CareDx (NasdaqGM:CDNA) FY Conference Transcript

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.