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OraSure Q3 Revenues Jump 33 Percent

NEW YORK – OraSure Technologies reported after the close of the market on Wednesday that its third quarter revenues increased 33 percent year over year driven by sales of its oral fluid collection devices for COVID-19 molecular tests.

For the three months ended Sept. 30, the point-of-care diagnostics company reported total revenues of $48.0 million, up from $36.0 million in the prior-year quarter. The Bethlehem, Pennsylvania-based company beat the consensus Wall Street estimate of $41.7 million.

The firm's product and service revenues for the quarter rose 32 percent to $46.7 million from $35.3 million in Q3 2019. Within products, molecular solutions revenues increased 79 percent to $31.7 million from $18.3 million, which included a 38 percent drop in revenues from genomics products to $8.5 million from $13.6 million. Microbiome products revenues fell 3 percent to $1.8 million from $1.9 million.

The firm also had $18.4 million in sales of sample collection devices for COVID-19 molecular testing, which CEO Stephen Tang said in a statement was "more than double the COVID-19 related revenue achieved in the first half of the year."

OraSure's subsidiary DNA Genotek's Omnigene Oral and Oracollect RNA collection devices were granted Emergency Use Authorization by the US Food and Drug Administration during the quarter for the collection, stabilization, and transport of saliva samples for SARS-CoV-2. The products can also be used as components of self-collection devices for at-home use.

Tang said on a conference call to discuss the financial results that he expects sales for saliva collection kits to continue to grow both within the US and outside the country as other countries complete validation work around saliva samples.

OraSure recently submitted its oral fluid SARS-CoV-2 Antibody ELISA test to the FDA for EUA, it added. The antibody test, which detects IgM, IgA, and IgG antibodies against the coronavirus, will be commercialized in the fourth quarter, depending on EUA receipt. Tang said that he thought the market for an oral fluid antibody test would be expansive, particularly as "discussion in the pandemic has moved toward seroprevalence and surveillance."

The company also said it expects to submit its OraQuick Coronavirus Rapid Antigen Self-Test to the FDA for EUA in the first quarter of 2021. The firm is currently working to finalize the device design and complete EUA studies. The test was originally targeted for EUA submission in the fourth quarter of 2020, but Tang said that it had been pushed back due to the company's desire to provide additional clinical data and ensure "extra care" in putting the test on the market. Part of the delay is due to the fact that OraSure is designing the test for professional use, prescription self-collection use, and over-the-counter self-collection use at the same time, with the same design for all uses.

EUA for professional use will be submitted first, but applications for prescription and OTC use will be submitted soon after, and the firm is currently running clinical trials in parallel to validate the tests' design and performance.

Tang also said that the sensitivity of the antigen test was competitive with products already on the market, although he declined to provide exact numbers. Once the antigen test is on the market, Tang said OraSure expects to sell "as many as we can make."

The firm's Q3 revenues from infectious disease testing fell 3 percent to $13.2 million from $13.6 million a year earlier. Risk assessment testing revenues fell 30 percent to $2.3 million from $3.3 million.

Within infectious disease testing, sales of OraQuick tests for HIV and hepatitis C were down 2 percent to $13.0 million from $13.3 million in Q3 2019. Total HIV sales rose 6 percent to $10.8 million from $10.2 million as domestic HIV testing sales fell 8 percent to $3.9 million from $4.3 million, offset by a 17 percent increase in international HIV testing sales to $6.9 million from $5.9 million.

Total HCV testing sales declined 29 percent to $2.2 million from $3.1 million in the year-ago quarter due to a 40 percent decrease in domestic HCV testing sales to $1.2 million from $2.0 million and a 9 percent decrease in international HCV testing revenues to $1.0 million from $1.1 million. 

OraSure CFO Roberto Cuca said on the call that non-COVID-19 revenues will likely be down in full-year 2020 compared to 2019, but the revenue opportunities from COVID-19 will offset that decrease and lead to higher total revenues this year compared to last year.

The firm's Q3 net income fell to $1.0 million, or $.01 per share, from $13.1 million, or $.21 per share in the year-ago period. It beat the consensus Wall Street estimate for a loss of $.07 per share.

OraSure's R&D expenses for the quarter rose 74 percent to $8.0 million from $4.6 million in Q3 2019, and its SG&A costs increased 8 percent to nearly $18 million from $16.6 million.

The company ended the quarter with $263.7 million in cash and cash equivalents and $73.0 million in short-term investments.

For the fourth quarter the company expects net revenues of $55 million to $60 million.