Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | Apr. 25, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CERS | |
Entity Registrant Name | CERUS CORP | |
Entity Central Index Key | 0001020214 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 137,835,944 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 29,002 | $ 28,859 |
Short-term investments | 71,426 | 88,718 |
Accounts receivable | 13,756 | 8,752 |
Inventories | 15,778 | 13,539 |
Prepaid and other current assets | 4,958 | 7,034 |
Total current assets | 134,920 | 146,902 |
Non-current assets: | ||
Property and equipment, net | 16,089 | 8,130 |
Goodwill | 1,316 | 1,316 |
Operating lease right-of-use assets | 15,631 | |
Intangible assets, net | 284 | 334 |
Restricted cash | 2,725 | 2,728 |
Other assets | 4,961 | 4,050 |
Total assets | 175,926 | 163,460 |
Current liabilities: | ||
Accounts payable | 20,912 | 18,595 |
Accrued liabilities | 18,397 | 19,800 |
Manufacturing and development obligations | 5,962 | 5,928 |
Debt – current | 7,857 | |
Operating lease liabilities – current | 1,560 | |
Deferred product revenue – current | 763 | 498 |
Total current liabilities | 47,594 | 52,678 |
Non-current liabilities: | ||
Debt – non-current | 39,433 | 22,013 |
Operating lease liabilities – non-current | 19,311 | |
Other non-current liabilities | 88 | 4,250 |
Total liabilities | 106,426 | 78,941 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock | 138 | 136 |
Additional paid-in capital | 867,091 | 863,531 |
Accumulated other comprehensive loss | (70) | (281) |
Accumulated deficit | (797,659) | (778,867) |
Total stockholders' equity | 69,500 | 84,519 |
Total liabilities and stockholders' equity | $ 175,926 | $ 163,460 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Cost of revenue | $ 8,432 | $ 7,330 |
Gross profit | 9,072 | 6,234 |
Operating expenses: | ||
Research and development | 13,440 | 9,437 |
Selling, general and administrative | 16,161 | 13,607 |
Total operating expenses | 29,601 | 23,044 |
Loss from operations | (16,068) | (13,355) |
Non-operating expense, net: | ||
Foreign exchange (loss) gain | (162) | 108 |
Interest expense | (2,924) | (915) |
Other income, net | 422 | 331 |
Total non-operating expense, net | (2,664) | (476) |
Loss before income taxes | (18,732) | (13,831) |
Provision for income taxes | 60 | 54 |
Net loss | $ (18,792) | $ (13,885) |
Net loss per share: | ||
Basic | $ (0.14) | $ (0.11) |
Diluted | $ (0.14) | $ (0.11) |
Weighted average shares outstanding used for calculating net loss per share: | ||
Basic | 137,108 | 124,814 |
Diluted | 137,108 | 124,814 |
Product | ||
Revenue | $ 17,504 | $ 13,564 |
Government Contract | ||
Revenue | $ 4,461 | $ 3,455 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (18,792) | $ (13,885) |
Other comprehensive income (loss) | ||
Unrealized gains (losses) on available-for-sale investments, net of taxes | 211 | (329) |
Comprehensive loss | $ (18,581) | $ (14,214) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED 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 | ||||
Net loss | (13,885) | (13,885) | |||
Other comprehensive income (loss) | (329) | (329) | |||
Issuance of common stock from public offering, net of offering costs | 57,262 | $ 15 | 57,247 | ||
Issuance of common stock from public offering, net of offering costs (in shares) | 14,039 | ||||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases | 1,295 | $ 1 | 1,294 | ||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases (in shares) | 951 | ||||
Stock-based compensation | 2,315 | 2,315 | |||
Balance at Mar. 31, 2018 | 85,598 | $ 131 | 821,081 | (426) | (735,188) |
Balance (in shares) at Mar. 31, 2018 | 130,545 | ||||
Balance at Dec. 31, 2018 | 84,519 | $ 136 | 863,531 | (281) | (778,867) |
Balance (in shares) at Dec. 31, 2018 | 136,853 | ||||
Net loss | (18,792) | (18,792) | |||
Other comprehensive income (loss) | 211 | 211 | |||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases | 684 | $ 2 | 682 | ||
Issuance of common stock from exercise of stock options, vesting of restricted stock units, and ESPP purchases (in shares) | 965 | ||||
Stock-based compensation | 2,878 | 2,878 | |||
Balance at Mar. 31, 2019 | $ 69,500 | $ 138 | $ 867,091 | $ (70) | $ (797,659) |
Balance (in shares) at Mar. 31, 2019 | 137,818 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities | ||
Net loss | $ (18,792) | $ (13,885) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 729 | 413 |
Stock-based compensation | 2,878 | 2,315 |
Non-cash interest expense | 197 | 269 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (5,004) | 1,926 |
Inventories | (2,286) | 1,224 |
Other assets | 2,165 | (1,475) |
Accounts payable | 2,597 | (122) |
Accrued liabilities and other non-current liabilities | (4,809) | (1,340) |
Manufacturing and development obligations | (118) | 164 |
Deferred product revenue | 265 | 186 |
Net cash used in operating activities | (22,178) | (10,325) |
Investing activities | ||
Capital expenditures | (3,315) | (52) |
Purchases of investments | (1,000) | (56,941) |
Proceeds from maturities and sale of investments | 17,500 | 12,250 |
Net cash provided by (used in) investing activities | 13,185 | (44,743) |
Financing activities | ||
Net proceeds from equity incentives | 710 | 1,295 |
Net proceeds from public offering | 57,564 | |
Proceeds from loans, net of discount | 39,433 | |
Repayment of debt | (31,010) | (32) |
Net cash provided by financing activities | 9,133 | 58,827 |
Net increase in cash, cash equivalents and restricted cash | 140 | 3,759 |
Cash, cash equivalents and restricted cash, beginning of period | 31,587 | 13,930 |
Cash, cash equivalents and restricted cash, end of period | $ 31,727 | $ 17,689 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 1. Summary of Significant Accounting Policies Principles of Consolidation and Basis of Presentation The accompanying unaudited condensed 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 unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring entries, considered necessary for a fair presentation have been made. Operating results for the three months ended March 31, 2019, are not necessarily indicative of the results that may be expected for the year ending December 31, 2019, or for any future periods. These unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2018, which were included in the Company’s 2018 Annual Report on Form 10-K, filed with the SEC on February 27, 2019. The accompanying condensed consolidated balance sheet as of December 31, 2018, has been derived from the Company’s audited consolidated financial statements as of that date . Use of Estimates The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to the nature and timing of satisfaction of performance obligations, the timing when the customer obtains control of products or services, the standalone selling price (“SSP”) of performance obligations, variable consideration, accounts receivable, inventory reserves, fair values of investments, stock-based compensation, intangible assets and goodwill, useful lives of intangible assets and property and equipment, income taxes, accrued liabilities, and incremental borrowing rate, among others. The Company bases its estimates on historical experience, future projections, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions. Revenue Revenue is recognized in accordance with that core principle by applying the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company’s main source of revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or “disposable kits”), UVA illumination devices (“illuminators”), spare parts and storage solutions, and maintenance services of illuminators. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. The Company uses a binding purchase order or signed sales contract as evidence of a contract and satisfaction of its policy. Generally, the Company’s contracts with its customers do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming product. The contracts with customers can include various combinations of products, and to a lesser extent, services. The Company must determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or are accounted for as a combined performance obligation. The Company must allocate the transaction price to each performance obligation on a relative SSP basis, and recognize the product revenue when the performance obligation is satisfied. The Company determines the SSP by using the historical selling price of the products and services. If the amount of consideration in a contract is variable, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely amount method, to the extent it is probable that a significant future reversal of cumulative product revenue under the contract will not occur. Product revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration to which the Company expects to receive in exchange for those products or services. Product revenue from the sale of illuminators, disposable kits, spare parts and storage solutions are recognized upon the transfer of control of the products to the customer. Product revenue from maintenance services are recognized ratably on a straight-line basis over the term of maintenance as customers simultaneously consume and receive benefits. Freight costs charged to customers are recorded as a component of product revenue. Taxes that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such tax from product revenue. The Company receives reimbursement under its U.S. government contract with the Biomedical Advanced Research and Development Authority (“BARDA”) that supports research and development of defined projects. See “Note 10. Development and License Agreements—Agreement with BARDA” below. The contract generally provides for reimbursement of approved costs incurred under the terms of the contract. Revenue related to the cost reimbursement provisions under the Company’s U.S. government contract are recognized as the qualified direct and indirect costs on the projects are incurred. The Company invoices under its U.S. government contract using the provisional rates in the government contract and thus is subject to future audits at the discretion of government. These audits could result in an adjustment to government contract revenue previously reported, which adjustments potentially could be significant. The Company believes that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. Costs incurred related to services performed under the contract are included as a component of research and development or selling, general and administrative expenses in the Company’s condensed consolidated statements of operations. The Company’s use of estimates in recording accrued liabilities for government contract activities (see “Use of Estimates” above) affects the revenue recorded from development funding and under the government contract. Disaggregation of Product Revenue Product revenue by geographical locations of customers during the three months ended March 31, 2019 and 2018, were as follows (in thousands): Three Months Ended March 31, 2019 2018 Product revenue: Europe, Middle East and Africa $ 12,653 $ 11,006 North America 4,551 2,387 Other 300 171 Total product revenue $ 17,504 $ 13,564 Contract Balances The Company invoices its customers based upon the terms in the contracts, which is generally from 30 to 60 days. Accounts receivable are recorded when the Company’s right to the consideration are estimated to be unconditional. The Company had no contract assets at March 31, 2019 and December 31, 2018. Contract liabilities mainly consist of deferred product revenue related to maintenance services, unshipped products, and uninstalled illuminators. Maintenance services are generally billed upfront at the beginning of each annual service period and recognized ratably over the service period. The increase in the deferred product revenue balance for the three months ended March 31, 2019 is primarily driven by performance obligations not satisfied but invoiced as of March 31, 2019, offset by $0.2 million of revenue recognized that were included in the deferred product revenue balance as of December 31, 2018. The Company applies an optional exemption to not disclose the value of unsatisfied performance obligations for contracts that have an original expected duration of one year or less. Research and Development Expenses Research and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of the Company’s U.S. government contract. Research and development expenses include salaries and related expenses for scientific and regulatory personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of R&D facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use. The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D expenses recorded from development funding and under its U.S. government contract. Actual results may differ from those estimates under different assumptions or conditions. Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be classified as cash equivalents. These investments primarily consist of money market instruments, and are classified as available-for-sale. Investments Investments with original maturities of greater than three months primarily include corporate debt and U.S. government agency securities that are designated as available-for-sale and classified as short-term investments. Available-for-sale securities are carried at estimated fair value. The Company views its available-for-sale portfolio as available for use in its current operations. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Unrealized losses on available-for-sale investments, net of taxes” on the Company’s unaudited condensed consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments, if any, were recorded in “Other income, net” on the Company’s unaudited condensed consolidated statements of operations. The costs of securities sold are based on the specific identification method, if applicable. The Company reported the amortization of any premium and accretion of any discount resulting from the purchase of debt securities as a component of interest income. The Company also reviews its available-for-sale securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value. Other-than-temporary declines in market value, if any, are recorded in “Other income, net” on the Company’s unaudited condensed consolidated statements of operations. Restricted Cash As of March 31, 2019, the Company’s “Restricted cash” primarily consisted of a letter of credit relating to the lease of the Company’s new office building. As of March 31, 2019 and December 31, 2018, the Company also had certain non-U.S. dollar denominated deposits recorded as “Restrict 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 March 31, 2019, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments. Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company establishes an allowance for doubtful accounts against the accounts receivable on its unaudited condensed consolidated balance sheets and records a charge on its unaudited condensed consolidated statements of operations as a component of selling, general and administrative expenses. The Company had three and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at March 31, 2019 and December 31, 2018, respectively. These customers cumulatively represented approximately 59% and 50% of the Company’s outstanding trade receivables at March 31, 2019 and December 31, 2018, respectively. To date, the Company has not experienced collection difficulties from these customers. Inventories At March 31, 2019 and December 31, 2018, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, illuminators, and certain replacement parts for the illuminators. Platelet and plasma systems’ disposable kits generally have 18 to 24 months shelf lives from the date of manufacture. Illuminators and replacement parts do not have regulated expiration dates. Work-in-process includes certain components that are manufactured over a protracted length of time before being sold to, and ultimately incorporated and assembled by Fresenius Kabi Deutschland GmbH or Fresenius, Inc. (with their affiliates, “Fresenius”) into the finished INTERCEPT disposable kits. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production of finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At March 31, 2019 and December 31, 2018, the Company classified its work-in-process inventory as a current asset on its condensed consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective subsequent twelve-month period. Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or net realizable value. The Company uses significant judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently reviews such determinations. The Company writes down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use in the period that it is first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded in “Cost of product revenue” on the Company’s condensed consolidated statements of operations. At March 31, 2019 and December 31, 2018, the Company had $0.4 million and $0.3 million, respectively, recorded for potential obsolete, expiring or unsalable product. Property and Equipment, net Property and equipment is comprised of furniture, equipment, leasehold improvements, construction-in-progress, information technology hardware and software and is recorded at cost. At the time the property and equipment is ready for its intended use, it is depreciated on a straight-line basis over the estimated useful lives of the assets (generally three to five years). Leasehold improvements are amortized on a straight-line basis over the shorter of the lease term or the estimated useful lives of the improvements. During the three months ended March 31, 2019 and 2018, the Company had non-cash purchases of capital expenditures of $2.9 million and less than $0.1 million, respectively. Goodwill and Intangible Assets, net Intangible assets, net, which include a license for the right to commercialize the INTERCEPT Blood System in Asia, are subject to ratable amortization over the original estimated useful life of ten years. Accumulated amortization of intangible assets as of March 31, 2019 and December 31, 2018, was $1.7 million and $1.7 million, respectively. Goodwill is not amortized but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each fiscal year, or more frequently if indicators of impairment exist. The test for goodwill impairment may be assessed using qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing the quantitative goodwill impairment test. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative impairment test; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The quantitative goodwill impairment test compares the fair value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it operates in one reporting unit and estimates the fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess, limited to the carrying amount of goodwill in the Company’s one reporting unit. The Company performs an impairment test on its intangible assets if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the excess amount of the carrying value of the intangible assets over its fair value. During the three months ended March 31, 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 the Company’s condensed consolidated statements of operations. Stock-Based Compensation Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved. For stock-based awards issued to non-employees, the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based awards in its condensed consolidated statements of operations. See Note 8 for further information regarding the Company’s stock-based compensation expense. 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 unaudited condensed consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s U.S. federal tax returns for years 1998 through 2017, California tax returns for years through 2017, and Netherlands tax returns for years 2015 through 2017 remain subject to examination by the taxing jurisdictions 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 three months ended March 31, 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 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 three months ended March 31, 2019 and 2018 (shares in thousands): Three Months Ended March 31, 2019 2018 Weighted average number of anti-dilutive potential shares: Stock options 17,648 17,879 Restricted stock units 2,247 1,579 Employee stock purchase plan rights 7 92 Total 19,902 19,550 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 on the condensed consolidated balance sheets. As of March 31, 2019 and December 31, 2018, the Company did not have finance leases. ROU assets and operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The ROU asset also includes any lease payments made and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain to be exercised. Operating leases are recognized on a straight-line basis over the lease term. Guarantee and Indemnification Arrangements The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a third party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions. The Company generally provides for a one-year warranty on certain of its INTERCEPT blood-safety products covering defects in materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. The Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims. Accordingly, the Company had not accrued for any future warranty costs for its products at March 31, 2019 and December 31, 2018. Fair Value of Financial Instruments The Company applies the provisions of fair value relating to its financial assets and liabilities. The carrying amounts of accounts receivables, accounts payable, and other accrued liabilities approximate their fair value due to the relative short-term maturities. Based on the borrowing rates currently available to the Company for loans with similar terms, the Company believes the fair value of its debt approximates their carrying amounts. The Company measures and records certain financial assets and liabilities at fair value on a recurring basis, including its available-for-sale securities. The Company classifies instruments within Level 1 if quoted prices are available in active markets for identical assets, which include the Company’s cash accounts and money market funds. The Company classifies instruments in Level 2 if the instruments are valued using observable inputs to quoted market prices, benchmark yields, reported trades, broker/dealer quotes or alternative pricing sources with reasonable levels of price transparency. These instruments include the Company’s corporate debt and U.S. government agency securities holdings. The available-for-sale securities are held by a custodian who obtains investment prices from a third party pricing provider that uses standard inputs (observable in the market) to models which vary by asset class. The Company classifies instruments in Level 3 if one or more significant inputs or significant value drivers are unobservable. The Company assesses any transfers among fair value measurement levels at the end of each reporting period. See Note 2 for further information regarding the Company’s valuation of financial instruments. New Accounting Pronouncements Recently adopted accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases Leases (Topic 842): Targeted Improvements Recently issued accounting pronouncements not yet adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, |
Available-for-sale Securities a
Available-for-sale Securities and Fair Value on Financial Instruments | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Available-for-sale Securities and Fair Value on Financial Instruments | Note 2. 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 March 31, 2019 (in thousands): March 31, 2019 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 4,145 $ — $ — $ 4,145 United States government agency securities 7,488 — (11 ) 7,477 Corporate debt securities 64,008 18 (77 ) 63,949 Total available-for-sale securities $ 75,641 $ 18 $ (88 ) $ 75,571 The following is a summary of available-for-sale securities at December 31, 2018 (in thousands): December 31, 2018 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 6,167 $ — $ — $ 6,167 United States government agency securities 15,971 — (23 ) 15,948 Corporate debt securities 73,028 2 (260 ) 72,770 Total available-for-sale securities $ 95,166 $ 2 $ (283 ) $ 94,885 Available-for-sale securities at March 31, 2019 and December 31, 2018, consisted of the following by contractual maturity (in thousands): March 31, 2019 December 31, 2018 Amortized Cost Fair Value Amortized Cost Fair Value One year or less $ 75,641 $ 75,571 $ 85,227 $ 84,957 Greater than one year and less than five years — — 9,939 9,928 Total available-for-sale securities $ 75,641 $ 75,571 $ 95,166 $ 94,885 The following tables show all available-for-sale marketable securities in an unrealized loss position for which an other-than-temporary impairment has not been recognized and the related gross unrealized losses and fair value, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands): March 31, 2019 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss United States government agency securities $ — $ — $ 7,477 $ (11 ) $ 7,477 $ (11 ) Corporate debt securities — — 47,479 (77 ) 47,479 (77 ) Total available-for-sale securities $ — $ — $ 54,956 $ (88 ) $ 54,956 $ (88 ) December 31, 2018 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss United States government agency securities $ 14,948 $ (22 ) $ 999 $ (1 ) $ 15,947 $ (23 ) Corporate debt securities 60,813 (231 ) 9,976 (29 ) 70,789 (260 ) Total available-for-sale securities $ 75,761 $ (253 ) $ 10,975 $ (30 ) $ 86,736 $ (283 ) As of March 31, 2019, the Company considered the declines in market value of its marketable securities investment portfolio to be temporary in nature and did not consider any of its investments other-than-temporarily impaired. The Company typically invests in highly-rated securities, and its investment policy limits the amount of credit exposure to any one issuer. The policy generally requires investments to be investment grade, with the primary objective of minimizing the potential risk of principal loss. Fair values were determined for each individual security in the investment portfolio. When evaluating an investment for other-than-temporary impairment, the Company reviews factors such as the length of time and extent to which fair value has been below its cost basis, the financial condition of the issuer and any changes thereto, changes in market interest rates, and the Company’s intent to sell, or whether it is more likely than not it will be required to sell, the investment before recovery of the investment’s cost basis. During the three months ended March 31, 2019 and 2018, the Company did not recognize any other-than-temporary impairment loss. The Company has no current requirement or intent to sell the securities in an unrealized loss position. The Company expects to recover up to (or beyond) the initial cost of investment for securities held. The Company did not record any gross realized gains or losses from the sale or maturity of available-for-sale investments during the three months ended March 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 March 31, 2019, the Company’s primary pricing service relies on inputs from multiple industry-recognized pricing sources to determine the price for each investment. Corporate debt and U.S. government agency securities are systematically priced by this service as of the close of business each business day. If the primary pricing service does not price a specific asset a secondary pricing service is utilized. The fair values of the Company’s financial assets and liabilities were determined using the following inputs at March 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 $ 4,145 $ 4,145 $ — $ — United States government agency securities Short-term investments 7,477 — 7,477 — Corporate debt securities Short-term investments 63,949 — 63,949 — Total financial assets $ 75,571 $ 4,145 $ 71,426 $ — The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2018 (in thousands): Balance sheet Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs classification Total (Level 1) (Level 2) (Level 3) Money market funds Cash and cash equivalents $ 6,167 $ 6,167 $ — $ — United States government agency securities Short-term investments 15,948 — 15,948 — Corporate debt securities Short-term investments 72,770 — 72,770 — Total financial assets $ 94,885 $ 6,167 $ 88,718 $ — The Company did not have any transfers among fair value measurement levels during the three months ended March 31, 2019. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories | Note 3. Inventories Inventories at March 31, 2019 and December 31, 2018, consisted of the following (in thousands): March 31, 2019 December 31, 2018 Work-in-process $ 4,342 $ 3,075 Finished goods 11,436 10,464 Total inventories $ 15,778 $ 13,539 |
Accrued Liabilities
Accrued Liabilities | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | Note 4. Accrued Liabilities Accrued liabilities at March 31, 2019 and December 31, 2018, consisted of the following (in thousands): March 31, 2019 December 31, 2018 Accrued professional services $ 8,323 $ 4,544 Accrued compensation and related costs 6,490 10,765 Accrued development costs 1,908 1,965 Other accrued expenses 1,676 2,526 Total accrued liabilities $ 18,397 $ 19,800 |
Debt
Debt | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | Note 5. Debt Debt at March 31, 2019, consisted of the following (in thousands): March 31, 2019 Principal Unamortized Discount Total Term Loan Credit Agreement $ 40,000 $ (567 ) $ 39,433 Less: debt – current — — — Debt – non-current $ 40,000 $ (567 ) $ 39,433 Debt at December 31, 2018, consisted of the following (in thousands): December 31, 2018 Principal Unamortized Discount Net Carrying Value Oxford Term Loan Agreement $ 30,000 $ (130 ) $ 29,870 Less: debt – current (7,857 ) — (7,857 ) Debt – non-current $ 22,143 $ (130 ) $ 22,013 Principal, interest and fee payments on debt at March 31, 2019, are expected to be as follows (in thousands): Year ended December 31, Principal Interest and Fees Total 2019 $ — $ 2,250 $ 2,250 2020 — 3,335 3,335 2021 — 3,326 3,326 2022 15,000 2,909 17,909 2023 20,000 1,315 21,315 2024 5,000 1,270 6,270 Total $ 40,000 $ 14,405 $ 54,405 Loan and Security Agreement Prior to March 29, 2019, the Company maintained a loan and security agreement (the “Oxford Term Loan Agreement”) with Oxford Finance LLC (“Oxford”). The Oxford Term Loan Agreement provided for secured growth capital term loans of up to $40.0 million. The Oxford Term Loan Agreement was available in two tranches. The first tranche of $30.0 million (“2017 Term Loan A”) was drawn by the Company on July 31, 2017, with the proceeds used in part to repay in full all of the outstanding term loans under the previous Term Loan Agreement of $17.6 million and the final payment of the previous Term Loan Agreement of $1.4 million. The availability of the second tranche of $10.0 million (“2017 Term Loan B”) expired on May 14, 2018, and the Company did not elect to draw the 2017 Term Loan B. On March 29, 2019 (the “Closing Date”), the Company entered into a Credit, Security and Guaranty Agreement (Term Loan) (the “Term Loan Credit Agreement”) with MidCap Financial Trust (“MidCap”) to borrow up to $70 million in three tranches (collectively “2019 Term Loan”), with a maturity date of March 1, 2024. The first advance of $40.0 million (“Tranche 1”) was drawn by the Company on March 29, 2019, with the proceeds used in part to repay in full the outstanding term loans and fees under the Oxford Term Loan Agreement. The Company repaid principal and interest in an aggregate amount equal to approximately $31.2 million and prepayment fees in an aggregate amount equal to approximately $0.6 million. As of March 31, 2019, all obligations under the Oxford Term Loan Agreement have terminated. As a result, the Company recorded a loss of $2.1 million on the extinguishment of Oxford term loans in “Interest expense” on the Company's condensed consolidated statements of operations. The second advance of $15.0 million (“Tranche 2”) will be available to the Company from January 1, 2020 through December 31, 2020, subject to the Company’s satisfaction of certain conditions described in the Term Loan Credit Agreement, and (ii) the third advance of $15.0 million (“Tranche 3”) will be available to the Company starting April 1, 2020, through March 31, 2021, subject to the Company’s satisfaction of certain other conditions described in the Term Loan Credit Agreement. The borrowings under the 2019 Term Loan bears interest at the sum of a fixed percentage spread and the greater of (i) 1.8% or (ii) one month LIBOR. The effective interest rate on the Term Loan at March 31, 2019 was approximately 8.20%. All three tranches require interest only payments through April 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, at which time there is no early termination fee. Upon the final payment, the Company must also pay an exit fee calculated based on a percentage of the aggregate principal amount of all tranches advanced to the Company. The Company also entered into a Credit, Security and Guaranty Agreement (Revolving Loan) (the “Revolving Loan Credit Agreement”) with MidCap on March 29, 2019, to initially borrow up to $5.0 million. The amount borrowed under the Revolving Loan Credit Agreement can be increased, upon request by the Company by up to an additional $15.0 million, subject to agent and lender approval and the satisfaction of certain conditions. The Revolving Loan Credit Agreement has a maturity date of March 1, 2024. Amounts drawn under the Revolving Loan Credit Agreement bear interest at the sum of a fixed percentage spread and the greater of (i) 1.80% or (ii) one month LIBOR. There are also fractional fees based on the amounts either drawn or undrawn. If the Revolving Loan Credit Agreement is terminated before maturity or the funding obligation is permanently reduced, there are declining fees for the entirety of its term. No amounts were borrowed under the Revolving Loan Credit Agreement as of March 31, 2019. The Term Loan Credit Agreement and Revolving Loan Credit Agreement contain certain non-financial covenants, with which the Company was in compliance at March 31, 2019. Additionally, both agreements are secured by most of the Company’s assets, excluding intellectual property. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 6. 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. We do not assume renewals in our 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 Three Months Ended March 31, 2019 Cash payments for operating leases $ 734 Right-of-use assets obtained in exchange for operating lease obligations 13,560 March 31, 2019 Weighted-average remaining lease term 9.9 years Weighted-average discount rate 9.0 % Future minimum non-cancelable payments under operating leases as of March 31, 2019, were as follows (in thousands): Operating Leases Remainder of 2019 $ 2,796 2020 3,047 2021 3,086 2022 2,714 2023 2,610 Thereafter 18,690 Total future lease payments $ 32,943 Less imputed interest 12,072 Present value of lease liabilities $ 20,871 During the three months ended March 31, 2019 and 2018, the Company recorded operating lease cost of $0.5 million and $0.3 million, respectively. As of March 31, 2019, the Company had no leases that have not yet commenced. Purchase Commitments The Company is party to agreements with certain providers for certain components of the INTERCEPT Blood System. Certain of these agreements require minimum purchase commitments from the Company. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | Note 7. Stockholders’ Equity Sales Agreement On August 4, 2017, the Company entered into Amendment No. 3 to the Controlled Equity Offering SM |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | Note 8. Stock-Based Compensation Employee Stock Plans Employee Stock Purchase Plan The Company maintains an Employee Stock Purchase Plan (the “Purchase Plan”), which is intended to qualify as an employee stock purchase plan within the meaning of Section 423(b) of the Internal Revenue Code. Under the Purchase Plan, the Company’s Board of Directors may authorize participation by eligible employees, including officers, in periodic offerings. Under the Purchase Plan eligible employee participants may purchase shares of common stock of the Company at a purchase price equal to 85% of the lower of the fair market value per share on the start date of the offering period or the fair market value per share on the purchase date. The Purchase Plan consists of a fixed offering period of 12 months with two purchase periods within each offering period. At March 31, 2019, the Company had 0.7 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. 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 and will 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 March 31, 2019, 45,000 performance-based stock awards were outstanding. At March 31, 2019, the Company had an aggregate of approximately 21.3 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 17.7 million shares and 2.4 million shares were subject to outstanding options and unvested RSUs, respectively, and approximately 1.2 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, 2018 17,560 $ 4.47 Granted 290 6.13 Exercised (71 ) 2.90 Forfeited/canceled (57 ) 5.56 Balances at March 31, 2019 17,722 4.50 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, 2018 (1) 2,001 $ 4.56 Granted (1) 1,201 6.79 Vested (800 ) 4.48 Forfeited (3 ) 4.32 Balances at March 31, 2019 2,399 5.70 (1) Includes shares issuable under performance-based restricted stock unit awards. 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. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 9. Income Taxes The Company recorded income tax expense of less than $0.1 million for the three months ended March 31, 2019 and 2018, primarily related to the operating income of the Company’s Cerus Europe B.V. subsidiary. |
Development and License Agreeme
Development and License Agreements | 3 Months Ended |
Mar. 31, 2019 | |
Development And License Agreements [Abstract] | |
Development and License Agreements | Note 10. 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 condensed consolidated balance sheets until such time as the Company purchases finished disposable kits using those components. The Supply Agreement also requires the Company to make certain payments totaling €8.6 million (“Manufacturing and Development Payments”) to Fresenius. In 2016, the Company paid €3.1 million to Fresenius. In August 2018, the Company entered into an amendment to the Supply Agreement accelerating the payment for the remaining €5.5 million to August 2019. Because these payments represent unconditional payment obligations, the Company recognized its liability for these payments at their net present value at discount rate of 9.72% based on the Company’s effective borrowing rate at that time. The Manufacturing and Development Payments liability is accreted through interest expense based on the estimated timing of its ultimate settlement. As of March 31, 2019 and December 31, 2018, the Company accrued $6.0 million (€5.3 million) and $5.9 million (€5.2 million), respectively, related to the Manufacturing and Development Payments. The Supply Agreement also requires the Company to make payments to support certain projects Fresenius has and will perform on behalf of the Company related to certain R&D activities and manufacturing efficiency activities for which certain assets have been established in the Company’s condensed 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 March 31, 2019 and December 31, 2018 (in thousands). March 31, 2019 December 31, 2018 Prepaid R&D asset – current (1) $ 46 $ 47 Prepaid R&D asset – non-current (2) 2,152 2,156 Manufacturing efficiency asset (2) 1,533 1,594 (1) Included in “Other current assets” in the Company's condensed consolidated balance sheets. (2) Included in “Other assets” in the Company's condensed 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 $7.8 million and $5.4 million relating to the manufacturing of the Company’s products during the three months ended March 31, 2019 and 2018, respectively. The following table summarizes the amounts of the Company’s payables to and receivables from Fresenius at March 31, 2019 and December 31, 2018 (in thousands). March 31, 2019 December 31, 2018 Payables to Fresenius (1) $ 7,507 $ 7,812 Receivables from Fresenius (2) 954 1,777 (1) Included in “Accounts Payable” and “Accrued Liabilities” in the Company's condensed consolidated balance sheets. (2) Included in “Other current assets” in the Company's condensed consolidated balance sheets. Agreement with BARDA In June 2016, the Company entered into an agreement with BARDA to support the Company’s development and implementation of pathogen reduction technology for platelet, plasma, and red blood cells. The five-year agreement with BARDA and its subsequent modifications include a base period (the “Base Period”) and options (each, an “Option Period”) with committed funding of up to $103.2 million for clinical development of the INTERCEPT Blood System for red blood cells (the “red blood cell system”), and the potential for the exercise by BARDA of subsequent Option Periods that, if exercised by BARDA and completed, would bring the total funding opportunity to $201.2 million over the five-year contract period. If exercised by BARDA, subsequent Option Periods would fund activities related to broader implementation of the platelet and plasma system or the red blood cell system in areas of Zika virus risk, clinical and regulatory development programs in support of the potential licensure of the red blood cell system in the U.S., and development, manufacturing and scale-up activities for the red blood cell system. The Company is responsible for co-investment of $5.0 million and would be responsible for an additional $9.6 million, if certain Option Periods are exercised. BARDA will make periodic assessments of the Company’s progress and the continuation of the agreement is based on the Company’s success in completing the required tasks under the Base Period and each exercised Option Period. BARDA has rights under certain contract clauses to terminate the agreement, including the ability to terminate the agreement for convenience at any time. As of March 31, 2019 and December 31, 2018, $4.2 million and $2.3 million, respectively, of billed and unbilled amounts were included in accounts receivable on the Company’s condensed consolidated balance sheets related to BARDA. |
Segment, Customer and Geographi
Segment, Customer and Geographic Information | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Segment, Customer and Geographic Information | Note 11. 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 three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Établissement Français du Sang 29% 41% American Red Cross 13% * |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Principles of Consolidation and Basis of Presentation | Principles of Consolidation and Basis of Presentation The accompanying unaudited condensed 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 unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring entries, considered necessary for a fair presentation have been made. Operating results for the three months ended March 31, 2019, are not necessarily indicative of the results that may be expected for the year ending December 31, 2019, or for any future periods. These unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2018, which were included in the Company’s 2018 Annual Report on Form 10-K, filed with the SEC on February 27, 2019. The accompanying condensed consolidated balance sheet as of December 31, 2018, has been derived from the Company’s audited consolidated financial statements as of that date . |
Use of Estimates | Use of Estimates The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to the nature and timing of satisfaction of performance obligations, the timing when the customer obtains control of products or services, the standalone selling price (“SSP”) of performance obligations, variable consideration, accounts receivable, inventory reserves, fair values of investments, stock-based compensation, intangible assets and goodwill, useful lives of intangible assets and property and equipment, income taxes, accrued liabilities, and incremental borrowing rate, among others. The Company bases its estimates on historical experience, future projections, and on various other assumptions that are believed to be reasonable under the circumstances. Actual results may differ from those estimates under different assumptions or conditions. |
Revenue | Revenue Revenue is recognized in accordance with that core principle by applying the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company’s main source of revenue is product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems” or “disposable kits”), UVA illumination devices (“illuminators”), spare parts and storage solutions, and maintenance services of illuminators. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. The Company uses a binding purchase order or signed sales contract as evidence of a contract and satisfaction of its policy. Generally, the Company’s contracts with its customers do not provide for open return rights, except within a reasonable time after receipt of goods in the case of defective or non-conforming product. The contracts with customers can include various combinations of products, and to a lesser extent, services. The Company must determine whether products or services are capable of being distinct and accounted for as separate performance obligations, or are accounted for as a combined performance obligation. The Company must allocate the transaction price to each performance obligation on a relative SSP basis, and recognize the product revenue when the performance obligation is satisfied. The Company determines the SSP by using the historical selling price of the products and services. If the amount of consideration in a contract is variable, the Company estimates the amount of variable consideration that should be included in the transaction price using the most likely amount method, to the extent it is probable that a significant future reversal of cumulative product revenue under the contract will not occur. Product revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration to which the Company expects to receive in exchange for those products or services. Product revenue from the sale of illuminators, disposable kits, spare parts and storage solutions are recognized upon the transfer of control of the products to the customer. Product revenue from maintenance services are recognized ratably on a straight-line basis over the term of maintenance as customers simultaneously consume and receive benefits. Freight costs charged to customers are recorded as a component of product revenue. Taxes that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such tax from product revenue. The Company receives reimbursement under its U.S. government contract with the Biomedical Advanced Research and Development Authority (“BARDA”) that supports research and development of defined projects. See “Note 10. Development and License Agreements—Agreement with BARDA” below. The contract generally provides for reimbursement of approved costs incurred under the terms of the contract. Revenue related to the cost reimbursement provisions under the Company’s U.S. government contract are recognized as the qualified direct and indirect costs on the projects are incurred. The Company invoices under its U.S. government contract using the provisional rates in the government contract and thus is subject to future audits at the discretion of government. These audits could result in an adjustment to government contract revenue previously reported, which adjustments potentially could be significant. The Company believes that revenue for periods not yet audited has been recorded in amounts that are expected to be realized upon final audit and settlement. Costs incurred related to services performed under the contract are included as a component of research and development or selling, general and administrative expenses in the Company’s condensed consolidated statements of operations. The Company’s use of estimates in recording accrued liabilities for government contract activities (see “Use of Estimates” above) affects the revenue recorded from development funding and under the government contract. Disaggregation of Product Revenue Product revenue by geographical locations of customers during the three months ended March 31, 2019 and 2018, were as follows (in thousands): Three Months Ended March 31, 2019 2018 Product revenue: Europe, Middle East and Africa $ 12,653 $ 11,006 North America 4,551 2,387 Other 300 171 Total product revenue $ 17,504 $ 13,564 Contract Balances The Company invoices its customers based upon the terms in the contracts, which is generally from 30 to 60 days. Accounts receivable are recorded when the Company’s right to the consideration are estimated to be unconditional. The Company had no contract assets at March 31, 2019 and December 31, 2018. Contract liabilities mainly consist of deferred product revenue related to maintenance services, unshipped products, and uninstalled illuminators. Maintenance services are generally billed upfront at the beginning of each annual service period and recognized ratably over the service period. The increase in the deferred product revenue balance for the three months ended March 31, 2019 is primarily driven by performance obligations not satisfied but invoiced as of March 31, 2019, offset by $0.2 million of revenue recognized that were included in the deferred product revenue balance as of December 31, 2018. The Company applies an optional exemption to not disclose the value of unsatisfied performance obligations for contracts that have an original expected duration of one year or less. |
Research and Development Expenses | Research and Development Expenses Research and development (“R&D”) expenses are charged to expense when incurred, including cost incurred pursuant to the terms of the Company’s U.S. government contract. Research and development expenses include salaries and related expenses for scientific and regulatory personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of R&D facilities, depreciation of equipment and external contract research expenses, including clinical trials, preclinical safety studies, other laboratory studies, process development and product manufacturing for research use. The Company’s use of estimates in recording accrued liabilities for R&D activities (see “Use of Estimates” above) affects the amounts of R&D expenses recorded from development funding and under its U.S. government contract. Actual results may differ from those estimates under different assumptions or conditions. |
Cash Equivalents | Cash Equivalents The Company considers all highly liquid investments with original maturities of three months or less from the date of purchase to be classified as cash equivalents. These investments primarily consist of money market instruments, and are classified as available-for-sale. |
Investments | Investments Investments with original maturities of greater than three months primarily include corporate debt and U.S. government agency securities that are designated as available-for-sale and classified as short-term investments. Available-for-sale securities are carried at estimated fair value. The Company views its available-for-sale portfolio as available for use in its current operations. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Unrealized losses on available-for-sale investments, net of taxes” on the Company’s unaudited condensed consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments, if any, were recorded in “Other income, net” on the Company’s unaudited condensed consolidated statements of operations. The costs of securities sold are based on the specific identification method, if applicable. The Company reported the amortization of any premium and accretion of any discount resulting from the purchase of debt securities as a component of interest income. The Company also reviews its available-for-sale securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value. Other-than-temporary declines in market value, if any, are recorded in “Other income, net” on the Company’s unaudited condensed consolidated statements of operations. |
Restricted Cash | Restricted Cash As of March 31, 2019, the Company’s “Restricted cash” primarily consisted of a letter of credit relating to the lease of the Company’s new office building. As of March 31, 2019 and December 31, 2018, the Company also had certain non-U.S. dollar denominated deposits recorded as “Restrict 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 March 31, 2019, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents and short-term investments. Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company establishes an allowance for doubtful accounts against the accounts receivable on its unaudited condensed consolidated balance sheets and records a charge on its unaudited condensed consolidated statements of operations as a component of selling, general and administrative expenses. The Company had three and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at March 31, 2019 and December 31, 2018, respectively. These customers cumulatively represented approximately 59% and 50% of the Company’s outstanding trade receivables at March 31, 2019 and December 31, 2018, respectively. To date, the Company has not experienced collection difficulties from these customers. |
Inventories | Inventories At March 31, 2019 and December 31, 2018, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, illuminators, and certain replacement parts for the illuminators. Platelet and plasma systems’ disposable kits generally have 18 to 24 months shelf lives from the date of manufacture. Illuminators and replacement parts do not have regulated expiration dates. Work-in-process includes certain components that are manufactured over a protracted length of time before being sold to, and ultimately incorporated and assembled by Fresenius Kabi Deutschland GmbH or Fresenius, Inc. (with their affiliates, “Fresenius”) into the finished INTERCEPT disposable kits. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production of finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At March 31, 2019 and December 31, 2018, the Company classified its work-in-process inventory as a current asset on its condensed consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective subsequent twelve-month period. Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or net realizable value. The Company uses significant judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently reviews such determinations. The Company writes down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use in the period that it is first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded in “Cost of product revenue” on the Company’s condensed consolidated statements of operations. At March 31, 2019 and December 31, 2018, the Company had $0.4 million and $0.3 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 three months ended March 31, 2019 and 2018, the Company had non-cash purchases of capital expenditures of $2.9 million and less than $0.1 million, respectively. |
Goodwill and Intangible Assets, net | Goodwill and Intangible Assets, net Intangible assets, net, which include a license for the right to commercialize the INTERCEPT Blood System in Asia, are subject to ratable amortization over the original estimated useful life of ten years. Accumulated amortization of intangible assets as of March 31, 2019 and December 31, 2018, was $1.7 million and $1.7 million, respectively. Goodwill is not amortized but instead is subject to an impairment test performed on an annual basis, or more frequently if events or changes in circumstances indicate that goodwill may be impaired. Such impairment analysis is performed on August 31 of each fiscal year, or more frequently if indicators of impairment exist. The test for goodwill impairment may be assessed using qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than the carrying amount. If the Company determines that it is more likely than not that the fair value of a reporting unit is less than the carrying amount, the Company must then proceed with performing the quantitative goodwill impairment test. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative impairment test; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The quantitative goodwill impairment test compares the fair value of each reporting unit with its respective carrying amount, including goodwill. The Company has determined that it operates in one reporting unit and estimates the fair value of its one reporting unit using the enterprise approach under which it considers the quoted market capitalization of the Company as reported on the Nasdaq Global Market. The Company considers quoted market prices that are available in active markets to be the best evidence of fair value. The Company also considers other factors, which include future forecasted results, the economic environment and overall market conditions. If the fair value of the reporting unit exceeds its carrying amount, goodwill of the reporting unit is considered not impaired. If the carrying amount of the reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess, limited to the carrying amount of goodwill in the Company’s one reporting unit. The Company performs an impairment test on its intangible assets if certain events or changes in circumstances occur which indicate that the carrying amounts of its intangible assets may not be recoverable. If the intangible assets are not recoverable, an impairment loss would be recognized by the Company based on the excess amount of the carrying value of the intangible assets over its fair value. During the three months ended March 31, 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 the Company’s condensed consolidated statements of operations. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved. For stock-based awards issued to non-employees, the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based awards in its condensed consolidated statements of operations. See Note 8 for further information regarding the Company’s stock-based compensation expense. |
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 unaudited condensed consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. Although the Company believes it more likely than not that a taxing authority would agree with its current tax positions, there can be no assurance that the tax positions the Company has taken will be substantiated by a taxing authority if reviewed. The Company’s U.S. federal tax returns for years 1998 through 2017, California tax returns for years through 2017, and Netherlands tax returns for years 2015 through 2017 remain subject to examination by the taxing jurisdictions 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 three months ended March 31, 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 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 three months ended March 31, 2019 and 2018 (shares in thousands): Three Months Ended March 31, 2019 2018 Weighted average number of anti-dilutive potential shares: Stock options 17,648 17,879 Restricted stock units 2,247 1,579 Employee stock purchase plan rights 7 92 Total 19,902 19,550 |
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 on the condensed consolidated balance sheets. As of March 31, 2019 and December 31, 2018, the Company did not have finance leases. ROU assets and operating lease liabilities are recognized at commencement date based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. The ROU asset also includes any lease payments made and excludes lease incentives. The lease terms may include options to extend or terminate the lease when it is reasonably certain to be exercised. Operating leases are recognized on a straight-line basis over the lease term. |
Guarantee and Indemnification Arrangements | Guarantee and Indemnification Arrangements The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a third party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions. The Company generally provides for a one-year warranty on certain of its INTERCEPT blood-safety products covering defects in materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. The Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims. Accordingly, the Company had not accrued for any future warranty costs for its products at March 31, 2019 and December 31, 2018. |
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 2 for further information regarding the Company’s valuation of financial instruments. |
New Accounting Pronouncements | New Accounting Pronouncements Recently adopted accounting pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases Leases (Topic 842): Targeted Improvements Recently issued accounting pronouncements not yet adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Product Revenue by Geographical Locations of Customers | Product revenue by geographical locations of customers during the three months ended March 31, 2019 and 2018, were as follows (in thousands): Three Months Ended March 31, 2019 2018 Product revenue: Europe, Middle East and Africa $ 12,653 $ 11,006 North America 4,551 2,387 Other 300 171 Total product revenue $ 17,504 $ 13,564 |
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 three months ended March 31, 2019 and 2018 (shares in thousands): Three Months Ended March 31, 2019 2018 Weighted average number of anti-dilutive potential shares: Stock options 17,648 17,879 Restricted stock units 2,247 1,579 Employee stock purchase plan rights 7 92 Total 19,902 19,550 |
Available-for-sale Securities_2
Available-for-sale Securities and Fair Value on Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Summary of Available-for-Sale Securities | The following is a summary of available-for-sale securities at March 31, 2019 (in thousands): March 31, 2019 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 4,145 $ — $ — $ 4,145 United States government agency securities 7,488 — (11 ) 7,477 Corporate debt securities 64,008 18 (77 ) 63,949 Total available-for-sale securities $ 75,641 $ 18 $ (88 ) $ 75,571 The following is a summary of available-for-sale securities at December 31, 2018 (in thousands): December 31, 2018 Amortized Cost Gross Unrealized Gain Gross Unrealized Loss Fair Value Money market funds $ 6,167 $ — $ — $ 6,167 United States government agency securities 15,971 — (23 ) 15,948 Corporate debt securities 73,028 2 (260 ) 72,770 Total available-for-sale securities $ 95,166 $ 2 $ (283 ) $ 94,885 |
Available-for-Sale Debt Securities by Original Contractual Maturity | Available-for-sale securities at March 31, 2019 and December 31, 2018, consisted of the following by contractual maturity (in thousands): March 31, 2019 December 31, 2018 Amortized Cost Fair Value Amortized Cost Fair Value One year or less $ 75,641 $ 75,571 $ 85,227 $ 84,957 Greater than one year and less than five years — — 9,939 9,928 Total available-for-sale securities $ 75,641 $ 75,571 $ 95,166 $ 94,885 |
Available-for-Sale Marketable Securities in Unrealized Position | The following tables show all available-for-sale marketable securities in an unrealized loss position for which an other-than-temporary impairment has not been recognized and the related gross unrealized losses and fair value, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position (in thousands): March 31, 2019 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss United States government agency securities $ — $ — $ 7,477 $ (11 ) $ 7,477 $ (11 ) Corporate debt securities — — 47,479 (77 ) 47,479 (77 ) Total available-for-sale securities $ — $ — $ 54,956 $ (88 ) $ 54,956 $ (88 ) December 31, 2018 Less than 12 Months 12 Months or Greater Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss United States government agency securities $ 14,948 $ (22 ) $ 999 $ (1 ) $ 15,947 $ (23 ) Corporate debt securities 60,813 (231 ) 9,976 (29 ) 70,789 (260 ) Total available-for-sale securities $ 75,761 $ (253 ) $ 10,975 $ (30 ) $ 86,736 $ (283 ) |
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 March 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 $ 4,145 $ 4,145 $ — $ — United States government agency securities Short-term investments 7,477 — 7,477 — Corporate debt securities Short-term investments 63,949 — 63,949 — Total financial assets $ 75,571 $ 4,145 $ 71,426 $ — The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2018 (in thousands): Balance sheet Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs classification Total (Level 1) (Level 2) (Level 3) Money market funds Cash and cash equivalents $ 6,167 $ 6,167 $ — $ — United States government agency securities Short-term investments 15,948 — 15,948 — Corporate debt securities Short-term investments 72,770 — 72,770 — Total financial assets $ 94,885 $ 6,167 $ 88,718 $ — |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories at March 31, 2019 and December 31, 2018, consisted of the following (in thousands): March 31, 2019 December 31, 2018 Work-in-process $ 4,342 $ 3,075 Finished goods 11,436 10,464 Total inventories $ 15,778 $ 13,539 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Liabilities | Accrued liabilities at March 31, 2019 and December 31, 2018, consisted of the following (in thousands): March 31, 2019 December 31, 2018 Accrued professional services $ 8,323 $ 4,544 Accrued compensation and related costs 6,490 10,765 Accrued development costs 1,908 1,965 Other accrued expenses 1,676 2,526 Total accrued liabilities $ 18,397 $ 19,800 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Debt | Debt at March 31, 2019, consisted of the following (in thousands): March 31, 2019 Principal Unamortized Discount Total Term Loan Credit Agreement $ 40,000 $ (567 ) $ 39,433 Less: debt – current — — — Debt – non-current $ 40,000 $ (567 ) $ 39,433 Debt at December 31, 2018, consisted of the following (in thousands): December 31, 2018 Principal Unamortized Discount Net Carrying Value Oxford Term Loan Agreement $ 30,000 $ (130 ) $ 29,870 Less: debt – current (7,857 ) — (7,857 ) Debt – non-current $ 22,143 $ (130 ) $ 22,013 |
Expected Principal, Interest and Fee Payments on Debt | Principal, interest and fee payments on debt at March 31, 2019, are expected to be as follows (in thousands): Year ended December 31, Principal Interest and Fees Total 2019 $ — $ 2,250 $ 2,250 2020 — 3,335 3,335 2021 — 3,326 3,326 2022 15,000 2,909 17,909 2023 20,000 1,315 21,315 2024 5,000 1,270 6,270 Total $ 40,000 $ 14,405 $ 54,405 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Supplemental Cash Flow Information Related to Operating Leases | Supplemental cash flow information related to operating leases is as follows Three Months Ended March 31, 2019 Cash payments for operating leases $ 734 Right-of-use assets obtained in exchange for operating lease obligations 13,560 March 31, 2019 Weighted-average remaining lease term 9.9 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 March 31, 2019, were as follows (in thousands): Operating Leases Remainder of 2019 $ 2,796 2020 3,047 2021 3,086 2022 2,714 2023 2,610 Thereafter 18,690 Total future lease payments $ 32,943 Less imputed interest 12,072 Present value of lease liabilities $ 20,871 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) - 2008 Equity Incentive Plan | 3 Months Ended |
Mar. 31, 2019 | |
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, 2018 17,560 $ 4.47 Granted 290 6.13 Exercised (71 ) 2.90 Forfeited/canceled (57 ) 5.56 Balances at March 31, 2019 17,722 4.50 |
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, 2018 (1) 2,001 $ 4.56 Granted (1) 1,201 6.79 Vested (800 ) 4.48 Forfeited (3 ) 4.32 Balances at March 31, 2019 2,399 5.70 (1) Includes shares issuable under performance-based restricted stock unit awards. |
Development and License Agree_2
Development and License Agreements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
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 March 31, 2019 and December 31, 2018 (in thousands). March 31, 2019 December 31, 2018 Prepaid R&D asset – current (1) $ 46 $ 47 Prepaid R&D asset – non-current (2) 2,152 2,156 Manufacturing efficiency asset (2) 1,533 1,594 (1) Included in “Other current assets” in the Company's condensed consolidated balance sheets. (2) Included in “Other assets” in the Company's condensed 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 March 31, 2019 and December 31, 2018 (in thousands). March 31, 2019 December 31, 2018 Payables to Fresenius (1) $ 7,507 $ 7,812 Receivables from Fresenius (2) 954 1,777 (1) Included in “Accounts Payable” and “Accrued Liabilities” in the Company's condensed consolidated balance sheets. (2) Included in “Other current assets” in the Company's condensed consolidated balance sheets. |
Segment, Customer and Geograp_2
Segment, Customer and Geographic Information (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Customer that Accounted for More Than Ten Percent of Total Product Revenue | The Company had the following significant customers that accounted for more than 10% of the Company’s total product revenue, during the three months ended March 31, 2019 and 2018: Three Months Ended March 31, 2019 2018 Établissement Français du Sang 29% 41% American Red Cross 13% * |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Summary of Product Revenue by Geographical Locations of Customers (Detail) - Product - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disaggregation Of Revenue [Line Items] | ||
Total product revenue | $ 17,504 | $ 13,564 |
North America | ||
Disaggregation Of Revenue [Line Items] | ||
Total product revenue | 4,551 | 2,387 |
Europe, Middle East and Africa | ||
Disaggregation Of Revenue [Line Items] | ||
Total product revenue | 12,653 | 11,006 |
Other | ||
Disaggregation Of Revenue [Line Items] | ||
Total product revenue | $ 300 | $ 171 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019USD ($)CustomerSegment | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($)Customer | Jan. 01, 2019USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Description of payment of customer invoice contract | The Company invoices its customers based upon the terms in the contracts, which is generally from 30 to 60 days. | |||
Contract asset | $ 0 | $ 0 | ||
Revenue recognized, that were included in deferred product revenue | $ 200,000 | |||
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 | 2 | ||
Protracted length of inventory | 1 year | |||
Inventory valuation reserves | $ 400,000 | $ 300,000 | ||
Accumulated amortization intangible assets | $ 1,700,000 | 1,700,000 | ||
Estimated useful life of intangible assets | 10 years | |||
Number of reportable segments | Segment | 1 | |||
Impairment charges acquired intangible asstes | $ 0 | $ 0 | ||
Period of warranty | 1 year | |||
Warranty claim liability | $ 0 | $ 0 | ||
Operating lease right-of-use assets | 15,631,000 | |||
Operating lease liabilities – current | 1,560,000 | |||
Operating lease liabilities – non-current | $ 19,311,000 | |||
ASU 2016-02 | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Operating lease right-of-use assets | $ 2,400,000 | |||
Operating lease liabilities – current | 2,400,000 | |||
Operating lease liabilities – non-current | $ 2,400,000 | |||
Trade Accounts Receivable | Customer Concentration Risk | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Concentration risk, percentage | 59.00% | 50.00% | ||
Minimum | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Payment of customer invoice contract period | 30 days | |||
Shelf lives of inventory | 18 months | |||
Estimated useful life of property and equipment | 3 years | |||
Maximum | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Payment of customer invoice contract period | 60 days | |||
Shelf lives of inventory | 24 months | |||
Estimated useful life of property and equipment | 5 years |
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 | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of anti-dilutive potential shares | 19,902 | 19,550 |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of anti-dilutive potential shares | 17,648 | 17,879 |
Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of anti-dilutive potential shares | 2,247 | 1,579 |
Employee Stock Purchase Plan Rights | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Weighted average number of anti-dilutive potential shares | 7 | 92 |
Summary of Available-for-Sale S
Summary of Available-for-Sale Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 75,641 | $ 95,166 |
Gross Unrealized Gain | 18 | 2 |
Gross Unrealized Loss | (88) | (283) |
Fair Value | 75,571 | 94,885 |
Money market funds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 4,145 | 6,167 |
Fair Value | 4,145 | 6,167 |
United States government agency securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 7,488 | 15,971 |
Gross Unrealized Loss | (11) | (23) |
Fair Value | 7,477 | 15,948 |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 64,008 | 73,028 |
Gross Unrealized Gain | 18 | 2 |
Gross Unrealized Loss | (77) | (260) |
Fair Value | $ 63,949 | $ 72,770 |
Available-for-Sale Debt Securit
Available-for-Sale Debt Securities by Original Contractual Maturity (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Investments Debt And Equity Securities [Abstract] | ||
One year or less, amortized cost | $ 75,641 | $ 85,227 |
Greater than one year and less than five years, amortized cost | 9,939 | |
Amortized Cost | 75,641 | 95,166 |
One year or less, fair value | 75,571 | 84,957 |
Greater than one year and less than five years, fair value | 9,928 | |
Total available-for-sale securities fair value | $ 75,571 | $ 94,885 |
Available-for-Sale Marketable S
Available-for-Sale Marketable Securities in Unrealized Position (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Schedule of Available-for-sale Securities [Line Items] | ||
Less than 12 Months, Fair Value | $ 75,761 | |
Less than 12 Months, Unrealized Loss | (253) | |
12 Months or Longer, Fair Value | $ 54,956 | 10,975 |
12 Months or Longer, Unrealized Loss | (88) | (30) |
Total, Fair Value | 54,956 | 86,736 |
Total, Unrealized Loss | (88) | (283) |
United States government agency securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less than 12 Months, Fair Value | 14,948 | |
Less than 12 Months, Unrealized Loss | (22) | |
12 Months or Longer, Fair Value | 7,477 | 999 |
12 Months or Longer, Unrealized Loss | (11) | (1) |
Total, Fair Value | 7,477 | 15,947 |
Total, Unrealized Loss | (11) | (23) |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less than 12 Months, Fair Value | 60,813 | |
Less than 12 Months, Unrealized Loss | (231) | |
12 Months or Longer, Fair Value | 47,479 | 9,976 |
12 Months or Longer, Unrealized Loss | (77) | (29) |
Total, Fair Value | 47,479 | 70,789 |
Total, Unrealized Loss | $ (77) | $ (260) |
Available-for-sale Securities_3
Available-for-sale Securities and Fair Value on Financial Instruments - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Investments Debt And Equity Securities [Abstract] | ||
Other-than-temporary impairment losses | $ 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 | $ 0 | $ 0 |
Fair Values on Financial Assets
Fair Values on Financial Assets and Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Fair value of financial assets and liabilities | ||
Total financial assets | $ 75,571 | $ 94,885 |
Money market funds | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 4,145 | 6,167 |
United States government agency securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 7,477 | 15,948 |
United States government agency securities | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 7,477 | 15,948 |
Corporate debt securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 63,949 | 72,770 |
Level 1 | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 4,145 | 6,167 |
Level 1 | Money market funds | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 4,145 | 6,167 |
Level 2 | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 71,426 | 88,718 |
Level 2 | United States government agency securities | Short-term Investments | ||
Fair value of financial assets and liabilities | ||
Total financial assets | 7,477 | 15,948 |
Level 2 | Corporate debt securities | ||
Fair value of financial assets and liabilities | ||
Total financial assets | $ 63,949 | $ 72,770 |
Inventories (Detail)
Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Work-in-process | $ 4,342 | $ 3,075 |
Finished goods | 11,436 | 10,464 |
Total inventories | $ 15,778 | $ 13,539 |
Accrued Liabilities (Detail)
Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Accrued professional services | $ 8,323 | $ 4,544 |
Accrued compensation and related costs | 6,490 | 10,765 |
Accrued development costs | 1,908 | 1,965 |
Other accrued expenses | 1,676 | 2,526 |
Total accrued liabilities | $ 18,397 | $ 19,800 |
Debt (Detail)
Debt (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Total debt, Principal | $ 40,000 | |
Less: debt-current | $ (7,857) | |
Debt-non-current | 39,433 | 22,013 |
Term Loan Credit Agreement | ||
Debt Instrument [Line Items] | ||
Total debt, Principal | 40,000 | |
Total debt, Unamortized Discount | (567) | |
Total debt | 39,433 | |
Debt - non-current, Principal | 40,000 | |
Debt - non-current, Unamortized Discount | (567) | |
Debt-non-current | $ 39,433 | |
Oxford Term Loan Agreement | ||
Debt Instrument [Line Items] | ||
Total debt, Principal | 30,000 | |
Total debt, Unamortized Discount | (130) | |
Total debt | 29,870 | |
Less: debt - current, Principal | (7,857) | |
Less: debt-current | (7,857) | |
Debt - non-current, Principal | 22,143 | |
Debt - non-current, Unamortized Discount | (130) | |
Debt-non-current | $ 22,013 |
Debt - Expected Principal, Inte
Debt - Expected Principal, Interest and Fee Payments on Debt (Detail) $ in Thousands | Mar. 31, 2019USD ($) |
Debt Disclosure [Abstract] | |
2022, Principal | $ 15,000 |
2023, Principal | 20,000 |
2024, Principal | 5,000 |
Total, Principal | 40,000 |
2019, Interest and Fees | 2,250 |
2020, Interest and Fees | 3,335 |
2021, Interest and Fees | 3,326 |
2022, Interest and Fees | 2,909 |
2023, Interest and Fees | 1,315 |
2024, Interest and Fees | 1,270 |
Total, Interest and Fees | 14,405 |
2019, Total | 2,250 |
2020, Total | 3,335 |
2021, Total | 3,326 |
2022, Total | 17,909 |
2023, Total | 21,315 |
2024, Total | 6,270 |
Total | $ 54,405 |
Debt - Additional Information (
Debt - Additional Information (Detail) | Mar. 29, 2019USD ($)Tranche | Jul. 31, 2017USD ($)Tranche | Mar. 31, 2019USD ($) |
Oxford Term Loan Agreement | 2017 Term Loans | |||
Debt Instrument [Line Items] | |||
Term loan, face amount | $ 40,000,000 | ||
Number of loan tranches | Tranche | 2 | ||
Repayments principal and interest aggregate amount | $ 31,200,000 | ||
Prepayment fees in aggregate amount | 600,000 | ||
Oxford Term Loan Agreement | 2017 Term Loans | Interest Expense | |||
Debt Instrument [Line Items] | |||
Extinguishment loss recorded | 2,100,000 | ||
Cerus Term Loans | 2017 Term Loans | |||
Debt Instrument [Line Items] | |||
Repay in full all of outstanding term loans | $ 1,400,000 | ||
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 | 8.20% | ||
Interest-only payments date | Apr. 1, 2022 | ||
Principal plus declining interest payments | 24 months | ||
Interest only payment period | 12 months | ||
Trailing net revenue target period | 12 months | ||
Revolving Loan Credit Agreement | |||
Debt Instrument [Line Items] | |||
Term loan, face amount | $ 5,000,000 | $ 0 | |
Loan and security agreement available upon revenue achievement | $ 15,000,000 | ||
Debt instrument floating interest rate percentage | 1.80% | ||
Revolving Loan Credit Agreement | Two Thousand Nineteen Term Loan | |||
Debt Instrument [Line Items] | |||
Debt instrument maturity date | Mar. 1, 2024 | ||
First Tranche (Term Loan A) | Oxford Term Loan Agreement | 2017 Term Loans | |||
Debt Instrument [Line Items] | |||
Term loan, face amount | 30,000,000 | ||
First Tranche (Term Loan A) | Cerus Term Loans | 2017 Term Loans | |||
Debt Instrument [Line Items] | |||
Repay in full all of outstanding term loans | 17,600,000 | ||
Second Tranche (Term Loan B) | Oxford Term Loan Agreement | 2017 Term Loans | |||
Debt Instrument [Line Items] | |||
Loan and security agreement available upon revenue achievement | $ 10,000,000 | ||
Expiration date to draw second tranche | May 14, 2018 | ||
Tranche 1 | Term Loan Credit Agreement | |||
Debt Instrument [Line Items] | |||
Term loan, face amount | $ 40,000,000 | ||
Tranche 2 | Term Loan Credit Agreement | Two Thousand Nineteen Term Loan | |||
Debt Instrument [Line Items] | |||
Loan and security agreement available upon revenue achievement | 15,000,000 | ||
Tranche 3 | Term Loan Credit Agreement | Two Thousand Nineteen Term Loan | |||
Debt Instrument [Line Items] | |||
Loan and security agreement available upon revenue achievement | $ 15,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
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 cost | $ 0.5 | $ 0.3 |
Operating lease not yet commenced | the Company had no leases that have not yet commenced. |
Commitments and Contingencies_2
Commitments and Contingencies - Supplemental Cash Flow Information Related to Operating Leases (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Commitments And Contingencies Disclosure [Abstract] | |
Cash payments for operating leases | $ 734 |
Right-of-use assets obtained in exchange for operating lease obligations | $ 13,560 |
Weighted-average remaining lease term | 9 years 10 months 24 days |
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 | Mar. 31, 2019USD ($) |
Commitments And Contingencies Disclosure [Abstract] | |
Remainder of 2019 | $ 2,796 |
2020 | 3,047 |
2021 | 3,086 |
2022 | 2,714 |
2023 | 2,610 |
Thereafter | 18,690 |
Total future lease payments | 32,943 |
Less imputed interest | 12,072 |
Present value of lease liabilities | $ 20,871 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - Cantor Fitzgerald & Co - Amendment No. 3 - Sales Agreement - USD ($) | Jan. 08, 2018 | Mar. 31, 2019 |
Stockholders Equity Note [Line Items] | ||
Maximum common stock offering price | $ 70,000,000 | |
Percentage of proceeds payable as compensation to underwriter | 2.00% | |
Unsold shares of common stock, value | $ 31,400,000 | |
Common stock, number of shares issued | 0 | |
Common stock registered for sale | $ 41,600,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) $ in Millions | 3 Months Ended | ||
Mar. 31, 2019USD ($)Periodshares | Dec. 31, 2018shares | ||
Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation, option to be granted at percentage of fair value of common stock | 85.00% | ||
Employee Stock Purchase Plan, offering period | 12 months | ||
Number of purchase periods within each offering period | Period | 2 | ||
Aggregate number of shares of common stock reserved for future issuance | 700,000 | ||
2008 Equity Incentive Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation, option to be granted at percentage of fair value of common stock | 100.00% | ||
Aggregate number of shares of common stock reserved for future issuance | 21,300,000 | ||
Stock-based compensation, award term | 10 years | ||
Performance-based stock awards, outstanding | 45,000 | ||
Outstanding options and other stock based awards | 17,722,000 | 17,560,000 | |
Number of shares available for future issuance | 1,200,000 | ||
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 | 2,399,000 | 2,001,000 | [1] |
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 | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Activity under the Company's equity incentive plans related to stock options | |
Number of Options Outstanding, Beginning Balance | shares | 17,560 |
Granted, Number of Options Outstanding | shares | 290 |
Exercised, Number of Options Outstanding | shares | (71) |
Forfeited/canceled, Number of Options Outstanding | shares | (57) |
Number of Options Outstanding, Ending Balance | shares | 17,722 |
Weighted Average Exercise Price per Share | |
Weighted Average Exercise Price per Share, Beginning Balance | $ / shares | $ 4.47 |
Granted, Weighted Average Exercise Price per Share | $ / shares | 6.13 |
Exercised, Weighted Average Exercise Price per Share | $ / shares | 2.90 |
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | 4.50 |
Forfeited/canceled, Weighted Average Exercise Price per Share | $ / shares | $ 5.56 |
Activity Under Equity Incenti_2
Activity Under Equity Incentive Plans Related to RSUs (Detail) - 2008 Equity Incentive Plan - Restricted Stock Units shares in Thousands | 3 Months Ended | |
Mar. 31, 2019$ / sharesshares | ||
Activity under the Company's equity incentive plans related to restricted stock units | ||
Number of Restricted Stock Units Unvested, Beginning Balance | shares | 2,001 | [1] |
Granted, Number of Restricted Stock Units Unvested | shares | 1,201 | [1] |
Vested, Number of Restricted Stock Units Unvested | shares | (800) | |
Forfeited, Number of Restricted Stock Units Unvested | shares | (3) | |
Number of Restricted Stock Units Unvested, Ending Balance | shares | 2,399 | |
Weighted Average Exercise Price per Share | ||
Weighted Average Exercise Price per Share, Beginning Balance | $ / shares | $ 4.56 | [1] |
Granted, Weighted Average Exercise Price per Share | $ / shares | 6.79 | [1] |
Vested, Weighted Average Exercise Price per Share | $ / shares | 4.48 | |
Forfeited, Weighted Average Exercise Price per Share | $ / shares | 4.32 | |
Weighted Average Exercise Price per Share, Ending Balance | $ / shares | $ 5.70 | |
[1] | Includes shares issuable under performance-based restricted stock unit awards. |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Income Tax Disclosure [Line Items] | ||
Income tax expense (benefit) | $ 60 | $ 54 |
Cerus Europe B.V. | Maximum | ||
Income Tax Disclosure [Line Items] | ||
Income tax expense (benefit) | $ 100 | $ 100 |
Development and License Agree_3
Development and License Agreements - Additional Information (Detail) € in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Aug. 31, 2018EUR (€) | Mar. 31, 2019USD ($) | Mar. 31, 2019EUR (€) | Mar. 31, 2018USD ($) | Dec. 31, 2016EUR (€) | Mar. 31, 2019EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2018EUR (€) | |
Licenses Agreements [Line Items] | ||||||||
Payments made relating to the manufacturing of the products | $ 7,800,000 | $ 5,400,000 | ||||||
BARDA Agreement | ||||||||
Licenses Agreements [Line Items] | ||||||||
Committed fund receivable | 103,200,000 | |||||||
Committed fund receivable | $ 201,200,000 | |||||||
Period of agreement | 5 years | 5 years | ||||||
Accounts receivable of billed and unbilled amounts | $ 4,200,000 | $ 2,300,000 | ||||||
Cerus Corporation | BARDA Agreement | ||||||||
Licenses Agreements [Line Items] | ||||||||
Co-investment by the company | 5,000,000 | |||||||
Additional co-investment by the company | 9,600,000 | |||||||
Manufacturing and Supply Agreement | Fresenius | ||||||||
Licenses Agreements [Line Items] | ||||||||
Payments made based on the successful achievement of production volumes | € | € 8.6 | |||||||
Manufacturing and development payments | € | € 3.1 | |||||||
Remaining amount payable for manufacturing and development | € | € 5.5 | |||||||
Accrual for manufacturing and development of entity products | $ 6,000,000 | € 5.3 | $ 5,900,000 | € 5.2 | ||||
Manufacturing and Supply Agreement | Fresenius | Measurement Input, Discount Rate | ||||||||
Licenses Agreements [Line Items] | ||||||||
Manufacturing and development obligations, discount rate | 0.0972 |
Development and License Agree_4
Development and License Agreements - Summary of Prepaid R&D Asset and Manufacturing Efficiency Asset (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | |
Other current assets | |||
Deferred Costs Capitalized Prepaid And Other Assets [Line Items] | |||
Prepaid R&D asset - current | [1] | $ 46 | $ 47 |
Other assets | |||
Deferred Costs Capitalized Prepaid And Other Assets [Line Items] | |||
Prepaid R&D asset - current | [2] | 2,152 | 2,156 |
Manufacturing efficiency asset | [2] | $ 1,533 | $ 1,594 |
[1] | Included in “Other current assets” in the Company's condensed consolidated balance sheets. | ||
[2] | Included in “Other assets” in the Company's condensed 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 | Mar. 31, 2019 | Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |||
Payables to Fresenius | [1] | $ 7,507 | $ 7,812 |
Receivables from Fresenius | [2] | $ 954 | $ 1,777 |
[1] | Included in “Accounts Payable” and “Accrued Liabilities” in the Company's condensed consolidated balance sheets. | ||
[2] | Included in “Other current assets” in the Company's condensed consolidated balance sheets |
Segment, Customer and Geograp_3
Segment, Customer and Geographic Information - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2019Segment | |
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 | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Etablissement Francais du Sang | ||
Revenue, Major Customer [Line Items] | ||
Concentration risk, percentage | 29.00% | 41.00% |
American Red Cross | ||
Revenue, Major Customer [Line Items] | ||
Concentration risk, percentage | 13.00% |