Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 15, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CERS | ||
Entity Registrant Name | CERUS CORP | ||
Entity Central Index Key | 1,020,214 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Shell Company | false | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 136,953,123 | ||
Entity Public Float | $ 873 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 28,859 | $ 13,683 |
Short-term investments | 88,718 | 47,013 |
Accounts receivable | 8,752 | 12,415 |
Inventories | 13,539 | 14,457 |
Prepaid and other current assets | 7,034 | 2,330 |
Total current assets | 146,902 | 89,898 |
Non-current assets: | ||
Property and equipment, net | 8,130 | 2,119 |
Goodwill | 1,316 | 1,316 |
Intangible assets, net | 334 | 536 |
Restricted cash | 2,728 | 247 |
Other assets | 4,050 | 4,128 |
Total assets | 163,460 | 98,244 |
Current liabilities: | ||
Accounts payable | 18,595 | 10,974 |
Accrued liabilities | 19,800 | 11,712 |
Debt - current | 7,857 | |
Manufacturing and development obligations – current | 5,928 | |
Deferred product revenue - current | 498 | 445 |
Total current liabilities | 52,678 | 23,131 |
Non-current liabilities: | ||
Debt - non-current | 22,013 | 29,798 |
Manufacturing and development obligations - non-current | 5,766 | |
Other non-current liabilities | 4,250 | 609 |
Total liabilities | 78,941 | 59,304 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 5,000 shares authorized, issuable in series; zero shares issued and outstanding at December 31, 2018 and 2017, respectively | ||
Common stock, $0.001 par value; 225,000 shares authorized; 136,853 and 115,555 shares issued and outstanding at December 31, 2018 and 2017, respectively | 136 | 115 |
Additional paid-in capital | 863,531 | 760,225 |
Accumulated other comprehensive loss | (281) | (97) |
Accumulated deficit | (778,867) | (721,303) |
Total stockholders' equity | 84,519 | 38,940 |
Total liabilities and stockholders' equity | $ 163,460 | $ 98,244 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
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 | 136,853,000 | 115,555,000 |
Common stock, shares outstanding | 136,853,000 | 115,555,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue | $ 76,051,000 | $ 51,326,000 | $ 39,275,000 |
Cost of revenue | 31,634,000 | 22,531,000 | 20,295,000 |
Gross profit | 29,274,000 | 21,037,000 | 16,888,000 |
Operating expenses: | |||
Research and development | 42,564,000 | 33,710,000 | 31,322,000 |
Selling, general and administrative | 56,841,000 | 52,615,000 | 48,955,000 |
Impairment of long-lived assets | 0 | 0 | 150,000 |
Total operating expenses | 99,405,000 | 86,325,000 | 80,427,000 |
Loss from operations | (54,988,000) | (57,530,000) | (61,447,000) |
Non-operating (expense) income, net: | |||
Foreign exchange (loss) gain | (87,000) | (10,000) | 21,000 |
Interest expense | (4,008,000) | (3,022,000) | (2,445,000) |
Other income, net | 1,748,000 | 3,864,000 | 1,140,000 |
Total non-operating (expense) income, net | (2,347,000) | 832,000 | (1,284,000) |
Loss before income taxes | (57,335,000) | (56,698,000) | (62,731,000) |
Provision for income taxes | 229,000 | 3,887,000 | 175,000 |
Net loss | $ (57,564,000) | $ (60,585,000) | $ (62,906,000) |
Net loss per share: | |||
Basic | $ (0.44) | $ (0.56) | $ (0.62) |
Diluted | $ (0.44) | $ (0.56) | $ (0.62) |
Weighted average shares outstanding used for calculating net loss per share: | |||
Basic | 131,663 | 108,221 | 101,826 |
Diluted | 131,663 | 108,221 | 101,826 |
Product | |||
Revenue | $ 60,908,000 | $ 43,568,000 | $ 37,183,000 |
Government Contract | |||
Revenue | $ 15,143,000 | $ 7,758,000 | $ 2,092,000 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (57,564) | $ (60,585) | $ (62,906) |
Other comprehensive loss: | |||
Unrealized losses on available-for-sale investments, net of taxes | (184) | (200) | (7,186) |
Comprehensive loss | $ (57,748) | $ (60,785) | $ (70,092) |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Balance at Dec. 31, 2015 | $ 94,765 | $ 99 | $ 685,189 | $ 7,289 | $ (597,812) |
Balance (in shares) at Dec. 31, 2015 | 99,095 | ||||
Net loss | (62,906) | (62,906) | |||
Other comprehensive loss | (7,186) | (7,186) | |||
Issuance of common stock from public offering, net of offering costs | 21,981 | $ 3 | 21,978 | ||
Issuance of common stock from public offering, net of offering costs (in shares) | 3,526 | ||||
Issuance of common stock from exercise of stock options and purchases from ESPP | 3,068 | $ 1 | 3,067 | ||
Issuance of common stock from exercise of stock options and purchases from ESPP (In Shares) | 854 | ||||
Stock-based compensation | 8,065 | 8,065 | |||
Balance at Dec. 31, 2016 | 57,787 | $ 103 | 718,299 | 103 | (660,718) |
Balance (in shares) at Dec. 31, 2016 | 103,475 | ||||
Net loss | (60,585) | (60,585) | |||
Other comprehensive loss | (200) | (200) | |||
Issuance of common stock from public offering, net of offering costs | 30,156 | $ 11 | 30,145 | ||
Issuance of common stock from public offering, net of offering costs (in shares) | 10,986 | ||||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and purchases from ESPP | 2,427 | $ 1 | 2,426 | ||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and purchases from ESPP (In Shares) | 1,094 | ||||
Stock-based compensation | 9,355 | 9,355 | |||
Balance at Dec. 31, 2017 | 38,940 | $ 115 | 760,225 | (97) | (721,303) |
Balance (in shares) at Dec. 31, 2017 | 115,555 | ||||
Net loss | (57,564) | (57,564) | |||
Other comprehensive loss | (184) | (184) | |||
Issuance of common stock from public offering, net of offering costs | 85,085 | $ 18 | 85,067 | ||
Issuance of common stock from public offering, net of offering costs (in shares) | 18,202 | ||||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and purchases from ESPP | 7,848 | $ 3 | 7,845 | ||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and purchases from ESPP (In Shares) | 3,096 | ||||
Stock-based compensation | 10,394 | 10,394 | |||
Balance at Dec. 31, 2018 | $ 84,519 | $ 136 | $ 863,531 | $ (281) | $ (778,867) |
Balance (in shares) at Dec. 31, 2018 | 136,853 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | |||
Net loss | $ (57,564,000) | $ (60,585,000) | $ (62,906,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 1,445,000 | 1,811,000 | 1,817,000 |
Stock-based compensation | 10,394,000 | 9,355,000 | 8,065,000 |
Non-cash interest expense | 1,248,000 | 551,000 | 1,017,000 |
Loss on disposal of property and equipment | 5,000 | ||
Deferred income taxes | 4,000 | (119,000) | 28,000 |
Impairment of long-lived assets | 0 | 0 | 150,000 |
Non-cash tax expense from realized gain on available-for-sale securities | 3,825,000 | ||
Gain on sale of investment in marketable equity securities | (3,466,000) | (750,000) | |
Changes in operating assets and liabilities: | |||
Accounts receivable | 3,663,000 | (5,547,000) | (1,074,000) |
Inventories | 806,000 | (2,092,000) | (1,781,000) |
Other assets | (2,744,000) | 1,107,000 | 1,327,000 |
Accounts payable | 5,683,000 | 2,487,000 | 3,261,000 |
Accrued liabilities and other non-current liabilities | 6,042,000 | (507,000) | 1,330,000 |
Manufacturing and development obligations | (266,000) | 680,000 | (3,568,000) |
Deferred product revenue | 38,000 | 265,000 | (445,000) |
Net cash used in operating activities | (31,246,000) | (52,235,000) | (53,529,000) |
Investing activities | |||
Capital expenditures | (1,144,000) | (353,000) | (563,000) |
Purchases of investments | (80,701,000) | (68,792,000) | (82,811,000) |
Proceeds from maturities and sale of investments | 37,997,000 | 69,566,000 | 63,450,000 |
Net cash (used in) provided by investing activities | (43,848,000) | 421,000 | (19,924,000) |
Financing activities | |||
Net proceeds from equity incentives | 7,848,000 | 2,428,000 | 3,068,000 |
Net proceeds from public offering | 85,036,000 | 30,197,000 | 22,121,000 |
Proceeds from loans | 30,000,000 | ||
Repayment of debt | (133,000) | (19,625,000) | (622,000) |
Net cash provided by financing activities | 92,751,000 | 43,000,000 | 24,567,000 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 17,657,000 | (8,814,000) | (48,886,000) |
Cash, cash equivalents and restricted cash, beginning of year | 13,930,000 | 22,744,000 | 71,630,000 |
Cash, cash equivalents and restricted cash, end of year | 31,587,000 | 13,930,000 | 22,744,000 |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | 2,728,000 | 2,034,000 | 1,366,000 |
Cash paid for income taxes | 254,000 | $ 160,000 | $ 157,000 |
Non-cash investing activities: | |||
Non-cash purchases of capital expenditures | $ 2,222,000 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 12 Months Ended |
Dec. 31, 2018 | |
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 Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
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, and accrued liabilities, 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 The Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers”, on January 1, 2018, using the modified retrospective method applied to the contracts which were not completed as of the date of adoption. Revenue is recognized in accordance with that core principle 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 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 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 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” below. 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, 2018, 2017 and 2016, were as follows (in thousands): Year Ended December 31, 2018 2017 2016 Product revenue: Europe, Middle East and Africa $ 46,974 $ 36,241 $ 30,716 North America 12,696 6,325 4,569 Other 1,238 1,002 1,898 Total product revenue $ 60,908 $ 43,568 $ 37,183 Contract Balances The Company invoices its customers based upon the terms in the contracts, which is generally from 30 to 60 days. 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, 2018 and December 31, 2017. 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, 2018, is primarily driven by performance obligations not satisfied but invoiced as of December 31, 2018, offset by $0.4 million of revenue recognized that were included in the deferred product revenue balance as of December 31, 2017. 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 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, 2018, the Company’s “Restricted cash” primarily consisted of a $2.5 million of letter of credit relating to the lease of the Company’s new office building. As of December 31, 2018 and December 31, 2017, 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, 2018, 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 two customers and three customers that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2018 and December 31, 2017, respectively. These customers cumulatively represented approximately 50% and 53% of the Company’s outstanding trade receivables at December 31, 2018 and December 31, 2017, respectively. To date, the Company has not experienced collection difficulties from these customers. Inventories At December 31, 2018 and December 31, 2017, 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 months 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 of 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, 2018 and December 31, 2017, 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, 2018 and December 31, 2017, the Company had $0.3 million and $0.1 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, 2018 and December 31, 2017, the Company capitalized construction-in-progress costs included in “Property and Equipment, net” on the Company’s consolidated balance sheets, of $6.9 million and $0.1 million, respectively, related to leasehold improvements, of which $3.7 million was unpaid as of December 31, 2018. As of December 31, 2018 and December 31, 2017, the Company had receivables included in “Prepaid and other current assets” on the Company's consolidated balance sheets, of $1.2 million and zero, 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, 2018 and December 31, 2017, was $1.7 million and $1.5 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, 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 measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based 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 1998 through 2017, California tax returns for years through 2017, and Netherlands tax returns for years 2015 through 2017 remain subject to examination by the taxing jurisdictions. 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, 2018, 2017 and 2016, 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, 2018, 2017 and 2016 (in thousands, except per share amounts): Year Ended December 31, 2018 2017 2016 Numerator for Basic and Diluted: Net loss used for basic calculation $ (57,564 ) $ (60,585 ) $ (62,906 ) Denominator: Basic weighted average number of shares outstanding 131,663 108,221 101,826 Effect of dilutive potential shares — — — Diluted weighted average number of shares outstanding 131,663 108,221 101,826 Net loss per share: Basic $ (0.44 ) $ (0.56 ) $ (0.62 ) Diluted (0.44 ) (0.56 ) (0.62 ) 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, 2018, 2017 and 2016 (shares in thousands): Year Ended December 31, 2018 2017 2016 Weighted average number of anti-dilutive potential shares: Stock options 18,031 17,373 15,592 Restricted stock units 1,902 1,225 576 Employee stock purchase plan rights 20 21 43 Total 19,953 18,619 16,211 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 one-year 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, 2018 and December 31, 2017. 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 May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The Company adopted the new accounting standard on January 1, 2018, using the modified retrospective method, and the adoption had no impact on the Company’s consolidated financial statements. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10), which requires all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under equity method of accounting or those that result in consolidation of the investee). The Company adopted this ASU on January 1, 2018, and the adoption had no impact on the Company’s consolidated financial statements. In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The Company adopted this ASU on January 1, 2018, and the adoption did not have a material impact on the Company’s consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The standard is effective for annual periods beginning after December 15, 2018, and interim periods thereafter, with early application permitted. The Company early adopted this new accounting standard on July 1, 2018, and the adoption did not have a material impact on the Company’s consolidated financial statements. Recently issued accounting pronouncements not yet adopted 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 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. This ASU will be effective for annual periods beginning after December 15, 2018, and interim periods thereafter, with early application permitted. 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. Companies may apply the practical expedient either retrospectively or prospectively. The Company will adopt these ASUs on January 1, 2019, using the modified retrospective approach and will apply the practical expedient prospectively. The Company is currently assessing the future impact of these ASUs on its consolidated financial statements. The Company anticipates that the Company’s operating lease commitments will be subject to the new standard. The Company will recognize right-of-use assets and lease liabilities on the Company’s consolidated balance sheets upon the adoption of these ASUs, which will increase the Company’s total assets and total liabilities. Based on the lease portfolio as of Decemb |
Available-for-sale Securities a
Available-for-sale Securities and Fair Value on Financial Instruments | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 (in thousands): December 31, 2018 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 6,167 $ — $ — $ 6,167 United States government agency securities 15,971 — (23 ) 15,948 Corporate debt securities 73,028 2 (260 ) 72,770 Total available-for-sale securities $ 95,166 $ 2 $ (283 ) $ 94,885 The following is a summary of available-for-sale securities at December 31, 2017 (in thousands): December 31, 2017 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 3,758 $ — $ — $ 3,758 United States government agency securities 11,252 — (24 ) 11,228 Corporate debt securities 35,858 — (73 ) 35,785 Total available-for-sale securities $ 50,868 $ — $ (97 ) $ 50,771 Available-for-sale securities at December 31, 2018 and 2017, consisted of the following by contractual maturity (in thousands): December 31, 2018 December 31, 2017 Amortized Cost Fair Value Amortized Cost Fair Value One year or less $ 85,227 $ 84,957 $ 38,836 $ 38,781 Greater than one year and less than five years 9,939 9,928 12,032 11,990 Total available-for-sale securities $ 95,166 $ 94,885 $ 50,868 $ 50,771 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): December 31, 2018 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss United States government agency securities $ 14,948 $ (22 ) $ 999 $ (1 ) $ 15,947 $ (23 ) Corporate debt securities 60,813 (231 ) 9,976 (29 ) 70,789 (260 ) Total available-for-sale securities $ 75,761 $ (253 ) $ 10,975 $ (30 ) $ 86,736 $ (283 ) December 31, 2017 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss United States government agency securities $ 8,729 $ (24 ) $ — $ — $ 8,729 $ (24 ) Corporate debt securities 35,785 (73 ) — — 35,785 (73 ) Total available-for-sale securities $ 44,514 $ (97 ) $ — $ — $ 44,514 $ (97 ) As of December 31, 2018, the Company considered the declines in market value of its marketable securities investment portfolio to be temporary in nature and did not consider any of its investments other-than-temporarily impaired. 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, 2018, 2017 and 2016, 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, 2018, 2017 and 2016, the Company sold zero, 346,700 and 50,000 shares of Aduro Biotech, Inc., or Aduro, common stock, respectively, and recognized zero, $3.5 million, and $0.8 million gross realized gains respectively, which were reclassified out of accumulated other comprehensive income into “Other income, net” on the Company’s consolidated statements of operations. As of December 31, 2018 and 2017, 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, 2018, 2017 and 2016. 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: • Level 1: Quoted prices in active markets for identical instruments • Level 2: Other significant observable inputs (including quoted prices in active markets for similar instruments) • Level 3: Significant unobservable inputs (including assumptions in determining the fair value of certain investments) 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, 2018, 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, 2018 (in thousands): Balance sheet Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs classification Total (Level 1) (Level 2) (Level 3) Money market funds Cash and cash equivalents $ 6,167 $ 6,167 $ — $ — United States government agency securities Short-term investments 15,948 — 15,948 — Corporate debt securities Short-term investments 72,770 — 72,770 — Total financial assets $ 94,885 $ 6,167 $ 88,718 $ — The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2017 (in thousands): Balance sheet Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs classification Total (Level 1) (Level 2) (Level 3) Money market funds Cash and cash equivalents $ 3,758 $ 3,758 $ — $ — United States government agency securities Short-term investments 11,228 — 11,228 — Corporate debt securities Short-term investments 35,785 — 35,785 — Total financial assets $ 50,771 $ 3,758 $ 47,013 $ — The Company did not have any transfers among fair value measurement levels during the years ended December 31, 2018 and 2017. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | Note 4. Inventories Inventories at December 31, 2018 and 2017, consisted of the following (in thousands): December 31, 2018 2017 Work-in-process $ 3,075 $ 4,299 Finished goods 10,464 10,158 Total inventories $ 13,539 $ 14,457 |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, net | Note 5. Property and Equipment, net Property and equipment, net at December 31, 2018 and 2017, consisted of the following (in thousands): December 31, 2018 2017 Construction-in-progress $ 6,864 $ 70 Machinery and equipment 1,945 2,205 Computer equipment and software 2,915 3,446 Furniture and fixtures 901 904 Leasehold improvements 5,715 5,698 Consigned equipment 1,299 1,190 Total property and equipment, gross 19,639 13,513 Accumulated depreciation and amortization (11,509 ) (11,394 ) Total property and equipment, net $ 8,130 $ 2,119 Depreciation and amortization expense related to property and equipment, net was $1.1 million, $1.2 million and $1.1 million for the years ended December 31, 2018, 2017 and 2016, respectively. The impairment of long-lived assets were zero, zero, and $0.2 million for the years ended December 31, 2018, 2017 and 2016, respectively. As part of the Company’s 2016 review of property and equipment, an impairment of long-lived assets on the consolidated statement of operations was recorded for construction-in-progress related to a deposit associated with a terminated agreement. |
Goodwill and Intangible Assets,
Goodwill and Intangible Assets, net | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, the Company did not dispose of or recognize additional goodwill. On August 31, 2018, 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, 2018 (in thousands): December 31, 2018 Gross Carrying Amount Accumulated Amortization Net Carrying Amount Acquisition-related intangible assets: Reacquired license - INTERCEPT Asia $ 2,017 $ (1,683 ) $ 334 Total intangible assets $ 2,017 $ (1,683 ) $ 334 The following is a summary of intangible assets, net at December 31, 2017 (in thousands): December 31, 2017 Gross Carrying Amount Accumulated Amortization Net Carrying Amount Acquisition-related intangible assets: Reacquired license - INTERCEPT Asia $ 2,017 $ (1,481 ) $ 536 Total intangible assets $ 2,017 $ (1,481 ) $ 536 During the years ended December 31, 2018, 2017 and 2016, there were no impairment charges recognized related to the Company’s intangible assets. At December 31, 2018, the expected annual amortization expense of the intangible assets, net is $0.2 million for the year ending December 31, 2019, and $0.1 million for the year ending December 31, 2020. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | Note 7. Accrued Liabilities Accrued liabilities at December 31, 2018 and 2017, consisted of the following (in thousands): December 31, 2018 2017 Accrued compensation and related costs $ 10,765 $ 7,372 Accrued professional services 4,544 1,811 Accrued development costs 1,965 794 Other accrued expenses 2,526 1,735 Total accrued liabilities $ 19,800 $ 11,712 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt | Note 8. Debt Debt at December 31, 2018, consisted of the following (in thousands): December 31, 2018 Principal Unamortized Discount Net Carrying Value Loan and Security Agreement $ 30,000 $ (130 ) $ 29,870 Less: debt - current (7,857 ) — (7,857 ) Debt - non-current $ 22,143 $ (130 ) $ 22,013 Debt at December 31, 2017, consisted of the following (in thousands): December 31, 2017 Principal Unamortized Discount Total Loan and Security Agreement $ 30,000 $ (202 ) $ 29,798 Less: debt - current — — — Debt - non-current $ 30,000 $ (202 ) $ 29,798 Expected future principal and interest payments based on debt balances at December 31, 2018, are expected to be as follows: Year ended December 31, Principal Interest Total 2019 $ 7,857 $ 2,579 10,436 2020 8,571 1,765 10,336 2021 8,572 931 9,503 2022 5,000 2,560 7,560 Total $ 30,000 $ 7,835 $ 37,835 Loan and Security Agreement Prior to December 31, 2016, the Company maintained a five-year loan and security agreement (the “Term Loan Agreement”) with Oxford Finance LLC (“Oxford”), under which the Company borrowed $20.0 million. The borrowings were set to mature on June 1, 2019, with various interest only periods. On April 27, 2017, the Term Loan Agreement was amended to include an additional interest-only period under the Term Loan Agreement. As amended, the Company was required to make interest only payments from May 2017 through December 2017, followed by eighteen months of equal principal and interest payments thereafter. The Company was also required to make a final payment equal to 7% of the principal amounts drawn payable on the earlier to occur of maturity or prepayment. On July 31, 2017 (the “Closing Date”), the Company entered into an amended and restated loan and security agreement (the “Amended Credit Agreement”) with Oxford, which amended and restated the Term Loan Agreement in its entirety. The Amended Credit Agreement provided for secured growth capital term loans of up to $40.0 million (the “2017 Term Loans”). All of the Company’s current and future assets, excluding its intellectual property and 35% of the Company’s investment in Cerus Europe B.V., are secured for its borrowings under the Amended Credit Agreement. The 2017 Term Loans were 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 Term Loan Agreement of $17.6 million and the final payment of the 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. The 2017 Term Loan A bears interest at a rate equal to the greater of (i) 8.01% and (ii) the three-month U.S. LIBOR rate plus 6.72%. The interest rate on the 2017 Term Loan A at December 31, 2018 was approximately 9.53%. The Company will also be required to make a final payment fee of 8.00% of the principal amounts of the 2017 Term Loan A. The Amended Credit Agreement contains certain nonfinancial covenants, with which the Company was in compliance at December 31, 2018. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
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’s leased facilities qualify as operating leases and as such, are not included on its consolidated balance sheets. Future minimum non-cancelable lease payments under operating leases as of December 31, 2018, were as follows (in thousands): Year ended December 31, Lease Payments 2019 $ 3,535 2020 3,027 2021 3,076 2022 2,703 2023 2,611 Thereafter 18,690 Total $ 33,642 Rent expense for office facilities was $1.0 million, $1.0 million and $0.8 million for the years ended December 31, 2018, 2017 and 2016, respectively. 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 $10.0 million, $6.7 million and $6.9 million for goods under agreements which are subject to minimum purchase commitments during the years ended December 31, 2018, 2017 and 2016, respectively. As of December 31, 2018, the Company had future minimum purchase commitments under these agreements of approximately $13.1 million, $3.2 million, $2.5 million, $2.6 million, and $0.1 million for the years ending December 31, 2019, 2020, 2021, 2022, and 2023, respectively. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | Note 10. Stockholders’ Equity Public Offering of Common Stock In January 2018, the Company issued and sold 14,030,000 shares of the Company’s common stock, par value $0.001 per share, at $4.10 per share in an underwritten public offering. The proceeds to the Company from this offering were approximately $57.2 million, net of the underwriting discount and other issuance costs. Sales Agreement On May 5, 2016, the Company entered into Amendment No. 2 to the Controlled Equity Offering SM On August 4, 2017, the Company entered into Amendment No. 3 to the Cantor Agreement (as amended on August 4, 2017, the “Amended Cantor Agreement”). The Amended Cantor Agreement became effective on January 8, 2018, and provides 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, which amount includes the $31.4 million of unsold shares of common stock available for sale under the Prior Cantor Agreement 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, 2018, 4.2 million shares of the Company’s common stock were sold under the Amended Cantor Agreement for aggregate net proceeds of $27.9 million. During the year ended December 31, 2017, 11.0 million shares of the Company’s common stock were sold under the Prior Cantor Agreement for net proceeds of $30.3 million. At December 31, 2018, the Company had approximately $41.6 million of common stock available to be sold under the Amended Cantor Agreement. Stockholder Rights Plan In October 2009, the Company’s Board of Directors adopted an amendment to its 1999 stockholder rights plan, commonly referred to as a “poison pill,” to reduce the exercise price, extend the expiration date and revise certain definitions under the plan. The stockholder rights plan is intended to deter hostile or coercive attempts to acquire the Company. The stockholder rights plan enables stockholders to acquire shares of the Company’s common stock, or the common stock of an acquirer, at a substantial discount to the public market price should any person or group acquire more than 15% of the Company’s common stock without the approval of the Board of Directors under certain circumstances. The Company has designated 250,000 shares of Series C Junior Participating preferred stock for issuance in connection with the stockholder rights plan. As of December 31, 2018, no Series C Junior Participating preferred stock has been issued. The expiration date of the rights issued under the is October 27, 2019. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, the Company had 0.8 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. 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 and will generally vest over three 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, 2018, 20,000 performance-based stock options were outstanding. On August 31, 2016, the Company’s Board of Directors adopted the Cerus Corporation Inducement Plan (the “Inducement Plan”), and reserved 1,250,000 shares of its common stock under the Inducement Plan to be used exclusively for the issuance of non-statutory stock options and restricted stock units to individuals who were not previously employees or directors of the Company, or who had experienced a bona fide period of non-employment, as an inducement material to the individual’s entry into employment with the Company. The terms and conditions of the Inducement Plan are substantially similar to the Amended 2008 Plan. Effective June 7, 2017, the Company no longer issues shares from the Inducement Plan. At December 31, 2018, the Company had an aggregate of approximately 22.9 million shares of its common stock subject to outstanding options or RSUs, or remaining available for future issuance under the Amended 2008 Plan, of which approximately 17.6 million shares and 2.0 million shares were subject to outstanding options and outstanding RSUs, respectively, and approximately 3.3 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): Number of Options Outstanding Weighted Average Exercise Price per Share Balances at December 31, 2017 17,138 $ 4.27 Granted 3,447 4.78 Exercised (2,195 ) 3.19 Forfeited (678 ) 4.73 Expired (152 ) 5.93 Balances at December 31, 2018 17,560 4.47 Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts): Number of Shares Outstanding Weighted Average Grant Date Fair Value per Share Balances at December 31, 2017 1,256 $ 4.53 Granted (1) 1,420 4.51 Vested (521 ) 4.45 Forfeited (154 ) 4.22 Balances at December 31, 2018 2,001 4.56 (1) Includes the number of shares issuable under the performance-based restricted stock unit awards granted during the twelve months ended December 31, 2018 . The total fair value of RSUs as of their respective vesting dates, for the years ended December 31, 2018, 2017 and 2016, were $2.8 million, $1.0 million and zero, respectively. Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2018, was as follows (in thousands except weighted average exercise price and contractual term): Number Weighted Exercise Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Balances at December 31, 2018 Stock options outstanding 17,560 $ 4.47 6.3 $ 14,345 Stock options vested and expected to vest 17,276 4.47 6.3 14,179 Stock options exercisable 12,336 4.37 5.4 11,402 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, 2018, 2017 and 2016, was $7.1 million, $0.6 million and $1.9 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, 2018, 2017 and 2016, was as follows (in thousands): Year Ended December 31, 2018 2017 2016 Research and development $ 1,669 $ 1,323 $ 1,091 Selling, general and administrative 8,725 8,032 6,974 Total stock-based compensation expense $ 10,394 $ 9,355 $ 8,065 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, 2018, 2017 and 2016. The Company has also not recorded any stock-based compensation associated with performance-based stock options during the years ended December 31, 2018, 2017 and 2016. As of December 31, 2018, the Company expects to recognize the remaining unamortized stock-based compensation expense of $10.3 million and $5.5 million, respectively, related to non-vested stock options and RSUs, net of estimated forfeitures, over an estimated remaining weighted average period of 2.5 years and 1.8 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, 2018, 2017 and 2016, was as follows: Year Ended December 31, 2018 2017 2016 Stock Options: Expected term (in years) 6.07 6.12 5.85 Estimated volatility 50% 47% 49% Risk-free interest rate 2.72% 2.14% 1.41% Expected dividend yield 0% 0% 0% Employee Stock Purchase Plan Rights: Expected term (in years) 0.74 0.92 0.76 Estimated volatility 47% 57% 47% Risk-free interest rate 2.34% 1.08% 0.55% Expected dividend yield 0% 0% 0% The weighted average grant-date fair value of stock options granted during the years ended December 31, 2018, 2017 and 2016, was $2.41 per share, $1.98 per share and $2.55 per share, respectively. The weighted average grant-date fair value of employee stock purchase rights during the years ended December 31, 2018, 2017 and 2016, was $2.29 per share, $1.18 per share and $1.87 per share, respectively. |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2018 | |
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 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. The Company has not contributed to the 401(k) Plan during the years ended December 31, 2018, 2017 and 2016. During the year ended December 31, 2018, the Company approved a 401(k) employer match that is effective in 2019. Under the 401(k) match, the Company will match 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. |
Development and License Agreeme
Development and License Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Development And License Agreements [Abstract] | |
Development and License Agreements | Note 13. Development and License Agreements Agreements with Fresenius 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 requires the Company to make certain payments totaling €8.6 million (“Manufacturing and Development Payments”) to Fresenius. In 2016, the Company paid €3.1 million to Fresenius. In August 2018, the Company entered into an amendment to the Supply Agreement accelerating the payment for the remaining €5.5 million to August 2019. Because these payments represent 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 is accreted through interest expense based on the estimated timing of its ultimate settlement. As of December 31, 2018 and 2017, the Company accrued $5.9 million (€5.2 million) and $5.8 million (€4.8 million), respectively, related to the remaining Manufacturing and Development Payments, which were included in “Manufacturing and development obligations – The Supply Agreement also requires 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 amount of prepaid R&D asset and manufacturing efficiency asset at December 31, 2018 and December 31, 2017 (in thousands). December 31, 2018 2017 Prepaid R&D asset - current (1) $ 47 $ 114 Prepaid R&D asset - non-current (2) 2,156 2,162 Manufacturing efficiency asset (2) 1,594 1,839 (1) Included in “Other current assets” in the Company's consolidated balance sheets. (2) Included in “Other assets” in the Company's consolidated balance sheets. 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 $21.3 million, $18.1 million and $16.1 million relating to the manufacturing of the Company’s products during the years ended December 31, 2018, 2017 and 2016, respectively. The following table summarizes the amounts of the Company’s payables to and receivables from Fresenius at December 31, 2018 and December 31, 2017(in thousands). December 31, 2018 2017 Payables to Fresenius (1) $ 7,812 $ 4,687 Receivables from Fresenius (2) 1,777 231 (1) Included in “Accounts Payable” and “Accrued Liabilities” in the Company's consolidated balance sheets. (2) Included in “Other current assets” in the Company's consolidated balance sheets. 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 five-year 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. 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, 2018 and 2017, $2.3 million and $1.4 million, respectively, of billed and unbilled amounts were included in accounts receivable on the Company’s consolidated balance sheets related to BARDA. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, 2017 and 2016, was as follows (in thousands): 2018 2017 2016 Loss before income taxes: U.S. $ (58,048 ) $ (57,925 ) $ (63,246 ) Foreign 713 1,227 515 Loss before income taxes $ (57,335 ) $ (56,698 ) $ (62,731 ) The provision for income taxes for the years ended December 31, 2018, 2017 and 2016, was as follows (in thousands): 2018 2017 2016 Provision for income taxes: Current: Foreign $ 225 $ 181 $ 147 Federal — — — State — — — Total current 225 181 147 Deferred: Foreign — — — Federal 3 3,659 28 State 1 47 — Total deferred 4 3,706 28 Provision for income taxes $ 229 $ 3,887 $ 175 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, 2018, 2017 and 2016, was as follows (in thousands): 2018 2017 2016 Federal statutory tax $ (12,040 ) $ (19,277 ) $ (21,329 ) Tax Act revaluation of deferred taxes — 81,923 — Tax Act deemed income inclusion — 1,083 — Federal research credits (1,390 ) (1,000 ) (809 ) State research credits (655 ) (628 ) (449 ) Expiration of federal carryovers 4,154 — — Expiration of state carryovers 1,344 1,475 1,193 Change in valuation allowance 9,913 (59,462 ) 3,940 Compensation related items (361 ) 1,382 484 State taxes (1,141 ) (803 ) (990 ) Revision to prior year items — — 17,200 Other 405 (806 ) 935 Provision for income taxes $ 229 $ 3,887 $ 175 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, 2018 and 2017, were as follows (in thousands): December 31, 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 125,016 $ 117,028 Research and development credit carryforwards 26,705 25,061 Capitalized research and development 15,293 17,195 Compensation related items 8,310 7,011 Other 4,013 3,116 Total deferred tax assets 179,337 169,411 Valuation allowance (179,245 ) (169,332 ) Net deferred tax assets $ 92 $ 79 Deferred tax liabilities: Amortization of goodwill $ 127 $ 111 Total deferred tax liabilities $ 127 $ 111 The valuation allowance increased by $9.9 million for the year ended December 31, 2018, compared to the decrease of $59.5 million and increase of $3.9 million for the years ended December 31, 2017 and 2016, 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, 2018, 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: Expires Expires Expires No Total 2019-2021 2022-2028 2029-2038 Expiration Federal losses carryovers $ 571,992 $ 66,880 $ 171,270 $ 273,585 $ 60,257 California loss carryovers 59,752 — — 59,752 — Federal research credits 18,631 5,269 7,626 5,736 — California research credits 10,220 — — — 10,220 Federal foreign tax credits 610 — 610 — — 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): December 31, December 31, 2018 2017 Unrecognized tax benefits at beginning of period $ 11,062 $ 10,836 Decreases related to expired carryforwards (401 ) — Increases related to prior year tax positions — 19 Increases related to current year tax positions 402 207 Unrecognized tax benefits at end of period $ 11,063 $ 11,062 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 Geographi
Segment, Customer and Geographic Information | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, 2017 and 2016 (in percentages): Year Ended December 31, 2018 2017 2016 Établissement Français du Sang 38% 22% * Advanced Technology Company K.S.C * * 12% * 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, 2018, 2017 and 2016, and was as follows (in thousands): Year Ended December 31, 2018 2017 2016 Product revenue: France $ 23,043 $ 9,692 $ 3,485 United States 12,563 6,316 4,480 Belgium 6,788 6,263 6,392 Kuwait 883 2,788 4,415 Other countries 17,631 18,509 18,411 Total product revenue 60,908 43,568 37,183 Government contract revenue: United States 15,143 7,758 2,092 Total government contract revenue 15,143 7,758 2,092 Total revenue $ 76,051 $ 51,326 $ 39,275 Long-lived assets by geographical location, which consist of property and equipment, net and intangible assets, net, at December 31, 2018 and 2017, were as follows (in thousands): December 31, 2018 2017 U.S. and territories $ 8,252 $ 2,443 Europe & other 212 212 Total long-lived assets $ 8,464 $ 2,655 |
Quarterly Financial Information
Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 and 2017 (in thousands except per share amounts): Three Months Ended March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018 Product revenue $ 13,564 $ 15,420 $ 15,399 $ 16,525 Gross profit on product revenue 6,234 7,700 7,257 8,083 Government contract revenue 3,455 4,047 3,928 3,713 Net loss (13,885 ) (13,282 ) (14,192 ) (16,205 ) Net loss per share: Basic (0.11 ) (0.10 ) (0.11 ) (0.12 ) Diluted (0.11 ) (0.10 ) (0.11 ) (0.12 ) Three Months Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Product revenue $ 7,006 $ 9,525 $ 10,797 $ 16,240 Gross profit on product revenue 3,312 5,165 5,449 7,111 Government contract revenue 1,428 1,667 2,285 2,378 Net loss (18,598 ) (17,083 ) (13,418 ) (11,486 ) Net loss per share: Basic (0.18 ) (0.16 ) (0.12 ) (0.10 ) Diluted (0.18 ) (0.16 ) (0.12 ) (0.10 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
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”). |
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, and accrued liabilities, 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 The Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers”, on January 1, 2018, using the modified retrospective method applied to the contracts which were not completed as of the date of adoption. Revenue is recognized in accordance with that core principle 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 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 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 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” below. 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, 2018, 2017 and 2016, were as follows (in thousands): Year Ended December 31, 2018 2017 2016 Product revenue: Europe, Middle East and Africa $ 46,974 $ 36,241 $ 30,716 North America 12,696 6,325 4,569 Other 1,238 1,002 1,898 Total product revenue $ 60,908 $ 43,568 $ 37,183 Contract Balances The Company invoices its customers based upon the terms in the contracts, which is generally from 30 to 60 days. 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, 2018 and December 31, 2017. 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, 2018, is primarily driven by performance obligations not satisfied but invoiced as of December 31, 2018, offset by $0.4 million of revenue recognized that were included in the deferred product revenue balance as of December 31, 2017. 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 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 | 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 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 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 | Restricted Cash As of December 31, 2018, the Company’s “Restricted cash” primarily consisted of a $2.5 million of letter of credit relating to the lease of the Company’s new office building. As of December 31, 2018 and December 31, 2017, 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 | 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, 2018, 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 two customers and three customers that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2018 and December 31, 2017, respectively. These customers cumulatively represented approximately 50% and 53% of the Company’s outstanding trade receivables at December 31, 2018 and December 31, 2017, respectively. To date, the Company has not experienced collection difficulties from these customers. |
Inventories | Inventories At December 31, 2018 and December 31, 2017, 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 months 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 of 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, 2018 and December 31, 2017, 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, 2018 and December 31, 2017, the Company had $0.3 million and $0.1 million, respectively, recorded for potential obsolete, expiring or unsalable product. |
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, 2018 and December 31, 2017, the Company capitalized construction-in-progress costs included in “Property and Equipment, net” on the Company’s consolidated balance sheets, of $6.9 million and $0.1 million, respectively, related to leasehold improvements, of which $3.7 million was unpaid as of December 31, 2018. As of December 31, 2018 and December 31, 2017, the Company had receivables included in “Prepaid and other current assets” on the Company's consolidated balance sheets, of $1.2 million and zero, respectively, related to its new office building. |
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, 2018 and December 31, 2017, was $1.7 million and $1.5 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, 2018 and 2017, there were no impairment charges recognized related to the acquired intangible assets. |
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. |
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. |
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 measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based 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 | 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 1998 through 2017, California tax returns for years through 2017, and Netherlands tax returns for years 2015 through 2017 remain subject to examination by the taxing jurisdictions. The Company continues to carry a valuation allowance on substantially all of its net deferred tax assets. |
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, 2018, 2017 and 2016, 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, 2018, 2017 and 2016 (in thousands, except per share amounts): Year Ended December 31, 2018 2017 2016 Numerator for Basic and Diluted: Net loss used for basic calculation $ (57,564 ) $ (60,585 ) $ (62,906 ) Denominator: Basic weighted average number of shares outstanding 131,663 108,221 101,826 Effect of dilutive potential shares — — — Diluted weighted average number of shares outstanding 131,663 108,221 101,826 Net loss per share: Basic $ (0.44 ) $ (0.56 ) $ (0.62 ) Diluted (0.44 ) (0.56 ) (0.62 ) 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, 2018, 2017 and 2016 (shares in thousands): Year Ended December 31, 2018 2017 2016 Weighted average number of anti-dilutive potential shares: Stock options 18,031 17,373 15,592 Restricted stock units 1,902 1,225 576 Employee stock purchase plan rights 20 21 43 Total 19,953 18,619 16,211 |
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 one-year 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, 2018 and December 31, 2017. |
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. |
New Accounting Pronouncements | New Accounting Pronouncements Recently adopted accounting pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The Company adopted the new accounting standard on January 1, 2018, using the modified retrospective method, and the adoption had no impact on the Company’s consolidated financial statements. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10), which requires all equity investments to be measured at fair value with changes in the fair value recognized through net income (other than those accounted for under equity method of accounting or those that result in consolidation of the investee). The Company adopted this ASU on January 1, 2018, and the adoption had no impact on the Company’s consolidated financial statements. In May 2017, the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting, which provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. The Company adopted this ASU on January 1, 2018, and the adoption did not have a material impact on the Company’s consolidated financial statements. In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The standard is effective for annual periods beginning after December 15, 2018, and interim periods thereafter, with early application permitted. The Company early adopted this new accounting standard on July 1, 2018, and the adoption did not have a material impact on the Company’s consolidated financial statements. Recently issued accounting pronouncements not yet adopted 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 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. This ASU will be effective for annual periods beginning after December 15, 2018, and interim periods thereafter, with early application permitted. 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. Companies may apply the practical expedient either retrospectively or prospectively. The Company will adopt these ASUs on January 1, 2019, using the modified retrospective approach and will apply the practical expedient prospectively. The Company is currently assessing the future impact of these ASUs on its consolidated financial statements. The Company anticipates that the Company’s operating lease commitments will be subject to the new standard. The Company will recognize right-of-use assets and lease liabilities on the Company’s consolidated balance sheets upon the adoption of these ASUs, which will increase the Company’s total assets and total liabilities. Based on the lease portfolio as of December 31, 2018, the Company anticipates recording both right-of-use assets and lease liabilities between approximately $2 million to $3 million on its consolidated balance sheets, and anticipates no material impact to its consolidated statements of operations. However, the ultimate impact of adopting ASU 2016-02 will depend on the Company’s final evaluation as of the adoption date. The most significant impact on the Company’s consolidated balance sheets is expected to be the Company’s lease to office space located in Concord, California, with commencement date of March 2019. The Company will continue to monitor industry activities and any additional guidance provided by regulators, standards setters, or the accounting profession as an ongoing component of its assessment and implementation plans. 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 transition method. The Company is currently assessing the future impact of this ASU on the Company’s consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, 2017 and 2016, were as follows (in thousands): Year Ended December 31, 2018 2017 2016 Product revenue: Europe, Middle East and Africa $ 46,974 $ 36,241 $ 30,716 North America 12,696 6,325 4,569 Other 1,238 1,002 1,898 Total product revenue $ 60,908 $ 43,568 $ 37,183 |
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, 2018, 2017 and 2016 (in thousands, except per share amounts): Year Ended December 31, 2018 2017 2016 Numerator for Basic and Diluted: Net loss used for basic calculation $ (57,564 ) $ (60,585 ) $ (62,906 ) Denominator: Basic weighted average number of shares outstanding 131,663 108,221 101,826 Effect of dilutive potential shares — — — Diluted weighted average number of shares outstanding 131,663 108,221 101,826 Net loss per share: Basic $ (0.44 ) $ (0.56 ) $ (0.62 ) Diluted (0.44 ) (0.56 ) (0.62 ) |
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, 2018, 2017 and 2016 (shares in thousands): Year Ended December 31, 2018 2017 2016 Weighted average number of anti-dilutive potential shares: Stock options 18,031 17,373 15,592 Restricted stock units 1,902 1,225 576 Employee stock purchase plan rights 20 21 43 Total 19,953 18,619 16,211 |
Available-for-sale Securities_2
Available-for-sale Securities and Fair Value on Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Summary of Available-for-Sale Securities | The following is a summary of available-for-sale securities at December 31, 2018 (in thousands): December 31, 2018 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 6,167 $ — $ — $ 6,167 United States government agency securities 15,971 — (23 ) 15,948 Corporate debt securities 73,028 2 (260 ) 72,770 Total available-for-sale securities $ 95,166 $ 2 $ (283 ) $ 94,885 The following is a summary of available-for-sale securities at December 31, 2017 (in thousands): December 31, 2017 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 3,758 $ — $ — $ 3,758 United States government agency securities 11,252 — (24 ) 11,228 Corporate debt securities 35,858 — (73 ) 35,785 Total available-for-sale securities $ 50,868 $ — $ (97 ) $ 50,771 |
Available-for-Sale Debt Securities by Original Contractual Maturity | Available-for-sale securities at December 31, 2018 and 2017, consisted of the following by contractual maturity (in thousands): December 31, 2018 December 31, 2017 Amortized Cost Fair Value Amortized Cost Fair Value One year or less $ 85,227 $ 84,957 $ 38,836 $ 38,781 Greater than one year and less than five years 9,939 9,928 12,032 11,990 Total available-for-sale securities $ 95,166 $ 94,885 $ 50,868 $ 50,771 |
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): December 31, 2018 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss United States government agency securities $ 14,948 $ (22 ) $ 999 $ (1 ) $ 15,947 $ (23 ) Corporate debt securities 60,813 (231 ) 9,976 (29 ) 70,789 (260 ) Total available-for-sale securities $ 75,761 $ (253 ) $ 10,975 $ (30 ) $ 86,736 $ (283 ) December 31, 2017 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss United States government agency securities $ 8,729 $ (24 ) $ — $ — $ 8,729 $ (24 ) Corporate debt securities 35,785 (73 ) — — 35,785 (73 ) Total available-for-sale securities $ 44,514 $ (97 ) $ — $ — $ 44,514 $ (97 ) |
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, 2018 (in thousands): Balance sheet Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs classification Total (Level 1) (Level 2) (Level 3) Money market funds Cash and cash equivalents $ 6,167 $ 6,167 $ — $ — United States government agency securities Short-term investments 15,948 — 15,948 — Corporate debt securities Short-term investments 72,770 — 72,770 — Total financial assets $ 94,885 $ 6,167 $ 88,718 $ — The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2017 (in thousands): Balance sheet Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs classification Total (Level 1) (Level 2) (Level 3) Money market funds Cash and cash equivalents $ 3,758 $ 3,758 $ — $ — United States government agency securities Short-term investments 11,228 — 11,228 — Corporate debt securities Short-term investments 35,785 — 35,785 — Total financial assets $ 50,771 $ 3,758 $ 47,013 $ — |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories at December 31, 2018 and 2017, consisted of the following (in thousands): December 31, 2018 2017 Work-in-process $ 3,075 $ 4,299 Finished goods 10,464 10,158 Total inventories $ 13,539 $ 14,457 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net at December 31, 2018 and 2017, consisted of the following (in thousands): December 31, 2018 2017 Construction-in-progress $ 6,864 $ 70 Machinery and equipment 1,945 2,205 Computer equipment and software 2,915 3,446 Furniture and fixtures 901 904 Leasehold improvements 5,715 5,698 Consigned equipment 1,299 1,190 Total property and equipment, gross 19,639 13,513 Accumulated depreciation and amortization (11,509 ) (11,394 ) Total property and equipment, net $ 8,130 $ 2,119 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets, net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Intangible Assets | The following is a summary of intangible assets, net at December 31, 2018 (in thousands): December 31, 2018 Gross Carrying Amount Accumulated Amortization Net Carrying Amount Acquisition-related intangible assets: Reacquired license - INTERCEPT Asia $ 2,017 $ (1,683 ) $ 334 Total intangible assets $ 2,017 $ (1,683 ) $ 334 The following is a summary of intangible assets, net at December 31, 2017 (in thousands): December 31, 2017 Gross Carrying Amount Accumulated Amortization Net Carrying Amount Acquisition-related intangible assets: Reacquired license - INTERCEPT Asia $ 2,017 $ (1,481 ) $ 536 Total intangible assets $ 2,017 $ (1,481 ) $ 536 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | Accrued liabilities at December 31, 2018 and 2017, consisted of the following (in thousands): December 31, 2018 2017 Accrued compensation and related costs $ 10,765 $ 7,372 Accrued professional services 4,544 1,811 Accrued development costs 1,965 794 Other accrued expenses 2,526 1,735 Total accrued liabilities $ 19,800 $ 11,712 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt | Debt at December 31, 2018, consisted of the following (in thousands): December 31, 2018 Principal Unamortized Discount Net Carrying Value Loan and Security Agreement $ 30,000 $ (130 ) $ 29,870 Less: debt - current (7,857 ) — (7,857 ) Debt - non-current $ 22,143 $ (130 ) $ 22,013 Debt at December 31, 2017, consisted of the following (in thousands): December 31, 2017 Principal Unamortized Discount Total Loan and Security Agreement $ 30,000 $ (202 ) $ 29,798 Less: debt - current — — — Debt - non-current $ 30,000 $ (202 ) $ 29,798 |
Expected Future Principal and Interest Payments Based on Debt Balances | Expected future principal and interest payments based on debt balances at December 31, 2018, are expected to be as follows: Year ended December 31, Principal Interest Total 2019 $ 7,857 $ 2,579 10,436 2020 8,571 1,765 10,336 2021 8,572 931 9,503 2022 5,000 2,560 7,560 Total $ 30,000 $ 7,835 $ 37,835 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Future Minimum Non-Cancelable Lease Payments Under Operating Leases | Future minimum non-cancelable lease payments under operating leases as of December 31, 2018, were as follows (in thousands): Year ended December 31, Lease Payments 2019 $ 3,535 2020 3,027 2021 3,076 2022 2,703 2023 2,611 Thereafter 18,690 Total $ 33,642 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, was as follows (in thousands except weighted average exercise price and contractual term): Number Weighted Exercise Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Balances at December 31, 2018 Stock options outstanding 17,560 $ 4.47 6.3 $ 14,345 Stock options vested and expected to vest 17,276 4.47 6.3 14,179 Stock options exercisable 12,336 4.37 5.4 11,402 |
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, 2018, 2017 and 2016, was as follows (in thousands): Year Ended December 31, 2018 2017 2016 Research and development $ 1,669 $ 1,323 $ 1,091 Selling, general and administrative 8,725 8,032 6,974 Total stock-based compensation expense $ 10,394 $ 9,355 $ 8,065 |
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, 2018, 2017 and 2016, was as follows: Year Ended December 31, 2018 2017 2016 Stock Options: Expected term (in years) 6.07 6.12 5.85 Estimated volatility 50% 47% 49% Risk-free interest rate 2.72% 2.14% 1.41% Expected dividend yield 0% 0% 0% Employee Stock Purchase Plan Rights: Expected term (in years) 0.74 0.92 0.76 Estimated volatility 47% 57% 47% Risk-free interest rate 2.34% 1.08% 0.55% Expected dividend yield 0% 0% 0% |
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): Number of Options Outstanding Weighted Average Exercise Price per Share Balances at December 31, 2017 17,138 $ 4.27 Granted 3,447 4.78 Exercised (2,195 ) 3.19 Forfeited (678 ) 4.73 Expired (152 ) 5.93 Balances at December 31, 2018 17,560 4.47 |
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): Number of Shares Outstanding Weighted Average Grant Date Fair Value per Share Balances at December 31, 2017 1,256 $ 4.53 Granted (1) 1,420 4.51 Vested (521 ) 4.45 Forfeited (154 ) 4.22 Balances at December 31, 2018 2,001 4.56 (1) Includes the number of shares issuable under the performance-based restricted stock unit awards granted during the twelve months ended December 31, 2018 . |
Development and License Agree_2
Development and License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Development And License Agreements [Abstract] | |
Summary of Prepaid R&D Asset and Manufacturing Efficiency Asset | The following table summarizes the amount of prepaid R&D asset and manufacturing efficiency asset at December 31, 2018 and December 31, 2017 December 31, 2018 2017 Prepaid R&D asset - current (1) $ 47 $ 114 Prepaid R&D asset - non-current (2) 2,156 2,162 Manufacturing efficiency asset (2) 1,594 1,839 (1) Included in “Other current assets” in the Company's consolidated balance sheets. (2) Included in “Other assets” in the Company's consolidated balance sheets. |
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, 2018 and December 31, 2017(in thousands). December 31, 2018 2017 Payables to Fresenius (1) $ 7,812 $ 4,687 Receivables from Fresenius (2) 1,777 231 (1) Included in “Accounts Payable” and “Accrued Liabilities” in the Company's consolidated balance sheets. (2) Included in “Other current assets” in the Company's consolidated balance sheets. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, 2017 and 2016, was as follows (in thousands): 2018 2017 2016 Loss before income taxes: U.S. $ (58,048 ) $ (57,925 ) $ (63,246 ) Foreign 713 1,227 515 Loss before income taxes $ (57,335 ) $ (56,698 ) $ (62,731 ) |
Provision Benefit for Income Taxes | The provision for income taxes for the years ended December 31, 2018, 2017 and 2016, was as follows (in thousands): 2018 2017 2016 Provision for income taxes: Current: Foreign $ 225 $ 181 $ 147 Federal — — — State — — — Total current 225 181 147 Deferred: Foreign — — — Federal 3 3,659 28 State 1 47 — Total deferred 4 3,706 28 Provision for income taxes $ 229 $ 3,887 $ 175 |
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, 2018, 2017 and 2016, was as follows (in thousands): 2018 2017 2016 Federal statutory tax $ (12,040 ) $ (19,277 ) $ (21,329 ) Tax Act revaluation of deferred taxes — 81,923 — Tax Act deemed income inclusion — 1,083 — Federal research credits (1,390 ) (1,000 ) (809 ) State research credits (655 ) (628 ) (449 ) Expiration of federal carryovers 4,154 — — Expiration of state carryovers 1,344 1,475 1,193 Change in valuation allowance 9,913 (59,462 ) 3,940 Compensation related items (361 ) 1,382 484 State taxes (1,141 ) (803 ) (990 ) Revision to prior year items — — 17,200 Other 405 (806 ) 935 Provision for income taxes $ 229 $ 3,887 $ 175 |
Significant Components of Deferred Tax Assets and Liabilities | The significant components of the Company’s deferred tax assets and liabilities at December 31, 2018 and 2017, were as follows (in thousands): December 31, 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 125,016 $ 117,028 Research and development credit carryforwards 26,705 25,061 Capitalized research and development 15,293 17,195 Compensation related items 8,310 7,011 Other 4,013 3,116 Total deferred tax assets 179,337 169,411 Valuation allowance (179,245 ) (169,332 ) Net deferred tax assets $ 92 $ 79 Deferred tax liabilities: Amortization of goodwill $ 127 $ 111 Total deferred tax liabilities $ 127 $ 111 |
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: Expires Expires Expires No Total 2019-2021 2022-2028 2029-2038 Expiration Federal losses carryovers $ 571,992 $ 66,880 $ 171,270 $ 273,585 $ 60,257 California loss carryovers 59,752 — — 59,752 — Federal research credits 18,631 5,269 7,626 5,736 — California research credits 10,220 — — — 10,220 Federal foreign tax credits 610 — 610 — — |
Reconciliation of Unrecognized Tax Benefits | The following is a tabular reconciliation of the total amounts of unrecognized tax benefits (in thousands): December 31, December 31, 2018 2017 Unrecognized tax benefits at beginning of period $ 11,062 $ 10,836 Decreases related to expired carryforwards (401 ) — Increases related to prior year tax positions — 19 Increases related to current year tax positions 402 207 Unrecognized tax benefits at end of period $ 11,063 $ 11,062 |
Segment, Customer and Geograp_2
Segment, Customer and Geographic Information (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018, 2017 and 2016 (in percentages): Year Ended December 31, 2018 2017 2016 Établissement Français du Sang 38% 22% * Advanced Technology Company K.S.C * * 12% * Represents an amount less than 10% of product revenue. |
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, 2018, 2017 and 2016, and was as follows (in thousands): Year Ended December 31, 2018 2017 2016 Product revenue: France $ 23,043 $ 9,692 $ 3,485 United States 12,563 6,316 4,480 Belgium 6,788 6,263 6,392 Kuwait 883 2,788 4,415 Other countries 17,631 18,509 18,411 Total product revenue 60,908 43,568 37,183 Government contract revenue: United States 15,143 7,758 2,092 Total government contract revenue 15,143 7,758 2,092 Total revenue $ 76,051 $ 51,326 $ 39,275 Long-lived assets by geographical location, which consist of property and equipment, net and intangible assets, net, at December 31, 2018 and 2017, were as follows (in thousands): December 31, 2018 2017 U.S. and territories $ 8,252 $ 2,443 Europe & other 212 212 Total long-lived assets $ 8,464 $ 2,655 |
Quarterly Financial Informati_2
Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 and 2017 (in thousands except per share amounts): Three Months Ended March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018 Product revenue $ 13,564 $ 15,420 $ 15,399 $ 16,525 Gross profit on product revenue 6,234 7,700 7,257 8,083 Government contract revenue 3,455 4,047 3,928 3,713 Net loss (13,885 ) (13,282 ) (14,192 ) (16,205 ) Net loss per share: Basic (0.11 ) (0.10 ) (0.11 ) (0.12 ) Diluted (0.11 ) (0.10 ) (0.11 ) (0.12 ) Three Months Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Product revenue $ 7,006 $ 9,525 $ 10,797 $ 16,240 Gross profit on product revenue 3,312 5,165 5,449 7,111 Government contract revenue 1,428 1,667 2,285 2,378 Net loss (18,598 ) (17,083 ) (13,418 ) (11,486 ) Net loss per share: Basic (0.18 ) (0.16 ) (0.12 ) (0.10 ) Diluted (0.18 ) (0.16 ) (0.12 ) (0.10 ) |
Summary of Significant Accoun_4
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, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | $ 76,051 | $ 51,326 | $ 39,275 | ||||||||
Product | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | $ 16,525 | $ 15,399 | $ 15,420 | $ 13,564 | $ 16,240 | $ 10,797 | $ 9,525 | $ 7,006 | 60,908 | 43,568 | 37,183 |
Product | North America | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | 12,696 | 6,325 | 4,569 | ||||||||
Product | Europe, Middle East and Africa | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | 46,974 | 36,241 | 30,716 | ||||||||
Product | Other | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total product revenue | $ 1,238 | $ 1,002 | $ 1,898 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2018USD ($)CustomerSegment | Dec. 31, 2017USD ($)Customer | Dec. 31, 2016USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Description of payment of customer invoice contract | The Company invoices its customers based upon the terms in the contracts, which is generally from 30 to 60 days. | ||
Contract asset | $ 0 | $ 0 | |
Revenue recognized, that were included in deferred product revenue | $ 400,000 | ||
Application of an optional exemption not to disclose the value of unsatisfied performance obligations | true | ||
Restricted cash | $ 2,500,000 | ||
Number of major customers representing outstanding trade receivables | Customer | 2 | 3 | |
Protracted length of inventory | 1 year | ||
Inventory valuation reserves | $ 300,000 | $ 100,000 | |
Capitalized construction-in-progress cost unpaid | 3,700,000 | ||
Accumulated amortization intangible assets | $ 1,683,000 | 1,481,000 | |
Estimated useful life of intangible assets | 10 years | ||
Number of reportable segments | Segment | 1 | ||
Impairment charges acquired intangible asstes | $ 0 | 0 | $ 0 |
Period of warranty | 1 year | ||
Warranty claim liability | $ 0 | 0 | |
Leasehold Improvements | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Capitalized construction-in-progress costs | 6,900,000 | 100,000 | |
Prepaid and Other Current Assets | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Receivables related to office building | $ 1,200,000 | $ 0 | |
Trade Accounts Receivable | Customer Concentration Risk | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 50.00% | 53.00% | |
Minimum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Payment of customer invoice contract period | 30 days | ||
Shelf lives of inventory | 18 months | ||
Estimated useful life of property and equipment | 3 years | ||
Minimum | ASU 2016-02 | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Right-of-use assets | $ 2,000,000 | ||
Lease liabilities | $ 2,000,000 | ||
Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Payment of customer invoice contract period | 60 days | ||
Shelf lives of inventory | 24 months | ||
Estimated useful life of property and equipment | 5 years | ||
Maximum | ASU 2016-02 | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Right-of-use assets | $ 3,000,000 | ||
Lease liabilities | $ 3,000,000 |
Reconciliation of Numerator and
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, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Numerator for Basic and Diluted: | |||||||||||
Net loss used for basic calculation | $ (16,205) | $ (14,192) | $ (13,282) | $ (13,885) | $ (11,486) | $ (13,418) | $ (17,083) | $ (18,598) | $ (57,564) | $ (60,585) | $ (62,906) |
Denominator: | |||||||||||
Basic weighted average number of shares outstanding | 131,663 | 108,221 | 101,826 | ||||||||
Diluted weighted average number of shares outstanding | 131,663 | 108,221 | 101,826 | ||||||||
Net loss per share: | |||||||||||
Basic | $ (0.12) | $ (0.11) | $ (0.10) | $ (0.11) | $ (0.10) | $ (0.12) | $ (0.16) | $ (0.18) | $ (0.44) | $ (0.56) | $ (0.62) |
Diluted | $ (0.12) | $ (0.11) | $ (0.10) | $ (0.11) | $ (0.10) | $ (0.12) | $ (0.16) | $ (0.18) | $ (0.44) | $ (0.56) | $ (0.62) |
Potential Shares, Excluded from
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 19,953 | 18,619 | 16,211 |
Stock Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 18,031 | 17,373 | 15,592 |
Restricted Stock Units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 1,902 | 1,225 | 576 |
Employee Stock Purchase Plan Rights | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 20 | 21 | 43 |
Summary of Available-for-Sale S
Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 95,166 | $ 50,868 |
Gross Unrealized Gain | 2 | |
Gross Unrealized Loss | (283) | (97) |
Fair Value | 94,885 | 50,771 |
Money market funds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 6,167 | 3,758 |
Fair Value | 6,167 | 3,758 |
United States government agency securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 15,971 | 11,252 |
Gross Unrealized Loss | (23) | (24) |
Fair Value | 15,948 | 11,228 |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 73,028 | 35,858 |
Gross Unrealized Gain | 2 | |
Gross Unrealized Loss | (260) | (73) |
Fair Value | $ 72,770 | $ 35,785 |
Available-for-Sale Debt Securit
Available-for-Sale Debt Securities by Original Contractual Maturity (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Investments Debt And Equity Securities [Abstract] | ||
One year or less, amortized cost | $ 85,227 | $ 38,836 |
Greater than one year and less than five years, amortized cost | 9,939 | 12,032 |
Amortized Cost | 95,166 | 50,868 |
One year or less, fair value | 84,957 | 38,781 |
Greater than one year and less than five years, fair value | 9,928 | 11,990 |
Total available-for-sale securities fair value | $ 94,885 | $ 50,771 |
Available-for-Sale Marketable S
Available-for-Sale Marketable Securities in Unrealized Position (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||
Less than 12 Months, Fair Value | $ 75,761 | $ 44,514 |
Less than 12 Months, Unrealized Loss | (253) | (97) |
12 Months or Longer, Fair Value | 10,975 | |
12 Months or Longer, Unrealized Loss | (30) | |
Total, Fair Value | 86,736 | 44,514 |
Total, Unrealized Loss | (283) | (97) |
United States government agency securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less than 12 Months, Fair Value | 14,948 | 8,729 |
Less than 12 Months, Unrealized Loss | (22) | (24) |
12 Months or Longer, Fair Value | 999 | |
12 Months or Longer, Unrealized Loss | (1) | |
Total, Fair Value | 15,947 | 8,729 |
Total, Unrealized Loss | (23) | (24) |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less than 12 Months, Fair Value | 60,813 | 35,785 |
Less than 12 Months, Unrealized Loss | (231) | (73) |
12 Months or Longer, Fair Value | 9,976 | |
12 Months or Longer, Unrealized Loss | (29) | |
Total, Fair Value | 70,789 | 35,785 |
Total, Unrealized Loss | $ (260) | $ (73) |
Available-for-sale Securities_3
Available-for-sale Securities and Fair Value on Financial Instruments - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Schedule Of Available For Sale Securities [Line Items] | |||
Other-than-temporary impairment losses | $ 0 | $ 0 | $ 0 |
Remaining investment in common stock | 136,853,000 | 115,555,000 | |
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 | $ 3,500,000 | $ 800,000 |
Sale of common stock available-for-sale investments | 0 | 346,700 | 50,000 |
Remaining investment in common stock | 0 | 0 |
Fair Values on Financial Assets
Fair Values on Financial Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Fair value of financial assets and liabilities | ||
Total financial assets | $ 94,885 | $ 50,771 |
Money market funds | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 6,167 | 3,758 |
United States government agency securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 15,948 | 11,228 |
United States government agency securities | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 15,948 | 11,228 |
Corporate debt securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 72,770 | 35,785 |
Level 1 | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 6,167 | 3,758 |
Level 1 | Money market funds | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 6,167 | 3,758 |
Level 2 | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 88,718 | 47,013 |
Level 2 | United States government agency securities | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 15,948 | 11,228 |
Level 2 | Corporate debt securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | $ 72,770 | $ 35,785 |
Inventories (Detail)
Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Work-in-process | $ 3,075 | $ 4,299 |
Finished goods | 10,464 | 10,158 |
Total inventories | $ 13,539 | $ 14,457 |
Property and Equipment Net (Det
Property and Equipment Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | $ 19,639 | $ 13,513 |
Accumulated depreciation and amortization | (11,509) | (11,394) |
Total property and equipment, net | 8,130 | 2,119 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 6,864 | 70 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 1,945 | 2,205 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 2,915 | 3,446 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 901 | 904 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 5,715 | 5,698 |
Consigned equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | $ 1,299 | $ 1,190 |
Property and Equipment Net - Ad
Property and Equipment Net - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property Plant And Equipment [Abstract] | |||
Property and equipment, depreciation and amortization expense | $ 1,100,000 | $ 1,200,000 | $ 1,100,000 |
Impairment of long-lived assets | $ 0 | $ 0 | $ 150,000 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets Net - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
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, 2019 | 200,000 | ||
Annual amortization expense of the intangible assets, 2020 | $ 100,000 |
Summary of Intangible Assets Ne
Summary of Intangible Assets Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 2,017 | $ 2,017 |
Accumulated Amortization | (1,683) | (1,481) |
Net Carrying Amount | 334 | 536 |
Reacquired license - INTERCEPT Asia | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 2,017 | 2,017 |
Accumulated Amortization | (1,683) | (1,481) |
Net Carrying Amount | $ 334 | $ 536 |
Accrued Liabilities (Detail)
Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Accrued compensation and related costs | $ 10,765 | $ 7,372 |
Accrued professional services | 4,544 | 1,811 |
Accrued development costs | 1,965 | 794 |
Other accrued expenses | 2,526 | 1,735 |
Total accrued liabilities | $ 19,800 | $ 11,712 |
Debt (Detail)
Debt (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | ||
Total debt, Principal | $ 30,000 | |
Less: debt-current | (7,857) | |
Debt-non-current | 22,013 | $ 29,798 |
Cerus Term Loans | ||
Debt Instrument [Line Items] | ||
Total debt, Principal | 30,000 | 30,000 |
Total debt, Unamortized Discount | (130) | (202) |
Total debt | 29,870 | 29,798 |
Less: debt - current, Principal | (7,857) | |
Less: debt-current | (7,857) | |
Debt - non-current, Principal | 22,143 | 30,000 |
Debt - non-current, Unamortized Discount | (130) | (202) |
Debt-non-current | $ 22,013 | $ 29,798 |
Debt - Expected Future Principa
Debt - Expected Future Principal and Interest Payments Based on Debt Balances (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Debt Disclosure [Abstract] | |
2019, Principal | $ 7,857 |
2020, Principal | 8,571 |
2021, Principal | 8,572 |
2022, Principal | 5,000 |
Total, Principal | 30,000 |
2019, Interest | 2,579 |
2020, Interest | 1,765 |
2021, Interest | 931 |
2022, Interest | 2,560 |
Total, Interest | 7,835 |
2019, Total | 10,436 |
2020, Total | 10,336 |
2021, Total | 9,503 |
2022, Total | 7,560 |
Total | $ 37,835 |
Debt - Additional Information (
Debt - Additional Information (Detail) | Apr. 27, 2017 | Dec. 30, 2016USD ($) | Jul. 31, 2017USD ($)Tranche | Dec. 31, 2018 |
Cerus Term Loans | ||||
Debt Instrument [Line Items] | ||||
Term loan, face amount | $ 20,000,000 | |||
Term of agreement | 5 years | |||
Maturity period | Jun. 1, 2019 | |||
Principal and interest payments | 18 months | |||
Terms of required periodic payments of interest and principal | On April 27, 2017, the Term Loan Agreement was amended to include an additional interest-only period under the Term Loan Agreement. As amended, the Company was required to make interest only payments from May 2017 through December 2017, followed by eighteen months of equal principal and interest payments thereafter. The Company was also required to make a final payment equal to 7% of the principal amounts drawn payable on the earlier to occur of maturity or prepayment. | |||
Final payment term percent | 7.00% | |||
Cerus Amended Credit Agreement | 2017 Term Loans | ||||
Debt Instrument [Line Items] | ||||
Term loan, face amount | $ 40,000,000 | |||
Percentage of investments made in subsidiary | 35.00% | |||
Number of loan tranches | Tranche | 2 | |||
Repay in full all of outstanding term loans | $ 1,400,000 | |||
Terms of required periodic payments of interest and principal | The Amended Credit Agreement provided for secured growth capital term loans of up to $40.0 million (the “2017 Term Loans”). All of the Company’s current and future assets, excluding its intellectual property and 35% of the Company’s investment in Cerus Europe B.V., are secured for its borrowings under the Amended Credit Agreement. The 2017 Term Loans were 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 Term Loan Agreement of $17.6 million and the final payment of the 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. | |||
Interest rate, description | The 2017 Term Loan A bears interest at a rate equal to the greater of (i) 8.01% and (ii) the three-month U.S. LIBOR rate plus 6.72%. The interest rate on the 2017 Term Loan A at December 31, 2018 was approximately 9.53%. The Company will also be required to make a final payment fee of 8.00% of the principal amounts of the 2017 Term Loan A. The Amended Credit Agreement contains certain nonfinancial covenants, with which the Company was in compliance at December 31, 2018 | |||
Cerus Amended Credit Agreement | 2017 Term Loans | Three-month U.S. LIBOR | ||||
Debt Instrument [Line Items] | ||||
Debt, applicable margin | 6.72% | |||
First Tranche (Term Loan A) | Cerus Amended Credit Agreement | 2017 Term Loans | ||||
Debt Instrument [Line Items] | ||||
Term loan, face amount | $ 30,000,000 | |||
Final payment term percent | 8.00% | |||
Repay in full all of outstanding term loans | $ 17,600,000 | |||
Interest rate | 9.53% | |||
First Tranche (Term Loan A) | Cerus Amended Credit Agreement | 2017 Term Loans | Minimum | ||||
Debt Instrument [Line Items] | ||||
Debt instrument floating interest rate percentage | 8.01% | |||
Second Tranche (Term Loan B) | Cerus Amended Credit Agreement | 2017 Term Loans | ||||
Debt Instrument [Line Items] | ||||
Loan and security agreement available upon revenue achievement | $ 10,000,000 | |||
Expiration date to draw second tranche | May 14, 2018 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |||
Minimum term of non-cancellable operating leases | 1 year | ||
Expiration of non-cancellable operating leases maximum year | 2,030 | ||
Operating lease, rent expense | $ 1 | $ 1 | $ 0.8 |
Purchase commitment, paid | 10 | $ 6.7 | $ 6.9 |
Future minimum purchase commitment 2019 | 13.1 | ||
Future minimum purchase commitment 2020 | 3.2 | ||
Future minimum purchase commitment 2021 | 2.5 | ||
Future minimum purchase commitment 2022 | 2.6 | ||
Future minimum purchase commitment 2023 | $ 0.1 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Non-Cancelable Lease Payments Under Operating Leases (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2,019 | $ 3,535 |
2,020 | 3,027 |
2,021 | 3,076 |
2,022 | 2,703 |
2,023 | 2,611 |
Thereafter | 18,690 |
Total | $ 33,642 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | Jan. 08, 2018 | Jan. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | May 05, 2016 |
Stockholders Equity Note [Line Items] | ||||||
Common stock, shares issued and sold | 136,853,000 | 115,555,000 | ||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||
Proceeds from common stock sold | $ 85,036,000 | $ 30,197,000 | $ 22,121,000 | |||
Preferred stock, shares issued | 0 | 0 | ||||
Stockholders rights plan expiration date | Oct. 27, 2019 | |||||
Stockholder Rights Plan | ||||||
Stockholders Equity Note [Line Items] | ||||||
Minimum percentage of common stock acquired by stockholders | 15.00% | |||||
Designated preferred stock for future issuance | 250,000 | |||||
Series C Junior Participating preferred stock | ||||||
Stockholders Equity Note [Line Items] | ||||||
Preferred stock, shares issued | 0 | |||||
Amendment No. 2 | Cantor | Sales Agreement | ||||||
Stockholders Equity Note [Line Items] | ||||||
Maximum common stock offering price | $ 132,200,000 | |||||
Common stock registered for sale | $ 70,000,000 | |||||
Amendment No. 3 | Cantor | Sales Agreement | ||||||
Stockholders Equity Note [Line Items] | ||||||
Proceeds from common stock sold | 27,900,000 | $ 30,300,000 | ||||
Maximum common stock offering price | $ 70,000,000 | |||||
Common stock registered for sale | $ 41,600,000 | |||||
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 | 4,200,000 | 11,000,000 | ||||
Common Stock | ||||||
Stockholders Equity Note [Line Items] | ||||||
Common stock, number of shares issued | 18,202,000 | 10,986,000 | 3,526,000 | |||
Common Stock | Underwritten Public Offering | ||||||
Stockholders Equity Note [Line Items] | ||||||
Common stock, shares issued and sold | 14,030,000 | |||||
Common stock, par value | $ 0.001 | |||||
Common stock, sale of stock, price per share | $ 4.10 | |||||
Proceeds from common stock sold | $ 57,200,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Millions | 12 Months Ended | ||||
Dec. 31, 2018USD ($)Period$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / shares | Aug. 31, 2016shares | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Total intrinsic value of options exercised | $ | $ 7.1 | $ 0.6 | $ 1.9 | ||
Stock-based compensation, expected dividend yield | 0.00% | ||||
Weighted average grant-date fair value of stock options granted | $ / shares | $ 2.41 | $ 1.98 | $ 2.55 | ||
Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense expected to be recognized | $ | $ 10.3 | ||||
Stock-based compensation, weighted average recognition period | 2 years 6 months | ||||
Stock-based compensation, expected dividend yield | 0.00% | 0.00% | 0.00% | ||
Restricted Stock Units (RSUs) | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense expected to be recognized | $ | $ 5.5 | ||||
Stock-based compensation, weighted average recognition period | 1 year 9 months 18 days | ||||
Employee Stock Purchase Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation, option to be granted at percentage of fair value of common stock | 85.00% | ||||
Employee Stock Purchase Plan, offering period | 12 months | ||||
Number of purchase periods within each offering period | Period | 2 | ||||
Aggregate number of shares of common stock reserved for future issuance | 800,000 | ||||
Stock-based compensation, expected dividend yield | 0.00% | 0.00% | 0.00% | ||
Weighted average grant-date fair value of awards granted | $ / shares | $ 2.29 | $ 1.18 | $ 1.87 | ||
2008 Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation, option to be granted at percentage of fair value of common stock | 100.00% | ||||
Aggregate number of shares of common stock reserved for future issuance | 22,900,000 | ||||
Stock-based compensation, award term | 10 years | ||||
Performance-based stock options, outstanding | 20,000 | ||||
Outstanding options and other stock based awards | 17,560,000 | 17,138,000 | |||
Number of shares available for future issuance | 3,300,000 | ||||
2008 Equity Incentive Plan | Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation, vesting period | 4 years | ||||
2008 Equity Incentive Plan | Restricted Stock Units (RSUs) | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation, vesting period | 3 years | ||||
Number of Restricted Stock Units Outstanding | 2,001,000 | 1,256,000 | |||
Total fair value | $ | $ 2.8 | $ 1 | $ 0 | ||
Weighted average grant-date fair value of awards granted | $ / shares | [1] | $ 4.51 | |||
2008 Equity Incentive Plan | Performance-based Stock or Cash Awards | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Employee Stock Purchase Plan, authorized shares for issuance | 500,000 | ||||
Stock option plan granted on cash award | $ | $ 1 | ||||
Cerus Corporation Inducement Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Aggregate number of shares of common stock reserved for future issuance | 1,250,000 | ||||
Share based compensation modification terms | Effective June 7, 2017, the Company no longer issues shares from the Inducement Plan. | ||||
[1] | Includes the number of shares issuable under the performance-based restricted stock unit awards granted during the twelve months ended December 31, 2018. |
Activity Under Equity Incentive
Activity Under Equity Incentive Plans Related to Stock Options (Detail) - 2008 Equity Incentive Plan shares in Thousands | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Activity under the Company's equity incentive plans related to stock options | |
Number of Options Outstanding, Beginning Balance | shares | 17,138 |
Granted, Number of Options Outstanding | shares | 3,447 |
Exercised, Number of Options Outstanding | shares | (2,195) |
Forfeited, Number of Options Outstanding | shares | (678) |
Expired, Number of Options Outstanding | shares | (152) |
Number of Options Outstanding, Ending Balance | shares | 17,560 |
Weighted Average Exercise Price per Share | |
Weighted Average Exercise Price per Share, Beginning Balance | $ / shares | $ 4.27 |
Granted, Weighted Average Exercise Price per Share | $ / shares | 4.78 |
Exercised, Weighted Average Exercise Price per Share | $ / shares | 3.19 |
Forfeited, Weighted Average Exercise Price per Share | $ / shares | 4.73 |
Expired, Weighted Average Exercise Price per Share | $ / shares | 5.93 |
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | $ 4.47 |
Activity Under Equity Incenti_2
Activity Under Equity Incentive Plans Related to RSUs (Detail) - 2008 Equity Incentive Plan - Restricted Stock Units shares in Thousands | 12 Months Ended | |
Dec. 31, 2018$ / sharesshares | ||
Activity under the Company's equity incentive plans related to restricted stock units | ||
Number of Restricted Stock Units Outstanding, Beginning Balance | shares | 1,256 | |
Granted, Number of Restricted Stock Units Outstanding | shares | 1,420 | [1] |
Vested, Number of Restricted Stock Units Outstanding | shares | (521) | |
Forfeited, Number of Restricted Stock Units Outstanding | shares | (154) | |
Number of Restricted Stock Units Outstanding, Ending Balance | shares | 2,001 | |
Weighted Average Exercise Price per Share | ||
Weighted Average Exercise Price per Share, Beginning Balance | $ / shares | $ 4.53 | |
Granted, Weighted Average Exercise Price per Share | $ / shares | 4.51 | [1] |
Vested, Weighted Average Exercise Price per Share | $ / shares | 4.45 | |
Forfeited, Weighted Average Exercise Price per Share | $ / shares | 4.22 | |
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | $ 4.56 | |
[1] | Includes the number of shares issuable under the performance-based restricted stock unit awards granted during the twelve months ended December 31, 2018. |
Information Regarding Stock Opt
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, 2018 | Dec. 31, 2017 | |
Number of Shares | ||
Outstanding options and other stock based awards | 17,560 | 17,138 |
Stock options vested and expected to vest | 17,276 | |
Stock options exercisable | 12,336 | |
Weighted Average Exercise Price | ||
Stock options outstanding | $ 4.47 | $ 4.27 |
Stock options vested and expected to vest | 4.47 | |
Stock options exercisable | $ 4.37 | |
Weighted Average Remaining Contractual (Years) | ||
Stock options outstanding | 6 years 3 months 18 days | |
Stock options vested and expected to vest | 6 years 3 months 18 days | |
Stock options exercisable | 5 years 4 months 24 days | |
Aggregate intrinsic value | ||
Stock options outstanding | $ 14,345 | |
Stock options vested and expected to vest | 14,179 | |
Stock options exercisable | $ 11,402 |
Stock-Based Compensation Recogn
Stock-Based Compensation Recognized on Condensed Consolidated Statements of Operations (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 10,394 | $ 9,355 | $ 8,065 |
Research and Development Expense | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 1,669 | 1,323 | 1,091 |
Selling, General and Administrative Expenses | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 8,725 | $ 8,032 | $ 6,974 |
Weighted Average Assumptions Us
Weighted Average Assumptions Used to Value Stock-Based Awards (Detail) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
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) | 6 years 25 days | 6 years 1 month 13 days | 5 years 10 months 6 days |
Estimated volatility | 50.00% | 47.00% | 49.00% |
Risk-free interest rate | 2.72% | 2.14% | 1.41% |
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) | 8 months 26 days | 11 months 1 day | 9 months 3 days |
Estimated volatility | 47.00% | 57.00% | 47.00% |
Risk-free interest rate | 2.34% | 1.08% | 0.55% |
Stock-based compensation, expected dividend yield | 0.00% | 0.00% | 0.00% |
Retirement Plan - Additional In
Retirement Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Benefit Plan Disclosure [Line Items] | |||
Retirement plan, employees maximum pre-tax contributions percentage | 60.00% | ||
Contributions to 401(k) plan | $ 0 | $ 0 | $ 0 |
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 Agree_3
Development and License Agreements - Additional Information (Detail) € in Millions | 1 Months Ended | 12 Months Ended | ||||||
Aug. 31, 2018EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2018EUR (€) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2016EUR (€) | Dec. 31, 2018EUR (€) | Dec. 31, 2017EUR (€) | |
Licenses Agreements [Line Items] | ||||||||
Payments made relating to the manufacturing of the products | $ 21,300,000 | $ 18,100,000 | $ 16,100,000 | |||||
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 | $ 2,300,000 | 1,400,000 | ||||||
Cerus Corporation | BARDA Agreement | ||||||||
Licenses Agreements [Line Items] | ||||||||
Co-investment by the company | 5,000,000 | |||||||
Additional co-investment by the company | 9,600,000 | |||||||
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 | € | € 3.1 | |||||||
Remaining amount payable for manufacturing and development | € | € 5.5 | |||||||
Accrual for manufacturing and development of entity products | $ 5,900,000 | $ 5,800,000 | € 5.2 | € 4.8 | ||||
Manufacturing and Supply Agreement | Measurement Input, Discount Rate | Fresenius | ||||||||
Licenses Agreements [Line Items] | ||||||||
Manufacturing and development obligations, discount rate | 0.0972 | 0.0972 |
Development and License Agree_4
Development and License Agreements - Summary of Prepaid R&D Asset and Manufacturing Efficiency Asset (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | |
Other current assets | |||
Deferred Costs Capitalized Prepaid And Other Assets [Line Items] | |||
Prepaid R&D asset - current | [1] | $ 47 | $ 114 |
Other assets | |||
Deferred Costs Capitalized Prepaid And Other Assets [Line Items] | |||
Prepaid R&D asset - current | [2] | 2,156 | 2,162 |
Manufacturing efficiency asset | [2] | $ 1,594 | $ 1,839 |
[1] | Included in “Other current assets” in the Company's consolidated balance sheets. | ||
[2] | Included in “Other assets” in the Company's consolidated balance sheets |
Development and License Agree_5
Development and License Agreements - Summary of Amounts Payable and Amounts Receivable from Fresenius (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |||
Payables to Fresenius | [1] | $ 7,812 | $ 4,687 |
Receivables from Fresenius | [2] | $ 1,777 | $ 231 |
[1] | Included in “Accounts Payable” and “Accrued Liabilities” in the Company's consolidated balance sheets. | ||
[2] | Included in “Other current assets” in the Company's consolidated balance sheets |
United States and Foreign Compo
United States and Foreign Components of Consolidated Loss before Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (58,048) | $ (57,925) | $ (63,246) |
Foreign | 713 | 1,227 | 515 |
Loss before income taxes | $ (57,335) | $ (56,698) | $ (62,731) |
Provision Benefit for Income Ta
Provision Benefit for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Foreign | $ 225 | $ 181 | $ 147 |
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Total current | 225 | 181 | 147 |
Foreign | 0 | 0 | 0 |
Federal | 3 | 3,659 | 28 |
State | 1 | 47 | |
Total deferred | 4 | 3,706 | 28 |
Provision for income taxes | $ 229 | $ 3,887 | $ 175 |
Difference Between Provision fo
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory tax | $ (12,040) | $ (19,277) | $ (21,329) |
Tax Act revaluation of deferred taxes | 81,923 | ||
Tax Act deemed income inclusion | 1,083 | ||
Federal research credits | (1,390) | (1,000) | (809) |
State research credits | 655 | 628 | 449 |
Expiration of federal carryovers | 4,154 | ||
Expiration of state carryovers | 1,344 | 1,475 | 1,193 |
Change in valuation allowance | 9,913 | (59,462) | 3,940 |
Compensation related items | (361) | 1,382 | 484 |
State taxes | (1,141) | (803) | (990) |
Revision to prior year items | 17,200 | ||
Other | 405 | (806) | 935 |
Provision for income taxes | $ 229 | $ 3,887 | $ 175 |
Significant Components of Defer
Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 125,016 | $ 117,028 |
Research and development credit carryforwards | 26,705 | 25,061 |
Capitalized research and development | 15,293 | 17,195 |
Compensation related items | 8,310 | 7,011 |
Other | 4,013 | 3,116 |
Total deferred tax assets | 179,337 | 169,411 |
Valuation allowance | (179,245) | (169,332) |
Net deferred tax assets | 92 | 79 |
Deferred tax liabilities: | ||
Amortization of goodwill | 127 | 111 |
Total deferred tax liabilities | $ 127 | $ 111 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Increase (decrease) in valuation allowance | $ 9.9 | $ (59.5) | $ 3.9 |
Gross Amounts and Dates of Expi
Gross Amounts and Dates of Expiration of Tax Credits and Carryovers (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | $ 571,992 | |
California loss carryovers | 59,752 | |
Research credits | 26,705 | $ 25,061 |
Federal foreign tax credits | 610 | |
Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 18,631 | |
California | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 10,220 | |
Expires 2019-2021 | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 66,880 | |
Expires 2019-2021 | Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 5,269 | |
Expires 2022-2028 | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 171,270 | |
Federal foreign tax credits | 610 | |
Expires 2022-2028 | Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 7,626 | |
Expires 2029-2038 | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 273,585 | |
California loss carryovers | 59,752 | |
Expires 2029-2038 | Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 5,736 | |
No Expiration | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 60,257 | |
No Expiration | California | ||
Income Tax Disclosure [Line Items] | ||
Research credits | $ 10,220 |
Reconciliation of Unrecognized
Reconciliation of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Unrecognized tax benefits at beginning of period | $ 11,062 | $ 10,836 |
Decreases related to expired carryforwards | (401) | |
Increases related to prior year tax positions | 19 | |
Increases related to current year tax positions | 402 | 207 |
Unrecognized tax benefits at end of period | $ 11,063 | $ 11,062 |
Segment, Customer and Geograp_3
Segment, Customer and Geographic Information - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2018Segment | |
Segment Reporting [Abstract] | |
Number of operating segments | 1 |
Segment, Customer and Geograp_4
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Etablissement Francais du Sang | |||
Revenue, Major Customer [Line Items] | |||
Concentration risk, percentage | 38.00% | 22.00% | |
Advanced Technology Company K.S.C. | |||
Revenue, Major Customer [Line Items] | |||
Concentration risk, percentage | 12.00% |
Segment, Customer and Geograp_5
Segment, Customer and Geographic Information - Revenue by Geographical Location (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | $ 76,051 | $ 51,326 | $ 39,275 | ||||||||
Product | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | $ 16,525 | $ 15,399 | $ 15,420 | $ 13,564 | $ 16,240 | $ 10,797 | $ 9,525 | $ 7,006 | 60,908 | 43,568 | 37,183 |
Product | FRANCE | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | 23,043 | 9,692 | 3,485 | ||||||||
Product | UNITED STATES | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | 12,563 | 6,316 | 4,480 | ||||||||
Product | BELGIUM | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | 6,788 | 6,263 | 6,392 | ||||||||
Product | KUWAIT | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | 883 | 2,788 | 4,415 | ||||||||
Product | Other Countries | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | 17,631 | 18,509 | 18,411 | ||||||||
Government Contract | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | $ 3,713 | $ 3,928 | $ 4,047 | $ 3,455 | $ 2,378 | $ 2,285 | $ 1,667 | $ 1,428 | 15,143 | 7,758 | 2,092 |
Government Contract | UNITED STATES | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Revenue | $ 15,143 | $ 7,758 | $ 2,092 |
Segment, Customer and Geograp_6
Segment, Customer and Geographic Information - Long Lived Assets by Geographical Location (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | $ 8,464 | $ 2,655 |
U.S. and Territories | ||
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | 8,252 | 2,443 |
Europe and Other | ||
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | $ 212 | $ 212 |
Summary of Quarterly Financial
Summary of Quarterly Financial Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Quarterly Financial Information [Line Items] | |||||||||||
Revenue | $ 76,051 | $ 51,326 | $ 39,275 | ||||||||
Gross profit | $ 8,083 | $ 7,257 | $ 7,700 | $ 6,234 | $ 7,111 | $ 5,449 | $ 5,165 | $ 3,312 | 29,274 | 21,037 | 16,888 |
Net loss | $ (16,205) | $ (14,192) | $ (13,282) | $ (13,885) | $ (11,486) | $ (13,418) | $ (17,083) | $ (18,598) | $ (57,564) | $ (60,585) | $ (62,906) |
Basic | $ (0.12) | $ (0.11) | $ (0.10) | $ (0.11) | $ (0.10) | $ (0.12) | $ (0.16) | $ (0.18) | $ (0.44) | $ (0.56) | $ (0.62) |
Diluted | $ (0.12) | $ (0.11) | $ (0.10) | $ (0.11) | $ (0.10) | $ (0.12) | $ (0.16) | $ (0.18) | $ (0.44) | $ (0.56) | $ (0.62) |
Product | |||||||||||
Quarterly Financial Information [Line Items] | |||||||||||
Revenue | $ 16,525 | $ 15,399 | $ 15,420 | $ 13,564 | $ 16,240 | $ 10,797 | $ 9,525 | $ 7,006 | $ 60,908 | $ 43,568 | $ 37,183 |
Government Contract | |||||||||||
Quarterly Financial Information [Line Items] | |||||||||||
Revenue | $ 3,713 | $ 3,928 | $ 4,047 | $ 3,455 | $ 2,378 | $ 2,285 | $ 1,667 | $ 1,428 | $ 15,143 | $ 7,758 | $ 2,092 |