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CareDx Q1 Revenues Grow 22 Percent

NEW YORK (GenomeWeb) – CareDx said after the close of the market on Tuesday that its first quarter revenues grew 22 percent year over year. 

For the three months ended March 31, the Brisbane, California-based molecular diagnostics firm posted $7.2 million in revenues, up from $5.9 million in Q1 2014, and beating the consensus Wall Street estimate of $6.8 million. 

Testing revenue — consisting of revenues generated by CareDx's AlloMap gene expression-based test for heart transplant rejection — increased to $7.1 million from $5.8 million a year ago, while collaboration and license revenues rose to $120,000 from $90,000. 

On a conference call following the release of the firm's financial results, CareDx CEO Peter Maag said that the AlloMap technology was used approximately 3,100 times in Q1 2015, an 11 percent increase year over year. 

He also said that the French Ministry of Health has approved funding for a multimillion-dollar initiative that will allow 15 transplant centers in France to use AlloMap technology for monitoring purposes. In January, CareDx announced that its European distributor for the test, Diaxonhit, had signed a service sublicensing deal with Strasbourg University Hospitals in France to perform AlloMap testing at a dedicated facility in Strasbourg. 

While Maag called the French funding an "important milestone" in driving up adoption of the test in Europe, he said CareDx anticipates only a "modest" contribution from revenues outside the US for 2015. 

In addition to increasing adoption of the AlloMap platform, CareDx is also focused on advancing its cell-free DNA surveillance program and has initiated a development and reproductive toxicology, or DART, study. 

The study is to evaluate the clinical performance of circulating cell-free DNA for detecting clinical and subclinical rejection in kidney allograft recipients. It also is designed to demonstrate the correlation of circulating cfDNA to renal functions. 

DART's first patients have been enrolled at the Cleveland Clinic, Maag said. In the first phase of the study, CareDx anticipates enrolling 200 patients in at least six centers and collecting patient samples during a period of 18 months. Interim results from the study are expected in the first half of 2016. 

"The team is laser-sharp focused on engaging centers and recruiting patients into the trial," he said on the call. 

CareDx had a net loss for the quarter of $2.3 million, or $.19 per share, compared to a net loss of $1.3 million, or $1.29 per share, in Q1 2014. The average analysts' estimate was for a loss of $.18 per share. 

The firm, which went public in July 2014, used more than 11.8 million shares to calculate its loss-per-share figure in the recently completed quarter, compared to 1 million shares in Q1 2014.

Its R&D spending nearly doubled year over year to $1.4 million from $720,000. On the call, CareDx CFO Kenneth Ludlum said the increase was driven by the initiation of its cell-free DNA program. The firm's SG&A costs grew 42 percent to $4.7 million from $3.3 million. 

CareDx finished the first quarter with $39 million in cash and cash equivalents. 

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