Original from: Genomeweb

CareDx reported after close of market on Thursday that its fourth quarter revenues increased 35 percent year over year, driven by testing services.

For the three months ending Dec. 31, 2021, the South San Francisco, California-based firm reported revenues of $79.2 million, compared to $58.6 million in Q4 of 2020, beating the average Wall Street analyst estimate of $78.1 million. 

Testing services drove this increase, logging $68.7 million in Q4 revenues, up 37 percent from $50.3 million in the year-ago period. Product revenues totaled $7.7 million in Q4, up 31 percent year over year from $5.9 million. Revenue from patient and digital solutions grew 21 percent in Q4 to $2.9 million from $2.4 million in Q4 of 2020.

The company provided approximately 41,900 AlloSure and AlloMap patient results in Q4, representing 67 percent year on year growth. 

"This was achieved despite Q4 being the second straight quarter of sequential decline in transplant volumes," CEO Reginald Seeto said during a conference call to discuss the financial results, "as Q4 saw the initial impact of the Omicron surge with kidney transplants down 4 percent and heart [transplants] down 2 percent sequentially versus Q3."

CareDx also launched its AlloSure Lung testing service in the fourth quarter and processed approximately 700 tests in that time. 

Net loss for the quarter amounted to $16.2 million, or $0.31 per share, up from $3.5 million, or $0.07 per share, during the same quarter last year. Adjusted net loss per share was $.03 in Q4, compared to net income of $.07 in the year-ago period, missing the average Wall Street estimate of a net income of $.02 per share. 

"Our profitability in Q4 was impacted by an increase in legal spending," Seeto said, reflecting the past year's litigation with Natera. 

The firm's Q4 research and development expenses increased by 66 percent to $22.1 million from $13.3 million during the same time period last year. 

Sales, marketing, general, and administrative expenses rose 55 percent in Q4 to $45.6 million from $29.5 million a year ago. 

For full-year 2021, the company reported revenues of $296.4 million, up 54 percent from $192.2 million in 2020 and beating the Wall Street consensus estimate of $295.0 million. 

Testing services revenues climbed 58 percent to $259.3 million in 2021 from $163.6 million in 2020, while product revenue increased 39 percent to $26.8 million from $19.3 million, and patient and digital solutions revenue rose 10 percent to $10.3 million from $9.3 million. 

AlloSure and AlloMap testing volumes grew 94 percent year over year to approximately 153,000 tests. 

The company's 2021 net loss totaled $30.7 million, or $.59 per share, compared to a net loss of $18.7 million, or $.40 per share, in 2020. Adjusted net loss per share was $.59, compared to $.40 in 2020, missing the Wall street average estimate of a net loss of $.35 per share. 

R&D expenses grew 56 percent in 2021 to $76.5 million from $48.9 million in 2020, while SG&A costs climbed 48 percent to $152.2 million from $102.7 million.

CareDx ended 2021 with $348.5 million in cash and cash equivalents. 

For 2022, the company expects revenues in the range of $330 million to $350 million. 

"The low end of the guidance assumes continued COVID-related impact on transplant procedure volumes, as well as impact on testing volumes," said Ankur Dhingra, the firm's CFO. He explained that the high end assumes recovery in demand from weak transplant volumes and the resumption of strong long-term growth trends in transplants. 

In Friday morning trading on Nasdaq, CareDx shares were down almost 4 percent at $38.53.

Source: CareDx Q4 Revenues Rise 35 Percent