Nature of Operations and Summary of Significant Accounting Policies | 1. Nature of Operations and Summary of Significant Accounting Policies Organization GenMark Diagnostics, Inc. (the “Company” or “GenMark”) is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. The Company offers a sample-to-answer ePlex instrument and associated molecular diagnostic panels. The Company’s products also include the XT-8 instrument and related diagnostic and research tests, as well as certain custom manufactured reagents. The Company sells its products directly to customers in the U.S. and primarily via a network of distribution partners internationally. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying consolidated financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and applicable regulations of the U.S. Securities and Exchange Commission (“SEC”). These consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. In June 2020, the Company made a policy election to reclassify freight revenue from product revenue to other revenue. The Company reclassified freight revenue of $0.7 million and $0.5 million for the years ended December 31, 2019 and 2018, respectively, from product revenue to other revenue to conform with the current year presentation. The reclassification had no impact to total revenue for the periods presented. The Company has experienced net losses since its inception and had an accumulated deficit of $532.9 million as of December 31, 2020. The Company’s ability to transition to profitable operations is dependent upon achieving a level of revenues adequate to support its cost structure through expanding its product offerings and consequently increasing its product revenues. As of December 31, 2020, the Company had available cash, cash equivalents, and marketable securities of $128.2 million and working capital of $128.8 million available to fund future operations. The Company has prepared cash flow forecasts which indicate, based on the Company’s current cash resources available and working capital, that the Company will have sufficient resources to fund its operations for at least one year after the date the financial statements are issued. Use of Estimates The preparation of these consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the notes thereto. The Company’s significant estimates included in the preparation of the financial statements are related to accounts receivable, inventories, property and equipment, leases, intangible assets, employee-related compensation accruals, warranty liabilities, tax valuation accounts, and stock-based compensation. Actual results could differ from those estimates. Segment Information The Company currently operates in one reportable business segment, which encompasses the development, manufacturing, sales and support of instruments and molecular tests based on its proprietary eSensor ® detection technology. Substantially all of the Company’s operations and assets are in the United States. Revenue The Company recognizes revenue from operations through the sale of products and other services. Product revenue comprises the sale of diagnostic tests and instruments. Other revenue primarily consists of freight revenue and revenue from extended service agreements. Revenue is recognized when control of products and services is transferred to the customer in an amount that reflects the consideration that the Company expects to receive from the customer in exchange for those products and services. This process involves identifying the contract with the customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. The Company considers a performance obligation satisfied once it has transferred control of a good or service to the customer, meaning the customer has the ability to use and obtain the benefit of the good or service. The Company recognizes revenue for satisfied performance obligations only when it determines there are no uncertainties regarding payment terms or transfer of control. Revenue from product sales is recognized generally upon shipment to the end customer, which is when control of the product is deemed to be transferred. Invoicing typically occurs upon shipment and the term between invoicing and when payment is due is not significant. Revenue from instrument services is recognized as the services are rendered, typically evenly over the contract term. Revenue is recorded net of discounts and sales taxes collected on behalf of governmental authorities. Employee sales commissions are recorded as sales and marketing expense when incurred or amortized over the estimated contract term when resulting from new contract acquisition efforts. The Company allocates contract price to each performance obligation in proportion to its stand-alone selling price. The stand-alone selling price is determined by the Company’s best estimate of stand-alone selling price using average selling prices over a rolling 12-month period along with a specific assessment of any unique circumstances of the contract. For those products for which there is limited sales history, the Company makes price determinations based on similar product sales data. The following table represents disaggregated revenue by source ( in thousands ): For the years ended December 31, 2020 2019 2018 Revenue Source ePlex product revenue $ 152,578 $ 59,799 $ 37,601 XT-8 product revenue 16,570 27,022 32,334 Total product revenue 169,148 86,821 69,935 License and other revenue 2,406 1,200 824 Total revenue $ 171,554 $ 88,021 $ 70,759 Cash, Cash Equivalents, and Marketable Securities Cash and cash equivalents consist of cash on deposit with banks, money market instruments, and certificates of deposit with original maturities of three months or less at the date of purchase. The Company classifies marketable securities as available-for-sale at the time of purchase and reevaluates such classification as of each balance sheet date. All marketable securities are recorded at estimated fair value. Unrealized gains and losses for available-for-sale securities are included in accumulated other comprehensive income, a component of stockholders’ equity. The Company evaluates its marketable securities to assess whether those with unrealized loss positions are other-than-temporarily impaired. Impairments are considered to be other-than-temporary if they are related to deterioration in credit risk or if it is likely that the Company will sell the securities before the recovery of its cost basis. Realized gains and losses and declines in value judged to be other-than-temporary are determined based on the specific identification method and are reported in other income (expense) in the consolidated statements of comprehensive loss. The Company has the ability, if necessary, to liquidate any of its short-term debt securities to meet liquidity needs in the next 12 months. Accordingly, those investments with contractual maturities greater than one year from the date of purchase are classified as short-term investments on the consolidated balance sheets. Restricted Cash Restricted cash represents amounts designated for uses other than current operations and was $1.6 million and $0.8 million at December 31, 2020 and 2019, respectively, which represented an amount held as security for the Company’s facility lease agreements. The following table shows a reconciliation of the Company’s cash and cash equivalents in the consolidated balance sheet to cash, cash equivalents, and restricted cash in the consolidated statement of cash flows as of December 31, 2020 and 2019 ( in thousands ): December 31, 2020 2019 Cash and cash equivalents $ 40,572 $ 44,360 Restricted cash 1,646 758 Total cash, cash equivalents, and restricted cash $ 42,218 $ 45,118 Fair Value of Financial Instruments The Company uses a fair value hierarchy with three levels of inputs, of which the first two are considered observable and the last unobservable, to measure fair value: • Level 1 —Quoted prices in active markets for identical assets or liabilities. • Level 2 —Inputs, other than Level 1, that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. • Level 3 —Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying amounts of financial instruments such as accounts receivable, prepaid expenses and other current assets, accounts payable, and accrued liabilities approximate the related fair values due to the short-term maturities of these instruments. Receivables Accounts receivable consists of amounts due to the Company from the sale of products and services to customers. Accounts receivable is recognized at amortized cost and is recorded net of an allowance for credit losses. The Company views its accounts receivable as a single portfolio and considers the period of delinquency, historical collection rates, and customer specific-factors in determining its allowance for credit losses. The following table summarizes the composition of the allowance for credit losses ( in thousands ): For the years ended December 31, 2020 2019 2018 Beginning balance $ 376 $ 75 $ 2,754 Provision for credit losses, net 17 338 23 Write off of uncollectible accounts (21) (37) (2,702) Ending balance $ 372 $ 376 $ 75 Inventories Inventories are stated at the lower of cost (first-in, first-out) or net realizable value and include direct labor, materials, and manufacturing overhead. The Company periodically reviews inventory for evidence of slow-moving or obsolete parts, and writes inventory down to net realizable value, as needed. This write-down is based on management’s review of inventories on hand, compared to estimated future usage and sales, shelf-life assumptions, and assumptions about the likelihood of obsolescence. If actual market conditions are less favorable than those projected by the Company, additional inventory write-downs may be required. Inventory impairment charges establish a new cost basis for inventory and charges are not reversed subsequently to income, even if circumstances later suggest that increased carrying amounts are recoverable. Product Warranties The Company generally offers a one The following table summarizes warranty reserve activity ( in thousands ): For the years ended December 31, 2020 2019 2018 Beginning balance $ 279 $ 330 $ 470 Provision 1,508 1,275 1,355 Warranty expenses incurred (1,551) (1,326) (1,495) Ending balance $ 236 $ 279 $ 330 Property and Equipment, net Property, equipment, and leasehold improvements are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets, which are identified below. Repair and maintenance costs are expensed as incurred. Machinery and laboratory equipment 3 - 5 years Instruments 4 - 7 years Office equipment 3 - 7 years Leasehold improvements Over the shorter of the remaining life of the lease or the useful economic life of the asset Property and equipment includes diagnostic instruments used for sales demonstrations or placed with customers under several types of arrangements, including performance evaluation programs (“PEPs”) and reagent rental agreements. Instruments are placed with customers under PEPs for limited evaluation periods. Instruments are also placed with customers under reagent rental agreements, which generally require customers to purchase a minimum number of test cartridges over the term of the agreement. The Company retains title to the instrument under these arrangements. Maintenance and repair costs are expensed as incurred. Leased property meeting certain finance lease criteria is capitalized, and the net present value of the related lease payments is recorded as a liability. Amortization for assets noted as finance leases is recorded using the straight-line method over the shorter of the estimated useful lives or the lease terms. Intangible Assets Intangible assets consist of licenses or sublicenses to technology covered by patents owned by third parties, and are amortized on a straight-line basis over the expected useful lives of these assets, which is generally ten Impairment of Long-Lived Assets The Company assesses the recoverability of long-lived assets, including intangible assets, by periodically evaluating the carrying value whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. If impairment is indicated, the Company writes down the carrying value of the asset to its estimated fair value. This fair value is primarily determined based on estimated discounted cash flows. The Company did not recognize any impairment of long-lived asset charges during the years ended December 31, 2020, 2019, and 2018. Other current liabilities The following table summarizes the composition of current liabilities ( in thousands ): December 31, 2020 2019 Accrued royalties $ 1,863 $ 882 Deferred revenue 508 323 Accrued interest 507 437 Accrued warranties 236 279 Other accrued liabilities 2,136 811 Total other current liabilities $ 5,250 $ 2,732 Employee Benefit Plan The Company has a 401(k) tax-deferred savings plan, whereby eligible employees may contribute a percentage of their eligible compensation. The Company makes matching contributions under the 401(k) plan to certain eligible employees. Leases The Company determines if an arrangement is a lease at inception. Operating leases are recorded in the consolidated balance sheets as operating lease right-of-use (“ROU”) assets and current and noncurrent operating lease liabilities. Finance leases are recorded in the consolidated balance sheets as other noncurrent assets and other current and noncurrent liabilities. ROU assets represent the Company’s right to use an underlying asset over the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease liabilities are recognized at the commencement date based on the present value of the Company’s lease payments over the lease term. As most of the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based on the information available at the commencement date to determine the present value of its lease payments. ROU assets are recognized at the commencement date based upon the initial measurement of the operating lease liability less any lease incentives received. The Company’s lease agreements can include both lease and non-lease components. The Company accounts for each lease component separately from the non-lease components within its lease agreements. Research and Development Costs The Company expenses all research and development costs in the periods in which they are incurred unless there is alternative future use that supports the capitalization of an asset. Stock-Based Compensation The Company recognizes stock-based compensation expense related to stock options, restricted stock units, market-based stock units, and shares purchased under the Company’s Amended and Restated 2013 Employee Stock Purchase Plan (“ESPP”) granted to employees, non-employees, and directors in exchange for services. The compensation expense is based on the fair value of the applicable award utilizing various assumptions regarding the underlying attributes of the award. The stock-based compensation expense is recorded in cost of revenues, sales and marketing, research and development, and/or general and administrative expenses based on the employee’s respective function. The estimated fair value of stock granted, net of forfeitures expected to occur during the vesting period, is amortized as compensation expense that approximates straight-line expense to reflect vesting as it occurs. The compensation expense related to the grant of restricted stock awards or units is calculated as the fair market value of the stock on the grant date as further adjusted to reflect expected forfeitures. The stock option expense is derived from the Black-Scholes option pricing model that uses several judgment-based variables to calculate the expense. The market-based stock expense is derived from the Monte Carlo Simulation Valuation. The inputs utilized in the valuation of the stock-based awards include the following factors: • Expected Term— Expected term represents the period that the stock-based awards are expected to be outstanding and is determined by using the simplified method. • Expected Volatility— Expected volatility represents the expected volatility in the Company’s stock price over the expected term of the option or market-based award and is determined by review of the Company’s and similar companies’ historical experience. • Expected Dividend— The valuation methods requires a single expected dividend yield as an input. The Company assumed no dividends as it has never paid dividends and has no current plans to do so. • Risk-Free Interest Rate— The risk-free interest rate is based on published U.S. Treasury rates in effect at the time of grant for periods corresponding with the expected term of the option or market-based award. Foreign Currency Translation The Company translates the assets and liabilities of the Company’s entities outside the U.S. into U.S. Dollars based on the foreign currency exchange rates at the end of each period. Gains or losses resulting from these foreign currency translations are recorded in accumulated other comprehensive income in the consolidated statement of stockholders’ equity. Foreign currency translation impacts recorded in accumulated other comprehensive income for the years ended December 31, 2020, 2019, and 2018 were $147,000, $11,000, and $44,000, respectively. Income Taxes Current income tax expense is the amount of income taxes expected to be payable for the current year. A deferred income tax liability or asset is established for the expected future tax consequences resulting from the differences in financial reporting and tax bases of assets and liabilities. A valuation allowance is provided if it is more likely than not that some or all of the deferred tax assets will not be realized. A full valuation allowance has been recorded against the Company’s net deferred tax assets due to the uncertainty surrounding the Company’s ability to utilize these assets in the future. The Company provides for uncertain tax positions when such tax positions do not meet the recognition thresholds or measurement standards prescribed by the authoritative guidance on income taxes. Amounts for uncertain tax positions are adjusted in periods when new information becomes available or when positions are effectively settled. The Company recognizes accrued interest related to uncertain tax positions as a component of income tax expense. A tax position that is more likely than not to be realized is measured at the largest amount of tax benefit that is greater than 50% likely of being realized upon settlement with the taxing authority that has full knowledge of all relevant information. Measurement of a tax position that meets the more likely than not threshold considers the amounts and probabilities of the outcomes that could be realized upon settlement using the facts, circumstances and information available at the reporting date. Net Loss Per Common Share Basic net loss per share is calculated by dividing loss available to stockholders of the Company’s common stock (the numerator) by the weighted average number of shares of the Company’s common stock outstanding during the period (the denominator). Shares issued during the period and shares reacquired during the period are weighted for the portion of the period that they were outstanding. Diluted loss per share is calculated in a similar way to basic loss per share except that the denominator is increased to include the number of additional shares that would have been outstanding if the dilutive potential shares had been issued, unless the effect would be anti-dilutive. The calculations of diluted net loss per share for the years ended December 31, 2020, 2019, and 2018 did not include the effects of the following stock options and other equity awards which were outstanding as of the end of each period because the inclusion of these securities would have been anti-dilutive ( in thousands ): For the years ended December 31, 2020 2019 2018 Options outstanding to purchase common stock 843 2,037 2,440 Other unvested equity awards 3,173 3,124 2,994 Total 4,016 5,161 5,434 Concentration of Risk Financial instruments which potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents, short-term investment securities, and accounts receivable. The Company limits its exposure to credit loss by placing its cash with high credit quality financial institutions. The Company has established guidelines to diversify its cash and investment securities and their maturities that are intended to secure safety and liquidity. For the years ended December 31, 2020, 2019, and 2018, revenue from one customer represented 10%, 14%, and 16%, respectively, of the Company’s total revenue. As of December 31, 2020, no customers accounted for more than 10% of net accounts receivable. As of December 31, 2019, two customers accounted for more than 10% of net accounts receivable, with such customers accounting for 24% and 11% of net accounts receivable. Comprehensive Loss The Company has the option to present the total of comprehensive income, the components of net income, and the components of other comprehensive income either in a single continuous statement of comprehensive income or in two separate but consecutive statements. The Company’s comprehensive loss comprises net loss, unrealized gains and losses on available for sale securities, and foreign currency translation. Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments , which introduced a new methodology for recognizing credit losses on financial instruments. The new standard requires entities to measure financial instruments at their amortized cost basis, net of an allowance for credit losses. The allowance for credit losses must reflect an entity's current estimate of all expected credit losses. The new guidance also requires entities to present credit losses on debt securities accounted for under the available-for-sale method as an allowance rather than a write-down. The Company adopted the new standard in the first quarter of 2020. The adoption of ASU 2016-13 did not have a material impact on the Company’s consolidated financial statements for the year ended December 31, 2020. |