Document and Entity Information
Document and Entity Information | 12 Months Ended |
Dec. 31, 2019 | |
Cover [Abstract] | |
Entity Registrant Name | DELCATH SYSTEMS, INC. |
Amendment Description | AMENDMENT NO. 1 TO FORM S-1 |
Entity Central Index Key | 0000872912 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Incorporation, State or Country Code | DE |
Entity Address, Address Line One | 1633 Broadway |
Entity Address Address Line2 | Suite 22C |
Entity Address City Or Town | New York |
Entity Address State Or Province | NY |
Entity Address Postal Zip Code | 10019 |
City Area Code | 212 |
Local Phone Number | 489-2100 |
Document Type | S-1/A |
Amendment Flag | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | |
Current assets | |||
Cash and cash equivalents | $ 10,002 | $ 2,516 | |
Restricted cash | 181 | 1,062 | |
Accounts receivables, net | 21 | 585 | |
Inventories | 654 | 858 | |
Prepaid expenses and other current assets | 1,759 | 898 | |
Total current assets | 12,617 | 5,919 | |
Property, plant and equipment, net | 735 | 925 | |
Right-of-use assets | 860 | 0 | |
Total assets | 14,212 | 6,844 | |
Current liabilities | |||
Accounts payable | 4,533 | 7,715 | |
Accrued expenses | 6,947 | 7,964 | |
Convertible notes payable, net of debt discount | 0 | 2,038 | |
Lease liabilities, current portion | 664 | 0 | |
Warrant liability | 3,368 | 33 | |
Total current liabilities | 15,512 | 17,750 | |
Deferred revenue | 2,860 | 3,405 | |
Lease liabilities, long-term portion | 197 | 0 | |
Convertible notes payable, net of debt discount | 2,000 | 0 | |
Other non-current liabilities | 0 | 628 | |
Total liabilities | 20,569 | 21,783 | |
Commitments and contingencies | |||
Stockholders' Deficit | |||
Preferred stock, $.01 par value; 10,000,000 shares authorized; 41,517 and 101 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively | 0 | 0 | |
Common stock, $.01 par value; 1,000,000,000 shares authorized; 67,091 and 14,715 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively* | [1] | 1 | 0 |
Additional paid-in capital | 364,785 | 329,065 | |
Accumulated deficit | (371,171) | (344,054) | |
Accumulated other comprehensive loss | 28 | 50 | |
Total stockholders' deficit | (6,357) | (14,939) | |
Total liabilities and stockholders' deficit | $ 14,212 | $ 6,844 | |
[1] | reflects, a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018, and a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 41,517 | 101 |
Preferred stock, shares outstanding (in shares) | 41,517 | 101 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
Common stock, shares issued (in shares) | 67,091 | 14,715 |
Common stock, shares outstanding (in shares) | 67,091 | 14,715 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | ||
Cost of goods sold | $ (719) | $ (1,009) | |
Gross profit | 861 | 2,398 | |
Operating expenses: | |||
Research and development expenses | 9,490 | 19,650 | |
Selling, general and administrative expenses | 11,279 | 9,819 | |
Total operating expenses | 20,769 | 29,469 | |
Operating loss | (19,908) | (27,071) | |
Change in fair value of the warrant liability, net | 17,493 | 19,706 | |
Loss on debt extinguishment | (1,123) | ||
Loss on issuance of financial instrument | (1,720) | (2,826) | |
Interest expense | (4,746) | (7,959) | |
Other income | 2 | 51 | |
Net loss | (8,879) | (19,222) | |
Other comprehensive loss: | |||
Foreign currency translation adjustments | (22) | 8 | |
Comprehensive loss | $ (8,901) | $ (19,214) | |
Common share data: | |||
Basic and diluted loss per share | [1] | $ (1,047) | $ (504) |
Weighted average number of basic and diluted shares outstanding | [1] | 25,900 | 38,151 |
Product Revenue [Member] | |||
Revenue | $ 1,101 | $ 3,378 | |
Other Revenue [Member] | |||
Revenue | $ 479 | $ 29 | |
[1] | reflects, a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018, and a one-for-seven hundred (1:700) reverse stock split effected on December 24, 2019. |
Consolidated Statements of Op_2
Consolidated Statements of Operations and Comprehensive Loss (Parenthetical) | Dec. 24, 2019 | May 02, 2018 |
Income Statement [Abstract] | ||
Reverse stock split | 1:700 | 1:500 |
Reverse stock split ratio | 0.00142 | 0.002 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Deficit - USD ($) $ in Thousands | Total | Series D Preferred Stock [Member] | Series E Preferred Stock [Member] | Series E-1 Preferred Stock [Member] | Common Stock [Member] | Common Stock [Member]Series D Warrants [Member] | Preferred Stock [Member] | Preferred Stock [Member]Series D Preferred Stock [Member] | Preferred Stock [Member]Series E Preferred Stock [Member] | Preferred Stock [Member]Series E-1 Preferred Stock [Member] | Treasury Stock [Member] | Additional Paid in Capital [Member] | Additional Paid in Capital [Member]Series D Preferred Stock [Member] | Additional Paid in Capital [Member]Series E Preferred Stock [Member] | Additional Paid in Capital [Member]Series E-1 Preferred Stock [Member] | Accumulated Deficit [Member] | Accumulated Deficit [Member]Series E Preferred Stock [Member] | Accumulated Deficit [Member]Series E-1 Preferred Stock [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Balance at Dec. 31, 2017 | $ 678 | $ (51) | $ 325,519 | $ (324,832) | $ 42 | ||||||||||||||
Balance (in shares) at Dec. 31, 2017 | 377 | (1) | |||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||
Compensation expense for issuance of restricted stock | 98 | 98 | |||||||||||||||||
Compensation expense for issuance of restricted stock (in shares) | 236 | ||||||||||||||||||
Compensation income related to cancellation of stock options | (40) | (40) | |||||||||||||||||
Sale of common stock, net of expenses | 10,916 | 10,916 | |||||||||||||||||
Sale of common stock, net of expenses (in shares) | 7,624 | ||||||||||||||||||
Issuance of pre-funded warrants | 520 | 520 | |||||||||||||||||
Cashless exercise of warrants (in shares) | 49 | ||||||||||||||||||
Fair value of warrants issued with Convertible Notes | 5,007 | 5,007 | |||||||||||||||||
Fair value of warrants reclassified from liability to equity | 4,210 | 4,210 | |||||||||||||||||
Beneficial conversion feature of convertible note | 44 | 44 | |||||||||||||||||
Issuance of Preferred Stock | $ 1,004 | $ 1,004 | |||||||||||||||||
Issuance of Preferred Stock (in shares) | 101 | ||||||||||||||||||
Fair value of warrants exchanged for Common Stock | 144 | 144 | |||||||||||||||||
Retirement of Treasury Stock | $ 51 | (51) | |||||||||||||||||
Retirement of Treasury Stock (in shares) | 1 | ||||||||||||||||||
Exercise of pre-funded warrants (in shares) | 5,250 | ||||||||||||||||||
Fair value of warrants issued | (18,306) | (18,306) | |||||||||||||||||
Foreign currency translation | 8 | ||||||||||||||||||
Exchange of warrants for common stock (in shares) | 1,179 | ||||||||||||||||||
Net (loss) income | (19,222) | (19,222) | |||||||||||||||||
Total comprehensive loss | 8 | 8 | |||||||||||||||||
Balance at Dec. 31, 2018 | (14,939) | 329,065 | (344,054) | 50 | |||||||||||||||
Balance (in shares) at Dec. 31, 2018 | 14,715 | 101 | |||||||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||||||||
Compensation expense for issuance of stock options | 273 | 273 | |||||||||||||||||
Compensation expense for issuance of restricted stock | 4 | 4 | |||||||||||||||||
Compensation expense for issuance of restricted stock (in shares) | 20 | ||||||||||||||||||
Shares issued due to fractional rounding upon reverse stock split | $ 1 | (1) | |||||||||||||||||
Shares issued due to fractional rounding upon reverse stock split (in shares) | 27,524 | ||||||||||||||||||
Issuance of Preferred Stock | $ 150 | $ 29,536 | $ 9,510 | $ 150 | $ 42,876 | $ 14,408 | $ (13,340) | $ (4,898) | |||||||||||
Issuance of Preferred Stock (in shares) | 15 | 32,572 | 9,510 | ||||||||||||||||
Retirement of Series D Preferred Stock | (1,160) | (1,160) | |||||||||||||||||
Retirement of Series D Preferred Stock (in Shares) | (116) | ||||||||||||||||||
Exercise of pre-funded warrants (in shares) | 11,285 | ||||||||||||||||||
Fair value of warrants issued | (20,844) | (20,844) | |||||||||||||||||
Foreign currency translation | (22) | ||||||||||||||||||
Exchange of warrants for Common Stock | $ 13 | 13 | |||||||||||||||||
Exchange of warrants for common stock (in shares) | 82,521 | 92 | |||||||||||||||||
Conversion of Preferred stock into common stock | $ 1 | 1 | |||||||||||||||||
Conversion of Preferred stock into common stock (in shares) | 13,455 | (565) | |||||||||||||||||
Net (loss) income | (8,879) | (8,879) | |||||||||||||||||
Total comprehensive loss | (22) | (22) | |||||||||||||||||
Balance at Dec. 31, 2019 | $ (6,357) | $ 1 | $ 364,785 | $ (371,171) | $ 28 | ||||||||||||||
Balance (in shares) at Dec. 31, 2019 | 67,091 | 41,517 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Deficit (Parenthetical) | Dec. 24, 2019 | May 02, 2018 |
Statement Of Stockholders Equity [Abstract] | ||
Reverse stock split | 1:700 | 1:500 |
Reverse stock split ratio | 0.00142 | 0.002 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (8,879) | $ (19,222) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock option compensation expense (income) | 273 | (40) |
Restricted stock compensation expense | 4 | 98 |
Depreciation expense | 212 | 444 |
Amortization of Right of Use Asset | 1,577 | 0 |
Warrant liability fair value adjustment | (17,493) | (19,706) |
Non-cash interest income | (11) | (1) |
Equitization of expenses | 1,474 | 0 |
Loss on issuance of financial instrument | 1,715 | 402 |
Interest expense accrued related to convertible notes | 74 | 7,572 |
Debt discount amortization | 4,467 | 2,826 |
Loss on debt settlements | 0 | 1,123 |
Changes in assets and liabilities: | ||
Prepaid expenses and other assets | (367) | (218) |
Accounts receivable | 497 | (293) |
Inventory | 204 | 385 |
Accounts payable and accrued expenses | (4,791) | 8,163 |
Deferred revenue | (479) | 3,503 |
Interest payments on financing lease | (3) | 0 |
Operating lease liability | (1,537) | 0 |
Other non-current liabilities | (627) | 232 |
Net cash used in operating activities | (23,690) | (14,732) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (24) | (76) |
Net cash used in investing activities | (24) | (76) |
Cash flows from financing activities: | ||
Repayment of convertible note debt | 0 | (4,870) |
Net proceeds from the issuance of debt | 3,719 | 0 |
Principal payments of financing leases | (39) | 0 |
Net proceeds from convertible note debt financing | 0 | 5,664 |
Net proceeds from sale of stock | 0 | 10,917 |
Net proceeds from exercise of warrants | 0 | 520 |
Net cash provided by financing activities | 30,305 | 13,236 |
Foreign currency effects on cash, cash equivalents and restricted cash | 14 | (174) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 6,605 | (1,746) |
Cash, cash equivalents and restricted cash: | ||
Beginning of period | 3,578 | 5,324 |
End of period | 10,183 | 3,578 |
Supplemental non-cash activities: | ||
Fair value of warrants issued | 20,844 | 28,539 |
Reclassification of Series D Warrants from liability to equity | 0 | 4,210 |
Equitization of debt, interest and expenses into July 2019 Private Placement | 12,572 | 0 |
Adoption of ASC 842 lease standard | 1,652 | 0 |
Right of use assets obtained in exchange for lease obligations | 874 | 0 |
Financing of insurance | 548 | 0 |
Series E and E-1 Preferred Stock and Warrants [member] | ||
Cash flows from financing activities: | ||
Net proceeds from the sale of Series E and E-1 Preferred Stock and warrants | 26,475 | 0 |
Series D Preferred Stock [Member] | ||
Cash flows from financing activities: | ||
Net proceeds from sale of Series D preferred shares | $ 150 | $ 1,005 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business | (1) Description of Business Our primary research focus is on ocular melanoma liver metastases, or mOM, and intrahepatic cholangiocarcinoma, or ICC, a type of primary liver cancer, as well as certain other cancers that are metastatic to the liver. We believe that the disease states we are investigating are unmet medical needs that represent significant market opportunities. In the United States, Melphalan/HDS is considered a combination drug and device product and is regulated as a drug by the United States Food and Drug Administration, or the FDA. The FDA has granted us six orphan drug designations, including three orphan designations for the potential use of the drug melphalan for the treatment of patients with mOM, hepatocellular carcinoma and ICC. Melphalan/HDS has not been approved for sale in the United States. In Europe, our CHEMOSAT product is regulated as a Class IIb medical device and received its CE Mark in 2012. We are commercializing the CHEMOSAT system in select markets in the United Kingdom and the European Union, or EU, where we believe the prospect of securing reimbursement coverage for the use of CHEMOSAT is strongest. Liquidity and Going Concern The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements during the year ended December 31, 2019, the Company incurred net operating losses of $8.9 million and used $23.7 million of cash for its operating activities. These factors among others raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to us on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If Delcath is not able to continue as a going concern, it is likely that holders of its common stock will lose all of their investment. The accompanying consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. At December 31, 2019, management believed that its capital resources were adequate to fund operations through June 2020. Additional working capital will be required to continue operations. |
Basis of Consolidated Financial
Basis of Consolidated Financial Statement Presentation | 12 Months Ended |
Dec. 31, 2019 | |
Basis Of Condensed Consolidated Financial Statement Presentation [Abstract] | |
Basis of Consolidated Financial Statement Presentation | (2) Basis of Consolidated Financial Statement Presentation The accounting and financial reporting policies of the Company conform to generally accepted accounting principles in the United States of America (“GAAP”). The preparation of consolidated financial statements in conformity with GAAP requires management to make assumptions and estimates that impact the amounts reported in the Company’s consolidated financial statements. The consolidated financial statements include the accounts of all entities controlled by Delcath. All significant inter-company accounts and transactions are eliminated. Reverse Stock Splits All share numbers presented in these financial statements, including these footnotes reflect a one-for-five hundred (1:500) |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | (3) Summary of Significant Accounting Policies Use of Estimates The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s consolidated balance sheets and the amount of revenues and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for derivative instrument liabilities, stock-based compensation, valuation of inventory, impairment of long-lived assets, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates. Cash Equivalents and Concentrations of Credit Risk The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation (“FDIC”), however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institution. Restricted Cash Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded as restricted cash on the accompanying consolidated balance sheets. Accounts Receivable Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. Collections and payments from customers are monitored and a provision for estimated credit losses may be created based upon historical experience and specific customer collection issues that may be identified. Inventories Inventories are valued at the lower of cost or net realizable value using the first-in, first-out method. The reported net value of inventory includes finished saleable products, work-in-process, and raw materials that will be sold or used in future periods. The Company reserves for expired, obsolete, and slow-moving inventory. Property, Plant and Equipment Property, plant and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight line basis over the estimated useful lives of the assets which range from three to seven years. Leasehold improvements will be amortized over the shorter of the lease term or the estimated useful life of the related assets when they are placed into service. The Company evaluates property, plant and equipment for impairment periodically to determine if changes in circumstances or the occurrence of events suggest the carrying value of the asset or asset group may not be recoverable. Derivative Instrument Liability The Company accounts for derivative instruments in accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of the hedging relationship designation. Accounting for changes in the fair value of the derivative instruments depends on whether the derivatives qualify as hedge relationships and the types of relationships designated are based on the exposures hedged. At December 31, 2019 and 2018, the Company did not have any derivative instruments that were designated as hedges. Fair Value Measurements The Company adheres to ASC 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances. ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy). • Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. • Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Revenue Recognition Revenue is generated from proprietary and partnered product sales and license and royalty arrangements. Revenue is recognized when or as we transfer control of the promised goods or services to our customers in an amount that reflects the consideration to which we expect to be entitled to in exchange for those goods or services. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied. We may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing and commercialization components. These arrangements are often complex and we may receive various types of consideration over the life of the arrangement, including: up-front fees, reimbursements for research and development services, milestone payments, payments on product shipments, margin sharing arrangements, license fees and royalties. Our results of operations for reporting periods beginning on or after January 1, 2018 are presented under ASC 606, Revenue from Contracts with Customers, while prior period amounts, as reported, are not adjusted. The effects of the adoption of the new standard in 2018 were not material to our consolidated financial statements. In assessing our revenue arrangements in accordance with ASC 606, Revenue from Contracts with Customers, we must identify the contract, determine the transaction price including an estimation of any variable consideration we expect to receive in connection with the contract, identify the promises of goods or services to the customer and each distinct performance obligation, allocate the transaction price to each of the performance obligations, and recognize revenue when or as the performance obligations are satisfied. Each of these steps in the revenue recognition process requires management to make judgements and/or estimates. The most significant judgements and estimates involve the determination of variable consideration to be included in the transaction price. Variable consideration is recognized at an amount we believe is not subject to significant reversal and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. We believe this provides a reasonable basis for recognizing revenue, however, actual results could differ from estimates and significant changes in estimates could impact our results of operations in future periods. Deferred Revenue License fees and milestones received in exchange for the grant of a license Selling, General and Administrative Selling, general and administrative costs include personnel costs and related expenses for the Company’s sales, marketing, general management and administrative staff, recruitment, costs related to the Company’s commercialization efforts in Europe, professional service fees, professional license fees, business development and certain general legal activities. All such costs are charged to expense when incurred. Research and Development Research and development costs include the costs of materials used for clinical trials and R&D, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company’s proprietary drug delivery system. All such costs are charged to expense when incurred. Stock Based Compensation The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, Stock-Based Compensation, which establishes accounting for equity instruments exchanged for employee services and ASC 505-50, Equity-Based Payments to Non-Employees, which establishes accounting for equity-based payments to non-employees. Under the provisions of ASC 718, share-based compensation is measured at the grant date, based upon the fair value of the award, and is recognized as an expense over the option holders’ requisite service period (generally the vesting period of the equity grant). The Company is required to record compensation cost for all share-based payments granted to employees based upon the grant date fair value, estimated in accordance with the provisions of ASC 718. Under the provisions of ASC 505-50, measurement of compensation cost related to common shares issued to non-employees for services is based on the value of the services provided or the fair value of the shares issued. The measurement of non-employee stock-based compensation is subject to periodic adjustment as the underlying equity instrument vests. The Company expenses its share-based compensation for share-based payments granted under the accelerated method, which treats each vesting tranche as if it were an individual grant. The Company periodically grants stock options for a fixed number of shares of common stock to its employees, directors and non-employee contractors, with an exercise price greater than or equal to the fair market value of Delcath’s common stock at the date of the grant. The Company estimates the fair value of stock options using an option pricing model. Key inputs used to estimate the fair value of stock options include the exercise price of the award, the expected post-vesting option life, the expected volatility of Delcath’s stock over the option’s expected term, the risk-free interest rate over the option’s expected term, and Delcath’s expected annual dividend yield. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons who receive equity awards. Income Taxes The Company accounts for income taxes following the asset and liability method in accordance with the ASC 740, Income Taxes. Under such method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company classifies interest and penalty expense related to uncertain tax positions as a component of income tax expense. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years that the asset is expected to be recovered or the liability settled. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in its assessment of a valuation allowance. See Note 14 for additional information. Net Loss per Common Share Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. However, in certain periods in which the exercise price of the warrants was less than the last reported sales price of Delcath’s common stock on the final trading day of the period and there is a gain recorded pursuant to the change in fair value of the warrant derivative liability, the impact of gains related to the mark-to-market adjustment of the warrants outstanding at the end of the period is reversed and the treasury stock method is used to determine diluted earnings per share. As discussed in Note 11, the Series E Preferred Stock and the Series E-1 Preferred Stock were each determined to have a beneficial conversion feature which was accounted for as a deemed dividend. For the years ended December 31, 2019 and 2018 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive: 2019 2018 Common stock warrants - equity — 6,005 Common stock warrants - liability 1,826,608 271 Assumed conversion of Series E and Series E-1 Preferred Stock 1,802,008 — Assumed conversion of convertible notes 63,493 3,681 Stock options 1,640 — Total 3,693,749 9,957 Segment Information The Company currently operates in one business segment, which is the development and commercialization of Melphalan/HDS and CHEMOSAT. A single management team that reports to the CEO and President comprehensively manages the business. Accordingly, the Company does not have separately reportable segments. Foreign Currency and Currency Translation Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses)/gains in the statements of operations. The assets and liabilities of the Company’s international subsidiaries are translated from their functional currencies into United States dollars at exchange rates prevailing at the balance sheet date. The majority of the foreign subsidiaries revenues and operating expenses are denominated in Euros. The reporting currency for the Company is the United States Dollar (“USD”). Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive income. Recently Adopted Accounting Pronouncements In February 2018, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220). ASU 2018-02 allows a company to elect a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. ASU 2018-02 is effective for periods beginning after December 15, 2018. Upon adoption of ASU 2018-02, the Company did not elect to reclassify the tax effects of the Tax Cuts and Jobs Act from accumulated other comprehensive income to retained earnings, as the stranded tax effects were insignificant. In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) Codification Improvements to Topic 842, Leases Leases (Topic 842)—Targeted Improvements Leases The Company has elected certain practical expedients permitted under the transition guidance within ASC 842 to leases that commenced before January 1, 2019, including the package of practical expedients. The election of the package of practical expedients resulted in the Company not reassessing prior conclusions under ASC 840 related to lease identification, lease classification and initial direct costs for expired and existing leases prior to January 1, 2019. The Company did not elect the practical expedient to not record short-term leases on its consolidated balance sheet. The adoption of ASU 2016-02 did not have a significant impact on the Company’s consolidated results of operations or cash flows. See Note 9 for additional information. SEC Disclosure Update and Simplification In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders' equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders' equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. This final rule was effective on November 5, 2018. The adoption did not have a material impact on the Company’s consolidated financial statements. |
Restricted Cash
Restricted Cash | 12 Months Ended |
Dec. 31, 2019 | |
Restricted Cash [Abstract] | |
Restricted Cash | ( 4 ) Restricted Cash Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded in Restricted Cash (in thousands) December 31, 2019 December 31, 2018 Cash and cash equivalents $ 10,002 $ 2,516 Convertible Notes — — Letters of credit 131 1,012 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 10,183 $ 3,578 |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventories | ( 5 ) Inventories Inventories consist of: (in thousands) December 31, 2019 December 31, 2018 Raw materials $ 375 $ 358 Work-in-process 279 500 Finished goods — — Total Inventory $ 654 $ 858 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2019 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses And Other Current Assets | ( 6 ) Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets include the following: (in thousands) December 31, 2019 December 31, 2018 Clinical trial expenses 725 — Insurance premiums 589 140 Security deposit 51 51 Income tax and VAT receivable 31 579 Other 1 363 128 Total prepaid expenses and other current assets $ 1,759 $ 898 1 |
Property, Plant, and Equipment
Property, Plant, and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property, Plant, and Equipment | ( 7 ) Property, Plant, and Equipment Property, plant, and equipment consists of: (in thousands) December 31, 2019 December 31, 2018 Estimated Useful Life Buildings and land $ 589 $ 589 30 years - Buildings Enterprise hardware and software 1,739 1,742 3 years Leaseholds 1,695 1,701 Lesser of lease term or estimated useful life Equipment 1,025 1,002 7 years Furniture 198 198 5 years Property, plant and equipment, gross 5,246 5,232 Accumulated depreciation (4,511 ) (4,307 ) Property, plant and equipment, net $ 735 $ 925 Depreciation expense for the years ended December 31, 2019 and 2018 was $0.2 million and $0.4 million, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | ( 8 ) Accrued Expenses Current accrued expenses include the following: (in thousands) December 31, 2019 December 31, 2018 Clinical trial expenses $ 2,497 $ 4,530 Compensation, excluding taxes 3,525 1,785 Professional fees 263 190 Short-term portion of lease restructuring - 184 Other 1 662 1,275 Total accrued expenses $ 6,947 $ 7,964 1 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | ( 9 ) Leases The Company recognizes right-of-use (“ROU”) assets and lease liabilities when it obtains the right to control an asset under a leasing arrangement with an initial term greater than twelve months. The Company leases its facilities under non-cancellable operating and financing leases. The Company evaluates the nature of each lease at the inception of an arrangement to determine whether it is an operating or financing lease and recognizes the ROU asset and lease liabilities based on the present value of future minimum lease payments over the expected lease term. The Company’s leases do not generally contain an implicit interest rate and therefore the Company uses the incremental borrowing rate it would expect to pay to borrow on a similar collateralized basis over a similar term in order to determine the present value of its lease payments. The following table summarizes the Company’s operating and financing leases as of December 31, 2019: (in thousands) US Ireland Total Lease Cost Operating lease cost $ 710 $ 210 $ 920 Financing lease cost 42 — 42 Sublease income (215 ) (175 ) (390 ) Total $ 537 $ 35 $ 572 Other information Operating cash flows out from operating leases (755 ) (210 ) (965 ) Operating cash flows in from operating leases 215 175 390 Operating cash flows out from financing leases (39 ) — (39 ) Right-of-use assets exchanged for new operating lease liabilities 874 — 874 Weighted average remaining lease term 1.1 1.8 Weighted average discount rate - operating leases 8 % 8 % Maturities of the Company’s operating leases, excluding short-term leases, are as follows: (in thousands) US Ireland Total Year ended December 31, 2020 $ 498 $ 210 $ 708 Year ended December 31, 2021 79 122 201 Total 577 332 909 Less present value discount (27 ) (21 ) (48 ) Operating lease liabilities included in the condensed consolidated balance sheet at December 31, 2019 $ 550 $ 311 $ 861 |
Outstanding Debt
Outstanding Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Outstanding Debt | ( 10 ) Outstanding Debt On June 6, 2019, the Company entered into an agreement with two institutional investors, pursuant to which the investors agreed to transfer and surrender warrants to purchase 5,605 shares of the Company’s common stock (the “Series D Warrants”) and warrants to purchase 0.1 million shares of the Company’s common stock (the “Pre-Funded Series D Warrants”) for cancellation by the Company. Under the terms of the Purchase Agreement, the Company agreed to sell and issue to the investors 8% Senior Secured Promissory Notes in an aggregate principal amount of $2.0 million in full payment and satisfaction of the purchase price for the Series D Warrants and Pre-Funded Series D Warrants. This agreement was effective on July 15, 2019, upon the closing of the Company’s Private Placement discussed further in Note 11. Following the closing of the Private Placement, the Company entered into an agreement under which the 8% Senior Secured Promissory Notes became convertible into shares of Series E Preferred Stock and Warrants at the price of $1,500 per Unit. The principal is recognized in Convertible notes payable, long-term on the consolidated balance sheet. On April 19, 2019, April 26, 2019, May 9, 2019 and May 23, 2019, the Company issued 8% senior secured notes (collectively, the “2019 Notes”) in the aggregate principal amount of $3.3 million, to two institutional investors. The 2019 Notes bore interest at the rate of 8% per annum and were to mature on the six-month anniversary of issuance in each case. The 2019 Notes were not convertible. The 2019 Notes contained standard events of default and remedies and are secured by a lien on the Company’s assets. The 2019 Notes were exchanged as part of the recent equity financing discussed further in Note 11 and are no longer outstanding. In March 2019, the Company exchanged all issued and outstanding shares of its Series D Preferred Stock (having an aggregate stated value of $1,160,000) and received $400,000 in cash proceeds in exchange for a senior secured promissory note (the “March 2019 Note”) in the principal amount of $1,560,000. The March 2019 Note bore interest at the rate of 8% per annum, and were to mature on April 1, 2020, and was not convertible. The March 2019 Note was exchanged as part of the recent equity financing discussed further in Note 9 and is no longer outstanding. On June 4, 2018, July 21, 2018, August 29, 2018, and September 21, 2018, the Company issued 8% senior secured convertible notes (collectively, the “2018 Notes”) in the aggregate principal amount of $9.4 million to several institutional investors. The 2018 Notes bore interest at the rate of 8% per annum and had maturity dates between December 2018 and March 2021. The 2018 Notes were initially convertible and secured pursuant to a Security Agreement which created a first priority security interest in all of the personal property (other than Excluded Collateral as defined in the Security Agreement) of the Company of every kind and description, tangible or intangible, whether currently owned and existing or created or acquired in the future. In March 2019, the Company amended the June 2018, July 2018 and August 2018 Notes to make them non-convertible. There was no impact to the financial statements. In April 2019, the Company received notices of default from the investors in the 2018 Notes which resulted in a 25%, or $1.1 million, increase in principal and an increase in the interest rates from 8% to 18%. The 2018 Notes were exchanged as part of the recent equity financing discussed further in Note 9 and are no longer outstanding. The following table provide a summary of the outstanding Note at December 31, 2019 : (in millions) Conversion price Current interest rate Principal Long term convertible notes payable 8.0% July 2019 Notes $ 1,500 8 % $ 2.0 The following table provides a summary of the Notes by their maturity dates (absent provisions of default) at December 31, 2018: (in millions) Interest rate Conversion price Principal Unamortized Discount Carrying value December 4, 2018 8.0% $ 1.75 $ 1.7 $ — $ 1.7 March 1, 2019 8.0% 1.75 0.6 (0.5 ) 0.1 March 21, 2019 8.0% 1.75 0.4 (0.2 ) 0.2 December 4, 2019 8.0% 1.75 0.9 (0.9 ) — March 1, 2020 8.0% 1.75 0.8 (0.8 ) — March 21, 2020 8.0% 1.75 0.1 (0.1 ) — Total Convertible Notes Payable, net $ 4.5 $ (2.5 ) $ 2.0 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | (1 1 ) Stockholders’ Equity Preferred Stock Issuances Series E and Series E-1 Preferred Stock On July 11, 2019, the Company entered into a securities purchase agreement with certain accredited investors pursuant to which Delcath sold to investors an aggregate of 20,000 shares of our Series E convertible preferred stock, par value $0.01 per share, or the Series E Preferred Stock, at a price of $1,000 per share and a warrant, or a 2019 E Warrant, to purchase a number of shares of common stock equal to the number of shares of common stock issuable upon conversion of the Series E Preferred Stock purchased by the investor, or the July 2019 Private Placement. In connection with the July 2019 Private Placement, the Company exchanged $11.8 million of debt, interest and Series D Warrants for 11,500 shares of Series E Preferred Stock and related 2019 Warrants, $0.1 million in accounts payables for 149 shares of Series E Preferred Stock and related 2019 Warrants and issued 923 shares of Series E Preferred Stock and related 2019 Warrants to certain investors in exchange for a waiver of rights under exchange agreements signed in December 2018 and March 2019, or the Debt Exchange. On August 19, 2019, the Company entered into a securities purchase agreement with certain accredited investors pursuant to which Delcath sold to investors an aggregate of 9,510 shares of Series E-1 convertible preferred stock, par value $0.01 per share, or the Series E-1 Preferred Stock, at a price of $1,000 per share and a warrant, or a 2019 E-1 Warrant, and together with the 2019 E Warrant, the 2019 Warrants, to purchase a number of shares of common stock of the Company equal to the number of shares of common stock issuable upon conversion of the Series E-1 Preferred Stock purchased by the investor, or the August 2019 Private Placement, and, collectively with the July 2019 Private Placement, the Private Placements. Each share of Series E Preferred Stock and Series E-1 Preferred Stock, or, collectively, the Preferred Stock, was originally convertible at any time at the option of the holder into the number of shares of common stock determined by dividing the stated value by the conversion price of $42.00, subject to certain limitations and adjustments, or the Conversion Price. Except for certain adjustments, the holders of the Preferred Stock are entitled to receive dividends on shares of Preferred Stock equal (on an “as converted” basis) to and in the same form as dividends paid on shares of the common stock. Any such dividends that are not paid to the holders of the Preferred Stock will increase the stated value. No other dividends will be paid on shares of Preferred Stock. Each 2019 Warrant had an original exercise price equal to $42.00, subject to adjustment in accordance with the terms of the 2019 Warrants, or the Exercise Price, and became exercisable at any time upon the consummation of the Reverse Split and will be exercisable until 5:00 p.m. (NYC time) on the date that is five years following the date of the Reverse Split. Pursuant to the terms of the Preferred Stock and the 2019 Warrants, the Conversion Price of the Preferred Stock and the Exercise Price of the 2019 Warrants were initially subject to adjustment in each of the following circumstances: (i) on the third trading day following the date that the Company effects a reverse stock split, or the Reverse Split Reset Date, (ii) the date that the initial registration statement covering the shares of common stock issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants is declared effective by the SEC, or the Registration Reset Date, and (iii) in the event that all of the shares of common stock which we were required to register with the SEC were not then registered on an effective registration statement, the date that all of the shares underlying the respective Preferred Stock and 2019 Warrants may be sold pursuant to Rule 144, or the Rule 144 Reset Date, each of such reset dates, a Reset Date and, collectively, the Reset Dates. On each Reset Date, the Conversion Price and the Exercise Price were to be reduced, and only reduced, to equal the lesser of (x) the then effective Conversion Price or Exercise Price, as applicable, and (y) 90% of the average of the five daily volume weighted average prices of the common stock immediately prior to each Reset Date, or the Reset Formula. In the event of a reduction in the Exercise Price, the aggregate number of Warrant Shares issuable upon the exercise of the 2019 Warrants were to be increased such that the aggregate Exercise Price of the Warrants on the day immediately following such Reset Date equaled the aggregate Exercise Price immediately prior to such adjustment. In addition, from the date of issuance of the Preferred Stock and Warrants until such time that the Company’s common stock is listed or quoted on a national exchange, the Conversion Price and the Exercise Price are subject to price-based anti-dilution protections. The Registration Reset Date occurred on November 7, 2019. However, pursuant to the Reset Formula, no reduction in the Conversion Price or the Exercise Price occurred on the Registration Reset Date. The Reverse Split Reset Date occurred on December 30, 2019. Pursuant to the Reset Formula, the Conversion Price and the Exercise Price were reduced to $23.04 per share as of the Reverse Split Reset Date. The Rule 144 Reset Date with respect to the Series E Preferred Stock and the Series E Warrants occurred on January 15, 2020, but no reset in the Conversion Price or the Exercise Price of the Series E Preferred Stock or the Series E Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale. The Rule 144 Reset Date with respect to the Series E-1 Preferred Stock and the Series E-1 Warrants occurred on February 19, 2020, but no reset in the Conversion Price or the Exercise Price of the Series E-1 Preferred Stock or the Series E-1 Warrants occurred as of such date because all of the shares of common stock issuable in respect of such securities had been registered for resale. As a consequence of the reduction of the Conversion Price on the Reverse Split Reset Date, an additional 813,473 shares of common stock became issuable upon the conversion of the Preferred Stock and, as a consequence of the reduction of the Exercise Price on the Reverse Split Reset Date, an additional 824,587 shares of common stock became issuable upon the exercise of the 2019 Warrants, or collectively the Reset Shares. Pursuant to the terms of the registration rights agreements entered into in connection with the Private Placements and the Debt Exchange we were required to register a number of shares of our common stock that would be issuable assuming that the Conversion Price and the Exercise Price were $16.10 per share, regardless of the actual Conversion Price or the Exercise Price. Pursuant to that requirement, we registered a total of 3,429,680 shares of common stock for sale or other disposition by the Selling Stockholders on our registration statement on Form S-1 (File No. 333-235751), or the Second Registration Statement, which included the Rosalind Shares, the Reset Shares and an additional 1,564,085 shares of our common stock, or the Registrable Shares, even though we were obligated to issue only the Reset Shares as a result of the Reverse Split. However, because the Second Registration Statement was not declared effective until January 7, 2020, the Company is liable to Rosalind for liquidated damages under the terms of the registration rights agreements relating to the Private Placements and the Debt Exchange for the period from December 28, 2019 and January 7, 2020. The Company received net proceeds after expenses of $26.6 million. As discussed above, the Company exchanged $11.8 million of debt, interest and Series D Warrants for 11,500 shares of Series E Preferred Stock and related warrants. The Company also exchanged $0.1 million in accounts payables for 149 shares of Series E Preferred Stock and related warrants and issued 923 shares of Series E Preferred Stock and related Warrants to certain investors in exchange for a waiver of rights under exchange agreements signed in December 2018 and March 2019. Of the net proceeds and equitized value received, the Company allocated an estimated fair value of $20.8 million to the 2019 Warrants. As a result of the Series E Preferred Stock and Series E-1 Preferred Stock having an effective conversion price that was lower than the market price on the date of issuance, the Company has recognized a beneficial conversion feature of $18.3 million. Due to the Series E Preferred Stock and Series E-1 Preferred Stock being immediately convertible, the beneficial conversion feature was recognized in full as a deemed dividend. Series D Preferred Stock On November 5, 2018, the Company’s Board authorized the establishment of a new series of preferred stock designated as Series D Preferred Stock, $0.01 par value, the terms of which are set forth in the certificate of designations for such series of Preferred Stock. On March 29, 2019, the Company exchanged all issued and outstanding shares of its Series D Preferred Stock (having an aggregate stated value of $1,160,000) and received $400,000 in cash proceeds in exchange for the issuance of the March 2019 Notes. Please see the discussion under Notes 10 and 11 above. Common Stock Issuances Series E and Series E-1 Convertible Preferred Stock Conversions 565 shares of Series E and Series E-1 Convertible Preferred Stock were converted into 13,455 shares of common stock, $0.01 par value per share, during 2019. Pre-Funded Series D Warrant Exercises 5,379 Pre-Funded Series D Warrants were exercised during 2018. December 2018 Warrant Exchange In December 2018, the Company entered into exchange agreements with several institutional investors with respect to their November 2017 Warrants and February 2018 Warrants. The Company issued to the investors 1,179 shares of Common Stock (the “Exchange Shares”) in exchange for the Existing Warrants (the “Exchange”). The Exchange was made in reliance upon the exemption from registration provided by Section 3(a)(9) of the Securities Act of 1933, as amended. September 2018 Rights Offering In September 2018, the Company completed the sale of 6,669 shares of its common stock, with net proceeds after expenses of approximately $7.0 million. The rights offering was made pursuant to a Registration Statement on Form S-1 that was made effective on August 3, 2018. February 2018 Financing In February 2018, the Company completed the sale of 606 shares of its Common Stock, 109 pre-funded warrants and the issuance of warrants to purchase 1,429 common shares (the “February 2018 Warrants”) pursuant to a placement agent agreement, with net proceeds after expenses of $4.3 million. The February 2018 Warrants are exercisable one year after the anniversary date of their issuance. At December 31, 2018, the February 2018 Warrants were exercisable at $7,000 per share with 273 warrants outstanding. The Company allocated an estimated fair value of $18.3 million to the February 2018 Warrants. The Company valued the February 2018 Warrants using the following inputs: exercise price of $7,000; contractual term of six years; volatility of 122.68% and risk-free rate of approximately one percent. Due to certain price protection features in the agreement, the February 2018 Warrants were accounted for as a derivative liability at issuance and will be subsequently marked to market through the statement of operations. In October 2018, the Company filed a registration statement on Form S-3 with the SEC, which was declared effective on December 21, 2018 and allows the Company to offer and sell, from time to time in one or more offerings, up to $100.0 million of common stock, preferred stock, warrants, debt securities and stock purchase contracts as it deems prudent or necessary to raise capital at a later date. The Company has lost its Form S-3 eligibility due to the late filing of its Form 10-K for the year ended December 31, 2018. Absent prior relief from the SEC, we expect to regain S-3 eligibility on June 1, 2020. Stock Incentive Plans The Company’s 2019 Equity Incentive Plan (the “Plan”) allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers, directors, employees, consultants and advisors are eligible to receive grants under the Plan. The maximum number of shares reserved for issuance under the Plan is 2,142. Options to purchase shares of common stock are granted at exercise prices not less than 100% of fair value on the dates of grant. As of December 31, 2019, the Plan had approximately 502 shares available for grant. The following is a summary of stock option activity under the Plan for the year ended December 31, 2019: Number of Shares Weighted Average Exercise Price Weighted Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2019 — Granted 1,782 $ 196.70 Exercised — Cancelled/Forfeited (142 ) $ 196.70 Outstanding at December 31, 2019 1,640 $ 196.70 9.1 $ — Exercisable at December 31, 2019 1,502 $ 196.70 9.1 $ — At December 31, 2019, there was approximately $25,000 of total unrecognized compensation expense related to non-vested share-based compensation awards under the plans for employee and board stock option grants. The cost is expected to be recognized over a weighted average period of 0.1 year. For the years ended December 31, 2019 and 2018, the Company recognized compensation expense $0.3 million and compensation income of $0.04 million, respectively, related to stock options granted to employees and board members. For the year ended December 31, 2019 the Company did not recognize any restricted stock compensation expense. For the year ended December 31, 2018, the Company recognized compensation expense of approximately $0.1 million related to restricted stock granted to employees and consultants. (in thousands) Twelve months ended December 31, 2019 Twelve months ended December 31, 2018 Selling, general and administrative $ 213,807 $ 120,850 Research and development 59,391 (61,867 ) Total $ 273,198 $ 58,983 Warrants The following is a summary of warrant activity for the years ended December 31, 2019 and 2018: Warrants Exercise Share Weighted Exercise Price Weighted Average Remaining (Years) Outstanding at January 1, 2018 20 $857,500 - $13,798,400,000 $ 4,868,205,366 4.88 Warrants issued 100,352 222 Warrants exercised (6,536 ) 1,252 Warrants expired (1 ) 13,798,400,000 Outstanding at December 31, 2018 93,835 $7 - $7,000 $ 151 5.75 Warrants issued 1,826,579 42 Warrants exercised (11,285 ) 7 Warrants exchanged (82,521 ) 170 Outstanding at December 31, 2019 1,826,608 $7 - $23 $ 23 4.99 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (1 2 ) Fair Value Measurements The table below presents the activity within Level 3 of the fair value hierarchy for the twelve months ended December 31, 2019: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at January 1, 2018 $ 560 Fair value of warrants issued 23,533 Total change in the liability included in earnings (19,706 ) Reclass from liability to equity (4,210 ) Fair value of warrants exchanged (144 ) Balance at December 31, 2018 33 Total change in the liability included in earnings (17,498 ) Reclass from liability to equity (11 ) Fair value of warrants issued 20,844 Balance at December 31, 2019 3,368 At December 31, 2018, the Company had a total of 179 February 2018 Warrants outstanding, which were surrendered pursuant to a settlement agreement entered into between the Company and the holders of the February 2018 Warrants on April 18, 2019 and final payment under the settlement was made on July 16, 2019. The fair value of the Warrants at December 31, 2019 was determined by using option pricing models assuming the following: December 31, December 31, 2019 2018 Expected life (in years) 4.6 1.1 - 5.1 Expected volatility 207.5% 145.7% - 265.3% Risk-free interest rates 1.7% 2.5% - 2.6% The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2019 and 2018, aggregated by the level in the fair value hierarchy within which those measurements fall. Assets and Liabilities Measured at Fair Value on a Recurring Basis Assets and Liabilities Measured at Fair Value on a Recurring Basis Level 1 Level 2 Level 3 Balance at December 31, (in thousands) 2019 2018 2019 2018 2019 2018 2019 2018 Liabilities Derivative instrument liabilities $ — $ — $ — $ — $ 3,368 $ 33 $ 3,368 $ 33 For the twelve months ended December 31, 2019 and 2018 there were no transfers in or out of Level 1, 2 or 3 inputs. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments | (13) Commitments Financing Lease In January 2019, the Company entered into an amendment (the “Park Road Lease Amendment”) to a lease agreement entered into in October 2018 (the “Park Road Lease”) for approximately 6,000 square feet of space located at 95-97 Park Road in Queensbury, New York. Under the terms of the Park Road Lease Amendment, the original two year term which began on October 31, 2018 was extended through November 2020 and provides for total annual base rent of $50,000 per year. Operating Leases In September 2018, the Company entered into an amendment (the “1633 Sublease Amendment”) to a sub-lease agreement executed in March 2016 (the “1633 Sublease) for approximately 6,877 square feet of office space at 1633 Broadway, New York, NY. The term began in April 2016 and under the terms of the 1633 Sublease Amendment is extended through February 2021 and provides for total annual base rent of $0.5 million. In August 2011, Delcath Systems Ltd. entered into an agreement of lease for an office and manufacturing facility located in the city of Galway, Ireland. This facility is approximately 19,200 square feet and is intended to be the location of Delcath’s European headquarters. The Lease is for a term of ten years, commencing August, 2011. The Lease provides for fixed annual lease amounts payable in advance in equal quarterly installments. The remaining annual lease amount is $0.2 million. Delcath Systems Ltd. is also required to pay for customary building operating expenses. Delcath Systems Ltd.’s payment obligations and performance of the Lease are guaranteed by Delcath. The Company has sub-leased a portion of this facility. Future minimum lease payments, net of receipts due under the terms of subleases, under all operating leases at December 31, 2019 are as follows: (in thousands) Future Lease Payments 2020 635 2021 79 $ 714 For the years ended December 31, 2019 and 2018 rent expense, net of receipts under the terms of subleases, totaled approximately $0.5 million and $0.6 million, respectively. Letters of Credit Under the terms of a sub-lease agreement for office space at 1633 Broadway, New York, NY, the Company is required to maintain a letter of credit in the amount of $0.1 million which will expire with the sublease in February 2021. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (1 4 ) Income Taxes There is no income tax expense recognized for the years ended December 31, 2019 and 2018, respectively. Loss before taxes consists of: (in thousands) December 31, 2019 December 31, 2018 Domestic $ (4,882 ) $ (12,961 ) Foreign (3,997 ) (6,261 ) Income (loss) before taxes $ (8,879 ) $ (19,222 ) The provision for income taxes differs from the amount computed by applying the statutory rate as follows: (in thousands) December 31, 2019 December 31, 2018 Income taxes using U.S federal statutory rate $ (1,865 ) $ (4,037 ) Tax Cuts and Jobs Act — — Nondeductible interest 994 2,273 Loss on extinguishment of debt 361 236 Loss of tax benefit of federal net operating loss carryforwards — (588 ) Loss of tax benefit of state net operating loss carryforwards 1,477 1,040 Loss of tax benefit of federal tax credit carryforwards 324 495 Amortization of gain on IP migration — — State income taxes, net of federal benefit (1,461 ) (2,355 ) Foreign rate differential 664 1,166 Valuation allowance 3,512 6,323 Derivative charge (3,674 ) (4,138 ) Stock option exercises and cancellations — 215 Research and development costs (316 ) (636 ) Other (16 ) 6 $ — $ — Significant components of the Company’s deferred tax assets are as follows: (in thousands) December 31, 2019 December 31, 2018 Deferred tax assets: Equity compensation $ 84 $ — Accrued liabilities — 519 Research tax credits 135 161 Lease obligation 206 Other 72 60 Net operating losses 14,502 10,624 Total deferred tax assets $ 14,999 $ 11,364 Deferred tax liabilities: Beneficial conversion feature — — Right of use asset 206 — Other — — Total deferred tax liabilities 206 — Valuation allowance 14,793 11,364 Net deferred tax assets $ — $ — As of December 31, 2019 and 2018 the Company had net operating loss carryforwards for U.S. federal income tax purposes of approximately $246.3 million and $230.0 million, respectively. A significant portion of the federal amount is subject to an annual limitation as low as $27,500 as a result of changes in the Company’s ownership in May 2003, November 2016, and multiple dates throughout 2017, 2018 and 2019, as defined by Federal Internal Revenue Code Section 382 and the related income tax regulations. As a result of the limitations caused by the May 2003, November 2016 and multiple 2017, 2018 and 2019 ownership changes, approximately $207.0 million of the total net operating loss carryforwards is expected to expire unutilized and will be unavailable to offset future federal taxable income. Approximately $39.3 million of net operating loss carryforwards remains available to offset future federal taxable income, of which $1.7 million will expire between 2020 and 2037 and $37.6 million will have an unlimited carryforward period as a result of the Tax Cuts and Jobs Act. In addition, the Company’s state net operating losses are also subject to annual limitations that generally follow the federal Section 382 provisions (with the exception of Connecticut), adjusted for each state’s respective income apportionment percentages. As of December 31, 2019 and 2018, the Company had net operating loss carryforwards for state and city income tax purposes between approximately $27.3 million and $180.6 million and between approximately $27.3 million and $167.3 million, respectively, which expire through 2039. As a result of the 382 limitations, approximately $169.4 million and $153.7 million of New York State and New York City net operating losses are expected to expire unutilized and will be unavailable to offset future taxable income. Approximately $11.2 million and $11.2 million of net operating loss carryforwards, respectively, will be available to offset future state and city taxable income. As of December 31, 2019 and 2018 the Company had a net operating loss carryforward for foreign income tax purposes of $26.1 million and $25.2 million, respectively, which have indefinite carryforward periods. As of December 31, 2019 and 2018, the Company had federal research and development tax credit carryforwards of approximately $5.3 million and $5.0 million respectively, which expire through 2039. As a result of the section 382 limitations, all but $0.1 million of the tax credit carryforwards is expected to expire unutilized. Management has established a 100% valuation allowance against the deferred tax assets as management does not believe it is more likely than not that these assets will be realized. The Company’s valuation allowance increased by approximately $3.4 million and increased by $5.4 million in 2019 and 2018, respectively. The change in valuation is as follows: (in thousands) December 31, 2019 December 31, 2018 Beginning balance $ 11,364 $ 5,972 Charged to costs and expenses 3,512 6,323 Charged to additional paid-in capital — — Charged to retained earnings — (834 ) Charged to other comprehensive income (83 ) (97 ) Ending balance $ 14,793 $ 11,364 On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act (the “Act”). The Act, which is also commonly referred to as “U.S. tax reform”, significantly changes U.S. corporate income tax laws by, among other provisions, reducing the maximum U.S. corporate income tax rate from 35% to 21% starting in 2018. During the year ended December 31, 2017, the Company reduced deferred tax assets by a provisional amount of $143,500, offset by a corresponding reduction to its valuation allowance, as a result of the re-measurement of deferred tax assets and liabilities from its 34% effective rate under existing law to the new lower statutory rate of 21%. The Company finalized its accounting of the effects of tax reform in 2018, which resulted in insignificant adjustments. The Act also requires a mandatory one-time inclusion of the deferred foreign income of controlled foreign corporations. The one-time transition tax is based on Delcath’s total post-1986 earnings and profits (E&P) for which the Company has previously deferred from U.S. income taxes. During the year ended December 31, 2017, the Company’s reasonable estimate resulted in no provisional amount for the one-time transition tax liability, as the Company’s international subsidiaries are expected to have a cumulative deficit in E&P. As the Company’s international subsidiaries have a cumulative deficit in earnings and profits, the Company did not anticipate being affected by the mandatory inclusion provisions of the Act. The Company finalized its calculation of the total post-1986 foreign E&P (including deficits) for these foreign subsidiaries during 2018 and was not impacted by the mandatory inclusion provisions of the Act. On December 22, 2017, Staff Accounting Bulletin 118 was issued due to the complexities involved in accounting for the recently enacted Act. SAB 118 requires the Company to include in its financial statements a reasonable estimate of the impact of the Act on earnings to the extent such estimate has been determined. Accordingly, the U.S. provision for income tax for December 31, 2017 was based on the reasonable estimate guidance provided by SAB 118. The Company finalized the impact from the Act during 2018 and recorded insignificant adjustments. The Company complies with the provisions of ASC 740-10, Income Taxes, in accounting for its uncertain tax positions. ASC 740-10 addresses the determination of whether tax benefits claimed or expected to be claimed on a tax return should be recorded in the financial statements. Under ASC 740-10, the Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The Company has determined that the Company has no significant uncertain tax positions requiring recognition under ASC 740-10 and therefore has not included a tabular rollforward of unrecognized tax benefits. As there are no uncertain tax positions recognized, interest and penalties have not been accrued. The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. The Company has not been audited by any state tax authorities in connection with income taxes. The Company has not been audited by international tax authorities or any states in connection with income taxes. The Company’s New York State tax returns have been subject to annual desk reviews which have resulted in insignificant adjustments to the related franchise tax liabilities and credits. The Company is no longer subject to federal and state examination for tax years ending prior to December 31, 2016; tax years ending December 31, 2016 through December 31, 2019 remain open to examination. The Republic of Ireland is the Company’s only significant foreign jurisdiction. The Company is no longer subject to Ireland tax examination for tax years ending prior to December 31, 2015 (as Ireland has not initiated an audit of 2014 as of December 31, 2019); tax years ending December 31, 2014 through December 31, 2018 remain open to examination. However, the Company’s tax years December 31, 1998 through December 31, 2019 generally remain open to adjustment for all federal, state and foreign tax matters until its net operating loss and tax credit carryforwards are utilized or expire prior to utilization, and the applicable statutes of limitation have expired in the utilization year. The federal and state tax authorities can generally reduce a net operating loss (but not create taxable income) for a period outside the statute of limitations in order to determine the correct amount of net operating loss which may be allowed as a deduction against income for a period within the statute of limitations. Delcath recognizes interest accrued related to unrecognized tax benefits and penalties, if incurred, as a component of income tax expense. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | (1 5 ) Subsequent Events Since January 1, 2020, the Company has issued 2,915 shares pursuant to conversions of Series E and Series E-1 Convertible Preferred Stock. In May 2018, the Company received a Demand Letter from a vendor for an outstanding balance owed at that time of $2.1 million. At that time, the Company agreed with the vendor on a payment plan for the balance owed. Subsequent to December 31, 2019, the vendor issued a notice of default relating to the Demand Letter. As a result, the Company paid $0.9 million, representing the remaining balance owed. In February 2020, we issued 2,717 shares of restricted common stock in relation to certain advisory services received by us. In connection with the foregoing, we relied upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended, for transactions not involving a public offering. In connection with our proposed public offering (the “Proposed Offering”) of our securities pursuant to our registration statement on Form S-1 (File No. 333-235904), and the potential listing of the Company’s common stock, par value $0.01 per share (the “Common Stock”) on the Nasdaq Capital Market in connection therewith, on March 11, 2020, the Company entered into a support and conversion agreement (the “Support and Conversion Agreement”) with Rosalind Master Fund L.P. and Rosalind Opportunities Fund I L.P. (collectively, “Rosalind”) and our executive officers. The Support and Conversion Agreement provides that, among other things, the executive officers have agreed to receive payment of the net after-tax amount of their 2019 annual incentive bonuses aggregating $221,000 in unregistered shares of Common Stock, valued at the public offering price of the securities sold in the Proposed Offering, upon the consummation of the Proposed Offering. In addition, following the consummation of the Proposed Offering, (i) Rosalind has agreed that from time to time the Company may require them to convert all or a portion of their 8% senior secured promissory notes in the aggregate principal amount of $2 million (the “Notes”) into shares of the Company’s Series E convertible preferred stock (the “Series E Preferred Stock”) and Series E warrants at the contractual conversion price of $1,500 per share of Series E Preferred Stock in certain circumstances described below (a “Rosalind Conversion”), and (ii) the Company’s executive officers have agreed to receive payment of the net after-tax amounts of back pay and deferred bonuses aggregating $765,000 in unregistered shares of Common Stock (an “Equitization Transaction,” and together with a Rosalind Conversion, an “Equity Infusion”). The shares of Common Stock issuable in an Equitization Transaction would have a value equal to the greater of (x) the last reported sale price per share as of the trading day immediately preceding the Equity Infusion Date (as defined below) and (y) the volume-weighted average price of the Common Stock for the five trading days immediately preceding the Equity Infusion Date. The recent outbreak of a novel strain of coronavirus (COVID-19) has had an impact on our ability to monitor data at our clinical trial sites and is likely to cause a decline in product revenue for the forseeable future as many hospitals are prioritizing the treatment of patients diagnosed with COVID-19. This situation is rapidly changing and additional impacts to the business may arise that we are not aware of currently. The ultimate impact of the pandemic on the Company’s results of operations, financial position, liquidity or capital resources cannot be reasonably estimated at this time. Unaudited On April 8, 2020, we, Rosalind and our executive officers entered into an amendment (the Amendment) to the Support and Conversion Agreement. Pursuant to the Amendment, we agreed to, among other things, extend the expiration date of the Support and Conversion Agreement. As so amended, the Support and Termination Agreement will expire on the earlier of (i) the date on which all of Rosalinds 8% senior secured promissory notes in the aggregate principal amount of $2 million have been converted or paid in full, or (ii) June 30, 2021; provided, however, that the Support and Conversion Agreement will terminate and be of no further force and effect (x) with respect to an executive officer, upon the effective date of the termination of the executive officers employment by us and (y) if Nasdaq approval is not obtained or the Proposed Offering is not consummated on or prior to the April 30, 2020 (the Closing Deadline) other than as a result of a failure by Rosalind to satisfy the Participation Condition (as such term is defined in the Board Appointment Agreement described below). In the Amendment, Rosalind notified us that it intends to participate in the Proposed Offering pursuant to the participation rights provided to it in the Support and Conversion Agreement. We have also entered into a Board Appointment Agreement (the Board Appointment Agreement) with Rosalind pursuant to which we agreed to provide Rosalind with certain representation rights on our Board of Directors (the Board). Pursuant to the terms of the Board Appointment Agreement, Rosalind will have the right to nominate, and to cause the removal or replacement of, up to two directors for election to the Board (the Rosalind Nominees) in the event that the Proposed Offering is consummated on or prior to the Closing Deadline and Rosalind invests at least $4.0 million in the Proposed Offering on the same terms as the other investors in the Proposed Offering (the Participation Condition), or in the event that the Proposed Offering is not consummated on or prior to the Closing Deadline other than as a result of Rosalinds failure to satisfy the Participation Condition. The Rosalind Nominees must meet all applicable requirements for treatment as independent directors under applicable SEC and Nasdaq rules and regulations. The Board has determined that Gil Aharon and Steven Salamon, the principals of Rosalind, would qualify as independent directors under such rules and One Rosalind Nominee would be appointed to the class of directors whose term expires at our 2022 annual meeting of stockholders and the other would be appointed to the class of directors whose term expires at our 2021 annual meeting of stockholders. If Rosalind exercises its rights to nominate one or more Rosalind Nominees, Rosalind will also have the right to designate a Rosalind Nominee for service on any committee of the Board so long as such Rosalind Nominee meets any applicable SEC and Nasdaq requirements for membership on such committee. If Rosalind exercises its rights to nominate one or more Rosalind Nominees, the Board will increase the size of the Board and elect the Rosalind Nominees to fill the vacancies created by such increase. Rosalinds right to nominate one or more Rosalind Nominees as described above will expire, if unexercised, at 5:00 p.m. on May 5, 2020 or, prior thereto, if Rosalind ceases to be the beneficial owner of at least 9.99% of our common stock (determined without giving effect to any provision of any security limiting Rosalinds beneficial ownership). Until the later of such time as Rosalind exercises its nomination rights and April 30, 2020, the Board will not fill any vacancy on the Board with a candidate who is not approved by Rosalind. If Rosalind exercises its right to nominate one or more Rosalind Nominees, the Board has agreed that prior to our 2020 annual meeting of stockholders and, in any event, no later than June 30, 2020, the Board will meet to consider and approve a reduction in the size of the Board from eight to no fewer than six members. Any director who is asked to step down from the Board has agreed to resign at the end of the meeting. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Liquidity and Going Concern | Liquidity and Going Concern The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying consolidated financial statements during the year ended December 31, 2019, the Company incurred net operating losses of $8.9 million and used $23.7 million of cash for its operating activities. These factors among others raise substantial doubt about the Company’s ability to continue as a going concern for a reasonable period of time. The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. Adequate additional financing may not be available to us on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce or eliminate our research and development programs or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. If Delcath is not able to continue as a going concern, it is likely that holders of its common stock will lose all of their investment. The accompanying consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern. The Company anticipates incurring additional losses until such time, if ever, that it can generate significant sales. At December 31, 2019, management believed that its capital resources were adequate to fund operations through June 2020. Additional working capital will be required to continue operations. |
Use of Estimates | Use of Estimates The Company bases its estimates and judgments on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s consolidated balance sheets and the amount of revenues and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for derivative instrument liabilities, stock-based compensation, valuation of inventory, impairment of long-lived assets, income taxes and operating expense accruals. Such assumptions and estimates are subject to change in the future as additional information becomes available or as circumstances are modified. Actual results could differ from these estimates. |
Cash Equivalents and Concentrations of Credit Risk | Cash Equivalents and Concentrations of Credit Risk The Company considers investments with original maturities of three months or less at date of acquisition to be cash equivalents. The Company has deposits that exceed amounts insured by the Federal Deposit Insurance Corporation (“FDIC”), however, the Company does not consider this a significant concentration of credit risk based on the strength of the financial institution. |
Restricted Cash | Restricted Cash Cash and cash equivalents that are restricted as to withdrawal or use under the terms of certain contractual agreements are recorded as restricted cash on the accompanying consolidated balance sheets. |
Accounts Receivable | Accounts Receivable Accounts receivable, principally trade, are generally due within 30 days and are stated at amounts due from customers. Collections and payments from customers are monitored and a provision for estimated credit losses may be created based upon historical experience and specific customer collection issues that may be identified. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value using the first-in, first-out method. The reported net value of inventory includes finished saleable products, work-in-process, and raw materials that will be sold or used in future periods. The Company reserves for expired, obsolete, and slow-moving inventory. |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are recorded at cost, less accumulated depreciation. The Company provides for depreciation on a straight line basis over the estimated useful lives of the assets which range from three to seven years. Leasehold improvements will be amortized over the shorter of the lease term or the estimated useful life of the related assets when they are placed into service. The Company evaluates property, plant and equipment for impairment periodically to determine if changes in circumstances or the occurrence of events suggest the carrying value of the asset or asset group may not be recoverable. |
Derivative Instrument Liability | Derivative Instrument Liability The Company accounts for derivative instruments in accordance with Accounting Standards Codification (“ASC”) 815, Derivatives and Hedging, which establishes accounting and reporting standards for derivative instruments and hedging activities, including certain derivative instruments embedded in other financial instruments or contracts and requires recognition of all derivatives on the balance sheet at fair value, regardless of the hedging relationship designation. Accounting for changes in the fair value of the derivative instruments depends on whether the derivatives qualify as hedge relationships and the types of relationships designated are based on the exposures hedged. At December 31, 2019 and 2018, the Company did not have any derivative instruments that were designated as hedges. |
Fair Value Measurements | Fair Value Measurements The Company adheres to ASC 820, Fair Value Measurement, which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. ASC 820 applies to reported balances that are required or permitted to be measured at fair value under existing accounting pronouncements; accordingly, the standard does not require any new fair value measurements of reported balances. ASC 820 emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Therefore, a fair value measurement should be determined based on the assumptions that market participants would use in pricing the asset or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a fair value hierarchy that distinguishes between market participant assumptions based on market data obtained from sources independent of the reporting entity (observable inputs that are classified within Levels 1 and 2 of the hierarchy) and the reporting entity’s own assumptions about market participant assumptions (unobservable inputs classified within Level 3 of the hierarchy). • Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. • Level 3 inputs are unobservable inputs for the asset or liability, which is typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. |
Revenue Recognition | Revenue Recognition Revenue is generated from proprietary and partnered product sales and license and royalty arrangements. Revenue is recognized when or as we transfer control of the promised goods or services to our customers in an amount that reflects the consideration to which we expect to be entitled to in exchange for those goods or services. When obligations or contingencies remain after the products are shipped, such as training and certifying the treatment centers, revenue is deferred until the obligations or contingencies are satisfied. We may enter into contracts with partners that contain multiple elements such as licensing, development, manufacturing and commercialization components. These arrangements are often complex and we may receive various types of consideration over the life of the arrangement, including: up-front fees, reimbursements for research and development services, milestone payments, payments on product shipments, margin sharing arrangements, license fees and royalties. Our results of operations for reporting periods beginning on or after January 1, 2018 are presented under ASC 606, Revenue from Contracts with Customers, while prior period amounts, as reported, are not adjusted. The effects of the adoption of the new standard in 2018 were not material to our consolidated financial statements. In assessing our revenue arrangements in accordance with ASC 606, Revenue from Contracts with Customers, we must identify the contract, determine the transaction price including an estimation of any variable consideration we expect to receive in connection with the contract, identify the promises of goods or services to the customer and each distinct performance obligation, allocate the transaction price to each of the performance obligations, and recognize revenue when or as the performance obligations are satisfied. Each of these steps in the revenue recognition process requires management to make judgements and/or estimates. The most significant judgements and estimates involve the determination of variable consideration to be included in the transaction price. Variable consideration is recognized at an amount we believe is not subject to significant reversal and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. We believe this provides a reasonable basis for recognizing revenue, however, actual results could differ from estimates and significant changes in estimates could impact our results of operations in future periods. |
Deferred Revenue | Deferred Revenue License fees and milestones received in exchange for the grant of a license |
Selling, General and Administrative | Selling, General and Administrative Selling, general and administrative costs include personnel costs and related expenses for the Company’s sales, marketing, general management and administrative staff, recruitment, costs related to the Company’s commercialization efforts in Europe, professional service fees, professional license fees, business development and certain general legal activities. All such costs are charged to expense when incurred. |
Research and Development | Research and Development Research and development costs include the costs of materials used for clinical trials and R&D, personnel costs associated with device and pharmaceutical R&D, clinical affairs, medical affairs, medical science liaisons, and regulatory affairs, costs of outside services and applicable indirect costs incurred in the development of the Company’s proprietary drug delivery system. All such costs are charged to expense when incurred. |
Stock Based Compensation | Stock Based Compensation The Company accounts for its share-based compensation in accordance with the provisions of ASC 718, Stock-Based Compensation, which establishes accounting for equity instruments exchanged for employee services and ASC 505-50, Equity-Based Payments to Non-Employees, which establishes accounting for equity-based payments to non-employees. Under the provisions of ASC 718, share-based compensation is measured at the grant date, based upon the fair value of the award, and is recognized as an expense over the option holders’ requisite service period (generally the vesting period of the equity grant). The Company is required to record compensation cost for all share-based payments granted to employees based upon the grant date fair value, estimated in accordance with the provisions of ASC 718. Under the provisions of ASC 505-50, measurement of compensation cost related to common shares issued to non-employees for services is based on the value of the services provided or the fair value of the shares issued. The measurement of non-employee stock-based compensation is subject to periodic adjustment as the underlying equity instrument vests. The Company expenses its share-based compensation for share-based payments granted under the accelerated method, which treats each vesting tranche as if it were an individual grant. The Company periodically grants stock options for a fixed number of shares of common stock to its employees, directors and non-employee contractors, with an exercise price greater than or equal to the fair market value of Delcath’s common stock at the date of the grant. The Company estimates the fair value of stock options using an option pricing model. Key inputs used to estimate the fair value of stock options include the exercise price of the award, the expected post-vesting option life, the expected volatility of Delcath’s stock over the option’s expected term, the risk-free interest rate over the option’s expected term, and Delcath’s expected annual dividend yield. Estimates of fair value are not intended to predict actual future events or the value ultimately realized by persons who receive equity awards. |
Income Taxes | Income Taxes The Company accounts for income taxes following the asset and liability method in accordance with the ASC 740, Income Taxes. Under such method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the consolidated financial statement carrying amounts of existing assets and liabilities and their respective tax bases. The Company applies the accounting guidance issued to address the accounting for uncertain tax positions. This guidance clarifies the accounting for income taxes, by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements as well as provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company classifies interest and penalty expense related to uncertain tax positions as a component of income tax expense. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years that the asset is expected to be recovered or the liability settled. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The ultimate realization of deferred tax assets depends on the generation of future taxable income during the period in which related temporary differences become deductible. The Company considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in its assessment of a valuation allowance. See Note 14 for additional information. |
Net Loss per Common Share | Net Loss per Common Share Basic net loss per share is determined by dividing net loss by the weighted average shares of common stock outstanding during the period, without consideration of potentially dilutive securities except for those shares that are issuable for little or no cash consideration. Diluted net loss per share is determined by dividing net loss by diluted weighted average shares outstanding. Diluted weighted average shares reflects the dilutive effect, if any, of potentially dilutive common shares, such as stock options and warrants calculated using the treasury stock method. In periods with reported net operating losses, all common stock options and warrants are generally deemed anti-dilutive such that basic net loss per share and diluted net loss per share are equal. However, in certain periods in which the exercise price of the warrants was less than the last reported sales price of Delcath’s common stock on the final trading day of the period and there is a gain recorded pursuant to the change in fair value of the warrant derivative liability, the impact of gains related to the mark-to-market adjustment of the warrants outstanding at the end of the period is reversed and the treasury stock method is used to determine diluted earnings per share. As discussed in Note 11, the Series E Preferred Stock and the Series E-1 Preferred Stock were each determined to have a beneficial conversion feature which was accounted for as a deemed dividend. For the years ended December 31, 2019 and 2018 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive: 2019 2018 Common stock warrants - equity — 6,005 Common stock warrants - liability 1,826,608 271 Assumed conversion of Series E and Series E-1 Preferred Stock 1,802,008 — Assumed conversion of convertible notes 63,493 3,681 Stock options 1,640 — Total 3,693,749 9,957 |
Segment Information | Segment Information The Company currently operates in one business segment, which is the development and commercialization of Melphalan/HDS and CHEMOSAT. A single management team that reports to the CEO and President comprehensively manages the business. Accordingly, the Company does not have separately reportable segments. |
Foreign Currency and Currency Translation | Foreign Currency and Currency Translation Transactions that are denominated in a foreign currency are remeasured into the functional currency at the current exchange rate on the date of the transaction. Any foreign currency-denominated monetary assets and liabilities are subsequently remeasured at current exchange rates, with gains or losses recognized as foreign exchange (losses)/gains in the statements of operations. The assets and liabilities of the Company’s international subsidiaries are translated from their functional currencies into United States dollars at exchange rates prevailing at the balance sheet date. The majority of the foreign subsidiaries revenues and operating expenses are denominated in Euros. The reporting currency for the Company is the United States Dollar (“USD”). Average rates of exchange during the period are used to translate the statement of operations, while historical rates of exchange are used to translate any equity transactions. Translation adjustments arising on consolidation due to differences between average rates and balance sheet rates, as well as unrealized foreign exchange gains or losses arising from translation of intercompany loans that are of a long-term-investment nature, are recorded in other comprehensive income. |
Recently Adopted Accounting Pronouncements and Accounting Standards to be Adopted | Recently Adopted Accounting Pronouncements In February 2018, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2018-02, Income Statement—Reporting Comprehensive Income (Topic 220). ASU 2018-02 allows a company to elect a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. ASU 2018-02 is effective for periods beginning after December 15, 2018. Upon adoption of ASU 2018-02, the Company did not elect to reclassify the tax effects of the Tax Cuts and Jobs Act from accumulated other comprehensive income to retained earnings, as the stranded tax effects were insignificant. In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) Codification Improvements to Topic 842, Leases Leases (Topic 842)—Targeted Improvements Leases The Company has elected certain practical expedients permitted under the transition guidance within ASC 842 to leases that commenced before January 1, 2019, including the package of practical expedients. The election of the package of practical expedients resulted in the Company not reassessing prior conclusions under ASC 840 related to lease identification, lease classification and initial direct costs for expired and existing leases prior to January 1, 2019. The Company did not elect the practical expedient to not record short-term leases on its consolidated balance sheet. The adoption of ASU 2016-02 did not have a significant impact on the Company’s consolidated results of operations or cash flows. See Note 9 for additional information. SEC Disclosure Update and Simplification In August 2018, the SEC adopted the final rule under SEC Release No. 33-10532, Disclosure Update and Simplification, amending certain disclosure requirements that were redundant, duplicative, overlapping, outdated or superseded. In addition, the amendments expanded the disclosure requirements on the analysis of stockholders' equity for interim financial statements. Under the amendments, an analysis of changes in each caption of stockholders' equity presented in the balance sheet must be provided in a note or separate statement. The analysis should present a reconciliation of the beginning balance to the ending balance of each period for which a statement of comprehensive income is required to be filed. This final rule was effective on November 5, 2018. The adoption did not have a material impact on the Company’s consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Anti-dilutive securities excluded from the computation of earnings per share | For the years ended December 31, 2019 and 2018 the following potentially dilutive securities were excluded from the computation of diluted earnings per share because their effects would be antidilutive: 2019 2018 Common stock warrants - equity — 6,005 Common stock warrants - liability 1,826,608 271 Assumed conversion of Series E and Series E-1 Preferred Stock 1,802,008 — Assumed conversion of convertible notes 63,493 3,681 Stock options 1,640 — Total 3,693,749 9,957 |
Restricted Cash (Tables)
Restricted Cash (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Restricted Cash [Abstract] | |
Schedule of Restricted Cash | (in thousands) December 31, 2019 December 31, 2018 Cash and cash equivalents $ 10,002 $ 2,516 Convertible Notes — — Letters of credit 131 1,012 Security for credit cards 50 50 Total cash, cash equivalents and restricted cash shown in the statement of cash flows $ 10,183 $ 3,578 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories | Inventories consist of: (in thousands) December 31, 2019 December 31, 2018 Raw materials $ 375 $ 358 Work-in-process 279 500 Finished goods — — Total Inventory $ 654 $ 858 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets include the following: (in thousands) December 31, 2019 December 31, 2018 Clinical trial expenses 725 — Insurance premiums 589 140 Security deposit 51 51 Income tax and VAT receivable 31 579 Other 1 363 128 Total prepaid expenses and other current assets $ 1,759 $ 898 1 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Components of property, plant and equipment | Property, plant, and equipment consists of: (in thousands) December 31, 2019 December 31, 2018 Estimated Useful Life Buildings and land $ 589 $ 589 30 years - Buildings Enterprise hardware and software 1,739 1,742 3 years Leaseholds 1,695 1,701 Lesser of lease term or estimated useful life Equipment 1,025 1,002 7 years Furniture 198 198 5 years Property, plant and equipment, gross 5,246 5,232 Accumulated depreciation (4,511 ) (4,307 ) Property, plant and equipment, net $ 735 $ 925 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables And Accruals [Abstract] | |
Schedule of current accrued expenses | Current accrued expenses include the following: (in thousands) December 31, 2019 December 31, 2018 Clinical trial expenses $ 2,497 $ 4,530 Compensation, excluding taxes 3,525 1,785 Professional fees 263 190 Short-term portion of lease restructuring - 184 Other 1 662 1,275 Total accrued expenses $ 6,947 $ 7,964 1 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Summary of Operating and Financing Leases | The following table summarizes the Company’s operating and financing leases as of December 31, 2019: (in thousands) US Ireland Total Lease Cost Operating lease cost $ 710 $ 210 $ 920 Financing lease cost 42 — 42 Sublease income (215 ) (175 ) (390 ) Total $ 537 $ 35 $ 572 Other information Operating cash flows out from operating leases (755 ) (210 ) (965 ) Operating cash flows in from operating leases 215 175 390 Operating cash flows out from financing leases (39 ) — (39 ) Right-of-use assets exchanged for new operating lease liabilities 874 — 874 Weighted average remaining lease term 1.1 1.8 Weighted average discount rate - operating leases 8 % 8 % |
Schedule of Maturity of Operating Leases Excluding Short-Term Leases | Maturities of the Company’s operating leases, excluding short-term leases, are as follows: (in thousands) US Ireland Total Year ended December 31, 2020 $ 498 $ 210 $ 708 Year ended December 31, 2021 79 122 201 Total 577 332 909 Less present value discount (27 ) (21 ) (48 ) Operating lease liabilities included in the condensed consolidated balance sheet at December 31, 2019 $ 550 $ 311 $ 861 |
Outstanding Debt (Tables)
Outstanding Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Summary of the Notes by Maturity Dates | The following table provide a summary of the outstanding Note at December 31, 2019 : (in millions) Conversion price Current interest rate Principal Long term convertible notes payable 8.0% July 2019 Notes $ 1,500 8 % $ 2.0 The following table provides a summary of the Notes by their maturity dates (absent provisions of default) at December 31, 2018: (in millions) Interest rate Conversion price Principal Unamortized Discount Carrying value December 4, 2018 8.0% $ 1.75 $ 1.7 $ — $ 1.7 March 1, 2019 8.0% 1.75 0.6 (0.5 ) 0.1 March 21, 2019 8.0% 1.75 0.4 (0.2 ) 0.2 December 4, 2019 8.0% 1.75 0.9 (0.9 ) — March 1, 2020 8.0% 1.75 0.8 (0.8 ) — March 21, 2020 8.0% 1.75 0.1 (0.1 ) — Total Convertible Notes Payable, net $ 4.5 $ (2.5 ) $ 2.0 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders Equity Note [Abstract] | |
Summary of Stock Option Activity | The following is a summary of stock option activity under the Plan for the year ended December 31, 2019: Number of Shares Weighted Average Exercise Price Weighted Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2019 — Granted 1,782 $ 196.70 Exercised — Cancelled/Forfeited (142 ) $ 196.70 Outstanding at December 31, 2019 1,640 $ 196.70 9.1 $ — Exercisable at December 31, 2019 1,502 $ 196.70 9.1 $ — |
Summary of Recognized Share-based Compensation Cost | (in thousands) Twelve months ended December 31, 2019 Twelve months ended December 31, 2018 Selling, general and administrative $ 213,807 $ 120,850 Research and development 59,391 (61,867 ) Total $ 273,198 $ 58,983 |
Summary of Warrant Activity | The following is a summary of warrant activity for the years ended December 31, 2019 and 2018: Warrants Exercise Share Weighted Exercise Price Weighted Average Remaining (Years) Outstanding at January 1, 2018 20 $857,500 - $13,798,400,000 $ 4,868,205,366 4.88 Warrants issued 100,352 222 Warrants exercised (6,536 ) 1,252 Warrants expired (1 ) 13,798,400,000 Outstanding at December 31, 2018 93,835 $7 - $7,000 $ 151 5.75 Warrants issued 1,826,579 42 Warrants exercised (11,285 ) 7 Warrants exchanged (82,521 ) 170 Outstanding at December 31, 2019 1,826,608 $7 - $23 $ 23 4.99 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements using significant unobservable inputs | The table below presents the activity within Level 3 of the fair value hierarchy for the twelve months ended December 31, 2019: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at January 1, 2018 $ 560 Fair value of warrants issued 23,533 Total change in the liability included in earnings (19,706 ) Reclass from liability to equity (4,210 ) Fair value of warrants exchanged (144 ) Balance at December 31, 2018 33 Total change in the liability included in earnings (17,498 ) Reclass from liability to equity (11 ) Fair value of warrants issued 20,844 Balance at December 31, 2019 3,368 |
Schedule of fair value of the outstanding warrants | The fair value of the Warrants at December 31, 2019 was determined by using option pricing models assuming the following: December 31, December 31, 2019 2018 Expected life (in years) 4.6 1.1 - 5.1 Expected volatility 207.5% 145.7% - 265.3% Risk-free interest rates 1.7% 2.5% - 2.6% |
Assets and liabilities measured at fair value on a recurring basis | The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2019 and 2018, aggregated by the level in the fair value hierarchy within which those measurements fall. Assets and Liabilities Measured at Fair Value on a Recurring Basis Assets and Liabilities Measured at Fair Value on a Recurring Basis Level 1 Level 2 Level 3 Balance at December 31, (in thousands) 2019 2018 2019 2018 2019 2018 2019 2018 Liabilities Derivative instrument liabilities $ — $ — $ — $ — $ 3,368 $ 33 $ 3,368 $ 33 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Schedule of future minimum lease payments, net of receipts due under terms of subleases under all operating leases | Future minimum lease payments, net of receipts due under the terms of subleases, under all operating leases at December 31, 2019 are as follows: (in thousands) Future Lease Payments 2020 635 2021 79 $ 714 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Loss Before Income Taxes | Loss before taxes consists of: (in thousands) December 31, 2019 December 31, 2018 Domestic $ (4,882 ) $ (12,961 ) Foreign (3,997 ) (6,261 ) Income (loss) before taxes $ (8,879 ) $ (19,222 ) |
Income tax reconciliation | The provision for income taxes differs from the amount computed by applying the statutory rate as follows: (in thousands) December 31, 2019 December 31, 2018 Income taxes using U.S federal statutory rate $ (1,865 ) $ (4,037 ) Tax Cuts and Jobs Act — — Nondeductible interest 994 2,273 Loss on extinguishment of debt 361 236 Loss of tax benefit of federal net operating loss carryforwards — (588 ) Loss of tax benefit of state net operating loss carryforwards 1,477 1,040 Loss of tax benefit of federal tax credit carryforwards 324 495 Amortization of gain on IP migration — — State income taxes, net of federal benefit (1,461 ) (2,355 ) Foreign rate differential 664 1,166 Valuation allowance 3,512 6,323 Derivative charge (3,674 ) (4,138 ) Stock option exercises and cancellations — 215 Research and development costs (316 ) (636 ) Other (16 ) 6 $ — $ — |
Significant components of deferred tax assets | Significant components of the Company’s deferred tax assets are as follows: (in thousands) December 31, 2019 December 31, 2018 Deferred tax assets: Equity compensation $ 84 $ — Accrued liabilities — 519 Research tax credits 135 161 Lease obligation 206 Other 72 60 Net operating losses 14,502 10,624 Total deferred tax assets $ 14,999 $ 11,364 Deferred tax liabilities: Beneficial conversion feature — — Right of use asset 206 — Other — — Total deferred tax liabilities 206 — Valuation allowance 14,793 11,364 Net deferred tax assets $ — $ — |
Summary of Change in Valuation | The change in valuation is as follows: (in thousands) December 31, 2019 December 31, 2018 Beginning balance $ 11,364 $ 5,972 Charged to costs and expenses 3,512 6,323 Charged to additional paid-in capital — — Charged to retained earnings — (834 ) Charged to other comprehensive income (83 ) (97 ) Ending balance $ 14,793 $ 11,364 |
Description of Business - Addit
Description of Business - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ||
Net loss | $ 8,879 | $ 19,222 |
Net cash used in operating activities | $ 23,690 | $ 14,732 |
Basis of Consolidated Financi_2
Basis of Consolidated Financial Statement Presentation - Additional Information (Details) | Dec. 24, 2019 | May 02, 2018 |
Basis Of Condensed Consolidated Financial Statement Presentation [Abstract] | ||
Reverse stock split ratio | 0.00142 | 0.002 |
Reverse stock split | 1:700 | 1:500 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 12 Months Ended | |
Dec. 31, 2019DerivativeSegment | Dec. 31, 2018Derivative | |
Summary Of Significant Accounting Policies [Line Items] | ||
Maximum period of investments with original maturities from date of acquisition to be cash equivalents | 3 months | |
Number of business segments | Segment | 1 | |
Designated as Hedges [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Number of derivative instruments | Derivative | 0 | 0 |
Minimum [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Property, plant and equipment, estimated useful life | 3 years | |
Maximum [Member] | ||
Summary Of Significant Accounting Policies [Line Items] | ||
Property, plant and equipment, estimated useful life | 7 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Shares Excluded from the Computation of Diluted Earnings per Share (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 3,693,749 | 9,957 |
Common Stock Warrants - Equity [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 6,005 | |
Common Stock Warrants - Liability [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,826,608 | 271 |
Assumed Conversion of Series E and Series E-1 Preferred Stock [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,802,008 | |
Assumed Conversion of Convertible Notes [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 63,493 | 3,681 |
Stock Options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 1,640 |
Restricted Cash - Schedule of R
Restricted Cash - Schedule of Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Restricted Cash [Abstract] | |||
Cash and cash equivalents | $ 10,002 | $ 2,516 | |
Letters of credit | 131 | 1,012 | |
Security for credit cards | 50 | 50 | |
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 10,183 | $ 3,578 | $ 5,324 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 375 | $ 358 |
Work-in-process | 279 | 500 |
Total Inventory | $ 654 | $ 858 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Clinical trial expenses | $ 725 | |
Insurance premiums | 589 | $ 140 |
Security deposit | 51 | 51 |
Income tax and VAT receivable | 31 | 579 |
Other | 363 | 128 |
Total prepaid expenses and other current assets | $ 1,759 | $ 898 |
Prepaid Expenses and Other Cu_4
Prepaid Expenses and Other Current Assets - Additional Information (Details) | Dec. 31, 2019 | Dec. 31, 2018 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Maximum percentage of prepaid expenses and other current assets (in hundredths) | 5.00% | 5.00% |
Property, Plant, and Equipmen_2
Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 5,246 | $ 5,232 |
Accumulated depreciation | (4,511) | (4,307) |
Property, plant and equipment, net | 735 | 925 |
Buildings and Land [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 589 | 589 |
Enterprise Hardware and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,739 | 1,742 |
Property, plant and equipment, estimated useful life | 3 years | |
Leaseholds [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,695 | 1,701 |
Property, plant and equipment, estimated useful life | Lesser of lease term or estimated useful life | |
Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 1,025 | 1,002 |
Property, plant and equipment, estimated useful life | 7 years | |
Furniture [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 198 | $ 198 |
Property, plant and equipment, estimated useful life | 5 years | |
Buildings [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, estimated useful life | 30 years |
Property, Plant, and Equipmen_3
Property, Plant, and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | ||
Depreciation expense | $ 212 | $ 444 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Current Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables And Accruals [Abstract] | ||
Clinical trial expenses | $ 2,497 | $ 4,530 |
Compensation, excluding taxes | 3,525 | 1,785 |
Professional fees | 263 | 190 |
Short-term portion of lease restructuring | 184 | |
Other | 662 | 1,275 |
Total accrued expenses | $ 6,947 | $ 7,964 |
Accrued Expenses - Schedule o_2
Accrued Expenses - Schedule of Current Accrued Expenses (Parenthetical) (Details) | Dec. 31, 2019 | Dec. 21, 2018 |
Payables And Accruals [Abstract] | ||
Maximum percentage of current liabilities accrued (in hundredths) | 5.00% | 5.00% |
Leases - Additional Information
Leases - Additional Information (Details) | Dec. 31, 2019 |
Leases [Abstract] | |
Lease term | 12 months |
Leases - Summary of Operating a
Leases - Summary of Operating and Financing Leases (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Lease Cost | ||
Operating lease cost | $ 920 | |
Financing lease cost | 42 | |
Sublease income | (390) | |
Total | 572 | |
Other information | ||
Operating cash flows out from operating leases | (965) | |
Operating cash flows in from operating leases | 390 | |
Operating cash flows out from financing leases | (39) | |
Right-of-use assets exchanged for new operating lease liabilities | 874 | $ 0 |
U.S. [Member] | ||
Lease Cost | ||
Operating lease cost | 710 | |
Financing lease cost | 42 | |
Sublease income | (215) | |
Total | 537 | |
Other information | ||
Operating cash flows out from operating leases | (755) | |
Operating cash flows in from operating leases | 215 | |
Operating cash flows out from financing leases | (39) | |
Right-of-use assets exchanged for new operating lease liabilities | $ 874 | |
Weighted average remaining lease term | 1 year 1 month 6 days | |
Weighted average discount rate - operating leases | 8.00% | |
Ireland [Member] | ||
Lease Cost | ||
Operating lease cost | $ 210 | |
Sublease income | (175) | |
Total | 35 | |
Other information | ||
Operating cash flows out from operating leases | (210) | |
Operating cash flows in from operating leases | $ 175 | |
Weighted average remaining lease term | 1 year 9 months 18 days | |
Weighted average discount rate - operating leases | 8.00% |
Leases - Schedule of Maturity o
Leases - Schedule of Maturity of Operating Leases Excluding Short-Term Leases (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2020 | $ 708 |
Year ended December 31, 2021 | 201 |
Total | 909 |
Less present value discount | (48) |
Operating lease liabilities included in the condensed consolidated balance sheet at December 31, 2019 | 861 |
U.S. [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2020 | 498 |
Year ended December 31, 2021 | 79 |
Total | 577 |
Less present value discount | (27) |
Operating lease liabilities included in the condensed consolidated balance sheet at December 31, 2019 | 550 |
Ireland [Member] | |
Lessee Lease Description [Line Items] | |
Year ended December 31, 2020 | 210 |
Year ended December 31, 2021 | 122 |
Total | 332 |
Less present value discount | (21) |
Operating lease liabilities included in the condensed consolidated balance sheet at December 31, 2019 | $ 311 |
Outstanding Debt - Additional I
Outstanding Debt - Additional Information (Details) - USD ($) | Mar. 29, 2019 | May 23, 2019 | Dec. 31, 2019 | Jun. 06, 2019 | Apr. 30, 2019 | Dec. 31, 2018 | Sep. 21, 2018 |
Debt Instrument [Line Items] | |||||||
Debt instrument, principal face amount | $ 4,500,000 | ||||||
Series D Preferred Shares [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Interest rate | 8.00% | ||||||
Preferred stock, stated value | $ 1,160,000 | ||||||
Proceeds from exchange of senior secured promissory note | 400,000 | ||||||
Issuance of senior secured promissory note in exchange of preferred stock | $ 1,560,000 | ||||||
Maturity date | Apr. 1, 2020 | ||||||
Senior Secured Promissory Notes [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, principal face amount | $ 2,000,000 | ||||||
Interest rate | 8.00% | ||||||
Senior Secured Notes | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, principal face amount | $ 3,300,000 | ||||||
Interest rate | 8.00% | ||||||
Maturity period | 6 months | ||||||
Senior Secured Convertible Notes | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, principal face amount | $ 9,400,000 | ||||||
Interest rate | 8.00% | ||||||
Debt instrument maturity start date | Dec. 31, 2018 | ||||||
Debt instrument maturity end date | Mar. 31, 2021 | ||||||
8.0% 2018 Notes [Member] | Short Term Notes Payable [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, notice of default description | Company received notices of default from the investors in the 2018 Notes which resulted in a 25%, or $1.1 million, increase in principal and an increase in the interest rates from 8% to 18%. | ||||||
Debt instrument, default amount percentage | 25.00% | ||||||
Debt instrument, default amount | $ 1,100,000 | ||||||
Increase in interest rate on notes in event of default | 18.00% | ||||||
Series D Warrants [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Number of common shares issuable on cancellation of warrants | 5,605 | ||||||
Pre-Funded Series D Warrants [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Number of common shares issuable on cancellation of warrants | 100,000 |
Outstanding Debt - Summary of V
Outstanding Debt - Summary of Various Notes Issued (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2019 | |
Debt Instrument [Line Items] | ||
Principal | $ 4.5 | |
Unamortized Discount | (2.5) | |
Carrying value | $ 2 | |
December 4, 2018 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Dec. 4, 2018 | |
Interest rate | 8.00% | |
Conversion price | $ 1.75 | |
Principal | $ 1.7 | |
Carrying value | $ 1.7 | |
March 1, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 1, 2019 | |
Interest rate | 8.00% | |
Conversion price | $ 1.75 | |
Principal | $ 0.6 | |
Unamortized Discount | (0.5) | |
Carrying value | $ 0.1 | |
March 21, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 21, 2019 | |
Interest rate | 8.00% | |
Conversion price | $ 1.75 | |
Principal | $ 0.4 | |
Unamortized Discount | (0.2) | |
Carrying value | $ 0.2 | |
December 4, 2019 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Dec. 4, 2019 | |
Interest rate | 8.00% | |
Conversion price | $ 1.75 | |
Principal | $ 0.9 | |
Unamortized Discount | $ (0.9) | |
March 1, 2020 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 1, 2020 | |
Interest rate | 8.00% | |
Conversion price | $ 1.75 | |
Principal | $ 0.8 | |
Unamortized Discount | $ (0.8) | |
March 21, 2020 [Member] | ||
Debt Instrument [Line Items] | ||
Maturity date | Mar. 21, 2020 | |
Interest rate | 8.00% | |
Conversion price | $ 1.75 | |
Principal | $ 0.1 | |
Unamortized Discount | $ (0.1) | |
Long Term Convertible Notes Payable [Member] | 8.0% July 2019 Notes [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate | 8.00% | |
Conversion price | $ 1,500 | |
Principal | $ 2 |
Stockholders' Equity - Preferre
Stockholders' Equity - Preferred Stock Issuances - Additional Information (Details) - USD ($) | Nov. 07, 2019 | Jul. 11, 2019 | Mar. 29, 2019 | Sep. 30, 2018 | Feb. 28, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Aug. 19, 2019 | Nov. 05, 2018 |
Stockholders Equity Note [Line Items] | |||||||||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | |||||||
Sale of common stock, net of expenses (in shares) | 6,669 | 606 | |||||||
Fair value of warrants issued | $ 20,844,000 | $ 28,539,000 | |||||||
Preferred stock, aggregate stated value | 0 | $ 0 | |||||||
Common Stock [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Conversion of stock, shares issued | 813,473 | ||||||||
Sale of common stock, net of expenses (in shares) | 7,624 | ||||||||
2019 Warrants [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Number of shares called upon exercise of warrant | 824,587 | ||||||||
Fair value of warrants issued | 20,800,000 | ||||||||
Series E Convertible Preferred Stock [Member] | July 2019 Private Placement [Member] | Securities Purchase Agreement [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Number of shares issued | 20,000 | ||||||||
Preferred stock, par value (in dollars per share) | $ 0.01 | ||||||||
Shares issued, price per share | $ 1,000 | ||||||||
Series E Preferred Stock and Related Warrants [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Debt and warrants exchanged for preferred stock | $ 11,800,000 | ||||||||
Number of preferred stock and warrants issued upon conversion | 11,500 | ||||||||
Value of accounts payable exchanged | $ 100,000 | ||||||||
Number of shares issued upon exchange of accounts payable | 149 | ||||||||
Number of shares issued upon exchange of investor waiver rights | 923 | ||||||||
Series E Preferred Stock and Related Warrants [Member] | July 2019 Private Placement [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Debt and warrants exchanged for preferred stock | $ 11,800,000 | ||||||||
Number of preferred stock and warrants issued upon conversion | 11,500 | ||||||||
Value of accounts payable exchanged | $ 100,000 | ||||||||
Number of shares issued upon exchange of accounts payable | 149 | ||||||||
Number of shares issued upon exchange of investor waiver rights | 923 | ||||||||
Series E-1 Convertible Preferred Stock [Member] | August 2019 Private Placement [Member] | Securities Purchase Agreement [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Number of shares issued | 9,510 | ||||||||
Preferred stock, par value (in dollars per share) | $ 0.01 | ||||||||
Shares issued, price per share | $ 1,000 | ||||||||
Preferred Stock [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Conversion price | $ 23.04 | $ 42 | |||||||
Warrant exercise price | 23.04 | $ 42 | |||||||
Warrant exercisable term | 5 years | ||||||||
Net proceeds from issuance of preferred stock | $ 26,600,000 | ||||||||
Beneficial conversion feature | $ 18,300,000 | ||||||||
Preferred Stock and 2019 Warrants [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Conversion of stock, description | The Conversion Price of the Preferred Stock and the Exercise Price of the 2019 Warrants were initially subject to adjustment in each of the following circumstances: (i) on the third trading day following the date that the Company effects a reverse stock split, or the Reverse Split Reset Date, (ii) the date that the initial registration statement covering the shares of common stock issuable upon the conversion of the Preferred Stock and the exercise of the 2019 Warrants is declared effective by the SEC, or the Registration Reset Date, and (iii) in the event that all of the shares of common stock which we were required to register with the SEC were not then registered on an effective registration statement, the date that all of the shares underlying the respective Preferred Stock and 2019 Warrants may be sold pursuant to Rule 144, or the Rule 144 Reset Date, each of such reset dates, a Reset Date and, collectively, the Reset Dates. On each Reset Date, the Conversion Price and the Exercise Price were to be reduced, and only reduced, to equal the lesser of (x) the then effective Conversion Price or Exercise Price, as applicable, and (y) 90% of the average of the five daily volume weighted average prices of the common stock immediately prior to each Reset Date, or the Reset Formula. | ||||||||
Private Placements and Debt Exchange [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Conversion price and exercise price per share | $ 16.10 | ||||||||
Private Placements and Debt Exchange [Member] | Common Stock [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Sale of common stock, net of expenses (in shares) | 3,429,680 | ||||||||
Second Registration Statement [Member] | Common Stock [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Sale of common stock, net of expenses (in shares) | 1,564,085 | ||||||||
Series D Preferred Shares [Member] | |||||||||
Stockholders Equity Note [Line Items] | |||||||||
Preferred stock, par value (in dollars per share) | $ 0.01 | ||||||||
Preferred stock, aggregate stated value | $ 1,160,000,000 | ||||||||
Proceeds from exchange of senior secured promissory note | $ 400,000 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock Issuances - Additional Information (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Stockholders Equity Note [Line Items] | ||
Common stock, shares issued (in shares) | 67,091 | 14,715 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Convertible preferred stock, shares upon Conversion | 13,455 | |
Common stock, par value (in dollars per share) | $ 0.01 | |
Series E and E1 Convertible Preferred Stock [Member] | ||
Stockholders Equity Note [Line Items] | ||
Common stock, shares issued (in shares) | 565 |
Stockholders' Equity - Pre-Fund
Stockholders' Equity - Pre-Funded Series D Warrant Exercises - Additional Information (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Stockholders Equity Note [Line Items] | ||
Warrants exercised | 11,285 | 6,536 |
Pre-Funded Series D Warrants [Member] | ||
Stockholders Equity Note [Line Items] | ||
Warrants exercised | 5,379 |
Stockholders' Equity - December
Stockholders' Equity - December 2018 Warrant Exchange - Additional Information (Details) | 1 Months Ended |
Dec. 31, 2018shares | |
Exchange Agreement [Member] | |
Stockholders Equity Note [Line Items] | |
Shares of common stock issued to investors | 1,179 |
Stockholders' Equity - Septembe
Stockholders' Equity - September 2018 Rights Offering - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2018 | Feb. 28, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stockholders Equity Note [Abstract] | ||||
Sale of common stock, net of expenses (in shares) | 6,669 | 606 | ||
Net proceeds from issuance of common stock | $ 7,000 | $ 0 | $ 10,917 |
Stockholders' Equity - February
Stockholders' Equity - February 2018 Financing - Additional Information (Details) $ / shares in Units, $ in Millions | 1 Months Ended | |||||
Sep. 30, 2018shares | Feb. 28, 2018USD ($)$ / sharesshares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2018$ / sharesshares | Dec. 21, 2018USD ($) | Dec. 31, 2017$ / sharesshares | |
Stockholders Equity Note [Line Items] | ||||||
Sale of common stock, net of expenses (in shares) | 6,669 | 606 | ||||
Number of pre-funded warrants | 109 | |||||
Net proceeds from issuance of private placement | $ | $ 4.3 | |||||
Number of warrants outstanding (in shares) | 1,826,608 | 93,835 | 20 | |||
Maximum [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants exercisable per share price (in dollars per share) | $ / shares | $ 23 | $ 7,000 | $ 13,798,400,000 | |||
Minimum [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants exercisable per share price (in dollars per share) | $ / shares | $ 7 | $ 7 | $ 857,500 | |||
Contractual Term [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants expiration period | 4 years 7 months 6 days | |||||
Contractual Term [Member] | Maximum [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants expiration period | 5 years 1 month 6 days | |||||
Contractual Term [Member] | Minimum [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants expiration period | 1 year 1 month 6 days | |||||
Volatility [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 2.075 | |||||
Volatility [Member] | Maximum [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 2.653 | |||||
Volatility [Member] | Minimum [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 1.457 | |||||
Risk Free Rate [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 0.017 | |||||
Risk Free Rate [Member] | Maximum [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 0.026 | |||||
Risk Free Rate [Member] | Minimum [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 0.025 | |||||
February 2018 Warrants [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants issued to purchase Common Stock | 1,429,000,000 | |||||
Value of warrants issued | $ | $ 18.3 | |||||
Warrants exercisable per share price (in dollars per share) | $ / shares | $ 7,000 | |||||
Number of warrants outstanding (in shares) | 273 | |||||
February 2018 Warrants [Member] | Exercise Price [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | $ / shares | 7,000 | |||||
February 2018 Warrants [Member] | Contractual Term [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants expiration period | 6 years | |||||
February 2018 Warrants [Member] | Volatility [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 1.2268 | |||||
February 2018 Warrants [Member] | Risk Free Rate [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Warrants measurement input | 0.01 | |||||
Pre-Funded Series D Warrants [Member] | Maximum [Member] | ||||||
Stockholders Equity Note [Line Items] | ||||||
Maximum offering and selling of stock and securities that entity make to raise capital | $ | $ 100 |
Stockholders' Equity - Stock In
Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Unrecognized compensation expense related to non-vested share-based compensation awards | $ 25,000 | |
Cost expected to be recognized over weighted average period | 1 month 6 days | |
Share-based compensation (Income) expense | $ 273,198,000 | $ 58,983,000 |
Stock Options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Share-based compensation (Income) expense | 300,000 | (40,000) |
Restricted Stock [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Restricted stock compensation expense | $ 0 | $ 100,000 |
2019 Equity Incentive Plan [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Shares available for grant | 502 | |
2019 Equity Incentive Plan [Member] | Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares reserved for issuance | 2,142 | |
2019 Equity Incentive Plan [Member] | Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock options, exercise price of common stock granted as percentage of fair value on the date of grant | 100.00% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Details) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Stockholders Equity Note [Abstract] | |
Number of Shares, Granted | shares | 1,782 |
Number of Shares, Cancelled/Forfeited | shares | (142) |
Number of Shares, Outstanding | shares | 1,640 |
Number of Shares, Exercisable | shares | 1,502 |
Weighted Average Exercise Price, Granted | $ / shares | $ 196.70 |
Weighted Average Exercise Price, Cancelled/Forfeited | $ / shares | 196.70 |
Weighted Average Exercise Price, Outstanding | $ / shares | 196.70 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 196.70 |
Weighted Average Remaining Contractual Term (Years), Outstanding | 9 years 1 month 6 days |
Weighted Average Remaining Contractual Term (Years), Exercisable | 9 years 1 month 6 days |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Recognized Share-based Compensation Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | $ 273,198 | $ 58,983 |
Selling, General and Administrative [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | 213,807 | 120,850 |
Research and Development [Member] | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Share-based compensation (Income) expense | $ 59,391 | $ (61,867) |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Warrant Activity (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Warrants outstanding [Roll Forward] | |||
Outstanding, beginning of period (in shares) | 93,835 | 20 | |
Warrants issued (in shares) | 1,826,579 | 100,352 | |
Warrants exercised (in shares) | (11,285) | (6,536) | |
Warrants expired (in shares) | (1) | ||
Warrants exchanged (in shares) | (82,521) | ||
Outstanding, end of period (in shares) | 1,826,608 | 93,835 | 20 |
Warrants, Weighted Average Exercise Price [Roll Forward] | |||
Outstanding, beginning of period (in dollars per share) | $ 151 | $ 4,868,205,366 | |
Warrants issued (in dollars per share) | 42 | 222 | |
Warrants exercised (in dollars per share) | 7 | 1,252 | |
Warrants expired (in dollars per share) | 13,798,400,000 | ||
Warrants exchanged (in dollars per share) | 170 | ||
Outstanding, end of period (in dollars per share) | $ 23 | $ 151 | $ 4,868,205,366 |
Weighted average remaining life | 4 years 11 months 26 days | 5 years 9 months | 4 years 10 months 17 days |
Minimum [Member] | |||
Warrants, Exercise Price per Share [Roll Forward] | |||
Outstanding, (in dollars per share) | $ 7 | $ 7 | $ 857,500 |
Maximum [Member] | |||
Warrants, Exercise Price per Share [Roll Forward] | |||
Outstanding, (in dollars per share) | $ 23 | $ 7,000 | $ 13,798,400,000 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) [Roll Forward] | ||
Beginning balance | $ 33 | $ 560 |
Fair value of warrants issued | 20,844 | 23,533 |
Total change in the liability included in earnings | (17,498) | (19,706) |
Reclass from liability to equity | (11) | (4,210) |
Fair value of warrants exchanged | (144) | |
Ending balance | $ 3,368 | $ 33 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - shares | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Class Of Warrant Or Right [Line Items] | |||
Number of warrants outstanding (in shares) | 1,826,608 | 93,835 | 20 |
Febuary 2018 Warrants [Member] | |||
Class Of Warrant Or Right [Line Items] | |||
Number of warrants outstanding (in shares) | 179 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value of Outstanding Warrants (Details) | Dec. 31, 2019 | Dec. 31, 2018 |
Contractual Term [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants expiration period | 4 years 7 months 6 days | |
Contractual Term [Member] | Minimum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants expiration period | 1 year 1 month 6 days | |
Contractual Term [Member] | Maximum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants expiration period | 5 years 1 month 6 days | |
Expected Volatility [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 2.075 | |
Expected Volatility [Member] | Minimum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 1.457 | |
Expected Volatility [Member] | Maximum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 2.653 | |
Risk-free Interest Rates [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 0.017 | |
Risk-free Interest Rates [Member] | Minimum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 0.025 | |
Risk-free Interest Rates [Member] | Maximum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 0.026 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Derivative Instruments Liabilities [Member] - Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Liabilities [Abstract] | ||
Total Liabilities | $ 3,368 | $ 33 |
Level 3 [Member] | ||
Liabilities [Abstract] | ||
Total Liabilities | $ 3,368 | $ 33 |
Commitments - Additional Inform
Commitments - Additional Information (Details) | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2019USD ($)ft² | Dec. 31, 2019USD ($)ft² | Dec. 31, 2018USD ($) | Sep. 30, 2018ft² | |
Operating Leased Assets [Line Items] | ||||
Rent expense, net of receipts under the terms of subleases | $ 500,000 | $ 600,000 | ||
Park Road Lease Agreement [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Square footage of office space (in square feet) | ft² | 6,000 | |||
Annual base rent | $ 50,000 | |||
Operating lease term | 2 years | |||
Lease expiration date | Nov. 30, 2020 | |||
Office Space At 1633 Broadway, New York, NY [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Square footage of office space (in square feet) | ft² | 6,877 | |||
Annual base rent | $ 500,000 | |||
Letter of credit [Abstract] | ||||
Minimum letter of credit amount required to be maintained under lease agreement | $ 100,000 | |||
Expiration date of letter of credit | Feb. 28, 2021 | |||
Delcath's European Headquarters Lease Agreement [Member] | ||||
Operating Leased Assets [Line Items] | ||||
Square footage of office space (in square feet) | ft² | 19,200 | |||
Annual base rent | $ 200,000 | |||
Operating lease term | 10 years |
Commitments - Schedule Future M
Commitments - Schedule Future Minimum Lease Payments, Net of Receipts Due Under Terms of Subleases Under All Operating Leases (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Future minimum lease payments under all operating leases [Abstract] | |
2020 | $ 635 |
2021 | 79 |
Total future minimum payments due | $ 714 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Loss Carryforwards [Line Items] | |||
Income tax expense | $ 0 | $ 0 | |
Percentage of valuation allowance against deferred tax assets | 100.00% | ||
Decrease in deferred tax assets valuation allowance | $ 3,400,000 | 5,400,000 | |
U.S. corporate income tax rate | 21.00% | 34.00% | |
Provisional income tax due to reduction in deferred tax assets | $ 143,500 | ||
New York State [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income | $ 169,400,000 | ||
New York City [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income | $ 153,700,000 | ||
Earliest Tax Year [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Open tax period | Dec. 31, 1998 | ||
Latest Tax Year [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Open tax period | Dec. 31, 2019 | ||
Federal [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $ 246,300,000 | 230,000,000 | |
Operating loss carryforwards, annual limitation | 27,500 | ||
Operating loss carryforwards net, expected to expire unutilized and unavailable to offset future federal taxable income | 207,000,000 | ||
Operating loss carryforwards available for offset future taxable income | 39,300,000 | ||
Operating loss carryforwards for unlimited period | 37,600,000 | ||
Federal [Member] | Expire Between 2019 and 2037 [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards available for offset future taxable income | $ 1,700,000 | ||
Federal [Member] | Earliest Tax Year [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, expiration dates | 2020 | ||
Federal [Member] | Latest Tax Year [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, expiration dates | 2037 | ||
Federal [Member] | Research and Development Tax Credit Carryforwards [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforwards | $ 5,300,000 | 5,000,000 | |
Tax credit carryforwards, expiration dates | 2039 | ||
Tax credit carryforwards expected to expire unutilized | $ 100,000 | ||
State and City [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $ 11,200,000 | 11,200,000 | |
Operating loss carryforwards, expiration dates | 2039 | ||
Foreign [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $ 26,100,000 | 25,200,000 | |
Federal and State [Member] | Earliest Tax Year [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Open tax period | Dec. 31, 2016 | ||
Federal and State [Member] | Latest Tax Year [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Open tax period | Dec. 31, 2019 | ||
Minimum [Member] | State and City [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $ 27,300,000 | 27,300,000 | |
Maximum [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
U.S. corporate income tax rate | 35.00% | ||
Maximum [Member] | State and City [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards | $ 180,600,000 | $ 167,300,000 |
Income Taxes - Schedule of Loss
Income Taxes - Schedule of Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Loss From Continuing Operations Before Income Taxes Minority Interest And Income Loss From Equity Method Investments [Abstract] | ||
Domestic | $ (4,882) | $ (12,961) |
Foreign | (3,997) | (6,261) |
Income (loss) before taxes | $ (8,879) | $ (19,222) |
Income Taxes - Income tax recon
Income Taxes - Income tax reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Provision for income taxes [Abstract] | ||
Income taxes using U.S federal statutory rate | $ (1,865) | $ (4,037) |
Nondeductible interest | 994 | 2,273 |
Loss on extinguishment of debt | 361 | 236 |
Loss of tax benefit of federal net operating loss carryforwards | (588) | |
Loss of tax benefit of state net operating loss carryforwards | 1,477 | 1,040 |
Loss of tax benefit of federal tax credit carryforwards | 324 | 495 |
State income taxes, net of federal benefit | (1,461) | (2,355) |
Foreign rate differential | 664 | 1,166 |
Valuation allowance | 3,512 | 6,323 |
Derivative charge | (3,674) | (4,138) |
Stock option exercises and cancellations | 215 | |
Research and development costs | (316) | (636) |
Other | (16) | 6 |
Total | $ 0 | $ 0 |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | |||
Equity compensation | $ 84 | ||
Accrued liabilities | $ 519 | ||
Research tax credits | 135 | 161 | |
Lease obligation | 206 | ||
Other | 72 | 60 | |
Net operating losses | 14,502 | 10,624 | |
Total deferred tax assets | 14,999 | 11,364 | |
Deferred tax liabilities: | |||
Right of use asset | 206 | ||
Total deferred tax liabilities | 206 | 0 | |
Valuation allowance | 14,793 | 11,364 | $ 5,972 |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Summary of Chang
Income Taxes - Summary of Change in Valuation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Beginning balance | $ 11,364 | $ 5,972 |
Charged to costs and expenses | 3,512 | 6,323 |
Charged to retained earnings | (834) | |
Charged to other comprehensive income | (83) | (97) |
Ending balance | $ 14,793 | $ 11,364 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) $ / shares in Units, $ in Millions | Apr. 08, 2020USD ($)Director | Mar. 11, 2020USD ($)$ / sharesshares | Jan. 01, 2020shares | Feb. 29, 2020$ / sharesshares | Mar. 23, 2020USD ($) | Dec. 31, 2019$ / shares | Jun. 06, 2019USD ($) | Dec. 31, 2018USD ($)$ / shares | May 31, 2018USD ($) |
Subsequent Event [Line Items] | |||||||||
Outstanding balance to vendor | $ 2.1 | ||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | |||||||
Principal | $ 4.5 | ||||||||
Senior Secured Promissory Notes [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Interest rate | 8.00% | ||||||||
Principal | $ 2 | ||||||||
Subsequent Event [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Remaining balance payment to vendor | $ 0.9 | ||||||||
Issue of restricted common stock for advisory services | shares | 2,717 | ||||||||
Subsequent Event [Member] | Proposed Offering [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.01 | ||||||||
Number of trading days required to measure weighted average price of common stock | 5 days | ||||||||
Proposed Offering Amount | $ 4 | ||||||||
Maximum Number Of Directors Investor Can Remove Or Replace | Director | 2 | ||||||||
Minimum Required Investment Percentage For Investors Option | 9.99% | ||||||||
Maximum Number Of Directors | Director | 8 | ||||||||
Minimum Number Of Directors | Director | 6 | ||||||||
Minimum Number Of Directors Investor Has Option To Nominate | Director | 1 | ||||||||
Subsequent Event [Member] | Proposed Offering [Member] | Rosalind [Member] | Senior Secured Promissory Notes [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Interest rate | 8.00% | ||||||||
Principal | $ 2 | ||||||||
Subsequent Event [Member] | Proposed Offering [Member] | Executive Officer [Member] | Deferred Bonus [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Unregistered shares of common stock | shares | 765,000 | ||||||||
Subsequent Event [Member] | Proposed Offering [Member] | 2019 Annual Incentive Bonuses [Member] | Executive Officer [Member] | Support and Conversion Agreement [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Unregistered shares of common stock | shares | 221,000 | ||||||||
Series E and E1 Convertible Preferred Stock [Member] | Subsequent Event [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Convertible preferred stock, shares upon Conversion | shares | 2,915 | ||||||||
Series E Preferred Stock [Member] | Subsequent Event [Member] | Proposed Offering [Member] | Rosalind [Member] | |||||||||
Subsequent Event [Line Items] | |||||||||
Conversion price | $ / shares | $ 1,500 |