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OraSure Technologies Q1 Revenues Jump 85 Percent

NEW YORK – OraSure Technologies reported after the close of the market on Wednesday that its first quarter revenues rose 85 percent year over year driven by sales of collection devices used for COVID-19 testing.

For the three months ended March 31, the Bethlehem, Pennsylvania-based company reported total revenues of $58.6 million, up from $31.6 million in Q1 2020 and beating the consensus Wall Street estimate of $57.0 million.

Total product and service revenues for the company's molecular business unit more than tripled to $43.2 million during the first quarter of 2021 from $13.2 million in Q1 2020.

Within the molecular business, the firm's COVID-19 testing-related sales were $27.4 million, up from $394,000 a year ago. The revenues came from sales of the firm's DNA Genotek molecular sample collection kits as well as its ORAcollect RNA saliva collection device.

Total genomics revenues in the molecular business in Q1 increased 32 percent year over year to $11.1 million from $8.4 million. Total laboratory service revenues in the molecular business unit were $2.5 million, up 3 percent from $2.4 million in the first quarter of 2020, while microbiome revenue increased 32 percent to $2.1 million from $1.6 million.

Within the infectious disease business unit, OraSure said that domestic HIV revenues grew 26 percent to $5.3 million from $4.2 million, driven by HIV over-the-counter test sales. Internationally, HIV sales declined 50 percent to $3.5 million from $6.9 million. Overall, HIV revenues dipped 21 percent to $8.8 million from $11.2 million.

Also within OraSure's infectious disease business unit, domestic hepatitis C virus test revenues decreased 21 percent to $1.2 million from $1.5 million, while international HCV revenues rose 8 percent to $1.2 million from $1.1 million. Total HCV revenues fell 9 percent to $2.4 million from $2.6 million.

The firm said in a statement it has submitted its COVID-19 rapid antigen test to the US Food and Drug Administration for Emergency Use Authorization, and plans to bring a prescription home test and a professional test for point-of-care use to market and to pursue an OTC claim for its antigen test in the future.

OraSure also said it has begun manufacturing the test as it awaits EUA and has expanded its antibody test manufacturing capacities to 70 million per year by Q3 2021. It will expand by an additional 50 million rapid antigen tests by the second quarter of 2022, bringing installed capacity to 120 million tests per year including tests for HIV, HCV, and Ebola.

"We are confident in the market potential for our COVID products, as well as the resilience of our other business segments as demonstrated by the strong first quarter performance of our commercial genomics, microbiome, and domestic HIV testing business," said Stephen Tang, OraSure's president and CEO.

On a call with investors and analysts on Wednesday, Tang also said that the EUA submission of the COVID-19 antigen test was "a significant milestone" for the firm, and that OraSure anticipates the global need for rapid, accurate SARS-CoV-2 tests will continue with a total global market need of between two billion and four billion tests in 2021.

"If we capture just a small percentage of the global COVID-19 testing market, it will have a meaningful impact on the company," Tang said.

Also on the call, CFO Roberto Cuca noted that OraSure is expanding its capacity to manufacture its molecular sample collection devices to 80 million per year by the end of the second quarter and up to 105 million annually by the end of 2021, with approximately 8 million units dedicated to non-COVID testing.

OraSure's net income for the first quarter was $3.8 million, or $.05 per share, compared to a net loss of $7.3 million, or $.12 per share, for Q1 2020. Analysts' average estimate was for EPS of $.04 per share.

The company's Q1 R&D costs rose 60 percent to $9.0 million from $5.6 million a year ago, and its SG&A costs rose 13 percent year over year to $19.7 million from $17.4 million.

OraSure ended the quarter with $177.7 million in cash and cash equivalents and $29.1 million in short-term investments.

The company said it is expecting second quarter 2021 net revenues to range from $55 million to $60 million.

In morning trading on the Nasdaq, shares of OraSure were down 1 percent to $8.98.

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