Form 8-K
8-K — ORASURE TECHNOLOGIES INC
Accession: 0001116463-26-000037
Filed: 2026-05-06
Period: 2026-05-06
CIK: 0001116463
SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)
Item: Results of Operations and Financial Condition
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — osur-20260506.htm (Primary)
EX-99.1 (osur-pressreleaseq12026.htm)
EX-99.2 (ex992_q1-26investorupdat.htm)
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8-K
8-K (Primary)
Filename: osur-20260506.htm · Sequence: 1
osur-20260506
FALSE000111646300011164632026-05-062026-05-06
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): May 6, 2026
OraSure Technologies, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware
001-16537
36-4370966
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
220 East First Street
Bethlehem, Pennsylvania
18015-1360
(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
Common Stock, $0.000001 par value per share
OSUR
The NASDAQ Stock Market LLC
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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 May 6, 2026, OraSure Technologies, Inc. (the “Company”) issued a press release announcing its consolidated financial results for the quarter ended March 31, 2026 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.
On May 6, 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 quarter ended March 31, 2026 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 May 6, 2026, announcing the consolidated financial results of OraSure Technologies, Inc. for the quarter ended March 31, 2026 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: May 6, 2026 By: /s/ Carrie Eglinton Manner
Carrie Eglinton Manner
President and Chief Executive Officer
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EX-99.1
EX-99.1
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Document
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 First Quarter 2026 Financial Results
BETHLEHEM, PA, May 6, 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 March 31, 2026.
“Our Q1 results were consistent with our expectations, and revenue of $27.9 million was above the midpoint of our guidance range,” said Carrie Eglinton Manner, President and CEO of OTI. “We delivered gross margin expansion in Q1 and remain focused on leveraging our manufacturing capabilities and capacity to drive additional operating efficiencies.”
She continued, “OraSure is well positioned to accelerate our growth as we approach a series of regulatory and commercial milestones in 2026 and continue to transform our business through our strategy to decentralize diagnostics and connect people to care that is more accessible, convenient, affordable, and private. Additionally, our strong balance sheet gives us the flexibility to pursue acquisitions and partnerships that strengthen our portfolio, while continuing to invest in R&D aimed at high‑value growth markets in order to drive long‑term value for shareholders.”
Financial Highlights ($ in 000’s, except per share amounts)
For the Three Months Ended March 31,
2026 2025 % Change
Core Business (1)
$ 27,907 $ 28,050 (1) %
COVID-19 18 461 (96)
Risk Assessment Testing — 1,420 (100)
Total Net Revenues $ 27,925 $ 29,931 (7) %
(1) Includes Diagnostics, Sample Management Solutions, other products and services revenues, and non-product and services revenues.
1
For the Three Months Ended March 31,
2026 2025 % Change
Net revenues 27,925 29,931 (7)%
Gross profit 11,804 12,299 (4)
Gross margin 42.3 % 41.1 %
Non-GAAP gross profit 12,107 12,468 (3)
Non-GAAP gross margin 43.4 % 41.7 %
Operating loss (23,269) (17,750) NM
Operating margin (83.3) % (59.3) %
Non-GAAP operating loss (19,034) (15,280) NM
Non-GAAP operating margin (68.2) % (51.1) %
Net loss (22,377) (16,040) NM
Non-GAAP net (loss) income (17,022) (13,139) NM
Diluted GAAP EPS $ (0.32) $ (0.21) NM
Diluted Non-GAAP EPS $ (0.24) $ (0.18) NM
NM – not meaningful
•Total net revenues for the first quarter of 2026 decreased 7% to $27.9 million from $29.9 million in the first quarter of 2025.
•Core revenues (all revenues excluding COVID-19, Molecular Services, and Risk Assessment Testing revenues) of $27.9 million in the first quarter decreased 0.5% year-over-year. Diagnostics revenues in the first quarter decreased 5% year-over-year to $16.9 million, with the decline attributable to lower revenue from our HCV tests. Sample Management Solutions revenues of $9.1 million in the first quarter decreased 0.6% year-over-year.
•GAAP gross margin was 42.3% in the first quarter of 2026 compared to 41.1% in the first quarter of 2025. Non-GAAP gross margin in the first quarter of 2026 was 43.4% and increased compared to 41.7% in the first quarter of 20251.
•GAAP operating loss in the first quarter of 2026 was $23.3 million compared to GAAP operating loss of $17.8 million in the first quarter of 2025. Non-GAAP operating loss was $19.0 million in the first quarter of 2026 compared to non-GAAP operating loss of $15.3 million in the first quarter of 2025.
•Cash and cash equivalents were $177 million as of March 31, 2026.
•OTI deployed $5 million during the first quarter to repurchase approximately 1.8 million shares of our common stock.
Recent Developments
•Appointed John D. Bertrand to our Board of Directors. Mr. Bertrand is a healthcare technology executive with more than a decade of experience driving AI-enabled innovation in diagnostics.
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
•Published our 2025-2026 “OTI Cares” Impact and Governance report, which highlights our progress in advancing the impact of our sustainability and governance-related initiatives that are meaningful to our internal and external stakeholders.
Financial Guidance
The Company is guiding to Q2 2026 Total revenues of $27 million to $30 million.
Conference Call
The Company will host a conference call and audio webcast to discuss the Company’s first quarter 2026 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.
Disclosure
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 March 31,
2026 2025
Results of Operations
Net revenues $ 27,925 $ 29,931
Cost of products and services sold 16,121 17,632
Gross profit 11,804 12,299
Operating expenses:
Research and development 13,654 9,603
Sales and marketing 6,770 6,859
General and administrative 14,556 14,102
Change in the estimated fair value of acquisition-related contingent consideration 93 478
Gain on sale of assets
— (993)
Total operating expenses 35,073 30,049
Operating loss (23,269) (17,750)
Other income 1,548 1,778
Loss before income taxes and equity investment (21,721) (15,972)
Income tax benefit
(432) (456)
Loss before equity investment
(21,289) (15,516)
Loss on equity investment (1,088) (524)
Net loss $ (22,377) $ (16,040)
Loss per share:
Basic $ (0.32) $ (0.21)
Diluted $ (0.32) $ (0.21)
Weighted average shares outstanding:
Basic 69,675 74,867
Diluted 69,675 74,867
For the Three Months Ended March 31,
2026 2025 % Change
Consolidated Net Revenues
Diagnostics $ 16,866 $ 17,689 (5) %
Sample Management Solutions 9,058 9,110 (1)
Other products and services 434 321 35
COVID-19 Diagnostics 18 457 (96)
Risk Assessment Testing — 1,420 (100)
Net product and services revenues 26,376 28,997 (9)
Non-product and services revenues 1,549 934 66
Net revenues $ 27,925 $ 29,931 (7) %
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Condensed Consolidated Balance Sheets (Unaudited, $ in 000’s)
March 31, 2026 December 31, 2025
Assets
Cash and cash equivalents $ 176,964 $ 199,278
Accounts receivable, net 24,807 22,203
Inventories 30,307 31,060
Other current assets 8,703 9,367
Property, plant and equipment, net 37,857 39,179
Intangible assets, net 18,940 19,046
Goodwill 43,047 43,363
Investment in equity method investee 24,868 25,956
Other noncurrent assets 13,676 13,716
Total assets $ 379,169 $ 403,168
Liabilities and Stockholders’ Equity
Accounts payable $ 10,628 $ 6,521
Deferred revenue 872 1,518
Acquisition-related contingent consideration obligation
18,777 18,380
Other current liabilities 13,807 13,376
Other noncurrent liabilities 21,761 22,546
Stockholders’ equity 313,324 340,827
Total liabilities and stockholders’ equity $ 379,169 $ 403,168
Additional Financial Data (Unaudited, $ in 000’s)
For the Three Months Ended March 31,
2026 2025
Capital expenditures $ 913 $ 420
Depreciation and amortization 2,341 2,808
Stock-based compensation 2,768 2,687
Cash used in operating activities
$ (13,895) $ (19,733)
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Consolidated Statement of Cash Flows (Unaudited, $ in 000’s)
For the Three Months Ended March 31,
2026 2025
OPERATING ACTIVITIES:
Net loss $ (22,377) $ (16,040)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation 2,768 2,687
Depreciation and amortization 2,341 2,808
Other non-cash amortization (82) (37)
Provision for credit losses 66 (248)
Unrealized foreign currency (gain) loss
(153) 194
Interest expense on finance leases 3 2
Loss on equity investment 1,088 524
Deferred income taxes (354) (384)
Gain on sale of fixed assets — (780)
Change in the estimated fair value of acquisition-related contingent consideration 93 478
Changes in assets and liabilities:
Accounts receivable (2,621) 2,413
Inventories 714 (1,482)
Prepaid expenses and other assets 583 (2,075)
Accounts payable 4,104 (726)
Deferred revenue (645) (451)
Accrued expenses and other liabilities 577 (6,616)
Net cash used in operating activities (13,895) (19,733)
INVESTING ACTIVITIES:
Proceeds from sale of assets — 790
Purchases of property and equipment (913) (420)
Net cash (used in) provided by investing activities (913) 370
FINANCING ACTIVITIES:
Cash payments for finance lease liabilities (21) (12)
Repurchase of common stock (5,000) —
Payment of taxes related to net share settlement of equity awards (1,261) (941)
Net cash used in financing activities (6,282) (953)
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH (1,224) 122
NET DECREASE IN CASH AND CASH EQUIVALENTS (22,314) (20,194)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 199,278 267,763
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 176,964 $ 247,569
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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 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
7
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, 2025, 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.
8
OraSure Technologies GAAP to Non-GAAP Reconciliation ($ in 000's, except per share amounts)
For the Three Months Ended March 31,
2026 2025
Net Revenues $ 27,925 $ 29,931
GAAP Cost of Products and Services Sold 16,121 17,632
GAAP Gross Margin 42.3 % 41.1 %
Stock compensation 190 169
Amortization of acquisition-related intangible assets 48 —
Reduction in workforce severance 65 —
Non-GAAP Cost of Goods Sold 15,818 17,463
Non-GAAP Gross Margin 43.4 % 41.7 %
GAAP Operating Loss (23,269) (17,750)
Stock compensation 2,768 2,687
Amortization of acquisition-related intangible assets 105 55
Reduction in workforce severance 1,269 —
Gain on sale of assets under product line discontinuance — (750)
Change in fair value of acquisition-related contingent consideration 93 478
Non-GAAP Operating Loss (19,034) (15,280)
GAAP Net Loss (22,377) (16,040)
Stock compensation 2,768 2,687
Amortization of acquisition-related intangible assets 105 55
Reduction in workforce severance 1,269 —
Gain on sale of assets under product line discontinuance — (750)
Change in fair value of acquisition-related contingent consideration 93 478
Loss on equity investment 1,088 524
Tax effect of non-GAAP adjustments 32 (93)
Non-GAAP Net Loss
$ (17,022) $ (13,139)
GAAP Loss Per Share: $ (0.32) $ (0.21)
Non-GAAP Loss Per Share:
$ (0.24) $ (0.18)
Diluted Shares Outstanding 69,675 74,867
Diluted Shares Outstanding Used For Computing Non-GAAP
Loss Per Share
69,675 74,867
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
•Reduction in workforce severance: termination benefits associated with the Company’s workforce reduction associated with certain business
•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
•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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EX-99.2
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ex992_q1-26investorupdat
OraSure Investor Update May 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, 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 acquisition transactions; 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, 2025, 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.
© 2026 OraSure Technologies, Inc. 3OTI Proprietary Disciplined execution driving stronger platform for growth 3+ 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 - 7 departed, 4 new independent directors • $40 million share buyback authorization with $20 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 Q1 results • Total Revenue: $27.9 million • +4% q/q growth • Non-GAAP Gross Margin: 43.4% External environment: We are seeing stable demand in key segments in 2026, including improved visibility to funding for important testing 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: $177M of cash and no debt as of Q1 2026 Q2 guidance • Total Revenue: $27 to $30 million • Non-GAAP Gross Margin: similar to Q1
© 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 $92B (traditional collection) Status RUO launched July 2025 Regulatory review underway following submission to FDA in December 2025 Regulatory review underway following submission to FDA in December 2025 Future launch via distribution agreement, subject to regulatory submission and review Note: Market sizing based on Company projections, modeling, and external research.
© 2026 OraSure Technologies, Inc. 7OTI Proprietary Expanding our pipeline in high-value growth markets Illustrative examples leveraging OTI strengths Notes: •Example criteria are not all inclusive •Matrix excludes less attractive opportunities Example criteria: Market size Growth rate Profitability to serve Clinical need / decision-making Speed to scale Barriers to entry Example criteria: Portfolio fit Platform / tech expertise Development feasibility Channel alignment OTI’s ability to compete and win S e g m e n t a tt ra ct iv e n e ss Medium High High Anti-microbial resistance (AMR) ID: Bacterial STIs ID: Parasitic Blood disease Wellness Liquid biopsy Infectious disease (ID): Viral OTI strengths • Chemistries for sample stabilization, transport, and storage • Expertise in oral fluid, urine, blood … non- and less invasive • Commercial reach and relationships, including international distribution • Regulatory capabilities for market access • Manufacturing automation and capacity
© 2026 OraSure Technologies, Inc. 8OTI Proprietary OraSure today: stronger, focused, and executing for sustainable growth Strengthen our Foundation Elevate our Core Growth Accelerate our Profitable Growth
© 2026 OraSure Technologies, Inc. 9OTI Proprietary Appendix
© 2026 OraSure Technologies, Inc. 10OTI Proprietary Reconciliation of Non-GAAP Gross Margin OraSure Technologies GAAP to Non-GAAP Reconciliation ($ in 000's)
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