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]

Core Viewpoint - CareDx (CDNA) has shown a significant price increase of 24.7% over the past four weeks, with a mean price target of $22.8 indicating a potential upside of 28% from the current price of $17.81 [1] Price Targets and Analyst Estimates - The mean estimate consists of five short-term price targets with a standard deviation of $5.54, where the lowest estimate is $14.00 (21.4% decline) and the highest is $28.00 (57.2% increase) [2] - A low standard deviation among price targets suggests a high degree of agreement among analysts regarding the stock's price movement [9] Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about CareDx's earnings prospects, with a strong consensus on higher EPS estimates, which correlates with potential stock price increases [11] - Over the last 30 days, two estimates have been revised upward, leading to a 38.8% increase in the Zacks Consensus Estimate for the current year [12] Zacks Rank and Investment Potential - CareDx holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13] - While consensus price targets may not be entirely reliable, the implied direction of price movement appears to be a useful guide for investors [14]

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.

Core Insights - CareDx, Inc. is a leading precision medicine company focused on healthcare solutions for transplant patients and caregivers [1] Inducement Grants - On November 4, 2025, CareDx awarded restricted stock units (RSUs) to 49 new employees as an inducement for accepting employment [1]

Core Insights - CareDx reported revenue of $100.06 million for the quarter ended September 2025, reflecting a year-over-year increase of 20.7% [1] - The earnings per share (EPS) for the quarter was $0.28, up from $0.14 in the same quarter last year, indicating a significant improvement [1] - The revenue exceeded the Zacks Consensus Estimate of $95.23 million by 5.07%, while the EPS surpassed the consensus estimate of $0.13 by 115.38% [1] Revenue Breakdown - Revenue from Patient and Digital Solutions was $15.41 million, exceeding the three-analyst average estimate of $13.63 million, with a year-over-year change of 29.9% [4] - Revenue from Testing Services reached $72.17 million, surpassing the three-analyst average estimate of $69.48 million, representing an 18.7% increase year over year [4] - Revenue from Products was $12.48 million, slightly above the average estimate of $12.13 million from three analysts, showing a year-over-year change of 22.2% [4] Stock Performance - CareDx shares have returned -1.3% over the past month, contrasting with the Zacks S&P 500 composite's increase of 2.1% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Core Insights - CareDx reported quarterly earnings of $0.28 per share, exceeding the Zacks Consensus Estimate of $0.13 per share, and showing an increase from $0.14 per share a year ago, resulting in an earnings surprise of +115.38% [1] - The company achieved revenues of $100.06 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 5.07% and up from $82.88 million year-over-year [2] Earnings Performance - Over the last four quarters, CareDx has surpassed consensus EPS estimates three times, indicating a positive trend in earnings performance [2] - The company had a previous earnings expectation of $0.12 per share but reported $0.10, resulting in a surprise of -16.67% [1] Stock Performance - CareDx shares have declined approximately 31% since the beginning of the year, contrasting with the S&P 500's gain of 16.5% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it is expected to perform in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $0.19 on revenues of $101.74 million, and for the current fiscal year, it is $0.51 on revenues of $368.34 million [7] - The outlook for the Medical Services industry, where CareDx operates, is currently in the bottom 43% of Zacks industries, which may impact the stock's performance [8]

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]

Q3 2025 Financial Results N O V E M B E R 4 , 2 0 2 5 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, "Care ...

Revenue Performance - Revenue for the three months ended September 30, 2025, was $100.1 million, an increase of 21% year-over-year [125]. - Total revenue for the nine months ended September 30, 2025, was $271.4 million, an increase of $24.2 million or 10% compared to $247.2 million in 2024 [145]. - Testing services revenue was $72.2 million, representing 72% of total revenue, with a 19% increase year-over-year and a testing volume growth of 13% [123][133]. - Testing services revenue increased by $10.6 million, or 6%, driven by a 13% growth in testing services volume [146]. - Product revenue increased by 22% year-over-year to $12.5 million, primarily due to higher sales of NGS-based kitted solutions [124][134]. - Product revenue rose by $5.7 million, or 19%, primarily due to higher sales of commercial NGS-based kitted solutions [147]. - Patient and digital solutions revenue grew by 30% year-over-year to $15.4 million, driven by an expanded customer base from Ottr software and higher pharmacy sales [127][135]. - Patient and digital solutions revenue grew by $7.9 million, or 25%, mainly from an expanded customer base and higher pharmacy sales [148]. Profitability and Income - Net income for the three months ended September 30, 2025, was $1.7 million, compared to a net loss of $10.6 million in the same period of 2024 [125][132]. - Net loss for the nine months ended September 30, 2025, was $17.2 million, a reduction of $17.9 million or 51% compared to a net loss of $35.1 million in 2024 [145]. Expenses - Research and development expenses decreased by 4% year-over-year to $16.8 million, influenced by lower clinical trial and laboratory supply expenses [139]. - Sales and marketing expenses increased by 23% year-over-year to $24.4 million, primarily due to higher personnel-related costs [140]. - General and administrative expenses decreased by 10% year-over-year to $28.4 million, mainly due to lower stock-based compensation expenses [141]. - Total operating expenses increased by $5.3 million, or 2%, totaling $296.2 million for the nine months ended September 30, 2025 [145]. Cash and Securities - Cash, cash equivalents, and marketable securities totaled $194.2 million as of September 30, 2025, with no debt [125]. - Cash provided by operating activities was $20.7 million for the nine months ended September 30, 2025, compared to $16.2 million in 2024 [161][162]. - Net cash used in financing activities was $80.9 million, primarily due to stock repurchases totaling $75.6 million [165]. - As of September 30, 2025, the company had cash and cash equivalents of $91.4 million, consisting of bank deposits and money market funds [181]. Foreign Currency and Risk Management - The company is exposed to foreign currency exchange risks, with a 10% unfavorable change in exchange rates potentially impacting product revenue by $1.4 million [182]. - Revenue from testing services is primarily denominated in U.S. dollars, while product revenue is mainly in U.S. dollars and Euros [182]. - Operating expenses incurred outside the U.S. are denominated in Swedish Krona and Euros, subject to fluctuations in exchange rates [182]. - The company does not currently have plans for a formal hedging program to mitigate foreign currency volatility but may consider it in the future [182]. - The company continues to reassess its approach to managing risks related to foreign currency exchange rate fluctuations [182]. Accounting Policies and Estimates - There were no material changes in critical accounting estimates during the three and nine months ended September 30, 2025 [177]. - Significant accounting policies include revenue recognition, business combinations, and impairment of goodwill and intangible assets [178]. - Recent accounting pronouncements and their expected effects on operations and financial position are detailed in the quarterly report [180]. Interest Income - Interest income decreased by 33% year-over-year to $2.0 million, primarily due to a decrease in cash and cash equivalents [142]. - A hypothetical 100 basis point increase or decrease in interest rates would have an approximate impact of $0.9 million on the company's balance sheets [181]. Registration Statement - The company has filed a universal shelf registration statement allowing for the sale of up to $250.0 million in various securities [169].

Financial Performance - Total revenue for Q3 2025 was $100.1 million, representing a 21% increase year-over-year from $82.9 million in Q3 2024[5] - Testing services revenue reached $72.2 million, up 19% from $60.8 million in the same quarter last year[6] - Adjusted EBITDA for Q3 2025 was $15.3 million, compared to $6.9 million in Q3 2024[8] - GAAP net income was $1.7 million, a significant improvement from a net loss of $10.6 million in Q3 2024[7] - GAAP total revenue for Q3 2025 was $100,055,000, an increase of 20.6% compared to $82,883,000 in Q3 2024[24] - GAAP net income for Q3 2025 was $1,675,000, a significant improvement from a net loss of $10,637,000 in Q3 2024[26] - Non-GAAP gross profit for Q3 2025 was $70,939,000, up from $57,207,000 in Q3 2024, resulting in a non-GAAP gross margin of 71%[24] - The company reported a non-GAAP net income of $14,896,000 for Q3 2025, up from $7,968,000 in Q3 2024[26] - GAAP gross margin improved to 69% in Q3 2025 from 67% in Q3 2024[24] Revenue Guidance and Projections - CareDx raised its 2025 revenue guidance to a range of $372 million to $376 million, up from the previous range of $367 million to $373 million[9] Product Development and Launches - The company introduced HistoMap Kidney, a new tissue-based gene expression profiler for kidney transplant patients[4] - CareDx launched AlloSeq Tx11, a next-generation HLA typing solution to enhance transplant risk profiling[4] Cash and Financial Position - Cash, cash equivalents, and marketable securities totaled $194.2 million as of September 30, 2025, with no debt outstanding[4] Leadership Changes - The company appointed Suresh Gunasekaran and Jeff Teuteberg to its Board of Directors and as Chief Medical Officer, respectively, to strengthen its leadership[4] Operating Expenses - Total GAAP operating expenses for Q3 2025 were $69,647,000, slightly higher than $69,032,000 in Q3 2024[22] - Non-GAAP operating expenses decreased to $57,853,000 in Q3 2025 from $52,221,000 in Q3 2024[22] - Sales and marketing expenses increased to $24,449,000 in Q3 2025 from $19,802,000 in Q3 2024, reflecting increased investment in growth initiatives[22] - Research and development expenses decreased to $15,449,000 in Q3 2025 from $15,711,000 in Q3 2024, indicating a focus on efficiency[22]