osur-20240331

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 March 31, 2024.


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 May 2, 2024, the registrant had 73,959,289 shares of common stock, $0.000001 par value per share, outstanding.


PART I. FINANCIAL INFORMATION

			Page No.

Item 1. Financial Statements (Unaudited)

Consolidated Balance Sheets at March 31, 2024 and December 31, 202 3			3

Consolidated Statements of Operations for the three months ended March 31, 2024 and 202 3			4

Consolidated Statements of Comprehensive Income (Loss) for the three months ended March 31, 2024 and 202 3			5

Consolidated Statements of Cash Flows for the three months ended March 31, 2024 and 202 3			6

Notes to the Consolidated Financial Statements			7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations			17

Item 3. Quantitative and Qualitative Disclosures About Market Risk			21

Item 4. Controls and Procedures			21

PART II. OTHER INFORMATION

Item 1. Legal Proceedings			22

Item 1A. Risk Factors			22

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds			23

Item 3. Defaults Upon Senior Securities			23

Item 4. Mine Safety Disclosures			23

Item 5. Other Information			23

Item 6. Exhibits			24

Signatures			25


	March 31, 2024		December 31, 2023
ASSETS
Current Assets:
Cash and cash equivalents	$	247,145	$	290,407
Short-term investments	16,627		—
Accounts receivable, net of allowance of $1,065 and $1,216	34,037		40,171
Inventories	43,180		47,614
Prepaid expenses	4,691		6,041
Other current assets	2,825		2,226
Total current assets	348,505		386,459
Noncurrent Assets:
Property, plant and equipment, net of accumulated depreciation of $86,332 and $85,143	42,597		45,420
Operating right-of-use assets, net	10,570		12,270
Finance right-of-use assets, net	158		576
Intangible assets, net of accumulated amortization of $33,261 and $33,649	1,010		1,206
Goodwill	35,172		35,696
Investment in equity method investee	28,333		—

Other noncurrent assets	1,213		1,218
Total noncurrent assets	119,053		96,386
TOTAL ASSETS	$	467,558	$	482,845
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable	$	12,683	$	13,151
Deferred revenue	1,597		1,559
Accrued expenses and other current liabilities	12,715		22,710
Finance lease liability	517		539
Operating lease liability	1,593		1,577
Total current liabilities	29,105		39,536
Noncurrent Liabilities:
Finance lease liability	204		226
Operating lease liability	10,676		11,162
Other noncurrent liabilities	727		696
Deferred income taxes	595		554
Total noncurrent liabilities	12,202		12,638
TOTAL LIABILITIES	41,307		52,174
Commitments and contingencies (Note 12)
STOCKHOLDERS' EQUITY
Preferred stock, par value $0.000001, 25,000 shares authorized, none issued	—		—
Common stock, par value $0.000001, 120,000 shares authorized, 73,959 and 73,528 shares issued and outstanding	—		—
Additional paid-in capital	531,263		529,543
Accumulated other comprehensive loss	(17,497)		(14,941)
Accumulated deficit	(87,515)		(83,931)
Total stockholders' equity	426,251		430,671
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$	467,558	$	482,845


	For the Three Months Ended March 31,
		2024		2023
NET REVENUES:
Products and services		$	53,779	$	152,914
Other		353		2,049
		54,132		154,963
COST OF PRODUCTS AND SERVICES SOLD		30,067		89,148
Gross profit		24,065		65,815
OPERATING EXPENSES:
Research and development		7,738		10,560
Sales and marketing		8,448		12,142
General and administrative		11,634		17,711
Loss on impairments		3,338		1,105
Change in the estimated fair value of acquisition-related contingent consideration		—		(24)
		31,158		41,494
Operating income (loss)		(7,093)		24,321
OTHER INCOME		3,491		2,673
Income (loss) before income taxes		(3,602)		26,994
INCOME TAX BENEFIT		(18)		(225)
NET INCOME (LOSS)		$	(3,584)	$	27,219

INCOME (LOSS) PER SHARE:
BASIC		$	(0.05)	$	0.37
DILUTED		$	(0.05)	$	0.37
WEIGHTED-AVERAGE SHARES OUTSTANDING:
BASIC		73,947		73,112
DILUTED		73,947		73,966


	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses		Fair Value
March 31, 2024
Guaranteed investment certificates	$	16,627	$	—	$	—	$	16,627

Total	$	16,627	$	—	$	—	$	16,627

At March 31, 2024, maturities of the Company's available-for-sale securities were as follows:

Less than one year	$	16,627	$	—	$	—	$	16,627
Greater than one year	$	—	$	—	$	—	$	—


	Foreign Currency		Total
Balance at December 31, 2023	$	(14,941)	$	(14,941)
Other comprehensive loss	(2,556)		(2,556)
Balance at March 31, 2024	$	(17,497)	$	(17,497)


	December 31,
	2023
Cost of assets, cumulative	$	86,993

Reduction for funding received to date	(86,993)
Total property, plant and equipment, net	$	—


	March 31,		December 31,
	2024		2023
Raw materials	$	17,621	$	20,727
Work in process	1,340		1,900
Finished goods	24,219		24,987
	$	43,180	$	47,614


	Three Months Ended March 31,
		2024		2023
COVID-19 (1)		$	23,128	$	118,409
HIV		13,380		13,904
Molecular Sample Management Solutions (2)		10,822		12,942
HCV		3,000		3,186
Risk assessment testing (3)		2,080		2,628
Molecular Services		873		1,379
Other product and service revenues		496		466
Net product and services revenues		53,779		152,914
Non-product and services revenues (4)		353		2,049
Net revenues		$	54,132	$	154,963


	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)
Unrealized gain on marketable securities	—	—		—		—		—		—
Balance at March 31, 2024	73,959	$	—	$	531,263	$	(17,497)	$	(87,515)	$	426,251


	Three Months Ended March 31,
	Dollars				% Change		Percentage of Total Net Revenues
	2024		2023				2024		2023
COVID-19 Diagnostics	$	23,097	$	118,254	(80)	%	43	%	76	%
Diagnostics (1)	16,380		17,090		(4)		30		11
Molecular Sample Management Solutions (2)	10,822		12,942		(16)		20		8
Other products and services (3)	2,576		3,094		(17)		5		2
Molecular Services	873		1,379		(37)		2		1
COVID-19 Molecular Products	31		155		(80)		—		—
Net product and services revenues	53,779		152,914		(65)		99		99
Non-product and services revenues (4)	353		2,049		(83)		1		1
Net revenues	$	54,132	$	154,963	(65)	%	100	%	100	%


	For the Three Months Ended March 31,
	2024		2023
OPERATING ACTIVITIES:
Net income (loss)	$	(3,584)	$	27,219
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
Stock-based compensation	2,968		2,655
Depreciation and amortization	2,725		3,696
Loss on impairments	3,338		1,105
Other non-cash amortization	6		—
Provision for credit losses	(85)		(67)
Unrealized foreign currency (gain) loss	(119)		44
Interest expense on finance leases	7		15
Deferred income taxes	53		—

Change in the estimated fair value of acquisition-related contingent consideration	—		(24)
Payment of acquisition-related contingent consideration	—		(19)
Changes in assets and liabilities:
Accounts receivable	6,199		(36,613)
Inventories	4,337		18,540
Prepaid expenses and other assets	603		5,299
Accounts payable	(68)		(12,097)
Deferred revenue	47		(279)
Accrued expenses and other liabilities	(9,688)		(3,472)
Net cash provided by operating activities	6,738		6,002
INVESTING ACTIVITIES:
Purchases of short-term investments	(25,850)		(22,330)
Purchase of equity method investee	(28,333)		—
Proceeds from maturities and redemptions of short-term investments	9,234		27,304
Purchases of property and equipment	(1,579)		(1,191)
Purchase of property and equipment under government contracts	—		(2,767)

Net cash provided by (used in) investing activities	(46,528)		1,016
FINANCING ACTIVITIES:
Cash payments for lease liabilities	(50)		(148)
Proceeds from exercise of stock options	215		66
Payment of acquisition-related contingent consideration	—		(46)
Repurchase of common stock	(1,462)		(1,203)
Net cash used in financing activities	(1,297)		(1,331)
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH	(2,175)		527


	March 31,		December 31,
	2024		2023
Land	$	1,118	$	1,118
Buildings and improvements	35,013		34,606
Machinery and equipment	62,308		64,156
Computer equipment and software	17,681		17,739
Furniture and fixtures	3,468		3,748
Construction in progress	9,341		9,196
	128,929		130,563
Accumulated depreciation	(86,332)		(85,143)
	$	42,597	$	45,420


	March 31,		December 31,
	2024		2023
Payroll and related benefits	$	5,475	$	14,654
Professional fees	1,980		2,827
Sales tax payable	1,268		1,245
Other	3,992		3,984
	$	12,715	$	22,710


	Three Months Ended March 31,
		2024		2023
United States		$	45,211	$	145,019
Europe		1,602		1,852
Other regions		7,319		8,092
		$	54,132	$	154,963


	March 31, 2024		December 31, 2023
	(in thousands)
Cash and cash equivalents	$	247,145	$	290,407
Short-term investments	16,627		—
Working capital	319,400		346,923


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, 2)
January 1, 2024 - January 31, 2024	59,151	(3)	$	8.19	—	$	11,984,720
February 1, 2024 - February 29, 2024	55,620	(3)	$	7.40	—	$	11,984,720
March 1, 2024 - March 31, 2024	78,707	(3)	$	7.18	—	$	11,984,720
	193,478				—


Exhibit Number						Exhibit

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).


	ORASURE TECHNOLOGIES, INC.

		/s/ Kenneth J. McGrath
Date: May 9, 2024		Kenneth J. McGrath
		Chief Financial Officer
		(Principal Financial Officer)

		/s/Michele M. Anthony
Date: May 9, 2024		Michele M. Anthony
		Senior Vice President, Controller and Chief Accounting Officer
		(Principal Accounting Officer)

SEC Form 10-Q filed by OraSure Technologies Inc.