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CareDx Q2 Revenues Rise 4 Percent; Miss Analyst Estimates

NEW YORK (GenomeWeb) – CareDx said after the close of the market on Monday that its revenues for the second quarter increased 4 percent year over year. 

For the three months ended June 30, the Brisbane, California-based firm recorded $7.1 million in total revenues, up from $6.8 million in Q2 2014. It missed the consensus Wall Street estimate of $7.3 million. 

Testing revenue for the recently completed quarter was $7 million, up from $6.8 million in the year-ago quarter, while collaboration and license revenues increased to $85,000 from $66,000. The firm said it administered and processed more than 3,250 AlloMap tests in Q2 2015, an 8 percent increase year over year and a record level, CareDx CFO Ken Ludlum said on company's conference call after the release of its financial results. AlloMap is a gene expression-based test for heart transplant rejection. 

On the call CareDx CEO Peter Maag said that the company is preparing for the release of AlloMap Variability as an additional tool for heart transplant clinicians. The tool uses four AlloMap test results during a 24-month period and will help physicians stratify patients, he said, adding early data suggests that higher AlloMap score variability is associated with poorer patient outcomes. 

"We believe that this will further enhance our heart transplant surveillance offering," Maag said. 

He also provided an update on the firm's DART kidney transplant study using cell-free DNA, and reiterated that the company expects to enroll 200 patients in six to 10 centers and to collect patients samples over a period of 18 months. 

The firm remains on track to provide an interim read-out in the first half of 2016. Following the interim analysis, CareDx plans to start the second phase of the DART study, which will be a clinical utility trial, in H2 2016, Maag said. 

On the company's Outcomes AlloMap Registry (OAR) study — which uses AlloMap to follow patients longitudinally over their lifetime — he said patient enrollment continues to grow, and as of June 30, more than 1,748 samples from 538 patients had been received. By comparison, at the end of Q1 2015 there were more than 1,300 samples received for the study. 

Meanwhile, the D-OAR study to assess cfDNA technology for heart transplants has been launched in 13 centers with 135 patients enrolled and 252 samples collected as of June 30. The number of patients and collected samples nearly doubled during Q2, Maag said.

CareDx reported a net loss of $3.2 million, or $.27 per share, in the quarter, compared to a profit of $877,000, or $.13 per share, in Q2 2014. It fell well short of analysts' average estimate of a loss of $.18 per share. 

Ludlam said on the call that CareDx's acquisition of Immumetrix in May 2014 provided the firm a one-time tax benefit of $1.5 million, "which swung earnings" into the black in Q2 2014.

Its research and development costs rose sharply year over year to $2.5 million from $792,000, while its SG&A expenses increased 26 percent to $4.9 million from $3.9 million.

The company ended Q2 with $36.9 million in cash and cash equivalents. 

It confirmed full-year 2015 revenue guidance of between $28 million and $30 million.