-standing relationships across urology and radiation oncology to accelerate awareness and adoption of our first TrueMRD test. In parallel, we are investing in the operational infrastructure, workflow enhancements, and automation needed to support larger testing volumes as we intentionally expand the platform over time. While we remain in the early stages of commercialization of TrueMRD for MIBC, we have been encouraged by the initial feedback from physicians who recognize the advantages of a truly whole genome approach and the complementarity to our overall bladder program. We continue to believe that the TrueMRD platform has the potential to become an important long-term growth driver for Veracyte. Moving on to Decipher Prostate.

We delivered another strong quarter of revenue growth, up 20% year-over-year, driven primarily by 17% volume growth with improved ASP contributing the balance. ASP growth reflects the significant focused work our market access and billing teams completed over the last year, including operational improvements, strong payer engagement, and expanded coverage across multiple accounts, which led to higher recoveries per test. With just under 30,000 tests resulted in the second quarter, we continued to see strong underlying demand for Decipher. Having said that, we are taking our expectations for volume for the year down by approximately 1% or slightly more than 1,000 tests, primarily in the low-risk setting. Importantly, our expectations for the rest of the business remain on track. Low-risk disease represents an important growth opportunity for Decipher, and one where we are also actively investing to generate additional high-quality evidence.