Revenue drops as OraSure (NASDAQ: OSUR) posts deeper 2025 loss
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
OraSure Technologies reported sharply lower results for the quarter and year ended December 31, 2025 as COVID-related demand faded and core markets softened. Q4 2025 net revenues were $26.8 million, down 29% from $37.4 million a year earlier, and full-year revenues fell to $115.0 million from $185.8 million. The company posted a Q4 GAAP net loss of $19.3 million and a full-year loss of $68.7 million, with Q4 non-GAAP operating loss widening to $15.2 million. Despite the downturn, Q4 non-GAAP gross margin improved to 41.4% and cash and cash equivalents totaled $199 million with no debt.
Core revenues of $26.7 million in Q4 declined 22% year-over-year, driven by a 20% drop in diagnostics sales to $15.1 million and a 39% decline in Sample Management Solutions revenues to $9.1 million. COVID-19 revenues nearly disappeared, falling 95% in Q4 and 99% for the year. Management highlighted cost actions, site consolidations, product line closures, and a $40 million share repurchase program, of which $5 million was used in Q4 to buy back about 1.9 million shares. Looking ahead, the company is guiding Q1 2026 total revenues to $26–29 million and expects low‑40% non-GAAP gross margins, while banking on potential FDA clearances for a rapid molecular self‑test for chlamydia and gonorrhea and the Colli‑Pee urine collection device to help return the business to growth.
Positive
- Strong balance sheet and margin improvement: Cash and cash equivalents were $199.3 million with no debt at December 31, 2025, and Q4 2025 non-GAAP gross margin improved to 41.4%, indicating healthier unit economics despite lower revenue.
Negative
- Severe revenue decline and rising losses: Total net revenues fell 38% year-over-year to $115.0 million in 2025, while GAAP net loss more than tripled to $68.7 million and operating cash flow swung to a $49.0 million use of cash.
Insights
Revenue fell sharply and losses deepened, but margins and liquidity remain solid.
OraSure showed a steep reset in 2025 as total net revenues dropped from
Profitability deteriorated, with full‑year operating loss widening to
Liquidity remains a key offset, with
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): February 25, 2026
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||
(Address of Principal Executive Offices) | (Zip Code) | ||||
Registrant’s telephone number, including area code: 610 -882-1820
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:
Indicate by a check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02 – Results of Operations and Financial Condition.
On February 25, 2026, OraSure Technologies, Inc. (the “Company”) issued a press release announcing its consolidated financial results for the full year and quarter ended December 31, 2025 and certain other matters. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01 – Regulation FD Disclosure.
Webcast
On February 25, 2026, the Company held a webcast conference call with analysts and investors, during which members of the Company’s management team, including Carrie Eglinton Manner, the Company’s President and Chief Executive Officer, and Kenneth J. McGrath, the Company’s Chief Financial Officer, discussed the Company’s consolidated financial results for the full year and quarter ended December 31, 2025 and described certain business developments.
Investor Presentation
The Company hereby furnishes the investor presentation that the Company will present to analysts and investors on or after the date hereof, which is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The investor presentation will also be available on the Company’s website at www.orasure.com.
The information in Items 2.02 and 7.01, and attached as Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall such information and Exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing. The fact that the information and Exhibit are being furnished should not be deemed an admission as to the materiality of any information contained therein. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Current Report on Form 8-K or attached Exhibits.
Item 9.01 – Financial Statements and Exhibits.
(d)Exhibits
| Exhibit Number | Description | |||||||
99.1 | Press Release, dated February 25, 2026, announcing the consolidated financial results of OraSure Technologies, Inc. for the full year and quarter ended December 31, 2025 and certain other matters. | |||||||
| 99.2 | Investor Presentation | |||||||
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |||||||
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ORASURE TECHNOLOGIES, INC. | ||||||||
| Date: February 25, 2026 | By: | /s/ Carrie Eglinton Manner | ||||||
| Carrie Eglinton Manner | ||||||||
| President and Chief Executive Officer | ||||||||
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EXHIBIT 99.1
| Investor Contact: | Media Contact: | ||||
| Jason Plagman | Amy Koch | ||||
| VP, Investor Relations | Director, Corporate Communications | ||||
| investorinfo@orasure.com | media@orasure.com | ||||
OraSure Announces Fourth Quarter 2025 Financial Results
BETHLEHEM, PA, February 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)
| For the Three Months Ended December 31, | For the Years Ended December 31, | ||||||||||||||||||||||||||||||||||
| 2025 | 2024 | % Change | 2025 | 2024 | % Change | ||||||||||||||||||||||||||||||
Core 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.
1
| For the Three Months Ended December 31, | For the Years Ended December 31, | ||||||||||||||||||||||||||||||||||
| 2025 | 2024 | % Change | 2025 | 2024 | % Change | ||||||||||||||||||||||||||||||
| Net 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) | NM | |||||||||||||||||||||||||||||
| Operating margin | (75.1) | % | (33.2) | % | (62.6) | % | (15.2) | % | |||||||||||||||||||||||||||
| Non-GAAP operating loss | (15,168) | (6,745) | NM | (56,329) | (6,422) | NM | |||||||||||||||||||||||||||||
| Non-GAAP operating margin | (56.7) | % | (18.0) | % | (49.0) | % | (3.5) | % | |||||||||||||||||||||||||||
| Net loss | (19,286) | (10,794) | NM | (68,731) | (19,500) | NM | |||||||||||||||||||||||||||||
| Non-GAAP net (loss) income | (13,649) | (4,230) | NM | (50,813) | 3,943 | NM | |||||||||||||||||||||||||||||
| Diluted GAAP EPS | $ | (0.27) | $ | (0.14) | NM | $ | (0.94) | $ | (0.26) | NM | |||||||||||||||||||||||||
| Diluted Non-GAAP EPS | $ | (0.19) | $ | (0.06) | NM | $ | (0.69) | $ | 0.05 | NM | |||||||||||||||||||||||||
NM – not meaningful
•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.
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
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.
2
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.
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.
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Financial Data (Unaudited, $ in 000’s, except per share amounts)
| For the Three Months Ended December 31, | For the Years Ended December 31, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Results of Operations | |||||||||||||||||||||||
| Net revenues | $ | 26,763 | $ | 37,445 | $ | 115,021 | $ | 185,827 | |||||||||||||||
| Cost of products and services sold | 15,795 | 23,879 | 66,823 | 106,437 | |||||||||||||||||||
| Gross profit | 10,968 | 13,566 | 48,198 | 79,390 | |||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | 11,418 | 6,087 | 42,528 | 26,047 | |||||||||||||||||||
| Sales and marketing | 6,584 | 6,992 | 26,117 | 30,986 | |||||||||||||||||||
| General and administrative | 9,818 | 12,905 | 47,677 | 46,215 | |||||||||||||||||||
| Loss on impairments | — | — | — | 4,392 | |||||||||||||||||||
| Change in the estimated fair value of acquisition-related contingent consideration | 2,983 | — | 4,570 | — | |||||||||||||||||||
| Loss (gain) on sale of assets | 268 | — | (725) | — | |||||||||||||||||||
| Total operating expenses | 31,071 | 25,984 | 120,167 | 107,640 | |||||||||||||||||||
| Operating loss | (20,103) | (12,418) | (71,969) | (28,250) | |||||||||||||||||||
| Other income | 1,671 | 2,911 | 7,383 | 12,249 | |||||||||||||||||||
| Loss before income taxes and equity investment | (18,432) | (9,507) | (64,586) | (16,001) | |||||||||||||||||||
| Income tax expense | 210 | 758 | 1,801 | 1,799 | |||||||||||||||||||
Loss before equity investment | (18,642) | (10,265) | (66,387) | (17,800) | |||||||||||||||||||
| Loss on equity investment | (644) | (529) | (2,344) | (1,700) | |||||||||||||||||||
| Net loss | $ | (19,286) | $ | (10,794) | $ | (68,731) | $ | (19,500) | |||||||||||||||
| Loss per share: | |||||||||||||||||||||||
| Basic | $ | (0.27) | $ | (0.14) | $ | (0.94) | $ | (0.26) | |||||||||||||||
| Diluted | $ | (0.27) | $ | (0.14) | $ | (0.94) | $ | (0.26) | |||||||||||||||
| Weighted average shares outstanding: | |||||||||||||||||||||||
| Basic | 71,566 | 74,597 | 73,485 | 74,434 | |||||||||||||||||||
| Diluted | 71,566 | 74,597 | 73,485 | 74,434 | |||||||||||||||||||
| For the Three Months Ended December 31, | For the Years Ended December 31, | ||||||||||||||||||||||||||||||||||
| 2025 | 2024 | % Change | 2025 | 2024 | % Change | ||||||||||||||||||||||||||||||
| Consolidated Net Revenues | |||||||||||||||||||||||||||||||||||
| Diagnostics | $ | 15,089 | $ | 18,768 | (20) | % | $ | 66,497 | $ | 75,917 | (12) | % | |||||||||||||||||||||||
| Sample Management Solutions | 9,085 | 14,809 | (39) | 38,356 | 51,046 | (25) | |||||||||||||||||||||||||||||
| Other product and services | 655 | 636 | 3 | 1,716 | 2,453 | (30) | |||||||||||||||||||||||||||||
| COVID-19 Diagnostics | 46 | 950 | (95) | 620 | 45,136 | (99) | |||||||||||||||||||||||||||||
| Risk Assessment Testing | — | 2,055 | (100) | 1,866 | 8,354 | (78) | |||||||||||||||||||||||||||||
| Molecular Services | — | 13 | (100) | — | 1,705 | (100) | |||||||||||||||||||||||||||||
| Net product and services revenues | 24,875 | 37,231 | (33) | 109,055 | 184,611 | (41) | |||||||||||||||||||||||||||||
| Non-product and services revenues | 1,888 | 214 | 782 | 5,966 | 1,216 | 391 | |||||||||||||||||||||||||||||
| Net revenues | $ | 26,763 | $ | 37,445 | (29) | % | $ | 115,021 | $ | 185,827 | (38) | % | |||||||||||||||||||||||
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Condensed Consolidated Balance Sheets (Unaudited, $ in 000’s)
| December 31, 2025 | December 31, 2024 | ||||||||||
| Assets | |||||||||||
| Cash and cash equivalents | $ | 199,278 | $ | 267,763 | |||||||
| Accounts receivable, net | 22,203 | 23,816 | |||||||||
| Inventories | 31,060 | 34,197 | |||||||||
| Other current assets | 9,367 | 7,444 | |||||||||
| Property, plant and equipment, net | 39,179 | 45,105 | |||||||||
| Intangible assets, net | 19,046 | 17,435 | |||||||||
| Goodwill | 43,363 | 40,330 | |||||||||
| Investment in equity method investee | 25,956 | 28,300 | |||||||||
| Other noncurrent assets | 13,716 | 15,269 | |||||||||
| Total assets | $ | 403,168 | $ | 479,659 | |||||||
| Liabilities and Stockholders’ Equity | |||||||||||
| Accounts payable | $ | 6,521 | $ | 8,173 | |||||||
| Deferred revenue | 1,518 | 2,961 | |||||||||
Acquisition-related contingent consideration obligation | 18,380 | — | |||||||||
| Other current liabilities | 13,376 | 22,349 | |||||||||
| Other noncurrent liabilities | 22,546 | 35,838 | |||||||||
| Stockholders’ equity | 340,827 | 410,338 | |||||||||
| Total liabilities and stockholders’ equity | $ | 403,168 | $ | 479,659 | |||||||
Additional Financial Data (Unaudited, $ in 000’s)
| For the Years Ended December 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| Capital expenditures | $ | 4,197 | $ | 3,797 | |||||||
| Depreciation and amortization | 10,192 | 10,872 | |||||||||
| Stock-based compensation | 10,147 | 11,920 | |||||||||
| Cash (used in) provided by operating activities | $ | (49,023) | $ | 27,374 | |||||||
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Consolidated Statement of Cash Flows (Unaudited, $ in 000’s)
| For the Years Ended December 31, | |||||||||||
| 2025 | 2024 | ||||||||||
| OPERATING ACTIVITIES: | |||||||||||
| Net loss | $ | (68,731) | $ | (19,500) | |||||||
| Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | |||||||||||
| Stock-based compensation | 10,147 | 11,920 | |||||||||
| Depreciation and amortization | 10,192 | 10,872 | |||||||||
| Loss on impairments | — | 4,392 | |||||||||
| Other non-cash amortization | (222) | (564) | |||||||||
| Provision for credit losses | (65) | 71 | |||||||||
| Unrealized foreign currency loss (gain) | 365 | (263) | |||||||||
| Interest expense on finance leases | 8 | 22 | |||||||||
| Loss on equity investment | 2,344 | 1,700 | |||||||||
| Deferred income taxes | (103) | (657) | |||||||||
| (Gain) loss on sale of fixed assets | (725) | 563 | |||||||||
| Change in the estimated fair value of acquisition-related contingent consideration | 4,570 | — | |||||||||
| Changes in assets and liabilities: | |||||||||||
| Accounts receivable | 1,949 | 15,872 | |||||||||
| Inventories | 3,562 | 13,096 | |||||||||
| Prepaid expenses and other assets | (2,368) | 4,089 | |||||||||
| Accounts payable | (1,720) | (7,577) | |||||||||
| Deferred revenue | (1,519) | (219) | |||||||||
| Accrued expenses and other liabilities | (6,707) | (6,443) | |||||||||
| Net cash (used in) provided by operating activities | (49,023) | 27,374 | |||||||||
| INVESTING ACTIVITIES: | |||||||||||
| Purchases of short-term investments | — | (53,244) | |||||||||
| Purchase of equity method investee | — | (30,000) | |||||||||
| Acquisition of business, net of cash acquired | (3,613) | (5,037) | |||||||||
| Proceeds from maturities and redemptions of short-term investments | — | 53,052 | |||||||||
| Proceeds from sale of assets | 1,000 | — | |||||||||
| Purchases of property and equipment | (4,197) | (3,797) | |||||||||
| Net cash used in investing activities | (6,810) | (39,026) | |||||||||
| FINANCING ACTIVITIES: | |||||||||||
| Cash payments for finance lease liabilities | (61) | (842) | |||||||||
| Proceeds from exercise of stock options | — | 214 | |||||||||
| Repurchase of common stock | (15,040) | — | |||||||||
| Payment of taxes related to net share settlement of equity awards | (1,843) | (3,548) | |||||||||
| Net cash used in financing activities | (16,944) | (4,176) | |||||||||
| EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH | 4,292 | (6,816) | |||||||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (68,485) | (22,644) | |||||||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 267,763 | 290,407 | |||||||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 199,278 | $ | 267,763 | |||||||
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About OraSure Technologies
OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OraSure improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com
Forward Looking Statements
This press release contains certain forward-looking statements, including with respect to products, product candidate development and manufacturing activities, regulatory submissions and authorizations, revenue growth and guidance, expected revenue from government orders, cost savings, cash flow, increasing margins and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: our ability to satisfy customer demand; ability to reduce our spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to market and sell our products and services, whether through our internal, direct sales force or third parties; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; significant customer concentrations that exist or may develop in the future; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; impact of replacing distributors; inventory levels at distributors and other customers; our ability to achieve its financial and strategic objectives and increase our revenues, including the ability to expand international sales and the ability to continue to reduce costs; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of our products and services; ability to achieve the anticipated benefits from the BioMedomics transaction; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of our products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to achieve and maintain sustained profitability; ability to increase our gross margins; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents, trade secrets and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in
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international funding sources and testing algorithms on international sales; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; cybersecurity incidents and other disruptions involving our computer systems or those of our third-party IT service providers, suppliers and customers; the impact of terrorist attacks, civil unrest, hostilities and war; and general political, business and economic conditions, including interest rates, inflationary pressures, capital market disruptions, changes in governmental agencies, international tariffs, trade protection measures, economic sanctions and economic slowdowns or recessions. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
Statement Regarding Use of Non-GAAP Financial Measures
In this press release, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures, including non-GAAP gross margin, non-GAAP gross profit, non-GAAP net income (loss), non-GAAP operating income (loss), and non-GAAP earnings (loss) per share. Management believes that presentation of operating results using these non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods, while excluding certain expenses that may not be indicative of the Company’s recurring core business operating results. In addition, management believes these non-GAAP financial measures are useful to investors both because they (1) allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) are used by OraSure’s institutional investors and the analysis community to help them analyze the health of OraSure’s business. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the schedules below and a description of the adjustments made to the GAAP financial measures is included at the end of the schedules.
The Company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Non-GAAP financial results are reported in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Further, non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared.
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OraSure Technologies GAAP to Non-GAAP Reconciliation ($ in 000's)
| For the Three Months Ended December 31, | For the Years Ended December 31, | ||||||||||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||||||||||
| Net Revenues | $ | 26,763 | $ | 37,445 | $ | 115,021 | $ | 185,827 | |||||||||||||||
| GAAP Cost of Products and Services Sold | 15,795 | 23,879 | 66,823 | 106,437 | |||||||||||||||||||
| GAAP Gross Margin | 41.0 | % | 36.2 | % | 41.9 | % | 42.7 | % | |||||||||||||||
| Stock compensation | 123 | 195 | 707 | 734 | |||||||||||||||||||
| Inventory reserve for product line discontinuance | — | 1,000 | 146 | 1,000 | |||||||||||||||||||
| Reduction in workforce severance | — | 239 | — | 1,366 | |||||||||||||||||||
| Non-GAAP Cost of Goods Sold | 15,672 | 22,445 | 65,970 | 103,337 | |||||||||||||||||||
| Non-GAAP Gross Margin | 41.4 | % | 40.1 | % | 42.6 | % | 44.4 | % | |||||||||||||||
| GAAP Operating Loss | (20,103) | (12,418) | (71,969) | (28,250) | |||||||||||||||||||
| Stock compensation | 1,459 | 2,741 | 10,147 | 11,919 | |||||||||||||||||||
| Amortization of acquisition-related intangible assets | 58 | 103 | 229 | 279 | |||||||||||||||||||
| Inventory reserve for product line discontinuance | — | 1,000 | 146 | 1,000 | |||||||||||||||||||
| Reduction in workforce severance | — | 849 | — | 3,258 | |||||||||||||||||||
| Executive severance expense | — | — | 751 | — | |||||||||||||||||||
| Loss on impairment | — | — | — | 4,392 | |||||||||||||||||||
| Gain on sale of assets under product line discontinuance | — | — | (750) | — | |||||||||||||||||||
| Transaction costs | 435 | 980 | 547 | 980 | |||||||||||||||||||
| Change in fair value of acquisition-related contingent consideration | 2,983 | — | 4,570 | — | |||||||||||||||||||
| Non-GAAP Operating Loss | (15,168) | (6,745) | (56,329) | (6,422) | |||||||||||||||||||
| GAAP Net Loss | (19,286) | (10,794) | $ | (68,731) | (19,500) | ||||||||||||||||||
| Stock compensation | 1,459 | 2,741 | 10,147 | 11,919 | |||||||||||||||||||
| Amortization of acquisition-related intangible assets | 58 | 103 | 229 | 279 | |||||||||||||||||||
| Inventory reserve for product line discontinuance | — | 1,000 | 146 | 1,000 | |||||||||||||||||||
| Reduction in workforce severance | — | 849 | — | 3,258 | |||||||||||||||||||
| Executive severance expense | — | — | 751 | — | |||||||||||||||||||
| Loss on impairment | — | — | — | 4,392 | |||||||||||||||||||
| Gain on sale of assets under product line discontinuance | — | — | (750) | — | |||||||||||||||||||
| Transaction costs | 435 | 980 | 547 | 980 | |||||||||||||||||||
| Change in fair value of acquisition-related contingent consideration | 2,983 | — | 4,570 | — | |||||||||||||||||||
| Loss on equity investment | 644 | 529 | 2,344 | 1,700 | |||||||||||||||||||
| Tax effect of non-GAAP adjustments | 58 | 362 | (66) | (85) | |||||||||||||||||||
| Non-GAAP Net (Loss) Income | $ | (13,649) | $ | (4,230) | $ | (50,813) | $ | 3,943 | |||||||||||||||
| GAAP Loss Per Share: | $ | (0.27) | $ | (0.14) | $ | (0.94) | $ | (0.26) | |||||||||||||||
| Non-GAAP (Loss) Earnings Per Share: | $ | (0.19) | $ | (0.06) | $ | (0.69) | $ | 0.05 | |||||||||||||||
| Diluted Shares Outstanding | 71,567 | 74,597 | 73,485 | 74,434 | |||||||||||||||||||
| Diluted Shares Outstanding Used For Computing Non-GAAP (Loss) Earnings Per Share | 71,567 | 74,597 | 73,485 | 75,329 | |||||||||||||||||||
The following is a description of the adjustments made to GAAP financial measures:
•Stock Compensation: non-cash equity-based compensation provided to OraSure employees and directors
•Amortization of acquisition-related intangible assets: represents recurring amortization charges resulting from the acquisition of intangible assets associated with our business combinations
•Inventory reserve for product line discontinuance: represents inventory associated with discontinued line of business
•Reduction in workforce severance: termination benefits associated with the Company’s workforce reduction associated with certain business events
•Executive severance expense: expenses associated with the departure of an executive
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•Loss on impairment: charges related to the write down of Company’s intangibles, PP&E, or leased assets
•Gain on sale of assets under product line discontinuance: represents the gain on the sale of fixed assets associated with the risk assessment line of business that was discontinued and sold to a 3rd party
•Transaction costs: expenses associated with the acquisition of businesses
•Change in fair value of acquisition-related contingent consideration: changes in the fair value of contingent consideration liability associated with an adjustment for the passage of time
•Loss on equity investment: we have excluded our proportionate share of our equity method investee’s net loss as we do not have direct control over the investee’s operations or resulting revenue and expenses
•Tax impact associated with non-GAAP adjustments: tax expense/(benefit) due to non-GAAP adjustments
A reconciliation of our non-GAAP measures to their most directly comparable GAAP measures can also be found at: https://orasure.gcs-web.com/gaap-non-gaap-reconciliation
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OraSure Investor Update FEBRUARY 2026 EXHIBIT 99.2
© 2026 OraSure Technologies, Inc. 2OTI Proprietary Disclaimers Forward-Looking Statements: This presentation of OraSure Technologies, Inc. (the “Company” or “OraSure”) contains certain “forward-looking statements” within the meaning of federal securities laws, including with respect to products, product candidate development and manufacturing activities, regulatory submissions and authorizations, revenue growth and guidance, expected revenue from government orders, cost savings, cash flow, increasing margins and other matters. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: OraSure’s ability to satisfy customer demand; ability to reduce OraSure’s spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to market and sell products, whether through the Company’s internal, direct sales force or third parties; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; impact of replacing distributors; inventory levels at distributors and other customers; OraSure’s ability to achieve its financial and strategic objectives and increase its revenues, including the ability to expand international sales; ability to achieve the anticipated benefits from the BioMedomics transaction; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of the Company’s products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to achieve and maintain sustained profitability; ability to increase OraSure’s gross margins; ability to utilize net operating loss carry forwards or other deferred tax assets; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents, trade secrets and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; impact of changes in international funding sources and testing algorithms on international sales; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of cybersecurity incidents and other disruptions involving the Company’s computer systems or those of our third-party IT service providers, suppliers and customers; the impact of terrorist attacks, civil unrest, hostilities and war; and general political, business and economic conditions, including interest rates, inflationary pressures, capital market disruptions, changes in governmental agencies, international tariffs, trade protection measures, economic sanctions and economic slowdowns or recession. These and other factors that could affect the Company’s results are discussed more fully in OraSure’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s registration statements, Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this presentation and OraSure undertakes no duty to update these statements. Estimates and Other Data: This presentation contains estimates and other data made by independent parties and the Company relating to market size and growth and other data about its industry. Such data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of the Company’s future performance and the future performance of the markets in which it operates are necessarily subject to a high degree of uncertainty and risks. Non-GAAP Financial Measures This presentation makes use of certain financial measures that are not prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). Please refer to the Appendix to this presentation for a reconciliation of any non-GAAP financial measures. We encourage investors to carefully consider the Company’s results under GAAP, as well as our supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand the Company’s business. Non-GAAP financial results are reported in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Further, non-GAAP financial measures, even if similarly titled, may not be calculated in the same manner by all companies, and therefore should not be compared. No Solicitation: This presentation does not constitute an offer to sell or a solicitation of an offer to buy securities in any potential transaction, nor shall there by any offer, solicitation or sale of any such securities in any jurisdiction, or to whom any person, where such offer, solicitation or sale would be unlawful.
© 2026 OraSure Technologies, Inc. 3OTI Proprietary Disciplined execution driving stronger platform for growth Three years of progress in transformation strategy Strengthen our Foundation Elevate our Core Growth Accelerate our Profitable Growth Cost productivity • One OTI: combined 2 business units into 1 • Org right-sizing: reduced headcount • Footprint consolidation: closed 4 global sites and in-sourced to PA • Closures: wound down 2 declining, unprofitable product lines Leadership & talent upskilling • New executive leadership Return core business to breakeven; create low-cost manufacturing capabilities; drive efficiency in operations; upgrade key talent Sales • Customer diversification • New Chief Commercial Officer Product & process rigor • COGS reductions: automation, design for manufacturing, optimized logistics • AI and digital tools implementation • Multi-year innovation product planning • Continuous improvement methodology Drive core growth and profitability; diversify our customer base; continuously reduce product cost; implement enterprise-wide rigor Execute focused strategy to drive innovation and create value through disciplined capital allocation … internal investment, plus M&A Governance • Board refresh - 6 departed, 3 new independent directors • $40 million share buyback authorization with $15 million deployed Pipeline expansion Organic investments • Urine: Colli-PeeTM self-collection • Blood: HEMAcollectTM ●Protein RUO M&A and partnerships • Sherlock molecular Dx platform: initial CT/NG self-test and pipeline of assays • Sapphiros: lateral flow roadmap and Satio self-collected blood • BioMedomics: SickleSCAN® • Dx Direct: Syphilis Health CheckTM
© 2026 OraSure Technologies, Inc. 4OTI Proprietary Financial performance summary Innovating and operating with disciplined execution and accountability Q4 results • Total Revenue: $26.8 million • Core Revenue: $26.7 million • Non-GAAP Gross Margin: 41.4% External environment: We are seeing increasing signs of stability in key segments in 2026, including improved visibility to funding for important testing and research programs. Growth: Positioned for growth in core business in 2026 and beyond ➢Pipeline of potential product milestones expected to accelerate growth Margin: Path to 50% adjusted gross margin ➢Opportunity for significant margin expansion as volumes grow Balance sheet: $199M of cash and no debt as of Q4 2025 Q1 guidance • Total Revenue: $26 to $29 million • Non-GAAP Gross Margin: low 40% range
© 2026 OraSure Technologies, Inc. 5OTI Proprietary Clear strategy to innovate and accelerate growth … with near-term catalysts in attractive markets Delivering our near-term product roadmap Plan to launch differentiated innovation by executing on near-term milestones … aligned with long-term healthcare trends Expanding our long-term innovation pipeline Leveraging OTI strengths to compete and win in large and growing segments … expected to accelerate long-term growth
© 2026 OraSure Technologies, Inc. 6OTI Proprietary Product roadmap: anticipated near-term milestones Description Protein-specific blood collection & sample stabilization At-home first-void urine self-collection Disposable molecular dx, rapid test Blood self-collection; Dot = dried blood spot vs. capillary blood draw Global market $ $700M $500M $1.5B $92B (traditional collection) Status RUO launched July 2025 Regulatory review underway following submission to FDA in December 2025 Regulatory review underway following submission to FDA in December 2025 Future launch via distribution agreement, subject to regulatory submission and review Note: Market sizing based on Company projections, modeling, and external research.
© 2026 OraSure Technologies, Inc. 7OTI Proprietary Expanding our pipeline in high-value growth markets Illustrative examples leveraging OTI strengths Notes: •Example criteria are not all inclusive •Matrix excludes less attractive opportunities Example criteria: Market size Growth rate Profitability to serve Clinical need / decision-making Speed to scale Barriers to entry Example criteria: Portfolio fit Platform / tech expertise Development feasibility Channel alignment OTI’s ability to compete and win S e g m e n t a tt ra ct iv e n e ss Medium High High Anti-microbial resistance (AMR) ID: Bacterial STIs ID: Parasitic Blood disease Wellness Liquid biopsy Infectious disease (ID): Viral OTI strengths • Chemistries for sample stabilization, transport, and storage • Expertise in oral fluid, urine, blood … non- and less invasive • Commercial reach and relationships, including international distribution • Regulatory capabilities for market access • Manufacturing automation and capacity
© 2026 OraSure Technologies, Inc. 8OTI Proprietary OraSure today: stronger, focused, and executing for sustainable growth Strengthen our Foundation Elevate our Core Growth Accelerate our Profitable Growth
© 2026 OraSure Technologies, Inc. 9 Appendix
© 2026 OraSure Technologies, Inc. 10 Reconciliation of Non-GAAP Gross Margin OraSure Technologies GAAP to Non-GAAP Reconciliation ($ in 000's) For the Three Months Ended December 31, For the Years Ended December 31, 2025 2024 2025 2024 Net Revenues $ 26,763 $ 37,445 $ 115,021 $ 185,827 GAAP Cost of Products and Services Sold 15,795 23,879 66,823 106,437 GAAP Gross Margin 41.0 % 36.2 % 41.9 % 42.7 % Stock compensation 123 195 707 734 Inventory reserve for product line discontinuance — 1,000 146 1,000 Reduction in workforce severance — 239 — 1,366 Non-GAAP Cost of Goods Sold 15,672 22,445 65,970 103,337 Non-GAAP Gross Margin 41.4 % 40.1 % 42.6 % 44.4 %
FAQ
How did OraSure Technologies (OSUR) perform financially in Q4 2025?
OraSure reported Q4 2025 net revenues of $26.8 million, down 29% from $37.4 million in Q4 2024, and a GAAP net loss of $19.3 million. Non-GAAP gross margin improved to 41.4%, reflecting cost actions despite lower sales volumes across diagnostics and sample management.
What were OraSure Technologies’ full-year 2025 revenues and net loss?
For 2025, OraSure generated net revenues of $115.0 million, down from $185.8 million in 2024, as COVID-19 revenues virtually disappeared. The company recorded a full-year GAAP net loss of $68.7 million, compared with a $19.5 million loss the prior year, and higher operating losses.
How strong is OraSure Technologies’ balance sheet at year-end 2025?
At December 31, 2025, OraSure held $199.3 million in cash and cash equivalents and reported no debt. Total assets were $403.2 million and stockholders’ equity was $340.8 million, providing substantial financial flexibility despite negative operating cash flow in 2025.
What guidance did OraSure Technologies provide for Q1 2026?
OraSure guided Q1 2026 total revenues to $26–29 million, including a negligible contribution from COVID-19 testing. Management also expects non-GAAP gross margin in the low 40% range, signaling continued focus on cost control and mix as the company pursues a return to growth.
Which new products could drive future growth for OraSure Technologies?
OraSure highlighted regulatory submissions to the FDA for a rapid molecular self-test for chlamydia and gonorrhea and the Colli-Pee at-home urine collection device for sexually transmitted infections. These innovations target large, growing diagnostics markets and are intended to support a return to growth from 2026 onward.
Did OraSure Technologies repurchase any shares in 2025?
Yes. OraSure has a $40 million share repurchase authorization and deployed $15.0 million in 2025. During Q4 alone, the company spent $5 million to buy back approximately 1.9 million shares of common stock, returning capital to shareholders while maintaining strong liquidity.
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Orasure Tech
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Jan 15, 2026
[DFAN14A] ORASURE TECHNOLOGIES INC SEC Filing
OSUR Stock Data
220.94M
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Medical Instruments & Supplies
Surgical & Medical Instruments & Apparatus
United States
BETHLEHEM