osur-20250630

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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 June 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

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 July 31, 2025, the registrant had 73,136,987 shares of common stock, $0.000001 par value per share, outstanding.

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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;

•The Company's ability to obtain and maintain new or existing product distribution channels;

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•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 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

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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.

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PART I. FINANCIAL INFORMATION

			Page No.

Item 1. Financial Statements (Unaudited)

Consolidated Balance Sheets at June 30 , 2025 and December 31, 2024			4

Consolidated Statements of Operations for the Three and Six Months Ended June 30 , 2025 and 2024			5

Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended J une 30 , 2025 and 2024			6

Consolidated Statements of Cash Flows for the Six Months Ended June 30 , 2025 a n d 2024			7

Notes to the Consolidated Financial Statements			8

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			25

Item 3. Quantitative and Qualitative Disclosures About Market Risk			31

Item 4. Controls and Procedures			31

PART II. OTHER INFORMATION

Item 1. Legal Proceedings			32

Item 1A. Risk Factors			32

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			33

Item 3. Defaults Upon Senior Securities			33

Item 4. Mine Safety Disclosures			33

Item 5. Other Information			33

Item 6. Exhibits			34

Signatures			35

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Item 1. FINANCIAL STATEMENTS

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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(Unaudited)

(in thousands, except per share amounts)


	June 30, 2025		December 31, 2024
ASSETS
Current Assets:
Cash and cash equivalents	$	234,578	$	267,763

Accounts receivable, net of allowance of $329 and $773	25,900		23,816
Inventories	33,375		34,197
Prepaid expenses	3,336		3,956
Other current assets	4,249		3,488
Total current assets	301,438		333,220
Noncurrent Assets:
Property, plant and equipment, net of accumulated depreciation of $71,100 and $65,918	42,155		45,105
Operating right-of-use assets	12,703		13,442
Finance right-of-use assets	181		145
Intangible assets, net of accumulated amortization of $27,234 and $32,413	17,266		17,435
Goodwill	41,745		40,330
Investment in equity method investee	26,974		28,300
Deferred tax asset	—		156
Other noncurrent assets	2,573		1,526
Total noncurrent assets	143,597		146,439
TOTAL ASSETS	$	445,035	$	479,659
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable	$	6,380	$	8,173
Deferred revenue	2,446		2,961
Accrued expenses and other current liabilities	14,395		20,179
Finance lease liability	62		41
Operating lease liability	2,086		2,129
Acquisition-related contingent consideration obligation	16,981		—
Total current liabilities	42,350		33,483
Noncurrent Liabilities:
Finance lease liability	133		113
Operating lease liability	11,844		12,321
Acquisition-related contingent consideration obligation	7,140		22,910
Other noncurrent liabilities	2,847		494

Total noncurrent liabilities	21,964		35,838
TOTAL LIABILITIES	64,314		69,321
Commitments and contingencies (Note 12)
STOCKHOLDERS' EQUITY
Preferred stock, par value $.000001, 25,000 shares authorized, none issued	—		—
Common stock, par value $0.000001, 120,000 shares authorized, 73,735 and 74,598 shares issued and outstanding	—		—
Additional paid-in capital	537,256		538,129
Accumulated other comprehensive loss	(17,371)		(24,360)
Accumulated deficit	(139,164)		(103,431)
Total stockholders' equity	380,721		410,338
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	445,035	$	479,659

See accompanying notes to the consolidated financial statements.

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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(in thousands, except per share amounts)


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2025		2024		2025		2024
NET REVENUES:
Products and services	$	29,847	$	53,949	$	58,844	$	107,728
Other	1,395		386		2,329		739
	31,242		54,335		61,173		108,467
COST OF PRODUCTS AND SERVICES SOLD	18,083		29,646		35,715		59,713
Gross profit	13,159		24,689		25,458		48,754
OPERATING EXPENSES:
Research and development	11,401		6,599		21,004		14,337
Sales and marketing	6,375		7,931		13,234		16,379
General and administrative	12,676		11,845		26,778		23,479
Loss on impairments	—		1,054		—		4,392
Change in the estimated fair value of acquisition-related contingent consideration	733		—		1,211		—
Gain on sale of assets	—		—		(993)		—
	31,185		27,429		61,234		58,587
Operating loss	(18,026)		(2,740)		(35,776)		(9,833)
OTHER INCOME	1,135		3,066		2,913		6,557
(Loss) income before income taxes and equity investment	(16,891)		326		(32,863)		(3,276)
INCOME TAX EXPENSE	2,000		381		1,544		363
LOSS BEFORE EQUITY INVESTMENT	(18,891)		(55)		(34,407)		(3,639)
LOSS ON EQUITY INVESTMENT	(802)		(560)		(1,326)		(560)
NET LOSS	$	(19,693)	$	(615)	$	(35,733)	$	(4,199)

LOSS PER SHARE:
BASIC	$	(0.26)	$	(0.01)	$	(0.48)	$	(0.06)
DILUTED	$	(0.26)	$	(0.01)	$	(0.48)	$	(0.06)
SHARES USED IN COMPUTING LOSS PER SHARE:
BASIC	74,541		74,159		74,703		74,127
DILUTED	74,541		74,159		74,703		74,127

See accompanying notes to the consolidated financial statements.

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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(Unaudited)

(in thousands)


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2025		2024		2025		2024
NET LOSS	$	(19,693)	$	(615)	$	(35,733)	$	(4,199)
OTHER COMPREHENSIVE INCOME (LOSS)
Currency translation adjustments	6,751		(1,134)		6,989		(3,690)

COMPREHENSIVE LOSS	$	(12,942)	$	(1,749)	$	(28,744)	$	(7,889)

See accompanying notes to the consolidated financial statements.

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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)


	For the Six Months Ended June 30,
	2025		2024
OPERATING ACTIVITIES:
Net loss	$	(35,733)	$	(4,199)
Adjustments to reconcile net loss to net cash (used in) provided by operating activities
Stock-based compensation	5,852		6,290
Depreciation and amortization	5,334		5,331
Loss on impairments	—		4,392
Other non-cash amortization	(147)		(88)
Provision for credit losses	(296)		149
Unrealized foreign currency loss (gain)	470		(48)
Interest expense on finance leases	4		13
Loss on equity investment	1,326		560
Deferred income taxes	(820)		91
Gain on sale of fixed assets	(780)		—
Change in the estimated fair value of acquisition-related contingent consideration	1,211		—

Changes in assets and liabilities:
Accounts receivable	(1,563)		1,802
Inventories	1,009		9,220
Prepaid expenses and other assets	(683)		1,727
Accounts payable	(1,548)		(3,469)
Deferred revenue	(520)		(105)
Accrued expenses and other liabilities	(3,072)		(7,083)
Net cash (used in) provided by operating activities	(29,956)		14,583
INVESTING ACTIVITIES:
Purchases of investments	—		(53,244)
Purchase of equity method investee	—		(28,333)
Proceeds from maturities and redemptions of investments	—		43,908
Proceeds from sale of assets	790		—
Purchases of property and equipment	(2,356)		(3,196)



Net cash used in investing activities	(1,566)		(40,865)
FINANCING ACTIVITIES:
Cash payments for finance lease liabilities	(26)		(107)
Proceeds from exercise of stock options	—		214
Repurchase of common stock	(5,000)		—

Payment of taxes related to net share settlement of equity awards	(1,725)		(3,446)
Net cash used in financing activities	(6,751)		(3,339)
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH	5,088		(2,547)
NET DECREASE IN CASH AND CASH EQUIVALENTS	(33,185)		(32,168)
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD	267,763		290,407
CASH AND CASH EQUIVALENTS, END OF PERIOD	$	234,578	$	258,239

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid for income taxes	$	2,579	$	1,607
Non-cash investing and financing activities
Accrued property and equipment purchases	$	182	$	638

See accompanying notes to the consolidated financial statements.

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ORASURE TECHNOLOGIES, INC. AND SUBSIDIARIES

Notes to the Consolidated Financial Statements

(Unaudited)

1. Summary of Significant Accounting Policies

Principles of Consolidation and Basis of Presentation

The accompanying interim unaudited consolidated financial statements include the accounts of OraSure Technologies, Inc. (“OraSure”) and its wholly-owned subsidiaries, DNA Genotek Inc. (“DNAG”), Diversigen, Inc. (“Diversigen”), Novosanis NV (“Novosanis”), and Sherlock Biosciences, Inc. ("Sherlock"). All intercompany transactions and balances have been eliminated. References herein to “we,” “us,” “our,” or the “Company” mean OraSure and its consolidated subsidiaries, unless otherwise indicated. The unaudited financial statements, in the opinion of management, include all adjustments (consisting only of normal and recurring adjustments) necessary for a fair presentation of the Company's financial position and results of operations for these interim periods. These financial statements should be read in conjunction with the financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024. Results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results of operations expected for the full year.

Summary of Significant Accounting Policies

There have been no changes to the Company's significant accounting policies described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 that have had a material impact on the consolidated financial statements and related notes except as discussed herein.

Change in Accounting Principle

Effective January 1, 2025, the Company changed its methodology for valuing certain inventories to the average cost method from the first-in, first-out ("FIFO") cost method. The change was applicable to all inventories. The Company concluded that the average cost basis of accounting is preferable as it results in greater precision in the calculation of acquisition cost of inventory on the balance sheet. The effect of this change in accounting principle was immaterial. Therefore, retroactive application was not determined to be necessary and a cumulative adjustment of $.08 million was recorded in the statement of operations for the six months ended June 30, 2025.

Cash Equivalents & Short-Term Investments

The Company considers all investments in debt securities to be available-for-sale securities. These securities consist of guaranteed investment certificates purchased with maturities greater than ninety days. Securities with maturities ninety days or less are considered cash equivalents. Available-for-sale securities are carried at fair value, based upon quoted market prices, with unrealized gains and losses, if any, reported in stockholders’ equity as a component of accumulated other comprehensive loss.

The Company records an allowance for credit loss for the Company's available-for-sale securities when a decline in investment market value is due to credit-related factors. When evaluating an investment for impairment, the Company reviews factors such as the severity of the impairment, changes in underlying credit ratings, forecasted recovery, the Company’s intent to sell or the likelihood that it would be required to sell the investment before its anticipated recovery in market value, and the probability that the scheduled cash payments will continue to be made.

The Company had no available-for-sale securities as of June 30, 2025 and December 31, 2024.

The Company maintains cash balances in the United States in excess of the federally insured limits. The Company periodically evaluates financial institutions and believe the risk of loss to be remote due to this evaluation.

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Fair Value of Financial Instruments

As of June 30, 2025 and December 31, 2024, the carrying values of cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their respective fair values based on their short-term nature.

Fair value measurements of all financial assets and liabilities that are being measured and reported on a fair value basis are required to be classified and disclosed in one of the following three categories:

Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;

Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and

Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).

To the extent that valuation is based on models or inputs that are unobservable in the market, determining fair value requires more judgment. Because of the inherent uncertainty of valuation, estimated values may be materially higher or lower than the values that would have been used had a ready market for the investments existed. Therefore, the degree of judgment exercised in determining fair value is greatest for assets or liabilities categorized in Level 3.


		June 30,		December 31,
	Level	2025		2024
Guaranteed investment certificates	1	$	68,447	$	66,584
Contingent consideration:	3
Current portion		16,981		—
Long-term portion		7,140		22,910
		$	24,121	$	22,910

All of the Company's guaranteed investment certificates are measured as Level 1 instruments as of June 30, 2025.

Included in cash and cash equivalents at June 30, 2025 and December 31, 2024 was $68.4 million and $66.6 million, respectively, of guaranteed investment certificates.

Also included in cash and cash equivalents at June 30, 2025 and December 31, 2024 was $121.1 million and $118.5 million, respectively, invested in money market funds. These money market funds have investments in U.S. government securities and are measured as Level 1 instruments.

The Company offers a nonqualified deferred compensation plan for certain eligible employees and members of its Board of Directors. The assets of the plan are held in the name of the Company at a third-party financial institution. Separate accounts are maintained for each participant to reflect the amounts deferred by the participant and all earnings and losses on those deferred amounts. The assets of the plan are held in mutual funds and company stock. The fair value of the plan assets as of June 30, 2025 and December 31, 2024 was $0.5 million and $0.7 million, respectively, and was calculated using the quoted market prices of the assets as of those dates. All investments in the plan are classified as trading securities and measured as Level 1 financial instruments. The fair value of plan assets is included in both current assets and noncurrent assets with the same amount included in accrued expenses and other noncurrent liabilities in the accompanying consolidated balance sheets.

Contingent Consideration

As further discussed in Note 11, Business Combinations, the Company has identified its contingent consideration obligations as Level 3 liabilities due to significant inputs that are required to measure the fair value of these obligations. The contingent consideration is comprised of two different tranches: milestone payments and royalty payments. The significant quantitative unobservable inputs for the milestone payments are the discount rate and probability achievement of a milestone of a regulatory approval.

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The fair value methodology for royalty payments is based on a discounted cash flow model. Significant quantitative unobservable inputs are internally developed future expected cash flows, discount rate and probability achievement of a milestone of a regulatory approval. The royalty payments represent a mid-single digit percentage of the net sales through 2034 associated with the acquired in-process and research developed intangible asset.

There was an increase of $1.2 million in the fair value of the Company's contingent consideration from date of acquisition to June 30, 2025.

Equity Method Investee

In January 2024, the Company lead the Series B financing and entered into wide-ranging strategic distribution agreements with KKR Sapphiros L.P. ("Sapphiros"), a privately held consumer diagnostic portfolio company, and certain of its related entities. Through this relationship, the Company expects to be able to offer a more comprehensive range of low-cost diagnostic tests and molecular sample management solutions to the Company's customers globally. As of June 30, 2025, the Company had funded $30.0 million for its interest in Sapphiros. The Company recorded the investment using the equity method in accordance with Accounting Standards Codification ("ASC") Topic 323, Investments—Equity Method and Joint Ventures—Overall. In accordance with the equity method, the Company's equity investment is presented net of its share of any gains or losses of the investee. The Company has elected as its accounting policy to recognize its share of any income or loss in Sapphiros on a three-month lag. The investment in Sapphiros of $27.0 million as of June 30, 2025 is included in the investment in equity method investee line of the Company's balance sheet and is measured as a Level 3 investment. The Company has no unconditional obligations or guarantees to, or in support of, its equity method investee and its operations. In conjunction with the preparation of the Company's June 30, 2025 financial statements, the Company considered whether the carrying value of the investment in Sapphiros was impaired and concluded that no such impairment existed. The Company's investment in Sapphiros was valued at $28.3 million as of December 31, 2024.

Foreign Currency Transactions

Net foreign exchange gains (losses) resulting from foreign currency transactions that are included in other income in the Company's consolidated statements of operations were $(0.9) million and $0.1 million for the three months ended June 30, 2025 and 2024, respectively.

Net foreign exchange gains (losses) resulting from foreign currency transactions for the six months ended June 30, 2025 and 2024 were $(1.3) million and $0.3 million respectively.

Accumulated Other Comprehensive Loss

Change in accumulated other comprehensive loss by component is listed below (in thousands):


	Foreign Currency		Total
Balance at December 31, 2024	$	(24,360)	$	(24,360)
Other comprehensive gain	6,989		6,989
Balance at June 30, 2025	$	(17,371)	$	(17,371)

Uncertain Tax Positions

Assets and liabilities are established for uncertain tax positions taken or positions expected to be taken in income tax returns when such positions fail to meet the "more likely than not" threshold based on the technical merits of the positions. We assess whether previously unrecognized tax benefits may be recognized when tax positions is (1) more likely than not of being sustained based on its technical merits, (2) effectively settled through examination, negotiation or litigation, or (3) settled through actual expiration of the relevant tax statures. The assessment of an uncertain tax position requires significant judgement.

Recent Accounting Pronouncements

In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures. The purpose of the update was to address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes

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paid information. The amendments in this ASU are effective for annual periods beginning after December 15, 2024. The amendments may be applied prospectively or retrospectively, and early adoption is permitted. Management determined the annual disclosures required under the new guidance will have a significant impact on the Company's consolidated financial statements.

In November 2024, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update ("ASU") No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), Disaggregation of Income Statement Expenses. The purpose of this update was to require disclosure, in the notes to financial statements, of specified information about certain costs and expenses on a disaggregated basis. The amendments in the ASU are effective for all public business entities for annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with early adoption permitted. The amendments are to be applied either prospectively to financial statements issued for reporting periods after the effective date of the update or retrospectively to any or all prior periods presented in the financial statements. Management is evaluating the impact on the Company's consolidated financial statements.

In March 2024, the FASB issued ASU No. 2024-01, Compensation—Stock Compensation (Topic 718), Scope Application of Profits Interest and Similar Awards. The purpose of this update was to provide illustrative examples to demonstrate how an entity should apply guidance to determine whether profits interests and similar awards should be accounted for in accordance with Topic 718. For public business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2024, and interim periods within those fiscal periods. The amendments may be applied prospectively or retrospectively, and early adoption is permitted. Management does not expect an impact on the Company's consolidated financial statements.

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2. Inventories (in thousands)


	June 30,		December 31,
	2025		2024
Raw materials	$	15,334	$	17,002
Work in process	559		420
Finished goods	17,482		16,775
	$	33,375	$	34,197

3. Property, Plant and Equipment, net (in thousands)


	June 30,		December 31,
	2025		2024
Land	$	1,118	$	1,118
Buildings and improvements	39,076		36,152
Machinery and equipment	57,527		51,015
Computer equipment and software	12,337		11,502
Furniture and fixtures	1,660		1,621
Construction in progress	1,537		9,615
	113,255		111,023
Accumulated depreciation	(71,100)		(65,918)
	$	42,155	$	45,105

4. Accrued Expenses and Other Current Liabilities (in thousands)


	June 30,		December 31,
	2025		2024
Payroll and related benefits	$	9,028	$	11,147
Professional fees	1,564		2,469
Sales tax payable	1,089		1,339
Other	2,714		5,224
	$	14,395	$	20,179

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5. Termination Benefits

Q1 2024 Reduction in Workforce

During the first quarter of 2024, the Company executed a reduction in workforce largely affecting its COVID-19 manufacturing workforce. This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations. The charges for termination benefits included in the Company's consolidated statements of operations are as follows (in thousands):


	For the Six Months Ended June 30,
	2024
Cost of products and services sold	$	231
Research and development	87
Sales and marketing	69
General and administrative	17
	$	404

As of June 30, 2025, the Company had fully paid the $0.4 million related to the reduction in workforce. This reduction in workforce was completed by December 31, 2024.

Q2 2024 Reduction in Workforce

During the second quarter of 2024, the Company executed an additional reduction in workforce as the Company notified employees of its intention to consolidate its Novosanis site in Belgium into other locations by the end of December 31, 2024, discontinue the Diversigen molecular services line of business by the end of June 30, 2024, and consolidate facilities by bringing third-party manufacturing activities into its Pennsylvania facilities by the end of the third quarter of 2025. This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations.


	For the Six Months Ended June 30,
	2024
Cost of products and services sold	$	889
Research and development	478
Sales and marketing	125
General and administrative	160
	$	1,652

As of June 30, 2025 the Company had $0.3 million accrued and had paid $1.4 million related to the reduction in workforce. No additional expense was incurred during the six months ended June 30, 2025. The Company expects this plan to be completed by September 2025.

Q3 2024 Reduction in Workforce

During the third quarter of 2024, the Company executed a reduction in workforce largely as the Company notified certain employees of its intention to discontinue its risk assessment business. Additional employees were notified in the fourth quarter of 2024 and additional severance costs will be incurred. This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations.

As of June 30, 2025 the Company had $0.5 million accrued and had paid $0.7 million related to the reduction in workforce. No additional expense was incurred during the six months ended June 30, 2025. The Company expects this plan to be completed by the third quarter of 2026.

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6. Revenues

Revenues by Product Line. The following table represents total net revenues by product line (in thousands):


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2025		2024		2025		2024
HIV	$	14,398	$	13,652	$	27,298	$	27,032
Sample Management Solutions (1)	9,855		12,609		18,965		23,431
HCV	4,126		4,734		8,459		7,734
Risk Assessment Testing (2)	446		2,308		1,866		4,352
Other product and services revenues (3)	994		897		1,767		1,429
COVID-19 (4)	28		18,939		489		42,067
Molecular Services	—		810		—		1,683
Net product and services revenues	$	29,847	$	53,949	$	58,844	$	107,728
Non-product and services revenues (5)	1,395		386		2,329		739
Net revenues	$	31,242	$	54,335	$	61,173	$	108,467

(1)Includes Genomics, Microbiome and Colli-Pee® product revenues.

(2)Includes substance abuse testing product revenues.

(3)Includes Syphilis revenues.

(4)Includes COVID-19 Diagnostics and COVID-19 Sample Management Solutions revenues.

(5)Includes funded research and development contracts, royalty income and grant revenues.

Revenues by Geographic Area. The following table represents total net revenues by geographic area, based on the location of the customer (in thousands):


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2025		2024		2025		2024
United States	$	19,852	$	44,386	$	40,187	$	89,597
Africa	8,027		6,366		15,216		12,070
Europe	2,117		2,164		3,754		3,766
Other regions	1,246		1,419		2,016		3,034
	$	31,242	$	54,335	$	61,173	$	108,467

Customer Concentration. The following table represents customer concentration risk:


	For the Three Months Ended June 30,		For the Six Months Ended June 30,
	2025	2024	2025	2024
Net Revenues
Non-commercial customer	N/A	33%	N/A	37%

			June 30,	December 31,
			2025	2024
Accounts Receivable
Commercial customer			19%	10%

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Vendor Concentration. The Company currently purchases certain products and critical components of its products from sole-supply vendors. If these vendors are unable or unwilling to supply the required components and products, the Company could be subject to increased costs and substantial delays in the delivery of its products to its customers. Third-party suppliers also manufacture certain products. The Company's inability to have a timely supply of any of these components and products could have a material adverse effect on its business, as well as its financial condition and results of operations.

Deferred Revenue. The Company records deferred revenue when funds are received prior to the recognition of the associated revenue. Deferred revenue as of June 30, 2025 and December 31, 2024 was comprised of customer prepayments of $2.4 million and $3.0 million, respectively.

The following table represents deferred revenue recognized:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
Deferred Revenue Recognized	2025		2024		2025		2024
Accrued at beginning of period	$	974	$	774	$	1,461	$	1,194

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7. Income Taxes

The components of income tax expense are as follows (in thousands):


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2025		2024		2025		2024
Federal income tax expense	$	157	$	—	$	165	$	—
State income tax expense (benefit)	2,394		3		2,403		(228)
Foreign income tax (benefit) expense	(551)		378		(1,024)		591

	$	2,000	$	381	$	1,544	$	363

During the three months ended June 30, 2025 and 2024, the Company recorded income tax expense of $2.0 million and $0.4 million, respectively. During the six months ended June 30, 2025 and 2024, the Company recorded income tax expense of $1.5 million and $0.4 million, respectively. The net tax expense increase in both periods is largely due to recording an uncertain tax position for certain tax matters, including penalties and interest.

Income tax expense reflects taxes due to the taxing authorities and the tax effects of temporary differences between the basis of assets and liabilities recognized for financial reporting and tax purposes, and net operating loss and tax credit carryforwards. The significant components of the Company's total deferred tax asset as of June 30, 2025 and at December 31, 2024 relate to the tax effects of the basis difference of acquired intangible assets.

A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. A full valuation allowance was recorded on the Company’s U.S. and U.K. deferred tax assets as of June 30, 2025 and December 31, 2024.

As of December 31, 2024 and June 30, 2025, uncertain tax positions were approximately $0.0 million and $2.5 million. The Company’s uncertain tax position relates to U.S. federal and other jurisdictions. Due to various factors, including the inherent complexities and uncertainties of the judicial, administrative, and regulatory processes in certain jurisdictions, the timing of the resolution of income tax controversies is highly uncertain, and the amounts ultimately paid, if any, upon resolution of the issues raised by the taxing authorities may differ from the amounts accrued. Any assessments or settlements could result in changes to our contingencies related to positions on prior years’ tax filings.

On July 4, 2025, Congress enacted the One Big Beautiful Bill Act (“OBBBA”), which includes several changes to the Internal Revenue Code which may result in changes to the Company’s income tax expense. The Company is currently evaluating the impacts of the OBBBA but does not believe that changes in tax law will materially affect the Company’s operating performance or financial position.

8. Income (Loss) Per Share

Basic earnings (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings (loss) per share is computed in a manner similar to basic earnings (loss) per share except that the weighted-average number of shares outstanding is increased to include incremental shares from the assumed vesting or exercise of dilutive securities, such as common stock options, unvested restricted stock or performance stock units, unless the impact is antidilutive. The number of incremental shares is calculated by assuming that outstanding stock options were exercised and unvested restricted shares and performance stock units were vested, and the proceeds from such exercises or vesting were used to acquire shares of common stock at the average market price during the reporting period. Basic and dilutive computations of net loss per share are the same in periods in which a net loss exists as the dilutive effects of excluded items would be anti-dilutive.

For the three months ended June 30, 2025 and 2024, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 581 shares and 1,010 shares, respectively, were excluded from the computation of diluted loss per share.

For the six months ended June 30, 2025 and 2024, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 618 shares and 1,333 shares, respectively, were excluded from the computation of diluted loss per share.

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9. Stockholders’ Equity

In March 2025, the Company's Board of Directors authorized a stock repurchase program (the "Repurchase Program") effective March 21, 2025, whereby the Company may purchase up to $40.0 million in shares of its common stock over a period of up to two years. The amount and timing of share repurchases under the Repurchase Program may be carried out at the discretion of the Company's management through various methods in compliance with applicable state and federal securities laws. The Company repurchased 1.8 million shares of its common stock under the Repurchase Program during the six months ended June 30, 2025.

The reconciliation of the changes in stockholders' equity for the three and six months ended June 30, 2025 and 2024 is as follows (in thousands):


	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total
	Shares	Amount
Balance at December 31, 2024	74,598	$	—	$	538,129	$	(24,360)	$	(103,431)	$	410,338

Vesting of restricted stock and performance stock units	768	—		—		—		—		—
Purchase and retirement of common shares	(252)	—		(941)		—		—		(941)
Stock-based compensation	—	—		2,687		—		—		2,687
Net loss	—	—		—		—		(16,040)		(16,040)
Currency translation adjustments	—	—		—		238		—		238

Balance at March 31, 2025	75,114	$	—	$	539,875	$	(24,122)	$	(119,471)	$	396,282

Vesting of restricted stock and performance stock units	713	—		—		—		—		—
Purchase and retirement of common shares	(271)	—		(784)		—		—		(784)
Stock-based compensation	—	—		3,165		—		—		3,165
Repurchase of common stock	(1,821)	—		(5,000)		—		—		(5,000)
Net loss	—	—		—		—		(19,693)		(19,693)
Currency translation adjustments	—	—		—		6,751		—		6,751

Balance at June 30, 2025	73,735	$	—	$	537,256	$	(17,371)	$	(139,164)	$	380,721

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	Common Stock			Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total
	Shares	Amount
Balance at December 31, 2023	73,528	$	—	$	529,543	$	(14,941)	$	(83,931)	$	430,671
Common stock issued upon exercise of options	32	—		214		—		—		214
Vesting of restricted stock and performance stock units	593	—		—		—		—		—
Purchase and retirement of common shares	(194)	—		(1,462)		—		—		(1,462)
Stock-based compensation	—	—		2,968		—		—		2,968
Net loss	—	—		—		—		(3,584)		(3,584)
Currency translation adjustments	—	—		—		(2,556)		—		(2,556)

Balance at March 31, 2024	73,959	$	—	$	531,263	$	(17,497)	$	(87,515)	$	426,251
Vesting of restricted stock and performance stock units	1,033	—		—		—		—		—
Purchase and retirement of common shares	(424)	—		(1,984)		—		—		(1,984)
Stock-based compensation	—	—		3,322		—		—		3,322
Net loss	—	—		—		—		(615)		(615)
Currency translation adjustments	—	—		—		(1,134)		—		(1,134)
Balance at June 30, 2024	74,568	$	—	$	532,601	$	(18,631)	$	(88,130)	$	425,840

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10. Business Segment Information

The Company's reportable segment derives its revenues from the sale of diagnostics products and sample management solutions, as described in Note 1 Summary of Significant Accounting Policies. As the Company has only one reportable segment, there are no inter-segment sales or transfers.

The Company's Chief Operating Decision Maker ("CODM") is its Chief Executive Officer. The CODM uses consolidated net income (loss) as reported in the consolidated statement of operations as the primary measure of the reportable segment's profit or loss. The CODM uses consolidated net income (loss) to assess the performance of the segment and make decisions about resource allocation. Consolidated gross profit and consolidated operating income (loss), as reported in the consolidated statement of operations, are also used by the CODM as measures of segment profit or loss. The CODM uses gross profit to assess the impact of the Company's efforts to achieve manufacturing efficiencies and consolidate its production activities. The CODM uses operating income (loss) to assess the impact of the Company's recent restructurings, reduction in workforce, and efforts to streamline its operations to achieve cost savings. The CODM uses consolidated total assets as the measure of segment assets, as reported on the consolidated balance sheet.

The accounting policies of the Company's reportable segment are the same as those described in Note 1 Summary of Significant Accounting Policies.

The following table represents total long-lived assets by geographic area:


	June 30,		December 31,
	2025		2024
United States	$	38,418	$	40,286
United Kingdom	11,037		12,849
Canada	5,237		5,468
Other regions	347		89
	$	55,039	$	58,692

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The following table represents reported segment revenues, segment loss, and significant segment expenses:


	For the Three Months Ended June 30,			For the Six Months Ended June 30,
	2025		2024	2025	2024
Net revenues	31,242		54,335	61,173	108,467
Cost of products and services sold (2)	18,083		29,646	35,715	59,713
Gross profit	13,159		24,689	25,458	48,754
Research and development (2)	11,401		6,599	21,004	14,337
Sales and marketing (2)	6,375		7,931	13,234	16,379
General and administrative (2)	12,676		11,845	26,778	23,479
Loss on impairments	—		1,054	—	4,392
Change in the estimated fair value of acquisition-related contingent consideration	733		—	1,211	—
Gain on sale of assets	—		—	(993)	—
Operating (loss) income	(18,026)		(2,740)	(35,776)	58,587
Other (expense) income	—		(43)	(16)	241
Interest revenue	2,073		3,031	4,228	6,052
Other segment items (1)	(938)		78	(1,299)	264
(Loss) income before income taxes	(16,891)		326	(32,863)	(3,276)
Income tax expense	2,000		381	1,544	363
Loss on equity investment	(802)		(560)	(1,326)	(560)
Net loss	$	(19,693)	(615)	(35,733)	(4,199)

(1) Includes interest expense and foreign currency gains (losses).

(2) The following tables represent additional significant segment expense categories:


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2025		2024		2025		2024
Stock-based Compensation
Cost of products and services sold	$	207	$	193	$	376	$	344
Research and development	279		264		482		530
Sales and marketing	217		313		435		570
General and administrative	2,462		2,552		4,559		4,846
	$	3,165	$	3,322	$	5,852	$	6,290


	For the Three Months Ended June 30,				For the Six Months Ended June 30,
	2025		2024		2025		2024
Depreciation and Amortization
Cost of products and services sold	$	1,060	$	1,507	$	2,449	$	3,054
Research and development	569		243		1,054		485
Sales and marketing	30		47		57		95
General and administrative	868		809		1,775		1,697
	$	2,526	$	2,606	$	5,334	$	5,331

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11. Business Combinations

Sherlock Biosciences

On December 19, 2024, the Company acquired all of the outstanding stock of Sherlock, pursuant to the terms of a merger agreement (the "Merger Agreement"). The Company began operating this entity as of the December 19, 2024 closing date.

The primary reason for the acquisition was Sherlock's first test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), which is in clinical studies and is expected to be submitted to the FDA for approval by the end of 2025. Subject to regulatory approvals, this test is expected to expand the Company's portfolio for rapid diagnostics for sexually transmitted infections.

The initial aggregate purchase price of this transaction was funded with cash on hand as shown in the table below:


Milestone contingent consideration	$	15,910
Royalty based contingent consideration	7,000
Cash paid to Sherlock	5,000
Legal expenses	389
Insurance policy expense	50
Initial aggregate purchase price	$	28,349

Pursuant to the Merger Agreement, the Company agreed to pay up to $20.0 million of contingent consideration based on the achievement of a regulatory milestone on or before December 31, 2026 as defined in the Merger Agreement. The fair value of the milestone contingent consideration was $15.9 million. The range of outcome for the milestone contingent consideration is zero to $20.0 million. There is also a mid-single digits quarterly royalty fee based on future sales until 2034 as defined in the Merger Agreement, the fair value of which was determined as part of the contingent consideration. The estimated acquisition-date fair value of the royalty fee acquisition-related contingent consideration was $7.0 million. The range of outcome for the royalty payment cannot be determined due to the fact it is based on future sales associated with the acquired in-process research and development technology through 2034 and thus does not have an upper limit.

During the year ended December 31, 2024, the Company incurred a total of $1.0 million of acquisition related costs, including accounting, legal, and other professional fees, all of which were expensed and reported as a component of general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2024.

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The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date:


Assets Acquired


Other current assets	$	2,570
Property, plant, and equipment, net	9,244
Other noncurrent assets	462
Operating right-of-use assets	4,080
In-process research and development technology intangible asset	17,000
Goodwill	6,382
Total assets acquired	39,738
Liabilities Assumed
Accounts payable	2,449
Current liabilities	3,621
Deferred revenue	1,641
Operating lease liability	4,080
Total liabilities assumed	11,791
Net Assets Acquired	27,947
Estimated fair value of contingent consideration	(22,910)
Net Cash Paid (net of cash acquired of ($402)	$	5,037

The purchase price was allocated to the tangible assets and identifiable intangible assets acquired and liabilities assumed based on their acquisition-date estimate fair values. The identifiable intangible assets included in-process research and development technology ("IPR&D Technology"), which is an indefinite lived asset.

The Company, with the assistance of an independent valuation specialist, assessed the fair value of the assets and contingent consideration of Sherlock. The income approach was used to value the acquired intangibles and the fair value measurements were primarily based on significant inputs that are not observable in the market and are considered Level 3 fair value measurements. The income approach estimates fair value for an asset based on the present value of cash flows projected to be generated by the asset. Projected cash flows are discounted at a required rate of return that reflects the relative risk of achieving the cash flows and the time value of money.

The regulatory milestone scenario based model was used to value the assumed milestone contingent consideration, were primarily based on significant unobservable inputs and are considered Level 3 fair value measurements. The regulatory milestone scenario based model estimates fair value for contingent consideration based on the probability of on the achievement of a certain milestone as defined under the agreements and the discount rate.

The income approach was used to value the royalty based contingent consideration, were primarily based on significant unobservable inputs and are considered Level 3 fair value measurements. The fair value of contingent payments approach were primarily based on projected cash flows, probability of on the achievement of a regulatory milestone as defined under the agreements, and discount rate.

Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of the net assets acquired, and represents the future economic benefits that we expect to achieve as a result of the acquisition. The Company believes the goodwill related to the acquisition was a result of Sherlock providing a product offering that will enable the Company to leverage those products with existing and new customers. The goodwill is not deductible for income tax purposes.

The Company continues to evaluate the fair value of certain assets acquired and liabilities assumed. Additional information, which existed as of the acquisition date, but was at that time unknown to the Company, may become known during the remainder of the measurement period. Changes to amounts recorded as a result of the final determination may result in a corresponding adjustment to these assets and liabilities, including goodwill. The determination of the estimated fair values of all assets acquired is expected to be completed within one year from the date of acquisition.

Revenues from Sherlock primarily consist of grant revenues for research and development purposes. Effective as of December 19, 2024, the financial results of Sherlock are included in the consolidated financial results of the Company.

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Unaudited Pro Forma Financial Information

The unaudited pro forma results presented below include the results of the Sherlock acquisition as if it had been consummated as of January 1, 2024. The unaudited pro forma results include depreciation of the acquired property plant and equipment and the estimated tax effect of adjustments to income before income taxes but do not include changes in the fair value of the Company's contingent consideration obligations. Material nonrecurring charges, directly attributable to the transactions, including direct acquisition costs, are also excluded. In addition, the unaudited pro forma results do not include any expected benefits of the acquisitions. Accordingly, the unaudited pro forma results are not necessarily indicative of either future results of operations or results that might have been achieved had the acquisition been consummated as of January 1, 2024.


	For the Three Months Ended June 30,		For the Six Months Ended June 30,
	2024		2024
Net revenues	$	54,575	$	109,038
Net loss	$	(9,865)	$	(24,203)

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12. Commitments and Contingencies

Litigation

From time to time, the Company is involved in certain legal actions arising in the ordinary course of business. In management’s opinion, the outcomes of such actions, either individually or in the aggregate, are not expected to have a material adverse effect on the Company's future financial position or results of operations.

On November 14, 2024 the Company filed a complaint against NowDiagnostics, Inc. ("NowDx"), Jody Berry ("Berry") and Janean Young ("Young") in the United States District Court for the Eastern District of Pennsylvania alleging misappropriation and misuse of the Company's proprietary information and trade secrets by NowDx, Berry and Young in violation of the Federal Defend Trade Secrets Act and the Pennsylvania Uniform Trade Secrets Act. The complaint also alleges breach of contract and duty of loyalty by Young, unfair competition by NowDx, and tortious interference with contractual relations by Berry and NowDx. NowDx filed Counterclaims against the Company on January 13, 2025 and the Company filed its Answer to the Counterclaims on February 3, 2025. Young filed a Motion to Dismiss the claims against her, which was denied by the court on February 4, 2025. NowDx, Berry, and Young agreed to a preliminary injunction which the Court entered on February 27, 2025. The trial is scheduled for March 9, 2026.

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of the Company's financial condition and results of operations should be read in conjunction with (i) the Company's unaudited condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and (ii) the Company's audited consolidated financial statements and related notes and management’s discussion and analysis of financial condition and results of operations included in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission on March 7, 2025. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to the Company's plans and strategy for its business and impact and potential impacts on its business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including, without limitation, those factors set forth in the “Risk Factors” section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and the “Risk Factors” section of subsequent Quarterly Reports on Form 10-Q, the Company's actual results or timing of certain events could differ materially from the results or timing described in, or implied by, these forward-looking statements.

Business Overview

The Company's business consists of the development, manufacture, marketing and sale of simple, easy to use diagnostic products and specimen collection devices using the Company's proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. These products include tests for diseases including HIV, Hepatitis C, Syphilis, and COVID-19 that are performed on a rapid basis at the point of care. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities. The Company's HIV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S. and, in the case of the HIV product, as a self-test to individuals in a number of other countries, including as an oral swab in-home test for HIV-1 and HIV-2 in Europe.

The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers. The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets. Customers span the disease risk management, diagnostics, pharmaceutical, biotech, companion animal and environmental markets. The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health. The Company also has a urine collection device which allows for the volumetric collection of first void urine. This product is in its early stages, and initial sales are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets.

Recent Developments

Risk Assessment Testing

In the third quarter of 2024, the Company announced the discontinuance of sales of its risk assessment product line which was completed in the second quarter of 2025. Sales of its risk assessment products contributed $0.4 million and $2.3 million to revenues during the three months ended June 30, 2025 and 2024, respectively. Sales of its risk assessment products contributed $1.9 million and $4.4 million to revenues during the six months ended June 30, 2025 and 2024, respectively. During the first quarter of 2025, the Company sold certain assets that made up the risk assessment product line including certain intellectual property, contracts, permits, and equipment.

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Results of Operations

For the three months ended June 30, 2025 compared to June 30, 2024.

CONSOLIDATED NET REVENUES

The table below shows total consolidated net revenues (dollars in thousands) for the three months ended June 30, 2025 and 2024:


	For the Three Months Ended June 30,
	Dollars				% Change		Percentage of Total Net Revenues
	2025		2024				2025		2024
Diagnostics (1)	$	19,222	$	18,746	3	%	62	%	35	%
Sample Management Solutions (2)	9,855		12,609		(22)		32		23
Risk Assessment Testing (3)	446		2,308		(81)		1		3
Other products and services (4)	296		542		(45)		1		1
COVID-19 Diagnostics	28		18,934		(100)		—		35

Molecular Services	—		810		(100)		—		1
Net product and services revenues	29,847		53,949		(45)		96		98
Non-product and services revenues (5)	1,395		386		261		4		2
Net revenues	$	31,242	$	54,335	(43)	%	100	%	100	%

(1)Includes HIV, HCV, Syphilis, and SureQuick® product revenues.

(2)Includes Genomics, Microbiome, and Colli-Pee® product revenues.

(3)Includes substance abuse testing product revenues.

(4)Includes COVID-19 Sample Management Solutions product revenues.

(5)Includes funded research and development contracts, royalty income and grant revenues.

Product and Services Revenues

Consolidated net revenues decreased 43% to $31.2 million for the three months ended June 30, 2025 from $54.3 million for the three months ended June 30, 2024.

Sales of the Company's Diagnostics products increased 3% to $19.2 million for the three months ended June 30, 2025 from $18.7 million for the three months ended June 30, 2024. This increase in revenues is largely due to higher international HIV revenues of approximately $1.3 million primarily driven by customer ordering patterns. Sales of a syphilis product, which were first sold in the second quarter of 2024 are also partially responsible for the increase. This increase in revenues was partially offset by decrease in domestic revenues of the Company's HIV product and a decline in international HCV revenues.

Sample Management Solutions revenues decreased 22% to $9.9 million for the three months ended June 30, 2025 from $12.6 million for the three months ended June 30, 2024. Sales of the Company's genomics products are being impacted by a large customer's bankruptcy proceedings.

Risk assessment revenue decreased 81% to $0.4 million for the three months ended June 30, 2025 from $2.3 million for the three months ended June 30, 2024. The Company discontinued this line of business at the end of 2024 and business is winding down in early 2025.

COVID-19 Diagnostics revenues decreased 100% to $0.03 million for the three months ended June 30, 2025 compared to $18.9 million for the three months ended June 30, 2024 due to decreased sales of the Company's InteliSwab® tests through its U.S. government procurement contracts. We expect this level of revenue to continue throughout the remainder of 2025 and for the foreseeable future due to the fulfillment of these contracts and lower overall demand for COVID-19 testing.

Molecular Services revenues, which are derived from the Company's microbiome molecular sequencing services, were zero during the three months ended June 30, 2025 compared to $0.8 million during the three months ended June 30, 2024. The decrease in services revenues was due to the Company's decision to exit this line of business in 2024.

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Non-Product and Services Revenues

Non-product and services revenues increased 261% to $1.4 million for the three months ended June 30, 2025 from $0.4 million for the three months ended June 30, 2024 primarily due to the recognition of revenue under funded R&D contracts that were assumed by the Company as a result of the Sherlock acquisition at the end of 2024.

CONSOLIDATED OPERATING RESULTS

Consolidated gross profit margin decreased to 42.1% for the three months ended June 30, 2025 from 45.4% for the three months ended June 30, 2024. The largest driver of the margin decline was a negative product mix driven by lower InteliSwab® sales that generate higher gross margins, lower genomics sales that also generate higher gross margins, and higher international product sales which generate lower margins. The termination of the microbiome molecular sequencing services business which historically dragged down the gross margin rate helped to improve the gross margin rate during the quarter. Higher scrap expense also contributed to the lower margins in the quarter but was partially offset by improved overhead absorption as the Company brings more production in-house to its Opus Way facility.

Consolidated operating loss for the three months ended June 30, 2025 was $18.0 million, a $15.3 million increase from the operating loss reported for the three months ended June 30, 2024. The increase in the operating loss reported in the second quarter of 2025 was largely a result of the lower revenues and lower gross margins generated on sales of the Company's products during the three months ended June 30, 2025 coupled with the increase spend on clinical trials. Results for the three months ended June 30, 2025 included change in the estimated fair value of acquisition-related contingent consideration of $0.7 million.

Research and development expenses increased 73% to $11.4 million for the three months ended June 30, 2025 from $6.6 million for the three months ended June 30, 2024 largely due to higher spend incurred for clinical trials associated with the Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) device and additional R&D expense layered in from the newly acquired Sherlock companies.

Sales and marketing expenses decreased 20% to $6.4 million for the three months ended June 30, 2025 from $7.9 million for the three months ended June 30, 2024 due to decreased bad debt expense, lower employee costs associated with a decrease in headcount and a decrease in consulting costs.

General and administrative expenses increased 7% to $12.7 million for the three months ended June 30, 2025 from $11.8 million for the three months ended June 30, 2024 largely due an increase in legal fees and severance expense associated with an executive's departure.

During the three months ended June 30, 2025, the Company recorded a non-cash adjustment of $0.7 million, reflecting the change in the estimated fair value of the Sherlock acquisition-related contingent consideration. The Sherlock acquisition was completed in December 2024 and there is no comparable amount in the first quarter of 2024.

All of the above contributed to the Company's operating loss of $18.0 million for the three months ended June 30, 2025, which included non-cash charges of $3.2 million for stock-based compensation, $2.5 million for depreciation and amortization, and $0.7 million of change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $2.7 million for the three months ended June 30, 2024 included a non-cash impairment charge of $1.1 million, non-cash charges of $2.6 million for depreciation and amortization, and $3.3 million for stock-based compensation.

OTHER INCOME

Other income for the three months ended June 30, 2025 was $1.1 million compared to $3.1 million for the three months ended June 30, 2024 due to lower interest income and higher foreign currency losses.

CONSOLIDATED INCOME TAXES

The Company continues to believe the full valuation allowance established against its total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. For the three months ended June 30, 2025 and 2024, the Company recorded income tax expense of $2.0 million and $0.4 million, respectively. The increase in the income tax expense is largely due to recording an uncertain tax position for certain tax matters, including penalties and interest.

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Results of Operations

For the six months ended June 30, 2025 compared to June 30, 2024.

CONSOLIDATED NET REVENUES

The table below shows an outline of total consolidated net revenues (dollars in thousands) for the six months ended June 30, 2025 and 2024:


	For the Six Months Ended June 30,
	Dollars				% Change		Percentage of Total Net Revenues
	2025		2024				2025		2024
Diagnostics (1)	$	36,911	$	35,139	5	%	60	%	32	%
Sample Management Solutions (2)	18,965		23,431		(19)		31		22
Risk Assessment Testing (3)	1,866		4,352		(57)		3		4
Other products and services (4)	617		1,092		(43)		1		1
COVID-19 Diagnostics	485		42,031		(99)		1		39

Molecular Services	—		1,683		(100)		—		2
Net product and services revenues	58,844		107,728		(45)		96		99
Non-product and services revenues (5)	2,329		739		215		4		1
Net revenues	$	61,173	$	108,467	(44)	%	100	%	100	%

(1)Includes HIV, HCV, Syphilis, and SureQuick® product revenues.

(2)Includes Genomics, Microbiome and Colli-Pee® product revenues.

(3)Includes substance abuse testing product revenues.

(4)Includes COVID-19 Sample Management Solutions product revenues.

(5)Includes funded research and development contracts, royalty income and grant revenues.

Product and Services Revenues

Consolidated net product and services revenues decreased 45% to $58.8 million for the six months ended June 30, 2025 from $107.7 million for the six months ended June 30, 2024.

Sales of the Company's Diagnostics products increased 5% to $36.9 million for the six months ended June 30, 2025 from $35.1 million for the six months ended June 30, 2024. This increase in revenue was primarily driven by higher HIV and HCV revenues in international markets of $1.9 million as a result of customer ordering patterns. Also contributing to the diagnostic revenue increase is a combined increase in HCV domestic and Syphilis revenues of $0.9 million. A decline in our HIV domestic revenue resulting from funding delays or reductions in funding for HIV products and customer order patterns partially offset the increased revenues from the other product lines.

Sample Management Solutions revenues decreased 19% to $19.0 million for the six months ended June 30, 2025 from $23.4 million for the six months ended June 30, 2024. Sales of the Company's Sample Management Solutions Products are being impacted by customer bankruptcy and economic pressures.

Risk assessment revenues decreased 57% to $1.9 million for the six months ended June 30, 2025, compared to $4.4 million for the six months ended June 30, 2024. The Company discontinued this line of business at the end of 2024 and business is winding down in early 2025.

COVID-19 Diagnostics revenues decreased 99% to $0.5 million for the six months ended June 30, 2025 compared to $42.0 million for the six months ended June 30, 2024 due to decreased sales of the Company's InteliSwab® tests through its U.S. government procurement contracts. We expect this level of revenue to continue for the remainder of 2025 and for the foreseeable future due to the fulfillment of these contracts and lower overall demand for COVID-19 testing.

Molecular Services revenues, which were largely derived from the Company's laboratory services, were zero for six months ended June 30, 2025 compared to $1.7 million for the six months ended June 30, 2024. The decrease in service revenues was due to the Company's decision to exit this line of business in 2024.

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Non-Product and Services Revenues

Non-product and services revenues increased 215% to $2.3 million for the six months ended June 30, 2025 from $0.7 million for the six months ended June 30, 2024 primarily due to the recognition of revenue under funded R&D contracts that were assumed by the Company as a result of the Sherlock acquisition at the of 2024. The increase is also due to funded R&D contracts with BARDA which did not commence until after the first half of 2024.

CONSOLIDATED OPERATING RESULTS

Consolidated gross profit margin decreased to 41.6% for the six months ended June 30, 2025 from 44.9% for the six months ended June 30, 2024. The largest driver of the margin decline was a negative product mix driven by lower InteliSwab® sales that generate higher gross margins, lower genomics sales that also generate higher gross margins, and higher international product sales which generate lower margins. The termination of the microbiome molecular sequencing services business which historically dragged down the gross margin rate helped to improve the gross margin rate during the period along with the higher non-product revenues which contribute 100% to gross margin. Lastly, improved overhead absorption helped to offset the negative impact to margins as the Company brings more production in-house to its Opus Way facility.

Consolidated operating loss for the six months ended June 30, 2025 was $35.8 million, compared to $9.8 million operating loss reported for the six months ended June 30, 2024. Results for the six months ended June 30, 2025 were negatively impacted by the decrease in revenues and lower gross margins generated on sales of the Company's products coupled with higher clinical trial spend. Results for the six months ended June 30, 2025 included change in the estimated fair value of acquisition-related contingent consideration of $1.2 million offset by gain on sale of assets of $1.0 million.

Research and development expenses increased 47% to $21.0 million for the six months ended June 30, 2025 from $14.3 million for the six months ended June 30, 2024, largely due to higher spend incurred for clinical trials for the Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) device and additional R&D expense layered in from the newly acquired Sherlock companies.

Sales and marketing expenses decreased 19% to $13.2 million for the six months ended June 30, 2025 from $16.4 million for the six months ended June 30, 2024 primarily due to decreased employee costs associated with the reduction in headcount, lower consulting spend, and a decrease in bad debt expense.

General and administrative expenses increased 14% to $26.8 million for the six months ended June 30, 2025 from $23.5 million for the six months ended June 30, 2024 largely due an increase in legal and accounting fees and the additional general and administrative costs associated with the newly acquired Sherlock companies.

All of the above contributed to the Company's operating loss of $35.8 million for the six months ended June 30, 2025, which included non-cash charges $5.9 million for stock-based compensation, $5.3 million for depreciation and amortization, and $1.2 million for change in the estimated fair value of acquisition-related contingent consideration. The Company's operating loss of $9.8 million for the six months ended June 30, 2024 included a non-cash impairment charge of $4.4 million, non-cash charges of $6.3 million for stock-based compensation and non-cash charges of $5.3 million for depreciation and amortization.

OTHER INCOME

Other income for the six months ended June 30, 2025 was $2.9 million compared to $6.6 million for the six months ended June 30, 2024. This decrease is largely due to lower interest income and higher foreign currency losses.

CONSOLIDATED INCOME TAXES

The Company continues to believe the full valuation allowance established against its total U.S. deferred tax asset is appropriate as the facts and circumstances necessitating the allowance have not changed. For the six months ended June 30, 2025 and 2024, the Company recorded income expense of $1.5 million and $0.4 million, respectively. The increase in the income tax expense is largely due to recording an uncertain tax position for certain tax matters, including penalties and interest.

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Liquidity and Capital Resources


	June 30, 2025		December 31, 2024
	(in thousands)
Cash and cash equivalents	$	234,578	$	267,763

Working capital	259,088		299,737

The Company's cash and cash equivalents decreased to $234.6 million at June 30, 2025 from $267.8 million at December 31, 2024. The Company's Canadian subsidiary, DNAG, held $85.1 million or 36% of the $234.6 million in cash and cash equivalents.

The Company's working capital decreased to $259.1 million at June 30, 2025 from $299.7 million at December 31, 2024.

Analysis of the Company's Cash Flows

Operating Activities

During the six months ended June 30, 2025, net cash used in operating activities was $30.0 million. Cash flows from operations can be significantly impacted by factors such as timing of receipt from customers, inventory purchases, and payments to vendors. The Company's net loss of $35.7 million included non-cash charges of stock-based compensation expense of $5.9 million and depreciation and amortization expense of $5.3 million, and other net non-cash losses of $1.0 million mostly consisting of the non-cash adjustment to the contingent consideration liabilities and the loss on equity investment. Cash used by the working capital accounts included a decrease in accrued expenses of $3.1 million largely consisting of the payment of year-end bonuses in March 2025, an increase in accounts receivable of $1.6 million largely due to timing of shipments at the end of the quarter, and a decrease in accounts payable of $1.5 million. Cash provided by working capital accounts included a decrease in inventory of $1.0 million due to the lower revenues.

Investing Activities

Net cash used in investing activities was $1.6 million for the six months ended June 30, 2025, associated with proceeds from sale of property and equipment offset by the acquisition of new property and equipment.

Financing Activities

Net cash used in financing activities was $6.8 million for the six months ended June 30, 2025, which was largely comprised of $5.0 million of repurchase of common stock and $1.7 million used for the repurchase of common stock to satisfy withholding taxes related to the vesting of restricted shares awarded to the Company's employees.

Resources

The Company expects existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements over the next twelve months. The Company's cash requirements, however, may vary materially from those now planned due to many factors, including, but not limited to, the scope and timing of future strategic acquisitions, the progress of its research and development programs, the scope and results of clinical testing, the cost of any future litigation, the magnitude of capital expenditures, changes in existing and potential relationships with business partners, the timing and cost of obtaining regulatory approvals, the timing and cost of future stock purchases, the costs involved in obtaining and enforcing patents, proprietary rights and any necessary licenses, the cost and timing of expansion of sales and marketing activities, market acceptance of new products, competing technological and market developments, the impact of the current economic environment and other factors.

A summary of the Company's obligations to make future payments under contracts existing at December 31, 2024 is included in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, of its Annual Report on Form 10-K for the year ended December 31, 2024. As of June 30, 2025, there were no significant changes to this information.

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Critical Accounting Policies and Estimates

A more detailed review of the Company's critical accounting policies is contained in its Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC. No material changes have been made to such critical accounting policies during the six months ended June 30, 2025.

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There has been no material change in the Company's assessment of its sensitivity to market risk since its presentation set forth in Item 7A, "Quantitative and Qualitative Disclosures About Market Risk," in its Annual Report on Form 10-K for the year ended December 31, 2024.

Item 4. CONTROLS AND PROCEDURES

(a) Evaluation of Disclosure Controls and Procedures. The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934) as of June 30, 2025. Based on that evaluation, the Company’s management, including such officers, concluded that the Company’s disclosure controls and procedures were effective as of June 30, 2025 to provide reasonable assurance that material information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 was accumulated and communicated to the Company’s management, including the Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure and was recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission.

(b) Changes in Internal Control Over Financial Reporting. There was no change in the Company’s internal control over financial reporting that occurred during the three months ended June 30, 2025 that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

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PART II. OTHER INFORMATION

Item 1. LEGAL PROCEEDINGS

From time to time, the Company is involved in certain legal actions arising in the ordinary course of business. In management’s opinion, based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material adverse effect on the Company's future financial position or results of operations.

NowDiagnostics Litigation

Item 1A. RISK FACTORS

There have been no material changes to the risk factors disclosed in Item 1A, entitled “Risk Factors,” in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on March 7, 2025, other than as set forth below.

Adding the following new risk factor:

Changes in tax laws or in their implementation or interpretation may adversely affect us or our investors.

The rules dealing with the U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service, or IRS, and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application), including with respect to net operating losses and research and development tax credits, could adversely affect us or holders of our common stock. In recent years, many changes have been made and changes are likely to continue to occur in the future. For example, recent legislation that was signed into law on July 4, 2025 made significant changes to U.S. federal tax law.

It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be enacted, promulgated or issued under existing or new tax laws, which could result in an increase in our or our stockholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof.

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Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS


Period	Total number of shares purchased		Average price paid per share		Total number of shares purchased as part of publicly announced plans or programs	Maximum number (or approximate dollar value) of shares that may yet be repurchased under the plans or programs (1)
April 1, 2025 - April 30, 2025	—	(2)	$	—	—	$	40,000,000
May 1, 2025 - May 31, 2025	1,217,912	(2)	$	2.64	1,187,456	$	38,000,000
June 1, 2025 - June 30, 2025	874,180	(2)	$	2.93	633,300	$	35,000,000
	2,092,092				1,820,756

(1)In March 2025, the Company's board of directors authorized a stock repurchase program (the “Repurchase Program”) effective March 21, 2025, whereby the Company may purchase up to $40.0 million in shares of its common stock over a period of up to two years. The amount and timing of share repurchases under the Repurchase Program may be carried out at the discretion of management through various methods in compliance with applicable state and federal securities laws.

(2)Includes shares retired to satisfy minimum tax withholdings, in connection with the vesting of restricted and performance shares, pursuant to the OraSure Technologies, Inc. Stock Award Plan.

Item 3. DEFAULTS UPON SENIOR SECURITIES

None

Item 4. MINE SAFETY DISCLOSURES

Not applicable

Item 5. OTHER INFORMATION

Amended and Restated Bylaws

On August 5, 2025, our Board approved and adopted the Company’s Third Amended and Restated Bylaws (the “Bylaws”), which became effective immediately. The Bylaws supersede and replace in their entirety the Company’s Second Amended and Restated Bylaws in effect immediately prior to effectiveness of the Bylaws.

The Bylaws, among other things:

•amend the advanced notice provisions of the Bylaws by changing the existing deadline for the submission of notices of director nominations and business proposals submitted by stockholders to provide that submissions must be made between 120 and 90 days before the anniversary date of the previous year’s annual meeting, subject to limited exceptions;

•clarify that stockholder proposals and nominations shall only be considered for annual meetings of stockholders and not special meetings of stockholders; and

•incorporate certain other administrative, technical, clarifying and conforming changes.

As a result of the changes to the advance notice provisions discussed herein and reflected in the Bylaws, any stockholder who wishes to submit a matter (other than a stockholder proposal brought in accordance with SEC Rule 14a-8) for consideration at the 2026 annual meeting of stockholders, including any stockholder proposal or director nomination, must submit the matter to the Company, in writing, to be received by the Secretary of the Company no later than 5:00 p.m. Eastern Time on February 13, 2026 and no earlier than 5:00 p.m. Eastern Time on January 14, 2026. The notice of such matter must contain the information and adhere to the procedures required by the Bylaws. This updated window for submissions amends the deadlines for stockholder proposals and director nominations previously disclosed in the Company’s 2025 proxy statement filed on April 4, 2025 and made available or mailed to stockholders on that date.

The foregoing description does not purport to be complete and is qualified in its entirety by reference to the full text of the Bylaws, a copy of which is attached hereto as Exhibit 3.1 and is incorporated herein by reference.

Rule 10b5-1 Trading Plans

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The disclosure set forth in Part II - Item 2 above is incorporated herein by reference.

During the three months ended June 30, 2025, none of our directors or officers adopted, amended, or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

Item 6. EXHIBITS


Exhibit Number						Exhibit

3.2*						Third Amended and Restated Bylaws of OraSure Technologies, Inc. as of August 5, 2025.

10.1						A mended and Restated OraSure Technologies, Inc. 2000 Stock Award Plan is incorporated by reference to Exhibit 10.1 to the Company's Current Repo rt on Form 8-K filed on May 14, 2025.

31.1*						Certification of Carrie Eglinton-Manner required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.

31.2*						Certification of Kenneth J. McGrath required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.

32.1*+						Certification of Carrie Eglinton-Manner required by Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2*+						Certification of Kenneth J. McGrath required by Rule 13a-14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS						Inline XBRL Instance Document – the Instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH						Inline XBRL Taxonomy Extension Schema Document

101.CAL						Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF						Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB						Inline XBRL Taxonomy Extension Labels Linkbase Document

101.PRE						Inline XBRL Taxonomy Extension Presentation Linkbase Document

104						Cover Page from Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in exhibits 101).

______________________

*Filed herewith

+This certification is deemed not filed for purposes of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned thereunto duly authorized.


	ORASURE TECHNOLOGIES, INC.

		/s/ Kenneth J. McGrath
Date: August 6, 2025		Kenneth J. McGrath
		Chief Financial Officer
		(Principal Financial Officer)

		/s/Michele M. Anthony
Date: August 6, 2025		Michele M. Anthony
		Senior Vice President, Controller and Chief Accounting Officer
		(Principal Accounting Officer)