Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Oct. 30, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | CTIC | |
Entity Registrant Name | CTI BIOPHARMA CORP. | |
Entity Central Index Key | 891,293 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 42,970,377 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 52,800 | $ 44,002 |
Accounts receivable | 180 | 378 |
Receivables from collaborative arrangements | 2,490 | 7,778 |
Inventory, net | 601 | 1,525 |
Prepaid expenses and other current assets | 1,429 | 2,141 |
Total current assets | 57,500 | 55,824 |
Property and equipment, net | 2,534 | 3,023 |
Other assets | 5,498 | 4,996 |
Total assets | 65,532 | 63,843 |
Current liabilities: | ||
Accounts payable | 2,020 | 7,227 |
Accrued expenses | 14,971 | 24,765 |
Current portion of deferred revenue | 872 | 103 |
Current portion of long-term debt | 7,766 | 7,949 |
Other current liabilities | 573 | 602 |
Total current liabilities | 26,202 | 40,646 |
Deferred revenue, less current portion | 716 | 514 |
Long-term debt, less current portion | 7,023 | 11,311 |
Other liabilities | 3,179 | 3,615 |
Total liabilities | 37,120 | 56,086 |
Commitments and contingencies | ||
Shareholders' equity: | ||
Preferred stock, no par value: Authorized shares - 33,333, Series N-3 Preferred Stock, $2,000 stated value per share, 22,500 shares designated, 575 and 0 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively | 1,090 | 0 |
Common stock, no par value: Authorized shares - 81,500,000 and 41,500,000 at September 30, 2017 and December 31, 2016, respectively, Issued and outstanding shares - 42,977,176 and 28,228,602 at September 30, 2017 and December 31, 2016, respectively | 2,220,448 | 2,170,300 |
Accumulated other comprehensive loss | (6,327) | (6,655) |
Accumulated deficit | (2,181,080) | (2,150,326) |
Total CTI shareholders' equity | 34,131 | 13,319 |
Noncontrolling interest | (5,719) | (5,562) |
Total shareholders' equity | 28,412 | 7,757 |
Total liabilities and shareholders' equity | $ 65,532 | $ 63,843 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
N-3 Preferred stock authorized (in shares) | 33,333 | 33,333 |
Common stock authorized (in shares) | 81,500,000 | 41,500,000 |
Common stock issued (in shares) | 42,977,176 | 28,228,602 |
Common stock outstanding (in shares) | 42,977,176 | 28,228,602 |
Series N-3 Preferred Stock, $2,000 stated value, 22,500 shares designated, 575 and 0 shares issued and outstanding as of June 30, 2017 and December 31, 2016, respectively | ||
N-3 Preferred stock stated value (in dollars per share) | $ 2,000 | $ 2,000 |
N-3 Preferred stock designated (in shares) | 22,500 | 22,500 |
N-3 Preferred stock issued (in shares) | 575 | 0 |
N-3 Preferred stock outstanding (in shares) | 575 | 0 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Revenues: | ||||
Product sales, net | $ 0 | $ 914 | $ 853 | $ 3,112 |
License and contract revenue | 1,705 | 3,519 | 23,831 | 45,157 |
Total revenues | 1,705 | 4,433 | 24,684 | 48,269 |
Operating costs and expenses: | ||||
Cost of product sold | 69 | 163 | 280 | 513 |
Research and development | 7,601 | 17,716 | 25,768 | 55,259 |
Selling, general and administrative | 5,802 | 15,218 | 24,452 | 36,101 |
Total operating costs and expenses | 13,472 | 33,097 | 50,500 | 91,873 |
Loss from operations | (11,767) | (28,664) | (25,816) | (43,604) |
Non-operating income (expense): | ||||
Interest expense | (457) | (634) | (1,479) | (2,025) |
Amortization of debt discount and issuance costs | (38) | (38) | (113) | (177) |
Foreign exchange gain (loss) | 161 | (69) | 775 | (107) |
Other non-operating income (expense) | 102 | 44 | 72 | (479) |
Total non-operating expense, net | (232) | (697) | (745) | (2,788) |
Net loss before noncontrolling interest | (11,999) | (29,361) | (26,561) | (46,392) |
Noncontrolling interest | 25 | 178 | 157 | 755 |
Net loss | (11,974) | (29,183) | (26,404) | (45,637) |
Deemed dividends on preferred stock | 0 | 0 | (4,350) | 0 |
Net loss attributable to common shareholders | $ (11,974) | $ (29,183) | $ (30,754) | $ (45,637) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.28) | $ (1.04) | $ (0.90) | $ (1.63) |
Shares used in calculation of basic and diluted net loss per common share (in shares) | 42,878 | 28,002 | 34,270 | 27,919 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss before noncontrolling interest | $ (11,999) | $ (29,361) | $ (26,561) | $ (46,392) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments | (1,029) | (426) | (3,474) | (976) |
Unrealized foreign exchange gain on intercompany balance | 1,131 | 484 | 3,795 | 1,024 |
Other-than-temporary impairment on available-for-sale securities | 0 | 0 | 0 | 519 |
Net unrealized gain (loss) on available-for-sale securities | 8 | 1 | 7 | (7) |
Other comprehensive income | 110 | 59 | 328 | 560 |
Comprehensive loss | (11,889) | (29,302) | (26,233) | (45,832) |
Comprehensive loss attributable to noncontrolling interest | 25 | 178 | 157 | 755 |
Comprehensive loss attributable to CTI | $ (11,864) | $ (29,124) | $ (26,076) | $ (45,077) |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Operating activities | ||
Net loss before noncontrolling interest | $ (26,561) | $ (46,392) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Baxalta milestone revenue | 0 | (32,000) |
Share-based compensation expense | 4,303 | 11,225 |
Depreciation and amortization | 541 | 636 |
Provision for bad debt | 0 | 1,736 |
Other-than-temporary impairment on available-for-sale securities | 0 | 519 |
Noncash interest expense | 113 | 177 |
Noncash rent benefit | (390) | (346) |
Other | (22) | 1 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 231 | (372) |
Receivables from collaborative arrangements | 5,366 | (3,024) |
Inventory | 1,047 | 339 |
Prepaid expenses and other current assets | 767 | 2,011 |
Other assets | 79 | 324 |
Accounts payable | (5,264) | 3,341 |
Accrued expenses | (9,976) | 636 |
Deferred revenue | 972 | (923) |
Other liabilities | 0 | 1 |
Total adjustments | (2,233) | (15,719) |
Net cash used in operating activities | (28,794) | (62,111) |
Investing activities | ||
Purchases of property and equipment | 0 | (137) |
Other | 11 | 0 |
Net cash provided by (used in) investing activities | 11 | (137) |
Financing activities | ||
Repayment of Hercules debt | (4,584) | (3,578) |
Payment of tax withholding obligations related to stock compensation | (62) | (311) |
Proceeds from issuance of preferred stock, net of issuance costs | 42,669 | (314) |
Other | (30) | 21 |
Net cash provided by (used in) financing activities | 37,993 | (4,182) |
Effect of exchange rate changes on cash and cash equivalents | (412) | (157) |
Net increase (decrease) in cash and cash equivalents | 8,798 | (66,587) |
Cash and cash equivalents at beginning of period | 44,002 | 128,182 |
Cash and cash equivalents at end of period | 52,800 | 61,595 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 1,523 | 3,848 |
Cash paid during the period for taxes | 0 | 0 |
Supplemental disclosure of noncash financing activities | ||
Conversion of preferred stock to common stock | 41,578 | 0 |
Baxalta milestone advance - earned in lieu of repayment | $ 0 | $ 32,000 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Description of Business and Summary of Significant Accounting Policies | Description of Business and Summary of Significant Accounting Policies CTI BioPharma Corp., together with its wholly-owned subsidiaries, also referred to collectively in this Quarterly Report on Form 10-Q as “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 evaluating pacritinib for the treatment of adult patients with myelofibrosis and the further development of PIXUVRI worldwide, for which our partners Les Laboratoires Servier and Institut de Recherches Internationales Servier, or collectively Servier, have commercialization rights outside the United States, or the U.S. We operate in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products requires approval from, and is subject to, ongoing oversight by the Food and Drug Administration, or the FDA, in the U.S., the European Medicines Agency, or the EMA, in the European Union, or the E.U., and comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain, may take many years and may involve expenditure of substantial resources. Basis of Presentation The accompanying unaudited financial information as of and for the three and nine months ended September 30, 2017 and 2016 has been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial position at such date and the operating results and cash flows for such periods. Operating results for the three and nine months ended September 30, 2017 are not necessarily indicative of the results that may be expected for the entire year or for any other subsequent interim period. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to the rules of the U.S. Securities and Exchange Commission, or the SEC. These unaudited financial statements and related notes should be read in conjunction with our audited financial statements for the year ended December 31, 2016 included in our Annual Report on Form 10-K filed with the SEC on March 2, 2017. The condensed consolidated balance sheet at December 31, 2016 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by generally accepted accounting principles in the U.S. for complete financial statements. Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of CTI and its wholly-owned subsidiaries, which include Systems Medicine LLC and CTI Life Sciences Limited, or CTILS. We also retain ownership of our branch, CTI BioPharma Corp.– Sede Secondaria, or CTI (Europe); however, we ceased operations related to this branch in September 2009. As of September 30, 2017 , 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 condensed 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. All impacted amounts included in the condensed 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 condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the condensed consolidated financial statements are issued. In accordance with Financial Accounting Standards Board, or the FASB, Accounting Standards Update 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. In October 2016, we resumed primary responsibility for the development and commercialization of pacritinib as a result of the termination of the Pacritinib License Agreement with Baxalta and are no longer eligible to receive cost sharing or milestone payments for pacritinib's development. We have incurred a net operating loss every year since our formation. As of September 30, 2017 , we had an accumulated deficit of $2.2 billion , and we expect to continue to incur net losses for the foreseeable future. Our available cash and cash equivalents were $52.8 million as of September 30, 2017 . 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 2018. 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 condensed consolidated financial statements do not include adjustments, if any, that may result from the outcome of this uncertainty. Receivables from Collaborative Arrangements Our receivables from collaborative arrangements relate to amounts payable or reimbursable to us under the terms of collaborative arrangements with our partners. The receivable balance as of September 30, 2017 primarily relates to a milestone receivable from Servier for the attainment of a regulatory milestone under the Restated Agreement (as defined below) and to Servier’s purchase of PIXUVRI drug product in July 2017. The receivable balance as of December 31, 2016 primarily relates to a milestone receivable from Servier for the attainment of a certain enrollment event in December 2016 in connection with our PIX306 study. When it is deemed probable that an amount is uncollectible, it is written off against the existing allowance. We had no allowance for doubtful accounts from collaborative arrangements as of September 30, 2017 or December 31, 2016 . 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 $4.7 million and $4.4 million as of September 30, 2017 and December 31, 2016 , respectively, of which $4.6 million and $4.1 million , respectively, was included in other assets and $0.1 million and $0.3 million , respectively, was included in prepaid expenses and other current assets . 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 generally approximately three to five years. As of September 30, 2017 , the VAT receivable related to operations in Italy was approximately $4.7 million . We review our VAT receivable balance for impairment whenever events or changes in circumstances indicate that the carrying amount might not be recoverable. Inventory We carry inventory at the lower of cost or net realizable value. 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 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. We had a reserve of $1.3 million and $1.5 million related to excess, obsolete or unsalable inventory as of September 30, 2017 and December 31, 2016 , respectively, which was included in Inventory, net. Inventory, net as of September 30, 2017 is comprised of bulk active pharmaceutical ingredient which we expect to be saleable to Servier under the terms of the Restated Agreement and to future emerging markets. Revenue Recognition We currently have conditional marketing authorization for PIXUVRI in the E.U. Revenue is recognized when there is persuasive evidence of the existence of an agreement, delivery has occurred, prices are fixed or determinable, and collectability is assured. Where the revenue recognition criteria are not met, we defer the recognition of revenue by recording deferred revenue until such time that all criteria under the provision are met. Product sales We sell PIXUVRI primarily 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. As of April 2017, Servier has the exclusive and sublicensable (subject to certain conditions) royalty-bearing license with respect to the development and commercialization of PIXUVRI for use in pharmaceutical products, or Licensed Products, outside of the U.S. (and its territories and possessions). As a result, we no longer have product sales. See Note 5. Collaborative Arrangement for further details. Collaboration Agreements Milestone payments under collaboration agreements 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 Accounting Standard Codification, or ASC, 605-25, Revenue Recognition – Multiple-Element Arrangements , and ASC 808, Collaborative Arrangements , if applicable, to determine the accounting of reimbursement arrangements under 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 allowances, if any, for excess inventory that may expire and become unsalable. Foreign Currency Translation and Transaction Gains and Losses We record foreign currency translation adjustments and transaction gains and losses in accordance with ASC 830, Foreign Currency Matters. For our operations that have a functional currency other than the U.S. dollar, gains and losses resulting from the translation of the functional currency into U.S. dollars for financial statement presentation are not included in determining net loss, but are accumulated in the cumulative foreign currency translation adjustment account as a separate component of shareholders’ equity, 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 condensed 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 condensed 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 unrealized foreign exchange gain of $1.1 million and $0.5 million was recorded in the cumulative foreign currency translation adjustment account for the three months ended September 30, 2017 and 2016 , respectively. An unrealized foreign exchange gain of $3.8 million and $1.0 million was recorded in the cumulative foreign currency translation adjustment account for the nine months ended September 30, 2017 and 2016 , respectively. As of September 30, 2017 , the intercompany balance due from CTILS was €26.6 million (or $31.5 million upon conversion from euros as of September 30, 2017 ). As of December 31, 2016 , the intercompany balance due from CTILS was €29.7 million (or $31.2 million upon conversion from euros as of December 31, 2016 ). Net Income (Loss) per Share Basic net income (loss) per share, or EPS, is calculated based on the net income (loss) attributable to common shareholders divided by the weighted average number of shares outstanding for the period. Diluted EPS 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. In periods when we have a net loss, equity awards, warrants and convertible securities are excluded from our calculation of net loss per share as their inclusion would have an anti-dilutive effect. Equity awards, warrants and convertible preferred stock aggregating 5.0 million shares and 4.5 million shares for the three and nine months ended September 30, 2017 , respectively, were excluded from the calculation of diluted net loss per common share because they were anti-dilutive. Equity awards and warrants aggregating 2.8 million shares and 2.7 million shares for the three and nine months ended September 30, 2016 , respectively, were excluded from the calculation of diluted net loss per common share because they were anti-dilutive. Recently Adopted Accounting Standards 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. The adoption of this standard in the first quarter of 2017 did not have a material impact on our condensed 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. The adoption of this standard in the fourth quarter of 2016 did not have a material impact on our condensed consolidated financial statements. In March 2016, the FASB issued 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). We have historically maintained a full valuation allowance against deferred tax assets. The adoption of this standard in the first quarter of 2017 did not have a material impact on our condensed consolidated financial statements, and we will continue to estimate expected forfeitures. 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 which 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 for 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 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 and 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 new accounting guidance on accounting for leases which requires lessees to recognize virtually all of their leases (other than leases that meet the definition of a short-term lease) on the balance sheet. 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 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 statements of cash flows. In May 2017, the FASB issued an amendment to the scope of modification accounting for share-based payment arrangements which provides guidance on the types of changes to the terms or conditions of share-based payment awards to which an entity would be required to apply modification accounting under ASC 718. Specifically, an entity would not apply modification accounting if the fair value, vesting conditions, and classification of the awards are the same immediately before and after the modification. The accounting guidance is effective for annual periods, and interim periods within those annual 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 consolidated financial statements. Reclassifications Certain prior year items have been reclassified to conform to current year presentation. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory The components of PIXUVRI inventory consisted of the following (in thousands): September 30, 2017 December 31, 2016 Finished goods $ 395 $ 477 Work-in-process 1,554 2,558 Inventory, gross 1,949 3,035 Reserve for excess, obsolete or unsalable inventory (1,348 ) (1,510 ) Inventory, net $ 601 $ 1,525 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2017 | |
Leases [Abstract] | |
Leases | Leases Our deferred rent balance was $3.1 million as of September 30, 2017 , of which $0.6 million was included in other current liabilities and $2.5 million was included in other liabilities . As of December 31, 2016 , our deferred rent balance was $3.5 million , of which $0.5 million was included in other current liabilities and $3.0 million was included in other liabilities . |
Preferred Stock
Preferred Stock | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Preferred Stock | Preferred Stock In June 2017, in an underwritten public offering, we issued 22,500 shares of Series N-3 Preferred Stock, for gross proceeds of $45.0 million before deducting underwriting commissions and discounts and other offering costs of approximately $2.3 million . BVF Partners L.P., or BVF, an existing shareholder of the Company, was one of our investors in this offering. See Note 9. Related Party Transactions for further details. Each share of Series N-3 Preferred Stock is convertible at the option of the holder (subject to a limited exception) and is entitled to a liquidation preference equal to the initial stated value of $2,000 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 N-3 Preferred Stock. The Series N-3 Preferred Stock is 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-3 Preferred Stock has no voting rights, except as otherwise expressly provided in the articles of amendment to amended and restated articles of incorporation of CTI or as otherwise required by law. In June 2017, 21,925 shares of Series N-3 Preferred Stock were converted into 14.6 million shares of common stock at a conversion price of $3.00 per share. For the nine months ended September 30, 2017 , we recognized $4.4 million in deemed dividends on preferred stock related to the beneficial conversion feature on our Series N-3 Preferred Stock. There were 575 shares of Series N-3 Preferred Stock outstanding as of September 30, 2017 . |
Collaborative Arrangement
Collaborative Arrangement | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative Arrangement | Collaborative Arrangement In April 2017 , we entered into an Amended and Restated Exclusive License and Collaboration Agreement (the “Restated Agreement”) with Servier, pursuant to which the Exclusive License and Collaboration Agreement (the “Original Agreement”), entered into in September 2014 with Servier, was amended and restated in its entirety. Under the Restated 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, or Licensed Products, outside of the U.S. (and its territories and possessions). In May 2017 , we received a non-refundable, non-creditable upfront cash payment of €12.0 million under the terms of the Restated Agreement. This amount included a €2.0 million payment for a milestone relating to EMA approval of an additional third-party manufacturer of PIXUVRI, which was not included in the Original Agreement and was deemed achieved at the time of the Restated Agreement. Subject to the achievement of certain conditions, the Restated Agreement provides for additional milestone payments of up to €76.0 million : up to €36.0 million in potential regulatory milestone payments, and up to €40.0 million in potential sales-based milestone payments. We have determined that all the regulatory milestones, other than the €2.0 million milestone mentioned above, are substantive due to significant uncertainty involved in each milestone and will be recognized as revenue upon achievement of the respective milestones, 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. We are eligible to receive tiered royalty payments on net sales of products containing PIXUVRI, ranging from a low-double-digit percentage up to a percentage in the low twenties, subject to certain reductions of up to mid-double-digit percentages under certain circumstances. Royalties are subject to expiration upon certain events, including upon expiration of exclusivity rights to products containing PIXUVRI in the respective country. We owe royalties on net sales of PIXUVRI products as well as other payments to certain third parties. Under the Restated Agreement, with the exception of the conclusion of the PIX306 trial and certain other services, Servier will be responsible for development, commercialization and manufacturing activities within its territory. We have agreed to enter into a commercialization transition plan whereby we will transfer to Servier medical affairs and commercialization activities relating to the Licensed Products in Israel, Turkey, Germany, Austria, the United Kingdom, Denmark, Finland, Norway and Sweden, or collectively, the Transition Territory. Upon the implementation of the commercialization transition plan, we will terminate or assign certain distributor and wholesaler contracts to Servier in the Transition Territory. Each party will be responsible for the manufacture and supply of drug products and substances in their respective territories. We record reimbursements received from Servier for their portion of operating expenses we pay on their behalf as revenue and the full amount of costs as operating expenses in the statements of operations. The Restated Agreement will expire on a country-by-country basis upon the expiration of the royalty terms in the countries in the Servier territory, at which time all licenses granted to Servier would become perpetual and royalty-free. Each party may terminate the Restated Agreement in the event of an uncured repudiatory breach of the other party’s obligations. Subject to applicable notification periods, Servier may terminate the Restated Agreement on a country-by-country basis upon 30 days’ written notice in the event of (i) certain safety or public health issues relating to the Licensed Product, (ii) suspension or withdrawal of marketing authorizations and (iii) without cause. 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 ASC 605-25 Revenue Recognition - Multiple-Element Arrangements , we identified the following non-contingent deliverables with standalone value at the inception of the Restated Agreement: • a license with respect to the development and commercialization of PIXUVRI • development services • joint committee obligations • regulatory responsibilities • commercialization responsibilities • manufacturing and supply responsibilities 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 in order 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 determined that the value of the joint committee obligations and the regulatory, commercial, and manufacturing and supply responsibilities were insignificant. These deliverables have been combined with the development services and included as “Other services” in the table below. We allocated the arrangement consideration of $12.8 million ( €12.0 million converted into U.S. dollars using the currency exchange rate as of the date of the Restated Agreement) based on the percentage of the relative selling price of each unit of accounting as follows (in thousands): License $ 11,487 Other services 1,348 Total upfront payment $ 12,835 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 Restated Agreement. We concluded that a change in the key assumptions used to determine the best estimate of the selling price for the license deliverable would not have a significant effect on the allocation of the arrangement consideration. During the nine months ended September 30, 2017 , we recognized $11.5 million of consideration allocated to the license as revenue upon delivery of the license and the satisfaction of the remaining revenue recognition criteria. The $1.3 million consideration allocated to other services was recorded as deferred revenue. This amount, along with the unamortized deferred revenue balance from the Original Agreement of $0.6 million , is expected to be recognized as revenue through approximately 2019 based on a proportional performance method, by which revenue is recognized in proportion to the development costs incurred. During the three and nine months ended September 30, 2017 , $0.2 million and $0.4 million , respectively, of other services consideration was recognized as revenue; the remaining $1.6 million is included in deferred revenue in the condensed consolidated balance sheet as of September 30, 2017 . In September 2017 , we attained a regulatory milestone under the Restated Agreement and recognized a €1.0 million milestone revenue (or $1.2 million using the currency exchange rate as of the date the milestone was achieved); the amount was recorded in Receivables from Collaborative Arrangements as of September 30, 2017 . |
Share-based Compensation Expens
Share-based Compensation Expense | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-based Compensation Expense | Share-based Compensation Expense The following table summarizes share-based compensation expense, which was allocated as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Research and development $ 229 $ 466 $ 521 $ 1,887 Selling, general and administrative 1,126 4,602 3,782 9,338 Total share-based compensation expense $ 1,355 $ 5,068 $ 4,303 $ 11,225 We incurred share-based compensation expense due to the following types of awards (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Performance rights $ — $ 7 $ — $ 575 Restricted stock 232 454 848 3,645 Options 1,123 4,607 3,455 7,005 Total share-based compensation expense $ 1,355 $ 5,068 $ 4,303 $ 11,225 |
Other Comprehensive Loss
Other Comprehensive Loss | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Other Comprehensive Loss | Other Comprehensive Loss Total accumulated other comprehensive loss consisted of the following (in thousands): Net Unrealized Loss on Available-For- Sale Securities Foreign Currency Translation Adjustments Unrealized Foreign Exchange Gain (Loss) on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2016 $ (6 ) $ (2,902 ) $ (3,747 ) $ (6,655 ) Current period other comprehensive income (loss) 7 (3,474 ) 3,795 328 September 30, 2017 $ 1 $ (6,376 ) $ 48 $ (6,327 ) The value of available-for-sale securities of $13,500 was included in Prepaid expenses and other current assets as of December 31, 2016 . We had no available-for-sale securities as of September 30, 2017 . |
Legal Proceedings
Legal Proceedings | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal Proceedings | 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 which were favorable to CTI with respect to each of the 2005, 2006 and 2007 VAT returns. The Italian Supreme Court held the first hearing for the 2005 VAT case on September 26, 2017, and we are waiting for the Supreme Court to issue its decision. No hearing has been fixed yet for the 2003 and consolidated 2006/2007 VAT cases. 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 $11.1 million converted using the currency exchange rate as of September 30, 2017 , plus collection fees, notification expenses and additional interest for the period lapsed between the date 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. Securities and Exchange Commission Subpoena We previously disclosed that we received a subpoena from the SEC in January 2016. The SEC's subpoena requested, 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, which is ongoing. In re CTI BioPharma Corp. Securities Litigation 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. 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. On July 26, 2017, we received a written offer for the global resolution and settlement of the consolidated action in exchange for cash payment of $20.0 million . The Company has insurance coverage related to this matter and such insurance is expected to cover $18.0 million of the claim. In August 2017, we agreed in principle to the terms of the settlement and submitted the terms and proposed class notice to the court for its preliminary approval. On October 24, 2017, the court granted preliminary approval and set a final approval hearing for February 1, 2018. Wei v. James A. Bianco, et al.; England v. James A Bianco, et al; Nahar v. James A. Bianco, et al.; Hill v. James A. Bianco, et al. On March 14, 2016, a Company shareholder filed the first of four similar derivative lawsuits on behalf of the Company seeking damages for alleged harm to the Company caused by certain current and former officers and directors. The first suit, Wei v. James A. Bianco, et al., 16-2-05818-3, was filed in King County Superior Court, Washington. A second suit, England v. James A. Bianco, et al., 16-2-14422-5, was filed in King County Superior Court, Washington, on June 16, 2016. Two additional derivative suits, Nahar v. James A. Bianco, et al., 2:16-cv-0756, and Hill v. James A. Bianco, et al., 2:16-cv-1250, were filed in the United States District Court for the Western District of Washington on May 24, 2016 and August 9, 2016, respectively. The four suits raise similar allegations and seek similar relief against certain current and former officers and directors , including 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 in each suit as a nominal defendant against which no monetary relief is sought. The complaints generally allege claims of: (1) breach of fiduciary duty; (2) abuse of control; (3) gross mismanagement; (4) waste of corporate assets and (5) unjust enrichment (receiving compensation that was unjust in light of the alleged conduct). Each claim 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. Plaintiffs in none of the suits made a pre-suit demand on the current board of directors of CTI, or 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. Each of plaintiffs’ suits 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. On March 29, 2017 during mediation, the parties to the derivative suits reached an agreement in principle to settle all four suits subject to Board and court approvals. Subject to the terms and conditions in the settlement agreement and court approval, CTI has agreed to adopt certain corporate governance reforms relating to, among other things, the content of CTI-retained independent data monitoring committee charters; engagement if an independent expert or entity to conduct yearly audits of compliance with Good Clinical Practices; the creation of a risk compliance officer position; certain improvements to CTI’s Audit Committee, including the requirement that the Audit Committee review CTI’s periodic public reports to facilitate proper disclosure of risks and risk factors; establishment of an internal audit function that will monitor the Company’s adherence to its policies and procedures, including those related to identification and disclosure of drug candidate safety issues; continuing-education requirements for members of the Board; and improvements to CTI’s nominating committee, compensation committee, and clawback policy. CTI also agreed not to object to an attorneys’ fee application by plaintiffs’ counsel of up to $0.8 million collectively, subject to the terms and conditions in the settlement agreement and court approval. There is no admission of liability or any wrongdoing by any of the individual defendants or CTI. On September 25, 2017, the King County Superior Court entered an order substituting Kevin Hammond for former Lead Plaintiff Gang Wei and Maurio Eley for former Lead Plaintiff Michael England, and the two case captions were amended as reflected above. The parties filed settlement-approval papers on October 26, 2017. In connection with the securities litigation and four derivative lawsuits described above, after taking into account our existing insurance coverage, we recorded $2.2 million of settlement expense in Selling, general and administrative expenses in our condensed consolidated statement of operations for the nine months ended September 30, 2017 . 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. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Aequus We have a majority ownership interest in Aequus. In May 2007, we entered into a license agreement with Aequus whereby Aequus gained rights to our Genetic Polymer™ technology. We also entered into an agreement to fund Aequus in exchange for a convertible promissory note. In March 2017 , we and Aequus entered into a License and Promissory Note Termination Agreement and a Note Cancellation Agreement, pursuant to which (i) all of the then-outstanding principal, plus all accrued and unpaid interest, approximately $13.7 million in total, was cancelled and terminated, (ii) our license agreement with Aequus was terminated, (iii) all obligations to Aequus were terminated with the exception of providing additional funding of up to $347,500 to Aequus, and (iv) Aequus agreed to pay us a) 20% of milestone and similar payments, up to a maximum amount of $20.0 million , and b) royalties, on a product-by-product and county-by country basis, of 5% of net sales of certain ACTH Products being developed by Aequus. The additional funding of $347,500 had been provided in full as of September 30, 2017. Payments from Aequus are due the later of (i) expiration of the last to expire valid patent claim that claims the ACTH Product, or (ii) ten years from the first commercial sale of the applicable ACTH Product. We have the right to terminate the License and Promissory Note Termination Agreement and require Aequus to assign all ACTH Product related assets to us if Aequus does not file an Investigational New Drug Application for an ACTH Product with the FDA by September 6, 2019 . BVF Partners, L.P. In June 2017, as discussed in Note 4. Preferred Stock, we completed an underwritten public offering of 22,500 shares of our Series N-3 Preferred Stock, no par value per share. BVF, an existing shareholder of the Company, purchased 6,750 shares of our Series N-3 Preferred Stock, of which 6,175 shares were converted into approximately 4.1 million shares of our common stock. As a result of this transaction, BVF beneficially owned approximately 20.00% of our outstanding common stock as of September 30, 2017 . BVF beneficially owned 15.87% of our outstanding common stock as of December 31, 2016 . In connection with the Series N-3 Preferred Stock offering, we entered into a letter agreement with BVF, pursuant to which, we agreed to, upon BVF’s election and subject to any board and committee approvals, exchange shares of common stock purchased by BVF directly from us or underlying convertible preferred stock purchased by BVF directly from us, including the shares of common stock underlying the Series N-3 Preferred Stock, into shares of a convertible non-voting preferred stock with substantially similar terms as the Series N-3 Preferred Stock, including a conversion “blocker” initially set at 9.99% of our common stock. Such right would terminate if at any time BVF’s beneficial ownership of our common stock falls below 5% . We will take commercially reasonable efforts to cooperate to effectuate such exchange, provided that such exchange does not adversely affect us and complies with applicable federal and state securities laws. |
Description of Business and S16
Description of Business and Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Description of Business | CTI BioPharma Corp., together with its wholly-owned subsidiaries, also referred to collectively in this Quarterly Report on Form 10-Q as “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 evaluating pacritinib for the treatment of adult patients with myelofibrosis and the further development of PIXUVRI worldwide, for which our partners Les Laboratoires Servier and Institut de Recherches Internationales Servier, or collectively Servier, have commercialization rights outside the United States, or the U.S. We operate in a highly regulated and competitive environment. The manufacturing and marketing of pharmaceutical products requires approval from, and is subject to, ongoing oversight by the Food and Drug Administration, or the FDA, in the U.S., the European Medicines Agency, or the EMA, in the European Union, or the E.U., and comparable agencies in other countries. Obtaining approval for a new therapeutic product is never certain, may take many years and may involve expenditure of substantial resources. |
Basis of Presentation | Basis of Presentation The accompanying unaudited financial information as of and for the three and nine months ended September 30, 2017 and 2016 has been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial position at such date and the operating results and cash flows for such periods. Operating results for the three and nine months ended September 30, 2017 are not necessarily indicative of the results that may be expected for the entire year or for any other subsequent interim period. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to the rules of the U.S. Securities and Exchange Commission, or the SEC. These unaudited financial statements and related notes should be read in conjunction with our audited financial statements for the year ended December 31, 2016 included in our Annual Report on Form 10-K filed with the SEC on March 2, 2017. The condensed consolidated balance sheet at December 31, 2016 has been derived from the audited financial statements at that date, but does not include all of the information and footnotes required by generally accepted accounting principles in the U.S. for complete financial statements. |
Principles of Consolidation | Principles of Consolidation The accompanying condensed consolidated financial statements include the accounts of CTI and its wholly-owned subsidiaries, which include Systems Medicine LLC and CTI Life Sciences Limited, or CTILS. We also retain ownership of our branch, CTI BioPharma Corp.– Sede Secondaria, or CTI (Europe); however, we ceased operations related to this branch in September 2009. As of September 30, 2017 , 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 condensed consolidated financial statements. All intercompany transactions and balances are eliminated in consolidation. |
Liquidity | Liquidity The accompanying condensed consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the condensed consolidated financial statements are issued. In accordance with Financial Accounting Standards Board, or the FASB, Accounting Standards Update 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. In October 2016, we resumed primary responsibility for the development and commercialization of pacritinib as a result of the termination of the Pacritinib License Agreement with Baxalta and are no longer eligible to receive cost sharing or milestone payments for pacritinib's development. We have incurred a net operating loss every year since our formation. As of September 30, 2017 , we had an accumulated deficit of $2.2 billion , and we expect to continue to incur net losses for the foreseeable future. Our available cash and cash equivalents were $52.8 million as of September 30, 2017 . 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 2018. 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 condensed consolidated financial statements do not include adjustments, if any, that may result from the outcome of this uncertainty. |
Receivables | Receivables from Collaborative Arrangements Our receivables from collaborative arrangements relate to amounts payable or reimbursable to us under the terms of collaborative arrangements with our partners. The receivable balance as of September 30, 2017 primarily relates to a milestone receivable from Servier for the attainment of a regulatory milestone under the Restated Agreement (as defined below) and to Servier’s purchase of PIXUVRI drug product in July 2017. The receivable balance as of December 31, 2016 primarily relates to a milestone receivable from Servier for the attainment of a certain enrollment event in December 2016 in connection with our PIX306 study. When it is deemed probable that an amount is uncollectible, it is written off against the existing allowance. |
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. We review our VAT receivable balance for impairment whenever events or changes in circumstances indicate that the carrying amount might not be recoverable. |
Inventory | Inventory We carry inventory at the lower of cost or net realizable value. 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 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. |
Revenue Recognition | Revenue Recognition We currently have conditional marketing authorization for PIXUVRI in the E.U. Revenue is recognized when there is persuasive evidence of the existence of an agreement, delivery has occurred, prices are fixed or determinable, and collectability is assured. Where the revenue recognition criteria are not met, we defer the recognition of revenue by recording deferred revenue until such time that all criteria under the provision are met. Product sales We sell PIXUVRI primarily 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. As of April 2017, Servier has the exclusive and sublicensable (subject to certain conditions) royalty-bearing license with respect to the development and commercialization of PIXUVRI for use in pharmaceutical products, or Licensed Products, outside of the U.S. (and its territories and possessions). As a result, we no longer have product sales. See Note 5. Collaborative Arrangement for further details. Collaboration Agreements Milestone payments under collaboration agreements 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 Accounting Standard Codification, or ASC, 605-25, Revenue Recognition – Multiple-Element Arrangements , and ASC 808, Collaborative Arrangements , if applicable, to determine the accounting of reimbursement arrangements under 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 allowances, if any, for excess inventory that may expire and become unsalable. |
Foreign Currency Translation and Transaction Gains and Losses | Foreign Currency Translation and Transaction Gains and Losses We record foreign currency translation adjustments and transaction gains and losses in accordance with ASC 830, Foreign Currency Matters. For our operations that have a functional currency other than the U.S. dollar, gains and losses resulting from the translation of the functional currency into U.S. dollars for financial statement presentation are not included in determining net loss, but are accumulated in the cumulative foreign currency translation adjustment account as a separate component of shareholders’ equity, 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 condensed 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 condensed 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. |
Net Income (Loss) per Share | Net Income (Loss) per Share Basic net income (loss) per share, or EPS, is calculated based on the net income (loss) attributable to common shareholders divided by the weighted average number of shares outstanding for the period. Diluted EPS 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. In periods when we have a net loss, equity awards, warrants and convertible securities are excluded from our calculation of net loss per share as their inclusion would have an anti-dilutive effect. |
Recently Adopted and Issued Accounting Standards | Recently Adopted Accounting Standards 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. The adoption of this standard in the first quarter of 2017 did not have a material impact on our condensed 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. The adoption of this standard in the fourth quarter of 2016 did not have a material impact on our condensed consolidated financial statements. In March 2016, the FASB issued 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). We have historically maintained a full valuation allowance against deferred tax assets. The adoption of this standard in the first quarter of 2017 did not have a material impact on our condensed consolidated financial statements, and we will continue to estimate expected forfeitures. 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 which 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 for 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 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 and 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 new accounting guidance on accounting for leases which requires lessees to recognize virtually all of their leases (other than leases that meet the definition of a short-term lease) on the balance sheet. 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 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 statements of cash flows. In May 2017, the FASB issued an amendment to the scope of modification accounting for share-based payment arrangements which provides guidance on the types of changes to the terms or conditions of share-based payment awards to which an entity would be required to apply modification accounting under ASC 718. Specifically, an entity would not apply modification accounting if the fair value, vesting conditions, and classification of the awards are the same immediately before and after the modification. The accounting guidance is effective for annual periods, and interim periods within those annual 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 consolidated financial statements. |
Reclassifications | Reclassifications Certain prior year items have been reclassified to conform to current year presentation. |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | The components of PIXUVRI inventory consisted of the following (in thousands): September 30, 2017 December 31, 2016 Finished goods $ 395 $ 477 Work-in-process 1,554 2,558 Inventory, gross 1,949 3,035 Reserve for excess, obsolete or unsalable inventory (1,348 ) (1,510 ) Inventory, net $ 601 $ 1,525 |
Collaborative Arrangement (Tabl
Collaborative Arrangement (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Arrangement Consideration Allocation | We allocated the arrangement consideration of $12.8 million ( €12.0 million converted into U.S. dollars using the currency exchange rate as of the date of the Restated Agreement) based on the percentage of the relative selling price of each unit of accounting as follows (in thousands): License $ 11,487 Other services 1,348 Total upfront payment $ 12,835 |
Share-based Compensation Expe19
Share-based Compensation Expense (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of Share-Based Compensation Expense | The following table summarizes share-based compensation expense, which was allocated as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Research and development $ 229 $ 466 $ 521 $ 1,887 Selling, general and administrative 1,126 4,602 3,782 9,338 Total share-based compensation expense $ 1,355 $ 5,068 $ 4,303 $ 11,225 |
Share-Based Compensation Expense by Types of Awards | We incurred share-based compensation expense due to the following types of awards (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Performance rights $ — $ 7 $ — $ 575 Restricted stock 232 454 848 3,645 Options 1,123 4,607 3,455 7,005 Total share-based compensation expense $ 1,355 $ 5,068 $ 4,303 $ 11,225 |
Other Comprehensive Loss (Table
Other Comprehensive Loss (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Equity [Abstract] | |
Total Accumulated Other Comprehensive Loss | Total accumulated other comprehensive loss consisted of the following (in thousands): Net Unrealized Loss on Available-For- Sale Securities Foreign Currency Translation Adjustments Unrealized Foreign Exchange Gain (Loss) on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2016 $ (6 ) $ (2,902 ) $ (3,747 ) $ (6,655 ) Current period other comprehensive income (loss) 7 (3,474 ) 3,795 328 September 30, 2017 $ 1 $ (6,376 ) $ 48 $ (6,327 ) |
Description of Business and S21
Description of Business and Summary of Significant Accounting Policies (Details) € in Millions, shares in Millions | Jan. 01, 2017 | Sep. 30, 2017USD ($)shares | Sep. 30, 2016USD ($)shares | Sep. 30, 2017USD ($)shares | Sep. 30, 2016USD ($)shares | Sep. 30, 2017EUR (€) | Sep. 30, 2017USD ($) | Dec. 31, 2016EUR (€) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) |
Description Of Business And Significant Accounting Policies [Line Items] | ||||||||||
Reverse stock split ratio | 0.1 | |||||||||
Accumulated deficit | $ 2,181,080,000 | $ 2,150,326,000 | ||||||||
Cash and cash equivalents | $ 61,595,000 | $ 61,595,000 | 52,800,000 | 44,002,000 | $ 128,182,000 | |||||
Allowance for doubtful accounts from collaborative arrangements | 0 | 0 | ||||||||
VAT receivable | 4,700,000 | 4,400,000 | ||||||||
Reserve for excess, obsolete or unsalable inventory | 1,348,000 | 1,510,000 | ||||||||
Unrealized foreign exchange gain on intercompany balance | $ 1,131,000 | $ 484,000 | $ 3,795,000 | $ 1,024,000 | ||||||
Intercompany foreign currency balance, amount | € 26.6 | 31,500,000 | € 29.7 | 31,200,000 | ||||||
Anti-dilutive securities excluded from computation of earnings per share (in shares) | shares | 5 | 2.8 | 4.5 | 2.7 | ||||||
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 | 4,700,000 | |||||||||
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 | 4,600,000 | 4,100,000 | ||||||||
Prepaid Expenses and Other Current Assets | ||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | ||||||||||
VAT receivable, current | $ 100,000 | $ 300,000 | ||||||||
Aequus Biopharma, Inc | Affiliated Entity | ||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | ||||||||||
Interest in majority-owned subsidiary | 60.00% | 60.00% |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 395 | $ 477 |
Work-in-process | 1,554 | 2,558 |
Inventory, gross | 1,949 | 3,035 |
Reserve for excess, obsolete or unsalable inventory | (1,348) | (1,510) |
Inventory, net | $ 601 | $ 1,525 |
Leases (Details)
Leases (Details) - USD ($) $ in Millions | Sep. 30, 2017 | Dec. 31, 2016 |
Leases [Abstract] | ||
Deferred rent balance | $ 3.1 | $ 3.5 |
Deferred rent balance, other current liabilities | 0.6 | 0.5 |
Deferred rent balance, other non-current liabilities | $ 2.5 | $ 3 |
Preferred Stock (Details)
Preferred Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Jun. 30, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Class of Stock [Line Items] | ||||
Proceeds from issuance of preferred stock, net of issuance costs | $ 42,669 | $ (314) | ||
Series N-3 Preferred Stock | ||||
Class of Stock [Line Items] | ||||
N-3 Preferred stock issued (in shares) | 22,500 | |||
Proceeds from issuance of preferred stock, net of issuance costs | $ 45,000 | |||
Issuance costs | $ 2,300 | |||
N-3 Preferred stock stated value (in dollars per share) | $ 2,000 | $ 2,000 | $ 2,000 | |
Shares converted (in shares) | 21,925 | |||
Shares issued in conversion (in shares) | 14,600,000 | |||
Conversion price (in dollars per share) | $ 3 | |||
Amount of deemed dividends on preferred stock | $ 4,400 | |||
N-3 Preferred stock outstanding (in shares) | 575 | 0 |
Collaborative Arrangement - Add
Collaborative Arrangement - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Sep. 30, 2017EUR (€) | Sep. 30, 2017USD ($) | May 31, 2017EUR (€) | May 31, 2017USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | May 31, 2017USD ($) | Sep. 30, 2014USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Consideration received | $ 1,705 | $ 4,433 | $ 24,684 | $ 48,269 | ||||||
Servier milestone revenue | $ 0 | $ 32,000 | ||||||||
Servier | Collaborative Arrangement | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Consideration received | € 12,000,000 | $ 12,835 | ||||||||
Servier milestone revenue | € 1,000,000 | $ 1,200 | 2,000,000 | |||||||
Potential milestone payments to be received | € | 76,000,000 | |||||||||
Potential regulatory milestone payments to be received | € | 36,000,000 | |||||||||
Potential sales milestone payments to be received | € | € 40,000,000 | |||||||||
Authorized termination period | 30 days | |||||||||
Servier | Collaborative Arrangement | License | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Consideration received | 11,487 | $ 11,500 | ||||||||
Servier | Collaborative Arrangement | Other services | ||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||
Consideration received | $ 1,348 | |||||||||
Unamortized deferred revenue | $ 1,600 | 1,600 | 1,600 | $ 1,300 | $ 600 | |||||
Revenue recognized | $ 200 | $ 400 |
Collaborative Arrangement - Arr
Collaborative Arrangement - Arrangement Consideration Allocation (Details) $ in Thousands, € in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
May 31, 2017EUR (€) | May 31, 2017USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total upfront payment | $ 1,705 | $ 4,433 | $ 24,684 | $ 48,269 | ||
Servier | Collaborative Arrangement | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total upfront payment | € 12 | $ 12,835 | ||||
License | Servier | Collaborative Arrangement | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total upfront payment | 11,487 | $ 11,500 | ||||
Other services | Servier | Collaborative Arrangement | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Total upfront payment | $ 1,348 |
Share-based Compensation Expe27
Share-based Compensation Expense - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense | $ 1,355 | $ 5,068 | $ 4,303 | $ 11,225 |
Research and development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense | 229 | 466 | 521 | 1,887 |
Selling, general and administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Total share-based compensation expense | $ 1,126 | $ 4,602 | $ 3,782 | $ 9,338 |
Share-based Compensation Expe28
Share-based Compensation Expense - Share-based Compensation Expense by Types of Awards (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 1,355 | $ 5,068 | $ 4,303 | $ 11,225 |
Performance rights | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | 0 | 7 | 0 | 575 |
Restricted stock | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | 232 | 454 | 848 | 3,645 |
Options | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Total share-based compensation expense | $ 1,123 | $ 4,607 | $ 3,455 | $ 7,005 |
Other Comprehensive Loss (Detai
Other Comprehensive Loss (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | |||||
Beginning balance | $ (6,655,000) | ||||
Current period other comprehensive income (loss) | $ 110,000 | $ 59,000 | 328,000 | $ 560,000 | |
Ending balance | (6,327,000) | (6,327,000) | |||
AFS included in prepaid expenses and other current assets | 1,429,000 | 1,429,000 | $ 2,141,000 | ||
Net Unrealized Loss on Available-For- Sale Securities | |||||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | |||||
Beginning balance | (6,000) | ||||
Current period other comprehensive income (loss) | 7,000 | ||||
Ending balance | 1,000 | 1,000 | |||
AFS included in prepaid expenses and other current assets | 0 | 0 | $ 13,500 | ||
Foreign Currency Translation Adjustments | |||||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | |||||
Beginning balance | (2,902,000) | ||||
Current period other comprehensive income (loss) | (3,474,000) | ||||
Ending balance | (6,376,000) | (6,376,000) | |||
Unrealized Foreign Exchange Gain (Loss) on Intercompany Balance | |||||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | |||||
Beginning balance | (3,747,000) | ||||
Current period other comprehensive income (loss) | 3,795,000 | ||||
Ending balance | $ 48,000 | $ 48,000 |
Legal Proceedings (Details)
Legal Proceedings (Details) € in Millions, $ in Millions | Jul. 26, 2017USD ($) | Mar. 29, 2017USD ($) | Mar. 31, 2014EUR (€) | Mar. 31, 2014USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2017EUR (€) | Sep. 30, 2017USD ($) |
CTI BioPharma Corp. Securities Litigation | |||||||
Loss Contingencies [Line Items] | |||||||
Settlement amount | $ 20 | ||||||
Settlement amount, portion expected to be covered by insurance | $ 18 | ||||||
Derivative Lawsuits | |||||||
Loss Contingencies [Line Items] | |||||||
Settlement amount | $ 0.8 | ||||||
Settlement expense | $ 2.2 | ||||||
VAT Assessments | |||||||
Loss Contingencies [Line Items] | |||||||
VAT assessment paid | € 0.4 | $ 0.6 | |||||
Range of possible loss, maximum | € 9.4 | $ 11.1 |
Related Party Transactions (Det
Related Party Transactions (Details) | 1 Months Ended | |||
Jun. 30, 2017shares | Mar. 31, 2017USD ($) | Sep. 30, 2017 | Dec. 31, 2016 | |
Series N-3 Preferred Stock | ||||
Related Party Transaction [Line Items] | ||||
N-3 Preferred stock issued (in shares) | 22,500 | |||
Shares converted (in shares) | 21,925 | |||
Shares issued in conversion (in shares) | 14,600,000 | |||
Affiliated Entity | Series N-3 Preferred Stock | ||||
Related Party Transaction [Line Items] | ||||
N-3 Preferred stock issued (in shares) | 22,500 | |||
Affiliated Entity | Series N-3 Preferred Stock | BVF Partners, L.P. | ||||
Related Party Transaction [Line Items] | ||||
N-3 Preferred stock issued (in shares) | 6,750 | |||
Shares converted (in shares) | 6,175 | |||
Shares issued in conversion (in shares) | 4,100,000 | |||
Percentage of outstanding common stock owned | 20.00% | 15.87% | ||
Affiliated Entity | Series N-3 Preferred Stock | BVF Partners, L.P. | Maximum | ||||
Related Party Transaction [Line Items] | ||||
Preferred share conversion threshold | 9.99% | |||
Affiliated Entity | Series N-3 Preferred Stock | BVF Partners, L.P. | Minimum | ||||
Related Party Transaction [Line Items] | ||||
Preferred share conversion threshold | 5.00% | |||
Affiliated Entity | Aequus Biopharma, Inc | License and Promissory Note | Convertible Debt | ||||
Related Party Transaction [Line Items] | ||||
Gain on termination of agreement | $ | $ 13,700,000 | |||
Affiliated Entity | Aequus Biopharma, Inc | License and Promissory Note Termination, and Note Cancellation Agreements | ||||
Related Party Transaction [Line Items] | ||||
Amount funded to subsidiary | $ | $ 347,500 | |||
Percentage of milestone and similar payments | 0.2 | |||
Maximum milestone amount to be received | $ | $ 20,000,000 | |||
Percentage of royalty to net sales | 5.00% |