Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Oct. 25, 2013 | |
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 30-Sep-13 | |
Document Fiscal Year Focus | 2013 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | CTIC | |
Entity Registrant Name | CELL THERAPEUTICS INC | |
Entity Central Index Key | 891293 | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 129,878,669 |
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 | $27,176 | $50,436 |
Accounts receivable | 540 | |
Inventory | 3,720 | 1,626 |
Prepaid expenses and other current assets | 2,310 | 8,249 |
Total current assets | 33,746 | 60,311 |
Property and equipment, net | 5,838 | 6,785 |
Other assets | 7,655 | 6,617 |
Total assets | 47,239 | 73,713 |
Current liabilities: | ||
Accounts payable | 10,364 | 12,065 |
Accrued expenses | 7,854 | 10,209 |
Warrant liability | 702 | |
Current portion of long-term debt | 1,216 | |
Other current liabilities | 393 | 393 |
Total current liabilities | 20,529 | 22,667 |
Long-term debt, less current portion | 7,126 | |
Other liabilities | 5,736 | 4,641 |
Total liabilities | 33,391 | 27,308 |
Commitments and contingencies | ||
Common stock purchase warrants | 13,461 | 13,461 |
Common stock, no par value: | ||
Authorized shares - 215,000,000 and 150,000,000 at September 30, 2013 and December 31, 2012, respectively Issued and outstanding shares - 129,865,869 and 109,823,748 at September 30, 2013 and December 31, 2012, respectively | 1,900,746 | 1,872,885 |
Accumulated other comprehensive loss | -8,272 | -8,273 |
Accumulated deficit | -1,889,899 | -1,830,060 |
Total CTI shareholders' equity | 2,575 | 34,552 |
Noncontrolling interest | -2,188 | -1,608 |
Total shareholders' equity | 387 | 32,944 |
Total liabilities and shareholders' equity | $47,239 | $73,713 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Common stock, no par value | ||
Common Stock, Authorized shares | 215,000,000 | 150,000,000 |
Common Stock, Issued shares | 129,865,869 | 109,823,748 |
Common Stock, outstanding shares | 129,865,869 | 109,823,748 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Revenues: | ||||
Product sales, net | $362 | $1,794 | ||
Total revenues | 362 | 1,794 | ||
Operating costs and expenses: | ||||
Cost of product sold | 13 | 104 | ||
Research and development | 7,245 | 6,951 | 23,620 | 24,080 |
Selling, general and administrative | 8,529 | 7,763 | 29,774 | 29,024 |
Acquired in-process research and development | 29,108 | |||
Settlement expense | 155 | 435 | 155 | 435 |
Total operating costs and expenses | 15,942 | 15,149 | 53,653 | 82,647 |
Loss from operations | -15,580 | -15,149 | -51,859 | -82,647 |
Other income (expense): | ||||
Investment and other income (expense), net | -173 | -270 | -433 | -179 |
Interest expense | -316 | -43 | -680 | -51 |
Amortization of debt discount and issuance costs | -162 | -349 | ||
Foreign exchange gain (loss) | 547 | 216 | -199 | -96 |
Total other expense, net | -104 | -97 | -1,661 | -326 |
Net loss before noncontrolling interest | -15,684 | -15,246 | -53,520 | -82,973 |
Noncontrolling interest | 140 | 57 | 581 | 200 |
Net loss attributable to CTI | -15,544 | -15,189 | -52,939 | -82,773 |
Deemed dividends on preferred stock | -6,900 | -5,014 | -6,900 | -13,472 |
Net loss attributable to CTI common shareholders | ($22,444) | ($20,203) | ($59,839) | ($96,245) |
Basic and diluted net loss per common share | ($0.20) | ($0.38) | ($0.55) | ($2.12) |
Shares used in calculation of basic and diluted net loss per common share | 110,996 | 52,921 | 108,489 | 45,442 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements Of Comprehensive Loss (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Net loss before noncontrolling interest | ($15,684) | ($15,246) | ($53,520) | ($82,973) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | -291 | -121 | 196 | 71 |
Net unrealized gain (loss) on securities available-for-sale: | -28 | 48 | -195 | -28 |
Other comprehensive income (loss): | -319 | -73 | 1 | 43 |
Comprehensive loss | -16,003 | -15,319 | -53,519 | -82,930 |
Comprehensive loss attributable to noncontrolling interest | 140 | 57 | 581 | 200 |
Comprehensive loss attributable to CTI | ($15,863) | ($15,262) | ($52,938) | ($82,730) |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 |
Operating activities | ||
Net loss | ($53,520) | ($82,973) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Acquired in-process research and development | 29,108 | |
Share-based compensation expense | 6,324 | 6,084 |
Depreciation and amortization | 1,207 | 1,745 |
Provision for VAT assessments | -2,118 | |
Noncash interest expense | 349 | |
Other | 332 | -195 |
Changes in operating assets and liabilities: | ||
Accounts receivable | -525 | |
Inventory | -1,995 | -509 |
Prepaid expenses and other current assets | 5,749 | -799 |
Other assets | -857 | -874 |
Accounts payable | -763 | 2,207 |
Accrued expenses | -2,468 | -1,895 |
Other liabilities | -26 | 4,462 |
Total adjustments | 7,327 | 37,216 |
Net cash used in operating activities | -46,193 | -45,757 |
Investing activities | ||
Purchases of property and equipment | -1,373 | -1,966 |
Proceeds from sales of property and equipment | 123 | |
Cash paid for acquisition of assets from S*BIO Pte Ltd. | -17,764 | |
Net cash used in investing activities | -1,250 | -19,730 |
Financing activities | ||
Proceeds from issuance of long-term debt, net | 9,501 | |
Other | -326 | -319 |
Net cash provided by financing activities | 24,175 | 32,609 |
Effect of exchange rate changes on cash and cash equivalents | 8 | 115 |
Net decrease in cash and cash equivalents | -23,260 | -32,763 |
Cash and cash equivalents at beginning of period | 50,436 | 47,052 |
Cash and cash equivalents at end of period | 27,176 | 14,289 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 618 | 10 |
Cash paid for taxes | ||
Supplemental disclosure of noncash financing and investing activities | ||
Issuance of Series 16 preferred stock for acquisition of assets from S*BIO Pte Ltd. | 11,344 | |
Issuance of common stock upon exercise or exchange of common stock purchase warrants | 12,351 | |
Series 15 Preferred Stock and Warrants | ||
Financing activities | ||
Proceeds from issuance of equity, net of issuance costs | 32,928 | |
Series 18 Preferred Stock | ||
Financing activities | ||
Proceeds from issuance of equity, net of issuance costs | 15,000 | |
Supplemental disclosure of noncash financing and investing activities | ||
Conversion of preferred stock to common stock | 14,859 | |
Series 14 Preferred Stock | ||
Supplemental disclosure of noncash financing and investing activities | ||
Conversion of preferred stock to common stock | 6,736 | |
Series 15 Preferred Stock | ||
Supplemental disclosure of noncash financing and investing activities | ||
Conversion of preferred stock to common stock | 15,442 | |
Series 16 Preferred Stock | ||
Supplemental disclosure of noncash financing and investing activities | ||
Conversion of preferred stock to common stock | $11,240 |
Description_of_Business_and_Su
Description of Business and Summary of Significant Accounting Policies | 9 Months Ended | |
Sep. 30, 2013 | ||
Description of Business and Summary of Significant Accounting Policies | 1 | Description of Business and Summary of Significant Accounting Policies |
Cell Therapeutics, Inc., also referred to in this Quarterly Report on Form 10-Q as CTI, the Company, we, us or our, is a biopharmaceutical company focused on the acquisition, development and commercialization of less toxic and more effective ways to treat cancer. Our goal is to build a profitable company by generating income from products we develop and commercialize, either alone or with one or more potential strategic partners. We are currently concentrating our efforts on treatments that target blood-related cancers where there is an unmet medical need. We are primarily focused on commercializing PIXUVRI® (pixantrone) in the European Union, or E.U., for multiply relapsed or refractory aggressive non-Hodgkin lymphoma, or NHL, and conducting the first of two planned Phase 3 clinical trials of pacritinib for the treatment of myelofibrosis. As of the date of this filing, PIXUVRI was available in Austria, Denmark, Finland, Germany, Netherlands, Norway, Sweden and the United Kingdom and had been granted market access in Italy and France. | ||
We operate in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products require approval from, and are subject to ongoing oversight by, the Food and Drug Administration, or the FDA, in the United States, by the European Medicines Agency, or EMA, in the E.U., and by comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain, may take many years and may involve the expenditure of substantial resources. | ||
Basis of Presentation | ||
The accompanying unaudited financial information of CTI as of September 30, 2013 and for the three and nine months ended September 30, 2013 and 2012 has been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial position at such date and the operating results and cash flows for such periods. Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for the entire year. | ||
Certain information and footnote disclosure normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to the rules of the U.S. Securities and Exchange Commission, or the SEC. These unaudited financial statements and related notes should be read in conjunction with our audited annual financial statements for the year ended December 31, 2012 included in our Annual Report on Form 10-K filed with the SEC on February 28, 2013. | ||
The condensed consolidated balance sheet at December 31, 2012 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by generally accepted accounting principles in the United States for complete financial statements. | ||
Principles of Consolidation | ||
The accompanying condensed consolidated financial statements include the accounts of CTI and its wholly-owned subsidiaries, which include Systems Medicine LLC, or SM, and CTI Life Sciences Limited. CTI Life Sciences Limited opened a branch in Italy in December 2009. We also retain ownership of our branch, Cell Therapeutics Inc. – Sede Secondaria, or CTI (Europe); however, we ceased operations related to this branch in September 2009. In addition, CTI Commercial LLC, a wholly-owned subsidiary, was included in the condensed consolidated financial statements until dissolution in March 2012. | ||
As of September 30, 2013, we also had a 61% interest in our majority-owned subsidiary, Aequus Biopharma, Inc., or Aequus. The remaining interest in Aequus not held by CTI is reported as noncontrolling interest in the condensed consolidated financial statements. | ||
All intercompany transactions and balances are eliminated in consolidation. | ||
Reverse Stock Splits | ||
On May 15, 2011 and September 2, 2012, we effected one-for-six and one-for-five reverse stock splits, respectively, collectively referred to as the Stock Splits. Unless otherwise noted, all impacted amounts included in the condensed consolidated financial statements and notes thereto have been retroactively adjusted for the Stock Splits. Unless otherwise noted, impacted amounts include shares of common stock authorized and outstanding, share issuances and cancellations, shares underlying preferred stock, convertible notes, warrants and stock options, shares reserved, conversion prices of convertible securities, exercise prices of warrants and options, and net loss per share. Additionally, the Stock Splits impacted preferred stock authorized (but not outstanding because there were no shares of preferred stock outstanding as of the time of the applicable reverse stock split). | ||
Accounts Receivable | ||
Our accounts receivable balance as of September 30, 2013 includes trade receivables related to PIXUVRI sales. We estimate an allowance for doubtful accounts based upon the age of outstanding receivables and our historical experience of collections, which includes adjustments for risk of loss for specific customer accounts. We periodically review the estimation process and make changes to our assumptions as necessary. When it is deemed probable that a customer account is uncollectible, the account balance is written off against the existing allowance. We also consider the customers’ country of origin to determine if an allowance is required based on the uncertainty associated with the recent European financial crisis. As of September 30, 2013, our accounts receivable did not include any balance from a customer in a country that has exhibited financial stress that would have had a material impact on our financial results. We did not record an allowance for doubtful accounts as of September 30, 2013. | ||
Value Added Tax Receivable | ||
Our European operations are subject to a value added tax, or VAT, which is usually applied to all goods and services purchased and sold throughout Europe. Our VAT receivable was $5.7 million and $8.1 million as of September 30, 2013 and December 31, 2012, of which $0.2 million and $3.0 million was included in prepaid expenses and other current assets, respectively, and $5.5 million and $5.1 million was included in other assets, respectively. The collection period of VAT receivable for our European operations ranges from approximately three months to five years. For our Italian VAT receivable, the collection period is approximately three to five years. As of September 30, 2013, the VAT receivable related to operations in Italy was $5.5 million. We review our VAT receivable balance for impairment whenever events or changes in circumstances indicate the carrying amount might not be recoverable. | ||
Inventory | ||
We began capitalizing costs related to the production of PIXUVRI in February 2012 upon receiving a positive opinion for conditional approval by the EMA’s Committee for Medicinal Products for Human Use, or CHMP. Based on the CHMP’s positive opinion, we estimated the likelihood of receiving conditional approval to market PIXUVRI in the E.U. to be probable. Production costs for our other product candidates continue to be charged to research and development expense as incurred prior to regulatory approval or until our estimate for regulatory approval becomes probable. We carry inventory at the lower of cost or market. The cost of finished goods and work in process is determined using the standard-cost method, which approximates actual cost based on a first-in, first-out method. Inventory includes the cost of materials, third-party contract manufacturing and overhead costs, quality control costs and shipping costs from the manufacturers to the final distribution warehouse associated with the production and distribution of PIXUVRI. We regularly review our inventories for impairment and reserves are established when necessary. Estimates of excess inventory consider our projected sales of the product and the remaining shelf lives of product. In the event we identify excess, obsolete or unsaleable inventory, the value is written down to the net realizable value. | ||
Revenue Recognition | ||
We currently have conditional approval to market PIXUVRI in the E.U. Revenue is recognized when there is persuasive evidence of the existence of an agreement, delivery has occurred, prices are fixed or determinable, and collectability is assured. Where the revenue recognition criteria are not met, we defer the recognition of revenue by recording deferred revenue until such time that all criteria under the provision are met. | ||
Product Sales | ||
We sell PIXUVRI directly to health care providers and through a limited number of distributors. We generally record product sales upon receipt of the product by the health care providers and certain distributors at which time title and risk of loss pass. Product sales are recorded net of distributor discounts, estimated government-mandated discounts and rebates, and estimated product returns. Reserves are established for these deductions and actual amounts incurred are offset against the applicable reserves. We reflect these reserves as either a reduction in the related account receivable or as an accrued liability depending on the nature of the sales deduction. These estimates are periodically reviewed and adjusted as necessary. | ||
Government-mandated discounts and rebates | ||
Our products are subject to certain programs with government entities in the E.U. whereby pricing on products is discounted below distributor list price to participating health care providers. These discounts are provided to participating health care providers either at the time of sale or through a claim by the participating health care providers for a rebate. Due to estimates and assumptions inherent in determining the amount of government discounts and rebates, the actual amount of future claims may be different from our estimates, at which time we would adjust our reserves accordingly. | ||
Product returns and other deductions | ||
At the time of sale, we also record estimates for certain sales deductions such as product returns, discounts and incentives. We offer certain distributors a limited right of return or replacement of product that is damaged in certain instances. When we cannot reasonably estimate the amount of future product returns and/or other sales deductions, we do not recognize revenue until the risk of product return and additional sales deductions has been substantially eliminated. To date, there have been no PIXUVRI product returns. | ||
Cost of Product Sold | ||
Cost of product sold includes third party manufacturing costs, shipping costs, contractual royalties, and other costs of PIXUVRI product sold. Cost of product sold also includes any necessary allowances for excess inventory that may expire and become unsalable. We did not record an allowance for excess inventory as of September 30, 2013. | ||
Net Loss per Share | ||
Basic net income (loss) per common share is calculated based on the net income (loss) attributable to common shareholders divided by the weighted average number of shares outstanding for the period excluding any dilutive effects of options, warrants, unvested share awards and convertible securities. Diluted net income (loss) per common share assumes the conversion of all dilutive convertible securities, such as convertible debt and convertible preferred stock using the if-converted method, and assumes the exercise or vesting of other dilutive securities, such as options, warrants and share awards using the treasury stock method. As of September 30, 2013 and 2012, options, warrants, unvested share awards and unvested share rights aggregating 12.2 million and 9.6 million common share equivalents, respectively, prior to the application of the as-if converted method for convertible securities and the treasury stock method for other dilutive securities, such as options and warrants, are not included in the calculation of diluted net loss per share as they are anti-dilutive. | ||
Fair Value Measurement | ||
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest: | ||
Level 1 – Observable inputs, such as unadjusted quoted prices in active markets for identical assets or liabilities. | ||
Level 2 - Observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, or other inputs that are observable directly or indirectly. | ||
Level 3 - Unobservable inputs that are supported by little or no market activity, requiring an entity to develop its own assumptions. | ||
If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument. | ||
Concentrations of Credit Risk | ||
Financial instruments which potentially subject us to concentrations of credit risk consist of accounts receivable. | ||
Recently Adopted Accounting Standards | ||
In February 2013, the FASB issued guidance requiring presentation of amounts reclassified from each component of accumulated other comprehensive income. In addition, disclosure is required of the effects of significant reclassifications on income statement line items either on the face of the statement where net income is presented or as a separate disclosure in the notes to the financial statements. For public entities, this guidance was effective prospectively for reporting periods beginning after December 15, 2012. The adoption of this guidance did not have a material impact on our consolidated financial statements. | ||
Recently Issued Accounting Standards | ||
In March 2013, the Financial Accounting Standards Board, or FASB, issued guidance to clarify when to release cumulative foreign currency translation adjustments when an entity ceases to have a controlling financial interest in a subsidiary or group of assets within a foreign entity. The amendment is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013 and should be applied prospectively to derecognition events occurring after the effective date. Early adoption is permitted. We do not expect the adoption of this guidance to have a material impact on our consolidated financial statements. | ||
In July 2013, the FASB issued guidance on the presentation of an unrecognized tax benefit when a net operating loss carryforward, similar tax loss or tax carryforward exists. FASB concluded that an unrecognized tax benefit should be presented as a reduction of a deferred tax asset except in certain circumstances the unrecognized tax benefit should be presented as a liability and should not be combined with deferred tax assets. The amendment is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013, with early adoption permitted. We are currently evaluating the impact this amendment may have on our consolidated financial statements. | ||
Reclassifications | ||
Certain prior year items have been reclassified to conform to current year presentation. |
Inventory
Inventory | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Inventory | 2 | Inventory | |||||||
The components of inventories are composed of the following as of September 30, 2013 and December 31, 2012 (in thousands): | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Finished goods | $ | 610 | $ | 220 | |||||
Work-in-process | 3,110 | 1,406 | |||||||
Total inventories | $ | 3,720 | $ | 1,626 | |||||
Longterm_Debt
Long-term Debt | 9 Months Ended | |
Sep. 30, 2013 | ||
Long-term Debt | 3 | Long-term Debt |
In March 2013, we entered into a Loan and Security Agreement with Hercules Technology Growth Capital, Inc., or HTGC, for a senior secured term loan of up to $15.0 million. The first $10.0 million was funded in March 2013, and we have the option to borrow an additional $5.0 million any time from November 30, 2013 through December 15, 2013, subject to satisfaction of certain conditions. The interest rate on the term loan floats at a rate per annum equal to 12.25% plus the amount by which the prime rate exceeds 3.25%. The term loan is repayable over 42 months after closing, including an initial interest-only period of 12 months after closing. The loan obligations are secured by a first priority security interest on substantially all of our personal property except our intellectual property and subject to certain other exceptions. We paid a facility charge of $150,000 at closing and a fee in the amount of $1.3 million is payable to HTGC on the date on which the term loan is paid or becomes due and payable in full. We recorded debt discount of $1.9 million, of which $1.7 million is unamortized as of September 30, 2013. We recorded issuance costs of $0.3 million, of which $0.3 million is unamortized as of September 30, 2013. | ||
In addition, we issued a warrant to HTGC to purchase shares of common stock. The warrant is exercisable for five years from the date of issuance for (i) 0.5 million shares of common stock, plus (ii) an amount of shares of common stock equal to (x) $150,000 if any additional funds are borrowed, divided by (y) the exercise price in effect on and as of such date. The initial exercise price of the warrant is $1.1045 per share of common stock. The exercise price and number of shares of common stock issuable upon exercise are subject to antidilution adjustments in certain events, including if within 12 months after closing the Company issues shares of common stock or securities that are exercisable or convertible into shares of common stock in transactions not registered under the Securities Act of 1933, as amended, at an effective price per share of common stock that is less than the exercise price of the warrant, then the exercise price shall automatically be reduced to equal the price per share of common stock in such transaction and the number of shares will be increased proportionately. Since the warrant did not meet the considerations necessary for equity classification in the applicable authoritative guidance, we determined the warrant is a liability instrument that is marked to fair value with changes in fair value recognized through earnings at each reporting period. We estimated the fair value of the warrant to be $0.5 million and $0.7 million as of the issuance date and September 30, 2013, respectively. We classified the warrant as Level 2 in the fair value hierarchy as the significant inputs used in determining fair value are considered observable market data. |
Legal_Proceedings
Legal Proceedings | 9 Months Ended | |
Sep. 30, 2013 | ||
Legal Proceedings | 4 | Legal Proceedings |
On August 3, 2009, SICOR Società Italiana Corticosteroidi S.R.L., or Sicor, filed a lawsuit in the Court of Milan to obtain the Court’s assessment that we were bound to source a chemical compound, BBR2778, from Sicor according to the terms of a supply agreement executed between Sicor and Novuspharma S.p.A, or Novuspharma, a pharmaceutical company located in Italy, on October 4, 2002. We are the successor in interest to such agreement by virtue of our merger with Novuspharma in January 2004. Sicor alleges that the agreement was not terminated according to its terms. We assert that the supply agreement in question was properly terminated and that we have no further obligation to comply with its terms. We are unable to estimate the loss, if any, at this time in the event we do not prevail. | ||
On December 10, 2009, CONSOB sent us a notice claiming, among other now resolved claims, violation of the provisions of Section 114, paragraph 1 of the Italian Legislative Decree no. 58/98 due to the asserted late disclosure of the contents of the opinion expressed by Stonefield Josephson, Inc., an independent registered public accounting firm, with respect to our 2008 financial statements. The sanction established by Section 193, paragraph 1 of the Italian Legislative Decree no. 58/98 for such violation could require us to pay a pecuniary administrative sanction amounting to between $7,000 and $677,000 upon conversion from euros as of September 30, 2013. | ||
The Italian Tax Authority, or ITA, issued notices of assessment to CTI (Europe) based on the ITA’s audit of CTI (Europe)’s VAT returns for the years 2003, 2005, 2006 and 2007. The ITA audits concluded that CTI (Europe) did not collect and remit VAT on certain invoices issued to non-Italian clients for services performed by CTI (Europe). We believe that the services invoiced were non-VAT taxable consultancy services and that the VAT returns are correct as originally filed. We are defending ourselves against the assessments both on procedural grounds and on the merits of the case. We received favorable rulings in 2012, which remain subject to further appeal, and our remaining deposit for the VAT assessments was refunded to us in January 2013. Due to the change of the position for the VAT assessment cases, we reversed the entire reserve for VAT assessed as of December 31, 2012. In June 2013, the Regional Tax Court issued decision no. 119/50/13 in regards to the 2003 VAT assessment, which accepted the appeal of the ITA and reversed the previous decision of the Provincial Tax Court. We believe that such decision has not carefully taken into account our arguments and the documentation we filed, therefore we plan to appeal such decision in front of the Supreme Court both on procedural grounds and on the merits of the case. If the final decisions of the Supreme Court are unfavorable to us, we may incur up to $12.7 million in losses for the VAT amount assessed including penalties, interest and fees upon conversion from euros as of September 30, 2013. |
Preferred_Stock
Preferred Stock | 9 Months Ended | |
Sep. 30, 2013 | ||
Preferred Stock | 5 | Preferred Stock |
In September 2013, we issued 15,000 shares of Series 18 preferred stock, or Series 18 Preferred Stock, for gross proceeds of $15.0 million in a registered direct offering. Issuance costs related to this transaction were $0.1 million. Each share of Series 18 Preferred Stock was entitled to a liquidation preference equal to the initial stated value of $1,000 per share of Series 18 Preferred Stock, plus any accrued and unpaid dividends, before the holders of our common stock or any other junior securities receive any payments upon such liquidation. The Series 18 Preferred Stock was not entitled to dividends except to share in any dividends actually paid on common stock or any pari passu or junior securities. The Series 18 Preferred Stock was convertible to common stock, at the option of the holder, at an initial conversion price of $1.00 per share, subject to a 9.99% blocker provision. The Series 18 Preferred Stock had no voting rights except as otherwise expressly provided in the amended articles or as otherwise required by law. For the three and nine months ended September 30, 2013, we recognized $6.9 million in deemed dividends on preferred stock related to the beneficial conversion feature on our Series 18 Preferred Stock. In September 2013, all 15,000 shares of Series 18 preferred stock were converted into 15.0 million shares of common stock. |
Product_Revenue
Product Revenue | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Product Revenue | 6 | Product Revenue | |||||||||||||||
Total revenue from product sales of PIXUVRI consisted of the following for the three and nine months ended September 30, 2013 and 2012 (in thousands): | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Product sales, gross | $ | 414 | $ | — | $ | 2,122 | $ | — | |||||||||
Discounts, rebates and other adjustments | (51 | ) | — | (290 | ) | — | |||||||||||
Returns reserve | (1 | ) | — | (38 | ) | — | |||||||||||
Product sales, net | $ | 362 | $ | — | $ | 1,794 | $ | — | |||||||||
Sharebased_Compensation_Expens
Share-based Compensation Expense | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Share-based Compensation Expense | 7 | Share-based Compensation Expense | |||||||||||||||
The following table summarizes share-based compensation expense for the three and nine months ended September 30, 2013 and 2012, which was allocated as follows (in thousands): | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Research and development | $ | 685 | $ | 363 | $ | 1,540 | $ | 1,379 | |||||||||
Selling, general and administrative | 1,243 | 653 | 4,784 | 4,705 | |||||||||||||
Total share-based compensation expense | $ | 1,928 | $ | 1,016 | $ | 6,324 | $ | 6,084 | |||||||||
For the three and nine months ended September 30, 2013 and 2012, we incurred share-based compensation expense due to the following types of awards (in thousands): | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Performance rights | $ | 280 | $ | (111 | ) | $ | 885 | $ | 2,158 | ||||||||
Restricted stock | 1,394 | 996 | 4,845 | 3,635 | |||||||||||||
Options | 254 | 131 | 594 | 291 | |||||||||||||
Total share-based compensation expense | $ | 1,928 | $ | 1,016 | $ | 6,324 | $ | 6,084 | |||||||||
Other_Comprehensive_Income_Los
Other Comprehensive Income (Loss) | 9 Months Ended | ||||||||||||
Sep. 30, 2013 | |||||||||||||
Other Comprehensive Income (Loss) | 8 | Other Comprehensive Income (Loss) | |||||||||||
Total accumulated other comprehensive income (loss) consisted of the following (in thousands): | |||||||||||||
Net Unrealized | Foreign | Accumulated | |||||||||||
Loss on | Currency | Other | |||||||||||
Securities | Translation | Comprehensive | |||||||||||
Available-For- | Adjustments | Income (Loss) | |||||||||||
Sale | |||||||||||||
December 31, 2012 | $ | (235 | ) | $ | (8,038 | ) | $ | (8,273 | ) | ||||
Current period other comprehensive income (loss) | (195 | ) | 196 | 1 | |||||||||
September 30, 2013 | $ | (430 | ) | $ | (7,842 | ) | $ | (8,272 | ) | ||||
Leases
Leases | 9 Months Ended | |
Sep. 30, 2013 | ||
Leases | 9 | Leases |
As of December 31, 2012, we had a receivable balance of $1.5 million, which was included in prepaid expenses and other current assets related to incentives for leasehold improvements and rent reimbursement under the terms of our operating lease for office space entered into January 2012. In addition, our deferred rent balance was $4.8 million as of September 30, 2013, of which $0.4 million was included in other current liabilities and $4.4 million was included in other liabilities. As of December 31, 2012, our deferred rent balance was $5.0 million, of which $0.4 million was included in other current liabilities and $4.6 million was included in other liabilities. |
Description_of_Business_and_Su1
Description of Business and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2013 | |
Basis of Presentation | Basis of Presentation |
The accompanying unaudited financial information of CTI as of September 30, 2013 and for the three and nine months ended September 30, 2013 and 2012 has been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial position at such date and the operating results and cash flows for such periods. Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for the entire year. | |
Certain information and footnote disclosure normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to the rules of the U.S. Securities and Exchange Commission, or the SEC. These unaudited financial statements and related notes should be read in conjunction with our audited annual financial statements for the year ended December 31, 2012 included in our Annual Report on Form 10-K filed with the SEC on February 28, 2013. | |
The condensed consolidated balance sheet at December 31, 2012 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by generally accepted accounting principles in the United States for complete financial statements. | |
Principles of Consolidation | Principles of Consolidation |
The accompanying condensed consolidated financial statements include the accounts of CTI and its wholly-owned subsidiaries, which include Systems Medicine LLC, or SM, and CTI Life Sciences Limited. CTI Life Sciences Limited opened a branch in Italy in December 2009. We also retain ownership of our branch, Cell Therapeutics Inc. – Sede Secondaria, or CTI (Europe); however, we ceased operations related to this branch in September 2009. In addition, CTI Commercial LLC, a wholly-owned subsidiary, was included in the condensed consolidated financial statements until dissolution in March 2012. | |
As of September 30, 2013, we also had a 61% interest in our majority-owned subsidiary, Aequus Biopharma, Inc., or Aequus. The remaining interest in Aequus not held by CTI is reported as noncontrolling interest in the condensed consolidated financial statements. | |
All intercompany transactions and balances are eliminated in consolidation. | |
Reverse Stock Splits | Reverse Stock Splits |
On May 15, 2011 and September 2, 2012, we effected one-for-six and one-for-five reverse stock splits, respectively, collectively referred to as the Stock Splits. Unless otherwise noted, all impacted amounts included in the condensed consolidated financial statements and notes thereto have been retroactively adjusted for the Stock Splits. Unless otherwise noted, impacted amounts include shares of common stock authorized and outstanding, share issuances and cancellations, shares underlying preferred stock, convertible notes, warrants and stock options, shares reserved, conversion prices of convertible securities, exercise prices of warrants and options, and net loss per share. Additionally, the Stock Splits impacted preferred stock authorized (but not outstanding because there were no shares of preferred stock outstanding as of the time of the applicable reverse stock split). | |
Accounts Receivable | Accounts Receivable |
Our accounts receivable balance as of September 30, 2013 includes trade receivables related to PIXUVRI sales. We estimate an allowance for doubtful accounts based upon the age of outstanding receivables and our historical experience of collections, which includes adjustments for risk of loss for specific customer accounts. We periodically review the estimation process and make changes to our assumptions as necessary. When it is deemed probable that a customer account is uncollectible, the account balance is written off against the existing allowance. We also consider the customers’ country of origin to determine if an allowance is required based on the uncertainty associated with the recent European financial crisis. As of September 30, 2013, our accounts receivable did not include any balance from a customer in a country that has exhibited financial stress that would have had a material impact on our financial results. We did not record an allowance for doubtful accounts as of September 30, 2013. | |
Inventory | Inventory |
We began capitalizing costs related to the production of PIXUVRI in February 2012 upon receiving a positive opinion for conditional approval by the EMA’s Committee for Medicinal Products for Human Use, or CHMP. Based on the CHMP’s positive opinion, we estimated the likelihood of receiving conditional approval to market PIXUVRI in the E.U. to be probable. Production costs for our other product candidates continue to be charged to research and development expense as incurred prior to regulatory approval or until our estimate for regulatory approval becomes probable. We carry inventory at the lower of cost or market. The cost of finished goods and work in process is determined using the standard-cost method, which approximates actual cost based on a first-in, first-out method. Inventory includes the cost of materials, third-party contract manufacturing and overhead costs, quality control costs and shipping costs from the manufacturers to the final distribution warehouse associated with the production and distribution of PIXUVRI. We regularly review our inventories for impairment and reserves are established when necessary. Estimates of excess inventory consider our projected sales of the product and the remaining shelf lives of product. In the event we identify excess, obsolete or unsaleable inventory, the value is written down to the net realizable value. | |
Revenue Recognition | Revenue Recognition |
We currently have conditional approval to market PIXUVRI in the E.U. Revenue is recognized when there is persuasive evidence of the existence of an agreement, delivery has occurred, prices are fixed or determinable, and collectability is assured. Where the revenue recognition criteria are not met, we defer the recognition of revenue by recording deferred revenue until such time that all criteria under the provision are met. | |
Product Sales | |
We sell PIXUVRI directly to health care providers and through a limited number of distributors. We generally record product sales upon receipt of the product by the health care providers and certain distributors at which time title and risk of loss pass. Product sales are recorded net of distributor discounts, estimated government-mandated discounts and rebates, and estimated product returns. Reserves are established for these deductions and actual amounts incurred are offset against the applicable reserves. We reflect these reserves as either a reduction in the related account receivable or as an accrued liability depending on the nature of the sales deduction. These estimates are periodically reviewed and adjusted as necessary. | |
Government-mandated discounts and rebates | |
Our products are subject to certain programs with government entities in the E.U. whereby pricing on products is discounted below distributor list price to participating health care providers. These discounts are provided to participating health care providers either at the time of sale or through a claim by the participating health care providers for a rebate. Due to estimates and assumptions inherent in determining the amount of government discounts and rebates, the actual amount of future claims may be different from our estimates, at which time we would adjust our reserves accordingly. | |
Product returns and other deductions | |
At the time of sale, we also record estimates for certain sales deductions such as product returns, discounts and incentives. We offer certain distributors a limited right of return or replacement of product that is damaged in certain instances. When we cannot reasonably estimate the amount of future product returns and/or other sales deductions, we do not recognize revenue until the risk of product return and additional sales deductions has been substantially eliminated. To date, there have been no PIXUVRI product returns. | |
Cost of Product Sold | Cost of Product Sold |
Cost of product sold includes third party manufacturing costs, shipping costs, contractual royalties, and other costs of PIXUVRI product sold. Cost of product sold also includes any necessary allowances for excess inventory that may expire and become unsalable. We did not record an allowance for excess inventory as of September 30, 2013. | |
Net Loss per Share | Net Loss per Share |
Basic net income (loss) per common share is calculated based on the net income (loss) attributable to common shareholders divided by the weighted average number of shares outstanding for the period excluding any dilutive effects of options, warrants, unvested share awards and convertible securities. Diluted net income (loss) per common share assumes the conversion of all dilutive convertible securities, such as convertible debt and convertible preferred stock using the if-converted method, and assumes the exercise or vesting of other dilutive securities, such as options, warrants and share awards using the treasury stock method. As of September 30, 2013 and 2012, options, warrants, unvested share awards and unvested share rights aggregating 12.2 million and 9.6 million common share equivalents, respectively, prior to the application of the as-if converted method for convertible securities and the treasury stock method for other dilutive securities, such as options and warrants, are not included in the calculation of diluted net loss per share as they are anti-dilutive. | |
Fair Value Measurement | Fair Value Measurement |
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest: | |
Level 1 – Observable inputs, such as unadjusted quoted prices in active markets for identical assets or liabilities. | |
Level 2 - Observable inputs other than Level 1 inputs, such as quoted prices for similar assets or liabilities, or other inputs that are observable directly or indirectly. | |
Level 3 - Unobservable inputs that are supported by little or no market activity, requiring an entity to develop its own assumptions. | |
If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument. | |
Concentrations of Credit Risk | Concentrations of Credit Risk |
Financial instruments which potentially subject us to concentrations of credit risk consist of accounts receivable. | |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards |
In February 2013, the FASB issued guidance requiring presentation of amounts reclassified from each component of accumulated other comprehensive income. In addition, disclosure is required of the effects of significant reclassifications on income statement line items either on the face of the statement where net income is presented or as a separate disclosure in the notes to the financial statements. For public entities, this guidance was effective prospectively for reporting periods beginning after December 15, 2012. The adoption of this guidance did not have a material impact on our consolidated financial statements. | |
Recently Issued Accounting Standards | Recently Issued Accounting Standards |
In March 2013, the Financial Accounting Standards Board, or FASB, issued guidance to clarify when to release cumulative foreign currency translation adjustments when an entity ceases to have a controlling financial interest in a subsidiary or group of assets within a foreign entity. The amendment is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013 and should be applied prospectively to derecognition events occurring after the effective date. Early adoption is permitted. We do not expect the adoption of this guidance to have a material impact on our consolidated financial statements. | |
In July 2013, the FASB issued guidance on the presentation of an unrecognized tax benefit when a net operating loss carryforward, similar tax loss or tax carryforward exists. FASB concluded that an unrecognized tax benefit should be presented as a reduction of a deferred tax asset except in certain circumstances the unrecognized tax benefit should be presented as a liability and should not be combined with deferred tax assets. The amendment is effective prospectively for fiscal years, and interim periods within those years, beginning after December 15, 2013, with early adoption permitted. We are currently evaluating the impact this amendment may have on our consolidated financial statements. | |
Reclassifications | Reclassifications |
Certain prior year items have been reclassified to conform to current year presentation. | |
Value Added Tax | |
Accounts Receivable | Value Added Tax Receivable |
Our European operations are subject to a value added tax, or VAT, which is usually applied to all goods and services purchased and sold throughout Europe. Our VAT receivable was $5.7 million and $8.1 million as of September 30, 2013 and December 31, 2012, of which $0.2 million and $3.0 million was included in prepaid expenses and other current assets, respectively, and $5.5 million and $5.1 million was included in other assets, respectively. The collection period of VAT receivable for our European operations ranges from approximately three months to five years. For our Italian VAT receivable, the collection period is approximately three to five years. As of September 30, 2013, the VAT receivable related to operations in Italy was $5.5 million. We review our VAT receivable balance for impairment whenever events or changes in circumstances indicate the carrying amount might not be recoverable. |
Inventory_Tables
Inventory (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Components of Inventories | The components of inventories are composed of the following as of September 30, 2013 and December 31, 2012 (in thousands): | ||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Finished goods | $ | 610 | $ | 220 | |||||
Work-in-process | 3,110 | 1,406 | |||||||
Total inventories | $ | 3,720 | $ | 1,626 | |||||
Product_Revenue_Tables
Product Revenue (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Revenue from Product Sales of PIXUVRI | Total revenue from product sales of PIXUVRI consisted of the following for the three and nine months ended September 30, 2013 and 2012 (in thousands): | ||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Product sales, gross | $ | 414 | $ | — | $ | 2,122 | $ | — | |||||||||
Discounts, rebates and other adjustments | (51 | ) | — | (290 | ) | — | |||||||||||
Returns reserve | (1 | ) | — | (38 | ) | — | |||||||||||
Product sales, net | $ | 362 | $ | — | $ | 1,794 | $ | — | |||||||||
Sharebased_Compensation_Expens1
Share-based Compensation Expense (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Summary of Share-Based Compensation Expense | The following table summarizes share-based compensation expense for the three and nine months ended September 30, 2013 and 2012, which was allocated as follows (in thousands): | ||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Research and development | $ | 685 | $ | 363 | $ | 1,540 | $ | 1,379 | |||||||||
Selling, general and administrative | 1,243 | 653 | 4,784 | 4,705 | |||||||||||||
Total share-based compensation expense | $ | 1,928 | $ | 1,016 | $ | 6,324 | $ | 6,084 | |||||||||
Share-Based Compensation Expense by Types of Awards | For the three and nine months ended September 30, 2013 and 2012, we incurred share-based compensation expense due to the following types of awards (in thousands): | ||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Performance rights | $ | 280 | $ | (111 | ) | $ | 885 | $ | 2,158 | ||||||||
Restricted stock | 1,394 | 996 | 4,845 | 3,635 | |||||||||||||
Options | 254 | 131 | 594 | 291 | |||||||||||||
Total share-based compensation expense | $ | 1,928 | $ | 1,016 | $ | 6,324 | $ | 6,084 | |||||||||
Other_Comprehensive_Income_Los1
Other Comprehensive Income (Loss) (Tables) | 9 Months Ended | ||||||||||||
Sep. 30, 2013 | |||||||||||||
Total Accumulated Other Comprehensive Loss | Total accumulated other comprehensive income (loss) consisted of the following (in thousands): | ||||||||||||
Net Unrealized | Foreign | Accumulated | |||||||||||
Loss on | Currency | Other | |||||||||||
Securities | Translation | Comprehensive | |||||||||||
Available-For- | Adjustments | Income (Loss) | |||||||||||
Sale | |||||||||||||
December 31, 2012 | $ | (235 | ) | $ | (8,038 | ) | $ | (8,273 | ) | ||||
Current period other comprehensive income (loss) | (195 | ) | 196 | 1 | |||||||||
September 30, 2013 | $ | (430 | ) | $ | (7,842 | ) | $ | (8,272 | ) | ||||
Description_of_Business_and_Su2
Description of Business and Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 1 Months Ended | 9 Months Ended | |||
In Millions, unless otherwise specified | Sep. 02, 2012 | 15-May-11 | Sep. 30, 2013 | Sep. 30, 2012 | Dec. 31, 2012 |
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Reverse stock split ratios | 0.2 | 0.1667 | |||
VAT receivable | $5.70 | $8.10 | |||
Anti-dilutive shares not included in calculation of diluted net loss per share | 12.2 | 9.6 | |||
ITALY | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
VAT receivable | 5.5 | ||||
Minimum | Europe | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
VAT receivable, collection period | 3 months | ||||
Minimum | ITALY | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
VAT receivable, collection period | 3 years | ||||
Maximum | Europe | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
VAT receivable, collection period | 5 years | ||||
Maximum | ITALY | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
VAT receivable, collection period | 5 years | ||||
Other Assets | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
VAT receivable | 5.5 | 5.1 | |||
Prepaid Expenses and Other Current Assets | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
VAT receivable | $0.20 | $3 | |||
Aequus Biopharma, Inc | |||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||
Interest in majority-owned subsidiary | 61.00% |
Components_of_Inventories_Deta
Components of Inventories (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Inventory [Line Items] | ||
Finished goods | $610 | $220 |
Work-in-process | 3,110 | 1,406 |
Total inventories | $3,720 | $1,626 |
Longterm_Debt_Additional_Infor
Long-term Debt - Additional Information (Detail) (USD $) | 1 Months Ended | |
Share data in Millions, unless otherwise specified | Mar. 31, 2013 | Sep. 30, 2013 |
Debt Instrument [Line Items] | ||
Fair value of warrant | $702,000 | |
Senior Secured Term Loan | ||
Debt Instrument [Line Items] | ||
Debt instrument maximum borrowing capacity | 15,000,000 | |
Debt instrument issued | 10,000,000 | |
Debt instrument to be issued beginning November 30, 2013 through December 15, 2013 | 5,000,000 | |
Interest rate terms | The interest rate on the term loan floats at a rate per annum equal to 12.25% plus the amount by which the prime rate exceeds 3.25%. | |
Debt instrument term | 42 months | |
Interest-only period | 12 months | |
Debt instrument discount | 1,900,000 | |
Debt instrument issuance cost | 300,000 | |
Debt instrument unamortized discount | 1,700,000 | |
Debt instrument unamortized issuance cost | 300,000 | |
Senior Secured Term Loan | Warrants | ||
Debt Instrument [Line Items] | ||
Warrant exercisable period | 5 years | |
Number of warrant issued | 0.5 | |
Warrant, additional shares | 150,000 | |
Warrant exercise price | 1.1045 | |
Fair value of warrant | 500,000 | 700,000 |
Senior Secured Term Loan | Closing Facility Charge | ||
Debt Instrument [Line Items] | ||
Amount of facility charges under debt instrument | 150,000 | |
Senior Secured Term Loan | Fee Due At Maturity | ||
Debt Instrument [Line Items] | ||
Amount of facility charges under debt instrument | $1,300,000 |
Legal_Proceedings_Additional_I
Legal Proceedings - Additional Information (Detail) (USD $) | Sep. 30, 2013 |
CONSOB | |
Loss Contingencies [Line Items] | |
Range of possible loss, minimum | $7,000 |
Range of possible loss, maximum | 677,000 |
VAT Assessments | |
Loss Contingencies [Line Items] | |
Range of possible loss, maximum | $12,700,000 |
Preferred_Stock_Additional_Inf
Preferred Stock - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | |
Series 18 Preferred Stock | Series 18 Preferred Stock | Series 18 Preferred Stock | |||||
Class of Stock [Line Items] | |||||||
Shares issued | 15,000 | ||||||
Proceed from issuance of preferred stock | $15,000,000 | ||||||
Issuance costs | 100,000 | ||||||
Preferred stock stated value | $1,000 | $1,000 | $1,000 | ||||
Preferred stock, conversion price | $1 | $1 | $1 | ||||
Preferred stock conversion blocker provision | 9.99% | 9.99% | 9.99% | ||||
Deemed dividends on preferred stock | $6,900,000 | $5,014,000 | $6,900,000 | $13,472,000 | $6,900,000 | $6,900,000 | |
Issuance of common stock upon conversion of convertible securities | 15,000,000 | ||||||
Number of preferred stock converted to common stock | 15,000 |
Revenue_From_Product_Sales_of_
Revenue From Product Sales of PIXUVRI (Detail) (USD $) | 3 Months Ended | 9 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2013 |
Revenues [Line Items] | ||
Product sales, gross | $414 | $2,122 |
Discounts, rebates and other adjustments | -51 | -290 |
Returns reserve | -1 | -38 |
Product sales, net | $362 | $1,794 |
Summary_of_ShareBased_Compensa
Summary of Share-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $1,928 | $1,016 | $6,324 | $6,084 |
Research and development | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | 685 | 363 | 1,540 | 1,379 |
Selling, general and administrative | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Share-based compensation expense | $1,243 | $653 | $4,784 | $4,705 |
Recovered_Sheet1
Share-Based Compensation Expense by Types of Awards (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $1,928 | $1,016 | $6,324 | $6,084 |
Performance Rights | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 280 | -111 | 885 | 2,158 |
Restricted stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | 1,394 | 996 | 4,845 | 3,635 |
Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation expense | $254 | $131 | $594 | $291 |
Total_Accumulated_Other_Compre
Total Accumulated Other Comprehensive Loss (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Beginning balance | ($8,273) | |||
Current period other comprehensive income (loss) | -319 | -73 | 1 | 43 |
Ending balance | -8,272 | -8,272 | ||
Net Unrealized Gain (Loss) on Securities Available-for-sale | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Beginning balance | -235 | |||
Current period other comprehensive income (loss) | -195 | |||
Ending balance | -430 | -430 | ||
Foreign Currency Translation Adjustments | ||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | ||||
Beginning balance | -8,038 | |||
Current period other comprehensive income (loss) | 196 | |||
Ending balance | ($7,842) | ($7,842) |
Leases_Additional_Information_
Leases - Additional Information (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Millions, unless otherwise specified | ||
Leases [Line Items] | ||
Lease incentive receivable | $1.50 | |
Deferred rent credit | 4.8 | 5 |
Deferred rent credit, current | 0.4 | 0.4 |
Deferred rent credit, non-current | $4.40 | $4.60 |