Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 28, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CTIC | ||
Entity Registrant Name | CTI BIOPHARMA CORP. | ||
Entity Central Index Key | 0000891293 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 57,980,075 | ||
Entity Public Float | $ 252.1 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 36,439 | $ 27,218 |
Restricted cash | 0 | 16,000 |
Short-term investments | 30,599 | 0 |
Receivables from license and development services arrangements | 13,679 | 1,278 |
Prepaid expenses and other current assets | 1,775 | 2,428 |
Total current assets | 82,492 | 46,924 |
Property and equipment, net | 1,793 | 2,365 |
Other assets | 5,547 | 5,597 |
Total assets | 89,832 | 54,886 |
Current liabilities: | ||
Accounts payable | 4,498 | 2,588 |
Accrued expenses | 12,852 | 13,890 |
Current portion of deferred revenue | 0 | 912 |
Current portion of long-term debt | 4,812 | 444 |
Other current liabilities | 893 | 1,424 |
Total current liabilities | 23,055 | 19,258 |
Deferred revenue, less current portion | 0 | 494 |
Long-term debt, less current portion | 9,267 | 13,575 |
Other liabilities | 4,571 | 5,469 |
Total liabilities | 36,893 | 38,796 |
Commitments and contingencies (Note 18) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value per share: Authorized shares - 101,500,000 and 81,500,000 as of December 31, 2018 and 2017, respectively, Issued and outstanding shares - 57,986,075 and 42,969,494 as of December 31, 2018 and 2017, respectively | 58 | 43 |
Additional paid-in capital | 2,294,025 | 2,223,388 |
Accumulated other comprehensive loss | (10,643) | (6,272) |
Accumulated deficit | (2,224,746) | (2,195,346) |
Total CTI stockholders' equity | 58,694 | 21,813 |
Noncontrolling interest | (5,755) | (5,723) |
Total stockholders' equity | 52,939 | 16,090 |
Total liabilities and stockholders' equity | 89,832 | 54,886 |
Preferred stock, $0.001 par value per share: Authorized shares - 33,333, Series O Preferred Stock, 12,575 shares and 0 shares issued and outstanding as of December 31, 2018 and 2017, respectively (Aggregate liquidation preference of $25,150 and $0 as of December 31, 2018 and 2017, respectively) | ||
Stockholders' equity: | ||
Preferred stock, Series O and N, $0.001 par value per share | 0 | 0 |
Preferred stock, $0.001 par value per share: Authorized shares - 33,333, Series N Preferred Stock, 0 shares and 575 shares issued and outstanding as of December 31, 2018 and 2017, respectively (Aggregate liquidation preference of $0 and $1,150 as of December 31, 2018 and 2017, respectively) | ||
Stockholders' equity: | ||
Preferred stock, Series O and N, $0.001 par value per share | $ 0 | $ 0 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Preferred stock authorized (in shares) | 33,333 | 33,333 |
Common stock par value (in USD per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 101,500,000 | 81,500,000 |
Common stock issued (in shares) | 57,986,075 | 42,969,494 |
Common stock outstanding (in shares) | 57,986,075 | 42,969,494 |
Series O Preferred Stock | ||
Preferred stock par value (in USD per share) | $ 0.001 | $ 0.001 |
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 USD per share) | $ 0.001 | $ 0.001 |
Preferred stock issued (in shares) | 0 | 575 |
Preferred stock outstanding (in shares) | 0 | 575 |
Preferred stock liquidation preference | $ 0 | $ 1,150 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | ||
Total revenues | $ 26,290 | $ 25,146 |
Operating costs and expenses: | ||
Cost of product sold | 879 | 364 |
Research and development | 36,467 | 32,866 |
Selling, general and administrative | 21,183 | 31,435 |
Restructuring expenses | 660 | 0 |
Total operating costs and expenses | 59,189 | 64,665 |
Loss from operations | (32,899) | (39,519) |
Non-operating expense: | ||
Interest income | 1,219 | 0 |
Interest expense | (1,209) | (1,872) |
Amortization of debt discount and issuance costs | (525) | (163) |
Foreign exchange (loss) gain | (233) | 817 |
Other non-operating income (expense) | 4,295 | (94) |
Total non-operating income (expense), net | 3,547 | (1,312) |
Net loss before noncontrolling interest | (29,352) | (40,831) |
Noncontrolling interest | 32 | 161 |
Net loss | (29,320) | (40,670) |
Deemed dividends on preferred stock | (80) | (4,350) |
Net loss attributable to common stockholders | $ (29,400) | $ (45,020) |
Basic and diluted net loss per common share (in USD per share) | $ (0.52) | $ (1.24) |
Shares used in calculation of basic and diluted net loss per common share (in shares) | 56,073 | 36,445 |
Product sales, net | ||
Revenues: | ||
Total revenues | $ 0 | $ 853 |
License and contract revenue | ||
Revenues: | ||
Total revenues | $ 26,290 | $ 24,293 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss before noncontrolling interest | $ (29,352) | $ (40,831) |
Other comprehensive (loss) income: | ||
Foreign currency translation adjustments | (2,843) | (3,927) |
Unrealized foreign exchange (loss) gain on intercompany balance | (1,513) | 4,303 |
Net unrealized (loss) gain on securities available-for-sale | (15) | 7 |
Other comprehensive (loss) income | (4,371) | 383 |
Comprehensive loss | (33,723) | (40,448) |
Comprehensive loss attributable to noncontrolling interest | 32 | 161 |
Comprehensive loss attributable to CTI | $ (33,691) | $ (40,287) |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Preferred Stock | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Noncontrolling Interest |
Beginning Balance (in shares) at Dec. 31, 2016 | 0 | 28,229,000 | |||||
Beginning Balance at Dec. 31, 2016 | $ 7,757 | $ 0 | $ 28 | $ 2,170,272 | $ (6,655) | $ (2,150,326) | $ (5,562) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of stock, net of issuance cots (in shares) | 22,500 | ||||||
Issuance of stock, net of issuance cots | 42,669 | 42,669 | |||||
Conversion of stock (in shares) | (21,900) | 14,616,000 | |||||
Conversion of stock | 0 | $ 15 | (15) | ||||
Value of beneficial conversion features related to preferred stock | 0 | 4,350 | (4,350) | ||||
Issuance of warrants | 470 | 470 | |||||
Equity-based compensation (in shares) | 150,000 | ||||||
Equity-based compensation | 5,746 | 5,746 | |||||
Noncontrolling interest | (161) | (161) | |||||
Other (in shares) | (26,000) | ||||||
Other | (104) | (104) | |||||
Net loss for the year ended | (40,670) | (40,670) | |||||
Other comprehensive income (loss) | 383 | 383 | |||||
Ending Balance (in shares) at Dec. 31, 2017 | 600 | 42,969,000 | |||||
Ending Balance at Dec. 31, 2017 | 16,090 | $ 0 | $ 43 | 2,223,388 | (6,272) | (2,195,346) | (5,723) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Issuance of stock, net of issuance cots (in shares) | 23,000,000 | ||||||
Issuance of stock, net of issuance cots | 64,170 | $ 23 | 64,147 | ||||
Conversion of stock (in shares) | 12,000 | (8,000,000) | |||||
Conversion of stock | 0 | $ (8) | 8 | ||||
Value of beneficial conversion features related to preferred stock | 0 | 80 | (80) | ||||
Equity-based compensation | 6,369 | 6,369 | |||||
Noncontrolling interest | (32) | (32) | |||||
Other (in shares) | 17,000 | ||||||
Other | 33 | 33 | |||||
Net loss for the year ended | (29,320) | (29,320) | |||||
Other comprehensive income (loss) | (4,371) | (4,371) | |||||
Ending Balance (in shares) at Dec. 31, 2018 | 12,600 | 57,986,000 | |||||
Ending Balance at Dec. 31, 2018 | $ 52,939 | $ 0 | $ 58 | $ 2,294,025 | $ (10,643) | $ (2,224,746) | $ (5,755) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities | ||
Net loss before noncontrolling interest | $ (29,352) | $ (40,831) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation expense | 6,369 | 5,746 |
Depreciation and amortization | 593 | 717 |
Loss on debt extinguishment | 0 | 163 |
Loss on sublease | 0 | 1,584 |
Gain on dissolution of a foreign entity | (4,288) | 0 |
Noncash interest expense | 525 | 163 |
Noncash rent benefit | (1,424) | (648) |
Unrealized foreign exchange loss | 362 | 0 |
Other | 432 | (18) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 4 | 402 |
Receivables from license and development services arrangements | (12,389) | 6,579 |
Inventory | 0 | 1,120 |
Prepaid expenses and other current assets | 253 | 326 |
Other assets | (420) | 63 |
Accounts payable | 1,869 | (4,730) |
Accrued expenses | (946) | (11,096) |
Deferred revenue | (1,407) | 790 |
Other liabilities | (5) | 374 |
Net cash used in operating activities | (39,824) | (39,296) |
Investing activities | ||
Purchases of property and equipment | (33) | (49) |
Purchases of short-term investments | (42,067) | 0 |
Proceeds from maturities of short-term investments | 11,610 | 0 |
Proceeds from sale of available-for-sale securities | 0 | 11 |
Net cash used in investing activities | (30,490) | (38) |
Financing activities | ||
Proceeds from common stock offering, net of issuance costs | 64,170 | 0 |
Cash paid for at-the-market equity offering issuance costs | (168) | 0 |
Proceeds from issuance of preferred stock, net of issuance costs | 0 | 42,669 |
Payments of issuance costs from Silicon Valley Bank debt, net of issuance costs | (100) | |
Proceeds from Silicon Valley Bank debt, net of issuance costs | 15,971 | |
Repayment of debt | (444) | (19,548) |
Payment of tax withholding obligations related to stock compensation | (21) | (87) |
Proceeds from stock option exercises | 46 | 0 |
Proceeds from ESPP stock issuance | 8 | 10 |
Cash paid for repurchase of fractional shares | 0 | (36) |
Net cash provided by financing activities | 63,491 | 38,979 |
Effect of exchange rate changes on cash and cash equivalents | 44 | (429) |
Net decrease in cash, cash equivalents and restricted cash | (6,779) | (784) |
Cash, cash equivalents and restricted cash at beginning of year | 43,218 | 44,002 |
Cash, cash equivalents and restricted cash at end of year | 36,439 | 43,218 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | 1,197 | 1,970 |
Supplemental disclosure of noncash financing and investing activities | ||
Exchange of common stock and preferred stock for preferred stock | 24,080 | 0 |
Conversion of preferred stock to common stock | $ 0 | $ 41,579 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Description of Business and Summary of Significant Accounting Policies | 1. Description of Business and Summary of Significant Accounting Policies CTI BioPharma Corp., together with its wholly-owned subsidiary, also referred to collectively in this Annual Report on Form 10-K as “we,” “us,” “our,” the “Company” and “CTI,” is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their 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 concentrate 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. 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. Principles of Consolidation The accompanying consolidated financial statements include the accounts of CTI and its wholly-owned subsidiary, CTI Life Sciences Limited, or CTILS. As of December 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 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 certain carrying amounts of our preferred stock and common stock to additional paid-in capital since, prior to the Reincorporation, our preferred stock and common stock had no par value. Subsequent to the Reincorporation, our preferred stock and common stock each have a par value of $0.001 per share. There was no impact on our assets and liabilities as a result of the Reincorporation. Liquidity The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the consolidated financial statements are issued. 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 December 31, 2018 , we had an accumulated deficit of $2.2 billion , and we expect to incur net losses for the foreseeable future. Our available cash, cash equivalents and short-term investments were $67.0 million as of December 31, 2018 . We completed the evaluation about our ability to continue as a going concern as required by Accounting Standards Update No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. Based on this analysis, we expect that our present financial resources will be sufficient to meet our obligations as they come due and to fund our operations through the second 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 consolidated financial statements do not include adjustments, if any, that may result from the outcome of this uncertainty. Use of Estimates The preparation of financial statements in conformity with U.S. Generally Accepted Accounting Principles requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. For example, estimates include assumptions used in calculating reserves for excess and obsolete inventory, recording share-based compensation expense, accruals, the allocation of operating expenses, provision for loss contingencies, the fair value of financial instruments, our tax provision and related valuation allowance, and determining the useful lives of fixed assets and potential impairment of long-lived assets. Actual results could differ from those estimates. Certain Risks, Uncertainties and Concentrations Our results of operations are subject to foreign currency exchange rate fluctuations primarily due to our activity in Europe. We report the results of our operations in U.S. dollars, while the functional currency of our foreign subsidiaries is the euro. As the net positions of our unhedged foreign currency transactions fluctuate, our earnings might be negatively affected. In addition, the reported carrying value of our euro-denominated assets and liabilities that remain in our European branches and subsidiaries will be affected by fluctuations in the value of the U.S. dollar as compared to the euro. We review our foreign currency risk periodically along with hedging options to mitigate such risk. We source our drug products for clinical trials from a concentrated group of third-party contractors. If we are unable to obtain sufficient quantities of source materials, manufacture or distribute our products to customers from existing suppliers and service providers, or obtain the materials or services from other suppliers, manufacturers or distributors, certain research and development and sales activities may be delayed. See Note 15. Customer and Geographic Concentrations for further concentration disclosure. Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest: • Level 1—Valuations based on unadjusted quoted prices for identical assets and liabilities in active markets. • Level 2—Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Valuations based on unobservable inputs that are supported by little or no market activity, reflecting our own assumptions. These valuations require significant judgment or estimation. Our cash equivalents and short-term investments are recorded at fair value. As of December 31, 2018 , our cash, cash equivalents and short-term investments consisted of cash, money market funds, U.S. government and agency securities and corporate debt securities. As of December 31, 2017 , our cash and cash equivalents consisted of cash. We measure the fair value of money market funds based on the closing price reported by a fund sponsor from an actively traded exchange. We value all other securities using broker quotes that utilize observable market inputs. We did not hold cash, cash equivalents and short-term investments categorized as Level 3 assets as of December 31, 2018 and 2017 . The following table summarizes, by major security type, our cash, cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): December 31, 2018 December 31, 2017 Cost or Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Estimated Fair Value Total Estimated Fair Value Cash $ 919 $ — $ — $ 919 $ 43,218 Level 1 securities: Money market funds 20,525 — — 20,525 — Level 2 securities: U.S. government and agency securities 15,217 1 (5 ) 15,213 — Corporate debt securities 30,393 1 (13 ) 30,381 — $ 67,054 $ 2 $ (18 ) $ 67,038 $ 43,218 Less: restricted cash — (16,000 ) Total cash, cash equivalents and short-term investments $ 67,038 $ 27,218 There were no other financial instruments requiring fair value measurement as of December 31, 2018 and 2017 . At December 31, 2018 and 2017 , the carrying value of our receivables and payables approximated their fair values due to their short-term maturities. The carrying value of our long-term debt approximated its fair value at December 31, 2018 and 2017 based on borrowing rates for similar loans and maturities. Cash and Cash Equivalents We consider all highly liquid instruments with original maturities of three months or less at the time acquired to be cash equivalents. Restricted Cash Restricted cash represented a legally restricted deposit held as a compensating balance against our senior 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 an amendment from SVB for such requirement and as a result, we no longer have restrictions placed on the cash balance. See Note 7. Long-term Debt for further details regarding our senior secured term loan with SVB. The following table provides reconciliations of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows. December 31, 2018 December 31, 2017 Cash and cash equivalents $ 36,439 $ 27,218 Restricted cash — 16,000 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 36,439 $ 43,218 Receivables from License and Development Services Arrangements Our receivables relate to amounts payable or reimbursable to us under the terms of license and development services arrangements with our partners. The receivable balance as of December 31, 2018 related primarily to a milestone receivable from Servier for the attainment of a regulatory milestone in November 2018 as well as a milestone receivable from Teva for the attainment of a worldwide net sales milestone of TRISENOX in December 2018. The receivable balance as of December 31, 2017 related primarily to the sale of PIXUVRI drug product to Servier. Receivables are reviewed for collectability whenever circumstances indicate that the carrying amount of the receivable may not be recoverable. During the year ended December 31, 2017 , we recorded $1.7 million in bad debt expense related to disputed invoices under the license and development services arrangement with Baxalta. We had no allowance for doubtful accounts as of December 31, 2018 and 2017 . Italian Value Added Tax Receivable We historically carried out research and development activities in Italy and incurred value added tax, or VAT, from Italian suppliers on the acquisition of goods and services in Italy. This VAT should be considered as an Input VAT credit. We treated the majority of our sales made in Italy without output VAT (on the basis that the supplies should be considered outside the scope of Italian VAT). This resulted in the value of input VAT exceeding the value of output VAT, and accordingly we submitted a refund claim for the VAT. The Italian Tax Authority, or the ITA, has challenged the treatment of the sales transactions and claimed that the sales transactions made by us should have been subject to output VAT. Our Italian VAT receivable was approximately $4.5 million and $4.8 million as of December 31, 2018 and 2017 , respectively. Substantially all of our VAT receivable is included in Other assets . As disclosed in Note 18. Commitments and Contingencies , the ITA assessed us for additional VAT payments for services we provided in Italy, which we do not believe we owe. We have not recorded an amount in the financial statements for this contingent liability as we do not believe the potential payment of up to €4.2 million (or approximately $4.8 million converted using the currency exchange rate as of December 31, 2018 ), to the ITA is probable at this time. Property and Equipment Property and equipment are carried at cost, less accumulated depreciation and amortization. Depreciation commences at the time assets are placed in service. We calculate depreciation using the straight-line method over the estimated useful lives of the assets, ranging from three to five years for assets other than leasehold improvements. We amortize leasehold improvements over the lesser of their useful lives of 10 years or the term of the applicable lease. Impairment of Long-lived Assets We review our long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. If an impairment is indicated, the asset is written down to its estimated fair value based on fair market values. Leases We analyze leases at the inception of each agreement for classification as either an operating or capital lease. Certain of our lease agreement terms include rent holidays, rent escalation clauses and incentives for leasehold improvements. We recognize deferred rent relating to incentives for rent holidays and leasehold improvements and amortize the deferred rent over the term of the leases as a reduction of rent expense. For rent escalation clauses, we recognize rent expense equal to the amount of total minimum lease payments on a straight-line basis over the term of the lease. A deferred liability recognized in connection with the December 2017 sublease arrangement is amortized over the term of the sublease as a reduction of rent expense. As discussed in Recently Issued Accounting Guidance below, the new lease accounting guidance, Accounting Standards Codification, or ASC, 842 - Leases , is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2018, and we will adopt this guidance on January 1, 2019. Contingencies We record liabilities associated with loss contingencies to the extent that we conclude that the occurrence of the contingency is probable and that the amount of the related loss is reasonably estimable. We record income from gain contingencies only upon the realization of assets resulting from the favorable outcome of the contingent event. See Note 10. Collaboration, Licensing and Milestone Agreements and Note 18. Commitments and Contingencies for further information regarding our current contingencies. Revenue Recognition We adopted ASC 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. License and Development Services Arrangements We recognize license and contract revenue under license and development services arrangements 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 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, was recognized as revenue through the end of 2018 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. See Note 10. Collaboration, Licensing and Milestone Agreements - Servier for further discussion. 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 year ended December 31, 2018 related to a provision for excess, obsolete or unsaleable inventory as well as contractual royalties as we no longer have product sales as discussed above. Cost of product sold for the year ended December 31, 2017 is related to sales of PIXUVRI and contractual royalties. Research and Development Expenses Research and development costs are expensed as incurred in accordance with the FASB ASC 730, Research and Development . Research and development expenses include related salaries and benefits, clinical trial and related manufacturing costs, contract and other outside service fees, and facilities and overhead costs related to our research and development efforts. Research and development expenses also consist of costs incurred for proprietary and collaboration research and development and include activities such as product registries and investigator-sponsored trials. In instances where we enter into agreements with third parties for research and development activities, we may prepay fees for services at the initiation of the contract. We record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Other types of arrangements with third parties may be fixed fee or fee for service, and may include monthly payments or payments upon completion of milestones or receipt of deliverables. We expense upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. Foreign Currency Translation and Transaction Gains and Losses We record foreign currency translation adjustments and transaction gains and losses in accordance with ASC 830, Foreign Currency Matters. For our operations that have a functional currency other than the U.S. dollar, gains and losses resulting from the translation of the functional currency into U.S. dollars for financial statement presentation are not included in determining net loss, but are accumulated in the cumulative foreign currency translation adjustment account as a separate component of 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 consolidated financial statements. We have transactions in foreign currencies other than the functional currency. We record transaction gains and losses in our consolidated statements of operations related to the recurring measurement and settlement of such transactions. The intercompany balance due from CTILS is considered to be of a long-term nature. An unrealized foreign exchange loss of $1.5 million and an unrealized foreign exchange gain of $4.3 million were recorded in the cumulative foreign currency translation adjustment account for the years ended December 31, 2018 and 2017 , respectively. As of December 31, 2018 and 2017 , the intercompany balance due from CTILS was €28.7 million and €26.2 million , respectively (or $32.8 million and $31.4 million upon conversion from euros as of December 31, 2018 and 2017 , respectively). Income Taxes We record a tax provision for the anticipated tax consequences of our results of operations. The provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, and for operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using the currently enacted tax rates in effect for the years in which those tax assets and liabilities are expected to be realized or settled. We provide a valuation allowance to reduce deferred tax assets to the amount that is more likely than not to be realized. Net Loss per Share Basic net loss per common share is calculated based on the net loss attributable to common stockholders divided by the weighted average number of shares outstanding for the period. The calculation of diluted net loss per common share excludes the potential conversion of all dilutive convertible securities, such as convertible preferred stock, using the if-converted method, and the potential exercise or vesting of other dilutive securities, such as options, warrants and restricted stock, using the treasury stock method, as their inclusion would have an anti-dilutive effect. Recently Adopted Accounting Standards In May 2014, the Financial Accounting Standards Board, or 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 consolidated financial statements. See " Revenue Recognition" above for further discussion. 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. The adoption of this guidance did not have a material impact on our consolidated statements of cash flows. 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 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 a material impact on our 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. We will adopt this guidance on January 1, 2019 using the modified retrospective approach and have elected to apply the package of practical expedients and certain other practical expedients permitted under the transition guidance. All identified leases are classified as operating leases. As a result, we expect to recognize right-of-use assets ranging from approximately $4.6 million to $4.9 million , and lease liabilities ranging from approximately $7.0 million to $7.3 million , respectively, in our consolidated balance sheet. In addition, we have elected to apply the additional transition method per ASU 2018-11 and expect to recognize a cumulative effect adjustment of approximately $1.2 million reducing the opening accumulated deficit balance. The adoption of the standard is not expected to materially impact our consolidated statements of operations or consolidated statements of cash flows. In June 2018, the FASB issued new accounting guidance which simplifies the accounting for share-based payments granted to nonemployees for goods and services by aligning it, with certain exceptions, with the accounting for share-based payments to employees. The guidance is effective for fiscal years beginning after December 15, 2018 (including interim periods within those fiscal years). Early adoption is permitted. We do not expect the adoption of this accounting guidance to have a material impact on our consolidated financial statements. In August 2018, the FASB issued new accounting guidance which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The guidance is effective for fiscal years beginning after December 15, 2019 (including interim periods within those fiscal years). Early adoption is permitted for either the entire standard or any eliminated or modified disclosures. We do not expect the adoption of this accounting guidance to have a material impact on our consolidated financial statements. Although there were several other new accounting pronouncements issued or proposed by the FASB, we do not believe any of these have had or will have a material impact on our consolidated financial statements. Reclassifications Certain prior year items have been reclassified to conform to current year presentation, including the reclassification of items in stockholders' equity section as discussed in Reincorporation Merger above. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 2. Property and Equipment Property and equipment are composed of the following as of December 31, 2018 and 2017 (in thousands): 2018 2017 Furniture and office equipment $ 4,445 $ 4,552 Leasehold improvements 5,168 5,168 Lab equipment 63 209 9,676 9,929 Less: accumulated depreciation and amortization (7,883 ) (7,564 ) Property and equipment, net $ 1,793 $ 2,365 Depreciation expense for the years ended December 31, 2018 and 2017 was $0.6 million and $0.7 million , respectively. |
Other Assets
Other Assets | 12 Months Ended |
Dec. 31, 2018 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Assets | 3. Other Assets Other assets consisted of the following as of December 31, 2018 and 2017 (in thousands): 2018 2017 Italian VAT receivables $ 4,480 $ 4,692 Italian VAT deposit 493 516 Rent deposit 194 194 Other 380 195 Other assets $ 5,547 $ 5,597 See Note 1. Description of Business and Summary of Significant Accounting Policies - Italian Value Added Tax Receivable and Note 18. Commitments and Contingencies for details regarding our Italian VAT receivables and Italian VAT deposit. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 4. Accrued Expenses Accrued expenses consisted of the following as of December 31, 2018 and 2017 (in thousands): 2018 2017 Clinical and investigator-sponsored trial expenses $ 6,573 $ 5,019 Employee compensation and related expenses 4,216 4,432 Restructuring expenses 660 — Manufacturing expenses 458 2,637 Other 945 1,802 Total accrued expenses $ 12,852 $ 13,890 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Leases | 5. Leases Lease Agreements In January 2012 , we entered into an operating lease agreement with Selig Holdings Company LLC to lease approximately 66,000 square feet of office space in Seattle, Washington for a term of 120 months , commencing May 1, 2012. We have two five -year options to extend the term of the lease at a market rate determined according to the lease. The initial rent amount was based on $27.00 per square foot per annum, but no payments were due during the initial five months of the lease term. Rent increases three percent over the prior year’s amount for each year thereafter for the duration of the lease. In addition, we were provided an allowance of $3.3 million for certain tenant improvements made by us. In December 2017 , we entered into an agreement to sublease approximately 44,000 square feet of our Seattle office space. No payments were due through May 2018, after which monthly rent is due through the sublease termination date in April 2022 . Monthly sublease rent increases by a minor amount each January 1. In connection with the sublease, we recognized a loss and a deferred liability of $1.6 million , representing future rental payments plus related expenses in excess of the future sublease payments to be received. The loss was recorded in Selling, general and administrative expense during the year ended December 31, 2017 . Other current liabilities and Other liabilities in the consolidated balance sheet include $0.2 million and $0.4 million , respectively, related to the sublease agreement as of December 31, 2018 , and $0.8 million and $0.6 million , respectively, as of December 31, 2017 . Rent expense, net of sublease-related income of $1.6 million and $0.1 million for the year ended December 31, 2018 and 2017 , amounted to $0.1 million and $1.6 million for the years ended December 31, 2018 and 2017 , respectively. Future Minimum Lease Payments Future minimum lease commitments for non-cancelable operating leases, net of sublease rentals, at December 31, 2018 were as follows (in thousands): Operating Sublease Lease Payments Rentals Receipts Net 2019 $ 2,581 $ 1,365 $ 1,216 2020 2,632 1,410 1,222 2021 2,628 1,454 1,174 2022 883 499 384 Thereafter — — — Total minimum lease commitments $ 8,724 $ 4,728 $ 3,996 |
Other Liabilities
Other Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Other Liabilities Disclosure [Abstract] | |
Other Liabilities | 6. Other Liabilities Other liabilities consisted of the following as of December 31, 2018 and 2017 (in thousands): 2018 2017 Deferred rent, less current portion $ 2,157 $ 3,050 Other long-term obligations 2,414 2,419 Total other liabilities $ 4,571 $ 5,469 Deferred rent, less current portion as of December 31, 2018 and 2017 includes amounts related to incentives for rent holidays and leasehold improvements associated with our operating lease for office space. In addition, deferred rent, less current portion as of December 31, 2018 and 2017 includes $0.4 million and $0.6 million of deferred liability, respectively, related to the sublease of Seattle office space as discussed in Note 5. Leases . Other long-term obligations as of December 31, 2018 and 2017 include a fee in the amount of $1.4 million payable to Silicon Valley Bank. See Note 7. Long-term Debt for additional information. |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 7. Long-term Debt Silicon Valley Bank In November 2017 , we entered into a Loan and Security Agreement with Silicon Valley Bank, or SVB, for a senior secured term loan of up to $18.0 million . The first $16.0 million of the term loan was funded in November 2017 . We had an option to borrow an additional $2.0 million , which option expired unexercised on July 31, 2018. The loan proceeds were used to repay in full all outstanding indebtedness under the Loan and Security Agreement with Hercules Technology Growth Capital, Inc., or Hercules, as discussed below and to fund our general business requirements. We were required to maintain unrestricted and unencumbered cash in an amount equal to at least $16.0 million under the terms of Loan and Security Agreement, and as such, $16.0 million of our cash was legally restricted as of December 31, 2017 and held as a compensating balance against the term loan. The restriction was removed in January 2018. See Note 1. Description of Business and Summary of Significant Accounting Policies for further details regarding restricted cash. The term loan is repayable over 36 months after an initial interest-only period of 12 months after closing. The interest rate on the term loan floats at a rate per annum equal to the greater of 2.5 percent above the prime rate and 6.75 percent . We may elect to prepay some or all of the loan balance at any time subject to a prepayment fee. A fee in the amount of 9 percent of the total principal amount funded to us is payable to SVB on the date on which the term loan is paid or becomes due and payable in full. Such back-end fee in the amount of $1.4 million was included in Other liabilities in the consolidated balance sheets as of December 31, 2018 and 2017 . The loan obligations are secured by a first priority security interest on substantially all of our personal property except our intellectual property and subject to certain other exceptions. In addition, we issued warrants to SVB and Life Science Loans II, LLC, pursuant to a participation arrangement among SVB, Loan Manager II, LLC and Life Science Loans II, LLC, to purchase up to 190,140 shares of our common stock. Warrants have an initial exercise price of $2.84 per share of our common stock and will expire on November 28, 2027 . In connection with the Loan and Security Agreement, we recorded debt discount and debt issuance costs of $1.9 million and $0.1 million , respectively, of which $1.4 million and $0.1 million , respectively, was unamortized as of December 31, 2018 . The outstanding principal balance on the term loan was $15.6 million as of December 31, 2018 . As of December 31, 2018 , the scheduled principal and interest payments (based on the interest rate of 8.0 percent as of December 31, 2018 ) as well as the back-end fee described above are as follows: Principal Interest Back-end fee Total 2019 $ 5,333 $ 1,061 $ — $ 6,394 2020 5,333 633 — 5,966 2021 4,889 198 1,440 6,527 Thereafter — — — — Total scheduled payments $ 15,555 $ 1,892 $ 1,440 $ 18,887 Less: debt discount and issuance costs $ (1,476 ) Less: current portion of long-term debt $ (4,812 ) Long-term debt $ 9,267 Hercules In November 2017 , we repaid Hercules the then-outstanding loan principal balance of $14.3 million in full, using the proceeds from the Loan and Security Agreement with SVB as discussed above. Accordingly, among other things, (1) all obligations under the loan agreement with Hercules and all related documents have been paid, satisfied, released and discharged in full, (2) all unfunded commitments to make credit extensions or financial accommodations to us or any other person under the loan agreement with Hercules have been automatically and irrevocably terminated, and (3) our obligations under the loan agreement with Hercules and all related documents have been automatically and irrevocably terminated (other than with respect to customary provisions and agreements that are expressly specified to survive the termination). Upon full repayment of the principal in November 2017 , we wrote-off the then-unamortized debt discount balance of $0.1 million to a loss on debt extinguishment, which was recorded in Other non-operating expense for the year ended December 31, 2017 . |
Equity Transactions
Equity Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Equity Transactions | 8. Equity Transactions Preferred Stock In June 2017 , in an underwritten public offering, we issued 22,500 shares of Series N 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 stockholder of the Company, was one of our investors in this offering. See Note 17. Related Party Transactions for further details. In June 2017, 21,925 shares of Series N Preferred Stock were converted into 14.6 million shares of common stock at a conversion price of $3.00 per share. For the year ended December 31, 2017 , we recognized $4.4 million in deemed dividends on preferred stock related to the beneficial conversion feature on our Series N Preferred Stock. There were 575 shares of Series N Preferred Stock outstanding as of December 31, 2017 , which were owned by BVF. In February 2018 , the 575 shares of Series N Preferred Stock owned by BVF, along with 8.0 million shares of our common stock owned by BVF were exchanged for 12,575 shares of Series O Preferred Stock. For the year ended December 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 December 31, 2018 , which are convertible into 8.4 million shares of common stock. 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 certificate of incorporation of CTI or as otherwise required by law. Common Stock 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 . In November 2018, we entered into a Sales Agreement with Cowen and Company, LLC, or Cowen, to sell shares of our common stock, having aggregate sales proceeds of up to $50.0 million , from time to time, through an “at the market” equity offering program under which Cowen will act as sales agent. Under the Sales Agreement, we will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitation on the number of shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, Cowen may sell the shares by methods deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including sales made directly on The Nasdaq Capital Market or on any other existing trading market for the common stock. Cowen will use commercially reasonable efforts in conducting such sales activities consistent with its normal trading and sales practices, applicable state and federal laws, rules and regulations and the rules of The Nasdaq Stock Market LLC. The Sales Agreement may be terminated by us upon five days’ notice to Cowen for any reason or by Cowen upon five days’ notice to us for any reason or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company. Under the terms of the Sales Agreement, we may also sell shares to Cowen acting as principal for Cowen’s own account at prices agreed upon at the time of sale upon our express authorization. The compensation to Cowen for sales of our common stock will be an amount equal to 3.0% of the gross proceeds of any shares of common stock sold under the Sales Agreement. We have no obligation to sell any shares under the Sales Agreement, and may at any time suspend solicitation and offers under the Sales Agreement. For the year ended December 31, 2018 , no shares have been sold under the Sales Agreement. Common Stock Authorized In May 2017 , the Company's Amended and Restated Articles of Incorporation were amended to increase the total number of authorized shares of common stock from 41.5 million to 81.5 million . In May 2018 , the Company's certificate of incorporation was amended to increase the total number of authorized shares of common stock from 81.5 million to 101.5 million . Common Stock Reserved A summary of common stock reserved for issuance is as follows as of December 31, 2018 (in thousands): Equity incentive plans 9,203 Option agreement with Adam R. Craig 1,120 Common stock purchase warrants 514 Series O convertible preferred stock 8,383 Employee stock purchase plan 178 Total common stock reserved 19,398 Warrants Warrants to purchase up to 29,239 shares of our common stock with an exercise price of $17.10 per share, issued in connection with the Third Amendment to the Loan Agreement with Hercules in 2015, were outstanding and exercisable as of December 31, 2018 . Warrants to purchase up to 190,140 shares of our common stock with an exercise price of $2.84 per share, issued in connection with the Loan and Security Agreement with SVB in 2017, were outstanding as of December 31, 2018 . Of this amount, warrants to purchase up to 169,014 shares of our common stock were exercisable as of December 31, 2018 . Warrants to purchase up to 294,117 shares of our common stock with an exercise price of $1.70 per share, which were issued to our vendor in 2018 as part of compensation for services, were outstanding but remained unexercisable as of December 31, 2018 . |
Other Comprehensive Loss
Other Comprehensive Loss | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Other Comprehensive Loss | 9. 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 (1) Unrealized Foreign Exchange Loss on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2017 $ 1 $ (6,829 ) $ 556 $ (6,272 ) Current period other comprehensive loss (15 ) (2,843 ) (1,513 ) (4,371 ) December 31, 2018 $ (14 ) $ (9,672 ) $ (957 ) $ (10,643 ) (1) In accordance with ASC 830 - Foreign Currency Matters , the current period change includes a release of cumulative translation adjustment in the amount of $4.3 million upon dissolution of our foreign branch, which was recognized in other non-operating income in our consolidated statement of operations for the year ended December 31, 2018 . |
Collaboration, Licensing and Mi
Collaboration, Licensing and Milestone Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Collaborations [Abstract] | |
Collaboration, Licensing and Milestone Agreements | 10. Collaboration, Licensing and Milestone Agreements Servier In September 2014 , we entered into an Exclusive License and Collaboration Agreement, or the Original Agreement, with Les Laboratoires Servier and Institut de Recherches Internationales Servier, or collectively, Servier. In April 2017 , we entered into an Amended and Restated Exclusive License and Collaboration Agreement, or the Restated Agreement, with Servier, pursuant to which the Original Agreement was amended and restated in its entirety. In February 2019, we entered into an agreement to terminate the Restated Agreement. For further details, see Note 20. Subsequent Events . 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 provided for additional milestone payments of up to €76.0 million : up to €36.0 million in potential regulatory milestone payments (which includes a €1.0 million payment for a regulatory milestone achieved in September 2017 as discussed below), and up to €40.0 million in potential sales-based milestone payments. The Restated Agreement also provided that we were 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, subject to expiration upon certain events, including upon expiration of exclusivity rights to products containing PIXUVRI in the respective country. Under the Restated Agreement, with the exception of the conclusion of the PIX306 trial and certain other services, Servier was responsible for development, commercialization and manufacturing activities within its territory. We entered into a commercialization transition plan whereby we transferred 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 completion of the commercialization transition plan, we terminated or assigned certain distributor and wholesaler contracts to Servier in the Transition Territory. Each party was responsible for the manufacture and supply of drug products and substances in their respective territories. We recorded 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. Prior to its termination, the Restated Agreement was scheduled to 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. We have determined that the Restated Agreement with Servier is within the scope of ASC 606 since we and Servier do not equally share risks and rewards of the arrangement under the Restated Agreement and as such a vendor-customer relationship exists. We identified the following performance obligations 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 is a distinct promise because it is sublicensable and separable from the remaining performance obligations and can be used for its intended purpose on its own. The remaining service performance obligations are also distinct because these services are not proprietary in nature, and other vendors could provide the same services in order to derive value from the license. We determined that performance obligations relating to the joint committee obligations and the regulatory, commercial, and manufacturing and supply responsibilities were insignificant in the context of the Restated Agreement, and as such these obligations were combined with the development services and included as “Development and other services” in the table below. At the inception of the Restated Agreement, 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) was included in the initial transaction price, which was then allocated based on the percentage of the relative selling price of each performance obligation as follows (in thousands): License $ 11,487 Development and 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 and other services, 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 would not have a significant effect on the allocation of the arrangement consideration. Regulatory and sales milestones, as well as royalty payments, are not included in the initial transaction price. Regulatory milestones under the Restated Agreement are subject to a constraint and as such, based on the most-likely amount approach, we recognize revenue when we deem probable that there will not be a significant reversal of revenue in the future periods. Royalty payments we receive from Servier are sales-based royalties in connection with the license of intellectual property. As such, royalty revenues are recognized as underlying sales occur. And sales milestone revenues are recognized when underlying sales milestones are achieved as the royalty exception under ASC 606 also applies to sales milestones. During the year ended December 31, 2017 , we recognized $11.5 million of consideration allocated to the license as revenue upon delivery of the license. The $1.3 million consideration allocated to development and other services was recorded as deferred revenue, along with the $0.6 million deferred revenue balance from the Original Agreement, for a total deferred revenue balance of $1.9 million as of the date of Restated Agreement. During the year ended December 31, 2017 , $0.5 million of the deferred revenue balance was recognized as revenue; the remaining $1.4 million was recognized as revenue for the year ended December 31, 2018 as the development service obligation under the Restated Agreement was deemed complete. 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). In November 2018 , we recognized a €3.0 million milestone revenue (or $3.4 million using the currency exchange rate as of the date the milestone was achieved) relating to the attainment of a regulatory milestone. Teva Pursuant to an acquisition agreement entered into with Cephalon, Inc., or Cephalon, in June 2005, we have the right to receive up to $100.0 million in payments upon achievement of specified sales and development milestones related to TRISENOX. Cephalon was subsequently acquired by Teva Pharmaceutical Industries Ltd., or Teva. As of December 31, 2018 , we have earned $60.0 million of such potential milestone payments as a result of having achieved certain milestones. For the year ended December 31, 2018 , we received $10.0 million from Teva upon the achievement of a milestone for FDA approval of TRISENOX for first line treatment of acute promyelocytic leukemia. In addition, for the years ended December 31, 2018 and 2017 , we earned $10.0 million in each respective period upon the achievement of worldwide net sales milestones of TRISENOX. The achievement of the remaining milestones is uncertain at this time. Baxalta In November 2013 , we entered into the Pacritinib License Agreement with Baxter for the development and commercialization of pacritinib for use in oncology and potentially additional therapeutic areas. Baxter assigned its rights and obligations under the Pacritinib License Agreement to Baxalta. Under the Pacritinib License Agreement, we granted to Baxter an exclusive, worldwide (subject to our certain co-promotion rights in the U.S.), royalty-bearing, non-transferable, and (under certain circumstances outside of the U.S.) sub-licensable license to our know-how and patents relating to pacritinib. In October 2016 , we entered into the Asset Return and Termination Agreement, or the Baxalta Termination Agreement, with Baxalta. Pursuant to the Baxalta Termination Agreement, the Pacritinib License Agreement was terminated in its entirety (other than with respect to certain customary provisions that survive termination, including those pertaining to confidentiality and indemnification), the Pacritinib License Agreement has no further force or effect, and all rights and obligations of the Company and Baxalta under the Pacritinib License Agreement were terminated. In October 2016 , we resumed primary responsibility for the development and commercialization of pacritinib as a result of the Baxalta Termination Agreement and are no longer eligible to receive cost sharing or milestone payments for pacritinib’s development from Baxalta. In addition, under the Baxalta Termination Agreement, we are required to make a milestone payment to Baxalta in the amount of approximately $10.3 million upon the first regulatory approval or any pricing and reimbursement approvals of a product containing pacritinib. Novartis In January 2014 , we entered into a Termination Agreement, or the Novartis Termination Agreement, with Novartis to reacquire the rights to PIXUVRI and Opaxio, or collectively, the Compounds, previously granted to Novartis under our License and Co-Development Agreement with Novartis, as amended, or the Original Novartis Agreement. Pursuant to the Novartis Termination Agreement, the Original Novartis Agreement was terminated in its entirety, other than with respect to certain customary provisions, including those pertaining to confidentiality and indemnification, which survive termination. Under the Novartis Termination Agreement, we agreed not to transfer, license, sublicense or otherwise grant rights with respect to intellectual property of the Compounds unless the transferee/licensee/sublicensee agrees to be bound by the terms of the Novartis Termination Agreement. We also agreed to provide potential payments to Novartis, including a percentage ranging from the low double-digits to the mid-teens, of any consideration received by us or our affiliates in connection with any transfer, license, sublicense or other grant of rights with respect to intellectual property of the Compounds, provided that such payments would not exceed certain prescribed ceilings in the low-single digit millions. Novartis is entitled to receive potential payments of up to $16.6 million upon the achievement of certain sales milestones of the Compounds. Novartis is also eligible to receive tiered low single-digit percentage royalty payments for the first several hundred million in annual net sales, and ten percent royalty payments thereafter based on annual net sales of each Compound, subject to reduction in the event generic drugs are introduced and sold by a third party, causing the sale of the Compounds to fall by a percentage in the high double-digits. Notwithstanding the foregoing, royalty payments for the Compounds are subject to certain minimum floor percentages in the low single-digits. University of Vermont In March 1995, the University of Vermont, or UVM, entered into an agreement, or the UVM Agreement, which, as amended in March 2000, grants us an exclusive, sublicensable license for the rights to PIXUVRI. Pursuant to the UVM Agreement, we acquired the rights to make, have made, sell and use PIXUVRI. We are obligated to make royalty payments to UVM that range from low-single digits to mid-single digits as a percentage of net sales. The higher royalty rate is payable for net sales in countries where specified UVM licensed patents exist, or where we have obtained orphan drug protection, until such UVM patents or such protection no longer exists. For a period of ten years after first commercialization of PIXUVRI, the lower royalty rate is payable for net sales in such countries after expiration of the designated UVM patents or loss of orphan drug protection, and in all other countries without such specified UVM patents or orphan drug protection. Unless otherwise terminated, the term of the UVM Agreement continues for the life of the licensed patents in those countries in which a licensed patent exists, and continues for ten years after the first sale of PIXUVRI in those countries where no such patents exist. We may terminate the UVM Agreement, on a country-by-country basis or on a patent-by-patent basis, at any time upon advance written notice. UVM may terminate the UVM Agreement upon advance written notice in the event royalty payments are not made. In addition, either party may terminate the UVM Agreement (1) in the event of an uncured material breach of the UVM Agreement by the other party or (2) in the event of bankruptcy of the other party. S*BIO Pte Ltd. We acquired the compounds SB1518 (which is referred to as “pacritinib”) and SB1578, which inhibit JAK2 and FLT3, from S*BIO Pte Ltd., or S*BIO, in May 2012 . Under our agreement with S*BIO, we are required to make milestone payments to S*BIO up to an aggregate amount of $132.5 million if certain U.S., E.U. and Japanese regulatory approvals are obtained or if certain worldwide net sales thresholds are met in connection with any pharmaceutical product containing or comprising any compound that we acquired from S*BIO for use for specific diseases, infections or other conditions. At our election, we may pay up to 50% of any milestone payments to S*BIO through the issuance of shares of our common stock or shares of our preferred stock convertible into our common stock. S*BIO will also be entitled to receive royalty payments from us at incremental rates in the low single-digits based on certain worldwide net sales thresholds on a product-by-product and country-by-country basis. Vernalis We entered into an amended and restated exclusive license agreement with Vernalis (R&D) Limited, or Vernalis, in October 2014, or the Vernalis License Agreement, for the exclusive worldwide right to use certain patents and other intellectual property rights to develop, market and commercialize tosedostat and certain other compounds. Under the Vernalis License Agreement, we have agreed to make tiered royalty payments of no more than a high single-digit percentage of net sales of products containing licensed compounds, with such obligation to continue on a country-by-country basis for the longer of ten years following commercial launch or the expiry of relevant patent claims. The Vernalis License Agreement will terminate when the royalty obligations expire, although the parties have early termination rights under certain circumstances, including the following: (1) we have the right to terminate, with three months’ notice, upon the belief that the continued development of tosedostat or any of the other licensed compounds is not commercially viable, (2) Vernalis has the right to terminate in the event of our uncured failure to pay sums due, and (3) either party has the right to terminate in the event of the other party’s uncured material breach or insolvency. We have ceased development of tosedostat and do not anticipate incurring additional material expenses related to this terminated program. Gynecologic Oncology Group We entered into an agreement with the Gynecologic Oncology Group, or GOG, now part of NRG Oncology, in March 2004 , as amended, related to the GOG-212 trial of Opaxio in patients with ovarian cancer. Pursuant to the terms of such agreement, we made a milestone payment of $0.5 million relating to the transfer of final datasets during the second quarter of 2017, which was included in research and development expenses . The agreement was terminated in May 2017. No further development of Opaxio is planned. PG-TXL In November 1998, we entered into an agreement with PG-TXL, as amended in February 2006, or the PG-TXL Agreement, which granted us an exclusive worldwide license for the rights to Opaxio and to all potential uses of PG-TXL’s polymer technology. Pursuant to the PG-TXL Agreement, we acquired the rights to research, develop, manufacture, market and sell anti-cancer drugs developed using this polymer technology. Pursuant to the PG-TXL Agreement, we were obligated to make payments to PG-TXL of up to $14.4 million upon the achievement of certain development and regulatory milestones. The timing of the remaining milestone payments under the PG-TXL Agreement was based on trial commencements and completions for compounds protected by PG-TXL license rights, and regulatory and marketing approval of those compounds by the FDA and the EMA. Additionally, we were required to make royalty payments to PG-TXL ranging from low to mid-single digits as a percentage of net sales. In February 2017, we terminated our agreement with PG-TXL and the exclusive worldwide license for rights to Opaxio and certain polymer technology thereunder. Other Agreements We have several agreements with contract research organizations, third-party manufacturers, and distributors which have durations of greater than one year for the development and distribution of certain of our compounds. |
Restructuring Activities
Restructuring Activities | 12 Months Ended |
Dec. 31, 2018 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Activities | 11. Restructuring Activities In December 2018, we announced a restructuring plan to improve efficiencies and reduce costs within the Company, which impacted a total of 21 positions. We expect to incur total restructuring expenses of approximately $1.5 million , of which $0.7 million had been incurred for the year ended December 31, 2018 . We anticipate the majority of restructuring activities to be completed by the end of first quarter 2019. The following table summarizes the accrual balance and utilization for the year ended December 31, 2018 (in thousands): Employee separation costs Restructuring accruals - December 31, 2017 $ — Restructuring expenses 660 Cash payments — Restructuring accruals - December 31, 2018 $ 660 |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation | 12. Share-Based Compensation Share-Based Compensation Expense Share-based compensation expense for all share-based payment awards made to employees and directors is measured based on the grant-date fair value estimated in accordance with U.S. generally accepted accounting principles, or GAAP. We recognize share-based compensation using the straight-line, single-award method based on the value of the portion of share-based payment awards that is ultimately expected to vest during the period. Share-based compensation is reduced for estimated forfeitures at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. During the years ended December 31, 2018 and 2017 , we recognized share-based compensation expense which consisted of the following types of awards (in thousands): 2018 2017 Restricted stock 102 1,015 Options 6,267 4,731 Total share-based compensation expense $ 6,369 $ 5,746 The following table summarizes share-based compensation expense for the years ended December 31, 2018 and 2017 , which was allocated as follows (in thousands): 2018 2017 Research and development $ 1,950 $ 911 Selling, general and administrative 4,419 4,835 Total share-based compensation expense $ 6,369 $ 5,746 Share-based compensation had a $6.4 million and $5.7 million effect on our net loss attributable to common stockholders for the years ended December 31, 2018 and 2017 , respectively. It had no effect on cash flows from operating activities for the periods presented; however, during the years ended December 31, 2018 and 2017 , we made payments of $21,000 and $0.1 million , respectively, relating to 5,800 shares and 21,000 shares, respectively, of our common stock withheld upon vesting of employee restricted stock awards based on taxes owed by employees upon vesting, which impacted cash flows used in financing activities. As of December 31, 2018 , unrecognized compensation cost related to unvested stock options and unvested restricted stock awards amounted to $7.8 million , which will be recognized over the remaining weighted-average requisite service period of 1.83 years . The unrecognized compensation cost related to unvested options and restricted stock does not include the value of performance-based awards. For the years ended December 31, 2018 and 2017 , no tax benefits were attributed to share-based compensation expense because a valuation allowance was maintained for all net deferred tax assets. Stock Plans In May 2017 , the Company's 2017 Equity Incentive Plan, or the 2017 Plan, was approved by the Company's shareholders, and no additional awards will be granted under the 2015 Equity Incentive Plan, or the 2015 Plan. The Company's 2007 Employee Stock Purchase Plan, as amended and restated in August 2009 and September 2015, or the Purchase Plan, was amended in September 2015 to increase the maximum number of shares of the Company’s common stock authorized for issuance by 0.2 million shares. Refer to Employee Stock Purchase Plan below for further details. Pursuant to our 2017 Plan, we may grant the following types of incentive awards: (1) stock options, including incentive stock options and non-qualified stock options, (2) stock appreciation rights, (3) restricted stock, (4) restricted stock units and (5) cash awards. The 2017 Plan is administered by the Compensation Committee of our Board, which has the discretion to determine the employees and consultants who shall be granted incentive awards. The Board retained sole authority under the 2017 Plan with respect to non-employee directors’ awards, although the Compensation Committee has authority under its charter to make recommendations to the Board concerning such awards. Options expire 10 years from the date of grant, subject to the recipients continued service to the Company. As of December 31, 2018 , 11.6 million shares were authorized for issuance under equity incentive plans, of which 2.8 million shares of common stock were available for future grants under the 2017 Plan. Stock Options Fair value for stock options was estimated at the date of grant using the Black-Scholes pricing model, with the following weighted average assumptions: Year Ended December 31, 2018 2017 Risk-free interest rate 2.9 % 1.9 % Expected dividend yield None None Expected life (in years) 5.4 5.2 Volatility 82 % 83 % The risk-free interest rate used in the Black-Scholes valuation method is based on the implied yield currently available for U.S. Treasury securities at maturity with an equivalent term. We have not declared or paid dividends on our common stock and do not currently expect to do so in the future. The expected term of options represents the period that our options are expected to be outstanding and was determined based on historical weighted average holding periods and projected holding periods for the remaining unexercised options. Consideration was given to the contractual terms of our options, vesting schedules and expectations of future employee behavior. Expected volatility is based on the annualized daily historical volatility, including consideration of the implied volatility and market prices of traded options for comparable entities within our industry. Our stock price volatility and option lives, both of which impact the fair value of options calculated under the Black-Scholes methodology and, ultimately, the expense that will be recognized over the life of the option, involve management’s best estimates. As we recognize compensation expense for only the portion of options expected to vest, we apply estimated forfeiture rates that we derive from historical employee termination behavior. If the actual number of forfeitures differs from our estimates, additional adjustments to compensation expense may be required in future periods. The following table summarizes stock option activity for all of our stock option plans: Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (Thousands) Outstanding at December 31, 2016 (1,913,000 exercisable) 2,806,000 $ 11.44 Granted 4,450,000 $ 3.68 Exercised — $ — Forfeited (378,000 ) $ 6.27 Cancelled and expired (210,000 ) $ 24.33 Outstanding at December 31, 2017 (2,500,000 exercisable) 6,668,000 $ 6.15 Granted 3,100,000 $ 3.04 Exercised (12,000 ) $ 3.89 Forfeited (408,000 ) $ 3.48 Cancelled and expired (2,129,000 ) $ 9.18 Outstanding at December 31, 2018 (2,597,000 exercisable) 7,219,000 $ 4.08 8.1 $ — Vested or expected to vest at December 31, 2018 6,321,000 $ 4.32 7.7 $ — Exercisable at December 31, 2018 2,597,000 $ 5.49 6.4 $ — The weighted average exercise price of options exercisable at December 31, 2018 and 2017 was $5.49 and $9.83 , respectively. The weighted average grant-date fair value of options granted during 2018 and 2017 was $2.09 and $2.47 per option, respectively. The number of options vested or expected to vest at December 31, 2018 does not include 715,000 performance-based options with the weighted average exercise price of $2.18 since the achievement of such performance-based milestone was not deemed probable as of December 31, 2018 . In March 2017 , Dr. Adam R. Craig, our President and CEO, was granted stock options to purchase 1.2 million shares of common stock at an exercise price of $4.24 per share. The stock options have a maximum term of ten years and vest in six equal semi-annual installments over the three -year period beginning March 20, 2017, subject to his continued employment through the applicable vesting dates and acceleration under certain circumstances. The stock options were granted in connection with his entering into employment with the Company as President and CEO. A portion of the stock options covering 80,000 shares were granted under the 2015 Plan. The balance of such stock options was granted in accordance with NASDAQ Listing Rule 5635(c)(4). Restricted Stock Awards We issued 2,000 shares of restricted stock awards in 2017 while we issued no restricted stock awards in 2018 . The weighted average grant-date fair value of restricted stock awards issued during 2017 was $5.78 . Additionally, 15,000 and 39,000 shares of restricted stock awards were cancelled during 2018 and 2017 , respectively. The total fair value of restricted stock awards vested during the years ended December 31, 2018 and 2017 was $0.1 million and $0.3 million , respectively. A summary of the status of nonvested restricted stock awards as of December 31, 2018 and 2017 and changes during the periods then ended, is presented below: Nonvested Shares Weighted Average Grant-Date Fair Value Per Share Nonvested at December 31, 2016 183,000 $ 12.76 Issued 2,000 $ 5.78 Vested (83,000 ) $ 9.43 Forfeited (39,000 ) $ 14.39 Nonvested at December 31, 2017 63,000 $ 15.93 Issued — $ — Vested (35,000 ) $ 12.00 Forfeited (15,000 ) $ 16.12 Nonvested at December 31, 2018 13,000 $ 26.23 Restricted Stock Units We issued 20,000 restricted stock units during 2017 while no restricted stock units were issued during 2018 . No restricted stock units were cancelled during 2018 or 2017 . The weighted average grant-date fair value of restricted stock units issued during 2017 was $4.97 per unit. The total fair value of restricted stock units vested during the year ended December 31, 2018 and 2017 was $0.1 million and $0.8 million , respectively. A summary of the status of nonvested restricted stock units as of December 31, 2018 and 2017 and changes during the periods then ended, is presented below: Nonvested Units Weighted Average Nonvested at December 31, 2016 187,000 $ 5.35 Issued 20,000 $ 4.97 Vested (187,000 ) $ 5.35 Forfeited — $ — Nonvested at December 31, 2017 20,000 $ 4.97 Issued — $ — Vested (20,000 ) $ 4.97 Forfeited — $ — Nonvested at December 31, 2018 — $ — Nonemployee Share-Based Compensation Share-based compensation expense for awards granted to nonemployees is determined using the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. The fair value of options and restricted stock awards granted to nonemployees is periodically remeasured as the underlying options or awards vest. The value of the instrument is amortized to expense over the vesting period with final valuation measured on the vesting date. As of December 31, 2018 and 2017 , unvested options to acquire approximately 12,000 shares and 4,000 shares, respectively, of common stock were outstanding. We recorded compensation expense of $6,000 during the year ended December 31, 2018 and reversed $8,000 during the year ended December 31, 2017 . Employee Stock Purchase Plan Under the Purchase Plan, eligible employees may purchase a limited number of shares of our common stock at 85% of the lower of the subscription date fair market value and the purchase date fair market value. There are two six-month offerings per year. Under the Purchase Plan, we issued approximately 5,000 and 4,000 shares of our common stock to employees in the years ended December 31, 2018 and 2017 , respectively. There are 0.2 million shares of common stock authorized under the Purchase Plan and approximately 0.2 million shares are reserved for future purchases as of December 31, 2018 . |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 13. Employee Benefit Plans Our U.S. employees participate in the CTI BioPharma Corp. 401(k) Plan whereby eligible employees may defer up to 80% of their compensation, up to the annual maximum allowed by the Internal Revenue Service. We may make discretionary matching contributions based on certain plan provisions. We recorded $0.2 million related to discretionary matching contributions during the year ended December 31, 2018 and $0.3 million during the year ended December 31, 2017 . |
Shareholder Rights Plan
Shareholder Rights Plan | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Shareholder Rights Plan | 14. Shareholder Rights Plan In December 2009, our Board approved and adopted a shareholder rights plan, or Rights Plan, in which one preferred stock purchase right was distributed for each common share held as of the close of business on January 7, 2010. Initially, the rights were not exercisable, and were attached to, and traded with, all of the shares of CTI’s common stock outstanding as of and issued subsequent to January 7, 2010. In 2012, 2015 and 2017, our Board approved certain amendments to the Rights Plan. The Rights Plan expired on December 2, 2018 . |
Customer and Geographic Concent
Customer and Geographic Concentrations | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Customer and Geographic Concentrations | 15. Customer and Geographic Concentrations We consider our operations to be a single operating segment focused on the development, acquisition and commercialization of novel treatments for cancer. Financial results of this reportable segment are presented in the accompanying consolidated financial statements. All sales of PIXUVRI during the year presented were in Europe. Product sales from PIXUVRI’s major customers as a percentage of total product sales were as follows: Year Ended December 31, 2017 Customer A 61 % Customer B 24 % Customer C 13 % In April 2017, we granted Servier an exclusive and sublicensable (subject to certain conditions) royalty-bearing license with respect to the development and commercialization of PIXUVRI for use in pharmaceutical products outside of the U.S. (and its territories and possessions). As a result, we no longer have product sales. See Note 10. Collaboration, Licensing and Milestone Agreements for further details. We had no long-lived assets located outside of the U.S. as of December 31, 2018 and 2017 . |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 16. 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. The calculation of diluted net loss per share excludes the potential conversion of all dilutive convertible securities, such as convertible debt and convertible preferred stock, and the potential exercise or vesting of other dilutive securities, such as options, warrants and restricted stock, as their inclusion would have an anti-dilutive effect. Accordingly, diluted net loss per share is the same as basic net loss per share . The computation of net loss per share is as follows (in thousands, except per share amounts): Year Ended December 31, 2018 2017 Net loss attributable to common stockholders $ (29,400 ) $ (45,020 ) Basic and diluted: Weighted average shares outstanding 56,106 36,569 Less: weighted average restricted shares outstanding (33 ) (124 ) Shares used in calculation of basic and diluted net loss per common share 56,073 36,445 Net loss per common share: Basic and diluted $ (0.52 ) $ (1.24 ) Common shares underlying equity awards, warrants, convertible preferred stock and other convertible securities aggregating 15.3 million shares and 5.2 million shares for the years ended December 31, 2018 and 2017 , respectively, prior to the application of the treasury stock method, have been excluded from the calculation of diluted net loss per share because they were anti-dilutive. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 17. 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 (1) all of the then-outstanding principal, plus all accrued and unpaid interest, approximately $13.7 million in total, was cancelled and terminated, (2) our license agreement with Aequus was terminated, (3) all obligations to Aequus were terminated with the exception of providing additional funding of up to $347,500 to Aequus, and (4) 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 (1) expiration of the last to expire valid patent claim that claims the ACTH Product, or (2) 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. As discussed in Note 8. Equity Transactions , we completed an underwritten public offering of 22,500 shares of our Series N Preferred Stock in June 2017 . BVF purchased 6,750 shares of our Series N Preferred Stock in such offering, of which, 6,175 shares were converted into approximately 4.1 million shares of our common stock. In February 2018 , in connection with the public offering of common stock (also discussed in Note 8. Equity Transactions ) , 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. Primarily as a result of these transactions, BVF beneficially owned approximately 12.0% and 20.0% of our outstanding common stock as of December 31, 2018 and 2017 , respectively. Matthew D. Perry, a member of our Board, is the President of BVF and portfolio manager for the underlying funds managed by the firm. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 18. Commitments and Contingencies Commitments See Note 5. Leases and Note 7. Long-term Debt for scheduled lease and debt payments. In addition, certain of our licensing agreements obligate us to make payments upon achievement of milestones and pay a royalty on net sales of products utilizing licensed compounds. See Note 10. Collaboration, Licensing and Milestone Agreements for further details. Purchase commitments relating to clinical trial contracts, manufacturing supply, insurance and others also arise in the ordinary course of business. We anticipate the timing of payments under these contracts to range from less than one year to more than three years. Contingencies 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 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, which is included in Other assets in our consolidated balance sheets. 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 have initiated steps to recover the amounts owed to us. We have applied for a refund based on the guidance from ITA; however the collectibility of the refund currently has not been determined. 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 $4.8 million converted using the currency exchange rate as of December 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. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 19. Income Taxes We file income tax returns in the U.S., Italy and the U.K. A substantial part of our operations takes place in the State of Washington, which does not impose an income tax as that term is defined in ASC 740, Accounting for Income Taxes . As such, our state income tax expense or benefit, if recognized, would be immaterial to our operations. We are not currently under examination by an income tax authority, nor have we been notified that an examination is contemplated. The U.S. signed into law, on December 22, 2017, tax reform legislation commonly referred to as the U.S. Tax Cuts and Jobs Act of 2017, or the 2017 Tax Act. The 2017 Tax Act was enacted in December 2017. The 2017 Tax Act significantly changed U.S. tax law by, among other things, lowering U.S. corporate income tax rates, implementing a territorial tax system and imposing a one-time transition tax on deemed repatriated earnings of foreign subsidiaries. The 2017 Tax Act reduced the U.S. corporate income tax rate from 34% to 21% , effective January 1, 2018. The SEC staff issued Staff Accounting Bulletin No. 118, or SAB 118, to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the 2017 Tax Act and allows the registrant to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. At December 31, 2017 , we had completed our accounting for all of the enactment date income tax effects of the 2017 Tax Act. While the 2017 Tax Act provides for a modified territorial tax system, beginning in 2018, Global Intangible Low-Taxed Income, or GILTI provisions will be applied providing an incremental tax on low taxed foreign income. The GILTI provisions require us to include in our U.S. income tax return foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s tangible assets. During 2018 , we made an accounting policy election to treat taxes related to GILTI as a current period expense when incurred. Loss before income taxes is attributable to the following tax jurisdictions (in thousands): Year ended December 31, 2018 2017 United States $ (29,162 ) $ (40,180 ) Foreign (190 ) (651 ) Net loss before income taxes $ (29,352 ) $ (40,831 ) The reconciliation between the income tax rate and our effective tax rate as of December 31 is as follows: 2018 2017 Federal income tax rate 21 % 34 % Research and development tax credits 6 3 Non-deductible executive compensation (1 ) — Valuation allowance (12 ) 304 Impact of tax reform — (101 ) Expired tax attribute carryforwards (17 ) (240 ) Gain on branch liquidation 3 — Foreign currency gains and losses 2 — Other (2 ) — Net effective tax rate — % — % The principal components of our deferred tax assets and liabilities as of December 31 were as follows (in thousands): 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 18,792 $ 21,005 Capitalized research and development 32,029 27,540 Research and development tax credit carryforwards 3,061 1,347 Stock-based compensation 2,940 2,004 Intangible assets 7,802 8,117 Depreciation and amortization 549 472 Other deferred tax assets 1,806 2,279 Total deferred tax assets 66,979 62,764 Less: valuation allowance (66,698 ) (62,472 ) 281 292 Deferred tax liabilities: Deductions for tax in excess of financial statements (281 ) (292 ) Total deferred tax liabilities (281 ) (292 ) Net deferred tax assets $ — $ — In preparing our December 31, 2018 financial statements, we determined that our December 31, 2017 deferred tax asset balance related to stock-based compensation and the corresponding valuation allowance were each overstated by $10.8 million . We evaluated the materiality of this adjustment and concluded that its impact was not material on our financial statements taken as a whole and did not affect our balance sheet, or statements of operations, stockholders' equity or cash flows, for any periods presented. We have elected to adjust the 2017 balances in the table above. As of December 31, 2018 and 2017 , we had U.S. federal net operating loss carryforwards, or the NOL, of approximately $56.6 million and $74.8 million respectively, which are available to reduce future taxable income. We also had U.S. federal tax credits of $3.1 million and $1.3 million as of December 31, 2018 and 2017 , respectively, which may be used to offset future tax liabilities. The NOL and tax credit carryforwards have begun to expire in 2018 and may become subject to annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code, or the IRC, of 1986, as amended. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or future tax liabilities. We have undertaken a formal IRC Section 382 study and the attributes disclosed in this footnote reflect the conclusion of that study. However, subsequent ownership changes may further affect the limitation in future years. At December 31, 2018 , the NOL carryforwards in the U.K.,which have an indefinite carryforward period, were approximately $33.0 million . Certain of the net operating loss deferred tax assets in the table above, totaling $9.9 million at December 31, 2018 are consolidated in our GAAP income tax provision due to our 60% ownership in Aequus; however, Aequus is not consolidated for income tax purposes and therefore these net operating losses will not be available to us in our future tax filings. We maintain a full valuation allowance on our net deferred tax assets. The assessment regarding whether a valuation allowance is required considers both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable. In making this assessment, significant weight is given to evidence that can be objectively verified. In our valuation, we considered our cumulative loss in recent years and forecasted losses in the near term as significant negative evidence. Based upon a review of the four sources of income identified within ASC 740, we determined that the negative evidence outweighed the positive evidence and that a full valuation allowance on our net deferred tax assets will be maintained. We will continue to assess the realizability of our deferred tax assets going forward and will adjust the valuation allowance as needed. Our valuation allowance increased by $4.2 million during the year ended December 31, 2018 primarily due to increases in capitalized research and development and research and development tax credit carryforwards, offset by net operating loss carryforward expirations. We follow the provisions in ASC 740 and the guidance related to accounting for uncertainty in income taxes. We determine our uncertain tax positions based on a determination of whether and how much of a tax benefit taken by us in our tax filings or positions is more likely than not to be sustained upon examination by the relevant income tax authorities. We are subject to U.S. federal and state, Italian and U.K. income taxes with varying statutes of limitations. Tax years from 1999 forward remain open to examination due to the carryover of net operating losses or tax credits. Our policy is to recognize interest related to unrecognized tax benefits as interest expense and penalties as operating expenses. As of December 31, 2018 , we had no unrecognized tax benefits and therefore no accrued interest or penalties related to unrecognized tax benefits. We believe that our income tax filing positions reflected in the various tax returns are more-likely-than not to be sustained on audit and thus there are no anticipated adjustments that would result in a material change to our consolidated balance sheets, statements of operations and cash flows. Therefore, no reserves for uncertain income tax positions have been recorded. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 20. Subsequent Events In February 2019 , we entered into a Termination and Transfer Agreement, or the Servier Termination Agreement, with Servier, which terminates the Restated Agreement. Under the Servier Termination Agreement, we will continue to be responsible for non-U.S. pharmacovigilance for PIXUVRI, the submission of a marketing authorization application for PIXUVRI and wind down of the PIX306 clinical trial during a transition period, which will last until the European Medicines Agency adopts a position on the PIXUVRI marketing authorization application. Servier agreed to reimburse us €620,000 for costs to be incurred in connection with transition period activities, and if the transition period extends beyond May 31, 2019, Servier will provide additional reimbursement to us not to exceed €50,000 per month or €200,000 in the aggregate. If the EMA’s definitive position results in a standard marketing authorization for PIXUVRI, we will transfer and assign all of our rights and responsibilities for PIXUVRI globally to Servier pursuant to an asset purchase agreement. Alternatively, if the EMA’s definitive position results in a conditional marketing authorization or suspension or withdrawal of the marketing authorization, then, at Servier’s election, we will either transfer and assign all of our rights and responsibilities for PIXUVRI globally to Servier pursuant to an asset purchase agreement or cooperate with Servier in the withdrawal of PIXUVRI from all jurisdictions other than the United States. The Servier Termination Agreement provides that, in either scenario, any asset purchase agreement will require, among other things, Servier to pay us €2.0 million and assume responsibility for all of the obligations related to PIXUVRI, including our remaining royalty payments to Novartis International Pharmaceutical Ltd. and the University of Vermont. |
Description of Business and S_2
Description of Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Description of Business | CTI BioPharma Corp., together with its wholly-owned subsidiary, also referred to collectively in this Annual Report on Form 10-K as “we,” “us,” “our,” the “Company” and “CTI,” is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their 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 concentrate 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. 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. |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of CTI and its wholly-owned subsidiary, CTI Life Sciences Limited, or CTILS. As of December 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 consolidated financial statements. All intercompany transactions and balances are eliminated in consolidation. |
Liquidity | Liquidity The accompanying consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the consolidated financial statements are issued. 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 December 31, 2018 , we had an accumulated deficit of $2.2 billion , and we expect to incur net losses for the foreseeable future. Our available cash, cash equivalents and short-term investments were $67.0 million as of December 31, 2018 . We completed the evaluation about our ability to continue as a going concern as required by Accounting Standards Update No. 2014-15, Presentation of Financial Statements-Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. Based on this analysis, we expect that our present financial resources will be sufficient to meet our obligations as they come due and to fund our operations through the second 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 consolidated financial statements do not include adjustments, if any, that may result from the outcome of this uncertainty. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. Generally Accepted Accounting Principles requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. For example, estimates include assumptions used in calculating reserves for excess and obsolete inventory, recording share-based compensation expense, accruals, the allocation of operating expenses, provision for loss contingencies, the fair value of financial instruments, our tax provision and related valuation allowance, and determining the useful lives of fixed assets and potential impairment of long-lived assets. Actual results could differ from those estimates. |
Certain Risks, Uncertainties and Concentrations | Certain Risks, Uncertainties and Concentrations Our results of operations are subject to foreign currency exchange rate fluctuations primarily due to our activity in Europe. We report the results of our operations in U.S. dollars, while the functional currency of our foreign subsidiaries is the euro. As the net positions of our unhedged foreign currency transactions fluctuate, our earnings might be negatively affected. In addition, the reported carrying value of our euro-denominated assets and liabilities that remain in our European branches and subsidiaries will be affected by fluctuations in the value of the U.S. dollar as compared to the euro. We review our foreign currency risk periodically along with hedging options to mitigate such risk. We source our drug products for clinical trials from a concentrated group of third-party contractors. If we are unable to obtain sufficient quantities of source materials, manufacture or distribute our products to customers from existing suppliers and service providers, or obtain the materials or services from other suppliers, manufacturers or distributors, certain research and development and sales activities may be delayed. See Note 15. Customer and Geographic Concentrations for further concentration disclosure. |
Fair Value Measurement | Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest: • Level 1—Valuations based on unadjusted quoted prices for identical assets and liabilities in active markets. • Level 2—Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. • Level 3—Valuations based on unobservable inputs that are supported by little or no market activity, reflecting our own assumptions. These valuations require significant judgment or estimation. Our cash equivalents and short-term investments are recorded at fair value. As of December 31, 2018 , our cash, cash equivalents and short-term investments consisted of cash, money market funds, U.S. government and agency securities and corporate debt securities. As of December 31, 2017 , our cash and cash equivalents consisted of cash. We measure the fair value of money market funds based on the closing price reported by a fund sponsor from an actively traded exchange. We value all other securities using broker quotes that utilize observable market inputs. We did not hold cash, cash equivalents and short-term investments categorized as Level 3 assets as of December 31, 2018 and 2017 . |
Cash, Cash Equivalents, and Restricted Cash | Cash and Cash Equivalents We consider all highly liquid instruments with original maturities of three months or less at the time acquired to be cash equivalents. Restricted Cash Restricted cash represented a legally restricted deposit held as a compensating balance against our senior 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 an amendment from SVB for such requirement and as a result, we no longer have restrictions placed on the cash balance. See Note 7. Long-term Debt for further details regarding our senior secured term loan with SVB. |
Receivables from License and Development Services Arrangements | Receivables from License and Development Services Arrangements Our receivables relate to amounts payable or reimbursable to us under the terms of license and development services arrangements with our partners. The receivable balance as of December 31, 2018 related primarily to a milestone receivable from Servier for the attainment of a regulatory milestone in November 2018 as well as a milestone receivable from Teva for the attainment of a worldwide net sales milestone of TRISENOX in December 2018. The receivable balance as of December 31, 2017 related primarily to the sale of PIXUVRI drug product to Servier. Receivables are reviewed for collectability whenever circumstances indicate that the carrying amount of the receivable may not be recoverable. |
Italian Value Added Tax Receivable | Italian Value Added Tax Receivable We historically carried out research and development activities in Italy and incurred value added tax, or VAT, from Italian suppliers on the acquisition of goods and services in Italy. This VAT should be considered as an Input VAT credit. We treated the majority of our sales made in Italy without output VAT (on the basis that the supplies should be considered outside the scope of Italian VAT). This resulted in the value of input VAT exceeding the value of output VAT, and accordingly we submitted a refund claim for the VAT. The Italian Tax Authority, or the ITA, has challenged the treatment of the sales transactions and claimed that the sales transactions made by us should have been subject to output VAT. Our Italian VAT receivable was approximately $4.5 million and $4.8 million as of December 31, 2018 and 2017 , respectively. Substantially all of our VAT receivable is included in Other assets . As disclosed in Note 18. Commitments and Contingencies , the ITA assessed us for additional VAT payments for services we provided in Italy, which we do not believe we owe. We have not recorded an amount in the financial statements for this contingent liability as we do not believe the potential payment of up to €4.2 million (or approximately $4.8 million converted using the currency exchange rate as of December 31, 2018 ), to the ITA is probable at this time. |
Property and Equipment | Property and Equipment Property and equipment are carried at cost, less accumulated depreciation and amortization. Depreciation commences at the time assets are placed in service. We calculate depreciation using the straight-line method over the estimated useful lives of the assets, ranging from three to five years for assets other than leasehold improvements. We amortize leasehold improvements over the lesser of their useful lives of 10 years or the term of the applicable lease. |
Impairment of Long-lived Assets | Impairment of Long-lived Assets We review our long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. If an impairment is indicated, the asset is written down to its estimated fair value based on fair market values. |
Leases | Leases We analyze leases at the inception of each agreement for classification as either an operating or capital lease. Certain of our lease agreement terms include rent holidays, rent escalation clauses and incentives for leasehold improvements. We recognize deferred rent relating to incentives for rent holidays and leasehold improvements and amortize the deferred rent over the term of the leases as a reduction of rent expense. For rent escalation clauses, we recognize rent expense equal to the amount of total minimum lease payments on a straight-line basis over the term of the lease. A deferred liability recognized in connection with the December 2017 sublease arrangement is amortized over the term of the sublease as a reduction of rent expense. As discussed in Recently Issued Accounting Guidance below, the new lease accounting guidance, Accounting Standards Codification, or ASC, 842 - Leases , is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2018, and we will adopt this guidance on January 1, 201 |
Contingencies | Contingencies We record liabilities associated with loss contingencies to the extent that we conclude that the occurrence of the contingency is probable and that the amount of the related loss is reasonably estimable. We record income from gain contingencies only upon the realization of assets resulting from the favorable outcome of the contingent event. See Note 10. Collaboration, Licensing and Milestone Agreements and Note 18. Commitments and Contingencies for further information regarding our current contingencies. |
Revenue Recognition | Revenue Recognition We adopted ASC 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. License and Development Services Arrangements We recognize license and contract revenue under license and development services arrangements 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 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, was recognized as revenue through the end of 2018 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. See Note 10. Collaboration, Licensing and Milestone Agreements - Servier for further discussion. 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 year ended December 31, 2018 related to a provision for excess, obsolete or unsaleable inventory as well as contractual royalties as we no longer have product sales as discussed above. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred in accordance with the FASB ASC 730, Research and Development . Research and development expenses include related salaries and benefits, clinical trial and related manufacturing costs, contract and other outside service fees, and facilities and overhead costs related to our research and development efforts. Research and development expenses also consist of costs incurred for proprietary and collaboration research and development and include activities such as product registries and investigator-sponsored trials. In instances where we enter into agreements with third parties for research and development activities, we may prepay fees for services at the initiation of the contract. We record the prepayment as a prepaid asset and amortize the asset into research and development expense over the period of time the contracted research and development services are performed. Other types of arrangements with third parties may be fixed fee or fee for service, and may include monthly payments or payments upon completion of milestones or receipt of deliverables. We expense upfront license payments related to acquired technologies that have not yet reached technological feasibility and have no alternative future use. |
Foreign Currency Translation and Transaction Gains and Losses | Foreign Currency Translation and Transaction Gains and Losses We record foreign currency translation adjustments and transaction gains and losses in accordance with ASC 830, Foreign Currency Matters. For our operations that have a functional currency other than the U.S. dollar, gains and losses resulting from the translation of the functional currency into U.S. dollars for financial statement presentation are not included in determining net loss, but are accumulated in the cumulative foreign currency translation adjustment account as a separate component of 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 consolidated financial statements. We have transactions in foreign currencies other than the functional currency. We record transaction gains and losses in our consolidated statements of operations related to the recurring measurement and settlement of such transactions. The intercompany balance due from CTILS is considered to be of a long-term nature. |
Income Taxes | Income Taxes We record a tax provision for the anticipated tax consequences of our results of operations. The provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, and for operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using the currently enacted tax rates in effect for the years in which those tax assets and liabilities are expected to be realized or settled. We provide a valuation allowance to reduce deferred tax assets to the amount that is more likely than not to be realized. |
Net Loss per Share | Net Loss per Share Basic net loss per common share is calculated based on the net loss attributable to common stockholders divided by the weighted average number of shares outstanding for the period. The calculation of diluted net loss per common share excludes the potential conversion of all dilutive convertible securities, such as convertible preferred stock, using the if-converted method, and the potential exercise or vesting of other dilutive securities, such as options, warrants and restricted stock, using the treasury stock method, as their inclusion would have an anti-dilutive effect. |
Recently Accounting Standards | Recently Adopted Accounting Standards In May 2014, the Financial Accounting Standards Board, or 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 consolidated financial statements. See " Revenue Recognition" above for further discussion. 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. The adoption of this guidance did not have a material impact on our consolidated statements of cash flows. 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 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 a material impact on our 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. We will adopt this guidance on January 1, 2019 using the modified retrospective approach and have elected to apply the package of practical expedients and certain other practical expedients permitted under the transition guidance. All identified leases are classified as operating leases. As a result, we expect to recognize right-of-use assets ranging from approximately $4.6 million to $4.9 million , and lease liabilities ranging from approximately $7.0 million to $7.3 million , respectively, in our consolidated balance sheet. In addition, we have elected to apply the additional transition method per ASU 2018-11 and expect to recognize a cumulative effect adjustment of approximately $1.2 million reducing the opening accumulated deficit balance. The adoption of the standard is not expected to materially impact our consolidated statements of operations or consolidated statements of cash flows. In June 2018, the FASB issued new accounting guidance which simplifies the accounting for share-based payments granted to nonemployees for goods and services by aligning it, with certain exceptions, with the accounting for share-based payments to employees. The guidance is effective for fiscal years beginning after December 15, 2018 (including interim periods within those fiscal years). Early adoption is permitted. We do not expect the adoption of this accounting guidance to have a material impact on our consolidated financial statements. In August 2018, the FASB issued new accounting guidance which eliminates certain disclosure requirements for fair value measurements for all entities, requires public entities to disclose certain new information and modifies some disclosure requirements. The guidance is effective for fiscal years beginning after December 15, 2019 (including interim periods within those fiscal years). Early adoption is permitted for either the entire standard or any eliminated or modified disclosures. We do not expect the adoption of this accounting guidance to have a material impact on our consolidated financial statements. Although there were several other new accounting pronouncements issued or proposed by the FASB, we do not believe any of these have had or will have a material impact on our consolidated financial statements. |
Reclassifications | Reclassifications Certain prior year items have been reclassified to conform to current year presentation, including the reclassification of items in stockholders' equity section as discussed in Reincorporation Merger above. |
Description of Business and S_3
Description of Business and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Cash and Cash Equivalents, Measured at Fair Value on a Recurring Basis | The following table summarizes, by major security type, our cash, cash equivalents and short-term investments that are measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands): December 31, 2018 December 31, 2017 Cost or Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Estimated Fair Value Total Estimated Fair Value Cash $ 919 $ — $ — $ 919 $ 43,218 Level 1 securities: Money market funds 20,525 — — 20,525 — Level 2 securities: U.S. government and agency securities 15,217 1 (5 ) 15,213 — Corporate debt securities 30,393 1 (13 ) 30,381 — $ 67,054 $ 2 $ (18 ) $ 67,038 $ 43,218 Less: restricted cash — (16,000 ) Total cash, cash equivalents and short-term investments $ 67,038 $ 27,218 |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides reconciliations of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the consolidated statements of cash flows. December 31, 2018 December 31, 2017 Cash and cash equivalents $ 36,439 $ 27,218 Restricted cash — 16,000 Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows $ 36,439 $ 43,218 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment are composed of the following as of December 31, 2018 and 2017 (in thousands): 2018 2017 Furniture and office equipment $ 4,445 $ 4,552 Leasehold improvements 5,168 5,168 Lab equipment 63 209 9,676 9,929 Less: accumulated depreciation and amortization (7,883 ) (7,564 ) Property and equipment, net $ 1,793 $ 2,365 |
Other Assets (Tables)
Other Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Other Assets | Other assets consisted of the following as of December 31, 2018 and 2017 (in thousands): 2018 2017 Italian VAT receivables $ 4,480 $ 4,692 Italian VAT deposit 493 516 Rent deposit 194 194 Other 380 195 Other assets $ 5,547 $ 5,597 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses | Accrued expenses consisted of the following as of December 31, 2018 and 2017 (in thousands): 2018 2017 Clinical and investigator-sponsored trial expenses $ 6,573 $ 5,019 Employee compensation and related expenses 4,216 4,432 Restructuring expenses 660 — Manufacturing expenses 458 2,637 Other 945 1,802 Total accrued expenses $ 12,852 $ 13,890 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Schedule of Future Minimum Operating Lease Payments and Receivables | Future minimum lease commitments for non-cancelable operating leases, net of sublease rentals, at December 31, 2018 were as follows (in thousands): Operating Sublease Lease Payments Rentals Receipts Net 2019 $ 2,581 $ 1,365 $ 1,216 2020 2,632 1,410 1,222 2021 2,628 1,454 1,174 2022 883 499 384 Thereafter — — — Total minimum lease commitments $ 8,724 $ 4,728 $ 3,996 |
Schedule of Future Minimum Operating Lease Payments and Receivables | Future minimum lease commitments for non-cancelable operating leases, net of sublease rentals, at December 31, 2018 were as follows (in thousands): Operating Sublease Lease Payments Rentals Receipts Net 2019 $ 2,581 $ 1,365 $ 1,216 2020 2,632 1,410 1,222 2021 2,628 1,454 1,174 2022 883 499 384 Thereafter — — — Total minimum lease commitments $ 8,724 $ 4,728 $ 3,996 |
Other Liabilities (Tables)
Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Other Liabilities Disclosure [Abstract] | |
Components of Other Liabilities | Other liabilities consisted of the following as of December 31, 2018 and 2017 (in thousands): 2018 2017 Deferred rent, less current portion $ 2,157 $ 3,050 Other long-term obligations 2,414 2,419 Total other liabilities $ 4,571 $ 5,469 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Principal and Interest Payments of Debt | As of December 31, 2018 , the scheduled principal and interest payments (based on the interest rate of 8.0 percent as of December 31, 2018 ) as well as the back-end fee described above are as follows: Principal Interest Back-end fee Total 2019 $ 5,333 $ 1,061 $ — $ 6,394 2020 5,333 633 — 5,966 2021 4,889 198 1,440 6,527 Thereafter — — — — Total scheduled payments $ 15,555 $ 1,892 $ 1,440 $ 18,887 Less: debt discount and issuance costs $ (1,476 ) Less: current portion of long-term debt $ (4,812 ) Long-term debt $ 9,267 |
Equity Transactions (Tables)
Equity Transactions (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Summary of Common Stock Reserved for Issuance | A summary of common stock reserved for issuance is as follows as of December 31, 2018 (in thousands): Equity incentive plans 9,203 Option agreement with Adam R. Craig 1,120 Common stock purchase warrants 514 Series O convertible preferred stock 8,383 Employee stock purchase plan 178 Total common stock reserved 19,398 |
Other Comprehensive Loss (Table
Other Comprehensive Loss (Tables) | 12 Months Ended |
Dec. 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 (1) Unrealized Foreign Exchange Loss on Intercompany Balance Accumulated Other Comprehensive Loss December 31, 2017 $ 1 $ (6,829 ) $ 556 $ (6,272 ) Current period other comprehensive loss (15 ) (2,843 ) (1,513 ) (4,371 ) December 31, 2018 $ (14 ) $ (9,672 ) $ (957 ) $ (10,643 ) (1) In accordance with ASC 830 - Foreign Currency Matters , the current period change includes a release of cumulative translation adjustment in the amount of $4.3 million upon dissolution of our foreign branch, which was recognized in other non-operating income in our consolidated statement of operations for the year ended December 31, 2018 . |
Collaboration, Licensing and _2
Collaboration, Licensing and Milestone Agreements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Collaborations [Abstract] | |
Allocation of Arrangement Consideration | At the inception of the Restated Agreement, 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) was included in the initial transaction price, which was then allocated based on the percentage of the relative selling price of each performance obligation as follows (in thousands): License $ 11,487 Development and other services 1,348 Total upfront payment $ 12,835 |
Restructuring Activities (Table
Restructuring Activities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Restructuring and Related Activities [Abstract] | |
Summary of the Accrual Balance and Utilization of Restructuring | The following table summarizes the accrual balance and utilization for the year ended December 31, 2018 (in thousands): Employee separation costs Restructuring accruals - December 31, 2017 $ — Restructuring expenses 660 Cash payments — Restructuring accruals - December 31, 2018 $ 660 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Share-Based Compensation Expense by Types of Awards | During the years ended December 31, 2018 and 2017 , we recognized share-based compensation expense which consisted of the following types of awards (in thousands): 2018 2017 Restricted stock 102 1,015 Options 6,267 4,731 Total share-based compensation expense $ 6,369 $ 5,746 |
Summary of Share-Based Compensation Expense | The following table summarizes share-based compensation expense for the years ended December 31, 2018 and 2017 , which was allocated as follows (in thousands): 2018 2017 Research and development $ 1,950 $ 911 Selling, general and administrative 4,419 4,835 Total share-based compensation expense $ 6,369 $ 5,746 |
Schedule of Black Scholes Stock Option Pricing Model Weighted Average Assumptions | Fair value for stock options was estimated at the date of grant using the Black-Scholes pricing model, with the following weighted average assumptions: Year Ended December 31, 2018 2017 Risk-free interest rate 2.9 % 1.9 % Expected dividend yield None None Expected life (in years) 5.4 5.2 Volatility 82 % 83 % |
Stock Option Activity for All Stock Plans | The following table summarizes stock option activity for all of our stock option plans: Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (Thousands) Outstanding at December 31, 2016 (1,913,000 exercisable) 2,806,000 $ 11.44 Granted 4,450,000 $ 3.68 Exercised — $ — Forfeited (378,000 ) $ 6.27 Cancelled and expired (210,000 ) $ 24.33 Outstanding at December 31, 2017 (2,500,000 exercisable) 6,668,000 $ 6.15 Granted 3,100,000 $ 3.04 Exercised (12,000 ) $ 3.89 Forfeited (408,000 ) $ 3.48 Cancelled and expired (2,129,000 ) $ 9.18 Outstanding at December 31, 2018 (2,597,000 exercisable) 7,219,000 $ 4.08 8.1 $ — Vested or expected to vest at December 31, 2018 6,321,000 $ 4.32 7.7 $ — Exercisable at December 31, 2018 2,597,000 $ 5.49 6.4 $ — |
Summary of Status of Nonvested Restricted Stock Awards and Units | A summary of the status of nonvested restricted stock units as of December 31, 2018 and 2017 and changes during the periods then ended, is presented below: Nonvested Units Weighted Average Nonvested at December 31, 2016 187,000 $ 5.35 Issued 20,000 $ 4.97 Vested (187,000 ) $ 5.35 Forfeited — $ — Nonvested at December 31, 2017 20,000 $ 4.97 Issued — $ — Vested (20,000 ) $ 4.97 Forfeited — $ — Nonvested at December 31, 2018 — $ — A summary of the status of nonvested restricted stock awards as of December 31, 2018 and 2017 and changes during the periods then ended, is presented below: Nonvested Shares Weighted Average Grant-Date Fair Value Per Share Nonvested at December 31, 2016 183,000 $ 12.76 Issued 2,000 $ 5.78 Vested (83,000 ) $ 9.43 Forfeited (39,000 ) $ 14.39 Nonvested at December 31, 2017 63,000 $ 15.93 Issued — $ — Vested (35,000 ) $ 12.00 Forfeited (15,000 ) $ 16.12 Nonvested at December 31, 2018 13,000 $ 26.23 |
Customer and Geographic Conce_2
Customer and Geographic Concentrations (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Segment Reporting [Abstract] | |
Product Sales from Major Customers | All sales of PIXUVRI during the year presented were in Europe. Product sales from PIXUVRI’s major customers as a percentage of total product sales were as follows: Year Ended December 31, 2017 Customer A 61 % Customer B 24 % Customer C 13 % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Shares | The computation of net loss per share is as follows (in thousands, except per share amounts): Year Ended December 31, 2018 2017 Net loss attributable to common stockholders $ (29,400 ) $ (45,020 ) Basic and diluted: Weighted average shares outstanding 56,106 36,569 Less: weighted average restricted shares outstanding (33 ) (124 ) Shares used in calculation of basic and diluted net loss per common share 56,073 36,445 Net loss per common share: Basic and diluted $ (0.52 ) $ (1.24 ) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Taxes | Loss before income taxes is attributable to the following tax jurisdictions (in thousands): Year ended December 31, 2018 2017 United States $ (29,162 ) $ (40,180 ) Foreign (190 ) (651 ) Net loss before income taxes $ (29,352 ) $ (40,831 ) |
Reconciliation Between Effective Tax Rate and Income Tax Rate | The reconciliation between the income tax rate and our effective tax rate as of December 31 is as follows: 2018 2017 Federal income tax rate 21 % 34 % Research and development tax credits 6 3 Non-deductible executive compensation (1 ) — Valuation allowance (12 ) 304 Impact of tax reform — (101 ) Expired tax attribute carryforwards (17 ) (240 ) Gain on branch liquidation 3 — Foreign currency gains and losses 2 — Other (2 ) — Net effective tax rate — % — % |
Significant Components of Deferred Tax Assets and Liabilities | The principal components of our deferred tax assets and liabilities as of December 31 were as follows (in thousands): 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 18,792 $ 21,005 Capitalized research and development 32,029 27,540 Research and development tax credit carryforwards 3,061 1,347 Stock-based compensation 2,940 2,004 Intangible assets 7,802 8,117 Depreciation and amortization 549 472 Other deferred tax assets 1,806 2,279 Total deferred tax assets 66,979 62,764 Less: valuation allowance (66,698 ) (62,472 ) 281 292 Deferred tax liabilities: Deductions for tax in excess of financial statements (281 ) (292 ) Total deferred tax liabilities (281 ) (292 ) Net deferred tax assets $ — $ — |
Description of Business and S_4
Description of Business and Summary of Significant Accounting Policies - Additional Information (Detail) $ / shares in Units, € in Millions | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2018EUR (€) | Dec. 31, 2018USD ($)$ / 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 USD per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0 | $ 0.001 | |||||||
Accumulated deficit | $ 2,224,746,000 | $ 2,195,346,000 | |||||||||
Available cash and cash equivalents | 67,000,000 | ||||||||||
Bad debt expense | $ 1,700,000 | ||||||||||
Allowance for doubtful accounts from collaborative arrangements | 0 | 0 | |||||||||
Italian VAT receivables | 4,500,000 | 4,800,000 | |||||||||
VAT receivable potential payment | € 4.2 | 4,800,000 | |||||||||
Unrealized foreign exchange gain (loss) | $ (362,000) | 0 | |||||||||
Leasehold Improvements | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Property and equipment useful life | 10 years | ||||||||||
Minimum | Assets Other Than Leasehold Improvements | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Property and equipment useful life | 3 years | ||||||||||
Maximum | Assets Other Than Leasehold Improvements | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Property and equipment useful life | 5 years | ||||||||||
Silicon Valley Bank | Secured Debt | Loan and Security Agreement | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Unrestricted and unencumbered cash required to be held per agreement | 16,000,000 | $ 16,000,000 | |||||||||
CTI Life Sciences Limited | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Unrealized foreign exchange gain (loss) | $ (1,500,000) | $ 4,300,000 | |||||||||
Intercompany balance, due from CTILS, noncurrent | € 28.7 | $ 32,800,000 | € 26.2 | $ 31,400,000 | |||||||
Development Services | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Deferred revenue | $ 1,400,000 | ||||||||||
Aequus Biopharma, Inc | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Interest in majority-owned subsidiary | 59.70% | 59.70% | |||||||||
Aequus Biopharma, Inc | Affiliated Entity | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Interest in majority-owned subsidiary | 60.00% | 60.00% | |||||||||
Subsequent Event | Minimum | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Right-of-use assets recognized | $ 4,600,000 | ||||||||||
Operating lease liabilities recognized | 7,000,000 | ||||||||||
Subsequent Event | Maximum | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Right-of-use assets recognized | 4,900,000 | ||||||||||
Operating lease liabilities recognized | 7,300,000 | ||||||||||
Subsequent Event | Accounting Standards Update 2018-11 | |||||||||||
Description Of Business And Significant Accounting Policies [Line Items] | |||||||||||
Cumulative effect adjustment to opening accumulated deficit | $ 1,200,000 |
Description of Business and S_5
Description of Business and Summary of Significant Accounting Policies - Cash and Cash Equivalents and Short-term Investments Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Level 2 securities: | ||
Gross Unrealized Gains | $ 2 | |
Gross Unrealized Losses | (18) | |
Less: restricted cash | 0 | $ (16,000) |
Total cash, cash equivalents and short-term investments | 67,000 | |
Cost or Amortized Cost | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash | 919 | |
Level 2 securities: | ||
Total | 67,054 | |
Total Estimated Fair Value | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Cash | 919 | 43,218 |
Level 2 securities: | ||
Total | 67,038 | 43,218 |
Less: restricted cash | 0 | (16,000) |
Total cash, cash equivalents and short-term investments | 67,038 | 27,218 |
Money market funds | Level 1 | Cost or Amortized Cost | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market funds | 20,525 | |
Money market funds | Level 1 | Total Estimated Fair Value | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Money market funds | 20,525 | 0 |
U.S. government and agency securities | Level 2 | ||
Level 2 securities: | ||
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (5) | |
U.S. government and agency securities | Level 2 | Cost or Amortized Cost | ||
Level 2 securities: | ||
Cost or Amortized Cost | 15,217 | |
U.S. government and agency securities | Level 2 | Total Estimated Fair Value | ||
Level 2 securities: | ||
Total Estimated Fair Value | 15,213 | 0 |
Corporate debt securities | Level 2 | ||
Level 2 securities: | ||
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | (13) | |
Corporate debt securities | Level 2 | Cost or Amortized Cost | ||
Level 2 securities: | ||
Cost or Amortized Cost | 30,393 | |
Corporate debt securities | Level 2 | Total Estimated Fair Value | ||
Level 2 securities: | ||
Total Estimated Fair Value | $ 30,381 | $ 0 |
Description of Business and S_6
Description of Business and Summary of Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents, and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 36,439 | $ 27,218 | |
Restricted cash | 0 | 16,000 | |
Total cash, cash equivalents and restricted cash shown in the consolidated statements of cash flows | $ 36,439 | $ 43,218 | $ 44,002 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Line Items] | ||
Property and Equipment, Gross | $ 9,676 | $ 9,929 |
Less: accumulated depreciation and amortization | (7,883) | (7,564) |
Property and equipment, net | 1,793 | 2,365 |
Depreciation expense | 593 | 717 |
Furniture and office equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, Gross | 4,445 | 4,552 |
Leasehold improvements | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, Gross | 5,168 | 5,168 |
Lab equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and Equipment, Gross | $ 63 | $ 209 |
Other Assets (Details)
Other Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Italian VAT receivables | $ 4,480 | $ 4,692 |
Italian VAT deposit | 493 | 516 |
Rent deposit | 194 | 194 |
Other | 380 | 195 |
Other assets | $ 5,547 | $ 5,597 |
Accrued Expenses (Detail)
Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Clinical and investigator-sponsored trial expenses | $ 6,573 | $ 5,019 |
Employee compensation and related expenses | 4,216 | 4,432 |
Restructuring expenses | 660 | 0 |
Manufacturing expenses | 458 | 2,637 |
Other | 945 | 1,802 |
Total accrued expenses | $ 12,852 | $ 13,890 |
Leases - Additional Information
Leases - Additional Information (Detail) ft² in Thousands | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2017USD ($)ft² | Jan. 31, 2012USD ($)ft²Option$ / ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Leases [Abstract] | ||||
Lease agreement area (square feet) | ft² | 44 | 66 | ||
Lease term | 120 months | |||
Number of options to extend the term | Option | 2 | |||
Extend option term | 5 years | |||
Initial annual rent payments per square foot | $ / ft² | 27 | |||
Rent payments due in initial five months | $ 0 | $ 0 | $ 0 | |
Percentage of annual rent increase | 3.00% | |||
Allowance for tenant improvements | $ 3,300,000 | |||
Sublease loss | 1,600,000 | $ 0 | 1,584,000 | |
Deferred liability | 1,600,000 | |||
Lessor, Lease, Description [Line Items] | ||||
Other current liabilities | 1,424,000 | 893,000 | 1,424,000 | |
Other liabilities | 5,469,000 | 4,571,000 | 5,469,000 | |
Sublease-related income | 1,600,000 | 100,000 | ||
Rent expense, net of sublease income | 100,000 | 1,600,000 | ||
Sublease | ||||
Lessor, Lease, Description [Line Items] | ||||
Other current liabilities | 800,000 | 200,000 | 800,000 | |
Other liabilities | $ 600,000 | $ 400,000 | $ 600,000 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments Under Noncancelable Operating Leases (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Operating Leases Future Minimum Payments | |
Operating Lease Payments, 2019 | $ 2,581 |
Operating Lease Payments, 2020 | 2,632 |
Operating Lease Payments, 2021 | 2,628 |
Operating Lease Payments, 2022 | 883 |
Operating Lease Payments, Thereafter | 0 |
Operating Lease Payments, Total minimum lease commitments | 8,724 |
Sublease Rentals Future Payments Receivable | |
Sublease Rentals Receipts, 2019 | 1,365 |
Sublease Rentals Receipts, 2020 | 1,410 |
Sublease Rentals Receipts, 2021 | 1,454 |
Sublease Rentals Receipts, 2022 | 499 |
Sublease Rentals Receipts, Thereafter | 0 |
Sublease Rentals Receipts, Total minimum lease commitments | 4,728 |
Net, 2019 | 1,216 |
Net, 2020 | 1,222 |
Net, 2021 | 1,174 |
Net, 2022 | 384 |
Net, Thereafter | 0 |
Net, Total minimum lease commitments | $ 3,996 |
Other Liabilities (Detail)
Other Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Other Liabilities Disclosure [Abstract] | ||
Deferred rent, less current portion | $ 2,157 | $ 3,050 |
Other long-term obligations | 2,414 | 2,419 |
Total other liabilities | 4,571 | 5,469 |
Deferred liability related to sublease execution | 400 | 600 |
Silicon Valley Bank | Secured Debt | Loan and Security Agreement | ||
Debt Instrument [Line Items] | ||
Fee amount on term loan | $ 1,400 | $ 1,400 |
Long-term Debt - Additional Inf
Long-term Debt - Additional Information (Detail) - Secured Debt - USD ($) | 1 Months Ended | |||
Nov. 30, 2017 | Dec. 31, 2018 | Jul. 31, 2018 | Dec. 31, 2017 | |
Loan and Security Agreement | Silicon Valley Bank | ||||
Debt Instrument [Line Items] | ||||
Debt instrument maximum borrowing capacity | $ 18,000,000 | |||
Proceeds from line of credit | 16,000,000 | |||
Remaining borrowing capacity | $ 2,000,000 | |||
Legally restricted cash | $ 16,000,000 | $ 16,000,000 | ||
Repayment term | 36 months | |||
Interest only period | 12 months | |||
Debt instrument stated interest rate percentage | 6.75% | |||
Fee payable when loan is paid or payable in full | 9.00% | |||
Fee amount on term loan | $ 1,400,000 | $ 1,400,000 | ||
Debt instrument unamortized discount | $ 1,900,000 | 1,400,000 | ||
Debt issuance costs | $ 100,000 | |||
Debt instrument unamortized issuance cost | 100,000 | |||
Outstanding principal balance | $ 15,600,000 | |||
Line of Credit Facility, Interest Rate at Period End | 8.00% | |||
Loan and Security Agreement | Participation Arrangement | Silicon Valley Bank | ||||
Debt Instrument [Line Items] | ||||
Number of warrants issued (in shares) | 190,140 | |||
Warrant exercise price (in USD per share) | $ 2.84 | |||
Loan and Security Agreement | Prime Rate | Silicon Valley Bank | ||||
Debt Instrument [Line Items] | ||||
Interest rate above prime rate | 2.50% | |||
Loan Agreement | Hercules | ||||
Debt Instrument [Line Items] | ||||
Debt instrument unamortized discount | $ 100,000 | |||
Repaid principle face amount | $ 14,300,000 |
Long-term Debt - Principal and
Long-term Debt - Principal and Interest Payments of Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Principal | ||
Total scheduled payments, Principal, 2019 | $ 5,333 | |
Total scheduled payments, Principal, 2020 | 5,333 | |
Total scheduled payments, Principal, 2021 | 4,889 | |
Total scheduled payments, Principal, Thereafter | 0 | |
Total scheduled payments, Principal | 15,555 | |
Less: debt discount and issuance costs | (1,476) | |
Less: current portion of long-term debt | (4,812) | $ (444) |
Long-term debt | 9,267 | |
Interest | ||
Total scheduled payments, Interest, 2019 | 1,061 | |
Total scheduled payments, Interest, 2020 | 633 | |
Total scheduled payments, Interest, 2021 | 198 | |
Total scheduled payments, Interest, Thereafter | 0 | |
Total scheduled payments, Interest | 1,892 | |
Back-end fee | ||
Total scheduled payments, Back-end fee, 2019 | 0 | |
Total scheduled payments, Back-end fee, 2020 | 0 | |
Total scheduled payments, Back-end fee, 2021 | 1,440 | |
Total scheduled payments, Back-end fee, Thereafter | 0 | |
Total scheduled payments, Back-end fee | 1,440 | |
Total scheduled payments, 2019 | 6,394 | |
Total scheduled payments, 2020 | 5,966 | |
Total scheduled payments, 2021 | 6,527 | |
Total scheduled payments, Thereafter | 0 | |
Total scheduled payments | $ 18,887 |
Equity Transactions - Preferred
Equity Transactions - Preferred and Common Stock Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||||
Nov. 30, 2018 | Feb. 28, 2018 | Jun. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | May 31, 2018 | Apr. 30, 2018 | May 31, 2017 | Apr. 30, 2017 | |
Class of Stock [Line Items] | |||||||||
Dividends and deemed dividends on preferred stock | $ 80 | $ 4,350 | |||||||
Proceeds from common stock offering | 64,170 | 0 | |||||||
Stock issuance costs | $ 168 | $ 0 | |||||||
Common stock authorized (in shares) | 101,500,000 | 81,500,000 | 101,500,000 | 81,500,000 | 81,500,000 | 41,500,000 | |||
Series N Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Stock Issued (in shares) | 22,500 | ||||||||
Proceeds from issuance of preferred stock | $ 45,000 | ||||||||
Underwriting commissions and discounts, and other offering costs | $ 2,300 | ||||||||
Number of shares converted (in shares) | 21,925 | ||||||||
Conversion price (in USD per share) | $ 3 | ||||||||
Dividends and deemed dividends on preferred stock | $ 4,400 | ||||||||
Preferred stock outstanding (in shares) | 0 | 575 | |||||||
Preferred stock stated value (in USD per share) | $ 0.001 | $ 0.001 | |||||||
Series O Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Preferred stock outstanding (in shares) | 12,575 | 0 | |||||||
Preferred stock stated value (in USD per share) | $ 0.001 | $ 0.001 | |||||||
Common Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Stock Issued (in shares) | 23,000,000 | 23,000,000 | |||||||
Number of shares issued in conversion (in shares) | (8,000,000) | 14,616,000 | |||||||
Stock issued, purchase price (in USD per share) | $ 3 | ||||||||
Proceeds from common stock offering | $ 69,000 | ||||||||
Stock issuance costs | $ 4,800 | ||||||||
Common Stock | Series N Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares issued in conversion (in shares) | 14,600,000 | ||||||||
BVF Partners, L.P. | Series N Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares converted (in shares) | 575 | ||||||||
Preferred stock outstanding (in shares) | 575 | ||||||||
BVF Partners, L.P. | Series O Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares issued in conversion (in shares) | 12,575 | ||||||||
Conversion price (in USD per share) | $ 3 | ||||||||
Dividends and deemed dividends on preferred stock | $ 100 | ||||||||
Preferred stock outstanding (in shares) | 12,575 | ||||||||
Preferred stock stated value (in USD per share) | $ 2,000 | ||||||||
BVF Partners, L.P. | Common Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Stock Issued (in shares) | 6,300,000 | ||||||||
Number of shares converted (in shares) | 8,000,000 | ||||||||
BVF Partners, L.P. | Common Stock | Series O Preferred Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Outstanding preferred convertible into common stock (in shares) | 8,400,000 | ||||||||
Cowen And Company, LLC | Common Stock | |||||||||
Class of Stock [Line Items] | |||||||||
Stock Issued (in shares) | 0 | ||||||||
Expected proceeds from common stock offering, net of issuance costs | $ 50,000 | ||||||||
Percent of gross proceeds, underwriter commission | 3.00% |
Equity Transactions - Summary o
Equity Transactions - Summary of Common Stock Reserved for Issuance (Detail) shares in Thousands | Dec. 31, 2018shares |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 19,398 |
Series O Preferred Stock | |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 8,383 |
Common stock purchase warrants | |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 514 |
Options | Chief Executive Officer | |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 1,120 |
Equity incentive plans | |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 9,203 |
Employee stock purchase plan | |
Class of Stock [Line Items] | |
Total common stock reserved (in shares) | 178 |
Equity Transactions - Warrant I
Equity Transactions - Warrant Information (Detail) - Common stock purchase warrants - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2015 |
Vendor | |||
Class Of Warrant Or Right [Line Items] | |||
Number of warrants issued (in shares) | 294,117 | ||
Warrant exercise price (in USD per share) | $ 1.7 | ||
Third Amendment | |||
Class Of Warrant Or Right [Line Items] | |||
Number of warrants issued (in shares) | 29,239 | ||
Warrant exercise price (in USD per share) | $ 17.1 | ||
Loan and Security Agreement | |||
Class Of Warrant Or Right [Line Items] | |||
Number of warrants issued (in shares) | 190,140 | ||
Warrant exercise price (in USD per share) | $ 2.84 | ||
Warrants outstanding (in shares) | 169,014 |
Other Comprehensive Loss (Detai
Other Comprehensive Loss (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Changes in AOCI [Roll Forward] | ||
Beginning Balance | $ (6,272) | |
Current period other comprehensive loss | (4,371) | $ 383 |
Ending Balance | (10,643) | (6,272) |
Net Unrealized Loss on Available-For-Sale Securities | ||
Changes in AOCI [Roll Forward] | ||
Beginning Balance | 1 | |
Current period other comprehensive loss | (15) | |
Ending Balance | (14) | 1 |
Foreign Currency Translation Adjustments | ||
Changes in AOCI [Roll Forward] | ||
Beginning Balance | (6,829) | |
Current period other comprehensive loss | (2,843) | |
Ending Balance | (9,672) | (6,829) |
Cumulative translation adjustment | 4,300 | |
Unrealized Foreign Exchange Loss on Intercompany Balance | ||
Changes in AOCI [Roll Forward] | ||
Beginning Balance | 556 | |
Current period other comprehensive loss | (1,513) | |
Ending Balance | $ (957) | $ 556 |
Collaboration, Licensing and _3
Collaboration, Licensing and Milestone Agreements - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||||||||
Nov. 30, 2018EUR (€) | Nov. 30, 2018USD ($) | Sep. 30, 2017EUR (€) | Sep. 30, 2017USD ($) | May 31, 2017EUR (€) | May 31, 2017USD ($) | Jan. 31, 2014USD ($) | Mar. 31, 2000 | Jun. 30, 2017USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | May 31, 2017USD ($) | Apr. 30, 2017USD ($) | Oct. 31, 2016USD ($) | Sep. 30, 2014USD ($) | May 31, 2012USD ($) | Jun. 30, 2005USD ($) | Nov. 30, 1998USD ($) | |
University of Vermont | PIXUVRI | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Period from first commercial sale | 10 years | |||||||||||||||||
Collaborative Arrangement Product Agreement | Cephalon, Inc | Products | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be received | $ 100,000,000 | |||||||||||||||||
Milestone payments received | $ 60,000,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | Novartis | Products | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be made | $ 16,600,000 | |||||||||||||||||
Percentage of royalty payable to net sales | 10.00% | |||||||||||||||||
Collaborative Arrangement Product Agreement | Gynecologic Oncology Group | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Milestones obligation paid | $ 500,000 | |||||||||||||||||
Collaborative Arrangement Product Agreement | PG-TXL | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be made | $ 14,400,000 | |||||||||||||||||
Asset Return and Termination Agreement | Borrowing Associated With License Agreement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be made | $ 10,300,000 | |||||||||||||||||
S_BIO Asset Purchase Agreement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Contingency milestone payment to be made | $ 132,500,000 | |||||||||||||||||
Milestone payments through the issuance of stock | 50.00% | |||||||||||||||||
Servier | Collaborative Arrangement | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Consideration received | € 12,000,000 | $ 12,800,000 | ||||||||||||||||
Revenue recognized | € 3,000,000 | $ 3,400,000 | € 1,000,000 | $ 1,200,000 | 2,000,000 | |||||||||||||
Contingency milestone payment to be received | € | 76,000,000 | |||||||||||||||||
Potential regulatory milestone payment | € | 36,000,000 | |||||||||||||||||
Potential sales based milestone payment | € | € 40,000,000 | |||||||||||||||||
Servier | Collaborative Arrangement | License | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Revenue recognized | $ 11,500,000 | |||||||||||||||||
Servier | Collaborative Arrangement | Development and Other Services | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Revenue recognized | 1,400,000 | 500,000 | ||||||||||||||||
Deferred revenue | $ 1,300,000 | $ 1,900,000 | $ 600,000 | |||||||||||||||
FDA Approval | Collaborative Arrangement Product Agreement | Cephalon, Inc | Products | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Revenue recognized | 10,000,000 | |||||||||||||||||
Worldwide Net Sales | Collaborative Arrangement Product Agreement | Cephalon, Inc | Products | ||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||||||||
Revenue recognized | $ 10,000,000 | $ 10,000,000 |
Collaboration, Licensing and _4
Collaboration, Licensing and Milestone Agreements - Allocated Arrangement Consideration (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
May 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
License | $ 26,290 | $ 25,146 | |
Servier | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
License | $ 11,487 | ||
Development and other services | 1,348 | ||
Total upfront payment | $ 12,835 |
Restructuring Activities (Detai
Restructuring Activities (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2018USD ($)position | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Restructuring and Related Activities [Abstract] | |||
Number of positions impacted | position | 21 | ||
Restructuring expense expected to incur | $ 1,500 | $ 1,500 | |
Restructuring expense incurred | 700 | 700 | |
Restructuring Reserve [Roll Forward] | |||
Restructuring expenses | 660 | $ 0 | |
Employee separation costs | |||
Restructuring Reserve [Roll Forward] | |||
Restructuring accruals - December 31, 2017 | 0 | ||
Restructuring expenses | 660 | ||
Cash payments | 0 | ||
Restructuring accruals - December 31, 2018 | $ 660 | $ 660 | $ 0 |
Share-Based Compensation - Expe
Share-Based Compensation - Expense by Types of Awards (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense | $ 6,369 | $ 5,746 |
Restricted stock | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense | 102 | 1,015 |
Options | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation expense | $ 6,267 | $ 4,731 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 6,369 | $ 5,746 |
Research and development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | 1,950 | 911 |
Selling, general and administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation expense | $ 4,419 | $ 4,835 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | |||
May 31, 2017 | Mar. 31, 2017installment$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Sep. 30, 2015shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share-based compensation expense | $ | $ 6,369,000 | $ 5,746,000 | |||
Unrecognized compensation cost | $ | $ 7,800,000 | ||||
Recognition period | 1 year 9 months 29 days | ||||
Tax benefits attributed to share-based compensation expense | $ | $ 0 | 0 | |||
Shares of common stock reserved for future issuance (in shares) | 19,398,000 | ||||
Compensation expense related to nonemployee stock options and restricted stock awards | $ | $ 6,000 | $ (8,000) | |||
2007 Equity Incentive Stock Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares authorized for issuance (in shares) | 11,600,000 | ||||
Shares available for future grants (in shares) | 2,800,000 | ||||
Employee stock purchase plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares of common stock reserved for future issuance (in shares) | 178,000 | ||||
Options | Chief Executive Officer | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares of common stock reserved for future issuance (in shares) | 1,120,000 | ||||
Options expiration period | 10 years | ||||
Options granted in period (in shares) | 1,200,000 | ||||
Exercise price of options granted (in USD per share) | $ / shares | $ 4.24 | ||||
Number semi-annual vesting installments | installment | 6 | ||||
Vesting period | 3 years | ||||
Options | Chief Executive Officer | Stock Option Plan, 2015 | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Options granted in period (in shares) | 80,000 | ||||
Employee stock | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares of common stock reserved for future issuance (in shares) | 200,000 | ||||
Employee stock | Employee stock purchase plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares of common stock reserved for future issuance (in shares) | 200,000 | ||||
Shares authorized for issuance (in shares) | 200,000 | ||||
Shares issued in period (in shares) | 5,000 | 4,000 | |||
Vested Restricted Stock | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Repurchased shares of common stock (in shares) | 5,800 | 21,000 | |||
Repurchased shares of common stock | $ | $ 21,000 | $ 100,000 | |||
Options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share-based compensation expense | $ | $ 6,267,000 | $ 4,731,000 | |||
Weighted average exercise price of options exercisable (in USD per share) | $ / shares | $ 5.49 | $ 9.83 | |||
Weighted average fair value of options granted (in USD per share) | $ / shares | $ 2.09 | 2.47 | |||
Options vested or expected to vest (in shares) | 6,321,000 | ||||
Weighted average exercise price, vested or expected to vest (in USD per share) | $ / shares | $ 4.32 | ||||
Exercise price of options granted (in USD per share) | $ / shares | $ 3.04 | $ 3.68 | |||
Options | 2007 Equity Incentive Stock Plan | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Options expiration period | 10 years | ||||
Performance-based options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Options vested or expected to vest (in shares) | 715,000 | ||||
Weighted average exercise price, vested or expected to vest (in USD per share) | $ / shares | $ 2.18 | ||||
Restricted stock | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Share-based compensation expense | $ | $ 102,000 | $ 1,015,000 | |||
Shares issued in period (in shares) | 0 | 2,000 | |||
Weighted average fair value of restricted shares issued (in USD per share) | $ / shares | $ 0 | $ 5.78 | |||
Restricted shares, cancelled (in shares) | 15,000 | 39,000 | |||
Total fair value of vested restricted stock awards | $ | $ 100,000 | $ 300,000 | |||
Restricted stock units (RSUs) | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Shares issued in period (in shares) | 0 | 20,000 | |||
Weighted average fair value of restricted shares issued (in USD per share) | $ / shares | $ 0 | $ 4.97 | |||
Restricted shares, cancelled (in shares) | 0 | 0 | |||
Total fair value of vested restricted stock awards | $ | $ 100,000 | $ 800,000 | |||
Nonemployee Stock Options | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Unvested options to acquire shares of common stock, outstanding (in shares) | 12,000 | 4,000 |
Share-Based Compensation - Weig
Share-Based Compensation - Weighted Average Assumptions (Detail) - Stock Options | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk-free interest rate | 2.90% | 1.90% |
Expected dividend yield | 0.00% | 0.00% |
Expected life (in years) | 5 years 5 months 5 days | 5 years 2 months 15 days |
Volatility | 82.00% | 83.00% |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Activity (Detail) - Stock Options - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Options | |||
Options, Beginning Balance (in shares) | 6,668,000 | 2,806,000 | |
Options, Granted (in shares) | 3,100,000 | 4,450,000 | |
Options, Exercised (in shares) | (12,000) | 0 | |
Options, Forfeited (in shares) | (408,000) | (378,000) | |
Options, Cancelled and expired (in shares) | (2,129,000) | (210,000) | |
Options, Ending Balance (in shares) | 7,219,000 | 6,668,000 | |
Options, Vested or expected to vest (in shares) | 6,321,000 | ||
Options, Exercisable (in shares) | 2,597,000 | 2,500,000 | 1,913,000 |
Weighted Average Exercise Price | |||
Weighted Average Exercise Price, Beginning balance (in USD per share) | $ 6.15 | $ 11.44 | |
Weighted Average Exercise Price, Granted (in USD per share) | 3.04 | 3.68 | |
Weighted Average Exercise Price, Exercised (in USD per share) | 3.89 | 0 | |
Weighted Average Exercise Price, Forfeited (in USD per share) | 3.48 | 6.27 | |
Weighted Average Exercise Price, Cancelled and expired (in USD per share) | 9.18 | 24.33 | |
Weighted Average Exercise Price, Ending balance (in USD per share) | 4.08 | 6.15 | |
Weighted Average Exercise Price, Vested or expected to vest (in USD per share) | 4.32 | ||
Weighted Average Exercise Price, Exercisable (in USD per share) | $ 5.49 | $ 9.83 | |
Weighted Average Remaining Contractual Term, Outstanding at end of period | 8 years 1 month 2 days | ||
Weighted Average Remaining Contractual Term, Vested and expected to vest at end of period | 7 years 8 months 1 day | ||
Weighted Average Remaining Contractual Term, Exercisable at end of period | 6 years 5 months 8 days | ||
Aggregate Intrinsic Value, Outstanding at end of period | $ 0 | ||
Aggregate Intrinsic Value, Vested and expected to vest at end of period | 0 | ||
Aggregate Intrinsic Value, Exercisable at end of period | $ 0 |
Share-Based Compensation - Su_2
Share-Based Compensation - Summary of Status of Nonvested Restricted Stock Awards (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Restricted stock | ||
Nonvested Shares | ||
Nonvested Shares, Beginning balance (in shares) | 63,000 | 183,000 |
Nonvested Shares, Issued (in shares) | 0 | 2,000 |
Nonvested Shares, Vested (in shares) | (35,000) | (83,000) |
Nonvested Shares, Forfeited (in shares) | (15,000) | (39,000) |
Nonvested Shares, Ending balance (in shares) | 13,000 | 63,000 |
Weighted Average Grant-Date Fair Value Per Share | ||
Weighted Average Grant-Date Fair Value Per Share, Beginning balance (in USD per share) | $ 15.93 | $ 12.76 |
Weighted Average Grant-Date Fair Value Per Share, Issued (in USD per share) | 0 | 5.78 |
Weighted Average Grant-Date Fair Value Per Share, Vested (in USD per share) | 12 | 9.43 |
Weighted Average Grant-Date Fair Value Per Share, Forfeited (in USD per share) | 16.12 | 14.39 |
Weighted Average Grant-Date Fair Value Per Share, Ending balance (in USD per share) | $ 26.23 | $ 15.93 |
Restricted stock units (RSUs) | ||
Nonvested Shares | ||
Nonvested Shares, Beginning balance (in shares) | 20,000 | 187,000 |
Nonvested Shares, Issued (in shares) | 0 | 20,000 |
Nonvested Shares, Vested (in shares) | (20,000) | (187,000) |
Nonvested Shares, Forfeited (in shares) | 0 | 0 |
Nonvested Shares, Ending balance (in shares) | 0 | 20,000 |
Weighted Average Grant-Date Fair Value Per Share | ||
Weighted Average Grant-Date Fair Value Per Share, Beginning balance (in USD per share) | $ 4.97 | $ 5.35 |
Weighted Average Grant-Date Fair Value Per Share, Issued (in USD per share) | 0 | 4.97 |
Weighted Average Grant-Date Fair Value Per Share, Vested (in USD per share) | 4.97 | 5.35 |
Weighted Average Grant-Date Fair Value Per Share, Forfeited (in USD per share) | 0 | 0 |
Weighted Average Grant-Date Fair Value Per Share, Ending balance (in USD per share) | $ 0 | $ 4.97 |
Employee Benefit Plans (Detail)
Employee Benefit Plans (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Retirement Benefits [Abstract] | ||
Maximum Annual Contributions Per Employee, Percent | 80.00% | |
Discretionary matching contributions | $ 0.2 | $ 0.3 |
Shareholder Rights Plan (Detail
Shareholder Rights Plan (Detail) | Dec. 31, 2009shares |
Rights plan | |
Class of Stock [Line Items] | |
Conversion rate of right (in shares) | 1 |
Customer and Geographic Conce_3
Customer and Geographic Concentrations (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2018 | |
Customer A | Sales Revenue, Goods, Net | Customer Concentration Risk | ||
Concentration Risk [Line Items] | ||
Percentage of product sales | 61.00% | |
Customer B | Sales Revenue, Goods, Net | Customer Concentration Risk | ||
Concentration Risk [Line Items] | ||
Percentage of product sales | 24.00% | |
Customer C | Sales Revenue, Goods, Net | Customer Concentration Risk | ||
Concentration Risk [Line Items] | ||
Percentage of product sales | 13.00% | |
Non-US | ||
Concentration Risk [Line Items] | ||
Total long-lived assets | $ 0 | $ 0 |
Net Loss Per Share - Calculatio
Net Loss Per Share - Calculation of Basic & Diluted Net Loss (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Earnings Per Share [Abstract] | ||
Net loss attributable to common stockholders | $ (29,400) | $ (45,020) |
Basic and diluted: | ||
Weighted average shares outstanding (in shares) | 56,106 | 36,569 |
Less: weighted average restricted shares outstanding (in shares) | (33) | (124) |
Shares used in calculation of basic and diluted net loss per common share (in shares) | 56,073 | 36,445 |
Net loss per common share: Basic and diluted (in USD per share) | $ (0.52) | $ (1.24) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares shares in Millions | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Earnings Per Share [Abstract] | ||
Anti-dilutive securities excluded from computation of let loss per share (in shares) | 15.3 | 5.2 |
Related Party Transactions (Det
Related Party Transactions (Detail) | 1 Months Ended | 12 Months Ended | |||
Feb. 28, 2018shares | Jun. 30, 2017shares | Mar. 31, 2017USD ($) | Dec. 31, 2018shares | Dec. 31, 2017shares | |
Series N Preferred Stock | |||||
Related Party Transaction [Line Items] | |||||
Stock Issued (in shares) | 22,500 | ||||
Number of shares converted (in shares) | 21,925 | ||||
BVF Partners, L.P. | Series N Preferred Stock | |||||
Related Party Transaction [Line Items] | |||||
Number of shares converted (in shares) | 575 | ||||
BVF Partners, L.P. | Series O Preferred Stock | |||||
Related Party Transaction [Line Items] | |||||
Conversion of stock (in shares) | 12,575 | ||||
Affiliated Entity | BVF Partners, L.P. | |||||
Related Party Transaction [Line Items] | |||||
Common stock owned by others, percentage | 12.00% | 20.00% | |||
Affiliated Entity | BVF Partners, L.P. | Series N Preferred Stock | |||||
Related Party Transaction [Line Items] | |||||
Stock Issued (in shares) | 6,750 | ||||
Number of shares converted (in shares) | 6,175 | ||||
Conversion of stock (in shares) | 4,100,000 | ||||
Aequus Biopharma, Inc | Affiliated Entity | License And Promissory Note Termination, And Note Cancellation Agreements | |||||
Related Party Transaction [Line Items] | |||||
Amount funded to subsidiary | $ | $ 347,500 | ||||
Percent of milestone payments to be received | 0.2 | ||||
Milestone payments to be received | $ | $ 20,000,000 | ||||
Percentage of royalty payable to net sales | 5.00% | ||||
Period from first commercial sale | 10 years | ||||
License And Promissory Note | Convertible Debt | Aequus Biopharma, Inc | Affiliated Entity | |||||
Related Party Transaction [Line Items] | |||||
Debt cancelled and terminated | $ | $ 13,700,000 | ||||
Common Stock | |||||
Related Party Transaction [Line Items] | |||||
Stock Issued (in shares) | 23,000,000 | 23,000,000 | |||
Conversion of stock (in shares) | (8,000,000) | 14,616,000 | |||
Common Stock | Series N Preferred Stock | |||||
Related Party Transaction [Line Items] | |||||
Conversion of stock (in shares) | 14,600,000 | ||||
Common Stock | BVF Partners, L.P. | |||||
Related Party Transaction [Line Items] | |||||
Stock Issued (in shares) | 6,300,000 | ||||
Number of shares converted (in shares) | 8,000,000 |
Commitments and Contingencies (
Commitments and Contingencies (Detail) - VAT Assessments € in Thousands, $ in Millions | 1 Months Ended | |||||||
Mar. 31, 2014EUR (€) | Mar. 31, 2014USD ($) | Nov. 30, 2013EUR (€) | Dec. 31, 2018EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2007EUR (€) | Dec. 31, 2006EUR (€) | Dec. 31, 2003EUR (€) | |
Loss Contingencies [Line Items] | ||||||||
Estimate of possible loss | € 4,200 | $ 4.8 | € 900 | € 2,700 | € 600 | |||
Taxes paid | € 400 | $ 0.6 | ||||||
Payments for attorney fees | € 12 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax [Line Items] | ||
Stock-based compensation | $ 2,940,000 | $ 2,004,000 |
Valuation allowance | 66,698,000 | 62,472,000 |
Net operating loss carryforwards | 56,600,000 | 74,800,000 |
U.S. federal tax credits | 3,100,000 | 1,300,000 |
Net operating loss deferred tax assets | 18,792,000 | 21,005,000 |
Increase (decrease) in valuation allowance | 4,200,000 | |
Unrecognized tax benefits | 0 | |
Accrued interest or penalties related to unrecognized tax benefits | 0 | |
Reserves for uncertain income tax positions | 0 | |
United Kingdom | ||
Income Tax [Line Items] | ||
Net operating loss carryforwards | 33,000,000 | |
Restatement Adjustment | ||
Income Tax [Line Items] | ||
Stock-based compensation | 10,800,000 | |
Valuation allowance | $ 10,800,000 | |
Aequus Biopharma, Inc | ||
Income Tax [Line Items] | ||
Net operating loss deferred tax assets | $ 9,900,000 | |
Interest in majority-owned subsidiary | 59.70% |
Income Taxes - Loss Before Inco
Income Taxes - Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Net loss before income taxes, United States | $ (29,162) | $ (40,180) |
Net loss before income taxes, Foreign | (190) | (651) |
Net loss before noncontrolling interest | $ (29,352) | $ (40,831) |
Income Taxes - Reconciliation B
Income Taxes - Reconciliation Between Effective and Income Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal income tax rate | 21.00% | 34.00% |
Research and development tax credits | 6.00% | 3.00% |
Non-deductible executive compensation | (1.00%) | 0.00% |
Valuation allowance | (12.00%) | 304.00% |
Impact of tax reform | 0.00% | (101.00%) |
Expired tax attribute carryforwards | (17.00%) | (240.00%) |
Gain on branch liquidation | 3.00% | 0.00% |
Foreign currency gains and losses | 2.00% | 0.00% |
Other | (2.00%) | 0.00% |
Net effective tax rate | 0.00% | 0.00% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 18,792 | $ 21,005 |
Capitalized research and development | 32,029 | 27,540 |
Research and development tax credit carryforwards | 3,061 | 1,347 |
Stock-based compensation | 2,940 | 2,004 |
Intangible assets | 7,802 | 8,117 |
Depreciation and amortization | 549 | 472 |
Other deferred tax assets | 1,806 | 2,279 |
Total deferred tax assets | 66,979 | 62,764 |
Less: valuation allowance | (66,698) | (62,472) |
Deferred Tax Assets, Net of Valuation Allowance, Total | 281 | 292 |
Deferred tax liabilities: | ||
Deductions for tax in excess of financial statements | (281) | (292) |
Total deferred tax liabilities | (281) | (292) |
Net deferred tax assets | $ 0 | $ 0 |
Subsequent Events (Details)
Subsequent Events (Details) - Collaborative Arrangement Product Agreement - Servier - Subsequent Event € in Thousands | 1 Months Ended |
Feb. 28, 2019EUR (€) | |
Subsequent Event [Line Items] | |
Reimbursement of contract costs | € 620 |
Gain on contract termination | 2,000 |
Extends Beyond May 31, 2019, Monthly Amount | |
Subsequent Event [Line Items] | |
Reimbursement of contract costs | 50 |
Extends Beyond May 31, 2019 | |
Subsequent Event [Line Items] | |
Reimbursement of contract costs | € 200 |