CareDx (NasdaqGM:CDNA) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsAndrew Cooper - VP of Equity ResearchBrandon Couillard - Managing DirectorCaroline Corner - Director of Investor RelationsJohn Hanna - President and CEOKeith Kennedy - COONathan Smith - CFOTycho Peterson - Managing DirectorConference Call ParticipantsAndrew Brackmann - Equity Research AnalystBill Bonello - Senior Research AnalystEduardo Martinez - Equity Research AnalystMason Carrico - Research AnalystVivian Cerva ...

CareDx (NasdaqGM:CDNA) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Company ParticipantsAndrew Cooper - VP of Equity ResearchBrandon Couillard - Managing DirectorCaroline Corner - Director of Investor RelationsJohn Hanna - President and CEOKeith Kennedy - COONathan Smith - CFOTycho Peterson - Managing DirectorConference Call ParticipantsAndrew Brackmann - Equity Research AnalystBill Bonello - Senior Research AnalystEduardo Martinez - Equity Research AnalystMason Carrico - Research AnalystVivian Cerva ...

CareDx (NasdaqGM:CDNA) Q4 2025 Earnings call February 24, 2026 04:30 PM ET Speaker9Hello, everyone. Thank you for joining us, welcome to the CareDx Q4 2025 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 one on your telephone keypad. To withdraw your question, press star one again. I will now hand the call over to Caroline Corner, Investor Relations. Please go ahead.Speaker4Thank you, operator ...

Safe Harbor Statement These slides and the accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this presentation, including statements regarding the future financial position of CareDx®, Inc. (together with its subsidiaries, "CareDx" or the "Company"), including financial targets and ...

Core Insights - CareDx (CDNA) announced clinical validation data for AlloHeme, a blood-based monitoring test aimed at predicting relapses in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) post-allogeneic hematopoietic cell transplant (HCT) [1][4] Group 1: AlloHeme Test Details - AlloHeme utilizes next-generation sequencing and artificial intelligence to enhance sensitivity in detecting early relapse signals compared to traditional methods [2][4] - The ACROBAT clinical study demonstrated that AlloHeme achieved 85% sensitivity and 92% specificity, detecting relapses a median of 41 days earlier than standard clinical diagnosis [9][12] - The assay's performance metrics indicate a 95% negative predictive value and a 79% positive predictive value, with an area under the curve of 0.89 [11] Group 2: Commercialization and Market Strategy - CareDx plans to roll out AlloHeme in the U.S. starting with CLIA readiness in 2026, followed by commercialization in 2027 and expected payer coverage by 2028 [3][9] - The company aims to expand its Transplant+ strategy into cell therapy and hematologic oncology, addressing unmet needs in AML and MDS monitoring [3][6] - The integrated offering will combine diagnostics, digital tools, and patient support solutions tailored for the cell therapy ecosystem [4][7] Group 3: Market Performance and Growth Potential - Following the announcement, CDNA shares increased by 2.8%, with a 65.6% rise over the past six months, significantly outperforming the industry and S&P 500 [5] - The clinical validation of AlloHeme is seen as a significant growth catalyst, enhancing CareDx's position in the cell therapy and hematologic oncology markets [6][7] - The cell therapy market is projected to reach $9.13 billion by 2026, with a compound annual growth rate (CAGR) of 22.9% through 2034, driven by advancements in technology and increasing disease prevalence [14][15]

Core Viewpoint - CareDx is focusing on advancing AI-enabled relapse monitoring for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) post-cell therapy, positioning itself as a leader in precision medicine for cell therapy [1]. Group 1: Company Overview - CareDx is conducting an investor webinar to discuss its initiatives and advancements in precision medicine [1]. - The company aims to enhance its competitive position and explore potential growth opportunities within the industry [2]. Group 2: Future Outlook - CareDx's future business plans include the development of testing services and digital solutions aimed at increasing revenue and commercial success [2]. - The company is engaged in clinical trial collaborations and registry studies to support its growth and market opportunities [2].

CareDx Investor Webinar Call Summary Company Overview - **Company**: CareDx - **Focus**: Development of AlloHeme, an AI-enabled solution for relapse monitoring in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) post-cell therapy, aiming to lead in precision medicine for cell therapy [2][9] Key Points Industry Context - **Market Growth**: Solid organ transplantation is a growing market, driven by federal policies and technological advances, with CareDx capturing over 70% of the serviced market [9] - **Cell Therapy Market**: The cell therapy market is expanding rapidly, with allogeneic hematopoietic cell transplants (HCT) and CAR T-cell therapies being primary focuses. The market is expected to grow at a 9% CAGR for HCT and 30% for CAR T-cell therapies from 2024 to 2028 [14][15] AlloHeme Development - **Target Population**: AlloHeme is designed for high-risk patients with hematologic malignancies, particularly those undergoing allogeneic HCT and CAR T-cell therapies [10][12] - **Monitoring Solution**: AlloHeme utilizes next-generation sequencing to analyze micro changes in cell populations from peripheral blood samples, providing a non-invasive method for relapse prediction [17][18] - **Clinical Validation**: The ACROBAT trial demonstrated AlloHeme's high sensitivity (85%) and specificity (92%) for detecting relapse, with a median lead time of 41 days before clinical relapse [41][45] Market Opportunity - **Total Addressable Market (TAM)**: Estimated at approximately $1 billion, driven by an increasing patient population eligible for HCT, with 70% for AML and 45% for MDS [57] - **Commercialization Timeline**: CareDx plans to launch AlloHeme in early 2027, following the publication of the ACROBAT study and completion of CLIA readiness activities [60] Competitive Landscape - **Current Monitoring Tools**: Existing tools for relapse monitoring, such as chimerism testing and MRD approaches, have limitations in sensitivity and require invasive procedures like bone marrow biopsies. AlloHeme aims to fill this gap with a more sensitive, non-invasive alternative [23][24][49] Future Directions - **Standardization Goal**: CareDx aims for AlloHeme to become a standardized tool for monitoring relapse in post-allogeneic HCT patients, addressing the variability in current monitoring practices [63][64] - **Clinical Utility Evidence**: Future studies will focus on demonstrating the clinical utility of AlloHeme in improving health outcomes through earlier detection and intervention [64][66] Additional Insights - **Patient Journey**: The patient journey post-transplant involves intensive monitoring for relapse, with a significant gap in current practices due to the infrequency of sensitive assessments like bone marrow biopsies [21][22] - **Regulatory Considerations**: CareDx anticipates that coverage decisions for AlloHeme will begin in 2028, which will be crucial for market adoption [60] This summary encapsulates the key points discussed during the CareDx Investor Webinar Call, highlighting the company's strategic focus on AlloHeme and its potential impact on the cell therapy market.

CareDx FY Conference Summary Company Overview - **Company**: CareDx (NasdaqGM:CDNA) - **Date of Conference**: November 20, 2025 - **Key Speakers**: John Hanna (CEO), Keith Kennedy (COO) Key Points Financial Performance - **Q3 Highlights**: - 21% top-line revenue growth - 13% growth in testing services volume - Approximately 15% adjusted EBITDA - 10% of stock repurchased year-to-date - $200 million in cash on the balance sheet with no debt [5][5][5] Market Dynamics - **Organ Transplant Market**: - Transplant growth is at a 5% CAGR over five years, expected to return to this trend in the next two years - Over 100,000 patients on the transplant waitlist in the U.S. - Surgeons are competitive, with a noted increase in transplant activity moving into Q4 [6][6][6] Testing Services - **Kidney Protocol Adoption**: - Strong growth in protocol adoption, with 60 programs now documented - Average testing frequency is 3.5 to 4 tests per year per patient [10][10][14] - **Impact of Draft LCD**: - No disruption in testing volumes due to the draft LCD; growth in tests per patient continues [13][13][13] Product Innovations - **HistoMap Launch**: - Expected to enhance diagnostic capabilities by providing gene expression profiling of biopsy tissues - Aims to improve understanding of rejection types and support product development [21][22][22] - **Digital Services**: - Strong growth driven by solution selling and product innovation, including new assays and integration of blood typing into existing products [66][66][66] Revenue Cycle Management (RCM) - **Improvements in RCM**: - Significant progress in cash collections, with the highest collections in company history reported in October - Focus on automating billing processes and improving appeal rates for denied claims [28][29][34] Coverage and Reimbursement - **Insurance Coverage**: - Expanded coverage for AlloMap Heart and AlloSure, with ongoing discussions with top payers - Challenges remain with Medicare Advantage contracts and reimbursement processes [33][37][41] - **CPT Code Acquisition**: - Obtained a CPT code for AlloSure, which is expected to facilitate better reimbursement outcomes [38][38][39] Future Outlook - **Growth Opportunities**: - Anticipated growth in kidney volumes due to reimbursement impacts - Plans to expand into cell therapy, leveraging existing relationships with transplant centers [9][71][71] - **Market Positioning**: - CareDx is positioned as an innovative leader in diagnostics, with a focus on comprehensive solutions that integrate testing, software, and pharmacy services [72][72][72] Risks and Challenges - **Draft LCD Scenarios**: - Two potential scenarios regarding the impact of the draft LCD on testing volumes, with a $15 million headwind anticipated if implemented as written [54][55][56] - **Market Perception**: - The company believes its growth story is underappreciated, with significant potential for future expansion in diagnostics and cell therapy [72][72][72] Conclusion CareDx is experiencing strong financial growth and is well-positioned in the organ transplant and diagnostics market. The company is focused on expanding its product offerings, improving reimbursement processes, and leveraging its innovative approach to enhance patient outcomes.