CareDx Reports First Quarter 2023 Results

Original from: CareDx

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 financial results for the first quarter ended March 31, 2023.​

First Quarter 2023 Highlights

- Delivered record number of patient test results for AlloMap® and AlloSure® of approximately 49,900 tests, growing year-over-year by 17%, and exceeding year-over-year market growth of 10%.

- Reported revenue of $77.3 million, a decrease of 3% year-over year. This excludes approximately $8.9 million in revenue associated with approximately 3,200 AlloSure Kidney Medicare tests that the Company did not submit for reimbursement in Q1 2023 (the “Impacted March Tests”), and plans to submit in Q2 2023. This was to allow the Company further time to understand and evaluate the implications of the new Billing Article related to the Local Coverage Determination covering AlloSure Kidney entitled Molecular Testing for Solid Organ Allograft Rejection (the “Billing Article”) issued in early March 2023.

Including the revenue associated with the Impacted March Tests, total revenue would have been $86.2 million and testing services revenue would have been $70.7 million, increases of 9% and 6% year-over-year, respectively, which would have been the highest ever quarterly revenues for the Company and its Testing Services business.

- Achieved record revenues of $8.6 million for Patient and Digital Solutions business, an increase of 39% year-over-year.

- Reported GAAP net loss of $23.7 million, non-GAAP net loss of $5.8 million and adjusted EBITDA loss of $6.4 million. Including revenue associated with the Impacted March Tests, the Company would have achieved a positive adjusted EBITDA of $2.5 million.

- Maintained strong balance sheet with $285.9 million in cash and cash equivalents and marketable securities, with no debt. Generated $0.7 million in net cash from operating activities compared to $21.5 million of cash used in operating activities in the first quarter of 2022. This represents the second consecutive quarter where the Company generated positive cash from its operating activities.

- Achieved cash collections at 110% of revenue for testing services, representing an approximate 10% year-over-year increase, and demonstrating continued strong operational progress on this key initiative.

- Strong transplant ecosystem support in response to the Billing Article from leading professional societies, including the American Society of Transplantation, American Society of Transplant Surgeons, and the International Society for Heart and Lung Transplantation.

- Leading patient groups, including the Transplant Life Foundation, Transplant Recipients International Organization (TRIO), Transplant Families, and the Heart Brothers Foundation announced in a press release the results of a survey from over 1,000 patients, as well as caregivers and family members that 95% of patients surveyed are concerned that a new Medicare Billing Article limits coverage of non-invasive post-transplant tests.

“The first quarter delivered strong operational execution against our 2022 strategic plan, reflected in our record testing services volumes, record patient and digital solutions revenue, and second consecutive quarter of testing services cash collections exceeding testing services revenue,” said Reg Seeto, CEO and President of CareDx. “That said, we are currently laser focused on the operational implementation of our plans to address the recent MolDX Billing Article changes. I am proud to see the transplant ecosystem coming together, including the professional and patient associations, and healthcare providers, to support transplant patients.”

First Quarter 2023 Financial Results

Revenue for the three months ended March 31, 2023 was $77.3 million, a decrease of 3% compared with $79.4 million in the first quarter of 2022. Testing services revenue for the quarter was $61.8 million, compared with $66.4 million in the same period in 2022. Total AlloSure® and AlloMap® patient results provided in the quarter were approximately 49,900. This excludes approximately $8.9 million in revenue associated with the Impacted March Tests. Including the revenue associated with the Impacted March Tests, CareDx’s total revenue would have been $86.2 million and its testing services revenue would have been $70.7 million, which would have been the highest ever for CareDx and its Testing Services business. Product revenue in the three months ended March 31, 2023 was $6.9 million, compared to $6.8 million in the same period in 2022. Patient and digital solutions revenue in the first quarter of 2023 was $8.6 million, compared to $6.2 million in the same period in 2022.

For the first quarter of 2023, net loss was $23.7 million, compared to a net loss of $19.6 million in the same period in 2022. Basic and diluted net loss per share in the first quarter of 2023 was $0.44, compared to basic and diluted net loss per share of $0.37 in the first quarter of 2022.

Non-GAAP net loss was $5.8 million in the first quarter of 2023, compared to a non-GAAP net loss of $6.8 million in the first quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.11 in the first quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.13 in the first quarter of 2022.

Adjusted EBITDA for the first quarter of 2023 was a loss of $6.4 million, compared to an adjusted EBITDA loss of $5.6 million in the first quarter of 2022. Including the $8.9 million revenue impact associated with Impacted March Tests, the Company would have achieved a positive adjusted EBITDA of $2.5 million.

Cash and cash equivalents and marketable securities were $285.9 million as of March 31, 2023.

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Source: CareDx Reports First Quarter 2023 Results