Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 |
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 our 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 our Annual Report on Form 10-K for the fiscal year ended December 31, 2021. Results of operations for the three and nine months ended September 30, 2022 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 our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 that have had a material impact on the consolidated financial statements and related notes except as discussed herein. |
Investments | Investments . We consider 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. We record an allowance for credit loss for our available-for-sale securities when a decline in investment market value is due to credit-related factors. When evaluating an investment for impairment, we review 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. During the nine months ended September 30, 2022, we recognized a provision for expected credit losses for our available-for-sale securities of $ 56 . The following is a summary of our available-for-sale securities as of September 30, 2022 and December 31, 2021: Amortized Gross Gross Fair Value September 30, 2022 Guaranteed investment certificates $ 21,688 $ — $ — $ 21,688 Corporate bonds 5,011 — ( 267 ) 4,744 Total available-for-sale securities $ 26,699 $ — $ ( 267 ) $ 26,432 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 September 30, 2022, maturities of our available-for-sale Less than one year $ 26,699 $ — $ ( 267 ) $ 26,432 Greater than one year $ — $ — $ — $ — |
Fair Value of Financial Instruments | Fair Value of Financial Instruments . As of September 30, 2022 and December 31, 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 unobservable (i.e., supported by little or no market activity). All of our available-for-sale debt securities are measured as Level 2 instruments as of September 30, 2022 and December 31, 2021. Our available-for-sale guaranteed investment certificates are measured as Level 1 instruments as of September 30, 2022 and December 31, 2021. Included in cash and cash equivalents at September 30, 2022 and December 31, 2021, was $ 1,717 and $ 1,160 invested in government money market funds. These funds have investments in government securities and are measured as Level 1 instruments. We offer a nonqualified deferred compensation plan for certain eligible employees and members of our 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 September 30, 2022 and December 31, 2021 was $ 1,599 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 noncurrent assets with the same amount included in accrued expenses and other noncurrent liabilities in the accompanying consolidated balance sheets. |
Property, Plant and Equipment | 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 depreciated over twenty years , while computer equipment, 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. Accumulated depreciation of property, plant and equipment as of September 30, 2022 and December 31, 2021 was $ 68,626 and $ 61,157 , respectively. |
Intangible Assets | Intangible Assets . Intangible assets consist of customer relationships, patents and product rights, acquired technology and tradenames. 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 . Accumulated amortization of intangible assets as of September 30, 2022 and December 31, 2021 was $ 29,943 and $ 30,412 , respectively. The decrease in intangible assets from $ 14,343 as of December 31, 2021 to $ 11,919 as of September 30, 2022 was due to $ 1,617 in amortization expense and foreign currency translation losses of $ 807 . |
Impairment of Long-Lived Assets | 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. We assess the recoverability of our 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, we measure 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 our assumptions about selling prices, volumes, costs and market conditions over a reasonable period of time. During the three months ended September 30, 2022, management determined several manufacturing lines and associated supporting assets will not be utilized due to changes in forecasted demand for the products the lines are intended to produce. As a result of this decision, we determined that the carrying values of the equipment is not recoverable and recorded an aggregate pre-tax asset impairment charge of $ 6,559 during the three months ended September 30, 2022 to write the assets down to their estimated fair values. This charge is reported within loss on impairment in the consolidated statement of operations. We estimated the fair value of the impaired long-lived assets using a market approach, which required us to estimate the value that would be received for the equipment in the 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 not significant. Our fair value estimates were representative of Level 3 measurements within the fair value hierarchy due to the significant level of estimation involved and the lack of transparency as to the inputs used. |
Foreign Currency Translation | Foreign Currency Translation . The assets and liabilities of our 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 a functional currency are included in our consolidated statements of operations in the period in which the change occurs. Net foreign exchange gains resulting from foreign currency transactions that are included in other income in our consolidated statements of operations were $ 2,342 and $ 7 for the three months ended September 30, 2022 and 2021, respectively. Net foreign exchange gains (losses) were $ 2,396 and $( 371 ) f or the nine months ended September 30, 2022 and 2021 , respectively. |
Accumulated Other Comprehensive Income (Loss) | Accumulated Other Comprehensive Loss . We classify items of other comprehensive loss by their nature and disclose the accumulated balance of other comprehensive loss separately from accumulated deficit and additional paid-in capital in the stockholders’ equity section of our consolidated balance sheets. We have defined the Canadian dollar as the functional currency of our Canadian subsidiary, DNAG, and we have defined the Euro as the functional currency of our Belgian subsidiary, Novosanis. The results of operations for those subsidiaries are translated into U.S. dollars, which is the reporting currency of the Company. Accumulated other comprehensive loss at September 30, 2022 consisted of $ 22,064 of currency translation adjustments and $ 267 of net unrealized losses on marketable securities, which represents the fair market value adjustment for our investment portfolio. 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 our investments portfolio. |
Recent Accounting Pronouncements | 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 a proposed amendment to the ASU in April 2022 which, if approved, will extend 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 . |
Revenues by Product | Revenues by product line . The following table represents total net revenues by product line: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 COVID-19 $ 79,920 $ 13,930 $ 154,331 $ 54,147 Genomics 13,980 19,018 44,558 49,333 HIV 9,054 10,022 27,577 29,745 HCV 3,234 2,715 10,182 9,382 Substance abuse 2,595 2,674 7,786 7,265 Microbiome 1,761 1,693 5,583 5,888 Laboratory services 1,957 2,406 4,895 8,017 Other product and service revenues 320 771 2,312 1,772 Net product and services revenues 112,821 53,229 257,224 165,549 Royalty income 409 500 1,735 2,636 Other non-product revenues* 3,233 188 5,442 1,921 Other revenues 3,642 688 7,177 4,557 Net revenues $ 116,463 $ 53,917 $ 264,401 $ 170,106 * Other non-product revenues include funded research and development under our BARDA contracts and other 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 September 30, Nine Months Ended September 30, 2022 2021 2022 2021 United States $ 108,941 $ 42,969 $ 237,248 $ 139,669 Europe 2,207 2,411 8,929 10,288 Other regions 5,315 8,537 18,224 20,149 $ 116,463 $ 53,917 $ 264,401 $ 170,106 |
Customer and Vendor Concentrations | Customer and Vendor Concentrations . At September 30, 2022 , one non-commercial customer accounted for 47 % of our accounts receivable. No customers accounted for more than 10 % of our accounts receivable as of December 31, 2021 . One non-commercial customer accounted for 69 % and 53 % of net consolidated revenues for the three and nine months ended September 30, 2022 , respectively. One customer accounted for 14 % of net consolidated revenues for the three months ended September 30, 2021 . Another customer accounted for 10 % of net consolidated revenues for the nine months ended September 30, 2021. We currently purchase certain products and critical components of our products from sole-supply vendors. If these vendors are unable or unwilling to supply the required components and products, we could be subject to increased costs and substantial delays in the delivery of our products to our customers. Third-party suppliers also manufacture certain products. Our inability to have a timely supply of any of these components and products could have a material adverse effect on our business, as well as our financial condition and results of operations. |
Deferred Revenue | Deferred Revenue . We record deferred revenue when funds are received prior to the recognition of the associated revenue. Deferred revenue as of September 30, 2022 and December 31, 2021 includes customer prepayments of $ 1,762 and $ 1,843 , respectively. Deferred revenue as of September 30, 2022 and December 31, 2021 also include s $ 774 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. |