CareDx, Inc.

Hello and thank you for standing by. My name is Regina and I will be your conference operator today. At this time, I'd like to welcome everyone to the CARE DX third quarter 2025 financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star then the number one on your telephone keypad. To withdraw your question, press star one again. I'd now like to turn the conference over to Tina Jacobson, Vice President of Investor Relations. Please go ahead.

Thank you, Alperator. Good afternoon. Thank you for joining us today. Earlier today, CareDX released financial results for the third quarter 2025 ending September 30, 2025. The result is 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, and Nathan Smith, Chief Financial 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 facts 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 are included in our filings with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, November 4th, 2025. 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 to our website. I will now turn the call over to John.

Thank you, Tina, and welcome to everyone joining today's call. We had a strong third quarter on many fronts, including record volume, and record revenue in testing services, patient and digital solutions, and our lab products businesses. Our strategy of solution selling is working. At CareDx, our mission is clear, to create life-changing solutions that enable transplant patients to thrive. We are uniquely positioned as the only company serving transplant patients from end to end, delivering innovative diagnostics, digital tools, and patient support that span the entire transplant journey. Our strategy is rooted in putting patients and their care teams at the center of everything we do, and you'll see this reflected in our product innovations, operational excellence, and the way we partner with transplant centers worldwide. At the core of this strategy lies an exceptional team, the true driving force behind our success. To further strengthen the outstanding group here at Cardiacs and advance our mission, I was delighted to announce in October the appointment of Suresh Gunasekron, President and CEO of UCSF Health, to our Board of Directors. With over two decades of experience leading major academic medical centers, including some of the largest solid organ and bone marrow transplant programs in the United States, Suresh brings to the organization the voice of our customers. offering invaluable perspectives as we advance our strategy to become the solutions provider to transplant centers. In addition, I was also pleased to welcome last month Dr. Jeff Teutoburg, our new chief medical officer. Jeff is one of the most forward-thinking clinicians in transplantation. He is internationally recognized for his track record of clinical innovation, research, and patient advocacy and is joining us from Stanford University, where he was section chief of heart failure, cardiac transplant, and mechanical circulatory support since 2017. Jeff has held prominent roles in the American Society of Transplantation and is the president of ISHLT, or the International Society of Heart and Lung Transplants. His deep experience will be instrumental as we strive to establish non-invasive molecular testing as the standard of care in solid organ transplantation and launch our next generation of precision medicine assays in stem cell transplant. The expertise and vision of these leaders reinforce our commitment to innovation in both new products and how we go to market and engage our customers. Now on to the third quarter results. Total revenue of $100.1 million grew 21% year over year. Adjusted EBITDA was $15.3 million, more than double Q3 last year. We repurchased an additional 2 million shares during the quarter at an average price of $12.87. Year-to-date, we have repurchased approximately 9% of shares outstanding. Today, we are raising 2025 revenue guidance. to $372 to $376 million, a reflection of our strong performance in the third quarter. We are also raising adjusted EBITDA guidance to $35 to $39 million. Nathan will provide additional details on the guide in his prepared remarks. In testing services, revenue was $72.2 million for the third quarter, an increase of 19% year over year. We delivered approximately 50,300 tests in the third quarter, up 13% year over year, with growth across all three organs, heart, kidney, and lung. I personally visited 20 transplant centers in the third quarter. I spoke with the clinicians and transplant program administrators to understand how our existing and future solutions can help improve the care of their patients. Their feedback was clear. Our team is highly engaged, consistently puts patients first, and is executing on the right priorities. I also spent time with our local commercial teams, gaining valuable insights into where our solution-selling strategy is working and where we can further improve. These conversations reinforced my confidence in our strategy and our people and left me inspired and optimistic about the significant growth opportunities ahead. This week at the American Society of Nephrology meeting, or ASN, we are launching Histomath Kidney, a breakthrough tissue-based molecular test that exemplifies our commitment to end-to-end transplant care. By integrating advanced histopathology with molecular insights, we're empowering clinicians to make more precise and timely decisions for their patients. This is just one example of how CARE-DX is bridging the gap between diagnostics and patient outcomes, reinforcing our leadership in delivering comprehensive solutions across the transplant continuum. Histamaptic kidney is built on the Banff Human Organ Transplant Gene Set, a research tool adopted by transplant researchers globally and leverages gene expression profiling for deeper insights into immune activity and rejection phenotypes to inform clinical decision making. We built HistoMap Kidney to address the critical unmet need in transplant care. If a patient's kidney function declines after transplant, clinicians need clarity on the type of rejection. With HistoMap Kidney, doctors can use the original biopsy tissue to obtain a precise molecular readout, confirming the subtyping rejection from an FFPE sample. By providing objective, actionable data, histamap kidney helps reduce uncertainty in biopsy interpretation, gives clinicians and patients greater confidence in their diagnosis and next steps. It will be available starting in early 26 in a clinical study and then for commercial use later in the year. Also at ASN Kidney Week, CareDx technologies will be showcased in five abstracts covering Allosure, and our AI-derived integrated risk assessment algorithm, Alisher Plus. The abstracts will present new insights, including biomarker interpretation in the early post-transplant period, including in the setting of delayed graft function, and new evidence supporting the use of Alisher in combination with clinical data to predict antibody-mediated rejection. Further, Allisher kidney will be featured in new analyses from the K.O.R. Registry, demonstrating its ability to predict long-term outcomes, and in research demonstrating the use of Allisher kidney to facilitate the transition to immune suppression monotherapy in kidney transplant patients. Belatacept monotherapy is preferred by clinicians because of its demonstrated improved clinical efficacy and tolerability in as compared to traditional regimens. This emerging evidence suggests AlloSure can be utilized to optimize immune suppression strategies and improve long-term outcomes for transplant recipients. In addition, an ASN abstract from Henry Ford Hospital in Detroit addresses whether donor kidney volume impacts AlloSure levels or one-year graft function. This is particularly relevant in pediatric transplantation, where size mismatch between donor and recipient has been a concern. The study found that kidney size did not significantly affect Allisher levels or graft function at one year, reinforcing the reliability of our noninvasive monitoring tools across a broad range of donor and recipient characteristics. These new data reflect our commitment to advance transplant care through rigorous science and innovation. We are proud to see our technologies validated across diverse clinical settings in patient populations and look forward to continuing to deliver meaningful solutions that improve transplant outcomes. Keeping with our commitment to evidence generation, I want to highlight a major milestone in heart transplantation. Just two weeks ago, the second study from the SURE registry was published in the Journal of the American College of Cardiology, Heart Failure. This is the largest prospective analysis of antibody-mediated rejection, or AMR, in heart transplantation ever published. The SURE study evaluated over 2,200 heart transplant patients across 59 U.S. centers, analyzing nearly 25,000 biopsies and almost 9,000 paired AlloSure Heart samples. This is truly a landmark data set. What's most exciting is that SURE validates heart care, which brings together AlloMAP and AlloSure Heart as a non-invasive, clinically proven approach to heart transplant surveillance and context-driven decision-making. The data show that AlloSure Heart results are highly specific for diagnosing AMR, Elevated AlloSure heart levels were strongly associated with biopsy-proven AMR and higher values correlated with more severe rejection. And when AlloSure is modestly elevated, a positive Allomap can help identify those at risk for acute cellular rejection. These findings demonstrate that heart care can optimize biopsy utilization and clinical decision-making in heart transplant care. Lastly, on the topic of evidence generation, I'm particularly proud of our leadership in response to the draft LCD policy for molecular testing for solid organ allograft rejection that was published in July. Our team delivered a comprehensive, evidence-based comment letter that champions patient access to personalized care. We submitted the letter to policymakers ahead of the public comment period close on August 31st. and it remains accessible at caretx.com slash LCD comment letter. We consider the draft policy to be a significant step forward in affirming coverage for surveillance testing without a tie to protocol biopsy. However, we noted that limits placed on surveillance testing conflict with clinical guidelines and restrict clinician decision-making in scenarios where patients have elevated risk of rejection. Specialty societies, key opinion leaders, advocacy groups, policymakers, and patient stakeholders also submitted comment letters emphasizing concerns with the proposed limits. We urged policymakers to maintain coverage for combination molecular tests such as Alimap Heart and Alisher Heart. Our comments provided the latest evidence and clinical data which demonstrates that testing with Alimap Heart and Alisher Heart identifies rejection with greater accuracy than gene expression testing or donor-derived cell-free DNA testing alone, resulting in improved patient outcomes. We continue to anticipate that the draft policy will be finalized in early 2026. On our earnings call last quarter, we commented on the likelihood of potential outcomes and the associated financial impacts, and those expectations are unchanged today. We plan to provide an update on our long-range plan financial assumptions once the policy has been finalized. We remain committed to supporting the transplant community and have not and do not anticipate to observe any business impact as the draft policy comments are being evaluated and the policy is being finalized. Moving on to our initiatives to drive operational excellence, Placing our customer at the center of everything we do has driven us to improve our enterprise infrastructure and business processes to operate more efficiently. We continue to push forward with the launch of our Epic instance to make it easier for healthcare providers to order CARE-DX testing and receive test results. We have eight Epic Aura Transplant Center Connection projects in process now and are officially live at Boston Children's, the U.S.' 's leading pediatric heart transplant program. Feedback from that pilot implementation has been exceptional. Because our Epic order set is tailored to transplant centers, it makes the center's workflow simple and fast. Since going live at Boston Children's, Alisher Plus results are now available directly through EpicAura. Medical records are received automatically with each order, and the center has seen a 20% reduction in order turnaround time and a 60% reduction in specimen holds. This is a great example of how we're making the clinician and patient experience better, not just faster. We continue to expect roughly 10% of our total volume will be serviced through EpicAura integrations by year end, and roughly 50% of total volume will be serviced through EpicAura integrations by year end 2026. This quarter, we also made remarkable progress on revenue cycle management, building on last year's foundational updates to the team and workflows We've now begun automating key RCM processes with AI, streamlining claim submission, accelerating appeals, and reducing manual intervention across the board. The investments are already delivering measurable results. This isn't just operational fine-tuning. This is a strategic move to unlock operational efficiency to drive margin expansion and support scalable growth as our testing volumes increase. In the third quarter, we achieved improvements across all of our RCM KPIs compared to our benchmark periods, including an over 200% improvement in total appeals volume, a 60% improvement in claims submission time, a 600 basis point improvement in overall zero pays, and a 1,300 basis point reduction in claims rejection rate. We believe these wins are key leading indicators for the growth and predictability of average revenue per test and are beginning to emerge in our financial statements. Cash collections in the third quarter were exceptional, with collections accelerating to 124% of testing services revenue. Nathan will provide additional color on our expectations for revenue per test in his prepared remarks. I'll now turn to patient and digital solutions, which includes our transplant pharmacy, software tools, and remote patient monitoring services. In the third quarter, we reported revenue of approximately $15.4 million, representing 30% growth compared to last year. Our solution selling strategy is driving strong results. By delivering integrated patient and digital solutions, we're unlocking new growth opportunities for testing services, deepening customer loyalty, and strengthening our brand equity. For example, at the largest kidney program and pediatric institute in Georgia, we have become the pharmacy of choice for the kidney transplant program to help more efficiently and effectively manage their post-transplant patients as they ramped up their kidney transplant volume and initiated an Allisher kidney surveillance protocol. Next, in lab products, which includes PCR kits for rapid deceased donor HLA typing, NGS kits for transplant recipient HLA typing globally, and IVD monitoring assays for solid organ and stem cell transplant recipients outside the U.S., revenue of $12.5 million was up 22% year over year. We just returned from ASHI, the American Society of Histocompatibility and Immunogenetics, annual conference, where we showcased CARE-DX's continued investment in creating life-changing solutions. This year at ASHI, we launched ALICEAK-TX11, our next-generation HLA typing solution with enhanced Class II coverage and expanded non-HLA markers to support broader transplant organ profiling. Alisig TX11 is designed for flexibility, working with low-quality samples, preventing allele dropouts, and reducing the need for retesting. We also introduced SCORE7, our modernized analysis software for Q-type, built for scalability and regulatory alignment and supporting future ADO typing and IVDR compliance. In addition, we announced that Allacy TX and Q-Type have received IVDR certification in the European Union, underscoring our commitment to delivering high-quality regulatory compliance solutions for transplant centers worldwide. Our well-attended user group meeting, entitled ABO Histocompatibility in Transplantation, Current Status, Unmet Needs, and Future Directions, featured leading experts from the Brigham and Women's Hospital, LifeLink Foundation, and the University of Alberta. The session addressed the clinical relevance of ABO antibodies in transplant rejection, genotype versus phenotype discrepancies, and the importance of advancing ABO blood typing for improved patient outcomes. Additionally, we announced our validation of a rapid ABO genotyping assay, which demonstrated 100% concordance with established methods and enables faster, more accurate blood group determination. By integrating ABO and HLA genotyping into a single workflow, we're helping transplant centers expand donor eligibility and streamline organ allocation, delivering real-world impact for patients and providers. This is the degree of innovation that defines CareDx and supports our confidence in continued strong lab products growth. Before I hand it over to Nathan, I want to reflect on our recent progress. Each achievement this quarter is a direct result of our strategy in action and underscores the importance of keeping patient needs at the center of every decision. Our progress isn't just measured in numbers, but in real-world impact we're having on transplant patients, their families, and the clinicians who care for them. The growth we're seeing is not just the result of isolated initiatives, but of a cohesive approach where each decision and investment is anchored in delivering meaningful value for patients and their care teams. These growth drivers clearly demonstrate how our investments in innovation, optimizing our go-to-market approach, building and amplifying evidence generation, and enhancing operational excellence through RCM progress and EpicAura integration are translating into meaningful impacts for patients, providers, and the broader transplant community. They serve as proof points that our strategy is working and that we are building lasting value for all stakeholders and including our shareholders. Our leadership team has a proven track record of disciplined capital allocation and operational execution. We are confident that these strategic investments will yield a strong return, fueling high quality, durable growth for years to come. There is no shortage of work left to be done, but I'm proud of our execution so far this year and anticipate continued progress. Now, I will turn the call over to Nathan to discuss our detailed financial results and guidance. This is Nathan's first call as our CFO at CareDX. I'm thrilled to have him on the team and look forward to his leadership as we execute on our strategic and financial goals. Nathan?