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OraSure Technologies Q1 Revenues Rise 5 Percent

NEW YORK – OraSure Technologies reported after the close of the market on Wednesday that its first quarter revenues rose 5 percent year over year.

For the three months ended March 31, the Bethlehem, Pennsylvania-based company reported revenues of $31.6 million, up from $30.1 million in Q1 2019.

The firm said its net product and services revenues for the quarter were $30.9 million, up 9 percent year over year from $28.3 million.

Excluding revenues from its cryosurgical business, which the company sold in August 2019, and revenues from Diversigen, which the company acquired in November 2019, net revenues grew 8 percent year over year and product and services revenues grew 13 percent year over year, the firm said.

Total genomics revenues in Q1 were $9.1 million, an increase of 14 percent year over year from $8.0 million.

Total laboratory service revenues were $2.4 million, up 235 percent from $717,000 in the first quarter of 2019. OraSure's laboratory services revenues in 2020 include service revenues generated by CoreBiome and Diversigen, the company’s subsidiaries.

Royalty income from a litigation settlement associated with a molecular collection device was $446,000 in Q1 2020, down 59 percent from $1.1 million in Q1 2019, the firm said, while other revenues were $264,000 for Q1 2020, down 63 percent from $706,000 in Q1 2019.

OraSure said that international sales of its OraQuick HIV products increased 74 percent year over year, primarily driven by higher sales of its OraQuick HIV Self-Test.

"Our underlying business was strong in the first quarter as evidenced by year-over-year double-digit growth in both infectious disease testing and molecular collection systems," Stephen Tang, the firm's president and CEO, said in a statement. "We are encouraged by the continued strength of our international HIV self-test franchise as well as our genomics business."

At the same time, he said, the company expects downward revenue pressure in certain parts of the business as customers repurpose funding and testing, and research projects are deferred because of the coronavirus pandemic.

OraSure's net loss for the first quarter widened to $7.3 million, or $.12 per share, compared to a net loss of $3.3 million, or $.05 per share, for Q1 2019.

The company said that its net loss for Q1 2020 included a $1.1 million non-cash pre-tax charge associated with the change in fair value of acquisition-related contingent consideration. Its net loss in the first quarter of 2019 included a $1.3 million non-cash pre-tax charge associated with the change in the fair value of acquisition-related contingent consideration and $597,000 of acquisition-related transaction costs. The combined impact of these charges reduced fully diluted EPS by approximately $.03, OraSure said.

The company noted that in Q1, it was awarded a $710,310 contract from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop a pan-SARS coronavirus rapid antigen in-home self-test that uses oral fluid samples.

BARDA support will enable OraSure to file for US Food and Drug Administration Emergency Use Authorization, potentially allowing for an in-home, self-test in the US market, the firm said. OraSure expects to file for an FDA EUA for an ELISA test in June and have the test on the market by the fall if its development efforts are successful. The ELISA test is for the detection of human anti-SARS-CoV-2 antibodies in oral fluid specimens.

Further, several of its customers are validating OraSure/DNA Genotek products as tests for the coronavirus, the firm said.

The company’s Q1 R&D costs rose 27 percent to $5.6 million from $4.4 million a year ago, and its SG&A costs rose 7 percent year over year to $17.4 million from $16.2 million.

OraSure ended the quarter with $83.4 million in cash and cash equivalents and $82.7 million in short-term investments.

The company said it is withdrawing its previously announced full-year 2020 financial guidance because of the unpredictable impact of the COVID-19 pandemic on its results.

The company said in February that for 2020, it expected net revenues of $145 million to $155 million and projected a net loss of $.07 to $.10 per share.