Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2014 | Apr. 24, 2014 | |
Document Information [Line Items] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 31-Mar-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q1 | ' |
Trading Symbol | 'CERS | ' |
Entity Registrant Name | 'CERUS CORP | ' |
Entity Central Index Key | '0001020214 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 72,513,000 |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | |
In Thousands, unless otherwise specified | |||
Current assets: | ' | ' | |
Cash and cash equivalents | $23,992 | $29,485 | [1] |
Short-term investments | 24,263 | 28,191 | [1] |
Accounts receivable | 4,943 | 6,125 | [1] |
Inventories | 11,307 | 13,063 | [1] |
Prepaid expenses | 1,661 | 848 | [1] |
Other current assets | 913 | 442 | [1] |
Total current assets | 67,079 | 78,154 | [1] |
Non-current assets: | ' | ' | |
Property and equipment, net | 3,166 | 2,189 | [1] |
Goodwill | 1,316 | 1,316 | [1] |
Intangible assets, net | 1,294 | 1,344 | [1] |
Restricted cash | 308 | 308 | [1] |
Other assets | 64 | 70 | [1] |
Total assets | 73,227 | 83,381 | [1] |
Current liabilities: | ' | ' | |
Accounts payable | 3,493 | 5,674 | [1] |
Accrued liabilities | 8,838 | 9,813 | [1] |
Deferred revenue | 279 | 181 | [1] |
Debt - current | 3,268 | 3,366 | [1] |
Warrant liability | 11,356 | 20,390 | [1] |
Total current liabilities | 27,234 | 39,424 | [1] |
Non-current liabilities: | ' | ' | |
Deferred income taxes | 95 | 89 | [1] |
Other non-current liabilities | 1,031 | 1,073 | [1] |
Total liabilities | 28,360 | 40,586 | [1] |
Commitments and contingencies | ' | ' | [1] |
Stockholders' equity: | ' | ' | |
Common stock | 72 | 72 | [1] |
Additional paid-in capital | 548,202 | 545,905 | [1] |
Accumulated other comprehensive income | 7 | 7 | [1] |
Accumulated deficit | -503,414 | -503,189 | [1] |
Total stockholders' equity | 44,867 | 42,795 | [1] |
Total liabilities and stockholders' equity | $73,227 | $83,381 | [1] |
[1] | The financial information in this column was derived from audited financial statements included in the Company's 2013 Annual Report on Form 10-K. |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Revenue: | ' | ' |
Product revenue | $7,866 | $9,733 |
Cost of product revenue | 4,157 | 5,090 |
Gross profit on product revenue | 3,709 | 4,643 |
Operating expenses: | ' | ' |
Research and development | 4,642 | 2,700 |
Selling, general and administrative | 8,236 | 6,853 |
Amortization of intangible assets | 50 | 50 |
Total operating expenses | 12,928 | 9,603 |
Loss from operations | -9,219 | -4,960 |
Non-operating gain (expense), net: | ' | ' |
Gain (loss) from revaluation of warrant liability | 9,034 | -5,073 |
Foreign exchange gain (loss) | 21 | -54 |
Interest expense | -193 | -131 |
Other income, net | 170 | 17 |
Total non-operating gain (expense), net | 9,032 | -5,241 |
Loss before income taxes | -187 | -10,201 |
Provision for income taxes | 38 | 51 |
Net loss | ($225) | ($10,252) |
Net loss per share: | ' | ' |
Basic | $0 | ($0.17) |
Diluted | ($0.12) | ($0.17) |
Weighted average shares outstanding used for calculating net loss per share: | ' | ' |
Basic | 72,088 | 59,730 |
Diluted | 75,158 | 59,730 |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Net loss | ($225) | ($10,252) |
Other comprehensive loss | 0 | 0 |
Comprehensive loss | ($225) | ($10,252) |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 3 Months Ended | ||
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | |
Operating activities | ' | ' | |
Net loss | ($225) | ($10,252) | |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | |
Depreciation and amortization | 325 | 167 | |
Stock-based compensation | 946 | 713 | |
Changes in revaluation of warrant liability | -9,034 | 5,073 | |
Non-cash interest expense | 0 | 4 | |
Deferred income taxes | 6 | 7 | |
Loss on disposal of fixed assets | 0 | 56 | |
Changes in operating assets and liabilities, net of effects of acquired business: | ' | ' | |
Accounts receivable | 1,182 | -289 | |
Inventories | 1,117 | -1,624 | |
Other assets | -764 | 910 | |
Accounts payable | -2,181 | -3,299 | |
Accrued liabilities | -1,295 | 85 | |
Deferred revenue | 98 | 97 | |
Net cash used in operating activities | -9,825 | -8,352 | |
Investing activities | ' | ' | |
Capital expenditures | -839 | -26 | |
Purchases of investments and certain other assets | -460 | 0 | |
Maturities of investments | 4,300 | 0 | |
Net cash provided by (used in) investing activities | 3,001 | -26 | |
Financing activities | ' | ' | |
Net proceeds from equity incentive plans | 1,425 | 152 | |
Net proceeds from public offering | 31 | 51,502 | |
Proceeds from revolving line of credit | 0 | 526 | |
Payments on debt, revolving line of credit and landlord provided leasehold incentives | -125 | -1,335 | |
Net cash provided by financing activities | 1,331 | 50,845 | |
Net increase in cash and cash equivalents | -5,493 | 42,467 | |
Cash and cash equivalents, beginning of period | 29,485 | [1] | 26,696 |
Cash and cash equivalents, end of period | $23,992 | $69,163 | |
[1] | The financial information in this column was derived from audited financial statements included in the Company's 2013 Annual Report on Form 10-K. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Summary of Significant Accounting Policies | ' | ||||||||
Note 1. Summary of Significant Accounting Policies | |||||||||
Principles of Consolidation and Basis of Presentation | |||||||||
The accompanying unaudited condensed consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (collectively referred to hereinafter as “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring entries, considered necessary for a fair presentation have been made. Operating results for the three months ended March 31, 2014, are not necessarily indicative of the results that may be expected for the year ending December 31, 2014, or for any future periods. | |||||||||
These condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2013, which were included in the Company’s 2013 Annual Report on Form 10-K, filed with the SEC on March 7, 2014. The accompanying consolidated balance sheet as of December 31, 2013 has been derived from the Company’s audited consolidated financial statements as of that date. | |||||||||
Use of Estimates | |||||||||
The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, 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. | |||||||||
Revenue | |||||||||
The Company recognizes revenue in accordance with ASC Topic 605-25, “Revenue Recognition – Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of an agreement with the funding party exists; (ii) services have been rendered or product has been delivered; (iii) pricing is fixed or determinable; and (iv) collection is reasonably assured. The Company’s source of revenues for the three months ended March 31, 2014 and 2013 was 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 a written agreement. 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 based on the best estimated selling price. The Company has determined that vendor specific objective evidence is not discernible due to the Company’s variability in its pricing across the regions into which it sells its products. Since the Company’s products are novel and unique and are not sold by others, third-party evidence of selling price is unavailable. | |||||||||
At March 31, 2014 and December 31, 2013, the Company had $0.3 million and $0.2 million, respectively, of short-term deferred revenue on its condensed 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. | |||||||||
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. 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. | |||||||||
Short-Term Investments | |||||||||
Investments with original maturities of greater than three months which included corporate debt and United States government agency securities are 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,” the Company classified all debt securities as available-for-sale at the time of purchase and reevaluates such designation as of each balance sheet date. 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 gains (losses) on available-for-sale securities, net of taxes” on the Company’s condensed consolidated statements of comprehensive loss. Realized gains and losses from the sale of available-for-sale investments were recorded in “Other income, net” on the Company’s condensed 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 are recorded in “Other income (expense), net” on the Company’s condensed 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-US 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 major financial institutions of high credit standing. The Company monitors the financial credit worthiness of the issuers of its investments and limits the concentration in individual securities and types of investments that exist within its investment portfolio. Generally, all of the Company’s investments carry high credit quality ratings, which is in accordance with its investment policy. At March 31, 2014, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents. | |||||||||
Concentrations of credit risk with respect to trade receivables exist. However, in connection with the Company’s revolving line of credit, as discussed in Note 8 in the Notes to Condensed Consolidated Financial Statements, the Company purchased a credit insurance policy that mitigates some of its credit risk, as the policy will pay either the Company or its lender on eligible claims filed on its outstanding receivables. On a regular basis, including at the time of sale, the Company performs credit evaluations of its customers. 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 reserves against the accounts receivable on its condensed consolidated balance sheets and records a charge on its condensed consolidated statements of operations. At March 31, 2014 and December 31, 2013, the Company had not recorded any reserves for potentially uncollectible accounts. | |||||||||
The Company had three customers and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at March 31, 2014, and December 31, 2013, respectively. These customers cumulatively represented approximately 65% and 55% of the Company’s outstanding trade receivables at March 31, 2014, and December 31, 2013, respectively. To date, the Company has not experienced collection difficulties from these customers. | |||||||||
Inventories | |||||||||
At March 31, 2014, and December 31, 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, Inc. (“Fresenius”) into the finished INTERCEPT disposable kits. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production of finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At March 31, 2014 and December 31, 2013, the Company classified its work-in-process inventory as a current asset on its condensed consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective subsequent twelve-month period. | |||||||||
Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or 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 condensed consolidated statements of operations. At March 31, 2014, and December 31, 2013, the Company had $0.3 million and $0.4 million, respectively, recorded for potential obsolete, expiring or unsalable product. | |||||||||
Property and Equipment, net | |||||||||
Property and equipment is comprised of furniture, equipment, leasehold improvements, 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, consultants, and payroll and payroll-related costs for employees 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. | |||||||||
Goodwill and Intangible Assets, net | |||||||||
Additions to goodwill and intangible assets, net are derived at the time of a business acquisition, in which the Company assigns the total consideration transferred to the acquired assets based on each asset’s fair value and any residual amount becomes goodwill, an indefinite life intangible asset. 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 condensed 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 segment and has 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 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.” Also, see Note 5 in the Notes to Unaudited Condensed Consolidated Financial Statements 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 three months ended March 31, 2014, and 2013. | |||||||||
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 condensed consolidated statements of operations. The Company recorded foreign currency gains (losses) of less than $0.1 million and $(0.1) million during the three months ended March 31, 2014, and 2013, respectively. | |||||||||
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 condensed consolidated statements of operations. | |||||||||
See Note 11 in the Notes to Unaudited Condensed Consolidated Financial Statements 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. The Company classifies the warrants as a liability on its condensed consolidated balance sheets as the warrants contain certain material terms which require the Company (or its successor) to purchase the warrants for cash in an amount equal to the value of the unexercised portion of the warrants (as determined in accordance with the Black-Scholes option pricing model) 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 these outstanding warrants is calculated using the binomial-lattice option-pricing model and is adjusted accordingly at each reporting period. The binomial-lattice option-pricing model requires that the Company uses significant assumptions and judgment to determine appropriate inputs to the model. Some of the assumptions that the Company relies on include the probability of a change of control occurring, the volatility of the Company’s stock over the life of the warrant and assumptions and inputs used to value the warrants under the Black-Scholes model should a change of control occur. | |||||||||
Changes resulting from the revaluation of warrants to fair value are recorded in “Revaluation of warrant liability” on the condensed 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 condensed consolidated balance sheets and no further adjustment to the fair value would be made in subsequent periods. | |||||||||
See Note 10 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s valuation of warrant liability. | |||||||||
Income Taxes | |||||||||
The Company accounts for income taxes using an 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 condensed consolidated statements of operations, nor has its accrued for or made payments for interest and penalties. 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. The Company’s tax years 1998 through 2013 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. | |||||||||
Net Income (Loss) Per Share | |||||||||
Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period. Diluted net income (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. Diluted net income (loss) per share also gives effect to potential adjustments to the numerator for changes 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. | |||||||||
Certain potential dilutive securities were excluded from the dilution calculation for the three months ended March 31, 2014, and 2013, 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 income (loss) per share for the three months ended March 31, 2014, and 2013 (in thousands, except per share amounts): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Numerator for Basic and Diluted: | |||||||||
Net loss used for basic calculation | $ | (225 | ) | $ | (10,252 | ) | |||
Effect of revaluation of warrant liability | (9,034 | ) | 0 | ||||||
Adjusted net loss used for diluted calculation | $ | (9,259 | ) | $ | (10,252 | ) | |||
Denominator: | |||||||||
Basic weighted average number of shares outstanding | 72,088 | 59,730 | |||||||
Effect of dilutive potential shares | 3,070 | 0 | |||||||
Diluted weighted average number of shares outstanding | 75,158 | 59,730 | |||||||
Net loss per share: | |||||||||
Basic | $ | (0.00 | ) | $ | (0.17 | ) | |||
Diluted | $ | (0.12 | ) | $ | (0.17 | ) | |||
The table below presents shares underlying stock options, employee stock purchase plan rights, warrants and restricted stock units that are excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the three months ended March 31, 2014 and 2013 (shares in thousands): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Weighted average number of anti-dilutive potential shares | 16,901 | 15,531 | |||||||
Guarantee and Indemnification Arrangements | |||||||||
The Company recognizes the fair value for guarantee and indemnification arrangements issued or modified by the Company after December 31, 2002. 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. | |||||||||
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 its 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 Note 2 and 10 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s valuation of financial instruments. | |||||||||
New Accounting Pronouncements | |||||||||
There have been no new accounting pronouncements issued during the three months ending March 31, 2014 that are of significance, or potential significance, to the Company. |
Fair_Value_on_Financial_Instru
Fair Value on Financial Instruments | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Fair Value on Financial Instruments | ' | ||||||||||||||||
Note 2. Fair Value on Financial Instruments | |||||||||||||||||
The Company determines 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 March 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 March 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) | $ | 9,648 | $ | 9,648 | $ | 0 | $ | 0 | |||||||||
Corporate debt securities (2) | 20,251 | 0 | 20,251 | 0 | |||||||||||||
United States government agency securities (2) | 4,012 | 0 | 4,012 | 0 | |||||||||||||
Total financial assets | $ | 33,911 | $ | 9,648 | $ | 24,263 | $ | 0 | |||||||||
Warrant liability (3) | $ | 11,356 | $ | 0 | $ | 0 | $ | 11,356 | |||||||||
Total financial liabilities | $ | 11,356 | $ | 0 | $ | 0 | $ | 11,356 | |||||||||
-1 | Included in cash and cash equivalents on the Company’s condensed consolidated balance sheets. | ||||||||||||||||
-2 | Included in short-term investments on the Company’s condensed consolidated balance sheets. | ||||||||||||||||
-3 | Included in current liabilities on the Company’s condensed 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 condensed consolidated balance sheets. | ||||||||||||||||
-2 | Included in short-term investments on the Company’s condensed consolidated balance sheets. | ||||||||||||||||
-3 | Included in current liabilities on the Company’s condensed consolidated balance sheets. | ||||||||||||||||
A reconciliation of the beginning and ending balances for warrant liability using significant unobservable inputs (Level 3) from December 31, 2013 to March 31, 2014 was as follows (in thousands): | |||||||||||||||||
Balance at December 31, 2013 | $ | 20,390 | |||||||||||||||
Decrease in fair value of warrants | (9,034 | ) | |||||||||||||||
Balance at March 31, 2014 | $ | 11,356 | |||||||||||||||
See Note 1 and 10 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s valuation techniques and unobservable inputs for warrant liability using significant unobservable inputs (Level 3). | |||||||||||||||||
The Company did not have any transfers among fair value measurement levels during the three months ended March 31, 2014 or the year ended December 31, 2013. |
Availableforsale_Securities
Available-for-sale Securities | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Available-for-sale Securities | ' | ||||||||||||||||
Note 3. Available-for-sale Securities | |||||||||||||||||
The following is a summary of available-for-sale securities at March 31, 2014 (in thousands): | |||||||||||||||||
March 31, 2014 | |||||||||||||||||
Carrying Value | Gross | Fair Value | |||||||||||||||
Unrealized Gain | |||||||||||||||||
Money market funds | $ | 9,648 | $ | 0 | $ | 9,648 | |||||||||||
Corporate debt securities | 20,243 | 8 | 20,251 | ||||||||||||||
United States government agency securities | 4,012 | 0 | 4,012 | ||||||||||||||
Total available-for-sale securities | $ | 33,903 | $ | 8 | $ | 33,911 | |||||||||||
The following is a summary of available-for-sale securities at December 31, 2013 (in thousands): | |||||||||||||||||
December 31, 2013 | |||||||||||||||||
Carrying Value | Gross | Fair Value | |||||||||||||||
Unrealized Gain | |||||||||||||||||
Money market funds | $ | 8,650 | $ | 0 | $ | 8,650 | |||||||||||
Corporate debt securities | 23,165 | 8 | 23,173 | ||||||||||||||
United States government agency securities | 5,019 | (1 | ) | 5,018 | |||||||||||||
Total available-for-sale securities | $ | 36,834 | $ | 7 | $ | 36,841 | |||||||||||
Available-for-sale securities at March 31, 2014 and December 31, 2013 consisted of the following by original contractual maturity (in thousands): | |||||||||||||||||
March 31, 2014 | December 31, 2013 | ||||||||||||||||
Carrying Value | Fair Value | Carrying Value | Fair Value | ||||||||||||||
Due in one year or less | $ | 33,903 | $ | 33,911 | $ | 30,700 | $ | 30,701 | |||||||||
Due greater than one year and less than three years | 0 | 0 | 6,134 | 6,140 | |||||||||||||
Total cash equivalents and short-term investments | $ | 33,903 | $ | 33,911 | $ | 36,834 | $ | 36,841 | |||||||||
The Company did not record any gross realized gains from the sale or maturity of available-for-sale investments during the three months ended March 31, 2014 and 2013. The Company did not record losses on investments experiencing an other-than-temporary decline in fair value nor did it record any gross realized losses from the sale or maturity of available-for-sale investments during the three months ended March 31, 2014 and 2013, respectively. |
Inventories
Inventories | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Inventories | ' | ||||||||
Note 4. Inventories | |||||||||
Inventories at March 31, 2014 and December 31, 2013 consisted of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
Work-in-process | $ | 2,142 | $ | 4,863 | |||||
Finished goods | 9,165 | 8,200 | |||||||
Total inventories | $ | 11,307 | $ | 13,063 | |||||
Goodwill_and_Intangible_Assets
Goodwill and Intangible Assets, net | 3 Months Ended | ||||||||||||
Mar. 31, 2014 | |||||||||||||
Goodwill and Intangible Assets, net | ' | ||||||||||||
Note 5. Goodwill and Intangible Assets, net | |||||||||||||
Goodwill | |||||||||||||
During the three months ended March 31, 2014, the Company did not dispose of or recognize additional goodwill. The Company expects to perform its annual review of goodwill on August 31, 2014, unless indicators of impairment are identified prior to that date. As of March 31, 2014, the Company has not identified any indicators of goodwill impairment. | |||||||||||||
Intangible Assets, net | |||||||||||||
The following is a summary of intangible assets, net at March 31, 2014 (in thousands): | |||||||||||||
March 31, 2014 | |||||||||||||
Gross | Accumulated | Net | |||||||||||
Carrying | Amortization | Carrying | |||||||||||
Amount | Amount | ||||||||||||
Acquisition-related intangible assets: | |||||||||||||
Reacquired license - INTERCEPT Asia | $ | 2,017 | $ | (723 | ) | $ | 1,294 | ||||||
Total intangible assets | $ | 2,017 | $ | (723 | ) | $ | 1,294 | ||||||
The following is a summary of intangible assets, net at December 31, 2013 (in thousands): | |||||||||||||
December 31, 2013 | |||||||||||||
Gross | Accumulated | Net | |||||||||||
Carrying | Amortization | Carrying | |||||||||||
Amount | Amount | ||||||||||||
Acquisition-related intangible assets: | |||||||||||||
Reacquired license - INTERCEPT Asia | $ | 2,017 | $ | (673 | ) | $ | 1,344 | ||||||
Total intangible assets | $ | 2,017 | $ | (673 | ) | $ | 1,344 | ||||||
The Company recognized $0.05 million in amortization expense related to intangible assets for each of the three months ended March 31, 2014 and 2013. During the three months ended March 31, 2014 and 2013, there were no impairment charges recognized related to the acquired intangible assets. | |||||||||||||
At March 31, 2014, the expected annual amortization expense of the intangible assets, net is $0.15 million for the remaining nine months of 2014, $0.2 million annually beginning with the year ending December 31, 2015 through the year ending December 31, 2019, and $0.1 million for the year ending December 31, 2020. |
LongTerm_Investments
Long-Term Investments | 3 Months Ended |
Mar. 31, 2014 | |
Long-Term Investments | ' |
Note 6. 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. Pursuant to these license agreements, the Company is eligible to receive a 1% royalty fee on any future sales resulting from the licensed technology. As of March 2014, the Company’s ownership in Aduro was less than 3% on a fully diluted basis. Since receiving preferred stock in Aduro, the Company has carried its investment in Aduro at zero in its condensed consolidated balance sheet. As of March 31, 2014, the Company has not received any royalties under this agreement. |
Accrued_Liabilities
Accrued Liabilities | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accrued Liabilities | ' | ||||||||
Note 7. Accrued Liabilities | |||||||||
Accrued liabilities at March 31, 2014 and December 31, 2013 consisted of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
Accrued compensation and related costs | $ | 1,899 | $ | 2,527 | |||||
Accrued inventory costs | 2,534 | 3,553 | |||||||
Accrued professional services | 2,995 | 2,722 | |||||||
Other accrued expenses | 1,410 | 1,011 | |||||||
Total accrued liabilities | $ | 8,838 | $ | 9,813 | |||||
Debt
Debt | 3 Months Ended | ||||||||||||
Mar. 31, 2014 | |||||||||||||
Debt | ' | ||||||||||||
Note 8. Debt | |||||||||||||
Debt at March 31, 2014 consisted of the following (in thousands): | |||||||||||||
March 31, 2014 | |||||||||||||
Principal | Unamortized | Total | |||||||||||
Discount | |||||||||||||
Comerica - Revolving Line of Credit, due 2014 | $ | 3,268 | $ | 0 | $ | 3,268 | |||||||
Less: debt - current | (3,268 | ) | 0 | (3,268 | ) | ||||||||
Debt - non-current | $ | 0 | $ | 0 | $ | 0 | |||||||
Debt at December 31, 2013 consisted of the following (in thousands): | |||||||||||||
December 31, 2013 | |||||||||||||
Principal | Unamortized | Total | |||||||||||
Discount | |||||||||||||
Comerica - Revolving Line of Credit, due 2014 | $ | 3,366 | $ | 0 | $ | 3,366 | |||||||
Less: debt - current | (3,366 | ) | 0 | (3,366 | ) | ||||||||
Debt - non-current | $ | 0 | $ | 0 | $ | 0 | |||||||
Principal and interest payments on debt at March 31, 2014 are expected to be $3.3 million through June 2014 when the Revolving Line of Credit becomes due. | |||||||||||||
2011 Growth Capital Facility | |||||||||||||
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 (“Comerica”) (collectively, the “Amended Credit Agreement”). The Amended Credit Agreement provides for an aggregate borrowing of up to $12.0 million, comprised of a growth capital loan of $5.0 million (“Growth Capital Loan”) and a formula based revolving line of credit (“RLOC”) of up to $7.0 million. 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 Amended Credit Agreement. | |||||||||||||
Growth Capital Loan | |||||||||||||
Concurrent with the execution of the original loan and security agreement in September 2011, the Company borrowed $5.0 million under the Growth Capital Loan, substantially all of which was used to repay the Company’s prior debt with Oxford Finance Corporation (“Oxford”), with the remainder used for general corporate purposes. The Growth Capital Loan was scheduled to mature on September 30, 2015 and bore a fixed interest rate of 6.37%, with interest–only payments due for the first twelve months, followed by equal principal and interest payments for the remaining 36 months. In April 2013, the Company repaid in full the Growth Capital Loan balance and all accrued interest as well as a scheduled final payment fee of $0.05 million, in an aggregate amount of $4.2 million. The Company has no further obligations under the Growth Capital Loan. | |||||||||||||
Revolving Line of Credit | |||||||||||||
The Amended Credit Agreement also provides for a RLOC of up to $7.0 million (the “RLOC Loan Amount”). The amount available under the RLOC is limited to the lesser of (i) 80% of eligible trade receivables or (ii) the RLOC Loan Amount. At March 31, 2014, and December 31, 2013, the Company had $3.3 million and $3.4 million, respectively, outstanding under the RLOC. The Company is required to repay the principal drawn from the RLOC at the end of the RLOC term on June 30, 2014, or earlier if a portion or all of the outstanding RLOC exceeds the amount available under the RLOC. The RLOC bears a floating rate based on the lender’s prime rate plus 1.50%, with interest–only payments due each month. At both March 31, 2014, and December 31, 2013, the floating rate of the RLOC was 4.75%. | |||||||||||||
Compliance with Covenants | |||||||||||||
The Company is required to maintain compliance with certain customary and routine financial covenants under the Amended Credit Agreement, including maintaining a minimum cash balance of $2.5 million at Comerica and achieving minimum revenue levels, which are measured monthly based on a six-month trailing basis and must be at least 75% of the pre-established future projected revenues for the trailing six-month period. Non-compliance with the covenants could result in the principal of the note becoming due and payable. As of March 31, 2014, the Company was in compliance with the financial covenants as set forth in the Amended Credit Agreement. |
Commitments_and_Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2014 | |
Commitments and Contingencies | ' |
Note 9. Commitments and Contingencies | |
Operating Leases | |
The Company leases its office facilities, located in Concord, California and Amersfoort, The Netherlands, and certain equipment 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, which may occur as early as January 2015. 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 lease commenced on August 1, 2013 and obligates the Company to make rent payments for the remaining nine months of $115,776 and $90,048 in 2014 and 2015, respectively. The Company’s leased facilities qualify as operating leases under ASC Topic 840, “Leases” and as such, are not included on its condensed consolidated balance sheets. | |
Financed Leasehold Improvements | |
In 2010, the Company financed $1.1 million of leasehold improvements at one of its facilities in Concord, California. 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 Concord California lease under which such improvements were made, which may occur as early as January 2015, the Company would be required to repay for any remaining portion of the landlord financed leasehold improvements at such time. At March 31, 2014, the Company had an outstanding liability of $0.7 million related to these leasehold improvements, of which $0.1 million was reflected in “Accrued liabilities” and $0.6 million was reflected in “Other non-current liabilities” on the Company’s condensed 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 and supplies to Fresenius at no cost for use in manufacturing finished INTERCEPT disposable kits. Certain of these agreements require minimum purchase commitments from the Company. |
Stockholders_Equity
Stockholders' Equity | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Stockholders' Equity | ' | ||||||||
Note 10. Stockholders’ Equity | |||||||||
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”). The 2009 Warrants are exercisable for a period of five years from the issue date. The fair value on the date of issuance of the 2009 Warrants was determined to be $2.8 million using the Black-Scholes model and/or binomial-lattice option valuation model and applying the following assumptions: (i) a risk-free rate of 2.48%, (ii) an expected term of 5.0 years, (iii) no dividend yield and (iv) a volatility of 77%. | |||||||||
In November 2010, the Company received net proceeds of approximately $19.7 million, after deducting underwriting discounts and commissions and stock issuance costs of approximately $1.3 million, from an underwritten public offering of 7.4 million units. Each unit sold consisted of one share of common stock and a warrant to purchase 1/2 of a share of common stock. Each unit was sold for $2.85, resulting in the issuance of 7.4 million shares of common stock and warrants to purchase 3.7 million shares of common stock, exercisable at an exercise price of $3.20 per share (“2010 Warrants”). The warrants issued in November 2010 became exercisable on May 15, 2011 and are exercisable for a period of five years from the issue date. The fair value on the date of issuance of the 2010 Warrants was determined to be $5.8 million using the Black-Scholes model and/or binomial-lattice option valuation model and applying the following assumptions: (i) a risk-free rate of 1.23%, (ii) an expected term of 5.0 years, (iii) no dividend yield and (iv) a volatility of 85%. | |||||||||
The fair value of the 2009 Warrants and 2010 Warrants was recorded on the consolidated balance sheets as a liability pursuant to “Accounting for Derivative Instruments and Hedging Activities” and “Accounting for Certain Financial Instruments with Characteristics of Both Liabilities and Equity” Topics of ASC and will be adjusted to fair value at each financial reporting date thereafter until the earlier of exercise 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 at March 31, 2014 and December 31, 2013 consisted of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
2009 Warrants | $ | 4,637 | $ | 8,542 | |||||
2010 Warrants | 6,719 | 11,848 | |||||||
Total warrant liability | $ | 11,356 | $ | 20,390 | |||||
The fair value of the Company’s warrants was based on using the binomial-lattice option valuation model and using the following assumptions at March 31, 2014 and December 31, 2013: | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
2009 Warrants: | |||||||||
Expected term (in years) | 0.4 | 0.65 | |||||||
Estimated volatility | 52 | % | 45 | % | |||||
Risk-free interest rate | 0.07 | % | 0.1 | % | |||||
Expected dividend yield | 0 | % | 0 | % | |||||
2010 Warrants: | |||||||||
Expected term (in years) | 1.61 | 1.86 | |||||||
Estimated volatility | 45 | % | 41 | % | |||||
Risk-free interest rate | 0.44 | % | 0.38 | % | |||||
Expected dividend yield | 0 | % | 0 | % | |||||
The Company recorded a non-cash gain of $9.0 million and a non-cash loss of $5.1 million during the three months ended March 31, 2014, and 2013, respectively, in “Gain (Loss) from Revaluation of warrant liability” on the condensed 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 warrant liability. Similarly, any significant decreases in the Company’s stock price will likely create a decrease to the fair value of warrant liability. During the three months ended March 31, 2014, there were no exercises of these warrants. In 2013, warrants to purchase 186,586 shares of common stock were exercised from the outstanding 2010 Warrants. | |||||||||
Sales Agreements | |||||||||
The Company entered into an At-The-Market Issuance Sales Agreement in June 2011, as amended in January 2012 and August 2012 (as amended, the “MLV Agreement”), with MLV & Co. LLC, formerly McNicoll, Lewis & Vlak LLC (“MLV”) that provides for the issuance and sale of shares of the Company’s common stock over the term of the MLV Agreement having an aggregate offering price of up to $20.0 million through MLV. At March 31, 2014, the Company had less than $0.1 million of common stock available to be sold under the MLV Agreement. During the three months ended March 31, 2014, the Company had no sales of its common stock under the MLV Agreement. The MLV Agreement expires in June 2014. | |||||||||
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 an aggregate of $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. During the year ended December 31, 2013, approximately 5.4 million shares of the Company’s common stock were sold under the Amended Cantor Agreement for aggregate net proceeds of $23.5 million. During the three months ended March 31, 2014, the Company had no sales of its common stock under the Amended Cantor Agreement. At March 31, 2014, the Company had approximately $41.5 million of common stock available to be sold under the Amended Cantor Agreement. | |||||||||
Public Offering of Common Stock | |||||||||
The Company completed a public offering of common stock on March 19, 2013. As a result of this offering, the Company issued approximately 8.3 million shares of its common stock at $4.20 per share. The Company provided the underwriters an overallotment of an additional approximately 1.3 million shares of its common stock, which was fully subscribed. Combined gross proceeds for the offering were approximately $40.3 million. Net proceeds to the Company were approximately $38.0 million after underwriters’ discount of approximately $1.8 million and offering costs of approximately $0.5 million. | |||||||||
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 | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Stock-Based Compensation | ' | ||||||||
Note 11. Stock-Based Compensation | |||||||||
The Company 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. 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 continue 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. On each of June 6, 2012 and June 12, 2013, the stockholders approved an amendment to the 2008 Plan (“Amended 2008 Plan”) which increased the aggregate number of shares of common stock authorized for issuance by 3,000,000 and 6,000,000 shares, respectively, such that the Amended 2008 Plan has reserved for issuance an amount not to exceed 19,540,940 shares effective June 12, 2013. At March 31, 2014, the Company had an aggregate of approximately 18.1 million shares of its common stock reserved for issuance under the Amended 2008 Plan, the Prior Plans and the 1996 Plan, of which approximately 12.3 million shares were subject to outstanding options and other stock-based awards, and approximately 5.8 million shares were available for future issuance under the Amended 2008 Plan. | |||||||||
The Company also 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. On June 6, 2012, the stockholders approved an amendment to the Purchase Plan to increase the aggregate number of shares of common stock authorized for issuance by 500,000 shares, such that the Purchase Plan has reserved for issuance an amount not to exceed 1,320,500 shares. At March 31, 2014, the Company had approximately 0.5 million shares available for future issuance under the Purchase Plan. | |||||||||
The Company has 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 vest in three annual installments from the date of grant and are generally issuable at the end of the three-year vesting term. At March 31, 2014, all restricted stock units were fully vested. | |||||||||
Activity under the Company’s equity incentive plans related to stock options is set forth below (in thousands except per share amounts): | |||||||||
Number of | Weighted | ||||||||
Options | Average | ||||||||
Outstanding | Exercise | ||||||||
Price per | |||||||||
Share | |||||||||
Balances at December 31, 2013 | 10,405 | $ | 3.46 | ||||||
Granted | 2,347 | 6.2 | |||||||
Forfeited | (36 | ) | 4.49 | ||||||
Expired | (30 | ) | 9.78 | ||||||
Exercised | (478 | ) | 2.65 | ||||||
Balances at March 31, 2014 | 12,208 | $ | 4 | ||||||
The Company 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. | |||||||||
Stock-based compensation recognized on the Company’s condensed consolidated statements of operations for the three months ended March 31, 2014 and 2013, was as follows (in thousands): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Stock-based compensation expense by caption: | |||||||||
Research and development | $ | 183 | $ | 87 | |||||
Selling, general and administrative | 762 | 626 | |||||||
Total stock-based compensation expense | $ | 945 | $ | 713 | |||||
The Company did not record any stock-based compensation associated with performance-based stock options during the three months ended March 31, 2014 and 2013 as the performance criteria was not probable of being achieved. Performance-based stock options of 50,000 remained outstanding at March 31, 2014. |
Development_and_License_Agreem
Development and License Agreements | 3 Months Ended |
Mar. 31, 2014 | |
Development and License Agreements | ' |
Note 12. Development and License Agreements | |
Agreements with Fresenius | |
The Company has certain agreements with Fresenius which require the Company to pay royalties on 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 three months ended March 31, 2014, and 2013, the Company made royalty payments to Fresenius of $0.7 million and $0.8 million, respectively. At March 31, 2014, and December 31, 2013, accrued royalties due to Fresenius were $0.6 million and $0.7 million, respectively. | |
The Company also paid Fresenius certain costs associated with the amended manufacturing and supply agreement the Company executed with Fresenius in December 2008 (the “Original Supply Agreement”), for the manufacture of INTERCEPT finished disposable kits for the Company’s platelet and plasma systems through December 31, 2013. Under the Original Supply Agreement, the Company paid Fresenius a set price per disposable kit, which was established annually, plus a fixed surcharge per disposable kit. In addition, volume driven manufacturing overhead was paid or refunded if actual manufacturing volumes were higher or lower than the annually estimated production volumes. The Company made payments to Fresenius of $4.6 million and $3.9 million relating to the manufacturing of the Company products during the three months ended March 31, 2014, and 2013, respectively. At March 31, 2014, and December 31, 2013, accrued amounts due to Fresenius were $3.4 million and $4.3 million, respectively, for INTERCEPT disposable kits manufactured. | |
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 decreases in pricing at certain 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. During the three months ended March 31, 2014, we sold $2.7 million of such components to Fresenius. We maintain the value of components sold to Fresenius as a current asset on our balance sheet until such time as we purchase 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. |
Segment_Customer_and_Geographi
Segment, Customer and Geographic Information | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Segment, Customer and Geographic Information | ' | ||||||||
Note 13. 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 are minimal. | |||||||||
The Company’s operations outside of the United States include a wholly-owned subsidiary headquartered in Europe. The Company’s operations in the United States are responsible for the research and development and global commercialization of the INTERCEPT Blood System, as discussed in further detail below, 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 three months ended March 31, 2014 and 2013 (in percentages): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Etablissement Francais du Sang | 23 | % | 16 | % | |||||
Movaco, S.A. | 19 | % | 19 | % | |||||
Delrus Inc. | * | 19 | % | ||||||
* | Represents an amount less than 10% of product revenue. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Principles of Consolidation and Basis of Presentation | ' | ||||||||
Principles of Consolidation and Basis of Presentation | |||||||||
The accompanying unaudited condensed consolidated financial statements include those of Cerus Corporation and its subsidiary, Cerus Europe B.V. (collectively referred to hereinafter as “Cerus” or the “Company”) after elimination of all intercompany accounts and transactions. These condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring entries, considered necessary for a fair presentation have been made. Operating results for the three months ended March 31, 2014, are not necessarily indicative of the results that may be expected for the year ending December 31, 2014, or for any future periods. | |||||||||
These condensed consolidated financial statements and notes thereto should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2013, which were included in the Company’s 2013 Annual Report on Form 10-K, filed with the SEC on March 7, 2014. The accompanying consolidated balance sheet as of December 31, 2013 has been derived from the Company’s audited consolidated financial statements as of that date. | |||||||||
Use of Estimates | ' | ||||||||
Use of Estimates | |||||||||
The preparation of financial statements requires management to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosures of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, 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. | |||||||||
Revenue | ' | ||||||||
Revenue | |||||||||
The Company recognizes revenue in accordance with ASC Topic 605-25, “Revenue Recognition – Arrangements with Multiple Deliverables,” as applicable. Revenue is recognized when (i) persuasive evidence of an agreement with the funding party exists; (ii) services have been rendered or product has been delivered; (iii) pricing is fixed or determinable; and (iv) collection is reasonably assured. The Company’s source of revenues for the three months ended March 31, 2014 and 2013 was 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 a written agreement. 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 based on the best estimated selling price. The Company has determined that vendor specific objective evidence is not discernible due to the Company’s variability in its pricing across the regions into which it sells its products. Since the Company’s products are novel and unique and are not sold by others, third-party evidence of selling price is unavailable. | |||||||||
At March 31, 2014 and December 31, 2013, the Company had $0.3 million and $0.2 million, respectively, of short-term deferred revenue on its condensed 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. | |||||||||
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. 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. | |||||||||
Short-Term Investments | ' | ||||||||
Short-Term Investments | |||||||||
Investments with original maturities of greater than three months which included corporate debt and United States government agency securities are 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,” the Company classified all debt securities as available-for-sale at the time of purchase and reevaluates such designation as of each balance sheet date. 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 gains (losses) on available-for-sale securities, net of taxes” on the Company’s condensed consolidated statements of comprehensive loss. Realized gains and losses from the sale of available-for-sale investments were recorded in “Other income, net” on the Company’s condensed 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 are recorded in “Other income (expense), net” on the Company’s condensed 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-US 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 major financial institutions of high credit standing. The Company monitors the financial credit worthiness of the issuers of its investments and limits the concentration in individual securities and types of investments that exist within its investment portfolio. Generally, all of the Company’s investments carry high credit quality ratings, which is in accordance with its investment policy. At March 31, 2014, the Company does not believe there is significant financial risk from non-performance by the issuers of the Company’s cash equivalents. | |||||||||
Concentrations of credit risk with respect to trade receivables exist. However, in connection with the Company’s revolving line of credit, as discussed in Note 8 in the Notes to Condensed Consolidated Financial Statements, the Company purchased a credit insurance policy that mitigates some of its credit risk, as the policy will pay either the Company or its lender on eligible claims filed on its outstanding receivables. On a regular basis, including at the time of sale, the Company performs credit evaluations of its customers. 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 reserves against the accounts receivable on its condensed consolidated balance sheets and records a charge on its condensed consolidated statements of operations. At March 31, 2014 and December 31, 2013, the Company had not recorded any reserves for potentially uncollectible accounts. | |||||||||
The Company had three customers and two customers that accounted for more than 10% of the Company’s outstanding trade receivables at March 31, 2014, and December 31, 2013, respectively. These customers cumulatively represented approximately 65% and 55% of the Company’s outstanding trade receivables at March 31, 2014, and December 31, 2013, respectively. To date, the Company has not experienced collection difficulties from these customers. | |||||||||
Inventories | ' | ||||||||
Inventories | |||||||||
At March 31, 2014, and December 31, 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, Inc. (“Fresenius”) into the finished INTERCEPT disposable kits. The Company maintains an inventory balance based on its current sales projections, and at each reporting period, the Company evaluates whether its work-in-process inventory would be sold to Fresenius for production of finished units in order to sell to existing and prospective customers within the next twelve-month period. It is not customary for the Company’s production cycle for inventory to exceed twelve months. Instead, the Company uses its best judgment to factor in lead times for the production of its work-in-process and finished units to meet the Company’s forecasted demands. If actual results differ from those estimates, work-in-process inventory could potentially accumulate for periods exceeding one year. At March 31, 2014 and December 31, 2013, the Company classified its work-in-process inventory as a current asset on its condensed consolidated balance sheets based on its evaluation that the work-in-process inventory would be sold to Fresenius for finished disposable kit production within each respective subsequent twelve-month period. | |||||||||
Inventory is recorded at the lower of cost, determined on a first-in, first-out basis, or 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 condensed consolidated statements of operations. At March 31, 2014, and December 31, 2013, the Company had $0.3 million and $0.4 million, respectively, recorded for potential obsolete, expiring or unsalable product. | |||||||||
Property and Equipment, net | ' | ||||||||
Property and Equipment, net | |||||||||
Property and equipment is comprised of furniture, equipment, leasehold improvements, 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, consultants, and payroll and payroll-related costs for employees 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. | |||||||||
Goodwill and Intangible Assets, net | ' | ||||||||
Goodwill and Intangible Assets, net | |||||||||
Additions to goodwill and intangible assets, net are derived at the time of a business acquisition, in which the Company assigns the total consideration transferred to the acquired assets based on each asset’s fair value and any residual amount becomes goodwill, an indefinite life intangible asset. 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 condensed 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 segment and has 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 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.” Also, see Note 5 in the Notes to Unaudited Condensed Consolidated Financial Statements 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 three months ended March 31, 2014, and 2013. | |||||||||
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 condensed consolidated statements of operations. The Company recorded foreign currency gains (losses) of less than $0.1 million and $(0.1) million during the three months ended March 31, 2014, and 2013, respectively. | |||||||||
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 condensed consolidated statements of operations. | |||||||||
See Note 11 in the Notes to Unaudited Condensed Consolidated Financial Statements 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. The Company classifies the warrants as a liability on its condensed consolidated balance sheets as the warrants contain certain material terms which require the Company (or its successor) to purchase the warrants for cash in an amount equal to the value of the unexercised portion of the warrants (as determined in accordance with the Black-Scholes option pricing model) 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 these outstanding warrants is calculated using the binomial-lattice option-pricing model and is adjusted accordingly at each reporting period. The binomial-lattice option-pricing model requires that the Company uses significant assumptions and judgment to determine appropriate inputs to the model. Some of the assumptions that the Company relies on include the probability of a change of control occurring, the volatility of the Company’s stock over the life of the warrant and assumptions and inputs used to value the warrants under the Black-Scholes model should a change of control occur. | |||||||||
Changes resulting from the revaluation of warrants to fair value are recorded in “Revaluation of warrant liability” on the condensed 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 condensed consolidated balance sheets and no further adjustment to the fair value would be made in subsequent periods. | |||||||||
See Note 10 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s valuation of warrant liability. | |||||||||
Income Taxes | ' | ||||||||
Income Taxes | |||||||||
The Company accounts for income taxes using an 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 condensed consolidated statements of operations, nor has its accrued for or made payments for interest and penalties. 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. The Company’s tax years 1998 through 2013 remain subject to examination by the taxing jurisdictions due to unutilized net operating losses and research credits. | |||||||||
Net Income (Loss) Per Share | ' | ||||||||
Net Income (Loss) Per Share | |||||||||
Basic net income (loss) per share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period. Diluted net income (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. Diluted net income (loss) per share also gives effect to potential adjustments to the numerator for changes 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. | |||||||||
Certain potential dilutive securities were excluded from the dilution calculation for the three months ended March 31, 2014, and 2013, 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 income (loss) per share for the three months ended March 31, 2014, and 2013 (in thousands, except per share amounts): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Numerator for Basic and Diluted: | |||||||||
Net loss used for basic calculation | $ | (225 | ) | $ | (10,252 | ) | |||
Effect of revaluation of warrant liability | (9,034 | ) | 0 | ||||||
Adjusted net loss used for diluted calculation | $ | (9,259 | ) | $ | (10,252 | ) | |||
Denominator: | |||||||||
Basic weighted average number of shares outstanding | 72,088 | 59,730 | |||||||
Effect of dilutive potential shares | 3,070 | 0 | |||||||
Diluted weighted average number of shares outstanding | 75,158 | 59,730 | |||||||
Net loss per share: | |||||||||
Basic | $ | (0.00 | ) | $ | (0.17 | ) | |||
Diluted | $ | (0.12 | ) | $ | (0.17 | ) | |||
The table below presents shares underlying stock options, employee stock purchase plan rights, warrants and restricted stock units that are excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the three months ended March 31, 2014 and 2013 (shares in thousands): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Weighted average number of anti-dilutive potential shares | 16,901 | 15,531 | |||||||
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 after December 31, 2002. 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. | |||||||||
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 its 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 Note 2 and 10 in the Notes to Unaudited Condensed Consolidated Financial Statements for further information regarding the Company’s valuation of financial instruments. | |||||||||
New Accounting Pronouncements | ' | ||||||||
New Accounting Pronouncements | |||||||||
There have been no new accounting pronouncements issued during the three months ending March 31, 2014 that are of significance, or potential significance, to the Company. |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Tables) | 3 Months Ended | ||||||||
Mar. 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 income (loss) per share for the three months ended March 31, 2014, and 2013 (in thousands, except per share amounts): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Numerator for Basic and Diluted: | |||||||||
Net loss used for basic calculation | $ | (225 | ) | $ | (10,252 | ) | |||
Effect of revaluation of warrant liability | (9,034 | ) | 0 | ||||||
Adjusted net loss used for diluted calculation | $ | (9,259 | ) | $ | (10,252 | ) | |||
Denominator: | |||||||||
Basic weighted average number of shares outstanding | 72,088 | 59,730 | |||||||
Effect of dilutive potential shares | 3,070 | 0 | |||||||
Diluted weighted average number of shares outstanding | 75,158 | 59,730 | |||||||
Net loss per share: | |||||||||
Basic | $ | (0.00 | ) | $ | (0.17 | ) | |||
Diluted | $ | (0.12 | ) | $ | (0.17 | ) | |||
Anti-Dilutive Effect of Common Shares | ' | ||||||||
The table below presents shares underlying stock options, employee stock purchase plan rights, warrants and restricted stock units that are excluded from the calculation of the weighted average number of shares outstanding used for the calculation of diluted net loss per share. These are excluded from the calculation due to their anti-dilutive effect for the three months ended March 31, 2014 and 2013 (shares in thousands): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Weighted average number of anti-dilutive potential shares | 16,901 | 15,531 |
Fair_Value_on_Financial_Instru1
Fair Value on Financial Instruments (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Fair Value of Financial Assets and Liabilities | ' | ||||||||||||||||
The fair values of the Company’s financial assets and liabilities were determined using the following inputs at March 31, 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) | $ | 9,648 | $ | 9,648 | $ | 0 | $ | 0 | |||||||||
Corporate debt securities (2) | 20,251 | 0 | 20,251 | 0 | |||||||||||||
United States government agency securities (2) | 4,012 | 0 | 4,012 | 0 | |||||||||||||
Total financial assets | $ | 33,911 | $ | 9,648 | $ | 24,263 | $ | 0 | |||||||||
Warrant liability (3) | $ | 11,356 | $ | 0 | $ | 0 | $ | 11,356 | |||||||||
Total financial liabilities | $ | 11,356 | $ | 0 | $ | 0 | $ | 11,356 | |||||||||
-1 | Included in cash and cash equivalents on the Company’s condensed consolidated balance sheets. | ||||||||||||||||
-2 | Included in short-term investments on the Company’s condensed consolidated balance sheets. | ||||||||||||||||
-3 | Included in current liabilities on the Company’s condensed 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 condensed consolidated balance sheets. | ||||||||||||||||
-2 | Included in short-term investments on the Company’s condensed consolidated balance sheets. | ||||||||||||||||
-3 | Included in current liabilities on the Company’s condensed 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, 2013 to March 31, 2014 was as follows (in thousands): | |||||||||||||||||
Balance at December 31, 2013 | $ | 20,390 | |||||||||||||||
Decrease in fair value of warrants | (9,034 | ) | |||||||||||||||
Balance at March 31, 2014 | $ | 11,356 | |||||||||||||||
Availableforsale_Securities_Ta
Available-for-sale Securities (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2014 | |||||||||||||||||
Summary of Available for Sale Securities | ' | ||||||||||||||||
The following is a summary of available-for-sale securities at March 31, 2014 (in thousands): | |||||||||||||||||
March 31, 2014 | |||||||||||||||||
Carrying Value | Gross | Fair Value | |||||||||||||||
Unrealized Gain | |||||||||||||||||
Money market funds | $ | 9,648 | $ | 0 | $ | 9,648 | |||||||||||
Corporate debt securities | 20,243 | 8 | 20,251 | ||||||||||||||
United States government agency securities | 4,012 | 0 | 4,012 | ||||||||||||||
Total available-for-sale securities | $ | 33,903 | $ | 8 | $ | 33,911 | |||||||||||
The following is a summary of available-for-sale securities at December 31, 2013 (in thousands): | |||||||||||||||||
December 31, 2013 | |||||||||||||||||
Carrying Value | Gross | Fair Value | |||||||||||||||
Unrealized Gain | |||||||||||||||||
Money market funds | $ | 8,650 | $ | 0 | $ | 8,650 | |||||||||||
Corporate debt securities | 23,165 | 8 | 23,173 | ||||||||||||||
United States government agency securities | 5,019 | (1 | ) | 5,018 | |||||||||||||
Total available-for-sale securities | $ | 36,834 | $ | 7 | $ | 36,841 | |||||||||||
Available for Sale Securities by Original Contractual Maturity | ' | ||||||||||||||||
Available-for-sale securities at March 31, 2014 and December 31, 2013 consisted of the following by original contractual maturity (in thousands): | |||||||||||||||||
March 31, 2014 | December 31, 2013 | ||||||||||||||||
Carrying Value | Fair Value | Carrying Value | Fair Value | ||||||||||||||
Due in one year or less | $ | 33,903 | $ | 33,911 | $ | 30,700 | $ | 30,701 | |||||||||
Due greater than one year and less than three years | 0 | 0 | 6,134 | 6,140 | |||||||||||||
Total cash equivalents and short-term investments | $ | 33,903 | $ | 33,911 | $ | 36,834 | $ | 36,841 | |||||||||
Inventories_Tables
Inventories (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Inventories | ' | ||||||||
Inventories at March 31, 2014 and December 31, 2013 consisted of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
Work-in-process | $ | 2,142 | $ | 4,863 | |||||
Finished goods | 9,165 | 8,200 | |||||||
Total inventories | $ | 11,307 | $ | 13,063 | |||||
Goodwill_and_Intangible_Assets1
Goodwill and Intangible Assets, net (Tables) | 3 Months Ended | ||||||||||||
Mar. 31, 2014 | |||||||||||||
Summary of Intangible Assets | ' | ||||||||||||
The following is a summary of intangible assets, net at March 31, 2014 (in thousands): | |||||||||||||
March 31, 2014 | |||||||||||||
Gross | Accumulated | Net | |||||||||||
Carrying | Amortization | Carrying | |||||||||||
Amount | Amount | ||||||||||||
Acquisition-related intangible assets: | |||||||||||||
Reacquired license - INTERCEPT Asia | $ | 2,017 | $ | (723 | ) | $ | 1,294 | ||||||
Total intangible assets | $ | 2,017 | $ | (723 | ) | $ | 1,294 | ||||||
The following is a summary of intangible assets, net at December 31, 2013 (in thousands): | |||||||||||||
December 31, 2013 | |||||||||||||
Gross | Accumulated | Net | |||||||||||
Carrying | Amortization | Carrying | |||||||||||
Amount | 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) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Accrued Liabilities | ' | ||||||||
Accrued liabilities at March 31, 2014 and December 31, 2013 consisted of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
Accrued compensation and related costs | $ | 1,899 | $ | 2,527 | |||||
Accrued inventory costs | 2,534 | 3,553 | |||||||
Accrued professional services | 2,995 | 2,722 | |||||||
Other accrued expenses | 1,410 | 1,011 | |||||||
Total accrued liabilities | $ | 8,838 | $ | 9,813 | |||||
Debt_Tables
Debt (Tables) | 3 Months Ended | ||||||||||||
Mar. 31, 2014 | |||||||||||||
Debt | ' | ||||||||||||
Debt at March 31, 2014 consisted of the following (in thousands): | |||||||||||||
March 31, 2014 | |||||||||||||
Principal | Unamortized | Total | |||||||||||
Discount | |||||||||||||
Comerica - Revolving Line of Credit, due 2014 | $ | 3,268 | $ | 0 | $ | 3,268 | |||||||
Less: debt - current | (3,268 | ) | 0 | (3,268 | ) | ||||||||
Debt - non-current | $ | 0 | $ | 0 | $ | 0 | |||||||
Debt at December 31, 2013 consisted of the following (in thousands): | |||||||||||||
December 31, 2013 | |||||||||||||
Principal | Unamortized | Total | |||||||||||
Discount | |||||||||||||
Comerica - Revolving Line of Credit, due 2014 | $ | 3,366 | $ | 0 | $ | 3,366 | |||||||
Less: debt - current | (3,366 | ) | 0 | (3,366 | ) | ||||||||
Debt - non-current | $ | 0 | $ | 0 | $ | 0 | |||||||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2014 | |||||||||
Fair Value of Warrants | ' | ||||||||
The fair value of the warrants at March 31, 2014 and December 31, 2013 consisted of the following (in thousands): | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
2009 Warrants | $ | 4,637 | $ | 8,542 | |||||
2010 Warrants | 6,719 | 11,848 | |||||||
Total warrant liability | $ | 11,356 | $ | 20,390 | |||||
Fair Value Assumptions of Warrants | ' | ||||||||
The fair value of the Company’s warrants was based on using the binomial-lattice option valuation model and using the following assumptions at March 31, 2014 and December 31, 2013: | |||||||||
March 31, | December 31, | ||||||||
2014 | 2013 | ||||||||
2009 Warrants: | |||||||||
Expected term (in years) | 0.4 | 0.65 | |||||||
Estimated volatility | 52 | % | 45 | % | |||||
Risk-free interest rate | 0.07 | % | 0.1 | % | |||||
Expected dividend yield | 0 | % | 0 | % | |||||
2010 Warrants: | |||||||||
Expected term (in years) | 1.61 | 1.86 | |||||||
Estimated volatility | 45 | % | 41 | % | |||||
Risk-free interest rate | 0.44 | % | 0.38 | % | |||||
Expected dividend yield | 0 | % | 0 | % |
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 3 Months Ended | ||||||||
Mar. 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 per share amounts): | |||||||||
Number of | Weighted | ||||||||
Options | Average | ||||||||
Outstanding | Exercise | ||||||||
Price per | |||||||||
Share | |||||||||
Balances at December 31, 2013 | 10,405 | $ | 3.46 | ||||||
Granted | 2,347 | 6.2 | |||||||
Forfeited | (36 | ) | 4.49 | ||||||
Expired | (30 | ) | 9.78 | ||||||
Exercised | (478 | ) | 2.65 | ||||||
Balances at March 31, 2014 | 12,208 | $ | 4 | ||||||
Recognition of Stock-Based Compensation Expense | ' | ||||||||
Stock-based compensation recognized on the Company’s condensed consolidated statements of operations for the three months ended March 31, 2014 and 2013, was as follows (in thousands): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Stock-based compensation expense by caption: | |||||||||
Research and development | $ | 183 | $ | 87 | |||||
Selling, general and administrative | 762 | 626 | |||||||
Total stock-based compensation expense | $ | 945 | $ | 713 | |||||
Segment_Customer_and_Geographi1
Segment, Customer and Geographic Information (Tables) | 3 Months Ended | ||||||||
Mar. 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 three months ended March 31, 2014 and 2013 (in percentages): | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2014 | 2013 | ||||||||
Etablissement Francais du Sang | 23 | % | 16 | % | |||||
Movaco, S.A. | 19 | % | 19 | % | |||||
Delrus Inc. | * | 19 | % | ||||||
* | Represents an amount less than 10% of product revenue. |
Summary_of_Significant_Account3
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | 3 Months Ended | 12 Months Ended | 3 Months Ended | ||||||
Share data in Millions, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 | Dec. 31, 2013 | Aug. 31, 2009 | Nov. 30, 2010 | Mar. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2014 | Mar. 31, 2014 | |
Segment | Customer | 2009 Unit Offering | 2010 Unit Offering | Trade Accounts Receivable | Trade Accounts Receivable | Minimum | Maximum | |||
Customer | ||||||||||
Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
Deferred revenue | $279,000 | ' | $181,000 | [1] | ' | ' | ' | ' | ' | ' |
Number of major customers representing outstanding trade receivables | 3 | ' | 2 | ' | ' | ' | ' | ' | ' | |
Cumulative outstanding trade receivables percentage by major customers | ' | ' | ' | ' | ' | 65.00% | 55.00% | ' | ' | |
Life of inventory | '2 years | ' | ' | ' | ' | ' | ' | ' | ' | |
Protracted length of inventory | '1 year | ' | ' | ' | ' | ' | ' | ' | ' | |
Inventory valuation reserves | 300,000 | ' | 400,000 | ' | ' | ' | ' | ' | ' | |
Estimated useful life of property and equipment | ' | ' | ' | ' | ' | ' | ' | '3 years | '5 years | |
Estimated useful life of intangible assets | '10 years | ' | ' | ' | ' | ' | ' | ' | ' | |
Number of operating segments | 1 | ' | ' | ' | ' | ' | ' | ' | ' | |
Number of reportable segments | 1 | ' | ' | ' | ' | ' | ' | ' | ' | |
Impairment charges on long-lived assets | 0 | 0 | ' | ' | ' | ' | ' | ' | ' | |
Foreign exchange gain (loss) | $100,000 | ($100,000) | ' | ' | ' | ' | ' | ' | ' | |
Warrants to purchase an aggregate shares of common stock | ' | ' | ' | 2.4 | 3.7 | ' | ' | ' | ' | |
Derecognition of tax positions, Maximum | ' | ' | ' | ' | ' | ' | ' | ' | 50.00% | |
Company's tax years subject to examination by the taxing jurisdictions | ' | ' | ' | ' | ' | ' | ' | '1998 | '2013 | |
Period of warranty | '1 year | ' | ' | ' | ' | ' | ' | ' | ' | |
[1] | The financial information in this column was derived from audited financial statements included in the Company's 2013 Annual Report on Form 10-K. |
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 | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Numerator for Basic and Diluted: | ' | ' |
Net loss used for basic calculation | ($225) | ($10,252) |
Effect of revaluation of warrant liability | -9,034 | 0 |
Adjusted net loss used for diluted calculation | ($9,259) | ($10,252) |
Denominator: | ' | ' |
Basic weighted average number of shares outstanding | 72,088 | 59,730 |
Effect of dilutive potential shares | 3,070 | 0 |
Diluted weighted average number of shares outstanding | 75,158 | 59,730 |
Net loss per share: | ' | ' |
Basic | $0 | ($0.17) |
Diluted | ($0.12) | ($0.17) |
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) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ' | ' |
Weighted average number of anti-dilutive potential shares | 16,901 | 15,531 |
Fair_Value_on_Financial_Assets
Fair Value on Financial Assets and Liabilities (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | ||
In Thousands, unless otherwise specified | ||||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | $33,911 | $36,841 | ||
Total financial liabilities | 11,356 | 20,390 | ||
Money market funds | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 9,648 | [1] | 8,650 | [1] |
Corporate debt securities | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 20,251 | [2] | 23,173 | [2] |
United States government agency securities | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 4,012 | [2] | 5,018 | [2] |
Warrant Liability | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial liabilities | 11,356 | [3] | 20,390 | [3] |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 9,648 | 8,650 | ||
Total financial liabilities | 0 | 0 | ||
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market funds | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 9,648 | [1] | 8,650 | [1] |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Corporate debt securities | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 0 | [2] | 0 | [2] |
Quoted Prices in Active Markets for Identical Assets (Level 1) | United States government agency securities | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 0 | [2] | 0 | [2] |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Warrant Liability | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial liabilities | 0 | [3] | 0 | [3] |
Significant Other Observable Inputs (Level 2) | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 24,263 | 28,191 | ||
Total financial liabilities | 0 | 0 | ||
Significant Other Observable Inputs (Level 2) | Money market funds | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 0 | [1] | 0 | [1] |
Significant Other Observable Inputs (Level 2) | Corporate debt securities | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 20,251 | [2] | 23,173 | [2] |
Significant Other Observable Inputs (Level 2) | United States government agency securities | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 4,012 | [2] | 5,018 | [2] |
Significant Other Observable Inputs (Level 2) | Warrant Liability | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial liabilities | 0 | [3] | 0 | [3] |
Significant Unobservable Inputs (Level 3) | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 0 | 0 | ||
Total financial liabilities | 11,356 | 20,390 | ||
Significant Unobservable Inputs (Level 3) | Money market funds | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 0 | [1] | 0 | [1] |
Significant Unobservable Inputs (Level 3) | Corporate debt securities | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 0 | [2] | 0 | [2] |
Significant Unobservable Inputs (Level 3) | United States government agency securities | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial assets | 0 | [2] | 0 | [2] |
Significant Unobservable Inputs (Level 3) | Warrant Liability | ' | ' | ||
Fair value of financial assets and liabilities | ' | ' | ||
Total financial liabilities | $11,356 | [3] | $20,390 | [3] |
[1] | Included in cash and cash equivalents on the Company's condensed consolidated balance sheets. | |||
[2] | Included in short-term investments on the Company's condensed consolidated balance sheets. | |||
[3] | Included in current liabilities on the Company's condensed consolidated balance sheets. |
Reconciliation_of_Beginning_an
Reconciliation of Beginning and Ending Balances for Warrant Liability Using Significant Unobservable Inputs (Detail) (USD $) | 3 Months Ended |
In Thousands, unless otherwise specified | Mar. 31, 2014 |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' |
Beginning balance | $20,390 |
Decrease in fair value of warrants | -9,034 |
Ending balance | $11,356 |
Summary_of_Available_for_Sale_
Summary of Available for Sale Securities (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Carrying Value | $33,903 | $36,834 |
Gross Unrealized Gain | 8 | 7 |
Fair Value | 33,911 | 36,841 |
Money market funds | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Carrying Value | 9,648 | 8,650 |
Gross Unrealized Gain | 0 | 0 |
Fair Value | 9,648 | 8,650 |
Corporate debt securities | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Carrying Value | 20,243 | 23,165 |
Gross Unrealized Gain | 8 | 8 |
Fair Value | 20,251 | 23,173 |
United States government agency securities | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Carrying Value | 4,012 | 5,019 |
Gross Unrealized Gain | 0 | -1 |
Fair Value | $4,012 | $5,018 |
Available_for_Sale_Securities_
Available for Sale Securities by Original Contractual Maturity (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Due in one year or less, carrying value | $33,903 | $30,700 |
Due greater than one year and less than three years, carrying value | 0 | 6,134 |
Total cash equivalents and short-term investments, carrying value | 33,903 | 36,834 |
Due in one year or less, fair value | 33,911 | 30,701 |
Due greater than one year and less than three years, fair value | 0 | 6,140 |
Total cash equivalents and short-term investments, fair value | $33,911 | $36,841 |
Inventories_Detail
Inventories (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Inventory [Line Items] | ' | ' |
Work-in-process | $2,142 | $4,863 |
Finished goods | 9,165 | 8,200 |
Total inventories | $11,307 | $13,063 |
Goodwill_and_Intangible_Assets2
Goodwill and Intangible Assets Net - Additional Information (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Acquired Finite-Lived Intangible Assets [Line Items] | ' | ' |
Disposal or recognition of additional goodwill | $0 | ' |
Impairment charges on goodwill | 0 | ' |
Amortization of intangible assets | 50,000 | 50,000 |
Impairment charges recognized related to the acquired intangible assets | 0 | 0 |
Annual amortization expense of the intangible assets, 2014 (remaining nine months) | 150,000 | ' |
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 $) | Mar. 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 | -723 | -673 |
Net Carrying Amount | 1,294 | 1,344 |
Reacquired license - INTERCEPT Asia | ' | ' |
Acquired Finite-Lived Intangible Assets [Line Items] | ' | ' |
Gross Carrying Amount | 2,017 | 2,017 |
Accumulated Amortization | -723 | -673 |
Net Carrying Amount | $1,294 | $1,344 |
LongTerm_Investments_Additiona
Long-Term Investments - Additional Information (Detail) (USD $) | 3 Months Ended |
In Millions, unless otherwise specified | Mar. 31, 2014 |
Investment [Line Items] | ' |
Eligibility to receive a royalty fee | 1.00% |
Royalty income, nonoperating | $0 |
Carrying value of investment | $0 |
Maximum | ' |
Investment [Line Items] | ' |
Ownership percentage under Cost Method for Investments | 3.00% |
Accrued_Liabilities_Detail
Accrued Liabilities (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | |
In Thousands, unless otherwise specified | |||
Schedule of Accrued Liabilities [Line Items] | ' | ' | |
Accrued compensation and related costs | $1,899 | $2,527 | |
Accrued inventory costs | 2,534 | 3,553 | |
Accrued professional services | 2,995 | 2,722 | |
Other accrued expenses | 1,410 | 1,011 | |
Total accrued liabilities | $8,838 | $9,813 | [1] |
[1] | The financial information in this column was derived from audited financial statements included in the Company's 2013 Annual Report on Form 10-K. |
Debt_Detail
Debt (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | |
In Thousands, unless otherwise specified | |||
Debt Instrument [Line Items] | ' | ' | |
Less: debt - current, Principal | ($3,268) | ($3,366) | |
Less: debt - current, Unamortized Discount | 0 | 0 | |
Less: debt - current | -3,268 | -3,366 | [1] |
Debt - non-current, Principal | 0 | 0 | |
Debt - non-current, Unamortized Discount | 0 | 0 | |
Debt - non-current | 0 | 0 | |
Comerica - Revolving Line of Credit, due 2014 | ' | ' | |
Debt Instrument [Line Items] | ' | ' | |
Total debt, Principal | 3,268 | 3,366 | |
Total debt, Unamortized amount | 0 | 0 | |
Total debt | $3,268 | $3,366 | |
[1] | The financial information in this column was derived from audited financial statements included in the Company's 2013 Annual Report on Form 10-K. |
Debt_Additional_Information_De
Debt - Additional Information (Detail) (USD $) | Mar. 31, 2014 | Jun. 30, 2012 | Jun. 30, 2012 | Mar. 31, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Jun. 30, 2012 | Apr. 30, 2013 | Sep. 30, 2011 | Jun. 30, 2012 |
In Millions, unless otherwise specified | Securities Pledged as Collateral | Comerica - Growth Capital Facility | Compliance With Covenants | Revolving Credit Facility | Revolving Credit Facility | Revolving Credit Facility | Capital Loan | Capital Loan | Capital Loan | |
Comerica - Growth Capital Facility | Comerica - Growth Capital Facility | Comerica - Growth Capital Facility | Comerica - Growth Capital Facility | Comerica - Growth Capital Facility | Comerica - Growth Capital Facility | |||||
Line of Credit Facility [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Principal and interest payments on debt | $3.30 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Amended Credit Agreement | ' | ' | 12 | ' | ' | ' | 7 | ' | 5 | ' |
Growth capital loan from amended Credit Agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5 |
Percentage of investments made in subsidiary | ' | 35.00% | ' | ' | ' | ' | ' | ' | ' | ' |
Principal and interest payments | ' | ' | ' | ' | ' | ' | ' | ' | 'The Growth Capital Loan was scheduled to mature on September 30, 2015 and bore a fixed interest rate of 6.37%, with interest-only payments due for the first twelve months, followed by equal principal and interest payments for the remaining 36 months. | ' |
Maturity period | ' | ' | ' | ' | 30-Jun-14 | ' | ' | ' | 30-Sep-15 | ' |
Fixed interest rate | ' | ' | ' | ' | ' | ' | ' | ' | 6.37% | ' |
Interest Only payments Period | ' | ' | ' | ' | ' | ' | ' | ' | '12 months | ' |
Principal and interest payments | ' | ' | ' | ' | ' | ' | ' | ' | '36 months | ' |
Final payment fee for early repayment of credit facility | ' | ' | ' | ' | ' | ' | ' | 0.05 | ' | ' |
Repayment of credit facility | ' | ' | ' | ' | ' | ' | ' | 4.2 | ' | ' |
Amount under RLOC available to the Company | ' | ' | ' | ' | 80.00% | ' | ' | ' | ' | ' |
Outstanding amounts | ' | ' | ' | ' | 3.3 | 3.4 | ' | ' | ' | ' |
Lender's prime rate plus 1.50% | ' | ' | ' | ' | 'Lender's prime rate plus 1.50% | ' | ' | ' | ' | ' |
Margin rate | ' | ' | ' | ' | 1.50% | ' | ' | ' | ' | ' |
Floating rate of interest | ' | ' | ' | ' | 4.75% | 4.75% | ' | ' | ' | ' |
Minimum cash balance | ' | ' | ' | $2.50 | ' | ' | ' | ' | ' | ' |
Minimum revenues levels percentage | ' | ' | ' | 75.00% | ' | ' | ' | ' | ' | ' |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2014 | Dec. 31, 2010 | |
Commitments and Contingencies Disclosure [Line Items] | ' | ' |
Minimum term of non-cancellable operating leases | '1 year | ' |
Expiration of non-cancellable operating leases maximum year | '2019 | ' |
Financing for leasehold improvement | ' | $1,100,000 |
Outstanding liability related to leasehold improvements | 700,000 | ' |
Leasehold Improvements reflected in Accrued liabilities | 100,000 | ' |
Leasehold Improvements reflected in Other non-current liabilities | 600,000 | ' |
Additional Concord Lease | ' | ' |
Commitments and Contingencies Disclosure [Line Items] | ' | ' |
Early termination of non-cancellable operating leases minimum period | '2015-01 | ' |
Initial term of operating lease | '2 years | ' |
Number of renewal options | 4 | ' |
Renewal period of operating lease | '2 years | ' |
Lease commencement date | 1-Aug-13 | ' |
Future rent payment, 2014 | 115,776 | ' |
Future rent payment, 2015 | $90,048 | ' |
Stockholders_Equity_Additional
Stockholders Equity - Additional Information (Detail) (USD $) | 3 Months Ended | 3 Months Ended | 3 Months Ended | 1 Months Ended | 12 Months Ended | 3 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Mar. 31, 2014 | Mar. 31, 2013 | Dec. 31, 2013 | Mar. 31, 2013 | Mar. 19, 2013 | Mar. 31, 2013 | Aug. 31, 2009 | Nov. 30, 2010 | Aug. 31, 2009 | Nov. 30, 2010 | Dec. 31, 2013 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | ||
IPO | IPO | IPO | 2009 Unit Offering | 2010 Unit Offering | Warrant | Warrant | Warrant | Stockholder Rights Plan | Sales Agreement | Sales Agreement | Sales Agreement | Sales Agreement | |||||
Overallotment Option | 2009 Unit Offering | 2010 Unit Offering | 2010 Unit Offering | Mlv | Mlv | Cantor | Cantor | ||||||||||
Maximum | |||||||||||||||||
Stockholders Equity Note [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
Warrants to purchase an aggregate shares of common stock | ' | ' | ' | ' | ' | ' | 2,400,000 | 3,700,000 | ' | ' | ' | ' | ' | ' | ' | ' | |
Warrant exercise price | ' | ' | ' | ' | ' | ' | 2.9 | 3.2 | ' | ' | ' | ' | ' | ' | ' | ' | |
Exercisable period | ' | ' | ' | ' | ' | ' | ' | ' | '5 years | '5 years | ' | ' | ' | ' | ' | ' | |
Warrant liability | $11,356,000 | ' | $20,390,000 | [1] | ' | ' | ' | ' | ' | $2,800,000 | $5,800,000 | ' | ' | ' | ' | ' | ' |
Risk-free interest rate | ' | ' | ' | ' | ' | ' | ' | ' | 2.48% | 1.23% | ' | ' | ' | ' | ' | ' | |
Expected term (in years) | ' | ' | ' | ' | ' | ' | ' | ' | '5 years | '5 years | ' | ' | ' | ' | ' | ' | |
Expected dividend yield | ' | ' | ' | ' | ' | ' | ' | ' | 0.00% | 0.00% | ' | ' | ' | ' | ' | ' | |
Estimated volatility | ' | ' | ' | ' | ' | ' | ' | ' | 77.00% | 85.00% | ' | ' | ' | ' | ' | ' | |
Net proceeds from underwritten public offering | ' | ' | ' | ' | ' | ' | ' | ' | ' | 19,700,000 | ' | ' | ' | ' | ' | ' | |
Payment for underwriting discounts and commissions and stock issuance cost | ' | ' | ' | 500,000 | ' | ' | ' | ' | ' | 1,300,000 | ' | ' | ' | ' | ' | ' | |
Number of units sold in underwritten public offering | ' | ' | ' | ' | ' | ' | ' | ' | ' | 7,400,000 | ' | ' | ' | ' | ' | ' | |
Number of common stock in each unit | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1 | ' | ' | ' | ' | ' | ' | |
Number of common stock shares purchasable with each warrant | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.5 | ' | ' | ' | ' | ' | ' | |
Units issued, price per unit | ' | ' | ' | ' | ' | ' | ' | ' | ' | $2.85 | ' | ' | ' | ' | ' | ' | |
Common stock, number of shares issued | ' | ' | ' | 8,300,000 | ' | 1,300,000 | ' | ' | ' | 7,400,000 | ' | ' | ' | ' | 0 | 5,400,000 | |
Warrants exercisable date | ' | ' | ' | ' | ' | ' | ' | ' | ' | 15-May-11 | ' | ' | ' | ' | ' | ' | |
Gain (loss) from revaluation of warrant liability | 9,034,000 | -5,073,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
Warrants exercised | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 186,586 | ' | ' | ' | ' | ' | |
Maximum common stock offering price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 20,000,000 | ' | 70,000,000 | ' | |
Common stock available for sale | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 100,000 | 41,500,000 | ' | |
Percentage of proceeds payable as compensation to underwriter | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2.00% | ' | |
Proceeds from common stock sold | 31,000 | 51,502,000 | ' | 38,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0 | 23,500,000 | |
Common stock, price per share | ' | ' | ' | ' | $4.20 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
Gross proceeds from public offering | ' | ' | ' | 40,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
Underwriter's discount | ' | ' | ' | $1,800,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | |
Minimum percentage of common stock acquired by stockholders | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 15.00% | ' | ' | ' | ' | |
Designated preferred stock for future issuance | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 250,000 | ' | ' | ' | ' | |
[1] | The financial information in this column was derived from audited financial statements included in the Company's 2013 Annual Report on Form 10-K. |
Fair_Value_of_Warrants_Detail
Fair Value of Warrants (Detail) (USD $) | Mar. 31, 2014 | Dec. 31, 2013 | |
In Thousands, unless otherwise specified | |||
Class of Warrant or Right [Line Items] | ' | ' | |
Warrant liability | $11,356 | $20,390 | [1] |
2009 Warrants | ' | ' | |
Class of Warrant or Right [Line Items] | ' | ' | |
Warrant liability | 4,637 | 8,542 | |
2010 Warrants | ' | ' | |
Class of Warrant or Right [Line Items] | ' | ' | |
Warrant liability | $6,719 | $11,848 | |
[1] | The financial information in this column was derived from audited financial statements included in the Company's 2013 Annual Report on Form 10-K. |
Fair_Value_of_Warrants_Using_V
Fair Value of Warrants Using Valuation Model (Detail) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2014 | Dec. 31, 2013 | |
2009 Warrants | ' | ' |
Class of Warrant or Right [Line Items] | ' | ' |
Expected term (in years) | '4 months 24 days | '7 months 24 days |
Estimated volatility | 52.00% | 45.00% |
Risk-free interest rate | 0.07% | 0.10% |
Expected dividend yield | 0.00% | 0.00% |
2010 Warrants | ' | ' |
Class of Warrant or Right [Line Items] | ' | ' |
Expected term (in years) | '1 year 7 months 10 days | '1 year 10 months 10 days |
Estimated volatility | 45.00% | 41.00% |
Risk-free interest rate | 0.44% | 0.38% |
Expected dividend yield | 0.00% | 0.00% |
StockBased_Compensation_Additi
Stock-Based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | 0 Months Ended | 0 Months Ended | |||||
Mar. 31, 2014 | Mar. 31, 2013 | Mar. 31, 2014 | Jun. 12, 2013 | Jun. 06, 2012 | Mar. 31, 2014 | Jun. 06, 2012 | Mar. 31, 2014 | |
Restricted Stock Units (RSUs) | 2008 Equity Incentive Plan | 2008 Equity Incentive Plan | 2008 Equity Incentive Plan | Employee Stock Purchase Plan | Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Increase in shares of common stock authorized for issuance | ' | ' | ' | 6,000,000 | 3,000,000 | ' | 500,000 | ' |
Maximum number of shares of common stock authorized for issuance | ' | ' | ' | 19,540,940 | ' | ' | 1,320,500 | ' |
Number of shares available for future issuance | 18,100,000 | ' | ' | ' | ' | 5,800,000 | ' | 500,000 |
Outstanding options and other stock based awards | 12,300,000 | ' | ' | ' | ' | ' | ' | ' |
Restricted stock units vesting Description | ' | ' | 'The restricted stock units generally vest in three annual installments from the date of grant and are generally issuable at the end of the three-year vesting term. | ' | ' | ' | ' | ' |
Performance-based stock options awards | $0 | $0 | ' | ' | ' | ' | ' | ' |
Performance-based stock options, outstanding | 50,000 | ' | ' | ' | ' | ' | ' | ' |
Activity_Under_Equity_Incentiv
Activity Under Equity Incentive Plans Related to Stock Options (Detail) (USD $) | 3 Months Ended |
In Thousands, except Per Share data, unless otherwise specified | Mar. 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 | 2,347 |
Forfeited, Number of Options Outstanding | -36 |
Expired, Number of Options Outstanding | -30 |
Exercised, Number of Options Outstanding | -478 |
Number of Options Outstanding, Ending Balance | 12,208 |
Weighted Average Exercise Price per Share | ' |
Weighted Average Exercise Price per Share, Beginning Balance | $3.46 |
Granted, Weighted Average Exercise Price per Share | $6.20 |
Forfeited, Weighted Average Exercise Price per Share | $4.49 |
Expired, Weighted Average Exercise Price per Share | $9.78 |
Exercised, Weighted Average Exercise Price per Share | $2.65 |
Weighted Average Exercise Price per Share, Ending Balance | $4 |
StockBased_Compensation_Recogn
Stock-Based Compensation Recognized on Condensed Consolidated Statements of Operations (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Stock-based compensation expense | $945 | $713 |
Research and Development Expense | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Stock-based compensation expense | 183 | 87 |
Selling, General and Administrative Expenses | ' | ' |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' |
Stock-based compensation expense | $762 | $626 |
Development_and_License_Agreem1
Development and License Agreements - Additional Information (Detail) (USD $) | 3 Months Ended | |
In Millions, unless otherwise specified | Mar. 31, 2014 | Mar. 31, 2013 |
Licenses Agreements [Line Items] | ' | ' |
Royalty payments on products | $0.70 | $0.80 |
Payments made relating to the manufacturing of the products | 4.6 | 3.9 |
Prior written notice for termination of agreement | '24 months | ' |
Revenue from sale of components | 2.7 | ' |
Fresenius | ' | ' |
Licenses Agreements [Line Items] | ' | ' |
Prior written notice for termination of agreement | '30 months | ' |
Royalty | ' | ' |
Licenses Agreements [Line Items] | ' | ' |
Royalties owed | 0.6 | 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 | $3.40 | $4.30 |
Segment_Customer_and_Geographi2
Segment, Customer and Geographic Information - Additional Information (Detail) | 3 Months Ended |
Mar. 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) | 3 Months Ended | |
Mar. 31, 2014 | Mar. 31, 2013 | |
Delrus Inc. | ' | ' |
Revenue, Major Customer [Line Items] | ' | ' |
Percentage of revenue derived from significant customer from Company's total product revenue | ' | 19.00% |
Movaco, S.A. | ' | ' |
Revenue, Major Customer [Line Items] | ' | ' |
Percentage of revenue derived from significant customer from Company's total product revenue | 19.00% | 19.00% |
Etablissement Francais du Sang | ' | ' |
Revenue, Major Customer [Line Items] | ' | ' |
Percentage of revenue derived from significant customer from Company's total product revenue | 23.00% | 16.00% |