CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Dec. 31, 2019 |
Dec. 31, 2018 |
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Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 144,291,000 | 136,853,000 |
Common stock, shares outstanding | 144,291,000 | 136,853,000 |
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands |
12 Months Ended | ||
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Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
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Revenue | $ 93,774 | $ 76,051 | $ 51,326 |
Cost of revenue | 33,419 | 31,634 | 22,531 |
Gross profit | 41,230 | 29,274 | 21,037 |
Operating expenses: | |||
Research and development | 60,376 | 42,564 | 33,710 |
Selling, general and administrative | 66,205 | 56,841 | 52,615 |
Total operating expenses | 126,581 | 99,405 | 86,325 |
Loss from operations | (66,226) | (54,988) | (57,530) |
Non-operating (expense) income, net: | |||
Foreign exchange loss | (86) | (87) | (10) |
Interest expense | (6,065) | (4,008) | (3,022) |
Other income, net | 1,396 | 1,748 | 3,864 |
Total non-operating (expense) income, net | (4,755) | (2,347) | 832 |
Loss before income taxes | (70,981) | (57,335) | (56,698) |
Provision for income taxes | 263 | 229 | 3,887 |
Net loss | $ (71,244) | $ (57,564) | $ (60,585) |
Net loss per share: | |||
Basic and diluted | $ (0.51) | $ (0.44) | $ (0.56) |
Weighted average shares used for calculating net loss per share: | |||
Basic and diluted | 139,831 | 131,663 | 108,221 |
Product | |||
Revenue | $ 74,649 | $ 60,908 | $ 43,568 |
Government Contract | |||
Revenue | $ 19,125 | $ 15,143 | $ 7,758 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
12 Months Ended | ||
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Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
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Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (71,244) | $ (57,564) | $ (60,585) |
Other comprehensive income (loss) | |||
Unrealized gains (losses) on available-for-sale investments, net of taxes | 395 | (184) | (200) |
Comprehensive loss | $ (70,849) | $ (57,748) | $ (60,785) |
Nature of Operations and Basis of Presentation |
12 Months Ended |
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Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Nature of Operations and Basis of Presentation |
Note 1. Nature of Operations and Basis of Presentation Cerus Corporation (the “Company”) was incorporated in September 1991 and is developing and commercializing the INTERCEPT Blood System, which is designed to enhance the safety of blood components through pathogen reduction. The Company has worldwide commercialization rights for the INTERCEPT Blood System for platelets, plasma and red blood cells. The Company sells its INTERCEPT platelet and plasma systems in the United States of America (“U.S.”), Europe, the Commonwealth of Independent States (“CIS”) countries, the Middle East and selected countries in other regions around the world. The Company conducts significant research, development, testing and regulatory compliance activities on its product candidates that, together with anticipated selling, general, and administrative expenses, are expected to result in substantial additional losses, and the Company may need to adjust its operating plans and programs based on the availability of cash resources. The Company’s ability to achieve a profitable level of operations will depend on successfully completing development, obtaining additional regulatory approvals and achieving widespread market acceptance of its products. There can be no assurance that the Company will ever achieve a profitable level of operations. |
Summary of Significant Accounting Policies |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Significant Accounting Policies |
Note 2. Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (together with Cerus Corporation, hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Use of Estimates The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to the nature and timing of satisfaction of performance obligations, the timing when the customer obtains control of products or services, the standalone selling price (“SSP”) of performance obligations, variable consideration, accounts receivable, inventory reserves, fair values of investments, stock-based compensation, intangible assets and goodwill, useful lives of intangible assets and property and equipment, income taxes, accrued liabilities, and incremental borrowing rate, among others. The Company bases its estimates on historical experience, future projections, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions. Revenue Revenue is recognized in accordance with Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers”, by applying the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company’s main source of revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or “disposable kits”), UVA illumination devices (“illuminators”), spare parts and storage solutions, and maintenance services of illuminators. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. The Company uses a binding purchase order or signed sales contract as evidence of a contract and satisfaction of its policy. Generally, the Company’s contracts with its customers do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming product. The contracts with customers can include various combinations of products, and to a lesser extent, services. The Company must determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or are accounted for as a combined performance obligation. The Company must allocate the transaction price to each performance obligation on a relative SSP basis, and recognize the product revenue when the performance obligation is satisfied. The Company determines the SSP by using the historical selling price of the products and services. If the amount of consideration in a contract is variable, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely amount method, to the extent it is probable that a significant future reversal of cumulative product revenue under the contract will not occur. Product revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration to which the Company expects to receive in exchange for those products or services. Product revenue from the sale of illuminators, disposable kits, spare parts and storage solutions are recognized upon the transfer of control of the products to the customer. Product revenue from maintenance services are recognized ratably on a straight-line basis over the term of maintenance as customers simultaneously consume and receive benefits. Freight costs charged to customers are recorded as a component of product revenue. Taxes that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such tax from product revenue. The Company receives reimbursement under its U.S. government contract with the Biomedical Advanced Research and Development Authority (“BARDA”) that supports research and development of defined projects. See “Note 13 Development and License Agreements—Agreement with BARDA”. The contract generally provides for reimbursement of approved costs incurred under the terms of the contract. Revenue related to the cost reimbursement provisions under the Company’s U.S. government contract are recognized as the qualified direct and indirect costs on the projects are incurred. The Company invoices under its U.S. government contract using the provisional rates in the government contract and thus is subject to future audits at the discretion of government. These audits could result in an adjustment to government contract revenue previously reported, which adjustments potentially could be significant. The Company believes that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. Costs incurred related to services performed under the contract are included as a component of research and development or selling, general and administrative expenses in the Company’s consolidated statements of operations. The Company’s use of estimates in recording accrued liabilities for government contract activities (see “Use of Estimates” above) affects the revenue recorded from development funding and under the government contract.
Disaggregation of Product Revenue Product revenue by geographical locations of customers during the years ended December 31, 2019, 2018 and 2017, were as follows (in thousands):
Contract Balances The Company invoices its customers based upon the terms in the contracts, which generally requires payment 30 to 60 days from the date of invoice. Accounts receivable are recorded when the Company’s right to the consideration are estimated to be unconditional. The Company had no contract assets at December 31, 2019 and December 31, 2018. Contract liabilities mainly consist of deferred product revenue related to maintenance services, unshipped products, and uninstalled illuminators. Maintenance services are generally billed upfront at the beginning of each annual service period and recognized ratably over the service period. The increase in the deferred product revenue balance for the year ended December 31, 2019, is primarily driven by performance obligations not satisfied but invoiced as of December 31, 2019, offset by $0.5 million of revenue recognized that were included in the deferred product revenue balance as of December 31, 2018. The Company applies an optional exemption to not disclose the value of unsatisfied performance obligations for contracts that have an original expected duration of one year or less. Research and Development Expenses Research and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of the Company’s U.S. government contract. Research and development expenses include salaries and related expenses for scientific and regulatory personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of R&D facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use. The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D expenses recorded from development funding and under its U.S. government contract. Actual results may differ from those estimates under different assumptions or conditions. Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be classified as cash equivalents. These investments primarily consist of money market instruments, and are classified as available-for-sale. Investments Investments with original maturities of greater than three months primarily include corporate debt and U.S. government agency securities that are designated as available-for-sale and classified as short-term investments. Available-for-sale securities are carried at estimated fair value. The Company views its available-for-sale portfolio as available for use in its current operations. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Unrealized gains (losses) on available-for-sale investments, net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments, if any, were recorded in “Other income, net” on the Company’s consolidated statements of operations. The costs of securities sold are based on the specific identification method, if applicable. The Company reported the amortization of any premium and accretion of any discount resulting from the purchase of debt securities as a component of interest income. The Company also reviews its available-for-sale securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value. Other-than-temporary declines in market value, if any, are recorded in “Other income, net” on the Company’s consolidated statements of operations. Restricted Cash As of December 31, 2019 and December 31, 2018, the Company’s “Restricted cash” primarily consisted of a letter of credit relating to the lease of the Company’s new office building. As of December 31, 2019 and December 31, 2018, the Company also had certain non-U.S. dollar denominated deposits recorded as “Restricted cash” in compliance with certain foreign contractual requirements. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, available-for-sale securities and accounts receivable. Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and available-for-sale securities are maintained at major financial institutions of high credit standing. The Company monitors the financial credit worthiness of the issuers of its investments and limits the concentration in individual securities and types of investments that exist within its investment portfolio. Generally, all of the Company’s investments carry high credit quality ratings, which is in accordance with its investment policy. At December 31, 2019, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments. Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company establishes an allowance for doubtful accounts against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general and administrative expenses. The Company had three customers and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2019 and December 31, 2018, respectively. These customers cumulatively represented approximately 56% and 50% of the Company’s outstanding trade receivables at December 31, 2019 and December 31, 2018, respectively. To date, the Company has not experienced collection difficulties from these customers. Inventories At December 31, 2019 and December 31, 2018, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, illuminators, and certain replacement parts for the illuminators. Platelet and plasma systems’ disposable kits generally have 18 to 24 month shelf lives from the date of manufacture. Illuminators and replacement parts do not have regulated expiration dates. Work-in-process includes certain components that are manufactured over a protracted length of time before being sold to, and ultimately incorporated and assembled by Fresenius Kabi Deutschland GmbH or Fresenius, Inc. (with their affiliates, “Fresenius”) into the finished INTERCEPT disposable kits. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production within the next twelve-month period and evaluates its finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At December 31, 2019 and December 31, 2018, the Company classified its work-in-process inventory as a current asset on its consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective subsequent twelve-month period. Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or net realizable value. The Company uses significant judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently reviews such determinations. The Company writes down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use in the period that it is first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded in “Cost of product revenue” on the Company’s consolidated statements of operations. At December 31, 2019 and December 31, 2018, the Company had $0.1 million and $0.3 million, respectively, recorded for potential obsolete, expiring or unsalable product. Property and Equipment, net Property and equipment is comprised of furniture, equipment, leasehold improvements, construction-in-progress, information technology hardware and software and is recorded at cost. At the time the property and equipment is ready for its intended use, it is depreciated on a straight-line basis over the estimated useful lives of the assets (generally three to five years). Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or the estimated useful lives of the improvements. As of December 31, 2019 and December 31, 2018, the Company capitalized construction-in-progress costs included in “Property and Equipment, net” on the Company’s consolidated balance sheets, of zero and $6.9 million, respectively, related to leasehold improvements. As of December 31, 2019 and December 31, 2018, the Company had receivables included in “Prepaid and other current assets” on the Company's consolidated balance sheets, of zero and $1.2 million, respectively, related to its new office building.
Goodwill and Intangible Assets, net Intangible assets, net, which include a license for the right to commercialize the INTERCEPT Blood System in Asia, are subject to ratable amortization over the original estimated useful life of ten years. Accumulated amortization of intangible assets as of December 31, 2019 and December 31, 2018, was $1.9 million and $1.7 million, respectively. Goodwill is not amortized but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each fiscal year, or more frequently if indicators of impairment exist. The test for goodwill impairment may be assessed using qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing the quantitative goodwill impairment test. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative impairment test; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The quantitative goodwill impairment test compares the fair value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it operates in one reporting unit and estimates the fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess, limited to the carrying amount of goodwill in the Company’s one reporting unit. The Company performs an impairment test on its intangible assets if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the excess amount of the carrying value of the intangible assets over its fair value. During the year ended December 31, 2019, 2018 and 2017, there were no impairment charges recognized related to the acquired intangible assets. Long-lived Assets The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the expected undiscounted future cash flows are less than the carrying amount of these assets, the Company then measures the amount of the impairment loss based on the excess of the carrying amount over the fair value of the assets. Foreign Currency Remeasurement The functional currency of the Company’s foreign subsidiary is the U.S. dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using historical exchange rates. Product revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated statements of operations. Stock-Based Compensation Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved. For stock-based awards issued to non-employees, the Company recognizes stock-based compensation expense for the grant date fair value of the vested portion of the awards in its consolidated statements of operations. See Note 11 for further information regarding the Company’s stock-based compensation assumptions and expenses. Income Taxes The provision for income taxes is accounted for using an asset and liability approach, under which deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company does not recognize tax positions that do not have a greater than 50% likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation allowance is not an appropriate substitute for derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s U.S. federal tax returns for years 1999 through 2018, California tax returns for years through 2018, and Netherlands tax returns for years 2015 through 2018 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a valuation allowance on substantially all of its net deferred tax assets. Net Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share gives effect to all potentially dilutive common shares outstanding for the period. The potentially dilutive securities include stock options, employee stock purchase plan rights and restricted stock units, which are calculated using the treasury stock method. For the years ended December 31, 2019, 2018 and 2017, all potentially dilutive securities outstanding have been excluded from the computation of dilutive weighted average shares outstanding because such securities have an antidilutive impact due to losses reported. The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the years ended December 31, 2019, 2018 and 2017 (in thousands, except per share amounts):
The table below presents potential shares that were excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2019, 2018 and 2017 (shares in thousands):
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the Company’s consolidated balance sheets. As of December 31, 2019 and December 31, 2018, the Company did not have finance leases.
ROU assets and operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The ROU asset also includes any lease payments made and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain to be exercised. Operating leases are recognized on a straight-line basis over the lease term.
Guarantee and Indemnification Arrangements The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a third-party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions. The Company generally provides for a warranty on certain of its INTERCEPT blood-safety products covering defects in materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. The Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims. Accordingly, the Company had not accrued for any future warranty costs for its products at December 31, 2019 and December 31, 2018.Fair Value of Financial Instruments The Company applies the provisions of fair value relating to its financial assets and liabilities. The carrying amounts of accounts receivables, accounts payable, and other accrued liabilities approximate their fair value due to the relative short-term maturities. Based on the borrowing rates currently available to the Company for loans with similar terms, the Company believes the fair value of its debt approximates their carrying amounts. The Company measures and records certain financial assets and liabilities at fair value on a recurring basis, including its available-for-sale securities. The Company classifies instruments within Level 1 if quoted prices are available in active markets for identical assets, which include the Company’s cash accounts and money market funds. The Company classifies instruments in Level 2 if the instruments are valued using observable inputs to quoted market prices, benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with reasonable levels of price transparency. These instruments include the Company’s corporate debt and U.S. government agency securities holdings. The available-for-sale securities are held by a custodian who obtains investment prices from a third-party pricing provider that uses standard inputs (observable in the market) to models which vary by asset class. The Company classifies instruments in Level 3 if one or more significant inputs or significant value drivers are unobservable. The Company assesses any transfers among fair value measurement levels at the end of each reporting period. See Note 3 for further information regarding the Company’s valuation of financial instruments. New Accounting Pronouncements Recently adopted accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases, which, for operating leases, requires a lessee to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its consolidated balance sheet. The standard also requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally straight-line basis. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which provides for certain practical expedient when implementing the new leases standard. The Company adopted the new accounting standard on January 1, 2019, using the modified retrospective method and elected the package of practical expedients for expired or existing contracts, which allowed the Company not to reassess (1) whether contracts are or contain leases, (2) lease classification and (3) initial direct costs. The Company recorded right-of-use assets of $2.4 million in “Operating lease right-of-use assets” in the Company's consolidated balance sheets, and lease liabilities of $2.4 million in aggregate in “Operating lease liabilities – current” and “Operating lease liabilities – non-current” in the Company’s consolidated balance sheets on the adoption date. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes, which eliminates certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard is effective for annual periods beginning after December 15, 2020, and interim periods thereafter, with early application permitted. The Company elected to early adopt the new standard prospectively at the beginning of the fourth quarter of 2019. The adoption of this ASU had no material impact on the Company’s consolidated financial statements. Recently issued accounting pronouncements not yet adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires measurement and recognition of expected credit losses for financial assets held. The standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with early application permitted. The Company plans to adopt this ASU on January 1, 2020, using the modified retrospective method. The adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements. |
Available-for-sale Securities and Fair Value on Financial Instruments |
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Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Available-for-sale Securities and Fair Value on Financial Instruments |
Note 3. Available-for-sale Securities and Fair Value on Financial Instruments Available-for-sale Securities The following is a summary of available-for-sale securities at December 31, 2019 (in thousands):
The following is a summary of available-for-sale securities at December 31, 2018 (in thousands):
Available-for-sale securities at December 31, 2019 and 2018, consisted of the following by contractual maturity (in thousands):
As of December 31, 2019, the Company did not have any available-for-sale securities in an unrealized net loss position. The following tables show all available-for-sale marketable securities in an unrealized loss position for which an other-than-temporary impairment has not been recognized and the related gross unrealized losses and fair value, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands):
The Company typically invests in highly-rated securities, and its investment policy limits the amount of credit exposure to any one issuer. The policy generally requires investments to be investment grade, with the primary objective of minimizing the potential risk of principal loss. Fair values were determined for each individual security in the investment portfolio. When evaluating an investment for other-than-temporary impairment, the Company reviews factors such as the length of time and extent to which fair value has been below its cost basis, the financial condition of the issuer and any changes thereto, changes in market interest rates, and the Company’s intent to sell, or whether it is more likely than not it will be required to sell, the investment before recovery of the investment’s cost basis. During the years ended December 31, 2019, 2018 and 2017, the Company did not recognize any other-than-temporary impairment loss. The Company has no current requirement or intent to sell the securities in an unrealized loss position. The Company expects to recover up to (or beyond) the initial cost of investment for securities held. During the years ended December 31, 2019, 2018 and 2017, the Company sold zero, zero and 346,700 shares of Aduro Biotech, Inc., or Aduro, common stock, respectively, and recognized zero, zero, and $3.5 million gross realized gains, respectively, which werereclassified out of accumulated other comprehensive income into “Other income, net” on the Company’s consolidated statements of operations. As of December 31, 2019 and 2018, the Company had no remaining investment in Aduro’s common stock. The Company did not record any gross realized losses during the years ended December 31, 2019, 2018 and 2017. Fair Value Disclosures The Company uses certain assumptions that market participants would use to determine the fair value of an asset or liability in pricing the asset or liability in an orderly transaction between market participants at the measurement date. The identification of market participant assumptions provides a basis for determining what inputs are to be used for pricing each asset or liability. A fair value hierarchy has been established which gives precedence to fair value measurements calculated using observable inputs over those using unobservable inputs. This hierarchy prioritized the inputs into three broad levels as follows:
Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. To estimate the fair value of Level 2 debt securities as of December 31, 2019, the Company’s primary pricing service relies on inputs from multiple industry-recognized pricing sources to determine the price for each investment. Corporate debt and U.S. government agency securities are systematically priced by this service as of the close of business each business day. If the primary pricing service does not price a specific asset a secondary pricing service is utilized. The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2019 (in thousands):
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2018 (in thousands):
The Company did not have any transfers among fair value measurement levels during the years ended December 31, 2019 and 2018. |
Inventories |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories |
Note 4. Inventories Inventories at December 31, 2019 and 2018, consisted of the following (in thousands):
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Property and Equipment, net |
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Property Plant And Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, net |
Note 5. Property and Equipment, net Property and equipment, net at December 31, 2019 and 2018, consisted of the following (in thousands):
Depreciation and amortization expense related to property and equipment, net was $2.2 million, $1.1 million and $1.2 million for the years ended December 31, 2019, 2018 and 2017, respectively. There were no impairments for long-lived assets for the years ended December 31, 2019, 2018 and 2017. |
Goodwill and Intangible Assets, net |
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Goodwill And Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets, net |
Note 6. Goodwill and Intangible Assets, net Goodwill During the year ended December 31, 2019, the Company did not dispose of or recognize additional goodwill. On August 31, 2019, the Company performed its impairment test of goodwill. As described in Note 2 above, the Company applied the enterprise approach by reviewing the quoted market capitalization of the Company as reported on the Nasdaq Global Market to calculate the fair value. In addition, the Company considered its future forecasted results, the economic environment and overall market conditions. As a result of the Company’s assessment that its fair value of the reporting unit exceeded its carrying amount, the Company determined that goodwill was not impaired. Intangible Assets, net The following is a summary of intangible assets, net at December 31, 2019 (in thousands):
The following is a summary of intangible assets, net at December 31, 2018 (in thousands):
During the years ended December 31, 2019, 2018 and 2017, there were no impairment charges recognized related to the Company’s intangible assets. At December 31, 2019, the expected remaining annual amortization expense of the intangible assets, net is $0.1 million for the year ending December 31, 2020. |
Accrued Liabilities |
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Payables And Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Liabilities |
Note 7. Accrued Liabilities Accrued liabilities at December 31, 2019 and 2018, consisted of the following (in thousands):
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Debt |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt |
Note 8. Debt Debt at December 31, 2019, consisted of the following (in thousands):
Debt at December 31, 2018, consisted of the following (in thousands):
Principal, interest and fee payments on Term Loan Credit Agreement at December 31, 2019, are expected to be as follows (in thousands):
Loan Agreements Prior to March 29, 2019, the Company maintained a loan and security agreement (the “Oxford Term Loan Agreement”) with Oxford Finance LLC (“Oxford”). The Oxford Term Loan Agreement provided for secured growth capital term loans of up to $40.0 million. The Oxford Term Loan Agreement was available in two tranches. The first tranche of $30.0 million (“2017 Term Loan A”) was drawn by the Company on July 31, 2017, with the proceeds used in part to repay in full all of the outstanding term loans under the previous Term Loan Agreement of $17.6 million and the final payment of the previous Term Loan Agreement of $1.4 million. The availability of the second tranche of $10.0 million (“2017 Term Loan B”) expired on May 14, 2018, and the Company did not elect to draw the 2017 Term Loan B.
On March 29, 2019 (the “Closing Date”), the Company entered into a Credit, Security and Guaranty Agreement (Term Loan) (the “Term Loan Credit Agreement”) with MidCap Financial Trust (“MidCap”) to borrow up to $70 million in three tranches (collectively “2019 Term Loan”), with a maturity date of March 1, 2024. The first advance of $40.0 million (“Tranche 1”) was drawn by the Company on March 29, 2019, with the proceeds used in part to repay in full the outstanding term loans and fees under the Oxford Term Loan Agreement. The Company repaid principal and interest in an aggregate amount equal to approximately $31.2 million and prepayment fees in an aggregate amount equal to approximately $0.6 million, and terminated all obligations under the Oxford Term Loan Agreement. As a result, the Company recorded a loss of $2.1 million on the extinguishment of Oxford term loans in “Interest expense” on the Company's consolidated statements of operations. The second advance of $15.0 million (“Tranche 2”) will be available to the Company from January 1, 2020 through December 31, 2020, subject to the Company’s satisfaction of certain conditions described in the Term Loan Credit Agreement, and (ii) the third advance of $15.0 million (“Tranche 3”) will be available to the Company starting April 1, 2020, through March 31, 2021, subject to the Company’s satisfaction of certain other conditions described in the Term Loan Credit Agreement. The borrowings under the 2019 Term Loan bears interest at the sum of a fixed percentage spread and the greater of (i) 1.8% or (ii) one month LIBOR. The effective interest rate on the Term Loan at December 31, 2019 was approximately 7.50%. All three tranches require interest only payments through March 1, 2022, followed by 24 months of payments with interest and equal payment of principal. The interest only payment period can be extended for 12 months upon achievement of a specified trailing twelve month net revenue target. Prepayments of the 2019 Term Loan under the Term Loan Credit Agreement, in whole or in part, will be subject to early termination fees which decline each year until the fourth anniversary of the applicable funding date, at which time there is no early termination fee. Upon the final payment, the Company must also pay an exit fee calculated based on a percentage of the aggregate principal amount of all tranches advanced to the Company.
The Company also entered into a Credit, Security and Guaranty Agreement (Revolving Loan) (the “Revolving Loan Credit Agreement”) with MidCap on March 29, 2019, to initially borrow up to $5.0 million. The amount borrowed under the Revolving Loan Credit Agreement can be increased, upon request by the Company by up to an additional $15.0 million, subject to agent and lender approval and the satisfaction of certain conditions. The Revolving Loan Credit Agreement has a maturity date of March 1, 2024. Amounts drawn under the Revolving Loan Credit Agreement bear interest at the sum of a fixed percentage spread and the greater of (i) 1.80% or (ii) one month LIBOR. There are also fractional fees based on the amounts either drawn or undrawn. If the Revolving Loan Credit Agreement is terminated before maturity or the funding obligation is permanently reduced, there are termination fees which decline each anniversary until the third anniversary, at which time there is no termination fee. As of December 31, 2019, the Company had borrowed $5.0 million under the Revolving Loan Credit Agreement, which is included in “Debt – current” in the Company’s consolidated balance sheets.
The Term Loan Credit Agreement and Revolving Loan Credit Agreement contain certain financial and non-financial covenants, with which the Company was in compliance at December 31, 2019. Additionally, both agreements are secured by substantially all of the Company’s assets, with some exclusions. |
Commitments and Contingencies |
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Commitments And Contingencies Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies |
Note 9. Commitments and Contingencies Operating Leases The Company leases its office facilities, located in Concord, California and Amersfoort, the Netherlands, and certain equipment and automobiles under non-cancelable operating leases with initial terms in excess of one year that require the Company to pay operating costs, property taxes, insurance and maintenance. The operating leases expire at various dates through 2030, with certain of the leases providing for renewal options, provisions for adjusting future lease payments based on the consumer price index, and the right to terminate the lease early. The Company does not assume renewals in determination of the lease term unless the renewals are deemed to be reasonably assured at lease commencement. The Company recorded the lease right-of-use asset and obligation at the present value of lease payments over the lease term. The rates implicit in the Company’s leases are generally not readily determinable. The Company must estimate its incremental borrowing rate to discount the lease payments to present value. Operating lease assets also include lease incentives. Supplemental cash flow information related to operating leases is as follows (dollars in thousands):
Future minimum non-cancelable payments under operating leases as of December 31, 2019, were as follows (in thousands):
During the years ended December 31, 2019, 2018 and 2017, the Company recorded operating lease expenses of $3.4 million, $1.6 million and $1.4 million, respectively. As of December 31, 2019, the Company had no leases that have not yet commenced.
Purchase Commitments The Company is party to agreements with certain providers for certain components of the INTERCEPT Blood System. Certain of these agreements require minimum purchase commitments from the Company. The Company has paid $13.7 million, $10.0 million and $6.7 million for goods under agreements which are subject to minimum purchase commitments during the years ended December 31, 2019, 2018 and 2017, respectively. As of December 31, 2019, the Company had future minimum purchase commitments under these agreements of approximately $9.7 million, $2.9 million, $0.2 million, $0.2 million, and $0.6 million for the years ending December 31, 2020, 2021, 2022, 2023, and 2024, respectively. |
Stockholders' Equity |
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Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity |
Note 10. Stockholders’ Equity Sales Agreement On August 4, 2017, the Company entered into Amendment No. 3 to the Controlled Equity Offering SM Sales Agreement with Cantor Fitzgerald & Co.(as amended on August 4, 2017, the “Amended Cantor Agreement”). The Amended Cantor Agreement became effective on January 8, 2018, and provided for the issuance and sale of shares of the Company’s common stock having an aggregate offering price of up to $70.0 million through Cantor Fitzgerald & Co. (“Cantor”), which amount included the $31.4 million of unsold shares of common stock available for sale immediately prior to the effectiveness of the Amended Cantor Agreement. Under the Amended Cantor Agreement, Cantor also acts as the Company’s sales agent and receives compensation based on an aggregate of 2% of the gross proceeds on the sale price per share of its common stock. The issuance and sale of these shares by the Company pursuant to the Amended Cantor Agreement are deemed an “at-the-market” offering and are registered under the Securities Act of 1933, as amended. During the year ended December 31, 2019, 5.6 million shares of the Company’s common stock were sold under the Amended Cantor Agreement for aggregate net proceeds of $26.9 million. During the year ended December 31, 2018, 4.2 million shares of the Company’s common stock were sold under the Amended Cantor Agreement for net proceeds of $27.9 million. At December 31, 2019, the Company had approximately $14.1 million of common stock available to be sold under the Amended Cantor Agreement. |
Stock-Based Compensation |
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Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation |
Note 11. Stock-Based Compensation Employee Stock Plans Employee Stock Purchase Plan The Company maintains an Employee Stock Purchase Plan (the “Purchase Plan”), which is intended to qualify as an employee stock purchase plan within the meaning of Section 423(b) of the Internal Revenue Code. Under the Purchase Plan, the Company’s Board of Directors may authorize participation by eligible employees, including officers, in periodic offerings. Under the Purchase Plan eligible employee participants may purchase shares of common stock of the Company at a purchase price equal to 85% of the lower of the fair market value per share on the start date of the offering period or the fair market value per share on the purchase date. The Purchase Plan consists of a fixed offering period of 12 months with two purchase periods within each offering period. At December 31, 2019, the Company had 0.6 million shares available for future issuance. 2008 Equity Incentive Plan and Inducement Plan The Company also maintains an equity compensation plan to provide long-term incentives for employees, contractors, and members of its Board of Directors. The Company currently grants equity awards from one plan, the 2008 Equity Incentive Plan and its subsequent amendments (collectively, the Amended “2008 Plan”). The Amended 2008 Plan allows for the issuance of non-statutory and incentive stock options, restricted stock, restricted stock units (“RSUs”), stock appreciation rights, other stock-related awards, and performance awards which may be settled in cash, stock, or other property. On June 5, 2019, the Company’s stockholders approved an amendment and restatement of the 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance under the 2008 Plan by 11,800,000 shares. Option awards under the Amended 2008 Plan generally have a maximum term of 10 years from the date of the award. The Amended 2008 Plan generally requires options to be granted at 100% of the fair market value of the Company’s common stock subject to the option on the date of grant. Options granted by the Company to employees generally vest over four years. RSUs are measured based on the fair market value of the underlying stock on the date of grant. RSUs granted by the Company to employees generally vest over three to four years. Performance-based stock or cash awards granted under the Amended 2008 Plan are limited to either 500,000 shares of common stock or $1.0 million per recipient per calendar year. At December 31, 2019, 35,000 performance-based stock awards were outstanding. At December 31, 2019, the Company had an aggregate of approximately 31.4 million shares of its common stock subject to outstanding options or unvested RSUs, or remaining available for future issuance under the Amended 2008 Plan, of which approximately 16.8 million shares and 4.1 million shares were subject to outstanding options and unvested RSUs, respectively, and approximately 10.5 million shares were available for future issuance under the Amended 2008 Plan. The Company’s policy is to issue new shares of common stock upon the exercise of options or vesting of RSUs. Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share amounts):
Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts):
The total fair value of RSUs as of their respective vesting dates, for the years ended December 31, 2019, 2018 and 2017, were $5.6 million, $2.8 million and $1.0 million, respectively.
Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2019, was as follows (in thousands except weighted average exercise price and contractual term):
The aggregate intrinsic value in the table above is calculated as the difference between the exercise price of the stock option and the Company’s closing stock price on the last trading day of each respective fiscal period. The total intrinsic value of options exercised for the years ended December 31, 2019, 2018 and 2017, was $1.6 million, $7.1 million and $0.6 million, respectively. The total intrinsic value of exercised stock options is calculated based on the difference between the exercise price and the quoted market price of the Company’s common stock as of the close of the exercise date. Stock-based Compensation Expense Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended December 31, 2019, 2018 and 2017, was as follows (in thousands):
Stock-based compensation expense in the above table does not reflect any income taxes as the Company has experienced a history of net losses since its inception and has a nearly full valuation allowance on its deferred tax assets. In addition, there was neither income tax benefits realized related to stock-based compensation expense nor any stock-based compensation costs capitalized as part of an asset during the years ended December 31, 2019, 2018 and 2017. The Company has also not recorded any stock-based compensation associated with performance-based stock options during the years ended December 31, 2019, 2018 and 2017. As of December 31, 2019, the Company expects to recognize the remaining unamortized stock-based compensation expense of $6.0 million and $14.1 million, respectively, related to non-vested stock options and RSUs, net of estimated forfeitures, over an estimated remaining weighted average period of 1.8 years and 1.9 years, respectively. Valuation Assumptions for Stock-based Compensation The Company uses the Black-Scholes option pricing model to determine the grant-date fair value of stock options and employee stock purchase plan rights. The Black-Scholes option-pricing model is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables, which include the expected term of the grants, actual and projected employee stock option exercise behaviors, including forfeitures, the Company’s expected stock price volatility, the risk-free interest rate and expected dividends. The Company recognizes the grant-date fair value of the stock award as stock-based compensation expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. The expected life of the stock options is based on observed historical exercise patterns. Groups of employees having similar historical exercise behavior are considered separately for valuation purposes. The Company estimates stock option forfeitures based on historical data for employee groups. The total number of stock options expected to vest is adjusted by actual and estimated forfeitures. The expected volatility is estimated by using historical volatility of the Company’s common stock. The risk-free interest rate is based on the implied yield on a U.S. Treasury zero-coupon issue with a remaining term commensurate with the expected term of the option. The Company does not anticipate paying any cash dividends in the foreseeable future and therefore uses an expected dividend yield of zero. The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2019, 2018 and 2017, was as follows:
The weighted average grant-date fair value of stock options granted during the years ended December 31, 2019, 2018 and 2017, was $2.73 per share, $2.41 per share and $1.98 per share, respectively. The weighted average grant-date fair value of employee stock purchase rights during the years ended December 31, 2019, 2018 and 2017, was $1.84 per share, $2.29 per share and $1.18 per share, respectively.
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Retirement Plan |
12 Months Ended |
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Dec. 31, 2019 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plan |
Note 12. Retirement Plan The Company maintains a defined contribution savings plan (the “401(k) Plan”) that qualifies under the provisions of Section 401(k) of the Internal Revenue Code and covers eligible U.S. employees of the Company. Under the terms of the 401(k) Plan, eligible U.S. employees may make pre-tax dollar or post-tax (Roth) contributions of up to 60% of their eligible pay up to a maximum cap established by the IRS. The Company may contribute a discretionary percentage of qualified individual employee’s salaries, as defined, to the 401(k) Plan. In 2019, the Company began providing a 401(k) match, subject to certain limitations. Under the 401(k) match, the Company matches 50% of the first 6% of each employee’s 401(k) contribution, up to an annual maximum of $5,000. The employer match will vest immediately.
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Development and License Agreements |
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Development And License Agreements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Development and License Agreements |
Note 13. Development and License Agreements Agreements with Fresenius Fresenius Kabi AG (“Fresenius”) manufactures and supplies the platelet and plasma systems to the Company under a supply agreement (the “Supply Agreement”). Fresenius is obligated to sell, and the Company is obligated to purchase, finished disposable kits for the Company’s platelet and plasma systems and the Company’s red blood cell system product candidate (the “RBC Sets”). The Supply Agreement permits the Company to purchase platelet and plasma systems and RBC Sets from third parties to the extent necessary to maintain supply qualifications with such third parties or where local or regional manufacturing is needed to obtain product registrations or sales. Pricing terms per unit are initially fixed and decline at specified annual production levels, and are subject to certain adjustments after the initial pricing term. Under the Supply Agreement, the Company maintains the amounts due from the components sold to Fresenius as a current asset on its accompanying consolidated balance sheets until such time as the Company purchases finished disposable kits using those components. The Supply Agreement also required the Company to make certain payments totaling €8.6 million (“Manufacturing and Development Payments”) to Fresenius. Because these payments represented unconditional payment obligations, the Company recognized its liability for these payments at their net present value at discount rate of 9.72% based on the Company’s effective borrowing rate at that time. The Manufacturing and Development Payments liability was accreted through interest expense based on the estimated timing of its ultimate settlement. In 2016, the Company paid €3.1 million to Fresenius. In August 2019, the Company paid the remaining €5.5 million to Fresenius. The Supply Agreement also required the Company to make payments to support certain projects Fresenius has and will perform on behalf of the Company related to certain R&D activities and manufacturing efficiency activities for which certain assets have been established in the Company’s consolidated balance sheets. The manufacturing efficiency asset is expensed on a straight line basis over the life of the Supply Agreement. The prepaid asset related to amounts paid up front for the R&D activities to be conducted by Fresenius on behalf of the Company is expensed over the period which such activities occur. The following table summarizes the amounts of prepaid R&D asset and manufacturing efficiency asset at December 31, 2019 and 2018(in thousands).
The initial term of the Supply Agreement extends through July 1, 2025 (the “Initial Term”) and is automatically renewed thereafter for additional two-year terms (each, a “Renewal Term”), subject to termination by either party upon (i) two years written notice prior to the expiration of the Initial Term or (ii) one year written notice prior to the expiration of any Renewal Term. Under the Supply Agreement, the Company has the right, but not the obligation, to purchase certain assets and assume certain liabilities from Fresenius. The Company made payments to Fresenius of $29.5 million, $21.3 million and $18.1 million relating to the manufacturing of the Company’s products during the years ended December 31, 2019, 2018 and 2017, respectively. The following table summarizes the amounts of the Company’s payables to and receivables from Fresenius at December 31, 2019 and December 31, 2018 (in thousands).
Agreement with BARDA In June 2016, the Company entered into an agreement with BARDA to support the Company’s development and implementation of pathogen reduction technology for platelet, plasma, and red blood cells. The agreement with BARDA and its subsequent modifications include a base period (the “Base Period”) and options (each, an “Option Period”) with committed funding of up to $103.2 million for clinical development of the INTERCEPT Blood System for red blood cells (the “red blood cell system”), and the potential for the exercise by BARDA of subsequent Option Periods that, if exercised by BARDA and completed, would bring the total funding opportunity to $201.2 million over the five-year contract period. If exercised by BARDA, subsequent Option Periods would fund activities related to broader implementation of the platelet and plasma system or the red blood cell system in areas of Zika virus risk, clinical and regulatory development programs in support of the potential licensure of the red blood cell system in the U.S., and development, manufacturing and scale-up activities for the red blood cell system. The Company is responsible for co-investment of $5.0 million and would be responsible for an additional $9.6 million, if certain Option Periods are exercised. Through December 31, 2019, the Company has incurred approximately $0.8 million related to the co-investment. BARDA will make periodic assessments of the Company’s progress and the continuation of the agreement is based on the Company’s success in completing the required tasks under the Base Period and each exercised Option Period. BARDA has rights under certain contract clauses to terminate the agreement, including the ability to terminate the agreement for convenience at any time.As of December 31, 2019 and 2018, $4.2 million and $2.3 million, respectively, of billed and unbilled amounts were included in accounts receivable on the Company’s consolidated balance sheets related to BARDA.
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Income Taxes |
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Income Tax Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Income Taxes |
Note 14. Income Taxes
U.S and foreign components of consolidated loss before income taxes for the years ended December 31, 2019, 2018 and 2017, was as follows (in thousands):
The provision for income taxes for the years ended December 31, 2019, 2018 and 2017, was as follows (in thousands):
The difference between the provision for income taxes and the amount computed by applying the federal statutory income tax rate to loss before taxes for the years ended December 31, 2019, 2018 and 2017, was as follows (in thousands):
The Tax Cuts and Jobs Act (the “Tax Act”) resulted in a significant revaluation in the Company’s deferred tax balances as of the date of December 22, 2017, enactment due to the change in the statutory rate. In addition, all of the previously unremitted earnings of Cerus Europe B.V. were deemed to be distributed as of December 31, 2017, which resulted in a one-time deemed income inclusion. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes at the enacted rates. The significant components of the Company’s deferred tax assets and liabilities at December 31, 2019 and 2018, were as follows (in thousands):
The valuation allowance increased by $13.1 million for the year ended December 31, 2019, compared to the increase of $9.9 million and decrease of $59.5 million for the years ended December 31, 2018 and 2017, respectively. The Company believes that, based on a number of factors, the available objective evidence creates sufficient uncertainty regarding the realizability of the deferred tax assets such that a valuation allowance has been recorded. These factors include the Company’s history of net losses since its inception, the need for regulatory approval of the Company’s products prior to commercialization and expected near-term future losses. The Company expects to maintain a valuation allowance until circumstances change. For the year ended December 31, 2019, the Company reported pretax net losses on its consolidated statement of operations and calculated taxable losses for both federal and state taxes. The difference between reported net loss and taxable loss are due to differences between book accounting and the respective tax laws.
The Company's tax losses and credits are subject to varying carryforward periods. The gross amounts and dates of expiration of the significant carryforwards are as follows:
The Company’s ability to utilize net operating loss and research and development credit carryforwards is limited by (a) its ability to generate future taxable income, (b) varying apportionment and allocation rules including new provisions as part of the Tax Act, and (c) limitations pursuant to the ownership change rules in accordance with Section 382 of the Internal Revenue Code of 1986 and with Section 383 of the Internal Revenue Code of 1986, as well as similar state provisions. The Company’s unrecognized tax benefits relate to federal and California research tax credits. These tax credits have not been utilized on any tax return and currently have no impact on the Company’s tax expense due to the Company’s operating losses and the related valuation allowances. The following is a tabular reconciliation of the total amounts of unrecognized tax benefits (in thousands):
The Company will recognize accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. |
Segment, Customer and Geographic Information |
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Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment, Customer and Geographic Information |
Note 15. Segment, Customer and Geographic Information The Company continues to operate in only one segment, blood safety. The Company’s chief executive officer is the chief operating decision maker who evaluates performance based on the net revenues and operating loss of the blood safety segment. The Company considers the sale of all of its INTERCEPT Blood System products to be similar in nature and function, and any revenue earned from services is minimal. The Company’s operations outside of the U.S. include a wholly-owned subsidiary headquartered in Europe. The Company’s operations in the U.S. are responsible for the R&D and global and domestic commercialization of the INTERCEPT Blood System, while operations in Europe are responsible for the commercialization efforts of the platelet and plasma systems in Europe, the Commonwealth of Independent States and the Middle East. Product revenues are attributed to each region based on the location of the customer, and in the case of non-product revenues, on the location of the collaboration partner. The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, during the years ended December 31, 2019, 2018 and 2017 (in percentages):
* Represents an amount less than 10% of product revenue.
Revenues by geographical location were based on the location of the customer during the years ended December 31, 2019, 2018 and 2017, and was as follows (in thousands):
Long-lived assets by geographical location at December 31, 2019 and 2018, were as follows (in thousands):
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Quarterly Financial Information (Unaudited) |
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Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Quarterly Financial Information (Unaudited) |
Note 16. Quarterly Financial Information (Unaudited) The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2019 and 2018 (in thousands except per share amounts):
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Subsequent Event |
12 Months Ended |
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Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Event |
Note 17. Subsequent Event
In January 2020, the Company issued and sold 16,866,667 shares of the Company’s common stock, par value $0.001 per share, at $3.75 per share in an underwritten public offering. The total proceeds to the Company from this offering were $63.3 million, before deducting estimated offering expenses payable by the Company. |
Summary of Significant Accounting Policies (Policies) |
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Accounting Policies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Principles of Consolidation |
Principles of Consolidation The accompanying consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (together with Cerus Corporation, hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). |
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Use of Estimates |
Use of Estimates The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to the nature and timing of satisfaction of performance obligations, the timing when the customer obtains control of products or services, the standalone selling price (“SSP”) of performance obligations, variable consideration, accounts receivable, inventory reserves, fair values of investments, stock-based compensation, intangible assets and goodwill, useful lives of intangible assets and property and equipment, income taxes, accrued liabilities, and incremental borrowing rate, among others. The Company bases its estimates on historical experience, future projections, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions. |
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Revenue |
Revenue Revenue is recognized in accordance with Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers”, by applying the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company’s main source of revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or “disposable kits”), UVA illumination devices (“illuminators”), spare parts and storage solutions, and maintenance services of illuminators. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. The Company uses a binding purchase order or signed sales contract as evidence of a contract and satisfaction of its policy. Generally, the Company’s contracts with its customers do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming product. The contracts with customers can include various combinations of products, and to a lesser extent, services. The Company must determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or are accounted for as a combined performance obligation. The Company must allocate the transaction price to each performance obligation on a relative SSP basis, and recognize the product revenue when the performance obligation is satisfied. The Company determines the SSP by using the historical selling price of the products and services. If the amount of consideration in a contract is variable, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely amount method, to the extent it is probable that a significant future reversal of cumulative product revenue under the contract will not occur. Product revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration to which the Company expects to receive in exchange for those products or services. Product revenue from the sale of illuminators, disposable kits, spare parts and storage solutions are recognized upon the transfer of control of the products to the customer. Product revenue from maintenance services are recognized ratably on a straight-line basis over the term of maintenance as customers simultaneously consume and receive benefits. Freight costs charged to customers are recorded as a component of product revenue. Taxes that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such tax from product revenue. The Company receives reimbursement under its U.S. government contract with the Biomedical Advanced Research and Development Authority (“BARDA”) that supports research and development of defined projects. See “Note 13 Development and License Agreements—Agreement with BARDA”. The contract generally provides for reimbursement of approved costs incurred under the terms of the contract. Revenue related to the cost reimbursement provisions under the Company’s U.S. government contract are recognized as the qualified direct and indirect costs on the projects are incurred. The Company invoices under its U.S. government contract using the provisional rates in the government contract and thus is subject to future audits at the discretion of government. These audits could result in an adjustment to government contract revenue previously reported, which adjustments potentially could be significant. The Company believes that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. Costs incurred related to services performed under the contract are included as a component of research and development or selling, general and administrative expenses in the Company’s consolidated statements of operations. The Company’s use of estimates in recording accrued liabilities for government contract activities (see “Use of Estimates” above) affects the revenue recorded from development funding and under the government contract.
Disaggregation of Product Revenue Product revenue by geographical locations of customers during the years ended December 31, 2019, 2018 and 2017, were as follows (in thousands):
Contract Balances The Company invoices its customers based upon the terms in the contracts, which generally requires payment 30 to 60 days from the date of invoice. Accounts receivable are recorded when the Company’s right to the consideration are estimated to be unconditional. The Company had no contract assets at December 31, 2019 and December 31, 2018. Contract liabilities mainly consist of deferred product revenue related to maintenance services, unshipped products, and uninstalled illuminators. Maintenance services are generally billed upfront at the beginning of each annual service period and recognized ratably over the service period. The increase in the deferred product revenue balance for the year ended December 31, 2019, is primarily driven by performance obligations not satisfied but invoiced as of December 31, 2019, offset by $0.5 million of revenue recognized that were included in the deferred product revenue balance as of December 31, 2018. The Company applies an optional exemption to not disclose the value of unsatisfied performance obligations for contracts that have an original expected duration of one year or less. |
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Research and Development Expenses |
Research and Development Expenses Research and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of the Company’s U.S. government contract. Research and development expenses include salaries and related expenses for scientific and regulatory personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of R&D facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use. The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D expenses recorded from development funding and under its U.S. government contract. Actual results may differ from those estimates under different assumptions or conditions. |
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Cash Equivalents |
Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be classified as cash equivalents. These investments primarily consist of money market instruments, and are classified as available-for-sale. |
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Investments |
Investments Investments with original maturities of greater than three months primarily include corporate debt and U.S. government agency securities that are designated as available-for-sale and classified as short-term investments. Available-for-sale securities are carried at estimated fair value. The Company views its available-for-sale portfolio as available for use in its current operations. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Unrealized gains (losses) on available-for-sale investments, net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments, if any, were recorded in “Other income, net” on the Company’s consolidated statements of operations. The costs of securities sold are based on the specific identification method, if applicable. The Company reported the amortization of any premium and accretion of any discount resulting from the purchase of debt securities as a component of interest income. The Company also reviews its available-for-sale securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value. Other-than-temporary declines in market value, if any, are recorded in “Other income, net” on the Company’s consolidated statements of operations. |
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Restricted Cash |
Restricted Cash As of December 31, 2019 and December 31, 2018, the Company’s “Restricted cash” primarily consisted of a letter of credit relating to the lease of the Company’s new office building. As of December 31, 2019 and December 31, 2018, the Company also had certain non-U.S. dollar denominated deposits recorded as “Restricted cash” in compliance with certain foreign contractual requirements. |
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Concentration of Credit Risk |
Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, available-for-sale securities and accounts receivable. Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and available-for-sale securities are maintained at major financial institutions of high credit standing. The Company monitors the financial credit worthiness of the issuers of its investments and limits the concentration in individual securities and types of investments that exist within its investment portfolio. Generally, all of the Company’s investments carry high credit quality ratings, which is in accordance with its investment policy. At December 31, 2019, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments. Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company establishes an allowance for doubtful accounts against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general and administrative expenses. The Company had three customers and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2019 and December 31, 2018, respectively. These customers cumulatively represented approximately 56% and 50% of the Company’s outstanding trade receivables at December 31, 2019 and December 31, 2018, respectively. To date, the Company has not experienced collection difficulties from these customers. |
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Inventories |
Inventories At December 31, 2019 and December 31, 2018, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, illuminators, and certain replacement parts for the illuminators. Platelet and plasma systems’ disposable kits generally have 18 to 24 month shelf lives from the date of manufacture. Illuminators and replacement parts do not have regulated expiration dates. Work-in-process includes certain components that are manufactured over a protracted length of time before being sold to, and ultimately incorporated and assembled by Fresenius Kabi Deutschland GmbH or Fresenius, Inc. (with their affiliates, “Fresenius”) into the finished INTERCEPT disposable kits. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production within the next twelve-month period and evaluates its finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At December 31, 2019 and December 31, 2018, the Company classified its work-in-process inventory as a current asset on its consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective subsequent twelve-month period. Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or net realizable value. The Company uses significant judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently reviews such determinations. The Company writes down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use in the period that it is first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded in “Cost of product revenue” on the Company’s consolidated statements of operations. At December 31, 2019 and December 31, 2018, the Company had $0.1 million and $0.3 million, respectively, recorded for potential obsolete, expiring or unsalable product. |
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Property and Equipment, net |
Property and Equipment, net Property and equipment is comprised of furniture, equipment, leasehold improvements, construction-in-progress, information technology hardware and software and is recorded at cost. At the time the property and equipment is ready for its intended use, it is depreciated on a straight-line basis over the estimated useful lives of the assets (generally three to five years). Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or the estimated useful lives of the improvements. As of December 31, 2019 and December 31, 2018, the Company capitalized construction-in-progress costs included in “Property and Equipment, net” on the Company’s consolidated balance sheets, of zero and $6.9 million, respectively, related to leasehold improvements. As of December 31, 2019 and December 31, 2018, the Company had receivables included in “Prepaid and other current assets” on the Company's consolidated balance sheets, of zero and $1.2 million, respectively, related to its new office building. |
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Goodwill and Intangible Assets, net |
Goodwill and Intangible Assets, net Intangible assets, net, which include a license for the right to commercialize the INTERCEPT Blood System in Asia, are subject to ratable amortization over the original estimated useful life of ten years. Accumulated amortization of intangible assets as of December 31, 2019 and December 31, 2018, was $1.9 million and $1.7 million, respectively. Goodwill is not amortized but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each fiscal year, or more frequently if indicators of impairment exist. The test for goodwill impairment may be assessed using qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing the quantitative goodwill impairment test. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative impairment test; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The quantitative goodwill impairment test compares the fair value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it operates in one reporting unit and estimates the fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess, limited to the carrying amount of goodwill in the Company’s one reporting unit. The Company performs an impairment test on its intangible assets if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the excess amount of the carrying value of the intangible assets over its fair value. During the year ended December 31, 2019, 2018 and 2017, there were no impairment charges recognized related to the acquired intangible assets. |
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Long-lived Assets |
Long-lived Assets The Company evaluates its long-lived assets for impairment by continually monitoring events and changes in circumstances that could indicate carrying amounts of its long-lived assets may not be recoverable. When such events or changes in circumstances occur, the Company assesses recoverability by determining whether the carrying value of such assets will be recovered through the undiscounted expected future cash flows. If the expected undiscounted future cash flows are less than the carrying amount of these assets, the Company then measures the amount of the impairment loss based on the excess of the carrying amount over the fair value of the assets. |
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Foreign Currency Remeasurement |
Foreign Currency Remeasurement The functional currency of the Company’s foreign subsidiary is the U.S. dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in U.S. dollars using historical exchange rates. Product revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated statements of operations. |
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Stock-Based Compensation |
Stock-Based Compensation Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved. For stock-based awards issued to non-employees, the Company recognizes stock-based compensation expense for the grant date fair value of the vested portion of the awards in its consolidated statements of operations. See Note 11 for further information regarding the Company’s stock-based compensation assumptions and expenses. |
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Income Taxes |
Income Taxes The provision for income taxes is accounted for using an asset and liability approach, under which deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company does not recognize tax positions that do not have a greater than 50% likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation allowance is not an appropriate substitute for derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s U.S. federal tax returns for years 1999 through 2018, California tax returns for years through 2018, and Netherlands tax returns for years 2015 through 2018 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a valuation allowance on substantially all of its net deferred tax assets. |
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Net Loss Per Share |
Net Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share gives effect to all potentially dilutive common shares outstanding for the period. The potentially dilutive securities include stock options, employee stock purchase plan rights and restricted stock units, which are calculated using the treasury stock method. For the years ended December 31, 2019, 2018 and 2017, all potentially dilutive securities outstanding have been excluded from the computation of dilutive weighted average shares outstanding because such securities have an antidilutive impact due to losses reported. The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the years ended December 31, 2019, 2018 and 2017 (in thousands, except per share amounts):
The table below presents potential shares that were excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2019, 2018 and 2017 (shares in thousands):
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Leases |
Leases
The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the Company’s consolidated balance sheets. As of December 31, 2019 and December 31, 2018, the Company did not have finance leases.
ROU assets and operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The ROU asset also includes any lease payments made and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain to be exercised. Operating leases are recognized on a straight-line basis over the lease term. |
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Guarantee and Indemnification Arrangements |
Guarantee and Indemnification Arrangements The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a third-party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions. The Company generally provides for a warranty on certain of its INTERCEPT blood-safety products covering defects in materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. The Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims. Accordingly, the Company had not accrued for any future warranty costs for its products at December 31, 2019 and December 31, 2018. |
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Fair Value of Financial Instruments |
Fair Value of Financial Instruments The Company applies the provisions of fair value relating to its financial assets and liabilities. The carrying amounts of accounts receivables, accounts payable, and other accrued liabilities approximate their fair value due to the relative short-term maturities. Based on the borrowing rates currently available to the Company for loans with similar terms, the Company believes the fair value of its debt approximates their carrying amounts. The Company measures and records certain financial assets and liabilities at fair value on a recurring basis, including its available-for-sale securities. The Company classifies instruments within Level 1 if quoted prices are available in active markets for identical assets, which include the Company’s cash accounts and money market funds. The Company classifies instruments in Level 2 if the instruments are valued using observable inputs to quoted market prices, benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with reasonable levels of price transparency. These instruments include the Company’s corporate debt and U.S. government agency securities holdings. The available-for-sale securities are held by a custodian who obtains investment prices from a third-party pricing provider that uses standard inputs (observable in the market) to models which vary by asset class. The Company classifies instruments in Level 3 if one or more significant inputs or significant value drivers are unobservable. The Company assesses any transfers among fair value measurement levels at the end of each reporting period. See Note 3 for further information regarding the Company’s valuation of financial instruments. |
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New Accounting Pronouncements |
New Accounting Pronouncements Recently adopted accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases, which, for operating leases, requires a lessee to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its consolidated balance sheet. The standard also requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally straight-line basis. In July 2018, the FASB issued ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which provides for certain practical expedient when implementing the new leases standard. The Company adopted the new accounting standard on January 1, 2019, using the modified retrospective method and elected the package of practical expedients for expired or existing contracts, which allowed the Company not to reassess (1) whether contracts are or contain leases, (2) lease classification and (3) initial direct costs. The Company recorded right-of-use assets of $2.4 million in “Operating lease right-of-use assets” in the Company's consolidated balance sheets, and lease liabilities of $2.4 million in aggregate in “Operating lease liabilities – current” and “Operating lease liabilities – non-current” in the Company’s consolidated balance sheets on the adoption date. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. In December 2019, the FASB issued ASU No. 2019-12, Simplifying the Accounting for Income Taxes, which eliminates certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard is effective for annual periods beginning after December 15, 2020, and interim periods thereafter, with early application permitted. The Company elected to early adopt the new standard prospectively at the beginning of the fourth quarter of 2019. The adoption of this ASU had no material impact on the Company’s consolidated financial statements. Recently issued accounting pronouncements not yet adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which requires measurement and recognition of expected credit losses for financial assets held. The standard is effective for annual periods beginning after December 15, 2019, and interim periods thereafter, with early application permitted. The Company plans to adopt this ASU on January 1, 2020, using the modified retrospective method. The adoption of this ASU is not expected to have a material impact on the Company’s consolidated financial statements. |
Summary of Significant Accounting Policies (Tables) |
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Accounting Policies [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Product Revenue by Geographical Locations of Customers |
Product revenue by geographical locations of customers during the years ended December 31, 2019, 2018 and 2017, were as follows (in thousands):
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Computation of Basic and Diluted Net Loss per Share |
The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the years ended December 31, 2019, 2018 and 2017 (in thousands, except per share amounts):
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Anti-Dilutive Effect of Common Shares |
The table below presents potential shares that were excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2019, 2018 and 2017 (shares in thousands):
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Available-for-sale Securities and Fair Value on Financial Instruments (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Available-for-Sale Securities |
The following is a summary of available-for-sale securities at December 31, 2019 (in thousands):
The following is a summary of available-for-sale securities at December 31, 2018 (in thousands):
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Available-for-Sale Debt Securities by Original Contractual Maturity |
Available-for-sale securities at December 31, 2019 and 2018, consisted of the following by contractual maturity (in thousands):
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Available-for-Sale Marketable Securities in Unrealized Position | The following tables show all available-for-sale marketable securities in an unrealized loss position for which an other-than-temporary impairment has not been recognized and the related gross unrealized losses and fair value, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands):
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Fair Values of Financial Assets and Liabilities |
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2019 (in thousands):
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2018 (in thousands):
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Inventories (Tables) |
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories |
Inventories at December 31, 2019 and 2018, consisted of the following (in thousands):
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Property and Equipment, net (Tables) |
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Property Plant And Equipment [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment, Net |
Property and equipment, net at December 31, 2019 and 2018, consisted of the following (in thousands):
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Goodwill and Intangible Assets, net (Tables) |
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Goodwill And Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Intangible Assets |
The following is a summary of intangible assets, net at December 31, 2019 (in thousands):
The following is a summary of intangible assets, net at December 31, 2018 (in thousands):
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Accrued Liabilities (Tables) |
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Payables And Accruals [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accrued Liabilities |
Accrued liabilities at December 31, 2019 and 2018, consisted of the following (in thousands):
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Debt (Tables) |
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Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt |
Debt at December 31, 2019, consisted of the following (in thousands):
Debt at December 31, 2018, consisted of the following (in thousands):
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Expected Principal, Interest and Fee Payments on Term Loan Credit Agreement |
Principal, interest and fee payments on Term Loan Credit Agreement at December 31, 2019, are expected to be as follows (in thousands):
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Commitments and Contingencies (Tables) |
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Commitments And Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Supplemental Cash Flow Information Related to Operating Leases |
Supplemental cash flow information related to operating leases is as follows (dollars in thousands):
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Future Minimum Non-Cancelable Lease Payments Under Operating Leases |
Future minimum non-cancelable payments under operating leases as of December 31, 2019, were as follows (in thousands):
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Stock-Based Compensation (Tables) |
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Information Regarding Stock Options Outstanding Stock Options Vested and Expected to Vest and Stock Options Exercisable |
Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2019, was as follows (in thousands except weighted average exercise price and contractual term):
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Recognition of Stock-Based Compensation Expense |
Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended December 31, 2019, 2018 and 2017, was as follows (in thousands):
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Weighted Average Assumptions Used to Value Stock-Based Awards |
The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2019, 2018 and 2017, was as follows:
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2008 Equity Incentive Plan | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Activity Under Equity Incentive Plans Related to Stock Options |
Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share amounts):
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Activity Under Equity Incentive Plans Related to RSUs |
Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts):
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Development and License Agreements (Tables) |
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Development And License Agreements [Abstract] | |||||||||||||||||||||||||||||||||||||||||
Summary of Prepaid R&D Asset and Manufacturing Efficiency Asset | The following table summarizes the amounts of prepaid R&D asset and manufacturing efficiency asset at December 31, 2019 and 2018(in thousands).
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Summary of Amounts Payable and Amounts Receivable from Fresenius | The following table summarizes the amounts of the Company’s payables to and receivables from Fresenius at December 31, 2019 and December 31, 2018 (in thousands).
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Income Taxes (Tables) |
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Income Tax Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
United States and Foreign Components of Consolidated Loss Before Income Taxes |
U.S and foreign components of consolidated loss before income taxes for the years ended December 31, 2019, 2018 and 2017, was as follows (in thousands):
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Provision Benefit for Income Taxes |
The provision for income taxes for the years ended December 31, 2019, 2018 and 2017, was as follows (in thousands):
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Difference Between Provision for Income Taxes and Amounts Computed by Applying Federal Statutory Income Tax Rate to Loss before Taxes |
The difference between the provision for income taxes and the amount computed by applying the federal statutory income tax rate to loss before taxes for the years ended December 31, 2019, 2018 and 2017, was as follows (in thousands):
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Significant Components of Deferred Tax Assets and Liabilities | The significant components of the Company’s deferred tax assets and liabilities at December 31, 2019 and 2018, were as follows (in thousands):
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Gross Amounts and Dates of Expiration of Tax Credits and Carryovers |
The Company's tax losses and credits are subject to varying carryforward periods. The gross amounts and dates of expiration of the significant carryforwards are as follows:
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Reconciliation of Unrecognized Tax Benefits |
The following is a tabular reconciliation of the total amounts of unrecognized tax benefits (in thousands):
|
Segment, Customer and Geographic Information (Tables) |
12 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Customer that Accounted for More Than Ten Percent of Total Product Revenue |
The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, during the years ended December 31, 2019, 2018 and 2017 (in percentages):
* Represents an amount less than 10% of product revenue. |
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Net Revenues and Long-Lived Assets by Geographical Location |
Revenues by geographical location were based on the location of the customer during the years ended December 31, 2019, 2018 and 2017, and was as follows (in thousands):
Long-lived assets by geographical location at December 31, 2019 and 2018, were as follows (in thousands):
|
Quarterly Financial Information (Unaudited) (Tables) |
12 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dec. 31, 2019 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Quarterly Financial Information Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Quarterly Unaudited Financial Data |
The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2019 and 2018 (in thousands except per share amounts):
|
Summary of Significant Accounting Policies - Summary of Product Revenue by Geographical Locations of Customers (Detail) - USD ($) $ in Thousands |
3 Months Ended | 12 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 |
Sep. 30, 2019 |
Jun. 30, 2019 |
Mar. 31, 2019 |
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | $ 93,774 | $ 76,051 | $ 51,326 | ||||||||
Product | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | $ 20,917 | $ 18,019 | $ 18,209 | $ 17,504 | $ 16,525 | $ 15,399 | $ 15,420 | $ 13,564 | 74,649 | 60,908 | 43,568 |
Product | Europe, Middle East and Africa | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | 52,499 | 46,974 | 36,241 | ||||||||
Product | North America | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | 20,936 | 12,696 | 6,325 | ||||||||
Product | Other | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | $ 1,214 | $ 1,238 | $ 1,002 |
Reconciliation of Numerator and Denominator Used in Computation of Basic and Diluted Net Income Loss per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
3 Months Ended | 12 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 |
Sep. 30, 2019 |
Jun. 30, 2019 |
Mar. 31, 2019 |
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Numerator for Basic and Diluted: | |||||||||||
Net loss used for basic calculation | $ (16,923) | $ (17,967) | $ (17,562) | $ (18,792) | $ (16,205) | $ (14,192) | $ (13,282) | $ (13,885) | $ (71,244) | $ (57,564) | $ (60,585) |
Denominator: | |||||||||||
Basic weighted average number of shares outstanding | 139,831 | 131,663 | 108,221 | ||||||||
Diluted weighted average number of shares outstanding | 139,831 | 131,663 | 108,221 | ||||||||
Net loss per share: | |||||||||||
Basic and diluted | $ (0.51) | $ (0.44) | $ (0.56) |
Potential Shares, Excluded from Calculation of Weighted Average Number of Shares Outstanding used for Calculation of Diluted Net Loss Per Share (Detail) - shares shares in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 20,834 | 19,953 | 18,619 |
Stock Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 17,401 | 18,031 | 17,373 |
Restricted Stock Units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 3,361 | 1,902 | 1,225 |
Employee Stock Purchase Plan Rights | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 72 | 20 | 21 |
Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 59,478 | $ 95,166 |
Gross Unrealized Gain | 114 | 2 |
Gross Unrealized Loss | (283) | |
Fair Value | 59,592 | 94,885 |
Money market funds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 8,860 | 6,167 |
Fair Value | 8,860 | 6,167 |
United States government agency securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 15,545 | 15,971 |
Gross Unrealized Gain | 16 | |
Gross Unrealized Loss | (23) | |
Fair Value | 15,561 | 15,948 |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 35,073 | 73,028 |
Gross Unrealized Gain | 98 | 2 |
Gross Unrealized Loss | (260) | |
Fair Value | $ 35,171 | $ 72,770 |
Available-for-Sale Debt Securities by Original Contractual Maturity (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Investments Debt And Equity Securities [Abstract] | ||
One year or less, amortized cost | $ 43,822 | $ 85,227 |
Greater than one year and less than five years, amortized cost | 15,656 | 9,939 |
Amortized Cost | 59,478 | 95,166 |
One year or less, fair value | 43,907 | 84,957 |
Greater than one year and less than five years, fair value | 15,685 | 9,928 |
Total available-for-sale securities fair value | $ 59,592 | $ 94,885 |
Available-for-sale Securities and Fair Value on Financial Instruments - Additional Information (Detail) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Schedule Of Available For Sale Securities [Line Items] | |||
Available-for-sale securities in unrealized net loss position | $ 0 | $ 283,000 | |
Other-than-temporary impairment losses | $ 0 | $ 0 | $ 0 |
Remaining investment in common stock | 144,291,000 | 136,853,000 | |
Gross realized losses from the sale or maturity of available-for-sale investments | $ 0 | $ 0 | 0 |
Aduro Biotech Inc | |||
Schedule Of Available For Sale Securities [Line Items] | |||
Gross realized gains from the sale of available-for-sale investments | $ 0 | $ 0 | $ 3,500,000 |
Sale of common stock available-for-sale investments | 0 | 0 | 346,700 |
Remaining investment in common stock | 0 | 0 |
Inventories (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Work-in-process | $ 5,160 | $ 3,075 |
Finished goods | 14,330 | 10,464 |
Total inventories | $ 19,490 | $ 13,539 |
Property and Equipment Net (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | $ 22,528 | $ 19,639 |
Accumulated depreciation and amortization | (7,630) | (11,509) |
Total property and equipment, net | 14,898 | 8,130 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 74 | 6,864 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 2,833 | 1,945 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 3,306 | 2,915 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 2,061 | 901 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 12,881 | 5,715 |
Consigned equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | $ 1,373 | $ 1,299 |
Property and Equipment Net - Additional Information (Detail) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Property Plant And Equipment [Abstract] | |||
Property and equipment, depreciation and amortization expense | $ 2,200,000 | $ 1,100,000 | $ 1,200,000 |
Impairments for long-lived assets | $ 0 | $ 0 | $ 0 |
Goodwill and Intangible Assets Net - Additional Information (Detail) - USD ($) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Goodwill And Intangible Assets Disclosure [Abstract] | |||
Dispose, impair or recognition of additional goodwill | $ 0 | ||
Impairment charges on goodwill | 0 | ||
Impairment losses recognized related to the acquired intangible assets | 0 | $ 0 | $ 0 |
Annual amortization expense of the intangible assets, 2020 | $ 100,000 |
Summary of Intangible Assets Net (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Accumulated Amortization | $ (1,900) | $ (1,700) |
Net Carrying Amount | 132 | 334 |
Reacquired license - INTERCEPT Asia | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 2,017 | 2,017 |
Accumulated Amortization | (1,885) | (1,683) |
Net Carrying Amount | $ 132 | $ 334 |
Accrued Liabilities (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Payables And Accruals [Abstract] | ||
Accrued compensation and related costs | $ 12,703 | $ 10,765 |
Accrued professional services | 3,489 | 4,544 |
Accrued development costs | 1,468 | 1,965 |
Other accrued expenses | 3,291 | 2,526 |
Total accrued liabilities | $ 20,951 | $ 19,800 |
Debt (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Debt Instrument [Line Items] | ||
Less: debt-current | $ (5,017) | $ (7,857) |
Debt-non-current | 39,414 | 22,013 |
Term Loan Credit Agreement | ||
Debt Instrument [Line Items] | ||
Total debt, Principal | 40,000 | |
Total debt, Unamortized Discount | (586) | |
Total debt | 39,414 | |
Debt - non-current, Principal | 40,000 | |
Debt - non-current, Unamortized Discount | (586) | |
Debt-non-current | $ 39,414 | |
Oxford Term Loan Agreement | ||
Debt Instrument [Line Items] | ||
Total debt, Principal | 30,000 | |
Total debt, Unamortized Discount | (130) | |
Total debt | 29,870 | |
Less: debt - current, Principal | (7,857) | |
Less: debt-current | (7,857) | |
Debt - non-current, Principal | 22,143 | |
Debt - non-current, Unamortized Discount | (130) | |
Debt-non-current | $ 22,013 |
Debt - Expected Principal, Interest and Fee Payments on Term Loan Credit Agreement (Detail) - Term Loan Credit Agreement $ in Thousands |
Dec. 31, 2019
USD ($)
|
---|---|
Debt Instrument [Line Items] | |
2022, Principal | $ 15,000 |
2023, Principal | 20,000 |
2024, Principal | 5,000 |
Total, Principal | 40,000 |
2020, Interest and Fees | 3,050 |
2021, Interest and Fees | 3,042 |
2022, Interest and Fees | 2,660 |
2023, Interest and Fees | 1,203 |
2024, Interest and Fees | 1,264 |
Total, Interest and Fees | 11,219 |
2020, Total | 3,050 |
2021, Total | 3,042 |
2022, Total | 17,660 |
2023, Total | 21,203 |
2024, Total | 6,264 |
Total | $ 51,219 |
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Commitments And Contingencies Disclosure [Abstract] | |||
Minimum term of non-cancellable operating leases | 1 year | ||
Expiration of non-cancellable operating leases maximum year | 2030 | ||
Operating lease expenses | $ 3.4 | $ 1.6 | $ 1.4 |
Operating lease not yet commenced | the Company had no leases that have not yet commenced. | ||
Purchase commitment, paid | $ 13.7 | $ 10.0 | $ 6.7 |
Future minimum purchase commitment 2020 | 9.7 | ||
Future minimum purchase commitment 2021 | 2.9 | ||
Future minimum purchase commitment 2022 | 0.2 | ||
Future minimum purchase commitment 2023 | 0.2 | ||
Future minimum purchase commitment 2024 | $ 0.6 |
Commitments and Contingencies - Supplemental Cash Flow Information Related to Operating Leases (Detail) $ in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2019
USD ($)
| |
Commitments And Contingencies Disclosure [Abstract] | |
Cash payments for operating leases | $ 3,204 |
Right-of-use assets obtained in exchange for operating lease obligations | $ 13,417 |
Weighted-average remaining lease term | 9 years 3 months 18 days |
Weighted-average discount rate | 8.90% |
Commitments and Contingencies - Future Minimum Non-Cancelable Lease Payments Under Operating Leases (Detail) $ in Thousands |
Dec. 31, 2019
USD ($)
|
---|---|
Commitments And Contingencies Disclosure [Abstract] | |
2020 | $ 3,307 |
2021 | 3,297 |
2022 | 2,884 |
2023 | 2,741 |
2024 | 2,706 |
Thereafter | 16,053 |
Total future lease payments | 30,988 |
Less imputed interest | 10,969 |
Present value of lease liabilities | $ 20,019 |
Stockholders' Equity - Additional Information (Detail) - USD ($) shares in Millions |
12 Months Ended | |||
---|---|---|---|---|
Jan. 08, 2018 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Stockholders Equity Note [Line Items] | ||||
Net proceeds from public offering | $ 26,931,000 | $ 85,036,000 | $ 30,197,000 | |
Cantor Fitzgerald & Co | Amendment No. 3 | Sales Agreement | ||||
Stockholders Equity Note [Line Items] | ||||
Maximum common stock offering price | $ 70,000,000.0 | |||
Percentage of proceeds payable as compensation to underwriter | 2.00% | |||
Unsold shares of common stock, value | $ 31,400,000 | |||
Common stock, number of shares issued | 5.6 | 4.2 | ||
Net proceeds from public offering | $ 26,900,000 | $ 27,900,000 | ||
Common stock registered for sale | $ 14,100,000 |
Activity Under Equity Incentive Plans Related to Stock Options (Detail) - 2008 Equity Incentive Plan shares in Thousands |
12 Months Ended |
---|---|
Dec. 31, 2019
$ / shares
shares
| |
Activity under the Company's equity incentive plans related to stock options | |
Number of Options Outstanding, Beginning Balance | shares | 17,560 |
Granted, Number of Options Outstanding | shares | 515 |
Exercised, Number of Options Outstanding | shares | (690) |
Number of Options Outstanding, Ending Balance | shares | 16,830 |
Forfeited/canceled, Number of Options Outstanding | shares | (555) |
Weighted Average Exercise Price per Share | |
Weighted Average Exercise Price per Share, Beginning Balance | $ / shares | $ 4.47 |
Granted, Weighted Average Exercise Price per Share | $ / shares | 5.68 |
Exercised, Weighted Average Exercise Price per Share | $ / shares | 3.11 |
Forfeited/canceled, Weighted Average Exercise Price per Share | $ / shares | 5.46 |
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | $ 4.53 |
Activity Under Equity Incentive Plans Related to RSUs (Detail) - 2008 Equity Incentive Plan - Restricted Stock Units shares in Thousands |
12 Months Ended | |||
---|---|---|---|---|
Dec. 31, 2019
$ / shares
shares
| ||||
Activity under the Company's equity incentive plans related to restricted stock units | ||||
Number of Restricted Stock Units Unvested, Beginning Balance | shares | 2,001 | |||
Granted, Number of Restricted Stock Units Unvested | shares | 3,207 | [1] | ||
Vested, Number of Restricted Stock Units Unvested | shares | (883) | |||
Forfeited, Number of Restricted Stock Units Unvested | shares | (227) | |||
Number of Restricted Stock Units Unvested, Ending Balance | shares | 4,098 | |||
Weighted Average Exercise Price per Share | ||||
Weighted Average Exercise Price per Share, Beginning Balance | $ / shares | $ 4.56 | |||
Granted, Weighted Average Exercise Price per Share | $ / shares | 5.56 | [1] | ||
Vested, Weighted Average Exercise Price per Share | $ / shares | 4.69 | |||
Forfeited, Weighted Average Exercise Price per Share | $ / shares | 5.93 | |||
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | $ 5.24 | |||
|
Information Regarding Stock Options Outstanding Stock Options Vested and Expected to Vest and Stock Options Exercisable (Detail) - 2008 Equity Incentive Plan - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Number of Shares | ||
Outstanding options and other stock based awards | 16,830 | 17,560 |
Stock options vested and expected to vest | 16,749 | |
Stock options exercisable | 13,751 | |
Weighted Average Exercise Price | ||
Stock options outstanding | $ 4.53 | $ 4.47 |
Stock options vested and expected to vest | 4.53 | |
Stock options exercisable | $ 4.49 | |
Weighted Average Remaining Contractual (Years) | ||
Stock options outstanding | 5 years 6 months | |
Stock options vested and expected to vest | 5 years 4 months 24 days | |
Stock options exercisable | 4 years 10 months 24 days | |
Aggregate intrinsic value | ||
Stock options outstanding | $ 4,169 | |
Stock options vested and expected to vest | 4,168 | |
Stock options exercisable | $ 4,077 |
Stock-Based Compensation Recognized on Condensed Consolidated Statements of Operations (Detail) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 13,312 | $ 10,394 | $ 9,355 |
Research and Development Expense | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 2,472 | 1,669 | 1,323 |
Selling, General and Administrative Expenses | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 10,840 | $ 8,725 | $ 8,032 |
Weighted Average Assumptions Used to Value Stock-Based Awards (Detail) |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation, expected dividend yield | 0.00% | ||
Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 7 months 2 days | 6 years 25 days | 6 years 1 month 13 days |
Estimated volatility | 50.00% | 50.00% | 47.00% |
Risk-free interest rate | 2.32% | 2.72% | 2.14% |
Stock-based compensation, expected dividend yield | 0.00% | 0.00% | 0.00% |
Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 9 months 18 days | 8 months 26 days | 11 months 1 day |
Estimated volatility | 46.00% | 47.00% | 57.00% |
Risk-free interest rate | 2.04% | 2.34% | 1.08% |
Stock-based compensation, expected dividend yield | 0.00% | 0.00% | 0.00% |
Retirement Plan - Additional Information (Detail) |
12 Months Ended |
---|---|
Dec. 31, 2019
USD ($)
| |
Defined Benefit Plan Disclosure [Line Items] | |
Retirement plan, employees maximum pre-tax contributions percentage | 60.00% |
401 (K) Plan | |
Defined Benefit Plan Disclosure [Line Items] | |
Retirement plan, employees maximum pre-tax contributions percentage | 6.00% |
Employer matching contribution, percent of employee's contribution | 50.00% |
Maximum annual contributions per employee, amount | $ 5,000 |
Development and License Agreements - Additional Information (Detail) € in Millions |
1 Months Ended | 12 Months Ended | ||||
---|---|---|---|---|---|---|
Aug. 31, 2019
EUR (€)
|
Dec. 31, 2019
USD ($)
|
Dec. 31, 2019
EUR (€)
|
Dec. 31, 2018
USD ($)
|
Dec. 31, 2017
USD ($)
|
Dec. 31, 2016
EUR (€)
|
|
Licenses Agreements [Line Items] | ||||||
Payments made relating to the manufacturing of the products | $ 29,500,000 | $ 21,300,000 | $ 18,100,000 | |||
BARDA Agreement | ||||||
Licenses Agreements [Line Items] | ||||||
Committed fund receivable | 103,200,000 | |||||
Committed fund receivable | $ 201,200,000 | |||||
Period of agreement | 5 years | 5 years | ||||
Accounts receivable of billed and unbilled amounts | $ 4,200,000 | $ 2,300,000 | ||||
Cerus Corporation | BARDA Agreement | ||||||
Licenses Agreements [Line Items] | ||||||
Co-investment by the company | 5,000,000.0 | |||||
Additional co-investment by the company | 9,600,000 | |||||
Co-investment incurred by the company | $ 800,000 | |||||
Manufacturing and Supply Agreement | Fresenius | ||||||
Licenses Agreements [Line Items] | ||||||
Payments made based on the successful achievement of production volumes | € | € 8.6 | |||||
Manufacturing and development payments | € | € 5.5 | € 3.1 | ||||
Manufacturing and Supply Agreement | Fresenius | Measurement Input, Discount Rate | ||||||
Licenses Agreements [Line Items] | ||||||
Manufacturing and development obligations, discount rate | 9.72 |
Development and License Agreements - Summary of Prepaid R&D Asset and Manufacturing Efficiency Asset (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
||||
---|---|---|---|---|---|---|
Other current assets | ||||||
Deferred Costs Capitalized Prepaid And Other Assets [Line Items] | ||||||
Prepaid R&D asset | [1] | $ 54 | $ 47 | |||
Other assets | ||||||
Deferred Costs Capitalized Prepaid And Other Assets [Line Items] | ||||||
Prepaid R&D asset | [2] | 2,094 | 2,156 | |||
Manufacturing efficiency asset | [2] | $ 1,349 | $ 1,594 | |||
|
Development and License Agreements - Summary of Amounts Payable and Amounts Receivable from Fresenius (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
||||
---|---|---|---|---|---|---|
Related Party Transactions [Abstract] | ||||||
Payables to Fresenius | [1] | $ 8,470 | $ 7,812 | |||
Receivables from Fresenius | [2] | $ 1,796 | $ 1,777 | |||
|
United States and Foreign Components of Consolidated Loss before Income Taxes (Detail) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Income Tax Disclosure [Abstract] | |||
U.S. | $ (71,946) | $ (58,048) | $ (57,925) |
Foreign | 965 | 713 | 1,227 |
Loss before income taxes | $ (70,981) | $ (57,335) | $ (56,698) |
Provision Benefit for Income Taxes (Detail) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Income Tax Disclosure [Abstract] | |||
Foreign | $ 255 | $ 225 | $ 181 |
Federal | 0 | 0 | 0 |
State | 2 | 0 | 0 |
Total current | 257 | 225 | 181 |
Foreign | 0 | 0 | 0 |
Federal | 4 | 3 | 3,659 |
State | 2 | 1 | 47 |
Total deferred | 6 | 4 | 3,706 |
Provision for income taxes | $ 263 | $ 229 | $ 3,887 |
Difference Between Provision for Income Taxes and Amounts Computed by Applying Federal Statutory Income Tax Rate to Loss before Taxes (Detail) - USD ($) $ in Thousands |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Income Tax Disclosure [Abstract] | |||
Federal statutory tax | $ (14,906) | $ (12,040) | $ (19,277) |
Tax Act revaluation of deferred taxes | 81,923 | ||
Tax Act deemed income inclusion | 1,083 | ||
Federal research credits | (1,857) | (1,390) | (1,000) |
State research credits | 821 | 655 | 628 |
Expiration of federal carryovers | 5,472 | 4,154 | |
Expiration of state carryovers | 1,344 | 1,475 | |
Change in valuation allowance | 13,059 | 9,913 | (59,462) |
Compensation related items | 158 | (361) | 1,382 |
State taxes | (1,111) | (1,141) | (803) |
Other | 269 | 405 | (806) |
Provision for income taxes | $ 263 | $ 229 | $ 3,887 |
Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Deferred tax assets: | ||
Net operating loss carryforwards | $ 135,536 | $ 125,016 |
Research and development credit carryforwards | 28,291 | 26,705 |
Capitalized research and development | 12,832 | 15,293 |
Compensation related items | 9,843 | 8,310 |
Operating leases | 4,374 | |
Other | 4,547 | 4,013 |
Total deferred tax assets | 195,423 | 179,337 |
Valuation allowance | (192,304) | (179,245) |
Net deferred tax assets | 3,119 | 92 |
Deferred tax liabilities: | ||
Right-of-use assets | 3,017 | |
Amortization of goodwill | 143 | 127 |
Total deferred tax liabilities | $ 3,160 | $ 127 |
Income Taxes - Additional Information (Detail) - USD ($) $ in Millions |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Income Tax Disclosure [Abstract] | |||
Increase (decrease) in valuation allowance | $ 13.1 | $ 9.9 | $ (59.5) |
Gross Amounts and Dates of Expiration of Tax Credits and Carryovers (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | $ 616,915 | |
California loss carryovers | 67,781 | |
Research credits | 28,291 | $ 26,705 |
Federal foreign tax credits | 610 | |
Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 19,397 | |
California | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 11,259 | |
Expires 2020-2022 | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 64,730 | |
Expires 2020-2022 | Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 6,928 | |
Expires 2023-2029 | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 186,421 | |
California loss carryovers | 14,732 | |
Federal foreign tax credits | 610 | |
Expires 2023-2029 | Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 4,875 | |
Expires 2030-2039 | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 239,731 | |
California loss carryovers | 53,049 | |
Expires 2030-2039 | Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 7,594 | |
No Expiration | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 126,033 | |
No Expiration | California | ||
Income Tax Disclosure [Line Items] | ||
Research credits | $ 11,259 |
Reconciliation of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
|
Income Tax Disclosure [Abstract] | ||
Unrecognized tax benefits at beginning of period | $ 11,063 | $ 11,062 |
Decreases related to expired carryforwards | (729) | (401) |
Increases related to current year tax positions | 508 | 402 |
Unrecognized tax benefits at end of period | $ 10,842 | $ 11,063 |
Segment, Customer and Geographic Information - Additional Information (Detail) |
12 Months Ended |
---|---|
Dec. 31, 2019
Segment
| |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Segment, Customer and Geographic Information - Significant Customer that Accounted for More than Ten Percentage of Total Product Revenue (Detail) - Customer Concentration Risk - Sales Revenue, Goods, Net |
12 Months Ended | ||
---|---|---|---|
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Etablissement Francais du Sang | |||
Revenue, Major Customer [Line Items] | |||
Concentration risk, percentage | 27.00% | 38.00% | 22.00% |
American Red Cross | |||
Revenue, Major Customer [Line Items] | |||
Concentration risk, percentage | 14.00% |
Segment, Customer and Geographic Information - Revenue by Geographical Location (Detail) - USD ($) $ in Thousands |
3 Months Ended | 12 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 |
Sep. 30, 2019 |
Jun. 30, 2019 |
Mar. 31, 2019 |
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | $ 93,774 | $ 76,051 | $ 51,326 | ||||||||
Product | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | $ 20,917 | $ 18,019 | $ 18,209 | $ 17,504 | $ 16,525 | $ 15,399 | $ 15,420 | $ 13,564 | 74,649 | 60,908 | 43,568 |
Product | UNITED STATES | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | 20,611 | 12,563 | 6,316 | ||||||||
Product | FRANCE | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | 20,075 | 23,043 | 9,692 | ||||||||
Product | BELGIUM | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | 7,272 | 6,788 | 6,263 | ||||||||
Product | Other Countries | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | 26,691 | 18,514 | 21,297 | ||||||||
Government Contract | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | $ 5,571 | $ 4,827 | $ 4,266 | $ 4,461 | $ 3,713 | $ 3,928 | $ 4,047 | $ 3,455 | 19,125 | 15,143 | 7,758 |
Government Contract | UNITED STATES | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | $ 19,125 | $ 15,143 | $ 7,758 |
Segment, Customer and Geographic Information - Long Lived Assets by Geographical Location (Detail) - USD ($) $ in Thousands |
Dec. 31, 2019 |
Dec. 31, 2018 |
---|---|---|
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | $ 15,030 | $ 8,464 |
U.S. and Territories | ||
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | 14,619 | 8,252 |
Europe and Other | ||
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | $ 411 | $ 212 |
Summary of Quarterly Financial Information (Detail) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 12 Months Ended | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Dec. 31, 2019 |
Sep. 30, 2019 |
Jun. 30, 2019 |
Mar. 31, 2019 |
Dec. 31, 2018 |
Sep. 30, 2018 |
Jun. 30, 2018 |
Mar. 31, 2018 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Quarterly Financial Information [Line Items] | |||||||||||
Revenue | $ 93,774 | $ 76,051 | $ 51,326 | ||||||||
Gross profit | $ 11,624 | $ 10,436 | $ 10,098 | $ 9,072 | $ 8,083 | $ 7,257 | $ 7,700 | $ 6,234 | 41,230 | 29,274 | 21,037 |
Net loss | $ (16,923) | $ (17,967) | $ (17,562) | $ (18,792) | $ (16,205) | $ (14,192) | $ (13,282) | $ (13,885) | (71,244) | (57,564) | (60,585) |
Basic | $ (0.12) | $ (0.13) | $ (0.13) | $ (0.14) | $ (0.12) | $ (0.11) | $ (0.10) | $ (0.11) | |||
Diluted | $ (0.12) | $ (0.13) | $ (0.13) | $ (0.14) | $ (0.12) | $ (0.11) | $ (0.10) | $ (0.11) | |||
Product | |||||||||||
Quarterly Financial Information [Line Items] | |||||||||||
Revenue | $ 20,917 | $ 18,019 | $ 18,209 | $ 17,504 | $ 16,525 | $ 15,399 | $ 15,420 | $ 13,564 | 74,649 | 60,908 | 43,568 |
Government Contract | |||||||||||
Quarterly Financial Information [Line Items] | |||||||||||
Revenue | $ 5,571 | $ 4,827 | $ 4,266 | $ 4,461 | $ 3,713 | $ 3,928 | $ 4,047 | $ 3,455 | $ 19,125 | $ 15,143 | $ 7,758 |
Subsequent Event - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended | 12 Months Ended | ||
---|---|---|---|---|
Jan. 31, 2020 |
Dec. 31, 2019 |
Dec. 31, 2018 |
Dec. 31, 2017 |
|
Subsequent Event [Line Items] | ||||
Common stock, shares issued | 144,291,000 | 136,853,000 | ||
Common stock, par value | $ 0.001 | $ 0.001 | ||
Net proceeds from public offering | $ 26,931 | $ 85,036 | $ 30,197 | |
Common Stock | Underwritten Public Offering | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Common stock, shares issued | 16,866,667 | |||
Common stock, par value | $ 0.001 | |||
Common stock, sale of stock, price per share | $ 3.75 | |||
Net proceeds from public offering | $ 63,300 |