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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): November 5, 2025
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 On November 5, 2025, OraSure Technologies, Inc. (the “Company”) issued a press release announcing its consolidated financial results for the quarter ended September 30, 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 2.02 – Results of Operations and Financial Condition.
Item 7.01 – Regulation FD Disclosure.
Webcast
On November 5, 2025, 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 September 30, 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
99.2
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: November 5, 2025 By: /s/ Carrie Eglinton Manner
Carrie Eglinton Manner
President and Chief Executive Officer
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EX-99.1 2 osur-pressreleaseq32025.htm EX-99.1 Document

otiwordmark.jpg

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 Third Quarter 2025 Financial Results

BETHLEHEM, PA, November 5, 2025 (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 September 30, 2025.
“In Q3 we delivered $27.1 million of revenue. While some of our customers continue to experience elevated levels of uncertainty related to funding for public health programs and research, we remain confident in our opportunities to return to growth in 2026, driven by diversification in our customer base and contributions from planned launches of new products in both rapid diagnostics and sample management solutions,” said Carrie Eglinton Manner, President and CEO of OTI.
She continued, “OTI’s focus on decentralizing diagnostics and connecting people to care that is more accessible, convenient, private, and personalized is well-aligned with important long-term trends in the healthcare industry. We believe that this strategy and our capabilities position us for sustainable, long-term growth. Additionally, our strong balance sheet provides us with flexibility to navigate the current short-term turbulence while we advance our innovation roadmap and prepare for important new products that are expected to launch next year, including our Sherlock over-the-counter molecular self-test for Chlamydia and Gonorrhoeae and our Colli-Pee urine self-collection for sexually transmitted infections.”

Financial Highlights ($ in 000’s, except per share amounts)
For the Three Months Ended September 30, For the Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Core Business (1)
$ 26,996  $ 35,840  (25)  % $ 85,818  $ 96,203  (11) %
COVID-19 89  2,155  (96) 574  44,222  (99) %
Risk Assessment Testing —  1,911  (100) 1,866  6,265  (70) %
Molecular Services —  (100) —  1,692  (100) %
Total Net Revenues $ 27,085  $ 39,915  (32)  % $ 88,258  $ 148,382  (41) %
(1) Includes Diagnostics, Sample Management Solutions, other products and services revenues, and non-product and services revenues.

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For the Three Months Ended September 30, For the Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Net revenues $ 27,085  $ 39,915  (32) % $ 88,258  $ 148,382  (41) %
Gross profit 11,772  17,070  (31) 37,230  65,824  (43)
Gross margin 43.5  % 42.8  % 42.2  % 44.4  %
Non-GAAP gross profit 11,980  17,272  (31) 37,960  67,490  (44)
Non-GAAP gross margin 44.2  % 43.3  % 43.0  % 45.5  %
Operating loss (16,090) (5,999) NM (51,866) (15,832) NM
Operating margin (59.4) % (15.0) % (58.8) % (10.7) %
Non-GAAP operating (loss) income
(12,709) (2,699) NM (41,162) 324  NM
Non-GAAP operating margin (46.9) % (6.8) % (46.6) % 0.2  %
Net loss (13,712) (4,507) NM (49,445) (8,706) NM
Non-GAAP net (loss) income (9,831) (689) NM (37,164) 8,173  NM
Diluted GAAP EPS $ (0.19) $ (0.06) NM $ (0.67) $ (0.12) NM
Diluted Non-GAAP EPS $ (0.13) $ (0.01) NM $ (0.50) $ 0.11  NM
NM – not meaningful

•Total net revenues for the third quarter of 2025 decreased 32% to $27.1 million from $39.9 million in the third quarter of 2024.
•Core revenues (all revenues excluding COVID-19, Molecular Services, and Risk Assessment Testing revenues) of $27.0 million in the third quarter decreased 25% year-over-year. Diagnostics revenues in the third quarter decreased 34% year-over-year to $14.5 million, with the decline attributable to lower revenue from our HIV tests. Sample Management Solutions revenues in the third quarter decreased 20% year-over-year to $10.3 million, with the decline attributable to a large customer in the consumer genomics segment.
•GAAP gross margin was 43.5% in the third quarter of 2025 compared to 42.8% in the third quarter of 2024. Non-GAAP gross margin in the third quarter of 2025 was 44.2% compared to 43.3% in the third quarter of 20241.
•GAAP operating loss in the third quarter of 2025 was $16.1 million compared to operating loss of $6.0 million in the third quarter of 2024. Non-GAAP operating loss was $12.7 million in the third quarter of 2025 compared to non-GAAP operating loss of $2.7 million in the third quarter of 2024.
•Cash and cash equivalents were $216 million as of September 30, 2025.
•OTI deployed $5 million during the third quarter to repurchase approximately 1.5 million shares of our common stock.

Recent Business Developments
•Signed a definitive agreement to acquire BioMedomics. The transaction expands OTI’s diagnostic portfolio by adding SickleSCAN®, a rapid, point-of-need test for sickle cell disease that is currently sold outside the U.S. We believe OTI can significantly expand the reach and
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.
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adoption of SickleSCAN® by leveraging our international sales channels and our existing relationships with national health programs.
•Extended our relationship with the Together Take Me Home program, a collaboration funded by the U.S. federal government that makes HIV self-tests available through the mail in order to reach at-risk populations.
Selected by the ENDO1000 project to provide devices for collection and stabilization of a variety of samples including saliva, urine, stool, and vaginal swab. The ENDO1000 project is a U.K.-wide initiative aimed at accelerating discovery and advancing data-driven research into the diagnosis and personalized treatment of endometriosis.
Appointed Steven K. Boyd to our Board of Directors as part of our ongoing refreshment efforts. Mr. Boyd is a seasoned investor who brings a valuable shareholder perspective and more than two decades of public markets experience across healthcare.
•Appointed Jack Kenny as Chair of our Board. Mr. Kenny has served as a director since September 2024. Mr. Kenny succeeds Mara Aspinall, who stepped down from the Board after more than eight years of service.

Financial Guidance
The Company is guiding to Q4 2025 Total revenues of $25 million to $28 million, which includes less than $100 thousand of COVID-19 testing revenues.

Conference Call
The Company will host a conference call and audio webcast to discuss the Company’s third 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 September 30, For the Nine Months Ended September 30,
2025 2024 2025 2024
Results of Operations
Net revenues $ 27,085  $ 39,915  $ 88,258  $ 148,382 
Cost of products and services sold 15,313  22,845  51,028  82,558 
Gross profit 11,772  17,070  37,230  65,824 
Operating expenses:
Research and development 10,106  5,623  31,110  19,960 
Sales and marketing 6,299  7,615  19,533  23,994 
General and administrative 11,081  9,831  37,859  33,310 
Loss on impairments —  —  —  4,392 
Change in the estimated fair value of acquisition-related contingent consideration 376  —  1,587  — 
Gain on sale of assets —  —  (993) — 
Total operating expenses 27,862  23,069  89,096  81,656 
Operating loss (16,090) (5,999) (51,866) (15,832)
Other income 2,799  2,781  5,712  9,338 
Loss before income taxes and equity
investment
(13,291) (3,218) (46,154) (6,494)
Income tax expense 47  678  1,591  1,041 
Loss before equity investment
(13,338) (3,896) (47,745) (7,535)
Loss on equity investment (374) (611) (1,700) (1,171)
Net loss $ (13,712) $ (4,507) $ (49,445) $ (8,706)
Loss per share:
Basic $ (0.19) $ (0.06) $ (0.67) $ (0.12)
Diluted $ (0.19) $ (0.06) $ (0.67) $ (0.12)
Weighted average shares outstanding:
Basic 73,004  74,583  74,131 74,330
Diluted 73,004  74,583  74,131 74,330

For the Three Months Ended September 30, For the Nine Months Ended September 30,
2025 2024 % Change 2025 2024 % Change
Consolidated Net Revenues
Diagnostics $ 14,499  $ 22,023  (34) % $ 51,410  $ 57,162  (10) %
Sample Management Solutions 10,306  12,806  (20) 29,271  36,237  (19)
Other product and services 442  748  (41) 1,059  1,838  (42)
COVID-19 Diagnostics 89  2,155  (96) 574  44,186  (99)
Risk Assessment Testing —  1,911  (100) 1,866  6,265  (70)
Molecular Services —  (100) —  1,692  (100)
Net product and services revenues 25,336  39,652  (36) 84,180  147,380  (43)
Non-product and services revenues 1,749  263  565  4,078  1,002  307 
Net revenues $ 27,085  $ 39,915  (32) % $ 88,258  $ 148,382  (41) %
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Condensed Consolidated Balance Sheets (Unaudited, $ in 000’s)
September 30, 2025 December 31, 2024
Assets
Cash and cash equivalents $ 216,478  $ 267,763 
Accounts receivable, net 24,300  23,816 
Inventories 33,401  34,197 
Other current assets 8,832  7,444 
Property, plant and equipment, net 40,795  45,105 
Intangible assets, net 17,202  17,435 
Goodwill 41,313  40,330 
Investment in equity method investee 26,600  28,300 
Other noncurrent assets 14,177  15,269 
Total assets $ 423,098  $ 479,659 
Liabilities and Stockholders’ Equity
Accounts payable $ 6,360  $ 8,173 
Deferred revenue 1,879  2,961 
Acquisition-related contingent consideration obligation
17,232  — 
Other current liabilities 14,777  22,349 
Other noncurrent liabilities 20,870  35,838 
Stockholders’ equity 361,980  410,338 
Total liabilities and stockholders’ equity $ 423,098  $ 479,659 
Additional Financial Data (Unaudited, $ in 000’s)
For the Nine Months Ended September 30,
2025 2024
Capital expenditures $ 3,275  $ 3,341 
Depreciation and amortization 7,789  8,380 
Stock-based compensation 8,687  9,178 
Cash (used in) provided by operating activities $ (40,027) $ 27,265 



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Consolidated Statement of Cash Flows (Unaudited, $ in 000’s)
For the Nine Months Ended September 30,
2025 2024
OPERATING ACTIVITIES:
Net loss $ (49,445) $ (8,706)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Stock-based compensation 8,687  9,178 
Depreciation and amortization 7,789  8,380 
Loss on impairments —  4,392 
Other non-cash amortization (221) (569)
Provision for credit losses (176) 521 
Unrealized foreign currency loss (gain) 294  (154)
Interest expense on finance leases 20 
Loss on equity investment 1,700  1,171 
Deferred income taxes (86) 165 
Gain on sale of fixed assets (993) (121)
Change in the estimated fair value of acquisition-related contingent consideration 1,587  — 
Changes in assets and liabilities:
Accounts receivable (16) 12,658 
Inventories 894  8,659 
Prepaid expenses and other assets (1,915) 2,622 
Accounts payable (1,733) (3,431)
Deferred revenue (1,085) 66 
Accrued expenses and other liabilities (5,314) (7,586)
Net cash (used in) provided by operating activities (40,027) 27,265 
INVESTING ACTIVITIES:
Purchases of short-term investments —  (53,244)
Investment in equity method investee —  (30,000)
Proceeds from maturities and redemptions of short-term investments —  53,052 
Proceeds from sale of assets 888  — 
Purchases of property and equipment (3,275) (3,341)
Net cash used in investing activities (2,387) (33,533)
FINANCING ACTIVITIES:
Cash payments for finance lease liabilities (43) (746)
Proceeds from exercise of stock options —  214 
Repurchase of common stock (10,001) — 
Payment of taxes related to net share settlement of equity awards (1,786) (3,533)
Net cash used in financing activities (11,830) (4,065)
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH 2,959  (1,503)
NET DECREASE IN CASH AND CASH EQUIVALENTS (51,285) (11,836)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 267,763  290,407 
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 216,478  $ 278,571 



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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. OraSure, together with its wholly-owned subsidiaries, DNA Genotek Inc. and Sherlock Biosciences, Inc., 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, physician’s 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; impact of significant customer concentration in the genomics business; 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 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.
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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 September 30, For the Nine Months Ended September 30,
2025 2024 2025 2024
Net Revenues $ 27,085  $ 39,915  $ 88,258  $ 148,382 
GAAP Cost of Products and Services Sold 15,313  22,845  51,028  82,558 
GAAP Gross Margin 43.5  % 42.8  % 42.2  % 44.4  %
Stock compensation 208  195  584  539 
Inventory reserve for product line discontinuance —  —  146  — 
Reduction in workforce severance —  —  1,127 
Non-GAAP Cost of Goods Sold 15,105  22,643  50,298  80,892 
Non-GAAP Gross Margin 44.2  % 43.3  % 43.0  % 45.5  %
GAAP Operating Loss (16,090) (5,999) (51,866) (15,832)
Stock compensation 2,835  2,888  8,687  9,178 
Amortization of acquisition-related intangible assets 58  59  171  176 
Inventory reserve for product line discontinuance —  —  146  — 
Reduction in workforce severance —  353  —  2,410 
Executive severance expense —  —  751  — 
Loss on impairment —  —  —  4,392 
Gain on sale of assets under product line discontinuance —  —  (750) — 
Transaction costs 112  —  112  — 
Change in fair value of acquisition-related contingent consideration 376  —  1,587  — 
Non-GAAP Operating (Loss) Income (12,709) (2,699) (41,162) 324 
GAAP Net Loss (13,712) (4,507) (49,445) (8,706)
Stock compensation 2,835  2,888  8,687  9,178 
Amortization of acquisition-related intangible assets 58  59  171  176 
Inventory reserve for product line discontinuance —  —  146  — 
Reduction in workforce severance —  353  —  2,409 
Executive severance expense —  —  751  — 
Loss on impairment —  —  —  4,392 
Gain on sale of assets under product line discontinuance —  —  (750) — 
Transaction costs 112  —  112  — 
Change in fair value of acquisition-related contingent consideration 376  —  1,587  — 
Loss on equity investment 374  611  1,700  1,171 
Tax effect of non-GAAP adjustments 126  (93) (123) (447)
Non-GAAP Net (Loss) Income $ (9,831) $ (689) $ (37,164) $ 8,173 
GAAP Loss Per Share: $ (0.19) $ (0.06) $ (0.67) $ (0.12)
Non-GAAP (Loss) Earnings Per Share: $ (0.13) $ (0.01) $ (0.50) $ 0.11 
Diluted Shares Outstanding 73,004  74,583  74,131  74,330 
Diluted Shares Outstanding Used For Computing Non-GAAP
(Loss) Earnings Per Share
73,004  74,583  74,131  75,328 
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 due diligence of targets
•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 3 exhibit992_investorprese.htm EX-99.2 exhibit992_investorprese
OraSure Q3 2025 Investor Update NOVEMBER 2025 Exhibit 99.2


 
© 2025 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; impact of significant customer concentration in the genomics business; 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.


 
© 2025 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 $10 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


 
© 2025 OraSure Technologies, Inc. 4OTI Proprietary Financial performance summary Innovating and operating with disciplined execution and accountability Q3 results • Total Revenue: $27.1 million • Core Revenue: $27.0 million • Non-GAAP Gross Margin: 44.2% External environment: OTI is diversifying its customer base while actively partnering with customers navigating uncertainty in U.S. funding for public health programs, infectious disease testing, and research Growth: Positioned for growth in core business in 2026 & 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: $216M of cash and no debt as of Q3 2025 Q4 guidance • Total Revenue: $25 to $28 million • Non-GAAP Gross Margin: low 40% range


 
© 2025 OraSure Technologies, Inc. 5OTI Proprietary Strategy to accelerate growth with near-term catalysts in attractive markets … Executing on Near-Term Innovation Delivering differentiated product pipeline with near-term milestones … aligned with long-term healthcare trends Expanding Product Pipeline Leveraging OTI strengths to compete and win in large & growing segments … expected to accelerate long-term growth


 
© 2025 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) Milestones / status RUO launch Complete July 2025 Clinical study underway for multiple STIs Submission to FDA late 2025 / early 2026 Clinical study underway for CT/NG initial assay Submission to FDA late 2025 / early 2026 Regulatory review for Dot initial application Future launch via distribution agreement Note: Market sizing based on Company projections, modeling, and external research.


 
© 2025 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


 
© 2025 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


 
© 2025 OraSure Technologies, Inc. 9 Appendix


 
© 2025 OraSure Technologies, Inc. 10 Reconciliation of Non-GAAP Gross Margin OraSure Technologies GAAP to Non-GAAP Reconciliation ($ in 000's)