osur-20250930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

______________________________________

FORM 10-Q

______________________________________

(Mark One)


x			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2025.


o			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________to _________ .

Commission File Number 001-16537

______________________________________

ORASURE TECHNOLOGIES, INC.

(Exact Name of Registrant as Specified in Its Charter)

______________________________________


Delaware			36-4370966
(State or Other Jurisdiction of Incorporation or Organization)			(IRS Employer Identification No.)


220 East First Street, Bethlehem, Pennsylvania			18015
(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

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files). Yes x No o

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

Table of Contents

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

Indicate by checkmark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of October 31, 2025, the registrant had 71,733,530 shares of common stock, $0.000001 par value per share, outstanding.

Table of Contents

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains certain “forward-looking statements” within the meaning of the Federal securities laws. These may include statements about the Company's expected revenues, earnings/losses per share, net income (loss), expenses, cash flow or other financial performance, or developments, clinical trial or development activities, expected regulatory filings and approvals, planned business transactions, views of future industry, competitive or market conditions, and other factors that could affect the Company's future operations, results of operations or financial position. These statements often include words, such as “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates,” “may,” “will,” “should,” “could,” or similar expressions.

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:

•Market acceptance of, and the Company's ability to market and sell, its products and services, whether through its 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 the Company's products;

•Significant customer concentrations that exist or may develop in the future;

•The Company's ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements;

•The Company's 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;

•The Company's ability to effectively resolve warning letters, audit observations and other findings or comments from the U.S. Food and Drug Administration (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;

•The Company's ability to meet increased demand for its products;

•The impact of replacing distributors on the Company's business;

•Inventory levels at distributors and other customers;

•The Company's ability to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales;

•The impact of competitors, competing products and technology changes on the Company's business;

•Reduction or deferral of public funding available to customers;

•Competition from new or better technology or lower cost products;

•The Company's 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 (the "CDC") or other agencies;

•The Company's ability to fund research and development and other products and operations;

Table of Contents

•The Company's 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;

•The impact of contracting with the U.S. government on the Company's business;

•The impact of negative economic conditions on the Company's business;

•The Company's ability to achieve and maintain sustained profitability;

•The Company's ability to increase its gross margins;

•The Company's ability to utilize net operating loss carry forwards or other deferred tax assets;

•Volatility of the Company's 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;

•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;

•The Company's ability to attract and retain qualified personnel;

•The Company's 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 terrorist attacks and civil unrest, hostilities and war;

•The impact of cybersecurity incidents and other disruptions involving our computer systems or those of our third-party IT service providers, suppliers and customers; 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 under the section titled “Risk Factors,” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q, if any, in Part I, Item 1A of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission (the “SEC”) on March 7, 2025, and in subsequent SEC filings. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be

Table of Contents

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 report and the Company undertakes no duty to update these statements, unless it is required to do so by law. If the Company does update one or more forward-looking statements, no inference should be drawn that it will make updates with respect to other forward-looking statements or that it will make any further updates to those forward-looking statements at any future time.

Investors should also be aware that while the Company does, from time to time, communicate with securities analysts, it is against the Company's policy to disclose any material non-public information or other confidential commercial information. Accordingly, stockholders should not assume that the Company agrees with any statement or report issued by any analyst irrespective of the content of the statement or report. Furthermore, the Company has a policy against issuing or confirming financial forecasts or projections issued by others. Thus, to the extent that reports issued by securities analysts contain any projections, forecasts or opinions, such reports are not the responsibility of OraSure.

Table of Contents


PART I. FINANCIAL INFORMATION

			Page No.

Item 1. Financial Statements (Unaudited)			7

Consolidated Balance Sheets at September 30, 2025 and December 31, 202 4			8

Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2025 and 2024			9

Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2025 and 2024			10

Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2025 and 2024			11

Notes to the Consolidated Financial Statements			12

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			29

Item 3. Quantitative and Qualitative Disclosures About Market Risk			36

Item 4. Controls and Procedures			36

PART II. OTHER INFORMATION

Item 1. Legal Proceedings			36

Item 1A. Risk Factors			36

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			38

Item 3. Defaults Upon Senior Securities			38

Item 4. Mine Safety Disclosures			38

Item 5. Other Information			38

Item 6. Exhibits			39

Signatures			40

Table of Contents

Item 1. FINANCIAL STATEMENTS (UNAUDITED)

Table of Contents

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

(in thousands, except per share amounts)


	September 30, 2025		December 31, 2024
ASSETS
Current Assets:
Cash and cash equivalents	$	216,478	$	267,763

Accounts receivable, net of allowance for doubtful accounts of $166 and $773	24,300		23,816
Inventories	33,401		34,197
Prepaid expenses	4,709		3,956
Other current assets	4,123		3,488
Total current assets	283,011		333,220
Noncurrent Assets:
Property, plant and equipment, net of accumulated depreciation of $73,118 and $65,918	40,795		45,105
Operating right-of-use assets, net	12,240		13,442
Finance right-of-use assets, net	164		145
Intangible assets, net of accumulated amortization of $26,802 and $32,413	17,202		17,435
Goodwill	41,313		40,330
Investment in equity method investee	26,600		28,300
Deferred tax asset	211		156
Other noncurrent assets	1,562		1,526
Total noncurrent assets	140,087		146,439
TOTAL ASSETS	$	423,098	$	479,659
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable	$	6,360	$	8,173
Deferred revenue	1,879		2,961

Accrued expenses and other current liabilities	12,669		20,179
Finance lease liability	63		41
Operating lease liability	2,045		2,129
Acquisition-related contingent consideration obligation	17,232		—
Total current liabilities	40,248		33,483
Noncurrent Liabilities:
Finance lease liability	117		113
Operating lease liability	11,240		12,321
Acquisition-related contingent consideration obligation	7,264		22,910
Other noncurrent liabilities	2,249		494

Total noncurrent liabilities	20,870		35,838
TOTAL LIABILITIES	61,118		69,321
Commitments and contingencies (Note 12)
STOCKHOLDERS' EQUITY
Preferred stock, par value $0.000001, 25,000 shares authorized, none issued	—		—
Common stock, par value $0.000001, 120,000 shares authorized, 72,265 and 74,598 shares issued and outstanding	—		—
Additional paid-in capital	535,029		538,129
Accumulated other comprehensive loss	(20,173)		(24,360)
Accumulated deficit	(152,876)		(103,431)
Total stockholders' equity	361,980		410,338
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	423,098	$	479,659

See accompanying notes to the consolidated financial statements.

Table of Contents

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(in thousands, except per share amounts)


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2025		2024		2025		2024
NET REVENUES:
Products and services	$	25,336	$	39,651	$	84,180	$	147,379
Other	1,749		264		4,078		1,003
	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)		—
	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)
SHARES USED IN COMPUTING LOSS PER SHARE:
BASIC	73,004		74,583		74,131		74,330
DILUTED	73,004		74,583		74,131		74,330

See accompanying notes to the consolidated financial statements.

Table of Contents

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

(in thousands)


	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
	2025		2024		2025		2024
NET LOSS	(13,712)		(4,507)		(49,445)		(8,706)
OTHER COMPREHENSIVE (LOSS) INCOME
Currency translation adjustments	(2,802)		1,431		4,187		(2,259)

COMPREHENSIVE LOSS	$	(16,514)	$	(3,076)	$	(45,258)	$	(10,965)

See accompanying notes to the consolidated financial statements.

Table of Contents

ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)


	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	6		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)
Purchase of 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)

SEC Form 10-Q filed by OraSure Technologies Inc.