CareDx, Inc. (NASDAQ:CDNA) Q4 2023 Earnings Conference Call February 28, 2024 4:30 PM ET Company Participants Gregory Chodaczek - Managing Director of Investor Relations Alexander Johnson - President of Patient and Testing Services Abhishek Jain - CFO Michael Goldberg - Chairman Robert Woodward - Chief Scientific Officer Conference Call Participants Andrew Cooper - Raymond James Alex Nowak - Craig-Hallum Yi Chen - H.C. Wainwright Operator Greetings, and welcome to CareDx, Inc. Fourth Quarter 2023 Earnings C ...

Stock-based Compensation We use the Black-Scholes Model, which requires the use of estimates such as stock price volatility and expected option lives, to value employee stock options. We estimate the expected option lives using historical data, estimate volatility using our own historical stock prices, estimate risk-free rates using the implied yield currently available in the U.S. Treasury zero-coupon issues with a remaining term equal to the expected option lives, and estimate dividend yield using our exp ...

Wall Street analysts forecast that CareDx (CDNA) will report quarterly loss of $0.24 per share in its upcoming release, pointing to a year-over-year decline of 242.9%. It is anticipated that revenues will amount to $65.1 million, exhibiting a decline of 21% compared to the year-ago quarter.Over the past 30 days, the consensus EPS estimate for the quarter has remained unchanged. This demonstrates the covering analysts' collective reassessment of their initial projections during this period.Ahead of a company ...

BRISBANE, Calif.--(BUSINESS WIRE)--CareDx, Inc. (Nasdaq: CDNA) —The Transplant Company™ — a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers — today announced that it will be showcasing the breadth of its specialized digital solutions and the latest advancements in its cellular therapy and transplant monitoring pipeline at the 2024 Tandem Meetings, Transplantati ...

BRISBANE, Calif.--(BUSINESS WIRE)--CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced the jury verdict in the patent litigation brought by Natera, Inc. (Nasdaq: NTRA). CareDx was found to have not infringed on Natera patent 10,655,180 (the ‘180 patent) and found to have infringed on Natera patent 11,111,544 (the ‘544 patent). ...

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 ...

CareDx, Inc. (NASDAQ:CDNA) Q2 2023 Earnings Conference Call August 8, 2023 4:30 PM ET Company Participants Greg Chodaczek - Gilmartin Group, IR Reg Seeto - President, CEO Abhishek Jain - CFO Robert Woodward - SVP, R&D Conference Call Participants Andrew Cooper - Raymond James Brandon Couillard - Jefferies Alex Nowak - Craig-Hallum Capital Mason Carrico - Stephens Inc. Operator Greetings, and welcome to the CareDx, Incorporated Second Quarter 2023 Earnings Conference Call. [Operator Instructions] As a remind ...

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]