Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Nov. 05, 2013 | |
Document and Entity Information [Abstract] | ' | ' |
Entity Registrant Name | 'DELCATH SYSTEMS, INC. | ' |
Entity Central Index Key | '0000872912 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Well-known Seasoned Issuer | 'No | ' |
Entity Voluntary Filers | 'No | ' |
Entity Current Reporting Status | 'Yes | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 126,289,659 |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-13 | ' |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (Unaudited) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current assets | ' | ' |
Cash and cash equivalents | $27,735 | $23,726 |
Accounts receivables | 111 | 144 |
Inventories, net | 963 | 1,105 |
Prepaid expenses and other current assets | 1,200 | 1,457 |
Total current assets | 30,009 | 26,432 |
Property, plant and equipment, net | 3,293 | 4,042 |
Total assets | 33,302 | 30,474 |
Current liabilities | ' | ' |
Accounts payable | 684 | 939 |
Accrued expenses | 3,375 | 5,790 |
Warrant liability | 863 | 3,427 |
Total current liabilities | 4,922 | 10,156 |
Long term liabilities | ' | ' |
Deferred revenue | 7 | 309 |
Accrued expenses | 490 | 0 |
Total long term liabilities | 497 | 309 |
Commitments and contingencies | ' | ' |
Stockholders' equity | ' | ' |
Preferred stock, $.01 par value; 10,000,000 shares authorized; no shares issued and outstanding at September 30, 2013 and December 31, 2012 | 0 | 0 |
Common stock, $.01 par value; 170,000,000 shares authorized; 103,318,021 and 76,849,033 shares issued and 103,289,921 and 76,820,933 outstanding at September 30, 2013 and December 31, 2012, respectively | 1,033 | 768 |
Additional paid-in capital | 250,821 | 218,063 |
Accumulated deficit | -224,341 | -198,808 |
Treasury stock, at cost; 28,100 shares at September 30, 2013 and December 31, 2012 | -51 | -51 |
Accumulated other comprehensive income | 421 | 37 |
Total stockholders' equity | 27,883 | 20,009 |
Total liabilities and stockholders' equity | $33,302 | $30,474 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Stockholders' equity | ' | ' |
Preferred stock, par value (in dollars per share) | $0.01 | $0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $0.01 | $0.01 |
Common stock, shares authorized (in shares) | 170,000,000 | 170,000,000 |
Common stock, shares issued (in shares) | 103,318,021 | 76,849,033 |
Common stock, shares outstanding (in shares) | 103,289,921 | 76,820,933 |
Treasury stock, at cost (in shares) | 28,100 | 28,100 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) [Abstract] | ' | ' | ' | ' |
Product revenue | $72 | $39 | $152 | $146 |
Other revenues | 0 | 0 | 300 | 0 |
Total revenue | 72 | 39 | 452 | 146 |
Costs of goods sold | -23 | 0 | -386 | 0 |
Gross profit | 49 | 39 | 66 | 146 |
Operating expenses | ' | ' | ' | ' |
Selling, general and administrative | 4,573 | 6,960 | 16,919 | 21,604 |
Research and development | 2,178 | 5,254 | 10,639 | 20,589 |
Total operating expenses | 6,751 | 12,214 | 27,558 | 42,193 |
Operating loss | -6,702 | -12,175 | -27,492 | -42,047 |
Change in fair value of warrant liability, net | -497 | 446 | 2,345 | 1,025 |
Interest income | 2 | 9 | 18 | 16 |
Other expense and interest expense | -9 | -93 | -404 | -204 |
Net loss | -7,206 | -11,813 | -25,533 | -41,210 |
Common share data: | ' | ' | ' | ' |
Basic and diluted loss per share (in dollars per share) | ($0.07) | ($0.18) | ($0.27) | ($0.72) |
Weighted average number of basic and diluted common shares outstanding (in shares) | 100,068,998 | 67,219,224 | 94,023,834 | 56,844,697 |
Other comprehensive income: | ' | ' | ' | ' |
Foreign currency translation adjustments | 15 | 87 | 384 | 83 |
Comprehensive loss | ($7,191) | ($11,726) | ($25,149) | ($41,127) |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 |
Cash flows from operating activities: | ' | ' |
Net loss | ($25,533) | ($41,210) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Stock option compensation expense | 407 | 2,159 |
Restricted stock compensation expense | 179 | 763 |
Depreciation expense | 866 | 1,044 |
Warrant liability fair value adjustment | -2,345 | -1,025 |
Non-cash interest income | -1 | -3 |
Changes in assets and liabilities: | ' | ' |
Decrease (increase) in prepaid expenses and other current assets | 305 | -206 |
Decrease (increase) in accounts receivable | 36 | -941 |
Decrease (increase) in inventories | 150 | -43 |
Decrease in accounts payable and accrued expenses | -3,149 | -1,250 |
Decrease in deferred revenue and long-term accrued expenses | -189 | 58 |
Net cash used in operating activities | -28,896 | -40,654 |
Cash flows from investing activities: | ' | ' |
Purchase of property, plant, and equipment | -113 | -2,076 |
Loss on disposal of equipment | 5 | 0 |
Proceeds from maturities of short-term investments | 0 | 4,980 |
Net cash (used in) provided by investing activities | -108 | 2,904 |
Cash flows from financing activities: | ' | ' |
Net proceeds from sale of stock and exercise of stock options and warrants | 32,218 | 40,188 |
Net cash provided by financing activities | 32,218 | 40,188 |
Foreign currency effects on cash | 795 | 83 |
Increase in cash and cash equivalents | 4,009 | 2,521 |
Cash and cash equivalents at beginning of period | 23,726 | 25,777 |
Cash and cash equivalents at end of period | 27,735 | 28,298 |
Supplemental non-cash activities: | ' | ' |
Fair value of warrants issued | 0 | 3,147 |
Fair value of warrants exercised | $219 | $0 |
Description_of_Business
Description of Business | 9 Months Ended | |
Sep. 30, 2013 | ||
Description of Business [Abstract] | ' | |
Description of Business | ' | |
-1 | Description of Business | |
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology. Our proprietary drug/device combination product, the Delcath Hepatic Delivery System (HDS), is designed to administer high dose chemotherapy and other therapeutic agents to the liver, while controlling the systemic exposure to those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. | ||
The Company has incurred losses since inception. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. Management believes that its capital resources are adequate to fund operations for the next twelve months, but anticipates that additional working capital may be required to continue operations. To the extent additional capital is not available when needed, the Company may be forced to abandon some or all of its development and commercialization efforts, which would have a material adverse effect on the prospects of the business. Operations of the Company are subject to certain risks and uncertainties, including, among others, uncertainty of product development; uncertainty regarding regulatory approval; technological uncertainty; uncertainty regarding patents and proprietary rights; comprehensive government regulations; limited commercial manufacturing, marketing or sales experience; and dependence on key personnel. |
Basis_of_Condensed_Consolidate
Basis of Condensed Consolidated Financial Statement Presentation | 9 Months Ended | |
Sep. 30, 2013 | ||
Basis of Condensed Consolidated Financial Statement Presentation [Abstract] | ' | |
Basis of Condensed Consolidated Financial Statement Presentation | ' | |
-2 | Basis of Condensed Consolidated Financial Statement Presentation | |
The accompanying condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Certain information and footnote disclosures normally included in the Company's annual financial statements have been condensed or omitted. The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make assumptions and estimates that impact the amounts reported in the Company's condensed consolidated financial statements. The condensed consolidated financial statements include the accounts of all entities controlled by Delcath. All significant inter-company accounts and transactions are eliminated. The unaudited interim condensed consolidated financial statements, in the opinion of management, reflect all adjustments (consisting of normal recurring accruals) necessary for a fair statement of the Company's results of operations, financial position and cash flows for the interim periods ended September 30, 2013 and 2012. | ||
The results of operations and cash flows for the interim periods are not necessarily indicative of the results of operations to be expected for the fiscal year. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2012, which are contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2012 as filed with the Securities and Exchange Commission (the "SEC") on March 13, 2013. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 9 Months Ended | ||
Sep. 30, 2013 | |||
Summary of Significant Accounting Policies [Abstract] | ' | ||
Summary of Significant Accounting Policies | ' | ||
-3 | Summary of Significant Accounting Policies | ||
Use of Estimates | |||
The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company's condensed consolidated balance sheets and the amount of expenses reported for each of its periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for derivative instrument liabilities, stock-based compensation, valuation of inventory, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates. | |||
Cash Equivalents and Concentrations of Credit Risk | |||
The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation (FDIC), however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institutions. | |||
Accounts Receivable | |||
Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. As the Company's commercial activities expand, collections and payments from customers will be monitored and a provision for estimated credit losses will be created based upon historical experience and specific customer collection issues that may be identified. At September 30, 2013 there were no accounts receivable determined to be uncollectable. | |||
Inventories | |||
Inventories are valued at the lower of cost or market value using the first-in, first-out method. The reported net value of inventory includes finished saleable products, work-in-process, and raw materials that will be sold or used in future periods. The Company reserves for expired, obsolete, and slow-moving inventory. | |||
Prior to obtaining authorization to affix the CE Mark to its Generation Two Delcath Hepatic CHEMOSAT® Delivery System in April 2012, the Company expensed all of its inventory costs as research and development. Inventory as of September 30, 2013 includes finished goods and components relating to Generation Two Delcath Hepatic CHEMOSAT® Delivery System that have been purchased since April 2012. Therefore, to the extent that materials expensed prior to April 2012 are used in manufacturing finished goods for sale, the Company's cost of goods sold will be adjusted accordingly. | |||
Property, Plant and Equipment | |||
Property, plant and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight line basis over the estimated useful lives of the assets which range from three to seven years. Leasehold improvements will be amortized over the shorter of the lease term or the estimated useful life of the related assets when they are placed into service. Maintenance and repairs are charged to operations as incurred. Expenditures which substantially increase the useful lives of the related assets are capitalized. | |||
Derivative Instrument Liability | |||
The Company accounts for derivative instruments in accordance with Accounting Standards Codification (ASC) 815, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of the hedging relationship designation. Accounting for changes in the fair value of the derivative instruments depends on whether the derivatives qualify as hedge relationships and the types of relationships designated are based on the exposures hedged. At September 30, 2013 and 2012, the Company did not have any derivative instruments that were designated as hedges. | |||
Fair Value Measurements | |||
The Company applies ASC 820, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances. | |||
ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity's own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy). | |||
• | Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access. | ||
• | Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. | ||
• | Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity's own assumptions, as there is little, if any, related market activity. | ||
In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company's assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment, and considers factors specific to the asset or liability. | |||
Deferred Revenue | |||
Deferred revenue on the accompanying condensed consolidated balance sheets includes payment received for product sales to a distributor. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied. The Company will recognize the revenue related to product sales when its obligations under the agreement have been satisfied. The Company recognized deferred revenue related to a research and distribution agreement upon the completion of certain requirements under the agreement. | |||
Product Revenue Recognition | |||
Revenue from product sales is generally recognized when all of the following criteria have been met: persuasive evidence of an arrangement exists; delivery has occurred; product price is fixed or determinable; and collection of the resulting receivable is reasonably assured. The Company recognizes product revenues derived from either direct sales to end hospital customers or indirect sales to distributors when the end hospital customers have completed trainings and are certified to perform patient treatments using our product. | |||
Other Revenue | |||
Other revenue is related to the recognition of previously deferred revenue upon the completion of certain requirements under the Research and Distribution Agreement with Chi-Fu Trading Co., Ltd. | |||
Selling, General and Administrative | |||
Selling, general and administrative costs include personnel costs and related expenses for the Company's sales, marketing, general management and administrative staff, costs related to the Company's commercialization efforts in Europe, professional service fees, professional license, business development and certain general legal activities. | |||
Research and Development | |||
Research and development costs include the costs of materials used for R&D and clinical trials, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company's proprietary drug delivery system. All such costs are charged to expense when incurred. | |||
Stock Based Compensation | |||
The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, which establishes accounting for equity instruments exchanged for employee services and ASC 505-50, which establishes accounting for equity-based payments to non-employees. Under the provisions of ASC 718, share-based compensation is measured at the grant date, based upon the fair value of the award, and is recognized as an expense over the option holders' requisite service period (generally the vesting period of the equity grant). The Company is required to record compensation cost for all share-based payments granted to employees based upon the grant date fair value, estimated in accordance with the provisions of ASC 718. Under the provisions of | |||
ASC 505-50, the measurement of compensation costs related to common shares issued to non-employees for services is based on the value of the services provided or the fair value of the shares issued. The measurement of non-employee stock-based compensation is subject to periodic adjustment as the underlying equity instrument vests. The Company expensed its share-based compensation for share-based payments granted under the accelerated method, which treats each vesting tranche as if it were an individual grant. | |||
The Company periodically grants stock options for a fixed number of shares of common stock to its employees, directors and non-employee contractors, with an exercise price greater than or equal to the fair market value of Delcath's common stock at the date of the grant. The Company estimates the fair value of stock options using an option pricing model. Key inputs used to estimate the fair value of stock options include the exercise price of the award, the expected post-vesting option life, the expected volatility of Delcath's stock over the option's expected term, the risk-free interest rate over the option's expected term, and Delcath's expected annual dividend yield. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons who receive equity awards. | |||
Recently Adopted Accounting Pronouncements | |||
In February 2013, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2013-02 which requires additional disclosures regarding the reporting of reclassifications out of accumulated other comprehensive income. ASU 2013-02 requires an entity to present, either on the face of the statement where net income is presented or in the notes, significant amounts reclassified out of accumulated other comprehensive income by the respective line items of net income but only if the amount reclassified is required under GAAP to be reclassified to net income in its entirety in the same reporting period. This guidance is effective for reporting periods beginning after December 15, 2012. The Company adopted this guidance effective January 1, 2013. The Company's adoption of this standard did not have a material impact on its consolidated financial statements. | |||
In March 2013, the FASB issued ASU 2013-05, which permits an entity to release cumulative translation adjustments into net income when a reporting entity (parent) ceases to have a controlling financial interest in a subsidiary or group of assets that is a business within a foreign entity. Accordingly, the cumulative translation adjustment should be released into net income only if the sale or transfer results in the complete or substantially complete liquidation of the foreign entity in which the subsidiary or group of assets had resided, or, if a controlling financial interest is no longer held. The revised standard is effective for fiscal years beginning after December 15, 2013; however, early adoption is permitted. The Company does not expect adoption of this ASU to materially impact its consolidated financial statements. |
Inventories
Inventories | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Inventories [Abstract] | ' | ||||||||
Inventories | ' | ||||||||
-4 | Inventories | ||||||||
Inventories consist of: | |||||||||
(in thousands) | 30-Sep-13 | 31-Dec-12 | |||||||
Raw materials | $ | 241 | $ | 197 | |||||
Work-in-process | 791 | 405 | |||||||
Finished goods | 263 | 503 | |||||||
Total inventory, gross | 1,295 | 1,105 | |||||||
Inventory reserves | (332 | ) | – | ||||||
Total inventory, net | $ | 963 | $ | 1,105 | |||||
Due to adjustments in the anticipated use of inventory, the Company recorded a $0.3 million reserve for expired, obsolete and slow-moving inventory during the nine months ended September 30, 2013. This cost is included in "Cost of goods sold" in the Condensed Consolidated Statements of Operations. |
Property_Plant_and_Equipment
Property, Plant, and Equipment | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Property, Plant, and Equipment [Abstract] | ' | ||||||||
Property, Plant, and Equipment | ' | ||||||||
-5 | Property, Plant, and Equipment | ||||||||
Property, plant, and equipment consists of: | |||||||||
(in thousands) | 30-Sep-13 | 31-Dec-12 | |||||||
Leaseholds | $ | 1,742 | $ | 1,716 | |||||
Furniture | 952 | 952 | |||||||
Equipment | 1,535 | 1,473 | |||||||
Enterprise hardware and software | 2,136 | 2,141 | |||||||
Buildings and land | 603 | 603 | |||||||
6,968 | 6,885 | ||||||||
Accumulated depreciation | (3,675 | ) | (2,843 | ) | |||||
Total | $ | 3,293 | $ | 4,042 | |||||
Depreciation expense for the three and nine months ended September 30, 2013 is $0.3 million and $0.9 million, respectively, as compared to $0.3 million and $1.0 million for the same period in 2012. |
Restructuring_Charges
Restructuring Charges | 9 Months Ended | ||||
Sep. 30, 2013 | |||||
Restructuring Charges [Abstract] | ' | ||||
Restructuring Charges | ' | ||||
-6 | Restructuring Charges | ||||
During the nine months ended September 30, 2013, the Company implemented restructurings of its workforce to better focus the Company's organizational structure, increase efficiency and concentrate financial resources on its clinical development program and European commercialization activity. This resulted in a reduction in the Company's workforce by 29 employees. As a result of termination benefits given to the impacted employees, the Company incurred a total cost of approximately $2.6 million which is reflected on the Condensed Consolidated Statements of Operations in both "Selling, general and administrative expenses" and "Research and development expenses", as appropriate. The $1.7 million in accrued severance expenses at September 30, 2013 is included in both Current "Accrued expenses" and Long-term Accrued expenses on the Condensed Consolidated Balance Sheets. | |||||
(in thousands) | 30-Sep-13 | ||||
Severance and restructuring expenses | $ | 2,628 | |||
Restructuring expenses paid by September 30, 2013 | (883 | ) | |||
Total restructuring expenses accrued as of September 30, 2013 | $ | 1,745 | |||
Assets_and_Liabilities_Measure
Assets and Liabilities Measured at Fair Value | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Assets and Liabilities Measured at Fair Value [Abstract] | ' | ||||||||||||||||
Assets and Liabilities Measured at Fair Value | ' | ||||||||||||||||
-7 | Assets and Liabilities Measured at Fair Value | ||||||||||||||||
Derivative Warrant Liability | |||||||||||||||||
The Company allocated part of the proceeds of a private placement and a public offering of the Company's common stock to warrants issued in connection with such transactions. The Company determined that these warrants should be classified as liabilities rather than equity. The valuation of the warrants is determined using an option pricing model. This model uses inputs such as the underlying price of the common stock on the date of valuation, the exercise price of the warrant, volatility, risk free interest rate and expected life of the instrument. The Company has determined that the warrant derivative liability should be classified within Level 3 of the fair-value hierarchy by evaluating each input for the model against the fair-value hierarchy criteria and using the lowest level of input as the basis for the fair-value classification as called for in ASC 820-10-35. There are six inputs: the closing price of the Company's common stock on the day of evaluation; the exercise price of the warrants; the remaining term of the warrants; the volatility of Delcath's stock over that term; annual rate of dividends; and the riskless rate of return. Of those inputs, the exercise price of the warrants and the remaining term are readily observable in the warrant agreements. The annual rate of dividends is based on our historical practice of not granting dividends. The closing price of the Company's common stock would fall under Level 1 of the fair-value hierarchy as it is a quoted price in an active market (ASC 820-10-35-40). The riskless rate of return is a Level 2 input as defined in ASC 820-10-35-48, while the historical volatility is a Level 3 input as defined in ASC 820-10-55-22. Since the lowest level input is a Level 3, the Company determined the warrant derivative liability is most appropriately classified within Level 3 of the fair value hierarchy. | |||||||||||||||||
In June 2009, the Company completed the sale of 0.9 million shares of its common stock and the issuance of warrants to purchase approximately 1.0 million common shares (the "2009 Warrants") pursuant to a subscription agreement with a single investor. The Company received gross proceeds of $3.0 million, with net cash proceeds after related expenses from this transaction of approximately $2.7 million. Of those proceeds, the Company allocated an estimated fair value of $2.2 million to the 2009 Warrants. As required by the 2009 Warrant agreement, the exercise price of the warrants was adjusted following the Company's sale of common stock under the "at the market" program during July 2012. At September 30, 2013, the 2009 Warrants were exercisable at $0.29 per share with approximately 1.0 million warrants outstanding. The 2009 Warrants have a five-year term. The shares and warrants were issued pursuant to an effective registration statement on Form S-3 (333-143280 and 333-159857). | |||||||||||||||||
In May 2012, the Company completed the sale of 15.3 million shares of its common stock and the issuance of warrants to purchase 4.6 million common shares (the "2012 Warrants") pursuant to an underwriting agreement. The Company received proceeds of $21.5 million, with net cash proceeds after related expenses from this transaction of approximately $21.1 million. Of those proceeds, the Company allocated an estimated fair value of $3.4 million to the 2012 Warrants. As required by the 2012 Warrant agreement, the exercise price of the warrants was adjusted following the Company's sale of common stock under the "at the market" program during July 2012. At September 30, 2013, the 2012 Warrants were exercisable at $0.29 per share with approximately 4.4 million warrants outstanding. The 2012 Warrants have a three-year term. The shares and warrants were issued pursuant to an effective registration statement on Form S-3 (333-178819). | |||||||||||||||||
The fair value of the Warrants totaled $0.9 million at September 30, 2013 and was determined by using an option pricing model assuming the following: | |||||||||||||||||
2012 | 2009 | ||||||||||||||||
Warrants | Warrants | ||||||||||||||||
Expected volatility | 93.89 | % | 105.91 | % | |||||||||||||
Risk-free interest rates | 0.27 | % | 0.07 | % | |||||||||||||
Expected life (in years) | 1.75 | 0.75 | |||||||||||||||
For the three and nine months ended September 30, 2013, the Company recorded pre-tax derivative instrument income of $0.5 million and pre-tax derivative instrument expense of $2.3 million, respectively. Management expects that the warrants will either be exercised or expire worthless. | |||||||||||||||||
Money Market Funds | |||||||||||||||||
The table below presents the Company's assets and liabilities measured at fair value on a recurring basis as of September 30, 2013, aggregated by the level in the fair value hierarchy within which those measurements fall: | |||||||||||||||||
Assets and Liabilities Measured at Fair Value on a Recurring Basis at September 30, 2013 | |||||||||||||||||
(in thousands) | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Balance at | ||||||||||||||
September 30, | |||||||||||||||||
2013 | |||||||||||||||||
Assets | |||||||||||||||||
Money market funds | $ | 1,956 | $ | — | $ | — | $ | 1,956 | |||||||||
Liabilities | |||||||||||||||||
Warrant liability | $ | — | $ | — | $ | 863 | $ | 863 | |||||||||
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | |||||||||||||||||
(in thousands) | |||||||||||||||||
Warrant Liability | |||||||||||||||||
Beginning balance as of December 31, 2012 | $ | 3,427 | |||||||||||||||
Total change in the liability included in earnings | (2,345 | ) | |||||||||||||||
Fair value of warrants exercised | (219 | ) | |||||||||||||||
Ending balance as of September 30, 2013 | $ | 863 | |||||||||||||||
Stock_Options_Plans
Stock Options Plans | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Stock Options Plans [Abstract] | ' | ||||||||||||||||
Stock Options Plans | ' | ||||||||||||||||
-8 | Stock Options Plans | ||||||||||||||||
The Company established the 2004 Stock Incentive Plan and the 2009 Stock Incentive Plan (collectively, the "Plans") under which 3,000,000 and 6,500,000 shares, respectively, were reserved for the issuance of stock options, stock appreciation rights, restricted stock, stock grants and other equity awards. A stock option grant allows the holder of the option to purchase a share of the Company's common stock in the future at a stated price. The Plans are administered by the Compensation and Stock Option Committee of the Board of Directors which determines the individuals to whom awards shall be granted as well as the type, terms and conditions of each award, the option price and the duration of each award. | |||||||||||||||||
Options granted under the Plans vest as determined by the Company's Compensation and Stock Option Committee and expire over varying terms, but not more than ten years from the date of grant. Stock option activity for the nine months ended September 30, 2013 is as follows: | |||||||||||||||||
Stock Option Activity under the Plans | |||||||||||||||||
Stock | Exercise | Weighted Average | Weighted Average Remaining | ||||||||||||||
Options | Price | Exercise | Life (Years) | ||||||||||||||
per Share | Price | ||||||||||||||||
Outstanding at December 31, 2012 | 4,788,887 | $ | 1.23-$15.54 | $ | 4.79 | 6.88 | |||||||||||
Granted | 943,020 | $ | 0.37-$2.13 | 2.04 | |||||||||||||
Forfeited | (1,000,773 | ) | $ | 1.31-$8.50 | 3.63 | ||||||||||||
Expired | (20,000 | ) | $ | 1.87 | 1.87 | ||||||||||||
Outstanding at September 30, 2013 | 4,711,134 | $ | 0.37-$15.54 | $ | 4.5 | 6.3 | |||||||||||
For the three and nine months ended September 30, 2013, the Company recognized compensation income of approximately $0.2 million and compensation expense of $0.4 million, respectively, relating to stock options granted to employees. The compensation income for the three months ended September 30, is a result of the cancellation of stock options related to the Company's restructuring activities discussed further in Note 6 to the Company's condensed consolidated financial statements contained in the Quarterly Report on Form 10-Q. For the three and nine months ended September 30, 2012, the Company recognized compensation expense of approximately $0.8 million and $2.1 million, respectively, relating to stock options granted to employees. | |||||||||||||||||
The Company accounts for stock-based compensation for employees in accordance with the provisions of ASC 718. An option pricing model is used to determine the fair value of stock options awarded to employees on the date of grant. The Company has expensed its stock-based compensation for share-based payments granted under the ratable method, which treats each vesting tranche as if it were an individual grant. | |||||||||||||||||
The Company accounts for stock-based compensation expense for non-employees in accordance with the provisions of ASC 505, which requires using the fair-value method. Under this method, the award is re-measured at each reporting date until the award has vested. The Company estimates the fair value using an option pricing model. The Company has expensed its share-based compensation for non-employees under the ratable method. | |||||||||||||||||
The assumptions used in the option pricing model to determine the fair value of stock options awarded to employees are as follows: | |||||||||||||||||
Nine Months Ended September 30, | |||||||||||||||||
2013 | 2012 | ||||||||||||||||
Dividend yield | None | None | |||||||||||||||
Expected volatility | 86.16%-93.91% | 77.37% - 84.47% | |||||||||||||||
Weighted average volatility | 86.37% | 79.87% | |||||||||||||||
Risk-free interest rates | 0.99%-1.79% | 0.78% - 1.49% | |||||||||||||||
Expected life (in years) | 6.7 | 6 | |||||||||||||||
No dividend yield was assumed because the Company has never paid a cash dividend on its common stock and does not expect to pay dividends in the foreseeable future. Volatilities were developed using the Company's historical volatility. The risk-free interest rate was developed using the U.S. Treasury yield for maturities equal to the expected life of the stock options on the grant date. The expected option term for grants made prior to June 30, 2012 was developed based on the mid-point between the vesting date and the expiration date of each respective grant as permitted under ASC 718. This method of determining the expected holding period was utilized because the Company did not have sufficient historical experience from which to estimate the period. The expected option term for grants made since July 1, 2012 was calculated based on actual historical results. | |||||||||||||||||
Restricted stock activity for the nine months ended September 30, 2013 is as follows: | |||||||||||||||||
Restricted Stock Activity | |||||||||||||||||
under the Plans | |||||||||||||||||
Restricted Stock | Weighted | ||||||||||||||||
Average | |||||||||||||||||
Grant | |||||||||||||||||
Date Fair | |||||||||||||||||
Value | |||||||||||||||||
Non-vested at December 31, 2012 | 501,468 | $ | 3.26 | ||||||||||||||
Granted | 259,750 | 0.43 | |||||||||||||||
Vested | (317,337 | ) | 2.58 | ||||||||||||||
Forfeited | (103,986 | ) | 4.29 | ||||||||||||||
Non-vested at September 30, 2013 | 339,895 | $ | 1.41 | ||||||||||||||
For the three and nine months ended September 30, 2013, the Company recognized compensation income of $0.1 million and compensation expense of $0.2 million, respectively, relating to restricted stock granted to employees. The compensation income for the three months ended September 30, is a result of the cancellation of restricted stock related to the Company's restructuring activities discussed further in Note 6 to the Company's condensed consolidated financial statements contained in the Quarterly Report on Form 10-Q. For the three and nine months ended September 30, 2012, the Company recognized compensation expense of approximately $0.3 million and $0.8 million, respectively, relating to restricted stock granted to employees. |
Common_Stock
Common Stock | 9 Months Ended | |
Sep. 30, 2013 | ||
Common Stock [Abstract] | ' | |
Common Stock | ' | |
-9 | Common Stock | |
In December 2012, the Company entered into a Common Stock Purchase Agreement (Purchase Agreement) with Terrapin Opportunity, L.P. (Terrapin) for a committed equity financing facility (CEFF) program. The Purchase Agreement provides that Terrapin is committed to purchase up to $35,000,000 of our common stock over the 24-month term of the Purchase Agreement. During the nine months ended September 30, 2013 the Company sold approximately 5.6 million shares of its common stock through the program. The Company received proceeds of approximately $9.0 million, with net cash proceeds after related expenses from this transaction of approximately $8.9 million. The shares were issued pursuant to registration statement on Form S-3 (333-183675). The net proceeds will be used for general corporate purposes, including, but not limited to, commercialization of our products, obtaining regulatory approvals, funding of our clinical trials, capital expenditures and working capital. In addition to the $9.0 million raised during the nine months ended September 30, 2013, the Company previously raised $2.1 million under the CEFF program. As a result, there was approximately $23.9 million available under this CEFF program as of September 30, 2013. | ||
During the three months ended March 31, 2013, the Company sold approximately 14.2 million shares of its common stock under a sales agreement with Cowen and Company, LLC through an "at the market" equity offering program for proceeds of approximately $20.9 million, with net cash proceeds after related expenses of approximately $20.8 million. There are no shares of common stock of the Company remaining for sale under this sales agreement or registered pursuant to registration statement on Form S-3 (333-165677). | ||
On March 13, 2013, the Company entered into a new sales agreement (the "March 2013 Sales Agreement") with Cowen and Company, LLC to sell shares of the Company's common stock, par value $.01 per share, having aggregate sales proceeds of $50,000,000, from time to time, through an "at the market" equity offering program under which Cowen and Company, LLC will act as sales agent. During the three months ended September 30, 2013, the Company sold approximately 6.4 million shares of its common stock under the March 2013 Sales Agreement with Cowen and Company, LLC for proceeds of approximately $2.2 million, with net cash proceeds after related expenses of approximately $2.3 million. The shares were issued pursuant to registration statement on Form S-3 (333-187230). The net proceeds will be used for general corporate purposes, including, but not limited to, commercialization of our products, obtaining regulatory approvals, funding of our clinical trials, capital expenditures and working capital. | ||
During the nine months ended September 30, 2013, the Company issued 0.2 million shares of its common stock upon the exercise of 2012 Warrants for proceeds of approximately $0.2 million. |
Net_Loss
Net Loss | 9 Months Ended | |
Sep. 30, 2013 | ||
Net Loss [Abstract] | ' | |
Net Loss | ' | |
-10 | Net Loss | |
Basic net loss per common share is calculated by dividing net loss by the weighted-average number of common shares outstanding for the period, without consideration for potentially dilutive securities. For the periods presented, basic and diluted net loss per common share are identical. Potentially dilutive securities from stock options, unvested restricted shares and warrants would be antidilutive as the Company incurred a net loss. The number of shares of common stock potentially issuable at September 30, 2013 and 2012 upon exercise or conversion that were not included in the computation of net loss per share totaled 10,490,922 and 10,992,644 shares, respectively. |
Taxes
Taxes | 9 Months Ended | |
Sep. 30, 2013 | ||
Taxes [Abstract] | ' | |
Taxes | ' | |
-11 | Taxes | |
As discussed in Note 11 to the Company's audited financial statements contained in the 2012 Annual Report on Form 10-K, the Company has a valuation allowance against the full amount of its net deferred tax assets. The Company currently provides a valuation allowance against deferred tax assets when it is more likely than not that some portion or all of its deferred tax assets will not be realized. The Company has not recognized any unrecognized tax benefits in its balance sheet. | ||
The Company is subject to income tax in the United States, the Republic of Ireland, and certain state jurisdictions. The Company has not been audited by the United States Internal Revenue Service (the "IRS"), international tax authorities, or any states in connection with income taxes. The periods from December 31, 2009 to December 31, 2012 remain open to examination by the IRS and state tax authorities. The periods from December 31, 2011 to December 31, 2012 remain open to examination by the Republic of Ireland. Also note that the federal, state, and international tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations. |
Legal_Proceedings
Legal Proceedings | 9 Months Ended | |
Sep. 30, 2013 | ||
Legal Proceedings [Abstract] | ' | |
Legal Proceedings [Text Block] | ' | |
-12 | Legal Proceedings | |
The Company is a party to several legal proceedings. Please see Part II, Item 1 in this Quarterly Report on Form 10-Q for more information. | ||
Subsequent_Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2013 | |
Subsequent Events [Abstract] | ' |
Subsequent Events | ' |
DELCATH SYSTEMS, INC. | |
Notes to Condensed Consolidated Financial Statements | |
for the Three and Nine Months Ended September 30, 2013 and 2012 | |
(13) Subsequent Events | |
On October 4, 2013, the Company announced that as part of its efforts to increase operating efficiencies, the Company completed a strategic reorganization under which it has eliminated 21 positions, or approximately 33% of its global workforce. In addition to the restructuring charges disclosed in Note 6 to the Company's condensed consolidated financial statements contained in their Quarterly Report on Form 10-Q, the Company expects to incur an additional approximately $1.4 million in expenses related to this reorganization. | |
On October 23, 2013, the Company announced the sale of 20,960,000 shares of its common stock and warrants to purchase up to 9,432,000 shares of common stock at a combined price to the public of $0.36 per share and related warrant resulting in approximately $7.5 million in gross proceeds. The transaction settled on October 28, 2013. The warrants are exercisable beginning on the date six months after the date of issuance at an exercise price of $0.44 per share and will expire, unless exercised, on the fifth anniversary of the date of issuance. The net proceeds from the sale of the shares and the related warrants, after deducting the placement agent fees and other estimated offering expenses payable by the Company, will be approximately $6.8 million, which does not include any potential proceeds from the cash exercise of any warrants. The Company intends to use the net proceeds from this offering (including any resulting from the exercise of the warrants, if any) for general corporate purposes, including, but not limited to, funding of its clinical trials, commercialization of its products, obtaining regulatory approvals, capital expenditures and working capital. | |
The Company completed an evaluation of the impact of any subsequent events through the date financial statements were issued and determined there were no other subsequent events requiring disclosure in or adjustment to these financial statements. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Policies) | 9 Months Ended | ||
Sep. 30, 2013 | |||
Summary of Significant Accounting Policies [Abstract] | ' | ||
Use of Estimates | ' | ||
Use of Estimates | |||
The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company's condensed consolidated balance sheets and the amount of expenses reported for each of its periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for derivative instrument liabilities, stock-based compensation, valuation of inventory, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates. | |||
Cash Equivalents and Concentrations of Credit Risk | ' | ||
Cash Equivalents and Concentrations of Credit Risk | |||
The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation (FDIC), however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institutions. | |||
Accounts Receivable | ' | ||
Accounts Receivable | |||
Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. As the Company's commercial activities expand, collections and payments from customers will be monitored and a provision for estimated credit losses will be created based upon historical experience and specific customer collection issues that may be identified. At September 30, 2013 there were no accounts receivable determined to be uncollectable. | |||
Inventories | ' | ||
Inventories | |||
Inventories are valued at the lower of cost or market value using the first-in, first-out method. The reported net value of inventory includes finished saleable products, work-in-process, and raw materials that will be sold or used in future periods. The Company reserves for expired, obsolete, and slow-moving inventory. | |||
Prior to obtaining authorization to affix the CE Mark to its Generation Two Delcath Hepatic CHEMOSAT® Delivery System in April 2012, the Company expensed all of its inventory costs as research and development. Inventory as of September 30, 2013 includes finished goods and components relating to Generation Two Delcath Hepatic CHEMOSAT® Delivery System that have been purchased since April 2012. Therefore, to the extent that materials expensed prior to April 2012 are used in manufacturing finished goods for sale, the Company's cost of goods sold will be adjusted accordingly. | |||
Property, Plant and Equipment | ' | ||
Property, Plant and Equipment | |||
Property, plant and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight line basis over the estimated useful lives of the assets which range from three to seven years. Leasehold improvements will be amortized over the shorter of the lease term or the estimated useful life of the related assets when they are placed into service. Maintenance and repairs are charged to operations as incurred. Expenditures which substantially increase the useful lives of the related assets are capitalized. | |||
Derivative Instrument Liability | ' | ||
Derivative Instrument Liability | |||
The Company accounts for derivative instruments in accordance with Accounting Standards Codification (ASC) 815, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of the hedging relationship designation. Accounting for changes in the fair value of the derivative instruments depends on whether the derivatives qualify as hedge relationships and the types of relationships designated are based on the exposures hedged. At September 30, 2013 and 2012, the Company did not have any derivative instruments that were designated as hedges. | |||
Fair Value Measurements | ' | ||
Fair Value Measurements | |||
The Company applies ASC 820, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances. | |||
ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity's own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy). | |||
• | Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access. | ||
• | Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. | ||
• | Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity's own assumptions, as there is little, if any, related market activity. | ||
In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company's assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment, and considers factors specific to the asset or liability. | |||
Deferred Revenue | ' | ||
Deferred Revenue | |||
Deferred revenue on the accompanying condensed consolidated balance sheets includes payment received for product sales to a distributor. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied. The Company will recognize the revenue related to product sales when its obligations under the agreement have been satisfied. The Company recognized deferred revenue related to a research and distribution agreement upon the completion of certain requirements under the agreement. | |||
Product Revenue Recognition | ' | ||
Product Revenue Recognition | |||
Revenue from product sales is generally recognized when all of the following criteria have been met: persuasive evidence of an arrangement exists; delivery has occurred; product price is fixed or determinable; and collection of the resulting receivable is reasonably assured. The Company recognizes product revenues derived from either direct sales to end hospital customers or indirect sales to distributors when the end hospital customers have completed trainings and are certified to perform patient treatments using our product. | |||
Other Revenue | ' | ||
Other Revenue | |||
Other revenue is related to the recognition of previously deferred revenue upon the completion of certain requirements under the Research and Distribution Agreement with Chi-Fu Trading Co., Ltd. | |||
Selling, General and Administrative | ' | ||
Selling, General and Administrative | |||
Selling, general and administrative costs include personnel costs and related expenses for the Company's sales, marketing, general management and administrative staff, costs related to the Company's commercialization efforts in Europe, professional service fees, professional license, business development and certain general legal activities. | |||
Research and Development | ' | ||
Research and Development | |||
Research and development costs include the costs of materials used for R&D and clinical trials, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company's proprietary drug delivery system. All such costs are charged to expense when incurred. | |||
Stock Based Compensation | ' | ||
Stock Based Compensation | |||
The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, which establishes accounting for equity instruments exchanged for employee services and ASC 505-50, which establishes accounting for equity-based payments to non-employees. Under the provisions of ASC 718, share-based compensation is measured at the grant date, based upon the fair value of the award, and is recognized as an expense over the option holders' requisite service period (generally the vesting period of the equity grant). The Company is required to record compensation cost for all share-based payments granted to employees based upon the grant date fair value, estimated in accordance with the provisions of ASC 718. Under the provisions of | |||
ASC 505-50, the measurement of compensation costs related to common shares issued to non-employees for services is based on the value of the services provided or the fair value of the shares issued. The measurement of non-employee stock-based compensation is subject to periodic adjustment as the underlying equity instrument vests. The Company expensed its share-based compensation for share-based payments granted under the accelerated method, which treats each vesting tranche as if it were an individual grant. | |||
The Company periodically grants stock options for a fixed number of shares of common stock to its employees, directors and non-employee contractors, with an exercise price greater than or equal to the fair market value of Delcath's common stock at the date of the grant. The Company estimates the fair value of stock options using an option pricing model. Key inputs used to estimate the fair value of stock options include the exercise price of the award, the expected post-vesting option life, the expected volatility of Delcath's stock over the option's expected term, the risk-free interest rate over the option's expected term, and Delcath's expected annual dividend yield. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons who receive equity awards. | |||
Recently Adopted Accounting Pronouncements | ' | ||
Recently Adopted Accounting Pronouncements | |||
In February 2013, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2013-02 which requires additional disclosures regarding the reporting of reclassifications out of accumulated other comprehensive income. ASU 2013-02 requires an entity to present, either on the face of the statement where net income is presented or in the notes, significant amounts reclassified out of accumulated other comprehensive income by the respective line items of net income but only if the amount reclassified is required under GAAP to be reclassified to net income in its entirety in the same reporting period. This guidance is effective for reporting periods beginning after December 15, 2012. The Company adopted this guidance effective January 1, 2013. The Company's adoption of this standard did not have a material impact on its consolidated financial statements. | |||
In March 2013, the FASB issued ASU 2013-05, which permits an entity to release cumulative translation adjustments into net income when a reporting entity (parent) ceases to have a controlling financial interest in a subsidiary or group of assets that is a business within a foreign entity. Accordingly, the cumulative translation adjustment should be released into net income only if the sale or transfer results in the complete or substantially complete liquidation of the foreign entity in which the subsidiary or group of assets had resided, or, if a controlling financial interest is no longer held. The revised standard is effective for fiscal years beginning after December 15, 2013; however, early adoption is permitted. The Company does not expect adoption of this ASU to materially impact its consolidated financial statements. |
Inventories_Tables
Inventories (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Inventories [Abstract] | ' | ||||||||
Schedule of inventories | ' | ||||||||
Inventories consist of: | |||||||||
(in thousands) | 30-Sep-13 | 31-Dec-12 | |||||||
Raw materials | $ | 241 | $ | 197 | |||||
Work-in-process | 791 | 405 | |||||||
Finished goods | 263 | 503 | |||||||
Total inventory, gross | 1,295 | 1,105 | |||||||
Inventory reserves | (332 | ) | – | ||||||
Total inventory, net | $ | 963 | $ | 1,105 | |||||
Property_Plant_and_Equipment_T
Property, Plant, and Equipment (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Property, Plant, and Equipment [Abstract] | ' | ||||||||
Components of property, plant and equipment | ' | ||||||||
Property, plant, and equipment consists of: | |||||||||
(in thousands) | 30-Sep-13 | 31-Dec-12 | |||||||
Leaseholds | $ | 1,742 | $ | 1,716 | |||||
Furniture | 952 | 952 | |||||||
Equipment | 1,535 | 1,473 | |||||||
Enterprise hardware and software | 2,136 | 2,141 | |||||||
Buildings and land | 603 | 603 | |||||||
6,968 | 6,885 | ||||||||
Accumulated depreciation | (3,675 | ) | (2,843 | ) | |||||
Total | $ | 3,293 | $ | 4,042 | |||||
Restructuring_Charges_Tables
Restructuring Charges (Tables) | 9 Months Ended | ||||
Sep. 30, 2013 | |||||
Restructuring Charges [Abstract] | ' | ||||
Schedule of restructuring and related costs | ' | ||||
During the nine months ended September 30, 2013, the Company implemented restructurings of its workforce to better focus the Company's organizational structure, increase efficiency and concentrate financial resources on its clinical development program and European commercialization activity. This resulted in a reduction in the Company's workforce by 29 employees. As a result of termination benefits given to the impacted employees, the Company incurred a total cost of approximately $2.6 million which is reflected on the Condensed Consolidated Statements of Operations in both "Selling, general and administrative expenses" and "Research and development expenses", as appropriate. The $1.7 million in accrued severance expenses at September 30, 2013 is included in both Current "Accrued expenses" and Long-term Accrued expenses on the Condensed Consolidated Balance Sheets. | |||||
(in thousands) | 30-Sep-13 | ||||
Severance and restructuring expenses | $ | 2,628 | |||
Restructuring expenses paid by September 30, 2013 | (883 | ) | |||
Total restructuring expenses accrued as of September 30, 2013 | $ | 1,745 | |||
Assets_and_Liabilities_Measure1
Assets and Liabilities Measured at Fair Value (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Assets and Liabilities Measured at Fair Value [Abstract] | ' | ||||||||||||||||
Schedule of fair value of the warrants | ' | ||||||||||||||||
The fair value of the Warrants totaled $0.9 million at September 30, 2013 and was determined by using an option pricing model assuming the following: | |||||||||||||||||
2012 | 2009 | ||||||||||||||||
Warrants | Warrants | ||||||||||||||||
Expected volatility | 93.89 | % | 105.91 | % | |||||||||||||
Risk-free interest rates | 0.27 | % | 0.07 | % | |||||||||||||
Expected life (in years) | 1.75 | 0.75 | |||||||||||||||
Assets and liabilities measured at fair value on a recurring basis | ' | ||||||||||||||||
The table below presents the Company's assets and liabilities measured at fair value on a recurring basis as of September 30, 2013, aggregated by the level in the fair value hierarchy within which those measurements fall: | |||||||||||||||||
Assets and Liabilities Measured at Fair Value on a Recurring Basis at September 30, 2013 | |||||||||||||||||
(in thousands) | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Balance at | ||||||||||||||
September 30, | |||||||||||||||||
2013 | |||||||||||||||||
Assets | |||||||||||||||||
Money market funds | $ | 1,956 | $ | — | $ | — | $ | 1,956 | |||||||||
Liabilities | |||||||||||||||||
Warrant liability | $ | — | $ | — | $ | 863 | $ | 863 | |||||||||
Fair value measurements using significant unobservable inputs | ' | ||||||||||||||||
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) | |||||||||||||||||
(in thousands) | |||||||||||||||||
Warrant Liability | |||||||||||||||||
Beginning balance as of December 31, 2012 | $ | 3,427 | |||||||||||||||
Total change in the liability included in earnings | (2,345 | ) | |||||||||||||||
Fair value of warrants exercised | (219 | ) | |||||||||||||||
Ending balance as of September 30, 2013 | $ | 863 | |||||||||||||||
Stock_Options_Plans_Tables
Stock Options Plans (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Stock Options Plans [Abstract] | ' | ||||||||||||||||
Stock option activity | ' | ||||||||||||||||
Options granted under the Plans vest as determined by the Company's Compensation and Stock Option Committee and expire over varying terms, but not more than ten years from the date of grant. Stock option activity for the nine months ended September 30, 2013 is as follows: | |||||||||||||||||
Stock Option Activity under the Plans | |||||||||||||||||
Stock | Exercise | Weighted Average | Weighted Average Remaining | ||||||||||||||
Options | Price | Exercise | Life (Years) | ||||||||||||||
per Share | Price | ||||||||||||||||
Outstanding at December 31, 2012 | 4,788,887 | $ | 1.23-$15.54 | $ | 4.79 | 6.88 | |||||||||||
Granted | 943,020 | $ | 0.37-$2.13 | 2.04 | |||||||||||||
Forfeited | (1,000,773 | ) | $ | 1.31-$8.50 | 3.63 | ||||||||||||
Expired | (20,000 | ) | $ | 1.87 | 1.87 | ||||||||||||
Outstanding at September 30, 2013 | 4,711,134 | $ | 0.37-$15.54 | $ | 4.5 | 6.3 | |||||||||||
Assumptions used to determine the fair value of stock options | ' | ||||||||||||||||
The assumptions used in the option pricing model to determine the fair value of stock options awarded to employees are as follows: | |||||||||||||||||
Nine Months Ended September 30, | |||||||||||||||||
2013 | 2012 | ||||||||||||||||
Dividend yield | None | None | |||||||||||||||
Expected volatility | 86.16%-93.91% | 77.37% - 84.47% | |||||||||||||||
Weighted average volatility | 86.37% | 79.87% | |||||||||||||||
Risk-free interest rates | 0.99%-1.79% | 0.78% - 1.49% | |||||||||||||||
Expected life (in years) | 6.7 | 6 | |||||||||||||||
Restricted stock activity | ' | ||||||||||||||||
Restricted stock activity for the nine months ended September 30, 2013 is as follows: | |||||||||||||||||
Restricted Stock Activity | |||||||||||||||||
under the Plans | |||||||||||||||||
Restricted Stock | Weighted | ||||||||||||||||
Average | |||||||||||||||||
Grant | |||||||||||||||||
Date Fair | |||||||||||||||||
Value | |||||||||||||||||
Non-vested at December 31, 2012 | 501,468 | $ | 3.26 | ||||||||||||||
Granted | 259,750 | 0.43 | |||||||||||||||
Vested | (317,337 | ) | 2.58 | ||||||||||||||
Forfeited | (103,986 | ) | 4.29 | ||||||||||||||
Non-vested at September 30, 2013 | 339,895 | $ | 1.41 | ||||||||||||||
Summary_of_Significant_Account2
Summary of Significant Accounting Policies (Details) (USD $) | 9 Months Ended |
Sep. 30, 2013 | |
Cash Equivalents and Concentrations of Credit Risk [Abstract] | ' |
Maximum number of months of investments with original maturities from date of acquisition to be cash equivalents | '3 months |
Accounts Receivable [Abstract] | ' |
Uncollectable, accounts receivable | $0 |
Minimum [Member] | ' |
Property, Plant and Equipment [Line Items] | ' |
Estimated useful lives | '3 years |
Maximum [Member] | ' |
Property, Plant and Equipment [Line Items] | ' |
Estimated useful lives | '7 years |
Inventories_Details
Inventories (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Inventories [Abstract] | ' | ' |
Raw materials | $241 | $197 |
Work-in-process | 791 | 405 |
Finished goods | 263 | 503 |
Total inventory, gross | 1,295 | 1,105 |
Inventory reserves | -332 | 0 |
Total inventory, net | $963 | $1,105 |
Property_Plant_and_Equipment_D
Property, Plant, and Equipment (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 |
Property, Plant and Equipment [Line Items] | ' | ' | ' | ' | ' |
Property, plant and equipment, gross | $6,968 | ' | $6,968 | ' | $6,885 |
Accumulated depreciation | -3,675 | ' | -3,675 | ' | -2,843 |
Total | 3,293 | ' | 3,293 | ' | 4,042 |
Depreciation expense | 300 | 300 | 866 | 1,044 | ' |
Leaseholds [Member] | ' | ' | ' | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' | ' | ' | ' |
Property, plant and equipment, gross | 1,742 | ' | 1,742 | ' | 1,716 |
Furniture [Member] | ' | ' | ' | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' | ' | ' | ' |
Property, plant and equipment, gross | 952 | ' | 952 | ' | 952 |
Equipment [Member] | ' | ' | ' | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' | ' | ' | ' |
Property, plant and equipment, gross | 1,535 | ' | 1,535 | ' | 1,473 |
Enterprise Hardware and Software [Member] | ' | ' | ' | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' | ' | ' | ' |
Property, plant and equipment, gross | 2,136 | ' | 2,136 | ' | 2,141 |
Buildings and Land [Member] | ' | ' | ' | ' | ' |
Property, Plant and Equipment [Line Items] | ' | ' | ' | ' | ' |
Property, plant and equipment, gross | $603 | ' | $603 | ' | $603 |
Restructuring_Charges_Details
Restructuring Charges (Details) (Operating Expense [Member], USD $) | 9 Months Ended |
Sep. 30, 2013 | |
Employee | |
Operating Expense [Member] | ' |
Restructuring Cost and Reserve [Line Items] | ' |
Number of positions eliminated | 29 |
Severance costs | $2,600,000 |
Restructuring Reserve [Roll Forward] | ' |
Severance and restructuring expenses, beginning balance | 2,628,000 |
Restructuring expenses paid by June 30, 2013 | -883,000 |
Severance and restructuring expenses, ending balance | $1,745,000 |
Assets_and_Liabilities_Measure2
Assets and Liabilities Measured at Fair Value (Details) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Share data in Millions, except Per Share data, unless otherwise specified | 31-May-12 | Jun. 30, 2009 | Sep. 30, 2013 | Sep. 30, 2013 |
Input | ||||
Derivative warrant liability [Abstract] | ' | ' | ' | ' |
Number of inputs used for valuation of warrants | ' | ' | ' | 6 |
Sale of common stock (in shares) | 15.3 | 0.9 | ' | ' |
Issuance of warrants to purchase common shares (in shares) | 4.6 | 1 | ' | ' |
Gross proceeds from issuance of common stock | $21,500,000 | $3,000,000 | ' | ' |
Proceeds from issuance of common stock | 21,100,000 | 2,700,000 | ' | ' |
Pre-tax derivative instrument income | ' | ' | 500,000 | ' |
Pre-tax derivative instrument expense | ' | ' | ' | 2,300,000 |
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) [Roll Forward] | ' | ' | ' | ' |
Beginning balance as of December 31, 2012 | ' | ' | ' | 3,427,000 |
Total change in the fair value of the liability included in earnings | ' | ' | ' | -2,345,000 |
Fair value of warrants exercised | ' | ' | ' | -219,000 |
Ending balance as of September 30, 2013 | ' | ' | 863,000 | 863,000 |
Recurring [Member] | Warrant liability [Member] | ' | ' | ' | ' |
Liabilities [Abstract] | ' | ' | ' | ' |
Total Liabilities | ' | ' | 863,000 | 863,000 |
Recurring [Member] | Warrant liability [Member] | Level 1 [Member] | ' | ' | ' | ' |
Liabilities [Abstract] | ' | ' | ' | ' |
Total Liabilities | ' | ' | 0 | 0 |
Recurring [Member] | Warrant liability [Member] | Level 2 [Member] | ' | ' | ' | ' |
Liabilities [Abstract] | ' | ' | ' | ' |
Total Liabilities | ' | ' | 0 | 0 |
Recurring [Member] | Warrant liability [Member] | Level 3 [Member] | ' | ' | ' | ' |
Liabilities [Abstract] | ' | ' | ' | ' |
Total Liabilities | ' | ' | 863,000 | 863,000 |
Recurring [Member] | Money market funds [Member] | ' | ' | ' | ' |
Assets [Abstract] | ' | ' | ' | ' |
Total Assets | ' | ' | 1,956,000 | 1,956,000 |
Recurring [Member] | Money market funds [Member] | Level 1 [Member] | ' | ' | ' | ' |
Assets [Abstract] | ' | ' | ' | ' |
Total Assets | ' | ' | 1,956,000 | 1,956,000 |
Recurring [Member] | Money market funds [Member] | Level 2 [Member] | ' | ' | ' | ' |
Assets [Abstract] | ' | ' | ' | ' |
Total Assets | ' | ' | 0 | 0 |
Recurring [Member] | Money market funds [Member] | Level 3 [Member] | ' | ' | ' | ' |
Assets [Abstract] | ' | ' | ' | ' |
Total Assets | ' | ' | 0 | 0 |
2009 Warrants [Member] | ' | ' | ' | ' |
Derivative warrant liability [Abstract] | ' | ' | ' | ' |
Proceeds from issuance of common stock | ' | 2,200,000 | ' | ' |
Exercise price of warrants (in dollars per share) | ' | ' | $0.29 | $0.29 |
Warrants outstanding (in shares) | ' | ' | 1 | 1 |
Term of warrant | ' | '5 years | ' | ' |
Expected volatility (in hundredths) | ' | ' | ' | 105.91% |
Risk-free interest rates (in hundredths) | ' | ' | ' | 0.07% |
Expected life | ' | ' | ' | '9 months |
2012 Warrants [Member] | ' | ' | ' | ' |
Derivative warrant liability [Abstract] | ' | ' | ' | ' |
Proceeds from issuance of common stock | $3,400,000 | ' | ' | ' |
Exercise price of warrants (in dollars per share) | ' | ' | $0.29 | $0.29 |
Warrants outstanding (in shares) | ' | ' | 4.4 | 4.4 |
Term of warrant | '3 years | ' | ' | ' |
Expected volatility (in hundredths) | ' | ' | ' | 93.89% |
Risk-free interest rates (in hundredths) | ' | ' | ' | 0.27% |
Expected life | ' | ' | ' | '1 year 9 months |
Stock_Options_Plans_Details
Stock Options Plans (Details) (USD $) | 9 Months Ended | 12 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||||||||
Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Restricted Stock [Member] | Restricted Stock [Member] | Restricted Stock [Member] | Restricted Stock [Member] | Stock Options [Member] | Stock Options [Member] | Minimum [Member] | Minimum [Member] | Minimum [Member] | Maximum [Member] | Maximum [Member] | Maximum [Member] | 2004 Stock Incentive Plan [Member] | 2009 Stock Incentive Plan [Member] | Options granted to employees [Member] | Options granted to employees [Member] | Options granted to employees [Member] | Options granted to employees [Member] | ||||
Stock Options [Member] | Stock Options [Member] | Stock Options [Member] | Stock Options [Member] | Stock Options [Member] | Stock Options [Member] | Stock Options [Member] | Stock Options [Member] | ||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares reserved for the issuance (in shares) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,000,000 | 6,500,000 | ' | ' | ' | ' |
Period for options to be vested from date of grant, maximum | '10 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock Options [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at December 31, 2012 (in shares) | 4,788,887 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Granted (in shares) | 943,020 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Forfeited (in shares) | -1,000,773 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Expired (in shares) | -20,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at September 30, 2013 (in shares) | 4,711,134 | ' | 4,788,887 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Stock Options, Exercise Price per Share [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at December 31, 2012 (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1.23 | ' | ' | $15.54 | ' | ' | ' | ' | ' | ' | ' | ' |
Granted (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | ' | ' | $0.37 | ' | ' | $2.13 | ' | ' | ' | ' | ' | ' | ' | ' |
Forfeited (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1.31 | ' | ' | $8.50 | ' | ' | ' | ' | ' | ' | ' | ' |
Expired (in dollars per share) | $1.87 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at September 30, 2013 (in dollars per share) | ' | ' | ' | ' | ' | ' | ' | ' | ' | $0.37 | ' | ' | $15.54 | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted Average Exercise Price [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at December 31, 2012 (in dollars per share) | $4.79 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Granted (in dollars per share) | $2.04 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Forfeited (in dollars per share) | $3.63 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Expired (in dollars per share) | $1.87 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at September 30, 2013 (in dollars per share) | $4.50 | ' | $4.79 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted Average Remaining Life [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted Average Remaining Life | '6 years 3 months 18 days | ' | '6 years 10 months 17 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Recognized compensation expense | $407,000 | $2,159,000 | ' | ' | $300,000 | $200,000 | $800,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $800,000 | $400,000 | $2,100,000 |
Recognized compensation income | ' | ' | ' | $100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $200,000 | ' | ' | ' |
Assumptions used to determine the fair value of stock options [Abstract] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Dividend yield (in hundredths) | ' | ' | ' | ' | ' | ' | ' | 0.00% | 0.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Expected volatility (in hundredths) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 86.16% | 77.37% | ' | 93.91% | 84.47% | ' | ' | ' | ' | ' | ' |
Weighted average volatility (in hundredths) | ' | ' | ' | ' | ' | ' | ' | 86.37% | 79.87% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Risk-free interest rates (in hundredths) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.99% | 0.78% | ' | 1.79% | 1.49% | ' | ' | ' | ' | ' | ' |
Expected life | ' | ' | ' | ' | ' | ' | ' | '6 years 8 months 12 days | '6 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Restricted Stock [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at December 31, 2012 (in shares) | ' | ' | ' | ' | ' | 501,468 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Granted (in shares) | ' | ' | ' | ' | ' | 259,750 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Vested (in shares) | ' | ' | ' | ' | ' | -317,337 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Forfeited (in shares) | ' | ' | ' | ' | ' | -103,986 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at September 30, 2013 (in shares) | ' | ' | ' | 339,895 | ' | 339,895 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Weighted Average Exercise Price [Roll Forward] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at December 31, 2012 (in dollars per share) | ' | ' | ' | ' | ' | $3.26 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Granted (in dollars per share) | ' | ' | ' | ' | ' | $0.43 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Vested (in dollars per share) | ' | ' | ' | ' | ' | $2.58 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Forfeited (in dollars per share) | ' | ' | ' | ' | ' | $4.29 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Outstanding at September 30, 2013 (in dollars per share) | ' | ' | ' | $1.41 | ' | $1.41 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common_Stock_Details
Common Stock (Details) (USD $) | 1 Months Ended | 9 Months Ended | 3 Months Ended | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Share data in Millions, except Per Share data, unless otherwise specified | 31-May-12 | Jun. 30, 2009 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Mar. 31, 2013 | Sep. 30, 2013 | Mar. 13, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Dec. 31, 2012 |
2012 Warrants [Member] | Cowen and Company, LLC [Member] | Cowen and Company, LLC [Member] | Cowen and Company, LLC [Member] | Terrapin Opportunity, L.P. [Member] | Terrapin Opportunity, L.P. [Member] | Terrapin Opportunity, L.P. [Member] | |||||
March 2013 Sales Agreement [Member] | March 2013 Sales Agreement [Member] | ||||||||||
Class of Stock [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Amount to be purchased by party under agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $35,000,000 |
Term of purchase agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '24 months |
Common stock sold through the program (in shares) | 15.3 | 0.9 | ' | ' | ' | 14.2 | 6.4 | ' | ' | 5.6 | ' |
Gross proceeds from issuance of common stock | 21,500,000 | 3,000,000 | ' | ' | ' | ' | ' | ' | 2,100,000 | 9,000,000 | ' |
Proceeds from issuance of common stock | 21,100,000 | 2,700,000 | ' | ' | 200,000 | 20,900,000 | 2,200,000 | ' | ' | 8,900,000 | ' |
Amount available under the program, assuming sufficient shares are available to be issued | ' | ' | ' | ' | ' | ' | ' | ' | ' | 23,900,000 | ' |
Common stock, par value under sales agreement (in dollars per share) | ' | ' | $0.01 | $0.01 | ' | ' | ' | $0.01 | ' | ' | ' |
Aggregate proceeds from sale of common stock under equity offering program, maximum | ' | ' | ' | ' | ' | ' | ' | 50,000,000 | ' | ' | ' |
Warrants issued (in shares) | ' | ' | ' | ' | 0.2 | ' | ' | ' | ' | ' | ' |
Proceeds of common stock issued, net of related expenses | ' | ' | ' | ' | ' | $20,800,000 | $2,300,000 | ' | ' | ' | ' |
Net_Loss_Details
Net Loss (Details) | 9 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | |
Net Loss [Abstract] | ' | ' |
Antidilutive securities excluded from computation of earnings per share (in shares) | 10,490,922 | 10,992,644 |
Taxes_Details
Taxes (Details) | 9 Months Ended |
Sep. 30, 2013 | |
IRS [Member] | ' |
Income Tax Contingency [Line Items] | ' |
Tax year open for examination | 'December 31, 2009 to December 31, 2012 |
State Authorities [Member] | ' |
Income Tax Contingency [Line Items] | ' |
Tax year open for examination | 'December 31, 2009 to December 31, 2012 |
Republic of Ireland [Member] | ' |
Income Tax Contingency [Line Items] | ' |
Tax year open for examination | 'December 31, 2011 to December 31, 2012 |
Subsequent_Events_Details
Subsequent Events (Details) (USD $) | 1 Months Ended | 0 Months Ended | |||
In Millions, except Share data, unless otherwise specified | 31-May-12 | Jun. 30, 2009 | Nov. 05, 2013 | Oct. 28, 2013 | Oct. 04, 2013 |
Subsequent Event [Member] | Subsequent Event [Member] | Subsequent Event [Member] | |||
Employee | |||||
Subsequent Event [Line Items] | ' | ' | ' | ' | ' |
Common stock issued (in shares) | 15,300,000 | 900,000 | 2,100,000 | ' | ' |
Proceeds from issuance of common stock | $21.10 | $2.70 | $0.60 | $6.80 | ' |
Remaining amount | ' | ' | 46.9 | ' | ' |
Number of positions eliminated | ' | ' | ' | ' | 21 |
Eliminated positions as a percentage of global workforce | ' | ' | ' | ' | 33.00% |
Additional expenses incurred related to the reorganization | ' | ' | ' | ' | 1.4 |
Common stock and warrants sold (in shares) | ' | ' | ' | 20,960,000 | ' |
Shares of common stock that can be purchased (in shares) | ' | ' | ' | 9,432,000 | ' |
Price per share (in dollars per share) | ' | ' | ' | $0.36 | ' |
Gross proceeds | $21.50 | $3 | ' | $7.50 | ' |
Investment Warrants, Exercise Price | ' | ' | ' | $0.44 | ' |