Financial Data and Key Metrics Changes - CareDx reported revenue of $67.2 million for Q3 2023, a 7% increase compared to the normalized revenue of $62.7 million in Q2 2023 [73][79] - Testing services revenue was $47.8 million, up approximately 5% from the normalized second quarter revenue of $45.6 million [68][96] - Adjusted EBITDA loss improved to $10.9 million from a normalized loss of $18.1 million in Q2 2023, reflecting a $7.2 million improvement [10][27][92] Business Line Data and Key Metrics Changes - The patient and digital solutions business generated $9.9 million in revenue, growing 33% year-over-year [12][74] - The lab products business achieved $9.5 million in revenue, also a 33% year-over-year increase, driven by the success of the NGS-based portfolio [74][80] - Non-GAAP gross margin for testing services was 74% in Q3 2023, up from 68% in the normalized second quarter [25][96] Market Data and Key Metrics Changes - Patient testing services volume stabilized, increasing by 2% quarter-over-quarter to approximately 38,400 tests [68][96] - The transplant market is expected to continue growing, with CareDx well-positioned to benefit from this trend [5][6] Company Strategy and Development Direction - CareDx's strategy focuses on investing in strong business lines and pipeline products to enhance transplant patient care and shareholder value [6] - The company is actively engaged in advocacy efforts to restore full patient access for Medicare beneficiaries, indicating a commitment to improving patient outcomes [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the leadership team during the CEO transition and emphasized the importance of executing the strategic plan for 2024 [3][28] - The company raised its full-year 2023 revenue guidance to a range of $274 million to $278 million, reflecting optimism about future performance [75][79] Other Important Information - CareDx maintained a strong cash position of $268.2 million with no debt, and collections exceeded 100% of reported test and services revenue for the fourth consecutive quarter [79][97] - The SEC concluded its inquiry without enforcement action against the company, providing a positive outcome for CareDx [79][120] Q&A Session Summary Question: What is the company's strategy for the new CEO search? - The board is looking for a leader who can execute the current strategic plan and improve performance for long-term growth [28] Question: Can you provide updates on the Sure study and heart care? - The company is actively analyzing data from the Sure study and expects to publish findings in 2024 [52] Question: What factors contributed to the stabilization of testing volumes? - Improved understanding and institutionalization of procedures at transplant centers have driven volume stabilization [112] Question: How does the company plan to address cash burn and improve margins? - The company is focusing on organic growth, increased reimbursement, and reducing elevated legal expenses to manage cash burn [99][108] Question: What is the status of reimbursement for heart care tests? - Currently, heart care tests are not being recognized for revenue post-Noridian adoption, impacting future revenue recognition [11][113]

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regu ...

Financial Data and Key Metrics Changes - The company reported revenues of $70.3 million for Q2 2023, a decrease of 13% year-over-year and 9% sequentially, primarily due to the impact of the billing article [58][34][35] - GAAP loss for the quarter was $25 million, with a non-GAAP loss of $9.9 million and adjusted EBITDA loss of $10.4 million [34][75] - The cash position remained strong at $283 million, debt-free, allowing for strategic acquisitions and share buybacks [18][50] Business Line Data and Key Metrics Changes - Testing services revenue was $53.4 million, down 14% sequentially and 20% year-over-year, attributed to billing article impacts [35][51] - Non-testing services business contributed approximately 30% of revenues, with Patient and Digital Solutions revenue at $9 million, a 33% increase year-over-year [40][58] - Product revenues reached $7.9 million, representing a 17% year-over-year increase [43][70] Market Data and Key Metrics Changes - The company achieved Medicare coverage for AlloSure Lung and reestablished coverage for HeartCare, which is expected to enhance market positioning [50][85] - The kidney testing services volume declined by approximately 25% compared to the previous quarter, primarily due to billing article restrictions [60][35] Company Strategy and Development Direction - The company is focused on executing its 2023 strategic plan centered around the "3 Cs": coverage, catalyst, and collections [16][19] - The recent acquisition of MediGO aims to strengthen the company's position in the transplant ecosystem [41][46] - The company plans to continue investing in transplant innovation and expanding its product offerings, particularly in the digital solutions space [41][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the transplant market, anticipating a rebound in transplant volumes [96][97] - The company expects Q3 2023 to be a low point for testing services revenue, with a return to growth anticipated in subsequent quarters [88][85] - Management highlighted the resilience of the organization in adapting to changes brought by the billing article and emphasized ongoing efforts to improve operational efficiency [31][84] Other Important Information - The company achieved an adoption target of over 80% for new Test Requisition Forms (TRFs) two quarters ahead of schedule [18][29] - Legal expenses are expected to remain elevated in the near term due to ongoing litigation matters [74][81] Q&A Session Summary Question: Volume trajectory and market trends - Management acknowledged a rebound in overall transplant market volumes but noted disruptions caused by multiple billing articles [96][97] Question: TRF goals and implementation - Management indicated that the rapid adoption of new TRFs was facilitated by strong relationships with transplant centers and ongoing education efforts [100][102] Question: Guidance for second half of the year - Management provided a revenue guidance range of $240 million to $260 million for 2023, factoring in uncertainties related to billing article revisions [85][88] Question: HeartCare approval implications - Management emphasized the strategic importance of HeartCare approval and its potential to influence commercial payer coverage [117][120] Question: SHORE study and Medicare coverage - Management confirmed ongoing efforts to generate data from the SHORE study to support future Medicare coverage requests [120][126] Question: Kidney care data submission to Medicare - Management highlighted the importance of completing the KOAR study to gather data for future submissions to Medicare [129][130]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________________________________ FORM 10-Q __________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36536 __ ...

Financial Data and Key Metrics Changes - The company reported total revenues of $77.3 million for Q1, down 3% year-over-year. If including the revenue associated with impacted March tests, revenues would have been $86.2 million, representing a 5% increase compared to the last quarter and 9% year-over-year [16] - Testing services revenue for Q1 was $61.8 million, down 7% year-over-year. Including impacted March tests, it would have been $70.7 million, marking an 8% growth compared to the last quarter and 6% year-over-year [17] - The company maintained a solid cash position of $286 million and generated positive cash from operations for the second consecutive quarter [13][30] Business Line Data and Key Metrics Changes - The Digital and Patient Solutions business revenue was $8.6 million, a growth of 39% year-over-year, marking the highest ever for this business line [25] - The Products business delivered $6.9 million in revenue, similar to the same quarter a year ago, with GAAP gross margin improving to 41% from 35% year-over-year [27] Market Data and Key Metrics Changes - Testing volume growth of 17% year-over-year outpaced market growth of 10%, demonstrating the value of the company's tests [18] - The company experienced lower testing volumes post-implementation of new billing articles as centers transitioned to updated processes [35] Company Strategy and Development Direction - The company is restructuring its workforce, aiming to reduce approximately 12% of its headcount to align with the evolving landscape and achieve annualized cost savings of $40 million to $50 million [40][42] - The management team is focused on operationalizing the updated 2023 plan in response to revised billing articles, emphasizing the importance of education and adoption among transplant centers [6][34] Management's Comments on Operating Environment and Future Outlook - Management has withdrawn guidance due to uncertainties related to the billing article revisions and plans to revisit this in the next quarterly earnings call [5][43] - The company expects to see an increase in the adoption of new forms to approximately 80% to 85% by the fourth quarter of 2023 as more transplant center systems are updated [3][37] Other Important Information - The company does not anticipate needing to raise cash in the near future, maintaining a strong financial profile with no debt [10][45] - The company is actively engaging with MolDx, Noridian, and CMS regarding the changes in billing articles and their implications [7][121] Q&A Session Summary Question: Can you provide more granularity on testing volumes and their trends? - Management indicated that testing volumes have dropped due to the transition to new test requisition forms, with early indications showing a range of high-teens in volume [54] Question: How do you foresee the impact of the new billing articles on testing frequency? - Management emphasized that operational readiness of centers is crucial, and the focus is on getting centers operationally ready to handle the new requirements [55] Question: Can you elaborate on the $40 million to $50 million in annualized cost savings? - Management stated that actions have already been initiated, with a significant portion of savings expected to be realized in Q3 [60] Question: What is the status of the $8.9 million in delayed March orders? - Management confirmed that these orders were not submitted due to the new billing requirements and will be recognized in Q2 once the necessary information is collected [73][76] Question: Are there any updates on the DOJ investigation and the lawsuit against the liability insurance provider? - Management indicated there are no material updates on the DOJ and SEC inquiries, and the lawsuit against the insurance provider is to recover expenses incurred from legal cases [127][129]

Table of Contents For the transition period from to Commission file number: 001-36536 __________________________________________________ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ Indicate by check m ...

Financial Data and Key Metrics Changes - The company reported quarterly revenues of $82.4 million, representing a 4% year-over-year growth, and full-year revenues of $321.8 million, reflecting a 9% year-over-year growth [80][81] - Testing services revenue for Q4 declined by 5% year-over-year to $65.4 million, while full-year testing services revenues grew by 2% year-over-year to $263.8 million [108][110] - The company achieved record cash collections at 110% of testing services revenues in Q4, marking a 10% year-over-year increase [78][93] Business Line Data and Key Metrics Changes - Testing volumes grew by 19% year-over-year, significantly outpacing the transplant volume market growth of 4% [80][109] - The product revenues and patient and digital solution revenues showed meaningful growth year-over-year, with products and digital accounting for over 20% of total revenues in Q4 [80][81] - The company expects testing services revenue growth to be in the low to mid-single digits, while non-testing services are projected to grow in the high single digits [66] Market Data and Key Metrics Changes - The payer mix shifted to 68% commercial in Q4, up from 62% in the same quarter last year, impacting revenue growth due to an increase in non-reimbursed tests [111] - The company noted a negative impact on revenue growth from the shift from Medicare to Medicare Advantage, estimating a potential $20 million in incremental cash revenue if paid at the same rate as other reimbursed tests [111] Company Strategy and Development Direction - The company is focused on the "3Cs": catalysts, coverage, and collections, which represent pivotal opportunities for growth [83][92] - The company plans to launch new products such as AlloMap Kidney and UroMap, which will enhance its portfolio of post-transplant monitoring solutions [83][84] - The company aims to achieve profitable adjusted EBITDA in the first half of 2023, supported by a robust balance sheet and improved cash collections [78][99] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the potential for increased coverage following new guidelines from the International Society of Heart and Lung Transplantation, which support the expanded use of the company's heart care solutions [90] - The management acknowledged challenges in the transplant market, including staffing shortages and a decline in living donor transplants, but remains hopeful for recovery in the coming years [102] - The company is committed to maintaining a strong financial profile and is focused on achieving adjusted EBITDA profitability [97][99] Other Important Information - The company ended 2022 with $293 million in cash and cash equivalents, with no debt, providing flexibility for future investments [78][99] - The company has initiated discussions with payers regarding the new guidelines, which could lead to increased reimbursement over time [90] Q&A Session Summary Question: What is the feedback from payers regarding the ISHLT guidelines? - Management reported positive receptivity from payers and initiated discussions to present information supporting earlier coverage based on the new guidelines [9][10] Question: What is the current status of the transplant volume growth? - Management indicated a negative 3% sequential decline in transplant volumes, with challenges such as staffing shortages and living donor transplants not rebounding [15][16] Question: How does the company plan to achieve adjusted EBITDA positivity? - Management highlighted the importance of market volume growth and managing expenses as key factors to maintain positive adjusted EBITDA [45][47] Question: What is the expected impact of the HLA Data Systems acquisition? - Management stated that the acquisition would not materially impact revenue in 2023 but is part of a strategy to enhance digital capabilities [51] Question: What are the expectations for cash collection improvements? - Management indicated that cash collections are expected to exceed testing services revenues as the company catches up on delayed processes [27]

Financial Performance - Q4 revenue reached $82.4 million, a 4% year-over-year increase[9, 60, 64, 83] - Testing services revenue accounted for $65.4 million[9, 60, 64, 83] - Product revenue was $8.6 million[9, 60, 64, 83] - Digital and Patient Solutions generated $8.4 million in revenue[9, 60, 64, 83] - The company holds $293 million in cash and marketable securities[9, 60, 64, 83] - Net loss was ($18.3 million), with an adjusted EBITDA of ($3.7 million)[9, 60, 64, 83] - GAAP gross margin was 64%, while adjusted gross margin was 67%[9, 60, 64, 83] Testing and Volume - Testing volume reached 47,700 tests, a 2% sequential increase and 14% year-over-year increase[9, 60, 64, 83] - Testing represented 73% of the business[8, 20, 50, 52, 59, 64, 72, 82] Future Outlook - 2023 revenue guidance is projected to be between $328 million and $338 million[33, 73]

Environmental Matters Table of Contents company☐ company☐ Portions of the registrant's Proxy Statement relating to the 2023 Annual Meeting of Stockholders, are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. Such Proxy Statement, or an amendment to this Annual Report on Form 10-K, will be filed with the Securities and Exchange Commission within 120 days after the end of the registrant's fiscal year ended December 31, 2022. TABLE OF CONTENTS PART III 127 Item 10. D ...

CareDx, Inc (NASDAQ:CDNA) Q3 2022 Earnings Conference Call November 3, 2022 4:30 PM ET Company Participants Ian Cooney - VP, IR Reg Seeto - CEO Abhishek Jain - Interim CFO Conference Call Participants Brandon Couillard - Jefferies Operator Good day, ladies and gentlemen, and welcome to the CareDx, Incorporated Third Quarter 2022 Earnings Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Ian Cooney. Please go ahead. Ian Cooney Good afternoon, and ...