Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Aug. 14, 2018 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | DELCATH SYSTEMS, INC. | |
Entity Central Index Key | 872,912 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 932,158 | |
Document Fiscal Year Focus | 2,018 | |
Trading Symbol | DCTH | |
Document Fiscal Period Focus | Q2 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2018 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | |
Current assets | |||
Cash and cash equivalents | $ 1,283 | $ 3,999 | |
Restricted cash | 1,062 | 1,325 | |
Accounts receivables, net | 397 | 317 | |
Inventories | 1,250 | 1,248 | |
Prepaid expenses and other current assets | 382 | 700 | |
Total current assets | 4,374 | 7,589 | |
Property, plant and equipment, net | 1,099 | 1,298 | |
Total assets | 5,473 | 8,887 | |
Current liabilities | |||
Accounts payable | 5,607 | 3,846 | |
Accrued expenses | 5,220 | 3,408 | |
Current portion of convertible notes payable, net of discount | 387 | 0 | |
Warrant liability | 6,883 | 560 | |
Total current liabilities | 18,097 | 7,814 | |
Convertible notes payable, net of current portion and debt discount | 27 | 0 | |
Other non-current liabilities | 439 | 395 | |
Total liabilities | 18,563 | 8,209 | |
Commitments and Contingencies | |||
Stockholders' equity (deficit) | |||
Preferred stock, $.01 par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 0 | 0 | |
Common stock, $.01 par value; 1,000,000,000 shares authorized; 932,159 and 263,305 shares issued and 932,158 and 263,304 shares outstanding at June 30, 2018 and December 31, 2017, respectively* | [1] | 9 | 3 |
Additional paid-in capital | 311,293 | 325,516 | |
Accumulated deficit | (324,305) | (324,832) | |
Treasury stock, at cost; 1 share at June 30, 2018 and December 31, 2017, respectively* | [1] | (51) | (51) |
Accumulated other comprehensive (loss) income | (36) | 42 | |
Total stockholders' (deficit) equity | (13,090) | 678 | |
Total liabilities and stockholders' equity | $ 5,473 | $ 8,887 | |
[1] | reflects a one-for-three hundred and fifty (1:350) reverse stock split effected on November 6, 2017 and a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018. |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2018 | Dec. 31, 2017 |
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) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
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) | 932,159 | 263,305 |
Common stock, shares outstanding (in shares) | 932,158 | 263,304 |
Treasury stock, at cost (in shares) | 1 | 1 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | ||
Income Statement [Abstract] | |||||
Revenue | $ 858 | $ 584 | $ 1,560 | $ 1,327 | |
Cost of goods sold | 220 | 135 | 367 | 354 | |
Gross profit | 638 | 449 | 1,193 | 973 | |
Operating expenses: | |||||
Selling, general and administrative | 2,641 | 2,532 | 5,007 | 4,947 | |
Research and development | 4,089 | 2,518 | 9,781 | 4,840 | |
Total operating expenses | 6,730 | 5,050 | 14,788 | 9,787 | |
Operating loss | (6,092) | (4,601) | (13,595) | (8,814) | |
Change in fair value of the warrant liability, net | 2,513 | (38) | 17,209 | 1,200 | |
Gain on warrant extinguishment | 0 | 9,613 | 0 | 9,613 | |
Loss on issuance of financial instrument | (2,826) | 0 | (2,826) | 0 | |
Interest expense | (248) | (6,916) | (251) | (15,282) | |
Other (expense) income | (5) | (1) | (10) | 7 | |
Net income (loss) | (6,658) | (1,943) | 527 | (13,276) | |
Other comprehensive loss: | |||||
Foreign currency translation adjustments | (36) | (30) | (78) | (8) | |
Comprehensive loss | $ (6,694) | $ (1,973) | $ 449 | $ (13,284) | |
Common share data: | |||||
Basic loss per common share | [1] | $ (7.26) | $ (1,373) | $ 0.67 | $ (15,656) |
Diluted loss per common share | [1] | $ (7.26) | $ (1,373) | $ (0.12) | $ (15,656) |
Weighted average number of basic shares outstanding | [1] | 916,706 | 1,416 | 788,512 | 848 |
Weighted average number of diluted shares outstanding | [1] | 916,706 | 1,416 | 799,430 | 848 |
[1] | reflects a one-for-three hundred and fifty (1:350) reverse stock split effected on November 6, 2017 and a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018. |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parenthetical) | May 02, 2018 | Nov. 06, 2017 |
Income Statement [Abstract] | ||
Reverse stock split | 1:500 | 1:350 |
Reverse stock split ratio | 0.002 | 0.0029 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) - 6 months ended Jun. 30, 2018 - USD ($) $ in Thousands | Total | Common Stock Issued [Member] | Treasury Stock [Member] | Additional Paid in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Income (Loss) [Member] |
Balance at Dec. 31, 2017 | $ 678 | $ 3 | $ (51) | $ 325,516 | $ (324,832) | $ 42 |
Balance (in shares) at Dec. 31, 2017 | 263,305 | (1) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Compensation income for issuance of stock options | (40) | (40) | ||||
Compensation income for issuance of restricted stock | (81) | (81) | ||||
Sale of common stock, net of expenses | 4,210 | $ 6 | 4,204 | |||
Sale of common stock, net of expenses (in shares) | 668,854 | |||||
Fair value of warrants issued | (18,306) | (18,306) | ||||
Net income | 527 | 527 | ||||
Total comprehensive loss | (78) | (78) | ||||
Balance at Jun. 30, 2018 | $ (13,090) | $ 9 | $ (51) | $ 311,293 | $ (324,305) | $ (36) |
Balance (in shares) at Jun. 30, 2018 | 932,159 | (1) |
Condensed Consolidated Stateme7
Condensed Consolidated Statements of Stockholders' Deficit (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2018 | Dec. 31, 2017 |
Statement Of Stockholders Equity [Abstract] | ||
Common stock issued, par value | $ 0.01 | $ 0.01 |
Condensed Consolidated Stateme8
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Cash flows from operating activities: | ||
Net income (loss) | $ 527 | $ (13,276) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock option compensation (income) expense | (40) | 46 |
Restricted stock compensation (income) expense | (81) | 64 |
Depreciation expense | 236 | 127 |
Loss on disposal of equipment | 0 | 20 |
Warrant liability fair value adjustment | (17,209) | (1,200) |
Gain on warrant extinguishment | 0 | (9,613) |
Non-cash interest income | (1) | (1) |
Deferred revenue | 0 | 2 |
Loss on issuance of financial instrument | 2,826 | 0 |
Debt discount amortization | 238 | 15,277 |
Changes in assets and liabilities: | ||
Prepaid expenses and other assets | 318 | 201 |
Accounts receivable | (163) | (94) |
Inventories | 43 | (208) |
Accounts payable and accrued expenses | 3,985 | 628 |
Other non-current liabilities | 44 | (110) |
Net cash used in operating activities | (9,277) | (8,137) |
Cash flows from investing activities: | ||
Purchase of property, plant and equipment | (39) | (276) |
Net cash used in investing activities | (39) | (276) |
Cash flows from financing activities: | ||
Net proceeds from the release of restricted cash | 263 | 5,954 |
Net proceeds from convertible note debt financing | 2,172 | 0 |
Net proceeds from sale of stock | 4,210 | 15 |
Net cash provided by financing activities | 6,645 | 5,969 |
Foreign currency effects on cash and cash equivalents | (45) | (149) |
Net decrease in cash and cash equivalents | (2,716) | (2,593) |
Cash and cash equivalents: | ||
Beginning of period | 3,999 | 4,409 |
End of period | 1,283 | 1,816 |
Supplemental non-cash financing activities: | ||
Conversion of convertible notes | 0 | 15,831 |
Fair value of warrants issued | 23,532 | 0 |
Fair value of warrants exercised | 0 | 19,000 |
Series C Warrants [Member] | ||
Cash flows from financing activities: | ||
Release of restricted cash for extinguishment of Series C Warrants | 0 | 7,876 |
Extinguishment of Series C Warrants | $ 0 | $ (7,876) |
General
General | 6 Months Ended |
Jun. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
General | (1) General The unaudited interim condensed consolidated financial statements of Delcath Systems, Inc. (“Delcath” or the “Company”) as of and for the three and six months ended June 30, 2018 and 2017 should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 (“Annual Report”), which has been filed with the Securities Exchange Commission (“SEC”) on March 16, 2018 and can also be found on the Company’s website (www.delcath.com). In these notes the terms “us”, “we” or “our” refer to Delcath and its consolidated subsidiaries. Description of Business Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. Our investigational product—Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) —is designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects. In Europe, our system is commercially available under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT®), where it has been used at major medical centers to treat a wide range of cancers of the liver. Our primary research focus is on ocular melanoma liver metastases (mOM) and intrahepatic cholangiocarcinoma (ICC), a type of primary liver cancer, and certain other cancers that are metastatic to the liver. We believe the disease states we are investigating represent a multi-billion dollar global market opportunity and a clear unmet medical need. Our clinical development program for CHEMOSAT and Melphalan/HDS is comprised of The FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma (The FOCUS Trial), a Global Phase 3 clinical trial that is investigating overall survival in mOM, and The ALIGN Trial, a registration trial for intrahepatic cholangiocarcinoma (ICC). Our clinical development plan (CDP) also includes a commercial registry for CHEMOSAT non-clinical commercial cases performed in Europe and sponsorship of select investigator initiated trials (IITs) in colorectal cancer metastatic to the liver (mCRC) and pancreatic cancer metastatic to the liver. Liquidity and Operating Matters The accompanying 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. The Company has incurred losses since inception and expects to continue incurring losses for the next several years. These losses, among other factors raises 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. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern. Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form 10-Q and Article 10 of Regulation S-X. They include the accounts of all entities controlled by Delcath and all significant inter-company accounts and transactions have been eliminated in consolidation. The preparation of interim financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements, in the opinion of management, reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended June 30, 2018 and 2017; however, certain information and footnote disclosures normally included in our Annual Report have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period. On May 2, 2018, the Company effected a reverse stock split at which time Delcath’s common stock began trading on the OTCQB on a one-for-five hundred (1:500) split-adjusted basis. All owners of record as of the open of the OTCQB market on May 2, 2018 received one issued and outstanding share of Delcath common stock in exchange for five hundred outstanding shares of Delcath common stock. No fractional shares were issued in connection with the reverse stock split. All fractional shares created by the one-for-five hundred exchange were rounded up to the next whole share. The reverse stock split had no impact on the par value per share of Delcath common stock, which remains at $0.01. All current and prior period amounts related to shares, share prices and earnings per share, presented in the Company’s consolidated financial statements contained in this Annual Report on Form 10-K and the accompanying Notes have been restated to give retrospective presentation for the reverse stock split. Significant Accounting Policies A description of our significant accounting policies has been provided in Note 3 Summary of Significant Accounting Policies Recently Adopted Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”) that updates the principles for recognizing revenue. The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 also amends the required disclosures of the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. On January 1, 2018, the Company adopted ASU 2014-09 using the modified retrospective method and the impact was determined to be immaterial on its consolidated financial statements. The new revenue standard was applied prospectively in Delcath’s condensed consolidated financial statements from January 1, 2018 forward and reported financial information for historical comparable periods will not be revised and will continue to be reported under the accounting standards in effect during those historical periods. Delcath generates revenue from the sales of its product in Europe, where its system is commercially available under the trade name Delcath Hepatic CHEMOSAT Delivery System for Melphalan (“CHEMOSAT®”). Revenue from product sales is generally recognized at the time of shipment to a treating center or distributor, when control of the promised goods has been transferred to our customers. When obligations or contingencies remain after the products are shipped, such as training and certifying new treatment centers, revenue is deferred until the obligations or contingencies are satisfied. Delcath has one distribution contract with a Turkish distributor. The contract has standard provisions for termination, renewal, limited warranty and right of return. CHEMOSAT kits are delivered to the Turkish distributor as orders are received and revenue is recognized at the time of shipment to the distributor. Delcath sells directly to centers in Europe with the exception of those centers located in Turkey. Sales are processed when purchase orders are received from the hospitals and revenue is recognized at the time of shipment to the treating center. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. The new guidance requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Entities will also be required to reconcile such total to amounts on the balance sheet and disclose the nature of the restrictions. ASU 2016-18 is effective for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years, and early adoption is permitted. The Company adopted this standard on January 1, 2018. In June 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230). The new guidance is intended to reduce diversity in practice in how certain transactions are classified in the statement of cash flows. The ASU is effective for public companies for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including interim periods within those fiscal years. An entity that elects early adoption must adopt all of the amendments in the same period. The guidance requires application using a retrospective transition method. The adoption of this standard did not have a material impact on the Company’s financial statements. Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases, which requires entities to report a right-to-use asset and liability for the obligation to make payments for all leases with the exception of those leases with a term of twelve months or less. ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018. The Company intends to adopt this standard on January 1, 2019 and is currently evaluating the impact it may have on its consolidated financial statements. In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260) Distinguishing Liabilities from Equity (Topic 480) Derivatives and Hedging (Topic 815). The new guidance intends to reduce the complexity associated with the issuer’s accounting for certain financial instruments with characteristics of liabilities and equity. Specifically, the Board determined that a down round feature would no longer cause a freestanding equity-linked financial instrument (or an embedded conversion option) to be accounted for as a derivative liability at fair value with changes in fair value recognized in current earnings. In addition, the Board re-characterized the indefinite deferral of certain provisions of Topic 480 to a scope exception. The re-characterization has no accounting effect. ASU 2017-11 is effective for public entities for fiscal years beginning after December 15, 2018. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | (2) Inventories Inventories consist of the following: June 30, December 31, (in thousands) 2018 2017 Raw materials $ 339 $ 298 Work-in-process 755 721 Finished goods 156 229 Total inventories $ 1,250 $ 1,248 |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2018 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses And Other Current Assets | (3) Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following: June 30, December 31, (in thousands) 2018 2017 Insurance premiums $ 168 $ 421 Security deposit 50 50 VAT/GST receivable 37 29 Software 26 15 Financing costs 25 70 Other 1 76 115 Total prepaid expenses and other current assets $ 382 $ 700 1 Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% of prepaid expenses and other current assets at June 30, 2018 and December 31, 2017. |
Property, Plant, and Equipment
Property, Plant, and Equipment | 6 Months Ended |
Jun. 30, 2018 | |
Property Plant And Equipment [Abstract] | |
Property, Plant, and Equipment | (4) Property, Plant, and Equipment Property, plant, and equipment consist of the following: June 30, December 31, (in thousands) 2018 2017 Buildings and land $ 579 $ 579 Enterprise hardware and software 1,743 1,744 Leaseholds 1,702 1,705 Equipment 979 971 Furniture 199 175 Property, plant and equipment, gross 5,202 5,174 Accumulated depreciation (4,103 ) (3,876 ) Property, plant and equipment, net $ 1,099 $ 1,298 Depreciation expense for the three and six months ended June 30, 2018 was approximately $0.1 million and $0.2 million, respectively, as compared to approximately $0.1 million and $0.1 million, respectively, for the same period in 2017. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | (5) Accrued Expenses Accrued expenses consist of the following: June 30, December 31, (in thousands) 2018 2017 Compensation, excluding taxes $ 1,573 $ 869 Clinical trial expenses 2,304 1,124 Professional fees 314 221 Short-term portion of lease restructuring 193 209 Other 1 836 985 Total accrued expenses $ 5,220 $ 3,408 1 Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at June 30, 2018 and December 31, 2017. |
Restructuring Expenses
Restructuring Expenses | 6 Months Ended |
Jun. 30, 2018 | |
Restructuring And Related Activities [Abstract] | |
Restructuring Expenses | (6) Restructuring Expenses In order to help reduce operating costs and more appropriately align its office space with the size of its workforce, the Company entered into two sub-leases for office space at its 810 Seventh Avenue office. On May 22, 2014, the Company entered into a sub-lease agreement (“Sub-lease #1”) for approximately one-half of the office space at this location (“Suite 3500”), resulting in a lease restructuring reserve of approximately $0.9 million. On August 18, 2014, the Company entered into a sub-lease agreement (“Sub-lease #2”) for the remaining one-half of office space at its 810 Seventh Avenue office (“Suite 3505”), resulting in a lease restructuring reserve of approximately $0.7 million. The following table provides the year-to-date activity of the Company’s restructuring reserves as of June 30, 2018: (in thousands) Lease Liability Reserve balance at December 31, 2017 $ 604 Charges — Payments/Utilizations (109 ) Reserve balance at June 30, 2018 $ 495 |
Secured Convertible Notes Payab
Secured Convertible Notes Payable and Common Stock Purchase Warrants | 6 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Secured Convertible Notes Payable and Common Stock Purchase Warrants | (7) Secured Convertible Notes Payable and Common Stock Purchase Warrants On June 4, 2018, the Company entered into a Securities Purchase Agreement (the “SPA”) with an institutional investor pursuant to which the Company issued $3.3 million in principal face amount of senior secured convertible notes of the Company (the “Notes”) and related Series D Warrants (the “Series D Warrants”) to purchase additional shares of the Company’s common stock (“Common Stock”). Notes in the amount of $3.3 million were issued for cash proceeds of $2.4 million with an original issue discount in the amount of $1.1 million. The Notes are secured pursuant to a Security Agreement which creates 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. The Notes bear 8% interest payable quarterly in cash. Of the $3.3 million in issued Notes, $2.5 million matures in six months; the balance of $0.8 million is payable in twelve installments beginning seven (7) months after the original issuance date. Each payment shall be paid in cash or, provided that the Market Price (as defined in the SPA) is at least the conversion price of $3.00, at the option of the Company, upon ten (10) Trading Days’ written notice to the Holder, in free trading Common Stock at the conversion price. In connection with the issuance of the Notes under the SPA, the Company also issued Series D Warrants. Warrant D-1 is exercisable to acquire 1.1 million shares of Common Stock at an initial exercise price of $4.00. Warrants D-2 101-113 are exercisable to acquire 13.0 million shares of Common Stock at a pre-funded exercise price of $0.01. The Company may buy back each D-2 Warrant on its date of initial exercisability so long as the Company is not in default and the applicable installment payment for each month commencing on January 4, 2019 through December 4, 2019 has been paid when due. In the event that Delcath’s Market Price (as defined in the Note Agreement) is less than $3.00, the Company can only purchase back these warrants if the Notes payable are settled for cash. The Company valued the Series D Warrants using the following inputs: Warrant D-1 Warrant D-2 Expected life (in years) 5.0 5.5 - 6.5 Expected volatility 194.10% 215.0% - 389.0% Risk-free interest rates 2.78% 2.13% - 2.30% The Company recognized a discount to debt of $2.3 million and additional expense of $2.8 million was recognized as a Loss on issuance of a financial instrument related to the initial fair value of the Series D Warrants. The D-1 Warrants have a five-year term; the D-2 Warrants have a five-year term from initial exercisability which begins on the fifth day of each month commencing December 5, 2018, through December 5, 2019, for each of Warrant D-2-101 through 113 respectively. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2018 | |
Stockholders Equity Note [Abstract] | |
Stockholders' Equity | (8 ) Stockholders’ Equity Stock Issuances Reverse Stock Split On May 2, 2018, the Company effected a reverse stock split at which time Delcath’s common stock began trading on the OTCQB on a one-for-five hundred (1:500) split-adjusted basis. All owners of record as of the open of the OTCQB market on May 2, 2018 received one issued and outstanding share of Delcath common stock in exchange for five hundred outstanding shares of Delcath common stock. No fractional shares were issued in connected with the reverse stock split. All fractional shares created by the one-for-five hundred exchange were rounded up to the next whole share. The reverse stock split had no impact on the par value per share of Delcath common stock, which remains at $0.01. All current and prior period amounts related to shares, share prices and earnings per share, presented in the Company’s consolidated financial statements contained in this Quarterly Report on Form 10-Q and the accompanying Notes have been restated to give retrospective presentation for the reverse stock split. February 2018 Financing In February 2018, the Company completed the sale of 424,000 shares of its common stock, 76,000 pre-funded warrants and the issuance of warrants to purchase 1.0 million 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 June 30, 2018, the February 2018 Warrants were exercisable at $10.00 per share with 1.0 million 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 $10.00; 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. Stock Incentive Plans As a result of the May 2, 2018 reverse stock split, the Company’s Stock Incentive Plans has no active grants and no further shares available to be granted. For the three and six months ended June 30, 2018, the Company recognized compensation income of $47,000 and $40,000 relating to stock options granted to employees. For the same period in 2017, the Company recognized compensation expense of approximately $24,000 and $46,000 respectively. For the three and six months ended June 30, 2018, the Company recognized compensation income of $94,000 and $81,000 relating to restricted stock granted to employees. For the same period in 2017, the Company recognized compensation expense of approximately $6,000 and $100,000, respectively. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | (9 ) Fair Value Measurements Derivative Warrant Liability For the three and six months ended June 30, 2018, the Company recorded derivative warrant expense of $2.5 million and $17.2 million, respectively. The resulting derivative warrant liabilities totaled $6.9 million at June 30, 2018. Management expects that the Warrants will either be exercised or expire worthless. The fair value of the Warrants at June 30, 2018 and December 31, 2017 was determined by using option pricing models with the following assumptions: June 30, December 31, 2018 2017 Expected life (in years) 0.33 - 6.40 0.82 - 4.88 Expected volatility 132.69% - 372.0% 130.88% - 266.92% Risk-free interest rates 1.99% - 2.92% 1.68% - 2.06% The table below presents the Company’s assets and liabilities measured at fair value on a recurring basis as of June 30, 2018, aggregated by the level in the fair value hierarchy within which those measurements fall in accordance with ASC 820. Assets and Liabilities Measured at Fair Value on a Recurring Basis (in thousands) Level 1 Level 2 Level 3 Balance at June 30, 2018 Liabilities Derivative instrument liabilities $ — $ — $ 6,883 $ 6,883 For the periods ended June 30, 2018 and 2017, there were no transfers in or out of Level 1, 2 or 3 inputs. The table below presents the activity within Level 3 of the fair value hierarchy for the six months ended June 30, 2018: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at December 31, 2017 $ 560 Fair value of warrants issued 23,532 Fair value of warrants exercised — Total change in the liability included in earnings (17,209 ) Balance at June 30, 2018 $ 6,883 |
Net Loss per Common Share
Net Loss per Common Share | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss per Common Share | (10 ) 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. 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. June 30, (in thousands, except share data) 2018 2017 Net income (loss) - basic $ 527 $ (13,276 ) Adjustment for gain on warrant income (619 ) — Net loss - diluted $ (92 ) $ (13,276 ) Weighted average shares outstanding - basic 788,512 848 Weighted average shares outstanding - diluted 799,430 848 Net income (loss) per share - basic $ 0.67 $ (15,656 ) Net income (loss) per share - diluted $ (0.12 ) $ (15,656 ) The following potentially dilutive securities were excluded from the computation of earnings per share as of June 30, 2018 and 2017 because their effects would be anti-dilutive: June 30, June 30, 2018 2017 Stock options — 55,846 Unvested restricted shares — 101,294 Warrants 2,116,296 36,848 Assumed conversion of convertible notes 1,116,255 — Total 3,232,551 193,988 |
Taxes
Taxes | 6 Months Ended |
Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Taxes | (11 ) Taxes As discussed in Note 13 Income Taxes The Company is subject to income tax in the U.S., as well as various state and international jurisdictions. During the third quarter of 2015, the Internal Revenue Service commenced an examination of the Company’s federal income tax return for the year ended December 31, 2013. The examination was completed in the third quarter of 2017 and no changes were made to the reported amounts. Accordingly, there was no effect on the financial statements as a result of the examination. 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. Additional information regarding the statutes of limitations can be found in Note 13 Income Taxes On December 22, 2017, the 2017 Tax Cuts and Jobs Act (the Tax Act) was enacted into law and the new legislation contains several key tax provisions that affected us, including a one-time mandatory transition tax on accumulated foreign earnings and a reduction of the corporate income tax rate to 21% effective January 1, 2018, among others. We were required to recognize the effect of the tax law changes in the period of enactment, such as determining the transition tax, remeasuring our U.S. deferred tax assets and liabilities as well as reassessing the net realizability of our deferred tax assets and liabilities. In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (SAB 118), which allows us to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. Since the Tax Act was passed late in the fourth quarter of 2017, and ongoing guidance and accounting interpretation are expected over the next 12 months, we consider the accounting of deferred tax re-measurements and the transition tax to be incomplete due to the forthcoming guidance and our ongoing analysis of final year-end data and tax positions. As of June 30, 2018, a SAB 118 measurement period adjustment has not been recorded, as the Company is continuing to assess the impact from the Tax Act and will record adjustments in 2018 if necessary. In October 2016, the Financial Accounting Standards Board ("FASB") issued accounting standards update 2016-16 which simplifies the income tax consequences of intra-entity transfers other than inventory. Prior to ASU 2016-16, GAAP prohibited the recognition of current and deferred income taxes for intra-entity asset transfers until the asset has been sold to an outside party. ASU 2016-16 eliminates this prohibition for intra-entity transfers of assets other than inventory but retain the prohibition for intra-entity transfers of inventory. This standard is effective for public entities for fiscal years beginning after December 15, 2017. The Company adopted ASU 2016-16, effective on January 1, 2018. As a result of adoption, the Company recognized a $834 decrease to its net operating loss deferred tax assets, offset by a $834 decrease to the corresponding valuation allowance. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | (12 ) Subsequent Events Additional Secured Convertible Note On July 20, 2018, the Company entered into a Securities Purchase Agreement with Discover Growth Fund, LLC for the remaining Notes and Warrants in proportionate amounts to those issued in the June 4, 2018 transaction which is discussed in Note 7, in a transaction exempt from registration pursuant to Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder, and received gross proceeds of $1,600,000. Warrant Amendments On July 20, 2018, the Company and Discover Growth Fund amended the June 4, 2018 Securities Purchase Agreement to delay the Company’s registration obligation, and amended the Warrants issued thereunder so that they are exercisable as of the amendment date and the Company may redeem them at any time the Notes are no longer outstanding as well as to amend the Fundamental Transaction clause in each which result in the Series D Warrants no longer being treated as a liability as of the date of the amendment. Litigation On July 27, 2018, Hudson Bay Master Fund Ltd. filed a summons and complaint against the Company in the New York State Supreme Court, New York County (the “Suit”). The Suit alleges breaches by the Company of Hudson Bay’s rights of participation in future Company offerings granted in the September 2017 Securities Purchase Agreement between the Company and Hudson Bay and in the February 2018 Securities Purchase Agreement among, inter alia Rights Offering On August 3, 2018, our registration statement on Form S-1 was declared effective by the SEC. Pursuant to our rights offering, we have distributed to holders of our common stock, and holders of certain of our instruments convertible or exchangeable into our common stock, on an as converted basis, non-transferrable subscription rights (500 shares per right) to purchase up to an aggregate of 28,571,429 shares of our common stock. Holders of our common stock will receive one subscription right for each share of common stock owned and holders of certain of our instruments convertible or exchangeable into our common stock will receive one subscription right for each share of common stock they would own upon full conversion of certain of our instruments convertible or exercisable into our common stock owned and settled by, 4:00 p.m., New York City time, on August 3, 2018; provided, that, the rights may only be exercised for a maximum of the lesser of 28,571,429 shares or $50.0 million of subscription proceeds. |
General (Policies)
General (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Liquidity and Operating Matters | Liquidity and Operating Matters The accompanying 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. The Company has incurred losses since inception and expects to continue incurring losses for the next several years. These losses, among other factors raises 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. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. The accompanying statements do not include any adjustments that might result should the Company be unable to continue as a going concern. |
Basis of Presentation | Basis of Presentation These interim condensed consolidated financial statements are unaudited and were prepared by the Company in accordance with generally accepted accounting principles in the United States of America (GAAP) and with the SEC’s instructions to Form 10-Q and Article 10 of Regulation S-X. They include the accounts of all entities controlled by Delcath and all significant inter-company accounts and transactions have been eliminated in consolidation. The preparation of interim financial statements requires management to make assumptions and estimates that impact the amounts reported. These interim condensed consolidated financial statements, in the opinion of management, reflect all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the Company’s results of operations, financial position and cash flows for the interim periods ended June 30, 2018 and 2017; however, certain information and footnote disclosures normally included in our Annual Report have been condensed or omitted as permitted by GAAP. It is important to note that the Company’s results of operations and cash flows for interim periods are not necessarily indicative of the results of operations and cash flows to be expected for a full fiscal year or any interim period. On May 2, 2018, the Company effected a reverse stock split at which time Delcath’s common stock began trading on the OTCQB on a one-for-five hundred (1:500) split-adjusted basis. All owners of record as of the open of the OTCQB market on May 2, 2018 received one issued and outstanding share of Delcath common stock in exchange for five hundred outstanding shares of Delcath common stock. No fractional shares were issued in connection with the reverse stock split. All fractional shares created by the one-for-five hundred exchange were rounded up to the next whole share. The reverse stock split had no impact on the par value per share of Delcath common stock, which remains at $0.01. All current and prior period amounts related to shares, share prices and earnings per share, presented in the Company’s consolidated financial statements contained in this Annual Report on Form 10-K and the accompanying Notes have been restated to give retrospective presentation for the reverse stock split. |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update 2014-09, Revenue from Contracts with Customers (“ASU 2014-09”) that updates the principles for recognizing revenue. The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 also amends the required disclosures of the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. On January 1, 2018, the Company adopted ASU 2014-09 using the modified retrospective method and the impact was determined to be immaterial on its consolidated financial statements. The new revenue standard was applied prospectively in Delcath’s condensed consolidated financial statements from January 1, 2018 forward and reported financial information for historical comparable periods will not be revised and will continue to be reported under the accounting standards in effect during those historical periods. Delcath generates revenue from the sales of its product in Europe, where its system is commercially available under the trade name Delcath Hepatic CHEMOSAT Delivery System for Melphalan (“CHEMOSAT®”). Revenue from product sales is generally recognized at the time of shipment to a treating center or distributor, when control of the promised goods has been transferred to our customers. When obligations or contingencies remain after the products are shipped, such as training and certifying new treatment centers, revenue is deferred until the obligations or contingencies are satisfied. Delcath has one distribution contract with a Turkish distributor. The contract has standard provisions for termination, renewal, limited warranty and right of return. CHEMOSAT kits are delivered to the Turkish distributor as orders are received and revenue is recognized at the time of shipment to the distributor. Delcath sells directly to centers in Europe with the exception of those centers located in Turkey. Sales are processed when purchase orders are received from the hospitals and revenue is recognized at the time of shipment to the treating center. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. The new guidance requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Entities will also be required to reconcile such total to amounts on the balance sheet and disclose the nature of the restrictions. ASU 2016-18 is effective for fiscal years beginning after December 15, 2017 and interim periods within those fiscal years, and early adoption is permitted. The Company adopted this standard on January 1, 2018. In June 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230). The new guidance is intended to reduce diversity in practice in how certain transactions are classified in the statement of cash flows. The ASU is effective for public companies for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including interim periods within those fiscal years. An entity that elects early adoption must adopt all of the amendments in the same period. The guidance requires application using a retrospective transition method. The adoption of this standard did not have a material impact on the Company’s financial statements. Recently Issued Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases, which requires entities to report a right-to-use asset and liability for the obligation to make payments for all leases with the exception of those leases with a term of twelve months or less. ASU 2016-02 is effective for annual reporting periods beginning after December 15, 2018. The Company intends to adopt this standard on January 1, 2019 and is currently evaluating the impact it may have on its consolidated financial statements. In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260) Distinguishing Liabilities from Equity (Topic 480) Derivatives and Hedging (Topic 815). The new guidance intends to reduce the complexity associated with the issuer’s accounting for certain financial instruments with characteristics of liabilities and equity. Specifically, the Board determined that a down round feature would no longer cause a freestanding equity-linked financial instrument (or an embedded conversion option) to be accounted for as a derivative liability at fair value with changes in fair value recognized in current earnings. In addition, the Board re-characterized the indefinite deferral of certain provisions of Topic 480 to a scope exception. The re-characterization has no accounting effect. ASU 2017-11 is effective for public entities for fiscal years beginning after December 15, 2018. |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of inventories | Inventories consist of the following: June 30, December 31, (in thousands) 2018 2017 Raw materials $ 339 $ 298 Work-in-process 755 721 Finished goods 156 229 Total inventories $ 1,250 $ 1,248 |
Prepaid Expenses and Other Cu23
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following: June 30, December 31, (in thousands) 2018 2017 Insurance premiums $ 168 $ 421 Security deposit 50 50 VAT/GST receivable 37 29 Software 26 15 Financing costs 25 70 Other 1 76 115 Total prepaid expenses and other current assets $ 382 $ 700 1 Other consists of various prepaid expenses and other current assets, with no individual item accounting for more than 5% of prepaid expenses and other current assets at June 30, 2018 and December 31, 2017. |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Property Plant And Equipment [Abstract] | |
Components of property, plant and equipment | Property, plant, and equipment consist of the following: June 30, December 31, (in thousands) 2018 2017 Buildings and land $ 579 $ 579 Enterprise hardware and software 1,743 1,744 Leaseholds 1,702 1,705 Equipment 979 971 Furniture 199 175 Property, plant and equipment, gross 5,202 5,174 Accumulated depreciation (4,103 ) (3,876 ) Property, plant and equipment, net $ 1,099 $ 1,298 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses consist of the following: June 30, December 31, (in thousands) 2018 2017 Compensation, excluding taxes $ 1,573 $ 869 Clinical trial expenses 2,304 1,124 Professional fees 314 221 Short-term portion of lease restructuring 193 209 Other 1 836 985 Total accrued expenses $ 5,220 $ 3,408 1 Other consists of various accrued expenses, with no individual item accounting for more than 5% of current liabilities at June 30, 2018 and December 31, 2017. |
Restructuring Expenses (Tables)
Restructuring Expenses (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Restructuring And Related Activities [Abstract] | |
Schedule of restructuring and related costs | The following table provides the year-to-date activity of the Company’s restructuring reserves as of June 30, 2018: (in thousands) Lease Liability Reserve balance at December 31, 2017 $ 604 Charges — Payments/Utilizations (109 ) Reserve balance at June 30, 2018 $ 495 |
Secured Convertible Notes Pay27
Secured Convertible Notes Payable and Common Stock Purchase Warrants (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Inputs Used to Value the Series D Warrants | The Company valued the Series D Warrants using the following inputs: Warrant D-1 Warrant D-2 Expected life (in years) 5.0 5.5 - 6.5 Expected volatility 194.10% 215.0% - 389.0% Risk-free interest rates 2.78% 2.13% - 2.30% |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of fair value of the warrants | The fair value of the Warrants at June 30, 2018 and December 31, 2017 was determined by using option pricing models with the following assumptions: June 30, December 31, 2018 2017 Expected life (in years) 0.33 - 6.40 0.82 - 4.88 Expected volatility 132.69% - 372.0% 130.88% - 266.92% Risk-free interest rates 1.99% - 2.92% 1.68% - 2.06% |
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 June 30, 2018, aggregated by the level in the fair value hierarchy within which those measurements fall in accordance with ASC 820. Assets and Liabilities Measured at Fair Value on a Recurring Basis (in thousands) Level 1 Level 2 Level 3 Balance at June 30, 2018 Liabilities Derivative instrument liabilities $ — $ — $ 6,883 $ 6,883 |
Fair value measurements using significant unobservable inputs | The table below presents the activity within Level 3 of the fair value hierarchy for the six months ended June 30, 2018: Fair Value Measurements Using Significant Unobservable Inputs (Level 3) (in thousands) Warrant Liability Balance at December 31, 2017 $ 560 Fair value of warrants issued 23,532 Fair value of warrants exercised — Total change in the liability included in earnings (17,209 ) Balance at June 30, 2018 $ 6,883 |
Net Loss per Common Share (Tabl
Net Loss per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Earnings Per Share [Abstract] | |
Calculation of net loss and number of shares used to compute basic and diluted earnings per 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. 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. June 30, (in thousands, except share data) 2018 2017 Net income (loss) - basic $ 527 $ (13,276 ) Adjustment for gain on warrant income (619 ) — Net loss - diluted $ (92 ) $ (13,276 ) Weighted average shares outstanding - basic 788,512 848 Weighted average shares outstanding - diluted 799,430 848 Net income (loss) per share - basic $ 0.67 $ (15,656 ) Net income (loss) per share - diluted $ (0.12 ) $ (15,656 ) |
Anti-dilutive securities excluded from the computation of earnings per share | The following potentially dilutive securities were excluded from the computation of earnings per share as of June 30, 2018 and 2017 because their effects would be anti-dilutive: June 30, June 30, 2018 2017 Stock options — 55,846 Unvested restricted shares — 101,294 Warrants 2,116,296 36,848 Assumed conversion of convertible notes 1,116,255 — Total 3,232,551 193,988 |
General - Additional Informatio
General - Additional Information (Details) | May 02, 2018$ / sharesshares | Nov. 06, 2017 | Jun. 30, 2018Contract$ / shares | Dec. 31, 2017$ / shares |
Class Of Stock [Line Items] | ||||
Reverse stock split | 1:500 | 1:350 | ||
Reverse stock split ratio | 0.002 | 0.0029 | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||
Number of distribution contracts with Turkish distributor | Contract | 1 | |||
OTCQB [Member] | ||||
Class Of Stock [Line Items] | ||||
Reverse stock split | 1:500 | |||
Reverse stock split ratio | 0.002 | |||
Number of fractional shares were issued in connection with the reverse stock split | shares | 0 | |||
Common stock, par value (in dollars per share) | $ 0.01 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 339 | $ 298 |
Work-in-process | 755 | 721 |
Finished goods | 156 | 229 |
Total inventories | $ 1,250 | $ 1,248 |
Prepaid Expenses and Other Cu32
Prepaid Expenses and Other Current Assets - Schedule of Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Insurance premiums | $ 168 | $ 421 |
Security deposit | 50 | 50 |
VAT/GST receivable | 37 | 29 |
Software | 26 | 15 |
Financing costs | 25 | 70 |
Other | 76 | 115 |
Total prepaid expenses and other current assets | $ 382 | $ 700 |
Prepaid Expenses and Other Cu33
Prepaid Expenses and Other Current Assets - Additional Information (Details) | Jun. 30, 2018 | Dec. 31, 2017 |
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 Equipmen34
Property, Plant, and Equipment - Components of Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 5,202 | $ 5,174 |
Accumulated depreciation | (4,103) | (3,876) |
Property, plant and equipment, net | 1,099 | 1,298 |
Buildings and Land [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 579 | 579 |
Enterprise Hardware and Software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,743 | 1,744 |
Leaseholds [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 1,702 | 1,705 |
Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | 979 | 971 |
Furniture [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property, plant and equipment, gross | $ 199 | $ 175 |
Property, Plant, and Equipmen35
Property, Plant, and Equipment - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Property Plant And Equipment [Abstract] | ||||
Depreciation expense | $ 100 | $ 100 | $ 236 | $ 127 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Compensation, excluding taxes | $ 1,573 | $ 869 |
Clinical trial expenses | 2,304 | 1,124 |
Professional fees | 314 | 221 |
Short-term portion of lease restructuring | 193 | 209 |
Other | 836 | 985 |
Total accrued expenses | $ 5,220 | $ 3,408 |
Accrued Expenses - Schedule o37
Accrued Expenses - Schedule of Accrued Expenses (Parenthetical) (Details) | Jun. 30, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Maximum percentage of current liabilities accrued (in hundredths) | 5.00% | 5.00% |
Restructuring Expenses - Additi
Restructuring Expenses - Additional Information (Details) $ in Millions | Aug. 18, 2014USD ($) | May 22, 2014USD ($) | Jun. 30, 2018Lease |
Property Subject to Operating Lease [Member] | |||
Restructuring Cost And Reserve [Line Items] | |||
Number of sub leases | Lease | 2 | ||
Sub-lease 1 [Member] | Facility Closing [Member] | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring reserve charges | $ 0.9 | ||
Sub Lease 2 [Member] | Facility Closing [Member] | |||
Restructuring Cost And Reserve [Line Items] | |||
Restructuring reserve charges | $ 0.7 |
Restructuring Expenses - Schedu
Restructuring Expenses - Schedule of Restructuring and Related Costs (Details) - Lease Liability [Member] $ in Thousands | 6 Months Ended |
Jun. 30, 2018USD ($) | |
Restructuring Cost And Reserve [Line Items] | |
Restructuring reserve balance | $ 604 |
Payments/Utilizations | (109) |
Restructuring reserve balance | $ 495 |
Secured Convertible Notes Pay40
Secured Convertible Notes Payable and Common Stock Purchase Warrants - Additional Information (Detail) - USD ($) $ / shares in Units, shares in Millions | Jun. 04, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 |
Debt Instrument [Line Items] | |||||
Loss on issuance of financial instrument | $ 2,826,000 | $ 0 | $ 2,826,000 | $ 0 | |
Series D Warrants [Member] | Securities Purchase Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt discount on senior notes | $ 2,300,000 | ||||
Loss on issuance of financial instrument | $ 2,800,000 | ||||
Series D-1 Warrants [Member] | Securities Purchase Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Shares issuable upon warrants exercised | 1.1 | ||||
Exercise price of warrants | $ 4 | ||||
Warrants term | 5 years | ||||
Series D-2 [101-113] Warrants [Member] | Securities Purchase Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Shares issuable upon warrants exercised | 13 | ||||
Exercise price of warrants | $ 0.01 | ||||
Buy back of warrants, description | The Company may buy back each D-2 Warrant on its date of initial exercisability so long as the Company is not in default and the applicable installment payment for each month commencing on January 4, 2019 through December 4, 2019 has been paid when due. | ||||
Warrants term | 5 years | ||||
Warrants exercisable, description | D-2 Warrants have a five-year term from initial exercisability which begins on the fifth day of each month commencing December 5, 2018, through December 5, 2019, for each of Warrant D-2-101 through 113 respectively. | ||||
Warrants exercisable, start date | Dec. 5, 2018 | ||||
Warrants exercisable, end date | Dec. 5, 2019 | ||||
Senior Secured Convertible Notes [Member] | Securities Purchase Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Interest rate | 8.00% | ||||
Notes payable terms | The Notes bear 8% interest payable quarterly in cash. Of the $3.3 million in issued Notes, $2.5 million matures in six months; the balance of $0.8 million is payable in twelve installments beginning seven (7) months after the original issuance date. | ||||
Debt instrument, conversion price | $ 3 | ||||
Maximum required market price of common shares, to settle notes payable in cash | $ 3 | ||||
Senior Secured Convertible Notes [Member] | Securities Purchase Agreement [Member] | Matures in Six Months [Member] | |||||
Debt Instrument [Line Items] | |||||
Notes payable maturity amount | $ 2,500,000 | ||||
Senior Secured Convertible Notes [Member] | Securities Purchase Agreement [Member] | Payable in Twelve Installments Beginning Seven Months After Original Issuance Date [Member] | |||||
Debt Instrument [Line Items] | |||||
Notes payable maturity amount | 800,000 | ||||
Senior Secured Convertible Notes [Member] | Series D Warrants [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, principal face amount | 3,300,000 | ||||
Senior Secured Convertible Notes [Member] | Series D Warrants [Member] | Securities Purchase Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Proceeds from issuance of notes and warrants | 2,400,000 | ||||
Debt discount on senior notes | $ 1,100,000 |
Secured Convertible Notes Pay41
Secured Convertible Notes Payable and Common Stock Purchase Warrants - Schedule of Inputs Used to Value the Series D Warrants (Detail) | Jun. 30, 2018 | Dec. 31, 2017 |
Expected Life [Member] | Minimum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Expected life (in years) | 3 months 29 days | 9 months 25 days |
Expected Life [Member] | Maximum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Expected life (in years) | 6 years 4 months 24 days | 4 years 10 months 17 days |
Expected Life [Member] | Warrant D-1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Expected life (in years) | 5 years | |
Expected Life [Member] | Warrant D-2 [Member] | Minimum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Expected life (in years) | 5 years 6 months | |
Expected Life [Member] | Warrant D-2 [Member] | Maximum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Expected life (in years) | 6 years 6 months | |
Expected Volatility [Member] | Minimum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 1.3269 | 1.3088 |
Expected Volatility [Member] | Maximum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 3.720 | 2.6692 |
Expected Volatility [Member] | Warrant D-1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 1.9410 | |
Expected Volatility [Member] | Warrant D-2 [Member] | Minimum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 2.150 | |
Expected Volatility [Member] | Warrant D-2 [Member] | Maximum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 3.890 | |
Risk-free Interest Rates [Member] | Minimum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 0.0199 | 0.0168 |
Risk-free Interest Rates [Member] | Maximum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 0.0292 | 0.0206 |
Risk-free Interest Rates [Member] | Warrant D-1 [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 0.0278 | |
Risk-free Interest Rates [Member] | Warrant D-2 [Member] | Minimum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 0.0213 | |
Risk-free Interest Rates [Member] | Warrant D-2 [Member] | Maximum [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Warrants measurement input | 0.0230 |
Stockholders' Equity - Reverse
Stockholders' Equity - Reverse Stock Split - Additional Information (Details) | May 02, 2018$ / sharesshares | Nov. 06, 2017 | Jun. 30, 2018$ / shares | Dec. 31, 2017$ / shares |
Stockholders Equity Note [Line Items] | ||||
Reverse stock split | 1:500 | 1:350 | ||
Reverse stock split ratio | 0.002 | 0.0029 | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | ||
OTCQB [Member] | ||||
Stockholders Equity Note [Line Items] | ||||
Reverse stock split | 1:500 | |||
Reverse stock split ratio | 0.002 | |||
Number of fractional shares were issued in connected with the reverse stock split | shares | 0 | |||
Common stock, par value (in dollars per share) | $ 0.01 |
Stockholders' Equity - February
Stockholders' Equity - February 2018 Financing - Additional Information (Details) $ / shares in Units, $ in Millions | 1 Months Ended | |
Feb. 28, 2018USD ($)$ / sharesshares | Jun. 30, 2018$ / sharesshares | |
Stockholders Equity Note [Line Items] | ||
Sale of common stock, net of expenses (in shares) | 424,000 | |
Number of pre-funded warrants | 76,000 | |
Net proceeds from issuance of private placement | $ | $ 4.3 | |
February 2018 Warrants [Member] | ||
Stockholders Equity Note [Line Items] | ||
Warrants issued to purchase Common Stock | 1,000,000 | |
Value of warrants issued | $ | $ 18.3 | |
Warrants exercisable per share price (in dollars per share) | $ / shares | $ 10 | |
Number of warrants outstanding (in shares) | 1,000,000 | |
February 2018 Warrants [Member] | Exercise Price [Member] | ||
Stockholders Equity Note [Line Items] | ||
Warrants measurement input | $ / shares | 10 | |
February 2018 Warrants [Member] | Contractual Term [Member] | ||
Stockholders Equity Note [Line Items] | ||
Warrants term | 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 |
Stockholders' Equity - Stock In
Stockholders' Equity - Stock Incentive Plans - Additional Information (Details) - USD ($) | May 02, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock options granted | 0 | ||||
Shares available for grant | 0 | ||||
Stock option compensation (income) expense | $ (40,000) | $ 46,000 | |||
Restricted stock compensation (income) expense | (81,000) | 64,000 | |||
Stock Options [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Stock option compensation (income) expense | $ (47,000) | $ 24,000 | (40,000) | 46,000 | |
Restricted Stock [Member] | |||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||
Restricted stock compensation (income) expense | $ (94,000) | $ 6,000 | $ (81,000) | $ 100,000 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Derivative warrant liability [Abstract] | ||||
Change in fair value of the warrant liability, net | $ 2,513 | $ (38) | $ 17,209 | $ 1,200 |
Derivative warrant liabilities | $ 6,900 | $ 6,900 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Fair Value of Warrants (Details) | Jun. 30, 2018 | Dec. 31, 2017 |
Minimum [Member] | Expected Life [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants term | 3 months 29 days | 9 months 25 days |
Minimum [Member] | Expected Volatility [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 1.3269 | 1.3088 |
Minimum [Member] | Risk-free Interest Rates [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 0.0199 | 0.0168 |
Maximum [Member] | Expected Life [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants term | 6 years 4 months 24 days | 4 years 10 months 17 days |
Maximum [Member] | Expected Volatility [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 3.720 | 2.6692 |
Maximum [Member] | Risk-free Interest Rates [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Warrants measurement input | 0.0292 | 0.0206 |
Fair Value Measurements - Asset
Fair Value Measurements - Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Derivative Instruments Liabilities [Member] - Recurring [Member] $ in Thousands | Jun. 30, 2018USD ($) |
Liabilities [Abstract] | |
Total Liabilities | $ 6,883 |
Level 3 [Member] | |
Liabilities [Abstract] | |
Total Liabilities | $ 6,883 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Measurements Using Significant Unobservable Inputs (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Fair Value Measurements Using Significant Unobservable Inputs (Level 3) [Roll Forward] | ||
Beginning balance | $ 560 | |
Fair value of warrants issued | 23,532 | $ 0 |
Fair value of warrants exercised | 0 | $ (19,000) |
Total change in the liability included in earnings | (17,209) | |
Ending balance | $ 6,883 |
Net Loss per Common Share - Cal
Net Loss per Common Share - Calculation of Net Loss and Number of Shares Used to Compute Basic and Diluted Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | ||
Earnings Per Share [Abstract] | |||||
Net income (loss) - basic | $ 527 | $ (13,276) | |||
Adjustment for gain on warrant income | (619) | ||||
Net loss - diluted | $ (92) | $ (13,276) | |||
Weighted average shares outstanding - basic | [1] | 916,706 | 1,416 | 788,512 | 848 |
Weighted average shares outstanding - diluted | [1] | 916,706 | 1,416 | 799,430 | 848 |
Net income (loss) per share - basic | [1] | $ (7.26) | $ (1,373) | $ 0.67 | $ (15,656) |
Net income (loss) per share - diluted | [1] | $ (7.26) | $ (1,373) | $ (0.12) | $ (15,656) |
[1] | reflects a one-for-three hundred and fifty (1:350) reverse stock split effected on November 6, 2017 and a one-for-five hundred (1:500) reverse stock split effected on May 2, 2018. |
Net Loss per Common Share - Ant
Net Loss per Common Share - Anti-Dilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 3,232,551 | 193,988 |
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) | 55,846 | |
Unvested Restricted Shares [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 101,294 | |
Warrants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of earnings per share (in shares) | 2,116,296 | 36,848 |
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) | 1,116,255 |
Taxes - Additional Information
Taxes - Additional Information (Details) | 6 Months Ended |
Jun. 30, 2018USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Reduction in corporate income tax rate | 21.00% |
Tax Cuts and Jobs Act, accounting complete | false |
ASU 2016-16 [Member] | |
Operating Loss Carryforwards [Line Items] | |
Decrease in net operating loss deferred tax assets | $ 834 |
Decrease in deferred tax assets valuation allowance | $ 834 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event [Member] | Aug. 03, 2018USD ($)SubscriptionRightshares | Jul. 27, 2018USD ($) | Jul. 20, 2018USD ($) |
Subsequent Event [Line Items] | |||
Maximum number of shares of common stock available to purchase under subscription right issue | shares | 28,571,429 | ||
Number of shares into which each right may be converted under subscription rights | shares | 500 | ||
Number of non-transferable subscription rights for each shares of common stock owned | SubscriptionRight | 1 | ||
Number of non-transferable subscription rights for each shares of common stock would own upon conversion of convertible instrument | SubscriptionRight | 1 | ||
Subscriptions proceeds | $ 50,000,000 | ||
Discover Growth Fund LLC [Member] | Securities Purchase Agreement [Member] | Additional Secured Convertible Note [Member] | |||
Subsequent Event [Line Items] | |||
Gross proceeds from issuance of notes and warrants | $ 1,600,000 | ||
Hudson Bay [Member] | Securities Purchase Agreement [Member] | Minimum [Member] | |||
Subsequent Event [Line Items] | |||
Claims for monetary damages | $ 1,000,000 |