Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 10, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CERS | ||
Entity Registrant Name | CERUS CORPORATION | ||
Entity Central Index Key | 0001020214 | ||
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 | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 168,220,090 | ||
Entity Public Float | $ 928 | ||
Title of 12(b) Security | Common Stock | ||
Security Exchange Name | NASDAQ | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Entity Interactive Data Current | Yes | ||
Entity File Number | 000-21937 | ||
Entity Tax Identification Number | 68-0262011 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 1220 Concord Avenue | ||
Entity Address, Address Line Two | Suite 600 | ||
Entity Address, City or Town | Concord | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94520 | ||
City Area Code | 925 | ||
Local Phone Number | 288-6000 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive proxy statement in connection with the registrant’s 2021 Annual Meeting of Stockholders, to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year ended December 31, 2020 incorporated by reference into Part III of this Annual Report on Form 10-K. |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 36,594 | $ 34,986 |
Short-term investments | 97,000 | 50,732 |
Accounts receivable | 21,166 | 16,882 |
Inventories, net | 23,254 | 19,490 |
Prepaid and other current assets | 5,417 | 6,018 |
Total current assets | 183,431 | 128,108 |
Non-current assets: | ||
Property and equipment, net | 13,867 | 14,898 |
Goodwill | 1,316 | 1,316 |
Operating lease right-of-use assets | 13,122 | 14,122 |
Intangible assets, net | 132 | |
Restricted cash | 2,309 | 2,435 |
Other assets | 7,370 | 4,524 |
Total assets | 221,415 | 165,535 |
Current liabilities: | ||
Accounts payable | 24,213 | 22,185 |
Accrued liabilities | 24,753 | 20,951 |
Debt – current | 8,516 | 5,017 |
Operating lease liabilities – current | 1,915 | 1,613 |
Deferred product revenue | 577 | 570 |
Total current liabilities | 59,974 | 50,336 |
Non-current liabilities: | ||
Debt – non-current | 39,588 | 39,414 |
Operating lease liabilities – non-current | 16,873 | 18,406 |
Other non-current liabilities | 1,174 | 327 |
Total liabilities | 117,609 | 108,483 |
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, 2020 and 2019, respectively | ||
Common stock, $0.001 par value; 225,000 shares authorized; 168,170 and 144,291 shares issued and outstanding at December 31, 2020 and 2019, respectively | 168 | 144 |
Additional paid-in capital | 1,012,932 | 906,905 |
Accumulated other comprehensive income | 674 | 114 |
Accumulated deficit | (909,968) | (850,111) |
Total stockholders' equity | 103,806 | 57,052 |
Total liabilities and stockholders' equity | $ 221,415 | $ 165,535 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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 | 168,170,000 | 144,291,000 |
Common stock, shares outstanding | 168,170,000 | 144,291,000 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue | $ 114,249 | $ 93,774 | $ 76,051 |
Cost of revenue | 41,157 | 33,419 | 31,634 |
Gross profit | 50,763 | 41,230 | 29,274 |
Operating expenses: | |||
Research and development | 64,410 | 60,376 | 42,564 |
Selling, general and administrative | 67,015 | 66,205 | 56,841 |
Total operating expenses | 131,425 | 126,581 | 99,405 |
Loss from operations | (58,333) | (66,226) | (54,988) |
Non-operating expense, net: | |||
Foreign exchange gain (loss) | 793 | (86) | (87) |
Interest expense | (3,746) | (6,065) | (4,008) |
Other income, net | 1,713 | 1,396 | 1,748 |
Total non-operating expense, net | (1,240) | (4,755) | (2,347) |
Loss before income taxes | (59,573) | (70,981) | (57,335) |
Provision for income taxes | 284 | 263 | 229 |
Net loss | $ (59,857) | $ (71,244) | $ (57,564) |
Net loss per share: | |||
Basic and diluted | $ (0.37) | $ (0.51) | $ (0.44) |
Weighted average shares used for calculating net loss per share: | |||
Basic and diluted | 163,949 | 139,831 | 131,663 |
Product | |||
Revenue | $ 91,920 | $ 74,649 | $ 60,908 |
Government Contract | |||
Revenue | $ 22,329 | $ 19,125 | $ 15,143 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (59,857) | $ (71,244) | $ (57,564) |
Other comprehensive income (loss) | |||
Unrealized gains (losses) on available-for-sale investments, net of taxes | 560 | 395 | (184) |
Comprehensive loss | $ (59,297) | $ (70,849) | $ (57,748) |
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, 2017 | $ 38,940 | $ 115 | $ 760,225 | $ (97) | $ (721,303) |
Balance (in shares) at Dec. 31, 2017 | 115,555 | ||||
Issuance of common stock from public offerings, net of offering costs | 85,085 | $ 18 | 85,067 | ||
Issuance of common stock from public offerings, net of offering costs (in shares) | 18,202 | ||||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases | 7,848 | $ 3 | 7,845 | ||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases (in shares) | 3,096 | ||||
Stock-based compensation | 10,394 | 10,394 | |||
Other comprehensive income (loss) | (184) | (184) | |||
Net loss | (57,564) | (57,564) | |||
Balance at Dec. 31, 2018 | 84,519 | $ 136 | 863,531 | (281) | (778,867) |
Balance (in shares) at Dec. 31, 2018 | 136,853 | ||||
Issuance of common stock from public offerings, net of offering costs | 26,860 | $ 6 | 26,854 | ||
Issuance of common stock from public offerings, net of offering costs (in shares) | 5,648 | ||||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases | 3,210 | $ 2 | 3,208 | ||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases (in shares) | 1,790 | ||||
Stock-based compensation | 13,312 | 13,312 | |||
Other comprehensive income (loss) | 395 | 395 | |||
Net loss | (71,244) | (71,244) | |||
Balance at Dec. 31, 2019 | 57,052 | $ 144 | 906,905 | 114 | (850,111) |
Balance (in shares) at Dec. 31, 2019 | 144,291 | ||||
Issuance of common stock from public offerings, net of offering costs | 76,272 | $ 19 | 76,253 | ||
Issuance of common stock from public offerings, net of offering costs (in shares) | 19,338 | ||||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases | 11,750 | $ 5 | 11,745 | ||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases (in shares) | 4,541 | ||||
Stock-based compensation | 18,029 | 18,029 | |||
Other comprehensive income (loss) | 560 | 560 | |||
Net loss | (59,857) | (59,857) | |||
Balance at Dec. 31, 2020 | $ 103,806 | $ 168 | $ 1,012,932 | $ 674 | $ (909,968) |
Balance (in shares) at Dec. 31, 2020 | 168,170 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities | |||
Net loss | $ (59,857) | $ (71,244) | $ (57,564) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 3,109 | 2,403 | 1,445 |
Stock-based compensation | 18,029 | 13,312 | 10,394 |
Non-cash operating lease cost | 1,346 | 1,580 | |
Changes in valuation of warrant investment | (422) | ||
Net loss on sale of available-for-sale securities | 234 | 1,248 | |
Loss on disposal of property and equipment | 15 | 5 | |
Impairment of long-lived assets | 274 | ||
Non-cash interest expense | 478 | 386 | |
Changes in operating assets and liabilities: | |||
Accounts receivable | (4,284) | (8,130) | 3,663 |
Inventories | (4,030) | (6,043) | 806 |
Other assets | (623) | 1,787 | (2,744) |
Accounts payable | 2,236 | 5,017 | 5,683 |
Accrued liabilities and other non-current liabilities | 2,760 | 1,295 | 6,046 |
Manufacturing and development obligations | (6,288) | (266) | |
Deferred product revenue | 7 | 72 | 38 |
Net cash used in operating activities | (40,743) | (65,838) | (31,246) |
Investing activities | |||
Capital expenditures | (1,615) | (8,935) | (1,144) |
Purchases of investments | (98,793) | (43,907) | (80,701) |
Proceeds from maturities and sale of investments | 50,850 | 81,027 | 37,997 |
Net cash (used in) provided by investing activities | (49,558) | 28,185 | (43,848) |
Financing activities | |||
Net proceeds from equity incentives | 11,750 | 3,210 | 7,848 |
Net proceeds from public offerings | 76,534 | 26,931 | 85,036 |
Net proceeds from revolving line of credit | 3,499 | 5,017 | |
Proceeds from loans | 39,433 | ||
Repayment of debt | (31,104) | (133) | |
Net cash provided by financing activities | 91,783 | 43,487 | 92,751 |
Net decrease in cash, cash equivalents and restricted cash | 1,482 | 5,834 | 17,657 |
Cash, cash equivalents and restricted cash, beginning of period | 37,421 | 31,587 | 13,930 |
Cash, cash equivalents and restricted cash, end of period | 38,903 | 37,421 | 31,587 |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | 3,269 | 3,077 | 2,728 |
Cash paid for income taxes | $ 265 | 229 | 254 |
Non-cash investing activities: | |||
Non-cash leasehold improvements | $ 2,949 | $ 2,222 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 | |
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, the collectability of Revenue Revenue is recognized by applying the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company’s main source of revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or “disposable kits”), UVA illumination devices (“illuminators”), spare parts and storage solutions, and maintenance services of illuminators. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. The Company uses a binding purchase order or signed sales contract as evidence of a contract and satisfaction of its policy. Generally, the Company’s contracts with its customers do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming product. The contracts with customers can include various combinations of products, and to a lesser extent, services. The Company must determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or are accounted for as a combined performance obligation. The Company must allocate the transaction price to each performance obligation on a relative SSP basis, and recognize the product revenue when the performance obligation is satisfied. The Company determines the SSP by using the historical selling price of the products and services. If the amount of consideration in a contract is variable, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely amount method, to the extent it is probable that a significant future reversal of cumulative product revenue under the contract will not occur. Product revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration to which the Company expects to receive in exchange for those products or services. Product revenue from the sale of illuminators, disposable kits, spare parts and storage solutions are recognized upon the transfer of control of the products to the customer. Product revenue from maintenance services are recognized ratably on a straight-line basis over the term of maintenance as customers simultaneously consume and receive benefits. Freight costs charged to customers are recorded as a component of product revenue. Taxes that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such tax from product revenue . The Company receives reimbursement under its U.S. government contracts that support research and development of defined projects. See “Note 13. Development and License Agreements—Government contracts”. The contracts generally provide for reimbursement of approved costs incurred under the terms of the contracts. Revenue related to the cost reimbursement provisions under the Company’s U.S. government contracts is recognized as the qualified direct and indirect costs on the projects are incurred. The Company invoices under its U.S. government contracts using the provisional rates in the government contracts and thus is subject to future audits at the discretion of the government. These audits could result in an adjustment to government contract revenue previously reported, which adjustments potentially could be significant. The Company believes that government contract 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 contracts 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 contracts. Disaggregation of Product Revenue Product revenue by geographical locations of customers during the years ended December 31, 2020, 2019 and 2018, were as follows (in thousands): Year Ended December 31, 2020 2019 2018 Product revenue: Europe, Middle East and Africa $ 57,427 $ 52,499 $ 46,974 North America 32,380 20,936 12,696 Other 2,113 1,214 1,238 Total product revenue $ 91,920 $ 74,649 $ 60,908 Contract Balances The Company invoices its customers based upon the terms in the contracts, which generally requires payment 30 to 60 days from the date of invoice. Accounts receivable are recorded when the Company’s right to the consideration are estimated to be unconditional. The Company had no contract assets at December 31, 2020 and December 31, 2019. 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 as of December 31, 2020 is primarily driven by performance obligations not satisfied but invoiced as of December 31, 2020, offset by $0.6 million of product revenue recognized that were included in the deferred product revenue balance as of December 31, 2019. The Company applies an optional exemption to not disclose the value of unsatisfied performance obligations for contracts that have an original expected duration of one year or less. Research and Development Expenses Research and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of the Company’s U.S. government contract. Research and development expenses include salaries and related expenses for scientific and regulatory personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of R&D facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use. The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D expenses recorded from development funding and under its U.S. government contract. Actual results may differ from those estimates under different assumptions or conditions. Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be classified as cash equivalents. These investments primarily consist of money market instruments, and are classified as available-for-sale. Investments Investments with original maturities of greater than three months primarily include corporate debt and U.S. government agency securities that are designated as available-for-sale and classified as short-term investments. Available-for-sale securities are carried at estimated fair value. The Company views its available-for-sale portfolio as available for use in its current operations. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Unrealized gains (losses) on available-for-sale investments, net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments, if any, were determined on a specific identification method, and 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 in an unrealized loss position has expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. Expected credit losses, if any, are recorded in “Other income, net” on the Company’s consolidated statements of operations. Deferred Compensation Plan The Company’s deferred compensation plan, pursuant to which compensation deferrals began in 2020, is a nonqualified deferred compensation plan that allows highly compensated employees to defer up to 80 percent of their base salary and up to 100 percent of their variable compensation each plan year. The Company may make discretionary contributions to each participant in an amount determined each year. To fund the deferred compensation plan's long-term liability, the Company purchases Company-owned life insurance contracts on certain employees. The insurance serves as an investment source for the funds being set aside. Participants in the deferred compensation plan select the mutual funds in which their compensation deferrals are deemed to be invested as a component of the insurance contracts. As of December 31, 2020 and December 31, 2019, $0.2 million and zero, respectively, were included in other assets, net, which represents the cash surrender value of the associated life insurance policies, and $0.2 million and zero, respectively, were included in other long-term liabilities, which represents the carrying value of the liability for deferred compensation. Gains and losses on the investments related to the nonqualified deferred compensation plan are included in other income (expense), net, and corresponding changes in their deferred compensation liability are included in operating expenses. Restricted Cash As of December 31, 2020 and December 31, 2019, the Company’s “Restricted cash” consisted primarily of a letter of credit relating to an office building lease. As of December 31, 2020 and December 31, 2019, 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, 2020, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments. Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company establishes an allowance for doubtful accounts against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general and administrative expenses . The Company had three customers that accounted for more than 10% of the Company’s outstanding trade receivables at both December 31, 2020 and December 31, 2019, respectively. These customers cumulatively represented approximately 51% and 56% of the Company’s outstanding trade receivables at December 31, 2020 and December 31, 2019, respectively. To date, the Company has not experienced collection difficulties from these customers. Inventories At December 31, 2020 and December 31, 2019, 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 within the next 12-month period and evaluates its finished units in order to sell to existing and prospective customers within the next 12-month period. It is not customary for the Company’s production cycle for inventory to exceed 12 months, however, in certain circumstances the Company may decide purchase inventory components it expects to consume beyond 12 months. 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, 2020 and December 31, 2019, the Company classified its work-in-process inventory as a component of inventory 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 12-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, 2020 and December 31, 2019, the Company had less than $0.1 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. During the twelve months ended December 31, 2020 and 2019, the Company had non-cash purchases of capital expenditures of $0.5 million and $3.1 million, respectively. Goodwill 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 . As a matter of policy, the Company performs an impairment test on its intangible assets, should they exist, 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, 2020, 2019 and 2018, 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 “Foreign exchange gain (loss)” on the Company’s consolidated statements of operations. Stock-Based Compensation Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved. For stock-based awards issued to non-employees, the Company recognizes stock-based compensation expense for the grant date fair value of the vested portion of the awards in its consolidated statements of operations. See Note 11 for further information regarding the Company’s stock-based compensation assumptions and expenses. Income Taxes The provision for income taxes is accounted for using an asset and liability approach, under which deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company does not recognize tax positions that do not have a greater than 50% likelihood of being recognized upon review by a taxing authority having full knowledge of all relevant information. Use of a valuation allowance is not an appropriate substitute for derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s U.S. federal tax returns for years 2000 through 2019, California tax returns for years through 2019, and Netherlands tax returns for years 2016 through 2019 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a valuation allowance on substantially all of its net deferred tax assets. Net Loss Per Share Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share gives effect to all potentially dilutive common shares outstanding for the period. The potentially dilutive securities include stock options, employee stock purchase plan rights and restricted stock units, which are calculated using the treasury stock method. For the years ended December 31, 2020, 2019 and 2018, 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, 2020, 2019 and 2018 (in thousands, except per share amounts): Year Ended December 31, 2020 2019 2018 Numerator for Basic and Diluted: Net loss used for basic calculation $ (59,857 ) $ (71,244 ) $ (57,564 ) Denominator: Basic weighted average number of shares outstanding 163,949 139,831 131,663 Effect of dilutive potential shares — — — Diluted weighted average number of shares outstanding 163,949 139,831 131,663 Net loss per share: Basic and diluted $ (0.37 ) $ (0.51 ) $ (0.44 ) 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, 2020, 2019 and 2018 (shares in thousands): Year Ended December 31, 2020 2019 2018 Weighted average number of anti-dilutive potential shares: Stock options 17,692 17,401 18,031 Restricted stock units 5,485 3,361 1,902 Employee stock purchase plan rights 32 72 20 Total 23,209 20,834 19,953 Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the Company’s consolidated balance sheets. As of December 31, 2020 and December 31, 2019, the Company did not have finance leases. ROU assets and operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The ROU asset also includes any lease payments made and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain to be exercised. Operating leases are recognized on a straight-line basis over the lease term. Guarantee and Indemnification Arrangements The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a third-party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions . The Company generally provides for a one-year 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 June 2016, the Financial Accounting Standard Board issued Accounting Standards Update (“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 adopted the new accounting standard on January 1, 2020, using the modified retrospective transition method. The adoption of this ASU had no material impact on the Company’s consolidated financial statements. |
Available-for-sale Securities a
Available-for-sale Securities and Fair Value on Financial Instruments | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 (in thousands): December 31, 2020 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Allowance for Credit Loss Fair Value Money market funds $ 6,203 $ — $ — $ — $ 6,203 United States government agency securities 29,570 66 — — 29,636 Corporate debt securities 66,756 611 (3 ) — 67,364 Total available-for-sale securities $ 102,529 $ 677 $ (3 ) $ — $ 103,203 The following is a summary of available-for-sale securities at December 31, 2019 (in thousands): December 31, 2019 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Allowance for Credit Loss Fair Value Money market funds $ 8,860 $ — $ — $ — $ 8,860 United States government agency securities 15,545 16 — — 15,561 Corporate debt securities 35,073 98 — — 35,171 Total available-for-sale securities $ 59,478 $ 114 $ — $ — $ 59,592 Available-for-sale securities at December 31, 2020 and December 31, 2019, consisted of the following by contractual maturity (in thousands): December 31, 2020 December 31, 2019 Amortized Cost Fair Value Amortized Cost Fair Value One year or less $ 64,857 $ 65,117 $ 43,822 $ 43,907 Greater than one year and less than five years 37,672 38,086 15,656 15,685 Total available-for-sale securities $ 102,529 $ 103,203 $ 59,478 $ 59,592 The following table shows all available-for-sale marketable securities in an unrealized loss position for which an allowance for credit losses 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, 2020 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate debt securities $ 5,105 $ (3 ) $ — $ — $ 5,105 $ (3 ) As of December 31, 2019, the Company did not have any available-for-sale securities in an unrealized net loss position. 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 expected credit losses, 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. The Company also regularly reviews its investments in an unrealized loss position and evaluates the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. During the years ended December 31, 2020, 2019 and 2018, the Company did not recognize any expected credit losses. 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. The Company recorded gross realized gains of less than $0.1 million and gross realized losses of $0.3 million from the sale or maturity of available-for-sale investments during the year ended December 31, 2020. The Company did not record any gross realized gains or losses from the sale or maturity of available-for-sale investments during the year ended December 31, 2019 and 2018. 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, 2020, 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. To estimate the fair value of Level 3 warrant investments as of December 31, 2020, the Company uses a standard Black-Scholes option pricing model, using a class volatility consistent with the seniority and preference rights of the underlying preferred stock. Key assumptions used in the valuation include the privately held company’s preferred stock price, warrant exercise price, equity volatility, expected term of warrant, risk-free interest rates, and details specific to the warrant. The Company recognizes the changes in the fair value of this warrant in “Other income, net” on the Company’s consolidated statements of operations. The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2020 (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 $ 6,203 $ 6,203 $ — $ — United States government agency securities Short-term investments 30,683 — 30,683 — Corporate debt securities Short-term investments 66,317 — 66,317 — Total short-term investments 103,203 6,203 97,000 — Warrants Other assets 422 422 Total financial assets $ 103,625 $ 6,203 $ 97,000 $ 422 The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2019 (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 $ 8,860 $ 8,860 $ — $ — United States government agency securities Short-term investments 15,561 — 15,561 — Corporate debt securities Short-term investments 35,171 — 35,171 — Total financial assets $ 59,592 $ 8,860 $ 50,732 $ — The Company did not have any transfers among fair value measurement levels during the years ended December 31, 2020 and December 31, 2019. The following table provides a summary of the total gain recognized in the Company’s consolidated statements of operations due to changes in the fair value of the warrant (in thousands): Years Ended December 31, 2020 2019 2018 Gain from changes in the fair value of level 3 investments $ 422 $ — $ — |
Inventories, net
Inventories, net | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories, net | Note 4. Inventories, net Inventories, net at December 31, 2020 and December 31, 2019, consisted of the following (in thousands): December 31, 2020 December 31, 2019 Work-in-process $ 5,097 $ 5,160 Finished goods 18,157 14,330 Total inventories $ 23,254 $ 19,490 |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, net | Note 5. Property and Equipment, net Property and equipment, net at December 31, 2020 and December 31, 2019, consisted of the following (in thousands): December 31, 2020 2019 Construction-in-progress $ 292 $ 74 Machinery and equipment 3,446 2,833 Computer equipment and software 3,425 3,306 Furniture and fixtures 2,065 2,061 Leasehold improvements 12,802 12,881 Consigned equipment 1,416 1,373 Total property and equipment, gross 23,446 22,528 Accumulated depreciation and amortization (9,579 ) (7,630 ) Total property and equipment, net $ 13,867 $ 14,898 Depreciation and amortization expense related to property and equipment, net was $2.2 million, $2.2 million and $1.1 million for the years ended December 31, 2020, 2019 and 2018, respectively. As part of the Company’s 2020 review of property and equipment, $0.3 million was recorded to impairment of long-lived assets for machinery and equipment associated with a terminated agreement in “ Research and development |
Goodwill and Intangible Assets,
Goodwill and Intangible Assets, net | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, the Company did not dispose of, impair or recognize additional goodwill. Intangible Assets, net Intangible assets, net, which include a license for the right to commercialize the INTERCEPT Blood System in Asia, were subject to ratable amortization over the original estimated useful life of ten years. Intangible assets were fully amortized as of December 31, 2020. Accumulated amortization of intangible assets as of December 31, 2020, and December 31, 2019, was $2.0 million and $1.9 million, respectively. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | Note 7. Accrued Liabilities Accrued liabilities at December 31, 2020 and December 31, 2019, consisted of the following (in thousands): December 31, 2020 December 31, 2019 Accrued compensation and related costs $ 15,999 $ 12,703 Accrued professional services 3,020 3,489 Other accrued expenses 5,734 4,759 Total accrued liabilities $ 24,753 $ 20,951 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Note 8. Debt Debt at December 31, 2020, consisted of the following (in thousands): December 31, 2020 Principal Unamortized Discount Total Term Loan Credit Agreement $ 40,000 $ (412 ) $ 39,588 Less: current portion of term loan — — — Non-current portion of term loan $ 40,000 $ (412 ) $ 39,588 Debt consisted of the following (in thousands): December 31, 2019 Principal Unamortized Discount Net Carrying Value Term Loan Agreement $ 40,000 $ (586 ) $ 39,414 Less: current portion of term loan — — — Non-current portion of term loan $ 40,000 $ (586 ) $ 39,414 Principal, interest and fee payments on the Term Loan Credit Agreement (as defined below) are expected to be as follows (in thousands): Year ended December 31, Principal Interest and Fees Total 2021 $ — $ 3,041 $ 3,041 2022 15,000 2,660 17,660 2023 20,000 1,203 21,203 2024 5,000 1,264 6,264 Total $ 40,000 $ 8,168 $ 48,168 Loan Agreements On March 29, 2019 (the “Closing Date”), the Company entered into a Credit, Security and Guaranty Agreement (Term Loan) (the “Term Loan Credit Agreement”) with MidCap Financial Trust (“MidCap”) to borrow up to $70 million in three tranches (collectively “2019 Term Loan”), with a maturity date of March 1, 2024. The first advance of $40.0 million (“Tranche 1”) was drawn by the Company on March 29, 2019, with the proceeds used in part to repay in full the outstanding term loans and fees under a prior loan agreement. The Company repaid principal and interest in an aggregate amount equal to approximately $31.2 million and prepayment fees in an aggregate amount equal to approximately $0.6 million, and terminated all obligations under prior loan agreement. As a result, the Company recorded a loss of $2.1 million on the extinguishment of the prior loan agreement within “Interest expense” on the Company's consolidated statements of operations during the year ended December 31, 2019. The second advance of $15.0 million (“Tranche 2”) is to be available to be drawn by the Company through March 31, 2021, and the third advance of $15.0 million (“Tranche 3”) will be available to the Company starting March 31, 2021, through September 30, 2021, subject to the Company’s satisfaction of certain other conditions described in the Term Loan Credit Agreement. The borrowings under the 2019 Term Loan bears interest at the sum of a fixed percentage spread and the greater of (i) 1.8% or (ii) one month LIBOR. The effective interest rate on the Term Loan, was approximately 7.50%. All three tranches require interest only payments through March 1, 2022, followed by 24 months of payments with interest and equal payment of principal. The interest only payment period can be extended for 12 months upon achievement of a specified trailing twelve month net revenue target. Prepayments of the 2019 Term Loan under the Term Loan Credit Agreement, in whole or in part, will be subject to early termination fees which decline each year until the fourth anniversary of the applicable funding date , at which time there is no early termination fee. Upon the final payment, the Company must also pay an exit fee calculated based on a percentage of the aggregate principal amount of all tranches advanced to the Company. The Company also entered into a Credit, Security and Guaranty Agreement (Revolving Loan) (the “Revolving Loan Credit Agreement”) with MidCap on March 29, 2019, to initially borrow up to $5.0 million. The borrowing limit was expanded to $10.0 million in December 2020. The amount borrowed under the Revolving Loan Credit Agreement can be increased, upon request by the Company by up to an additional $10.0 million, subject to agent and lender approval and the satisfaction of certain conditions. The Revolving Loan Credit Agreement has a maturity date of March 1, 2024. Amounts drawn under the Revolving Loan Credit Agreement bear interest at the sum of a fixed percentage spread and the greater of (i) 1.80% or (ii) one month LIBOR. There are also fractional fees based on the amounts either drawn or undrawn. If the Revolving Loan Credit Agreement is terminated before maturity or the funding obligation is permanently reduced, there are termination fees which decline each anniversary until the third anniversary, at which time there is no termination fee. As of December 31, 2020 and December 31, 2019, the Company had borrowed $8.5 million and $5.0 million under the Revolving Loan Credit Agreement, respectively, which is included in “Debt – current” in the Company’s consolidated balance sheets. The Term Loan Credit Agreement and Revolving Loan Credit Agreement contain certain financial and non-financial covenants, with which the Company was in compliance at December 31, 2020. Additionally, both agreements are secured by substantially all of the Company’s assets, with some exclusions. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 9. Commitments and Contingencies Operating Leases The Company leases its office facilities, located in Concord, California and Amersfoort, the Netherlands, and certain equipment and automobiles under non-cancelable operating leases with initial terms in excess of one year that require the Company to pay operating costs, property taxes, insurance and maintenance. The operating leases expire at various dates through 2030, with certain of the leases providing for renewal options, provisions for adjusting future lease payments based on the consumer price index, and the right to terminate the lease early. The Company does not assume renewals in determination of the lease term unless the renewals are deemed to be reasonably assured at lease commencement. The Company recorded the lease right-of-use asset and obligation at the present value of lease payments over the lease term. The rates implicit in the Company’s leases are generally not readily determinable. The Company must estimate its incremental borrowing rate to discount the lease payments to present value. Operating lease assets also include lease incentives. Supplemental cash flow information related to operating leases is as follows (dollars in thousands): Year Ended December 31, 2020 Cash payments for operating leases $ 3,400 Right-of-use assets obtained in exchange for operating lease obligations 344 December 31, 2020 Weighted-average remaining lease term 8.5 years Weighted-average discount rate 9.0 % Future minimum non-cancelable payments under operating leases as of December 31, 2020, were as follows (in thousands): Operating Leases 2021 $ 3,535 2022 3,008 2023 2,840 2024 2,735 2025 2,716 Thereafter 13,337 Total future lease payments 28,171 Less imputed interest 9,383 Present value of lease liabilities $ 18,788 During the years ended December 31, 2020, 2019 and 2018, the Company recorded operating lease expenses of $3.3 million, $3.4 million and $1.6 million, respectively. As of December 31, 2020, the Company had no leases that have not yet commenced. Purchase Commitments The Company is party to agreements with certain providers for certain components of the INTERCEPT Blood System. Certain of these agreements require minimum purchase commitments from the Company. As of December 31, 2020, the Company had $28.9 million of short-term purchase commitments and $4.0 million of long-term purchase commitments, which are not recorded in the Company’s consolidated balance sheets. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Note 10. Stockholders’ Equity Public Offering of Common Stock In January 2020, the Company issued and sold 16,866,667 shares of common stock, par value $0.001 per share, at $3.75 per share in an underwritten public offering. The total proceeds from this offering were approximately $62.7 million, net of the underwriting discount and other issuance costs. Sales Agreements On August 4, 2017, the Company entered into Amendment No. 3 to the Controlled Equity Offering SM On December 11, 2020, the Company entered into the Controlled Equity Offering SM |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
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. In June 2020, the Company’s stockholders approved an amendment and restatement of the Purchase Plan that increased the aggregate number of shares of common stock authorized for issuance under the Purchase Plan by 1.5 million shares. At December 31, 2020, the Company had 1.8 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. In June 2019, the Company’s stockholders approved an amendment and restatement of the Amended 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance by 11.8 million shares. In June 2020, the Company’s stockholders approved an amendment and restatement of the Amended 2008 Plan that increased the aggregate number of shares of common stock authorized for issuance by 5.0 million shares. Option awards under the Amended 2008 Plan generally have a maximum term of 10 years from the date of the award. The Amended 2008 Plan generally requires options to be granted at 100 % of the fair market value of the Company’s common stock subject to the option on the date of grant. Options granted by the Company to employees generally vest over four years . RSUs are measured based on the fair market value of the underlying stock on the date of grant . RSUs granted by the Company to employees generally vest over three to four years . Performance-based stock or cash awards granted under the Amended 2008 Plan are limited to either 500,000 shares of common stock or $ 1.0 million per recipient per calendar year. At December 31, 2020 , performance-based stock award s were outstanding. At December 31, 2020, the Company had an aggregate of approximately 30.5 million shares of its common stock subject to outstanding options or unvested RSUs, or remaining available for future issuance under the Amended 2008 Plan, of which approximately 16.3 million shares and 5.7 million shares were subject to outstanding options and unvested RSUs, respectively, and approximately 8.4 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, 2019 16,830 $ 4.53 Granted 2,237 5.22 Exercised (2,658 ) 4.01 Forfeited/canceled (103 ) 5.27 Balances at December 31, 2020 16,306 4.71 Activity under the Company’s equity incentive plans related to RSUs is set forth below (in thousands except per share amounts): Number of RSUs Unvested Weighted Average Grant Date Fair Value per Share Balances at December 31, 2019 4,098 $ 5.24 Granted (1) 3,433 5.17 Vested (1) (1,631 ) 5.05 Forfeited (1) (161 ) 5.73 Balances at December 31, 2020 5,739 5.24 (1) Includes shares issuable under performance-based restricted stock unit awards. The total fair value of RSUs as of their respective vesting dates, for the years ended December 31, 2020, 2019 and 2018, were $6.8 million, $5.6 million and $2.8 million, respectively. Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2020, 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, 2020 Stock options outstanding 16,306 $ 4.71 5.26 $ 36,180 Stock options vested and expected to vest 16,151 4.70 5.22 35,905 Stock options exercisable 12,735 4.61 4.36 29,535 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, 2020, 2019 and 2018, was $7.9 million, $1.6 million and $7.1 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, 2020, 2019 and 2018, was as follows (in thousands): Year Ended December 31, 2020 2019 2018 Research and development $ 3,739 $ 2,472 $ 1,669 Selling, general and administrative 14,290 10,840 8,725 Total stock-based compensation expense $ 18,029 $ 13,312 $ 10,394 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, 2020, 2019 and 2018. The Company has also not recorded any stock-based compensation associated with performance-based stock options during the years ended. As of December 31, 2020, the Company expects to recognize the remaining unamortized stock-based compensation expense of $7.0 million and $18.2 million, respectively, related to non-vested stock options and RSUs, net of estimated forfeitures, over an estimated remaining weighted average period of 2.3 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, 2020, 2019 and 2018, was as follows: Year Ended December 31, 2020 2019 2018 Stock Options: Expected term (in years) 6.89 5.59 6.07 Estimated volatility 52% 50% 50% Risk-free interest rate 0.94% 2.32% 2.72% Expected dividend yield 0% 0% 0% Employee Stock Purchase Plan Rights: Expected term (in years) 0.72 0.80 0.74 Estimated volatility 53% 46% 47% Risk-free interest rate 0.86% 2.04% 2.34% Expected dividend yield 0% 0% 0% The weighted average grant-date fair value of stock options granted during the years ended December 31, 2020, 2019 and 2018, was $2.71 per share, $2.73 per share and $2.41 per share, respectively. The weighted average grant-date fair value of employee stock purchase rights during the years ended December 31, 2020, 2019 and 2018, was $1.71 per share, $1.84 per share and $2.29 per share, respectively. |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2020 | |
Compensation And Retirement Disclosure [Abstract] | |
Retirement Plan | Note 12. Retirement Plan The Company maintains a defined contribution savings plan (the “401(k) Plan”) that qualifies under the provisions of Section 401(k) of the Internal Revenue Code and covers eligible U.S. employees of the Company. Under the terms of the 401(k) Plan, eligible U.S. employees may make pre-tax dollar or post-tax (Roth) contributions of up to 60% of their eligible pay up to a maximum cap established by the IRS. The Company may contribute a discretionary percentage of qualified individual employee’s salaries, as defined, to the 401(k) Plan. In 2019, the Company began providing a 401(k) match, subject to certain limitations. Under the 401(k) match, the Company matches 50% of the first 6% of each employee’s 401(k) contribution, up to an annual maximum of $5,000. The employer match will vest immediately. |
Development and License Agreeme
Development and License Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Development And License Agreements [Abstract] | |
Development and License Agreements | Note 13. Development and License Agreements Agreements with Fresenius Fresenius Kabi AG (“Fresenius”) manufactures and supplies the platelet and plasma systems to the Company under a supply agreement (the “Supply Agreement”). Fresenius is obligated to sell, and the Company is obligated to purchase, finished disposable kits for the Company’s platelet and plasma systems and the Company’s red blood cell system product candidate (the “RBC Sets”). The Supply Agreement permits the Company to purchase platelet and plasma systems and RBC Sets from third parties to the extent necessary to maintain supply qualifications with such third parties or where local or regional manufacturing is needed to obtain product registrations or sales. Pricing terms per unit are initially fixed and decline at specified annual production levels, and are subject to certain adjustments after the initial pricing term. Under the Supply Agreement, the Company maintains the amounts due from the components sold to Fresenius as a current asset on its accompanying consolidated balance sheets until such time as the Company purchases finished disposable kits using those components. The Supply Agreement also required the Company to make certain payments totaling €8.6 million (“Manufacturing and Development Payments”) to Fresenius. In 2016, the Company paid $3.4 million (€3.1 million) to Fresenius. In August 2019, the Company paid the remaining $6.2 million (€5.5 million) to Fresenius. The Supply Agreement also required the Company to make payments to support certain projects Fresenius has and will perform on behalf of the Company related to certain R&D activities and manufacturing efficiency activities for which certain assets have been established in the Company’s consolidated balance sheets. The manufacturing efficiency asset is expensed on a straight-line basis over the life of the Supply Agreement. The prepaid asset related to amounts paid up front for the R&D activities to be conducted by Fresenius on behalf of the Company is expensed over the period which such activities occur. The following table summarizes the amounts of prepaid R&D asset and manufacturing efficiency asset at December 31, 2020 and December 31, 2019 (in thousands). December 31, 2020 December 31, 2019 Prepaid R&D asset – current (1) $ — $ 54 Prepaid R&D asset – non-current (2) 2,088 2,094 Manufacturing efficiency asset (2) 1,104 1,349 (1) Included in “Prepaid and 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 $31.3 million, $29.5 million and $21.3 million relating to the manufacturing of the Company’s products during the years ended December 31, 2020, 2019 and 2018, respectively. The following table summarizes the amounts of the Company’s payables to and receivables from Fresenius at December 31, 2020 and December 31, 2019 (in thousands). December 31, 2020 December 31, 2019 Payables to Fresenius (1) $ 13,838 $ 8,470 Receivables from Fresenius (2) 2,380 1,796 (1) Included in “Accounts Payable” and “Accrued Liabilities” in the Company's consolidated balance sheets. (2) Included in “Prepaid and other current assets” in the Company's consolidated balance sheets. Government contracts In June 2016, the Company entered into an agreement with Biomedical Advanced Research and Development Authority (“BARDA”) to support the Company’s development and implementation of pathogen reduction technology for platelet, plasma, and red blood cells. The agreement with BARDA and its subsequent modifications include a base period (the “Base Period”) and options (each, an “Option Period”). The agreement includes committed funding for clinical development of the INTERCEPT Blood System for red blood cells (the “red blood cell system”). In April 2020, BARDA committed an additional $13.8 million raising the committed funding to up to $116.9 million as of December 31, 2020, 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 $213.9 million through December 31, 2021. 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 emerging pathogens, clinical and regulatory development programs in support of the potential licensure of the red blood cell system in the U.S., and development, manufacturing and scale-up activities for the red blood cell system. The Company is responsible for co-investment of $5.0 million and would be responsible for an additional $9.6 million, if certain Option Periods are exercised. Through December 31, 2020, the Company has incurred approximately $2.2 million related to the co-investment. BARDA will make periodic assessments of the Company’s progress and the continuation of the agreement is based on the Company’s success in completing the required tasks under the Base Period and each exercised Option Period. BARDA has rights under certain contract clauses to terminate the agreement, including the ability to terminate the agreement for convenience at any time. As of December 31, 2020 and December 31, 2019, $4.6 million and $4.2 million, respectively, of billed and unbilled amounts were included in accounts receivable on the Company’s consolidated balance sheets related to BARDA. In September 2020, the Company entered into a five-year |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, 2019 and 2018, was as follows (in thousands): 2020 2019 2018 Loss before income taxes: U.S. $ (61,246 ) $ (71,946 ) $ (58,048 ) Foreign 1,673 965 713 Loss before income taxes $ (59,573 ) $ (70,981 ) $ (57,335 ) The provision for income taxes for the years ended December 31, 2020, 2019 and 2018, was as follows (in thousands): 2020 2019 2018 Provision for income taxes: Current: Foreign $ 274 $ 255 $ 225 Federal — — — State — 2 — Total current 274 257 225 Deferred: Foreign — — — Federal 6 4 3 State 4 2 1 Total deferred 10 6 4 Provision for income taxes $ 284 $ 263 $ 229 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, 2020, 2019 and 2018, was as follows (in thousands): 2020 2019 2018 Federal statutory tax $ (12,510 ) $ (14,906 ) $ (12,040 ) Federal research credits (1,630 ) (1,857 ) (1,390 ) State research credits (749 ) (821 ) (655 ) Expiration of federal carryovers 9,200 5,472 4,154 Expiration of state carryovers — — 1,344 Change in valuation allowance 6,738 13,059 9,913 Compensation related items 978 158 (361 ) State taxes (1,921 ) (1,111 ) (1,141 ) Other 178 269 405 Provision for income taxes $ 284 $ 263 $ 229 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, 2020, 2019 and 2018, were as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 141,176 $ 135,536 Research and development credit carryforwards 28,892 28,291 Capitalized research and development 10,756 12,832 Compensation related items 10,957 9,843 Operating leases 4,214 4,374 Other 6,051 4,547 Total deferred tax assets 202,046 195,423 Valuation allowance (199,042 ) (192,304 ) Net deferred tax assets $ 3,004 $ 3,119 Deferred tax liabilities: Right-of-use assets $ 2,892 $ 3,017 Amortization of goodwill 163 143 Total deferred tax liabilities $ 3,055 $ 3,160 The valuation allowance increased by $6.7 million for the year ended December 31, 2020, compared to the increase of $13.1 million and $9.9 million for the years ended December 31, 2019 and 2018, 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, 2020, 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 2021-2023 2024-2030 2031-2040 Expiration Federal losses carryovers $ 638,103 $ 55,587 $ 190,581 $ 209,368 $ 182,567 California loss carryovers 75,407 — 28,779 46,628 — Federal research credits 19,249 7,786 2,248 9,215 — California research credits 12,207 — — — 12,207 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, 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, 2020 2019 Unrecognized tax benefits at beginning of period $ 10,842 $ 11,063 Decreases related to expired carryforwards (1,171 ) (729 ) Increases related to current year tax positions 439 508 Unrecognized tax benefits at end of period $ 10,110 $ 10,842 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, 2020 | |
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, 2020, 2019 and 2018 (in percentages): Year Ended December 31, 2020 2019 2018 Établissement Français du Sang 21% 27% 38% American Red Cross 20% 14% * * 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, 2020, 2019 and 2018, and was as follows (in thousands): Year Ended December 31, 2020 2019 2018 Product revenue: United States $ 31,517 $ 20,611 $ 12,563 France 19,404 20,075 23,043 Belgium 6,921 7,272 6,788 Other countries 34,078 26,691 18,514 Total product revenue 91,920 74,649 60,908 Government contract revenue: United States 22,329 19,125 15,143 Total government contract revenue 22,329 19,125 15,143 Total revenue $ 114,249 $ 93,774 $ 76,051 Long-lived assets by geographical location at December 31, 2020 and December 31, 2019, were as follows (in thousands): December 31, 2020 2019 U.S. and territories $ 13,559 $ 14,619 Europe & other 308 411 Total long-lived assets $ 13,867 $ 15,030 |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Event | Note 16. Subsequent Event In February 2021, the Company entered into a joint venture (“JV”) agreement with a company in China with the intent to develop, obtain regulatory approval for, manufacture and commercialize the INTERCEPT Blood System for platelets and red blood cells in China. Cerus and the Chinese company are the sole equity holders in the JV, with Cerus owning a majority (51%) of the entity. Cerus will contribute an exclusive license to commercialize the INTERCEPT Blood System for platelets and red blood cells for the JV to market in China. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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, the collectability of |
Revenue | Revenue Revenue is recognized by applying the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company’s main source of revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or “disposable kits”), UVA illumination devices (“illuminators”), spare parts and storage solutions, and maintenance services of illuminators. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. The Company uses a binding purchase order or signed sales contract as evidence of a contract and satisfaction of its policy. Generally, the Company’s contracts with its customers do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming product. The contracts with customers can include various combinations of products, and to a lesser extent, services. The Company must determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or are accounted for as a combined performance obligation. The Company must allocate the transaction price to each performance obligation on a relative SSP basis, and recognize the product revenue when the performance obligation is satisfied. The Company determines the SSP by using the historical selling price of the products and services. If the amount of consideration in a contract is variable, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely amount method, to the extent it is probable that a significant future reversal of cumulative product revenue under the contract will not occur. Product revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration to which the Company expects to receive in exchange for those products or services. Product revenue from the sale of illuminators, disposable kits, spare parts and storage solutions are recognized upon the transfer of control of the products to the customer. Product revenue from maintenance services are recognized ratably on a straight-line basis over the term of maintenance as customers simultaneously consume and receive benefits. Freight costs charged to customers are recorded as a component of product revenue. Taxes that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such tax from product revenue . The Company receives reimbursement under its U.S. government contracts that support research and development of defined projects. See “Note 13. Development and License Agreements—Government contracts”. The contracts generally provide for reimbursement of approved costs incurred under the terms of the contracts. Revenue related to the cost reimbursement provisions under the Company’s U.S. government contracts is recognized as the qualified direct and indirect costs on the projects are incurred. The Company invoices under its U.S. government contracts using the provisional rates in the government contracts and thus is subject to future audits at the discretion of the government. These audits could result in an adjustment to government contract revenue previously reported, which adjustments potentially could be significant. The Company believes that government contract 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 contracts 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 contracts. Disaggregation of Product Revenue Product revenue by geographical locations of customers during the years ended December 31, 2020, 2019 and 2018, were as follows (in thousands): Year Ended December 31, 2020 2019 2018 Product revenue: Europe, Middle East and Africa $ 57,427 $ 52,499 $ 46,974 North America 32,380 20,936 12,696 Other 2,113 1,214 1,238 Total product revenue $ 91,920 $ 74,649 $ 60,908 Contract Balances The Company invoices its customers based upon the terms in the contracts, which generally requires payment 30 to 60 days from the date of invoice. Accounts receivable are recorded when the Company’s right to the consideration are estimated to be unconditional. The Company had no contract assets at December 31, 2020 and December 31, 2019. 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 as of December 31, 2020 is primarily driven by performance obligations not satisfied but invoiced as of December 31, 2020, offset by $0.6 million of product revenue recognized that were included in the deferred product revenue balance as of December 31, 2019. 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 gains (losses) on available-for-sale investments, net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments, if any, were determined on a specific identification method, and 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 in an unrealized loss position has expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. Expected credit losses, if any, are recorded in “Other income, net” on the Company’s consolidated statements of operations. |
Deferred Compensation Plan | Deferred Compensation Plan The Company’s deferred compensation plan, pursuant to which compensation deferrals began in 2020, is a nonqualified deferred compensation plan that allows highly compensated employees to defer up to 80 percent of their base salary and up to 100 percent of their variable compensation each plan year. The Company may make discretionary contributions to each participant in an amount determined each year. To fund the deferred compensation plan's long-term liability, the Company purchases Company-owned life insurance contracts on certain employees. The insurance serves as an investment source for the funds being set aside. Participants in the deferred compensation plan select the mutual funds in which their compensation deferrals are deemed to be invested as a component of the insurance contracts. As of December 31, 2020 and December 31, 2019, $0.2 million and zero, respectively, were included in other assets, net, which represents the cash surrender value of the associated life insurance policies, and $0.2 million and zero, respectively, were included in other long-term liabilities, which represents the carrying value of the liability for deferred compensation. Gains and losses on the investments related to the nonqualified deferred compensation plan are included in other income (expense), net, and corresponding changes in their deferred compensation liability are included in operating expenses. |
Restricted Cash | Restricted Cash As of December 31, 2020 and December 31, 2019, the Company’s “Restricted cash” consisted primarily of a letter of credit relating to an office building lease. As of December 31, 2020 and December 31, 2019, 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, 2020, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments. Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company establishes an allowance for doubtful accounts against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general and administrative expenses . The Company had three customers that accounted for more than 10% of the Company’s outstanding trade receivables at both December 31, 2020 and December 31, 2019, respectively. These customers cumulatively represented approximately 51% and 56% of the Company’s outstanding trade receivables at December 31, 2020 and December 31, 2019, respectively. To date, the Company has not experienced collection difficulties from these customers. |
Inventories | Inventories At December 31, 2020 and December 31, 2019, 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 within the next 12-month period and evaluates its finished units in order to sell to existing and prospective customers within the next 12-month period. It is not customary for the Company’s production cycle for inventory to exceed 12 months, however, in certain circumstances the Company may decide purchase inventory components it expects to consume beyond 12 months. 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, 2020 and December 31, 2019, the Company classified its work-in-process inventory as a component of inventory 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 12-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, 2020 and December 31, 2019, the Company had less than $0.1 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. During the twelve months ended December 31, 2020 and 2019, the Company had non-cash purchases of capital expenditures of $0.5 million and $3.1 million, respectively. |
Goodwill | Goodwill 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 . As a matter of policy, the Company performs an impairment test on its intangible assets, should they exist, 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, 2020, 2019 and 2018, 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 “Foreign exchange gain (loss)” on 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 Company recognizes stock-based compensation expense for the grant date fair value of the vested portion of the awards in its consolidated statements of operations. See Note 11 for further information regarding the Company’s stock-based compensation assumptions and expenses. |
Income Taxes | 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 2000 through 2019, California tax returns for years through 2019, and Netherlands tax returns for years 2016 through 2019 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. The Company continues to carry a valuation allowance on substantially all of its net deferred tax assets. |
Net Loss Per Share | 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, 2020, 2019 and 2018, 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, 2020, 2019 and 2018 (in thousands, except per share amounts): Year Ended December 31, 2020 2019 2018 Numerator for Basic and Diluted: Net loss used for basic calculation $ (59,857 ) $ (71,244 ) $ (57,564 ) Denominator: Basic weighted average number of shares outstanding 163,949 139,831 131,663 Effect of dilutive potential shares — — — Diluted weighted average number of shares outstanding 163,949 139,831 131,663 Net loss per share: Basic and diluted $ (0.37 ) $ (0.51 ) $ (0.44 ) 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, 2020, 2019 and 2018 (shares in thousands): Year Ended December 31, 2020 2019 2018 Weighted average number of anti-dilutive potential shares: Stock options 17,692 17,401 18,031 Restricted stock units 5,485 3,361 1,902 Employee stock purchase plan rights 32 72 20 Total 23,209 20,834 19,953 |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets and operating lease liabilities in the Company’s consolidated balance sheets. As of December 31, 2020 and December 31, 2019, the Company did not have finance leases. ROU assets and operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The ROU asset also includes any lease payments made and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain to be exercised. Operating leases are recognized on a straight-line basis over the lease term. |
Guarantee and Indemnification Arrangements | 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 |
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 June 2016, the Financial Accounting Standard Board issued Accounting Standards Update (“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 adopted the new accounting standard on January 1, 2020, using the modified retrospective transition method. The adoption of this ASU had no material impact on the Company’s consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, 2019 and 2018, were as follows (in thousands): Year Ended December 31, 2020 2019 2018 Product revenue: Europe, Middle East and Africa $ 57,427 $ 52,499 $ 46,974 North America 32,380 20,936 12,696 Other 2,113 1,214 1,238 Total product revenue $ 91,920 $ 74,649 $ 60,908 |
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, 2020, 2019 and 2018 (in thousands, except per share amounts): Year Ended December 31, 2020 2019 2018 Numerator for Basic and Diluted: Net loss used for basic calculation $ (59,857 ) $ (71,244 ) $ (57,564 ) Denominator: Basic weighted average number of shares outstanding 163,949 139,831 131,663 Effect of dilutive potential shares — — — Diluted weighted average number of shares outstanding 163,949 139,831 131,663 Net loss per share: Basic and diluted $ (0.37 ) $ (0.51 ) $ (0.44 ) |
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, 2020, 2019 and 2018 (shares in thousands): Year Ended December 31, 2020 2019 2018 Weighted average number of anti-dilutive potential shares: Stock options 17,692 17,401 18,031 Restricted stock units 5,485 3,361 1,902 Employee stock purchase plan rights 32 72 20 Total 23,209 20,834 19,953 |
Available-for-sale Securities_2
Available-for-sale Securities and Fair Value on Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Summary of Available-for-Sale Securities | The following is a summary of available-for-sale securities at December 31, 2020 (in thousands): December 31, 2020 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Allowance for Credit Loss Fair Value Money market funds $ 6,203 $ — $ — $ — $ 6,203 United States government agency securities 29,570 66 — — 29,636 Corporate debt securities 66,756 611 (3 ) — 67,364 Total available-for-sale securities $ 102,529 $ 677 $ (3 ) $ — $ 103,203 The following is a summary of available-for-sale securities at December 31, 2019 (in thousands): December 31, 2019 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Allowance for Credit Loss Fair Value Money market funds $ 8,860 $ — $ — $ — $ 8,860 United States government agency securities 15,545 16 — — 15,561 Corporate debt securities 35,073 98 — — 35,171 Total available-for-sale securities $ 59,478 $ 114 $ — $ — $ 59,592 |
Available-for-Sale Debt Securities by Original Contractual Maturity | Available-for-sale securities at December 31, 2020 and December 31, 2019, consisted of the following by contractual maturity (in thousands): December 31, 2020 December 31, 2019 Amortized Cost Fair Value Amortized Cost Fair Value One year or less $ 64,857 $ 65,117 $ 43,822 $ 43,907 Greater than one year and less than five years 37,672 38,086 15,656 15,685 Total available-for-sale securities $ 102,529 $ 103,203 $ 59,478 $ 59,592 |
Available-for-Sale Marketable Securities in Unrealized Position | The following table shows all available-for-sale marketable securities in an unrealized loss position for which an allowance for credit losses 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, 2020 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate debt securities $ 5,105 $ (3 ) $ — $ — $ 5,105 $ (3 ) |
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, 2020 (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 $ 6,203 $ 6,203 $ — $ — United States government agency securities Short-term investments 30,683 — 30,683 — Corporate debt securities Short-term investments 66,317 — 66,317 — Total short-term investments 103,203 6,203 97,000 — Warrants Other assets 422 422 Total financial assets $ 103,625 $ 6,203 $ 97,000 $ 422 The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2019 (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 $ 8,860 $ 8,860 $ — $ — United States government agency securities Short-term investments 15,561 — 15,561 — Corporate debt securities Short-term investments 35,171 — 35,171 — Total financial assets $ 59,592 $ 8,860 $ 50,732 $ — |
Summary of Gain Recognized in Consolidated Statements of Operations Due to Changes in Fair Value of Warrant | The following table provides a summary of the total gain recognized in the Company’s consolidated statements of operations due to changes in the fair value of the warrant (in thousands): Years Ended December 31, 2020 2019 2018 Gain from changes in the fair value of level 3 investments $ 422 $ — $ — |
Inventories, net (Tables)
Inventories, net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories, net | Inventories, net at December 31, 2020 and December 31, 2019, consisted of the following (in thousands): December 31, 2020 December 31, 2019 Work-in-process $ 5,097 $ 5,160 Finished goods 18,157 14,330 Total inventories $ 23,254 $ 19,490 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net at December 31, 2020 and December 31, 2019, consisted of the following (in thousands): December 31, 2020 2019 Construction-in-progress $ 292 $ 74 Machinery and equipment 3,446 2,833 Computer equipment and software 3,425 3,306 Furniture and fixtures 2,065 2,061 Leasehold improvements 12,802 12,881 Consigned equipment 1,416 1,373 Total property and equipment, gross 23,446 22,528 Accumulated depreciation and amortization (9,579 ) (7,630 ) Total property and equipment, net $ 13,867 $ 14,898 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | Accrued liabilities at December 31, 2020 and December 31, 2019, consisted of the following (in thousands): December 31, 2020 December 31, 2019 Accrued compensation and related costs $ 15,999 $ 12,703 Accrued professional services 3,020 3,489 Other accrued expenses 5,734 4,759 Total accrued liabilities $ 24,753 $ 20,951 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
Debt | Debt at December 31, 2020, consisted of the following (in thousands): December 31, 2020 Principal Unamortized Discount Total Term Loan Credit Agreement $ 40,000 $ (412 ) $ 39,588 Less: current portion of term loan — — — Non-current portion of term loan $ 40,000 $ (412 ) $ 39,588 Debt consisted of the following (in thousands): December 31, 2019 Principal Unamortized Discount Net Carrying Value Term Loan Agreement $ 40,000 $ (586 ) $ 39,414 Less: current portion of term loan — — — Non-current portion of term loan $ 40,000 $ (586 ) $ 39,414 |
Expected Principal, Interest and Fee Payments on Term Loan Credit Agreement | Principal, interest and fee payments on the Term Loan Credit Agreement (as defined below) are expected to be as follows (in thousands): Year ended December 31, Principal Interest and Fees Total 2021 $ — $ 3,041 $ 3,041 2022 15,000 2,660 17,660 2023 20,000 1,203 21,203 2024 5,000 1,264 6,264 Total $ 40,000 $ 8,168 $ 48,168 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to operating leases is as follows (dollars in thousands): Year Ended December 31, 2020 Cash payments for operating leases $ 3,400 Right-of-use assets obtained in exchange for operating lease obligations 344 December 31, 2020 Weighted-average remaining lease term 8.5 years Weighted-average discount rate 9.0 % |
Future Minimum Non-Cancelable Lease Payments Under Operating Leases | Future minimum non-cancelable payments under operating leases as of December 31, 2020, were as follows (in thousands): Operating Leases 2021 $ 3,535 2022 3,008 2023 2,840 2024 2,735 2025 2,716 Thereafter 13,337 Total future lease payments 28,171 Less imputed interest 9,383 Present value of lease liabilities $ 18,788 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, 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, 2020 Stock options outstanding 16,306 $ 4.71 5.26 $ 36,180 Stock options vested and expected to vest 16,151 4.70 5.22 35,905 Stock options exercisable 12,735 4.61 4.36 29,535 |
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, 2020, 2019 and 2018, was as follows (in thousands): Year Ended December 31, 2020 2019 2018 Research and development $ 3,739 $ 2,472 $ 1,669 Selling, general and administrative 14,290 10,840 8,725 Total stock-based compensation expense $ 18,029 $ 13,312 $ 10,394 |
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, 2020, 2019 and 2018, was as follows: Year Ended December 31, 2020 2019 2018 Stock Options: Expected term (in years) 6.89 5.59 6.07 Estimated volatility 52% 50% 50% Risk-free interest rate 0.94% 2.32% 2.72% Expected dividend yield 0% 0% 0% Employee Stock Purchase Plan Rights: Expected term (in years) 0.72 0.80 0.74 Estimated volatility 53% 46% 47% Risk-free interest rate 0.86% 2.04% 2.34% 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, 2019 16,830 $ 4.53 Granted 2,237 5.22 Exercised (2,658 ) 4.01 Forfeited/canceled (103 ) 5.27 Balances at December 31, 2020 16,306 4.71 |
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 RSUs Unvested Weighted Average Grant Date Fair Value per Share Balances at December 31, 2019 4,098 $ 5.24 Granted (1) 3,433 5.17 Vested (1) (1,631 ) 5.05 Forfeited (1) (161 ) 5.73 Balances at December 31, 2020 5,739 5.24 (1) Includes shares issuable under performance-based restricted stock unit awards. |
Development and License Agree_2
Development and License Agreements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Development And License Agreements [Abstract] | |
Summary of Prepaid R&D Asset and Manufacturing Efficiency Asset | The following table summarizes the amounts of prepaid R&D asset and manufacturing efficiency asset at December 31, 2020 and December 31, 2019 (in thousands). December 31, 2020 December 31, 2019 Prepaid R&D asset – current (1) $ — $ 54 Prepaid R&D asset – non-current (2) 2,088 2,094 Manufacturing efficiency asset (2) 1,104 1,349 (1) Included in “Prepaid and 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, 2020 and December 31, 2019 (in thousands). December 31, 2020 December 31, 2019 Payables to Fresenius (1) $ 13,838 $ 8,470 Receivables from Fresenius (2) 2,380 1,796 (1) Included in “Accounts Payable” and “Accrued Liabilities” in the Company's consolidated balance sheets. (2) Included in “Prepaid and other current assets” in the Company's consolidated balance sheets. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, 2019 and 2018, was as follows (in thousands): 2020 2019 2018 Loss before income taxes: U.S. $ (61,246 ) $ (71,946 ) $ (58,048 ) Foreign 1,673 965 713 Loss before income taxes $ (59,573 ) $ (70,981 ) $ (57,335 ) |
Provision Benefit for Income Taxes | The provision for income taxes for the years ended December 31, 2020, 2019 and 2018, was as follows (in thousands): 2020 2019 2018 Provision for income taxes: Current: Foreign $ 274 $ 255 $ 225 Federal — — — State — 2 — Total current 274 257 225 Deferred: Foreign — — — Federal 6 4 3 State 4 2 1 Total deferred 10 6 4 Provision for income taxes $ 284 $ 263 $ 229 |
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, 2020, 2019 and 2018, was as follows (in thousands): 2020 2019 2018 Federal statutory tax $ (12,510 ) $ (14,906 ) $ (12,040 ) Federal research credits (1,630 ) (1,857 ) (1,390 ) State research credits (749 ) (821 ) (655 ) Expiration of federal carryovers 9,200 5,472 4,154 Expiration of state carryovers — — 1,344 Change in valuation allowance 6,738 13,059 9,913 Compensation related items 978 158 (361 ) State taxes (1,921 ) (1,111 ) (1,141 ) Other 178 269 405 Provision for income taxes $ 284 $ 263 $ 229 |
Significant Components of Deferred Tax Assets and Liabilities | The significant components of the Company’s deferred tax assets and liabilities at December 31, 2020, 2019 and 2018, were as follows (in thousands): |
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 2021-2023 2024-2030 2031-2040 Expiration Federal losses carryovers $ 638,103 $ 55,587 $ 190,581 $ 209,368 $ 182,567 California loss carryovers 75,407 — 28,779 46,628 — Federal research credits 19,249 7,786 2,248 9,215 — California research credits 12,207 — — — 12,207 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, 2020 2019 Unrecognized tax benefits at beginning of period $ 10,842 $ 11,063 Decreases related to expired carryforwards (1,171 ) (729 ) Increases related to current year tax positions 439 508 Unrecognized tax benefits at end of period $ 10,110 $ 10,842 |
Segment, Customer and Geograp_2
Segment, Customer and Geographic Information (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, 2019 and 2018 (in percentages): Year Ended December 31, 2020 2019 2018 Établissement Français du Sang 21% 27% 38% American Red Cross 20% 14% * * 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, 2020, 2019 and 2018, and was as follows (in thousands): Year Ended December 31, 2020 2019 2018 Product revenue: United States $ 31,517 $ 20,611 $ 12,563 France 19,404 20,075 23,043 Belgium 6,921 7,272 6,788 Other countries 34,078 26,691 18,514 Total product revenue 91,920 74,649 60,908 Government contract revenue: United States 22,329 19,125 15,143 Total government contract revenue 22,329 19,125 15,143 Total revenue $ 114,249 $ 93,774 $ 76,051 Long-lived assets by geographical location at December 31, 2020 and December 31, 2019, were as follows (in thousands): December 31, 2020 2019 U.S. and territories $ 13,559 $ 14,619 Europe & other 308 411 Total long-lived assets $ 13,867 $ 15,030 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Summary of Product Revenue by Geographical Locations of Customers (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | |||
Total product revenue | $ 114,249 | $ 93,774 | $ 76,051 |
Product | |||
Disaggregation Of Revenue [Line Items] | |||
Total product revenue | 91,920 | 74,649 | 60,908 |
Product | Europe, Middle East and Africa | |||
Disaggregation Of Revenue [Line Items] | |||
Total product revenue | 57,427 | 52,499 | 46,974 |
Product | North America | |||
Disaggregation Of Revenue [Line Items] | |||
Total product revenue | 32,380 | 20,936 | 12,696 |
Product | Other | |||
Disaggregation Of Revenue [Line Items] | |||
Total product revenue | $ 2,113 | $ 1,214 | $ 1,238 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2020USD ($)CustomerSegment | Dec. 31, 2019USD ($)Customer | Dec. 31, 2018USD ($) | |
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 generally requires payment 30 to 60 days from the date of invoice. | ||
Contract asset | $ 0 | $ 0 | |
Product revenue recognized, that were included in deferred product revenue | $ 600,000 | ||
Application of an optional exemption not to disclose the value of unsatisfied performance obligations | true | ||
Number of major customers representing outstanding trade receivables | Customer | 3 | 3 | |
Protracted length of inventory | 1 year | ||
Inventory valuation reserves | $ 100,000 | ||
Non-cash purchases of capital expenditures | $ 500,000 | 3,100,000 | |
Number of reportable segments | Segment | 1 | ||
Impairment charges acquired intangible assets | $ 0 | 0 | $ 0 |
Period of warranty | 1 year | ||
Warranty claim liability | $ 0 | $ 0 | |
Trade Accounts Receivable | Customer Concentration Risk | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk, percentage | 51.00% | 56.00% | |
Other Assets | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Cash surrender value of associated life insurance policies | $ 200,000 | $ 0 | |
Other Long-term Liabilities | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Liability for deferred compensation | $ 200,000 | $ 0 | |
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 | ||
Maximum | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Payment of customer invoice contract period | 60 days | ||
Percentage of deferred compensation from base salary | 80.00% | ||
Percentage of deferred compensation from variable compensation | 100.00% | ||
Shelf lives of inventory | 24 months | ||
Inventory valuation reserves | $ 100,000 | ||
Estimated useful life of property and equipment | 5 years |
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 | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Numerator for Basic and Diluted: | |||
Net loss used for basic calculation | $ (59,857) | $ (71,244) | $ (57,564) |
Denominator: | |||
Basic weighted average number of shares outstanding | 163,949 | 139,831 | 131,663 |
Diluted weighted average number of shares outstanding | 163,949 | 139,831 | 131,663 |
Net loss per share: | |||
Basic and diluted | $ (0.37) | $ (0.51) | $ (0.44) |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 23,209 | 20,834 | 19,953 |
Stock Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 17,692 | 17,401 | 18,031 |
Restricted Stock Units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 5,485 | 3,361 | 1,902 |
Employee Stock Purchase Plan Rights | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 32 | 72 | 20 |
Summary of Available-for-Sale S
Summary of Available-for-Sale Securities (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | $ 102,529,000 | $ 59,478,000 | |
Gross Unrealized Gain | 677,000 | 114,000 | |
Gross Unrealized Loss | (3,000) | 0 | |
Allowance for Credit Loss | 0 | 0 | $ 0 |
Fair Value | 103,203,000 | 59,592,000 | |
Money market funds | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 6,203,000 | 8,860,000 | |
Gross Unrealized Loss | 0 | 0 | |
Allowance for Credit Loss | 0 | 0 | |
Fair Value | 6,203,000 | 8,860,000 | |
United States government agency securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 29,570,000 | 15,545,000 | |
Gross Unrealized Gain | 66,000 | 16,000 | |
Gross Unrealized Loss | 0 | 0 | |
Allowance for Credit Loss | 0 | 0 | |
Fair Value | 29,636,000 | 15,561,000 | |
Corporate debt securities | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Amortized Cost | 66,756,000 | 35,073,000 | |
Gross Unrealized Gain | 611,000 | 98,000 | |
Gross Unrealized Loss | (3,000) | 0 | |
Allowance for Credit Loss | 0 | 0 | |
Fair Value | $ 67,364,000 | $ 35,171,000 |
Available-for-Sale Debt Securit
Available-for-Sale Debt Securities by Original Contractual Maturity (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Investments Debt And Equity Securities [Abstract] | ||
One year or less, amortized cost | $ 64,857 | $ 43,822 |
Greater than one year and less than five years, amortized cost | 37,672 | 15,656 |
Amortized Cost | 102,529 | 59,478 |
One year or less, fair value | 65,117 | 43,907 |
Greater than one year and less than five years, fair value | 38,086 | 15,685 |
Total available-for-sale securities fair value | $ 103,203 | $ 59,592 |
Available-for-Sale Marketable S
Available-for-Sale Marketable Securities in Unrealized Position (Detail) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Schedule of Available-for-sale Securities [Line Items] | ||
Total, Unrealized Loss | $ 0 | |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less than 12 Months, Fair Value | $ 5,105,000 | |
Less than 12 Months, Unrealized Loss | (3,000) | |
Total, Fair Value | 5,105,000 | |
Total, Unrealized Loss | $ (3,000) |
Available-for-sale Securities_3
Available-for-sale Securities and Fair Value on Financial Instruments - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of Available-for-sale Securities [Line Items] | |||
Available-for-sale securities in unrealized net loss position | $ 0 | ||
Credit losses recognized | $ 0 | 0 | $ 0 |
Gross realized gains from the sale or maturity of available-for-sale investments | 0 | 0 | |
Gross realized losses from the sale or maturity of available-for-sale investments | 300,000 | $ 0 | $ 0 |
Maximum | |||
Schedule of Available-for-sale Securities [Line Items] | |||
Gross realized gains from the sale or maturity of available-for-sale investments | $ 100,000 |
Fair Values on Financial Assets
Fair Values on Financial Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Fair value of financial assets and liabilities | ||
Total financial assets | $ 103,625 | $ 59,592 |
Total financial assets | 103,625 | 59,592 |
Money market funds | ||
Fair value of financial assets and liabilities | ||
Total short-term investments | 6,203 | 8,860 |
Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total short-term investments | 103,203 | |
United States government agency securities | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total short-term investments | 30,683 | 15,561 |
Corporate debt securities | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total short-term investments | 66,317 | 35,171 |
Warrant | Other Assets | ||
Fair value of financial assets and liabilities | ||
Warrants | 422 | |
Level 1 | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 6,203 | 8,860 |
Total financial assets | 6,203 | 8,860 |
Level 1 | Money market funds | ||
Fair value of financial assets and liabilities | ||
Total short-term investments | 6,203 | 8,860 |
Level 1 | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total short-term investments | 6,203 | |
Level 2 | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 97,000 | 50,732 |
Total financial assets | 97,000 | 50,732 |
Level 2 | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total short-term investments | 97,000 | |
Level 2 | United States government agency securities | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total short-term investments | 30,683 | 15,561 |
Level 2 | Corporate debt securities | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total short-term investments | 66,317 | $ 35,171 |
Level 3 | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 422 | |
Total financial assets | 422 | |
Level 3 | Warrant | Other Assets | ||
Fair value of financial assets and liabilities | ||
Warrants | $ 422 |
Summary of Gain Recognized in C
Summary of Gain Recognized in Consolidated Statements of Operations Due to Changes in Fair Value of Warrant (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Warrant | Level 3 | |
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation [Line Items] | |
Gain from changes in the fair value of level 3 investments | $ 422 |
Inventories, net (Detail)
Inventories, net (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Work-in-process | $ 5,097 | $ 5,160 |
Finished goods | 18,157 | 14,330 |
Total inventories | $ 23,254 | $ 19,490 |
Property and Equipment Net (Det
Property and Equipment Net (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | $ 23,446 | $ 22,528 |
Accumulated depreciation and amortization | (9,579) | (7,630) |
Total property and equipment, net | 13,867 | 14,898 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 292 | 74 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 3,446 | 2,833 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 3,425 | 3,306 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 2,065 | 2,061 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | 12,802 | 12,881 |
Consigned equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, gross | $ 1,416 | $ 1,373 |
Property and Equipment Net - Ad
Property and Equipment Net - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |||
Property and equipment, depreciation and amortization expense | $ 2,200,000 | $ 2,200,000 | $ 1,100,000 |
Impairments for long-lived assets | $ 300,000 | $ 0 | $ 0 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets Net - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Goodwill And Intangible Assets Disclosure [Abstract] | ||
Dispose, impair or recognition of additional goodwill | $ 0 | |
Estimated useful life of intangible assets | 10 years | |
Accumulated amortization intangible assets | $ 2,000,000 | $ 1,900,000 |
Accrued Liabilities (Detail)
Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued compensation and related costs | $ 15,999 | $ 12,703 |
Accrued professional services | 3,020 | 3,489 |
Other accrued expenses | 5,734 | 4,759 |
Total accrued liabilities | $ 24,753 | $ 20,951 |
Debt (Detail)
Debt (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
Less: current portion of term loan | $ (8,516) | $ (5,017) |
Non-current portion of term loan | 39,588 | 39,414 |
Term Loan Credit Agreement | ||
Debt Instrument [Line Items] | ||
Total term loan, Principal | 40,000 | 40,000 |
Total term loan, Unamortized Discount | (412) | (586) |
Total term loan | 39,588 | 39,414 |
Non-current portion of term loan, Principal | 40,000 | 40,000 |
Non-current portion of term loan, Unamortized Discount | (412) | (586) |
Non-current portion of term loan | $ 39,588 | $ 39,414 |
Debt - Expected Principal, Inte
Debt - Expected Principal, Interest and Fee Payments on Term Loan Credit Agreement (Detail) - Term Loan Credit Agreement - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | ||
2022, Principal | $ 15,000 | |
2023, Principal | 20,000 | |
2024, Principal | 5,000 | |
Total, Principal | 40,000 | $ 40,000 |
2021, Interest and Fees | 3,041 | |
2022, Interest and Fees | 2,660 | |
2023, Interest and Fees | 1,203 | |
2024, Interest and Fees | 1,264 | |
Total, Interest and Fees | 8,168 | |
2021, Total | 3,041 | |
2022, Total | 17,660 | |
2023, Total | 21,203 | |
2024, Total | 6,264 | |
Total | $ 48,168 |
Debt - Additional Information (
Debt - Additional Information (Detail) | Mar. 29, 2019USD ($)Tranche | Dec. 31, 2019USD ($) | Dec. 31, 2020USD ($) |
Term Loan Credit Agreement | |||
Debt Instrument [Line Items] | |||
Term loan, face amount | $ 70,000,000 | ||
Number of loan tranches | Tranche | 3 | ||
Debt instrument maturity date | Mar. 1, 2024 | ||
Term Loan Credit Agreement | Two Thousand Nineteen Term Loan | |||
Debt Instrument [Line Items] | |||
Debt instrument floating interest rate percentage | 1.80% | ||
Effective interest rate | 7.50% | ||
Interest-only payments date | Mar. 1, 2022 | ||
Principal plus declining interest payments | 24 months | ||
Interest only payment period | 12 months | ||
Trailing net revenue target period | 12 months | ||
Term Loan Credit Agreement | Tranche 1 | |||
Debt Instrument [Line Items] | |||
Term loan, face amount | $ 40,000,000 | ||
Term Loan Credit Agreement | Tranche 2 | Two Thousand Nineteen Term Loan | |||
Debt Instrument [Line Items] | |||
Term loan, face amount | 15,000,000 | ||
Term Loan Credit Agreement | Tranche 3 | Two Thousand Nineteen Term Loan | |||
Debt Instrument [Line Items] | |||
Loan and security agreement available upon revenue achievement | 15,000,000 | ||
Prior Loan Agreement | 2017 Term Loans | |||
Debt Instrument [Line Items] | |||
Repayments principal and interest aggregate amount | 31,200,000 | ||
Prepayment fees in aggregate amount | 600,000 | ||
Prior Loan Agreement | Interest Expense | 2017 Term Loans | |||
Debt Instrument [Line Items] | |||
Extinguishment loss recorded | $ 2,100,000 | ||
Revolving Loan Credit Agreement | |||
Debt Instrument [Line Items] | |||
Term loan, face amount | 5,000,000 | $ 5,000,000 | $ 8,500,000 |
Loan and security agreement available upon revenue achievement | $ 10,000,000 | ||
Debt instrument floating interest rate percentage | 1.80% | ||
Borrowing limit | $ 10,000,000 | ||
Revolving Loan Credit Agreement | Two Thousand Nineteen Term Loan | |||
Debt Instrument [Line Items] | |||
Debt instrument maturity date | Mar. 1, 2024 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2018 | Dec. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |||
Minimum term of non-cancellable operating leases | 1 year | ||
Expiration of non-cancellable operating leases maximum year | 2030 | ||
Operating lease expenses | $ 3.3 | $ 3.4 | $ 1.6 |
Operating lease not yet commenced | the Company had no leases that have not yet commenced. | ||
Short-term purchase commitments | $ 28.9 | ||
Long-term purchase commitments | $ 4 |
Commitments and Contingencies_2
Commitments and Contingencies - Supplemental Cash Flow Information Related to Operating Leases (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |
Cash payments for operating leases | $ 3,400 |
Right-of-use assets obtained in exchange for operating lease obligations | $ 344 |
Weighted-average remaining lease term | 8 years 6 months |
Weighted-average discount rate | 9.00% |
Commitments and Contingencies_3
Commitments and Contingencies - Future Minimum Non-Cancelable Lease Payments Under Operating Leases (Detail) $ in Thousands | Dec. 31, 2020USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
2021 | $ 3,535 |
2022 | 3,008 |
2023 | 2,840 |
2024 | 2,735 |
2025 | 2,716 |
Thereafter | 13,337 |
Total future lease payments | 28,171 |
Less imputed interest | 9,383 |
Present value of lease liabilities | $ 18,788 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | Dec. 11, 2020 | Jan. 08, 2018 | Jan. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Stockholders Equity Note [Line Items] | ||||||
Common stock, shares issued and sold | 168,170,000 | 144,291,000 | ||||
Common stock, par value | $ 0.001 | $ 0.001 | ||||
Net proceeds from public offering | $ 76,534,000 | $ 26,931,000 | $ 85,036,000 | |||
Common Stock | ||||||
Stockholders Equity Note [Line Items] | ||||||
Common stock, number of shares issued | 19,338,000 | 5,648,000 | 18,202,000 | |||
Underwritten Public Offering | Common Stock | ||||||
Stockholders Equity Note [Line Items] | ||||||
Common stock, shares issued and sold | 16,866,667 | |||||
Common stock, par value | $ 0.001 | |||||
Common stock, sale of stock, price per share | $ 3.75 | |||||
Net proceeds from public offering | $ 62,700,000 | |||||
Amendment No. 3 | Cantor Fitzgerald & Co | Sales Agreements | ||||||
Stockholders Equity Note [Line Items] | ||||||
Net proceeds from public offering | $ 13,900,000 | |||||
Percentage of proceeds payable as compensation to underwriter | 2.00% | |||||
Common stock, number of shares issued | 2,500,000 | |||||
Amendment No. 3 | Cantor Fitzgerald & Co. and Stifel, Nicolaus & Company, Incorporated | Sales Agreements | ||||||
Stockholders Equity Note [Line Items] | ||||||
Percentage of proceeds payable as compensation to underwriter | 2.00% | |||||
Common stock, number of shares issued | 0 | |||||
Maximum common stock offering price | $ 100,000,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||
Jun. 30, 2020shares | Jun. 30, 2019shares | Dec. 31, 2020USD ($)Period$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / shares | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Total intrinsic value of options exercised | $ | $ 7.9 | $ 1.6 | $ 7.1 | |||
Stock-based compensation, expected dividend yield | 0.00% | |||||
Weighted average grant-date fair value of stock options granted | $ / shares | $ 2.71 | $ 2.73 | $ 2.41 | |||
Stock Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense expected to be recognized | $ | $ 7 | |||||
Stock-based compensation, weighted average recognition period | 2 years 3 months 18 days | |||||
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 | $ | $ 18.2 | |||||
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 | |||||
Increase in shares of common stock authorized for issuance | 1,500,000 | |||||
Aggregate number of shares of common stock reserved for future issuance | 1,800,000 | |||||
Stock-based compensation, expected dividend yield | 0.00% | 0.00% | 0.00% | |||
Weighted average grant-date fair value of awards granted | $ / shares | $ 1.71 | $ 1.84 | $ 2.29 | |||
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% | |||||
Increase in shares of common stock authorized for issuance | 5,000,000 | 11,800,000 | ||||
Aggregate number of shares of common stock reserved for future issuance | 30,500,000 | |||||
Stock-based compensation, award term | 10 years | |||||
Performance-based stock options, outstanding | 20,000 | |||||
Outstanding options and other stock based awards | 16,306,000 | 16,830,000 | ||||
Number of shares available for future issuance | 8,400,000 | |||||
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] | ||||||
Number of unvested Restricted Stock Units | 5,739,000 | 4,098,000 | ||||
Total fair value | $ | $ 6.8 | $ 5.6 | $ 2.8 | |||
Weighted average grant-date fair value of awards granted | $ / shares | [1] | $ 5.17 | ||||
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 | |||||
2008 Equity Incentive Plan | Minimum | Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation, vesting period | 3 years | |||||
2008 Equity Incentive Plan | Maximum | Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation, vesting period | 4 years | |||||
[1] | Includes shares issuable under performance-based restricted stock unit awards. |
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, 2020$ / sharesshares | |
Activity under the Company's equity incentive plans related to stock options | |
Number of Options Outstanding, Beginning Balance | shares | 16,830 |
Granted, Number of Options Outstanding | shares | 2,237 |
Exercised, Number of Options Outstanding | shares | (2,658) |
Forfeited/canceled, Number of Options Outstanding | shares | (103) |
Number of Options Outstanding, Ending Balance | shares | 16,306 |
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 | 5.22 |
Exercised, Weighted Average Exercise Price per Share | $ / shares | 4.01 |
Forfeited/canceled, Weighted Average Exercise Price per Share | $ / shares | 5.27 |
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | $ 4.71 |
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, 2020$ / sharesshares | ||
Activity under the Company's equity incentive plans related to restricted stock units | ||
Number of Restricted Stock Units Unvested, Beginning Balance | shares | 4,098 | |
Granted, Number of Restricted Stock Units Unvested | shares | 3,433 | [1] |
Vested, Number of Restricted Stock Units Unvested | shares | (1,631) | [1] |
Forfeited, Number of Restricted Stock Units Unvested | shares | (161) | [1] |
Number of Restricted Stock Units Unvested, Ending Balance | shares | 5,739 | |
Weighted Average Exercise Price per Share | ||
Weighted Average Exercise Price per Share, Beginning Balance | $ / shares | $ 5.24 | |
Granted, Weighted Average Exercise Price per Share | $ / shares | 5.17 | [1] |
Vested, Weighted Average Exercise Price per Share | $ / shares | 5.05 | [1] |
Forfeited, Weighted Average Exercise Price per Share | $ / shares | 5.73 | [1] |
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | $ 5.24 | |
[1] | Includes shares issuable under performance-based restricted stock unit awards. |
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, 2020 | Dec. 31, 2019 | |
Number of Shares | ||
Outstanding options and other stock based awards | 16,306 | 16,830 |
Stock options vested and expected to vest | 16,151 | |
Stock options exercisable | 12,735 | |
Weighted Average Exercise Price | ||
Stock options outstanding | $ 4.71 | $ 4.53 |
Stock options vested and expected to vest | 4.70 | |
Stock options exercisable | $ 4.61 | |
Weighted Average Remaining Contractual (Years) | ||
Stock options outstanding | 5 years 3 months 3 days | |
Stock options vested and expected to vest | 5 years 2 months 19 days | |
Stock options exercisable | 4 years 4 months 9 days | |
Aggregate intrinsic value | ||
Stock options outstanding | $ 36,180 | |
Stock options vested and expected to vest | 35,905 | |
Stock options exercisable | $ 29,535 |
Stock-Based Compensation Recogn
Stock-Based Compensation Recognized on Condensed Consolidated Statements of Operations (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 18,029 | $ 13,312 | $ 10,394 |
Research and Development Expense | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 3,739 | 2,472 | 1,669 |
Selling, General and Administrative Expenses | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 14,290 | $ 10,840 | $ 8,725 |
Weighted Average Assumptions Us
Weighted Average Assumptions Used to Value Stock-Based Awards (Detail) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
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 10 months 20 days | 5 years 7 months 2 days | 6 years 25 days |
Estimated volatility | 52.00% | 50.00% | 50.00% |
Risk-free interest rate | 0.94% | 2.32% | 2.72% |
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 19 days | 9 months 18 days | 8 months 26 days |
Estimated volatility | 53.00% | 46.00% | 47.00% |
Risk-free interest rate | 0.86% | 2.04% | 2.34% |
Stock-based compensation, expected dividend yield | 0.00% | 0.00% | 0.00% |
Retirement Plan - Additional In
Retirement Plan - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Defined Benefit Plan Disclosure [Line Items] | |
Retirement plan, employees maximum pre-tax contributions percentage | 60.00% |
401 (K) Plan | |
Defined Benefit Plan Disclosure [Line Items] | |
Retirement plan, employees maximum pre-tax contributions percentage | 6.00% |
Employer matching contribution, percent of employee's contribution | 50.00% |
Maximum annual contributions per employee, amount | $ 5,000 |
Development and License Agree_3
Development and License Agreements - Additional Information (Detail) € in Millions | 1 Months Ended | 12 Months Ended | ||||||||
Sep. 30, 2020USD ($) | Aug. 31, 2019USD ($) | Aug. 31, 2019EUR (€) | Dec. 31, 2020USD ($) | Dec. 31, 2020EUR (€) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2016EUR (€) | Apr. 30, 2020USD ($) | |
Licenses Agreements [Line Items] | ||||||||||
Payments made relating to the manufacturing of the products | $ 31,300,000 | $ 29,500,000 | $ 21,300,000 | |||||||
BARDA Agreement | ||||||||||
Licenses Agreements [Line Items] | ||||||||||
Additional committed fund receivable | $ 13,800,000 | |||||||||
Committed fund receivable | 116,900,000 | |||||||||
Committed fund receivable | 213,900,000 | |||||||||
Accounts receivable of billed and unbilled amounts | 4,600,000 | $ 4,200,000 | ||||||||
FDA Agreement | ||||||||||
Licenses Agreements [Line Items] | ||||||||||
Contract agreement term | 5 years | |||||||||
Total potential contract value | $ 11,100,000 | |||||||||
FDA Agreement | Maximum | ||||||||||
Licenses Agreements [Line Items] | ||||||||||
Accounts receivable of billed and unbilled amounts | 100,000 | |||||||||
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 | |||||||||
Co-investment incurred by the company | $ 2,200,000 | |||||||||
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 | $ 6,200,000 | € 5.5 | $ 3,400,000 | € 3.1 |
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, 2020 | Dec. 31, 2019 | |
Other Current Assets | |||
Deferred Costs Capitalized Prepaid And Other Assets [Line Items] | |||
Prepaid R&D asset | [1] | $ 54 | |
Other Assets | |||
Deferred Costs Capitalized Prepaid And Other Assets [Line Items] | |||
Prepaid R&D asset | [2] | $ 2,088 | 2,094 |
Manufacturing efficiency asset | [2] | $ 1,104 | $ 1,349 |
[1] | Included in “Prepaid and 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, 2020 | Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |||
Payables to Fresenius | [1] | $ 13,838 | $ 8,470 |
Receivables from Fresenius | [2] | $ 2,380 | $ 1,796 |
[1] | Included in “Accounts Payable” and “Accrued Liabilities” in the Company's consolidated balance sheets. | ||
[2] | Included in “Prepaid and 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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
U.S. | $ (61,246) | $ (71,946) | $ (58,048) |
Foreign | 1,673 | 965 | 713 |
Loss before income taxes | $ (59,573) | $ (70,981) | $ (57,335) |
Provision Benefit for Income Ta
Provision Benefit for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Foreign | $ 274 | $ 255 | $ 225 |
Federal | 0 | 0 | 0 |
State | 0 | 2 | 0 |
Total current | 274 | 257 | 225 |
Foreign | 0 | 0 | 0 |
Federal | 6 | 4 | 3 |
State | 4 | 2 | 1 |
Total deferred | 10 | 6 | 4 |
Provision for income taxes | $ 284 | $ 263 | $ 229 |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory tax | $ (12,510) | $ (14,906) | $ (12,040) |
Federal research credits | (1,630) | (1,857) | (1,390) |
State research credits | 749 | 821 | 655 |
Expiration of federal carryovers | 9,200 | 5,472 | 4,154 |
Expiration of state carryovers | 1,344 | ||
Change in valuation allowance | 6,738 | 13,059 | 9,913 |
Compensation related items | 978 | 158 | (361) |
State taxes | (1,921) | (1,111) | (1,141) |
Other | 178 | 269 | 405 |
Provision for income taxes | $ 284 | $ 263 | $ 229 |
Significant Components of Defer
Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 141,176 | $ 135,536 |
Research and development credit carryforwards | 28,892 | 28,291 |
Capitalized research and development | 10,756 | 12,832 |
Compensation related items | 10,957 | 9,843 |
Operating leases | 4,214 | 4,374 |
Other | 6,051 | 4,547 |
Total deferred tax assets | 202,046 | 195,423 |
Valuation allowance | (199,042) | (192,304) |
Net deferred tax assets | 3,004 | 3,119 |
Deferred tax liabilities: | ||
Right-of-use assets | 2,892 | 3,017 |
Amortization of goodwill | 163 | 143 |
Total deferred tax liabilities | $ 3,055 | $ 3,160 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Increase (decrease) in valuation allowance | $ 6.7 | $ 13.1 | $ (9.9) |
Gross Amounts and Dates of Expi
Gross Amounts and Dates of Expiration of Tax Credits and Carryovers (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | $ 638,103 | |
California loss carryovers | 75,407 | |
Research credits | 28,892 | $ 28,291 |
Federal foreign tax credits | 610 | |
Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 19,249 | |
California | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 12,207 | |
Expires 2021-2023 | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 55,587 | |
Expires 2021-2023 | Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 7,786 | |
Expires 2024-2030 | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 190,581 | |
California loss carryovers | 28,779 | |
Federal foreign tax credits | 610 | |
Expires 2024-2030 | Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 2,248 | |
Expires 2031-2040 | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 209,368 | |
California loss carryovers | 46,628 | |
Expires 2031-2040 | Federal | ||
Income Tax Disclosure [Line Items] | ||
Research credits | 9,215 | |
No Expiration | ||
Income Tax Disclosure [Line Items] | ||
Federal losses carryovers | 182,567 | |
No Expiration | California | ||
Income Tax Disclosure [Line Items] | ||
Research credits | $ 12,207 |
Reconciliation of Unrecognized
Reconciliation of Unrecognized Tax Benefits (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Unrecognized tax benefits at beginning of period | $ 10,842 | $ 11,063 |
Decreases related to expired carryforwards | (1,171) | (729) |
Increases related to current year tax positions | 439 | 508 |
Unrecognized tax benefits at end of period | $ 10,110 | $ 10,842 |
Segment, Customer and Geograp_3
Segment, Customer and Geographic Information - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2020Segment | |
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, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Etablissement Francais du Sang | |||
Revenue, Major Customer [Line Items] | |||
Concentration risk, percentage | 21.00% | 27.00% | 38.00% |
American Red Cross | |||
Revenue, Major Customer [Line Items] | |||
Concentration risk, percentage | 20.00% | 14.00% |
Segment, Customer and Geograp_5
Segment, Customer and Geographic Information - Revenue by Geographical Location (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue, Major Customer [Line Items] | |||
Revenue | $ 114,249 | $ 93,774 | $ 76,051 |
Product | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 91,920 | 74,649 | 60,908 |
Product | UNITED STATES | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 31,517 | 20,611 | 12,563 |
Product | FRANCE | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 19,404 | 20,075 | 23,043 |
Product | BELGIUM | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 6,921 | 7,272 | 6,788 |
Product | Other Countries | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 34,078 | 26,691 | 18,514 |
Government Contract | |||
Revenue, Major Customer [Line Items] | |||
Revenue | 22,329 | 19,125 | 15,143 |
Government Contract | UNITED STATES | |||
Revenue, Major Customer [Line Items] | |||
Revenue | $ 22,329 | $ 19,125 | $ 15,143 |
Segment, Customer and Geograp_6
Segment, Customer and Geographic Information - Long Lived Assets by Geographical Location (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | $ 13,867 | $ 15,030 |
U.S. and Territories | ||
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | 13,559 | 14,619 |
Europe and Other | ||
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | $ 308 | $ 411 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) | Feb. 25, 2021 |
Subsequent Event | |
Subsequent Event [Line Items] | |
Ownership percentage | 51.00% |