Summary of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: Principles of Consolidation and Basis of Presentation The consolidated financial statements include the accounts of OraSure Technologies, Inc. (“OraSure”) and its wholly-owned subsidiaries, DNAG, Diversigen, and 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. Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions about future events. These estimates and underlying assumptions affect the amounts of assets and liabilities reported, disclosures about contingent assets and liabilities, and reported amounts of revenues and expenses. Such estimates include the fair value of assets acquired and liabilities assumed for business combinations, the valuation of accounts receivable and inventories and assumptions utilized in impairment testing for intangible assets and goodwill, as well as estimates related to taxes, contingent consideration, and performance-based compensation expense. These estimates and assumptions are based on management’s best estimates and judgment. Management evaluates its estimates and assumptions on an ongoing basis, using historical experience and other factors, which management believes to be reasonable under the circumstances, including the current economic environment. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Changes in those estimates resulting from continuing changes in the economic environment and other factors will be reflected in the financial statements in those future periods. Employee Retention Credit In December 2021, the Company applied for the Employee Retention Credit for payroll taxes paid in the first and second quarters of 2021 as provided by the Coronavirus Aid, Relief and Economic Security Act . The amount due from the Internal Revenue Service of $ 5,728 is recorded in other current assets in the Company's consolidated balance sheet as of December 31, 2022 and 2021. The amount was received in 2023. The credit is reported in the Company's consolidated statement of operations, for the year ended December 31, 2021, within cost of products and services sold, research and development, sales and marketing and general and administrative costs in the amounts of $ 2,536 , $ 1,134 , $ 924 , and $ 1,134 , respectively. Supplemental Cash Flow Information In 2022, 2021 and 2020 , the Company paid income taxes of $ 9,446 , $ 13,727 and $ 9,263 , respectively. The Company had account receivable write-offs of $ 2,296 , $ 115 , and $ 501 in 2022, 2021, and 2020, respectively. As of December 31, 2022, 2021 and 2020 , the Company had accruals for purchases of property and equipment of $ 227 , $ 8,166 and $ 802 , respectively. Investments The Company considers all investments in debt securities to be available-for-sale securities. These securities are comprised of guaranteed investment certificates and corporate bonds with purchased 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 the Company's available-for-sale securities when a decline in investment market value is due to credit-related factors. When evaluating an investment for impairment, the Company reviews factors such as the severity of the impairment, changes in underlying credit ratings, forecasted recovery, the Company’s intent to sell or the likelihood that it would be required to sell the investment before its anticipated recovery in market value, and the probability that the scheduled cash payments will continue to be made. The following is a summary of the Company's available-for-sale securities as of December 31, 2022 and 2021: Amortized Gross Gross Fair Value December 31, 2022 Guaranteed investment certificates $ 22,109 $ — $ — $ 22,109 Corporate bonds 4,978 — ( 220 ) 4,758 Total available-for-sale securities $ 27,087 $ — $ ( 220 ) $ 26,867 December 31, 2021 Guaranteed investment certificates $ 33,249 $ — $ — $ 33,249 Corporate bonds 20,473 — ( 434 ) 20,039 Total available-for-sale securities $ 53,722 $ — $ ( 434 ) $ 53,288 At December 31, 2022, maturities of the Company's available-for-sale securities were as follows: Less than one year $ 27,087 $ — $ ( 220 ) $ 26,867 Greater than one year $ — $ — $ — $ — Fair Value of Financial Instruments As of December 31, 2022 and 2021, 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 un-observable (i.e., supported by little or no market activity). All of the Company's available-for-sale debt securities are measured as Level 2 instruments as of December 31, 2022 and 2021. The Company's guaranteed investment certificates are measured as Level 1 instruments as of December 31, 2022 and 2021. Included in cash and cash equivalents at December 31, 2022 and 2021, was $ 1,730 and $ 1,160 invested in government money market funds. These 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 the Company's 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. The fair value of the plan assets as of December 31, 2022 and 2021 was $ 747 and $ 1,763 , 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 other non-current assets with the same amounts included in accrued expenses and other non-current liabilities in the accompanying consolidated balance sheets. As further discussed in Note 3, Business Combinations, the Company has identified the Company's contingent consideration obligations as Level 3 liabilities due to significant inputs that are required to measure the fair value of these obligations. Accounts Receivable Accounts receivable have been reduced by an estimated allowance for amounts that may become uncollectible in the future. This estimated allowance is based primarily on management’s evaluation of specific balances as they become past due, the financial condition of the Company's customers and the Company's historical experience related to write-offs. Inventories Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis, and include the cost of raw materials, labor and overhead. The majority of the Company's inventories are subject to expiration dating, which can be extended in certain circumstances. The Company continually evaluates quantities on hand and the carrying value of the Company's inventories to determine the need for net realizable value adjustments, based primarily on prior experience with consideration of expected changes in the business and estimated forecasts of product sales. The Company reserves for unidentified scrap or spoilage based on historical write-off rates. The Company also considers items identified through specific identification procedures in assessing the adequacy of the Company's reserve. Although the Company makes every effort to ensure the accuracy of its forecasts of future product demand, any significant unanticipated changes in demand could have a significant impact on the carrying value of its inventories and reported operating results Property, Plant and Equipment Property, plant and equipment are stated at cost. Additions or improvements are capitalized, while repairs and maintenance are charged to expense. Depreciation and amortization are provided using the straight-line method over the estimated useful lives of the related assets. Buildings are typically depreciated over twenty years , while computer equipment and software, machinery and equipment, and furniture and fixtures are depreciated over two to ten years . Building improvements are amortized over their estimated useful lives. When assets are sold, retired, or discarded, the related property amounts are relieved from the accounts, and any gain or loss is recorded in the consolidated statements of operations. Intangible Assets Intangible assets consist of customer relationships, patents and product rights, acquired technology and trade names. Patents and product rights consist of costs associated with the acquisition of patents, licenses and product distribution rights. Intangible assets are amortized using the straight-line method over their estimated useful lives of five to fifteen years . Impairment of Long-Lived Assets Long-lived assets, which include property and equipment and definite-lived intangible assets, are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. The Company assesses the recoverability of the Company's long-lived assets by determining whether the carrying value of such assets can be recovered through the sum of the undiscounted future cash flows generated from the use and eventual disposition of the asset. If indicators of impairment exist, the Company measures the amount of such impairment by comparing the carrying value of the assets to the fair value of these assets, which is generally determined based on the present value of the expected future cash flows associated with the use of the assets. Expected future cash flows reflect the Company's assumptions about selling prices, volumes, costs and market conditions over a reasonable period of time. See Note 6 for discussion of impairments recorded in 2022. Goodwill Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired. Goodwill is not amortized but rather is tested annually for impairment or more frequently if the Company believes that indicators of impairment exist. Current generally accepted accounting principles permit the Company to make a qualitative evaluation about the likelihood of goodwill impairment. If the Company concludes that it is more likely than not that the carrying value of a reporting unit is greater than its fair value, then the Company would be required to recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to the reporting unit. The Company performs an annual goodwill impairment assessment as of July 31 each year. Historically this involved a qualitative analysis that resulted in a conclusion that it was more likely than not that the fair value of the Company's reporting units is greater than their carrying value. A more frequent evaluation is performed if an event occurs or circumstances change between annual tests that could more likely than not reduce the fair value of a reporting unit below its carrying amount. Revenue Product sales . Revenue from product sales is recognized upon transfer of control of a product to a customer based on an amount that reflects the consideration the Company is entitled to, net of allowances for any discounts or rebates. The Company generally does not grant product return rights to the Company's customers, except for warranty returns and return rights on sales of the Company's OraQuick ® In-Home HIV test to the retail trade, and InteliSwab ® products to the retail trade and certain customers. Historically, returns arising from warranty issues have been infrequent and immaterial. Accordingly, the Company expenses warranty returns as incurred. The Company records shipping and handling charges billed to the Company's customers as product revenue and the related expense as cost of products sold. Service revenues. Service revenues represent microbiome laboratory testing and analytical services. The Company recognizes revenues when the Company satisfies its performance obligations for services rendered. Arrangements with multiple-performance obligations . In arrangements involving more than one performance obligation, which largely applies to the Company's service revenue stream, each required performance obligation is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available and (ii) the good or services is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on their respective relative stand-alone selling price. The estimated selling price of each deliverable is determined using an observable cost plus margin approach. The consideration allocated to each distinct performance obligation is recognized as revenue when control is transferred for the related goods or services or when the performance obligation has been satisfied. Other revenues . Other revenues consist primarily of royalty income and funding from grants of research and development efforts. For the year ended December 31, 2021, other revenue also included cost reimbursements under a charitable support agreement which ended in June 2021. Royalties from licensees are based on third-party sales of licensed products and are recorded when the related third-party product sale occurs. Research and development grant revenue is recognized pursuant to International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance ("IAS 20") . The expenses are recorded in research and development expense and the reimbursements are recorded in other revenue. Funding of research and development efforts and charitable support reimbursements are recorded as the activities are performed in accordance with the respective agreements. Deferred Revenue. The Company records deferred revenue when funds are received prior to the recognition of the associated revenue. Deferred revenue as of December 31, 2022 and 2021 included customer prepayments of $ 1,533 and $ 1,843 , respectively. Deferred revenue as of December 31, 2022 and 2021 also included $ 740 and $ 1,093 , respectively, associated with a long-term contract that has variable pricing based on volume. The average price over the life of contract was determined based on expected revenues and revenue is recognized at that rate when the product is delivered to the customer. Financing and Payment . The Company's payment terms vary by the type and location of our customer and products or services offered. Payment terms differ by jurisdiction and customer but payment is generally required in a term ranging from 30 to 120 days from date of shipment or satisfaction of the performance obligation. For certain products or services and customer types, the Company may require payment before the products are delivered or services are rendered to the customer. Practical expedients and exemptions . Taxes assessed by governmental authorities, such as sales or value-added taxes, are excluded from product revenues. Sales commissions are expensed when incurred if the amortization period is one year or less. These costs are recorded in sales and marketing expense in the consolidated statements of operations. If the amortization period exceeds one year, the Company defers the cost of the commission and expenses it over the life of the related sales contract. Revenues by product . The following table represents total net revenues by product line: Years ended December 31, 2022 2021 2020 COVID-19 $ 243,325 $ 76,874 $ 50,927 Genomics 54,335 63,350 36,878 HIV 38,812 42,144 44,224 HCV 13,369 11,783 8,448 Risk assessment testing 10,269 9,678 9,194 Microbiome 7,503 7,944 5,474 Laboratory services 7,296 11,840 8,746 Other product and service revenues 3,138 3,284 2,490 Net product and services revenues $ 378,047 $ 226,897 $ 166,381 Royalty income 2,683 4,420 3,432 Other non-product revenues 6,749 2,357 1,908 Other revenues 9,432 6,777 5,340 Net revenues $ 387,479 $ 233,674 $ 171,721 Revenues by geographic area . The following table represents total net revenues by geographic area, based on the location of the customer: Years ended December 31, 2022 2021 2020 United States $ 350,206 $ 188,383 $ 130,835 Europe 11,536 13,799 12,068 Other regions 25,737 31,492 28,818 $ 387,479 $ 233,674 $ 171,721 Customer and Vendor Concentrations. The Company had one customer that accounted for more than 57 % of the Company's consolidated accounts receivable as of December 31, 2022 and no ne as of December 31, 2021. The same customer accounted for approximately 58 % of the Company's consolidated revenues for the year ended December 31, 2022. The Company had no customers that accounted for more than 10% of the Company's consolidated net revenues for the years ended December 31, 2021 and 2020. The Company currently purchases certain products and critical components of the Company's 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 the Company's products to the Company's 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 the Company's business, as well as the Company's financial condition and results of operations. The Company’s Intercept i2 ® he collection device is manufactured and supplied under a long-term agreement with Thermo Fisher, the sole-source supplier for these products. DNAG has three long-term contract manufacturing relationships to supply virtually all of its products, including the Oragene ® product line. Many of the raw materials and components used in these products are also purchased from third parties, some of which are purchased from a single source supplier. The Company is actively seeking to qualify other suppliers that can manufacture and supply the raw materials and components for the DNAG products. Business Combinations and Contingent Consideration Acquired businesses are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. Amounts allocated to contingent consideration are recorded to the balance sheet at the date of acquisition based on their relative fair values. The purchase price allocation requires the Company to make significant estimates and assumptions, especially at the acquisition date, with respect to intangible assets. Although the Company believes the assumptions and estimates it has made are reasonable, they are based in part on historical experience and information obtained from the management of the acquired companies and are inherently uncertain. The Company accounts for contingent consideration in accordance with applicable guidance provided within the business combination accounting standard. As part of the Company's consideration for the recent acquisitions, the Company is contractually obligated to pay certain consideration resulting from the outcome of future events. Therefore, the Company is required to update the Company's underlying assumptions each reporting period, based on new developments, and record such contingent consideration liabilities at fair value until the contingency is resolved. Changes in the fair value of the contingent consideration liabilities are recognized each reporting period and included in the Company's consolidated statements of operations. The Company's estimates of fair value are based on assumptions the Company believes to be reasonable, but the assumptions are uncertain and involve significant judgment by management. Updates to these assumptions could have a significant impact on the Company's results of operations in any given period and any updates to the fair value of the contingent consideration could differ materially from the previous estimates. Examples of critical estimates used in valuing certain intangible assets and contingent consideration include: • future expected cash flows from sales and acquired developed technologies; • the acquired company's trade name and customer relationships as well as assumptions about the period of time the acquired trade name and customer relationships will continue to be used in the combined company's portfolio; • the probability of meeting the future events; and • discount rates used to determine the present value of estimated future cash flows. These estimates are inherently uncertain and unpredictable, and if different estimates were used the purchase price for the acquisition could be allocated to the acquired assets and liabilities differently from the allocation that the Company has made. In addition, unanticipated events and circumstances may occur, which may affect the accuracy or validity of such estimates, and if such events occur the Company may be required to record a charge against the value ascribed to an acquired asset or an increase in the amounts recorded for assumed liabilities . Research and Development Research and development expenses consist of costs incurred in performing research and development activities, including salaries and benefits, facilities expenses, overhead expenses, clinical trial and related clinical manufacturing expenses, contract services and other outside expenses. Research and development costs are charged to expense as incurred. Advertising Expenses Advertising costs are charged to expense as incurred. During 2022, 2021, and 2020, the Company incurred $ 4,849 , $ 5,103 , and $ 1,126 , respectively, in advertising expenses. Stock-Based Compensation The Company accounts for stock-based compensation to employees and directors using the fair value method. The Company recognizes compensation expense for stock option and restricted stock awards issued to employees and directors on a straight-line basis over the requisite service period of the award. The Company recognizes compensation expense related to performance-based restricted stock units based on assumptions as to what percentage of each performance target will be achieved. The Company evaluates these target assumptions on a quarterly basis and adjusts compensation expense related to these awards, as appropriate. To satisfy the exercise of options, issuance of restricted stock, or redemption of performance-based restricted stock units, the Company issues new shares rather than purchase shares in the open market. Income Taxes The Company follows the asset and liability method for accounting for income taxes. Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax basis of assets and liabilities, as well as operating loss and credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates for the respective taxing jurisdiction that are expected to apply to taxable income in the years in which those temporary differences and operating loss and credit carryforwards are expected to be recovered, settled or utilized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The Company assesses the realizability of the Company's net deferred tax assets on a quarterly basis. If, after considering all relevant positive and negative evidence, it is more likely than not that some portion or all of the net deferred tax assets will not be realized, the Company reduces its net deferred tax assets by a valuation allowance. The realization of the net deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the Company's net operating loss carryforwards. Foreign Currency Translation The assets and liabilities of the Company's foreign operations are translated into U.S. dollars at current exchange rates as of the balance sheet date, and revenues and expenses are translated at average exchange rates for the period. Resulting translation adjustments are reflected in accumulated other comprehensive loss, which is a separate component of stockholders’ equity. Transaction gains and losses resulting from exchange rate changes on transactions denominated in currencies other than functional currency are included in the Company's consolidated statements of operations in the period in which the change occurs. Net foreign exchange gains (losses) resulting from foreign currency transactions that are included in other income in the Company's consolidated statements of operations were $ 1,553 , $( 667 ) , and $( 337 ) for the years ended December 31, 2022, 2021, and 2020 , respectively. Earnings (Loss) Per Share Basic earnings (loss) per share is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings (loss) per share is computed in a manner similar to basic earnings (loss) per share except that the weighted-average number of shares outstanding is increased to include incremental shares from the assumed vesting or exercise of dilutive securities, such as common stock options, unvested restricted stock or performance stock units, unless the impact is anti-dilutive. 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 years ended December 31, 2022, 2021, and 2020 outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 436 , 769 , and 984 shares, respectively, were excluded from the computation of diluted loss per share. Accumulated Other Comprehensive Loss The Company classifies items of other comprehensive income (loss) by their nature and discloses the accumulated balance of other comprehensive loss separately from accumulated deficit and additional paid-in capital in the stockholders’ equity section of the Company's consolidated balance sheets. The Company has defined the Canadian dollar as the functional currency of the Company's Canadian subsidiary, DNAG, and the Company has defined the Euro as the functional currency of the Company's Belgian subsidiary, Novosanis. The results of operations are translated into U.S. dollars, which is the reporting currency of the Company. Accumulated other comprehensive loss at December 31, 2022 consists of $ 18,215 of currency translation adjustments and $ 220 of net unrealized losses on marketable securities. Accumulated other comprehensive loss at December 31, 2021 consists of $ 9,643 of currency translation adjustments and $ 434 of net unrealized losses on marketable securities, which represents the fair market value adjustment for the Company's investments portfolio. Recent Accounting Pronouncements In March 2020, the FASB issued Accounting Standards Update (“ASU”) No. 2020-04, Reference Rate Reform (Topic 848) Facilitation of the Effects of Reference Rate Reform on Financial Reporting . The purpose of this update is to provide optional guidance for a limited time to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. The amendments provide optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The amendments in this ASU were effective upon issuance and could be applied prospectively through December 31, 2022. The FASB issued an amendment, ASU 2022-06, Deferral of the Sunset Date of Topic 848, in December 2022, which, extends the date for prospective application to December 31, 2024. Management has evaluated this ASU and concluded that it will not have a material impact on the Company's Consolidated Financial Statements . Reclassifications Certain prior period amounts have been reclassified to conform to current year presentation. See Note 4 for discussion of the reclassification related to the U.S. Department of Defense contract. |