Original from: 360DX

CareDx reported after the close of the market on Monday year-over-year revenue gains of 4 percent for the fourth quarter of 2022 and 9 percent for the full year.

The Brisbane, California-based company finished the three months ended Dec. 31 with $82.4 million in revenues compared to $79.2 million for the same quarter in 2021, narrowly beating analysts' average estimate of $81.7 million. 

The firm attributed much of the increase to cash collection, which amounted to 110 percent of testing service revenues in the quarter, representing an approximately 10 percent year-over-year rise. The company also said that it provided approximately 47,700 AlloMap and AlloSure patient results in Q4, up 14 percent from the prior-year quarter. Fourth quarter test volume also included 2,300 AlloSure Lung tests.

Testing services revenue for the fourth quarter of 2021 fell 5 percent to $65.4 million from $68.7 million in the same period of 2021. At the same time, fourth quarter product revenues rose 12 percent year-over-year to $8.6 million from $7.7 million. Revenue from patient and digital solutions nearly tripled Q4 to $8.4 million from $2.9 million.

In a conference call with investors, CareDx President and CEO Reg Seeto commented on the potential for further growth in test revenue, noting that during the fourth quarter, the International Society of Heart and Lung Transplantation announced new guidelines that support expanded use of AlloMap and AlloSure in routine monitoring of heart transplant patients. 

"This inclusion in ISHL guidelines should lead to increased reimbursement over time," he said.

Seeto also noted that the company is working with Palmetto's MolDx program to acquire Medicare coverage for AlloSure Lung. 

"This potential improvement in coverage represents the single greatest opportunity for the company," he stated.

CareDx's Q4 R&D spending rose 7 percent to $23.6 million from $22.0 million a year ago, while its SG&A expenses grew 7 percent to $48.5 million from $45.5 million a year ago.

Fourth quarter net loss increased to $18.3 million, or $.34 per share, from $16.2 million, or $.31 per share, in the same quarter a year ago. CareDx reported an adjusted loss per share of $.07, bettering the Wall St. expectation of a loss per share of $.09.

CareDx reported $321.8 million in total revenues for 2022, up 9 percent from $296.4 million in 2021. Annual testing service revenue rose 2 percent year-over-year to $263.7 million from $259.3 million. Similarly, product revenue rose 9 percent to $29.3 million from $26.8 million in the prior year. Full-year revenue from patient and digital solutions again nearly tripled to $28.8 million in 2022 from $10.3 million a year ago.

The company said that its full-year AlloMap and AlloSure testing volumes grew 19 percent to approximately 182,000 tests.

The company's full-year R&D spending shot up 18 percent to $90.4 million from $76.5 million in 2021, while its SG&A expenses ballooned 29 percent to $196.4 million from $152.2 million a year earlier.

CareDx CFO Abishek Jain attributed part of the spending spike to clinical study payments and to a partnership-related milestone payment made to an undisclosed entity.

Full-year net loss rose to $76.6 million, or $1.44 per share, from $30.7 million, or $.59 per share in 2021. Adjusted loss per share was $.39, bettering analysts' average expectation of a loss per share of $.41.

Seeto noted that fourth quarter transplant volumes only grew by 2 percent sequentially, part of a downward sequential trend that has continued into 2023, with current quarterly data for the first seven weeks showing a 3 percent decline across all organs. 

"One of the key reasons behind this trend is that living donor kidney transplants remain below the pre-COVID levels and staffing shortages [are] continuing in the transplant hospital centers," he said.

However, Seeto stated that the firm sees potential for volumes to double in the next five to 10 years. 

CareDx finished the year with $89.9 million in cash and cash equivalents and $203.2 million in marketable securities.

The company said it anticipates full-year 2023 revenue within the range of $328 million to $338 million.

Source: CareDx Q4, Full-Year Revenues Rise on Back of Cash Collections, Test Volumes