Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | Apr. 29, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CTIC | |
Entity Registrant Name | CTI BIOPHARMA CORP | |
Entity Central Index Key | 891293 | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 180,242,408 |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $44,395 | $70,933 |
Accounts receivable, net | 1,272 | 2,011 |
Inventory | 3,591 | 4,182 |
Prepaid expenses and other current assets | 4,209 | 3,379 |
Total current assets | 53,467 | 80,505 |
Property and equipment, net | 4,391 | 4,646 |
Other assets | 5,212 | 7,136 |
Total assets | 63,070 | 92,287 |
Current liabilities: | ||
Accounts payable | 10,279 | 6,356 |
Accrued expenses | 14,607 | 19,734 |
Current portion of deferred revenue | 779 | 826 |
Current portion of long-term debt | 9,294 | 9,014 |
Other current liabilities | 424 | 410 |
Total current liabilities | 35,383 | 36,340 |
Deferred revenue, less current portion | 1,612 | 1,779 |
Long-term debt, less current portion | 5,943 | 8,363 |
Other liabilities | 5,775 | 5,882 |
Total liabilities | 48,713 | 52,364 |
Commitments and contingencies | ||
Common stock purchase warrants | 240 | 1,445 |
Shareholders' equity: | ||
Issued and outstanding shares - 180,247,408 and 176,761,099 at March 31, 2015 and December 31, 2014, respectively | 2,028,975 | 2,023,949 |
Accumulated other comprehensive loss | -7,001 | -6,499 |
Accumulated deficit | -2,004,291 | -1,975,695 |
Total CTI shareholders' equity | 17,683 | 41,755 |
Noncontrolling interest | -3,566 | -3,277 |
Total shareholders' equity | 14,117 | 38,478 |
Total liabilities and shareholders' equity | $63,070 | $92,287 |
CONDENSED_CONSOLIDATED_BALANCE1
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Statement Of Financial Position [Abstract] | ||
Common stock, no par value | $0 | $0 |
Common Stock, Authorized shares | 315,000,000 | 215,000,000 |
Common Stock, Issued shares | 180,247,408 | 176,761,099 |
Common Stock, outstanding shares | 180,247,408 | 176,761,099 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (USD $) | 3 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Revenues: | ||
Product sales, net | $805 | $1,268 |
License and contract revenue | 1,923 | 143 |
Total revenues | 2,728 | 1,411 |
Operating costs and expenses: | ||
Cost of product sold | 190 | 145 |
Research and development | 17,471 | 12,179 |
Selling, general and administrative | 12,297 | 16,750 |
Other operating expense | 253 | |
Total operating costs and expenses | 30,211 | 29,074 |
Loss from operations | -27,483 | -27,663 |
Non-operating expense: | ||
Interest expense | -494 | -464 |
Amortization of debt discount and issuance costs | -180 | -178 |
Foreign exchange loss | -728 | -5 |
Other non-operating expense | -886 | |
Total non-operating expense, net | -1,402 | -1,533 |
Net loss before noncontrolling interest | -28,885 | -29,196 |
Noncontrolling interest | 288 | 194 |
Net loss | ($28,597) | ($29,002) |
Basic and diluted net loss per common share | ($0.16) | ($0.20) |
Shares used in calculation of basic and diluted net loss per common share | 173,936 | 142,138 |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss before noncontrolling interest | ($28,885) | ($29,196) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments | 2,247 | -29 |
Unrealized foreign exchange loss on intercompany balance | -2,754 | |
Net unrealized gain on securities available-for-sale: | 5 | 8 |
Other comprehensive loss | -502 | -21 |
Comprehensive loss | -29,387 | -29,217 |
Comprehensive loss attributable to noncontrolling interest | 288 | 194 |
Comprehensive loss attributable to CTI | ($29,099) | ($29,023) |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Operating activities | ||
Net loss | ($28,885) | ($29,196) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 4,336 | 7,829 |
Depreciation and amortization | 261 | 360 |
Noncash interest expense | 180 | 178 |
Change in value of warrant liability | 886 | |
Other | -93 | 499 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 537 | -267 |
Inventory | 125 | 50 |
Prepaid expenses and other current assets | -939 | -139 |
Other assets | 1,219 | -504 |
Accounts payable | 4,331 | -410 |
Accrued expenses and other | -4,861 | 68 |
Deferred revenue | -214 | -143 |
Total adjustments | 4,882 | 8,407 |
Net cash used in operating activities | -24,003 | -20,789 |
Investing activities | ||
Purchases of property and equipment | -24 | -35 |
Net cash used in investing activities | -24 | -35 |
Financing activities | ||
Cash paid for long-term debt issuance costs | -73 | |
Repayment of long-term debt | -2,297 | |
Payment of tax withholding obligations related to stock compensation | -527 | -105 |
Other | 12 | -28 |
Net cash used in financing activities | -3,037 | -206 |
Effect of exchange rate changes on cash and cash equivalents | 526 | -8 |
Net decrease in cash and cash equivalents | -26,538 | -21,038 |
Cash and cash equivalents at beginning of period | 70,933 | 71,639 |
Cash and cash equivalents at end of period | 44,395 | 50,601 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 524 | 439 |
Supplemental disclosure of noncash financing and investing activities | ||
Issuance of common stock upon exercise of common stock purchase warrants | 1,877 | |
Series 21 Preferred Stock | ||
Financing activities | ||
Cash paid for Series 21 preferred stock issuance costs | ($225) |
Description_of_Business_and_Su
Description of Business and Summary of Significant Accounting Policies | 3 Months Ended | |
Mar. 31, 2015 | ||
Accounting Policies [Abstract] | ||
Description of Business and Summary of Significant Accounting Policies | 1 | Description of Business and Summary of Significant Accounting Policies |
CTI BioPharma Corp., together with its wholly-owned subsidiaries, also referred to collectively 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 novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and health care providers. Our goal is to build a profitable company by generating income from products we develop and commercialize, either alone or with partners. We are currently concentrating our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are primarily focused on commercializing PIXUVRI® (pixantrone), or PIXUVRI, in the European Union, or the E.U., for multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, or NHL, and conducting a Phase 3 clinical trial program evaluating pacritinib for the treatment of adult patients with myelofibrosis to support regulatory submission for approval in the United States, or the U.S., and Europe. We are also evaluating pacritinib in earlier clinical trials as treatment for other blood-related cancers. | ||
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 U.S., the European Medicines Agency, or the EMA, in the E.U. and comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain, may take many years and may involve expenditure of substantial resources. | ||
Basis of Presentation | ||
The accompanying unaudited financial information of CTI as of March 31, 2015 and for the three months ended March 31, 2015 and 2014 has been prepared in accordance with accounting principles generally accepted in the U.S. 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 months ended March 31, 2015 are not necessarily indicative of the results that may be expected for the entire year or for any other subsequent interim period. | ||
Certain information and footnote disclosures 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, 2014 included in our Annual Report on Form 10-K filed with the SEC on March 12, 2015. | ||
The condensed consolidated balance sheet at December 31, 2014 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 U.S. 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 and CTI Life Sciences Limited, or CTILS. We also retain ownership of our branch, CTI BioPharma Corp.– 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 consolidated financial statements until dissolution in March 2012. | ||
As of March 31, 2015, 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 consolidated financial statements. | ||
All intercompany transactions and balances are eliminated in consolidation. | ||
Accounts Receivable | ||
Our accounts receivable balance 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. We continue to monitor economic conditions, including the volatility associated with international economies, the sovereign debt crisis in certain European countries and associated impacts on the financial markets and our business. As of March 31, 2015 and December 31, 2014, 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. Our allowance for doubtful accounts balance was $25,000 as of March 31, 2015 and $0.1 million as of December 31, 2014. | ||
Liquidity | ||
The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the date of these condensed consolidated financial statements. However, we have incurred net losses since inception and expect to generate losses for the next few years primarily due to research and development costs for pacritinib, PIXUVRI, Opaxio, and tosedostat. | ||
Our available cash and cash equivalents were $44.4 million as of March 31, 2015. We believe that our present financial resources, together with additional milestone payments projected to be received under certain of our contractual agreements, our ability to control costs and expected net sales of PIXUVRI, will only be sufficient to fund our operations into the mid-third quarter of 2015. This raises substantial doubt about our ability to continue as a going concern. | ||
Accordingly, we will need to raise additional funds to operate our business. We may seek to raise such capital through public or private equity financings, partnerships, collaborations, joint ventures, disposition of assets, debt financings or restructurings, bank borrowings or other sources of financing. However, we have a limited number of authorized shares of common stock available for issuance and additional funding may not be available on favorable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing shareholders may result. If we fail to obtain additional capital when needed, our ability to operate as a going concern will be harmed, and we may be required to delay, scale back or eliminate some or all of our research and development programs, reduce our selling, general and administrative expenses, be unable to attract and retain highly qualified personnel, refrain from making our contractually required payments when due (including debt payments) and/or may be forced to cease operations, liquidate our assets and possibly seek bankruptcy protection. The accompanying condensed consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty. | ||
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. The VAT receivable is approximately $4.4 million and $4.9 million as of March 31, 2015 and December 31, 2014, of which $4.2 million and $4.7 million is included in other assets and $0.2 million and $0.2 million is included in prepaid expenses and other current assets as of March 31, 2015 and December 31, 2014, 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 March 31, 2015, the VAT receivable related to operations in Italy is approximately $4.3 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 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. 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 review our inventories on a quarterly basis 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. Based on assessment of shelf lives and net realizable value of the product, $33,000 reserve for excess, obsolete or unsalesable inventory was recorded as of March 31, 2015. | ||
Revenue Recognition | ||
We currently have conditional marketing authorization for 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 through a limited number of distributors and directly to health care providers in Austria, Denmark, Finland, Germany, Norway, Sweden and the United Kingdom, or the U.K. 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 rebates, trade discounts, 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-mandated 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 and distributor discounts and incentives. We offer certain customers 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 have been substantially eliminated. | ||
Milestone payments | ||
In February 2015, under our exclusive license and collaboration agreement with Les Laboratoires Servier and Institut de Recherches Internationales Servier, or the Servier Agreement, we received a €1.5 million milestone payment (or $1.7 million using the currency exchange rate as of the date we received the funds) relating to the attainment of reimbursement approval for PIXUVRI in Spain. We allocated the milestone payment based on the relative-selling-price percentages originally used to allocate the arrangement consideration under the Servier Agreement. This revenue was accounted for under the milestone method of accounting since this milestone was determined to be substantive at the inception of the arrangement. There were no such milestone payments received for the three months ended March 31, 2014. | ||
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. | ||
Foreign Currency Translation and Transaction Gains and Losses | ||
We record foreign currency translation adjustments and transaction gains and losses in accordance with ASC 830, Foreign Currency Matters. For our operations that have a functional currency other than the U.S. dollar, gains and losses resulting from the translation of the functional currency into U.S. dollars for financial statement presentation are not included in determining net loss, but are accumulated in the cumulative foreign currency translation adjustment account as a separate component of shareholders’ equity (deficit), except for intercompany transactions that are of a short-term nature with entities that are consolidated, combined or accounted for by the equity method in our consolidated financial statements. We and our subsidiaries also have transactions in foreign currencies other than the functional currency. We record transaction gains and losses in our consolidated statements of operations related to the recurring measurement and settlement of such transactions. | ||
Using most recent information available to date, we have determined that the intercompany balance of €21.9 million due from CTILS may no longer be considered of a short-term nature. In accordance with this change in accounting estimate, unfavourable unrealized foreign exchange loss of $2.8 million was recorded in cumulative foreign currency translation adjustment account for the three months ended March 31, 2015. | ||
Net Income (Loss) Per Share | ||
Basic net income (loss) per 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 restricted stock using the treasury stock method. | ||
Equity awards, warrants, and unvested share rights aggregating 14.5 million shares and 16.3 million shares for the three months ended March 31, 2015 and 2014, respectively, prior to the application of the treasury stock method, were excluded from the calculation of diluted EPS because they are anti-dilutive. | ||
Recently Issued Accounting Standards | ||
In May 2014, the Financial Accounting Standards Board, or the FASB, issued a new financial accounting standard which outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes current revenue recognition guidance. The accounting standard is effective for annual reporting periods (including interim reporting periods within those periods) beginning after December 15, 2016. Early adoption is not permitted. We are currently evaluating the impact of this accounting standard on our consolidated financial statements. | ||
In August 2014, the FASB issued a new accounting standard which requires management to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern for each annual and interim reporting period and to provide related footnote disclosures in certain circumstances. The accounting standard is effective for annual reporting periods (including interim reporting periods within those periods) beginning after December 15, 2016. Early adoption is permitted. We are currently evaluating the impact of this accounting standard on our consolidated financial statements. | ||
In April 2015, the FASB issued a new accounting standard which changes the presentation of debt issuance costs in financial statements. Under the new standard, an entity presents such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs is reported as interest expense. The accounting standard is effective for annual reporting periods beginning after December 15, 2015 and interim periods beginning after December 15, 2016. Early adoption is allowed for all entities for financial statements that have not been previously issued. The adoption of this standard is not expected to have a material impact on our financial position or results of operations. | ||
Reclassifications | ||
Certain prior year items have been reclassified to conform to current year presentation. |
Inventory
Inventory | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Inventory Disclosure [Abstract] | ||||||||
Inventory | 2 | Inventory | ||||||
The components of inventories are composed of the following as of March 31, 2015 and December 31, 2014 (in thousands): | ||||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
Finished goods | 709 | $ | 850 | |||||
Work-in-process | $ | 2,882 | 3,332 | |||||
Total inventories | $ | 3,591 | $ | 4,182 | ||||
Legal_Proceedings
Legal Proceedings | 3 Months Ended | |
Mar. 31, 2015 | ||
Commitments And Contingencies Disclosure [Abstract] | ||
Legal Proceedings | 3 | Legal Proceedings |
On December 10, 2009, the Commissione Nazionale per le Società e la Borsa (which is the public authority responsible for regulating the Italian securities markets), or CONSOB, sent us a notice claiming, among other things, 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 sanctions established by Section 193, paragraph 1 of the Italian Legislative Decree no. 58/98 for such violations could require us to pay a pecuniary administrative sanction amounting to between $5,000 and $537,000 upon conversion from euros as of March 31, 2015. Until CONSOB’s right is barred, CONSOB may, at any time, confirm the occurrence of the asserted violation and apply a pecuniary administrative sanction within the foregoing range. To date, we have not received any such notification. | ||
The Italian Tax Authority, or the 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, or, collectively, the VAT Assessments. 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, although we can make no assurances regarding the ultimate outcomes of these cases. As of December 31, 2012, we reversed the entire reserve we had previously recorded relating to the VAT Assessments after having received favorable court rulings. In January 2013, our then remaining deposit for the VAT Assessments was refunded to us. The current status of the legal proceedings surrounding each respective VAT year return at issue is as follows: | ||
2003. 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. In January 2014, we were notified that the ITA requested partial payment of the 2003 VAT assessment in the amount of €0.4 million translated to $0.6 million, which we paid in March 2014. We believe that the decision of the Regional Tax Court did not carefully take into account our arguments and the documentation we filed, and in January 2014, we appealed such decision to the Italian Supreme Court both on procedural grounds and on the merits of the case. | ||
2005, 2006 and 2007. The ITA has appealed to the Italian Supreme Court the decisions of the respective appellate court with respect to each of the 2005, 2006 and 2007 VAT returns. | ||
If the final decisions of the Italian Supreme Court for the VAT Assessments are unfavorable to us, we may incur up to $10.1 million in losses for the VAT amount assessed including penalties, interest and fees upon conversion from euros as of March 31, 2015. | ||
In July 2014, Joseph Lopez and Gilbert Soper, shareholders of the Company, filed a derivative lawsuit purportedly on behalf of the Company, which is named a nominal defendant, against all current and one past member of the Company’s Board of Directors in King County Superior Court in the State of Washington, docketed as Lopez & Gilbert v. Nudelman, et al ., Case No. 14-2-18941-9 SEA. The lawsuit alleges that the directors exceeded their authority under the Company’s 2007 Equity Incentive Plan, or the Plan, by improperly transferring 4,756,137 shares of the Company’s common stock from the Company to themselves. It alleges that the directors breached their fiduciary duties by granting themselves fully vested shares of Company common stock, which the plaintiffs allege were not among the six types of grants authorized by the Plan, and that the non-employee directors were unjustly enriched by these grants. The lawsuit also alleges that from 2011 through 2014, the non-employee members of the Board of Directors granted themselves grossly excessive compensation, and in doing so breached their fiduciary duties and were unjustly enriched. Among other remedies, the lawsuit seeks a declaration that the specified grants of common stock violated the Plan, rescission of the granted shares, disgorgement of the compensation awards to the non-employee directors from 2011 through 2014, disgorgement of all compensation and other benefits received by the defendant directors in the course of their breaches of fiduciary duties, damages, an order for certain corporate reforms and plaintiffs’ costs and attorneys’ fees. Because the complaint is derivative in nature, it does not seek monetary damages from the Company. In September 2014, the director defendants moved to dismiss the complaint. The motion to dismiss was heard on November 21, 2014, and the Court entered an order denying the motion to dismiss on December 5, 2014. Defendants' answer to the complaint was filed on January 13, 2015. The trial date is currently set for August 24, 2015. At this stage of the litigation, no probability of loss can be predicted. |
Sharebased_Compensation_Expens
Share-based Compensation Expense | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||||||
Share-based Compensation Expense | 4 | Share-based Compensation Expense | ||||||
The following table summarizes share-based compensation expense for the three months ended March 31, 2015 and 2014, which was allocated as follows (in thousands): | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2015 | 2014 | |||||||
Research and development | $ | 990 | $ | 782 | ||||
Selling, general and administrative | 3,346 | 7,047 | ||||||
Total share-based compensation expense | $ | 4,336 | $ | 7,829 | ||||
For the three months ended March 31, 2015 and 2014, we incurred share-based compensation expense due to the following types of awards (in thousands): | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2015 | 2014 | |||||||
Performance rights | $ | 418 | $ | 503 | ||||
Restricted stock | 3,372 | 5,969 | ||||||
Options | 546 | 1,357 | ||||||
Total share-based compensation expense | $ | 4,336 | $ | 7,829 | ||||
Other_Comprehensive_Income_Los
Other Comprehensive Income (Loss) | 3 Months Ended | |||||||||||||||
Mar. 31, 2015 | ||||||||||||||||
Equity [Abstract] | ||||||||||||||||
Other Comprehensive Income (Loss) | ||||||||||||||||
5 | Other Comprehensive Income (Loss) | |||||||||||||||
Total accumulated other comprehensive income (loss) consisted of the following (in thousands): | ||||||||||||||||
Net Unrealized | Foreign | Unrealized foreign exchange loss on intercompany balance | Accumulated | |||||||||||||
Loss on | Currency | Other | ||||||||||||||
Securities | Translation | Comprehensive | ||||||||||||||
Available-For- | Adjustments | Loss | ||||||||||||||
Sale | ||||||||||||||||
31-Dec-14 | $ | (490 | ) | $ | (6,009 | ) | $ | - | $ | (6,499 | ) | |||||
Current period other comprehensive income | 5 | 2,247 | (2,754 | ) | (502 | ) | ||||||||||
31-Mar-15 | $ | (485 | ) | $ | (3,762 | ) | $ | (2,754 | ) | $ | (7,001 | ) | ||||
Leases
Leases | 3 Months Ended | |
Mar. 31, 2015 | ||
Leases [Abstract] | ||
Leases | 6 | Leases |
Our deferred rent balance was $4.3 million as of March 31, 2015, of which $0.4 million was included in other current liabilities and $3.9 million was included in other liabilities. As of December 31, 2014, our deferred rent balance was $4.4 million, of which $0.4 million was included in other current liabilities and $4.0 million was included in other liabilities. |
Description_of_Business_and_Su1
Description of Business and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2015 | |
Accounting Policies [Abstract] | |
Description of Business | CTI BioPharma Corp., together with its wholly-owned subsidiaries, also referred to collectively 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 novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and health care providers. Our goal is to build a profitable company by generating income from products we develop and commercialize, either alone or with partners. We are currently concentrating our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are primarily focused on commercializing PIXUVRI® (pixantrone), or PIXUVRI, in the European Union, or the E.U., for multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, or NHL, and conducting a Phase 3 clinical trial program evaluating pacritinib for the treatment of adult patients with myelofibrosis to support regulatory submission for approval in the United States, or the U.S., and Europe. We are also evaluating pacritinib in earlier clinical trials as treatment for other blood-related cancers. |
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 U.S., the European Medicines Agency, or the EMA, in the E.U. and comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain, may take many years and may involve expenditure of substantial resources. | |
Basis of Presentation | Basis of Presentation |
The accompanying unaudited financial information of CTI as of March 31, 2015 and for the three months ended March 31, 2015 and 2014 has been prepared in accordance with accounting principles generally accepted in the U.S. 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 months ended March 31, 2015 are not necessarily indicative of the results that may be expected for the entire year or for any other subsequent interim period. | |
Certain information and footnote disclosures 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, 2014 included in our Annual Report on Form 10-K filed with the SEC on March 12, 2015. | |
The condensed consolidated balance sheet at December 31, 2014 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 U.S. 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 and CTI Life Sciences Limited, or CTILS. We also retain ownership of our branch, CTI BioPharma Corp.– 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 consolidated financial statements until dissolution in March 2012. | |
As of March 31, 2015, 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 consolidated financial statements. | |
All intercompany transactions and balances are eliminated in consolidation. | |
Accounts Receivable | Accounts Receivable |
Our accounts receivable balance 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. We continue to monitor economic conditions, including the volatility associated with international economies, the sovereign debt crisis in certain European countries and associated impacts on the financial markets and our business. As of March 31, 2015 and December 31, 2014, 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. Our allowance for doubtful accounts balance was $25,000 as of March 31, 2015 and $0.1 million as of December 31, 2014. | |
Liquidity | Liquidity |
The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the date of these condensed consolidated financial statements. However, we have incurred net losses since inception and expect to generate losses for the next few years primarily due to research and development costs for pacritinib, PIXUVRI, Opaxio, and tosedostat. | |
Our available cash and cash equivalents were $44.4 million as of March 31, 2015. We believe that our present financial resources, together with additional milestone payments projected to be received under certain of our contractual agreements, our ability to control costs and expected net sales of PIXUVRI, will only be sufficient to fund our operations into the mid-third quarter of 2015. This raises substantial doubt about our ability to continue as a going concern. | |
Accordingly, we will need to raise additional funds to operate our business. We may seek to raise such capital through public or private equity financings, partnerships, collaborations, joint ventures, disposition of assets, debt financings or restructurings, bank borrowings or other sources of financing. However, we have a limited number of authorized shares of common stock available for issuance and additional funding may not be available on favorable terms or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing shareholders may result. If we fail to obtain additional capital when needed, our ability to operate as a going concern will be harmed, and we may be required to delay, scale back or eliminate some or all of our research and development programs, reduce our selling, general and administrative expenses, be unable to attract and retain highly qualified personnel, refrain from making our contractually required payments when due (including debt payments) and/or may be forced to cease operations, liquidate our assets and possibly seek bankruptcy protection. The accompanying condensed consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty. | |
Value Added Tax 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. The VAT receivable is approximately $4.4 million and $4.9 million as of March 31, 2015 and December 31, 2014, of which $4.2 million and $4.7 million is included in other assets and $0.2 million and $0.2 million is included in prepaid expenses and other current assets as of March 31, 2015 and December 31, 2014, 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 March 31, 2015, the VAT receivable related to operations in Italy is approximately $4.3 million. We review our VAT receivable balance for impairment whenever events or changes in circumstances indicate the carrying amount might not be recoverable. | |
Inventory | Inventory |
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. 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 review our inventories on a quarterly basis 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. Based on assessment of shelf lives and net realizable value of the product, $33,000 reserve for excess, obsolete or unsalesable inventory was recorded as of March 31, 2015. | |
Revenue Recognition | |
Revenue Recognition | |
We currently have conditional marketing authorization for 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 through a limited number of distributors and directly to health care providers in Austria, Denmark, Finland, Germany, Norway, Sweden and the United Kingdom, or the U.K. 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 rebates, trade discounts, 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-mandated 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 and distributor discounts and incentives. We offer certain customers 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 have been substantially eliminated. | |
Milestone payments | |
In February 2015, under our exclusive license and collaboration agreement with Les Laboratoires Servier and Institut de Recherches Internationales Servier, or the Servier Agreement, we received a €1.5 million milestone payment (or $1.7 million using the currency exchange rate as of the date we received the funds) relating to the attainment of reimbursement approval for PIXUVRI in Spain. We allocated the milestone payment based on the relative-selling-price percentages originally used to allocate the arrangement consideration under the Servier Agreement. This revenue was accounted for under the milestone method of accounting since this milestone was determined to be substantive at the inception of the arrangement. There were no such milestone payments received for the three months ended March 31, 2014. | |
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. | |
Foreign Currency Translation and Transaction Gains and Losses | Foreign Currency Translation and Transaction Gains and Losses |
We record foreign currency translation adjustments and transaction gains and losses in accordance with ASC 830, Foreign Currency Matters. For our operations that have a functional currency other than the U.S. dollar, gains and losses resulting from the translation of the functional currency into U.S. dollars for financial statement presentation are not included in determining net loss, but are accumulated in the cumulative foreign currency translation adjustment account as a separate component of shareholders’ equity (deficit), except for intercompany transactions that are of a short-term nature with entities that are consolidated, combined or accounted for by the equity method in our consolidated financial statements. We and our subsidiaries also have transactions in foreign currencies other than the functional currency. We record transaction gains and losses in our consolidated statements of operations related to the recurring measurement and settlement of such transactions. | |
Using most recent information available to date, we have determined that the intercompany balance of €21.9 million due from CTILS may no longer be considered of a short-term nature. In accordance with this change in accounting estimate, unfavourable unrealized foreign exchange loss of $2.8 million was recorded in cumulative foreign currency translation adjustment account for the three months ended March 31, 2015. | |
Net Income (Loss) Per Share | |
Net Income (Loss) Per Share | |
Basic net income (loss) per 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 restricted stock using the treasury stock method. | |
Recently Issued Accounting Standards | |
Recently Issued Accounting Standards | |
In May 2014, the Financial Accounting Standards Board, or the FASB, issued a new financial accounting standard which outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes current revenue recognition guidance. The accounting standard is effective for annual reporting periods (including interim reporting periods within those periods) beginning after December 15, 2016. Early adoption is not permitted. We are currently evaluating the impact of this accounting standard on our consolidated financial statements. | |
In August 2014, the FASB issued a new accounting standard which requires management to evaluate whether there is substantial doubt about an entity’s ability to continue as a going concern for each annual and interim reporting period and to provide related footnote disclosures in certain circumstances. The accounting standard is effective for annual reporting periods (including interim reporting periods within those periods) beginning after December 15, 2016. Early adoption is permitted. We are currently evaluating the impact of this accounting standard on our consolidated financial statements. | |
In April 2015, the FASB issued a new accounting standard which changes the presentation of debt issuance costs in financial statements. Under the new standard, an entity presents such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs is reported as interest expense. The accounting standard is effective for annual reporting periods beginning after December 15, 2015 and interim periods beginning after December 15, 2016. Early adoption is allowed for all entities for financial statements that have not been previously issued. The adoption of this standard is not expected to have a material impact on our financial position or results of operations. | |
Reclassifications | Reclassifications |
Certain prior year items have been reclassified to conform to current year presentation. |
Inventory_Tables
Inventory (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Inventory Disclosure [Abstract] | ||||||||
Components of Inventories | The components of inventories are composed of the following as of March 31, 2015 and December 31, 2014 (in thousands): | |||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
Finished goods | 709 | $ | 850 | |||||
Work-in-process | $ | 2,882 | 3,332 | |||||
Total inventories | $ | 3,591 | $ | 4,182 | ||||
Sharebased_Compensation_Expens1
Share-based Compensation Expense (Tables) | 3 Months Ended | |||||||
Mar. 31, 2015 | ||||||||
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||||||||
Summary of Share-Based Compensation Expense | The following table summarizes share-based compensation expense for the three months ended March 31, 2015 and 2014, which was allocated as follows (in thousands): | |||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2015 | 2014 | |||||||
Research and development | $ | 990 | $ | 782 | ||||
Selling, general and administrative | 3,346 | 7,047 | ||||||
Total share-based compensation expense | $ | 4,336 | $ | 7,829 | ||||
Share-Based Compensation Expense by Types of Awards | For the three months ended March 31, 2015 and 2014, we incurred share-based compensation expense due to the following types of awards (in thousands): | |||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2015 | 2014 | |||||||
Performance rights | $ | 418 | $ | 503 | ||||
Restricted stock | 3,372 | 5,969 | ||||||
Options | 546 | 1,357 | ||||||
Total share-based compensation expense | $ | 4,336 | $ | 7,829 | ||||
Other_Comprehensive_Income_Los1
Other Comprehensive Income (Loss) (Tables) | 3 Months Ended | |||||||||||||||
Mar. 31, 2015 | ||||||||||||||||
Equity [Abstract] | ||||||||||||||||
Total Accumulated Other Comprehensive Income (Loss) | Total accumulated other comprehensive income (loss) consisted of the following (in thousands): | |||||||||||||||
Net Unrealized | Foreign | Unrealized foreign exchange loss on intercompany balance | Accumulated | |||||||||||||
Loss on | Currency | Other | ||||||||||||||
Securities | Translation | Comprehensive | ||||||||||||||
Available-For- | Adjustments | Loss | ||||||||||||||
Sale | ||||||||||||||||
31-Dec-14 | $ | (490 | ) | $ | (6,009 | ) | $ | - | $ | (6,499 | ) | |||||
Current period other comprehensive income | 5 | 2,247 | (2,754 | ) | (502 | ) | ||||||||||
31-Mar-15 | $ | (485 | ) | $ | (3,762 | ) | $ | (2,754 | ) | $ | (7,001 | ) | ||||
Description_of_Business_and_Su2
Description of Business and Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 3 Months Ended | 3 Months Ended | 1 Months Ended | 3 Months Ended | ||||||||||||||
Share data in Millions, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Mar. 31, 2015 | Dec. 31, 2014 | Mar. 31, 2015 | Dec. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2015 | Mar. 31, 2015 | Feb. 28, 2015 | Feb. 28, 2015 | Mar. 31, 2014 | Mar. 31, 2014 |
USD ($) | USD ($) | EUR (€) | USD ($) | USD ($) | Other Assets | Other Assets | Prepaid Expenses and Other Current Assets | Prepaid Expenses and Other Current Assets | Europe | Europe | ITALY | ITALY | ITALY | Aequus Biopharma, Inc | Servier | Servier | Servier | Servier | |
USD ($) | USD ($) | USD ($) | USD ($) | Minimum | Maximum | USD ($) | Minimum | Maximum | Affiliated Entity | Collaborative Arrangement Product Agreement | Collaborative Arrangement Product Agreement | Collaborative Arrangement Product Agreement | Collaborative Arrangement Product Agreement | ||||||
Up-front Payment Arrangement | Up-front Payment Arrangement | Up-front Payment Arrangement | Up-front Payment Arrangement | ||||||||||||||||
USD ($) | EUR (€) | USD ($) | EUR (€) | ||||||||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||||||||||
Interest in majority-owned subsidiary | 61.00% | ||||||||||||||||||
Allowance for doubtful accounts | $25,000 | $100,000 | |||||||||||||||||
Cash and cash equivalents | 44,395,000 | 50,601,000 | 70,933,000 | 71,639,000 | |||||||||||||||
VAT receivable | 4,400,000 | 4,900,000 | 4,300,000 | ||||||||||||||||
VAT receivable, non-current | 4,200,000 | 4,700,000 | |||||||||||||||||
VAT receivable, current | 200,000 | 200,000 | |||||||||||||||||
VAT receivable, collection period | 3 months | 5 years | 3 years | 5 years | |||||||||||||||
Reserve for excess, obsolete or unsalesable inventory | 33,000 | ||||||||||||||||||
Total consideration received | 1,700,000 | 1,500,000 | 0 | 0 | |||||||||||||||
Intercompany foreign currency balance, amount | 21,900,000 | ||||||||||||||||||
Unrealized foreign exchange loss on intercompany balance | $2,754,000 | ||||||||||||||||||
Anti-dilutive securities excluded from computation of earnings per share amount | 14.5 | 16.3 |
Components_of_Inventories_Deta
Components of Inventories (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Thousands, unless otherwise specified | ||
Inventory Disclosure [Abstract] | ||
Finished goods | $709 | $850 |
Work-in-process | 2,882 | 3,332 |
Total inventories | $3,591 | $4,182 |
Legal_Proceedings_Additional_I
Legal Proceedings - Additional Information (Detail) | 1 Months Ended | 1 Months Ended | |||
Jul. 31, 2014 | Mar. 31, 2015 | Mar. 31, 2014 | Mar. 31, 2014 | Mar. 31, 2015 | |
2007 Equity Incentive Plan | CONSOB | VAT Assessments | VAT Assessments | VAT Assessments | |
grants | USD ($) | USD ($) | EUR (€) | USD ($) | |
Loss Contingencies [Line Items] | |||||
Range of possible loss, minimum | $5,000 | ||||
Range of possible loss, maximum | 537,000 | 10,100,000 | |||
Taxes paid | $600,000 | € 400,000 | |||
Number of common stock transferred | 4,756,137 | ||||
Types of grants authorized by plan | 6 |
Summary_of_ShareBased_Compensa
Summary of Share-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $4,336 | $7,829 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 990 | 782 |
Selling, general and administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $3,346 | $7,047 |
Recovered_Sheet1
Share-Based Compensation Expense by Types of Awards (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense | $4,336 | $7,829 |
Performance Rights | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense | 418 | 503 |
Restricted stock | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense | 3,372 | 5,969 |
Stock Options | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense | $546 | $1,357 |
Total_Accumulated_Other_Compre
Total Accumulated Other Comprehensive Income (Loss) (Detail) (USD $) | 3 Months Ended | |
In Thousands, unless otherwise specified | Mar. 31, 2015 | Mar. 31, 2014 |
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Beginning balance | ($6,499) | |
Current period other comprehensive income | -502 | -21 |
Ending balance | -7,001 | |
Net Unrealized Loss on Securities Available-for-sale | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Beginning balance | -490 | |
Current period other comprehensive income | 5 | |
Ending balance | -485 | |
Foreign Currency Translation Adjustments | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Beginning balance | -6,009 | |
Current period other comprehensive income | 2,247 | |
Ending balance | -3,762 | |
Unrealized Foreign Exchange Loss on Intercompany Balance | ||
Accumulated Other Comprehensive Income Loss [Line Items] | ||
Current period other comprehensive income | -2,754 | |
Ending balance | ($2,754) |
Leases_Additional_Information_
Leases - Additional Information (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
In Millions, unless otherwise specified | ||
Leases [Abstract] | ||
Deferred rent credit | $4.30 | $4.40 |
Deferred rent credit, other current Liabilities | 0.4 | 0.4 |
Deferred rent credit, other Liabilities | $3.90 | $4 |