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CareDx Reports Preliminary Revenue Results for Fourth Quarter and Full Year 2023

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CareDx, Inc. (CDNA) reported preliminary financial results for Q4 and full year 2023, with revenue expected to be in the range of $279-280 million, above guidance for fiscal year 2023. Testing Services patient results grew by 4%, while revenue for Patient and Digital Solutions and Products is expected to increase by 29% and 14% year-over-year, respectively. The company repurchased 2.8 million shares of common stock for $26 million and maintained a strong balance sheet with approximately $235 million in cash and cash equivalents and marketable securities, with no debt. However, revenue for the fourth quarter is expected to decrease by approximately 3% compared to the third quarter, driven by the impact of the Medicare Billing Article on Testing Services revenue.
Positive
  • Revenue expected to be above guidance for fiscal year 2023
  • Testing Services patient results grew by 4%
  • Patient and Digital Solutions and Products revenue expected to increase by 29% and 14% year-over-year, respectively
  • Repurchased 2.8 million shares of common stock for $26 million
  • Maintained a strong balance sheet with approximately $235 million in cash and cash equivalents and marketable securities, with no debt
Negative
  • Revenue for the fourth quarter is expected to decrease by approximately 3% compared to the third quarter
  • Revenue for the full year 2023 is expected to decrease by approximately 13% compared to 2022, primarily driven by the impact of the Medicare Billing Article on Testing Services revenue

The preliminary financial results from CareDx, Inc. indicate a mixed performance with both positive and negative takeaways for the company's stakeholders. The projected full-year 2023 revenue surpassing the high end of guidance presents a positive outlook, suggesting effective revenue management and potentially increased market demand for the company's transplant-related services. However, the anticipated year-over-year revenue decline of approximately 13% could raise concerns about the company's growth trajectory and market conditions, particularly in light of the Medicare Billing Article's impact on Testing Services revenue.

From a financial perspective, the share repurchase program, which saw 2.8 million shares bought back for $26 million, reflects a management strategy to return value to shareholders and possibly signal confidence in the company's intrinsic value. The strong balance sheet, characterized by substantial cash reserves and absence of debt, provides CareDx with financial flexibility and resilience against economic downturns or unexpected expenditures.

The sustained collection rate of over 100% of revenue for Testing Services for five consecutive quarters is noteworthy. This metric often reflects efficient billing and collection processes, which are crucial for cash flow stability in healthcare companies. However, investors might scrutinize the sequential decrease in Testing Services revenue in the fourth quarter, seeking clarity on whether this trend indicates a temporary fluctuation or a more systemic issue.

CareDx's performance in the transplant care sector reflects broader industry trends, where technological advancements and patient-centered solutions are increasingly valued. The growth in the Patient and Digital Solutions segment, with a year-over-year increase of 29%, aligns with the healthcare industry's shift towards digitalization and personalized patient care. This suggests that CareDx is effectively capitalizing on this trend and could be positioned to capture additional market share as digital health solutions continue to gain traction.

On the other hand, the decrease in Testing Services revenue, particularly when contrasted with the growth in patient testing volume, may point to pricing pressures or changes in reimbursement policies that could affect future earnings. The advocacy efforts to restore Medicare coverage for molecular blood testing underscore the significance of regulatory and reimbursement environments in the healthcare sector. Changes in these areas can have material implications for companies like CareDx that rely on such reimbursements for a substantial portion of their revenue.

Moreover, the growth in the Products segment, though modest at 14% year-over-year, indicates a steady demand for CareDx's transplant-related products. This could be a sign of the company's ability to maintain a competitive edge through innovation and quality in a market that is sensitive to technological advancements and clinical outcomes.

Analyzing CareDx's preliminary financial results from a healthcare industry perspective reveals several critical insights. The increase in patient results for Testing Services for the second consecutive quarter suggests that CareDx's diagnostic tests, such as AlloSure® and AlloMap®, maintain clinical relevance and are likely well-received in the transplant community. This is a positive indicator of the company's core service adoption and potential for long-term customer retention.

However, the broader financial context, with a decrease in overall revenue, brings to light the challenges faced in the reimbursement landscape. The Medicare Billing Article's impact highlights the vulnerability of healthcare companies to policy changes. This underscores the importance of having a diversified revenue stream and the ability to quickly adapt to regulatory shifts. For CareDx, maintaining momentum in Patient and Digital Solutions and Products may help mitigate the risks associated with its Testing Services segment.

The company's advocacy efforts to influence policy changes regarding Medicare coverage also demonstrate a proactive approach to managing external challenges that could have a significant impact on its financial health. The outcome of these efforts could be a determining factor in CareDx's future revenue potential and market position within the transplant diagnostic and care solutions space.

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 reported preliminary financial results for the fourth quarter and full year ended December 31, 2023.

Fourth Quarter and Full Year 2023 Highlights

  • Full year 2023 revenue is expected to be in the range of $279 million to $280 million, which is above the high end of guidance for fiscal year 2023.
  • Testing Services patient results grew for the second quarter in a row to approximately 39,900, an increase of 4% as compared to the third quarter of 2023.
  • Fourth quarter revenue for Testing Services is expected to be between $46 million and $47 million, a decrease of 3% as compared to the third quarter of 2023, which included one-time items previously discussed during third quarter earnings call.1
  • Full year revenue for Patient and Digital Solutions is expected to be approximately $37 million and for Products is expected to be approximately $33 million, up 29% and 14% year-over-year, respectively.
  • Repurchased 2.8 million shares of common stock for $26 million under share buyback program.
  • Maintained a strong balance sheet, with approximately $235 million in cash and cash equivalents and marketable securities, with no debt.
  • Achieved the fifth consecutive quarter of collections at over 100% of revenue for Testing Services.
  • Supported hundreds of transplant patient advocates on Capitol Hill urging President Biden and Health and Human Services (HHS) Secretary Becerra to restore Medicare coverage for molecular blood testing.

Preliminary revenue for the three months ended December 31, 2023, is expected to be between $65 million and $66 million, a decrease of approximately 3% compared with $67.2 million in the third quarter of 2023. Testing services revenue for the fourth quarter is expected to be between $46 million and $47 million, compared with $47.8 million in the third quarter of 2023 and compared with $65.4 million in the same period in 2022. Total AlloSure® and AlloMap® patient results provided in the fourth quarter were approximately 39,900. Patient and Digital Solutions revenue for the fourth quarter is expected to be $9.7 million, compared to $8.4 million in the same period in 2022. Product revenue for the fourth quarter is expected to be $9.2 million, compared to $8.6 million in the same period in 2022.

Preliminary revenue for the full year ended December 31, 2023, is expected to be between $279 million and $280 million, a decrease of approximately 13% compared with $321.8 million in 2022, primarily driven by the impact of the Medicare Billing Article on Testing Services revenue. Testing services revenue for 2023 is expected to be between $209 million and $210 million, compared with $263.7 million in 2022. Patient and Digital Solutions revenue for 2023 is expected to be $37.2 million, compared to $28.8 million in 2022. Product revenue for 2023 is expected to be $33.5 million, compared to $29.3 million in 2022.

Preliminary cash, cash equivalents, and marketable securities were approximately $235 million as of December 31, 2023.

“After setting a new volume baseline in Testing Services in the third quarter of 2023, we finished the year with upward momentum. The fourth quarter showed a second sequential quarter of patient testing volume growth,” said Alex Johnson, President of Patient and Testing Services, and a member of the Office of the Chief Executive Officer at CareDx. “Our team continues to execute well as we advance transplant patient care."

The preliminary financial information presented in this press release is based on CareDx’s current expectations and may be adjusted as a result of, among other things, the completion of customary annual audit procedures. CareDx will report its fourth quarter and full year 2023 financial results, and anticipates providing 2024 financial guidance during its earnings call for the fourth quarter of 2023.

About CareDx – The Transplant Company

CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.

Forward Looking Statements

This press release includes forward-looking statements, including expectations regarding CareDx’s fourth quarter and full year 2023 revenue, number of patient results, and cash, cash equivalents, and marketable securities as of December 31, 2023, its ability to advance transplant patient care, its prospects in 2024, and its anticipation to report 2023 financial results and provide 2024 financial guidance during its earnings call for the fourth quarter of 2023. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including the completion of the audit of CareDx’s 2023 financial statements, general economic and market factors, and global economic and marketplace uncertainties, among others discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed by CareDx with the SEC on February 27, 2023, the quarterly report on Form 10-Q for the quarter ended March 31, 2023 filed by CareDx with the SEC on May 10, 2023, the quarterly report on Form 10-Q for the quarter ended June 30, 2023 filed by CareDx with the SEC on August 8, 2023, and the quarterly report on Form 10-Q for the quarter ended September 30, 2023 filed by CareDx with the SEC on November 8, 2023, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Reference

  1. In the third quarter of 2023, MolDX covered HeartCare® for use in heart transplant surveillance for the first 12 months post-transplant. HeartCare tests not meeting the coverage criteria were not recognized in revenues in the third quarter, post Noridian adoption of the Billing Article. Lastly, revenues in the third quarter were positively impacted by a one-time claims settlement with a large Medicare advantage payer for outstanding claims.

 

CareDx, Inc.

Media Relations

Anna Czene

818-731-2203

aczene@caredx.com

Investor Relations

Greg Chodaczek

investor@caredx.com

Source: CareDx, Inc.

FAQ

What are CareDx, Inc.'s preliminary financial results for Q4 and full year 2023?

CareDx, Inc. (CDNA) reported preliminary financial results with revenue expected to be in the range of $279-280 million, above guidance for fiscal year 2023.

How much did CareDx, Inc. repurchase in shares of common stock?

CareDx, Inc. repurchased 2.8 million shares of common stock for $26 million.

What is the expected change in revenue for the fourth quarter of 2023 compared to the third quarter?

Revenue for the fourth quarter is expected to decrease by approximately 3% compared to the third quarter.

What is the impact of the Medicare Billing Article on CareDx, Inc.'s revenue for the full year 2023?

The revenue for the full year 2023 is expected to decrease by approximately 13% compared to 2022, primarily driven by the impact of the Medicare Billing Article on Testing Services revenue.

CareDx, Inc.

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caredx: transforming transplant patient care through novel surveillance management solutions caredx, inc. is dedicated to improving the lives of organ transplant patients through non-invasive diagnostics. by combining the latest advances in genomics and bioinformatics technology, with a commitment to generating high quality clinical evidence through trials and registries, caredx is at the forefront of organ transplant surveillance and pre-transplant hla typing solutions. nasdaq:cdna about allosure® allosure is the first and only non-invasive blood test that directly measures allograft injury and identifies the probability of active rejection to better manage kidney transplant patients. allosure is a clinical-grade, proprietary next-generation sequencing (ngs) based test to detect donor-derived cell-free dna (dd-cfdna) in order to identify organ injury in kidney transplant recipients. allosure is analytically validated as a sensitive, specific, and precise measurement of dd-cfdna. allos