Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
In Millions, except Share data, unless otherwise specified | Dec. 31, 2014 | Feb. 27, 2015 | Jun. 30, 2014 |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | FALSE | ||
Document Period End Date | 31-Dec-14 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CERS | ||
Entity Registrant Name | CERUS CORP | ||
Entity Central Index Key | 1020214 | ||
Current Fiscal Year End Date | -19 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 95,177,692 | ||
Entity Public Float | $268 |
CONSOLIDATED_BALANCE_SHEETS
CONSOLIDATED BALANCE SHEETS (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $22,781 | $29,485 |
Short-term investments | 28,513 | 28,191 |
Accounts receivable, net of allowance of $0 at December 31, 2014 and 2013 | 5,493 | 6,125 |
Inventories | 14,956 | 13,063 |
Prepaid expenses | 1,210 | 848 |
Other current assets | 1,932 | 442 |
Total current assets | 74,885 | 78,154 |
Non-current assets: | ||
Property and equipment, net | 3,781 | 2,189 |
Goodwill | 1,316 | 1,316 |
Intangible assets, net | 1,142 | 1,344 |
Restricted cash | 508 | 308 |
Other assets | 144 | 70 |
Total assets | 81,776 | 83,381 |
Current liabilities: | ||
Accounts payable | 9,882 | 5,674 |
Accrued liabilities | 8,444 | 9,813 |
Deferred revenue-current | 376 | 181 |
Debt-current | 0 | 3,366 |
Warrant liability | 10,485 | 20,390 |
Total current liabilities | 29,187 | 39,424 |
Non-current liabilities: | ||
Debt-non-current | 9,872 | 0 |
Deferred income taxes | 115 | 89 |
Other non-current liabilities | 1,081 | 1,073 |
Total liabilities | 40,255 | 40,586 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value 225,000 and 112,500 shares authorized; 80,404 and 71,859 shares issued and outstanding at December 31, 2014 and 2013, respectively | 80 | 72 |
Additional paid-in capital | 583,416 | 545,905 |
Accumulated other comprehensive (loss) income | -31 | 7 |
Accumulated deficit | -541,944 | -503,189 |
Total stockholders' equity | 41,521 | 42,795 |
Total liabilities and stockholders' equity | $81,776 | $83,381 |
CONSOLIDATED_BALANCE_SHEETS_Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, except Share data, unless otherwise specified | ||
Accounts receivable, allowance | $0 | $0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 225,000,000 | 112,500,000 |
Common stock, shares issued | 80,404,000 | 71,859,000 |
Common stock, shares outstanding | 80,404,000 | 71,859,000 |
CONSOLIDATED_STATEMENTS_OF_OPE
CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 12 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Product related: | |||
Product revenue | $36,416 | $39,657 | $36,695 |
Cost of product revenue | 21,188 | 22,602 | 20,616 |
Gross profit on product revenue | 15,228 | 17,055 | 16,079 |
Government grants and cooperative agreements revenue | 0 | 0 | 91 |
Operating expenses: | |||
Research and development | 21,800 | 15,187 | 7,603 |
Selling, general and administrative | 37,729 | 29,965 | 25,665 |
Amortization of intangible assets | 202 | 202 | 202 |
Total operating expenses | 59,731 | 45,354 | 33,470 |
Loss from operations | -44,503 | -28,299 | -17,300 |
Non-operating income (expense), net: | |||
Gain (loss) from revaluation of warrant liability | 7,708 | -15,099 | 2,059 |
Foreign exchange (loss) gain | -1,296 | 533 | 86 |
Interest expense | -599 | -332 | -551 |
Other income, net | 130 | 78 | 31 |
Total non-operating income (expense), net | 5,943 | -14,820 | 1,625 |
Loss before income taxes | -38,560 | -43,119 | -15,675 |
Provision for income taxes | 195 | 218 | 242 |
Net loss | ($38,755) | ($43,337) | ($15,917) |
Net loss per share: | |||
Basic | ($0.52) | ($0.64) | ($0.29) |
Diluted | ($0.61) | ($0.64) | ($0.33) |
Weighted average shares outstanding used for calculating net loss per share: | |||
Basic | 74,767 | 67,569 | 54,515 |
Diluted | 76,534 | 67,569 | 55,061 |
CONSOLIDATED_STATEMENTS_OF_COM
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Net loss | ($38,755) | ($43,337) | ($15,917) |
Other comprehensive income (loss): | |||
Net unrealized gains (losses) on available-for-sale securities, net of taxes | -38 | 7 | 0 |
Comprehensive loss | ($38,793) | ($43,330) | ($15,917) |
CONSOLIDATED_STATEMENTS_OF_STO
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (USD $) | Total | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit |
In Thousands, except Share data | ||||||
Beginning Balance at Dec. 31, 2011 | $18,313 | $9,496 | $51 | $452,701 | $0 | ($443,935) |
Beginning Balance (in shares) at Dec. 31, 2011 | 3,000 | 51,211,000 | ||||
Net loss | -15,917 | 0 | 0 | 0 | 0 | -15,917 |
Issuance of common stock from public offering, net of expenses of $470 for 2014, $2733 for 2013 , and $550 for 2012 | 13,821 | 0 | 5 | 13,816 | 0 | 0 |
Issuance of common stock from public offering, net of expenses of $470 for 2014, $2733 for 2013 , and $550 for 2012 (in shares) | 4,487,000 | |||||
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP(In Shares) | 221,000 | |||||
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP | 349 | 0 | 0 | 349 | 0 | 0 |
Preferred stock conversion (in shares) | -3,000 | 333,000 | ||||
Preferred stock conversion | 0 | -9,496 | 0 | 9,496 | 0 | 0 |
Stock-based compensation | 2,541 | 0 | 0 | 2,541 | 0 | 0 |
Ending Balance at Dec. 31, 2012 | 19,107 | 0 | 56 | 478,903 | 0 | -459,852 |
Ending Balance (in shares) at Dec. 31, 2012 | 0 | 56,252,000 | ||||
Net loss | -43,337 | 0 | 0 | 0 | 0 | -43,337 |
Other comprehensive income | 7 | 0 | 0 | 0 | 7 | 0 |
Issuance of common stock from public offering, net of expenses of $470 for 2014, $2733 for 2013 , and $550 for 2012 | 61,454 | 0 | 15 | 61,439 | 0 | 0 |
Issuance of common stock from public offering, net of expenses of $470 for 2014, $2733 for 2013 , and $550 for 2012 (in shares) | 15,019,000 | |||||
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP(In Shares) | 588,000 | |||||
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP | 2,296 | 0 | 1 | 2,295 | 0 | 0 |
Stock-based compensation | 3,268 | 0 | 0 | 3,268 | 0 | 0 |
Ending Balance at Dec. 31, 2013 | 42,795 | 0 | 72 | 545,905 | 7 | -503,189 |
Ending Balance (in shares) at Dec. 31, 2013 | 0 | 71,859,000 | ||||
Net loss | -38,755 | 0 | 0 | 0 | 0 | -38,755 |
Other comprehensive income | -38 | 0 | 0 | 0 | -38 | 0 |
Issuance of common stock from public offering, net of expenses of $470 for 2014, $2733 for 2013 , and $550 for 2012 | 18,521 | 0 | 4 | 18,517 | 0 | 0 |
Issuance of common stock from public offering, net of expenses of $470 for 2014, $2733 for 2013 , and $550 for 2012 (in shares) | 4,341,000 | |||||
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP(In Shares) | 4,204,000 | |||||
Issuance of common stock from exercise of stock options and/or warrants, and purchases from ESPP | 13,845 | 0 | 4 | 13,841 | 0 | 0 |
Stock-based compensation | 5,153 | 0 | 0 | 5,153 | 0 | 0 |
Ending Balance at Dec. 31, 2014 | $41,521 | $0 | $80 | $583,416 | ($31) | ($541,944) |
Ending Balance (in shares) at Dec. 31, 2014 | 0 | 80,404,000 |
CONSOLIDATED_STATEMENTS_OF_STO1
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Issuance of common stock from public offering, expenses | $470 | $2,733 | $550 |
CONSOLIDATED_STATEMENTS_OF_CAS
CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Operating activities | |||
Net loss | ($38,755) | ($43,337) | ($15,917) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 1,415 | 745 | 744 |
Stock-based compensation | 5,153 | 3,268 | 2,541 |
Changes in valuation of warrant liability | -7,708 | 15,099 | -2,059 |
Non-cash interest expense | 131 | -25 | 20 |
Deferred income taxes | 26 | 27 | 62 |
Loss on disposal of fixed assets | 3 | 56 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable | 632 | -1,681 | 1,652 |
Inventories | 3,033 | -1,813 | -3,740 |
Other assets | -1,655 | 286 | -1,663 |
Accounts payable | -973 | -1,512 | 2,506 |
Accrued liabilities | -1,382 | 2,121 | 1,971 |
Deferred revenue | 269 | 104 | -34 |
Net cash used in operating activities | -39,811 | -26,662 | -13,917 |
Investing activities | |||
Capital expenditures | -2,106 | -663 | -81 |
Purchases of investments | -25,981 | -30,146 | 0 |
Proceeds from maturities of investments | 24,915 | 1,631 | 287 |
Restricted cash | -175 | -14 | -1 |
Net cash (used in) provided by investing activities | -3,347 | -29,192 | 205 |
Financing activities | |||
Net proceeds from exercise/purchase of equity incentives and warrants | 11,592 | 1,684 | 332 |
Net proceeds from public offering | 18,488 | 61,425 | 14,226 |
Proceeds from debt, net of discount | 9,848 | 3,102 | 1,810 |
Repayment of debt | -3,474 | -7,568 | -1,457 |
Net cash provided by financing activities | 36,454 | 58,643 | 14,911 |
Net (decrease) increase in cash and cash equivalents | -6,704 | 2,789 | 1,199 |
Cash and cash equivalents, beginning of year | 29,485 | 26,696 | 25,497 |
Cash and cash equivalents, end of year | 22,781 | 29,485 | 26,696 |
Supplemental disclosures: | |||
Non-cash conversion of preferred stock to common stock | 9,496 | ||
Cash paid for interest | 563 | 294 | 460 |
Cash paid for income taxes | 177 | 146 | 162 |
Non-cash settlement of warranty claim | $1,272 |
Nature_of_Operations_and_Basis
Nature of Operations and Basis of Presentation | 12 Months Ended |
Dec. 31, 2014 | |
Nature of Operations and Basis of Presentation | Note 1. Nature of Operations and Basis of Presentation |
Cerus Corporation (the “Company”) was incorporated in September 1991 and is developing and commercializing the INTERCEPT Blood System, which is designed to enhance the safety of blood components through pathogen reduction. The Company has worldwide commercialization rights for the INTERCEPT Blood System for platelets, plasma and red blood cells. | |
The Company sells its INTERCEPT platelet and plasma systems in the United States, Europe, the Commonwealth of Independent States (“CIS”) countries, the Middle East and selected countries in other regions around the world. In December 2014, the U.S. Food and Drug Administration (“FDA”) approved INTERCEPT platelet and plasma systems in the U.S. The Company conducts significant research, development, testing and regulatory compliance activities on its product candidates that, together with anticipated selling, general, and administrative expenses, are expected to result in substantial additional losses, and the Company may need to adjust its operating plans and programs based on the availability of cash resources. The Company’s ability to achieve a profitable level of operations will depend on successfully completing development, obtaining additional regulatory approvals and achieving widespread market acceptance of its products. There can be no assurance that the Company will ever achieve a profitable level of operations. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies | ||||||||||||
Principles of Consolidation | |||||||||||||
The accompanying consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (together with Cerus Corporation, hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). | |||||||||||||
Use of Estimates | |||||||||||||
The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, which are based on historical experience 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. | |||||||||||||
Reclassifications | |||||||||||||
In 2014, certain reclassifications have been made to prior period reported amounts to conform to the current period presentations. Previously the Company had presented the amortization of premium and accretion of any discount resulting from the purchase of debt securities as a component of “Interest expense” on the consolidated statements of operations. The Company has reclassified approximately $0.2 million of the amortization of premium resulting from the purchase of debt securities as a component of “Other income, net” on the consolidated statements of operations. This reclassification had no impact on net loss, total assets or total stockholders’ equity. | |||||||||||||
Revenue | |||||||||||||
The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue Recognition—Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of the arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) pricing is fixed or determinable; and (iv) collectibility is reasonably assured. The Company’s main sources of revenues for the years ended December 31, 2014, 2013 and 2012, were product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems”). | |||||||||||||
Revenue related to product sales is generally recognized when the Company fulfills its obligations for each element of an agreement. For all sales of the Company’s INTERCEPT Blood System products, the Company uses a binding purchase order and signed sales contract as evidence of an arrangement. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. 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. Deliverables and the units of accounting vary according to the provisions of each purchase order or sales contract. For revenue arrangements with multiple elements, the Company determines whether the delivered elements meet the criteria as separate units of accounting. Such criteria require that the deliverable have stand-alone value to the customer and that if a general right of return exists relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially in the control of the Company. Once the Company determines if the deliverable meets the criteria for a separate unit of accounting, the Company must determine how the consideration should be allocated between the deliverables and how the separate units of accounting should be recognized as revenue. Consideration received is allocated to elements that are identified as discrete units of accounting. Because the Company has no vendor specific objective evidence or third party evidence for its systems due to the Company’s variability in its pricing across the regions into which it sells its products, the allocation of revenue is based on best estimated selling price for the systems sold. The objective of best estimated selling price is to determine the price at which the Company would transact a sale, had the product been sold on a stand-alone basis. The Company determines best estimated selling price for its systems by considering multiple factors, including, but not limited to, features and functionality of the system, geographies, type of customer, and market conditions. The Company regularly reviews best estimated selling price. | |||||||||||||
At December 31, 2014 and 2013, the Company had $0.4 million and $0.2 million, respectively, of short-term deferred revenue on its consolidated balance sheets related to future performance obligations. At December 31, 2014 and 2013, the Company had $0.1 million and $0, respectively, of long-term deferred revenue included in “Other non-current liabilities” on it consolidated balance sheets related to future performance obligations. Freight costs charged to customers are recorded as a component of revenue under ASC Topic 605, “Accounting for Shipping and Handling Fees and Costs.” Value-added-taxes (“VAT”) that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such VAT from product revenue. | |||||||||||||
Revenue related to the cost reimbursement provisions under development contracts or United States government grants was recognized as the costs on the projects were incurred. The Company received certain United States government grants and contracts that support research in defined research projects. These grants generally provided for reimbursement of approved costs incurred as defined in the various grants. There were no such government grants in 2014 or 2013 and none are expected in the foreseeable future. | |||||||||||||
Research and Development Expenses | |||||||||||||
In accordance with ASC Topic 730, “Accounting for Research and Development Expenses,” research and development expenses are charged to expense when incurred, including cost incurred under each grant that has been awarded to the Company by the United States government or development contracts. Research and development expenses include salaries and related expenses for scientific personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of research and development 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 research and development activities (see “Use of Estimates” above) affects the amounts of research and development expenses recorded and revenue recorded from development funding and government grants and collaborative agreements. 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 designated as available-for-sale and classified as short-term investments, in accordance with ASC Topic 320, “Accounting for Certain Investments in Debt and Equity Securities”. Available-for-sale securities are carried at estimated fair value. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Net unrealized losses on available-for-sale securities, net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments were recorded in “Other income, net” on the Company’s consolidated statements of operations. The cost of securities sold was based on the specific identification method. 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 marketable securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value. Other-than-temporary declines in market value, if any, are recorded in “Other income, net” on the Company’s consolidated statements of operations. | |||||||||||||
Restricted Cash | |||||||||||||
The Company holds a certificate of deposit with a domestic bank for any potential decommissioning resulting from the Company’s possession of radioactive material. The certificate of deposit is held to satisfy the financial surety requirements of the California Department of Health Services and is recorded in “Restricted cash” on the Company’s condensed consolidated balance sheets. The Company also has certain non-U.S. dollar denominated deposits recorded as “Restricted cash” in compliance with certain foreign contractual requirements. | |||||||||||||
Concentration of Credit Risk | |||||||||||||
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, short-term investments and accounts receivable. | |||||||||||||
Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and short-term investments are maintained at a major financial institution 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. The Company has not experienced any losses in its investments and believes it is not exposed to any significant risk. | |||||||||||||
Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company establishes an allowance for doubtful accounts against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general and administrative expenses. | |||||||||||||
The Company had one customer and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2014 and 2013, respectively. These customers cumulatively represented approximately 36% and 48% of the Company’s outstanding trade receivables at December 31, 2014 and 2013, respectively. To date, the Company has not experienced collection difficulties from these customers. | |||||||||||||
Inventories | |||||||||||||
At December 31, 2014 and 2013, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, UVA illumination devices (“illuminators”), and certain replacement parts for the illuminators. Platelet and plasma systems’ disposable kits generally have a two-year life 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 its affiliates, “Fresenius”) into the finished INTERCEPT disposable kits. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production of finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At December 31, 2014 and 2013, the Company classified its work-in-process inventory as a current asset on its consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective subsequent twelve-month period. | |||||||||||||
Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or market value. The Company uses significant judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently reviews such determinations. The Company writes-down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use in the period that it is first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded in “Cost of product revenue” on the Company’s consolidated statements of operations. At December 31, 2014, and 2013, the Company had $0.1 million and $0.4 million, respectively, recorded for obsolete, expiring or unsalable product. | |||||||||||||
Property and Equipment, net | |||||||||||||
Property and equipment is comprised of furniture, equipment, 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. | |||||||||||||
Capitalization of Software Costs | |||||||||||||
The Company capitalizes certain significant costs incurred in the acquisition and development of software for internal use, including the costs of the software, materials, and consultants during the application development stage. Costs incurred prior to the application development stage, costs incurred once the application is substantially complete and ready for its intended use, and other costs not qualifying for capitalization, including training and maintenance costs, are charged to expense as incurred. At December 31, 2014, and 2013, the Company capitalized costs related to its enterprise resource planning software system of $1.8 million and zero, respectively. The capitalized costs associated with the enterprise resource planning system are being amortized over the estimated useful life of five years. | |||||||||||||
Costs incurred in connection with the development of software products for sale are accounted for in accordance with the ASC 985—Costs of Software to Be Sold, Leased or Marketed. Costs incurred prior to the establishment of technological feasibility are charged to research and development expense. Software development costs are capitalized after a product is determined to be technologically feasible and is in the process of being developed for market. | |||||||||||||
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 estimated useful life of ten years. The amortization of the Company’s intangible assets, net, is recorded in “Amortization of intangible assets” on the Company’s consolidated statements of operations. 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 two-step process to test goodwill for impairment; otherwise, goodwill is not considered impaired and no further testing is warranted. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative two-step process; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The first step of the two-step process 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 not considered impaired and, therefore, the second step of the impairment test is unnecessary. The second step of the two-step process, which is used to measure the amount of impairment loss, compares the implied fair value of each reporting unit’s goodwill, based on the present value of future cash flows, with the respective carrying amount of that goodwill. 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. | |||||||||||||
The Company performs an impairment test on its intangible assets, in accordance ASC Topic 360-10, “Property, Plant and Equipment,” 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. For further details regarding the impairment analysis, reference is made to the section below under “Long-lived Assets.” See Note 7 for further information regarding the Company’s impairment analysis and the valuation of goodwill and intangible assets, net. | |||||||||||||
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. The Company did not recognize impairment charges related to its long-lived assets during the years ended December 31, 2014, 2013 or 2012. | |||||||||||||
Foreign Currency Remeasurement | |||||||||||||
The functional currency of the Company’s foreign subsidiary is the United States dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in United States dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in United States dollars using historical exchange rates. Revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated statements of operations. | |||||||||||||
Stock-Based Compensation | |||||||||||||
The Company accounts for stock-based compensation in accordance with ASC Topic 718,“Compensation—Stock Compensation.” Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved. | |||||||||||||
For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50, “Equity Based Payment to Non-Employees” and considers the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based awards in its consolidated statements of operations. | |||||||||||||
See Note 13 for further information regarding the Company’s stock-based compensation assumptions and expenses. | |||||||||||||
Warrant Liability | |||||||||||||
In August 2009, and November 2010, the Company issued warrants to purchase an aggregate of 2.4 million and 3.7 million shares of common stock, respectively. The material terms of the warrants were identical under each issuance except for the exercise price, date issued and expiration date. In August 2014, all of the outstanding August 2009 warrants were exercised in full. The Company classifies warrants outstanding on the reporting date as a liability on its consolidated balance sheets as the warrants contain certain material terms which require the Company to purchase the warrants for cash in an amount equal to the value of the unexercised portion of the warrants in connection with certain change of control transactions. In addition, the Company may also be required to pay cash to a warrant holder under certain circumstances if the Company is unable to timely deliver the shares acquired upon warrant exercise to such holder. | |||||||||||||
The fair value of outstanding warrants is calculated using the Black-Scholes model and was adjusted accordingly at December 31, 2014. Prior to December 31, 2014, the Company calculated the fair value of these warrants using a combination of the Black-Scholes model and/or binomial-lattice option-pricing model. | |||||||||||||
Changes resulting from the revaluation of warrants to fair value are recorded in “Gain (loss) from revaluation of warrant liability” on the consolidated statements of operations. Upon the exercise or modification to remove the provisions which require the warrants to be treated as a liability, the fair value of the warrants will be reclassified from a liability to stockholders’ equity on the Company’s consolidated balance sheets and no further adjustment to the fair value would be made in subsequent periods. | |||||||||||||
See Note 12 for further information regarding the Company’s valuation of warrant liability. | |||||||||||||
Income Taxes | |||||||||||||
The Company accounts for income taxes using the asset and liability approach in accordance with ASC Topic 740 “Accounting for Income Taxes.” Under this method, 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. ASC Topic 740 requires derecognition of 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 as described in ASC Topic 740 is not an appropriate substitute for the derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. The Company had no unrecognized tax benefits as of December 31, 2014 and 2013. The Company continues to carry a full valuation allowance on all of its deferred tax assets. 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. | |||||||||||||
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, warrants and restricted stock units, which are calculated using the treasury stock method, and convertible preferred stock, which is calculated using the if-converted method. Diluted net loss per share also gives effect to potential adjustments to the numerator for gains resulting from the revaluation of warrants to fair value for the period, even if the Company is in a net loss position if the effect would result in more dilution. | |||||||||||||
Diluted net loss per common share used the same weighted average number of common shares outstanding for the year ended December 31, 2013, as calculated for the basic net loss per common share as the inclusion of any potential dilutive securities would be anti-dilutive. Certain potential dilutive securities were excluded from the dilution calculation for the years ended December 31, 2014 and 2012, as their inclusion would have been anti-dilutive. | |||||||||||||
The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the years ended December 31, 2014, 2013 and 2012 (in thousands, except per share amounts): | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Numerator for Basic and Diluted: | |||||||||||||
Net loss used for basic calculation | $ | (38,755 | ) | $ | (43,337 | ) | $ | (15,917 | ) | ||||
Effect of revaluation of warrant liability | (7,708 | ) | 0 | (2,059 | ) | ||||||||
Adjusted net loss used for dilution calculation | $ | (46,463 | ) | $ | (43,337 | ) | $ | (17,976 | ) | ||||
Denominator: | |||||||||||||
Basic weighted average number of shares outstanding | 74,767 | 67,569 | 54,515 | ||||||||||
Effect of dilutive potential shares | 1,767 | 0 | 546 | ||||||||||
Diluted weighted average number of shares outstanding | 76,534 | 67,569 | 55,061 | ||||||||||
Net loss per share: | |||||||||||||
Basic | $ | (0.52 | ) | $ | (0.64 | ) | $ | (0.29 | ) | ||||
Diluted | $ | (0.61 | ) | $ | (0.64 | ) | $ | (0.33 | ) | ||||
The table below presents shares underlying stock options, employee stock purchase plan rights, warrants, restricted stock units and/or convertible preferred stock 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 were excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2014, 2013 and 2012 (shares in thousands): | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Weighted average number of anti-dilutive potential shares | 11,722 | 16,370 | 8,716 | ||||||||||
Guarantee and Indemnification Arrangements | |||||||||||||
The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a third party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions. | |||||||||||||
The Company generally provides for a one-year warranty on certain of its INTERCEPT blood-safety products covering defects in materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. The Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims. Accordingly, the Company had not accrued for any future warranty costs for its products at December 31, 2014 or 2013. | |||||||||||||
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 and warrant liability. 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 available-for-sale securities related to corporate debt and United States government agency securities. 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, which include its warrant liability. The Company assesses any transfers among fair value measurement levels at the end of each reporting period. | |||||||||||||
See Notes 3 and 12 for further information regarding the Company’s valuation on financial instruments. | |||||||||||||
New Accounting Pronouncements | |||||||||||||
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and will supersede most current revenue recognition guidance. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The ASU’s effective date for the Company will be the first quarter of fiscal year 2017, using one of two retrospective application methods. Early adoption is not permitted. The Company has not selected a transition method and is currently assessing the potential effects of this ASU on its consolidated financial statements. | |||||||||||||
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which requires management to evaluate, in connection with preparing financial statements for each annual and interim reporting period, whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued and provide related disclosures. This ASU will be effective for the Company in fiscal year 2016. Early adoption is permitted. The Company is currently assessing the future impact of this ASU on its consolidated financial statements. |
Fair_Value_on_Financial_Instru
Fair Value on Financial Instruments | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Fair Value on Financial Instruments | Note 3. Fair Value on Financial Instruments | ||||||||||||||||
The Company determined the fair value of an asset or liability based on the assumptions that market participants would use in pricing the asset or liability in an orderly transaction between market participants at the measurement date. The identification of market participant assumptions provides a basis for determining what inputs are to be used for pricing each asset or liability. A fair value hierarchy has been established which gives precedence to fair value measurements calculated using observable inputs over those using unobservable inputs. This hierarchy prioritized the inputs into three broad levels as follows: | |||||||||||||||||
• | Level 1: Quoted prices in active markets for identical instruments | ||||||||||||||||
• | Level 2: Other significant observable inputs (including quoted prices in active markets for similar instruments) | ||||||||||||||||
• | Level 3: Significant unobservable inputs (including assumptions in determining the fair value of certain investments) | ||||||||||||||||
Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. | |||||||||||||||||
To estimate the fair value of Level 2 debt securities as of December 31, 2014, the Company’s primary service relies on inputs from multiple industry-recognized pricing sources to determine the price for each investment. Corporate debt and United States government agency securities are systematically priced by this service as of the close of business each business day. If the primary pricing service does not price a specific asset a secondary pricing service is utilized. | |||||||||||||||||
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2014 (in thousands): | |||||||||||||||||
Total | Quoted | Significant | Significant | ||||||||||||||
Prices in | Other | Unobservable | |||||||||||||||
Active | Observable | Inputs | |||||||||||||||
Markets for | Inputs | (Level 3) | |||||||||||||||
Identical | (Level 2) | ||||||||||||||||
Assets | |||||||||||||||||
(Level 1) | |||||||||||||||||
Money market funds(1) | $ | 3,912 | $ | 3,912 | $ | 0 | $ | 0 | |||||||||
Corporate debt securities(2) | 26,088 | 0 | 26,088 | 0 | |||||||||||||
United States government agency securities(2) | 3,426 | 0 | 3,426 | 0 | |||||||||||||
Total financial assets | $ | 33,426 | $ | 3,912 | $ | 29,514 | $ | 0 | |||||||||
Warrant liability(3) | $ | 10,485 | $ | 0 | $ | 0 | $ | 10,485 | |||||||||
Total financial liabilities | $ | 10,485 | $ | 0 | $ | 0 | $ | 10,485 | |||||||||
-1 | Included in cash and cash equivalents on the Company’s consolidated balances sheets. | ||||||||||||||||
-2 | Included in short-term investments on the Company’s consolidated balance sheets, except for approximately $1.0 million of corporate debt securities that are included in cash and cash equivalents on the Company’s consolidated balance sheets. | ||||||||||||||||
-3 | Included in current liabilities on the Company’s consolidated balance sheets. | ||||||||||||||||
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2013 (in thousands): | |||||||||||||||||
Total | Quoted | Significant | Significant | ||||||||||||||
Prices in | Other | Unobservable | |||||||||||||||
Active | Observable | Inputs | |||||||||||||||
Markets for | Inputs | (Level 3) | |||||||||||||||
Identical | (Level 2) | ||||||||||||||||
Assets | |||||||||||||||||
(Level 1) | |||||||||||||||||
Money market funds(1) | $ | 8,650 | $ | 8,650 | $ | 0 | $ | 0 | |||||||||
Corporate debt securities(2) | 23,173 | 0 | 23,173 | 0 | |||||||||||||
United States government agency securities(2) | 5,018 | 0 | 5,018 | 0 | |||||||||||||
Total financial assets | $ | 36,841 | $ | 8,650 | $ | 28,191 | $ | 0 | |||||||||
Warrant liability(3) | $ | 20,390 | $ | 0 | $ | 0 | $ | 20,390 | |||||||||
Total financial liabilities | $ | 20,390 | $ | 0 | $ | 0 | $ | 20,390 | |||||||||
-1 | Included in cash and cash equivalents on the Company’s consolidated balances sheets. | ||||||||||||||||
-2 | Included in short-term investments on the Company’s consolidated balance sheets. | ||||||||||||||||
-3 | Included in current liabilities on the Company’s consolidated balance sheets. | ||||||||||||||||
A reconciliation of the beginning and ending balances for warrant liability using significant unobservable inputs (Level 3) from December 31, 2012 to December 31, 2014, was as follows (in thousands): | |||||||||||||||||
Balance at December 31, 2012 | $ | 5,903 | |||||||||||||||
Increase in fair value of warrants | 15,099 | ||||||||||||||||
Settlement of warrants exercised | (612 | ) | |||||||||||||||
Balance at December 31, 2013 | 20,390 | ||||||||||||||||
Decrease in fair value of warrants | (7,708 | ) | |||||||||||||||
Settlement of warrants exercised | (2,197 | ) | |||||||||||||||
Balance at December 31, 2014 | $ | 10,485 | |||||||||||||||
See Notes 1 and 12 for further information regarding the Company’s valuation techniques and unobservable inputs for the warrant liability using significant unobservable inputs (Level 3). | |||||||||||||||||
The Company did not have any transfers among fair value measurement levels during the years ended December 31, 2014 and 2013. |
Availableforsale_Securities
Available-for-sale Securities | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Available-for-sale Securities | Note 4. Available-for-sale Securities | ||||||||||||||||
The following is a summary of available-for-sale securities at December 31, 2014 (in thousands): | |||||||||||||||||
December 31, 2014 | |||||||||||||||||
Amortized Cost | Gross | Fair Value | |||||||||||||||
Unrealized Loss | |||||||||||||||||
Money market funds | $ | 3,912 | $ | 0 | $ | 3,912 | |||||||||||
United States government agency securities | 3,427 | (1 | ) | 3,426 | |||||||||||||
Corporate debt securties | 26,118 | (30 | ) | 26,088 | |||||||||||||
Total available-for-sale securities | $ | 33,457 | ($ | 31 | ) | $ | 33,426 | ||||||||||
The following is a summary of available-for-sale securities at December 31, 2013 (in thousands): | |||||||||||||||||
December 31, 2013 | |||||||||||||||||
Amortized Cost | Gross | Fair Value | |||||||||||||||
Unrealized (Loss) | |||||||||||||||||
Gain | |||||||||||||||||
Money market funds | $ | 8,650 | $ | 0 | $ | 8,650 | |||||||||||
United States government agency securities | 5,019 | (1 | ) | 5,018 | |||||||||||||
Corporate debt securties | 23,165 | 8 | 23,173 | ||||||||||||||
Total available-for-sale securities | $ | 36,834 | $ | 7 | $ | 36,841 | |||||||||||
Available-for-sale securities at December 31, 2014 and 2013, consisted of the following by original contractual maturity (in thousands): | |||||||||||||||||
December 31, 2014 | December 31, 2013 | ||||||||||||||||
Amortized | Fair Value | Amortized | Fair Value | ||||||||||||||
Cost | Cost | ||||||||||||||||
One year or less | $ | 27,752 | $ | 27,727 | $ | 30,700 | $ | 30,701 | |||||||||
Greater than one year and less than five years | 5,705 | 5,699 | 6,134 | 6,140 | |||||||||||||
Total available-for-sale securities | $ | 33,457 | $ | 33,426 | $ | 36,834 | $ | 36,841 | |||||||||
As of December 31, 2014, the Company considered the declines in market value of its marketable securities investment portfolio to be temporary in nature and did not consider any of its investments other-than-temporarily impaired. The Company typically invests in highly-rated securities, and its investment policy limits the amount of credit exposure to any one issuer. The policy generally requires investments to be investment grade, with the primary objective of minimizing the potential risk of principal loss. Fair values were determined for each individual security in the investment portfolio. When evaluating an investment for other-than-temporary impairment, the Company reviews factors such as the length of time and extent to which fair value has been below its cost basis, the financial condition of the issuer and any changes thereto, changes in market interest rates, and the Company’s intent to sell, or whether it is more likely than not it will be required to sell, the investment before recovery of the investment’s cost basis. During the years ended December 31, 2014, 2013, and 2012, the Company did not recognize any other-than-temporary impairment loss. | |||||||||||||||||
The Company recorded minimal gross realized gains from the sale or maturity of available-for-sale investments during the year ended December 31, 2014, and did not record any gross realized gains from the sale or maturity of available-for-sale investments during the years ended December 31, 2013 and 2012. The Company recorded insignificant gross realized losses from the sale of available-for-sale investments during the year ended December 31, 2013, and did not record any gross realized losses during the years ended December 31, 2014 and 2012. The Company did not record losses on investments experiencing an other-than-temporary decline in fair value during the years ended December 31, 2014, 2013, and 2012. |
Inventories
Inventories | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Inventories | Note 5. Inventories | ||||||||
Inventories at December 31, 2014 and 2013, consisted of the following (in thousands): | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Work-in-process | $ | 2,222 | $ | 4,863 | |||||
Finished goods | 12,734 | 8,200 | |||||||
Total inventories | $ | 14,956 | $ | 13,063 | |||||
Property_and_Equipment_net
Property and Equipment, net | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Property and Equipment, net | Note 6. Property and Equipment, net | ||||||||
Property and equipment, net at December 31, 2014 and 2013, consisted of the following (in thousands): | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Leasehold improvements | $ | 5,638 | $ | 5,628 | |||||
Machinery and equipment | 1,351 | 1,751 | |||||||
Demonstration equipment | 123 | 100 | |||||||
Office furniture | 783 | 763 | |||||||
Computer equipment | 663 | 651 | |||||||
Computer software | 2,913 | 1,083 | |||||||
Consigned demonstration equipment | 980 | 642 | |||||||
Construction-in-progress | 150 | 155 | |||||||
Total property and equipment, gross | 12,601 | 10,773 | |||||||
Accumulated depreciation and amortization | (8,820 | ) | (8,584 | ) | |||||
Total property and equipment, net | $ | 3,781 | $ | 2,189 | |||||
Depreciation and amortization expense related to property and equipment, net was $0.7 million, $0.4 million and $0.4 million for the years ended December 31, 2014, 2013 and 2012, respectively. |
Goodwill_and_Intangible_Assets
Goodwill and Intangible Assets, net | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Goodwill and Intangible Assets, net | Note 7. Goodwill and Intangible Assets, net | ||||||||||||
Goodwill | |||||||||||||
During the year ended December 31, 2014, the Company did not dispose of or recognize additional goodwill. On August 31, 2014, the Company performed its impairment test of goodwill. As described in Note 2 above, the Company applied the enterprise approach by reviewing the quoted market capitalization of the Company as reported on the Nasdaq Global Market to calculate the fair value. In addition, the Company considered its future forecasted results, the economic environment and overall market conditions. As a result of the Company’s assessment that its fair value of the reporting unit exceeded its carrying amount, the Company determined that goodwill was not impaired. | |||||||||||||
Intangible Assets, net | |||||||||||||
The following is a summary of intangible assets, net at December 31, 2014 (in thousands): | |||||||||||||
December 31, 2014 | |||||||||||||
Gross Carrying | Accumulated | Net Carrying | |||||||||||
Amount | Amortization | Amount | |||||||||||
Acquisition-related intangible assets: | |||||||||||||
Reacquired license—INTERCEPT Asia | $ | 2,017 | $ | (875 | ) | $ | 1,142 | ||||||
Total intangible assets | $ | 2,017 | $ | (875 | ) | $ | 1,142 | ||||||
The following is a summary of intangible assets, net at December 31, 2013 (in thousands): | |||||||||||||
December 31, 2013 | |||||||||||||
Gross Carrying | Accumulated | Net Carrying | |||||||||||
Amount | Amortization | Amount | |||||||||||
Acquisition-related intangible assets: | |||||||||||||
Reacquired license—INTERCEPT Asia | $ | 2,017 | $ | (673 | ) | $ | 1,344 | ||||||
Total intangible assets | $ | 2,017 | $ | (673 | ) | $ | 1,344 | ||||||
During the years ended December 31, 2014, 2013 and 2012, there were no impairment charges recognized related to the Company’s intangible assets. | |||||||||||||
At December 31, 2014, the expected annual amortization expense of the intangible assets, net is $0.2 million beginning with the year ending December 31, 2015, and each subsequent year thereafter through the year ending December 31, 2019, and $0.1 million for the year ending December 31, 2020. |
LongTerm_Investments
Long-Term Investments | 12 Months Ended |
Dec. 31, 2014 | |
Long-Term Investments | Note 8. Long-Term Investments |
In connection with the agreements to license the immunotherapy technologies to Aduro Biotech (“Aduro”) in 2009, the Company received preferred shares of Aduro, a privately held company. Pursuant to these license agreements, the Company is eligible to receive a 1% royalty fee on any future sales resulting from the licensed technology. For the years ended December 31, 2014, 2013 or 2012, the Company has not received any royalty payments from Aduro pursuant to this agreement. As of December 31, 2014, the Company’s ownership in Aduro was less than 1% on a fully diluted basis. Since receiving preferred stock in Aduro, the Company has carried its investment in Aduro at zero in its consolidated balance sheets. |
Accrued_Liabilities
Accrued Liabilities | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued Liabilities | Note 9. Accrued Liabilities | ||||||||
Accrued liabilities at December 31, 2014 and 2013, consisted of the following (in thousands): | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Accrued compensation and related costs | $ | 3,951 | $ | 2,527 | |||||
Accrued professional services | 2,123 | 2,722 | |||||||
Accrued inventory costs | 870 | 3,553 | |||||||
Accrued customer costs | 385 | 59 | |||||||
Accrued insurance premiums | 264 | 226 | |||||||
Other accrued expenses | 851 | 726 | |||||||
Total accrued liabilities | $ | 8,444 | $ | 9,813 | |||||
Debt
Debt | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Debt | Note 10. Debt | ||||||||||||
Debt at December 31, 2014, consisted of the following (in thousands): | |||||||||||||
December 31, 2014 | |||||||||||||
Principal | Unamortized | Net Carrying | |||||||||||
Discount | Value | ||||||||||||
Loan and Security Agreement | $ | 10,000 | $ | (128 | ) | $ | 9,872 | ||||||
Less: debt—current | 0 | 0 | 0 | ||||||||||
Debt—non-current | $ | 10,000 | $ | (128 | ) | $ | 9,872 | ||||||
Principal and interest payments on debt at December 31, 2014, are expected to be as follows*: | |||||||||||||
Year ended December 31, | Principal | Interest | Total | ||||||||||
2015 | $ | — | $ | 695 | $ | 695 | |||||||
2016 | 2,614 | 613 | 3,227 | ||||||||||
2017 | 2,802 | 425 | 3,227 | ||||||||||
2018 | 3,003 | 224 | 3,227 | ||||||||||
2019 | 1,581 | 733 | 2,314 | ||||||||||
Total | $ | 10,000 | $ | 2,690 | $ | 12,690 | |||||||
* | Unless interest only period extends to December 31, 2016, as described below. | ||||||||||||
Loan and Security Agreement | |||||||||||||
On June 30, 2014, the Company entered into a five year loan and security agreement with Oxford Finance LLC (the “Term Loan Agreement”) to borrow up to $30.0 million in term loans in three equal tranches (the “Term Loans”). On June 30, 2014, the Company received $10.0 million from the first tranche (“Term Loan A”). The second tranche of $10.0 million (“Term Loan B”) was contingent upon the approval, by the U.S. Food and Drug Administration (“FDA”) of the Company’s premarket approval application for either the plasma or platelet system (the “PMA Approval”), which occurred in December 2014. The availability of Term Loan B expires on June 15, 2015. The third tranche of $10.0 million (“Term Loan C”) will be available from July 1, 2015 through December 31, 2015, contingent upon the Company achieving trailing six months’ revenue at a specified threshold (the “Revenue Event”). Term Loan A bears an interest rate of 6.95%. Term Loan B and Term Loan C will bear an interest rate calculated at the greater of 6.95% or 6.72% plus the three month U.S. LIBOR rate in effect three business days prior to the applicable Term Loan funding date. All of the Term Loans mature on June 1, 2019. The Company is required to make interest only payments through December 2015 followed by forty-two months of equal principal and interest payments thereafter; however, if the Revenue Event is achieved no later than November 30, 2015, then the interest-only period may be extended through December 31, 2016, and the amortization period will be reduced to thirty months. The Company is also required to make a final payment equal to 7% of the principal amounts of the Term Loans drawn payable on the earlier to occur of maturity or prepayment. The costs associated with the final payment are recognized as interest expense over the life of the Term Loans. The Company may prepay at any time the Term Loans subject to declining prepayment fees over the term of the Term Loan Agreement. The Company paid the lender a $0.2 million commitment fee related to the Term Loan Agreement which has been recorded as a discount on the Term Loans and will be amortized to interest expense using the effective interest method over the life of the Term Loans. In addition, the Company paid $0.1 million of the lender legal fees, which are capitalized on the Company’s condensed consolidated balance sheets and will be recognized using the effective interest method over the life of the Term Loans. The Company pledged all current and future assets, excluding its intellectual property and 35% of the Company’s investment in its subsidiary, Cerus Europe B.V., as security for borrowings under the Term Loan Agreement. The Term Loan Agreement contains certain nonfinancial covenants, with which the Company was in compliance at December 31, 2014. | |||||||||||||
Amended Credit Agreement | |||||||||||||
The Company entered into a loan and security agreement on September 30, 2011, as amended effective on December 13, 2011, and June 30, 2012, with Comerica Bank (collectively, the “Amended Credit Agreement”). The Amended Credit Agreement provided for a formula-based revolving line of credit (“RLOC”) of up to $7.0 million and a $5.0 million term loan. At December 31, 2013, the Company had $3.4 million outstanding under the RLOC, which was repaid in May 2014. In April 2013, the Company repaid in full the outstanding balance of the $5.0 million term loan along with all accrued interest and a scheduled final payment fee of $0.05 million, all totaling an aggregate amount of $4.2 million. The Amended Credit Agreement expired in June 2014. |
Commitments_and_Contingencies
Commitments and Contingencies | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Commitments and Contingencies | Note 11. Commitments and Contingencies | ||||
Operating Leases | |||||
The Company leases its office facilities, located in Concord, California and Amersfoort, the Netherlands, and certain equipment 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 2019, with certain of the leases providing for renewal options, provisions for adjusting future lease payments, which is based on the consumer price index and the right to terminate the lease early. In June 2013 the Company entered into a new lease for additional space in Concord. The lease has a two-year initial term with four (4) two-year options for the Company to renew, the first of which the Company exercised in March 2015. The Company’s leased facilities qualify as operating leases under ASC Topic 840, “Leases” and as such, are not included on its consolidated balance sheets. | |||||
Future minimum non-cancelable lease payments under operating leases as of December 31, 2014, are as follows (in thousands): | |||||
Year ended December 31, | |||||
2015 | $ | 891 | |||
2016 | 163 | ||||
2017 | 93 | ||||
2018 | 25 | ||||
2019 and thereafter | 0 | ||||
Total minimum non-cancellable lease payments | $ | 1,172 | |||
Rent expense for office facilities was $0.8 million, $0.7 million and $0.6 million for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||
Financed Leasehold Improvements | |||||
In 2010, the Company financed $1.1 million of leasehold improvements. The Company pays for the financed leasehold improvements as a component of rent and is required to reimburse its landlord over the remaining life of the respective leases. If the Company exercises its right to early terminate the original Concord, California lease, which may occur at any time hereafter, the Company would be required to repay for any remaining portion of the landlord financed leasehold improvements at such time. At December 31, 2014, the Company had an outstanding liability of $0.6 million related to these leasehold improvements, of which $0.1 million was reflected in “Accrued liabilities” and $0.5 million was reflected in “Other non-current liabilities” on the Company’s consolidated balance sheets. | |||||
Purchase Commitments | |||||
The Company is party to agreements with certain providers for certain components of INTERCEPT Blood System which the Company purchases from third party manufacturers. Certain of these agreements require minimum purchase commitments from the Company. The Company has paid $6.8 million, $6.5 million and $7.2 million for goods under agreements which are subject to minimum purchase commitments during the years ended December 31, 2014, 2013 and 2012, respectively. As of December 31, 2014, the Company has future minimum purchase commitments under these agreements of $8.5 million for the year ending December 31, 2015, and approximately $2.3 million for the year ending December 31, 2016. | |||||
In June 2014, the Company terminated its distribution agreement with one of its distributors in certain countries and entered into an agreement to provide for specific post-termination obligations (the “Transition Agreement”). The Transition Agreement expired September 30, 2014. The Company is required to pay this former distributor a fee of €10 per disposable kit for platelet systems sold by the Company to any customer in certain countries commencing with the termination of the agreement through April 1, 2018, subject to a maximum payment of €3 million. During the year ended December 31, 2014, the Company accrued approximately $0.1 million associated with this fee. As this former distributor will remain as a customer in other countries, in accordance with ASC Topic 605-50 “Customer Payments and Incentives” any fees paid to the former distributor related to INTERCEPT disposable kits will be offset against the revenue associated with the sale of INTERCEPT disposable kits in those territories. |
Stockholders_Equity
Stockholders' Equity | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Stockholders' Equity | Note 12. Stockholders’ Equity | ||||||||
On June 12, 2014, the Company filed a Certificate of Amendment to the Company’s Amended and Restated Certificate of Incorporation with the Secretary of the State of Delaware to increase the number of authorized shares of the Company’s common stock, par value $0.001 per share, from 112,500,000 shares to 225,000,000 shares. The amendment was approved by the Company’s stockholders at the Company’s 2014 Annual Meeting of Stockholders held on June 11, 2014. | |||||||||
Common Stock and Associated Warrant Liability | |||||||||
In August 2009, the Company issued warrants to purchase 2.4 million shares of common stock, exercisable at an exercise price of $2.90 per share (“2009 Warrants”). In August 2014, all outstanding 2009 Warrants were exercised in full and accordingly were no longer outstanding at December 31, 2014. | |||||||||
In November 2010, the Company issued warrants to purchase 3.7 million shares of common stock, exercisable at an exercise price of $3.20 per share. The warrants issued in November 2010 (“2010 Warrants”) became exercisable on May 15, 2011, and are exercisable for a period of five years from the issue date. | |||||||||
The fair value of the 2009 Warrants and 2010 Warrants was recorded on the consolidated balance sheets as a liability pursuant to ASC Topic 480-10 “Distinguishing Liabilities from Equity” and are adjusted to fair value at each financial reporting date thereafter until the earlier of exercise, expiration or modification to remove the provisions which require the warrants to be treated as a liability, at which time, these warrants would be reclassified into stockholders’ equity. The Company classified the 2009 Warrants and 2010 Warrants as a liability as these warrants contain certain provisions that, under certain circumstances, which may be out of the Company’s control, could require the Company to pay cash to settle the exercise of the warrants or may require the Company to redeem the warrants. | |||||||||
The fair value of the warrants outstanding at December 31, 2014 and 2013, consisted of the following (in thousands): | |||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
2009 Warrants | $ | — | $ | 8,542 | |||||
2010 Warrants | 10,485 | 11,848 | |||||||
Total warrant liability | $ | 10,485 | $ | 20,390 | |||||
The fair value of the Company’s warrants was based on option valuation model and using the following assumptions at December 31, 2014 and 2013: | |||||||||
December 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
2009 Warrants: | |||||||||
Expected term (in years) | — | 0.65 | |||||||
Estimated volatility | — | 45% | |||||||
Risk-free interest rate | — | 0.10% | |||||||
Expected dividend yield | — | 0% | |||||||
December 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
2010 Warrants: | |||||||||
Expected term (in years) | 0.86 | 1.86 | |||||||
Estimated volatility | 55% | 41% | |||||||
Risk-free interest rate | 0.25% | 0.38% | |||||||
Expected dividend yield | 0% | 0% | |||||||
The Company recognizes non-cash loss and gains in “Gain (loss) from revaluation of warrant liability” on the consolidated statements of operations due to the changes in fair value of the warrants. Significant changes to the Company’s market price for its common stock will impact the implied and/or historical volatility used to fair value the warrants. Any significant increases in the Company’s stock price will likely create an increase to the fair value of the warrant liability. Similarly, any significant decreases in the Company’s stock price will likely create a decrease to the fair value of the warrant liability. During the years ended December 31, 2014, 2013 and 2012, Warrants to purchase 2.6 million, 0.2 million and 0.005 million shares of common stock, respectively were exercised. At December 31, 2014, the Company had 2010 Warrants outstanding to purchase an aggregate 3.3 million shares of common stock. | |||||||||
Sales Agreement | |||||||||
On March 21, 2014, the Company entered into Amendment No. 1 to the Controlled Equity OfferingSM Sales Agreement, dated August 31, 2012 (as amended, the “Amended Cantor Agreement”) with Cantor Fitzgerald & Co. (“Cantor”) that provides for the issuance and sale of shares of its common stock over the term of the Amended Cantor Agreement having an aggregate offering price of up to $70.0 million through Cantor. Under the Amended Cantor Agreement, Cantor also acts as the Company’s sales agent and receives compensation based on an aggregate of 2% of the gross proceeds on the sale price per share of its common stock. The issuance and sale of these shares by the Company pursuant to the Amended Cantor Agreement are deemed an “at-the-market” offering and are registered under the Securities Act of 1933, as amended. During the year ended December 31, 2014 and 2013, approximately, 4.3 million and 5.4 million shares, respectively, of the Company’s common stock were sold under the Amended Cantor Agreement for aggregate net proceeds of $18.6 million and $23.5 million, respectively. At December 31, 2014, the Company had approximately $22.5 million of common stock available to be sold under the Amended Cantor Agreement. | |||||||||
Stockholder Rights Plan | |||||||||
In October 2009, the Company’s Board of Directors adopted an amendment to its 1999 stockholder rights plan, commonly referred to as a “poison pill,” to reduce the exercise price, extend the expiration date and revise certain definitions under the plan. The stockholder rights plan is intended to deter hostile or coercive attempts to acquire the Company. The stockholder rights plan enables stockholders to acquire shares of the Company’s common stock, or the common stock of an acquirer, at a substantial discount to the public market price should any person or group acquire more than 15% of the Company’s common stock without the approval of the Board of Directors under certain circumstances. The Company has designated 250,000 shares of Series C Junior Participating preferred stock for issuance in connection with the stockholder rights plan. |
StockBased_Compensation
Stock-Based Compensation | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Stock-Based Compensation | Note 13. 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 ordinary shares at a discount of 15% through payroll deductions. The Purchase Plan consists of a fixed offering period of 12 months with two purchase periods within each offering period. The Purchase Plan is authorized to issue an aggregate of 1,320,500 shares. At December 31, 2014, the Company had 387,349 shares available for future issuance. | |||||||||||||||||
2008 Equity Incentive 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 (the “2008 Plan”). The 2008 Plan allows for the issuance of non-statutory and incentive stock options, restricted stock, restricted stock units, stock appreciation rights, other stock-related awards, and performance awards which may be settled in cash, stock, or other property. On June 6, 2012 and June 12, 2013, the stockholders approved amendments to the 2008 Plan (collectively the “Amended 2008 Plan”) such that the Amended 2008 Plan has reserved for issuance an amount not to exceed 19,540,940 shares. 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 and will generally vest over 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. The attainment of any performance-based awards granted shall be conclusively determined by a committee designated by the Company’s Board of Directors. At December 31, 2014, no performance-based stock options were outstanding. | |||||||||||||||||
1996 Equity Incentive Plan, 1998 Non-Officer Stock Option Plan, and 1999 Equity Incentive Plan | |||||||||||||||||
The Company continues to have equity awards outstanding under its previous stock plans: 1998 Non-Officer Stock Option Plan and 1999 Equity Incentive Plan (collectively, the “Prior Plans”) and 1996 Equity Incentive Plan (the “1996 Plan”). Equity awards issued under the Prior Plans and the 1996 Plan continues to adhere to the terms of those respective stock plans and no further options may be granted under those previous plans. However, at June 2, 2008, any shares that remained available for future grants under the Prior Plans became available for issuance under the 2008 Plan. | |||||||||||||||||
At December 31, 2014, the Company had an aggregate of approximately 17.1 million shares of its common stock subject to outstanding options or remaining available for future issuance under the Amended 2008 Plan, the Prior Plans and the 1996 Plan, of which approximately 11.3 million shares were subject to outstanding options, and approximately 5.8 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. | |||||||||||||||||
Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except weighted average exercise price): | |||||||||||||||||
Number of | Weighted Average | ||||||||||||||||
Options | Exercise Price per | ||||||||||||||||
Outstanding | Share | ||||||||||||||||
Balances at December 31, 2013 | 10,405 | $ | 3.46 | ||||||||||||||
Granted | 2,783 | 5.9 | |||||||||||||||
Forfeited | (233 | ) | 4.31 | ||||||||||||||
Expired | (114 | ) | 8.64 | ||||||||||||||
Exercised | (1,518 | ) | 2.44 | ||||||||||||||
Balances at December 31, 2014 | 11,323 | 4.13 | |||||||||||||||
Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2014, was as follows (in thousands except weighted average exercise price and contractual term): | |||||||||||||||||
Number | Weighted | Weighted | Aggregate | ||||||||||||||
of Shares | Average | Average | Intrinsic | ||||||||||||||
Exercise | Remaining | Value | |||||||||||||||
Price | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Balances at December 31, 2014 | |||||||||||||||||
Stock options outstanding | 11,323 | $ | 4.13 | 6.8 | $ | 25,517 | |||||||||||
Stock options vested and expected to vest | 10,920 | $ | 4.08 | 6.7 | $ | 25,174 | |||||||||||
Stock options exercisable | 7,006 | $ | 3.7 | 5.7 | $ | 19,324 | |||||||||||
The aggregate intrinsic value in the table above is calculated as the difference between the exercise price of the stock option and the Company’s closing stock price on the last trading day of each respective fiscal period. | |||||||||||||||||
The total intrinsic value of options exercised for the years ended December 31, 2014, 2013 and 2012, was $3.8 million, $0.6 million and $0.3 million, respectively. | |||||||||||||||||
Restricted Stock Units | |||||||||||||||||
The Company has previously granted restricted stock units primarily to its senior management in accordance with the Amended 2008 Plan. Subject to each grantee’s continued employment, the restricted stock units generally vested in three annual installments from the date of grant and were generally issuable at the end of the three-year vesting term. The fair value of restricted stock units which vested during the years ended December 31, 2013 and 2012, were both $0.05 million. As of December 31, 2013, all previously granted restricted stock units were fully vested. | |||||||||||||||||
Stock-based Compensation Expense | |||||||||||||||||
Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended December 31, 2014, 2013 and 2012, was as follows (in thousands): | |||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Stock-based compensation expense by caption: | |||||||||||||||||
Research and development | $ | 998 | $ | 482 | $ | 554 | |||||||||||
Selling, general and administrative | 4,155 | 2,786 | 1,987 | ||||||||||||||
Total stock-based compensation expense | $ | 5,153 | $ | 3,268 | $ | 2,541 | |||||||||||
Stock-based compensation expense in the above table does not reflect any income taxes as the Company has experienced a history of net losses since its inception and has a full valuation allowance on its deferred tax assets. In addition, there was neither income tax benefits realized related to stock-based compensation expense nor any stock-based compensation costs capitalized as part of an asset during the years ended December 31, 2014, 2013 and 2012. The Company has also not recorded any stock-based compensation associated with performance-based stock options during the years ended December 31, 2014, 2013 and 2012. | |||||||||||||||||
As of December 31, 2014, the Company expects to recognize the remaining unamortized stock-based compensation expense of $9.1 million related to non-vested stock options, net of estimated forfeitures, over an estimated remaining weighted average period of 2.4 years. | |||||||||||||||||
Valuation Assumptions for Stock-based Compensation | |||||||||||||||||
The Company currently uses the Black-Scholes option pricing model to determine the grant-date fair value of stock options and employee stock purchase plan shares. The Black-Scholes option-pricing model is affected by the Company’s stock price, as well as assumptions regarding a number of complex and subjective variables, which include the expected term of the grants, actual and projected employee stock option exercise behaviors, including forfeitures, the Company’s expected stock price volatility, the risk-free interest rate and expected dividends. The Company recognizes the grant-date fair value of the stock award as stock-based compensation expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. | |||||||||||||||||
The expected life of the stock options is based on observed historical exercise patterns. Groups of employees having similar historical exercise behavior are considered separately for valuation purposes. The Company estimates stock option forfeitures based on historical data for employee groups. The total number of stock options expected to vest is adjusted by actual and estimated forfeitures. | |||||||||||||||||
The expected volatility is estimated by using historical volatility of the Company’s common stock. The risk-free interest rate is based on the implied yield on a U.S. Treasury zero-coupon issue with a remaining term commensurate with the expected term of the option. The Company does not anticipate paying any cash dividends in the foreseeable future and therefore uses an expected dividend yield of zero. | |||||||||||||||||
The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2014, 2013 and 2012, was as follows: | |||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Stock Options: | |||||||||||||||||
Expected term (in years) | 5.71 | 5.59 | 5.54 | ||||||||||||||
Estimated volatility | 61 | % | 60 | % | 67 | % | |||||||||||
Risk-free interest rate | 1.73 | % | 0.87 | % | 1.03 | % | |||||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % | |||||||||||
Employee Stock Purchase Plan Rights: | |||||||||||||||||
Expected term (in years) | 0.76 | 0.5 | 0.5 | ||||||||||||||
Estimated volatility | 52 | % | 39 | % | 101 | % | |||||||||||
Risk-free interest rate | 0.1 | % | 0.1 | % | 0.14 | % | |||||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % | |||||||||||
The weighted average grant-date fair value of stock options granted during the years ended December 31, 2014, 2013 and 2012, was $3.28 per share, $2.03 per share and $2.13 per share, respectively. The weighted average grant-date fair value of employee stock purchase rights during the years ended December 31, 2014, 2013 and 2012, was $1.42 per share, $1.18 per share and $1.43 per share, respectively. |
Retirement_Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2014 | |
Retirement Plan | Note 14. Retirement Plan |
The Company maintains a defined contribution savings plan (the “401(k) Plan”) that qualifies under the provisions of Section 401(k) of the Internal Revenue Code and covers eligible U.S. employees of the Company. Under the terms of the 401(k) Plan, eligible U.S. employees may make pre-tax dollar contributions of up to 60% of their eligible pay up to a maximum cap established by the IRS. The Company may contribute a discretionary percentage of qualified individual employee’s salaries, as defined, to the 401(k) Plan. The Company has not contributed to the 401(k) Plan during the years ended December 31, 2014, 2013 and 2012. |
Development_and_License_Agreem
Development and License Agreements | 12 Months Ended |
Dec. 31, 2014 | |
Development and License Agreements | Note 15. Development and License Agreements |
Agreements with Fresenius | |
The Company has certain agreements with Fresenius which require the Company to pay royalties on future INTERCEPT Blood System product sales at royalty rates that vary by product: 10% of product sales for the platelet system and 3% of product sales for the plasma system. During the years ended December 31, 2014, 2013 and 2012, the Company made royalty payments to Fresenius of $2.5 million, $3.0 million and $2.7 million, respectively. At both December 31, 2014 and December 31, 2013, the Company owed Fresenius $0.7 million, respectively, for royalties. | |
Until 2014, the Company and Fresenius operated under a supply agreement (the “Original Supply Agreement”) for the manufacture of the Company’s platelet and plasma systems. Under the Original Supply Agreement, the Company paid Fresenius a set price per kit, which was established annually, plus a fixed surcharge per kit. In addition, volume driven manufacturing overhead was to be paid or refunded if actual manufacturing volumes were lower or higher than the estimated production volumes. | |
In November 2013, the Company amended the Original Supply Agreement with Fresenius, with the new terms effective January 1, 2014 (the “2013 Amendment”). Under the 2013 Amendment, Fresenius is obligated to sell, and the Company is obligated to purchase, up to a certain specified annual volume of finished disposable kits for the platelet and plasma systems from Fresenius for both clinical and commercial use. Once the specified annual volume of disposable kits is purchased from Fresenius, the Company is able to purchase additional quantities of disposable kits from other third-party manufacturers. The 2013 Amendment also provides for fixed pricing for finished kits with successive decreasing pricing tiers at various annual production volumes. In addition, the 2013 Amendment requires the Company to purchase additional specified annual volumes of sets per annum if and when an additional Fresenius manufacturing site is identified and qualified to make INTERCEPT disposable kits subject to mutual agreement on pricing for disposable kits manufactured at the additional site. Fresenius is also obligated to purchase and maintain specified inventory levels of the Company’s proprietary inactivation compounds and adsorption media from the Company at fixed prices. The Company maintains the amounts due from the components sold to Fresenius as a current asset on its accompanying unaudited condensed consolidated balance sheets until such time as the Company purchases finished disposable kits using those components. The term of the 2013 Amendment extends through December 31, 2018, subject to termination by either party upon thirty months prior written notice, in the case of Fresenius, or twenty-four months prior written notice, in the Company’s case. The Company and Fresenius each have normal and customary termination rights, including termination for material breach. | |
The Company made payments to Fresenius of $19.1 million, $15.0 million and $12.2 million relating to the manufacturing of the Company products during the years ended December 31, 2014, 2013 and 2012, respectively. At December 31, 2014 and December 31, 2013, the Company owed Fresenius $5.1 million and $4.3 million, respectively, for INTERCEPT disposable kits manufactured. At December 31, 2014 and 2013, amounts due from Fresenius were $1.3 million and zero, respectively. |
Income_Taxes
Income Taxes | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Income Taxes | Note 16. Income Taxes | ||||||||||||
U.S and foreign components of consolidated loss before income taxes for the years ended December 2014, 2013 and 2012, was as follows (in thousands): | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Loss before income taxes: | |||||||||||||
U.S. | $ | (38,928 | ) | $ | (44,035 | ) | $ | (16,360 | ) | ||||
Foreign | 368 | 916 | 685 | ||||||||||
Loss before income taxes | $ | (38,560 | ) | $ | (43,119 | ) | $ | (15,675 | ) | ||||
The provision for income taxes for the years ended December 2014, 2013 and 2012, was as follows (in thousands): | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Provision for income taxes: | |||||||||||||
Current: | |||||||||||||
Foreign | $ | 168 | $ | 191 | $ | 180 | |||||||
Federal | 0 | 0 | 0 | ||||||||||
State | 1 | 0 | 0 | ||||||||||
Total Current | 169 | 191 | 180 | ||||||||||
Deferred: | |||||||||||||
Foreign | 0 | 0 | 0 | ||||||||||
Federal | 22 | 21 | 48 | ||||||||||
State | 4 | 6 | 14 | ||||||||||
Total Deferred | 26 | 27 | 62 | ||||||||||
Provision for income taxes | $ | 195 | $ | 218 | $ | 242 | |||||||
The difference between the provision for income taxes and the amount computed by applying the federal statutory income tax rate to loss before taxes for the years ended December 31, 2014, 2013 and 2012, was as follows (in thousands): | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Federal statutory tax | $ | (13,110 | ) | $ | (14,661 | ) | $ | (5,329 | ) | ||||
Stock-based compensation | (8 | ) | (10 | ) | 99 | ||||||||
Lobbying expenses | 33 | 107 | 51 | ||||||||||
Warrants | (3,367 | ) | 4,926 | (706 | ) | ||||||||
Foreign rate differential | 43 | (121 | ) | (53 | ) | ||||||||
Expiration of federal net operating losses and credits—tax effected | 0 | 0 | 4,352 | ||||||||||
Change in valuation allowance | 16,576 | 9,955 | 1,809 | ||||||||||
Other | 28 | 22 | 19 | ||||||||||
Provision for income taxes | $ | 195 | $ | 218 | $ | 242 | |||||||
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes at the enacted rates. The significant components of the Company’s deferred tax assets at December 31, 2014 and 2013, were as follows (in thousands): | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | ||||||||||||
Deferred tax assets: | |||||||||||||
Net operating loss carryforwards | $ | 151,100 | $ | 142,500 | |||||||||
Research and development credit carryforwards | 33,800 | 32,100 | |||||||||||
Capitalized research and development | 15,500 | 12,300 | |||||||||||
Deferred compensation | 5,800 | 4,900 | |||||||||||
Capital loss carryforwards | 3,700 | 3,900 | |||||||||||
Other | 3,200 | 3,300 | |||||||||||
Total deferred tax assets | 213,100 | 199,000 | |||||||||||
Valuation allowance | (213,100 | ) | (199,000 | ) | |||||||||
Net deferred tax assets | 0 | 0 | |||||||||||
Deferred tax liabilities: | |||||||||||||
Amortization of goodwill | 115 | 89 | |||||||||||
Total deferred tax liabilities | $ | 115 | $ | 89 | |||||||||
The valuation allowance increased by $14.1 million for the year ended December 31, 2014, compared to the increase of $8.5 million and a decrease of $0.8 million for the years ended December 31, 2013 and 2012, respectively. The Company believes that, based on a number of factors, the available objective evidence creates sufficient uncertainty regarding the realizability of the deferred tax assets such that a full valuation allowance has been recorded. These factors include the Company’s history of net losses since its inception, the need for regulatory approval of the Company’s products prior to commercialization, expected near-term future losses and the absence of taxable income in prior carryback years. The Company expects to maintain a full valuation allowance until circumstances change. | |||||||||||||
Undistributed earnings of the Company’s foreign subsidiary, Cerus Europe B.V., amounted to approximately $4.6 million at December 31, 2014. The earnings are considered to be permanently reinvested and accordingly, no deferred U.S. income taxes have been provided thereon. Upon distribution of those earnings in the form of dividends or otherwise, the Company would be subject to U.S. income taxes. The unrecognized deferred tax liability for unrepatriated earnings at December 31, 2014, was approximately $1.7 million. In the event all foreign undistributed earnings were remitted to the U.S., any incremental tax liability would be fully offset by the Company’s domestic net operating loss. | |||||||||||||
For the year ended December 31, 2014, the Company reported pretax net losses of $38.6 million on its consolidated statement of operations and calculated taxable losses for both federal and state taxes. The difference between reported net loss and taxable loss are due to temporary differences between book accounting and the respective tax laws. | |||||||||||||
At December 31, 2014, the Company had federal and state net operating loss carryforwards of approximately $416 million and $255 million, respectively. The net operating loss carryforwards for federal and state expire at various dates beginning in 2015 through 2034. The Company’s net operating losses do not include $2.2 million related to windfall tax deductions associated with stock based compensation. The stock based compensation windfall deductions, if utilized, would serve to reduce any income taxes payable. | |||||||||||||
At December 31, 2014, the Company had federal research and development credit carryforwards of approximately $22.5 million that expire in various years between 2018 and 2034. The state research and development credits are approximately $17.1 million as of December 31, 2014, have an indefinite carryover period. | |||||||||||||
The utilization of net operating loss carryforwards, as well as research and development credit carryforwards, is limited by current tax regulations. These net operating loss carryforwards, as well as research and development credit carryforwards, will be utilized in future periods if sufficient income is generated. The Company believes it more likely than not that its tax positions would be recognized upon review by a taxing authority having full knowledge of all relevant information. The Company’s ability to utilize certain loss carryforwards and certain research credit carryforwards are subject to limitations pursuant to the ownership change rules in accordance with Section 382 of the Internal Revenue Code of 1986 and with Section 383 of the Internal Revenue Code of 1986, as well as similar state provisions. | |||||||||||||
The Company will recognize accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. The Company had no unrecognized tax benefits as of December 31, 2014 and 2013. The Company’s tax years 2010 through 2013 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. |
Segment_Customer_and_Geographi
Segment, Customer and Geographic Information | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Segment, Customer and Geographic Information | Note 17. 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 United States of America are responsible for the research and development 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, all of which operate in a country outside of the United States, during the years ended December 31, 2014, 2013 and 2012 (in percentages): | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Etablissement Francais du Sang | 25 | % | 17 | % | 20 | % | |||||||
Grifols | * | 18 | % | 19 | % | ||||||||
Delrus Inc. | * | * | 12 | % | |||||||||
* | Represents an amount less than 10% of product revenue. | ||||||||||||
Revenues by geographical location was based on the location of the customer, in the case of product revenues, and in the location of the collaboration partner, in the case of non-product revenues, during the years ended December 31, 2014, 2013 and 2012 and was as follows (in thousands): | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Product Revenue: | |||||||||||||
France | $ | 9,184 | $ | 7,030 | $ | 7,321 | |||||||
Spain and Portugal | 2,776 | 7,033 | 7,061 | ||||||||||
CIS | 6,636 | 8,220 | 8,016 | ||||||||||
Belgium | 4,456 | 3,971 | 4,016 | ||||||||||
Switzerland | 3,784 | 4,078 | 3,866 | ||||||||||
Other countries | 9,580 | 9,325 | 6,415 | ||||||||||
Total product revenue | 36,416 | 39,657 | 36,695 | ||||||||||
Government grants and cooperative agreements: | |||||||||||||
United States | 0 | 0 | 91 | ||||||||||
Total government grants and cooperative agreements | 0 | 0 | 91 | ||||||||||
Total revenue | $ | 36,416 | $ | 39,657 | $ | 36,786 | |||||||
Long-lived assets by geographical location, which consist of property and equipment, net and intangible assets, net, at December 31, 2014 and 2013, were as follows (in thousands): | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | ||||||||||||
United States | $ | 4,624 | $ | 3,088 | |||||||||
Europe & other | 299 | 445 | |||||||||||
Total long-lived assets | $ | 4,923 | $ | 3,533 | |||||||||
Quarterly_Financial_Informatio
Quarterly Financial Information (Unaudited) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Quarterly Financial Information (Unaudited) | Note 18. Quarterly Financial Information (Unaudited) | ||||||||||||||||
The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2014 and 2013 (in thousands except per share amounts): | |||||||||||||||||
Three Months Ended | |||||||||||||||||
March 31, | June 30, | September 30, | December 31, | ||||||||||||||
2014 | 2014 | 2014 | 2014 | ||||||||||||||
Product revenue | $ | 7,866 | $ | 8,601 | $ | 10,362 | $ | 9,587 | |||||||||
Gross profit on product revenue | 3,709 | 3,849 | 4,673 | 2,997 | |||||||||||||
Net loss | $ | (225 | ) | $ | (7,589 | ) | $ | (10,759 | ) | $ | (20,182 | ) | |||||
Net loss per common share: | |||||||||||||||||
Basic | $ | (0.00 | ) | $ | (0.10 | ) | $ | (0.14 | ) | $ | (0.26 | ) | |||||
Diluted | $ | (0.12 | ) | $ | (0.16 | ) | $ | (0.16 | ) | $ | (0.26 | ) | |||||
Three Months Ended | |||||||||||||||||
March 31, | June 30, | September 30, | December 31, | ||||||||||||||
2013 | 2013 | 2013 | 2013 | ||||||||||||||
Product revenue | $ | 9,733 | $ | 10,150 | $ | 10,542 | $ | 9,232 | |||||||||
Gross profit on product revenue | 4,643 | 4,403 | 3,716 | 4,293 | |||||||||||||
Net loss | $ | (10,252 | ) | $ | (6,724 | ) | $ | (20,501 | ) | $ | (5,860 | ) | |||||
Net loss per common share: | |||||||||||||||||
Basic | $ | (0.17 | ) | $ | (0.10 | ) | $ | (0.29 | ) | $ | (0.08 | ) | |||||
Diluted | $ | (0.17 | ) | $ | (0.10 | ) | $ | (0.29 | ) | $ | (0.10 | ) |
Subsequent_Events_Unaudited
Subsequent Events (Unaudited) | 12 Months Ended |
Dec. 31, 2014 | |
Subsequent Events (Unaudited) | Note 19. Subsequent Events (Unaudited) |
In January 2015, the Company issued 14,636,363 shares of its common stock, par value $0.001 per share, in an underwritten public offering. The price to the public in the offering was $5.50 per share. The net proceeds from this offering were approximately $75.7 million, net of underwriting discounts and other issuance costs of $5.1 million. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Principles of Consolidation | Principles of Consolidation | ||||||||||||
The accompanying consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (together with Cerus Corporation, hereinafter “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). | |||||||||||||
Use of Estimates | Use of Estimates | ||||||||||||
The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, which are based on historical experience 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. | |||||||||||||
Reclassifications | Reclassifications | ||||||||||||
In 2014, certain reclassifications have been made to prior period reported amounts to conform to the current period presentations. Previously the Company had presented the amortization of premium and accretion of any discount resulting from the purchase of debt securities as a component of “Interest expense” on the consolidated statements of operations. The Company has reclassified approximately $0.2 million of the amortization of premium resulting from the purchase of debt securities as a component of “Other income, net” on the consolidated statements of operations. This reclassification had no impact on net loss, total assets or total stockholders’ equity. | |||||||||||||
Revenue | Revenue | ||||||||||||
The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 605-25, “Revenue Recognition—Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of the arrangement exists; (ii) delivery has occurred or services have been rendered; (iii) pricing is fixed or determinable; and (iv) collectibility is reasonably assured. The Company’s main sources of revenues for the years ended December 31, 2014, 2013 and 2012, were product revenue from sales of the INTERCEPT Blood System for platelets and plasma (“platelet and plasma systems”). | |||||||||||||
Revenue related to product sales is generally recognized when the Company fulfills its obligations for each element of an agreement. For all sales of the Company’s INTERCEPT Blood System products, the Company uses a binding purchase order and signed sales contract as evidence of an arrangement. The Company sells its platelet and plasma systems directly to blood banks, hospitals, universities, government agencies, as well as to distributors in certain regions. 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. Deliverables and the units of accounting vary according to the provisions of each purchase order or sales contract. For revenue arrangements with multiple elements, the Company determines whether the delivered elements meet the criteria as separate units of accounting. Such criteria require that the deliverable have stand-alone value to the customer and that if a general right of return exists relative to the delivered item, delivery or performance of the undelivered item(s) is considered probable and substantially in the control of the Company. Once the Company determines if the deliverable meets the criteria for a separate unit of accounting, the Company must determine how the consideration should be allocated between the deliverables and how the separate units of accounting should be recognized as revenue. Consideration received is allocated to elements that are identified as discrete units of accounting. Because the Company has no vendor specific objective evidence or third party evidence for its systems due to the Company’s variability in its pricing across the regions into which it sells its products, the allocation of revenue is based on best estimated selling price for the systems sold. The objective of best estimated selling price is to determine the price at which the Company would transact a sale, had the product been sold on a stand-alone basis. The Company determines best estimated selling price for its systems by considering multiple factors, including, but not limited to, features and functionality of the system, geographies, type of customer, and market conditions. The Company regularly reviews best estimated selling price. | |||||||||||||
At December 31, 2014 and 2013, the Company had $0.4 million and $0.2 million, respectively, of short-term deferred revenue on its consolidated balance sheets related to future performance obligations. At December 31, 2014 and 2013, the Company had $0.1 million and $0, respectively, of long-term deferred revenue included in “Other non-current liabilities” on it consolidated balance sheets related to future performance obligations. Freight costs charged to customers are recorded as a component of revenue under ASC Topic 605, “Accounting for Shipping and Handling Fees and Costs.” Value-added-taxes (“VAT”) that the Company invoices to its customers and remits to governments are recorded on a net basis, which excludes such VAT from product revenue. | |||||||||||||
Revenue related to the cost reimbursement provisions under development contracts or United States government grants was recognized as the costs on the projects were incurred. The Company received certain United States government grants and contracts that support research in defined research projects. These grants generally provided for reimbursement of approved costs incurred as defined in the various grants. There were no such government grants in 2014 or 2013 and none are expected in the foreseeable future. | |||||||||||||
Research and Development Expenses | Research and Development Expenses | ||||||||||||
In accordance with ASC Topic 730, “Accounting for Research and Development Expenses,” research and development expenses are charged to expense when incurred, including cost incurred under each grant that has been awarded to the Company by the United States government or development contracts. Research and development expenses include salaries and related expenses for scientific personnel, payments to consultants, supplies and chemicals used in in-house laboratories, costs of research and development 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 research and development activities (see “Use of Estimates” above) affects the amounts of research and development expenses recorded and revenue recorded from development funding and government grants and collaborative agreements. 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 designated as available-for-sale and classified as short-term investments, in accordance with ASC Topic 320, “Accounting for Certain Investments in Debt and Equity Securities”. Available-for-sale securities are carried at estimated fair value. Unrealized gains and losses derived by changes in the estimated fair value of available-for-sale securities were recorded in “Net unrealized losses on available-for-sale securities, net of taxes” on the Company’s consolidated statements of comprehensive loss. Realized gains (losses) from the sale of available-for-sale investments were recorded in “Other income, net” on the Company’s consolidated statements of operations. The cost of securities sold was based on the specific identification method. 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 marketable securities on a regular basis to evaluate whether any security has experienced an other-than-temporary decline in fair value. Other-than-temporary declines in market value, if any, are recorded in “Other income, net” on the Company’s consolidated statements of operations. | |||||||||||||
Restricted Cash | Restricted Cash | ||||||||||||
The Company holds a certificate of deposit with a domestic bank for any potential decommissioning resulting from the Company’s possession of radioactive material. The certificate of deposit is held to satisfy the financial surety requirements of the California Department of Health Services and is recorded in “Restricted cash” on the Company’s condensed consolidated balance sheets. The Company also has certain non-U.S. dollar denominated deposits recorded as “Restricted cash” in compliance with certain foreign contractual requirements. | |||||||||||||
Concentration of Credit Risk | Concentration of Credit Risk | ||||||||||||
Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash equivalents, short-term investments and accounts receivable. | |||||||||||||
Pursuant to the Company’s investment policy, substantially all of the Company’s cash, cash equivalents and short-term investments are maintained at a major financial institution 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. The Company has not experienced any losses in its investments and believes it is not exposed to any significant risk. | |||||||||||||
Concentrations of credit risk with respect to trade receivables exist. On a regular basis, including at the time of sale, the Company performs credit evaluations of its significant customers that it expects to sell to on credit terms. Generally, the Company does not require collateral from its customers to secure accounts receivable. To the extent that the Company determines specific invoices or customer accounts may be uncollectible, the Company establishes an allowance for doubtful accounts against the accounts receivable on its consolidated balance sheets and records a charge on its consolidated statements of operations as a component of selling, general and administrative expenses. | |||||||||||||
The Company had one customer and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at December 31, 2014 and 2013, respectively. These customers cumulatively represented approximately 36% and 48% of the Company’s outstanding trade receivables at December 31, 2014 and 2013, respectively. To date, the Company has not experienced collection difficulties from these customers. | |||||||||||||
Inventories | Inventories | ||||||||||||
At December 31, 2014 and 2013, inventory consisted of work-in-process and finished goods only. Finished goods include INTERCEPT disposable kits, UVA illumination devices (“illuminators”), and certain replacement parts for the illuminators. Platelet and plasma systems’ disposable kits generally have a two-year life 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 its affiliates, “Fresenius”) into the finished INTERCEPT disposable kits. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production of finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At December 31, 2014 and 2013, the Company classified its work-in-process inventory as a current asset on its consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective subsequent twelve-month period. | |||||||||||||
Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or market value. The Company uses significant judgment to analyze and determine if the composition of its inventory is obsolete, slow-moving or unsalable and frequently reviews such determinations. The Company writes-down specifically identified unusable, obsolete, slow-moving, or known unsalable inventory that has no alternative use in the period that it is first recognized by using a number of factors including product expiration dates, open and unfulfilled orders, and sales forecasts. Any write-down of its inventory to net realizable value establishes a new cost basis and will be maintained even if certain circumstances suggest that the inventory is recoverable in subsequent periods. Costs associated with the write-down of inventory are recorded in “Cost of product revenue” on the Company’s consolidated statements of operations. At December 31, 2014, and 2013, the Company had $0.1 million and $0.4 million, respectively, recorded for obsolete, expiring or unsalable product. | |||||||||||||
Property and Equipment, net | Property and Equipment, net | ||||||||||||
Property and equipment is comprised of furniture, equipment, 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. | |||||||||||||
Capitalization of Software Costs | Capitalization of Software Costs | ||||||||||||
The Company capitalizes certain significant costs incurred in the acquisition and development of software for internal use, including the costs of the software, materials, and consultants during the application development stage. Costs incurred prior to the application development stage, costs incurred once the application is substantially complete and ready for its intended use, and other costs not qualifying for capitalization, including training and maintenance costs, are charged to expense as incurred. At December 31, 2014, and 2013, the Company capitalized costs related to its enterprise resource planning software system of $1.8 million and zero, respectively. The capitalized costs associated with the enterprise resource planning system are being amortized over the estimated useful life of five years. | |||||||||||||
Costs incurred in connection with the development of software products for sale are accounted for in accordance with the ASC 985—Costs of Software to Be Sold, Leased or Marketed. Costs incurred prior to the establishment of technological feasibility are charged to research and development expense. Software development costs are capitalized after a product is determined to be technologically feasible and is in the process of being developed for market. | |||||||||||||
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 estimated useful life of ten years. The amortization of the Company’s intangible assets, net, is recorded in “Amortization of intangible assets” on the Company’s consolidated statements of operations. 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 two-step process to test goodwill for impairment; otherwise, goodwill is not considered impaired and no further testing is warranted. The Company may choose not to perform the qualitative assessment to test goodwill for impairment and proceed directly to the quantitative two-step process; however, the Company may revert to the qualitative assessment to test goodwill for impairment in any subsequent period. The first step of the two-step process 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 not considered impaired and, therefore, the second step of the impairment test is unnecessary. The second step of the two-step process, which is used to measure the amount of impairment loss, compares the implied fair value of each reporting unit’s goodwill, based on the present value of future cash flows, with the respective carrying amount of that goodwill. 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. | |||||||||||||
The Company performs an impairment test on its intangible assets, in accordance ASC Topic 360-10, “Property, Plant and Equipment,” 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. For further details regarding the impairment analysis, reference is made to the section below under “Long-lived Assets.” See Note 7 for further information regarding the Company’s impairment analysis and the valuation of goodwill and intangible assets, net. | |||||||||||||
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. The Company did not recognize impairment charges related to its long-lived assets during the years ended December 31, 2014, 2013 or 2012. | |||||||||||||
Foreign Currency Remeasurement | Foreign Currency Remeasurement | ||||||||||||
The functional currency of the Company’s foreign subsidiary is the United States dollar. Monetary assets and liabilities denominated in foreign currencies are remeasured in United States dollars using the exchange rates at the balance sheet date. Non-monetary assets and liabilities denominated in foreign currencies are remeasured in United States dollars using historical exchange rates. Revenues and expenses are remeasured using average exchange rates prevailing during the period. Remeasurements are recorded in the Company’s consolidated statements of operations. | |||||||||||||
Stock-Based Compensation | Stock-Based Compensation | ||||||||||||
The Company accounts for stock-based compensation in accordance with ASC Topic 718,“Compensation—Stock Compensation.” Stock-based compensation expense is measured at the grant-date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period, which is the vesting period, and is adjusted for estimated forfeitures. To the extent that stock options contain performance criteria for vesting, stock-based compensation is recognized once the performance criteria are probable of being achieved. | |||||||||||||
For stock-based awards issued to non-employees, the Company follows ASC Topic 505-50, “Equity Based Payment to Non-Employees” and considers the measurement date at which the fair value of the stock-based award is measured to be the earlier of (i) the date at which a commitment for performance by the grantee to earn the equity instrument is reached or (ii) the date at which the grantee’s performance is complete. The Company recognizes stock-based compensation expense for the fair value of the vested portion of the non-employee stock-based awards in its consolidated statements of operations. | |||||||||||||
See Note 13 for further information regarding the Company’s stock-based compensation assumptions and expenses. | |||||||||||||
Warrant Liability | Warrant Liability | ||||||||||||
In August 2009, and November 2010, the Company issued warrants to purchase an aggregate of 2.4 million and 3.7 million shares of common stock, respectively. The material terms of the warrants were identical under each issuance except for the exercise price, date issued and expiration date. In August 2014, all of the outstanding August 2009 warrants were exercised in full. The Company classifies warrants outstanding on the reporting date as a liability on its consolidated balance sheets as the warrants contain certain material terms which require the Company to purchase the warrants for cash in an amount equal to the value of the unexercised portion of the warrants in connection with certain change of control transactions. In addition, the Company may also be required to pay cash to a warrant holder under certain circumstances if the Company is unable to timely deliver the shares acquired upon warrant exercise to such holder. | |||||||||||||
The fair value of outstanding warrants is calculated using the Black-Scholes model and was adjusted accordingly at December 31, 2014. Prior to December 31, 2014, the Company calculated the fair value of these warrants using a combination of the Black-Scholes model and/or binomial-lattice option-pricing model. | |||||||||||||
Changes resulting from the revaluation of warrants to fair value are recorded in “Gain (loss) from revaluation of warrant liability” on the consolidated statements of operations. Upon the exercise or modification to remove the provisions which require the warrants to be treated as a liability, the fair value of the warrants will be reclassified from a liability to stockholders’ equity on the Company’s consolidated balance sheets and no further adjustment to the fair value would be made in subsequent periods. | |||||||||||||
See Note 12 for further information regarding the Company’s valuation of warrant liability. | |||||||||||||
Income Taxes | Income Taxes | ||||||||||||
The Company accounts for income taxes using the asset and liability approach in accordance with ASC Topic 740 “Accounting for Income Taxes.” Under this method, 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. ASC Topic 740 requires derecognition of 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 as described in ASC Topic 740 is not an appropriate substitute for the derecognition of a tax position. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax expense. To date, the Company has not recognized any interest and penalties in its consolidated statements of operations, nor has it accrued for or made payments for interest and penalties. The Company had no unrecognized tax benefits as of December 31, 2014 and 2013. The Company continues to carry a full valuation allowance on all of its deferred tax assets. 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. | |||||||||||||
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, warrants and restricted stock units, which are calculated using the treasury stock method, and convertible preferred stock, which is calculated using the if-converted method. Diluted net loss per share also gives effect to potential adjustments to the numerator for gains resulting from the revaluation of warrants to fair value for the period, even if the Company is in a net loss position if the effect would result in more dilution. | |||||||||||||
Diluted net loss per common share used the same weighted average number of common shares outstanding for the year ended December 31, 2013, as calculated for the basic net loss per common share as the inclusion of any potential dilutive securities would be anti-dilutive. Certain potential dilutive securities were excluded from the dilution calculation for the years ended December 31, 2014 and 2012, as their inclusion would have been anti-dilutive. | |||||||||||||
The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the years ended December 31, 2014, 2013 and 2012 (in thousands, except per share amounts): | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Numerator for Basic and Diluted: | |||||||||||||
Net loss used for basic calculation | $ | (38,755 | ) | $ | (43,337 | ) | $ | (15,917 | ) | ||||
Effect of revaluation of warrant liability | (7,708 | ) | 0 | (2,059 | ) | ||||||||
Adjusted net loss used for dilution calculation | $ | (46,463 | ) | $ | (43,337 | ) | $ | (17,976 | ) | ||||
Denominator: | |||||||||||||
Basic weighted average number of shares outstanding | 74,767 | 67,569 | 54,515 | ||||||||||
Effect of dilutive potential shares | 1,767 | 0 | 546 | ||||||||||
Diluted weighted average number of shares outstanding | 76,534 | 67,569 | 55,061 | ||||||||||
Net loss per share: | |||||||||||||
Basic | $ | (0.52 | ) | $ | (0.64 | ) | $ | (0.29 | ) | ||||
Diluted | $ | (0.61 | ) | $ | (0.64 | ) | $ | (0.33 | ) | ||||
The table below presents shares underlying stock options, employee stock purchase plan rights, warrants, restricted stock units and/or convertible preferred stock 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 were excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2014, 2013 and 2012 (shares in thousands): | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Weighted average number of anti-dilutive potential shares | 11,722 | 16,370 | 8,716 | ||||||||||
Guarantee and Indemnification Arrangements | Guarantee and Indemnification Arrangements | ||||||||||||
The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company. In addition, the Company monitors the conditions that are subject to the guarantees and indemnifications in order to identify if a loss has occurred. If the Company determines it is probable that a loss has occurred, then any such estimable loss would be recognized under those guarantees and indemnifications. Some of the agreements that the Company is a party to contain provisions that indemnify the counter party from damages and costs resulting from claims that the Company’s technology infringes the intellectual property rights of a third party or claims that the sale or use of the Company’s products have caused personal injury or other damage or loss. The Company has not received any such requests for indemnification under these provisions and has not been required to make material payments pursuant to these provisions. | |||||||||||||
The Company generally provides for a one-year warranty on certain of its INTERCEPT blood-safety products covering defects in materials and workmanship. The Company accrues costs associated with warranty obligations when claims become known and are estimable. The Company has not experienced significant or systemic warranty claims nor is it aware of any existing current warranty claims. Accordingly, the Company had not accrued for any future warranty costs for its products at December 31, 2014 or 2013. | |||||||||||||
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 and warrant liability. 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 available-for-sale securities related to corporate debt and United States government agency securities. 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, which include its warrant liability. The Company assesses any transfers among fair value measurement levels at the end of each reporting period. | |||||||||||||
See Notes 3 and 12 for further information regarding the Company’s valuation on financial instruments. | |||||||||||||
New Accounting Pronouncements | New Accounting Pronouncements | ||||||||||||
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which provides a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and will supersede most current revenue recognition guidance. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. The ASU’s effective date for the Company will be the first quarter of fiscal year 2017, using one of two retrospective application methods. Early adoption is not permitted. The Company has not selected a transition method and is currently assessing the potential effects of this ASU on its consolidated financial statements. | |||||||||||||
In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, which requires management to evaluate, in connection with preparing financial statements for each annual and interim reporting period, whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern within one year after the date that the financial statements are issued and provide related disclosures. This ASU will be effective for the Company in fiscal year 2016. Early adoption is permitted. The Company is currently assessing the future impact of this ASU on its consolidated financial statements. |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Computation of Basic and Diluted Net Loss per Share | The following table sets forth the reconciliation of the numerator and denominator used in the computation of basic and diluted net loss per share for the years ended December 31, 2014, 2013 and 2012 (in thousands, except per share amounts): | ||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Numerator for Basic and Diluted: | |||||||||||||
Net loss used for basic calculation | $ | (38,755 | ) | $ | (43,337 | ) | $ | (15,917 | ) | ||||
Effect of revaluation of warrant liability | (7,708 | ) | 0 | (2,059 | ) | ||||||||
Adjusted net loss used for dilution calculation | $ | (46,463 | ) | $ | (43,337 | ) | $ | (17,976 | ) | ||||
Denominator: | |||||||||||||
Basic weighted average number of shares outstanding | 74,767 | 67,569 | 54,515 | ||||||||||
Effect of dilutive potential shares | 1,767 | 0 | 546 | ||||||||||
Diluted weighted average number of shares outstanding | 76,534 | 67,569 | 55,061 | ||||||||||
Net loss per share: | |||||||||||||
Basic | $ | (0.52 | ) | $ | (0.64 | ) | $ | (0.29 | ) | ||||
Diluted | $ | (0.61 | ) | $ | (0.64 | ) | $ | (0.33 | ) | ||||
Anti-Dilutive Effect of Common Shares | The table below presents shares underlying stock options, employee stock purchase plan rights, warrants, restricted stock units and/or convertible preferred stock 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 were excluded from the calculation due to their anti-dilutive effect for the years ended December 31, 2014, 2013 and 2012 (shares in thousands): | ||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Weighted average number of anti-dilutive potential shares | 11,722 | 16,370 | 8,716 |
Fair_Value_on_Financial_Instru1
Fair Value on Financial Instruments (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Fair Values of Financial Assets and Liabilities | The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2014 (in thousands): | ||||||||||||||||
Total | Quoted | Significant | Significant | ||||||||||||||
Prices in | Other | Unobservable | |||||||||||||||
Active | Observable | Inputs | |||||||||||||||
Markets for | Inputs | (Level 3) | |||||||||||||||
Identical | (Level 2) | ||||||||||||||||
Assets | |||||||||||||||||
(Level 1) | |||||||||||||||||
Money market funds(1) | $ | 3,912 | $ | 3,912 | $ | 0 | $ | 0 | |||||||||
Corporate debt securities(2) | 26,088 | 0 | 26,088 | 0 | |||||||||||||
United States government agency securities(2) | 3,426 | 0 | 3,426 | 0 | |||||||||||||
Total financial assets | $ | 33,426 | $ | 3,912 | $ | 29,514 | $ | 0 | |||||||||
Warrant liability(3) | $ | 10,485 | $ | 0 | $ | 0 | $ | 10,485 | |||||||||
Total financial liabilities | $ | 10,485 | $ | 0 | $ | 0 | $ | 10,485 | |||||||||
-1 | Included in cash and cash equivalents on the Company’s consolidated balances sheets. | ||||||||||||||||
-2 | Included in short-term investments on the Company’s consolidated balance sheets, except for approximately $1.0 million of corporate debt securities that are included in cash and cash equivalents on the Company’s consolidated balance sheets. | ||||||||||||||||
-3 | Included in current liabilities on the Company’s consolidated balance sheets. | ||||||||||||||||
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at December 31, 2013 (in thousands): | |||||||||||||||||
Total | Quoted | Significant | Significant | ||||||||||||||
Prices in | Other | Unobservable | |||||||||||||||
Active | Observable | Inputs | |||||||||||||||
Markets for | Inputs | (Level 3) | |||||||||||||||
Identical | (Level 2) | ||||||||||||||||
Assets | |||||||||||||||||
(Level 1) | |||||||||||||||||
Money market funds(1) | $ | 8,650 | $ | 8,650 | $ | 0 | $ | 0 | |||||||||
Corporate debt securities(2) | 23,173 | 0 | 23,173 | 0 | |||||||||||||
United States government agency securities(2) | 5,018 | 0 | 5,018 | 0 | |||||||||||||
Total financial assets | $ | 36,841 | $ | 8,650 | $ | 28,191 | $ | 0 | |||||||||
Warrant liability(3) | $ | 20,390 | $ | 0 | $ | 0 | $ | 20,390 | |||||||||
Total financial liabilities | $ | 20,390 | $ | 0 | $ | 0 | $ | 20,390 | |||||||||
-1 | Included in cash and cash equivalents on the Company’s consolidated balances sheets. | ||||||||||||||||
-2 | Included in short-term investments on the Company’s consolidated balance sheets. | ||||||||||||||||
-3 | Included in current liabilities on the Company’s consolidated balance sheets. | ||||||||||||||||
Reconciliation of Fair Value Measurement on Liabilities Using Significant Unobservable Inputs | A reconciliation of the beginning and ending balances for warrant liability using significant unobservable inputs (Level 3) from December 31, 2012 to December 31, 2014, was as follows (in thousands): | ||||||||||||||||
Balance at December 31, 2012 | $ | 5,903 | |||||||||||||||
Increase in fair value of warrants | 15,099 | ||||||||||||||||
Settlement of warrants exercised | (612 | ) | |||||||||||||||
Balance at December 31, 2013 | 20,390 | ||||||||||||||||
Decrease in fair value of warrants | (7,708 | ) | |||||||||||||||
Settlement of warrants exercised | (2,197 | ) | |||||||||||||||
Balance at December 31, 2014 | $ | 10,485 | |||||||||||||||
Availableforsale_Securities_Ta
Available-for-sale Securities (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Summary of Available for Sale Securities | The following is a summary of available-for-sale securities at December 31, 2014 (in thousands): | ||||||||||||||||
December 31, 2014 | |||||||||||||||||
Amortized Cost | Gross | Fair Value | |||||||||||||||
Unrealized Loss | |||||||||||||||||
Money market funds | $ | 3,912 | $ | 0 | $ | 3,912 | |||||||||||
United States government agency securities | 3,427 | (1 | ) | 3,426 | |||||||||||||
Corporate debt securties | 26,118 | (30 | ) | 26,088 | |||||||||||||
Total available-for-sale securities | $ | 33,457 | ($ | 31 | ) | $ | 33,426 | ||||||||||
The following is a summary of available-for-sale securities at December 31, 2013 (in thousands): | |||||||||||||||||
December 31, 2013 | |||||||||||||||||
Amortized Cost | Gross | Fair Value | |||||||||||||||
Unrealized (Loss) | |||||||||||||||||
Gain | |||||||||||||||||
Money market funds | $ | 8,650 | $ | 0 | $ | 8,650 | |||||||||||
United States government agency securities | 5,019 | (1 | ) | 5,018 | |||||||||||||
Corporate debt securties | 23,165 | 8 | 23,173 | ||||||||||||||
Total available-for-sale securities | $ | 36,834 | $ | 7 | $ | 36,841 | |||||||||||
Available for Sale Securities by Original Contractual Maturity | Available-for-sale securities at December 31, 2014 and 2013, consisted of the following by original contractual maturity (in thousands): | ||||||||||||||||
December 31, 2014 | December 31, 2013 | ||||||||||||||||
Amortized | Fair Value | Amortized | Fair Value | ||||||||||||||
Cost | Cost | ||||||||||||||||
One year or less | $ | 27,752 | $ | 27,727 | $ | 30,700 | $ | 30,701 | |||||||||
Greater than one year and less than five years | 5,705 | 5,699 | 6,134 | 6,140 | |||||||||||||
Total available-for-sale securities | $ | 33,457 | $ | 33,426 | $ | 36,834 | $ | 36,841 | |||||||||
Inventories_Tables
Inventories (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Inventories | Inventories at December 31, 2014 and 2013, consisted of the following (in thousands): | ||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Work-in-process | $ | 2,222 | $ | 4,863 | |||||
Finished goods | 12,734 | 8,200 | |||||||
Total inventories | $ | 14,956 | $ | 13,063 | |||||
Property_and_Equipment_net_Tab
Property and Equipment, net (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Property and Equipment, Net | Property and equipment, net at December 31, 2014 and 2013, consisted of the following (in thousands): | ||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Leasehold improvements | $ | 5,638 | $ | 5,628 | |||||
Machinery and equipment | 1,351 | 1,751 | |||||||
Demonstration equipment | 123 | 100 | |||||||
Office furniture | 783 | 763 | |||||||
Computer equipment | 663 | 651 | |||||||
Computer software | 2,913 | 1,083 | |||||||
Consigned demonstration equipment | 980 | 642 | |||||||
Construction-in-progress | 150 | 155 | |||||||
Total property and equipment, gross | 12,601 | 10,773 | |||||||
Accumulated depreciation and amortization | (8,820 | ) | (8,584 | ) | |||||
Total property and equipment, net | $ | 3,781 | $ | 2,189 | |||||
Goodwill_and_Intangible_Assets1
Goodwill and Intangible Assets, net (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Summary of Intangible Assets | The following is a summary of intangible assets, net at December 31, 2014 (in thousands): | ||||||||||||
December 31, 2014 | |||||||||||||
Gross Carrying | Accumulated | Net Carrying | |||||||||||
Amount | Amortization | Amount | |||||||||||
Acquisition-related intangible assets: | |||||||||||||
Reacquired license—INTERCEPT Asia | $ | 2,017 | $ | (875 | ) | $ | 1,142 | ||||||
Total intangible assets | $ | 2,017 | $ | (875 | ) | $ | 1,142 | ||||||
The following is a summary of intangible assets, net at December 31, 2013 (in thousands): | |||||||||||||
December 31, 2013 | |||||||||||||
Gross Carrying | Accumulated | Net Carrying | |||||||||||
Amount | Amortization | Amount | |||||||||||
Acquisition-related intangible assets: | |||||||||||||
Reacquired license—INTERCEPT Asia | $ | 2,017 | $ | (673 | ) | $ | 1,344 | ||||||
Total intangible assets | $ | 2,017 | $ | (673 | ) | $ | 1,344 | ||||||
Accrued_Liabilities_Tables
Accrued Liabilities (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued Liabilities | Accrued liabilities at December 31, 2014 and 2013, consisted of the following (in thousands): | ||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
Accrued compensation and related costs | $ | 3,951 | $ | 2,527 | |||||
Accrued professional services | 2,123 | 2,722 | |||||||
Accrued inventory costs | 870 | 3,553 | |||||||
Accrued customer costs | 385 | 59 | |||||||
Accrued insurance premiums | 264 | 226 | |||||||
Other accrued expenses | 851 | 726 | |||||||
Total accrued liabilities | $ | 8,444 | $ | 9,813 | |||||
Debt_Tables
Debt (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Debt | Debt at December 31, 2014, consisted of the following (in thousands): | ||||||||||||
December 31, 2014 | |||||||||||||
Principal | Unamortized | Net Carrying | |||||||||||
Discount | Value | ||||||||||||
Loan and Security Agreement | $ | 10,000 | $ | (128 | ) | $ | 9,872 | ||||||
Less: debt—current | 0 | 0 | 0 | ||||||||||
Debt—non-current | $ | 10,000 | $ | (128 | ) | $ | 9,872 | ||||||
Expected Principal and Interest Payments on Debt | Principal and interest payments on debt at December 31, 2014, are expected to be as follows*: | ||||||||||||
Year ended December 31, | Principal | Interest | Total | ||||||||||
2015 | $ | — | $ | 695 | $ | 695 | |||||||
2016 | 2,614 | 613 | 3,227 | ||||||||||
2017 | 2,802 | 425 | 3,227 | ||||||||||
2018 | 3,003 | 224 | 3,227 | ||||||||||
2019 | 1,581 | 733 | 2,314 | ||||||||||
Total | $ | 10,000 | $ | 2,690 | $ | 12,690 | |||||||
* | Unless interest only period extends to December 31, 2016, as described below. |
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 12 Months Ended | ||||
Dec. 31, 2014 | |||||
Future Minimum Non-Cancelable Lease Payments Under Operating Leases | Future minimum non-cancelable lease payments under operating leases as of December 31, 2014, are as follows (in thousands): | ||||
Year ended December 31, | |||||
2015 | $ | 891 | |||
2016 | 163 | ||||
2017 | 93 | ||||
2018 | 25 | ||||
2019 and thereafter | 0 | ||||
Total minimum non-cancellable lease payments | $ | 1,172 | |||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Fair Value of Warrants Outstanding | The fair value of the warrants outstanding at December 31, 2014 and 2013, consisted of the following (in thousands): | ||||||||
December 31, | |||||||||
2014 | 2013 | ||||||||
2009 Warrants | $ | — | $ | 8,542 | |||||
2010 Warrants | 10,485 | 11,848 | |||||||
Total warrant liability | $ | 10,485 | $ | 20,390 | |||||
Fair Value Assumptions of Warrants | The fair value of the Company’s warrants was based on option valuation model and using the following assumptions at December 31, 2014 and 2013: | ||||||||
December 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
2009 Warrants: | |||||||||
Expected term (in years) | — | 0.65 | |||||||
Estimated volatility | — | 45% | |||||||
Risk-free interest rate | — | 0.10% | |||||||
Expected dividend yield | — | 0% | |||||||
December 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
2010 Warrants: | |||||||||
Expected term (in years) | 0.86 | 1.86 | |||||||
Estimated volatility | 55% | 41% | |||||||
Risk-free interest rate | 0.25% | 0.38% | |||||||
Expected dividend yield | 0% | 0% |
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
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 weighted average exercise price): | ||||||||||||||||
Number of | Weighted Average | ||||||||||||||||
Options | Exercise Price per | ||||||||||||||||
Outstanding | Share | ||||||||||||||||
Balances at December 31, 2013 | 10,405 | $ | 3.46 | ||||||||||||||
Granted | 2,783 | 5.9 | |||||||||||||||
Forfeited | (233 | ) | 4.31 | ||||||||||||||
Expired | (114 | ) | 8.64 | ||||||||||||||
Exercised | (1,518 | ) | 2.44 | ||||||||||||||
Balances at December 31, 2014 | 11,323 | 4.13 | |||||||||||||||
Information Regarding Stock Options Outstanding Stock Options Vested and Expected to Vest and Stock Options Exercisable | Information regarding the Company’s stock options outstanding, stock options vested and expected to vest, and stock options exercisable at December 31, 2014, was as follows (in thousands except weighted average exercise price and contractual term): | ||||||||||||||||
Number | Weighted | Weighted | Aggregate | ||||||||||||||
of Shares | Average | Average | Intrinsic | ||||||||||||||
Exercise | Remaining | Value | |||||||||||||||
Price | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Balances at December 31, 2014 | |||||||||||||||||
Stock options outstanding | 11,323 | $ | 4.13 | 6.8 | $ | 25,517 | |||||||||||
Stock options vested and expected to vest | 10,920 | $ | 4.08 | 6.7 | $ | 25,174 | |||||||||||
Stock options exercisable | 7,006 | $ | 3.7 | 5.7 | $ | 19,324 | |||||||||||
Recognition of Stock-Based Compensation Expense | Stock-based compensation expense recognized on the Company’s consolidated statements of operations for the years ended December 31, 2014, 2013 and 2012, was as follows (in thousands): | ||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Stock-based compensation expense by caption: | |||||||||||||||||
Research and development | $ | 998 | $ | 482 | $ | 554 | |||||||||||
Selling, general and administrative | 4,155 | 2,786 | 1,987 | ||||||||||||||
Total stock-based compensation expense | $ | 5,153 | $ | 3,268 | $ | 2,541 | |||||||||||
Weighted Average Assumptions Used to Value Stock-Based Awards | The weighted average assumptions used to value the Company’s stock-based awards for the years ended December 31, 2014, 2013 and 2012, was as follows: | ||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Stock Options: | |||||||||||||||||
Expected term (in years) | 5.71 | 5.59 | 5.54 | ||||||||||||||
Estimated volatility | 61 | % | 60 | % | 67 | % | |||||||||||
Risk-free interest rate | 1.73 | % | 0.87 | % | 1.03 | % | |||||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % | |||||||||||
Employee Stock Purchase Plan Rights: | |||||||||||||||||
Expected term (in years) | 0.76 | 0.5 | 0.5 | ||||||||||||||
Estimated volatility | 52 | % | 39 | % | 101 | % | |||||||||||
Risk-free interest rate | 0.1 | % | 0.1 | % | 0.14 | % | |||||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % |
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
United States and Foreign Components of Consolidated Loss Before Income Taxes | U.S and foreign components of consolidated loss before income taxes for the years ended December 2014, 2013 and 2012, was as follows (in thousands): | ||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Loss before income taxes: | |||||||||||||
U.S. | $ | (38,928 | ) | $ | (44,035 | ) | $ | (16,360 | ) | ||||
Foreign | 368 | 916 | 685 | ||||||||||
Loss before income taxes | $ | (38,560 | ) | $ | (43,119 | ) | $ | (15,675 | ) | ||||
Provision Benefit for Income Taxes | The provision for income taxes for the years ended December 2014, 2013 and 2012, was as follows (in thousands): | ||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Provision for income taxes: | |||||||||||||
Current: | |||||||||||||
Foreign | $ | 168 | $ | 191 | $ | 180 | |||||||
Federal | 0 | 0 | 0 | ||||||||||
State | 1 | 0 | 0 | ||||||||||
Total Current | 169 | 191 | 180 | ||||||||||
Deferred: | |||||||||||||
Foreign | 0 | 0 | 0 | ||||||||||
Federal | 22 | 21 | 48 | ||||||||||
State | 4 | 6 | 14 | ||||||||||
Total Deferred | 26 | 27 | 62 | ||||||||||
Provision for income taxes | $ | 195 | $ | 218 | $ | 242 | |||||||
Difference Between Provision for Income Taxes and Amounts Computed by Applying Federal Statutory Income Tax Rate to Loss before Taxes | The difference between the provision for income taxes and the amount computed by applying the federal statutory income tax rate to loss before taxes for the years ended December 31, 2014, 2013 and 2012, was as follows (in thousands): | ||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Federal statutory tax | $ | (13,110 | ) | $ | (14,661 | ) | $ | (5,329 | ) | ||||
Stock-based compensation | (8 | ) | (10 | ) | 99 | ||||||||
Lobbying expenses | 33 | 107 | 51 | ||||||||||
Warrants | (3,367 | ) | 4,926 | (706 | ) | ||||||||
Foreign rate differential | 43 | (121 | ) | (53 | ) | ||||||||
Expiration of federal net operating losses and credits—tax effected | 0 | 0 | 4,352 | ||||||||||
Change in valuation allowance | 16,576 | 9,955 | 1,809 | ||||||||||
Other | 28 | 22 | 19 | ||||||||||
Provision for income taxes | $ | 195 | $ | 218 | $ | 242 | |||||||
Significant Components of Deferred Tax Assets | The significant components of the Company’s deferred tax assets at December 31, 2014 and 2013, were as follows (in thousands): | ||||||||||||
December 31, | |||||||||||||
2014 | 2013 | ||||||||||||
Deferred tax assets: | |||||||||||||
Net operating loss carryforwards | $ | 151,100 | $ | 142,500 | |||||||||
Research and development credit carryforwards | 33,800 | 32,100 | |||||||||||
Capitalized research and development | 15,500 | 12,300 | |||||||||||
Deferred compensation | 5,800 | 4,900 | |||||||||||
Capital loss carryforwards | 3,700 | 3,900 | |||||||||||
Other | 3,200 | 3,300 | |||||||||||
Total deferred tax assets | 213,100 | 199,000 | |||||||||||
Valuation allowance | (213,100 | ) | (199,000 | ) | |||||||||
Net deferred tax assets | 0 | 0 | |||||||||||
Deferred tax liabilities: | |||||||||||||
Amortization of goodwill | 115 | 89 | |||||||||||
Total deferred tax liabilities | $ | 115 | $ | 89 | |||||||||
Segment_Customer_and_Geographi1
Segment, Customer and Geographic Information (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Customers 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, all of which operate in a country outside of the United States, during the years ended December 31, 2014, 2013 and 2012 (in percentages): | ||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Etablissement Francais du Sang | 25 | % | 17 | % | 20 | % | |||||||
Grifols | * | 18 | % | 19 | % | ||||||||
Delrus Inc. | * | * | 12 | % | |||||||||
* | Represents an amount less than 10% of product revenue. | ||||||||||||
Net Revenues and Long-Lived Assets by Geographical Location | Revenues by geographical location was based on the location of the customer, in the case of product revenues, and in the location of the collaboration partner, in the case of non-product revenues, during the years ended December 31, 2014, 2013 and 2012 and was as follows (in thousands): | ||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Product Revenue: | |||||||||||||
France | $ | 9,184 | $ | 7,030 | $ | 7,321 | |||||||
Spain and Portugal | 2,776 | 7,033 | 7,061 | ||||||||||
CIS | 6,636 | 8,220 | 8,016 | ||||||||||
Belgium | 4,456 | 3,971 | 4,016 | ||||||||||
Switzerland | 3,784 | 4,078 | 3,866 | ||||||||||
Other countries | 9,580 | 9,325 | 6,415 | ||||||||||
Total product revenue | 36,416 | 39,657 | 36,695 | ||||||||||
Government grants and cooperative agreements: | |||||||||||||
United States | 0 | 0 | 91 | ||||||||||
Total government grants and cooperative agreements | 0 | 0 | 91 | ||||||||||
Total revenue | $ | 36,416 | $ | 39,657 | $ | 36,786 | |||||||
Long-lived assets by geographical location, which consist of property and equipment, net and intangible assets, net, at December 31, 2014 and 2013, were as follows (in thousands): | |||||||||||||
December 31, | |||||||||||||
2014 | 2013 | ||||||||||||
United States | $ | 4,624 | $ | 3,088 | |||||||||
Europe & other | 299 | 445 | |||||||||||
Total long-lived assets | $ | 4,923 | $ | 3,533 | |||||||||
Quarterly_Financial_Informatio1
Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Quarterly Unaudited Financial Data | The following tables summarize the Company’s quarterly financial information for the years ended December 31, 2014 and 2013 (in thousands except per share amounts): | ||||||||||||||||
Three Months Ended | |||||||||||||||||
March 31, | June 30, | September 30, | December 31, | ||||||||||||||
2014 | 2014 | 2014 | 2014 | ||||||||||||||
Product revenue | $ | 7,866 | $ | 8,601 | $ | 10,362 | $ | 9,587 | |||||||||
Gross profit on product revenue | 3,709 | 3,849 | 4,673 | 2,997 | |||||||||||||
Net loss | $ | (225 | ) | $ | (7,589 | ) | $ | (10,759 | ) | $ | (20,182 | ) | |||||
Net loss per common share: | |||||||||||||||||
Basic | $ | (0.00 | ) | $ | (0.10 | ) | $ | (0.14 | ) | $ | (0.26 | ) | |||||
Diluted | $ | (0.12 | ) | $ | (0.16 | ) | $ | (0.16 | ) | $ | (0.26 | ) | |||||
Three Months Ended | |||||||||||||||||
March 31, | June 30, | September 30, | December 31, | ||||||||||||||
2013 | 2013 | 2013 | 2013 | ||||||||||||||
Product revenue | $ | 9,733 | $ | 10,150 | $ | 10,542 | $ | 9,232 | |||||||||
Gross profit on product revenue | 4,643 | 4,403 | 3,716 | 4,293 | |||||||||||||
Net loss | $ | (10,252 | ) | $ | (6,724 | ) | $ | (20,501 | ) | $ | (5,860 | ) | |||||
Net loss per common share: | |||||||||||||||||
Basic | $ | (0.17 | ) | $ | (0.10 | ) | $ | (0.29 | ) | $ | (0.08 | ) | |||||
Diluted | $ | (0.17 | ) | $ | (0.10 | ) | $ | (0.29 | ) | $ | (0.10 | ) |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 12 Months Ended | ||||
Share data in Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Aug. 31, 2009 | Nov. 30, 2010 |
Segment | Customer | ||||
Customer | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Deferred revenue | $376,000 | $181,000 | |||
Long-term deferred revenue | 100,000 | 0 | |||
Revenue from government grants | 0 | 0 | 91,000 | ||
Number of major customers representing outstanding trade receivables | 1 | 2 | |||
Life of inventory | 2 years | ||||
Protracted length of inventory | 1 year | ||||
Inventory valuation reserves | 100,000 | 400,000 | |||
Capitalized costs for enhancement of enterprise resource planning software system and other internal use software | 1,800,000 | 0 | |||
Estimated useful life of intangible assets | 10 years | ||||
Number of reportable segments | 1 | ||||
Impairment charges on long-lived assets | 0 | 0 | 0 | ||
Unrecognized Tax Benefits | 0 | 0 | |||
Period of warranty | 1 year | ||||
Computer Software, Intangible Asset | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Enterprise resource planning system, estimated useful life | 5 years | ||||
2009 Unit Offering | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Warrants to purchase an aggregate shares of common stock | 2.4 | ||||
2010 Unit Offering | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Warrants to purchase an aggregate shares of common stock | 3.7 | ||||
Other income, net | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Reclassified amortization of premium from purchase of debt securities | $200,000 | ||||
Trade Accounts Receivable | Customer Concentration Risk | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Cumulative outstanding trade receivables percentage by major customers | 36.00% | 48.00% | |||
Minimum | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Estimated useful life of property and equipment | 3 years | ||||
Maximum | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Estimated useful life of property and equipment | 5 years |
Reconciliation_of_Numerator_an
Reconciliation of Numerator and Denominator Used in Computation of Basic and Diluted Net Income Loss per Share (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Numerator for Basic and Diluted: | |||||||||||
Net loss used for basic calculation | ($20,182) | ($10,759) | ($7,589) | ($225) | ($5,860) | ($20,501) | ($6,724) | ($10,252) | ($38,755) | ($43,337) | ($15,917) |
Effect of revaluation of warrant liability | -7,708 | 0 | -2,059 | ||||||||
Adjusted net loss used for dilution calculation | ($46,463) | ($43,337) | ($17,976) | ||||||||
Denominator: | |||||||||||
Basic weighted average number of shares outstanding | 74,767 | 67,569 | 54,515 | ||||||||
Effect of dilutive potential shares | 1,767 | 0 | 546 | ||||||||
Diluted weighted average number of shares outstanding | 76,534 | 67,569 | 55,061 | ||||||||
Net loss per share: | |||||||||||
Basic | ($0.26) | ($0.14) | ($0.10) | $0 | ($0.08) | ($0.29) | ($0.10) | ($0.17) | ($0.52) | ($0.64) | ($0.29) |
Diluted | ($0.26) | ($0.16) | ($0.16) | ($0.12) | ($0.10) | ($0.29) | ($0.10) | ($0.17) | ($0.61) | ($0.64) | ($0.33) |
Shares_Underlying_Stock_Option
Shares Underlying Stock Options, Employee Stock Purchase Plan Rights, Warrants and Restricted Stock Units Excluded from Calculation of Weighted Average Number of Shares Outstanding used for Calculation of Diluted Net Income Loss Per Share (Detail) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted average number of anti-dilutive potential shares | 11,722 | 16,370 | 8,716 |
Fair_Values_on_Financial_Asset
Fair Values on Financial Assets and Liabilities (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | ||
In Thousands, unless otherwise specified | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | $33,426 | $36,841 | ||
Total financial liabilities | 10,485 | 20,390 | ||
Money market funds | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 3,912 | [1] | 8,650 | [1] |
Corporate debt securities | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 26,088 | [2] | 23,173 | [3] |
United States government agency securities | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 3,426 | [2] | 5,018 | [3] |
Warrant Liability | ||||
Fair value of financial assets and liabilities | ||||
Total financial liabilities | 10,485 | [4] | 20,390 | [4] |
Level 1 | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 3,912 | 8,650 | ||
Total financial liabilities | 0 | 0 | ||
Level 1 | Money market funds | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 3,912 | [1] | 8,650 | [1] |
Level 1 | Corporate debt securities | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 0 | [2] | 0 | [3] |
Level 1 | United States government agency securities | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 0 | [2] | 0 | [3] |
Level 1 | Warrant Liability | ||||
Fair value of financial assets and liabilities | ||||
Total financial liabilities | 0 | [4] | 0 | [4] |
Level 2 | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 29,514 | 28,191 | ||
Total financial liabilities | 0 | 0 | ||
Level 2 | Money market funds | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 0 | [1] | 0 | [1] |
Level 2 | Corporate debt securities | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 26,088 | [2] | 23,173 | [3] |
Level 2 | United States government agency securities | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 3,426 | [2] | 5,018 | [3] |
Level 2 | Warrant Liability | ||||
Fair value of financial assets and liabilities | ||||
Total financial liabilities | 0 | [4] | 0 | [4] |
Level 3 | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 0 | 0 | ||
Total financial liabilities | 10,485 | 20,390 | ||
Level 3 | Money market funds | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 0 | [1] | 0 | [1] |
Level 3 | Corporate debt securities | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 0 | [2] | 0 | [3] |
Level 3 | United States government agency securities | ||||
Fair value of financial assets and liabilities | ||||
Total financial assets | 0 | [2] | 0 | [3] |
Level 3 | Warrant Liability | ||||
Fair value of financial assets and liabilities | ||||
Total financial liabilities | $10,485 | [4] | $20,390 | [4] |
[1] | Included in cash and cash equivalents on the Company's consolidated balances sheets. | |||
[2] | Included in short-term investments on the Company's consolidated balance sheets, except for approximately $1.0 million of corporate debt securities that are included in cash and cash equivalents on the Company's consolidated balance sheets. | |||
[3] | Included in short-term investments on the Company's consolidated balance sheets. | |||
[4] | Included in current liabilities on the Company's consolidated balance sheets. |
Fair_Values_on_Financial_Asset1
Fair Values on Financial Assets and Liabilities (Parenthetical) (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
In Thousands, unless otherwise specified | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Cash and cash equivalents | $22,781 | $29,485 | $26,696 | $25,497 |
Corporate debt securities | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Cash and cash equivalents | $1,000 |
Reconciliation_of_Beginning_an
Reconciliation of Beginning and Ending Balances for Warrant Liability Using Significant Unobservable Inputs (Detail) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | $20,390 | $5,903 |
Increase / (Decrease)in fair value of warrants | -7,708 | 15,099 |
Settlement of warrants exercised | -2,197 | -612 |
Ending balance | $10,485 | $20,390 |
Summary_of_Available_for_Sale_
Summary of Available for Sale Securities (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $33,457 | $36,834 |
Gross Unrealized (Loss) Gain | -31 | 7 |
Fair Value | 33,426 | 36,841 |
Money market funds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 3,912 | 8,650 |
Gross Unrealized (Loss) Gain | 0 | 0 |
Fair Value | 3,912 | 8,650 |
United States government agency securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 3,427 | 5,019 |
Gross Unrealized (Loss) Gain | -1 | -1 |
Fair Value | 3,426 | 5,018 |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 26,118 | 23,165 |
Gross Unrealized (Loss) Gain | -30 | 8 |
Fair Value | $26,088 | $23,173 |
Available_for_Sale_Securities_
Available for Sale Securities by Original Contractual Maturity (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ||
One year or less | $27,752 | $30,700 |
Greater than one year and less than five years | 5,705 | 6,134 |
Total available-for-sale securities | 33,457 | 36,834 |
One year or less | 27,727 | 30,701 |
Greater than one year and less than five years | 5,699 | 6,140 |
Total available-for-sale securities | $33,426 | $36,841 |
AvailableforSale_Securities_Ad
Available-for-Sale Securities - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Schedule of Available-for-sale Securities [Line Items] | |||
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 | |
Other-than-temporary impairments from the sale or maturity of available-for-sale investments | $0 | $0 | $0 |
Inventories_Detail
Inventories (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventory [Line Items] | ||
Work-in-process | $2,222 | $4,863 |
Finished goods | 12,734 | 8,200 |
Total inventories | $14,956 | $13,063 |
Property_and_Equipment_Net_Det
Property and Equipment Net (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Property, Plant and Equipment [Line Items] | ||
Leasehold improvements | $5,638 | $5,628 |
Machinery and equipment | 1,351 | 1,751 |
Demonstration equipment | 123 | 100 |
Office furniture | 783 | 763 |
Computer equipment | 663 | 651 |
Computer software | 2,913 | 1,083 |
Construction-in-progress | 150 | 155 |
Total property and equipment, gross | 12,601 | 10,773 |
Accumulated depreciation and amortization | -8,820 | -8,584 |
Total property and equipment, net | 3,781 | 2,189 |
Consigned Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Demonstration equipment | $980 | $642 |
Property_and_Equipment_Net_Add
Property and Equipment Net - Additional Information (Detail) (USD $) | 12 Months Ended | ||
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Property, Plant and Equipment [Line Items] | |||
Property and equipment, depreciation and amortization expense | $0.70 | $0.40 | $0.40 |
Goodwill_and_Intangible_Assets2
Goodwill and Intangible Assets Net - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Acquired Finite-Lived Intangible Assets [Line Items] | |||
Dispose, impair or recognition of additional goodwill | $0 | ||
Impairment charges on goodwill | 0 | ||
Impairment losses recognized related to the acquired intangible assets | 0 | 0 | 0 |
Annual amortization expense of the intangible assets, 2015 | 200,000 | ||
Annual amortization expense of the intangible assets, 2016 | 200,000 | ||
Annual amortization expense of the intangible assets, 2017 | 200,000 | ||
Annual amortization expense of the intangible assets, 2018 | 200,000 | ||
Annual amortization expense of the intangible assets, 2019 | 200,000 | ||
Annual amortization expense of the intangible assets, 2020 | $100,000 |
Summary_of_Intangible_Assets_N
Summary of Intangible Assets Net (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $2,017 | $2,017 |
Accumulated Amortization | -875 | -673 |
Net Carrying Amount | 1,142 | 1,344 |
Reacquired license - INTERCEPT Asia | ||
Acquired Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 2,017 | 2,017 |
Accumulated Amortization | -875 | -673 |
Net Carrying Amount | $1,142 | $1,344 |
LongTerm_Investments_Additiona
Long-Term Investments - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Investment [Line Items] | |||
Eligibility to receive a royalty fee | 1.00% | ||
Royalty income, nonoperating | $0 | $0 | $0 |
Carrying value of investment | $0 | ||
Maximum | |||
Investment [Line Items] | |||
Ownership percentage under Cost Method for Investments | 1.00% |
Accrued_Liabilities_Detail
Accrued Liabilities (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Accrued Liabilities [Line Items] | ||
Accrued compensation and related costs | $3,951 | $2,527 |
Accrued professional services | 2,123 | 2,722 |
Accrued inventory costs | 870 | 3,553 |
Accrued customer costs | 385 | 59 |
Accrued insurance premiums | 264 | 226 |
Other accrued expenses | 851 | 726 |
Total accrued liabilities | $8,444 | $9,813 |
Debt_Detail
Debt (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Debt Instrument [Line Items] | ||
Less: debt-current, Principal | $0 | |
Less: debt-current, Unamortized Discount | 0 | |
Less: debt-current | 0 | -3,366 |
Debt-non-current, Principal | 10,000 | |
Debt-non-current, Unamortized Discount | -128 | |
Debt-non-current | 9,872 | 0 |
Loan and Security Agreement | ||
Debt Instrument [Line Items] | ||
Total debt, Principal | 10,000 | |
Total debt, Unamortized amount | -128 | |
Total debt, At carrying value | $9,872 |
Debt_Principal_and_Interest_Pa
Debt - Principal and Interest Payments on Debt (Detail) (USD $) | Dec. 31, 2014 |
In Thousands, unless otherwise specified | |
Debt Instrument [Line Items] | |
2015 | $695 |
2016 | 3,227 |
2017 | 3,227 |
2018 | 3,227 |
2019 | 2,314 |
Total | 12,690 |
2015 | 695 |
2016 | 613 |
2017 | 425 |
2018 | 224 |
2019 | 733 |
Total | 2,690 |
2015 | 0 |
2016 | 2,614 |
2017 | 2,802 |
2018 | 3,003 |
2019 | 1,581 |
Total | $10,000 |
Debt_Additional_Information_De
Debt - Additional Information (Detail) (USD $) | 0 Months Ended | 12 Months Ended | 1 Months Ended | |
In Millions, unless otherwise specified | Jun. 30, 2014 | Dec. 31, 2014 | Apr. 30, 2013 | 31-May-14 |
Tranche | ||||
Loan and Security Agreement | ||||
Line of Credit Facility [Line Items] | ||||
Maximum borrowing limit | $30 | |||
Term of agreement | 5 years | |||
Number of loan tranches | 3 | |||
Interest rate, description | Term Loan A bears an interest rate of 6.95%. Term Loan B and Term Loan C will bear an interest rate calculated at the greater of 6.95% or 6.72% plus the three month U.S. LIBOR rate in effect three business days prior to the applicable Term Loan funding date. | |||
Maturity period | 1-Jun-19 | |||
Principal and interest payments | 42 months | |||
Final payment term percent | 7.00% | |||
Terms of required periodic payments of interest and principal | The Company is required to make interest only payments through December 2015 followed by forty-two months of equal principal and interest payments thereafter; however, if the Revenue Event is achieved no later than November 30, 2015, then the interest-only period may be extended through December 31, 2016, and the amortization period will be reduced to thirty months. The Company is also required to make a final payment equal to 7% of the principal amounts of the Term Loans drawn payable on the earlier to occur of maturity or prepayment. | |||
Commitment fee | 0.2 | |||
Lender legal fees | 0.1 | |||
Loan and Security Agreement | Securities Pledged as Collateral | ||||
Line of Credit Facility [Line Items] | ||||
Percentage of investments made in subsidiary | 35.00% | |||
Amended Credit Agreement | ||||
Line of Credit Facility [Line Items] | ||||
Maturity period | 30-Jun-14 | |||
Amended Credit Agreement | Revolving line of credit ("RLOC") | ||||
Line of Credit Facility [Line Items] | ||||
Maximum borrowing limit | 7 | |||
Loan and security agreement | 3.4 | |||
Amended Credit Agreement | Term Loan | ||||
Line of Credit Facility [Line Items] | ||||
Maximum borrowing limit | 5 | |||
Loan and security agreement | 5 | |||
Final payment fee for early repayment of credit facility | 0.05 | |||
Repayment of credit facility | 4.2 | |||
First Tranche (Term Loan A) | Loan and Security Agreement | ||||
Line of Credit Facility [Line Items] | ||||
Loan and security agreement | 10 | |||
Interest rate | 6.95% | |||
Second Tranche (Term Loan B) | Loan and Security Agreement | ||||
Line of Credit Facility [Line Items] | ||||
Loan and security agreement | 10 | |||
Borrowing conditions | The second tranche of $10.0 million ("Term Loan B") was contingent upon the approval, by the U.S. Food and Drug Administration ("FDA") of the Company's premarket approval application for either the plasma or platelet system (the "PMA Approval"), which occurred in December 2014. The availability of Term Loan B expires on June 15, 2015. | |||
Third Tranche (Term Loan C) | Loan and Security Agreement | ||||
Line of Credit Facility [Line Items] | ||||
Loan and security agreement | $10 | |||
Borrowing conditions | The third tranche of $10.0 million ("Term Loan C") will be available from July 1, 2015 through December 31, 2015, contingent upon the Company achieving trailing six months' revenue at a specified threshold (the "Revenue Event"). |
Commitments_and_Contingencies_1
Commitments and Contingencies - Additional Information (Detail) | 12 Months Ended | |||||
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2010 | Dec. 31, 2014 |
USD ($) | EUR (€) | USD ($) | USD ($) | USD ($) | Additional Concord Lease | |
Option | ||||||
Commitments and Contingencies Disclosure [Line Items] | ||||||
Minimum term of non-cancellable operating leases | 1 year | 1 year | ||||
Expiration of non-cancellable operating leases maximum year | 2019 | 2019 | ||||
Early termination of non-cancellable operating leases minimum period | 2016-02 | |||||
Initial term of operating lease | 2 years | |||||
Number of renewal options | 4 | |||||
Renewal period of operating lease | 2 years | |||||
Operating lease, rent expense | $0.80 | $0.70 | $0.60 | |||
Financing for leasehold improvement | 1.1 | |||||
Outstanding liability related to leasehold improvements | 0.6 | |||||
Leasehold Improvements reflected in Accrued liabilities | 0.1 | |||||
Leasehold Improvements reflected in Other non-current liabilities | 0.5 | |||||
Purchase commitment, paid | 6.8 | 6.5 | 7.2 | |||
Future minimum purchase commitment 2015 | 8.5 | |||||
Future minimum purchase commitment 2016 | 2.3 | |||||
Transition agreement expiration date | 30-Sep-14 | 30-Sep-14 | ||||
Distribution fee per disposable kit | 10 | 10 | ||||
Potential maximum payment of distribution fee | 3 | |||||
Distribution related expense accrued | $0.10 |
Future_Minimum_NonCancelable_L
Future Minimum Non-Cancelable Lease Payments Under Operating Leases (Detail) (USD $) | Dec. 31, 2014 |
In Thousands, unless otherwise specified | |
Future Minimum Payments Under Non-Cancelable Operating Leases With Initial Terms Of One-Year Or More [Line Items] | |
2015 | $891 |
2016 | 163 |
2017 | 93 |
2018 | 25 |
2019 and thereafter | 0 |
Total minimum non-cancellable lease payments | $1,172 |
Stockholders_Equity_Additional
Stockholders Equity - Additional Information (Detail) (USD $) | 12 Months Ended | 1 Months Ended | ||||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Nov. 30, 2010 | Jun. 12, 2014 | Aug. 31, 2009 | |
Stockholders Equity Note [Line Items] | ||||||
Common stock, par value | $0.00 | $0.00 | $0.00 | |||
Common stock, shares authorized | 225,000,000 | 112,500,000 | 112,500,000 | |||
Warrant liability | $10,485,000 | $20,390,000 | ||||
Proceeds from common stock sold | 18,488,000 | 61,425,000 | 14,226,000 | |||
2009 Unit Offering | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants to purchase an aggregate shares of common stock | 2,400,000 | |||||
Warrant exercise price | $2.90 | |||||
Warrant liability | 0 | |||||
2010 Unit Offering | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants to purchase an aggregate shares of common stock | 3,700,000 | |||||
Warrant exercise price | 3.2 | |||||
Warrant liability | 3,300,000 | |||||
2010 Unit Offering | Warrant | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants exercisable date | 15-May-11 | |||||
Exercisable period | 5 years | |||||
Warrants exercised | 2,600,000 | 200,000 | 5,000 | |||
Stockholder Rights Plan | ||||||
Stockholders Equity Note [Line Items] | ||||||
Minimum percentage of common stock acquired by stockholders | 15.00% | |||||
Designated preferred stock for future issuance | 250,000 | |||||
Sales Agreement | Cantor | ||||||
Stockholders Equity Note [Line Items] | ||||||
Maximum common stock offering price | 70,000,000 | |||||
Percentage of proceeds payable as compensation to underwriter | 2.00% | |||||
Common stock, number of shares issued | 4,300,000 | 5,400,000 | ||||
Proceeds from common stock sold | 18,600,000 | 23,500,000 | ||||
Common stock available for sale | $22,500,000 |
Fair_Value_of_Warrants_Outstan
Fair Value of Warrants Outstanding (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Class of Warrant or Right [Line Items] | ||
Warrant liability | $10,485,000 | $20,390,000 |
2009 Warrants | ||
Class of Warrant or Right [Line Items] | ||
Warrant liability | 8,542,000 | |
2010 Warrants | ||
Class of Warrant or Right [Line Items] | ||
Warrant liability | $10,485,000 | $11,848,000 |
Fair_Value_of_Warrants_Using_V
Fair Value of Warrants Using Valuation Model (Detail) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
2009 Warrants | ||
Class of Warrant or Right [Line Items] | ||
Expected term (in years) | 7 months 24 days | |
Estimated volatility | 45.00% | |
Risk-free interest rate | 0.10% | |
Expected dividend yield | 0.00% | |
2010 Warrants | ||
Class of Warrant or Right [Line Items] | ||
Expected term (in years) | 10 months 10 days | 1 year 10 months 10 days |
Estimated volatility | 55.00% | 41.00% |
Risk-free interest rate | 0.25% | 0.38% |
Expected dividend yield | 0.00% | 0.00% |
StockBased_Compensation_Additi
Stock-Based Compensation - Additional Information (Detail) (USD $) | 12 Months Ended | ||||
In Millions, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jun. 12, 2014 | Jun. 12, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Aggregate number of shares of common stock reserved for future issuance | 17,100,000 | ||||
Maximum number of shares of common stock authorized for issuance | 225,000,000 | 112,500,000 | 112,500,000 | ||
Outstanding options and other stock based awards | 11,300,000 | ||||
Total intrinsic value of options exercised | $3.80 | $0.60 | $0.30 | ||
Stock-based compensation, expected dividend yield | 0.00% | ||||
Weighted average grant-date fair value of stock options granted | $3.28 | $2.03 | $2.13 | ||
Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense expected to be recognized | 9.1 | ||||
Stock-based compensation, weighted average recognition period | 2 years 4 months 24 days | ||||
Stock-based compensation, expected dividend yield | 0.00% | 0.00% | 0.00% | ||
Restricted Stock Units (RSUs) | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Restricted stock units vesting Description | The restricted stock units generally vested in three annual installments from the date of grant and were generally issuable at the end of the three-year vesting term. | ||||
Fair value of restricted stock units which vested during the year | 0.05 | 0.05 | |||
Employee Stock Purchase Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Increase in shares of common stock authorized for issuance | 1,320,500 | ||||
Aggregate number of shares of common stock reserved for future issuance | 387,349 | ||||
Employee Stock Purchase Plan, offering period | 12 months | ||||
Employee Stock Purchase Plan, discount on purchase price of common stock as percentage of fair market value | 15.00% | ||||
Number of purchase periods within each offering period | 2 | ||||
Weighted average grant-date fair value of awards granted | $1.42 | $1.18 | $1.43 | ||
2008 Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Aggregate number of shares of common stock reserved for future issuance | 5,800,000 | ||||
Maximum number of shares of common stock authorized for issuance | 19,540,940 | ||||
Stock-based compensation, award term | 10 years | ||||
Stock-based compensation, option to be granted at percentage of fair value of common stock | 100.00% | ||||
Performance-based stock options, outstanding | 0 | ||||
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 | 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 |
Activity_Under_Equity_Incentiv
Activity Under Equity Incentive Plans Related to Stock Options (Detail) (USD $) | 12 Months Ended |
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 |
Activity under the Company's equity incentive plans related to stock options | |
Number of Options Outstanding, Beginning Balance | 10,405 |
Granted, Number of Options Outstanding | 2,783 |
Forfeited, Number of Options Outstanding | -233 |
Expired, Number of Options Outstanding | -114 |
Exercised, Number of Options Outstanding | -1,518 |
Number of Options Outstanding, Ending Balance | 11,323 |
Weighted Average Exercise Price per Share | |
Weighted Average Exercise Price per Share, Beginning Balance | $3.46 |
Granted, Weighted Average Exercise Price per Share | $5.90 |
Forfeited, Weighted Average Exercise Price per Share | $4.31 |
Expired, Weighted Average Exercise Price per Share | $8.64 |
Exercised, Weighted Average Exercise Price per Share | $2.44 |
Weighted Average Exercise Price per Share, Ending Balance | $4.13 |
Information_Regarding_Stock_Op
Information Regarding Stock Options Outstanding Stock Options Vested and Expected to Vest and Stock Options Exercisable (Detail) (USD $) | 12 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Number of Shares | ||
Stock options outstanding | 11,323 | 10,405 |
Stock options vested and expected to vest | 10,920 | |
Stock options exercisable | 7,006 | |
Weighted Average Exercise Price | ||
Stock options outstanding | $4.13 | $3.46 |
Stock options vested and expected to vest | $4.08 | |
Stock options exercisable | $3.70 | |
Weighted Average Remaining Contractual (Years) | ||
Stock options outstanding | 6 years 9 months 18 days | |
Stock options vested and expected to vest | 6 years 8 months 12 days | |
Stock options exercisable | 5 years 8 months 12 days | |
Aggregate intrinsic value | ||
Stock options outstanding | $25,517 | |
Stock options vested and expected to vest | 25,174 | |
Stock options exercisable | $19,324 |
StockBased_Compensation_Recogn
Stock-Based Compensation Recognized on Condensed Consolidated Statements of Operations (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $5,153 | $3,268 | $2,541 |
Research and Development Expense | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 998 | 482 | 554 |
Selling, General and Administrative Expenses | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $4,155 | $2,786 | $1,987 |
Weighted_Average_Assumptions_U
Weighted Average Assumptions Used to Value Stock-Based Awards (Detail) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected dividend yield | 0.00% | ||
Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 8 months 16 days | 5 years 7 months 2 days | 5 years 6 months 15 days |
Estimated volatility | 61.00% | 60.00% | 67.00% |
Risk-free interest rate | 1.73% | 0.87% | 1.03% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 9 months 4 days | 6 months | 6 months |
Estimated volatility | 52.00% | 39.00% | 101.00% |
Risk-free interest rate | 0.10% | 0.10% | 0.14% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Retirement_Plan_Additional_Inf
Retirement Plan - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2014 | |
Defined Benefit Plan Disclosure [Line Items] | |
Retirement plan, employees maximum pre-tax contributions percentage | 60.00% |
Development_and_License_Agreem1
Development and License Agreements - Additional Information (Detail) (USD $) | 12 Months Ended | ||
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Licenses Agreements [Line Items] | |||
Royalty payments on products | $2.50 | $3 | $2.70 |
Prior written notice for termination of agreement | 24 months | ||
Payments made relating to the manufacturing of the products | 19.1 | 15 | 12.2 |
Amounts due from Fresenius | 1.3 | 0 | |
Fresenius | |||
Licenses Agreements [Line Items] | |||
Prior written notice for termination of agreement | 30 months | ||
Royalty | |||
Licenses Agreements [Line Items] | |||
Royalties owed | 0.7 | 0.7 | |
Royalty | Platelet system | |||
Licenses Agreements [Line Items] | |||
Royalty rate applied towards sale of products | 10.00% | ||
Royalty | Plasma system | |||
Licenses Agreements [Line Items] | |||
Royalty rate applied towards sale of products | 3.00% | ||
Manufacturing Costs | |||
Licenses Agreements [Line Items] | |||
Royalties owed | $5.10 | $4.30 |
United_States_and_Foreign_Comp
United States and Foreign Components of Consolidated Loss before Income Taxes (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Schedule Of Income Loss From Continuing Operations [Line Items] | |||
U.S. | ($38,928) | ($44,035) | ($16,360) |
Foreign | 368 | 916 | 685 |
Loss before income taxes | ($38,560) | ($43,119) | ($15,675) |
Provision_Benefit_for_Income_T
Provision Benefit for Income Taxes (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Schedule Of Components Of Income Tax Expense Benefit [Line Items] | |||
Foreign | $168 | $191 | $180 |
Federal | 0 | 0 | 0 |
State | 1 | 0 | 0 |
Total Current | 169 | 191 | 180 |
Foreign | 0 | 0 | 0 |
Federal | 22 | 21 | 48 |
State | 4 | 6 | 14 |
Total Deferred | 26 | 27 | 62 |
Provision for income taxes | $195 | $218 | $242 |
Difference_Between_Provision_f
Difference Between Provision for Income Taxes and Amounts Computed by Applying Federal Statutory Income Tax Rate to Loss before Taxes (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Reconciliation of Provision of Income Taxes [Line Items] | |||
Federal statutory tax | ($13,110) | ($14,661) | ($5,329) |
Stock-based compensation | -8 | -10 | 99 |
Lobbying expenses | 33 | 107 | 51 |
Warrants | -3,367 | 4,926 | -706 |
Foreign rate differential | 43 | -121 | -53 |
Expiration of federal net operating losses and credits-tax effected | 0 | 0 | 4,352 |
Change in valuation allowance | 16,576 | 9,955 | 1,809 |
Other | 28 | 22 | 19 |
Provision for income taxes | $195 | $218 | $242 |
Significant_Components_of_Defe
Significant Components of Deferred Tax Assets (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Deferred tax assets: | ||
Net operating loss carryforwards | $151,100 | $142,500 |
Research and development credit carryforwards | 33,800 | 32,100 |
Capitalized research and development | 15,500 | 12,300 |
Deferred compensation | 5,800 | 4,900 |
Capital loss carryforwards | 3,700 | 3,900 |
Other | 3,200 | 3,300 |
Total deferred tax assets | 213,100 | 199,000 |
Valuation allowance | -213,100 | -199,000 |
Net deferred tax assets | 0 | 0 |
Deferred tax liabilities: | ||
Amortization of goodwill | 115 | 89 |
Total deferred tax liabilities | $115 | $89 |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Income Tax Disclosure [Line Items] | |||
Increase (Decrease) in valuation allowance | $14,100,000 | $8,500,000 | ($800,000) |
Pretax net losses | -38,560,000 | -43,119,000 | -15,675,000 |
Operating loss carryforwards related to windfall tax deductions | 2,200,000 | ||
Research and development tax credit carryforwards | 33,800,000 | 32,100,000 | |
Internal Revenue Service (IRS) | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | 416,000,000 | ||
Research and development tax credit carryforwards | 22,500,000 | ||
Internal Revenue Service (IRS) | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2015 | ||
Research and development tax credit carryforwards, expiration year | 2018 | ||
Internal Revenue Service (IRS) | Maximum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2034 | ||
Research and development tax credit carryforwards, expiration year | 2034 | ||
State and Local Jurisdiction | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards | 255,000,000 | ||
Research and development tax credit carryforwards | 17,100,000 | ||
State and Local Jurisdiction | Minimum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2015 | ||
State and Local Jurisdiction | Maximum | |||
Income Tax Disclosure [Line Items] | |||
Net operating loss carryforwards, expiration year | 2034 | ||
Cerus Europe B.V. | |||
Income Tax Disclosure [Line Items] | |||
Undistributed earning of foreign subsidiary | 4,600,000 | ||
Unrecognized deferred tax liability for unrepatriated earnings | $1,700,000 |
Segment_Customer_and_Geographi2
Segment, Customer and Geographic Information - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2014 | |
Segment | |
Segment Reporting Information [Line Items] | |
Number of operating segments | 1 |
Significant_Customers_that_Acc
Significant Customers that Accounted for More than Ten Percentage of Total Product Revenue (Detail) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Etablissement Francais du Sang | |||
Revenue, Major Customer [Line Items] | |||
Percentage of revenue derived from significant customer from Company's total product revenue | 25.00% | 17.00% | 20.00% |
Grifols | |||
Revenue, Major Customer [Line Items] | |||
Percentage of revenue derived from significant customer from Company's total product revenue | 18.00% | 19.00% | |
Delrus Inc. | |||
Revenue, Major Customer [Line Items] | |||
Percentage of revenue derived from significant customer from Company's total product revenue | 12.00% |
Revenue_by_Geographical_Locati
Revenue by Geographical Location (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Revenue, Major Customer [Line Items] | |||||||||||
Product revenue | $9,587 | $10,362 | $8,601 | $7,866 | $9,232 | $10,542 | $10,150 | $9,733 | $36,416 | $39,657 | $36,695 |
Government grants and cooperative agreements | 0 | 0 | 91 | ||||||||
Total revenue | 36,416 | 39,657 | 36,786 | ||||||||
FRANCE | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Product revenue | 9,184 | 7,030 | 7,321 | ||||||||
SPAIN | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Product revenue | 2,776 | 7,033 | 7,061 | ||||||||
CIS | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Product revenue | 6,636 | 8,220 | 8,016 | ||||||||
BELGIUM | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Product revenue | 4,456 | 3,971 | 4,016 | ||||||||
SWITZERLAND | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Product revenue | 3,784 | 4,078 | 3,866 | ||||||||
Other Countries | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Product revenue | 9,580 | 9,325 | 6,415 | ||||||||
UNITED STATES | |||||||||||
Revenue, Major Customer [Line Items] | |||||||||||
Government grants and cooperative agreements | $0 | $0 | $91 |
Long_Lived_Assets_by_Geographi
Long Lived Assets by Geographical Location (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | $4,923 | $3,533 |
UNITED STATES | ||
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | 4,624 | 3,088 |
Europe And Other | ||
Long-Lived Assets by Geographical Areas [Line Items] | ||
Total long-lived assets | $299 | $445 |
Summary_of_Quarterly_Financial
Summary of Quarterly Financial Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Quarterly Financial Information [Line Items] | |||||||||||
Product revenue | $9,587 | $10,362 | $8,601 | $7,866 | $9,232 | $10,542 | $10,150 | $9,733 | $36,416 | $39,657 | $36,695 |
Gross profit on product revenue | 2,997 | 4,673 | 3,849 | 3,709 | 4,293 | 3,716 | 4,403 | 4,643 | 15,228 | 17,055 | 16,079 |
Net loss | ($20,182) | ($10,759) | ($7,589) | ($225) | ($5,860) | ($20,501) | ($6,724) | ($10,252) | ($38,755) | ($43,337) | ($15,917) |
Basic | ($0.26) | ($0.14) | ($0.10) | $0 | ($0.08) | ($0.29) | ($0.10) | ($0.17) | ($0.52) | ($0.64) | ($0.29) |
Diluted | ($0.26) | ($0.16) | ($0.16) | ($0.12) | ($0.10) | ($0.29) | ($0.10) | ($0.17) | ($0.61) | ($0.64) | ($0.33) |
Subsequent_Events_Additional_I
Subsequent Events - Additional Information (Detail) (USD $) | 12 Months Ended | 1 Months Ended | |||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jan. 31, 2015 | Jun. 12, 2014 |
Subsequent Event [Line Items] | |||||
Common stock, par value | $0.00 | $0.00 | $0.00 | ||
Net proceeds from public offering | $18,488 | $61,425 | $14,226 | ||
Underwriting discounts and other issuance costs | 470 | 2,733 | 550 | ||
Subsequent Event | |||||
Subsequent Event [Line Items] | |||||
Common stock, shares issued | 14,636,363 | ||||
Common stock, par value | $0.00 | ||||
Public offering, price per share | $5.50 | ||||
Net proceeds from public offering | 75,700 | ||||
Underwriting discounts and other issuance costs | $5,100 |