CareDx FY Conference Summary Company Overview - **Company**: CareDx (NasdaqGM:CDNA) - **Date of Conference**: December 03, 2025 - **Key Speakers**: CEO John Hanna, COO Keith Kennedy Key Points Industry and Company Performance - CareDx reported strong growth across all business segments in Q3 2025 - **Testing Services**: Up nearly 19% year-over-year - **Patient and Digital Services**: Grew by 30% - **Lab Products**: Increased by 22% - The company's strategy focuses on solution selling, enhancing efficiency for transplant centers, and post-transplant monitoring [2][4][5] Product Launches and Innovations - Launched **AlloSure Heart** for pediatric patients and validated it for simultaneous pancreas and kidney transplants [4] - Introduced **HistoMap** and **AlloSure Plus**, enhancing monitoring capabilities for clinicians [5][6] - Evidence generation from studies like **AlloSure 2** and **AlloSure 3** supports product adoption and demonstrates the effectiveness of their tests [6][21][22] Revenue Cycle Management - Achieved record cash collections in Q3, with over 120% of revenue collected in cash [9][10] - Focus on operational excellence and automation in revenue cycle management [9][10] - Targeting a blended revenue per test of $1,000, with a 10% increase anticipated [10] Capital Allocation Strategy - Generated $35 million in cash last quarter, with $75 million used for share repurchases [16][18] - Aiming for a 20% EBITDA margin and a disciplined approach to capital allocation [18][20] - Preference for share buybacks due to perceived undervaluation of stock [20] Regulatory and Market Dynamics - Draft LCD proposal from Medicare includes coverage for surveillance testing, with potential revenue impacts discussed [38][39] - Two scenarios outlined regarding the finalization of the LCD, with a focus on increasing testing frequency for better patient outcomes [40][41] Future Clinical Studies and Product Pipeline - Plans for additional publications on **AlloSure** and **HeartCare** in 2026 [27] - Ongoing trials for **AlloSure Lung** and **Acrobat** for stem cell transplantation, with results expected in 2026 [27][43] - Anticipated launch of **HistoMap Kidney** in early 2026, enhancing diagnostic capabilities for rejection types [49] Competitive Positioning - CareDx differentiates itself by offering a comprehensive solution set, including software products and services tailored to transplant centers [31][32] - The company emphasizes its role as a leader in the transplant space, focusing on clinician and patient support [35][36] Conclusion - CareDx is positioned for continued growth with a strong product pipeline, effective revenue management, and a clear strategy for capital allocation and market expansion [2][4][9][16][18]

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.

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $100.1 million, representing a 21% year-over-year increase [8][26] - Adjusted EBITDA reached $15.3 million, more than double compared to Q3 last year [9][28] - Cash collections in Q3 were exceptional, reaching 124% of testing services revenue [21][28] - The company raised its 2025 revenue guidance to $372-$376 million and adjusted EBITDA guidance to $35-$39 million [9][29] Business Line Data and Key Metrics Changes - Testing services revenue was $72.2 million, a 19% increase year-over-year, with approximately 50,300 tests delivered, up 13% [9][27] - Patient and digital solutions revenue was approximately $15.4 million, reflecting a 30% growth compared to last year [21][27] - Lab products revenue reached $12.5 million, up 22% year-over-year, driven by NGS transplant test kits and PCR-based rapid HLA typing kits [22][27] Market Data and Key Metrics Changes - The company noted that transplant volumes across all three solid organs remained relatively flat year-over-year, with a slight increase of about 1% [41] - Kidney transplant volumes did not accelerate as anticipated, attributed to media scrutiny affecting transplant practices [42] Company Strategy and Development Direction - The company is focused on solution selling, aiming to provide end-to-end care for transplant patients through innovative diagnostics and digital tools [5][6] - Recent appointments to the Board of Directors and executive team are expected to enhance the company's strategic direction and customer engagement [6][7] - The launch of HistoMap Kidney is part of the strategy to bridge diagnostics and patient outcomes, addressing unmet needs in transplant care [11][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth strategy, emphasizing the importance of patient-centric solutions [5][25] - The company anticipates continued growth in kidney transplant numbers over the next two to three years, despite current market challenges [42] - Management highlighted the transformative impact of revenue cycle management initiatives on cash collections and operational efficiency [20][28] Other Important Information - The company achieved a gross profit margin of 70.9%, an increase of 190 basis points [28] - The company has no debt and closed the quarter with $194.2 million in cash and cash equivalents [28] Q&A Session Summary Question: How should we think about the durability of ASPs moving forward? - Management indicated that strong cash collections on historical claims will increase base ASP, with a 5% increase observed over the last six months [33] Question: What are the expectations for Epic Aura integrations? - The company anticipates going live with about 40 centers in 2026, expecting a 10% uplift in volume post-integration [34][35] Question: Were there any prior period collections in the quarter? - Yes, approximately $5.9 million in cash collections exceeded historical claims [36] Question: What are the overall trends in transplant volume? - Management noted that transplant volumes have remained flat year-over-year, with expectations for growth in kidney transplants over the next few years [41][42] Question: Can you provide insight into the delta in patient testing frequency at centers with protocols? - Since the reinitiation of kidney surveillance protocols, growth in kidney volume has been nearly 20% year-over-year [49]