CareDx, Inc.

Hello, everyone. Thank you for joining us and welcome to CareDX Q1 2026 Financial Results Earnings Call. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please press star 1 on your keypad to raise your hand. To withdraw your question, press star 1 again. I will now hand the conference over to Caroline Corner, Investor Relations. Caroline, please go ahead.

Thank you, Operator. Good afternoon. Thank you for joining us today. Earlier today, CareDX released financial results for the first quarter of 2026, ending March 31, 2026. The results are currently available on the company's website at www.CareDX.com. Joining me on today's call are John Hanna, President and Chief Executive Officer, Keith Kennedy, Chief Operating Officer and Chief Financial Officer, and Dr. Jeffrey Teutoburg, Chief Medical Officer. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements. Any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements. All forward-looking statements are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. Information concerning the risks, uncertainties, and other factors that could cause results to differ from these forward-looking statements is included in our filings with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, April 28, 2026. We disclaim any intention or obligation, except as required by law, to update or revise any information, financial projections, or other forward-looking statements, whether because of new information, future events, or otherwise. This call will also include a discussion of certain non-GAAP financial measures. These non-GAAP financial measures should be considered in addition to, not as a substitute or in isolation from, GAAP measures. Reconciliations of our non-GAAP financial measures to the most directly comparable GAAP financial measures may be found in today's earnings release. which is posted on our website. With that, I will now turn the call over to John.

Thank you, Caroline. Good afternoon, and thank you all for joining today's call. Since I joined CareDX in 2024, I have been singularly focused on transforming this company into a precision diagnostics market leader. Today, I'm going to highlight two portfolio actions we have taken to accelerate our growth strategy and including the divestiture of our lab products business, which we announced on April 15th, and the acquisition of Nevaris, announced today. In my prepared remarks, I'm going to briefly review our strategy in solid organ transplant that is propelling the growth in our core business. I'll then cover the two portfolio actions in more detail. After that, Keith will walk through the financials and our updated outlook for 2026. At CareDx, our growth strategy is focused on extending our leadership in precision medicine testing services and patient and digital solutions by addressing markets where our core competencies give us the right to win. We are addressing clinical markets where we hold a clear number one position. These markets are characterized by patients with a high cost and burden of disease that warrants repeat molecular testing to inform clinical management. These patients are managed by a concentrated group of subspecialty providers and that we service through our solution selling approach that integrates digital solutions and pharmacy to support clinical workflows and patient engagement and adherence to our testing services. Our organic growth strategy is anchored on three connected drivers. First is our pipeline programs. Innovation is central to how we maintain leadership and extend our model into new markets and grow our TAM. Q1 marked continued progress across our pipeline, with advancement in both new clinical programs and platform capabilities that extend our core monitoring model over time. In 2026, we are advancing three key pipeline initiatives. First, during the quarter, we advanced our lead cell therapy program, Alaheem. with clinical data from the Acrobat study. The Acrobat data have now been presented at both Tandem and EBMT, and we anticipate publication submission in the second quarter. In solid organ transplant, we are progressing our program to expand AlloSure into liver transplantation. Liver transplantation is unique in its biology and clinical management. And in our MAPLE trial, we are gathering follow-up data for patients enrolled in the study to validate our solution for this important indication. Strategically, Allishore Liver would extend our core monitoring model into a new organ system, enabling total addressable market while remaining tightly aligned with the same workflow-driven, repeat testing solutions-based approach that underpins our core business. Additionally, Late last year, we announced the launch of Histomap Kidney, which extends molecular insights to the moment of biopsy and complements our existing blood-based kidney monitoring. For example, when a kidney transplant patient undergoes a biopsy, clinicians typically rely only on histology, looking at tissue under a microscope, to assess what may be happening in the graft. Histomap kidney adds a molecular layer, providing additional biological context that can be evaluated alongside traditional pathology. During the quarter, we continue to make progress toward the planned histomap kidney launch, including submission of our second clinical validation manuscript and advancing our CLIA readiness. Together, Alaheem, Alisher Liver, and HistoMath demonstrate how we are innovating on our core platform to extend our leadership into new clinical markets. Second, our go-to-market strategy is focused on building belief in molecular testing as the standard of care in solid organ transplant and simplifying the workflow for health systems to drive operational efficiencies in their practice and adherence to testing protocols, while improving the quality and consistency of how customers experience working with CareDx. We are executing this through two primary go-to-market initiatives. First is emphasizing the clinical differentiation of our solutions, where we lead with indication-specific strategies tailored to how transplant clinicians make decisions. With heart care, our focus is on informing prognosis and treatment decisions, leveraging our sure data. In kidney, we are expanding the context of use for Alisher beyond surveillance with a focus on four cause testing indications, which currently account for 50% of our kidney testing volume. In lung, we continue to build adoption by promoting early findings from our Alamo registry. This approach allows us to drive relevance within each indication rather than relying on a single commercial message across markets. The second initiative is driving workflow improvements and ease of use, which is increasingly critical to scale. We are embedding our solutions more deeply into clinical workflows through a combination of center-based software, Epic Aura integrations, and Epic Enterprise LIMS infrastructure. Together, these capabilities are designed to support more consistent ordering, reporting, and cash collection by reducing friction within transplant center workflows. As we look ahead, we are targeting approximately 50% of testing volume through Epic integrated sites by year end, reflecting our belief that workflow integration is central to sustained adoption. We made continued progress on this strategy during the quarter with nine centers live and 16 additional integrations underway. While still early, these integrations are showing early signs that they reduce friction for care teams and enable increased adherence to center-specific testing protocols. These initiatives are supported by continued investment in sales, medical education, and patient engagement through our CareDX CARES team, with a clear emphasis on improving the customer experience. We are deploying resources to accelerate growth, And today, we have over 120 field support team members that assist transplant centers with their workflow and assist patients with blood collection. Overall, our go-to-market approach reflects a clear strategic intent to establish molecular testing as the standard of care by combining clinical differentiation, workflow simplicity, and scalable execution. Our evidence generation strategy is intentionally designed to support how we scale the business and extend our leadership position. The objective is to advance the clinical utility of our on-market products, inform how clinicians use molecular testing over time, and support expansion into new indications in a disciplined way. In solid organ transplant, studies such as Alamo and Harbor focus on demonstrating longitudinal utility and monitoring relevance. MERIT is a meaningful step beyond that. MERIT is an interventional study which evaluates how molecular insights can actively inform therapeutic decision-making. Strategically, this is important because it makes molecular testing integral to clinical action, reinforcing its role within routine care pathways. In cell therapy and heme oncology, we are advancing our Transplant Plus strategy starting with Acrobat, which serves as the foundation for the clinical validation of alloheem and our entrance into AML and MDS markets. We are also extending that same molecular monitoring model into DLBCL and multiple myeloma in our ACROSS study, evaluating CAR-T persistence, This work focuses on understanding expansion and persistence kinetics in real-world CAR-T care. Strategically, this study helps define where molecular monitoring can add value in a rapidly evolving market, which may become an important part of our future pipeline. We announced in March the launch of VANTIX, our AI-enabled clinical insights platform, which adds an intelligence layer to clinical decision-making. In practical terms, consider a kidney transplant patient who is undergoing routine molecular testing as a part of follow-up care. Over time, those results, such as serial Allisher measurements, are generated alongside clinical data already captured in the care workflow. With VANTIX, centers can securely aggregate and analyze center-specific molecular and clinical data across cohorts, enabling more consistent interpretation of trends over time. The supporting algorithms are informed by CARE-DX's large clinical study databases, including SHORE and KOR, helping translate real-world longitudinal data into scalable program-level insights. Together, these efforts reflect a consistent strategy, extend molecular monitoring in adjacent clinical settings in a disciplined way, prioritizing evidence, clinical relevance, and timing. Last week, CARE-DX's precision medicine testing services were featured in more than 50 abstracts, including 16 oral presentations at the International Society for Heart and Lung Transplantations annual meeting, drawing on data generated from across approximately 95 transplant centers. This breadth reflects one of the largest coordinated bodies of real-world longitudinal molecular monitoring data presented at a national transplant meeting. The data spanned both heart and lung transplantation and included findings from large prospective registries such as SURE and Alamo, as well as early interventional work supporting MERIT. Across these studies and key features of the highlighted abstracts on this slide, the consistent theme was the clinical relevance of longitudinal molecular signals over time, supporting risk stratification, earlier signal detection, and more informed post-transplant management. The scientific momentum we highlighted at ISHLT reinforces our broader strategy and the growth drivers we've discussed. demonstrating how molecular monitoring is becoming increasingly embedded in clinical practice. Next, I'd like to briefly turn to the divestiture of our lab products business, an important step in our recent portfolio actions. This transaction simplifies the company to what we do best, precision medicine testing services and digital and patient solutions. The lab products business includes manufacturing, regulatory, and commercial operations that are distinct from our U.S.-based testing services platform. By separating these activities, we are streamlining our operating model and allowing each business to move forward with greater focus and alignment. Strategically, this reinforces our testing services and patient and digital solutions core business, which are driving growth. In the first quarter, they delivered 48% and 33% revenue growth, respectively. Financially, the transaction provides upfront cash consideration of $170 million at closing, improving our financial flexibility and supporting our capital allocation strategy. At the same time, the transaction positions the lab products business for continued success under Eurobio Scientific. a longstanding partner and global IVD manufacturer with scale and distribution capabilities. Keith will walk through the pro forma financial impacts of the transaction in more detail in his remarks. Now onto the big news. We announced today an agreement to acquire Nevaris. This is a thoughtful and deliberate step in our growth strategy. Along with our Alehyme and CAR-T organic pipeline in oncology, we are taking a very selective and differentiated approach to solid tumor MRD with a category-defining and indication-leading platform with Naveris. Importantly, this is not a move to broadly pursue MRD as a category. Rather, is it a targeted addition in a specific viral-mediated cancer space where longitudinal molecular monitoring is already reimbursed, embedded in specialty workflows, and aligned with how we operate our core business today? Novaris' platform is built around a tumor-naive blood test used across the care continuum from diagnosis through MRD surveillance. First, I'd like to share a little bit about the business at a high level. To date, the company has performed more than 130,000 commercial tests, has approximately 2,000 active ordering physicians, and is operated by a strong U.S.-based team of approximately 100 employees. The testing is currently covered for approximately 100 million lives, including Medicare. and has advanced diagnostic laboratory test or ADLT designation with an $1,800 Medicare reimbursement per test. For 2025, the estimated unaudited revenue is $34 million, and we expect it will grow by 30% to 40% or greater over the next three years. The Naveris testing platform uses a proprietary and differentiated tumor tissue modified viral DNA, or TTMV, approach to detecting tumor-derived viral DNA in a blood sample. The liquid biopsy platform is tumor-naive by design, meaning it does not require access to tumor tissue. As a result, testing can be performed through a simple blood drawl. while also differentiating malignant signal from transient or benign HPV infection without reliance on having a tissue sample. The platform is built on an ultra-sensitive digital PCR technology combined with proprietary analytical methods supporting both strong clinical performance and scalable operations. Multiple indications for nevaris testing are supported by a large and growing body of evidence that now totals 56 peer-reviewed publications. In a large multi-center real-world observational study of 543 cancer patients reflecting use in routine clinical practice, The Nevaris test demonstrated strong performance with a negative predictive value of 98% and a positive predictive value of 95% during post-treatment MRD surveillance. As shown in the Kaplan-Meier curve on the right, patients with persistent negative TTMV DNA results during surveillance experienced improved recurrence-free and overall survival compared with those with one or more positive tests. and the median lead time to identify recurrence was four months ahead of standard of care methods. Based on these findings, the study authors recommended post-treatment monitoring and guideline-specified routine surveillance intervals. Viral-driven cancers represent a growing specialty oncology market, with HPV playing a central role across multiple solid tumors. According to U.S. population-level data from the CDC, HPV is associated with the majority of cases of several of these tumor types, reaching approximately 80% of head and neck cancers and close to 90% of anal cancers, Nevaris' two lead indications. Importantly, the incidence of HPV-associated cancers continues to increase, demonstrated here by the growth in head and neck cancer on the right. The Naveris platform is validated across multiple viral-mediated cancer indications. In aid to diagnosis, Naveris is validated in head and neck and planned validation in anal cancers. In MRD surveillance, Naveris is clinically validated and Medicare covered in head and neck and anal cancers and has planned validation in gynecological cancers. And now, I would like to ask our Chief Medical Officer, Dr. Jeff Tutteberg, to walk us through the patient journey for head and neck cancer diagnosis and molecular MRD monitoring. Jeff?