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CareDx Q1 Revenues Up 84 Percent

NEW YORK (GenomeWeb) – CareDx reported after the close of the market on Wednesday that its first quarter revenues rose 84 percent year over year, thanks largely to a 103 percent increase in testing services revenues.

For the three months ended March 31, the molecular diagnostics company reported total revenues of $26.0 million, up from $14.1 million during the same period a year earlier, and beating the average Wall Street analyst estimate of $24.3 million.

Testing services revenues more than doubled to $21.5 million from $10.6 million in the prior-year quarter and product revenues rose 33 percent to $4.4 million from $3.3 million in Q1 2018. License and other revenues sank 78 percent to $31,000 from $142,000.

CareDx also said it returned 5,710 results from its AlloSure blood-based, donor-derived, cell-free DNA test for organ transplant rejection to approximately 4,300 kidney transplant patients during Q1, and that it provided 4,280 AlloMap heart transplant test results, an increase of 11 percent year over year. On a conference call with analysts following the release of the earnings, CareDx CEO Peter Maag said that 101 US transplant centers provided AlloSure results to their patients during Q1.

"We estimate these 101 centers account for approximately 60 percent of the transplant volume in the United States," he added. "Since launching AlloSure in October 2017, we have provided results to over 8,000 patients, which equates to approximately 4 percent of the total number of living kidney transplant patients. Demand for AlloSure remains broad and includes both patients who recently received a kidney transplant, as well as patients that received their kidney allograft in previous years."

Maag also noted that overall reimbursement in the first quarter was consistent with previous quarters, with 70 percent to 80 percent of AlloSure volume attributed to Medicare patients. The Brisbane, California-based company finished Q1 with 3,644 surveillance patients, defined as patients who are managed by CareDx on a predefined transplant center testing protocol. "These 3,644 surveillance patients helped build the recurring revenue effect of AlloSure," Maag said.

Growth in the firm's product revenues was driven by sales of its TruSight HLA and QType products. Maag added that CareDx is on track to introduce its planned new AlloSeq NGS products in 2019: AlloSeq for HLA typing, an AlloSeq cell-free DNA kit, and AlloSeq BMT for bone marrow transplant testing.

He further noted that CareDx closed its acquisition of OTTR Complete Transplant Management. The firm announced its $16 million acquisition of OTTR in late April.

CareDx CFO Michael Bell added that the company expects OTTR revenues for full-year 2019 to be $6 million to $8 million, or $4 million to $5 million from May through December, with breakeven net income.

CareDx's Q1 net loss narrowed to $7.5 million, or $.18 per share, from $9.0 million, or $.30 per share, in Q1 2018. On an adjusted basis, CareDx reported earnings per share of $.05, significantly beating the analyst estimate of a loss per share of $.03.

The firm's Q1 R&D costs rose 65 percent to $5.6 million from $3.4 million in the year-ago quarter, and its SG&A expenses rose 70 percent to $16.0 million from $9.4 million.

The company ended the quarter with $57.4 million in cash and cash equivalents, and $191,000 in restricted cash.

CareDx increased its revenue guidance for the full year and now expects revenues of $113 million to $115 million for 2019. The company had previously anticipated revenues of $105 million to $107 million. Analysts were expecting revenues of $106.3 million.

The firm's shares rose more than 11 percent to $32.49 in Thursday morning trading on the Nasdaq.