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CareDx Q4 Revenues Up 64 Percent

NEW YORK – CareDx reported after the close of the market on Wednesday that its fourth quarter revenues rose 64 percent year over year, largely in line with the preliminary Q4 revenues the company reported in January.

For the three months ended Dec. 31, 2020, the molecular diagnostics company reported total revenues of $58.6 million, up from $35.8 million during the same period a year earlier and beating the average Wall Street estimate of $55.5 million.

Testing services revenues rose 73 percent to $50.3 million from $29.1 million in the prior-year quarter, while product revenues rose 16 percent to $5.9 million from $5.1 million. Digital and other revenues rose 50 percent to $2.4 million from $1.6 million in Q4 2019.

"2020 was transformational for CareDx, because we extended our leadership position in transplant centers through RemoTraC, implemented and validated the next wave of innovation through our multi-modality platforms, HeartCare and KidneyCare, and accelerated the direct to patient journey through AlloCare," CareDx President and CEO Reg Seeto said in a statement. "We look forward to 2021 and beyond as we invest in advancing our robust pipeline and continue our mission to serve transplant patients and improve outcomes."

CareDx said it returned more than 25,000 results from its AlloSure Kidney blood-based, donor-derived, cell-free DNA test for organ transplant rejection, AlloMap Heart transplant test, and other diagnostic tests to patients in Q4. On a conference call with analysts and investors following the release of the earnings, Seeto said this represented 78 percent growth in the year-over-year return of results. The company also returned more than 79,000 test results to patients in FY2020.

Approximately 40 percent of CareDx's testing volume originated from its mobile phlebotomy business in Q4, Seeto added. And as of the end of December, more than 55 transplant centers in the US are now using AlloSure testing protocols as part of their standard of care.

Seeto also noted that while the company's AlloSeq cfDNA and AlloSeq Tx 17 kits did generate revenue in 2020, CareDx expects both products to gain momentum as more COVID-19 vaccines are rolled out in 2021.

The firm's Q4 net loss narrowed to $3.5 million, or $.07 per share, from $4.8 million, or $.11 per share, in Q4 2019. On an adjusted basis, the company reported earnings of $.08 per share for the quarter, beating analysts' consensus expectation for earnings of $.02 per share.

CareDx's Q4 R&D costs rose 49 percent to $13.3 million from $8.9 million in the year-ago quarter, and its SG&A expenses rose 50 percent to $29.5 million from $19.7 million.

For fiscal year 2020, the company reported that total revenues rose 51 percent to $192.2 million from $127.1 million in 2019, beating the average Wall Street estimate of $189.1 million.

Testing services revenues rose 56 percent to $163.6 million from $104.6 million in the prior year, while product revenues rose 5 percent to $19.3 million from $18.3 million. Digital and other revenues rose 121 percent to $9.3 million from $4.2 million in 2019.

The firm's 2020 net loss narrowed to $18.7 million, or $.40 per share, from $22.0 million, or $.52 per share, in 2019. On an adjusted basis, the company reported earnings of $.23 per share for the year, beating analysts' consensus expectation for earnings of $.17 per share.

CareDx's 2020 R&D costs rose 59 percent to $48.9 million from $30.7 million in 2019, and its SG&A expenses rose 36 percent to $102.6 million from $75.4 million.

The company ended the year with $134.7 million in cash and cash equivalents, and $90.0 million in marketable securities.

For full-year 2021, CareDx expects revenues of $255 million to $265 million. Analysts, on average, are expecting revenues of $249.8 million for the year.

The company's shares rose more than 3 percent to $81.64 in Thursday morning trading on the Nasdaq.