Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2023 | Aug. 01, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-16537 | |
Entity Registrant Name | ORASURE TECHNOLOGIES, INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 36-4370966 | |
Entity Address, Address Line One | 220 East First Street | |
Entity Address, City or Town | Bethlehem | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 18015 | |
City Area Code | 610 | |
Local Phone Number | 882-1820 | |
Title of 12(b) Security | Common Stock, $0.000001 par value per share | |
Trading Symbol | OSUR | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 73,414,695 | |
Entity Central Index Key | 0001116463 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Jun. 30, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 185,936,000 | $ 83,980,000 |
Short-term investments | 0 | 26,867,000 |
Accounts receivable, net of allowance of $1,908 and $2,365 | 52,750,000 | 70,797,000 |
Inventories | 73,284,000 | 95,704,000 |
Prepaid expenses | 5,248,000 | 6,273,000 |
Other current assets | 24,349,000 | 41,569,000 |
Total current assets | 341,567,000 | 325,190,000 |
Noncurrent Assets: | ||
Property, plant and equipment, net of accumulated depreciation of $84,423 and $69,881 | 49,282,000 | 59,413,000 |
Operating right-of-use assets, net | 13,443,000 | 10,399,000 |
Finance right-of-use assets, net | 803,000 | 1,293,000 |
Finance right-of-use assets, net | 10,665,000 | 11,694,000 |
Goodwill | 35,606,000 | 35,104,000 |
Deferred tax asset | 1,230,000 | 0 |
Other noncurrent assets | 998,000 | 1,087,000 |
Total noncurrent assets | 112,027,000 | 118,990,000 |
TOTAL ASSETS | 453,594,000 | 444,180,000 |
Current Liabilities: | ||
Accounts payable | 17,753,000 | 38,020,000 |
Deferred revenue | 1,841,000 | 2,273,000 |
Accrued expenses and other current liabilities | 23,811,000 | 25,762,000 |
Finance lease liability | 1,080,000 | 1,179,000 |
Operating lease liability | 1,895,000 | 1,764,000 |
Acquisition-related contingent consideration obligation | 40,000 | 65,000 |
Total current liabilities | 46,420,000 | 69,063,000 |
Noncurrent Liabilities: | ||
Finance lease liability | 436,000 | 503,000 |
Operating lease liability | 12,013,000 | 9,101,000 |
Acquisition-related contingent consideration obligation | 0 | 99,000 |
Other noncurrent liabilities | 586,000 | 581,000 |
Deferred income taxes | 0 | 408,000 |
Total noncurrent liabilities | 13,035,000 | 10,692,000 |
TOTAL LIABILITIES | 59,455,000 | 79,755,000 |
Commitments and contingencies (Note 12) | ||
STOCKHOLDERS' EQUITY | ||
Preferred stock, par value $0.000001, 25,000 shares authorized, none issued | 0 | 0 |
Common stock, par value $0.000001, 120,000 shares authorized, 73,413 and 72,734 shares issued and outstanding | 0 | 0 |
Additional paid-in capital | 523,861,000 | 520,446,000 |
Accumulated other comprehensive loss | (14,559,000) | (18,435,000) |
Accumulated deficit | (115,163,000) | (137,586,000) |
Total stockholders' equity | 394,139,000 | 364,425,000 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 453,594,000 | $ 444,180,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 1,908 | $ 2,365 |
Accumulated depreciation of property and equipment | 84,423 | 69,881 |
Accumulated amortization of intangible assets | $ 32,737 | $ 31,077 |
Preferred stock, par value (in USD per share) | $ 0.000001 | $ 0.000001 |
Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Common stock, par value (in USD per share) | $ 0.000001 | $ 0.000001 |
Common stock, shares authorized (in shares) | 120,000,000 | 120,000,000 |
Common stock, shares issued (in shares) | 73,413,000 | 72,734,000 |
Common stock, shares outstanding (in shares) | 73,413,000 | 72,734,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
NET REVENUES: | ||||
Total revenue | $ 85,441,000 | $ 80,231,000 | $ 240,404,000 | $ 147,938,000 |
COST OF PRODUCTS AND SERVICES SOLD | 59,070,000 | 52,434,000 | 148,218,000 | 95,842,000 |
Gross profit | 26,371,000 | 27,797,000 | 92,186,000 | 52,096,000 |
OPERATING EXPENSES: | ||||
Research and development | 7,661,000 | 9,463,000 | 18,221,000 | 18,097,000 |
Sales and marketing | 8,535,000 | 11,684,000 | 20,677,000 | 24,401,000 |
General and administrative | 16,424,000 | 17,579,000 | 34,135,000 | 36,735,000 |
Loss on impairments | 215,000 | 10,542,000 | 1,320,000 | 10,542,000 |
Change in the estimated fair value of acquisition-related contingent consideration | (35,000) | 0 | (59,000) | (36,000) |
Total operating expenses | 32,800,000 | 49,268,000 | 74,294,000 | 89,739,000 |
Operating income (loss) | (6,429,000) | (21,471,000) | 17,892,000 | (37,643,000) |
OTHER INCOME | 1,467,000 | 1,713,000 | 4,140,000 | 1,881,000 |
Income (loss) before income taxes | (4,962,000) | (19,758,000) | 22,032,000 | (35,762,000) |
INCOME TAX (BENEFIT) EXPENSE | (166,000) | (1,169,000) | (391,000) | 2,767,000 |
NET INCOME (LOSS) | $ (4,796,000) | $ (18,589,000) | $ 22,423,000 | $ (38,529,000) |
INCOME (LOSS) PER SHARE: | ||||
BASIC (in USD per share) | $ (0.07) | $ (0.26) | $ 0.31 | $ (0.53) |
DILUTED (in USD per share) | $ (0.07) | $ (0.26) | $ 0.30 | $ (0.53) |
WEIGHTED-AVERAGE SHARES OUTSTANDING: | ||||
BASIC (in shares) | 73,324 | 72,496 | 73,219 | 72,361 |
DILUTED (in shares) | 73,324 | 72,496 | 74,115 | 72,361 |
Products and services | ||||
NET REVENUES: | ||||
Total revenue | $ 84,738,000 | $ 79,167,000 | $ 237,652,000 | $ 144,403,000 |
Other | ||||
NET REVENUES: | ||||
Total revenue | $ 703,000 | $ 1,064,000 | $ 2,752,000 | $ 3,535,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
NET INCOME (LOSS) | $ (4,796) | $ (18,589) | $ 22,423 | $ (38,529) |
OTHER COMPREHENSIVE INCOME | ||||
Currency translation adjustments | 2,859 | (4,349) | 3,656 | (2,593) |
Unrealized gain on marketable securities | 0 | 82 | 220 | 156 |
COMPREHENSIVE INCOME (LOSS) | $ (1,937) | $ (22,856) | $ 26,299 | $ (40,966) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | 18 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | Jun. 30, 2023 | |
OPERATING ACTIVITIES: | ||||||||
NET INCOME (LOSS) | $ (4,796,000) | $ 27,219,000 | $ (18,589,000) | $ (19,940,000) | $ 22,423,000 | $ (38,529,000) | ||
Adjustments to reconcile net income (loss) to net cash (used in) provided by operating activities: | ||||||||
Stock-based compensation | 5,012,000 | 6,804,000 | ||||||
Depreciation and amortization | 14,011,000 | 7,464,000 | ||||||
Loss on impairments | 215,000 | 10,542,000 | 1,320,000 | 10,542,000 | ||||
Other non-cash amortization | 1,000 | 313,000 | ||||||
Provision for credit losses | (478,000) | (152,000) | ||||||
Unrealized foreign currency gain (loss) | 106,000 | (62,000) | ||||||
Interest expense on finance leases | 28,000 | 55,000 | ||||||
Deferred income taxes | (1,815,000) | 361,000 | ||||||
Loss on sale of fixed assets | 0 | 718,000 | ||||||
Change in the estimated fair value of acquisition-related contingent consideration | (35,000) | 0 | (59,000) | (36,000) | ||||
Payment of acquisition-related contingent consideration | (19,000) | 0 | ||||||
Changes in assets and liabilities: | ||||||||
Accounts receivable | 18,652,000 | (18,646,000) | ||||||
Inventories | 22,556,000 | (18,179,000) | $ 528,000 | |||||
Prepaid expenses and other assets | 5,495,000 | (4,416,000) | ||||||
Accounts payable | (22,187,000) | 11,485,000 | (1,329,000) | |||||
Deferred revenue | (450,000) | (252,000) | ||||||
Accrued expenses and other liabilities | (1,326,000) | (2,959,000) | ||||||
Net cash provided by (used in) operating activities | 63,270,000 | (45,489,000) | ||||||
INVESTING ACTIVITIES: | ||||||||
Proceeds from maturities and redemptions of investments | 27,305,000 | 23,017,000 | ||||||
Purchases of property and equipment | (2,893,000) | (25,440,000) | ||||||
Purchase of property and equipment under government contracts | (4,034,000) | (33,803,000) | ||||||
Proceeds from funding under government contract | 17,793,000 | 33,962,000 | $ 78,124,000 | |||||
Net cash provided by (used in) investing activities | 38,171,000 | (2,264,000) | ||||||
FINANCING ACTIVITIES: | ||||||||
Cash payments for lease liabilities | (320,000) | (392,000) | ||||||
Proceeds from exercise of stock options | 66,000 | 15,000 | ||||||
Payment of acquisition-related contingent consideration | (46,000) | (208,000) | ||||||
Repurchase of common stock | (1,663,000) | (1,954,000) | ||||||
Net cash used in financing activities | (1,963,000) | (2,539,000) | ||||||
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH | 2,478,000 | (311,000) | ||||||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 101,956,000 | (50,603,000) | ||||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | $ 83,980,000 | $ 116,762,000 | 83,980,000 | 116,762,000 | 116,762,000 | 116,762,000 | ||
CASH AND CASH EQUIVALENTS, END OF PERIOD | $ 185,936,000 | $ 66,159,000 | 185,936,000 | 66,159,000 | $ 83,980,000 | $ 185,936,000 | ||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||
Cash paid for income taxes | 623,000 | 9,107,000 | ||||||
Non-cash investing and financing activities | ||||||||
Accrued property and equipment purchases | 314,000 | 1,900,000 | ||||||
Accrued property and equipment purchases under government contracts | 0 | 2,023,000 | ||||||
Unrealized gain on marketable securities | $ 0 | $ 156,000 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 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”), and Novosanis NV (“Novosanis”). 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, 2022. Results of operations for the three and six months ended June 30, 2023 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, 2022 that have had a material impact on the consolidated financial statements and related notes except as discussed herein. See Note 11 for the discussion regarding the change in business segments. Cash Equivalents & Investments . The Company considers all investments in debt securities to be available-for-sale securities. These securities consist of guaranteed investment certificates and corporate bonds purchased with maturities greater than ninety days. 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 its 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 following is a summary of the Company's available-for-sale securities: Amortized Gross Gross Fair Value December 31, 2022 Guaranteed investment certificates $ 22,109 $ — $ — $ 22,109 Corporate bonds 4,978 — (220) 4,758 Total $ 27,087 $ — $ (220) $ 26,867 Fair Value of Financial Instruments . As of June 30, 2023 and December 31, 2022, 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). All of the Company's available-for-sale corporate bonds are measured as Level 2 instruments and the Company's available-for-sale guaranteed investment certificates are measured as Level 1 instruments as of December 31, 2022. Included in cash and cash equivalents at June 30, 2023 and December 31, 2022, was $6,928 and $1,730 invested in money market funds. These money market funds have investments in government securities and are measured as Level 1 instruments. Included in cash and cash equivalents at June 30, 2023 was $22,642 of guaranteed investment certificates which are also 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, 2023 and December 31, 2022 was $644 and $747, 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 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. Foreign Currency Translation . Net foreign exchange gains and (losses) resulting from foreign currency transactions that are included in other income in the Company's consolidated statements of operations were $(492) and $783 for the three months ended June 30, 2023 and 2022, respectively. Net foreign exchange gains and (losses) resulting from foreign currency transactions for the six months ended June 30, 2023 and 2022 were $(542) and $54, respectively. Accumulated Other Comprehensive Loss . Changes in accumulated other comprehensive loss by component is listed below. Foreign Currency Marketable Securities Total Balance at December 31, 2022 $ (18,215) $ (220) $ (18,435) Other comprehensive gain 3,656 220 3,876 Balance at June 30, 2023 $ (14,559) $ — $ (14,559) Immaterial Correction of Errors. Inventories, accounts payable and cost of products and services were reduced by $528, $1,329 and $801, respectively, as of and for the year ended December 31, 2022 to correct for the accounting of a vendor rebate earned in 2022. The tax impact of the vendor rebate was negligible. This correction was deemed to be immaterial to the consolidated financial statements as of and for the year ended December 31, 2022. For the three and six months ended June 30, 2022, cost of products and services sold was reduced by $213 and $240, respectively. The respective operating activities on the consolidated statement of cash flows for the six months ended June 30, 2022 has also been adjusted. Furthermore, stockholder's equity at June 30, 2022 has been adjusted to reflect the reduction in cost of products and services sold. Reclassification . Certain prior period amounts have been reclassified to conform to current year presentations. For the three and six months ended June 30, 2022, $395 and $616 of research and development expenses were reclassified to other income in relation to the U.S. Department of Defense (the “DOD”) engineering consulting costs further described in Note 2. This reclassification was made to conform to the presentation in our Annual Report on Form 10-K for the year ended December 31, 2022. Change in Accounting Estimate. During the three months ended June 30, 2023, the Company shortened the useful lives of machinery and equipment utilized for InteliSwab® production in Thailand. This reduction in useful lives resulted in $6,900 of accelerated depreciation during the three months ended June 30, 2023, recorded in cost of products and services sold. |
Government Capital Contracts
Government Capital Contracts | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Government Capital Contracts | Government Capital Contracts In September 2021, the Company entered into an agreement for $109,000 in funding from the DOD, in coordination with the Department of Health and Human Services, to build additional manufacturing capacity in the United States for its InteliSwab ® COVID-19 Rapid Tests as part of the nation’s pandemic preparedness plan. Funding will be paid to the Company based on achievement of milestones through December 2023 for the design, acquisition, installation, qualification and acceptance of the manufacturing equipment, as set forth in the agreement. In accordance with the milestone payment schedule, 15% of the total will not be funded until the completion of the final validation testing, which is scheduled to occur in late 2023. The Company began making payments to vendors for the capital project during the fourth quarter of 2021. The Company began receiving funds from the DOD in January 2022 and has received $78,124, as of June 30, 2023. The remaining $30,876 is expected to be collected during the remainder of 2023. Activity for these capital contracts is accounted for pursuant to International Accounting Standards ("IAS") 20, Accounting for Government Grants and Disclosure of Government Assistance . Funding received in relation to capital-related costs incurred for government contracts is recorded as a reduction to the cost of property, plant and equipment and reflected within investing activities in the consolidated statements of cash flows; and associated unpaid liabilities and government proceeds receivable are considered non-cash changes in such balances within the operating section of the consolidated statements of cash flows. Amounts earned for the Company's guaranteed profit which covers project management costs are recognized straight-line in other income over the term of the government contract. Any amount received in excess of the guaranteed profit discussed above will be recorded in other income at time of payment. The Company recognized $561 of such income, which is reported as other income in the Company's consolidated statement of operations for both the three months ended June 30, 2023 and 2022. The Company recognize $1,123 of such income, for both the six months ended June 30, 2023 and 2022. The DOD also reimburses the Company for certain engineering consulting costs. These expenses are reflected in research and development as incurred with the corresponding reimbursement presented in other income. For the three months ended June 30, 2023 and 2022, $537 and $395, respectively, were recorded in research and development and other income. For the six months ended June 30, 2023 and 2022, $1,588 and $616, respectively, were recorded in research and development and other income. The balances corresponding to government contracts included in the Company's consolidated balance sheet are as follows: June 30, December 31, Other current assets: Billed receivables $ — $ — Unbilled receivables 15,429 27,013 Total other current assets 15,429 27,013 Accrued expenses and other current liabilities $ (118) $ (318) The activity corresponding to the government contracts included in the Company's consolidated statements of cash flows is as follows: June 30, December 31, Cost of assets, cumulative $ 87,057 $ 83,359 Reduction for funding earned to date, not yet received (8,402) (22,497) Reduction for funding received to date (78,655) (60,862) Total property, plant and equipment, net $ — $ — |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories June 30, December 31, 2023 2022 Raw materials $ 29,647 $ 42,445 Work in process 1,885 2,335 Finished goods 41,752 50,924 $ 73,284 $ 95,704 |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment, Net | Property, Plant and Equipment, net June 30, December 31, 2023 2022 Land $ 1,118 $ 1,118 Buildings and improvements 35,765 35,582 Machinery and equipment 65,204 60,725 Computer equipment and software 17,065 16,681 Furniture and fixtures 4,100 4,064 Construction in progress 10,453 11,124 133,705 129,294 Accumulated depreciation (84,423) (69,881) $ 49,282 $ 59,413 During the six months ended June 30, 2023, the Company determined several manufacturing lines will not be utilized due to changes in forecasted demand for the products the equipment is intended to produce. Additionally, the Company elected not to proceed with certain leasehold improvements to its research and development laboratories. As a result of these decisions, the Company determined that the carrying values of the equipment and leasehold improvements made to date are not recoverable and recorded an aggregate pre-tax asset impairment charge of $1,320 during the six months ended June 30, 2023. Due to the extremely specialized nature of the equipment and various market data points, the estimated fair value was zero. These charges are reported within loss on impairments in the consolidated statement of operations. |
Accrued Expenses and other curr
Accrued Expenses and other current liabilities | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and other current liabilities | Accrued Expenses and other current liabilities June 30, December 31, 2023 2022 Payroll and related benefits $ 11,028 $ 14,103 Professional fees 7,038 4,685 Sales tax payable 1,321 1,519 Other 4,424 5,455 $ 23,811 $ 25,762 |
Termination Benefits
Termination Benefits | 6 Months Ended |
Jun. 30, 2023 | |
Termination Benefits [Abstract] | |
Termination Benefits | Termination Benefits During the first and second quarters of 2023, the Company executed a reduction in workforce. This was accounted for pursuant to Accounting Standards Codification ("ASC") 420, Exit or Disposal Cost Obligations . The expense included in the Company's consolidated statements of operations are as follows: Three Months Ended June 30, 2023 Six months ended June 30, 2023 Cost of products and services sold $ 334 $ 369 Research and development — 566 Sales and marketing 95 1,543 General and administrative 201 787 Total $ 629 $ 3,264 As of June 30, 2023 the Company had $1,591 accrued and had paid $1,674 related to the reduction in workforce. |
Revenues
Revenues | 6 Months Ended |
Jun. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenues | Revenues Revenues by product line . The following table represents total net revenues by product line: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 COVID-19 (1) $ 47,507 $ 43,378 $ 165,916 $ 74,411 HIV 15,964 10,357 29,868 18,523 Molecular Products (2) 13,050 17,581 25,992 35,514 HCV 3,870 3,691 7,056 6,948 Risk assessment testing 2,358 2,630 4,986 5,191 Molecular Services 1,354 1,204 2,733 2,938 Other product and service revenues 635 326 1,101 878 Net product and services revenues 84,738 79,167 237,652 144,403 Other non-product revenues (3) 703 1,064 2,752 3,535 Net revenues $ 85,441 $ 80,231 $ 240,404 $ 147,938 (1) Includes COVID-19 Diagnostics and COVID-19 Molecular Products. (2) Includes Genomics and Microbiome and Novosanis Products. (3) Other non-product and services revenues include 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: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 United States $ 73,871 $ 70,320 $ 218,890 $ 128,307 Europe 2,453 2,436 4,305 6,722 Other regions 9,117 7,475 17,209 12,909 $ 85,441 $ 80,231 $ 240,404 $ 147,938 Customer and Vendor Concentrations . At June 30, 2023, one non-commercial customer accounted for 47% of the Company's consolidated accounts receivable. The same non-commercial customer accounted for more than 57% of the Company's consolidated accounts receivable as of December 31, 2022. The same non-commercial customer also accounted for 56% of net consolidated revenues for both the three months ended June 30, 2023 and 2022, respectively. The same non-commercial customer also accounted for 70% and 39% of net consolidated revenues for the six months ended June 30, 2023 and 2022, respectively. 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, 2023 and December 31, 2022 included customer prepayments of $1,285 and $1,533, respectively. Deferred revenue as of June 30, 2023 and December 31, 2022 also included $556 and $740, respectively, associated with a long-term contract that has variable pricing based on volume. The average price over the life of the contract was determined and revenue is recognized at that average price. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The components of income tax expense (benefits) are as follows: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 State income tax expense (benefit) $ 1,481 $ 183 $ 1,257 $ 400 Foreign income tax expense (benefit) (1,648) (1,352) (1,648) 665 Foreign withholding tax — — — 1,702 $ (166) $ (1,169) $ (391) $ 2,767 Income taxes for the first six months of 2022 includes $1,702 of Canadian withholding tax on the repatriation of $65,000 of unremitted earnings from Canada to the United States. The increase in state tax expense in 2023 compared to 2022 is a result of the increase in projected income before taxes to be generated by the Company's U.S. operations. Conversely, the increase in foreign tax benefit in 2023 compared to 2022 is a result of the decrease in projected income before taxes expected to be generated by the Company's Canadian subsidiary. 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, 2023 relate to foreign net operating losses. The significant components of the Company's total deferred tax liability at December 31, 2022 relate to the tax effects of the basis difference between the intangible assets acquired in its acquisitions for financial reporting and for tax purposes along with basis differences arising from accelerated tax depreciation of fixed 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. deferred tax assets as of June 30, 2023 and December 31, 2022. |
Income (Loss) Per Share
Income (Loss) Per Share | 6 Months Ended |
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
Income (Loss) Per Share | Income (Loss) Per Share Basic income (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, 2023 outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 966 shares were excluded from the computation of diluted loss per share. For the six months ended June 30, 2023, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 2,030 shares were excluded from the computation of diluted earnings per share as their inclusion |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ Equity Reconciliation of the changes in stockholder's equity for the three and six months ended June 30, 2023 and 2022. Common Stock Additional Accumulated Accumulated Total Shares Amount Balance at December 31, 2022 72,734 $ — $ 520,446 $ (18,435) $ (137,586) $ 364,425 Common stock issued upon exercise of options 12 — 66 — — 66 Vesting of restricted stock and performance stock units 737 — — — — — Purchase and retirement of common shares (229) — (1,203) — — (1,203) Stock-based compensation — — 2,655 — — 2,655 Net income — — — — 27,219 27,219 Currency translation adjustments — — — 797 — 797 Unrealized gain on marketable securities — — — 220 — 220 Balance at March 31, 2023 73,254 $ — $ 521,964 $ (17,418) $ (110,367) $ 394,179 Vesting of restricted stock and performance stock units 241 — — — — — Purchase and retirement of common shares (82) — (460) — — (460) Stock-based compensation — — 2,357 — — 2,357 Net loss — — — — (4,796) (4,796) Currency translation adjustments — — — 2,859 — 2,859 Balance at June 30, 2023 73,413 $ — $ 523,861 $ (14,559) $ (115,163) $ 394,139 Common Stock Additional Accumulated Accumulated Total Shares Amount Balance at December 31, 2021 72,069 $ — $ 511,063 $ (10,077) $ (120,453) $ 380,533 Common stock issued upon exercise of options 2 — 15 — — 15 Vesting of restricted stock and performance stock units 352 — — — — — Purchase and retirement of common shares (116) — (1,049) — — (1,049) Stock-based compensation — — 3,524 — — 3,524 Net loss — — — — (19,940) (19,940) Currency translation adjustments — — — 1,756 — 1,756 Unrealized gain on marketable securities — — — 74 — 74 Balance at March 31, 2022 72,307 $ — $ 513,553 $ (8,247) $ (140,393) $ 364,913 Common stock issued upon exercise of options 407 — — — — — Vesting of restricted stock and performance stock units (142) — (905) — — (905) Stock-based compensation — — 3,280 — — 3,280 Net loss — — — — (18,589) (18,589) Currency translation adjustments — — — (4,349) — (4,349) Unrealized gain on marketable securities — — — 82 — 82 Balance at June 30, 2022 72,572 $ — $ 515,928 $ (12,514) $ (158,982) $ 344,432 |
Business Segments
Business Segments | 6 Months Ended |
Jun. 30, 2023 | |
Segment Reporting [Abstract] | |
Business Segments | Business SegmentsThe Company is organized on the basis of products and services under a new organizational structure. All products and services reside under the same reporting hierarchy. Historically there was separate management leading the Company's Diagnostics and Molecular Solutions businesses. In February 2023, the Company announced a corporate restructuring to combine the commercial and innovation teams across the Diagnostics and Molecular Solutions segments into one operating segment with sales, marketing, product development and research teams covering all product lines and reporting to a Chief Product Officer. Resources are allocated and performance is assessed on a consolidated basis by our Chief Executive Officer, whom we have determined to be our Chief Operating Decision Maker ("CODM"). The CODM reviews the business based on individual product success. Therefore, our historical reportable segments, Diagnostics and Molecular Solutions are now considered one reportable segment and there will no longer be a distinction between Diagnostics and Molecular Solutions, only the Company holistically. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 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. In June 2021, the Company filed a complaint against Spectrum Solutions, LLC ("Spectrum") in the United States District Court for the Southern District of California alleging that certain saliva collection devices manufactured and sold by Spectrum infringe a patent held by DNAG. Spectrum has filed an answer to the initial complaint, asserting that its device does not infringe the Company's patent and that the Company's patent is invalid. In August 2021, the Company amended its complaint to add a second patent to this litigation. Spectrum responded to the Company's amended complaint and asserted counterclaims for inequitable conduct and antitrust violations with respect to one of the patents in the litigation and subsequently filed a request for review of the second patent at the Patent and Trademark Office ("PTO"), which was granted by the PTO. The District Court issued multiple pretrial orders, resolving the infringement, antitrust, and inequitable conduct claims without trial. First, the District Court granted Spectrum’s motion for summary judgment of noninfringement, holding that Spectrum’s saliva collection devices are not “kits for collecting and preserving a biological sample,” among other rulings. The Company has appealed the grant of summary judgment to the Court of Appeal on June 8, 2023. Second, the District Court denied Spectrum’s motion to amend its allegations of alleged antitrust violations, finding that if such an amendment were allowed, Spectrum’s claims would not survive a motion for summary judgment. Spectrum thereafter withdrew its antitrust and inequitable conduct counterclaims. Spectrum did not appeal the District Court's denial of its motion to amend. Both parties have filed motions seeking sanctions in the District Court. An inter partes review is currently pending before the PTO regarding the second asserted patent. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Pay vs Performance Disclosure | ||||||
NET INCOME (LOSS) | $ (4,796) | $ 27,219 | $ (18,589) | $ (19,940) | $ 22,423 | $ (38,529) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 6 Months Ended |
Jun. 30, 2023 shares | Jun. 30, 2023 shares | |
Trading Arrangements, by Individual | ||
Non-Rule 10b5-1 Arrangement Adopted | false | |
Rule 10b5-1 Arrangement Terminated | false | |
Non-Rule 10b5-1 Arrangement Terminated | false | |
Kathleen Weber [Member] | ||
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | On May 25, 2023, Kathleen Weber, our Chief Product Officer, adopted a trading arrangement (the “Trading Plan”) intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c) with respect to the sale of up to an aggregate of 64,129 shares of our common stock between August 30 and May 17, 2024 pursuant to the terms of the Trading Plan. The Trading Plan was entered into during an open insider trading window and is intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act and the Company’s policies regarding insider transactions.The number of shares to be withheld, and thus the exact number of shares to be sold pursuant to Ms. Weber’s Trading Plan, can only be determined upon the occurrence of the future vesting events. For purposes of this disclosure, without subtracting any shares to be withheld upon future vesting events, the aggregate number of shares to be sold pursuant to Ms. Weber’s 10b5-1 Plan is 64,129 | |
Name | Kathleen Weber | |
Title | Chief Product Officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | May 25, 2023 | |
Aggregate Available | 64,129 | 64,129 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Principles of Consolidation and Basis of Presentation | 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”), and Novosanis NV (“Novosanis”). 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, 2022. Results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the results of operations expected for the full year. Summary of Significant Accounting Policies . |
Investments | Investments . The Company considers all investments in debt securities to be available-for-sale securities. These securities consist of guaranteed investment certificates and corporate bonds purchased with maturities greater than ninety days. 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. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments . As of June 30, 2023 and December 31, 2022, 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). All of the Company's available-for-sale corporate bonds are measured as Level 2 instruments and the Company's available-for-sale guaranteed investment certificates are measured as Level 1 instruments as of December 31, 2022. Included in cash and cash equivalents at June 30, 2023 and December 31, 2022, was $6,928 and $1,730 invested in money market funds. These money market funds have investments in government securities and are measured as Level 1 instruments. Included in cash and cash equivalents at June 30, 2023 was $22,642 of guaranteed investment certificates which are also 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, 2023 and December 31, 2022 was $644 and $747, 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 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. |
Foreign Currency Translation | Foreign Currency Translation . Net foreign exchange gains and (losses) resulting from foreign currency transactions that are included in other income in the Company's consolidated statements of operations were $(492) and $783 for the three months ended June 30, 2023 and 2022, respectively. Net foreign exchange gains and (losses) resulting from foreign currency transactions for the six months ended June 30, 2023 and 2022 were $(542) and $54, respectively. |
Accumulated Other Comprehensive Loss | Accumulated Other Comprehensive Loss . Changes in accumulated other comprehensive loss by component is listed below. Foreign Currency Marketable Securities Total Balance at December 31, 2022 $ (18,215) $ (220) $ (18,435) Other comprehensive gain 3,656 220 3,876 Balance at June 30, 2023 $ (14,559) $ — $ (14,559) |
Immaterial Correction of Errors and Reclassification | Immaterial Correction of Errors. Inventories, accounts payable and cost of products and services were reduced by $528, $1,329 and $801, respectively, as of and for the year ended December 31, 2022 to correct for the accounting of a vendor rebate earned in 2022. The tax impact of the vendor rebate was negligible. This correction was deemed to be immaterial to the consolidated financial statements as of and for the year ended December 31, 2022. For the three and six months ended June 30, 2022, cost of products and services sold was reduced by $213 and $240, respectively. The respective operating activities on the consolidated statement of cash flows for the six months ended June 30, 2022 has also been adjusted. Furthermore, stockholder's equity at June 30, 2022 has been adjusted to reflect the reduction in cost of products and services sold. Reclassification . Certain prior period amounts have been reclassified to conform to current year presentations. For the three and six months ended June 30, 2022, $395 and $616 of research and development expenses were reclassified to other income in relation to the U.S. Department of Defense (the “DOD”) engineering consulting costs further described in Note 2. This reclassification was made to conform to the presentation in our Annual Report on Form 10-K for the year ended December 31, 2022. |
Customer and Vendor Concentrations | Customer and Vendor Concentrations . At June 30, 2023, one non-commercial customer accounted for 47% of the Company's consolidated accounts receivable. The same non-commercial customer accounted for more than 57% of the Company's consolidated accounts receivable as of December 31, 2022. The same non-commercial customer also accounted for 56% of net consolidated revenues for both the three months ended June 30, 2023 and 2022, respectively. The same non-commercial customer also accounted for 70% and 39% of net consolidated revenues for the six months ended June 30, 2023 and 2022, respectively. |
Deferred Revenue | 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, 2023 and December 31, 2022 included customer prepayments of $1,285 and $1,533, respectively. Deferred revenue as of June 30, 2023 and December 31, 2022 also included $556 and $740, respectively, associated with a long-term contract that has variable pricing based on volume. The average price over the life of the contract was determined and revenue is recognized at that average price. |
Change in Accounting Estimate | Change in Accounting Estimate. During the three months ended June 30, 2023, the Company shortened the useful lives of machinery and equipment utilized for InteliSwab® production in Thailand. This reduction in useful lives resulted in $6,900 of accelerated depreciation during the three months ended June 30, 2023, recorded in cost of products and services sold. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Available-for-sale Securities | The following is a summary of the Company's available-for-sale securities: Amortized Gross Gross Fair Value December 31, 2022 Guaranteed investment certificates $ 22,109 $ — $ — $ 22,109 Corporate bonds 4,978 — (220) 4,758 Total $ 27,087 $ — $ (220) $ 26,867 |
Summary of Changes in Accumulated Other Comprehensive Loss by Component | Changes in accumulated other comprehensive loss by component is listed below. Foreign Currency Marketable Securities Total Balance at December 31, 2022 $ (18,215) $ (220) $ (18,435) Other comprehensive gain 3,656 220 3,876 Balance at June 30, 2023 $ (14,559) $ — $ (14,559) |
Government Capital Contracts (T
Government Capital Contracts (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Government Contracts Balances Included in Consolidated Balance Sheet | The balances corresponding to government contracts included in the Company's consolidated balance sheet are as follows: June 30, December 31, Other current assets: Billed receivables $ — $ — Unbilled receivables 15,429 27,013 Total other current assets 15,429 27,013 Accrued expenses and other current liabilities $ (118) $ (318) |
Summary of Government Contracts Balances Included in Consolidated Statements of Cash flows | The activity corresponding to the government contracts included in the Company's consolidated statements of cash flows is as follows: June 30, December 31, Cost of assets, cumulative $ 87,057 $ 83,359 Reduction for funding earned to date, not yet received (8,402) (22,497) Reduction for funding received to date (78,655) (60,862) Total property, plant and equipment, net $ — $ — |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | June 30, December 31, 2023 2022 Raw materials $ 29,647 $ 42,445 Work in process 1,885 2,335 Finished goods 41,752 50,924 $ 73,284 $ 95,704 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment, Net | June 30, December 31, 2023 2022 Land $ 1,118 $ 1,118 Buildings and improvements 35,765 35,582 Machinery and equipment 65,204 60,725 Computer equipment and software 17,065 16,681 Furniture and fixtures 4,100 4,064 Construction in progress 10,453 11,124 133,705 129,294 Accumulated depreciation (84,423) (69,881) $ 49,282 $ 59,413 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | June 30, December 31, 2023 2022 Payroll and related benefits $ 11,028 $ 14,103 Professional fees 7,038 4,685 Sales tax payable 1,321 1,519 Other 4,424 5,455 $ 23,811 $ 25,762 |
Termination Benefits (Tables)
Termination Benefits (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Termination Benefits [Abstract] | |
Summary of One-Time Termination Benefits | The expense included in the Company's consolidated statements of operations are as follows: Three Months Ended June 30, 2023 Six months ended June 30, 2023 Cost of products and services sold $ 334 $ 369 Research and development — 566 Sales and marketing 95 1,543 General and administrative 201 787 Total $ 629 $ 3,264 |
Revenues (Tables)
Revenues (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenue by Product and Geographic Area | Revenues by product line . The following table represents total net revenues by product line: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 COVID-19 (1) $ 47,507 $ 43,378 $ 165,916 $ 74,411 HIV 15,964 10,357 29,868 18,523 Molecular Products (2) 13,050 17,581 25,992 35,514 HCV 3,870 3,691 7,056 6,948 Risk assessment testing 2,358 2,630 4,986 5,191 Molecular Services 1,354 1,204 2,733 2,938 Other product and service revenues 635 326 1,101 878 Net product and services revenues 84,738 79,167 237,652 144,403 Other non-product revenues (3) 703 1,064 2,752 3,535 Net revenues $ 85,441 $ 80,231 $ 240,404 $ 147,938 (1) Includes COVID-19 Diagnostics and COVID-19 Molecular Products. (2) Includes Genomics and Microbiome and Novosanis Products. (3) Other non-product and services revenues include 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: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 United States $ 73,871 $ 70,320 $ 218,890 $ 128,307 Europe 2,453 2,436 4,305 6,722 Other regions 9,117 7,475 17,209 12,909 $ 85,441 $ 80,231 $ 240,404 $ 147,938 |
Income Taxes (Tables)
Income Taxes (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) | The components of income tax expense (benefits) are as follows: Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 State income tax expense (benefit) $ 1,481 $ 183 $ 1,257 $ 400 Foreign income tax expense (benefit) (1,648) (1,352) (1,648) 665 Foreign withholding tax — — — 1,702 $ (166) $ (1,169) $ (391) $ 2,767 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Equity [Abstract] | |
Summary of Reconciliation of Changes in Stockholder's Equity | Common Stock Additional Accumulated Accumulated Total Shares Amount Balance at December 31, 2022 72,734 $ — $ 520,446 $ (18,435) $ (137,586) $ 364,425 Common stock issued upon exercise of options 12 — 66 — — 66 Vesting of restricted stock and performance stock units 737 — — — — — Purchase and retirement of common shares (229) — (1,203) — — (1,203) Stock-based compensation — — 2,655 — — 2,655 Net income — — — — 27,219 27,219 Currency translation adjustments — — — 797 — 797 Unrealized gain on marketable securities — — — 220 — 220 Balance at March 31, 2023 73,254 $ — $ 521,964 $ (17,418) $ (110,367) $ 394,179 Vesting of restricted stock and performance stock units 241 — — — — — Purchase and retirement of common shares (82) — (460) — — (460) Stock-based compensation — — 2,357 — — 2,357 Net loss — — — — (4,796) (4,796) Currency translation adjustments — — — 2,859 — 2,859 Balance at June 30, 2023 73,413 $ — $ 523,861 $ (14,559) $ (115,163) $ 394,139 Common Stock Additional Accumulated Accumulated Total Shares Amount Balance at December 31, 2021 72,069 $ — $ 511,063 $ (10,077) $ (120,453) $ 380,533 Common stock issued upon exercise of options 2 — 15 — — 15 Vesting of restricted stock and performance stock units 352 — — — — — Purchase and retirement of common shares (116) — (1,049) — — (1,049) Stock-based compensation — — 3,524 — — 3,524 Net loss — — — — (19,940) (19,940) Currency translation adjustments — — — 1,756 — 1,756 Unrealized gain on marketable securities — — — 74 — 74 Balance at March 31, 2022 72,307 $ — $ 513,553 $ (8,247) $ (140,393) $ 364,913 Common stock issued upon exercise of options 407 — — — — — Vesting of restricted stock and performance stock units (142) — (905) — — (905) Stock-based compensation — — 3,280 — — 3,280 Net loss — — — — (18,589) (18,589) Currency translation adjustments — — — (4,349) — (4,349) Unrealized gain on marketable securities — — — 82 — 82 Balance at June 30, 2022 72,572 $ — $ 515,928 $ (12,514) $ (158,982) $ 344,432 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Summary of Available-for-sale Securities (Detail) $ in Thousands | Dec. 31, 2022 USD ($) |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | $ 27,087 |
Gross Unrealized Gains | 0 |
Gross Unrealized Losses | (220) |
Fair Value | 26,867 |
Guaranteed Investment Certificates | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 22,109 |
Gross Unrealized Gains | 0 |
Gross Unrealized Losses | 0 |
Fair Value | 22,109 |
Corporate Bonds | |
Schedule of Available-for-sale Securities [Line Items] | |
Amortized Cost | 4,978 |
Gross Unrealized Gains | 0 |
Gross Unrealized Losses | (220) |
Fair Value | $ 4,758 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Cash and cash equivalents | $ 185,936,000 | $ 185,936,000 | $ 83,980,000 | ||
Fair value of plan assets | 644,000 | 644,000 | 747,000 | ||
Net foreign exchange gains (losses) | (492,000) | $ 783,000 | (542,000) | $ 54,000 | |
Reduced inventories | 22,556,000 | (18,179,000) | 528,000 | ||
Reduced accounts payable | 22,187,000 | (11,485,000) | 1,329,000 | ||
Reduced cost of products and services sold | 213,000 | 240,000 | 801,000 | ||
COST OF PRODUCTS AND SERVICES SOLD | 59,070,000 | 52,434,000 | 148,218,000 | 95,842,000 | |
Service Life | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
COST OF PRODUCTS AND SERVICES SOLD | 6,900,000 | ||||
Research and Development Expenses and Other Income | Government Contract | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Reimbursement of engineering cost | 537,000 | $ 395,000 | 1,588,000 | $ 616,000 | |
Money Market Fund | Level I Instruments | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Cash and cash equivalents | 6,928,000 | 6,928,000 | $ 1,730,000 | ||
Guaranteed Investment Certificates | Level I Instruments | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Cash and cash equivalents | $ 22,642,000 | $ 22,642,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Changes in Accumulated Other Comprehensive Loss by Component (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2023 USD ($) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |
Beginning balance | $ (18,435) |
Other comprehensive gain | 3,876 |
Ending balance | (14,559) |
Foreign Currency | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |
Beginning balance | (18,215) |
Other comprehensive gain | 3,656 |
Ending balance | (14,559) |
Marketable Securities | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |
Beginning balance | (220) |
Other comprehensive gain | 220 |
Ending balance | $ 0 |
Government Capital Contracts -
Government Capital Contracts - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 18 Months Ended | |||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Sep. 30, 2021 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Government capital contracts funding amount | $ 109,000 | |||||
Percentage withheld under government contracts subject to validation testing | 15% | 15% | 15% | |||
Proceeds from funding under government contract | $ 17,793 | $ 33,962 | $ 78,124 | |||
Remaining expected funding under government grant | 30,876 | |||||
Net revenues | $ 85,441 | $ 80,231 | 240,404 | 147,938 | ||
Research and Development Expenses and Other Income | Government Contract | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Reimbursement of engineering cost | 537 | 395 | 1,588 | 616 | ||
Other | Government Contract | ||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||
Net revenues | $ 561 | $ 561 | $ 1,123 | $ 1,123 |
Government Capital Contracts _2
Government Capital Contracts - Summary of Government Contracts Balances Included in Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Other current assets: | ||
Total other current assets | $ 24,349 | $ 41,569 |
Accrued expenses and other current liabilities | 23,811 | 25,762 |
Government Contract | ||
Other current assets: | ||
Billed receivables | 0 | 0 |
Unbilled receivables | 15,429 | 27,013 |
Total other current assets | 15,429 | 27,013 |
Accrued expenses and other current liabilities | $ (118) | $ (318) |
Government Capital Contracts _3
Government Capital Contracts - Summary of Government Contracts Balances Included in Consolidated Statements of Cash flows (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Cost of assets, cumulative | $ 133,705 | $ 129,294 |
Total property, plant and equipment, net | 49,282 | 59,413 |
Government Contract | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Cost of assets, cumulative | 87,057 | 83,359 |
Reduction for funding earned to date, not yet received | (8,402) | (22,497) |
Reduction for funding received to date | (78,655) | (60,862) |
Total property, plant and equipment, net | $ 0 | $ 0 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Inventory, Net [Abstract] | ||
Raw materials | $ 29,647 | $ 42,445 |
Work in process | 1,885 | 2,335 |
Finished goods | 41,752 | 50,924 |
Inventories | $ 73,284 | $ 95,704 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | $ 133,705 | $ 129,294 |
Accumulated depreciation | (84,423) | (69,881) |
Total property, plant and equipment, net | 49,282 | 59,413 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 1,118 | 1,118 |
Buildings and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 35,765 | 35,582 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 65,204 | 60,725 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 17,065 | 16,681 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 4,100 | 4,064 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | $ 10,453 | $ 11,124 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Loss on impairments | $ 215,000 | $ 10,542,000 | $ 1,320,000 | $ 10,542,000 |
Estimated fair value on manufacturing equipment and various market data points | $ 0 | $ 0 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Payroll and related benefits | $ 11,028 | $ 14,103 |
Professional fees | 7,038 | 4,685 |
Sales tax payable | 1,321 | 1,519 |
Other | 4,424 | 5,455 |
Accrued expenses and other current liabilities | $ 23,811 | $ 25,762 |
Termination Benefits - Addition
Termination Benefits - Additional Information (Details) $ in Thousands | Jun. 30, 2023 USD ($) |
Termination Benefits [Abstract] | |
Accrued reduction in workforce | $ 1,591 |
Payment of reduction in workforce | $ 1,674 |
Termination Benefits - Summary
Termination Benefits - Summary of One-Time Termination Benefits (Details) - One-time Termination Benefits - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2023 | Jun. 30, 2023 | |
Termination Benefits [Line Items] | ||
Termination benefits | $ 629 | $ 3,264 |
Cost of products and services sold | ||
Termination Benefits [Line Items] | ||
Termination benefits | 334 | 369 |
Research and development | ||
Termination Benefits [Line Items] | ||
Termination benefits | 0 | 566 |
Sales and marketing | ||
Termination Benefits [Line Items] | ||
Termination benefits | 95 | 1,543 |
General and administrative | ||
Termination Benefits [Line Items] | ||
Termination benefits | $ 201 | $ 787 |
Revenues - Summary of Total Net
Revenues - Summary of Total Net Revenues by Product Line (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | $ 85,441 | $ 80,231 | $ 240,404 | $ 147,938 |
Product and Services Revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 84,738 | 79,167 | 237,652 | 144,403 |
Product and Services Revenues | COVID-19 | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 47,507 | 43,378 | 165,916 | 74,411 |
Product and Services Revenues | HIV | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 15,964 | 10,357 | 29,868 | 18,523 |
Product and Services Revenues | Molecular Products | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 13,050 | 17,581 | 25,992 | 35,514 |
Product and Services Revenues | HCV | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 3,870 | 3,691 | 7,056 | 6,948 |
Product and Services Revenues | Risk assessment testing | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 2,358 | 2,630 | 4,986 | 5,191 |
Product and Services Revenues | Molecular Services | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 1,354 | 1,204 | 2,733 | 2,938 |
Product and Services Revenues | Other product and service revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 635 | 326 | 1,101 | 878 |
Other | Other Non Product Revenues | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | $ 703 | $ 1,064 | $ 2,752 | $ 3,535 |
Revenues - Summary of Total N_2
Revenues - Summary of Total Net Revenues by Geographic Area (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | $ 85,441 | $ 80,231 | $ 240,404 | $ 147,938 |
United States | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 73,871 | 70,320 | 218,890 | 128,307 |
Europe | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | 2,453 | 2,436 | 4,305 | 6,722 |
Other regions | ||||
Disaggregation Of Revenue [Line Items] | ||||
Net revenues | $ 9,117 | $ 7,475 | $ 17,209 | $ 12,909 |
Revenues - Additional Informati
Revenues - Additional Information (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 USD ($) customer | Jun. 30, 2022 | Jun. 30, 2023 USD ($) customer | Jun. 30, 2022 | Dec. 31, 2022 USD ($) customer | |
Revenue from contract with customer [Line Items] | |||||
Deferred revenue | $ 1,841 | $ 1,841 | $ 2,273 | ||
Up-Front Payment | |||||
Revenue from contract with customer [Line Items] | |||||
Deferred revenue | 1,285 | 1,285 | 1,533 | ||
Long-term Contract | |||||
Revenue from contract with customer [Line Items] | |||||
Deferred revenue | $ 556 | $ 556 | $ 740 | ||
Customer One | Accounts Receivable | Customer Concentration Risk | |||||
Revenue from contract with customer [Line Items] | |||||
Number of customers | customer | 1 | 1 | 1 | ||
Percentage of concentration risk | 47% | ||||
Customer One | Accounts Receivable | Customer Concentration Risk | Maximum | |||||
Revenue from contract with customer [Line Items] | |||||
Percentage of concentration risk | 57% | ||||
Customer One | Net Consolidated Revenue | Customer Concentration Risk | |||||
Revenue from contract with customer [Line Items] | |||||
Percentage of concentration risk | 56% | 56% | 70% | 39% |
Income Taxes - Summary Of Incom
Income Taxes - Summary Of Income Tax Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
State income tax expense (benefit) | $ 1,481 | $ 183 | $ 1,257 | $ 400 |
Foreign income tax expense (benefit) | (1,648) | (1,352) | (1,648) | 665 |
Foreign withholding tax | 0 | 0 | 0 | 1,702 |
Income tax expense (benefit) | $ (166) | $ (1,169) | $ (391) | $ 2,767 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Foreign withholding tax | $ 0 | $ 0 | $ 0 | $ 1,702 |
Foreign earnings repatriated | $ 65 |
Income (Loss) Per Share - Addit
Income (Loss) Per Share - Additional Information (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Common Stock Options Unvested Restricted Stock and Unvested Performance Stock Units | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Number of anti-dilutive securities excluded from EPS computation | 966,000 | 226,000 | 2,030 | 381 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Reconciliation of Changes in Stockholders' Equity (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Beginning Balance | $ 394,179 | $ 364,425 | $ 364,913 | $ 380,533 | $ 364,425 | $ 380,533 |
Common stock issued upon exercise of options | 66 | 0 | 15 | |||
Vesting of restricted stock and performance stock units | (905) | |||||
Purchase and retirement of common shares | (460) | (1,203) | (1,049) | |||
Stock-based compensation | 2,357 | 2,655 | 3,280 | 3,524 | ||
Net income | (4,796) | 27,219 | (18,589) | (19,940) | 22,423 | (38,529) |
Currency translation adjustments | 2,859 | 797 | (4,349) | 1,756 | 3,656 | (2,593) |
Unrealized gain on marketable securities | 0 | 220 | 82 | 74 | 220 | 156 |
Ending Balance | $ 394,139 | $ 394,179 | $ 344,432 | $ 364,913 | $ 394,139 | $ 344,432 |
Common Stock | ||||||
Beginning balance (in shares) | 73,254,000 | 72,734,000 | 72,307,000 | 72,069,000 | 72,734,000 | 72,069,000 |
Common stock issued upon exercise of options (in shares) | 12,000 | 407,000 | 2,000 | |||
Vesting of restricted stock and performance stock units (in shares) | (241,000) | (737,000) | (142,000) | (352,000) | ||
Purchase and retirement of common shares (in shares) | (82,000) | (229,000) | (116,000) | |||
Ending balance (in shares) | 73,413,000 | 73,254,000 | 72,572,000 | 72,307,000 | 73,413,000 | 72,572,000 |
Additional Paid-in Capital | ||||||
Beginning Balance | $ 521,964 | $ 520,446 | $ 513,553 | $ 511,063 | $ 520,446 | $ 511,063 |
Common stock issued upon exercise of options | 66 | 15 | ||||
Vesting of restricted stock and performance stock units | (905) | |||||
Purchase and retirement of common shares | (460) | (1,203) | (1,049) | |||
Stock-based compensation | 2,357 | 2,655 | 3,280 | 3,524 | ||
Ending Balance | 523,861 | 521,964 | 515,928 | 513,553 | 523,861 | 515,928 |
Accumulated Other Comprehensive Loss | ||||||
Beginning Balance | (17,418) | (18,435) | (8,247) | (10,077) | (18,435) | (10,077) |
Currency translation adjustments | 2,859 | 797 | (4,349) | 1,756 | ||
Unrealized gain on marketable securities | 220 | 82 | 74 | |||
Ending Balance | (14,559) | (17,418) | (12,514) | (8,247) | (14,559) | (12,514) |
Accumulated Deficit | ||||||
Beginning Balance | (110,367) | (137,586) | (140,393) | (120,453) | (137,586) | (120,453) |
Net income | 27,219 | (19,940) | ||||
Ending Balance | $ (115,163) | $ (110,367) | $ (158,982) | $ (140,393) | $ (115,163) | $ (158,982) |
Business Segments - Additional
Business Segments - Additional Information (Detail) - Segment | 1 Months Ended | 6 Months Ended |
Feb. 28, 2023 | Jun. 30, 2023 | |
Segment Reporting [Abstract] | ||
Number of operating segments | 1 | |
Number of reportable segments | 1 |