NEW YORK (GenomeWeb) – CareDx reported after the close of the market on Thursday that its fourth quarter revenues rose 15 percent year over year thanks largely to an uptick in testing revenues.
For the three months ended Dec. 31, the diagnostics company said Q4 2017 revenues rose to $12.5 million from $10.9 million in Q4 2016, beating analysts' average estimate of $12.3 million.
Testing revenues rose 16 percent to $8.6 million from $7.4 million, while product revenues rose 6 percent to $3.7 million from $3.5 million in the year-ago period. Collaboration and license revenues rose to $164,000 from $10,000.
Testing revenues from CareDx kidney transplant test Allosure, which was commercially launched on Oct. 9, 2017, were $500,000, representing 282 test results. Revenues from the firm's AlloMap heart transplant test were $8.1 million, with Q4 US test volume increasing 8 percent year over year to 3,840 tests.
The company noted that as of Feb. 28, 47 US transplant centers are providing AlloSure to their patients.
"The initial AlloSure interest and traction we experienced in the fourth quarter of 2017 continues in 2018. We enrolled our first patients and [nine] centers in the [Kidney Allograft Outcomes AlloSure Registry] registry and remain on track to initiate 35 centers in this innovative study collecting longer-term outcome data on kidney transplant patients," CareDx President and CEO Peter Maag said in a statement. "We believe our new and simplified capital structure positions CareDx to achieve its financial and operational goals going forward. CareDx is well-positioned to become a leading provider of diagnostic solutions to the transplant community."
On a conference call with analysts following the release of the earnings, Maag added that a recent change to the Centers for Medicare and Medicaid Services' Date of Service policy now allows CareDx to bill Medicare directly for AlloMap and AlloSure tests drawn in the hospital on the day of the patient's clinic visit. "As we are dealing with large medical institutions, it will take a while to implement this new workflow for AlloMap. However, we believe this will ultimately have a positive impact on patient access to both AlloMap and AlloSure and will likely improve patient adherence to transplant center testing protocols," he said.
He also estimated that the firm's Olerup pre-transplantation tissue typing products are used in more than 50 percent of the estimated 1,000 transplant labs in the world, and noted that the Olerup QType is now validated on both the Roche Lifecycler and the ABI instruments. Maag also said that CareDx anticipates receiving CE marking as well as revenues from Olerup testing done on both of these platforms in the first half of 2018.
The firm's Q4 net loss widened to $31.7 million, or $1.13 per share, from $15.5 million, or $.73 per share, in the year-ago period. On an adjusted basis, CareDx reported a Q4 loss per share of $.09, beating the Wall Street estimate of $.14.
CareDx's Q4 R&D costs fell 6 percent to $3.0 million from $3.2 million in Q4 2016, and its SG&A expenses rose 3 percent to $7.3 million from $7.1 million.
For full-year 2017, the company's revenues rose 19 percent to $48.3 million from $40.6 million in 2016, beating the Wall Street estimate for revenues of $48.2 million.
Testing revenues rose 11 percent to $33.1 million from $29.7 million, while product revenues rose 36 percent to $14.6 million from $10.7 million in the year-ago period. Collaboration and license revenues rose to $584,000 from $236,000.
The firm's 2017 net loss widened to $55.5 million from $39.5 million in 2016. On a per-share basis, the net loss narrowed to $2.38 in 2017 on 23.3 million shares of common stock outstanding from a loss of $2.39 per share in 2016 on 16.5 million shares of common stock outstanding. On an adjusted basis, CareDx reported a 2017 loss per share of $.69, beating the Wall Street estimate of $.73.
CareDx's 2017 R&D costs were flat at $12.4 million, and its SG&A expenses fell less than 1 percent to $31.7 million from $31.9 million in 2016.
At the end of the year, CareDx had $16.9 million in cash and cash equivalents.
For 2018, CareDx expects revenues of $61 million to $63 million, with profitability expected during the second half of the year. Analysts are expecting full-year revenues of $61.5 million.
The company's shares rose nearly 23 percent to $7.33 in Friday morning trading on the Nasdaq.