BETHLEHEM, Pa., Feb. 25, 2026 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced its financial results for the three months ended December 31, 2025.
“Our Q4 results were consistent with our expectations, and revenue of $26.8 million was above the midpoint of our guidance range,” said Carrie Eglinton Manner, President and CEO of OTI. “We supported our customers in navigating a challenging funding environment in 2025, and we are encouraged to see increasing signs of stability in key segments as we enter 2026.”
She continued, “We are confident that OTI is positioned to return to growth in 2026, supported by anticipated U.S. regulatory clearance and launches of our rapid molecular self-test for Chlamydia and Gonorrhoeae and our Colli-Pee™ at-home urine collection device for sexually transmitted infections. We are making meaningful progress on our innovation roadmap and executing on our strategy to decentralize diagnostics and connect people to care that is more accessible, convenient, affordable, and private. Additionally, our strong balance sheet allows us to make disciplined investments in value-enhancing organic and inorganic opportunities while prudently returning capital to shareholders through our $40 million share repurchase program which we continue to execute.”
Financial Highlights ($ in 000’s, except per share amounts)
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For the Three Months Ended December 31, For the Years Ended December 31, 2025
2024
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% Change 2025
2024
% ChangeCore Business(1)$26,717 $34,427 (22)% $112,531 $130,596 (14)%COVID-19 46 950 (95) 624 45,172 (99)Risk Assessment Testing – 2,055 (100) 1,866 8,354 (78)Molecular Services – 13 (100) – 1,705 (100)Total Net Revenues$26,763 $37,445 (29)% $115,021 $185,827 (38)% (1) Includes Diagnostics, Sample Management Solutions, other products and services revenues, and non-product and services revenues.
For the Three Months Ended December 31, For the Years Ended December 31, 2025 2024 % Change 2025 2024 % ChangeNet revenues$26,763 $37,445 (29)% $115,021 $185,827 (38)%Gross profit 10,968 13,566 (19) 48,198 79,390 (39)Gross margin 41.0% 36.2% 41.9% 42.7% Non-GAAP gross profit 11,091 15,000 (26) 49,051 82,490 (41)Non-GAAP gross margin 41.4% 40.1% 42.6% 44.4% Operating loss (20,103) (12,418) NM (71,969) (28,250) NMOperating margin(75.1)% (33.2)% (62.6)% (15.2)% Non-GAAP operating loss (15,168) (6,745) NM (56,329) (6,422) NMNon-GAAP operating margin(56.7)% (18.0)% (49.0)% (3.5)% Net loss (19,286) (10,794) NM (68,731) (19,500) NMNon-GAAP net (loss) income (13,649) (4,230) NM (50,813) 3,943 NMDiluted GAAP EPS$(0.27) $(0.14) NM $(0.94) $(0.26) NMDiluted Non-GAAP EPS$(0.19) $(0.06) NM $(0.69) $0.05 NM NM – not meaningful
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* Total net revenues for the fourth quarter of 2025 decreased 29% to $26.8 million from $37.4 million in the fourth quarter of 2024.
* Core revenues (all revenues excluding COVID-19, Molecular Services, and Risk Assessment Testing revenues) of $26.7 million in the fourth quarter decreased 22% year-over-year. Diagnostics revenues in the fourth quarter decreased 20% year-over-year to $15.1 million, with the decline attributable to lower revenue from our HIV tests. Sample Management Solutions revenues in the fourth quarter decreased 39% year-over-year to $9.1 million, with the majority of the decline attributable to a large customer in the consumer genomics segment.
* GAAP gross margin was 41.0% in the fourth quarter of 2025 compared to 36.2% in the fourth quarter of 2024. Non-GAAP gross margin in the fourth quarter of 2025 was 41.4% compared to 40.1% in the fourth quarter of 20241.
* GAAP operating loss in the fourth quarter of 2025 was $20.1 million compared to operating loss of $12.4 million in the fourth quarter of 2024. Non-GAAP operating loss was $15.2 million in the fourth quarter of 2025 compared to non-GAAP operating loss of $6.7 million in the fourth quarter of 2024.
* Cash and cash equivalents were $199 million as of December 31, 2025.
* OTI deployed $5 million during the fourth quarter to repurchase approximately 1.9 million shares of our common stock. 1 For additional information on non-GAAP financial measures and a reconciliation of the GAAP financial results to non-GAAP financial results, see the schedules below. A description of the adjustments made to the GAAP financial measures is included at the end of the schedules.
Recent Business Developments
* Submitted an application in December 2025 to the U.S. Food and Drug Administration (FDA) for clearance of our rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG). OTI’s rapid self-test for CT/NG is built on the Sherlock molecular diagnostics platform and is designed to provide results in approximately 30 minutes in a disposable, over-the-counter format. The test uses a self-collected swab, and results are intended to be read directly on the hand-held testing device without the need for an electrical connection, enhancing flexibility and convenience.
* Submitted an application in December 2025 to the FDA for clearance of our Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs). The submission covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider. Receipt of clearance for the Colli-Pee™ device for these indications is expected to expand access to testing and further strengthen OTI’s leadership position in novel collection devices and chemistries.
* Received a license from Health Canada authorizing the use of the OraQuick™ HIV Self-Test in Canada. St. Michael’s Hospital (Unity Health Toronto) is the exclusive distributor in Canada of the OraQuick HIV Self-Test, which is the country’s first oral HIV self-test.Financial Guidance
The Company is guiding to Q1 2026 Total revenues of $26 million to $29 million, which includes a negligible amount of COVID-19 testing revenues.
Conference Call
The Company will host a conference call and audio webcast to discuss the Company’s fourth quarter 2025 results and certain business developments, beginning today at 5 p.m. Eastern Time. The call will include prepared remarks by management and a question and answer session.
A webcast of the conference call will be available on the investor relations page of OTI’s website at https://orasure.gcs-web.com/events-and-presentations. Please click on the webcast link and follow the prompts for registration and access at least 10 minutes prior to the call. The webcast will be archived on OTI’s website shortly after the call has ended.
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OTI intends to use the Investor Relations Section of its website as a means of disclosing material non-public information (MNPI) and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor OTI’s website in addition to following its press releases, SEC filings, public conference calls, presentations, and webcasts.
Financial Data (Unaudited, $ in 000’s, except per share amounts)
