Core Viewpoint - A shareholder class action lawsuit has been filed against CareDx, Inc. for allegedly making false and misleading statements regarding its business practices and financial success during the Class Period from April 30, 2020, to November 3, 2022 [1] Group 1: Allegations Against CareDx - CareDx is accused of attributing its financial success to legitimate demand for its testing services, while in reality, it relied on unethical practices, including fraudulent billing to Medicare for unnecessary tests and paying kickbacks to doctors [2] - The company allegedly exploited its RemoTraC home testing program to promote its AlloSure tests, which cost Medicare $2,841 each, to patients who did not require them [2] Group 2: Impact on Stock and Investor Awareness - The lawsuit highlights a series of partial disclosures that revealed the truth about CareDx's operations between October 2021 and November 2022 [3] - On October 28, 2021, CareDx's stock price dropped by $19.34 per share, over 27%, following the announcement of investigations by the DOJ, SEC, and a state regulatory agency related to a False Claims Act investigation [4] - The stock continued to decline, reaching as low as $16.00 per share, as further negative information was disclosed, including executive resignations and a whistleblower complaint [4] Group 3: Legal Proceedings - The investigation aims to determine whether CareDx's board of directors violated securities laws or breached fiduciary duties in connection with the alleged misconduct [5] - Current shareholders who purchased shares before October 28, 2021, are encouraged to seek information about their legal rights and options [6]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ________________________________________________________________________________________________________ Form 10-K ________________________________________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF TH ...

The Transplant Solutions Company •F E B R U A R Y 2 6 , 2 0 2 5 Click to edit Master text styles Click to edit Master title style Patrick G, Kidney Transplant Recipient 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, i ...

Financial Data and Key Metrics Changes - CareDx reported quarterly revenue of $86.6 million for Q4 2024, representing a 32% year-over-year increase [10] - Full year 2024 revenue reached $334 million, up 19% year-over-year, exceeding the high end of guidance [36] - Adjusted EBITDA for Q4 was $9.8 million, with a full year adjusted EBITDA of $27.8 million, a significant improvement from a loss of $38 million in 2023 [10][42] - The company ended the year with a cash balance of $261 million and no debt, generating $22 million in cash from operations in Q4 [10][44] Business Line Data and Key Metrics Changes - Testing Services revenue for Q4 was $63.8 million, up 37% year-over-year, with approximately 45,500 tests delivered, marking a 14% increase [12][13] - Patient and Digital Solutions revenue was approximately $11.4 million in Q4, representing an 18% year-over-year growth [15] - Lab Products revenue also reached $11.4 million, showing a 23% year-over-year increase, driven by sales of AlloSeq Tx NGS-based HLA typing kits [17] Market Data and Key Metrics Changes - CareDx expanded payer coverage significantly, adding or expanding coverage for 28 million lives for AlloMap Heart and 36 million lives for AlloSure in 2024 [14] - Approximately 5% of CareDx's revenue comes from outside the U.S., with significant potential for growth in the European market [19] Company Strategy and Development Direction - The company aims for long-term profitable growth, targeting $370 million in revenue for 2025 and $500 million by 2027, with a focus on operational excellence and scaling business profitably [10][48] - Key growth drivers include a go-to-market strategy to provide comprehensive solutions to transplant centers, evidence generation to expand payer coverage, and operational excellence to improve efficiency [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving significant milestones in 2025, particularly with the anticipated implementation of the IOTA program for kidney transplant centers [23][24] - The company is focused on enhancing patient adherence to immunosuppressants through a medication therapy management program launching in 2025 [26] Other Important Information - The company has initiated a share buyback program of up to $50 million over two years, reflecting confidence in its financial position [44] - A significant legal victory reversed a prior $96 million verdict, positively impacting the company's financial statements for 2024 [42] Q&A Session Summary Question: Can you discuss efforts in converting existing accounts with fewer than three solutions to three or more solutions? - Management highlighted the focus on the XynQAPI product for quality reporting and the launch of a medication therapy management program to assist patients with drug interactions, which will drive the use of AlloSure [56] Question: What is the path forward regarding litigation after the reversal of the $96 million verdict? - Management indicated that while an appeal is likely, the reversal allows for strategic capital allocation, including reinvestment in growth opportunities and share buybacks [66] Question: Can you clarify the impact of prior period collections on Q4 revenue and guidance for 2025? - Q4 revenue included approximately $2.2 million from prior period collections, with no contributions from these one-time tests included in the 2025 guidance [72][73] Question: How much of the mid-teens volume growth in 2025 is expected from increased surveillance testing? - Management believes surveillance testing will significantly contribute to mid-teens volume growth, with ongoing discussions to turn on protocols at transplant centers [75] Question: What opportunities exist to improve revenue capture through the billing organization? - The company is focused on enhancing billing processes and systems to improve cash collection, with a new leader in place to drive these initiatives [87][90] Question: Can you remind us of the objectives of the KOAR study? - The KOAR study is a prospective multicenter study evaluating the efficacy of AlloSure Kidney to detect rejection, which is crucial for payer acceptance and product adoption [96]

CareDx (CDNA) Q4 2024 Earnings Call February 27, 2025 08:49 AM ET Company Participants Caroline Corner - Vice President of Finance and Investor RelationsJohn Hanna - President and CEOAbhishek Jain - CFOPrashant Kota - Equity Research AssociateAndrew Cooper - VP - Equity ResearchEduardo Martinez-Montes - Biotechnology Equity Research AssociateThomas DeBourcy - Principal Conference Call Participants None - AnalystMark Massaro - Managing Director - Senior Equity Research AnalystWilliam Bonello - Senior Researc ...

Core Insights - CareDx reported $86.58 million in revenue for Q4 2024, a 32% year-over-year increase, with an EPS of $0.18 compared to -$0.17 a year ago [1] - The revenue exceeded the Zacks Consensus Estimate of $85.5 million by 1.26%, and the EPS surpassed the consensus estimate of $0.07 by 157.14% [1] Revenue Breakdown - Revenue from Patient and Digital Solutions was $11.39 million, exceeding the average estimate of $10.99 million by analysts, representing an 18.4% year-over-year increase [4] - Revenue from Testing Services reached $63.82 million, compared to the average estimate of $62.20 million, marking a 36.7% year-over-year increase [4] - Revenue from Products was $11.37 million, surpassing the average estimate of $10.83 million, reflecting a 23% year-over-year increase [4] Stock Performance - CareDx shares have returned -8.5% over the past month, while the Zacks S&P 500 composite has changed by -2.3% [3] - The stock currently holds a Zacks Rank 2 (Buy), indicating potential for outperformance in the near term [3]

Financial Results and Guidance - CareDx, Inc. announced preliminary financial results for Q4 and the year ended December 31, 2024[4]. - The company provided 2025 revenue guidance, details of which are included in the press release[4]. - The financial results and guidance are intended to inform stakeholders and are not deemed "filed" under the Exchange Act[5]. - The company has not disclosed specific financial figures in the provided documents[4]. Corporate Communication - The corporate presentation dated January 13, 2025, is intended to be posted on the company's website[6]. - The press release and corporate presentation are attached as Exhibits 99.1 and 99.2, respectively[9]. - The report was issued on January 13, 2025, indicating the company's commitment to timely communication with investors[12]. Company Information - CareDx, Inc. is registered under the Securities Exchange Act of 1934 and is listed on The Nasdaq Stock Market LLC with the symbol CDNA[2]. - The company is not classified as an emerging growth company under the relevant regulations[3]. - The report was signed by John W. Hanna, President and CEO of CareDx, Inc.[13].

Core Insights - CareDx (CDNA) shares increased by 11.2% to $24.91, following a significant trading volume, contrasting with a 5.2% decline over the past month [1] - The upcoming fourth-quarter 2024 financial results are anticipated to show approximately 30% year-over-year revenue growth, with testing services volume increasing by 14% [2] - The consensus EPS estimate for the quarter is $0.07, reflecting a year-over-year increase of 141.2%, with expected revenues of $85.5 million, up 30.4% from the previous year [3] Earnings and Revenue Expectations - Adjusted EBITDA is projected to be between $25 million and $26 million for the fourth quarter [2] - The consensus EPS estimate has been revised 13.2% higher in the last 30 days, indicating a positive trend that typically leads to price appreciation [4] Industry Context - CareDx is part of the Zacks Medical Services industry, which includes other companies like LifeMD, Inc. (LFMD), that saw a 5.5% increase in its last trading session [4] - LifeMD's EPS estimate remains unchanged at -$0.06, representing a 50% year-over-year change [5]

Group 1 - CareDx (CDNA) closed at $23.10, with a 1.7% gain over the past four weeks, and a mean price target of $32.86 indicating a 42.3% upside potential [1] - The average price targets range from a low of $24 to a high of $40, with a standard deviation of $6.39, suggesting variability in analyst estimates [2] - Analysts show strong agreement in revising earnings estimates higher, with a 21.9% increase in the Zacks Consensus Estimate for the current year [10][11] Group 2 - The consensus price target is often questioned for its reliability, as empirical research indicates that it rarely predicts actual stock price movements [5][6] - A low standard deviation among price targets indicates a high degree of agreement among analysts regarding the stock's price direction [7] - CDNA holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11][12]

Company Overview - CareDx (CDNA) is a notable stock within the Medical group, which consists of 1010 companies and currently ranks 3 in the Zacks Sector Rank [2] - CareDx has a Zacks Rank of 2 (Buy), indicating a positive earnings outlook with a 36.9% increase in the consensus estimate for full-year earnings over the past quarter [3] Performance Comparison - Year-to-date, CareDx has returned approximately 6.7%, significantly outperforming the Medical sector's average return of -0.6% [4] - In comparison, DaVita HealthCare (DVA) has also outperformed the sector with a year-to-date return of 15.8% [4] Industry Context - CareDx operates within the Medical Services industry, which includes 59 companies and currently ranks 151 in the Zacks Industry Rank; this industry has seen an average loss of 6.7% this year, highlighting CareDx's superior performance [5] - DaVita HealthCare belongs to the Medical - Outpatient and Home Healthcare industry, which consists of 18 stocks and is ranked 69, with a year-to-date increase of 16.9% [6]