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CareDx Q1 Revenues up 76 Percent

NEW YORK – CareDx reported after the close of the market on Wednesday that its first quarter revenues rose 76 percent year over year, thanks largely to an 89 percent increase in testing service revenues during the quarter.

For the three months ended March 31, the South San Francisco, California-based molecular diagnostics company reported total revenues of $67.4 million, up from $38.4 million during the same period a year earlier and beating the average Wall Street estimate of $61.1 million.

Testing services revenues rose to $59.3 million from $31.4 million in the prior-year quarter, while product revenues rose 23 percent to $5.8 million from $4.7 million. Digital and other revenues rose slightly to $2.3 million from $2.2 million in Q1 2020.

"Our record first quarter is a testament to the transplant focused, patient journey driven approach we have taken, as we deliver on our vision on being the leader in the transplant ecosystem," said Reg Seeto, CareDx's president and CEO, in a statement. "2021 has started off strong because we continue to lead with innovation with our first and best-in-class offerings with AlloSure and AlloMap. Our strategy to bring multi-modality innovation and to connect the patient journey is working very well."

CareDx said it returned approximately 33,200 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 Q1. On a conference call with analysts following the release of the earnings, Seeto said that this indicated 121 percent year-over-year growth. This also included approximately 5,900 results from its AlloSure Heart test.

The company also said that more than 60 US-based transplant centers have adopted an AlloSure Kidney testing protocol, and that it can now connect more than 20,000 dialysis patients seeking to be referred for transplant to more than 30 centers and more than 500 dialysis centers through its Tx Connect service.

On the call, Seeto further highlighted a recent decision by Medicare Administrative Contractor Palmetto GBA to finalize a limited coverage decision for molecular tests to evaluate and manage solid organ transplant patients. The decision covered AlloMap and AlloSure Heart, but Seeto said it also "provides a pathway for our future pipeline and multimodality surveillance approach to be introduced."

The recent LCD decision now includes a path for CareDx's AlloSure Lung test, and could accelerate adoption for lung surveillance, he added. The company had previously submitted its technical assessment of AlloSure Lung to Palmetto and believes the MAC will review its submission within the second quarter.

In the products business, he highlighted the continuing development of AlloID. CareDx announced in January that it was partnering with IDbyDNA on the development of metagenomic infectious disease testing specific to transplant patients. AlloID will identify more than 100 pathogens and drug resistance in viruses and bacteria, and is meant to be used in managing the health of immunocompromised, immunosuppressed patients, Seeto said.

The firm's Q1 net loss narrowed to $687,000, or $.01 per share, from $5.8 million, or $.14 per share, in Q1 2020. On an adjusted basis, the company reported earnings of $.14 per share for the quarter, beating analysts' consensus expectation for a break-even quarter.

CareDx's Q1 R&D costs rose 60 percent to $16.0 million from $10.0 million in the year-ago quarter, and its SG&A expenses rose 41 percent to $30.7 million from $21.7 million.

The company ended the quarter with $309.3 million in cash and cash equivalents, and $65.0 million in marketable securities.

For full-year 2021, CareDx raised its revenue guidance to $270 million to $280 million from a previous expectation of $255 million to $265 million. Analysts, on average, are expecting revenues of $260.9 million for the year.

The company's shares fell 3 percent to $70.90 in Thursday morning trading on the Nasdaq.