Financial Data and Key Metrics Changes - The company reported Q4 2025 revenue of $108 million, representing a 25% year-over-year growth [9][27] - Testing volume accelerated to 17% growth year-over-year, with approximately 53,000 tests delivered in Q4 [9][10] - Non-GAAP gross margin was maintained at 69%, with positive adjusted EBITDA of $7 million in the quarter [9][28] - Full year 2025 revenue reached $379.8 million, a 14% increase year-over-year [30] - Adjusted EBITDA for the year was $31.7 million, reflecting a 14% increase over 2024 [31] Business Line Data and Key Metrics Changes - Testing services revenue for Q4 was $78 million, up 23% year-over-year, with kidney testing leading growth [10][27] - Patient and digital solutions revenue for Q4 was $17 million, a 47% increase year-over-year [15][28] - Lab products revenue for Q4 was $13 million, reflecting a 17% year-over-year increase [16][28] Market Data and Key Metrics Changes - Kidney testing growth was supported by increased surveillance protocol adoption and expanded use of AlloSure Kidney [10][11] - Heart transplantation saw significant clinical evidence published, reinforcing the value of HeartCare in patient management [12][19] Company Strategy and Development Direction - The company aims to advance its cell therapy pipeline, referred to as Transplant Plus, and expand into new high-impact markets [17][20] - A significant focus on Epic integrations is expected to enhance customer experience and drive volume growth [21][22] - The company is investing in infrastructure improvements, including automation and AI deployment in revenue cycle management [8][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position for sustained growth and innovation in precision diagnostics [8][39] - The anticipated finalization of the Local Coverage Determination (LCD) is expected to impact revenue negatively by approximately $15 million [32][56] - Management highlighted the importance of evidence generation and clinical validation to support market access and adoption [24][25] Other Important Information - The company repurchased approximately 9% of its outstanding shares in 2025, totaling $88 million [9][31] - The CFO announced plans to transition from his role, with Keith Kennedy appointed as the new CFO [37][39] Q&A Session Summary Question: Volume guidance for the year and contribution from Epic Aura - Management is not assuming an increase in transplant procedural volume and believes it is too early to quantify the impact of Epic Aura [42][44] Question: Sustainability of growth in patient digital solutions - The company expects patient and digital solutions to grow in the range of 8%-12% next year, with margins for software ranging from 60%-70% [45][46] Question: Guidance assumptions and impact of LCD - The guidance includes a $7.5 million revenue reduction due to the LCD, with anticipated revenue per test negatively impacted by $33 [51][55] Question: Path to achieving higher reimbursement - The company is targeting a three-year goal to reach 2,000 tests, emphasizing the need for streamlined operations and real-time information [64][66] Question: Commercial readiness for AlloHeme - A broad clinician education effort is planned, along with submission for reimbursement to prepare for the product launch [71][72]

Financial Data and Key Metrics Changes - The company reported Q4 2025 revenue of $108 million, reflecting a 25% year-over-year growth [9][27] - Testing volume increased by 17% year-over-year, with approximately 53,000 tests delivered in Q4 [10][27] - Non-GAAP gross margin was maintained at 69%, with adjusted EBITDA of $7 million for the quarter [9][28] - Full-year 2025 revenue reached $379.8 million, a 14% increase year-over-year [30] - Adjusted EBITDA for the year was $31.7 million, representing a 14% increase over 2024 [31] Business Line Data and Key Metrics Changes - Testing services revenue for Q4 was $78 million, up 23% year-over-year, with kidney testing leading growth [10][27] - Patient and digital solutions revenue for Q4 was $17 million, a 47% increase year-over-year [15][28] - Lab products revenue for Q4 was $13 million, reflecting a 17% year-over-year increase [16][28] Market Data and Key Metrics Changes - The company noted that kidney transplant numbers were relatively flat year-over-year, but regulatory changes may provide a tailwind for testing services [11] - The heart transplantation market saw significant clinical evidence published, reinforcing the value of the company's testing solutions [12] Company Strategy and Development Direction - The company aims to advance its cell therapy pipeline, referred to as Transplant Plus, and has launched AlloHeme, an AI-powered NGS surveillance solution [18][20] - A focus on operational excellence and customer experience is central to the go-to-market strategy, with significant investments in Epic integrations [20][21] - The company is committed to expanding its evidence generation efforts to support clinical adoption and reimbursement [23][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position for sustained growth and innovation, emphasizing the importance of evidence generation and interventional trials [40] - The anticipated impact of the draft Local Coverage Determination (LCD) is expected to negatively affect revenue by approximately $15 million in 2026 [32] Other Important Information - The company ended Q4 with approximately $200 million in cash equivalents and no debt, providing financial flexibility [9][30] - A transition in the CFO role was announced, with Keith Kennedy appointed as the new Chief Financial Officer [39] Q&A Session Summary Question: Volume guidance for the year seems low relative to the exit rate - Management is not assuming an increase in transplant procedural volume and believes it's too early to quantify the impact of Epic Aura [42][44] Question: Sustainability of growth in patient digital solutions - The company expects growth in patient and digital solutions to be in the range of 8%-12% for the upcoming year, with margins in the mid-sixties for software [45][46] Question: Guidance assumptions regarding the LCD impact - The guidance includes a $7.5 million revenue reduction due to the LCD, with additional factors affecting revenue per test [51][55] Question: Path to achieving higher reimbursement rates - The company is targeting a three-year goal to reach 2,000 tests, emphasizing the importance of streamlined operations and real-time information [64][66] Question: Commercial readiness for AlloHeme - A broad clinician education effort is planned, alongside submission for reimbursement, to ensure market readiness for AlloHeme [71][73] Question: Strength drivers in the digital solutions business - The company has gained market share in testing services, driven by a focus on solution selling and innovative products [78][80]

Financial Data and Key Metrics Changes - The company reported Q4 2025 revenue of $108 million, reflecting a 25% year-over-year growth [7][26] - Testing volume increased by 17% year-over-year, with approximately 53,000 tests delivered in Q4 [9][26] - Non-GAAP gross margin was maintained at 69%, with positive adjusted EBITDA of $7 million for the quarter [8][27] - Full year 2025 revenue reached $379.8 million, a 14% increase year-over-year [29][30] - Adjusted EBITDA for the year was $31.7 million, representing a 14% increase over 2024 [31] Business Line Data and Key Metrics Changes - Testing services revenue for Q4 was $78 million, up 23% year-over-year, with kidney testing leading growth [9][26] - Patient and digital solutions revenue for Q4 was $17 million, a 47% increase year-over-year [13][27] - Lab products revenue for Q4 was $13 million, reflecting a 17% year-over-year increase [14][27] Market Data and Key Metrics Changes - Kidney testing growth was supported by increased adoption of surveillance protocols and expanded use of AlloSure Kidney [10][12] - Heart transplantation data showed significant clinical value from HeartCare, with findings published in a major journal [11][12] Company Strategy and Development Direction - The company aims to advance its cell therapy pipeline, referred to as Transplant Plus, and expand into new markets [16][19] - A significant focus on Epic integrations is expected to enhance customer experience and drive volume growth [20][21] - The company is investing in evidence generation through translational research and observational studies to support market access [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position for sustained growth and innovation in precision diagnostics [6][39] - The anticipated impact of the draft Local Coverage Determination (LCD) is expected to negatively affect revenue by approximately $15 million [32][33] - The company is optimistic about the potential of AlloHeme in the cell therapy market, with plans for commercialization in early 2027 [18][19] Other Important Information - The company ended Q4 with approximately $200 million in cash equivalents and no debt, providing significant financial flexibility [8][31] - A transition in the CFO role was announced, with Keith Kennedy appointed as the new Chief Operating Officer and Chief Financial Officer [38][39] Q&A Session Summary Question: Volume guidance for the year seems low relative to the exit rate - Management is not assuming an increase in transplant procedural volume and believes it's too early to quantify the impact of Epic Aura [41][42] Question: Sustainability of growth in patient digital solutions - The company expects patient and digital solutions to grow in the range of 8%-12% next year, with margins for software ranging from 60%-70% [43][45] Question: Guidance assumptions and impact of LCD - The guidance includes a $7.5 million revenue reduction due to the LCD, with anticipated revenue per test negatively impacted by $33 [49][53] Question: Opportunities from Epic integration - The company is targeting a three-year goal to increase testing volume, emphasizing the importance of streamlined operations for clean claims [62][63] Question: Commercial readiness for AlloHeme - A broad clinician education effort is planned, along with submission for reimbursement to prepare for the product launch [69][70]

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 ...