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CareDx Q2 Revenues Up 48 Percent on Rapid Adoption of AlloSure Kidney Dx

NEW YORK (GenomeWeb) – CareDx reported after the close of the market on Thursday that its second quarter revenues rose 48 percent year over year, thanks to continued momentum from its kidney transplant test AlloSure.

For the three months ended June 30, the diagnostics company said revenues rose to $17.8 million from $12.0 million in Q2 2017, beating analysts' average estimate of $15.5 million.

Testing revenues rose 67 percent year over year to $14.0 million from $8.4 million, while product revenues rose 6 percent to $3.6 million from $3.4 million in the year-ago period. Collaboration and licensing revenues rose 10 percent to $276,000 from $250,000.

"The CareDx team delivered a record quarter, including 48 percent year-over-year revenue growth. The rapid clinical adoption of AlloSure demonstrates the medical need and the potential for better surveillance in this patient population," CareDx President and CEO Peter Maag said in a statement." We are executing well on our strategy to focus on peer-reviewed published clinical and analytical validation data and Medicare reimbursement. Our sole focus on transplantation sets us apart and creates a genomic informatics platform for future innovations and partnerships in transplant patient care."

The firm said it provided 2,300 AlloSure tests results to about 1,700 patients in Q2. It also provided 4,132 AlloMap heart transplant test results during the quarter, a 7 percent increase year over year. AlloSure is now being provided in 76 transplant centers in the US, supporting approximately 1 percent of the living kidney transplant patient population, the company added. On a conference call with analysts following the release of the earnings, Maag noted that this number of transplant centers exceeds the firm's projections and represents about half of the kidney transplant volume in the US.

Maag also said that the company is focusing on driving adherence to the AlloSure testing protocol, and that 793 new standing-order patients for AlloSure were added in Q2 for a total of about 1,500 standing-order patients who will follow the protocol for at least one year.

AlloMap rebounded from the small 3 percent growth it showed Q1, Maag noted, when it was adversely affected by inclement weather in several territories in the US. On the call, CareDx CFO Michael Bell also said that the Medicare reimbursement rate for AlloMap increased to $3,240 from $2,840 in January.

Also this quarter, the company said it launched HeartCare, a comprehensive diagnostic for the surveillance of heart transplant patients. The test combines AlloMap with AlloSure-Heart results to give clinicians indications of patients' immune system activity and graft health. Further, CareDx said it validated its Olerup QType HLA typing kit on multiple platforms in Q2 and received CE marking. The QType provides tissue typing laboratories with real-time HLA typing of donors and recipients of organ transplants, and can be performed on the Roche LightCycler and Applied Biosystems' platforms.

On the call, Maag said CareDx has been scaling up manufacturing of the QType to meet customer demand in the US and Europe, and that the kit is being used in 17 transplant labs. 

CareDx's Q2 2018 net loss widened to $14.1 million, or $.40 per share, from $4.0 million, or $.19 per share, a year ago. On an adjusted basis, the firm reported a net loss of $.04 per share for the quarter.

The company's R&D expenses for the quarter rose 13 percent to $3.5 million from $3.1 million in Q2 2017, and its SG&A costs rose 55 percent to $11.5 million from $7.4 million in the year-ago period.

CareDx ended the quarter with $16.2 million in cash and cash equivalents.

For full-year 2018, CareDx raised its guidance and now expects revenues of $68 million to $70 million. The firm had previously guided for revenues of $64 million to $66 million for the year. Analysts are expecting 2018 revenues of $65.2 million.

In morning trading on the Nasdaq, CareDx's shares rose 17 percent to $17.50.