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 ...

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]

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]

Financial Performance - Total revenue grew by 21% year-over-year, reaching $100.1 million in Q3 2025[15,47] - Testing Services revenue increased by 19% year-over-year, totaling $72.2 million in Q3 2025[22,47] - Patient & Digital Solutions revenue grew by 30% year-over-year, reaching $15.4 million in Q3 2025[41,47] - Adjusted EBITDA increased significantly by 122% year-over-year, reaching $15.3 million in Q3 2025[15,51] - The company raised revenue guidance for FY 2025 to a range of $372 million to $376 million[20] - The company raised adjusted EBITDA guidance for FY 2025 to a range of $35 million to $39 million[20] - Corporate Free Cash Flow increased by 233% year-over-year, reaching $36.1 million in Q3 2025[54] - Non-GAAP gross margin improved by 190 basis points year-over-year, reaching 71% in Q3 2025[49,61] Operational Highlights - Testing volume grew by 13% year-over-year, reaching 50.3K in Q3 2025[15,22] - The company launched HistoMap Kidney, a tissue-based molecular test[23]