The story has been updated to include comments from the company's conference call.
NEW YORK – OraSure Technologies said after the close of the market on Tuesday that its fourth quarter core revenues increased 10 percent over the year-ago quarter, while the firm's total revenues declined 51 percent on a sharp drop in its COVID-19 testing business.
"Our Q4 revenue was consistent with our expectations," OraSure President and CEO Carrie Eglinton Manner said in a statement.
"We continue to see signs of gradual recovery in our key end markets, and we are diversifying our business by expanding our product portfolio and adding new customers," Manner added, noting that this was offset by elevated uncertainty for some of the Bethlehem, Pennsylvania, firm's existing customers related to government funding sources.
On a call with investors, Manner further elucidated possible impacts to OraSure's business related to these uncertainties.
Specifically, freezes on US foreign aid have roiled the firm's international HIV testing and treatment partners, and Manner noted that customers supported in part by the President's Emergency Plan for AIDS Relief (PEPFAR), in particular, made up a sizeable portion of the firm's international diagostics business in 2024. Following an initial funding freeze, PEPFAR was granted a waiver to continue its work, she said, but added that providers in some countries are still sorting out the impact changes may have on their operations and budgets.
Meanwhile, academic users of OraSure's sample management solutions could potentially be impacted by potential reductions in National Health Institutes research funding support covering indirect costs. However, the firm believes its solutions would be considered under direct costs, Manner said, and OraSure has not seen any slowdown in academic revenues to date.
Nevertheless, "These are fluid situations, impacted by the changing dynamics of the federal government and including judicial review in many cases," Manner said, adding that the firm continues to monitor the situation while remaining confident in its current position and opportunity for long-term growth.
In total, OraSure incorporated approximately $1 million in international and academic order impacts into its Q1 guidance, with Manner noting that the firm would be able to provide additional guidance once it has better visibility on future federal funding.
For the three months ended Dec. 31, 2024, OraSure reported $37.4 million in total revenues, down from $75.9 million a year ago but above the consensus Wall Street estimate of $36.8 million.
Core business revenues were $36.5 million compared to $33.3 million in Q4 2023. COVID-19-related revenues declined 98 percent to $950,000 from $41.7 million a year ago, while molecular services revenues fell 99 percent to $13,000 from $907,000. OraSure announced in May 2024 that it will exit its molecular services business.
In the quarter, OraSure acquired Sherlock Biosciences as part of a strategy to expand its innovation pipeline. The acquisition adds a molecular diagnostics platform to OraSure's portfolio, subject to US Food and Drug Administration clearance of Sherlock's disposable self-test for chlamydia and gonorrhea pathogens.
The firm also received FDA approval in the quarter for a labeling change that increases access of its OraQuick HIV self-test to adolescents. OraSure was also awarded up to $11 million from the Rapid Response Partnership Vehicle, a consortium funded by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA), to support development of a single-use rapid antigen test for Marburg viruses.
OraSure also said that it made significant progress in the quarter exiting its risk assessment testing business, a move it announced in November 2024, noting that it plans to continue to support customers as it winds down inventory in the first half of 2025.
OraSure's research and development expenses in the fourth quarter declined approximately 13 percent to $6.1 million from $7.0 million in Q4 2023, while its SG&A spending declined approximately 5 percent to $19.9 million from $20.9 million.
Net loss in Q4 was $10.8 million, or $.14 per share, compared to net income of $20.1 million, or $.27 per share, a year ago. Non-GAAP loss per share for Q4 2024 was $.06, below the consensus Wall Street estimate of a loss per share of $.01.
For full-year 2024, the company recorded revenues of $185.8 million, down 54 percent from $405.5 million in 2023 and below analysts' average estimate of $186.0 million.
Core business revenues declined 3 percent to $139.0 million from $143.2 million in the prior year. COVID-19-related revenues dropped 82 percent year over year to $45.2 million from $257.8 million, while molecular services revenues fell 62 percent to $1.7 million from $4.5 million.
OraSure's research and development expenses in 2024 declined approximately 23 percent to $26.0 million from $33.7 million, while SG&A spending was down 18 percent to $77.2 million from $94.5 million.
OraSure reported a net loss for 2024 of $19.5 million, or $.26 per share, versus net income of $53.7 million, or $.72 per share, in 2023. Non-GAAP EPS for 2024 was $.05, below the consensus Wall Street estimate of $.10 per share.
OraSure ended 2024 with $267.8 million in cash and cash equivalents.
For Q1 2025, OraSure guided for revenues of $27.5 million to $31.5 million, with core revenues of $27 million to $31 million in the quarter including approximately $1 million of risk assessment testing revenues. OraSure said it anticipates COVID-19 revenues in Q1 2025 of approximately $500,000.
Shares of OraSure were down approximately 25 percent to $2.99 in Wednesday afternoon trading on the Nasdaq.