Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | Apr. 26, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 | |
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 | 57,976,631 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 104,633 | $ 27,218 |
Restricted cash | 0 | 16,000 |
Accounts receivable | 0 | 4 |
Receivables from collaborative arrangements | 775 | 1,278 |
Inventory, net | 564 | 550 |
Prepaid expenses and other current assets | 1,783 | 1,874 |
Total current assets | 107,755 | 46,924 |
Property and equipment, net | 2,233 | 2,365 |
Other assets | 5,734 | 5,597 |
Total assets | 115,722 | 54,886 |
Current liabilities: | ||
Accounts payable | 2,194 | 2,588 |
Accrued expenses | 14,774 | 13,890 |
Current portion of deferred revenue | 915 | 912 |
Current portion of long-term debt | 1,258 | 444 |
Other current liabilities | 1,099 | 1,424 |
Total current liabilities | 20,240 | 19,258 |
Deferred revenue, less current portion | 303 | 494 |
Long-term debt, less current portion | 12,880 | 13,575 |
Other liabilities | 5,252 | 5,469 |
Total liabilities | 38,675 | 38,796 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value per share: Authorized shares - 81,500,000 , Issued and outstanding shares - 57,980,903 and 42,969,494 as of March 31, 2018 and December 31, 2017, respectively | 58 | 43 |
Additional paid-in capital | 2,288,977 | 2,223,388 |
Accumulated other comprehensive loss | (6,804) | (6,272) |
Accumulated deficit | (2,199,447) | (2,195,346) |
Total CTI stockholders' equity | 82,784 | 21,813 |
Noncontrolling interest | (5,737) | (5,723) |
Total stockholders' equity | 77,047 | 16,090 |
Total liabilities and stockholders' equity | 115,722 | 54,886 |
Series O Preferred Stock, 12,575 and 0 shares issued and outstanding as of March 31, 2018 and December 31, 2017, respectively (Aggregate liquidation preference of $25,150 and $0 as of March 31, 2018 and December 31, 2017, respectively) | ||
Stockholders' equity: | ||
Preferred stock | 0 | 0 |
Series N Preferred Stock, 0 shares and 575 shares issued and outstanding as of March 31, 2018 and December 31, 2017, respectively (Aggregate liquidation preference of $0 and $1,150 as of March 31, 2018 and December 31, 2017, respectively) | ||
Stockholders' equity: | ||
Preferred stock | $ 0 | $ 0 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Common stock par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 81,500,000 | 81,500,000 |
Common stock issued (in shares) | 57,980,903 | 42,969,494 |
Common stock outstanding (in shares) | 57,980,903 | 42,969,494 |
Series O Preferred Stock | ||
Preferred stock par value (in dollars per share) | $ 1 | $ 1 |
Preferred stock authorized (in shares) | 33,333 | 33,333 |
Preferred stock issued (in shares) | 12,575 | 0 |
Preferred stock outstanding (in shares) | 12,575 | 0 |
Preferred stock liquidation preference | $ 25,150 | $ 0 |
Series N Preferred Stock | ||
Preferred stock par value (in dollars per share) | $ 1 | $ 1 |
Preferred stock authorized (in shares) | 33,333 | 33,333 |
Preferred stock issued (in shares) | 0 | 575 |
Preferred stock outstanding (in shares) | 0 | 575 |
Preferred stock liquidation preference | $ 0 | $ 1,150 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenues: | ||
Product sales, net | $ 0 | $ 626 |
License and contract revenue | 10,477 | 128 |
Total revenues | 10,477 | 754 |
Operating costs and expenses: | ||
Cost of product sold | 90 | 133 |
Research and development | 9,685 | 9,253 |
Selling, general and administrative | 5,409 | 10,688 |
Other operating income | 371 | 0 |
Total operating costs and expenses, net | 14,813 | 20,074 |
Loss from operations | (4,336) | (19,320) |
Non-operating income (expense): | ||
Interest expense | (288) | (534) |
Amortization of debt discount and issuance costs | (134) | (38) |
Foreign exchange gain (loss) | 723 | (43) |
Total non-operating expense, net | 301 | (615) |
Net loss before noncontrolling interest | (4,035) | (19,935) |
Noncontrolling interest | 14 | 107 |
Net loss | (4,021) | (19,828) |
Deemed dividends on preferred stock | (80) | 0 |
Net loss attributable to common stockholders | $ (4,101) | $ (19,828) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.08) | $ (0.71) |
Shares used in calculation of basic and diluted net loss per common share (in shares) | 50,312 | 28,045 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss before noncontrolling interest | $ (4,035) | $ (19,935) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments | (810) | (501) |
Unrealized foreign exchange gain on intercompany balance | 278 | 546 |
Net unrealized loss on available-for-sale securities | 0 | (1) |
Other comprehensive income | (532) | 44 |
Comprehensive loss | (4,567) | (19,891) |
Comprehensive loss attributable to noncontrolling interest | 14 | 107 |
Comprehensive loss attributable to CTI | $ (4,553) | $ (19,784) |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Operating activities | ||
Net loss before noncontrolling interest | $ (4,035) | $ (19,935) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 1,336 | 1,799 |
Depreciation and amortization | 152 | 193 |
Noncash interest expense | 134 | 38 |
Noncash rent benefit | (538) | (122) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 4 | 73 |
Receivables from collaborative arrangements | 536 | 7,660 |
Inventory | 0 | 48 |
Prepaid expenses and other current assets | 97 | 590 |
Other assets | 9 | 15 |
Accounts payable | (419) | 4,635 |
Accrued expenses | 495 | (3,870) |
Deferred revenue | (189) | 176 |
Other liabilities | (5) | 0 |
Total adjustments | 1,612 | 11,235 |
Net cash used in operating activities | (2,423) | (8,700) |
Investing activities | ||
Purchases of property and equipment | (33) | 0 |
Net cash used in investing activities | (33) | 0 |
Financing activities | ||
Proceeds from common stock offering, net of issuance costs | 64,588 | 0 |
Repayment of Hercules debt | 0 | (1,934) |
Other | (3) | (38) |
Net cash provided by (used in) financing activities | 64,585 | (1,972) |
Effect of exchange rate changes on cash and cash equivalents | (714) | (47) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 61,415 | (10,719) |
Cash, cash equivalents and restricted cash at beginning of period | 43,218 | 44,002 |
Cash, cash equivalents and restricted cash at end of period | 104,633 | 33,283 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 284 | 551 |
Cash paid during the period for taxes | 0 | 0 |
Supplemental disclosure of noncash financing activities | ||
Exchange of common stock and preferred stock for preferred stock | 24,080 | 0 |
Debt issuance costs included in accounts payable and accrued expenses | 93 | 0 |
Common stock issuance costs included in accounts payable and accrued expenses | $ 399 | $ 0 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2018 | |
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 currently have conditional marketing authorization for PIXUVRI in the E.U. 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 months ended March 31, 2018 and 2017 has been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial position at such date and the operating results and cash flows for such periods. Operating results for the three months ended March 31, 2018 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, 2017 included in our Annual Report on Form 10-K filed with the SEC on March 7, 2018. The condensed consolidated balance sheet at December 31, 2017 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 subsidiary, CTI Life Sciences Limited, or CTILS. As of March 31, 2018 , 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. Reincorporation Merger In January 2018, we effected a reincorporation merger, or the Reincorporation, following approval by our Board and our shareholders at our Special Meeting of Shareholders held on January 24, 2018, for the sole purpose of changing the state of incorporation from the State of Washington to the State of Delaware. The Reincorporation resulted in reclassification of carrying amounts for our preferred stock and common stock to additional paid-in capital since, prior to the Reincorporation, we had no par value for our preferred stock and common stock. Subsequent to the Reincorporation, our preferred stock and common stock each have a par value of $0.001 per share. The stockholders' equity section of our condensed consolidated balance sheets have been retroactively adjusted as if the Reincorporation had taken place as of January 1, 2017. There was no impact on our assets and liabilities as a result of the Reincorporation. 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. 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 a Development, Commercialization and License Agreement, or 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 March 31, 2018 , 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 $104.6 million as of March 31, 2018 . 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 be sufficient to fund our operations into the first quarter of 2020. We may need to acquire additional funds in order to develop 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 stockholders 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. Restricted Cash The restricted cash balance as of December 31, 2017 represents a legally restricted deposit held as a compensating balance against our secured term loan with Silicon Valley Bank, or SVB. Pursuant to the loan and security agreement entered into with SVB in November 2017, we were required to maintain unrestricted and unencumbered cash in an amount equal to at least $16.0 million at all times prior to the occurrence of an event relating to the delivery to SVB of duly executed signatures to a control agreement from Bank of America with respect to all of our accounts maintained with Bank of America. In January 2018, we obtained a waiver from SVB for such requirement and as a result, we no longer have restrictions placed on the cash balance. 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 March 31, 2018 primarily relates to royalties as well as the sale of PIXUVRI drug product to Servier . The receivable balance as of December 31, 2017 primarily relates to the sale of PIXUVRI drug product to Servier. 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 March 31, 2018 or December 31, 2017 . 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 $4.9 million and $4.8 million as of March 31, 2018 and December 31, 2017 , respectively, of which $4.8 million and $4.7 million , respectively, was included in other assets and $0.1 million and $0.1 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 March 31, 2018 , the VAT receivable related to operations in Italy was approximately $4.9 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 $0.6 million and $1.4 million related to excess, obsolete or unsalable inventory as of March 31, 2018 and December 31, 2017 , respectively, which was included in Inventory, net. Inventory, net is comprised of bulk active pharmaceutical ingredient which we expect to be saleable to Servier under the terms of the Amended and Restated Exclusive License and Collaboration Agreement, or the Restated Agreement, that we entered into with Servier in April 2017, and to future emerging markets. Revenue Recognition We adopted Accounting Standards Codification, or ASC, Topic 606 - Revenue from Contracts with Customers , on January 1, 2018, or the adoption date, using a modified retrospective method. This standard applies to all contracts with customers, except for contracts that are within the scope of other authoritative literature. Under ASC 606, we recognize revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) we satisfy a performance obligation. We apply the five-step model to arrangements that meet the definition of a contract under ASC 606 including when it is probable that we will collect the consideration we are entitled to in exchange for goods or services we transfer to the customer. At contract inception, we assess the goods or services promised within each contract and determine those that are performance obligations, and assesses whether each promised good or service is distinct. We recognize revenue for the amount of the transaction price that is allocated to the respective performance obligation as the performance obligation is satisfied. Product sales In April 2017, Servier was granted 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). As a result, we no longer have product sales. Prior to April 2017, PIXUVRI was sold primarily through a limited number of wholesale distributors. Under ASC 606, we would record product sales upon receipt of the product by health care providers and certain distributors, or the Customers, at which time the Customers obtain control of our product. Product sales are recorded net of applicable reserves for variable considerations, including distributor discounts, estimated government-mandated rebates, trade discounts and estimated product returns. Reserves are established for these variable considerations that are subject to constraints under ASC 606 and are included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Collaborative Arrangements We recognize license and contract revenue under collaborative agreements that are within the scope of ASC 606. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. We evaluate these agreements under ASC 606 to determine distinct performance obligations. Prior to recognizing revenue, we make estimates of the transaction price, including any variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that there will not be a significant reversal in the amount of cumulative revenue recognized and when the uncertainty associated with the variable consideration is subsequently resolved. Variable consideration may include nonrefundable upfront license fees, payments for research and development activities, reimbursement of certain third-party costs, payments based upon the achievement of specified milestones, and royalty payments based on product sales derived from the collaboration. If there are multiple distinct performance obligations, we allocate the transaction price to each distinct performance obligation based on its relative standalone selling price. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure in accordance with ASC-340-40, Other Assets and Deferred Costs: Contracts with Customers . We have determined that our collaborative agreement with Servier is within the scope of ASC 606 and that the license and development services separately accounted for under the legacy standard would have remained two distinct performance obligations to Servier under ASC 606. As a result, the deferred revenue balance of $1.4 million as of the adoption date, relating to development services will continue to be recognized as revenue through approximately 2019 using an input measure. In addition, there were no milestones recognized as a cumulative effect adjustment to the opening accumulated deficit balance because we were not yet able to overcome constraints associated with the remaining milestones as of the adoption date. There was no change to the timing of revenue recognition with respect to royalties. The adoption of ASC 606 did not have a material impact on our condensed consolidated financial statements. 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. Cost of product sold for the three months ended March 31, 2018 solely relates to contractual royalties as we no longer have product sales as discussed above. 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 stockholders’ 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 $0.3 million and $0.5 million was recorded in the cumulative foreign currency translation adjustment account for the three months ended March 31, 2018 and 2017 , respectively. As of March 31, 2018 , the intercompany balance due from CTILS was €24.6 million (or $30.3 million upon conversion from euros as of March 31, 2018 ). As of December 31, 2017 , the intercompany balance due from CTILS was €26.2 million (or $31.4 million upon conversion from euros as of December 31, 2017 ). Net Loss per Share Basic net loss per share is calculated based on the net loss attributable to common stockholders divided by the weighted average number of shares outstanding for the period. Diluted net loss per share assumes the conversion of all dilutive convertible securities, such as convertible debt and convertible preferred stock, using the if-converted method, and assumes the exercise or vesting of other dilutive securities, such as options, warrants and restricted stock, using the treasury stock method. 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. Common shares underlying equity awards, warrants and convertible preferred stock aggregating 11.8 million shares for the three months ended March 31, 2018 and common shares underlying equity awards and warrants aggregating 3.5 million shares for the three months ended March 31, 2017 were excluded from the calculation of diluted net loss per common share because they were anti-dilutive. Recently Adopted Accounting Standards In May 2014, the FASB issued a comprehensive new standard which amends revenue recognition principles and provides a single set of criteria for revenue recognition among all industries. The new standard provides a five-step framework whereby revenue is recognized when promised goods or services are transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The standard is effective for interim and annual periods beginning after December 15, 2017 and allows for adoption using a full retrospective method, or a modified retrospective method. We adopted the new standard in the first quarter 2018 using the modified retrospective method. The adoption of the standard did not have a material impact on our condensed consolidated financial statements. See " Revenue Recognition" above for further discussion. In March 2018, the FASB issued "Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118," or SAB 118. The guidance adds various SEC paragraphs pursuant to SAB 118 to Accounting Standard Codification 740 “Income Taxes." SAB No. 118 was issued in December 2017 to provide immediate guidance for accounting implications of U.S. tax reform under the Tax Cuts and Jobs Act, which became effective for us on January 1, 2018. The adoption of this guidance did not have material impact on our condensed consolidated financial statements. Recently Issued Accounting Standards 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 condensed consolidated financial statements. Reclassifications Certain prior year items have been reclassified to conform to current year presentation. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory The components of PIXUVRI inventory consisted of the following (in thousands): March 31, 2018 December 31, 2017 Finished goods $ — $ 394 Work-in-process 1,134 1,523 Inventory, gross 1,134 1,917 Reserve for excess, obsolete or unsalable inventory (570 ) (1,367 ) Inventory, net $ 564 $ 550 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2018 | |
Leases [Abstract] | |
Leases | Leases The deferred rent balance was $3.9 million as of March 31, 2018 , of which $1.1 million was included in other current liabilities and $2.8 million was included in other liabilities . As of December 31, 2017 , the deferred rent balance was $4.5 million , of which $1.4 million was included in other current liabilities and $3.1 million was included in other liabilities . Deferred rent includes $0.5 million and $0.6 million in other current liabilities and other liabilities , respectively, as of March 31, 2018 , and $0.8 million and $0.6 million in other current liabilities and other liabilities , respectively, as of December 31, 2017 , associated with the sublease of office space entered into in December 2017. |
Equity Transactions
Equity Transactions | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
Equity Transactions | Equity Transactions In February 2018, we offered and sold 23.0 million shares of our common stock, referred to as the Offering. The price to the public in this Offering was $3.00 per share of common stock. The gross proceeds from the Offering were $69.0 million before deducting underwriting commissions and discounts and other offering costs of approximately $4.8 million . BVF Partners L.P., or BVF, an existing stockholder of the Company, was one of our investors in the Offering. In connection with the Offering, BVF purchased 6.3 million shares of our common stock. In addition, BVF exchanged 8.0 million shares of our common stock owned by BVF and 575 shares of our Series N Preferred Stock owned by BVF for 12,575 shares of our Series O Preferred Stock, pursuant to the exchange agreement executed in February 2018 as well as the letter agreements we entered into with BVF in connection with our Series N-2 Preferred Stock offering in 2015 and our Series N-3 Preferred Stock offering in 2017. Each share of Series O Preferred Stock is convertible at the option of the holder (subject to certain limitations) into shares of common stock at a conversion price of $3.00 per share of common stock. Each share of Series O Preferred Stock 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 O Preferred Stock. The Series O 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 O Preferred Stock has no voting rights, except as otherwise expressly provided in the articles of incorporation of CTI or as otherwise required by law. For the three months ended March 31, 2018 , we recognized $0.1 million in deemed dividends on preferred stock related to the beneficial conversion feature on Series O Preferred Stock. There were 12,575 shares of Series O Preferred Stock outstanding as of March 31, 2018 which are convertible into 8.4 million shares of common stock. |
Share-based Compensation Expens
Share-based Compensation Expense | 3 Months Ended |
Mar. 31, 2018 | |
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 March 31, 2018 2017 Research and development $ 379 $ 32 Selling, general and administrative 957 1,767 Total share-based compensation expense $ 1,336 $ 1,799 We incurred share-based compensation expense due to the following types of awards (in thousands): Three Months Ended March 31, 2018 2017 Restricted stock $ 169 $ 320 Options 1,167 1,479 Total share-based compensation expense $ 1,336 $ 1,799 |
Other Comprehensive Loss
Other Comprehensive Loss | 3 Months Ended |
Mar. 31, 2018 | |
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 on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2017 $ 1 $ (6,829 ) $ 556 $ (6,272 ) Current period other comprehensive income (loss) — (810 ) 278 (532 ) March 31, 2018 $ 1 $ (7,639 ) $ 834 $ (6,804 ) |
Legal Proceedings
Legal Proceedings | 3 Months Ended |
Mar. 31, 2018 | |
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 - Sede Secondaria, or CTI (Europe), based on the ITA’s audit of CTI (Europe)’s value added tax, or 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). The assessments, including interest and penalties, for the years 2003, 2006 and 2007 are €0.6 million , €2.7 million and €0.9 million , respectively. We believe that the services invoiced were non-VAT taxable consultancy services and that the VAT returns are correct as originally filed. We have appealed against all the assessments and are defending ourselves against the assessments both on procedural grounds and on the merits of the cases, 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 VAT Assessment . In June 2013, the Regional Tax Court issued decision no. 119/50/13 in regards to the 2003 VAT Assessment, which accepted the October 2012 appeal of the ITA and reversed a 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 VAT Assessment. In January 2018, the Italian Supreme Court issued decision No. 02250/2018 which (i) rejected the April 2013 appeal of the ITA, (ii) confirmed the October 2012 decision of the Regional Tax Court (127/31/2012), which fully accepted the merits of our earlier appeal and confirmed that no penalties could be imposed against us, and (iii) due to the novelty of the arguments at stake, compensated the legal expenses incurred by the parties. ITA may not use any ordinary means of appeal against the Italian Supreme Court decision, and we intend to take steps to recover the amounts owed to us. 2006 and 2007 VAT Assessments. In November 2013, the ITA appealed to the Italian Supreme Court an April 2013 decision of the Regional Tax Court (57/35/13), that fully rejected the merits of an earlier ITA appeal, declared that no penalties could be imposed against us and found ITA liable to pay us approximately €12,000 , as a partial refund of legal expenses we incurred. No hearing dates have been fixed yet for either the 2003 VAT Assessment or consolidated 2006 and 2007 VAT Assessment 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 €4.2 million , or approximately $5.1 million converted using the currency exchange rate as of March 31, 2018 , including interest and penalties 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. SEC Subpoena We previously disclosed that we had received a subpoena from the SEC in January 2016. 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 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. |
Description of Business and S14
Description of Business and Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2018 | |
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 currently have conditional marketing authorization for PIXUVRI in the E.U. 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 months ended March 31, 2018 and 2017 has been prepared in accordance with accounting principles generally accepted in the U.S. for interim financial information and with the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, such financial information includes all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation of our financial position at such date and the operating results and cash flows for such periods. Operating results for the three months ended March 31, 2018 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, 2017 included in our Annual Report on Form 10-K filed with the SEC on March 7, 2018. The condensed consolidated balance sheet at December 31, 2017 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 subsidiary, CTI Life Sciences Limited, or CTILS. As of March 31, 2018 , 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. 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 a Development, Commercialization and License Agreement, or 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 March 31, 2018 , 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 $104.6 million as of March 31, 2018 . 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 be sufficient to fund our operations into the first quarter of 2020. We may need to acquire additional funds in order to develop 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 stockholders 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. |
Restricted Cash | Restricted Cash The restricted cash balance as of December 31, 2017 represents a legally restricted deposit held as a compensating balance against our secured term loan |
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 March 31, 2018 primarily relates to royalties as well as the sale of PIXUVRI drug product to Servier . The receivable balance as of December 31, 2017 primarily relates to the sale of PIXUVRI drug product to Servier. When it is deemed probable that an amount is uncollectible, it is written off against the existing allowance. |
Value Added Tax Receivable | We review our VAT receivable balance for impairment whenever events or changes in circumstances indicate that the carrying amount might not be recoverable. 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. |
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 adopted Accounting Standards Codification, or ASC, Topic 606 - Revenue from Contracts with Customers , on January 1, 2018, or the adoption date, using a modified retrospective method. This standard applies to all contracts with customers, except for contracts that are within the scope of other authoritative literature. Under ASC 606, we recognize revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) we satisfy a performance obligation. We apply the five-step model to arrangements that meet the definition of a contract under ASC 606 including when it is probable that we will collect the consideration we are entitled to in exchange for goods or services we transfer to the customer. At contract inception, we assess the goods or services promised within each contract and determine those that are performance obligations, and assesses whether each promised good or service is distinct. We recognize revenue for the amount of the transaction price that is allocated to the respective performance obligation as the performance obligation is satisfied. Product sales In April 2017, Servier was granted 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). As a result, we no longer have product sales. Prior to April 2017, PIXUVRI was sold primarily through a limited number of wholesale distributors. Under ASC 606, we would record product sales upon receipt of the product by health care providers and certain distributors, or the Customers, at which time the Customers obtain control of our product. Product sales are recorded net of applicable reserves for variable considerations, including distributor discounts, estimated government-mandated rebates, trade discounts and estimated product returns. Reserves are established for these variable considerations that are subject to constraints under ASC 606 and are included in the transaction price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. |
Collaborative Arrangements | Collaborative Arrangements We recognize license and contract revenue under collaborative agreements that are within the scope of ASC 606. The terms of these agreements may contain multiple performance obligations, which may include licenses and research and development activities. We evaluate these agreements under ASC 606 to determine distinct performance obligations. Prior to recognizing revenue, we make estimates of the transaction price, including any variable consideration that is subject to a constraint. Amounts of variable consideration are included in the transaction price to the extent that it is probable that there will not be a significant reversal in the amount of cumulative revenue recognized and when the uncertainty associated with the variable consideration is subsequently resolved. Variable consideration may include nonrefundable upfront license fees, payments for research and development activities, reimbursement of certain third-party costs, payments based upon the achievement of specified milestones, and royalty payments based on product sales derived from the collaboration. If there are multiple distinct performance obligations, we allocate the transaction price to each distinct performance obligation based on its relative standalone selling price. Revenue is recognized by measuring the progress toward complete satisfaction of the performance obligations using an input measure in accordance with ASC-340-40, Other Assets and Deferred Costs: Contracts with Customers . We have determined that our collaborative agreement with Servier is within the scope of ASC 606 and that the license and development services separately accounted for under the legacy standard would have remained two distinct performance obligations to Servier under ASC 606. As a result, the deferred revenue balance of $1.4 million as of the adoption date, relating to development services will continue to be recognized as revenue through approximately 2019 using an input measure. In addition, there were no milestones recognized as a cumulative effect adjustment to the opening accumulated deficit balance because we were not yet able to overcome constraints associated with the remaining milestones as of the adoption date. There was no change to the timing of revenue recognition with respect to royalties. |
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 stockholders’ 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 Loss per Share | Net Loss per Share Basic net loss per share is calculated based on the net loss attributable to common stockholders divided by the weighted average number of shares outstanding for the period. Diluted net loss per share assumes the conversion of all dilutive convertible securities, such as convertible debt and convertible preferred stock, using the if-converted method, and assumes the exercise or vesting of other dilutive securities, such as options, warrants and restricted stock, using the treasury stock method. 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 May 2014, the FASB issued a comprehensive new standard which amends revenue recognition principles and provides a single set of criteria for revenue recognition among all industries. The new standard provides a five-step framework whereby revenue is recognized when promised goods or services are transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The standard is effective for interim and annual periods beginning after December 15, 2017 and allows for adoption using a full retrospective method, or a modified retrospective method. We adopted the new standard in the first quarter 2018 using the modified retrospective method. The adoption of the standard did not have a material impact on our condensed consolidated financial statements. See " Revenue Recognition" above for further discussion. In March 2018, the FASB issued "Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118," or SAB 118. The guidance adds various SEC paragraphs pursuant to SAB 118 to Accounting Standard Codification 740 “Income Taxes." SAB No. 118 was issued in December 2017 to provide immediate guidance for accounting implications of U.S. tax reform under the Tax Cuts and Jobs Act, which became effective for us on January 1, 2018. The adoption of this guidance did not have material impact on our condensed consolidated financial statements. Recently Issued Accounting Standards 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 condensed consolidated financial statements. |
Reclassifications | Reclassifications Certain prior year items have been reclassified to conform to current year presentation. |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | The components of PIXUVRI inventory consisted of the following (in thousands): March 31, 2018 December 31, 2017 Finished goods $ — $ 394 Work-in-process 1,134 1,523 Inventory, gross 1,134 1,917 Reserve for excess, obsolete or unsalable inventory (570 ) (1,367 ) Inventory, net $ 564 $ 550 |
Share-based Compensation Expe16
Share-based Compensation Expense (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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 March 31, 2018 2017 Research and development $ 379 $ 32 Selling, general and administrative 957 1,767 Total share-based compensation expense $ 1,336 $ 1,799 |
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 March 31, 2018 2017 Restricted stock $ 169 $ 320 Options 1,167 1,479 Total share-based compensation expense $ 1,336 $ 1,799 |
Other Comprehensive Loss (Table
Other Comprehensive Loss (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
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 on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2017 $ 1 $ (6,829 ) $ 556 $ (6,272 ) Current period other comprehensive income (loss) — (810 ) 278 (532 ) March 31, 2018 $ 1 $ (7,639 ) $ 834 $ (6,804 ) |
Description of Business and S18
Description of Business and Summary of Significant Accounting Policies (Details) $ / shares in Units, € in Millions, shares in Millions | 3 Months Ended | |||||||||
Mar. 31, 2018USD ($)shares | Mar. 31, 2017USD ($)shares | Mar. 31, 2018EUR (€) | Mar. 31, 2018USD ($)$ / shares | Jan. 24, 2018$ / shares | Jan. 23, 2018$ / shares | Jan. 01, 2018USD ($) | Dec. 31, 2017EUR (€) | Dec. 31, 2017USD ($)$ / shares | Nov. 30, 2017USD ($) | |
Description Of Business And Significant Accounting Policies [Line Items] | ||||||||||
Common stock par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0 | $ 0.001 | ||||||
Preferred stock par value (in dollars per share) | $ / shares | $ 0.001 | $ 0 | ||||||||
Accumulated deficit | $ 2,199,447,000 | $ 2,195,346,000 | ||||||||
Cash and cash equivalents | 104,633,000 | 27,218,000 | ||||||||
Allowance for doubtful accounts from collaborative arrangements | 0 | 0 | ||||||||
VAT receivable | 4,900,000 | 4,800,000 | ||||||||
Reserve for excess, obsolete or unsalable inventory | (570,000) | (1,367,000) | ||||||||
Deferred revenue | $ 1,400,000 | |||||||||
Unrealized foreign exchange gain on intercompany balance | $ 278,000 | $ 546,000 | ||||||||
Intercompany foreign currency balance, amount | € 24.6 | 30,300,000 | € 26.2 | 31,400,000 | ||||||
Anti-dilutive securities excluded from computation of earnings per share (in shares) | shares | 11.8 | 3.5 | ||||||||
Loan And Security Agreement | Secured Debt | Silicon Valley Bank | ||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | ||||||||||
Unrestricted and unencumbered cash | $ 16,000,000 | |||||||||
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 | 4,900,000 | |||||||||
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 | 4,800,000 | 4,700,000 | ||||||||
Prepaid Expenses and Other Current Assets | ||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | ||||||||||
VAT receivable, current | $ 100,000 | $ 100,000 | ||||||||
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 | Mar. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 0 | $ 394 |
Work-in-process | 1,134 | 1,523 |
Inventory, gross | 1,134 | 1,917 |
Reserve for excess, obsolete or unsalable inventory | (570) | (1,367) |
Inventory, net | $ 564 | $ 550 |
Leases (Details)
Leases (Details) - USD ($) $ in Millions | Mar. 31, 2018 | Dec. 31, 2017 |
Lessor, Lease, Description [Line Items] | ||
Deferred rent balance | $ 3.9 | $ 4.5 |
Deferred rent balance, other current liabilities | 1.1 | 1.4 |
Deferred rent balance, other non-current liabilities | 2.8 | 3.1 |
Sublease | ||
Lessor, Lease, Description [Line Items] | ||
Deferred rent balance, other current liabilities | 0.5 | 0.8 |
Deferred rent balance, other non-current liabilities | $ 0.6 | $ 0.6 |
Equity Transactions (Details)
Equity Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Feb. 28, 2018 | Mar. 31, 2018 | Mar. 31, 2017 | Jan. 24, 2018 | Jan. 23, 2018 | Dec. 31, 2017 | |
Class of Stock [Line Items] | ||||||
Shares issued issued (in shares) | 23,000,000 | |||||
Offering price (in dollars per share) | $ 3 | |||||
Proceeds from common stock offering | $ 69,000 | $ 64,588 | $ 0 | |||
Issuance costs | $ 4,800 | |||||
Preferred stock stated value (in dollars per share) | $ 0.001 | $ 0 | ||||
Series N Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Preferred stock stated value (in dollars per share) | $ 1 | $ 1 | ||||
Preferred stock outstanding (in shares) | 0 | 575 | ||||
Series O Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Conversion price (in dollars per share) | $ 3 | |||||
Preferred stock stated value (in dollars per share) | $ 2,000 | $ 1 | $ 1 | |||
Amount of deemed dividends on preferred stock | $ 100 | |||||
Preferred stock outstanding (in shares) | 12,575 | 0 | ||||
Shares issued in conversion (in shares) | 8,400,000 | |||||
BVF Partners, L.P. | Series N Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Shares converted (in shares) | 575 | |||||
BVF Partners, L.P. | Series O Preferred Stock | ||||||
Class of Stock [Line Items] | ||||||
Converted shares (in shares) | 12,575 | |||||
Common Stock | BVF Partners, L.P. | ||||||
Class of Stock [Line Items] | ||||||
Shares issued issued (in shares) | 6,300,000 | |||||
Shares converted (in shares) | 8,000,000 |
Share-based Compensation Expe22
Share-based Compensation Expense - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total share-based compensation expense | $ 1,336 | $ 1,799 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total share-based compensation expense | 379 | 32 |
Selling, general and administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Total share-based compensation expense | $ 957 | $ 1,767 |
Share-based Compensation Expe23
Share-based Compensation Expense - Share-based Compensation Expense by Types of Awards (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 1,336 | $ 1,799 |
Restricted stock | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | 169 | 320 |
Options | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Total share-based compensation expense | $ 1,167 | $ 1,479 |
Other Comprehensive Loss (Detai
Other Comprehensive Loss (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||
Beginning balance | $ (6,272) | |
Current period other comprehensive income (loss) | (532) | $ 44 |
Ending balance | (6,804) | |
Net Unrealized Loss on Available-For- Sale Securities | ||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||
Beginning balance | 1 | |
Current period other comprehensive income (loss) | 0 | |
Ending balance | 1 | |
Foreign Currency Translation Adjustments | ||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||
Beginning balance | (6,829) | |
Current period other comprehensive income (loss) | (810) | |
Ending balance | (7,639) | |
Unrealized Foreign Exchange Gain on Intercompany Balance | ||
AOCI Including Portion Attributable to Noncontrolling Interest, Net of Tax [Roll Forward] | ||
Beginning balance | 556 | |
Current period other comprehensive income (loss) | 278 | |
Ending balance | $ 834 |
Legal Proceedings (Details)
Legal Proceedings (Details) € in Thousands, $ in Millions | 1 Months Ended | |||||||
Mar. 31, 2014EUR (€) | Mar. 31, 2014USD ($) | Nov. 30, 2013EUR (€) | Mar. 31, 2018EUR (€) | Mar. 31, 2018USD ($) | Dec. 31, 2007EUR (€) | Dec. 31, 2006EUR (€) | Dec. 31, 2003EUR (€) | |
Loss Contingencies [Line Items] | ||||||||
Range of possible loss | € 900 | € 2,700 | € 600 | |||||
VAT Assessments | ||||||||
Loss Contingencies [Line Items] | ||||||||
Range of possible loss | € 4,200 | $ 5.1 | ||||||
VAT assessment paid | € 400 | $ 0.6 | ||||||
Judicial Ruling | ||||||||
Loss Contingencies [Line Items] | ||||||||
Reimbursement of legal fees related to VAT | € 12 |