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CareDx, Inc.
7/30/2026
Hello, everyone. Thank you for joining us and welcome to the CareDx Q2 2026 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 one to raise your hand. To withdraw your question, press star one again. I will now hand the conference over to Nina Deca. CareDx, Head of Investor Relations. Nina, please go ahead.
Thank you, operator. Good afternoon. Thank you for joining us today. Earlier today, CareDx released financial results for the second quarter 2026 ending June 30th, 2026. The results and our earnings presentation are available on the company's website at caredx.com. Joining me on today's call are John Hanna, President and Chief Executive Officer, and Keith Kennedy, Chief Operating Officer and 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 is included in our filing with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, July 30, 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 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 compatible 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, Nina. Good afternoon, and thank you for joining us today. Two years ago, we set out to transform CareDx into a leading precision medicine diagnostics company. Today, that transformation is largely complete. We deepened our leadership in transplantation. We sharpened the portfolio, exiting non-core businesses to focus on our highest value opportunities. And we extended that same solutions approach into specialty oncology and cell therapy, new markets with the same proven model. The CARDI-X model is built on longitudinal molecular testing that informs clinical decision making, supported by robust clinical evidence, integrated workflows, and patient engagement. It's repeatable and differentiated, and it connects everything we do across transplant, specialty oncology, and cell therapy. Our growth strategy is working. We are pursuing markets where our core competencies give us the right to win, where we can hold a clear number one position and where patients face a high cost and burden of disease warranting repeat molecular testing to inform clinical decision making. In these markets, our solution selling model creates value and stickiness with clinicians and patients. Today in my prepared remarks, I'm going to share an update on progress with our pipeline, the integration of our strategic acquisition of NavDx and our execution on the quarter in solid organ transplantation. Innovation remains central to how we plan to maintain our leadership position, extend our model into new markets, and grow our TAM. We continue to advance ALAHEME, our recurrence monitoring test for patients undergoing cell therapy to treat AML and MDS hematologic malignancies. During the second quarter, investigators from the ACROBAT trial submitted the Allaheim clinical validation manuscript to a peer-reviewed journal. One of the most compelling findings from the ACROBAT study was Allaheim's ability to predict relapse ahead of standard of care. Allaheim predicted relapse a median of 41 days before clinical relapse was diagnosed. This lead time may provide an opportunity for earlier clinical intervention. potentially enabling clinicians to take action before overt relapse occurs. These data support the potential role of Alekheme as a blood-based surveillance tool for risk stratification and earlier detection. Publication of these results is an important milestone in our evidence generation strategy, helping to build clinical confidence in Alekheme and support future adoption. We believe the publication represents a key step toward our reimbursement objectives, including future coverage submissions to both private and Medicare payers. We remain on track to complete CLIA readiness activities before year end, positioning Alaheim for a planned 2027 commercial launch. Alaheim represents the organic expansion of the CareDx model into cell therapy. a market where we believe we have a first mover advantage and are positioned to win by creating meaningful value for patients and providers. Histomap kidney also continues to advance toward launch. Histomap adds a molecular layer to tissue biopsy assessment to complement Allisher kidney blood-based monitoring. Last week, investigators from the University of Wisconsin published new data in the journal Transplantation Evaluating Histomap Kidney in 138 Kidney Transplant Biopsy Specimens, including 42 patients with microvascular inflammation that is donor-specific antibody negative and CD4 negative. DSA negative and CD4 negative MVI was recognized in the 2022 BAMF classification as a distinct rejection phenotype that can appear low risk by conventional biopsy assessment, yet may progress to rejection and graft loss. In the study, histamap kidney distinguished patients with MVI pathology with markedly different outcomes, with more than three times the rate of graft loss at six years in the histamap high-risk group compared with the low-risk group. supporting the potential of histamap kidney to provide clinically meaningful information beyond conventional biopsy assessment. Histamap is an example of how we are establishing clinical differentiation and providing molecular solutions to our customers from non-invasive blood-based monitoring to prognostic tissue analysis of high-risk patients undergoing biopsy. We intend to launch histamap kidney in a clinical study this year and make it available more broadly commercially in 2027. In addition to our pipeline programs, we have significantly expanded our TAM with the recent NavDx acquisition in specialty oncology. NavDx adds a clinically differentiated solid tumor MRD platform to the CareDx portfolio. We are already seeing encouraging momentum as we integrate the business. Since closing the acquisition on July 1st, we've made meaningful progress executing the integration priorities that support the strategic rationale for the transaction. Our focus has been on three areas where we believe CareDx's core competencies can drive growth and create value. First, leveraging our commercial capabilities in evidence generation, building belief in molecular testing as a standard of care, and patient support infrastructure to expand adoption of NavDx. Second, applying our workflow expertise, including epic integration and connectivity capabilities to simplify the customer experience and support incorporation into routine clinical practice. And third, integrating revenue cycle management and reimbursement capabilities to create a scalable operational foundation and support broader market access. Together, these initiatives reflect the core value creation opportunity behind the acquisition, combining NavDx's differentiated technology with CareDx's commercial reach, workflow expertise and operational scale. In July, I had the fortune to attend the 2026 American Head and Neck Society Annual Meeting in Boston. and meet with head and neck surgeons, radiation oncologists and medical oncologists from over 60 institutions across the US. Their conviction for using NavDx in their practice is strong and they were enthusiastic about how our solutions address their key challenges with broader adoption. At the event, over 30 presentations and sessions focused on circulating tumor HPV DNA or other biomarker related topics. New data were presented from a nationwide cohort of approximately 40,000 patients with HPV-driven cancers. The study focused on patients whose NavDx tests became positive during surveillance monitoring, indicating molecular recurrence of disease. The authors evaluated the clinical significance of the NavDx quantitative score, a differentiating feature of the test, in predicting response to treatment, otherwise known as salvage therapy. The data demonstrated that lower NavDx scores at the time of molecular recurrence were associated with higher rates of ctDNA clearance and faster clearance to undetectable levels, supporting the role of NavDx in predicting response to salvage therapy. These findings suggest the test kinetics may provide prognostic information helping clinicians better understand how patients respond to treatment in the recurrent setting. Also at AH&S, we hosted a symposia featuring leading clinicians of the Californian Head and Neck Cancer Consortia who recently published consensus recommendations on the use of circulating tumor HPV DNA in head and neck cancer. The session drew strong engagement from the head and neck oncology community. 33 experts across 15 institutions reached a strong consensus that circulating tumor HPV DNA is a valuable tool for diagnosis and surveillance and that serial testing should be performed throughout the years following definitive treatment. This is an important milestone. When leading clinicians converge on consensus recommendations for how a technology should be used, It signals that molecular testing is becoming an established part of how these patients are managed in clinical practice. Moving on to solid organ transplant, we continue to see molecular testing increasingly integrated in the clinical decision-making across transplant care. As the evidence base grows, clinicians are using molecular insights not only to detect rejection, but also to assess rejection risk evaluate treatment response, and support longitudinal patient management. At the American Transplant Congress, the largest transplant meeting of the year, we continued to build belief in molecular testing as a standard of care by advancing our evidence generation strategy with new data that support both adoption of Alloshore surveillance testing and the expansion of its use into new for-cause contexts of use. At ATC, CARE-Dx data were featured in more than 30 abstracts and nine oral presentations spanning kidney, heart, lung, and multi-organ transplantation, with findings generated from studies conducted across more than 110 transplant centers in the United States. One of the clearest themes at ATC was the continued evolution of Alloshore kidney beyond surveillance, increasingly being evaluated for risk assessment, treatment response, and long-term graph outcomes, not just to identify injury. One of the most notable studies presented at ATC evaluated more than 1,100 kidney transplant recipients from the KOR Registry and examined how AL-Assure trajectories during the first four months of surveillance testing following transplant related to long-term outcomes. The findings were striking. Approximately 35% of patients with persistently elevated Alloshore levels experienced rejection and had a nine-fold higher risk of graft loss compared to patients with consistently low Alloshore levels. Patients whose elevations resolved over time had outcomes similar to those who were never elevated at all. In other words, it's not a single result that matters. but the trajectory over time, which is exactly the insight that longitudinal molecular monitoring with AlloSure is designed to provide. In the four cause setting, we saw AlloSure used as the endpoint to judge whether a therapy is working. In a single center prospective study, patients with persistent chronic antibody mediated rejection were followed with serial AlloSure testing through monthly to Soluzumab infusions. Donor-specific antibodies declined and kidney function stabilized, yet AlloSure did not change over 12 months, and follow-up biopsies confirmed that antibody-mediated rejection was still present. The conventional markers suggested that patients were improving. AlloSure, confirmed by biopsy, showed the injury was ongoing. That raises real questions about how sensitive conventional markers are for monitoring treatment response, and it supports AlloSure as a potential surrogate endpoint in clinical trials of transplant therapies. Taken together, these data speak to our growth model. More patients monitored over time, more clinical context of use where a treating physician needs an objective molecular answer, and a growing role for AlloSure and how new transplant therapies are evaluated. The data presented at ATC reinforced both the strength of our evidence generation engine and the leadership position we have built in transplant diagnostics. Separately, this quarter marked another milestone with the publication of our second CAOR analysis in the esteemed Journal of the American Society of Nephrology. In more than 1,250 kidney transplant recipients across 56 U.S. centers, roughly a third of patients saw their Alloshore levels rise over time, and those elevations mattered. Patients with elevated Alloshore levels faced a nearly four to six times higher risk of losing their transplant. Most of these elevations appeared subclinically before any measurable decline in kidney function. meaning Alishor identified patients at risk well before other measures. And on the other end, patients who stayed consistently low represented a clearly low risk group with low rates of rejection, graft dysfunction, or graft loss. This is what Alishor makes possible, identifying risk earlier and supporting more informed clinical decision making. Together with the ATC data, these Allishore kidney findings continue to differentiate our platform, reinforce our leadership in transplant, and demonstrate why monitoring with Allishore is becoming a routine part of how transplant patients are managed. Another development announced on July 16th was the finalization of the Medicare local coverage determination for solid organ transplant molecular testing. The policy affirms coverage for surveillance testing across kidney, heart, and lung transplant and reinforces the role of AlloSure and Allomap in post-transplant patient management. In addition, what we find encouraging is that the foundational policy extends beyond existing coverage. It establishes a pathway for histomap coverage for molecular assessment in situations where conventional biopsy findings may be indeterminate were discrepant with clinical presentation, which is supported by the histamab data published this quarter. The policy also establishes a framework that can support future innovation in additional organs such as liver transplant. As a reminder, today nearly 500,000 Americans are on kidney dialysis and approximately 100,000 Americans are on a transplant wait list. Improving access to transplantation will require the field to make greater use of available donor organs, manage increasingly high-risk recipients, and ultimately support emerging transplant solutions such as gene-edited organs and xenotransplantation. As transplant medicine evolves, tools that can assess immunological activity, detect injury earlier, and support clinical decision making become increasingly important. We believe the final policy acknowledges that molecular diagnostics are an integral part of transplant management, not only for today's standard of care surveillance with AlloSure and Allomap, but also for the next generation of transplant innovation. With that, I'd like to turn the call over to Keith to review our financial results and outlook for the remainder of the year. Keith?
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