You should read the following in conjunction with the "Selected Consolidated Financial Data" and the consolidated financial statements of GenMark and the related notes thereto that appear elsewhere in this Annual Report. In addition to historical information, the following discussion and analysis includes forward looking information that involves risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated by these forward looking statements as a result of many factors, including those discussed under the heading "Risk Factors" included elsewhere in this Annual Report. See also "Forward Looking Statements" included elsewhere in this filing. Overview GenMark is a molecular diagnostics company focused on developing and commercializing multiplex solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. We currently develop and commercialize high-value, simple to perform, clinically relevant multiplex molecular tests based on our proprietary eSensor electrochemical detection technology. Since inception, we have incurred net losses from operations each year, and we expect to continue to incur losses for the foreseeable future. Our net losses for the years endedDecember 31, 2020 , 2019, and 2018 were approximately$18.6 million ,$47.4 million , and$50.5 million , respectively. As ofDecember 31, 2020 , we had an accumulated deficit of$532.9 million . Our operations to date have been funded principally through sales of capital stock, borrowings, and cash from operations. Our Products and Technology We offer our ePlex sample-to-answer instrument and Respiratory Pathogen ("RP") Panel,Respiratory Pathogen Panel 2 ("RP2 "), Blood Culture Identification Gram-Positive ("BCID-GP") Panel, Blood Culture Identification Gram-Negative ("BCID-GN") Panel, and Blood Culture Identification Fungal Pathogen ("BCID-FP") Panel for sale inthe United States and internationally. In addition, in response to the COVID-19 outbreak, we received Emergency Use Authorization ("EUA") from theU.S. Food and Drug Administration (the "FDA"), inMarch 2020 for our ePlex SARS-CoV-2 Test. We discontinued sales of our ePlex SARS-CoV-2 Test in the fourth quarter of 2020. We also received CE Mark and FDA EUA forRP2 , which is designed to provide results for SARS-CoV-2 in addition to the other respiratory viruses contained on our ePlexRP Panel . We are also developing our ePlex Gastrointestinal Pathogen ("GI") Panel for the detection of pathogens associated with gastrointestinal infections. We continue to actively evaluate the development of additional assay panels that we believe will meet important, unmet clinical needs, which our ePlex system is uniquely positioned to address. We offer four FDA-cleared diagnostic tests which run on our XT-8 instrument: ourRespiratory Viral Panel ; our Cystic Fibrosis Genotyping Test; our Warfarin Sensitivity Test; and our Thrombophilia Risk Test. We also offer a Hepatitis C ("HCV") Genotyping Test and associated custom manufactured reagents, as well as a 2C19 Genotyping Test, each of which is available for use with our XT-8 instrument for research use only ("RUO"). In addition, inAugust 2020 we submitted an EUA to the FDA for our eSensor SARS-CoV-2 Test. COVID-19 Impact Our priorities following the COVID-19 outbreak have been, among others, protecting the health and safety of our employees; and increasing our manufacturing capacity for our ePlex tests includingRP2 , which includes the SARS-CoV-2 pathogen target, and the SARS-CoV-2 single target test in order to assist our customers with the current pandemic. We discontinued the sale of our ePlex SARS-CoV-2 test in the fourth quarter of 2020. We continued to expand our manufacturing capacity to address demand for our tests. During the year endedDecember 31, 2020 , portions of our workforce worked remotely as their positions allowed. Our ability to continue to operate without any significant negative operational impact from the COVID-19 pandemic will, in part, depend on our ability to protect our employees and maintain our supply chain. We continue to endeavor to follow the recommended actions of government and health authorities to protect our employees, with particular measures in place for employees who manufacture our products. However, the complications resulting from the pandemic could result in unforeseen disruptions to our workforce and supply chain (for example, the inability of a key supplier or transportation supplier to source, transport and supply materials to us that are necessary for continued operations) that could negatively impact our operations. We believe the extent of the COVID-19 pandemic's impact on our operating results and financial condition will be driven by many factors, most of which are beyond our control and ability to forecast. Such factors include, but are not limited to, the severity and duration of the pandemic, our ability to timely develop, commercialize and manufacture solutions related to the pandemic, the extent and the effectiveness of responsive actions taken by authorities of impacted countries, the impact of these and other factors on our employees, customers and suppliers, as well as any resulting impact of the economic uncertainty and volatility that could affect demand for our products. Because of these and other uncertainties, we cannot estimate the length or extent of the impact of the pandemic on our business. For additional information on risk factors related to the pandemic or other risks that could impact our results, please refer to "Risk Factors" included in Part I, Item 1A of this Annual Report on Form 10-K. 23 --------------------------------------------------------------------------------
Revenue
Revenue from operations includes revenue from the sale of our products and other services. Product revenue comprises the sale of diagnostic tests and instruments. In addition to selling our instruments, we also place our instruments with customers through a reagent rental agreement, under which we retain title to the instrument and customers generally commit to purchasing minimum quantities of reagents and test cartridges over a period of one to five years. Under our reagent rental agreements, a portion of the price charged to customers from the sale of test cartridges is attributable to the usage fee for the instrument. Other revenue primarily consists of freight revenue and revenue from extended service agreements. Cost of Revenues Cost of revenues includes the cost of materials, direct labor, and manufacturing overhead costs used in the manufacture of our consumable tests. Cost of revenues also includes depreciation on revenue generating instruments that have been placed with our customers under a reagent rental agreement, cost of instruments sold to customers, amortization of licenses related to our products, and other costs such as warranty, royalty, and customer and product technical support. Any potential underutilized capacity may result in a high cost of revenues relative to revenue, if manufacturing volumes are not able to fully absorb operating costs. Our instruments are procured from contract manufacturers. We expect our cost of revenues to increase as we place additional instruments and manufacture and sell additional diagnostic panels; however, over time, we expect our cost per unit to decrease as production volume increases, manufacturing efficiencies are realized, improvements to procurement practices are made, product reliability increases, and other improvements decrease costs. Sales and Marketing Expenses Sales and marketing expenses include costs associated with our direct sales force, sales management, marketing, customer support, and business development activities. These expenses primarily consist of salaries, commissions, benefits, stock-based compensation, travel, advertising, promotions, product samples, and trade show expenses. Research and Development Expenses Research and development expenses primarily include costs associated with the development and expansion of our ePlex instrument's diagnostic test menu. These expenses also include certain clinical study expenses incurred in preparation for FDA clearance for these products, intellectual property prosecution and maintenance costs, and quality assurance expenses. The expenses primarily consist of salaries, benefits, stock-based compensation, outside design and consulting services, laboratory supplies, costs of consumables and materials used in product development, and clinical studies and facility costs. We expense all research and development expenses in the periods in which they are incurred. General and Administrative Expenses Our general and administrative expenses include costs associated with our executive, accounting and finance, compliance, information technology, legal, facilities, human resources, administrative, and investor relations activities. These expenses consist primarily of salaries, benefits, stock-based compensation, independent auditor costs, legal fees, consultant costs, insurance premiums, and public company expenses, such as stock transfer agent fees and listing fees for NASDAQ. Foreign Exchange Gains and Losses Transactions in currencies other than our functional currency, theU.S. Dollar, are translated at the prevailing rates on the dates of the applicable transaction. Foreign exchange gains and losses arise from differences in exchange rates during the period between the date a transaction denominated in a foreign currency is consummated and the date on which it is settled or translated. Interest Income and Interest Expense Interest income includes interest earned on our cash and cash equivalents and investments. Interest expense represents interest incurred on our loan payable and on other liabilities. Provision for Income Taxes We make certain estimates and judgments in determining income tax expense for financial statement purposes. These estimates and judgments occur in the calculation of certain tax assets and liabilities, which arise from differences in the timing of recognition of revenue and expense for tax and financial statement purposes. We assess the likelihood that we will be able to recover our deferred tax assets. We consider all available evidence, both positive and negative, including historical levels of income, expectations and risks associated with estimates of future taxable income, and ongoing prudent and feasible tax planning strategies in assessing the need for the valuation allowance. If it is more likely than not that we will not recover our deferred tax assets, we will increase our provision for income taxes by recording a valuation allowance against the deferred tax assets that we estimate will not ultimately be recoverable. 24 -------------------------------------------------------------------------------- Our income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of our tax liabilities involves dealing with uncertainties in the application of complex tax regulations. We recognize liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While we believe we have appropriate support for the positions taken on our tax returns, we regularly assess the potential outcomes of examinations by tax authorities in determining the adequacy of our provision for income taxes. We continually assess the likelihood and amount of potential adjustments and adjust the income tax provision, income taxes payable, and deferred taxes in the period in which the facts that give rise to a revision become known. Results of Operations-Comparison of Years endedDecember 31, 2020 , 2019, and 2018 (dollars in thousands): Years Ended December 31, 2020 vs 2019 2019 vs 2018 2020 2019 2018 $ Change % Change $ Change % Change Revenue$ 171,554 $ 88,021 $ 70,759 $ 83,533 95 %$ 17,262 24 % Our revenue consists primarily of revenue from the sale of test cartridges (which we refer to as consumables), instruments, and other revenues. Revenue increased by$83.5 million , or 95%, when comparing the years endedDecember 31, 2020 and 2019, primarily driven by growth in ePlex product revenue. For the year endedDecember 31, 2020 , ePlex product revenue increased by$92.8 million , or 155%, to$152.6 million primarily due to increases in the sale ofRP2 and SARS-CoV-2 test consumables and instrument sales to both new and existing customers. XT-8 product revenue decreased by$10.5 million over the prior year period, or 39%, to$16.6 million during the year endedDecember 31, 2020 , primarily due to XT-8 customers that converted to our ePlex system for respiratory testing. Revenue increased by$17.3 million , or 24%, when comparing the years endedDecember 31, 2019 and 2018, primarily driven by growth in ePlex product revenue which features a higher selling price than our XT-8 system due to the additional technology and features of its sample-to-answer capabilities. For year endedDecember 31, 2019 , ePlex product revenue increased by$22.2 million , or 59%, to$59.8 million due to new customers adopting the ePlex system for respiratory and blood stream infection testing. ePlex product revenue represented 69% of total product revenue during the year endedDecember 31, 2019 . XT-8 product revenue decreased by$5.3 million to$27.0 million during the year endedDecember 31, 2019 , primarily due to XT-8 customers that converted in 2018 to our ePlex system for respiratory testing. Years Ended December 31, 2020 vs 2019 2019 vs 2018 2020 2019 2018 $ Change % Change $ Change % Change Cost of revenue$ 103,610 $ 59,418 $ 51,278 $ 44,192 74 %$ 8,140 16 % Gross profit$ 67,944 $ 28,603 $ 19,481 $ 39,341 138 %$ 9,122 47 % Gross margin 39.6% 32.5% 27.5% The increase in cost of revenue for the year endedDecember 31, 2020 , compared to the prior year was a result of the growth in ePlex product revenue, which increased by 155% when compared to the prior year and represented 90% of total product revenue during the period. Standard product costs increased by$39.7 million over the prior year due to increases in ePlex product revenue. Cost of revenue also increased by$3.4 million in royalties expense,$0.9 million in freight expense,$0.5 million in customer and product technical support expense, and$0.4 million in instrument repair expense, all as a result of the increases in ePlex product revenue. These increases were offset by decreases of$0.3 million attributable to the realization of manufacturing efficiencies and improvements to overhead absorption and$0.2 million in inventory reserve expense when compared to the prior year. Gross profit increased by$39.3 million , or a gross margin increase of seven percentage points during the year endedDecember 31, 2020 , when compared to the prior year, primarily due to the increase in revenue. The increase in gross margin to 39.6% in the current period was attributable to continued gains in efficiency in the manufacture of ePlex consumables as well as changes in the composition of ePlex product revenue. ePlex instrument sales also comprised a higher percentage of total product revenue and contributed to increased gross profit during 2020 when compared to the prior year. The increase in cost of revenue for the year endedDecember 31, 2019 , when compared to the prior year, is primarily a result of the growth in ePlex product revenue. ePlex revenue increased by 59% when compared to the prior year and represented 69% of total product revenue during the period. The increase in ePlex sales resulted in increased standard product costs of$12.5 million over the prior year as ePlex products carry higher cost profiles due to the enhanced technology and features as compared to XT-8 and corresponding higher average selling prices. Other cost of revenue increased due to increases of$1.1 million in inventory reserves expense and$0.8 million from increased royalties expense resulting from higher product revenue. 25 -------------------------------------------------------------------------------- Gross profit increased by$9.1 million , or a gross margin increase of five percentage points during the year endedDecember 31, 2019 , when compared to the prior year driven entirely by improvements to ePlex gross margin. These increases are the result of continued production gains in the manufacture of ePlex consumables. The increase in gross margin to 32.5% was attributable to decreased costs of$5.8 million due to improved overhead cost absorption and the realization of manufacturing efficiencies and$0.6 million from decreased warranty and customer and product technical support expenses. Years Ended December 31, 2020 vs 2019 2019 vs 2018 2020 2019 2018 $ Change % Change $ Change % Change Sales and marketing$ 23,164 $ 24,118 $ 21,777 $ (954) (4) %$ 2,341 11 % The decrease in sales and marketing expense for the year endedDecember 31, 2020 , when compared to the prior year, was primarily driven by decreases of$1.2 million in evaluation kit expense resulting from the commercial launch of our ePlex BCID Panels during the prior year,$1.2 million in travel expense,$0.3 million in bad debt expense,$0.3 million in depreciation expense, and$0.1 million in marketing expense. These decreases were partially offset by increases of$2.2 million in personnel expense. The increase in sales and marketing expense for the year endedDecember 31, 2019 , when compared to the prior year, was primarily driven by increases of$1.5 million in personnel expense,$0.6 million in evaluation kits expense resulting from new ePlex system evaluations, and$0.3 million in higher allocated facility and information technology expense resulting from increased headcount. Years Ended December 31, 2020 vs 2019 2019 vs 2018 2020 2019 2018 $ Change % Change $ Change % Change General and administrative$ 25,572 $ 19,159 $ 17,545 $ 6,413 33 %$ 1,614 9 % The increase in general and administrative expense for the year endedDecember 31, 2020 , when compared to the prior year, was primarily driven by$4.0 million in costs related to severance payments and stock-based compensation expense resulting from the departure of our former CEO in 2020, as well as increases of$1.0 million in legal related expenses,$0.8 million in professional services expense, and$0.5 million in supplies expense. The increase in general and administrative expense for the year endedDecember 31, 2019 , when compared to the prior year, was primarily related to increases of$1.1 million in personnel expense, including$0.8 million in stock-based compensation expense, and$0.5 million in higher facility and information technology expense. Years Ended December 31, 2020 vs 2019 2019 vs 2018 2020 2019 2018 $ Change % Change $ Change % Change Research and development$ 30,259 $ 27,140 $ 27,931 $ 3,119 11 %$ (791) (3) % The increase in research and development expense for the year endedDecember 31, 2020 , when compared to the prior year, was primarily driven by increases of$2.8 million in personnel expense and$1.0 million increase in prototype materials used by our assay development teams, partially offset by a reduction in expense of$0.7 million related to a grant from BARDA received in the current period. The decrease in research and development expense for the year endedDecember 31, 2019 , when compared to the prior year, was primarily driven by a decrease of$1.5 million in clinical study expense based upon the timing of the completed ePlex BCID clinical studies, which was partially offset by a$0.7 million increase in prototype materials used by our assay development teams. Years Ended December 31, 2020 vs 2019 2019 vs 2018 2020 2019 2018 $ Change % Change $ Change % Change Other expense$ (7,512) $ (5,472) $ (2,589) $ (2,040) 37 %$ (2,883) 111 % Other expense represents non-operating income and expense, including, but not limited to, earnings on cash, cash equivalents, restricted cash, marketable securities, exchange gains and losses of foreign currency denominated balances, and interest expense related to debt. The increases in other expense in each of the years endedDecember 31, 2020 and 2019 were primarily due to higher interest expense from borrowings from our loan and security agreement. Years Ended December 31, 2020 vs 2019 2019 vs 2018 2020 2019 2018 $ Change % Change $ Change % Change Income tax expense$ 81 $ 64 $ 139 $ 17 27 %$ (75) (54) % 26
-------------------------------------------------------------------------------- Due to net losses incurred, we have only recorded tax provisions related to minimum tax payments inthe United States and tax liabilities generated by our foreign subsidiaries, which have remained immaterial. Liquidity and Capital Resources To date, we have funded our operations primarily from the sale of our common stock, borrowings, and cash from operations. We have incurred net losses from continuing operations each year and have not yet achieved profitability. As ofDecember 31, 2020 , we had$128.8 million of working capital, including$128.2 million in cash, cash equivalents, and marketable securities. We believe our existing cash, cash equivalents, and marketable securities as ofDecember 31, 2020 will enable us to fund our operations for at least one year from the date this Annual Report on Form 10-K is filed with theSEC . The following table summarizes, for the periods indicated, selected items in our consolidated statements of cash flows (dollars in thousands): Years
Ended
2020 2019 2018 Net cash provided by (used in) operating activities$ 6,134 $ (34,926) $ (32,512) Net cash provided by (used in) investing activities (96,509) (2,172) 33,947 Net cash provided by financing activities 87,570 45,173 8,069 Effect of exchange rate changes on cash, cash equivalents, and restricted cash (95) (1) 28
Net increase (decrease) in cash, cash equivalents, and restricted cash
$ (2,900) $
8,074
Cash Flows from Operating Activities Net cash provided by operating activities increased by$41.1 million for the year endedDecember 31, 2020 , when compared to the prior year. The increase in cash provided by operating activities was primarily due to a decrease of$28.7 million in net loss, favorable changes in operating assets and liabilities of$11.7 million , and an increase of$0.6 million in non-cash adjustments. The changes in operating assets and liabilities was primarily a result of increases in accounts payable, accrued compensation, operating lease liabilities, and other liabilities, and a decrease in accounts receivable. These favorable changes were partially offset by an increase in inventory. Net cash used in operating activities increased by$2.4 million for the year endedDecember 31, 2019 , when compared to the prior year. The increase in cash used in operating activities was primarily due to unfavorable changes in operating assets and liabilities of$8.9 million , partially offset by a decrease of$3.2 million in net loss and an increase of$3.4 million in non-cash adjustments. The changes in operating assets and liabilities was primarily a result of increases in accounts receivable and inventory due to the growth of ePlex product revenue, a decrease in accrued compensation, and an increase in prepaid expenses and other current assets. These unfavorable changes were partially offset by an increase in accounts payable due to the timing of our payments and an increase in other liabilities. Cash Flows from Investing Activities Net cash used in investing activities increased by$94.3 million for the year endedDecember 31, 2020 , when compared to the prior year, primarily due to increases of$82.1 million in purchases of marketable securities and$15.7 million in purchases of property and equipment. These increases were partially offset by a decrease of$3.4 million in the sale and maturities of marketable securities. Net cash used in investing activities increased by$36.1 million for the year endedDecember 31, 2019 , when compared to the prior year, primarily due to a decrease of$34.2 million in the sale and maturities of marketable securities and an increase of$2.4 million in purchases of marketable securities. The increases in net cash used in investing activities were partially offset by a decrease of$0.5 million in purchases of property and equipment. Cash Flows from Financing Activities Net cash provided by financing activities increased by$42.4 million for the year endedDecember 31, 2020 , when compared to the prior year, primarily due to increases of$65.2 million in net proceeds from the issuance of common stock and$8.6 million from stock option exercises. The increase in cash provided by financing activities was partially offset by a decrease of$31.4 million from net payments on borrowings under our loan and security agreement. Net cash provided by financing activities increased by$37.1 million for the year endedDecember 31, 2019 , when compared to the prior year, primarily due to increases of$24.3 million in net proceeds from borrowings under our loan and security agreement,$12.4 million in net proceeds from the issuance of common stock, and$0.4 million from stock option exercises. 27 -------------------------------------------------------------------------------- We have prepared cash flow forecasts which indicate, based on our current cash resources available, that we will have sufficient resources to fund our business for at least the next 12 months. Factors that could affect our capital requirements, in addition to those previously identified, include, but are not limited to: • the level of revenues and the rate of our revenue growth; • changes in demand from our customers; • the level of cost of revenues and their impact to our gross margin; • the level of expenses required to expand our commercial (sales and marketing) activities; • the level of research and development investment required to develop our diagnostic systems and test menu; • our need to acquire or license complementary technologies; • the costs of filing, prosecuting, defending, and enforcing patent claims and other intellectual property rights; • competing technological and market developments; and • changes in regulatory policies or laws that affect our operations. Loan and Security Agreement OnFebruary 1, 2019 (the "Effective Date"), we entered into a Loan and Security Agreement (the "LSA"), with Solar Capital Ltd. and certain other financial institutions (collectively, the "Lenders"). Pursuant to the LSA and certain subsequent amendments, the Lenders have provided us with$70.0 million in a series of term loans, of which$50.0 million was funded on the Effective Date and an additional$20.0 million was funded inDecember 2019 upon our achievement of a designated amount of product revenues on a trailing six-month basis. The term loans under the LSA accrue interest at a floating per annum rate in effect from time-to-time equal to (a) the greater of 2.51% or the one-monthIntercontinental Exchange Benchmark Administration, Ltd. rate then in effect as of the applicable payment date, plus (b) 5.90% per annum. We are only required to make interest payments on amounts borrowed pursuant to the term loans from the applicable funding date untilFebruary 28, 2022 (the "Interest Only Period"). Following the Interest Only Period, monthly installments of principal and interest under the term loans will be due until the original principal amount and applicable interest is fully repaid byFebruary 1, 2023 . Pursuant to the terms of the LSA, the Lenders are granted a security interest in (a) all of our personal property, other than intellectual property (which is subject to a negative pledge), but including our rights to payment in respect of intellectual property, and (b) the stock of all of our subsidiaries; provided that if the pledge of 100% of the voting shares of our non-U.S. subsidiaries would result in adverse tax consequences, such pledge shall be limited to 65% of the voting stock and 100% of the non-voting stock of each of our non-U.S. subsidiaries. The LSA contains customary affirmative and negative covenants, including, without limitation, delivering reports and notices relating to our financial condition and certain regulatory events and intellectual property matters, as well as limiting the creation of liens, the incurrence of indebtedness, and the making of certain investments, payments and acquisitions, other than as specifically permitted by the LSA. The LSA also contains customary events of default (subject, in certain instances, to specified cure periods), including, but not limited to, the failure to make payments of interest or premium when due, the failure to comply with certain covenants and agreements specified in the LSA, and the occurrence of a material adverse change, certain regulatory events, or certain insolvency events. Upon the occurrence of an event of default, the Lenders may declare all outstanding principal and accrued but unpaid interest under the LSA immediately due and payable and may exercise the other rights and remedies as set forth in the LSA. Equity Distribution Agreement OnAugust 5, 2019 , we entered into an Equity Distribution Agreement (the "Distribution Agreement") withCanaccord Genuity LLC ("Canaccord"), pursuant to which we may offer and sell, from time to time, shares of our common stock having an aggregate offering price of up to$35.0 million . Under the Distribution Agreement, Canaccord may sell shares by any method deemed to be an "at-the-market" offering as defined in Rule 415 under theU.S. Securities Act of 1933, as amended, or any other method permitted by law, including in privately negotiated transactions. We are not obligated to sell any shares under the Distribution Agreement. Canaccord is entitled to a commission of 3% of the aggregate gross proceeds from each sale of shares occurring pursuant to the Distribution Agreement. During the twelve months endedDecember 31, 2020 , we sold 363,120 shares of common stock under the Distribution Agreement at a weighted average price per share of$6.13 resulting in aggregate gross proceeds of$2.2 million . We incurred$67,000 in commissions paid to Canaccord in connection with such sales. As ofDecember 31, 2020 , the Company may issue up to an additional$19.7 million of its common stock under the Distribution Agreement. 28 -------------------------------------------------------------------------------- Biomedical Advanced Research and Development Authority Funding InMarch 2020 , we were awarded$0.7 million from theBiomedical Advanced Research and Development Authority ("BARDA"), part of theDepartment of Health andHuman Services Office of the Assistant Secretary for Preparedness and Response, to develop and pursue FDA EUA of a diagnostic panel that incorporates the new SARS-CoV-2 viral target into our existing ePlexRP Panel . The full$0.7 million was received inSeptember 2020 . InJune 2020 , we submitted ourRP2 Panel to the FDA for EUA. InOctober 2020 , ourRP2 Panel received EUA from the FDA. Underwriting Agreement OnMay 6, 2020 , the Company entered into an Underwriting Agreement (the "Underwriting Agreement") withCowen and Company, LLC andWilliam Blair & Company, LLC acting as joint book-running managers and as representatives of the underwriters named therein (collectively, the "Underwriters") relating to the issuance and sale of 7,253,886 shares of common stock and an option, exercisable by the Underwriters for 30 days, to purchase up to an additional 1,088,082 shares of common stock (the "Offering"). The Offering closed onMay 11, 2020 and the Company sold 8,341,968 shares of common stock, including the full exercise of the Underwriters' option, at a public offering price of$9.65 per share before underwriting discounts and commissions. The Company raised$75.4 million in net proceeds from the Offering, after deducting underwriters discounts and commissions and offering expenses. Letter of Credit The Company has provided an aggregate of$1.6 million in letters of credit to the landlords of certain of its leased facilities and maintains$42,000 in required minimum account balances with the financial institutions issuing such letters of credit. As a result, the Company maintains$1.6 million of restricted cash in connection with these lease agreements as ofDecember 31, 2020 . If we require additional capital, we cannot be certain that it will be available when needed or that our actual cash requirements will not be greater than anticipated. If we raise additional funds through the issuance of equity or convertible debt securities, the percentage ownership of our stockholders could be significantly diluted, and these newly issued securities may have rights, preferences, or privileges senior to those of existing stockholders. If we raise additional funds through collaborations and licensing arrangements, we may be required to relinquish significant rights to our technologies or products, or grant licenses on terms that are not favorable to us. Off-Balance Sheet Arrangements We have no off-balance sheet arrangements as defined in Item 304(a)(4)(ii) of Regulation S-K.The Company has provided$1.6 million in letters of credit to the landlords of certain of its leased facilities, which is recorded as restricted cash on our consolidated balance sheets. Impact of Inflation The effect of inflation and changing prices on our operations was not significant during the periods presented. Contractual Obligations As ofDecember 31, 2020 , we had the following contractual obligations (in thousands):
Payments due by period
Less than 1 More than 5 year 1-3 years 4-5 years years Total
Operating lease obligations(1)
8,822 - - 16,623 Debt obligations(3) 5,969 78,583 - - 84,552 Other contractual obligations 63 117 88 - 268 Total obligations$ 17,126 $ 94,446 $ 5,256 $ 9,491 $ 126,319
(1) We enter into leases in the ordinary course of business with respect to our facilities.
Our lease agreements have fixed payment terms based on the passage of time. Certain
facility leases require payment of maintenance expenses and real estate taxes. Our future
operating lease obligations could change if we terminate certain contracts or if we enter
into additional leases.
(2) We enter into supplier contracts in the ordinary course of our business. Certain supplier
agreements require us to purchase minimum quantities of goods or services on an annual
basis.
(3) Our contractual obligations under the LSA consist of principal payments, interest, and
fees due to the Lenders.
29 -------------------------------------------------------------------------------- Critical Accounting Policies and Estimates Revenue We recognize 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 we expect 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. We consider a performance obligation satisfied once we have 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. We recognize revenue for satisfied performance obligations only when we determine 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. We allocate contract price to each performance obligation in proportion to its stand-alone selling price. The stand-alone selling price is determined by our 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, we make price determinations based on similar product sales data. Inventory We value inventories at the lower of cost or net realizable value on a part-by-part basis and provide an inventory reserve for estimated obsolescence and excess inventory based upon historical turnover, assumptions about future demand for our products, and market conditions. We determine excess and obsolete inventories based on an estimate of the future demand for our products within a specified time horizon, which is generally twelve months. The estimates we use for demand are also used for near-term capacity planning and inventory purchasing and are consistent with our revenue forecasts. If our actual demand is less than our forecast demand, we may be required to take additional excess inventory charges, which would decrease gross margin and adversely impact net operating results in the future. Stock-Based Compensation We generally grant employees and non-employee directors stock-based awards, which typically comprise stock options, restricted stock units, and/or market-based stock units, in connection with their employment or service. We grant stock options with an exercise price equal to the closing price of our common stock on the NASDAQ Global Market on the applicable grant date. We use the Black-Scholes option-pricing model as the method for determining the estimated fair value of stock options, the Monte Carlo Simulation Valuation Model as the method for determining the estimated fair value of our market-based stock units, and we use the grant date fair value of our common stock for valuing restricted stock units. The estimated fair value of stock-based awards exchanged for employee and non-employee director services are expensed over the requisite service period. The stock-based compensation expense related to shares issued under our 2013 Employee Stock Purchase Plan, or ESPP, is also estimated using the Black-Scholes option-pricing model. These models require the use of highly subjective and complex assumptions which determine the fair value of stock-based awards, including the stock award's expected term and the price volatility of the underlying stock. These assumptions include: •Expected Term-expected term represents the period that our 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 our stock price over the expected term of the stock option or award. •Expected Dividend-the pricing models require a single expected dividend yield as an input. We assumed no dividends as we have never paid dividends and have no plans to do so. 30
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•Risk-Free Interest Rate-the risk-free interest rates used in the models are based on published government rates in effect at the time of grant for periods corresponding with the expected term of the option or award. Recent Accounting Pronouncements For a summary of recent accounting pronouncements applicable to our consolidated financial statements, see Note 1, "Summary of Significant Accounting Policies and Significant Accounts" to the Consolidated Financial Statements in Part II, Item 8 of this Annual Report.
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