Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 03, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | OSUR | |
Entity Registrant Name | ORASURE TECHNOLOGIES, INC | |
Entity Central Index Key | 0001116463 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Shell Company | false | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Title of 12(b) Security | Common Stock, $0.000001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity File Number | 001-16537 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 36-4370966 | |
Entity Address, Address Line One | 220 East First Street | |
Entity Address, City or Town | Bethlehem | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 18015 | |
City Area Code | 610 | |
Local Phone Number | 882-1820 | |
Entity Common Stock, Shares Outstanding | 73,262,370 | |
Document Quarterly Report | true | |
Document Transition Report | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 90,194 | $ 83,980 |
Short-term investments | 22,178 | 26,867 |
Accounts receivable, net of allowance of $2,297 and $2,365 | 107,445 | 70,797 |
Inventories | 77,189 | 95,704 |
Prepaid expenses | 6,161 | 6,273 |
Other current assets | 40,428 | 41,569 |
Total current assets | 343,595 | 325,190 |
Noncurrent Assets: | ||
Property, plant and equipment, net of accumulated depreciation of $72,400 and $69,881 | 57,343 | 59,413 |
Operating right-of-use assets, net | 9,922 | 10,399 |
Finance right-of-use assets, net | 1,136 | 1,293 |
Intangible assets, net of accumulated amortization of $31,732 and $31,077 | 11,184 | 11,694 |
Goodwill | 35,204 | 35,104 |
Other noncurrent assets | 1,031 | 1,087 |
Total noncurrent assets | 115,820 | 118,990 |
TOTAL ASSETS | 459,415 | 444,180 |
Current Liabilities: | ||
Accounts payable | 27,396 | 38,020 |
Deferred revenue | 1,989 | 2,273 |
Accrued expenses and other current liabilities | 22,673 | 25,762 |
Finance lease liability | 1,229 | 1,179 |
Operating lease liability | 1,761 | 1,764 |
Acquisition-related contingent consideration obligation | 75 | 65 |
Total current liabilities | 55,123 | 69,063 |
Noncurrent Liabilities: | ||
Finance lease liability | 472 | 503 |
Operating lease liability | 8,623 | 9,101 |
Acquisition-related contingent consideration obligation | 0 | 99 |
Other noncurrent liabilities | 609 | 581 |
Deferred income taxes | 409 | 408 |
Total noncurrent liabilities | 10,113 | 10,692 |
TOTAL LIABILITIES | 65,236 | 79,755 |
Commitments and contingencies (Note 12) | ||
STOCKHOLDERS' EQUITY | ||
Preferred stock, par value $.000001, 25,000 shares authorized, none issued | ||
Common stock, par value $.000001, 120,000 shares authorized, 73,254 and 72,734 shares issued and outstanding | 0 | 0 |
Additional paid-in capital | 521,964 | 520,446 |
Accumulated other comprehensive loss | (17,418) | (18,435) |
Accumulated deficit | (110,367) | (137,586) |
Total stockholders' equity | 394,179 | 364,425 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 459,415 | $ 444,180 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Allowance for doubtful accounts | $ 2,297 | $ 2,365 |
Accumulated depreciation of property and equipment | 72,400 | 69,881 |
Accumulated amortization of intangible assets | $ 31,732 | $ 31,077 |
Preferred stock, par value | $ 0.000001 | $ 0.000001 |
Preferred stock, shares authorized | 25,000,000 | 25,000,000 |
Preferred stock, shares issued | 0 | 0 |
Common stock, par value | $ 0.000001 | $ 0.000001 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares issued | 73,254,000 | 72,734,000 |
Common stock, shares outstanding | 73,254,000 | 72,734,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
NET REVENUES: | ||
Total revenue | $ 154,963 | $ 67,707 |
COST OF PRODUCTS AND SERVICES SOLD | 89,148 | 43,408 |
Gross profit | 65,815 | 24,299 |
OPERATING EXPENSES: | ||
Research and development | 10,560 | 8,634 |
Sales and marketing | 12,142 | 12,717 |
General and administrative | 17,711 | 19,156 |
Loss on impairments | 1,105 | |
Change in the estimated fair value of acquisition-related contingent consideration | (24) | (36) |
Total operating expenses | 41,494 | 40,471 |
Operating income (loss) | 24,321 | (16,172) |
OTHER INCOME | 2,673 | 168 |
Income (loss) before income taxes | 26,994 | (16,004) |
INCOME TAX (BENEFIT) EXPENSE | (225) | 3,936 |
NET INCOME (LOSS) | $ 27,219 | $ (19,940) |
INCOME (LOSS) PER SHARE: | ||
BASIC | $ 0.37 | $ (0.28) |
DILUTED | $ 0.37 | $ (0.28) |
WEIGHTED-AVERAGE SHARES OUTSTANDING: | ||
BASIC | 73,112 | 72,194 |
DILUTED | 73,966 | 72,194 |
Products and Services [Member] | ||
NET REVENUES: | ||
Total revenue | $ 152,914 | $ 65,236 |
Other Revenues [Member] | ||
NET REVENUES: | ||
Total revenue | $ 2,049 | $ 2,471 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
NET INCOME (LOSS) | $ 27,219 | $ (19,940) |
OTHER COMPREHENSIVE INCOME | ||
Currency translation adjustments | 797 | 1,756 |
Unrealized gain on marketable securities | 220 | 74 |
COMPREHENSIVE INCOME (LOSS) | $ 28,236 | $ (18,110) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
OPERATING ACTIVITIES: | ||||
Net income (loss) | $ 27,219 | $ (19,940) | ||
Adjustments to reconcile net income (loss) to net cash (used in) provided by operating activities: | ||||
Stock-based compensation | 2,655 | 3,524 | ||
Depreciation and amortization | 3,696 | 3,682 | ||
Loss on impairments | 1,105 | |||
Other non-cash amortization | 80 | |||
Provision for credit losses | (67) | 347 | ||
Unrealized foreign currency loss | 44 | 169 | ||
Interest expense on finance leases | 15 | 32 | ||
Deferred income taxes | 200 | |||
Loss on sale of fixed assets | 710 | |||
Change in the estimated fair value of acquisition-related contingent consideration | (24) | (36) | ||
Payment of acquisition-related contingent consideration | (19) | |||
Changes in assets and liabilities | ||||
Accounts receivable | (36,613) | (15,295) | ||
Inventories | 18,540 | (8,198) | $ 528 | |
Prepaid expenses and other assets | 5,299 | (736) | ||
Accounts payable | (12,097) | 4,287 | (1,329) | |
Deferred revenue | (279) | (44) | ||
Accrued expenses and other liabilities | (3,472) | (4,603) | ||
Net cash provided by (used in) operating activities | 6,002 | (35,821) | ||
INVESTING ACTIVITIES: | ||||
Purchases of investments | (22,330) | |||
Proceeds from maturities and redemptions of investments | 27,304 | 12,135 | ||
Purchases of property and equipment | (1,191) | (20,219) | ||
Purchase of property and equipment under government contracts | (2,767) | (28,188) | ||
Proceeds from funding under government contract | $ 60,862 | 26,333 | ||
Net cash provided by (used in) investing activities | 1,016 | (9,939) | ||
FINANCING ACTIVITIES: | ||||
Cash payments for lease liabilities | (148) | (153) | ||
Proceeds from exercise of stock options | 66 | 15 | ||
Payment of acquisition-related contingent consideration | (46) | (208) | ||
Repurchase of common stock | (1,203) | (1,049) | ||
Net cash used in financing activities | (1,331) | (1,395) | ||
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH | 527 | 1,114 | ||
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 6,214 | (46,041) | ||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 83,980 | 116,762 | 116,762 | |
CASH AND CASH EQUIVALENTS, END OF PERIOD | $ 90,194 | 90,194 | 70,721 | $ 83,980 |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||
Cash paid for income taxes | (10) | 3,570 | ||
Non-cash investing activities | ||||
Accrued property and equipment purchases | $ 733 | 642 | ||
Accrued property and equipment purchases under government contracts | $ 1,905 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 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”), 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 months ended March 31, 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. 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 March 31, 2023 Guaranteed investment certificates $ 22,178 $ — $ — $ 22,178 Corporate bonds — — — — Total $ 22,178 $ — $ — $ 22,178 December 31, 2022 Guaranteed investment certificates $ 22,109 $ — $ — $ 22,109 Corporate bonds 4,978 — ( 220 ) 4,758 Total $ 27,087 $ — $ ( 220 ) $ 26,867 At March 31, 2023, maturities of the Company's available-for-sale securities were as follows: Less than one year $ 22,178 $ — $ — $ 22,178 Greater than one year $ — $ — $ — $ — Fair Value of Financial Instruments . As of March 31, 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 as of December 31, 2022. The Company's available-for-sale guaranteed investment certificates are measured as Level 1 instruments as of March 31, 2023 and December 31, 2022. Included in cash and cash equivalents at March 31, 2023 and December 31, 2022, was $ 6,846 and $ 1,730 invested in money market funds. These money market funds have investments in 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 March 31, 2023 and December 31, 2022 was $ 678 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 $( 50 ) and $ 729 for the three months ended March 31, 2023 and 2022 , 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 797 220 1,017 Balance at March 31, 2023 $ ( 17,418 ) $ 0 $ ( 17,418 ) 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 months ended March 31, 2022, cost of products and services sold was reduced by $ 27 . The respective operating activities on the consolidated statement of cash flows for the three months ended March 31, 2022 has also been adjusted. Furthermore, stockholder's equity at March 31, 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 months ended March 31, 2022, $ 221 of research and development expenses were reclassed 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. |
Government Capital Contracts
Government Capital Contracts | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Government Capital Contracts | 2. Government Capital Contracts In September 2021, the Company entered into an agreement fo r $ 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 $ 60,862 , as of March 31, 2023. The remaining $ 48,138 is expected to be collected during 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. 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 March 31, 2023 and 2022, $ 1,051 and $ 221 , respectively, were recorded in research and development and other income. Amounts earned in excess of the Company's expected costs for the project for project management are recognized straight-line in other income over the term of the government contract. 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 March 31, 2023 and 2022. The balances corresponding to government contracts included in the Company's consolidated balance sheet are as follows: March 31, December 31, Other current assets: Billed receivables $ 17,792 $ — Unbilled receivables 13,604 27,013 Total other current assets 31,396 27,013 Accrued expenses and other current liabilities $ ( 679 ) $ ( 318 ) The activity corresponding to the government contracts included in the Company's consolidated statements of cash flows is as follows: March 31, December 31, Cost of assets, cumulative $ 86,126 $ 83,359 Reduction for funding earned to date, not yet received ( 25,264 ) ( 22,497 ) Reduction for funding received to date ( 60,862 ) ( 60,862 ) Total property, plant and equipment, net $ — $ — |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories | 3. Inventories March 31, December 31, 2023 2022 Raw materials $ 35,607 $ 42,445 Work in process 2,182 2,335 Finished goods 39,400 50,924 $ 77,189 $ 95,704 |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment, Net | 4. Property, Plant and Equipment, net March 31, December 31, 2023 2022 Land $ 1,118 $ 1,118 Buildings and improvements 35,626 35,582 Machinery and equipment 61,827 60,725 Computer equipment and software 16,917 16,681 Furniture and fixtures 4,068 4,064 Construction in progress 10,187 11,124 129,743 129,294 Accumulated depreciation ( 72,400 ) ( 69,881 ) $ 57,343 $ 59,413 During the three months ended March 31, 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. As a result of this decision, the Company determined that the carrying values of the equipment is not recoverable and recorded an aggregate pre-tax asset impairment charge of $ 1,105 during the three months ended March 31, 2023 . This charge is reported within loss on impairments in the consolidated statement of operations. The Company estimated the fair value of the impaired long-lived assets using a market approach, which required the Company to estimate the value that would be received for the equipment in the principal or most advantageous market for that equipment in an orderly transaction between market participants. Due to the extremely specialized nature of the manufacturing equipment and various market data points, the estimated fair value was zero . |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and other current liabilities March 31, December 31, 2023 2022 Payroll and related benefits $ 7,989 $ 14,103 Professional fees 7,981 4,685 Sales tax payable 1,512 1,519 Other 5,191 5,455 $ 22,673 $ 25,762 |
Termination Benefits
Termination Benefits | 3 Months Ended |
Mar. 31, 2023 | |
Termination Benefits [Abstract] | |
Termination Benefits | 6. Termination Benefits On February 14, 2023, the Company announced a reduction in its non-production 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 March 31, 2023 Cost of products and services sold $ 35 Research and development 566 Sales and marketing 1,448 General and administrative 586 Total $ 2,635 As of March 31, 2023, the Company had $ 1,894 accrued and had paid $ 741 related to the reduction in workforce. |
Revenues
Revenues | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenues | 7. Revenues Revenues by product line . The following table represents total net revenues by product line: Three Months Ended March 31, 2023 2022 COVID-19 (1) $ 118,409 $ 31,032 HIV 13,904 8,166 Molecular Products (2) 12,942 17,933 HCV 3,186 3,257 Risk assessment testing 2,628 2,560 Molecular Services 1,379 1,733 Other product and service revenues 466 555 Net product and services revenues 152,914 65,236 Other non-product revenues (3) 2,049 2,471 Net revenues $ 154,963 $ 67,707 (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 March 31, 2023 2022 United States $ 145,019 $ 57,987 Europe 1,852 4,286 Other regions 8,092 5,434 $ 154,963 $ 67,707 Customer and Vendor Concentrations . At March 31, 2023 , one non-commercial customer accounted for 77 % 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 78 % and 18 % of net consolidated revenues for the three months ended March 31, 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 March 31, 2023 and December 31, 2022 included customer prepayments of $ 1,358 and $ 1,180 , respectively. Deferred revenue as of March 31, 2023 and December 31, 2022 also included $ 631 and $ 1,093 , 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 | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes During the three months ended March 31, 2023 and 2022, the Company recorded income tax expense (benefit) of $( 225 ) and $ 3,936 , respectively. Income taxes for 2023 is comprised of a U.S. state tax benefit. Income taxes for the first quarter of 2022 are primarily comprised of Canadian withholding tax on the repatriation of $ 65,000 of unremitted earnings from Canada to the United States with the remainder of tax primarily consisted of foreign tax expense. The decline in foreign tax expense 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 liability as of March 31, 2023 and 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 the 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 March 31, 2023 and December 31, 2022. |
Earnings (Loss) Per Share
Earnings (Loss) Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Income (Loss) Per Share | 9. 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 March 31, 2022 , outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 463 shares, were excluded from the computation of diluted loss per share. For the three months ended March 31, 2023, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 2,237 shares were excluded from the computation of dilute earnings per share as their inclusion would have been anti-dilutive. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | . Stockholders’ Equity Reconciliation of the changes in stockholder's equity for the three months ended March 31, 2023 and 2022. Common Stock Additional Accumulated Accumulated Shares Amount Capital Loss Deficit Total Balance at December 31, 2022 72,734 $ — $ 520,446 $ ( 18,435 ) $ ( 137,586 ) $ 364,425 Common stock issued upon exercise 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 Balance at December 31, 2021 72,069 $ 511,063 $ ( 10,077 ) $ ( 120,453 ) $ 380,533 Common stock issued upon exercise 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 |
Business Segments
Business Segments | 3 Months Ended |
Mar. 31, 2023 | |
Segment Reporting [Abstract] | |
Business Segments | 11. Business Segments The 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 | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 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. In March 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. On May 2, 2023, the District Court issued two orders. 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 intends to appeal the Court’s grant of summary judgment. Second, the Court denied Spectrum’s motion to supplement its allegations of alleged antitrust violations. A separate motion by Spectrum to amend its counterclaims remains pending. An inter partes review is currently pending before the PTO regarding the second asserted patent. The final pretrial conference in the District Court is set for October 26, 2023. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 13. Subsequent Events In May 2023, the Company announced a reduction in its workforce and estimates the expense will be in the range of $ 500 to $ 600 . This will be accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 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 months ended March 31, 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. |
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. 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 March 31, 2023 Guaranteed investment certificates $ 22,178 $ — $ — $ 22,178 Corporate bonds — — — — Total $ 22,178 $ — $ — $ 22,178 December 31, 2022 Guaranteed investment certificates $ 22,109 $ — $ — $ 22,109 Corporate bonds 4,978 — ( 220 ) 4,758 Total $ 27,087 $ — $ ( 220 ) $ 26,867 At March 31, 2023, maturities of the Company's available-for-sale securities were as follows: Less than one year $ 22,178 $ — $ — $ 22,178 Greater than one year $ — $ — $ — $ — |
Fair Value of Financial Instruments | Fair Value of Financial Instruments . As of March 31, 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 as of December 31, 2022. The Company's available-for-sale guaranteed investment certificates are measured as Level 1 instruments as of March 31, 2023 and December 31, 2022. Included in cash and cash equivalents at March 31, 2023 and December 31, 2022, was $ 6,846 and $ 1,730 invested in money market funds. These money market funds have investments in 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 March 31, 2023 and December 31, 2022 was $ 678 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 $( 50 ) and $ 729 for the three months ended March 31, 2023 and 2022 , 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 797 220 1,017 Balance at March 31, 2023 $ ( 17,418 ) $ 0 $ ( 17,418 ) |
Revenues by Product Line | Revenues by product line . The following table represents total net revenues by product line: Three Months Ended March 31, 2023 2022 COVID-19 (1) $ 118,409 $ 31,032 HIV 13,904 8,166 Molecular Products (2) 12,942 17,933 HCV 3,186 3,257 Risk assessment testing 2,628 2,560 Molecular Services 1,379 1,733 Other product and service revenues 466 555 Net product and services revenues 152,914 65,236 Other non-product revenues (3) 2,049 2,471 Net revenues $ 154,963 $ 67,707 (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 | Revenues by geographic area . The following table represents total net revenues by geographic area, based on the location of the customer: Three Months Ended March 31, 2023 2022 United States $ 145,019 $ 57,987 Europe 1,852 4,286 Other regions 8,092 5,434 $ 154,963 $ 67,707 |
Customer and Vendor Concentrations | Customer and Vendor Concentrations . At March 31, 2023 , one non-commercial customer accounted for 77 % 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 78 % and 18 % of net consolidated revenues for the three months ended March 31, 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 | Deferred Revenue . The Company records deferred revenue when funds are received prior to the recognition of the associated revenue. Deferred revenue as of March 31, 2023 and December 31, 2022 included customer prepayments of $ 1,358 and $ 1,180 , respectively. Deferred revenue as of March 31, 2023 and December 31, 2022 also included $ 631 and $ 1,093 , 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. |
Reclassifications and Immaterial Correction of Errors | 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 months ended March 31, 2022, cost of products and services sold was reduced by $ 27 . The respective operating activities on the consolidated statement of cash flows for the three months ended March 31, 2022 has also been adjusted. Furthermore, stockholder's equity at March 31, 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 months ended March 31, 2022, $ 221 of research and development expenses were reclassed 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. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2023 Guaranteed investment certificates $ 22,178 $ — $ — $ 22,178 Corporate bonds — — — — Total $ 22,178 $ — $ — $ 22,178 December 31, 2022 Guaranteed investment certificates $ 22,109 $ — $ — $ 22,109 Corporate bonds 4,978 — ( 220 ) 4,758 Total $ 27,087 $ — $ ( 220 ) $ 26,867 At March 31, 2023, maturities of the Company's available-for-sale securities were as follows: Less than one year $ 22,178 $ — $ — $ 22,178 Greater than one year $ — $ — $ — $ — |
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 797 220 1,017 Balance at March 31, 2023 $ ( 17,418 ) $ 0 $ ( 17,418 ) |
Government Capital Contracts (T
Government Capital Contracts (Tables) | 3 Months Ended |
Mar. 31, 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: March 31, December 31, Other current assets: Billed receivables $ 17,792 $ — Unbilled receivables 13,604 27,013 Total other current assets 31,396 27,013 Accrued expenses and other current liabilities $ ( 679 ) $ ( 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: March 31, December 31, Cost of assets, cumulative $ 86,126 $ 83,359 Reduction for funding earned to date, not yet received ( 25,264 ) ( 22,497 ) Reduction for funding received to date ( 60,862 ) ( 60,862 ) Total property, plant and equipment, net $ — $ — |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | March 31, December 31, 2023 2022 Raw materials $ 35,607 $ 42,445 Work in process 2,182 2,335 Finished goods 39,400 50,924 $ 77,189 $ 95,704 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment, Net | March 31, December 31, 2023 2022 Land $ 1,118 $ 1,118 Buildings and improvements 35,626 35,582 Machinery and equipment 61,827 60,725 Computer equipment and software 16,917 16,681 Furniture and fixtures 4,068 4,064 Construction in progress 10,187 11,124 129,743 129,294 Accumulated depreciation ( 72,400 ) ( 69,881 ) $ 57,343 $ 59,413 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | March 31, December 31, 2023 2022 Payroll and related benefits $ 7,989 $ 14,103 Professional fees 7,981 4,685 Sales tax payable 1,512 1,519 Other 5,191 5,455 $ 22,673 $ 25,762 |
Termination Benefits (Tables)
Termination Benefits (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2023 Cost of products and services sold $ 35 Research and development 566 Sales and marketing 1,448 General and administrative 586 Total $ 2,635 |
Revenues (Tables)
Revenues (Tables) | 3 Months Ended |
Mar. 31, 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 March 31, 2023 2022 COVID-19 (1) $ 118,409 $ 31,032 HIV 13,904 8,166 Molecular Products (2) 12,942 17,933 HCV 3,186 3,257 Risk assessment testing 2,628 2,560 Molecular Services 1,379 1,733 Other product and service revenues 466 555 Net product and services revenues 152,914 65,236 Other non-product revenues (3) 2,049 2,471 Net revenues $ 154,963 $ 67,707 (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 March 31, 2023 2022 United States $ 145,019 $ 57,987 Europe 1,852 4,286 Other regions 8,092 5,434 $ 154,963 $ 67,707 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Summary of Reconciliation of Changes in Stockholder's Equity | Reconciliation of the changes in stockholder's equity for the three months ended March 31, 2023 and 2022. Common Stock Additional Accumulated Accumulated Shares Amount Capital Loss Deficit Total Balance at December 31, 2022 72,734 $ — $ 520,446 $ ( 18,435 ) $ ( 137,586 ) $ 364,425 Common stock issued upon exercise 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 Balance at December 31, 2021 72,069 $ 511,063 $ ( 10,077 ) $ ( 120,453 ) $ 380,533 Common stock issued upon exercise 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 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Summary of Available-for-sale Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 22,178 | $ 27,087 |
Gross Unrealized Losses | (220) | |
Fair Value | 22,178 | 26,867 |
Guaranteed Investment Certificates [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 22,178 | 22,109 |
Fair Value | 22,178 | 22,109 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 4,978 | |
Gross Unrealized Losses | (220) | |
Fair Value | $ 4,758 | |
Less Than One Year [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 22,178 | |
Fair Value | $ 22,178 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Cash and cash equivalents | $ 90,194 | $ 83,980 | |
Fair value of plan assets | 678 | 747 | |
Net foreign exchange gains (losses) | (50) | $ 729 | |
Reduced inventories | (18,540) | 8,198 | (528) |
Reduced accounts payable | (12,097) | 4,287 | (1,329) |
Reduced cost of products and services sold | (27) | (801) | |
Research and Development Expenses and Other Income [Member] | Government Contract [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Reimbursement of engineering cost | 1,051 | $ 221 | |
Money Market Fund [Member] | Level I Instruments [Member] | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Cash and cash equivalents | $ 6,846 | $ 1,730 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Changes in Accumulated Other Comprehensive Loss by Component (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Beginning balance | $ (18,435) |
Other comprehensive gain | 1,017 |
Ending balance | (17,418) |
Foreign Currency [Member] | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
Beginning balance | (18,215) |
Other comprehensive gain | 797 |
Ending balance | (17,418) |
Marketable Securities [Member] | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |
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 | |||
Mar. 31, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | 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% | ||
Proceeds from funding under government contract | $ 60,862 | $ 26,333 | ||
Remaining expected Fund Under Government Contract | $ 48,138 | |||
Net revenues | 154,963 | 67,707 | ||
Research and Development Expenses and Other Income [Member] | Government Contract [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Reimbursement of engineering cost | 1,051 | 221 | ||
Other Income [Member] | Government Contract [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Net revenues | $ 561 | $ 561 |
Government Capital Contracts _2
Government Capital Contracts - Summary of Government Contracts Balances Included in Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Other current assets: | ||
Total other current assets | $ 40,428 | $ 41,569 |
Other non-current assets | 1,031 | 1,087 |
Accrued expenses and other current liabilities | 22,673 | 25,762 |
Government Contract [Member] | ||
Other current assets: | ||
Billed receivables | 17,792 | 0 |
Unbilled receivables | 13,604 | 27,013 |
Total other current assets | 31,396 | 27,013 |
Accrued expenses and other current liabilities | $ (679) | $ (318) |
Government Capital Contracts _3
Government Capital Contracts - Summary of Government Contracts Balances Included in Consolidated Statements of Cash flows (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Cost of assets, cumulative | $ 129,743 | $ 129,294 |
Total property, plant and equipment, net | 57,343 | 59,413 |
Government Contract [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Cost of assets, cumulative | 86,126 | 83,359 |
Reduction for funding earned to date, not yet received | (25,264) | (22,497) |
Reduction for funding received to date | (60,862) | (60,862) |
Total property, plant and equipment, net | $ 0 | $ 0 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory, Net [Abstract] | ||
Raw materials | $ 35,607 | $ 42,445 |
Work in process | 2,182 | 2,335 |
Finished goods | 39,400 | 50,924 |
Inventories | $ 77,189 | $ 95,704 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | $ 129,743 | $ 129,294 |
Accumulated depreciation | (72,400) | (69,881) |
Total property, plant and equipment, net | 57,343 | 59,413 |
Land [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 1,118 | 1,118 |
Buildings and Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 35,626 | 35,582 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 61,827 | 60,725 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 16,917 | 16,681 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | 4,068 | 4,064 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property plant and equipment Gross | $ 10,187 | $ 11,124 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net - Additional Information (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Property, Plant and Equipment [Line Items] | |
Pre-tax asset impairment charge | $ 1,105 |
Impairment, Long-Lived Asset, Held-for-Use, Statement of Income or Comprehensive Income [Extensible Enumeration] | Asset Impairment Charges |
Estimated fair value on manufacturing equipment and various market data points | $ 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 | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued Liabilities, Current [Abstract] | ||
Payroll and related benefits | $ 7,989 | $ 14,103 |
Professional fees | 7,981 | 4,685 |
Sales tax payable | 1,512 | 1,519 |
Other | 5,191 | 5,455 |
Accrued expenses and other current liabilities | $ 22,673 | $ 25,762 |
Termination Benefits - Addition
Termination Benefits - Additional Information (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Termination Benefits [Abstract] | |
Accrued reduction in workforce | $ 1,894 |
Payment of reduction in workforce | $ 741 |
Termination Benefits - Summary
Termination Benefits - Summary of One-Time Termination Benefits (Details) - One-Time Termination Benefits [Member] $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Termination Benefits [Line Items] | |
Termination benefits | $ 2,635 |
Cost of Products and Services Sold [Member] | |
Termination Benefits [Line Items] | |
Termination benefits | 35 |
Research and Development [Member] | |
Termination Benefits [Line Items] | |
Termination benefits | 566 |
Sales and Marketing [Member] | |
Termination Benefits [Line Items] | |
Termination benefits | 1,448 |
General and Administrative [Member] | |
Termination Benefits [Line Items] | |
Termination benefits | $ 586 |
Revenues - Summary of Total Net
Revenues - Summary of Total Net Revenues by Product Line (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation Of Revenue [Line Items] | ||
Net revenues | $ 154,963 | $ 67,707 |
Product and Services Revenues [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 152,914 | 65,236 |
Product and Services Revenues [Member] | COVID-19 [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 118,409 | 31,032 |
Product and Services Revenues [Member] | HIV [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 13,904 | 8,166 |
Product and Services Revenues [Member] | Molecular Products [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 12,942 | 17,933 |
Product and Services Revenues [Member] | HCV [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 3,186 | 3,257 |
Product and Services Revenues [Member] | Risk Assessment Testing [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 2,628 | 2,560 |
Product and Services Revenues [Member] | Molecular Services [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 1,379 | 1,733 |
Product and Services Revenues [Member] | Other Product and Service Revenues [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 466 | 555 |
Other [Member] | Other Non Product Revenues [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | $ 2,049 | $ 2,471 |
Revenues - Summary of Total N_2
Revenues - Summary of Total Net Revenues by Geographic Area (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation Of Revenue [Line Items] | ||
Net revenues | $ 154,963 | $ 67,707 |
United States [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 145,019 | 57,987 |
Europe [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | 1,852 | 4,286 |
Other Regions [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Net revenues | $ 8,092 | $ 5,434 |
Revenues - Additional Informati
Revenues - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Revenue from contract with customer [Line Items] | |||
Deferred revenue | $ 1,989 | $ 2,273 | |
Long-term Contract [Member] | |||
Revenue from contract with customer [Line Items] | |||
Deferred revenue | 631 | 1,093 | |
Up Front Payment Arrangement [Member] | |||
Revenue from contract with customer [Line Items] | |||
Deferred revenue | $ 1,358 | $ 1,180 | |
Customer [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | Maximum [Member] | |||
Revenue from contract with customer [Line Items] | |||
Percentage of concentration risk | 57% | ||
Non-commercial Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||
Revenue from contract with customer [Line Items] | |||
Percentage of concentration risk | 77% | ||
Non-commercial Customer One [Member] | Net Consolidated Revenue [Member] | Customer Concentration Risk [Member] | |||
Revenue from contract with customer [Line Items] | |||
Percentage of concentration risk | 78% | 18% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Income tax expense (benefit) | $ (225) | $ 3,936 |
Foreign earnings repatriated | $ 65,000 |
Income (Loss) Per Share - Addit
Income (Loss) Per Share - Additional Information (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Common Stock Options Unvested Restricted Stock and Unvested Performance Stock Units [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Number of anti-dilutive securities excluded from EPS computation | 2,237 | 463 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Reconciliation of Changes in Stockholders' Equity (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Beginning Balance | $ 364,425 | $ 380,533 |
Common stock issued upon exercise of options | 66 | 15 |
Purchase and retirement of common shares | (1,203) | (1,049) |
Stock-based compensation | 2,655 | 3,524 |
Net income (loss) | 27,219 | (19,940) |
Currency translation adjustments | 797 | 1,756 |
Unrealized gain on marketable securities | 220 | 74 |
Ending Balance | $ 394,179 | $ 364,913 |
Common Stock [Member] | ||
Beginning Balance, Shares | 72,734,000 | 72,069,000 |
Exercised | 12,000 | 2,000 |
Vesting of restricted stock and performance stock units, Shares | 737,000 | 352,000 |
Purchase and retirement of common shares, Shares | (229,000) | (116,000) |
Ending Balance, Shares | 73,254,000 | 72,307,000 |
Additional Paid-in Capital [Member] | ||
Beginning Balance | $ 520,446 | $ 511,063 |
Common stock issued upon exercise of options | 66 | 15 |
Purchase and retirement of common shares | (1,203) | (1,049) |
Stock-based compensation | 2,655 | 3,524 |
Ending Balance | 521,964 | 513,553 |
Accumulated Other Comprehensive Loss [Member] | ||
Beginning Balance | (18,435) | (10,077) |
Currency translation adjustments | 797 | 1,756 |
Unrealized gain on marketable securities | 220 | 74 |
Ending Balance | (17,418) | (8,247) |
Accumulated Deficit [Member] | ||
Beginning Balance | (137,586) | (120,453) |
Net income (loss) | 27,219 | (19,940) |
Ending Balance | $ (110,367) | $ (140,393) |
Business Segments - Additional
Business Segments - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2023 Segment | |
Segment Reporting [Abstract] | |
Number of Reportable Segments | 1 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] $ in Thousands | May 03, 2023 USD ($) |
Minimum [Member] | |
Subsequent Event [Line Items] | |
Estimated expense upon reduction of workforce | $ 500 |
Maximum [Member] | |
Subsequent Event [Line Items] | |
Estimated expense upon reduction of workforce | $ 600 |