Original from: CareDx

CareDx, Inc. (Nasdaq: CDNA) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Fourth Quarter and Full Year 2023 Highlights

·    Reported full year revenue of $280.3 million, exceeding the high end of updated guidance for 2023.

·    Reported full year Testing Services revenue of $209.7 million and delivered approximately 165,700 patient results in 2023.

·    Grew Testing Services patient results for the second quarter in a row to approximately 39,900, an increase of 4% as compared to the third quarter of 2023.

·    Reported full year revenue of $37.1 million for Patient and Digital Solutions and $33.5 million for Product, representing year-over-year growth of 29% and 15%, respectively.

·    Ended 2023 with cash and cash equivalents, and marketable securities of approximately $235.4 million, with no debt.

·    Achieved the fifth consecutive quarter of collections at over 100% of Testing Services revenue driven by revenue cycle management initiatives. Collected $17 million in cash over its revenue in 2023.

·    Repurchased 2.9 million shares of common stock for $27.5 million under share buyback program in 2023.

·    Received Medicare coverage for HeartCare and AlloSure Lung.

·    CareDx is in the process of seeking judicial review of January 2024 jury decision and monetary damages related to alleged infringement of patent ‘544.

“In 2023, we met our challenges head-on as we navigated the impact of Medicare coverage changes. We reset our operations, strategically reduced our cost structure, and created a growth pathway for the company in the second half of the year, as we continued to focus on care for transplant patients,” said Alex Johnson, President of Patient and Testing Services, and a member of the Office of the CEO at CareDx. “Looking forward to 2024, we are focused on delivering high-value clinical and digital solutions to improve allograft survival, while generating evidence for expanding payer coverage and accelerating our path back to profitability.”

Q4 2023 Financial Results

Revenue for the three months ended December 31, 2023, was $65.6 million, a decrease of 20% compared with $82.4 million for the fourth quarter of 2022. Testing Services revenue for the fourth quarter 2023 was $46.7 million, a decrease of 29% compared with $65.4 million in the same period in 2022. Testing Services revenue was negatively impacted due to the Medicare Billing Article changes.

Total AlloSure and AlloMap patient results provided in the fourth quarter 2023 were approximately 39,900, a decrease of 16% as compared to the same quarter a year ago, and an increase of 4% compared to the third quarter of 2023. Patient and Digital Solutions revenue for the fourth quarter 2023 was $9.6 million, compared to $8.4 million in the same period in 2022, an increase of 14%. Product revenue for the fourth quarter 2023 was $9.2 million, compared to $8.6 million in the same period in 2022, an increase of 8%.

For the fourth quarter of 2023, net loss was $118.1 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $18.3 million in the fourth quarter of 2022. Basic and diluted net loss per share in the fourth quarter of 2023 was $2.21, compared to basic and diluted net loss per share of $0.34 in the fourth quarter of 2022.

Non-GAAP net loss was $9.3 million in the fourth quarter of 2023, compared to a non-GAAP net loss of $3.7 million in the fourth quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.17 in the fourth quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.07 in the fourth quarter of 2022.

Adjusted EBITDA for the fourth quarter of 2023 was a loss of $10.3 million, compared to an adjusted EBITDA loss of $3.7 million in the fourth quarter of 2022.

Full Year 2023 Financial Results

Total revenue for the full year ended December 31, 2023, was $280.3 million, a decrease of 13% compared with $321.8 million in 2022. Testing Services revenue for the full year 2023 was $209.7 million, compared with $263.7 million in 2022, a decrease of 20%. Patient and Digital Solutions revenue for the full year 2023 was $37.1 million, compared to $28.8 million in 2022, an increase of 29%. Product revenue for the full year 2023 was $33.5 million, compared to $29.3 million in 2022, an increase of 15%.

Net loss for the full year 2023 was $190.3 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $76.6 million in 2022. Basic and diluted net loss per share for the full year 2023 was $3.54, compared to basic and diluted net loss per share of $1.44 in the full year 2022.

Non-GAAP net loss was $34.5 million for the full year 2023, compared to a non-GAAP net loss of $20.9 million for the full year ended 2022. Basic and diluted non-GAAP net loss per share was $0.64 in the full year of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.39 in the full year of 2022.

Adjusted EBITDA for the full year of 2023 was a loss of $38.0 million, compared to an adjusted EBITDA loss of $17.5 million for the full year of 2022.

Cash and cash equivalents and marketable securities were $235.4 million as of December 31, 2023. Reduced cash used in operations from $25.2 million in 2022 to $18.4 million in 2023.

For additional information regarding non-GAAP financial measures discussed herein, please see “Use of Non-GAAP Financial Measures,” “Reconciliation of GAAP to Non-GAAP Financial Measures,” “Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin,” and “Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures” below.

2024 Guidance

For the full year 2024, CareDx expects revenue to be in the range of $260 million to $274 million.

Source: CareDx Announces Fourth Quarter and Full Year 2023 Financial Results