Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Feb. 23, 2017 | Jun. 30, 2016 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CTIC | ||
Entity Registrant Name | CTI BIOPHARMA CORP | ||
Entity Central Index Key | 891,293 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 28,225,792 | ||
Entity Public Float | $ 65,150,355 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 44,002 | $ 128,182 |
Accounts receivable | 378 | 282 |
Receivable from collaborative arrangement | 7,778 | 0 |
Inventory, net | 1,525 | 2,845 |
Prepaid expenses and other current assets | 2,141 | 3,666 |
Total current assets | 55,824 | 134,975 |
Property and equipment, net | 3,023 | 3,718 |
Other assets | 4,996 | 5,504 |
Total assets | 63,843 | 144,197 |
Current liabilities: | ||
Accounts payable | 7,227 | 10,584 |
Accrued expenses | 24,765 | 22,133 |
Current portion of deferred revenue | 103 | 578 |
Current portion of long-term debt | 7,949 | 37,371 |
Other current liabilities | 602 | 1,743 |
Total current liabilities | 40,646 | 72,409 |
Deferred revenue, less current portion | 514 | 1,110 |
Long-term debt, less current portion | 11,311 | 19,124 |
Other liabilities | 3,615 | 4,141 |
Total liabilities | 56,086 | 96,784 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Common stock, no par value: Authorized shares - 41,500,000 and 31,500,000 at December 31, 2016 and 2015, respectively; Issued and outstanding shares - 28,228,602 and 28,046,109 at December 31, 2016 and 2015, respectively | 2,170,300 | 2,157,300 |
Accumulated other comprehensive loss | (6,655) | (6,952) |
Accumulated deficit | (2,150,326) | (2,098,317) |
Total CTI shareholders' equity | 13,319 | 52,031 |
Noncontrolling interest | (5,562) | (4,618) |
Total shareholders' equity | 7,757 | 47,413 |
Total liabilities and shareholders' equity | $ 63,843 | $ 144,197 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
Common stock, no par value (in USD per share) | $ 0 | $ 0 |
Common stock authorized (in shares) | 41,500,000 | 31,500,000 |
Common stock issued (in shares) | 28,228,602 | 28,046,109 |
Common stock outstanding (in shares) | 28,228,602 | 28,046,109 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | |||
Product sales, net | $ 4,331 | $ 3,496 | $ 6,917 |
License and contract revenue | 53,074 | 12,620 | 53,160 |
Total revenues | 57,405 | 16,116 | 60,077 |
Operating costs and expenses: | |||
Cost of product sold | 1,377 | 1,940 | 895 |
Research and development | 64,961 | 76,627 | 64,596 |
Selling, general and administrative | 45,306 | 53,962 | 56,241 |
Acquired in-process research and development | 0 | 0 | 21,859 |
Other operating (income) expense, net | (5,077) | 253 | 2,719 |
Total operating costs and expenses, net | 106,567 | 132,782 | 146,310 |
Loss from operations | (49,162) | (116,666) | (86,233) |
Non-operating expense: | |||
Interest expense | (2,614) | (2,104) | (1,947) |
Amortization of debt discount and issuance costs | (214) | (390) | (729) |
Foreign exchange loss | (484) | (703) | (4,435) |
Other non-operating expense | (479) | (900) | (885) |
Total non-operating expense | (3,791) | (4,097) | (7,996) |
Net loss before noncontrolling interest | (52,953) | (120,763) | (94,229) |
Noncontrolling interest | 944 | 1,341 | 862 |
Net loss attributable to CTI | (52,009) | (119,422) | (93,367) |
Deemed dividends on preferred stock | 0 | (3,200) | (2,625) |
Net loss attributable to common shareholders | $ (52,009) | $ (122,622) | $ (95,992) |
Basic and diluted net loss per common share (USD per share) | $ (1.86) | $ (6.51) | $ (6.46) |
Shares used in calculation of basic and diluted net loss per common share (in shares) | 27,948 | 18,837 | 14,853 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss before noncontrolling interest | $ (52,953) | $ (120,763) | $ (94,229) |
Other comprehensive income (loss): | |||
Foreign currency translation adjustments | 947 | 2,160 | 1,998 |
Unrealized foreign exchange loss on intercompany balance | (1,162) | (2,585) | 0 |
Other-than-temporary impairment on available-for-sale securities | 520 | 0 | 0 |
Net unrealized loss on securities available-for-sale | (8) | (28) | (68) |
Other comprehensive income (loss) | 297 | (453) | 1,930 |
Comprehensive loss | (52,656) | (121,216) | (92,299) |
Comprehensive loss attributable to noncontrolling interest | 944 | 1,341 | 862 |
Comprehensive loss attributable to CTI | $ (51,712) | $ (119,875) | $ (91,437) |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) shares in Thousands, $ in Thousands | Total | Preferred Stock | Common Stock | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Noncontrolling Interest | Series 20 Preferred Stock | Series 20 Preferred StockPreferred Stock | Series 20 Preferred StockCommon Stock | Series 21 Preferred Stock | Series 21 Preferred StockPreferred Stock | Series 21 Preferred StockCommon Stock | Series N-1 Preferred Stock | Series N-1 Preferred StockPreferred Stock | Series N-1 Preferred StockCommon Stock | Series N-2 Preferred Stock | Series N-2 Preferred StockPreferred Stock | Series N-2 Preferred StockCommon Stock |
Beginning Balance at Dec. 31, 2013 | $ 42,758 | $ 0 | $ 1,933,305 | $ (1,879,703) | $ (8,429) | $ (2,415) | ||||||||||||
Beginning Balance (in shares) at Dec. 31, 2013 | 0 | 14,551 | ||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||
Stock Issued | $ 21,486 | $ 21,486 | $ 32,342 | $ 32,342 | ||||||||||||||
Stock Issued (in shares) | 9 | 35 | ||||||||||||||||
Conversion of preferred stock to common stock | $ 0 | $ (21,486) | $ 21,486 | $ 0 | $ (32,342) | $ 32,342 | ||||||||||||
Conversion of preferred stock to common stock (in shares) | (9) | 900 | 1,800 | (35) | 1,750 | |||||||||||||
Value of beneficial conversion features related to preferred stock | 2,625 | $ 2,625 | ||||||||||||||||
Exercise of common stock purchase warrants | 1,877 | $ 1,877 | ||||||||||||||||
Exercise of common stock purchase warrants (in shares) | 49 | |||||||||||||||||
Equity-based compensation | 20,196 | $ 20,196 | ||||||||||||||||
Equity-based compensation (in shares) | 413 | |||||||||||||||||
Stock option exercises | 272 | $ 272 | ||||||||||||||||
Stock option exercises (in shares) | 18 | |||||||||||||||||
Noncontrolling interest | (862) | (862) | ||||||||||||||||
Expiry of mezzanine equity | 12,016 | $ 12,016 | ||||||||||||||||
Expiry of mezzanine equity (in shares) | 0 | |||||||||||||||||
Other | (170) | $ (170) | ||||||||||||||||
Other (in shares) | (5) | |||||||||||||||||
Deemed dividends on preferred stock | (2,625) | (2,625) | $ (2,600) | |||||||||||||||
Net loss for the year ended | (93,367) | (93,367) | ||||||||||||||||
Other comprehensive income (loss) | 1,930 | 1,930 | ||||||||||||||||
Ending Balance at Dec. 31, 2014 | 38,478 | $ 0 | $ 2,023,949 | (1,975,695) | (6,499) | (3,277) | ||||||||||||
Ending Balance (in shares) at Dec. 31, 2014 | 0 | 17,676 | ||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||
Stock Issued | 15,147 | $ 15,147 | $ 46,611 | $ 46,611 | $ 52,409 | $ 52,409 | ||||||||||||
Stock Issued (in shares) | 1,000 | 50 | 55 | |||||||||||||||
Conversion of preferred stock to common stock | 0 | $ (46,611) | $ 46,611 | 0 | $ (52,409) | $ 52,409 | ||||||||||||
Conversion of preferred stock to common stock (in shares) | (50) | 4,000 | (55) | 5,000 | ||||||||||||||
Value of beneficial conversion features related to preferred stock | 3,200 | $ 3,200 | ||||||||||||||||
Expiry of exercise price provision features related to common stock purchase warrant | 150 | 150 | ||||||||||||||||
Equity-based compensation | 14,828 | $ 14,828 | ||||||||||||||||
Equity-based compensation (in shares) | 393 | |||||||||||||||||
Stock option exercises | 156 | $ 156 | ||||||||||||||||
Stock option exercises (in shares) | 8 | |||||||||||||||||
Noncontrolling interest | (1,341) | (1,341) | ||||||||||||||||
Expiry of mezzanine equity | 1,445 | $ 1,445 | ||||||||||||||||
Other | (595) | $ (595) | ||||||||||||||||
Other (in shares) | (31) | |||||||||||||||||
Deemed dividends on preferred stock | (3,200) | (3,200) | (3,200) | |||||||||||||||
Net loss for the year ended | (119,422) | (119,422) | ||||||||||||||||
Other comprehensive income (loss) | (453) | (453) | ||||||||||||||||
Ending Balance at Dec. 31, 2015 | 47,413 | $ 0 | $ 2,157,300 | (2,098,317) | (6,952) | (4,618) | ||||||||||||
Ending Balance (in shares) at Dec. 31, 2015 | 0 | 28,046 | ||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||||||
Equity-based compensation | 13,324 | $ 13,324 | ||||||||||||||||
Equity-based compensation (in shares) | 207 | |||||||||||||||||
Noncontrolling interest | (944) | $ (944) | ||||||||||||||||
Other | (324) | $ (324) | ||||||||||||||||
Other (in shares) | (24) | |||||||||||||||||
Deemed dividends on preferred stock | 0 | |||||||||||||||||
Net loss for the year ended | (52,009) | (52,009) | $ (52,009) | |||||||||||||||
Other comprehensive income (loss) | 297 | 297 | ||||||||||||||||
Ending Balance at Dec. 31, 2016 | $ 7,757 | $ 0 | $ 2,170,300 | $ (2,150,326) | $ (6,655) | $ (5,562) | ||||||||||||
Ending Balance (in shares) at Dec. 31, 2016 | 0 | 28,229 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating activities | |||
Net loss | $ (52,953) | $ (120,763) | $ (94,229) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Baxalta milestone revenue | (32,000) | 0 | 0 |
Acquired in-process research and development | 0 | 0 | 21,859 |
Share-based compensation expense | 13,324 | 14,828 | 20,196 |
Depreciation and amortization | 831 | 990 | 1,100 |
Loss on debt extinguishment | 0 | 1,211 | 0 |
Provision for bad debts | 1,735 | 0 | 0 |
Reserve for excess, obsolete or unsalable inventory | 692 | 1,326 | 0 |
Other-than-temporary impairment on available-for-sale securities | 520 | 0 | 0 |
Noncash interest expense | 214 | 390 | 729 |
Noncash rent benefit | (467) | (409) | (354) |
Change in value of warrant liability | 0 | (232) | 886 |
Provision for VAT Assessments | 0 | 0 | 600 |
Other | 0 | 0 | (20) |
Changes in operating assets and liabilities: | |||
Accounts receivable | (156) | 1,555 | (1,980) |
Receivables from collaborative arrangements | (9,476) | 0 | 0 |
Inventory | 567 | (402) | 305 |
Prepaid expenses and other current assets | 1,609 | (402) | 46 |
Other assets | 355 | 826 | (356) |
Accounts payable | (3,025) | 4,368 | 1,454 |
Accrued expenses | 2,620 | 2,426 | 10,250 |
Deferred revenue | (1,071) | (918) | (31) |
Other liabilities | 1 | 3 | (5) |
Total adjustments | (23,727) | 25,560 | 54,679 |
Net cash used in operating activities | (76,680) | (95,203) | (39,550) |
Investing activities | |||
Purchases of property and equipment | (137) | (78) | (333) |
Other | 0 | 0 | (208) |
Net cash used in investing activities | (137) | (78) | (541) |
Financing activities | |||
Proceeds from common stock offering, net of issuance costs | 0 | 15,147 | 0 |
Repayment of Hercules debt | (5,452) | (4,659) | (1,526) |
Payment of a Hercules fee | (1,275) | 0 | 0 |
Payment of tax withholding obligations related to stock compensation | (355) | (604) | (178) |
Other | 30 | 165 | 280 |
Net cash (used in) provided by financing activities | (7,366) | 152,017 | 36,026 |
Effect of exchange rate changes on cash and cash equivalents | 3 | 513 | 3,359 |
Net (decrease) increase in cash and cash equivalents | (84,180) | 57,249 | (706) |
Cash and cash equivalents at beginning of year | 128,182 | 70,933 | 71,639 |
Cash and cash equivalents at end of year | 44,002 | 128,182 | 70,933 |
Supplemental disclosure of cash flow information | |||
Cash paid during the period for interest | 4,446 | 2,067 | 1,894 |
Supplemental disclosure of noncash financing and investing activities | |||
Issuance of common stock upon exercise or exchange of common stock purchase warrants | 0 | 0 | 1,877 |
Repayment and issuance of Hercules debt | 0 | 13,815 | 0 |
Baxalta milestone advance - earned in lieu of repayment | (32,000) | 0 | 0 |
Baxalta | |||
Financing activities | |||
Proceeds from debt, net of issuance costs | 0 | 31,922 | 0 |
Hercules | |||
Financing activities | |||
Proceeds from debt, net of issuance costs | 0 | 10,820 | 4,963 |
Series 19 Preferred Stock | |||
Financing activities | |||
Proceeds from issuance of preferred stock, net of issuance costs | 0 | 0 | (28) |
Series 20 Preferred Stock | |||
Financing activities | |||
Cash paid for Series 20 preferred stock issuance costs | 0 | 0 | (106) |
Supplemental disclosure of noncash financing and investing activities | |||
Conversion of preferred stock to common stock | 0 | 0 | 21,486 |
Issuance of Series 20 preferred stock for acquisition of assets from Chroma Therapeutics Limited | 0 | 0 | 21,600 |
Series 21 Preferred Stock | |||
Financing activities | |||
Proceeds from issuance of preferred stock, net of issuance costs | 0 | (227) | 32,621 |
Supplemental disclosure of noncash financing and investing activities | |||
Conversion of preferred stock to common stock | 0 | 0 | 32,342 |
Series N-1 Preferred Stock | |||
Financing activities | |||
Proceeds from issuance of preferred stock, net of issuance costs | (37) | 46,653 | 0 |
Supplemental disclosure of noncash financing and investing activities | |||
Conversion of preferred stock to common stock | 0 | 46,611 | 0 |
Series N-2 Preferred Stock | |||
Financing activities | |||
Proceeds from issuance of preferred stock, net of issuance costs | (277) | 52,800 | 0 |
Supplemental disclosure of noncash financing and investing activities | |||
Conversion of preferred stock to common stock | $ 0 | $ 52,409 | $ 0 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
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 Annual Report on Form 10-K as “we,” “us,” “our,” the “Company” and “CTI”, 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 in select countries in the European Union, or the E.U., for multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, or NHL, and evaluating pacritinib for the treatment of adult patients with myelofibrosis. 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, or 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. Principles of Consolidation The accompanying 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. As of December 31, 2016 , we also had an approximately 60% 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. Reverse Stock Split On January 1, 2017, we effected a one-for- ten reverse stock split, or the Stock Split. Unless otherwise noted, all impacted amounts included in the consolidated financial statements and notes thereto have been retroactively adjusted for the Stock Split. Unless otherwise noted, impacted amounts include shares of common stock authorized and outstanding, share issuances and cancellations, shares underlying warrants and stock options, shares reserved, conversion prices of convertible securities, exercise prices of warrants and options, and loss per share. Additionally, the Stock Split impacted preferred stock authorized (but not outstanding because there were no shares of preferred stock outstanding as of the time of the Stock Split). Liquidity The accompanying 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 within one year after the date the consolidated financial statements are issued. In accordance with Financial Accounting Standards Board, or the FASB, ASU No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40), our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued. We will need to continue to conduct research, development, testing and regulatory compliance activities with respect to our compounds and ensure the procurement of manufacturing and drug supply services, the costs of which, together with projected general and administrative expenses, is expected to result in operating losses for the foreseeable future. Additionally, we have resumed primary responsibility for the development and commercialization of pacritinib as a result of the termination of the Pacritinib License Agreement in October 2016, and we will no longer be eligible to receive cost sharing or milestone payments for pacritinib's development from Baxalta. We have incurred a net operating loss every year since our formation. As of December 31, 2016 , we had an accumulated deficit of $2.2 billion , and we expect to incur net losses for the foreseeable future. Our available cash and cash equivalents were $44.0 million as of December 31, 2016 . We believe that our present financial resources, together with payments projected to be received under certain contractual agreements and our ability to control costs, will only be sufficient to fund our operations into the third quarter of 2017. 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, be unable to obtain and maintain contracts necessary to continue our operations and at affordable rates with competitive terms, 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 consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. For example, estimates include assumptions used in calculating reserves for sales deductions such as rebates and returns of product sold, allowances for credit losses, excess and obsolete inventory, share-based compensation expense, accruals, the allocation of our operating expenses, the allocation of purchase price to acquired assets and liabilities, restructuring charges and our liability for excess facilities, our provision for loss contingencies, the useful lives of fixed assets, the fair value of our financial instruments, our tax provision and related valuation allowance, and determining potential impairment of long-lived assets. Actual results could differ from those estimates. Certain Risks and Uncertainties Our results of operations are subject to foreign currency exchange rate fluctuations primarily due to our activity in Europe. We report the results of our operations in U.S. dollars, while the functional currency of our foreign subsidiaries is the euro. As the net positions of our unhedged foreign currency transactions fluctuate, our earnings might be negatively affected. In addition, the reported carrying value of our euro-denominated assets and liabilities that remain in our European branches and subsidiaries will be affected by fluctuations in the value of the U.S. dollar as compared to the euro. We review our foreign currency risk periodically along with hedging options to mitigate such risk. Financial instruments which potentially subject us to concentrations of credit risk consist of accounts receivable. Our accounts receivable are from the sale of PIXUVRI to a small number of distributors and health care providers. Additionally, we do not require collateral on amounts due from our distributors and are therefore subject to credit risk. We have not experienced significant credit losses to date as a result of credit risk concentration. Additionally, see Note 16. Customer and Geographic Concentrations for further concentration disclosure. Concentrations We source our drug products for commercial operations and clinical trials from a concentrated group of third-party contractors. If we are unable to obtain sufficient quantities of source materials, manufacture or distribute our products to customers from existing suppliers and service providers, or obtain the materials or services from other suppliers, manufacturers or distributors, certain research and development and sales activities may be delayed. Cash and Cash Equivalents We consider all highly liquid debt instruments with maturities of three months or less at the time acquired to be cash equivalents. Cash equivalents represent short-term investments consisting of investment-grade corporate and government obligations, carried at cost, which approximates market value. 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 December 31, 2016 and 2015 , 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 recorded no allowance for doubtful accounts as of December 31, 2016 and 2015 . Receivables from Collaborative Arrangements Our receivables from collaborative arrangements relate to amounts receivable or reimbursable to us under the terms of collaborative arrangements with our partners. When it is deemed probable that an amount is uncollectible, it is written off against the existing allowance. During the year ended December 31, 2016 , we recorded $1.7 million in bad debt expense related to disputed invoices under the collaborative arrangement with Baxalta. The receivable balance as of December 31, 2016 relates to a milestone receivable from Servier for the attainment of a certain enrollment event in December 2016 in connection with our PIX306 study. We had no allowance for doubtful accounts from collaborative arrangements as of December 31, 2016 and 2015 . 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 was approximately $4.4 million and $4.7 million as of December 31, 2016 and 2015 , of which $4.1 million and $4.2 million was included in other assets and $0.3 million and $0.5 million was included in prepaid expenses and other current assets as of December 31, 2016 and 2015 , 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 December 31, 2016 , the VAT receivable related to operations in Italy was approximately $4.2 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 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 unsalable inventory, the value is written down to the net realizable value. Based on assessment of shelf lives and net realizable value of the product, a $1.5 million reserve for excess, obsolete or unsalable inventory was recorded as of December 31, 2016 . A $1.3 million reserve was recorded as of December 31, 2015 . Property and Equipment Property and equipment are carried at cost, less accumulated depreciation and amortization. Depreciation commences at the time assets are placed in service. We calculate depreciation using the straight-line method over the estimated useful lives of the assets ranging from three to five years for assets other than leasehold improvements. We amortize leasehold improvements over the lesser of their useful life of 10 years or the term of the applicable lease. Impairment of Long-lived Assets We review our long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Each impairment test is based on a comparison of the undiscounted future cash flows to the recorded value of the asset. If an impairment is indicated, the asset is written down to its estimated fair value based on fair market values. Leases We analyze leases at the inception of each agreement for classification as either an operating or capital lease. Certain of our lease agreement terms include rent holidays, rent escalation clauses and incentives for leasehold improvements. We recognize deferred rent relating to incentives for rent holidays and leasehold improvements and amortize the deferred rent over the term of the leases as a reduction of rent expense. For rent escalation clauses, we recognize rent expense on a straight-line basis equal to the amount of total minimum lease payments over the term of the lease. Acquisitions We account for acquired businesses using the acquisition method of accounting, which requires that most assets acquired and liabilities assumed be recognized at fair value as of the acquisition date. Any excess of the consideration transferred over the fair value of the net assets acquired is recorded as goodwill, and the fair value of the acquired in-process research and development, or IPR&D, is recorded on the balance sheet. If the acquired net assets do not constitute a business, the transaction is accounted for as an asset acquisition and no goodwill is recognized. In an asset acquisition, the amount allocated to acquired IPR&D with no alternative future use is charged to expense at the acquisition date. 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. At December 31, 2016 and 2015 , the carrying value of financial instruments such as receivables and payables approximated their fair values due to their short-term maturities. The carrying value of our long-term debt approximated its fair value at December 31, 2016 and 2015 based on borrowing rates for similar loans and maturities. Contingencies We record liabilities associated with loss contingencies to the extent that we conclude the occurrence of the contingency is probable and that the amount of the related loss is reasonably estimable. We record income from gain contingencies only upon the realization of assets resulting from the favorable outcome of the contingent event. See Note 12. Collaboration, Licensing and Milestone Agreements and Note 19. Legal Proceedings for further information regarding our current gain and loss contingencies. 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 primarily sell PIXUVRI through a limited number of wholesale 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 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. Collaboration Agreements We evaluate collaboration agreements to determine whether the multiple elements and associated deliverables can be considered separate units of accounting in accordance with Accounting Standards Codification, or ASC, 605-25, Revenue Recognition — Multiple-Element Arrangements. If it is determined that the deliverables under the collaboration agreement are a single unit of accounting, all amounts received or due, including any upfront payments, are recognized as revenue over the performance obligation periods of each agreement. Upon the completion of the performance obligation, such amounts will be recognized as revenue when collectability is reasonably assured. The assessment of multiple element arrangements requires judgment in order to determine the allocation of revenue to each deliverable and the appropriate point in time, or period of time, that revenue should be recognized. In order to account for these agreements, we identify deliverables included within the agreement and evaluate which deliverables represent separate units of accounting based on whether certain criteria are met, including whether the delivered element has standalone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. Milestone payments under the collaboration agreement are generally aggregated into three categories for reporting purposes: (i) development milestones, (ii) regulatory milestones, and (iii) sales milestones. Development milestones are typically payable when a product candidate initiates or advances into different clinical trial phases. Regulatory milestones are typically payable upon submission for marketing approval with the FDA, or with the regulatory authorities of other countries, or on receipt of actual marketing approvals for the compound or for additional indications. Sales milestones are typically payable when annual sales reach certain levels. At the inception of each agreement that includes milestone payments, we evaluate whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity's performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity's performance to achieve the milestone, (b) the consideration relates solely to past performance and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. We evaluate factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. Non-refundable development and regulatory milestones that are expected to be achieved as a result of our efforts during the period of substantial involvement are considered substantive and are recognized as revenue upon the achievement of the milestone, assuming all other revenue recognition criteria are met. We follow ASC 605-25, Revenue Recognition – Multiple-Element Arrangements and ASC 808, Collaborative Arrangements , if applicable, to determine the accounting for reimbursement arrangements under our collaborative research and development and commercialization agreements. 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. Research and Development Expenses Research and development costs are expensed as incurred in accordance with the FASB, ASC 730, Research and Development . Research and development expenses include related salaries and benefits, clinical trial and related manufacturing costs, contract and other outside service fees, and facilities and overhead costs related to our research and development efforts. Research and development expenses also consist of costs incurred for proprietary and collaboration research and development and include activities such as product registries and investigator-sponsored trials. In instances where we enter into agreements with third parties for research and development activities, we may prepay fees for services at the initiation of the contract. We record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Other types of arrangements with third parties may be fixed fee or fee for service, and may include monthly payments or payments upon completion of milestones or receipt of deliverables. We expense upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. 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, 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. The intercompany balance due from CTILS is considered to be of a long-term nature. An unfavorable unrealized foreign exchange loss of $1.2 million and $2.6 million was recorded in the cumulative foreign currency translation adjustment account for the years ended December 31, 2016 and 2015 , respectively. As of December 31, 2016 and 2015 , the intercompany balance due from CTILS was €29.7 million and €27.2 million , respectively (or $31.2 million and $29.5 million upon conversion from euros as of December 31, 2016 and 2015 , respectively). Income Taxes We record a tax provision for the anticipated tax consequences of our results of operations. The provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, and for operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using the currently enacted tax rates in effect for the years in which those tax assets and liabilities are expected to be realized or settled. We provide a valuation allowance to reduce deferred tax assets to the amount that is more likely than not to be realized. 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 Adopted Accounting Standards 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. The adoption of this guidance did not have a material impact on our consolidated financial statements. In November 2015, the FASB issued new guidance on the balance sheet classification of deferred taxes. To simplify presentation, the new guidance requires that all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet . 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. The adoption of this guidance did not have an impact 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 ending after December 15, 2016 and interim periods within annual periods beginning after December 15, 2016. Early adoption is permitted. We adopted this new standard in the fourth quarter of 2016. The adoption of this standard did not have a material impact on our consolidated financial statements. Recently Issued Accounting Standards In May 2014, 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. In March 2016, the FASB issued an amendment to clarify the implementation guidance around considerations of whether an entity is a principal or an agent, impacting whether an entity reports revenue on a gross or net basis. In April 2016, the FASB issued an amendment to clarify guidance on identifying performance obligations and the implementation guidance on licensing. In May 2016, the FASB issued amendments to certain aspects of the new revenue guidance (including transition, collectability, noncash consideration and the presentation of sales and other similar taxes) and provided certain practical expedients. The accounting standard is effective for annual reporting periods (including interim reporting periods within those periods) beginning after December 15, 2017. Early adoption is permitted as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. We are currently evaluating the impact of this accounting standard on our consolidated financial statements. In July 2015, the FASB issued new accounting guidance on simplifying the measurement of inventory which requires that inventory within the scope of the guidance be measured at the lower of cost and net realizable value. Prior to the issuance of the standard, inventory was measured at the lower of cost or market (where market was defined as replacement cost, with a ceiling of net realizable value and floor of net realizable value less a normal profit margin). The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2016. Early adoption is permitted. The adoption of this standard is not expected to have a material impact on our consolidated financial statements. In January 2016, the FASB issued a new accounting standard on recognition and measurement of financial assets and financial liabilities. The accounting standard primarily affects the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. Early adoption is permitted for the provision to record fair value changes for financial liabilities under the fair value option resulting from instrument-specific credit risk in other comprehensive income. The adoption of this standard is not expected to have a material impact on our consolidated financial statements. In February 2016, the FASB issued a new accounting guidance on accounting for leases which requires the lessees to recognize virtually all of their leases on the balance sheet (other than leas |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Inventory | 2. Inventory The components of PIXUVRI inventories consisted of the following as of December 31, 2016 and 2015 (in thousands): 2016 2015 Finished goods $ 477 $ 724 Work-in-process 2,558 3,386 Inventory, gross $ 3,035 $ 4,110 Reserve for excess, obsolete or unsalable inventory $ (1,510 ) $ (1,265 ) Inventory, net $ 1,525 $ 2,845 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 3. Property and Equipment Property and equipment are composed of the following as of December 31, 2016 and 2015 (in thousands): 2016 2015 Furniture and office equipment $ 6,521 $ 6,484 Leasehold improvements 5,106 5,078 Lab equipment 201 203 11,828 11,765 Less: accumulated depreciation and amortization (8,805 ) (8,047 ) Property and equipment, net $ 3,023 $ 3,718 Depreciation expense for the years ended December 31, 2016 , 2015 and 2014 was $0.8 million , $1.0 million and $1.1 million , respectively. |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2016 | |
Business Combinations [Abstract] | |
Acquisitions | 4. Acquisitions Chroma Asset Purchase Agreement In October 2014 , we entered into an Asset Purchase Agreement, or the Chroma APA, with Chroma Therapeutics Limited, or Chroma, pursuant to which we acquired all of Chroma’s right, title and interest in the compound tosedostat and certain related assets. Concurrently, we and Chroma terminated our Co-Development and License Agreement relating to tosedostat, or the Chroma License Agreement, thereby eliminating potential future milestone payments thereunder of up to $209.0 million , and we acquired an exclusive worldwide license with respect to tosedostat directly from Vernalis R&D Limited, or Vernalis (as discussed below). As consideration under the Chroma APA, we issued an aggregate of 9,000 shares of our Series 20 Preferred Stock convertible into shares of common stock, of which 7,920 shares were delivered to Chroma. The remaining 1,080 shares, which were converted into shares of common stock as discussed below and held in escrow for nine months from the initial issuance date, were released to Chroma in 2015. Each share of Series 20 Preferred Stock had a stated value of $2,370 per share and was convertible into shares of common stock at a conversion price of $23.70 per share. Shares of the Series 20 Preferred Stock would receive dividends in the same amount as any dividends declared and paid on shares of common stock, but were entitled to a liquidation preference over the common stock in certain liquidation events. The total initial purchase consideration was as follows (in thousands): Fair value of Series 20 Preferred Stock $ 21,600 Transaction costs 259 Total initial purchase consideration $ 21,859 All outstanding shares of Series 20 Preferred stock were converted into 0.9 million shares of common stock in October 2014 . There was no beneficial conversion feature as the Series 20 Preferred Stock was recorded at fair value as of the acquisition date. The transaction was treated as an asset acquisition because it was determined that the assets acquired did not meet the definition of a business. We determined that the acquired assets could only be economically used for the specific and intended purpose and had no alternative future use after taking into consideration further research and development, regulatory and marketing approval efforts required in order to reach technological feasibility. Accordingly, the entire initial purchase consideration of $21.9 million was expensed to acquired in-process research and development during the year ended December 31, 2014 . Concurrently with the termination of the Chroma License Agreement and the execution of the Chroma APA, we also entered into an amended and restated license agreement with Vernalis, or the Vernalis License Agreement, for the exclusive worldwide right to use certain patents and other intellectual property rights to develop, market and commercialize tosedostat and certain other compounds, as well as deed of novation pursuant to which all rights of Chroma under its prior license agreement with Vernalis relating to tosedostat were novated to us. Under the Vernalis License Agreement, we have agreed to make tiered royalty payments of no more than a high single digit percentage of net sales of products containing licensed compounds, with such obligation to continue on a country-by-country basis for the longer of ten years following commercial launch or the expiry of relevant patent claims. The Vernalis License Agreement will terminate when the royalty obligations expire, although the parties have early termination rights under certain circumstances, including the following: (i) we have the right to terminate, with three months’ notice, upon the belief that the continued development of tosedostat or any of the other licensed compounds is not commercially viable; (ii) Vernalis has the right to terminate in the event of our uncured failure to pay sums due; and (iii) either party has the right to terminate in event of the other party’s uncured material breach or insolvency. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 5. Accrued Expenses Accrued expenses consisted of the following as of December 31, 2016 and 2015 (in thousands): 2016 2015 Clinical and investigator-sponsored trial expenses $ 7,303 $ 8,976 Employee compensation and related expenses 6,364 5,498 Manufacturing expenses 7,616 921 Legal expenses 1,037 1,274 Accrued selling expenses 136 1,697 Insurance financing 888 679 Accrued interest expenses 2 1,817 Other 1,419 1,271 Total accrued expenses $ 24,765 $ 22,133 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2016 | |
Leases [Abstract] | |
Leases | 6. Leases Lease Agreements We lease our office space under operating leases for our U.S. and European offices. Rent expense amounted to $2.0 million for each of the years ended December 31, 2016 , 2015 and 2014 . Rent expense is net of sublease income and amounts offset to excess facilities charges. In January 2012 , we entered into an agreement with Selig Holdings Company LLC to lease approximately 66,000 square feet of office space in Seattle, Washington. The term of this lease is for a period of 120 months , which commenced on May 1, 2012. We have two five -year options to extend the term of the lease at a market rate determined according to the lease. The initial rent amount was based on $27.00 per square foot per annum, but no payments were due during the initial five months of the lease term. Rent increases three percent over the prior year’s amount for each year thereafter for the duration of the lease. In addition, we were provided an allowance of $3.3 million for certain tenant improvements made by us. Future Minimum Lease Payments Future minimum lease commitments for non-cancelable operating leases at December 31, 2016 are as follows (in thousands): Operating Leases 2017 $ 2,579 2018 2,486 2019 2,490 2020 2,555 2021 2,622 Thereafter 882 Total minimum lease commitments $ 13,614 |
Other Liabilities
Other Liabilities | 12 Months Ended |
Dec. 31, 2016 | |
Other Liabilities Disclosure [Abstract] | |
Other Liabilities | 7. Other Liabilities Other liabilities consisted of the following as of December 31, 2016 and 2015 (in thousands): 2016 2015 Deferred rent, less current portion $ 3,011 $ 3,538 Other long-term obligations 604 603 Total other liabilities $ 3,615 $ 4,141 The balance of deferred rent as of December 31, 2016 and 2015 relates to incentives for rent holidays and leasehold improvements associated with our operating lease for office space as discussed in Note 6. Leases . |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 8. Long-term Debt Hercules In March 2013 , we entered into a Loan and Security Agreement, or the Loan Agreement, with Hercules, providing for a senior secured term loan of up to $15.0 million , or the Term Loan. The first $10.0 million was funded in March 2013 , and we exercised our option to borrow an additional $5.0 million in December 2013. The interest rate on the Term Loan floated at a rate per annum equal to 12.25% plus the amount by which the prime rate exceeded 3.25% . The Term Loan was repayable in 30 equal monthly installments of principal and interest (mortgage style) over 42 months , including an initial interest-only period of 12 months after closing. We paid a facility charge of $150,000 at closing. In connection with the Loan Agreement, in March 2013 , we issued a warrant to Hercules to purchase shares of common stock. The warrant was exercisable for five years from the date of issuance for 68,000 shares of common stock. The initial exercise price of the warrant was $11.045 per share of common stock. The exercise price and number of shares of common stock issuable upon exercise were subject to antidilution adjustments in certain events, including if within 12 months after closing the Company issued shares of common stock or securities that were 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 was less than the exercise price of the warrant. In such an event, the exercise price would have been automatically reduced to equal the price per share of common stock in such transaction, and the number of shares issuable upon conversion of the warrant would have been increased proportionately. Since the warrant did not meet the considerations necessary for equity classification in the applicable authoritative guidance, we determined the warrant was a liability instrument that is marked to fair value with changes in fair value recognized through earnings at each reporting period. The warrant was categorized as Level 2 in the fair value hierarchy as the significant inputs used in determining fair value were considered observable market data. In January 2014 , all of the warrant was exercised in exchange for 49,000 shares of common stock via cashless exercise. In March 2014 , we entered into a First Amendment to the Loan Agreement, or the First Amendment. The First Amendment modified certain terms applicable to the loan balance then-outstanding of $15.0 million , as described above, and provided us with the option to borrow an additional $5.0 million , or the 2014 Term Loan, through October 31, 2014 , subject to certain conditions. We exercised such option and received the funds in October 2014 . In connection with the First Amendment, we paid a facility charge of $72,500 of which $35,000 was refunded to us in October 2014 pursuant to the terms of the First Amendment. Pursuant to the First Amendment, the interest-only period of the Term Loan was extended by six months such that the 24 equal monthly installments of principal and interest (mortgage style) commenced on November 1, 2014 (rather than May 1, 2014 ). In addition, the interest rate on the Term Loan was, upon Hercules’ receipt of evidence of the achievement of positive Phase 3 data in connection with our PERSIST-1 clinical trial for pacritinib, reduced from 12.25% to 11.25% plus the amount by which the prime rate would exceed 3.25% . The interest on the 2014 Term Loan floated at a rate per annum equal to 10.00% plus the amount by which the prime rate would exceed 3.25% . The modified terms were not considered substantially different pursuant to ASC 470-50, Modification and Extinguishment . In June 2015 , we entered into a Third Amendment to the Loan Agreement, or the Third Amendment. Under the Third Amendment, Hercules agreed to provide term loans in an aggregate principal amount of up to $25.0 million , inclusive of the principal balance outstanding immediately prior to closing of the Third Amendment of $13.8 million , or collectively, the Term Loan Borrowings. We drew $6.2 million upon closing of the Third Amendment, resulting in a then-outstanding principal balance of $20.0 million under the Term Loan Borrowings. The remaining $5.0 million was available for borrowing at our option through June 30, 2016, subject to certain conditions. In connection with the Third Amendment, we paid a commitment fee of $15,000 and a facility charge of $0.3 million . The provision under the Loan Agreement requiring us to pay a fee to Hercules of $1.3 million on the date of repayment of the borrowings thereunder was amended pursuant to the Third Amendment, such that the fee would be payable on the earliest to occur of (1) October 1, 2016 , (2) the date on which the Term Loan Borrowings are prepaid in full or (3) the date on which the Term Loan Borrowings become due and payable in full. The $1.3 million fee was paid in October 2016 . Pursuant to the Third Amendment, the interest rate on the Term Loan Borrowings floats at a rate per annum equal to 10.95% plus the amount by which the prime rate exceeds 3.25% . We were initially required to make interest payments only on a monthly basis, followed by 36 equal monthly installments of principal and interest (mortgage style) commencing on January 1, 2016 , which was further extended to April 1, 2016 in connection with the Fourth Amendment discussed below. In connection with the Third Amendment, we issued a warrant to Hercules to purchase shares of common stock. The warrant is exercisable for five years from the date of issuance for 29,239 shares of common stock at an initial exercise price of $17.10 per share. Since the warrant contained the exercise price adjustment provision similar to the one in the March 2013 warrant as discussed above, it did not meet the considerations necessary for equity classification under the applicable authoritative guidance. As such, 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. The warrant was categorized as Level 2 in the fair value hierarchy as the significant inputs used in determining fair value are considered observable market data. As of the issuance date, we estimated the fair value of the warrant to be $0.4 million . Upon expiry of the exercise price adjustment provision in December 2015 , the then-estimated fair value of the warrant of $0.2 million was reclassified from liability to equity. The modified terms under the Third Amendment were considered substantially different as compared to the terms of the Loan Agreement immediately prior to the Third Amendment, pursuant to ASC 470-50, Modification and Extinguishment . As such, the Third Amendment was accounted for as a debt extinguishment, resulting in a loss on debt extinguishment of $1.2 million which is included in other non-operating expense for the year ended December 31, 2015 . In December 2015 , we entered into a Fourth Amendment to the Loan Agreement, or the Fourth Amendment, pursuant to which Hercules funded the remaining $5.0 million term loan available under the facility, resulting in a then-outstanding principal balance of $25.0 million under the Term Loan Borrowings. Commencing on April 1, 2016 , we are required to make monthly interest plus principal payments through December 1, 2018 in the approximate amount of $0.8 million with the final principal payment of $3.3 million on the maturity date of December 1, 2018 . We may elect to prepay some or all of the Term Loan Borrowings at any time subject to a prepayment fee, if any, pursuant to the terms of the Fourth Amendment. Under certain circumstances, we may be required to prepay the Term Loan Borrowings with proceeds of asset dispositions. The Term Loan Borrowings 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. In connection with the original Loan Agreement in 2013, we recorded a debt discount of $2.1 million and issuance costs of $0.3 million . In connection with the First Amendment in March 2014, we recorded an additional debt discount of $0.1 million . For the Third and Fourth Amendments in 2015, we recorded an additional debt discount of $0.4 million and issuance costs of $0.1 million . As of December 31, 2016 and 2015 , unamortized debt discount was $0.2 million and $0.4 million , unamortized issuance costs were $45,000 and $0.1 million , and the outstanding principal balance was $19.5 million and $25.0 million , respectively. Baxalta In November 2013 , we entered into a Development, Commercialization and License agreement, or the Pacritinib License Agreement, with Baxter International Inc., or Baxter, for the development and commercialization of pacritinib for use in oncology and potentially additional therapeutic areas. Baxalta Incorporated and its affiliates, or Baxalta, have been assigned Baxter’s rights and obligations under the Pacritinib License Agreement. In June 2015 , we entered into the First Amendment to the Pacritinib License Agreement, or the Pacritinib License Amendment. Pursuant to the Pacritinib License Amendment, two potential milestone payments in the aggregate amount of $32.0 million from Baxalta to us were accelerated from the schedule contemplated by the original Pacritinib License Agreement relating to the following: the $12.0 million development milestone payment payable in connection with the regulatory submission of the Marketing Authorization Application, or the MAA, to the EMA with respect to pacritinib, or the MAA Milestone, and the $20.0 million development milestone payment payable in connection with the first treatment dosing of the 300th patient enrolled per the protocol in PERSIST-2, or the PERSIST-2 Milestone. Under the Pacritinib License Amendment, each of the two milestone advances bears interest at an annual rate of 9% until the earlier of the date of the first occurrence of the respective milestone or the date that the respective advance plus accrued interest is repaid in full. In the event that pacritinib development is terminated due to certain specified reasons or the milestones are not achieved by respective deadlines ( December 31, 2016 for the PERSIST-2 Milestone and March 31, 2017 for the MMA Milestone), we would be required to repay the respective advance to Baxalta in eight quarterly installments of $1.5 million relating to the MMA Milestone and $2.5 million relating to the PERSIST-2 Milestone, in each case beginning 30 days after the end of the calendar quarter of the first occurrence of such event, and a final payment equal to the remainder of the unpaid balance. Repayment of the advances would be accelerated in the event of the commencement of insolvency proceedings and certain other events of default. Additionally, in the event that we did not spend a specified amount on the development of pacritinib from the date of the amendment through February 29, 2016 , payments to Baxalta in an amount equal to such deficiency may be required or credited against amounts owed to us under certain circumstances. As of December 31, 2015 , the outstanding balance of such advance was $32.0 million . In January 2016 and February 2016 , we successfully achieved the $20 million PERSIST-2 Milestone and the $12.0 million MAA Milestone, respectively, which were recorded in License and contract revenue. Refer to the Note 12. Collaboration, Licensing and Milestone Agreements for further details regarding the Baxalta Agreement. |
Preferred Stock
Preferred Stock | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Preferred Stock | 9. Preferred Stock Series 19 Preferred Stock See Note 12. Collaboration, Licensing and Milestone Agreements - Baxalta for information concerning our issuance of Series 19 Preferred Stock. Series 20 Preferred Stock See Note 4. Acquisitions - Chroma Asset Purchase Agreement , for information concerning our issuance of Series 20 Preferred Stock. Series 21 Preferred Stock In November 2014 , we issued 35,000 shares of our Series 21 convertible preferred stock, or Series 21 Preferred Stock, in an underwritten public offering for gross proceeds of $35.0 million , before deducting underwriting commissions and discounts and other offering costs of $2.7 million , including $2.1 million in underwriting commissions and discounts. Each share of Series 21 Preferred Stock was convertible at the option of the holder and was entitled to a liquidation preference equal to the initial stated value of such holder’s Series 21 Preferred Stock of $1,000 per share, plus any declared and unpaid dividends and any other payments that may be due on such shares, before any distribution of assets may be made to holders of capital stock ranking junior to the Series 21 Preferred Stock. The Series 21 Preferred Stock was not entitled to dividends except to share in any dividends actually paid on the common stock or any pari passu or junior securities. The Series 21 Preferred Stock had no voting rights, except as otherwise expressly provided in the amended articles or as otherwise required by law. During the year ended December 31, 2014 , we recognized $2.6 million in deemed dividends on preferred stock related to the beneficial conversion feature on our Series 21 Preferred Stock, and all 35,000 shares of Series 21 Preferred Stock were converted into 1.8 million shares of our common stock at a conversion price of $20.00 per share. Series N-1 Preferred Stock In October 2015 , in an underwritten public offering, we issued 50,000 shares of our Series N-1 convertible preferred stock, or Series N-1 Preferred Stock, for gross proceeds of $50.0 million before deducting underwriting commissions and discounts and other offering costs of approximately $3.4 million , including $3.0 million in underwriting commissions and discounts. Each share of Series N-1 Preferred Stock was convertible at the option of the holder and was entitled to a liquidation preference equal to the initial stated value of $1,000 per share of Series N-1 Preferred Stock, plus any declared and unpaid dividends, and any other payments that may be due on such shares, before any distribution of assets may be made to holders of capital stock ranking junior to the Series N-1 Preferred Stock. The Series N-1 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 N-1 Preferred Stock had no voting rights, except as otherwise expressly provided in the amended articles or as otherwise required by law. In October 2015 , all 50,000 shares of Series N-1 Preferred Stock were converted into 4.0 million shares of common stock at a conversion price of $12.50 per share. During the year ended December 31, 2015 , we recognized $3.2 million in deemed dividends on preferred stock related to the beneficial conversion feature on our Series N-1 Preferred Stock. Series N-2 Preferred Stock In December 2015 , in an underwritten public offering, we issued 55,000 shares of our Series N-2 Preferred Stock for gross proceeds of $55.0 million before deducting underwriting commissions and discounts and other offering costs of approximately $2.6 million , including $2.2 million in underwriting commissions and discounts. Each share of Series N-2 Preferred Stock was convertible at the option of the holder (subject to a limited exception) and was entitled to a liquidation preference equal to the initial stated value of $1,000 per share of Series N-1 Preferred Stock, plus any declared and unpaid dividends, and any other payments that may be due on such shares, before any distribution of assets may be made to holders of capital stock ranking junior to the Series N-2 Preferred Stock. The Series N-2 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 N-2 Preferred Stock had no voting rights, except as otherwise expressly provided in the amended articles or as otherwise required by law. In December 2015 , all 55,000 shares of Series N-2 Preferred Stock were converted into 5.0 million shares of common stock at a conversion price of $11.00 per share. There was no beneficial conversion feature on Series N-2 Preferred Stock. |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Common Stock | 10. Common Stock Common Stock Authorized In February 2015 , the Company's Amended and Restated Articles of Incorporation were amended to increase the total number of authorized shares of common stock from 21.5 million to 31.5 million . In April 2016 , the Company's Amended and Restated Articles of Incorporation were amended to increase the total number of authorized shares of common stock from 31.5 million to 41.5 million . Common Stock Issued In September 2015 , we entered into a subscription agreement with certain affiliates of BVF Partners L.P., or collectively, BVF. Pursuant to the subscription agreement, we issued to BVF an aggregate of 1.0 million shares of common stock at a purchase price per share of $15.70 . The shares of common stock were offered directly to BVF without a placement agent or underwriter. The net proceeds from the offering, after deducting offering expenses, were approximately $15.1 million . Common Stock Reserved A summary of common stock reserved for issuance is as follows as of December 31, 2016 (in thousands): Equity incentive plans 4,070 Common stock purchase warrants 29 Employee stock purchase plan 187 Total common stock reserved 4,286 Warrants Warrants to purchase up to 60,846 shares of our common stock with an exercise price of $120.00 per share, issued in connection with the issuance of our Series 12 Preferred Stock in May 2011 , were outstanding as of December 31, 2015 . Warrants to purchase up to 3,042 shares of our common stock with an exercise price of $131.25 per share issued to the placement agent for the Series 12 Preferred Stock transaction were outstanding as of December 31, 2015 . These warrants expired in May 2016 and were no longer outstanding as of December 31, 2016 . Warrants to purchase up to 176,400 shares of our common stock with an exercise price of $107.50 per share, issued in connection with the issuance of our Series 13 Preferred Stock in July 2011 , were outstanding as of December 31, 2015 . Warrants to purchase up to 7,059 shares of our common stock with an exercise price of $122.50 per share and warrants to purchase up to 3,529 shares with an exercise price of $122.50 per shares, issued to the placement agent and to the financial advisor, respectively, were outstanding as of December 31, 2015 . These warrants expired in July 2016 and were no longer outstanding as of December 31, 2016 . Warrants to purchase up to 139,130 shares of our common stock with an exercise price of $72.50 per share, issued in connection with the issuance of our Series 14 Preferred Stock in December 2011 , were outstanding as of December 31, 2015 . Warrants to purchase up to 6,957 shares of our common stock with an exercise price of $86.25 per share and warrants to purchase up to 3,478 shares with an exercise price of $86.25 per shares, issued to the placement agent and to the financial advisor, respectively, were outstanding as of December 31, 2015 . These warrants expired in December 2016 and were no longer outstanding as of December 31, 2016 . See Note 8. Long-term Debt for additional information concerning our warrants. |
Other Comprehensive Loss
Other Comprehensive Loss | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Other Comprehensive Loss | 11. Other Comprehensive Loss Total accumulated other comprehensive loss consisted of the following (in thousands): Net Unrealized Gain (Loss) and Impairment on Available-For-Sale Securities Foreign Currency Translation Adjustments Unrealized Foreign Exchange Loss on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2015 $ (518 ) $ (3,849 ) $ (2,585 ) $ (6,952 ) Current period other comprehensive income (loss) 512 947 (1,162 ) 297 December 31, 2016 $ (6 ) $ (2,902 ) $ (3,747 ) $ (6,655 ) In the first quarter of 2016, we recognized other-than-temporary impairment on available-for-sale securities of $0.5 million in our consolidated statements of operations. The value of available-for-sale securities of $13,500 and $22,000 was included in Prepaid expenses and other current assets as of December 31, 2016 and 2015 , respectively. |
Collaboration, Licensing and Mi
Collaboration, Licensing and Milestone Agreements | 12 Months Ended |
Dec. 31, 2016 | |
Collaborations [Abstract] | |
Collaboration, Licensing and Milestone Agreements | 12. Collaboration, Licensing and Milestone Agreements Baxalta In November 2013 , we entered into the Pacritinib License Agreement with Baxter, for the development and commercialization of pacritinib for use in oncology and potentially additional therapeutic areas. Baxalta had been assigned Baxter’s rights and obligations under the Pacritinib License Agreement. Under the Pacritinib License Agreement, we granted to Baxter an exclusive, worldwide (subject to our certain co-promotion rights in the U.S.), royalty-bearing, non-transferable, and (under certain circumstances outside of the U.S.) sub-licensable license to its know-how and patents relating to pacritinib. We received an upfront payment of $60.0 million upon execution of the Pacritinib License Agreement, which included an equity investment of $30.0 million to acquire our Series 19 Preferred Stock as discussed below. Under the Pacritinib License Agreement, we would receive potential clinical, regulatory and commercial launch milestone payments of up to $112.0 million and potential additional sales-based milestone payments of up to $190.0 million . We determined that all of the sales-based milestone payments were contingent consideration and would be accounted for as revenue in the period in which the respective revenue recognition criteria were met. We also determined that all of the clinical, regulatory and commercial launch milestones were substantive and would be recognized as revenue upon the achievement of the milestone, assuming all other revenue recognition criteria were met. Under the Pacritinib License Agreement, we would commercialize and share profits and losses on sales of pacritinib in the U.S jointly with Baxalta. Outside of the U.S., we were also eligible to receive tiered high single-digit to mid-teen percentage royalties based on net sales for myelofibrosis, and higher double-digit royalties for other indications, subject to reduction by up to 50% (i) if Baxalta is required to obtain third-party royalty-bearing licenses to fulfill its obligations under the Pacritinib License Agreement, and (ii) in any jurisdiction where there is no longer either regulatory exclusivity or patent protection. Under the Pacritinib License Agreement, we were responsible for all development costs incurred prior to January 1, 2014 as well as up to approximately $96.0 million on or after January 1, 2014 for U.S. and E.U. development costs, subject to potential adjustment in certain circumstances. All development costs exceeding such threshold would generally be shared as follows: (i) costs generally applicable worldwide would be shared 75% to Baxalta and 25% to the Company, (ii) costs applicable to territories exclusive to Baxalta would be 100% borne by Baxalta and (iii) costs applicable exclusively to co-promotion in the U.S. would be shared equally between the parties, subject to certain exceptions. We record the development cost reimbursements received from Baxalta as license and contract revenue in the statements of operations, and we record the full amount of development costs as research and development expense. Pursuant to the accounting guidance under ASC 605-25, Revenue Recognition – Multiple-Element Arrangements , we determined that the following non-contingent deliverables under the Pacritinib License Agreement met the criteria for separation and were therefore treated as separate units of accounting: • a license from the Company to develop and commercialize pacritinib worldwide (subject to certain co-promotion rights of the Company in the U.S.); and • development services provided by the Company related to jointly agreed-upon development activities with cost sharing as discussed above. Both of the above non-contingent deliverables have no general right of return and are determined to have standalone values. The Pacritinib License Agreement also required Baxalta and the Company to negotiate and enter into a manufacturing and supply agreement providing for the manufacture of the licensed products. The manufacturing and supply agreement contemplated under the Pacritinib License Agreement was not considered as a deliverable at the inception of the arrangement because the critical terms such as pricing and quantities were not defined and delivery of the services would be dependent on successful clinical results that are uncertain. Also under the Pacritinib License Agreement, joint commercialization, manufacturing, development and steering committees with representatives from the Company and Baxalta would be established. We considered whether our participation on the joint development committees may be a separate deliverable and determined that it did not represent a separate unit of accounting as the committee’s activities were primarily related to governance and oversight of development activities and were therefore combined with the development services. Our participation on the joint commercialization and manufacturing committees was also determined to be a non-deliverable. We also considered whether our regulatory roles under the Pacritinib License Agreement constituted a separate deliverable and determined that it should also be combined with the development services. Either party may terminate the Pacritinib License Agreement prior to expiration in certain circumstances. We may terminate the Pacritinib License Agreement if Baxalta has not undertaken requisite regulatory or commercialization efforts in the applicable countries and certain other conditions are met. Baxalta may terminate the Pacritinib License Agreement prior to expiration in certain circumstances including (i) in the event development costs for myelofibrosis for the period commencing January 1, 2014 were reasonably projected to exceed a specified threshold, (ii) as to some or all countries in the event of commercial failure of the licensed product or (iii) without cause following the one-year anniversary of the Pacritinib License Agreement date, provided that such termination would have a lead-in period of six months before it became effective. Additionally, either party may terminate the Pacritinib License Agreement in events of force majeure, or the other party’s uncured material breach or insolvency. In the event of a termination prior to the expiration date, rights in pacritinib would revert to us. We allocated the fixed and determinable Pacritinib License Agreement consideration of $30 million based on the percentage of the relative selling price of each unit of accounting. We estimated the selling price of the license using the income approach which values the license by discounting direct cash flow expected to be generated over the remaining life of the license, net of cash flow adjustments related to working capital. We estimated the selling price of the development services by discounting the estimated development expenditures to the date of arrangement which include internal estimates of personnel needed to perform the development services as well as third-party costs for services and supplies. Of the $30 million consideration, $27.3 million was allocated to the license and $2.7 million was allocated to the development services. Because delivery of the license occurred upon the execution of the Pacritinib License Agreement in November 2013 and the remaining revenue recognition criteria were met, all $27.3 million of the allocated arrangement consideration related to the license was recognized as revenue during the year ended December 31, 2013 . The allocated amount of $2.7 million to the development services was recognized as development service revenue based on a proportional performance method. During the years ended December 31, 2016 , 2015 and 2014 , $1.0 million , $0.8 million , $0.9 million , respectively, of development services was recognized as revenue. There was no deferred revenue relating to the development services remaining in the balance sheet as of December 31, 2016 due to our entry into the Asset Return and Termination Agreement with Baxalta in October 2016 as discussed below. The balance of deferred revenue as of December 31, 2015 was $1.0 million . Concurrently with the execution of the Pacritinib License Agreement, we issued 30,000 shares of Series 19 convertible preferred stock, no par value, or Series 19 Preferred Stock, to Baxter for $30.0 million . Issuance costs related to this transaction were $0.2 million . Each share of Series 19 Preferred Stock was convertible at the option of the holder into shares of common stock and was entitled to a liquidation preference equal to the stated value of $1,000 per share plus any accrued and unpaid dividends before the holders of our common stock or any other junior securities received any payments upon such liquidation. The holder of Series 19 Preferred Stock was not entitled to receive dividends except to share in any dividends actually paid on shares of our common stock or other junior securities and had no voting rights except as otherwise expressly provided in our amended and restated articles of incorporation or as otherwise required by law. During the year ended December 31, 2013 , all 30,000 shares of Series 19 Preferred Stock were converted into 1,567,398 shares of our common stock at a conversion price of $19.14 per share. In August 2014, we received a $20.0 million milestone payment from Baxter in connection with the first treatment dosing of the last patient enrolled in PERSIST-1, which was recorded in license and contract revenue during the year ended December 31, 2014 . In June 2015 , we entered into the Pacritinib License Amendment to the Pacritinib License Agreement. Pursuant to the Pacritinib License Amendment, two potential milestone payments in the aggregate amount of $32.0 million from Baxalta to us were accelerated from the schedule contemplated by the original Pacritinib License Agreement. Refer to the Note 8. Long-term Debt for further details regarding these milestone advances received. During the first quarter of 2016, we achieved these milestones and recorded $32.0 million in license and contract revenue for the year ended December 31, 2016 . During the year ended December 31, 2016 , we recorded $11.4 million of development services revenue relating to reimbursable development costs from Baxalta under the terms of the Pacritinib License Agreement. There was no such revenue recorded during the years ended December 31, 2015 and 2014 . In October 2016 , we entered into the Asset Return and Termination Agreement (the “Termination Agreement”) with Baxalta. Pursuant to the Termination Agreement, the original Pacritinib License Agreement was terminated in its entirety (other than certain customary provisions that survive termination, including those pertaining to confidentiality and indemnification), the original Pacritinib License Agreement has no further force or effect, and all rights and obligations of the Company and Baxalta under the original Pacritinib License Agreement were terminated. In connection with this termination, we recorded a gain of $5.9 million which was included in Other operating expense (income) for the year ended December 31, 2016 . In October 2016 , we resumed primary responsibility for the development and commercialization of pacritinib as a result of the Termination Agreement and will no longer be eligible to receive cost sharing or milestone payments for pacritinib’s development from Baxalta. Servier In September 2014 , we entered into an Exclusive License and Collaboration Agreement, or the Servier Agreement, with Les Laboratoires Servier and Institut de Recherches Internationales Servier, or collectively, Servier. Under the Servier Agreement, we granted Servier an exclusive and sublicensable (subject to certain conditions) royalty-bearing license with respect to the development and commercialization of PIXUVRI for use in pharmaceutical products outside of the CTI Territory (defined below). We retained rights to PIXUVRI in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, the U.K. and the U.S., or collectively, the CTI Territory. In October 2014 , we received a non-refundable, non-creditable cash upfront payment of €14.0 million . Subject to the achievement of certain conditions, we are eligible to receive milestone payments under the Servier Agreement of up to approximately €89.0 million , which is comprised of the following: up to €49.0 million in potential clinical and regulatory milestone payments (of which €9.5 million is payable upon occurrence of certain enrollment events in connection with the post-authorization trial, which we refer to as PIX306, for PIXUVRI); and up to €40.0 million in potential sales-based milestone payments. We have determined that all of the clinical and regulatory milestones are substantive and will be recognized as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. We have also determined that the sales-based milestone payments are contingent consideration and will be recognized as revenue in the period in which the respective revenue recognition criteria are met. Of the foregoing potential milestone payments, we received a €1.5 million (or $1.7 million upon conversion from euros as of the date we received the funds) milestone payment in February 2015 relating to the attainment of reimbursement approval for PIXUVRI in Spain. In December 2016 , we recorded €7.5 million in milestone revenue (or $8.0 million upon conversion from euros as of the date we achieved the milestone) relating to the attainment of a certain enrollment event in connection with our PIX306 study. This was included in Receivable from collaborative arrangement as of December 2016 , and we received the funds in January 2017 . These milestone revenues were accounted for under the milestone method of accounting since this milestone was determined to be substantive at the inception of the arrangement. For a number of years following the first commercial sale of a product containing PIXUVRI in the respective country, regardless of patent expiration or expiration of regulatory exclusivity rights, we are eligible to receive tiered royalty payments ranging from a low double-digit percentage up to a percentage in the mid-twenties based on net sales of PIXUVRI products, subject to certain reductions of up to mid-double-digit percentages under certain circumstances. As previously disclosed, we owe royalties on net sales of PIXUVRI products as well as other payments to certain third parties, including the €2.1 million payment (or $2.7 million using the currency exchange rate as of the date of the Servier Agreement) to Novartis International Pharmaceutical Ltd., or Novartis, which was recorded in Other operating expense (income), net during the year ended December 31, 2014 . Furthermore, in connection with the milestone payments received in February 2015 and January 2017 , we paid $0.3 million and accrued a $0.8 million payment, respectively, to Novartis, which is recorded in Other operating expense (income), net for the years ended December 31, 2015 and December 31, 2016 , respectively. Unless otherwise agreed by the parties, (i) certain development costs incurred pursuant to a development plan and (ii) certain marketing costs incurred pursuant to a marketing plan will be shared equally by the parties, subject to a maximum dollar obligation of each party. We record reimbursements received from Servier as revenue and record the full amount of costs as operating expenses in the statements of operations. The Servier Agreement will expire on a country-by-country basis upon the expiration of the royalty terms in the countries outside of the CTI Territory, at which time all licenses granted to Servier will become perpetual and royalty-free. Each party may terminate the Servier Agreement in the event of an uncured repudiatory breach (as defined under English law) of the other party’s obligations. Servier may terminate the Servier Agreement without cause on a country-by-country basis upon written notice to us within a specified time period or upon written notice within a certain period of days in the event of (i) certain safety or public health issues involving PIXUVRI or (ii) cessation of certain marketing authorizations. In the event of a termination prior to the expiration date, rights granted to Servier will terminate, subject to certain exceptions. Pursuant to accounting guidance under as 605-25, Revenue Recognition – Multiple-Element Arrangements , we identified the following non-contingent deliverables with standalone value at the inception of the Servier Agreement: • a license with respect to the development and commercialization of PIXUVRI in certain countries; and • development services under the development plans. We have determined that our regulatory, commercial, and manufacturing and supply responsibilities, as well as our joint committee obligations also have standalone value, but are insignificant. The license deliverable has standalone value because it is sublicensable and can be used for its intended purpose without the receipt of the remaining deliverables. The service deliverables have standalone value because these services are not proprietary in nature, and other vendors could provide the same services to derive value from the license. Further, there is no general right of return associated with these deliverables. As such, the deliverables meet the criteria for separation and qualify as separate units of accounting. We allocated the arrangement consideration of $18.1 million ( €14.0 million using the currency exchange rate as of the date of the Servier Agreement) based on the percentage of the relative selling price of each unit of accounting as follows (in thousands): License $ 17,277 Development and other services 852 Total upfront payment $ 18,129 We estimated the selling price of the license using the income approach that values the license by discounting direct cash flow expected to be generated over the remaining life of the license, net of cash flow adjustments related to working capital. The estimates and assumptions include, but are not limited to, estimated market opportunity, expected market share, and contractual royalty rates. We estimated the selling price of the development services deliverable, which includes personnel costs as well as third-party costs for applicable services and supplies, by discounting estimated expenditures for services to the date of the Servier Agreement. We concluded that a change in the key assumptions used to determine the best estimate of selling price for the license deliverable would not have a significant effect on the allocation of the arrangement consideration. During the year ended December 31, 2014 , we recognized $17.3 million of the arrangement consideration allocated to the license as revenue since the delivery of the license occurred upon the execution of the Servier Agreement in September 2014 and the remaining revenue recognition criteria were satisfied. The amount allocated to the development and other services is expected to be recognized as revenue through approximately 2022 on a straight-line basis. In February 2016 , we entered into an agreement with one of Servier's affiliates whereby we conduct the pharmacokinetic sub-study on behalf of Servier in conjunction with our ongoing clinical trial, PIX-306. During the year ended December 31, 2016 , $0.5 million of expense reimbursements in relation to this study was included in development services revenue. There was no such revenue during the years ended December 31, 2015 and 2014 . Novartis In January 2014 , we entered into a Termination Agreement, or the Novartis Termination Agreement, with Novartis to reacquire the rights to PIXUVRI and Opaxio, or collectively, the Compounds, previously granted to Novartis under our License and Co-Development Agreement with Novartis, as amended, or the Original Novartis Agreement. Pursuant to the Novartis Termination Agreement, the Original Novartis Agreement was terminated in its entirety, other than certain customary provisions, including those pertaining to confidentiality and indemnification, which survive termination. Under the Novartis Termination Agreement, we agreed not to transfer, license, sublicense or otherwise grant rights with respect to intellectual property of the Compounds unless the transferee/licensee/sublicensee agrees to be bound by the terms of the Novartis Termination Agreement. We also agreed to provide potential payments to Novartis, including a percentage ranging from the low double-digits to the mid-teens, of any consideration received by us or our affiliates in connection with any transfer, license, sublicense or other grant of rights with respect to intellectual property of the Compounds, respectively, provided that such payments would not exceed certain prescribed ceilings in the low-single digit millions. Novartis is entitled to receive potential payments of up to $16.6 million upon the successful achievement of certain sales milestones of the Compounds. Novartis is also eligible to receive tiered low single-digit percentage royalty payments for the first several hundred million in annual net sales, and ten percent royalty payments thereafter based on annual net sales of each Compound, subject to reduction in the event generic drugs are introduced and sold by a third party, causing the sale of the Compounds to fall by a percentage in the high double-digits. Notwithstanding the foregoing, royalty payments for the Compounds are subject to certain minimum floor percentages in the low single-digits. University of Vermont In March 1995, the University of Vermont, or UVM, entered into an agreement, which, as amended in March 2000, grants us an exclusive, sublicensable license for the rights to PIXUVRI, or the UVM Agreement. Pursuant to the UVM Agreement, we acquired the rights to make, have made, sell and use PIXUVRI. We are obligated to make royalty payments to UVM that range from low-single digits to mid-single digits as a percentage of net sales. The higher royalty rate is payable for net sales in countries where specified UVM licensed patents exist, or where we have obtained orphan drug protection, until such UVM patents or such protection no longer exists. For a period of ten years after first commercialization of PIXUVRI, the lower royalty rate is payable for net sales in such countries after expiration of the designated UVM patents or loss of orphan drug protection, and in all other countries without such specified UVM patents or orphan drug protection. Unless otherwise terminated, the term of the UVM Agreement continues for the life of the licensed patents in those countries in which a licensed patent exists, and continues for ten years after the first sale of PIXUVRI in those countries where no such patents exist. We may terminate the UVM Agreement, on a country-by-country basis or on a patent-by-patent basis, at any time upon advance written notice. UVM may terminate the UVM Agreement upon advance written notice in the event royalty payments are not made. In addition, either party may terminate the UVM Agreement (a) in the event of an uncured material breach of the UVM Agreement by the other party; or (b) in the event of bankruptcy of the other party. S*BIO Pte Ltd. We acquired the compounds SB1518 (which is referred to as “pacritinib”) and SB1578, which inhibit JAK2 and FLT3, from S*BIO Pte Ltd., or S*BIO, in May 2012 . Under our agreement with S*BIO, we are required to make milestone payments to S*BIO up to an aggregate amount of $132.5 million if certain U.S., E.U. and Japanese regulatory approvals are obtained or if certain worldwide net sales thresholds are met in connection with any pharmaceutical product containing or comprising any compound that we acquired from S*BIO for use for specific diseases, infections or other conditions. At our election, we may pay up to 50% of any milestone payments to S*BIO through the issuance of shares of our common stock or shares of our preferred stock convertible into our common stock. In addition, S*BIO will also be entitled to receive royalty payments from us at incremental rates in the low single-digits based on certain worldwide net sales thresholds on a product-by-product and country-by-country basis. Chroma In October 2014 , the Chroma License Agreement was terminated in connection with the Chroma APA. See Note 4. Acquisitions - Chroma Asset Purchase Agreement, for further information. Vernalis Concurrently with the termination of the Chroma License Agreement and the execution of the Chroma APA, we also entered into (i) the Vernalis License Agreement for the exclusive worldwide right to use certain patents and other intellectual property rights to develop, market and commercialize tosedostat and certain other compounds and (ii) a deed of novation pursuant to which all rights of Chroma under Chroma’s prior license agreement with Vernalis relating to tosedostat were novated to us. Under the Vernalis License Agreement, we have agreed to make tiered royalty payments of no more than a high single-digit percentage of net sales of products containing licensed compounds, with such obligation to continue on a country-by-country basis for the longer of ten years following commercial launch or the expiry of relevant patent claims. The Vernalis License Agreement will terminate when the royalty obligations expire, although the parties have early termination rights under certain circumstances, including the following: (i) we have the right to terminate, with three months’ notice, upon the belief that the continued development of tosedostat or any of the other licensed compounds is not commercially viable; (ii) Vernalis has the right to terminate in the event of our uncured failure to pay sums due; and (iii) either party has the right to terminate in event of the other party’s uncured material breach or insolvency. Gynecologic Oncology Group We entered into an agreement with the Gynecologic Oncology Group, or GOG, now part of NRG Oncology, in March 2004 , as amended, related to the GOG-212 trial of Opaxio in patients with ovarian cancer, which the GOG is conducting. We recorded a $0.9 million obligation due to the GOG based on the 1,100 patient enrollment milestone achieved in the third quarter of 2013 which was subsequently paid in the first half of 2014. In the first quarter of 2014, we also recorded a $0.3 million obligation to GOG, as required under the agreement, based on the additional 50 patients enrolled, with such amount being paid in April 2014. We may be required to pay up to an additional $1.0 million upon the attainment of certain other milestones, of which $0.5 million has been recorded in accrued expenses as of each of December 31, 2016 and 2015 . PG-TXL In November 1998, we entered into an agreement with PG-TXL, as amended in February 2006, which granted us an exclusive worldwide license for the rights to Opaxio and to all potential uses of PG-TXL’s polymer technology, or the PG-TXL Agreement. Pursuant to the PG-TXL Agreement, we acquired the rights to research, develop, manufacture, market and sell anti-cancer drugs developed using this polymer technology. We were obligated to make payments to PG-TXL upon the achievement of certain development and regulatory milestones of up to $14.4 million . The timing of the remaining milestone payments under the PG-TXL Agreement was based on trial commencements and completions for compounds protected by PG-TXL license rights, and regulatory and marketing approval of those compounds by the FDA and the EMA. Additionally, we were required to make royalty payments to PG-TXL ranging from low-single digits to mid-single digits as a percentage of net sales. Unless otherwise terminated, the term of the PG-TXL Agreement would continue until no royalties were payable to PG-TXL. We were allowed to terminate the PG-TXL Agreement (i) upon advance written notice to PG-TXL in the event issues regarding the safety of the products licensed pursuant to the PG-TXL Agreement arose during development or clinical data obtained revealed a materially adverse tolerability profile for the licensed product in humans or (ii) for any reason upon advance written notice. In addition, either party was allowed to terminate the PG-TXL Agreement (a) upon advance written notice in the event certain license fee payments were not made; (b) in the event of an uncured material breach of the respective material obligations and conditions of the PG-TXL Agreement; or (c) in the event of liquidation or bankruptcy of a party. In February 2017, we terminated our agreement with PG-TXL and the exclusive worldwide license for rights to Opaxio and certain polymer technology under our agreement with PG-TXL. Nerviano Medical Sciences Under a license agreement entered into with Nerviano Medical Sciences, S.r.l. in October 2006, for brostallicin, we were required to pay up to $80.0 million in milestone payments based on the achievement of certain product development results. In April 2015 we terminated our license agreement with Nerviano Medical Sciences, S.r.l. for brostallicin. No milestone payments were made prior to the termination of the license agreement. Teva Pursuant to an acquisition agreement entered into with Cephalon, Inc., or Cephalon, in June 2005, we have the right to receive up to $100.0 million in payments upon achievement of specified sales and development milestones related to TRISENOX. Cephalon was subsequently acquired by Teva Pharmaceutical Industries Ltd., or Teva. During the years ended December 31, 2015 and 2014 , we received $10.0 million and $15.0 million , respectively, from Teva, upon the achievement of worldwide net sales milestones of TRISENOX, which was included in license and contract revenue . We received no milestone payment from Teva during the year ended December 31, 2016 . The achievement of the remaining milestones is uncertain at this time. Other Agreements We have several agreements with contract research organizations, third-party manufacturers, and distributors which have durations of greater than one year for the development and distribution of certain of our compounds. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 13. Share-Based Compensation Share-Based Compensation Expense Share-based compensation expense for all share-based payment awards made to employees and directors is measured based on the grant-date fair value estimated in accordance with generally accepted accounting principles. We recognize share-based compensation using the straight-line, single-award method based on the value of the portion of share-based payment awards that is ultimately expected to vest during the period. Share-based compensation is reduced for estimated forfeitures at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. During the years ended December 31, 2016 , 2015 and 2014 , we recognized share-based compensation expense which consisted of the following types of awards (in thousands): 2016 2015 2014 Performance rights $ 575 $ 3,017 $ 1,549 Restricted stock 4,199 8,656 14,749 Options 8,550 3,155 3,898 Total share-based compensation expense $ 13,324 $ 14,828 $ 20,196 The following table summarizes share-based compensation expense for the years ended December 31, 2016 , 2015 and 2014 , which was allocated as follows (in thousands): 2016 2015 2014 Research and development $ 2,320 $ 3,964 $ 3,437 Selling, general and administrative 11,004 10,864 16,759 Total share-based compensation expense $ 13,324 $ 14,828 $ 20,196 Share-based compensation had a $13.3 million , $14.8 million and $20.2 million effect on our net loss attributable to common shareholders, which resulted in a $(0.48) , $(0.79) and $(1.36) effect on basic and diluted net loss per common share for the years ended December 31, 2016 , 2015 and 2014 , respectively. It had no effect on cash flows from operations or financing activities for the periods presented; however, during the years ended 2016 , 2015 and 2014 , we repurchased 35,000 , 32,000 and 6,000 shares of our common stock totaling $0.4 million , $0.6 million and $0.2 million , respectively, for cash in connection with the vesting of employee restricted stock awards based on taxes owed by employees upon vesting of the awards. As of December 31, 2016 , unrecognized compensation cost related to unvested stock options and restricted stock awards and restricted stock units amounted to $5.9 million , which will be recognized over the remaining weighted-average requisite service period of 1.87 years . The unrecognized compensation cost related to unvested options and restricted stock does not include the value of performance-based awards. For the years ended December 31, 2016 , 2015 and 2014 , no tax benefits were attributed to the share-based compensation expense because a valuation allowance was maintained for all net deferred tax assets. Stock Plans In September 2015 , the Company's 2015 Equity Incentive Plan, or the 2015 Plan, was approved by the Company's shareholders and no additional awards will be granted under the 2007 Equity Incentive Plan, as amended and restated, or the 2007 Plan. In addition, the Company's 2007 Employee Stock Purchase Plan, as amended and restated in August 2009 and September 2015, or the Purchase Plan, was amended in September 2015 to increase the maximum number of shares of the Company’s common stock authorized for issuance by 0.2 million shares. Refer to Employee Stock Purchase Plan below for further details regarding the Purchase Plan. Pursuant to our 2015 Plan, we may grant the following types of incentive awards: (1) stock options, including incentive stock options and non-qualified stock options, (2) stock appreciation rights, (3) restricted stock, (4) restricted stock units and (5) cash awards. The 2015 Plan is administered by the Compensation Committee of our Board of Directors, which has the discretion to determine the employees and consultants who shall be granted incentive awards. The Board retained sole authority under the 2015 Plan with respect to non-employee directors’ awards, although the Compensation Committee has authority under its charter to make recommendations to the Board concerning such awards. Options expire 10 years from the date of grant, subject to the recipients continued service to the Company. As of December 31, 2016 , 6.3 million shares were authorized for issuance, of which 1.1 million shares of common stock were available for future grants, under the 2015 Plan. Stock Options Fair value for stock options was estimated at the date of grant using the Black-Scholes pricing model, with the following weighted average assumptions: Year Ended December 31, 2016 2015 2014 Risk-free interest rate 1.2 % 1.7 % 1.7 % Expected dividend yield None None None Expected life (in years) 4.0 5.3 5.2 Volatility 75 % 80 % 97 % The risk-free interest rate used in the Black-Scholes valuation method is based on the implied yield currently available for U.S. Treasury securities at maturity with an equivalent term. We have not declared or paid any dividends on our common stock and do not currently expect to do so in the future. The expected term of options represents the period that our options are expected to be outstanding and was determined based on historical weighted average holding periods and projected holding periods for the remaining unexercised options. Consideration was given to the contractual terms of our options, vesting schedules and expectations of future employee behavior. Expected volatility is based on the annualized daily historical volatility, including consideration of the implied volatility and market prices of traded options for comparable entities within our industry. Our stock price volatility and option lives involve management’s best estimates, both of which impact the fair value of options calculated under the Black-Scholes methodology and, ultimately, the expense that will be recognized over the life of the option. As we also recognize compensation expense for only the portion of options expected to vest, we apply estimated forfeiture rates that we derive from historical employee termination behavior. If the actual number of forfeitures differs from our estimates, additional adjustments to compensation expense may be required in future periods. The following table summarizes stock option activity for all of our stock option plans: Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (Thousands) Outstanding at December 31, 2013 (156,000 exercisable) 452,000 $ 30.40 Granted 102,000 $ 34.85 Exercised (18,000 ) $ 14.89 Forfeited (36,000 ) $ 22.53 Cancelled and expired (8,000 ) $ 98.63 Outstanding at December 31, 2014 (317,400 exercisable) 492,000 $ 31.39 Granted 1,149,000 $ 13.94 Exercised (8,000 ) $ 13.98 Forfeited (62,000 ) $ 21.70 Cancelled and expired (12,000 ) $ 242.92 Outstanding at December 31, 2015 (436,100 exercisable) 1,559,000 $ 17.45 Granted 1,511,000 $ 6.43 Exercised — $ — Forfeited (128,000 ) $ 9.07 Cancelled and expired (136,000 ) $ 25.58 Outstanding at December 31, 2016 2,806,000 $ 11.50 5.3 $ 153 Vested or expected to vest at December 31, 2016 2,749,000 $ 11.58 5.3 $ 153 Exercisable at December 31, 2016 1,913,000 $ 12.58 3.6 $ 151 The weighted average exercise price of options exercisable at December 31, 2016 , 2015 and 2014 was $12.58 , $25.71 and $34.18 , respectively. The weighted average grant-date fair value of options granted during 2016 , 2015 and 2014 was $3.01 , $9.17 and $25.90 per option, respectively. Restricted Stock We issued 0.3 million , 0.6 million and 0.4 million shares of restricted stock awards in 2016 , 2015 and 2014 , respectively. The weighted average grant-date fair value of restricted stock awards issued during 2016 , 2015 and 2014 was $5.64 , $20.61 and $32.29 , respectively. Additionally, 0.1 million , 0.2 million and 30,000 shares of restricted stock awards were cancelled during 2016 , 2015 and 2014 , respectively. The total fair value of restricted stock awards vested during the years ended December 31, 2016 , 2015 and 2014 was $1.3 million , $7.3 million and $18.0 million , respectively. A summary of the status of nonvested restricted stock awards as of December 31, 2016 and changes during the period then ended, is presented below: Nonvested Shares Weighted Average Grant-Date Fair Value Per Share Nonvested at December 31, 2015 267,000 $ 22.39 Issued 270,000 $ 5.64 Vested (257,000 ) $ 15.02 Forfeited (97,000 ) $ 13.38 Nonvested at December 31, 2016 183,000 $ 12.76 We issued 0.2 million and 46,000 restricted stock units during 2016 and 2015 , respectively, and cancelled 13,000 restricted stock units during 2015 . No restricted stock units were cancelled during 2016 . The weighted average grant-date fair value of restricted stock units issued during 2016 and 2015 was $5.35 and $15.70 , respectively. There were no restricted stock units issued or cancelled during 2014 . The total fair value of restricted stock units vested during the year ended December 31, 2016 was $0.2 million . No restricted stock units vested during the year ended December 31, 2015 and 2014 . A summary of the status of nonvested restricted stock units as of December 31, 2016 and changes during the period then ended, is presented below: Nonvested Units Weighted Average Nonvested at December 31, 2015 33,000 $ 15.70 Issued 187,000 $ 5.35 Vested (33,000 ) $ 15.70 Forfeited — $ — Nonvested at December 31, 2016 187,000 $ 5.35 Long-Term Performance Awards In November 2011, we granted restricted stock units to our executive officers and directors that became effective on January 3, 2012, or the Long-Term Performance Awards. The Long-Term Performance Awards vest upon achievement of milestone-based performance conditions. There were eight such performance conditions, one of which is a market-based performance condition. If one or more of the underlying performance-based conditions were timely achieved, the award recipient would be entitled to receive a number of shares of our common stock (subject to share limits of the 2007 Plan or 2015 Plan, as applicable), determined by multiplying (i) the award percentage corresponding to that particular performance goal by (ii) the total number of outstanding shares of our common stock as of the date that the particular performance goal is achieved. In March 2013 , certain performance criteria of the Long-Term Performance Awards were modified, two new performance-based awards were granted, one performance-based award was cancelled, and the expiration date was extended to December 31, 2015 . In January 2014 , the expiration date of the Long-Term Performance Awards was further extended to December 31, 2016 , and two new performance-based awards were granted. In September 2015 , one of the performance conditions was achieved as discussed below. In September 2015, our Board of Directors certified completion of the performance condition relating to Pacritinib Phase III trial result that satisfies the primary point set forth in the statistical plan then in effect and an aggregate of 0.2 million shares vested to our executive officers and directors. We recognized $2.8 million in share-based compensation upon satisfaction of this performance condition during the year ended December 31, 2015 . In December 2015 , the Long-Term Performance Awards were modified so that as to any particular performance goal that is achieved after December 23, 2015 and on or before December 31, 2016 , the executive officers would be granted a stock option with respect to the number of shares determined under the formula described above (as opposed to receiving or retaining such number of fully-vested shares of our common stock). Each option had an exercise price equal to the closing price of the Company’s common stock on the grant date (which would be the date the Compensation Committee of our Board of Directors certifies the performance goal is achieved) and would be scheduled to vest in semi-annual installments over a period of three years following the grant date. On December 31, 2016, the Long-Term Performance Awards expired. The fair value of the Long-Term Performance Awards was estimated based on the average present value of the awards to be issued upon achievement of the performance conditions. The average present value was calculated based upon the expected date the shares of common stock underlying the performance awards will vest, or the event date, the expected stock price on the event date, and the expected shares outstanding as of the event date. The event date, stock price and the shares outstanding were estimated using a Monte Carlo simulation model, which is based on assumptions by management, including the likelihood of achieving the milestones and potential future financings. We determined the Long-Term Performance Awards with a market-based performance condition had a grant-date fair value of $3.6 million for the executive officers and director participants. We determined that the market-based performance condition had an incremental fair value of $0.8 million on the first modification date in March 2013 and an additional incremental fair value of $1.8 million on the second modification date in January 2014 for the executive officers and director participants, which were recognized in addition to the unrecognized grant-date fair value as of the modification date over the remaining estimated requisite service period. The December 2015 modification discussed above did not result in incremental fair value. In December 2015, we reversed the total share-based compensation expense of $1.0 million , which was previously recorded for awards granted to directors who agreed to forfeit their Long-Term Performance Awards as part of the derivative lawsuit settlement. See Note 19. Legal Proceedings for further information. We recognized $0.6 million , $0.3 million and $1.4 million in share-based compensation expense related to the performance awards with a market-based performance condition during the years ended December 31, 2016 , 2015 and 2014 , respectively. Nonemployee Share-Based Compensation Share-based compensation expense for awards granted to nonemployees is determined using the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. The fair value of options and restricted stock awards granted to nonemployees is periodically remeasured as the underlying options or awards vest. The value of the instrument is amortized to expense over the vesting period with final valuation measured on the vesting date. As of December 31, 2014 , unvested nonemployee options to acquire approximately 7,800 shares of common stock were outstanding. Additionally, unvested nonemployee restricted stock awards totaled approximately 2,100 as of December 31, 2014 . As of December 31, 2015 , all nonemployee options and restricted stock awards had vested, and no compensation expense related to nonemployee options and restricted stock was recorded during the year-ended December 31, 2015 . As of December 31, 2016 , due to issuance of nonemployee options during 2016, unvested options to acquire approximately 11,000 shares of common stock were outstanding. We recorded compensation expense related to nonemployee options and restricted stock of $16,000 and $0.3 million in 2016 and 2014 , respectively. Employee Stock Purchase Plan Under the Purchase Plan, eligible employees may purchase a limited number of shares of our common stock at 85% of the lower of the subscription date fair market value and the purchase date fair market value. There are two six-month offerings per year. Under the Purchase Plan, we issued approximately 10,000 , 700 and 400 shares of our common stock to employees in the years ended December 31, 2016 , 2015 and 2014 , respectively. There are 0.2 million shares of common stock authorized under the Purchase Plan and approximately 0.2 million shares are reserved for future purchases as of December 31, 2016 . |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2016 | |
Compensation and Retirement Disclosure [Abstract] | |
Employee Benefit Plans | 14. Employee Benefit Plans Our U.S. employees participate in the CTI BioPharma Corp. 401(k) Plan whereby eligible employees may defer up to 80% of their compensation, up to the annual maximum allowed by the Internal Revenue Service. We may make discretionary matching contributions based on certain plan provisions. We recorded $0.2 million related to discretionary matching contributions during each of the years ended December 31, 2016 , 2015 and 2014 . |
Shareholder Rights Plan
Shareholder Rights Plan | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Shareholder Rights Plan | 15. Shareholder Rights Plan In December 2009, our Board of Directors approved and adopted a shareholder rights plan, or Rights Plan, in which one preferred stock purchase right was distributed for each common share held as of the close of business on January 7, 2010. Initially, the rights are not exercisable, and are attached to and trade with, all of the shares of CTI’s common stock outstanding as of, and issued subsequent to January 7, 2010. In 2012 and 2015, our Board of Directors approved certain amendments to the Rights Plan. The Rights Plan will expire on December 2, 2018 . Each right, if and when it becomes exercisable, will entitle the holder to purchase a unit consisting of ten ten-thousandth of a share of Series ZZ Junior Participating Cumulative Preferred Stock, no par value per share, at a cash exercise price of $80.00 per unit, subject to standard adjustment in the Rights Plan. The rights will separate from the common stock and become exercisable if a person or group acquires 20% or more of our common stock. Upon acquisition of 20% or more of our common stock, the Board could decide that each right (except those held by a 20% shareholder, which become null and void) would become exercisable entitling the holder to receive upon exercise, in lieu of a number of units of preferred stock, that number of shares of our common stock having a market value of two times the exercise price of the right. In certain circumstances, including if there are insufficient shares of our common stock to permit the exercise in full of the rights, the holder may receive units of preferred stock, other securities, cash or property, or any combination of the foregoing. In addition, if we are acquired in a merger or other business combination transaction, each holder of a right, except those rights held by a 20% shareholder which become null and void, would have the right to receive, upon exercise, common stock of the acquiring company having a market value equal to two times the exercise price of the right. The Board may redeem the rights for $0.001 per right or terminate the Rights Plan at any time prior to an acquisition by a person or group holding 20% or more of our common stock. |
Customer and Geographic Concent
Customer and Geographic Concentrations | 12 Months Ended |
Dec. 31, 2016 | |
Segment Reporting [Abstract] | |
Customer and Geographic Concentrations | 16. Customer and Geographic Concentrations We consider our operations to be a single operating segment focused on the development, acquisition and commercialization of novel treatments for cancer. Financial results of this reportable segment are presented in the accompanying consolidated financial statements. All sales of PIXUVRI during the years presented were in Europe. Product sales from PIXUVRI’s major customers as a percentage of total product sales were as follows: Year Ended December 31, 2016 2015 2014 Customer A 60 % 42 % 27 % Customer B 27 % 41 % 57 % The following table depicts long-lived assets based on the following geographic locations (in thousands): Year Ended December 31, 2016 2015 United States $ 2,990 $ 3,657 Europe 33 61 Total long-lived assets $ 3,023 $ 3,718 |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 17. Net Loss Per Share The numerator for both basic and diluted loss per share, or EPS, is net loss. The denominator for basic EPS (referred to as basic shares) is the weighted average number of common shares outstanding during the period, whereas the denominator for diluted EPS (referred to as diluted shares) also takes into account the dilutive effect of outstanding stock options and restricted stock awards using the treasury stock method. Basic and diluted shares for the years ended December 31, 2016 , 2015 and 2014 are as follows (in thousands, except per share amounts): Year Ended December 31, 2016 2015 2014 Net loss attributable to common shareholders $ (52,009 ) $ (122,622 ) $ (95,992 ) Basic and diluted: Weighted average shares outstanding 28,198 19,324 15,347 Less weighted average restricted shares outstanding (250 ) (487 ) (494 ) Shares used in calculation of basic and diluted net loss per common share 27,948 18,837 14,853 Net loss per common share: Basic and diluted $ (1.86 ) $ (6.51 ) $ (6.46 ) Equity awards, warrants, and unvested share rights aggregating 2.7 million shares, 1.5 million shares and 1.5 million shares for the year ended December 31, 2016 , 2015 and 2014 , respectively, prior to the application of the treasury stock method, are excluded from the calculation of diluted EPS because they are anti-dilutive. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2016 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 18. Related Party Transactions Aequus In May 2007 , we formed Aequus, a majority-owned subsidiary of which our ownership was approximately 60% as of December 31, 2016 . We entered into a license agreement with Aequus whereby Aequus gained rights to our Genetic Polymer™ technology which Aequus continues to develop. The Genetic Polymer technology may speed the manufacture, development, and commercialization of follow-on and novel protein-based therapeutics. In May 2007 , we also entered into an agreement to fund Aequus in exchange for a convertible promissory note. The terms of the note provide that (i) interest accrues at a rate of 6% per annum until maturity, (ii) in the event the note balance is not paid on or before the maturity date, interest accrues at a rate of 10% per annum and (iii) prior to maturity, the note is convertible into a number of shares of Aequus equity securities equal to the quotient obtained by dividing (a) the outstanding balance of the note by (b) the price per share of the Aequus equity securities. While the original note matured and was due and payable in May 2012 , in June 2015 we and Aequus entered into an amendment to the note pursuant to which the maturity date was extended to June 30, 2016. We are currently in negotiation with Aequus to, among other things, terminate the note. In addition, we entered into a services agreement to provide certain administrative and research and development services to Aequus. The amounts charged for these services, if unpaid by Aequus within 30 days , will be considered additional principal advanced under the promissory note. We funded Aequus $1.8 million , $2.3 million and $2.0 million during the years ended December 31, 2016 , 2015 and 2014, respectively, including amounts advanced in association with the services agreement. The Aequus note balance, including accrued interest, was approximately $13.5 million and $11.0 million as of December 31, 2016 and 2015, respectively. This intercompany balance was eliminated in consolidation. James A. Bianco, M.D., a member of our Board of Directors, and Jack W. Singer, M.D., our Executive Vice President, Chief Scientific Officer, Interim Chief Medical Officer, and Global Head of Translational Medicine, are both minority shareholders of Aequus, each owning approximately 4.3% of the equity in Aequus as of December 31, 2016 . Richard Love, our Interim President and Chief Executive Officer, and Dr. Singer are members of Aequus’ Board of Directors. Dr. Bianco resigned from Aequus' Board of Directors in December 2016. Additionally, Frederick W. Telling, Ph.D., a member of our Board of Directors, owns approximately 3.8% of Aequus as of December 31, 2016 . BVF Partners L.P. In September 2015 , as discussed in Note 10. Common Stock , we entered into a subscription agreement with BVF pursuant to which we issued 1.0 million shares of our common stock. Further, in December 2015 , as discussed in Note 9. Preferred Stock , we completed an underwritten public offering of 55,000 shares of our Series N-2 Preferred Stock, no par value per share. BVF purchased 30,000 shares of our Series N-2 Preferred Stock in such offering, which were converted into approximately 2.7 million shares of our common stock. Primarily as a result of these transactions, BVF beneficially owned approximately 15.9% and 15.6% of our outstanding common stock as of December 31, 2016 and 2015 , respectively. In connection with the Series N-2 Preferred Stock offering, we entered into a letter agreement with BVF, or the Letter Agreement, pursuant to which we granted BVF a one-time right, subject to certain conditions, to nominate not more than two individuals to serve as members of our Board, subject to the Board’s consent, which is not to be unreasonably withheld and which consent shall be deemed automatically given with respect to two individuals specified in such Letter Agreement. One of such nominees (the “Independent Nominee”) must (i) qualify as an “independent” director as defined under the applicable rules and regulations of the U.S. Securities and Exchange Commission, or the SEC, and NASDAQ and (ii) must not be considered an “affiliate” of BVF as such term is defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act. We have agreed, for the period hereinafter described and subject to a limited exception, to include the nominated directors in the slate of nominees for election to the Board at each annual or special meeting at which directors are to be elected, recommend that shareholders vote in favor of the election of such nominees and support such nominees for election in a manner no less favorable than how we support our own nominees. This obligation will terminate with respect to: (x) the Independent Nominee, and such Independent Nominee must tender his or her resignation to the Board, if requested, promptly upon BVF ceasing to beneficially own at least 11% of the issued and outstanding common stock or voting power of the Company (determined on an as-converted basis that gives effect to the conversion of all outstanding preferred stock), and (y) each of the Independent Nominee and the other individual nominated by BVF, and each such nominee shall tender his or her resignation to the Board promptly upon the earlier to occur of (a) BVF and its affiliates ceasing to beneficially own at least 5% of the issued and outstanding common stock or voting power of the Company (determined on an as-converted basis that gives effect to the conversion of all outstanding preferred stock), (b) BVF ceasing to beneficially own at least 50% of the shares of the common stock beneficially owned by BVF immediately after consummation of the Series N-2 Preferred Stock offering (on an as-converted basis), (c) the continuation of such nomination right would cause any violation of the applicable listing rules of NASDAQ, (d) such time as BVF informs us in writing that it wishes to terminate the foregoing nomination right, or (e) any breach of the Letter Agreement by BVF. |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | 19. Legal Proceedings In April 2009, December 2009 and June 2010, 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 outcome of these cases. Following is a summary of the status of the legal proceedings surrounding each respective VAT year return at issue: 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 appealed such decision to the Italian Supreme Court both on procedural grounds and on the merits of the case. In March 2014 , we paid a deposit in respect of the 2013 VAT matter of €0.4 million (or $0.6 million upon conversion from euros as of the date of payment), following the ITA's request for such payment. 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 decision of the Italian Supreme Court is unfavorable to us, or if, in the interim, the ITA were to make a demand for payment and we were to be unsuccessful in suspending collection efforts, we may be requested to pay the ITA an amount up to €9.4 million , or approximately $9.9 million converted using the currency exchange rate as of December 31, 2016 , plus collection fees, notification expenses and additional interest for the period lapsed between the dates in which the assessments were issued and the date of effective payment. In January 2013, our then remaining deposit for the VAT Assessments was refunded to us. 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 our 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 (or 475,613 shares adjusted for the 1-for-10 reverse stock split effective January 1, 2017) 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 our 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. On May 13, 2015, the Company (as nominal defendant) and our directors (as individual defendants) entered into a memorandum of understanding to settle the pending lawsuit 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, or the Settlement. On December 10, 2015 , the court issued an order granting final approval to the Settlement. The provisions of the Settlement include the following terms: • We will cancel, and the non-employee directors will agree to, the rescission of all currently outstanding equity awards that we previously granted to non-employee directors that included performance-based vesting metrics and as to which the performance goals remained unsatisfied as of May 13, 2015; • Our current non-employee directors will agree to hold (not transfer or sell or encumber in any way) until September 14, 2015 shares of our stock that they currently own and that we awarded to them during 2011, or at any time after 2011 to the present, and that, at the time of the award by us, was fully-vested and unrestricted; • We will cap the total annual compensation provided by it to its non-employee directors for each of 2015 and 2016. Such annual compensation cap for each non-employee director for each of 2015 and 2016 will be at the greater of (i) $375,000 , plus, as to our Board Chairman, an additional $100,000 , or (ii) the 75th percentile of compensation paid by a group of peer companies to their non-employee directors (and, in the case of our Chairman, the 75th percentile of compensation paid by such peers who have a non-employee director chair of their respective board of directors to such non-employee director chairs). The peer group for these purposes will be selected based on advice from the outside compensation consultant. For purposes of the compensation cap and the peer group comparison, compensation will be determined and measured consistent with the rules under Item 402 of Regulation S-K under the Securities Exchange Act of 1934, as amended, and based on publicly-available information at the applicable time ; and • We will implement, if not already implemented, within 90 days following final approval of the Settlement by the court, and maintain until at least the end of calendar year 2017 the following: an annual board discussion of non-employee director compensation philosophy; the use of a compensation consultant to advise the Compensation Committee on material decisions concerning non-employee director compensation issues and compare our non-employee director compensation program to a group of our peers; the use of plain language in our compensation-related public filings; and obtain confirmation from our legal department and outside legal counsel advising on executive compensation matters that any contemplated non-employee director awards do not materially violate the applicable plan or materially fail to comply with applicable law. In connection with the Settlement, we accrued $0.3 million in attorneys’ fees awarded to plaintiffs (net of existing insurance coverage) in our financial statements for the year-ended December 31, 2015 , which was paid in 2016 . We are also in the process of providing documents in response to a subpoena received from the SEC in January 2016. The SEC's subpoena requests, among other things; internal and external communications related to pacritinib Phase 3 trials, including communications with the independent data monitoring committee, or IDMC, for pacritinib's Phase 3 trials, our steering committee, our board of directors, our audit committee, representatives of Baxter and Baxalta, and the FDA, and other documents related to pacritinib. We believe that the SEC is seeking to determine whether there have been possible violations of the antifraud and certain other provisions of the federal securities laws related to the Company's disclosures concerning, among other things, the clinical test results of pacritinib. The SEC Staff's letter sent with the subpoena stated that the investigation is a fact-finding inquiry, and the investigation and subpoena do not mean that the SEC has concluded that we or anyone else has violated any law. We are cooperating with this investigation. On February 10, 2016 and February 12, 2016, class action lawsuits entitled Ahrens v. CTI BioPharma Corp. et al., Case No. 1:16-cv-01044 and McGlothlin v. CTI BioPharma Corp. et al., Case No. C16-216, respectively, were filed in the United States District Court for the Southern District of New York and the United States District Court for the Western District of Washington, respectively, on behalf of shareholders that purchased or acquired the Company’s securities pursuant to our September 24, 2015 public offering and/or shareholders who otherwise acquired our stock between March 4, 2014 and February 9, 2016, inclusive. The complaints assert claims against the Company and certain of our current and former directors and officers for violations of the federal securities laws under Sections 11 and 15 of the Securities Act of 1933, as amended, or the Securities Act, and Sections 10 and 20 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, Plaintiffs’ Securities Act claims allege that the Company’s Registration Statement and Prospectus for the September 24, 2015 public offering contained materially false and misleading statements and failed to disclose certain material adverse facts about the Company’s business, operations and prospects, including with respect to the clinical trials and prospects for pacritinib. Plaintiffs’ Exchange Act claims allege that the Company’s public disclosures were knowingly or recklessly false and misleading or omitted material adverse facts, again with a primary focus on the clinical trials and prospects for pacritinib. On May 2, 2016, the Company filed a motion to transfer the Ahrens case to the United States District Court for the Western District of Washington. The motion was unopposed and granted by the court on May 19, 2016. On June 3, 2016, the parties filed a joint motion to consolidate the McGlothlin case with the Ahrens case in order to proceed as a single consolidated proceeding. On June 13, 2016, the court granted the motion to consolidate with the action being captioned In re CTI BioPharma Corp. Securities Litigation, Master File No. 2:16-cv-00216-RSL. On September 2, 2016, the court appointed Lead Plaintiffs and Lead Counsel. On September 28, 2016, the court entered a scheduling order, as revised by order entered December 8, 2016, setting November 8, 2016 as the deadline to file a consolidated class action complaint and deadlines for briefing defendants’ motion to dismiss. Briefing concluded on February 22, 2017. A hearing on the defendants' motion to dismiss has not been set. The consolidated class action complaint asserts claims similar to those asserted in the initial complaints, although it no longer asserts claims relating to the September 24, 2015 public offering, but adds claims relating to the Company’s October 27, 2015 and December 4, 2015 public offerings. The lawsuit seeks damages in an unspecified amount. We believe that the allegations contained in the complaints are without merit and intend to vigorously defend ourselves against all claims asserted therein. A reasonable estimate of the amount of any possible loss or range of loss cannot be made at this time and, as such, we have not recorded an accrual for any possible loss. On March 14, 2016, a Company shareholder filed a derivative lawsuit on behalf of the Company seeking damages for alleged harm to the Company caused by certain current and former officers and directors. The suit, Wei v. James A. Bianco, et al., 16-2-05818-3, was filed in King County Superior Court, Washington, and names as individual defendants James A. Bianco, Louis A. Bianco, Jack W. Singer, Bruce J. Seeley, John H. Bauer, Phillip M. Nudelman, Reed V. Tuckson, Karen Ignagni, Richard L. Love, Mary O. Mundinger and Frederick W. Telling. Consistent with the requirements of a derivative action, the Company is named as a nominal defendant against which no monetary relief is sought. The complaint alleges four claims: (1) breach of fiduciary duty; (2) abuse of control; (3) gross mismanagement; and (4) unjust enrichment (receiving compensation that was unjust in light of the alleged conduct). Each is based on the assertion that the Company made materially false and misleading statements and omitted material information from its disclosures about pacritinib and its safety. Plaintiff did not make a pre-suit demand on the current Board to investigate whether to pursue claims against officers or directors, instead claiming demand is excused because the named defendants lack independence, are not disinterested because they lack impartiality, received and want to continue to receive their compensation, have longstanding personal and business relationships, and cannot evaluate a demand since they are facing personal liability. Plaintiff has requested the court to award the Company the damages allegedly sustained as a result of the conduct and to direct the Company and the individual defendants to reform and improve the Company’s corporate governance to avoid future damages. We understand that the individuals named as defendants believe the allegations contained in the complaint lack merit and plan to vigorously defend themselves against all claims asserted therein. A reasonable estimate of the amount of any possible loss or range of loss cannot be made at this time and, as such, we have not recorded an accrual for any possible loss. On May 24, 2016, two CTI shareholders filed a derivative lawsuit in the name of the Company seeking damages for alleged harm to the Company caused by officers and directors. The suit, Nahar v. James A. Bianco, et al., Case 2:16-cv-00756, was filed in the United States District Court for the Western District of Washington and names certain officers and directors as defendants. Consistent with the requirements of a derivative action, the Company is named as a nominal defendant. The complaint alleges three claims: 1) breach of fiduciary duty; 2) waste of corporate assets; and 3) gross mismanagement. Each is based on the assertion that the Company made materially false and misleading statements and omitted material information from its disclosures about pacritinib and its safety. Plaintiff did not make pre-suit demand on the current Board to investigate whether to pursue claims against officers or directors, instead claiming demand is excused because a majority of the current Board is predisposed to refuse demand because they lack independence and are not disinterested, have already determined that the allegations lack merit and are facing personal liability. Plaintiffs have requested the court determine and award the Company the damages sustained and to be sustained as a result of the alleged conduct, and directing the Company to reform its corporate governance and internal procedures to comply with applicable laws and protect the Company and its shareholders from reoccurrence of the alleged wrongful conduct. On July 14, 2016, the parties filed a stipulated motion to stay the case pending a resolution of the defendants’ motion to dismiss to be filed in In re CTI BioPharma Corp. Securities Litigation. On August 4, 2016, the court granted the motion to stay. We understand that the individuals named as defendants believe the allegations contained in the complaint lack merit and plan to vigorously defend themselves against all claims asserted therein. A reasonable estimate of the amount of any possible loss or range of loss cannot be made at this time and, as such, we have not recorded an accrual for any possible loss. On June 16, 2016 a CTI shareholder filed a derivative lawsuit in the name of the Company seeking damages for alleged harm to the Company caused by officers and directors. The suit, England v. James A. Bianco, et al., 16-2-14422-5, was filed in King County Superior Court and names certain officers and directors as defendants. Consistent with the requirements of a derivative action, the Company is named as a nominal defendant. The complaint alleges four claims: 1) breach of fiduciary duty; 2) abuse of control; 3) gross mismanagement; and 4) unjust enrichment (receiving compensation that was unjust in light of the alleged conduct). Each is based on the assertion that the Company made materially false and misleading statements and omitted material information from its disclosures about pacritinib and its safety. Plaintiff did not make pre-suit demand on the current Board to investigate whether to pursue claims against officers or directors, instead claiming demand is excused because the named defendants lack independence and are not disinterested because they lack impartiality, received and want to continue to receive their compensation, have longstanding personal and business relationships and cannot evaluate a demand since they are facing personal liability. Plaintiff has requested the court determine and award the Company the damages sustained as a result of the alleged conduct, and directing the Company and the individual defendants reform and improve its corporate governance to avoid future damages. On August 25, 2016, the plaintiff in Wei v. James A. Bianco jointly moved with the plaintiff in England v. James A. Bianco to consolidate and stay the cases pending a resolution of the defendants’ motion to dismiss in In re CTI BioPharma Corp. Securities Litigation. On September 2, 2016, the court granted the motion to consolidate and stay the cases. We understand that the individuals named as defendants believe the allegations contained in the complaint lack merit and plan to vigorously defend themselves against all claims asserted therein. A reasonable estimate of the amount of any possible loss or range of loss cannot be made at this time and, as such, we have not recorded an accrual for any possible loss. On August 9, 2016, a CTI shareholder filed a derivative lawsuit in the name of the Company seeking damages for alleged harm to the Company caused by officers and directors. The suit, Hill v. James A. Bianco, et al., 2:16-cv-1250, was filed in the United States District Court for the Western District of Washington and names certain officers and directors as defendants. Consistent with the requirements of a derivative action, the Company is named as a nominal defendant. The complaint alleges three claims: 1) Breach of Fiduciary Duty; 2) Gross Mismanagement; and 3) Unjust Enrichment (receiving compensation that was unjust in light of the alleged conduct). Each is based on the assertion that the Company made materially false and misleading statements and omitted material information from its disclosures about pacritinib and its safety. Plaintiff did not make pre-suit demand on the current Board to investigate whether to pursue claims against officers or directors, instead claiming demand is excused because the named defendants lack independence and are not disinterested because they lack impartiality, received and want to continue to receive their compensation, have longstanding personal and business relationships and cannot evaluate a demand since they are facing personal liability. Plaintiff has requested the court determine and award the Company the damages sustained as a result of the alleged conduct, and directing the Company and the individual defendants reform and improve its corporate governance to avoid future damages. On November 4, 2016, the plaintiff in Nahar v. James A. Bianco jointly moved with the plaintiff in Hill v. James A. Bianco to consolidate and stay the cases pending a resolution of the defendants’ motion to dismiss in In re CTI BioPharma Corp. Securities Litigation. On November 8, 2016, the court granted the motion to consolidate and stay the cases. We understand that the individuals named as defendants believe the allegations contained in the complaint lack merit and plan to vigorously defend themselves against all claims asserted therein. A reasonable estimate of the amount of any possible loss or range of loss cannot be made at this time and, as such, we have not recorded an accrual for any possible loss. In addition to the items discussed above, we are from time to time subject to legal proceedings and claims arising in the ordinary course of business. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 20. Income Taxes We file income tax returns in the United States, Italy and the U.K. A substantial part of our operations takes place in the State of Washington, which does not impose an income tax as that term is defined in ASC 740, Accounting for Income Taxes. As such, our state income tax expense or benefit, if recognized, would be immaterial to our operations. We are not currently under examination by an income tax authority, nor have we been notified that an examination is contemplated. Loss before income taxes is attributable to the following tax jurisdictions (in thousands): 2016 2015 2014 United States $ (51,856 ) $ (110,831 ) $ (84,883 ) Foreign (1,097 ) (9,932 ) (9,346 ) Net loss before income taxes $ (52,953 ) $ (120,763 ) $ (94,229 ) The reconciliation between our effective tax rate and the income tax rate as of December 31, 2016 , 2015 and 2014 is as follows: 2016 2015 2014 Federal income tax rate 34 % 34 % 34 % Research and development tax credits 1 3 3 Non-deductible executive compensation — (1 ) (3 ) Valuation allowance (33 ) (32 ) (30 ) Foreign tax rate differential — (3 ) (3 ) Other (2 ) (1 ) (1 ) Net effective tax rate — % — % — % The principal components of our deferred tax assets and liabilities as of December 31, 2016 and 2015 were as follows (in thousands): December 31, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ 108,372 $ 94,024 Capitalized research and development 43,768 39,537 Research and development tax credit carryforwards 7,253 6,685 Stock-based compensation 19,288 15,242 Intangible assets 14,525 15,694 Depreciation and amortization 626 260 Other deferred tax assets 3,721 3,180 Total deferred tax assets 197,553 174,622 Less: valuation allowance (197,131 ) (173,947 ) 422 675 Deferred tax liabilities: GAAP adjustments on Novuspharma merger — (208 ) Deductions for tax in excess of financial statements (422 ) (467 ) Total deferred tax liabilities (422 ) (675 ) Net deferred tax assets $ — $ — As of December 31, 2016 and 2015 , we had U.S. federal net operating loss carryforwards, or the NOL, of approximately $305.4 million and $276.4 million respectively, which are available to reduce future taxable income. We also had U.S. federal tax credits of $7.3 million and $6.7 million as of December 31, 2016 and 2015 , respectively, which may be used to offset future tax liabilities. The NOL and tax credit carryforwards will begin to expire in 2018 and may become subject to annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the IRC of 1986. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or future tax liabilities. We have undertaken a formal IRC Section 382 study and the attributes disclosed in this footnote reflect the conclusion of that study. However, subsequent ownership changes may further affect the limitation in future years. At December 31, 2016 , the NOL carryforwards in the U.K. were approximately $26.7 million , which have an indefinite carryforward period. We maintain a full valuation allowance on our net deferred tax assets. The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In our valuation, we considered our cumulative loss in recent years and its forecast losses in the near term as significant negative evidence. Based upon a review of the four sources of income identified within ASC 740, we determined that the negative evidence outweighed the positive evidence and that a full valuation allowance on our net deferred tax assets will be maintained. We will continue to assess the realizability of our deferred tax assets going forward and will adjust the valuation allowance as needed. Our valuation allowance increased by $23.2 million , $38.7 million and $28.0 million during the years ended December 31, 2016 , 2015 and 2014 , respectively. We follow the provisions ASC 740, Accounting for Income Taxes, and the guidance related to accounting for uncertainty in income taxes. We determine our uncertain tax positions based on a determination of whether and how much of a tax benefit taken by us in our tax filings or positions is more likely than not to be sustained upon examination by the relevant income tax authorities. We are subject to U.S. federal and state, Italian and U.K. income taxes with varying statutes of limitations. Tax years from 1998 forward remain open to examination due to the carryover of net operating losses or tax credits. Our policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. As of December 31, 2016 , we had no unrecognized tax benefits and therefore no accrued interest or penalties related to unrecognized tax benefits. We believe that our income tax filing positions reflected in the various tax returns are more-likely-than not to be sustained on audit and thus there are no anticipated adjustments that would result in a material change to our consolidated financial position, results of operations and cash flows. Therefore, no reserves for uncertain income tax positions have been recorded. |
Unaudited Quarterly Data
Unaudited Quarterly Data | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Unaudited Quarterly Data | 21. Unaudited Quarterly Data The following table presents summarized unaudited quarterly financial data (in thousands, except per share data): First Quarter Second Quarter Third Quarter Fourth Quarter 2016 Total revenues (1) $ 36,475 $ 7,361 $ 4,433 $ 9,136 Product sales, net 1,223 1,051 986 1,071 Gross profit (2) 1,033 891 823 207 Net income (loss) attributable to CTI 3,312 (19,766 ) (29,183 ) (6,372 ) Net income (loss) attributable to CTI common shareholders 3,312 (19,766 ) (29,183 ) (6,372 ) Net income (loss) per common share—basic 0.12 (0.71 ) (1.04 ) (0.23 ) Net income (loss) per common share—diluted 0.12 (0.71 ) (1.04 ) (0.23 ) 2015 Total revenues (3) $ 2,728 $ 1,100 $ 964 $ 11,324 Product sales, net 812 852 745 1,087 Gross profit (2) 622 669 (86 ) 351 Net loss attributable to CTI (28,597 ) (32,596 ) (32,592 ) (25,637 ) Net loss attributable to CTI common shareholders (28,597 ) (32,596 ) (32,592 ) (28,837 ) Net loss per common share—basic and diluted (1.64 ) (1.86 ) (1.85 ) (1.27 ) (1) Total revenues for the first quarter of 2016 include $32.0 million in milestone revenue upon achievements of two milestones during the quarter, which the payments from Baxalta relating to these milestones were received in 2015. See Note 8. Long-term Debt for additional information. The fourth quarter of 2016 includes $8.0 million in milestone revenue from Servier relating to the attainment of a certain enrollment event in connection with our PIX306 study. (2) Gross profit is computed by subtracting cost of product sold from net product sales. (3) Total revenues for the fourth quarter of 2015 include $10.0 million of milestone payments received from Teva in November 2015 upon the achievement of worldwide net sales milestones of TRISENOX. See Note 12. Collaboration, Licensing and Milestone Agreements for additional information. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | 22. Subsequent Events Reverse stock split In December 2016 , our board of directors approved a one-for- ten reverse stock split of our common stock, and a proportionate reduction of the authorized number of shares of our common stock in order to regain compliance with NASDAQ's minimum closing bid price of $1.00 per share. On January 1, 2017 , the reverse stock split became effective. In January, 2017, we announced that we received a letter from NASDAQ indicating that as of that date we had regained compliance with NASDAQ Marketplace Rule 5550(a)(2). As a result, our common stock will continue to be listed and traded on The NASDAQ Capital Market. However, notwithstanding our current compliance with NASDAQ listing standards, there can be no assurance that we will be able to maintain our continued listing on The NASDAQ Capital Market in the future. As a result of the reverse stock split, every ten shares of our issued and outstanding common stock were automatically combined into one issued and outstanding share. The reverse stock split affected all of our authorized shares, including all outstanding shares of common stock as well as the number of shares of common stock underlying stock options, warrants and other exercisable or convertible instruments outstanding at the effective time of the reverse stock split. Any shares of our common stock or shares of common stock underlying options, warrants and other exercisable or convertible instruments were proportionately reduced and the exercise prices of any options, warrants and other exercisable or convertible instruments were proportionately increased in accordance with the terms of the related agreements. All impacted amounts included in the consolidated financial statements and notes thereto have been retroactively adjusted for the reverse stock split. |
Schedule II Valuation and Quali
Schedule II Valuation and Qualifying Accounts | 12 Months Ended |
Dec. 31, 2016 | |
Valuation and Qualifying Accounts [Abstract] | |
Schedule II Valuation and Qualifying Accounts | Schedule II. Valuation and Qualifying Accounts Valuation and qualifying accounts include the following (in thousands): Additions (1) (2) Balance at Charged to Charged to Balance at beginning of costs and other (3) end of Description period expenses accounts Deductions period Reserve for excess, obsolete or unsalable inventory: Year ended December 31, 2016 $ 1,265 $ 692 $ (19 ) $ (428 ) $ 1,510 Year ended December 31, 2015 $ — $ 1,326 $ (25 ) $ (36 ) $ 1,265 Allowance for doubtful accounts: Year ended December 31, 2016 $ — $ 1,735 $ — $ (1,735 ) $ — (1) We review our inventories on a quarterly basis for impairment and reserves are established when necessary. (2) We record inventory in euros and we record foreign currency translation gains and losses from recurring measurement of our inventory in Accumulated other comprehensive loss in our consolidated balance sheets. (3) The amount of inventory reserve is adjusted for the items disposed of during the period. |
Description of Business and S31
Description of Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Description of Business | CTI BioPharma Corp., together with its wholly-owned subsidiaries, also referred to collectively in this Annual Report on Form 10-K as “we,” “us,” “our,” the “Company” and “CTI”, 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 in select countries in the European Union, or the E.U., for multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma, or NHL, and evaluating pacritinib for the treatment of adult patients with myelofibrosis. 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, or 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. |
Principles of Consolidation | Principles of Consolidation The accompanying 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. As of December 31, 2016 , we also had an approximately 60% 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. |
Liquidity | Liquidity The accompanying 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 within one year after the date the consolidated financial statements are issued. In accordance with Financial Accounting Standards Board, or the FASB, ASU No. 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40), our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued. We will need to continue to conduct research, development, testing and regulatory compliance activities with respect to our compounds and ensure the procurement of manufacturing and drug supply services, the costs of which, together with projected general and administrative expenses, is expected to result in operating losses for the foreseeable future. Additionally, we have resumed primary responsibility for the development and commercialization of pacritinib as a result of the termination of the Pacritinib License Agreement in October 2016, and we will no longer be eligible to receive cost sharing or milestone payments for pacritinib's development from Baxalta. We have incurred a net operating loss every year since our formation. As of December 31, 2016 , we had an accumulated deficit of $2.2 billion , and we expect to incur net losses for the foreseeable future. Our available cash and cash equivalents were $44.0 million as of December 31, 2016 . We believe that our present financial resources, together with payments projected to be received under certain contractual agreements and our ability to control costs, will only be sufficient to fund our operations into the third quarter of 2017. 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, be unable to obtain and maintain contracts necessary to continue our operations and at affordable rates with competitive terms, 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 consolidated financial statements do not include any adjustments that may result from the outcome of this uncertainty. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. For example, estimates include assumptions used in calculating reserves for sales deductions such as rebates and returns of product sold, allowances for credit losses, excess and obsolete inventory, share-based compensation expense, accruals, the allocation of our operating expenses, the allocation of purchase price to acquired assets and liabilities, restructuring charges and our liability for excess facilities, our provision for loss contingencies, the useful lives of fixed assets, the fair value of our financial instruments, our tax provision and related valuation allowance, and determining potential impairment of long-lived assets. Actual results could differ from those estimates. |
Certain Risks and Uncertainties | Certain Risks and Uncertainties Our results of operations are subject to foreign currency exchange rate fluctuations primarily due to our activity in Europe. We report the results of our operations in U.S. dollars, while the functional currency of our foreign subsidiaries is the euro. As the net positions of our unhedged foreign currency transactions fluctuate, our earnings might be negatively affected. In addition, the reported carrying value of our euro-denominated assets and liabilities that remain in our European branches and subsidiaries will be affected by fluctuations in the value of the U.S. dollar as compared to the euro. We review our foreign currency risk periodically along with hedging options to mitigate such risk. Financial instruments which potentially subject us to concentrations of credit risk consist of accounts receivable. Our accounts receivable are from the sale of PIXUVRI to a small number of distributors and health care providers. Additionally, we do not require collateral on amounts due from our distributors and are therefore subject to credit risk. We have not experienced significant credit losses to date as a result of credit risk concentration. Additionally, see Note 16. Customer and Geographic Concentrations for further concentration disclosure. |
Concentrations | Concentrations We source our drug products for commercial operations and clinical trials from a concentrated group of third-party contractors. If we are unable to obtain sufficient quantities of source materials, manufacture or distribute our products to customers from existing suppliers and service providers, or obtain the materials or services from other suppliers, manufacturers or distributors, certain research and development and sales activities may be delayed. |
Cash and Cash Equivalents | Cash and Cash Equivalents We consider all highly liquid debt instruments with maturities of three months or less at the time acquired to be cash equivalents. Cash equivalents represent short-term investments consisting of investment-grade corporate and government obligations, carried at cost, which approximates market value. |
Accounts Receivable | Receivables from Collaborative Arrangements Our receivables from collaborative arrangements relate to amounts receivable or reimbursable to us under the terms of collaborative arrangements with our partners. When it is deemed probable that an amount is uncollectible, it is written off against the existing allowance. 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 December 31, 2016 and 2015 , 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. |
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 was approximately $4.4 million and $4.7 million as of December 31, 2016 and 2015 , of which $4.1 million and $4.2 million was included in other assets and $0.3 million and $0.5 million was included in prepaid expenses and other current assets as of December 31, 2016 and 2015 , 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 December 31, 2016 , the VAT receivable related to operations in Italy was approximately $4.2 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 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 unsalable inventory, the value is written down to the net realizable value. Based on assessment of shelf lives and net realizable value of the product, a $1.5 million reserve for excess, obsolete or unsalable inventory was recorded as of December 31, 2016 . A $1.3 million reserve was recorded as of December 31, 2015 . |
Property and Equipment | Property and Equipment Property and equipment are carried at cost, less accumulated depreciation and amortization. Depreciation commences at the time assets are placed in service. We calculate depreciation using the straight-line method over the estimated useful lives of the assets ranging from three to five years for assets other than leasehold improvements. We amortize leasehold improvements over the lesser of their useful life of 10 years or the term of the applicable lease. |
Impairment of Long-lived Assets | Impairment of Long-lived Assets We review our long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Each impairment test is based on a comparison of the undiscounted future cash flows to the recorded value of the asset. If an impairment is indicated, the asset is written down to its estimated fair value based on fair market values. |
Leases | Leases We analyze leases at the inception of each agreement for classification as either an operating or capital lease. Certain of our lease agreement terms include rent holidays, rent escalation clauses and incentives for leasehold improvements. We recognize deferred rent relating to incentives for rent holidays and leasehold improvements and amortize the deferred rent over the term of the leases as a reduction of rent expense. For rent escalation clauses, we recognize rent expense on a straight-line basis equal to the amount of total minimum lease payments over the term of the lease. |
Acquisitions | Acquisitions We account for acquired businesses using the acquisition method of accounting, which requires that most assets acquired and liabilities assumed be recognized at fair value as of the acquisition date. Any excess of the consideration transferred over the fair value of the net assets acquired is recorded as goodwill, and the fair value of the acquired in-process research and development, or IPR&D, is recorded on the balance sheet. If the acquired net assets do not constitute a business, the transaction is accounted for as an asset acquisition and no goodwill is recognized. In an asset acquisition, the amount allocated to acquired IPR&D with no alternative future use is charged to expense at the acquisition date. |
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. At December 31, 2016 and 2015 , the carrying value of financial instruments such as receivables and payables approximated their fair values due to their short-term maturities. The carrying value of our long-term debt approximated its fair value at December 31, 2016 and 2015 based on borrowing rates for similar loans and maturities. |
Contingencies | Contingencies We record liabilities associated with loss contingencies to the extent that we conclude the occurrence of the contingency is probable and that the amount of the related loss is reasonably estimable. We record income from gain contingencies only upon the realization of assets resulting from the favorable outcome of the contingent event. See Note 12. Collaboration, Licensing and Milestone Agreements and Note 19. Legal Proceedings for further information regarding our current gain and loss contingencies. |
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 primarily sell PIXUVRI through a limited number of wholesale 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 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. |
Collaboration Agreements | Collaboration Agreements We evaluate collaboration agreements to determine whether the multiple elements and associated deliverables can be considered separate units of accounting in accordance with Accounting Standards Codification, or ASC, 605-25, Revenue Recognition — Multiple-Element Arrangements. If it is determined that the deliverables under the collaboration agreement are a single unit of accounting, all amounts received or due, including any upfront payments, are recognized as revenue over the performance obligation periods of each agreement. Upon the completion of the performance obligation, such amounts will be recognized as revenue when collectability is reasonably assured. The assessment of multiple element arrangements requires judgment in order to determine the allocation of revenue to each deliverable and the appropriate point in time, or period of time, that revenue should be recognized. In order to account for these agreements, we identify deliverables included within the agreement and evaluate which deliverables represent separate units of accounting based on whether certain criteria are met, including whether the delivered element has standalone value to the collaborator. The consideration received is allocated among the separate units of accounting, and the applicable revenue recognition criteria are applied to each of the separate units. Milestone payments under the collaboration agreement are generally aggregated into three categories for reporting purposes: (i) development milestones, (ii) regulatory milestones, and (iii) sales milestones. Development milestones are typically payable when a product candidate initiates or advances into different clinical trial phases. Regulatory milestones are typically payable upon submission for marketing approval with the FDA, or with the regulatory authorities of other countries, or on receipt of actual marketing approvals for the compound or for additional indications. Sales milestones are typically payable when annual sales reach certain levels. At the inception of each agreement that includes milestone payments, we evaluate whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity's performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity's performance to achieve the milestone, (b) the consideration relates solely to past performance and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. We evaluate factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. Non-refundable development and regulatory milestones that are expected to be achieved as a result of our efforts during the period of substantial involvement are considered substantive and are recognized as revenue upon the achievement of the milestone, assuming all other revenue recognition criteria are met. We follow ASC 605-25, Revenue Recognition – Multiple-Element Arrangements and ASC 808, Collaborative Arrangements , if applicable, to determine the accounting for reimbursement arrangements under our collaborative research and development and commercialization agreements. |
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. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred in accordance with the FASB, ASC 730, Research and Development . Research and development expenses include related salaries and benefits, clinical trial and related manufacturing costs, contract and other outside service fees, and facilities and overhead costs related to our research and development efforts. Research and development expenses also consist of costs incurred for proprietary and collaboration research and development and include activities such as product registries and investigator-sponsored trials. In instances where we enter into agreements with third parties for research and development activities, we may prepay fees for services at the initiation of the contract. We record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Other types of arrangements with third parties may be fixed fee or fee for service, and may include monthly payments or payments upon completion of milestones or receipt of deliverables. We expense upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. |
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, 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. The intercompany balance due from CTILS is considered to be of a long-term nature. |
Income Taxes | Income Taxes We record a tax provision for the anticipated tax consequences of our results of operations. The provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, and for operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using the currently enacted tax rates in effect for the years in which those tax assets and liabilities are expected to be realized or settled. We provide a valuation allowance to reduce deferred tax assets to the amount that is more likely than not to be realized. |
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 Accounting Standards | Recently Adopted Accounting Standards 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. The adoption of this guidance did not have a material impact on our consolidated financial statements. In November 2015, the FASB issued new guidance on the balance sheet classification of deferred taxes. To simplify presentation, the new guidance requires that all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet . 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. The adoption of this guidance did not have an impact 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 ending after December 15, 2016 and interim periods within annual periods beginning after December 15, 2016. Early adoption is permitted. We adopted this new standard in the fourth quarter of 2016. The adoption of this standard did not have a material impact on our consolidated financial statements. Recently Issued Accounting Standards In May 2014, 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. In March 2016, the FASB issued an amendment to clarify the implementation guidance around considerations of whether an entity is a principal or an agent, impacting whether an entity reports revenue on a gross or net basis. In April 2016, the FASB issued an amendment to clarify guidance on identifying performance obligations and the implementation guidance on licensing. In May 2016, the FASB issued amendments to certain aspects of the new revenue guidance (including transition, collectability, noncash consideration and the presentation of sales and other similar taxes) and provided certain practical expedients. The accounting standard is effective for annual reporting periods (including interim reporting periods within those periods) beginning after December 15, 2017. Early adoption is permitted as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. We are currently evaluating the impact of this accounting standard on our consolidated financial statements. In July 2015, the FASB issued new accounting guidance on simplifying the measurement of inventory which requires that inventory within the scope of the guidance be measured at the lower of cost and net realizable value. Prior to the issuance of the standard, inventory was measured at the lower of cost or market (where market was defined as replacement cost, with a ceiling of net realizable value and floor of net realizable value less a normal profit margin). The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2016. Early adoption is permitted. The adoption of this standard is not expected to have a material impact on our consolidated financial statements. In January 2016, the FASB issued a new accounting standard on recognition and measurement of financial assets and financial liabilities. The accounting standard primarily affects the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. Early adoption is permitted for the provision to record fair value changes for financial liabilities under the fair value option resulting from instrument-specific credit risk in other comprehensive income. The adoption of this standard is not expected to have a material impact on our consolidated financial statements. In February 2016, the FASB issued a new accounting guidance on accounting for leases which requires the lessees to recognize virtually all of their leases on the balance sheet (other than leases that meet the definition of a short-term lease). The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2018. Early adoption is permitted. We are currently evaluating the impact of this accounting standard on our consolidated financial statements. In March 2016, the FASB issued a new accounting guidance for employee share-based payments accounting. The accounting standard primarily affects the accounting for forfeitures, minimum statutory tax withholding requirements, and income tax effects related to share-based payments at settlement (or expiration). The accounting guidance is effective for annual reporting periods beginning after December 15, 2016 (including interim periods within those periods). Early adoption is permitted. We have historically maintained a full valuation allowance against deferred tax assets. If this continues in 2017, we do not expect the adoption of this standard to have a significant impact on our consolidated financial statements. The adoption of the other areas of this standard is not expected to have a material impact on our consolidated financial statements. In August 2016, the FASB issued an amendment to add or clarify guidance on the classification of certain cash receipts and payments in the statement of cash flows with the objective of reducing diversity in practice regarding eight types of cash flows. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. Early adoption is permitted. We do not expect the adoption of this standard to have a material impact on our statement of cash flows. |
Reclassifications | Reclassifications Certain prior year items have been reclassified to conform to current year presentation. |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | |
Components of Inventories | The components of PIXUVRI inventories consisted of the following as of December 31, 2016 and 2015 (in thousands): 2016 2015 Finished goods $ 477 $ 724 Work-in-process 2,558 3,386 Inventory, gross $ 3,035 $ 4,110 Reserve for excess, obsolete or unsalable inventory $ (1,510 ) $ (1,265 ) Inventory, net $ 1,525 $ 2,845 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment are composed of the following as of December 31, 2016 and 2015 (in thousands): 2016 2015 Furniture and office equipment $ 6,521 $ 6,484 Leasehold improvements 5,106 5,078 Lab equipment 201 203 11,828 11,765 Less: accumulated depreciation and amortization (8,805 ) (8,047 ) Property and equipment, net $ 3,023 $ 3,718 |
Acquisitions (Tables)
Acquisitions (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Business Combinations [Abstract] | |
Summary of Initial Purchase Consideration | The total initial purchase consideration was as follows (in thousands): Fair value of Series 20 Preferred Stock $ 21,600 Transaction costs 259 Total initial purchase consideration $ 21,859 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consisted of the following as of December 31, 2016 and 2015 (in thousands): 2016 2015 Clinical and investigator-sponsored trial expenses $ 7,303 $ 8,976 Employee compensation and related expenses 6,364 5,498 Manufacturing expenses 7,616 921 Legal expenses 1,037 1,274 Accrued selling expenses 136 1,697 Insurance financing 888 679 Accrued interest expenses 2 1,817 Other 1,419 1,271 Total accrued expenses $ 24,765 $ 22,133 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Leases [Abstract] | |
Schedule of Future Minimum Operating Lease Payments | Future minimum lease commitments for non-cancelable operating leases at December 31, 2016 are as follows (in thousands): Operating Leases 2017 $ 2,579 2018 2,486 2019 2,490 2020 2,555 2021 2,622 Thereafter 882 Total minimum lease commitments $ 13,614 |
Other Liabilities (Tables)
Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Other Liabilities Disclosure [Abstract] | |
Other Liabilities | Other liabilities consisted of the following as of December 31, 2016 and 2015 (in thousands): 2016 2015 Deferred rent, less current portion $ 3,011 $ 3,538 Other long-term obligations 604 603 Total other liabilities $ 3,615 $ 4,141 |
Common Stock (Tables)
Common Stock (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Summary of Common Stock Reserved for Issuance | A summary of common stock reserved for issuance is as follows as of December 31, 2016 (in thousands): Equity incentive plans 4,070 Common stock purchase warrants 29 Employee stock purchase plan 187 Total common stock reserved 4,286 |
Other Comprehensive Loss (Table
Other Comprehensive Loss (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Total Accumulated Other Comprehensive Loss | Total accumulated other comprehensive loss consisted of the following (in thousands): Net Unrealized Gain (Loss) and Impairment on Available-For-Sale Securities Foreign Currency Translation Adjustments Unrealized Foreign Exchange Loss on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2015 $ (518 ) $ (3,849 ) $ (2,585 ) $ (6,952 ) Current period other comprehensive income (loss) 512 947 (1,162 ) 297 December 31, 2016 $ (6 ) $ (2,902 ) $ (3,747 ) $ (6,655 ) |
Collaboration, Licensing and 40
Collaboration, Licensing and Milestone Agreements (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Collaborations [Abstract] | |
Allocation of Arrangement Consideration | We allocated the arrangement consideration of $18.1 million ( €14.0 million using the currency exchange rate as of the date of the Servier Agreement) based on the percentage of the relative selling price of each unit of accounting as follows (in thousands): License $ 17,277 Development and other services 852 Total upfront payment $ 18,129 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation Expense by Types of Awards | During the years ended December 31, 2016 , 2015 and 2014 , we recognized share-based compensation expense which consisted of the following types of awards (in thousands): 2016 2015 2014 Performance rights $ 575 $ 3,017 $ 1,549 Restricted stock 4,199 8,656 14,749 Options 8,550 3,155 3,898 Total share-based compensation expense $ 13,324 $ 14,828 $ 20,196 |
Summary of Share-Based Compensation Expense | The following table summarizes share-based compensation expense for the years ended December 31, 2016 , 2015 and 2014 , which was allocated as follows (in thousands): 2016 2015 2014 Research and development $ 2,320 $ 3,964 $ 3,437 Selling, general and administrative 11,004 10,864 16,759 Total share-based compensation expense $ 13,324 $ 14,828 $ 20,196 |
Schedule of Black Scholes Stock Option Pricing Model Weighted Average Assumptions | Fair value for stock options was estimated at the date of grant using the Black-Scholes pricing model, with the following weighted average assumptions: Year Ended December 31, 2016 2015 2014 Risk-free interest rate 1.2 % 1.7 % 1.7 % Expected dividend yield None None None Expected life (in years) 4.0 5.3 5.2 Volatility 75 % 80 % 97 % |
Stock Option Activity for All Stock Plans | The following table summarizes stock option activity for all of our stock option plans: Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (Thousands) Outstanding at December 31, 2013 (156,000 exercisable) 452,000 $ 30.40 Granted 102,000 $ 34.85 Exercised (18,000 ) $ 14.89 Forfeited (36,000 ) $ 22.53 Cancelled and expired (8,000 ) $ 98.63 Outstanding at December 31, 2014 (317,400 exercisable) 492,000 $ 31.39 Granted 1,149,000 $ 13.94 Exercised (8,000 ) $ 13.98 Forfeited (62,000 ) $ 21.70 Cancelled and expired (12,000 ) $ 242.92 Outstanding at December 31, 2015 (436,100 exercisable) 1,559,000 $ 17.45 Granted 1,511,000 $ 6.43 Exercised — $ — Forfeited (128,000 ) $ 9.07 Cancelled and expired (136,000 ) $ 25.58 Outstanding at December 31, 2016 2,806,000 $ 11.50 5.3 $ 153 Vested or expected to vest at December 31, 2016 2,749,000 $ 11.58 5.3 $ 153 Exercisable at December 31, 2016 1,913,000 $ 12.58 3.6 $ 151 |
Summary of Status of Nonvested Restricted Stock Awards and Units | A summary of the status of nonvested restricted stock units as of December 31, 2016 and changes during the period then ended, is presented below: Nonvested Units Weighted Average Nonvested at December 31, 2015 33,000 $ 15.70 Issued 187,000 $ 5.35 Vested (33,000 ) $ 15.70 Forfeited — $ — Nonvested at December 31, 2016 187,000 $ 5.35 A summary of the status of nonvested restricted stock awards as of December 31, 2016 and changes during the period then ended, is presented below: Nonvested Shares Weighted Average Grant-Date Fair Value Per Share Nonvested at December 31, 2015 267,000 $ 22.39 Issued 270,000 $ 5.64 Vested (257,000 ) $ 15.02 Forfeited (97,000 ) $ 13.38 Nonvested at December 31, 2016 183,000 $ 12.76 |
Customer and Geographic Conce42
Customer and Geographic Concentrations (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Segment Reporting [Abstract] | |
Product Sales from Major Customers | All sales of PIXUVRI during the years presented were in Europe. Product sales from PIXUVRI’s major customers as a percentage of total product sales were as follows: Year Ended December 31, 2016 2015 2014 Customer A 60 % 42 % 27 % Customer B 27 % 41 % 57 % |
Long-Lived Assets Based on Geographical Locations | The following table depicts long-lived assets based on the following geographic locations (in thousands): Year Ended December 31, 2016 2015 United States $ 2,990 $ 3,657 Europe 33 61 Total long-lived assets $ 3,023 $ 3,718 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Shares | Basic and diluted shares for the years ended December 31, 2016 , 2015 and 2014 are as follows (in thousands, except per share amounts): Year Ended December 31, 2016 2015 2014 Net loss attributable to common shareholders $ (52,009 ) $ (122,622 ) $ (95,992 ) Basic and diluted: Weighted average shares outstanding 28,198 19,324 15,347 Less weighted average restricted shares outstanding (250 ) (487 ) (494 ) Shares used in calculation of basic and diluted net loss per common share 27,948 18,837 14,853 Net loss per common share: Basic and diluted $ (1.86 ) $ (6.51 ) $ (6.46 ) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Taxes | Loss before income taxes is attributable to the following tax jurisdictions (in thousands): 2016 2015 2014 United States $ (51,856 ) $ (110,831 ) $ (84,883 ) Foreign (1,097 ) (9,932 ) (9,346 ) Net loss before income taxes $ (52,953 ) $ (120,763 ) $ (94,229 ) |
Reconciliation Between Effective Tax Rate and Income Tax Rate | The reconciliation between our effective tax rate and the income tax rate as of December 31, 2016 , 2015 and 2014 is as follows: 2016 2015 2014 Federal income tax rate 34 % 34 % 34 % Research and development tax credits 1 3 3 Non-deductible executive compensation — (1 ) (3 ) Valuation allowance (33 ) (32 ) (30 ) Foreign tax rate differential — (3 ) (3 ) Other (2 ) (1 ) (1 ) Net effective tax rate — % — % — % |
Significant Components of Deferred Tax Assets and Liabilities | The principal components of our deferred tax assets and liabilities as of December 31, 2016 and 2015 were as follows (in thousands): December 31, 2016 2015 Deferred tax assets: Net operating loss carryforwards $ 108,372 $ 94,024 Capitalized research and development 43,768 39,537 Research and development tax credit carryforwards 7,253 6,685 Stock-based compensation 19,288 15,242 Intangible assets 14,525 15,694 Depreciation and amortization 626 260 Other deferred tax assets 3,721 3,180 Total deferred tax assets 197,553 174,622 Less: valuation allowance (197,131 ) (173,947 ) 422 675 Deferred tax liabilities: GAAP adjustments on Novuspharma merger — (208 ) Deductions for tax in excess of financial statements (422 ) (467 ) Total deferred tax liabilities (422 ) (675 ) Net deferred tax assets $ — $ — |
Unaudited Quarterly Data (Table
Unaudited Quarterly Data (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Unaudited Quarterly Financial Information | The following table presents summarized unaudited quarterly financial data (in thousands, except per share data): First Quarter Second Quarter Third Quarter Fourth Quarter 2016 Total revenues (1) $ 36,475 $ 7,361 $ 4,433 $ 9,136 Product sales, net 1,223 1,051 986 1,071 Gross profit (2) 1,033 891 823 207 Net income (loss) attributable to CTI 3,312 (19,766 ) (29,183 ) (6,372 ) Net income (loss) attributable to CTI common shareholders 3,312 (19,766 ) (29,183 ) (6,372 ) Net income (loss) per common share—basic 0.12 (0.71 ) (1.04 ) (0.23 ) Net income (loss) per common share—diluted 0.12 (0.71 ) (1.04 ) (0.23 ) 2015 Total revenues (3) $ 2,728 $ 1,100 $ 964 $ 11,324 Product sales, net 812 852 745 1,087 Gross profit (2) 622 669 (86 ) 351 Net loss attributable to CTI (28,597 ) (32,596 ) (32,592 ) (25,637 ) Net loss attributable to CTI common shareholders (28,597 ) (32,596 ) (32,592 ) (28,837 ) Net loss per common share—basic and diluted (1.64 ) (1.86 ) (1.85 ) (1.27 ) (1) Total revenues for the first quarter of 2016 include $32.0 million in milestone revenue upon achievements of two milestones during the quarter, which the payments from Baxalta relating to these milestones were received in 2015. See Note 8. Long-term Debt for additional information. The fourth quarter of 2016 includes $8.0 million in milestone revenue from Servier relating to the attainment of a certain enrollment event in connection with our PIX306 study. (2) Gross profit is computed by subtracting cost of product sold from net product sales. (3) Total revenues for the fourth quarter of 2015 include $10.0 million of milestone payments received from Teva in November 2015 upon the achievement of worldwide net sales milestones of TRISENOX. See Note 12. Collaboration, Licensing and Milestone Agreements for additional information. |
Description of Business and S46
Description of Business and Summary of Significant Accounting Policies (Detail) € in Millions | Jan. 01, 2017 | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2016EUR (€)shares | Dec. 31, 2016USD ($)shares | Dec. 31, 2015EUR (€) | Dec. 31, 2015USD ($) | Dec. 31, 2013USD ($) |
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
Preferred stock outstanding (in shares) | shares | 0 | 0 | |||||||
Accumulated deficit | $ (2,150,326,000) | $ (2,098,317,000) | |||||||
Cash and cash equivalents | $ 70,933,000 | 44,002,000 | 128,182,000 | $ 71,639,000 | |||||
Allowance for doubtful accounts | 0 | 0 | |||||||
Bad debt expense | $ 1,735,000 | $ 0 | $ 0 | ||||||
Allowance for doubtful accounts from collaborative arrangements | 0 | ||||||||
VAT receivable | 4,400,000 | 4,700,000 | |||||||
Reserve for inventory | 1,510,000 | 1,265,000 | |||||||
Unrealized foreign exchange loss | $ 1,200,000 | $ 2,600,000 | |||||||
Intercompany balance, due from CTILS, noncurrent | € 29.7 | 31,200,000 | € 27.2 | 29,500,000 | |||||
Minimum | Assets Other Than Leasehold Improvements | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
Property and equipment useful life | 3 years | ||||||||
Maximum | Assets Other Than Leasehold Improvements | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
Property and equipment useful life | 5 years | ||||||||
Maximum | Leasehold Improvements | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
Property and equipment useful life | 10 years | ||||||||
Europe | Minimum | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
VAT receivable, collection period | 3 months | ||||||||
Europe | Maximum | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
VAT receivable, collection period | 5 years | ||||||||
ITALY | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
VAT receivable | 4,200,000 | ||||||||
ITALY | Minimum | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
VAT receivable, collection period | 3 years | ||||||||
ITALY | Maximum | |||||||||
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, non-current | 4,100,000 | 4,200,000 | |||||||
Prepaid Expenses and Other Current Assets | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
VAT receivable, current | $ 300,000 | $ 500,000 | |||||||
Subsequent Event | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
Reverse stock split ratio | 0.1 | ||||||||
Aequus Biopharma, Inc | Affiliated Entity | |||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||
Interest in majority-owned subsidiary | 60.00% | 60.00% |
Inventory (Detail)
Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 477 | $ 724 |
Work-in-process | 2,558 | 3,386 |
Inventory, gross | 3,035 | 4,110 |
Reserve for excess, obsolete or unsalable inventory | (1,510) | (1,265) |
Inventory, net | $ 1,525 | $ 2,845 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Property Plant And Equipment [Line Items] | |||
Property and Equipment, Gross | $ 11,828 | $ 11,765 | |
Less: accumulated depreciation and amortization | (8,805) | (8,047) | |
Property and equipment, net | 3,023 | 3,718 | |
Depreciation expense | 831 | 990 | $ 1,100 |
Furniture and office equipment | |||
Property Plant And Equipment [Line Items] | |||
Property and Equipment, Gross | 6,521 | 6,484 | |
Leasehold improvements | |||
Property Plant And Equipment [Line Items] | |||
Property and Equipment, Gross | 5,106 | 5,078 | |
Lab equipment | |||
Property Plant And Equipment [Line Items] | |||
Property and Equipment, Gross | $ 201 | $ 203 |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Research And Development Assets Acquired Other Than Through Business Combination [Line Items] | ||||
Asset acquisition purchase price allocation in process research and development | $ 0 | $ 0 | $ 21,859 | |
Chroma License Agreement | Maximum | ||||
Research And Development Assets Acquired Other Than Through Business Combination [Line Items] | ||||
Elimination of potential future milestone payments | $ 209,000 | |||
Chroma Asset Purchase Agreement | Series 20 Preferred Stock | ||||
Research And Development Assets Acquired Other Than Through Business Combination [Line Items] | ||||
Shares issued in exchange for asset (in shares) | 9,000 | |||
Preferred stock, stated value (in USD per share) | $ 2,370 | |||
Preferred stock, conversion price (in USD per share) | $ 23.70 | |||
Conversion of preferred stock to common stock (in shares) | 900,000 | |||
Asset acquisition purchase price allocation in process research and development | $ 21,900 | |||
Chroma Asset Purchase Agreement | Series 20 Preferred Stock | Escrow | ||||
Research And Development Assets Acquired Other Than Through Business Combination [Line Items] | ||||
Shares issued in exchange for asset (in shares) | 1,080 | |||
Chroma Asset Purchase Agreement | Series 20 Preferred Stock | Chroma Therapeutics Limited | ||||
Research And Development Assets Acquired Other Than Through Business Combination [Line Items] | ||||
Shares issued in exchange for asset (in shares) | 7,920 |
Acquisitions - Initial Purchase
Acquisitions - Initial Purchase Consideration (Detail) - Chroma Asset Purchase Agreement $ in Thousands | Oct. 31, 2014USD ($) |
Asset Acquisition [Line Items] | |
Fair value of Series 20 Preferred Stock | $ 21,600 |
Transaction costs | 259 |
Total initial purchase consideration | $ 21,859 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Payables and Accruals [Abstract] | ||
Clinical and investigator-sponsored trial expenses | $ 7,303 | $ 8,976 |
Employee compensation and related expenses | 6,364 | 5,498 |
Manufacturing expenses | 7,616 | 921 |
Legal expenses | 1,037 | 1,274 |
Accrued selling expenses | 136 | 1,697 |
Insurance financing | 888 | 679 |
Accrued interest expenses | 2 | 1,817 |
Other | 1,419 | 1,271 |
Total accrued expenses | $ 24,765 | $ 22,133 |
Leases - Additional Information
Leases - Additional Information (Detail) ft² in Thousands | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2012USD ($)ft²Option$ / ft² | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Leases [Abstract] | ||||
Rent expense, net sublease income | $ 2,000,000 | $ 2,000,000 | $ 2,000,000 | |
Lease agreement area | ft² | 66 | |||
Lease term | 120 months | |||
Number of options to extend the term | Option | 2 | |||
Extend option term | 5 years | |||
Initial annual rent payments per square foot | $ / ft² | 27 | |||
Rent payments due in initial five months | $ 0 | |||
Percentage of annual rent increase | 3.00% | |||
Allowance for tenant improvements | $ 3,300,000 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments Under Noncancelable Operating Leases (Detail) $ in Thousands | Dec. 31, 2016USD ($) |
Operating Leases Future Minimum Payments | |
2,017 | $ 2,579 |
2,018 | 2,486 |
2,019 | 2,490 |
2,020 | 2,555 |
2,021 | 2,622 |
Thereafter | 882 |
Total minimum lease commitments | $ 13,614 |
Other Liabilities (Detail)
Other Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Other Liabilities Disclosure [Abstract] | ||
Deferred rent, less current portion | $ 3,011 | $ 3,538 |
Other long-term obligations | 604 | 603 |
Total other liabilities | $ 3,615 | $ 4,141 |
Long-term Debt (Detail)
Long-term Debt (Detail) | Apr. 01, 2016USD ($) | Feb. 29, 2016USD ($) | Jan. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Jun. 30, 2015USD ($)installment$ / sharesshares | Oct. 31, 2014USD ($) | Mar. 31, 2014USD ($)installment | Jan. 31, 2014shares | Dec. 31, 2013USD ($) | Mar. 31, 2013USD ($)installment$ / sharesshares | Mar. 31, 2013USD ($)installment$ / sharesshares | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Mar. 31, 2015USD ($) |
Debt Instrument [Line Items] | |||||||||||||||
Loss on debt extinguishment | $ 0 | $ 1,211,000 | $ 0 | ||||||||||||
License and contract revenue | 53,074,000 | 12,620,000 | $ 53,160,000 | ||||||||||||
Borrowing Associated With License Agreement | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument stated interest rate percentage | 9.00% | ||||||||||||||
Debt outstanding | $ 32,000,000 | ||||||||||||||
Borrowing Associated With License Agreement | Baxalta | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument, outstanding amount | $ 32,000,000 | 32,000,000 | |||||||||||||
Period after which milestone repayment begins | 30 days | ||||||||||||||
Borrowing Associated With License Agreement | EMA Milestone | Baxalta | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Installment payments on outstanding debt, principal and interest | $ 1,500,000 | ||||||||||||||
License and contract revenue | $ 12,000,000 | ||||||||||||||
Number of milestone quarterly payments | installment | 8 | ||||||||||||||
Borrowing Associated With License Agreement | Persist2 Milestone | Baxalta | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Installment payments on outstanding debt, principal and interest | $ 2,500,000 | ||||||||||||||
License and contract revenue | $ 20,000,000 | ||||||||||||||
Secured Debt | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument number of monthly installments | installment | 30 | 30 | |||||||||||||
Debt instrument term | 42 months | ||||||||||||||
Facility charge | $ 150,000 | ||||||||||||||
Warrant exercisable period | 5 years | ||||||||||||||
Number of warrant issued (in shares) | shares | 68,000 | 68,000 | |||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 11.045 | $ 11.045 | |||||||||||||
Conversion of preferred stock to common stock (in shares) | shares | 49,000 | ||||||||||||||
Debt outstanding | $ 15,000,000 | ||||||||||||||
Debt Instrument unamortized discount | 400,000 | 200,000 | 400,000 | ||||||||||||
Debt instrument unamortized issuance cost | 100,000 | 45,000 | 100,000 | ||||||||||||
Debt outstanding | 25,000,000 | 19,500,000 | 25,000,000 | ||||||||||||
Secured Debt | Original Loan | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument maximum borrowing capacity | $ 15,000,000 | $ 15,000,000 | |||||||||||||
Proceeds from line of credit | $ 5,000,000 | $ 10,000,000 | |||||||||||||
Debt instrument stated interest rate percentage | 12.25% | 12.25% | |||||||||||||
Debt Instrument unamortized discount | $ 2,100,000 | $ 2,100,000 | |||||||||||||
Debt instrument issuance cost | $ 300,000 | $ 300,000 | |||||||||||||
Secured Debt | Original Loan | Prime Rate | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument, basis spread on variable rate | 3.25% | ||||||||||||||
Secured Debt | Term loan | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument stated interest rate percentage | 10.95% | 10.00% | |||||||||||||
Secured Debt | Term loan | Prime Rate | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument, basis spread on variable rate | 3.25% | 3.25% | 3.25% | ||||||||||||
Secured Debt | Third Amendment | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument maximum borrowing capacity | $ 25,000,000 | ||||||||||||||
Proceeds from line of credit | $ 6,200,000 | ||||||||||||||
Debt instrument number of monthly installments | installment | 36 | ||||||||||||||
Interest-only extension period | 12 months | ||||||||||||||
Facility charge | $ 300,000 | ||||||||||||||
Warrant exercisable period | 5 years | ||||||||||||||
Number of warrant issued (in shares) | shares | 29,239 | ||||||||||||||
Warrant exercise price (in USD per share) | $ / shares | $ 17.10 | ||||||||||||||
Debt instrument, outstanding amount | $ 20,000,000 | $ 13,800,000 | |||||||||||||
Debt instrument unused additional borrowing capacity | 5,000,000 | ||||||||||||||
Commitment fee | $ 15,000 | ||||||||||||||
Fee amount on term loan | 1,300,000 | ||||||||||||||
Warrant liability | 200,000 | $ 400,000 | 200,000 | ||||||||||||
Loss on debt extinguishment | 1,200,000 | ||||||||||||||
Secured Debt | Amended Original Loan | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt instrument maximum borrowing capacity | $ 5,000,000 | ||||||||||||||
Debt instrument stated interest rate percentage | 11.25% | ||||||||||||||
Debt instrument number of monthly installments | installment | 24 | ||||||||||||||
Interest-only extension period | 6 months | ||||||||||||||
Facility charge | $ 72,500 | ||||||||||||||
Facility charge refund, amount | $ 35,000 | ||||||||||||||
Debt Instrument unamortized discount | $ 100,000 | ||||||||||||||
Secured Debt | Fourth Amendment | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Proceeds from line of credit | 5,000,000 | ||||||||||||||
Debt instrument, outstanding amount | 25,000,000 | 25,000,000 | |||||||||||||
Secured Debt | Fourth Amendment | Regular Monthly Payments | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Installment payments on outstanding debt, principal and interest | $ 800,000 | ||||||||||||||
Secured Debt | Fourth Amendment | Maturity Payment | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Installment payments on outstanding debt, principal and interest | $ 3,300,000 | ||||||||||||||
Secured Debt | Third and Fourth Amendments | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Debt Instrument unamortized discount | 400,000 | 400,000 | |||||||||||||
Debt instrument issuance cost | $ 100,000 | $ 100,000 |
Preferred Stock (Detail)
Preferred Stock (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Dec. 31, 2015 | Oct. 31, 2015 | Nov. 30, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Class of Stock [Line Items] | ||||||
Dividends and deemed dividends on preferred stock | $ 0 | $ 3,200 | $ 2,625 | |||
Series 21 Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Stock Issued (in shares) | 35,000 | |||||
Proceeds from issuance of preferred stock | $ 35,000 | |||||
Underwriting commissions and discounts, and other offering costs | $ 2,700 | |||||
Preferred stock, stated value (in USD per share) | $ 1,000 | |||||
Dividends and deemed dividends on preferred stock | $ 2,600 | |||||
Number of preferred stock converted to common stock (in shares) | 35,000 | |||||
Conversion of preferred stock to common stock (in shares) | 1,800,000 | |||||
Conversion price (in USD per share) | $ 20 | |||||
Series 21 Preferred Stock | Underwriters Commissions and Discounts | ||||||
Class of Stock [Line Items] | ||||||
Underwriting commissions and discounts | $ 2,100 | |||||
Series N-1 Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Stock Issued (in shares) | 50,000 | |||||
Proceeds from issuance of preferred stock | $ 50,000 | |||||
Underwriting commissions and discounts, and other offering costs | $ 3,400 | |||||
Preferred stock, stated value (in USD per share) | $ 1,000 | |||||
Dividends and deemed dividends on preferred stock | $ 3,200 | |||||
Number of preferred stock converted to common stock (in shares) | 50,000 | |||||
Conversion of preferred stock to common stock (in shares) | 4,000,000 | |||||
Conversion price (in USD per share) | $ 12.50 | |||||
Series N-1 Preferred Stock | Underwriters Commissions and Discounts | ||||||
Class of Stock [Line Items] | ||||||
Underwriting commissions and discounts | $ 3,000 | |||||
Series N-2 Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Stock Issued (in shares) | 55,000 | |||||
Proceeds from issuance of preferred stock | $ 55,000 | |||||
Underwriting commissions and discounts, and other offering costs | $ 2,600 | |||||
Preferred stock, stated value (in USD per share) | $ 1,000 | $ 1,000 | ||||
Number of preferred stock converted to common stock (in shares) | 55,000 | |||||
Conversion of preferred stock to common stock (in shares) | 5,000,000 | |||||
Conversion price (in USD per share) | $ 11 | $ 11 | ||||
Series N-2 Preferred Stock | Underwriters Commissions and Discounts | ||||||
Class of Stock [Line Items] | ||||||
Underwriting commissions and discounts | $ 2,200 |
Common Stock - Additional Infor
Common Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | |||
Sep. 30, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Class Of Warrant Or Right [Line Items] | ||||
Common stock authorized (in shares) | 41,500,000 | 31,500,000 | 21,500,000 | |
Series 12 Preferred | Common stock purchase warrants | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of warrant issued (in shares) | 60,846 | |||
Warrant exercise price (in USD per share) | $ 120 | |||
Warrants outstanding | 0 | |||
Series 13 Preferred Stock | Common stock purchase warrants | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of warrant issued (in shares) | 176,400 | |||
Warrant exercise price (in USD per share) | $ 107.50 | |||
Warrants outstanding | 0 | |||
Series 14 Preferred Stock | Common stock purchase warrants | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of warrant issued (in shares) | 139,130 | |||
Warrant exercise price (in USD per share) | $ 72.5 | |||
Warrants outstanding | 0 | |||
Placement Agent | Series 12 Preferred | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of warrant issued (in shares) | 3,042 | |||
Warrant exercise price (in USD per share) | $ 131.25 | |||
Warrants outstanding | 0 | |||
Placement Agent | Series 13 Preferred Stock | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of warrant issued (in shares) | 7,059 | |||
Warrant exercise price (in USD per share) | $ 122.50 | |||
Warrants outstanding | 0 | |||
Placement Agent | Series 14 Preferred Stock | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of warrant issued (in shares) | 6,957 | |||
Warrant exercise price (in USD per share) | $ 86.25 | |||
Warrants outstanding | 0 | |||
Financial Advisory | Series 13 Preferred Stock | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of warrant issued (in shares) | 3,529 | |||
Warrant exercise price (in USD per share) | $ 122.50 | |||
Warrants outstanding | 0 | |||
Financial Advisory | Series 14 Preferred Stock | ||||
Class Of Warrant Or Right [Line Items] | ||||
Number of warrant issued (in shares) | 3,478 | |||
Warrant exercise price (in USD per share) | $ 86.25 | |||
Warrants outstanding | 0 | |||
Affiliates | BVF Partner | ||||
Class Of Warrant Or Right [Line Items] | ||||
Stock Issued (in shares) | 1,000,000 | |||
Stock issued, purchase price (USD per share) | $ 15.70 | |||
Proceeds from issuance of private placement | $ 15.1 |
Common Stock - Summary of Commo
Common Stock - Summary of Common Stock Reserved for Issuance (Detail) shares in Thousands | Dec. 31, 2016shares |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 4,286 |
Common stock purchase warrants | |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 29 |
Equity incentive plans | |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 4,070 |
Employee stock purchase plan | |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 187 |
Other Comprehensive Loss (Detai
Other Comprehensive Loss (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Changes in AOCI [Roll Forward] | ||||
Beginning Balance | $ (6,952,000) | $ (6,952,000) | ||
Current period other comprehensive income (loss) | 297,000 | $ (453,000) | $ 1,930,000 | |
Ending Balance | (6,655,000) | (6,952,000) | ||
Other-than-temporary impairment on available-for-sale securities | 500,000 | 520,000 | 0 | $ 0 |
AFS included in prepaid expenses and other current assets | 2,141,000 | 3,666,000 | ||
Net Unrealized Gain (Loss) and Impairment on Available-For-Sale Securities | ||||
Changes in AOCI [Roll Forward] | ||||
Beginning Balance | (518,000) | (518,000) | ||
Current period other comprehensive income (loss) | 512,000 | |||
Ending Balance | (6,000) | (518,000) | ||
AFS included in prepaid expenses and other current assets | 13,500 | 22,000 | ||
Foreign Currency Translation Adjustments | ||||
Changes in AOCI [Roll Forward] | ||||
Beginning Balance | (3,849,000) | (3,849,000) | ||
Current period other comprehensive income (loss) | 947,000 | |||
Ending Balance | (2,902,000) | (3,849,000) | ||
Unrealized Foreign Exchange Loss on Intercompany Balance | ||||
Changes in AOCI [Roll Forward] | ||||
Beginning Balance | $ (2,585,000) | (2,585,000) | ||
Current period other comprehensive income (loss) | (1,162,000) | |||
Ending Balance | $ (3,747,000) | $ (2,585,000) |
Collaboration, Licensing and 60
Collaboration, Licensing and Milestone Agreements - Additional Information (Detail) | Jan. 01, 2014USD ($) | Dec. 31, 2016EUR (€) | Dec. 31, 2016USD ($) | Feb. 28, 2015EUR (€) | Feb. 28, 2015USD ($) | Oct. 31, 2014EUR (€) | Aug. 31, 2014USD ($) | Jan. 31, 2014USD ($) | Nov. 30, 2013USD ($)$ / sharesshares | Mar. 31, 2014USD ($)patient | Sep. 30, 2013USD ($)patient | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014EUR (€) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($)$ / sharesshares | Jun. 30, 2015USD ($) | May 31, 2012USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Purchase of preferred stock | $ 15,147,000 | |||||||||||||||||
Milestone payment received | $ 32,000,000 | 0 | $ 0 | |||||||||||||||
License and contract revenue | 53,074,000 | 12,620,000 | 53,160,000 | |||||||||||||||
Accrued expenses | $ 24,765,000 | 24,765,000 | 22,133,000 | |||||||||||||||
Servier | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
License revenue | 17,277,000 | |||||||||||||||||
Total upfront payment | 18,129,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Development cost percentage | 25.00% | |||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Maximum amount allowed for the development costs | $ 96,000,000 | |||||||||||||||||
Development cost percentage | 75.00% | |||||||||||||||||
Deferred revenue | 0 | 0 | 1,000,000 | |||||||||||||||
Development services revenue | 1,000,000 | 800,000 | 900,000 | |||||||||||||||
Milestone payment received | $ 20,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | United States Territory | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Development cost percentage | 100.00% | |||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | Series 19 Preferred Stock | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Stock Issued (in shares) | shares | 30,000 | |||||||||||||||||
Preferred stock, par value (in USD per share) | $ / shares | $ 0 | |||||||||||||||||
Issuance costs | $ 200,000 | |||||||||||||||||
Preferred stock, stated value (in USD per share) | $ / shares | $ 1,000 | |||||||||||||||||
Number of preferred stock converted to common stock (in shares) | shares | 30,000 | |||||||||||||||||
Conversion of preferred stock to common stock (in shares) | shares | 1,567,398 | |||||||||||||||||
Preferred stock, conversion price (in USD per share) | $ / shares | $ 19.14 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | Up-front Payment Arrangement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Total consideration received | $ 60,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | Up-front Payment Arrangement | Series 19 Preferred Stock | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Purchase of preferred stock | 30,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | Development Milestone Payments | Maximum | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be received | 112,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | Sales Events Milestone | Maximum | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be received | 190,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | License and Development Services Agreement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Cash consideration received | 30,000,000 | |||||||||||||||||
Proceeds from issuance of convertible preferred stock | 30,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | License | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
License revenue | 27,300,000 | $ 27,300,000 | ||||||||||||||||
Collaborative Arrangement Product Agreement | Baxter | Development Services | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Deferred revenue | $ 2,700,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Servier | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Development services revenue | 500,000 | 0 | 0 | |||||||||||||||
Milestone payment received | € 7,500,000 | 8,000,000 | ||||||||||||||||
Milestones obligation paid | € 2,100,000 | 2,700,000 | ||||||||||||||||
Operating expenses | 300,000 | |||||||||||||||||
Accrued expenses | 800,000 | 800,000 | ||||||||||||||||
Total upfront payment | € 14,000,000 | 18,100,000 | ||||||||||||||||
Collaborative Arrangement Product Agreement | Servier | Clinical and Regulatory Milestone Payment | Phase 3 Clinical Trial | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be received | € | € 9,500,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Servier | Up-front Cash Payment Received | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
License revenue | 17,300,000 | |||||||||||||||||
Upfront cash payment received | € | 14,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Servier | Maximum | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be received | € | 89,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Servier | Maximum | Clinical and Regulatory Milestone Payment | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be received | € | 49,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Servier | Maximum | Sales-based Milestone Payment | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be received | € | € 40,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Servier | Up-front Payment Arrangement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Total consideration received | € 1,500,000 | $ 1,700,000 | ||||||||||||||||
Collaborative Arrangement Product Agreement | Novartis | PIXUVRI | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Percentage of royalty payable to net sales | 10.00% | |||||||||||||||||
Collaborative Arrangement Product Agreement | Novartis | Maximum | PIXUVRI | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be made | $ 16,600,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Gynecologic Oncology Group | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Milestones obligation paid | $ 300,000 | $ 900,000 | ||||||||||||||||
Accrued expenses | 500,000 | 500,000 | 500,000 | |||||||||||||||
Contingency milestone payment to be made | 1,000,000 | 1,000,000 | ||||||||||||||||
Number of patients enrolled | patient | 50 | 1,100 | ||||||||||||||||
Collaborative Arrangement Product Agreement | PG-TXL | Maximum | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be made | 14,400,000 | 14,400,000 | ||||||||||||||||
Collaborative Arrangement Product Agreement | Nerviano Medical Sciences | Maximum | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be made | 80,000,000 | 80,000,000 | ||||||||||||||||
Collaborative Arrangement Product Agreement | Cephalon, Inc | TRISENOX | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
License revenue | 0 | 10,000,000 | 15,000,000 | |||||||||||||||
Collaborative Arrangement Product Agreement | Cephalon, Inc | Maximum | TRISENOX | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be received | $ 100,000,000 | 100,000,000 | ||||||||||||||||
Pacritinib License Agreement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
License and contract revenue | 32,000,000 | |||||||||||||||||
Pacritinib License Agreement | Baxter | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Development services revenue | $ 11,400,000 | $ 0 | $ 0 | |||||||||||||||
S_BIO Asset Purchase Agreement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Milestone payments through the issuance of stock | 50.00% | 50.00% | ||||||||||||||||
S_BIO Asset Purchase Agreement | Maximum | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be made | $ 132,500,000 | |||||||||||||||||
Borrowing Associated With License Agreement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Debt outstanding | $ 32,000,000 | |||||||||||||||||
Borrowing Associated With License Agreement | Pacritinib License Agreement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Debt outstanding | $ 32,000,000 | |||||||||||||||||
Borrowing Associated With License Agreement | Asset Return and Termination Agreement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Gain on termination of agreement | $ 5,900,000 |
Collaboration, Licensing and 61
Collaboration, Licensing and Milestone Agreements - Allocated Arrangement Consideration (Detail) - Servier $ in Thousands | 12 Months Ended |
Dec. 31, 2014USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
License | $ 17,277 |
Development and other services | 852 |
Total upfront payment | $ 18,129 |
Share-Based Compensation - Expe
Share-Based Compensation - Expense by Types of Awards (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Share-based compensation expense | $ 13,324 | $ 14,828 | $ 20,196 |
Performance rights | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Share-based compensation expense | 575 | 3,017 | 1,549 |
Restricted stock | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Share-based compensation expense | 4,199 | 8,656 | 14,749 |
Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Share-based compensation expense | $ 8,550 | $ 3,155 | $ 3,898 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ 13,324 | $ 14,828 | $ 20,196 |
Research and development | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | 2,320 | 3,964 | 3,437 |
Selling, general and administrative | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Share-based compensation expense | $ 11,004 | $ 10,864 | $ 16,759 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2015USD ($)$ / sharesshares | Sep. 30, 2015conditionshares | Jan. 31, 2014USD ($)award | Mar. 31, 2013USD ($)award | Nov. 30, 2011condition | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share-based compensation expense | $ | $ 13,324,000 | $ 14,828,000 | $ 20,196,000 | |||||
Effect on basic and diluted net loss (USD per common share) | $ / shares | $ (0.48) | $ (0.79) | $ (1.36) | |||||
Unrecognized compensation cost | $ | $ 5,900,000 | |||||||
Recognition period | 1 year 10 months 14 days | |||||||
Tax benefits attributed to share-based compensation expense | $ | $ 0 | $ 0 | $ 0 | |||||
Shares of common stock reserved for future issuance (in shares) | 4,286,000 | |||||||
Weighted average exercise price of options exercisable (in USD per share) | $ / shares | $ 25.71 | $ 25.71 | $ 34.18 | |||||
Weighted average fair value of options granted (in USD per share) | $ / shares | $ 3.01 | $ 9.17 | $ 25.90 | |||||
Compensation expense related to nonemployee stock options and restricted stock awards | $ | $ 16,000 | $ 0 | $ 300,000 | |||||
2007 Equity Incentive Stock Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares authorized for issuance (in shares) | 6,300,000 | |||||||
Shares available for future grants (in shares) | 1,100,000 | |||||||
Employee stock purchase plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares of common stock reserved for future issuance (in shares) | 187,000 | |||||||
Vested Restricted Stock | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Repurchased shares of common stock (in shares) | 35,000 | 32,000 | 6,000 | |||||
Repurchased shares of common stock | $ | $ 400,000 | $ 600,000 | $ 200,000 | |||||
Stock Options | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share-based compensation expense | $ | $ 8,550,000 | 3,155,000 | 3,898,000 | |||||
Weighted average exercise price of options exercisable (in USD per share) | $ / shares | $ 12.58 | |||||||
Stock Options | 2007 Equity Incentive Stock Plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Options expiration period | 10 years | |||||||
Restricted stock | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share-based compensation expense | $ | $ 4,199,000 | $ 8,656,000 | $ 14,749,000 | |||||
Shares issued in period (in shares) | 270,000 | 600,000 | 400,000 | |||||
Weighted average fair value of restricted shares issued (in USD per share) | $ / shares | $ 5.64 | $ 20.61 | $ 32.29 | |||||
Restricted shares, cancelled (in shares) | 97,000 | 200,000 | 30,000 | |||||
Total fair value of vested restricted stock awards | $ | $ 1,300,000 | $ 7,300,000 | $ 18,000,000 | |||||
Number of shares vested (in shares) | 257,000 | |||||||
Unvested nonemployee restricted stock awards (in shares) | 267,000 | 183,000 | 267,000 | |||||
Restricted stock units (RSUs) | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares issued in period (in shares) | 187,000 | 46,000 | 0 | |||||
Weighted average fair value of restricted shares issued (in USD per share) | $ / shares | $ 5.35 | $ 15.70 | ||||||
Restricted shares, cancelled (in shares) | 0 | 13,000 | 0 | |||||
Total fair value of vested restricted stock awards | $ | $ 200,000 | |||||||
Number of shares vested (in shares) | 33,000 | 0 | 0 | |||||
Unvested nonemployee restricted stock awards (in shares) | 33,000 | 187,000 | 33,000 | |||||
Long Term Performance Awards | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share-based compensation expense | $ | $ 2,800,000 | |||||||
Number of shares vested (in shares) | 200,000 | |||||||
Total performance conditions | condition | 8 | |||||||
Performance-based award granted | award | 2 | 2 | ||||||
Performance-based award cancelled | award | 1 | |||||||
Performance condition | condition | 1 | |||||||
Vesting period | 3 years | |||||||
Long Term Performance Awards, With Market Based Performance Goals | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Share-based compensation expense | $ | $ 600,000 | $ 300,000 | $ 1,400,000 | |||||
Long-Term Performance Award, total grant-date fair value | $ | $ 3,600,000 | |||||||
Long-Term Performance Award, incremental grant-date fair value | $ | $ (1,000,000) | $ 1,800,000 | $ 800,000 | |||||
Nonemployee Stock Options | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unvested options to acquire shares of common stock, outstanding (in shares) | 11,000 | 7,800 | ||||||
Nonemployee Restricted stock | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unvested nonemployee restricted stock awards (in shares) | 2,100 | |||||||
Employee stock | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares of common stock reserved for future issuance (in shares) | 200,000 | |||||||
Employee stock | Employee stock purchase plan | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Shares of common stock reserved for future issuance (in shares) | 200,000 | |||||||
Shares authorized for issuance (in shares) | 200,000 | |||||||
Shares issued in period (in shares) | 10,000 | 700 | 400 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted Average Assumptions (Detail) - Stock Options | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Risk-free interest rate | 1.20% | 1.70% | 1.70% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected life (in years) | 4 years | 5 years 3 months 20 days | 5 years 2 months 13 days |
Volatility | 75.00% | 80.00% | 97.00% |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Weighted Average Exercise Price | ||||
Weighted Average Exercise Price, Exercisable (in USD per share) | $ 25.71 | $ 34.18 | ||
Stock Options | ||||
Options | ||||
Options, Beginning Balance (in shares) | 1,559,000 | 492,000 | 452,000 | |
Options, Granted (in shares) | 1,511,000 | 1,149,000 | 102,000 | |
Options, Exercised (in shares) | 0 | (8,000) | (18,000) | |
Options, Forfeited (in shares) | (128,000) | (62,000) | (36,000) | |
Options, Cancelled and expired (in shares) | (136,000) | (12,000) | (8,000) | |
Options, Ending Balance (in shares) | 2,806,000 | 1,559,000 | 492,000 | |
Options, Vested or expected to vest (in shares) | 2,749,000 | |||
Options, Exercisable (in shares) | 1,913,000 | 436,100 | 317,400 | 156,000 |
Weighted Average Exercise Price | ||||
Weighted Average Exercise Price, Beginning balance (in USD per share) | $ 17.45 | $ 31.39 | $ 30.40 | |
Weighted Average Exercise Price, Granted (in USD per share) | 6.43 | 13.94 | 34.85 | |
Weighted Average Exercise Price, Exercised (in USD per share) | 0 | 13.98 | 14.89 | |
Weighted Average Exercise Price, Forfeited (in USD per share) | 9.07 | 21.70 | 22.53 | |
Weighted Average Exercise Price, Cancelled and expired (in USD per share) | 25.58 | 242.92 | 98.63 | |
Weighted Average Exercise Price, Ending balance (in USD per share) | 11.50 | $ 17.45 | $ 31.39 | |
Weighted Average Exercise Price, Vested or expected to vest (in USD per share) | 11.58 | |||
Weighted Average Exercise Price, Exercisable (in USD per share) | $ 12.58 | |||
Weighted Average Remaining Contractual Term, Outstanding at end of period | 5 years 3 months 18 days | |||
Weighted Average Remaining Contractual Term, Vested and expected to vest at end of period | 5 years 3 months 18 days | |||
Weighted Average Remaining Contractual Term, Exercisable at end of period | 3 years 7 months 6 days | |||
Aggregate Intrinsic Value, Outstanding at end of period | $ 153 | |||
Aggregate Intrinsic Value, Vested and expected to vest at end of period | 153 | |||
Aggregate Intrinsic Value, Exercisable at end of period | $ 151 |
Share-Based Compensation - Su67
Share-Based Compensation - Summary of Status of Nonvested Restricted Stock Awards (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Restricted stock | |||
Nonvested Shares | |||
Nonvested Shares, Beginning balance (in shares) | 267,000 | ||
Nonvested Shares, Issued (in shares) | 270,000 | 600,000 | 400,000 |
Nonvested Shares, Vested (in shares) | (257,000) | ||
Nonvested Shares, Forfeited (in shares) | (97,000) | (200,000) | (30,000) |
Nonvested Shares, Ending balance (in shares) | 183,000 | 267,000 | |
Weighted Average Grant-Date Fair Value Per Share | |||
Weighted Average Grant-Date Fair Value Per Share, Beginning balance (in USD per share) | $ 22.39 | ||
Weighted Average Grant-Date Fair Value Per Share, Issued (in USD per share) | 5.64 | $ 20.61 | $ 32.29 |
Weighted Average Grant-Date Fair Value Per Share, Vested (in USD per share) | 15.02 | ||
Weighted Average Grant-Date Fair Value Per Share, Forfeited (in USD per share) | 13.38 | ||
Weighted Average Grant-Date Fair Value Per Share, Ending balance (in USD per share) | $ 12.76 | $ 22.39 | |
Restricted stock units (RSUs) | |||
Nonvested Shares | |||
Nonvested Shares, Beginning balance (in shares) | 33,000 | ||
Nonvested Shares, Issued (in shares) | 187,000 | 46,000 | 0 |
Nonvested Shares, Vested (in shares) | (33,000) | 0 | 0 |
Nonvested Shares, Forfeited (in shares) | 0 | (13,000) | 0 |
Nonvested Shares, Ending balance (in shares) | 187,000 | 33,000 | |
Weighted Average Grant-Date Fair Value Per Share | |||
Weighted Average Grant-Date Fair Value Per Share, Beginning balance (in USD per share) | $ 15.70 | ||
Weighted Average Grant-Date Fair Value Per Share, Issued (in USD per share) | 5.35 | $ 15.70 | |
Weighted Average Grant-Date Fair Value Per Share, Vested (in USD per share) | 15.70 | ||
Weighted Average Grant-Date Fair Value Per Share, Forfeited (in USD per share) | 0 | ||
Weighted Average Grant-Date Fair Value Per Share, Ending balance (in USD per share) | $ 5.35 | $ 15.70 |
Employee Benefit Plans (Detail)
Employee Benefit Plans (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Compensation and Retirement Disclosure [Abstract] | |||
Maximum Annual Contributions Per Employee, Percent | 80.00% | ||
Discretionary matching contributions | $ 0.2 | $ 0.2 | $ 0.2 |
Shareholder Rights Plan (Detail
Shareholder Rights Plan (Detail) - Rights plan | 1 Months Ended |
Dec. 31, 2009$ / shares$ / rightshares | |
Class of Stock [Line Items] | |
Conversion rate of right (in shares) | 1 |
Warrant exercise price (in USD per share) | $ / shares | $ 80 |
Percentage of rights held by single shareholder | 20.00% |
Market value of rights | 200.00% |
Redemption price of rights (in USD per right) | $ / right | 0.001 |
Series ZZ Preferred Stock | |
Class of Stock [Line Items] | |
Conversion rate of right (in shares) | 0.001 |
Customer and Geographic Conce70
Customer and Geographic Concentrations - Product Sales by Major Customers (Detail) - Sales Revenue, Goods, Net - Customer Concentration Risk | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Customer A | |||
Revenue, Major Customer [Line Items] | |||
Percentage of product sales | 60.00% | 42.00% | 27.00% |
Customer B | |||
Revenue, Major Customer [Line Items] | |||
Percentage of product sales | 27.00% | 41.00% | 57.00% |
Customer and Geographic Conce71
Customer and Geographic Concentrations - Long-Lived Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total long-lived assets | $ 3,023 | $ 3,718 |
United States | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total long-lived assets | 2,990 | 3,657 |
Europe | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Total long-lived assets | $ 33 | $ 61 |
Net Loss Per Share - Calculatio
Net Loss Per Share - Calculation of Basic & Diluted Net Loss (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Earnings Per Share [Abstract] | |||||||||||
Net loss attributable to common shareholders | $ (6,372) | $ (29,183) | $ (19,766) | $ 3,312 | $ (28,837) | $ (32,592) | $ (32,596) | $ (28,597) | $ (52,009) | $ (122,622) | $ (95,992) |
Basic and diluted: | |||||||||||
Weighted average shares outstanding (in shares) | 28,198 | 19,324 | 15,347 | ||||||||
Less weighted average restricted shares outstanding (in shares) | (250) | (487) | (494) | ||||||||
Shares used in calculation of basic and diluted net loss per common share (in shares) | 27,948 | 18,837 | 14,853 | ||||||||
Net loss per common share: Basic and diluted (USD per share) | $ (1.27) | $ (1.85) | $ (1.86) | $ (1.64) | $ (1.86) | $ (6.51) | $ (6.46) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares shares in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Earnings Per Share [Abstract] | |||
Anti-dilutive securities excluded from computation of earnings per share (in shares) | 2.7 | 1.5 | 1.5 |
Related Party Transactions (Det
Related Party Transactions (Detail) $ in Millions | 1 Months Ended | 12 Months Ended | |||
Dec. 31, 2015USD ($)shares | Sep. 30, 2015shares | Dec. 31, 2016USD ($)member_of_board | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($) | |
Series N-2 Preferred Stock | |||||
Related Party Transaction [Line Items] | |||||
Stock Issued (in shares) | 55,000 | ||||
Number of preferred stock converted to common stock (in shares) | 55,000 | ||||
Conversion of preferred stock to common stock (in shares) | 5,000,000 | ||||
Affiliated Entity | BVF Partner | |||||
Related Party Transaction [Line Items] | |||||
Stock Issued (in shares) | 1,000,000 | ||||
Conversion of preferred stock to common stock (in shares) | 2,700,000 | ||||
Common stock owned by others, percentage | 15.60% | 15.90% | 15.60% | ||
Right to elect members of the board | member_of_board | 2 | ||||
Threshold for voting in board members | 11.00% | ||||
Ownership threshold for resignation from board | 5.00% | ||||
Beneficial ownership threshold for resignation from board | 50.00% | ||||
Affiliated Entity | BVF Partner | Series N-2 Preferred Stock | |||||
Related Party Transaction [Line Items] | |||||
Number of preferred stock converted to common stock (in shares) | 30,000 | ||||
Aequus Biopharma, Inc | Affiliated Entity | |||||
Related Party Transaction [Line Items] | |||||
Percentage of ownership in subsidiary | 60.00% | ||||
Amount funded to subsidiary | $ | $ 1.8 | $ 2.3 | $ 2 | ||
Convertible promissory note balance | $ | $ 11 | $ 13.5 | $ 11 | ||
Aequus Biopharma, Inc | Affiliated Entity | Initial Interest Rate Provided on Note | |||||
Related Party Transaction [Line Items] | |||||
Promissory note interest rate | 6.00% | ||||
Aequus Biopharma, Inc | Affiliated Entity | Interest Rate if Note Not Paid in Full on, or Before Maturity | |||||
Related Party Transaction [Line Items] | |||||
Promissory note interest rate | 10.00% | ||||
Aequus Biopharma, Inc | James A. Bianco, M.D. | James A. Bianco, M.D. | |||||
Related Party Transaction [Line Items] | |||||
Percentage of ownership in subsidiary | 4.30% | ||||
Aequus Biopharma, Inc | Executive Vice President | Jack W. Singer, M.D. | |||||
Related Party Transaction [Line Items] | |||||
Percentage of ownership in subsidiary | 4.30% | ||||
Aequus Biopharma, Inc | Member of Board of Directors | Frederick W. Telling, Ph.D. | |||||
Related Party Transaction [Line Items] | |||||
Percentage of ownership in subsidiary | 3.80% |
Legal Proceedings (Detail)
Legal Proceedings (Detail) $ in Thousands, € in Millions | Jan. 01, 2017 | Jul. 31, 2014grantshares | Mar. 31, 2014EUR (€) | Mar. 31, 2014USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2016EUR (€) | Dec. 31, 2016USD ($) |
Subsequent Event | ||||||||
Loss Contingencies [Line Items] | ||||||||
Reverse stock split ratio | 0.1 | |||||||
2007 Equity Incentive Plan | ||||||||
Loss Contingencies [Line Items] | ||||||||
Number of common stock transferred (in shares) | shares | 4,756,137 | |||||||
Number of common stock transferred, adjusted for reversed stock split (in shares) | shares | 475,613 | |||||||
Types of grants authorized by plan | grant | 6 | |||||||
Non-employee director annual compensation | $ 375 | |||||||
Additional compensation for board chairman | $ 100 | |||||||
Payments for attorney fees | $ 300 | |||||||
VAT Assessments | ||||||||
Loss Contingencies [Line Items] | ||||||||
Taxes paid | € 0.4 | $ 600 | ||||||
Estimate of possible loss | € 9.4 | $ 9,900 |
Income Taxes - Loss Before Inco
Income Taxes - Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
Net loss before income taxes, United States | $ (51,856) | $ (110,831) | $ (84,883) |
Net loss before income taxes, Foreign | (1,097) | (9,932) | (9,346) |
Net loss before noncontrolling interest | $ (52,953) | $ (120,763) | $ (94,229) |
Income Taxes - Reconciliation B
Income Taxes - Reconciliation Between Effective and Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
Federal income tax rate | 34.00% | 34.00% | 34.00% |
Research and development tax credits | 1.00% | 3.00% | 3.00% |
Non-deductible executive compensation | 0.00% | (1.00%) | (3.00%) |
Valuation allowance | (33.00%) | (32.00%) | (30.00%) |
Foreign tax rate differential | 0.00% | (3.00%) | (3.00%) |
Other | (2.00%) | (1.00%) | (1.00%) |
Net effective tax rate | 0.00% | 0.00% | 0.00% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 108,372 | $ 94,024 |
Capitalized research and development | 43,768 | 39,537 |
Research and development tax credit carryforwards | 7,253 | 6,685 |
Stock-based compensation | 19,288 | 15,242 |
Intangible assets | 14,525 | 15,694 |
Depreciation and amortization | 626 | 260 |
Other deferred tax assets | 3,721 | 3,180 |
Total deferred tax assets | 197,553 | 174,622 |
Less: valuation allowance | (197,131) | (173,947) |
Deferred Tax Assets, Net of Valuation Allowance, Total | 422 | 675 |
Deferred tax liabilities: | ||
GAAP adjustments on Novuspharma merger | 0 | (208) |
Deductions for tax in excess of financial statements | (422) | (467) |
Total deferred tax liabilities | (422) | (675) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax [Line Items] | |||
Net operating loss carryforwards | $ 305,400,000 | $ 276,400,000 | |
U.S. federal tax credits | 7,300,000 | 6,700,000 | |
Net operating loss carryforward expiration year | 2,018 | ||
Increase (decrease) in valuation allowance | 23,200,000 | $ 38,700,000 | $ 28,000,000 |
Unrecognized tax benefits | 0 | ||
Accrued interest or penalties related to unrecognized tax benefits | 0 | ||
Reserves for uncertain income tax positions | 0 | ||
United Kingdom | |||
Income Tax [Line Items] | |||
Net operating loss carryforwards | $ 26,700,000 |
Unaudited Quarterly Data (Detai
Unaudited Quarterly Data (Detail) $ / shares in Units, $ in Thousands, € in Millions | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2016EUR (€) | Dec. 31, 2016USD ($) | Dec. 31, 2016USD ($)$ / shares | Sep. 30, 2016USD ($)$ / shares | Jun. 30, 2016USD ($)$ / shares | Mar. 31, 2016USD ($)$ / shares | Dec. 31, 2015USD ($)$ / shares | Sep. 30, 2015USD ($)$ / shares | Jun. 30, 2015USD ($)$ / shares | Mar. 31, 2015USD ($)$ / shares | Dec. 31, 2016USD ($)$ / shares | Dec. 31, 2015USD ($)$ / shares | Dec. 31, 2014USD ($)$ / shares | |
Quarterly Financial Data [Line Items] | |||||||||||||
Total revenues | $ 9,136 | $ 4,433 | $ 7,361 | $ 36,475 | $ 11,324 | $ 964 | $ 1,100 | $ 2,728 | $ 57,405 | $ 16,116 | $ 60,077 | ||
Product sales, net | 1,071 | 986 | 1,051 | 1,223 | 1,087 | 745 | 852 | 812 | 4,331 | 3,496 | 6,917 | ||
Gross profit | 207 | 823 | 891 | 1,033 | 351 | (86) | 669 | 622 | |||||
Net income (loss) attributable to CTI | (6,372) | (29,183) | (19,766) | 3,312 | (25,637) | (32,592) | (32,596) | (28,597) | (52,009) | (119,422) | (93,367) | ||
Net income (loss) attributable to CTI common shareholders | $ (6,372) | $ (29,183) | $ (19,766) | $ 3,312 | $ (28,837) | $ (32,592) | $ (32,596) | $ (28,597) | $ (52,009) | $ (122,622) | $ (95,992) | ||
Net income (loss) per common share—basic (in USD per share) | $ / shares | $ (0.23) | $ (1.04) | $ (0.71) | $ 0.12 | |||||||||
Net income (loss) per common share—diluted (in USD per share) | $ / shares | $ (0.23) | $ (1.04) | $ (0.71) | $ 0.12 | |||||||||
Net loss per common share: Basic and diluted (in USD per share) | $ / shares | $ (1.27) | $ (1.85) | $ (1.86) | $ (1.64) | $ (1.86) | $ (6.51) | $ (6.46) | ||||||
License and contract revenue | $ 53,074 | $ 12,620 | $ 53,160 | ||||||||||
Milestone payment received | $ 32,000 | $ 0 | $ 0 | ||||||||||
Baxter | |||||||||||||
Quarterly Financial Data [Line Items] | |||||||||||||
License and contract revenue | $ 32,000 | ||||||||||||
Collaborative Arrangement Product Agreement | Servier | |||||||||||||
Quarterly Financial Data [Line Items] | |||||||||||||
Milestone payment received | € 7.5 | $ 8,000 | |||||||||||
Teva | |||||||||||||
Quarterly Financial Data [Line Items] | |||||||||||||
License and contract revenue | $ 10,000 |
Subsequent Events (Details)
Subsequent Events (Details) | Jan. 01, 2017 |
Subsequent Event | |
Subsequent Event [Line Items] | |
Reverse stock split ratio | 0.1 |
Schedule II Valuation and Qua82
Schedule II Valuation and Qualifying Accounts (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Reserve for excess, obsolete or unsalable inventory: | ||
Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at beginning of period | $ 1,265 | $ 0 |
Charged to costs and expenses | 692 | 1,326 |
Charged to other accounts | (19) | (25) |
Deductions | (428) | (36) |
Balance at end of period | 1,510 | 1,265 |
Allowance for doubtful accounts: | ||
Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance at beginning of period | 0 | |
Charged to costs and expenses | 1,735 | |
Charged to other accounts | 0 | |
Deductions | (1,735) | |
Balance at end of period | $ 0 | $ 0 |