NEW YORK – OraSure Technologies reported after the close of the market Wednesday that its fourth quarter 2021 revenues increased 1 percent year over year.
For the three months ended Dec. 31, OraSure reported $63.6 million in revenues compared to $62.9 million a year ago, beating analysts' average expectation of $62.0 million and the high end of previous guidance of $60 million to $63 million. Excluding COVID-19 product sales, Q4 revenues increased 3 percent year over year.
Revenues from the firm's Diagnostics business unit grew 58 percent to $32.7 million from $20.7 million a year ago, driven entirely by a year-over-year increase in InteliSwab revenue of $14.7 million.
"InteliSwab is an outstanding product in terms of its combination of simplicity and accuracy, and we are excited about its growth potential," OraSure CEO Stephen Tang said in a statement, adding that the company has confirmed through an outside independent laboratory that InteliSwab detects the SARS-CoV-2 Omicron variant at the same level as other variants of concern.
In addition, the company received US Food and Drug Administration Emergency Use Authorization for its pediatric claim for InteliSwab and for the InteliSwab Connect reporting app.
"We continue to scale up InteliSwab production, which includes plans for commissioning additional production sites," Tang said. "We continue to address the many typical challenges associated with scale-up, which will take time to fully implement. Even so, we expect InteliSwab to scale modestly in the first quarter and then more meaningfully throughout the year."
Revenues from the firm's Molecular Solutions business totaled $30.9 million, down 27 percent year over year from $42.1 million, driven entirely by lower sales of COVID-19 collection kits, which decreased 65 percent to $8.0 million from $22.9 million a year ago. Excluding these revenues, Molecular Solutions grew 19 percent year over year.
"We continue to execute our multiomic strategy, which drove 35 percent year-over-year growth in Molecular Solutions, and have aggressive plans to continue expanding our product offerings in the coming years," Tang said.
On a call with investors to recap the earnings, Kathleen Weber, president of OraSure's Molecular Solutions unit, said the firm launched a meta-transcriptome service for microbiome analyses through its Diversigen subsidiary in late 2021 and also received FDA clearance for its Omnigene-Gut DX collection product. Its Diversigen services and microbiome kits revenue was $5.9 million, which Weber said marked the "second highest quarter ever" for that business.
OraSure recorded a Q4 net loss of $10.4 million, or $.14 per share, compared to net income of $1.9 million, or $.03 per share, in the year-ago quarter. On average, analysts had expected a loss per share of $.16.
The company's Q4 R&D expenses fell 15 percent to $8.9 million from $10.5 million, while its SG&A spending jumped 29 percent to $27.5 million from $21.3 million.
For full-year 2021, OraSure logged $233.7 million in revenues, up 36 percent from $171.7 million in 2020. Revenues were ahead of analysts' average estimate of $232.5 million and slightly above the high end of prior company guidance of $230 million to $233 million.
Full-year Diagnostics revenues grew 38 percent to $90.0 million from $65.2 million in 2020, while revenues from the Molecular Solutions unit jumped 35 percent to $143.6 million from $106.5 million in 2020.
Lisa Nibauer, the president of the Diagnostics business, said on the call that OraSure is optimistic regarding the long-term durability of the COVID-19 market in the US, and plans to scale InteliSwab production capacity to over 200 million tests per year beginning with a modest scale up in Q1.
Weber also noted on the call that in 2021 OraSure added 650 new customers in its molecular solutions business and extended multi-year contracts with six large existing customers, "positioning us well for future growth." The firm's microbiome kits and services business, specifically, grew almost 40 percent in 2021, she said, adding, "We anticipate this to be a strong source of growth looking forward."
OraSure reported a full-year net loss of $23.0 million, or $.32 per share, compared to a net loss of $14.9 million, or $.22 per share, in 2020. On average, analysts had expected a loss per share of $.34.
Full-year R&D spending grew 10 percent to $34.2 million from $31.0 million a year ago, while SG&A expenses ballooned 23 percent to $95.1 million from $77.2 million.
OraSure finished the year with $116.8 million in cash and cash equivalents, and $36.3 million in short-term investments.
On Jan. 5, OraSure announced it was exploring strategic alternatives to maximize shareholder value. This review is ongoing, and as such the company said it would not provide full-year or first quarter 2022 financial guidance. As part of this strategic review, Tang, CEO of four years, will be leaving the company on March 31. The company also said it would adopt a vertically integrated business unit structure, with operations, R&D, and manufacturing now reporting to each of the respective business unit leaders.
On Wednesday's call, Tang said that he is confident in OraSure's outlook and the capabilities of its executive leadership team to transform the company in the coming years. "I will leave knowing the company has a strong foundation and is in extremely capable hands," he said.
In morning trading on the Nasdaq, OraSure's shares were up 1 percent at $7.59.