NEW YORK – OraSure Technologies reported after the close of the market on Tuesday that its second quarter revenues grew 97 percent year over year.
For the three months ended June 30, the Bethlehem, Pennsylvania-based company reported revenues of $57.6 million, up from $29.3 million a year earlier and above analysts' average estimate of $56.7 million.
Excluding COVID-19 revenues, sales were up 122 percent from the second quarter of 2020, which the firm attributed to the beginning of a return of its core business to pre-pandemic levels.
Total product and service revenues for its molecular solutions business unit were $38.3 million during the second quarter of 2021, up 103 percent from $18.8 million a year ago.
Within its molecular solutions business, OraSure's genomics collection kit revenue tripled year over year, from $6.5 million to $19.7 million, driven by growth in consumer genomics, disease risk management, companion animal testing, and research markets, the firm said.
Revenues from sales of sample collection devices for molecular COVID-19 testing increased 36 percent to $11.5 million from $8.5 million in the prior year period. However, on a sequential bases these sales declined by $15.9 million compared to the first quarter, as US PCR test volumes for COVID-19 "declined meaningfully from the March 2021 quarter to the June 2021 quarter," OraSure noted.
The firm also saw a 234 percent increase in microbiome product revenues to $2.9 million from $853,000, while laboratory services revenue rose 40 percent to $3.1 million from $2.2 million.
The firm's Q2 revenues from its diagnostics business also increased, up 85 percent to $19.3 million from $10.4 million in the prior year period.
Total infectious disease testing revenues increased 79 percent to $15.6 million from $8.7 million a year earlier. Its risk assessment testing revenues increased 71 percent to $2.6 million from $1.5 million.
In the quarter, OraSure received Emergency Use Authorization from the US Food and Drug Administration for its InteliSwab rapid over-the-counter at-home antigen assay to detect SARS-CoV-2 from a nasal swab.
On a conference call recapping Q2 earnings, OraSure CEO Stephen Tang said that the firm sees an increased demand for COVID-19 testing globally, and anticipates increased testing will also be needed to support the safe return to work and school, particularly in the face of new viral variants. He outlined an estimated $13.9 billion in recent US federal funding "to, in large part, address testing in congregate, underserved, and vulnerable communities, places where vaccination rates are low and COVID-19 variants are now surging." For those uses, he added, the InteliSwab test is "ideally suited."
Tang also noted that the firm is seeing interest in InteliSwab from countries outside the US that are having intense COVID-19 outbreaks, and the firm plans to begin by focusing its sales efforts on countries that accept US EUA as part of their local authorization process.
However, OraSure CFO Roberto Cuca also noted on the call that although the firm currently has capacity to manufacture 55 million tests per year, it is facing a "tech transfer" obstacle that is impacting scaling up and that will likely decrease the number of tests it can produce in the third quarter. Because of this, "we'll see most of our InteliSwab sales for the year in the fourth quarter," Cuca said.
Tang also highlighted on the call that the firm's sample collection device for molecular testing of urine samples, called Colli-Pee, has been the subject of recent scientific research for human papillomavirus testing and is a component of the MDxHealth SelectMDx prostate cancer test that received a draft local coverage determination from Palmetto GBA in the quarter. "Typically, these types of reimbursement coverage decisions are catalysts for more significant commercial adoption of laboratory tests," he added.
OraSure's Q2 net loss for the second quarter of 2021 was $1.4 million, or a loss of $.02 per share, compared to a net loss of $10.5 million, or $.16 per share, for the second quarter of 2020. Analysts on average had estimated EPS of $.04.
The firm's R&D expenses for the quarter rose 12 percent to $7.7 million from $6.9 million in Q2 2019, and its SG&A and marketing costs rose 5 percent to $21.4 million from $20.4 million.
OraSure ended the quarter with $158 million in cash and cash equivalents and $35.2 million in short-term investments.
On the call, Tang said that OraSure is currently pursuing mergers and acquisitions for its point-of-care diagnostics business that expand the firm's menu of tests "on a global basis, and provide long-term competitive differentiation," while within the molecular solutions business OraSure is looking into innovative sample collection technologies.
For the full year, the firm guided for total revenue of approximately $230 million, with expected third quarter net revenues of $45 million to $50 million.
In Wednesday morning trading on the Nasdaq, OraSure's stock was down nearly 9 percent to $11.33.