Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 28, 2020 | Jun. 30, 2019 | |
Cover [Abstract] | |||
Entity Registrant Name | CHF Solutions, Inc. | ||
Entity Central Index Key | 0001506492 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Shell Company | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Public Float | $ 8.3 | ||
Entity Common Stock, Shares Outstanding | 20,806,978 | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Address, State or Province | MN |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets | ||
Cash and cash equivalents | $ 1,279 | $ 5,480 |
Accounts receivable | 799 | 786 |
Inventories | 1,797 | 1,658 |
Other current assets | 161 | 203 |
Total current assets | 4,036 | 8,127 |
Property, plant and equipment, net | 991 | 536 |
Operating lease right-of-use asset, net | 442 | 0 |
Other assets | 133 | 113 |
TOTAL ASSETS | 5,602 | 8,776 |
Current liabilities | ||
Accounts payable | 1,488 | 1,133 |
Accrued compensation | 1,592 | 1,498 |
Current portion of operating lease liability | 186 | 0 |
Other current liabilities | 85 | 209 |
Total current liabilities | 3,351 | 2,840 |
Operating lease liability | 261 | 0 |
Total liabilities | 3,612 | 2,840 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of December 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 4,674,068 and 513,445, respectively | 0 | 0 |
Additional paid-in capital | 218,278 | 204,101 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | 1,214 | 1,223 |
Accumulated deficit | (217,502) | (199,388) |
Total stockholders' equity | 1,990 | 5,936 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 5,602 | 8,776 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | $ 0 | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,969,465 | 39,969,465 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 4,674,068 | 513,445 |
Common stock, shares outstanding (in shares) | 4,674,068 | 513,445 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 30,000 | 30,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 535 | 535 |
Preferred stock, shares issued (in shares) | 535 | 535 |
Preferred stock, shares outstanding (in shares) | 535 | 535 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||
Net sales | $ 5,511 | $ 4,998 |
Costs and Expenses: | ||
Cost of goods sold | 2,660 | 3,670 |
Selling, general and administrative | 16,285 | 15,311 |
Research and development | 4,672 | 3,053 |
Total costs and expenses | 23,617 | 22,034 |
Loss from operations | (18,106) | (17,036) |
Other income, net | 0 | 10 |
Loss before income taxes | (18,106) | (17,026) |
Income tax expense | (8) | (6) |
Net loss | $ (18,114) | $ (17,032) |
Basic and diluted loss per share (in dollars per share) | $ (9.30) | $ (42.14) |
Weighted average shares outstanding - basic and diluted (in shares) | 2,433 | 404 |
Other comprehensive loss: | ||
Foreign currency translation adjustment | $ (9) | $ (4) |
Total comprehensive loss | $ (18,123) | $ (17,036) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 0 | $ 197,367 | $ 1,227 | $ (182,356) | $ 16,238 |
Balance (in shares) at Dec. 31, 2017 | 271,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (17,032) | (17,032) |
Foreign currency translation adjustment | 0 | 0 | (4) | 0 | (4) |
Stock-based compensation, net | $ 0 | 2,087 | 0 | 0 | 2,087 |
Stock-based compensation, net (in shares) | 12 | ||||
Issuance of unregistered shares | $ 0 | 0 | 0 | 0 | 0 |
Issuance of unregistered shares (in shares) | 7,116 | ||||
Issuance of common stock, net | $ 0 | 4,647 | 0 | 0 | 4,647 |
Issuance of common stock, net (in shares) | 181,941 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 53,019 | ||||
Balance at Dec. 31, 2018 | $ 0 | 204,101 | 1,223 | (199,388) | 5,936 |
Balance (in shares) at Dec. 31, 2018 | 513,445 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (18,114) | (18,114) |
Foreign currency translation adjustment | 0 | 0 | (9) | 0 | (9) |
Stock-based compensation, net | $ 0 | 1,512 | 0 | 0 | 1,512 |
Stock-based compensation, net (in shares) | 3 | ||||
Issuance of common stock, net | $ 0 | 12,665 | 0 | 0 | 12,665 |
Issuance of common stock, net (in shares) | 2,250,084 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 1,910,536 | ||||
Balance at Dec. 31, 2019 | $ 0 | $ 218,278 | $ 1,214 | $ (217,502) | $ 1,990 |
Balance (in shares) at Dec. 31, 2019 | 4,674,068 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Activities: | ||
Net loss | $ (18,114) | $ (17,032) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization | 239 | 232 |
Stock-based compensation expense | 1,512 | 2,087 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (13) | (241) |
Inventories | (343) | (70) |
Other current assets | 42 | (67) |
Other assets and liabilities | 18 | (14) |
Accounts payable and accrued expenses | 292 | 545 |
Net cash used in operations | (16,367) | (14,560) |
Investing activities: | ||
Purchase of property and equipment | (490) | (198) |
Net cash used in investing activities | (490) | (198) |
Financing activities: | ||
Net proceeds from public stock offerings, net | 12,665 | 4,647 |
Net cash provided by financing activities | 12,665 | 4,647 |
Effect of exchange rate changes on cash | (9) | (4) |
Net decrease in cash and cash equivalents | (4,201) | (10,115) |
Cash and cash equivalents - beginning of year | 5,480 | 15,595 |
Cash and cash equivalents - end of year | 1,279 | 5,480 |
Supplemental schedule of non-cash activities | ||
Financing fees incurred for subsequent equity financing included in other assets and accounts payable | 111 | 78 |
Inventory transferred to property, plant and equipment | 204 | 0 |
Supplemental cash flow information | ||
Cash paid for income taxes | $ 4 | $ 2 |
Nature of Business and Signific
Nature of Business and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Nature of Business and Significant Accounting Policies | No te 1 — Nature of Business CHF Solutions, Inc. (the “Company”) is a medical device company focused on developing, manufacturing and commercializing the Aquadex FlexFlow® and Aquadex SmartFlow™ systems (herein referred to as the “Aquadex System”) for aquapheresis therapy. The Aquadex SmartFlow™ system is indicated for temporary (up to hours) or extended (longer than hours in patients who require hospitalization) use in adult and pediatric patients weighing kg or more whose fluid overload is unresponsive to medical management, including diuretics Previously, the Company was focused on developing the C-Pulse® Heart Assist System for treatment of Class III and ambulatory Class IV heart failure. In August 2016, the Company acquired the business associated with the Aquadex System (herein referred to as the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”), and refocused its strategy to fully devote its resources to the Aquadex Business. Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2019 and 2018, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. At December 31, 2019, the Company had an accumulated deficit of $217.5 million and it expects to incur losses for the immediate future. To date, the Company has been funded by debt and equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months. The Company became a revenue generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2018, 2019 and through January 28, 2020, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $26.0 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (see Note 5 – Shareholders' Equity and Note 12-Subsequent Events). The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. Basis of Presentation The accompanying consolidated financial statements include the accounts of CHF Solutions, Inc. and its wholly-owned subsidiaries, CHF Solutions, LLC, Sunshine Heart Company Pty Limited, and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximate fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. Accounts Receivable Accounts receivable are unsecured, recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and managements’ evaluation of specific accounts and will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2019 or December 31, 2018. As of December 31, 2019, two customers represented 13% and 12% of the accounts receivable balance. As of December 31, 2018, three customers represented 18%, 13% and 13% of the accounts receivable balance. Inventories I 2019 2018 Finished Goods $ 750 $ 517 Work in Process 79 34 Raw Materials 968 1,107 Total $ 1,797 $ 1,658 Other Current Assets Other current assets represent prepayments and deposits made by the Company. Property, Plant and Equipment Property and equipment is stated at cost less accumulated depreciation. Depreciation is computed based upon the estimated useful lives of the respective assets. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life of the assets. Repairs and maintenance costs are expensed as incurred. The cost and accumulated depreciation of property, plant and equipment retired, or otherwise disposed of are removed from the related accounts, and any residual values are charged to expense. Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and Demo Equipment 3-7 years Leasehold Improvements 3-5 years Depreciation expense was $239,000 and $232,000 for the years ended December 31, 2019, and 2018, respectively. Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the impairment tests indicate that the carrying value of the asset, or asset group is greater than the expected undiscounted cash flows to be generated by such asset or asset group, further analysis is performed to determine the fair value of the asset or asset group. To the extent the fair value of the asset or asset group is less than its carrying value, an impairment loss is recognized equal to the amount the fair value of the asset or asset group is exceeded by its carrying amount. The Company generally measures fair value by considering sale prices for similar assets or asset groups, or by discounting estimated future cash flows from such assets or asset groups using an appropriate discount rate. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company periodically reviews its property and equipment for potential impairment and determines if the fair value of property and equipment equals or exceeds its carrying value. There have been no impairment losses recognized for the years ended December 31, 2019 or 2018. Contingent consideration In connection with the Company’s purchase of the Aquadex Business in August the Company had an obligation to pay additional consideration that was contingent upon the occurrence of certain future events (see Note - Commitments and Contingencies). Contingent consideration was recognized at the acquisition date at the estimated fair value of the contingent milestone payments. The fair value of the contingent consideration was remeasured to its estimated fair value at the end of each reporting period, with changes recorded to earnings. this contingency had expired, therefore its fair value was Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recognized to cumulative translation adjustment, a component of accumulated other comprehensive income other expense, net Stock-Based Compensation The Company recognizes all share-based payments to employees and directors, including grants of stock options, warrants and common stock awards in the consolidated statement of operations and comprehensive loss as an operating expense based on their fair values as established at the grant date. Equity instruments issued to non-employees include common stock awards or warrants to purchase shares of our common stock. These common stock awards or warrants are either fully-vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. In accordance with Accounting Standards Update 2018-07, unvested awards are no longer remeasured to fair value until vesting and rather the fair value is established at the grant date consistent with the treatment of employee director awards. The Company computes the estimated fair values of stock options and warrants using the Black-Scholes option pricing model and market-based warrants using a Monte Carlo valuation model. Market price at the date of grant is used to calculate the fair value of restricted stock units and common stock awards. Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for estimated forfeitures except for market-based warrants which are expensed based on the grant date fair value regardless of whether the award vests. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. See Note 6- Stock-Based Compensation, for further information regarding the assumptions used to calculate the fair value of share-based compensation. Income Taxes Deferred income taxes are provided on a liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards. Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 2019, reflects a $4.5 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the public offering of Series G Convertible Preferred Stock on March 12, 2019 (see Note 5 – Shareholders' Equity), representing the intrinsic value of the shares at the time of issuance. Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 2019 2018 Stock options 405,730 140,546 Restricted stock units (RSU) — 3 Warrants to purchase common stock 6,948,466 599,293 Series F convertible preferred stock 538,210 18,190 Total 7,892,406 758,032 The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2019 2018 Net loss $ (18,114 ) $ (17,032 ) Deemed dividend to preferred shareholders (see Note 6) (4,509 ) — Net loss after deemed dividend (22,623 ) (17,032 ) Weighted average shares outstanding 2,433 404 Basic and diluted loss per share $ (9.30 ) $ (42.14 ) Research and Development Research and development costs include activities related to research, development, design, and testing improvements of the Aquadex System and potential related products. Research and development costs also include expenses related to clinical research that the Company may sponsor or conduct to enhance understanding of the product and its use. Research and development expenses are expensed as incurred. Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued updated guidance to improve financial reporting about leasing transactions. This guidance required organizations that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. The original guidance required application on a modified retrospective basis with the earliest period presented. In August 2018, the FASB issued new guidance which included an option to not restate comparative periods in transition. retrospective adjustments to prior comparative periods assets and in short and long-term liabilities recorded on its consolidated balance sheet. In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard which allowed it to carry forward the historical lease classification. See Note 9 –Operating Leases for additional qualitative and quantitative disclosures In August 2018, the FASB issued updated guidance to improve and simplify the disclosure requirements on fair value measurements for level 3 assets and liabilities valued at fair value. The Company early-adopted the guidance effective in its second quarter of 2019 and the effect on the consolidated financial statements was not material. The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2019 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | N ote 2 — Net Sales The Company sells its products in the United States primarily through a direct sales force. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in the United Kingdom, Italy, Spain, Germany, Austria, Switzerland, Southeast Asia, Brazil, India and Greece. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. Revenue from product sales are recognized when the customer or distributor obtains control of the product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point, unless the customer requests that control and title to the inventory transfer upon delivery. Revenue is measured as the amount of consideration the Company expects to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when the Company satisfies its performance obligations under the contract. The majority of the Company contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers which are recognized over time. This revenue represents less than 1% of net sales for the years ended December 31, 2019 and 2018. The unfulfilled performance obligations related to these extended service plans is included in deferred revenue, which is included in other current liabilities on the consolidated balance sheets. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns: believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns. |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | No te 3 —P Property, plant and equipment were as follows: (in thousands) December December Production Equipment $ 1,113 $ 991 Loaners and Demo Equipment 801 309 Computer Software and Equipment 579 499 Office Furniture & Fixtures 291 291 Leasehold Improvements 224 224 Total 3,008 2,314 Accumulated Depreciation (2,017 ) (1,778 ) $ 991 $ 536 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2019 | |
Debt [Abstract] | |
Debt | Not e 4 —D On August 5, 2016, the Company entered into a loan and security agreement with Silicon Valley Bank (the Bank). Under this agreement, the Bank agreed to provide the Company with up to $5.0 million in debt financing, consisting of a term loan in an aggregate original principal amount not to exceed $4.0 million (the “Term Loan”) and a revolving line of credit in an aggregate principal amount not to exceed $1.0 million outstanding at any time (the “Revolving Line”). Proceeds from the loans were to be used for general corporate and working capital purposes. Advances under the Term Loan were available to the Company until November 30, 2016 and were subject to the Company’s compliance with liquidity covenants. The Term Loan expired unused on November 30, 2016 and is no longer available to be drawn. Advances under the Revolving Line are available to the Company until March 31, 2020 and accrue interest at a floating annual rate equal to 1.75% or 1.0% above the prime rate, depending on liquidity factors. Outstanding borrowings, if any, are collateralized by all of the Company’s assets, excluding intellectual property which is subject to a negative pledge. There were no borrowings outstanding under this facility as of December 31, 2019 or 2018. |
Shareholder's Equity
Shareholder's Equity | 12 Months Ended |
Dec. 31, 2019 | |
Shareholder's Equity [Abstract] | |
Shareholder's Equity | No te 5 —S Series F Convertible Preferred Stock The offering was comprised of Series F convertible preferred stock, convertible into shares of the Company’s common stock at an initial conversion price of $63.00 per share. Each share of Series F preferred stock was accompanied by a Series 1 warrant, which was to expire on the first anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share. The Series F preferred stock has full ratchet price based anti-dilution protection, subject to customary carve outs, in the event of a down-round financing at a price per share below the conversion price of the Series F preferred stock (which protection will expire if, during any 20 of 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 300% of the then-effective conversion price of the Series F preferred stock and the daily dollar trading volume for each trading day during such period exceeds $200,000). The exercise price of the warrants is fixed and does not contain any variable pricing features, nor any price based anti-dilutive features, apart from customary adjustments for stock splits, combinations, reclassifications, stock dividends or fundamental transactions. A total of 18,000 shares of Series F Convertible Preferred Stock initially convertible into 286,714 shares of common stock and warrants to purchase 573,310 shares of common stock were issued in the offering. As noted below, effective July the conversion price of the Series F convertible preferred stock was reduced from to the per share price in the July Offering described below. Effective March the conversion price of the Series F convertible preferred stock was reduced from to the per share price to the public of the Series G convertible preferred stock which closed in an underwritten public offering on March Effective October the conversion price of the Series F convertible preferred stock was reduced from to and on November from to the per share price to the public in the October and November transactions, respectively, described below. As of December and shares of the Series F convertible preferred stock remained outstanding. July 2018 Offering: On July the Company closed on an underwritten public offering of shares of its common stock at a public offering price of per share, for gross proceeds of , including the full exercise of the underwriters’ over-allotment option to purchase additional shares of the Company’s common stock (the “July Offering”). deducting underwriting discounts and commissions and offering expenses. In connection with the July Offering, and to induce certain institutional investors who hold warrants issued by the Company in November (“November Warrants”) to participate in the July Offering, the Company entered into letter agreements with such institutional investors. Pursuant to the terms of these agreements, the Company agreed, effective July to reduce the per share exercise price of the November Warrants held by such institutional investors to and to extend the expiration date of the warrants that were to expire on November to November The number of common shares underlying the warrants that were repriced did not change. The repriced warrants are exercisable for shares of common stock in the aggregate, of which, following such amendment, half expire on November and half expire on November The repricing of the warrants was accounted as an equity financing cost, with no impact to net proceeds from the offering. Series G Convertible Preferred Stock and March 2019 Offering The March 2019 Offering was comprised of 455,178 shares of common stock priced at $5.25 per share and 1,910,536 shares of Series G convertible preferred stock, convertible into common stock at $5.25 per share. Each share of Series G convertible preferred stock and each share of common stock was accompanied by a Series 1 warrant and a Series 2 warrant. The Series 1 warrants are exercisable into 2,365,714 shares of common stock and the Series 2 warrants are exercisable into 2,365,714 shares of common stock. Series 1 warrants expire on the fifth anniversary of the date of issuance and are exercisable at $5.25 to purchase one share of common stock. Series 2 warrants expire on the earlier of: (i) the eighteen -month anniversary of the date of issuance and (ii) the 30 th trading day following the public announcement of the receipt from the U.S. Food and Drug Administration of clearance or approval of a modification to the product label for the Aquadex System to include pediatric patients. Series 2 warrants are exercisable at $5.25 per share of common stock. As of December 31, 2019, all 1,910,536 shares of the Series G convertible preferred stock had been converted into common stock and none remained outstanding. October and November 2019 Offerings On October the Company closed on a registered direct offering of shares of common stock at a price of per share, for gross proceeds of approximately prior to deducting commissions and expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to shares of its common stock at an exercise price of per share, which will be exercisable months from the date of issuance, and will expire years from the initial exercise date. On November the Company closed on a registered direct offering of shares of common stock, or common equivalents, at a price of per share, for gross proceeds of approximately prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to shares of our common stock at an exercise price of per share, which were exercisable upon the date of issuance, and will expire years from the initial exercise date. The unregistered warrants issued in each offering were subsequently registered pursuant to a registration statement on Form S- that was declared effective by the SEC on December Placement Agent Fees: Market-Based Warrants |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2019 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | Not e 6 — Stock Options and Restricted Stock Awards The Company has various share-based compensation plans, including the Amended and Restated 2002 Stock Plan, the Third Amended and Restated 2017 Equity Incentive Plan, the 2013 Non-Employee Directors’ Equity Incentive Plan and the New-Hire Equity Incentive Plan (collectively, the “Plans” The Company recognized stock-based compensation expense related to grants of stock options, RSUs and common stock awards to employees, directors and consultants of $1.5 million, and $2.1 million during the years ended December 31, 2019 and 2018, respectively. The following table summarizes the stock-based compensation expense which was recognized in the consolidated statements of operations for the years ended December 31, (Dollars in thousands) Selling, general and administrative $ 1,387 $ 1,958 Research and development 125 129 Total $ 1,512 $ 2,087 The majority of the RSUs and options to purchase common stock vest on the anniversary of the date of grant, which ranges from one to four years. Stock-based compensation expense related to these awards is recognized on a straight-line basis over the related vesting term in most cases, which generally is the service period. It is the Company’s policy to issue new shares upon the exercise of options. Stock Options 2019 2018 Options Weighted Options Weighted Beginning Balance 140,546 $ 61.25 2,562 $ 1,049.93 Granted 281,834 2.38 163,997 45.76 Exercised — — — — Forfeited/expired (16,650 ) 31.77 (26,013 ) 61.01 Outstanding at December 405,730 $ 21.56 140,546 $ 61.25 Vested at December 31 72,377 $ 74.21 16,206 $ 169.07 For options outstanding and vested at December 31, 2019, the weighted average remaining contractual life was 9.13 years and 8.18 years, respectively. There were no option exercises in 2019 or 2018. The total fair value of options that vested in 2019 and 2018 was $2.4 million, and $0.9 million, respectively, at the fair value of the options as of the date of grant. Valuation Assumptions The Company has not historically paid cash dividends to its stockholders, and currently does not anticipate paying any cash dividends in the foreseeable future. As a result, the Company has assumed a dividend yield of 0%. The risk-free interest rate is based upon the rates of U.S. Treasury bills with a term that approximates the expected life of the option. Since the Company has limited historical exercise data to reasonably estimate the expected life of its option awards, the expected life is calculated using a simplified method. Expected volatility is based on historical volatility of the Company’s stock. The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2019 2018 Expected dividend yield 0 % 0 % Risk-free interest rate 1.85 % 2.49 % Expected volatility 121.67 % 120.54 % Expected life (in years) 6.22 6.23 The weighted-average fair value of stock options granted in 2019 and 2018 was $2.07 and $41.04, respectively. As of December 31, 2019, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $2.9 million and is expected to be recognized over the remaining weighted-average period of 3.2 years. Restricted Stock Awards 2019 2018 RSUs Weighted RSUs Weighted Nonvested, beginning balance 3 $ 7,297.22 15 $ 7,297.22 Granted — — — — Vested (3 ) $ 7,297.22 (12 ) 7,297.22 Forfeited — — — — Nonvested at December — — 3 $ 7,297.22 Warrants Warrants to purchase 6,948,466 and 599,293 shares of common stock were outstanding at December 31, 2019 and 2018, respectively. As of December 31, 2019, warrants outstanding were exercisable at prices ranging from $0.99 to $43,848 per share, and are exercisable over a period ranging from nine months to 5.5 years. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | N ote 7 — The Company’s financial instruments consist of cash and cash equivalents, warrants, and contingent consideration. Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” • Level 1 • Level 2 • Level 3 The fair value of the Company's contingent consideration, as described in Note 1, was initially measured based on the consideration expected to be transferred (probability-weighted), discounted back to present value, and it was considered a Level 3 instrument. The discount rate used was determined at the time of measurement in accordance with accepted valuation methods. The Company measured the liability on a recurring basis using Level 3 inputs including probabilities of payment and projected payment dates. As of December this contingency had expired, therefore its fair value was recorded at The following is a rollforward of the fair value of Level 3 items: (in s) Balance December $ 126 Change in fair value (126 ) Balance as of December 31, 2019 $ - The fair value of the market-based warrants described in Note 5 was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy. These warrants are classified as permanent equity and as a result, were measured at the grant date and are not required to be remeasured to fair value at each reporting period end. All cash equivalents are considered Level 1 measurements for all periods presented. The Company does not have any financial instruments classified as Level 2 or any other classified as Level 3 and there were no movements between these categories during the periods ended December 31, 2019 and December 31, 2018. The Company believes that the carrying amounts of all remaining financial instruments approximate their fair value due to their relatively short maturities. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes [Abstract] | |
Income Taxes | No te 8 —I Domestic and foreign loss before income taxes, consists of the following for the years ended December 31: (in thousands) Domestic $ (18,114 ) $ (17,027 ) Foreign 8 1 Loss before income taxes $ (18,106 ) $ (17,026 ) The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2019 2018 Current: United States and state $ — $ — Foreign, net (8 ) (6 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (8 ) $ (6 ) Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2019 2018 Statutory federal income tax benefit $ 3,802 $ 3,578 State tax benefit, net of federal taxes 46 45 Foreign tax 1 (2 ) Foreign deferred exchange rate adjustments (59 ) (1,112 ) Nondeductible/nontaxable items (272 ) (259 ) Other (113 ) (72 ) Valuation allowance increase (3,413 ) (2,184 ) Total income tax expense $ (8 ) $ (6 ) Deferred taxes consist of the following as of December 31: (in thousands) 2019 2018 Deferred tax assets: Noncurrent: Accrued leave $ 51 $ 50 Other accrued expenses — — Stock based compensation 449 483 Net operating loss carryforward 44,572 41,032 Other 69 125 Intangibles 809 847 R&D credit carryforward 531 531 Total deferred tax assets 46,481 43,068 Less: valuation allowance (46,481 ) (43,068 ) Total $ — $ — As of December 31, 2019, the Company had federal net operating loss (“NOLs”) The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of the deferred tax assets. The Company has established a valuation allowance for U.S. and foreign deferred tax assets due to the uncertainty that enough taxable income will be generated in those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any benefit of such deferred tax assets in the accompanying consolidated financial statements. During 2018 and 2019, the Company believes it experienced an ownership change as defined in Section 382 of the Internal Revenue Code which will limit the ability to utilize the Company’s net operating losses (NOLs). The Company may have experienced additional ownership changes in earlier years further limiting the NOL carry-forwards that may be utilized. The Company has not yet completed a formal Section 382 analysis. The general limitation rules allow the Company to utilize its NOLs subject to an annual limitation that is determined by multiplying the federal long-term tax-exempt rate by the Company’s value immediately before the ownership change. The accounting guidance related to uncertain tax positions prescribes a recognition threshold and measurement attribute for recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company had no material uncertain tax positions as of December 31, 2019 or 2018. The Company recognizes interest and penalties on unrecognized tax benefits as well as interest received from favorable tax settlements within income tax expense. At December 31, 2019 and 2018, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2016 through December 31, 2019 remain open to examination by the Internal Revenue Service and for the various states where the Company is subject to taxation. Additionally, the returns of the Company’s Australian and Irish subsidiary are subject to examination by tax authorities of those jurisdictions for the tax years ended and subsequent to June 30, 2014 and December 31, 2014, respectively. |
Operating Leases
Operating Leases | 12 Months Ended |
Dec. 31, 2019 | |
Operating Leases [Abstract] | |
Operating Leases | N ote 9 —O The Company leases office and manufacturing space under a non-cancelable operating lease that expires in March 2022. In August 2018, the Company entered into a third amendment to the lease, extending the term of the lease from March 31, 2019 to March 31, 2022. Beginning on April 1, 2019, the annual base rent is $9.00 per square foot, subject to annual increases of $0.25 per square foot. The cost components of the Company’s operating lease were as follows for the year ended December : (in s) Operating lease cost $ 213 Variable lease cost 102 Total $ 315 Variable lease costs consist primarily of taxes, insurance, and common area or other maintenance costs for our leased office and manufacturing space. Maturities of our lease liability for the Company’s operating lease are as follows as of December : (in s) 2020 $ 213 2021 219 2022 55 Total lease payments 487 Less: Interest (40 ) Present value of lease liability $ 447 As of December the remaining lease term was years and discount rate was . For the year ended December the operating cash outflows from the Company’s operating lease for office and manufacturing space were Rent expense related to operating leases for office and manufacturing space and office equipment was approximately for the year ended December Future minimum lease payments, under non-cancelable operating leases as of December were approximately and for each of the years ended December through respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | No te 10 —Co Employee Retirement Plan The Company has a 401(k)-profit sharing plan that provides retirement benefit to substantially all full-time U.S. employees. Eligible employees may contribute a percentage of their annual compensation, subject to Internal Revenue Service limitations, with the Company matching a portion of the employee’s contributions at the discretion of the Company. Matching contributions totaled $227,000 and $197,000 for the years ended December 31, 2019 and 2018, respectively. Contingent Consideration In connection with the Company’s purchase of the Aquadex Business in August the Company had an obligation to pay additional consideration that was contingent upon the occurrence of certain future events. Contingent consideration was recognized at the acquisition date at the estimated fair value of the contingent milestone payments. The fair value of the contingent consideration was remeasured to its estimated fair value at the end of each reporting period, with changes recorded to earnings. During this contingency had expired, therefore its fair value was |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 11 — R In January 2019, we entered into a consulting agreement with Steven Brandt, one of our non-employee directors, pursuant to which Mr. Brandt provided services, on an interim basis, until May 31, 2019, to support our commercial strategy under the direction of our Chief Executive Officer. Mr. Brandt was paid a fee of $19,000 per month, for a total of $76,000 for his services. Mr. Brandt also received $2,453 for reimbursement of expenses. |
Segment and Geographic Informat
Segment and Geographic Information | 12 Months Ended |
Dec. 31, 2019 | |
Segment and Geographic Information [Abstract] | |
Segment and Geographic Information | Note 12 —Segm The Company has one reportable segment, cardiac and coronary disease products. At December 31, 2019 and 2018, long-lived assets were located primarily in the United States. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | No te 13 — On January the Company closed on an underwritten public offering of shares of common stock, shares of Series H Preferred Stock and warrants to purchase shares of Common Stock, which includes the full exercise of the underwriter’s over-allotment option, for gross proceeds of . Net proceeds totaled approximately after deducting the underwriting discounts and commissions and other costs associated with the offering. |
Nature of Business and Signif_2
Nature of Business and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Going Concern | Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2019 and 2018, the Company incurred losses from operations and net cash outflows from operating activities as disclosed in the consolidated statements of operations and cash flows, respectively. At December 31, 2019, the Company had an accumulated deficit of $217.5 million and it expects to incur losses for the immediate future. To date, the Company has been funded by debt and equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through the next twelve months. The Company became a revenue generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex System. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing and distributing the Aquadex System and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. During 2018, 2019 and through January 28, 2020, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $26.0 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (see Note 5 – Shareholders' Equity and Note 12-Subsequent Events). The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of CHF Solutions, Inc. and its wholly-owned subsidiaries, CHF Solutions, LLC, Sunshine Heart Company Pty Limited, and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximate fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. |
Accounts Receivable | Accounts Receivable Accounts receivable are unsecured, recorded at net realizable value, and do not bear interest. The Company makes judgments as to its ability to collect outstanding receivables based upon significant patterns of collectability, historical experience, and managements’ evaluation of specific accounts and will provide an allowance for credit losses when collection becomes doubtful. The Company performs credit evaluations of its customers’ financial condition on an as-needed basis. Payment is generally due 30 days from the invoice date and accounts past 30 days are individually analyzed for collectability. When all collection efforts have been exhausted, the account is written off against the related allowance. To date the Company has not experienced any write-offs or significant deterioration of the aging of its accounts receivable, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2019 or December 31, 2018. As of December 31, 2019, two customers represented 13% and 12% of the accounts receivable balance. As of December 31, 2018, three customers represented 18%, 13% and 13% of the accounts receivable balance. |
Inventories | Inventories I 2019 2018 Finished Goods $ 750 $ 517 Work in Process 79 34 Raw Materials 968 1,107 Total $ 1,797 $ 1,658 |
Other Current Assets | Other Current Assets Other current assets represent prepayments and deposits made by the Company. |
Property, Plant and Equipment | Property, Plant and Equipment Property and equipment is stated at cost less accumulated depreciation. Depreciation is computed based upon the estimated useful lives of the respective assets. Leasehold improvements are amortized using the straight-line method over the shorter of the lease term or the estimated useful life of the assets. Repairs and maintenance costs are expensed as incurred. The cost and accumulated depreciation of property, plant and equipment retired, or otherwise disposed of are removed from the related accounts, and any residual values are charged to expense. Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and Demo Equipment 3-7 years Leasehold Improvements 3-5 years Depreciation expense was $239,000 and $232,000 for the years ended December 31, 2019, and 2018, respectively. Property and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. If the impairment tests indicate that the carrying value of the asset, or asset group is greater than the expected undiscounted cash flows to be generated by such asset or asset group, further analysis is performed to determine the fair value of the asset or asset group. To the extent the fair value of the asset or asset group is less than its carrying value, an impairment loss is recognized equal to the amount the fair value of the asset or asset group is exceeded by its carrying amount. The Company generally measures fair value by considering sale prices for similar assets or asset groups, or by discounting estimated future cash flows from such assets or asset groups using an appropriate discount rate. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company periodically reviews its property and equipment for potential impairment and determines if the fair value of property and equipment equals or exceeds its carrying value. There have been no impairment losses recognized for the years ended December 31, 2019 or 2018. |
Contingent Consideration | Contingent consideration In connection with the Company’s purchase of the Aquadex Business in August the Company had an obligation to pay additional consideration that was contingent upon the occurrence of certain future events (see Note - Commitments and Contingencies). Contingent consideration was recognized at the acquisition date at the estimated fair value of the contingent milestone payments. The fair value of the contingent consideration was remeasured to its estimated fair value at the end of each reporting period, with changes recorded to earnings. this contingency had expired, therefore its fair value was |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers |
Foreign Currency Translation | Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recognized to cumulative translation adjustment, a component of accumulated other comprehensive income other expense, net |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes all share-based payments to employees and directors, including grants of stock options, warrants and common stock awards in the consolidated statement of operations and comprehensive loss as an operating expense based on their fair values as established at the grant date. Equity instruments issued to non-employees include common stock awards or warrants to purchase shares of our common stock. These common stock awards or warrants are either fully-vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. In accordance with Accounting Standards Update 2018-07, unvested awards are no longer remeasured to fair value until vesting and rather the fair value is established at the grant date consistent with the treatment of employee director awards. The Company computes the estimated fair values of stock options and warrants using the Black-Scholes option pricing model and market-based warrants using a Monte Carlo valuation model. Market price at the date of grant is used to calculate the fair value of restricted stock units and common stock awards. Stock-based compensation expense is based on awards ultimately expected to vest and is reduced for estimated forfeitures except for market-based warrants which are expensed based on the grant date fair value regardless of whether the award vests. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. See Note 6- Stock-Based Compensation, for further information regarding the assumptions used to calculate the fair value of share-based compensation. |
Income Taxes | Income Taxes Deferred income taxes are provided on a liability method, whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards. Deferred tax liabilities are recognized for taxable temporary differences, which are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not threshold, the amount recognized in the consolidated financial statements is the largest benefit that has a greater than 50 percent likelihood of being realized upon ultimate settlement with the relevant tax authority. |
Loss per Share | Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 2019, reflects a $4.5 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the public offering of Series G Convertible Preferred Stock on March 12, 2019 (see Note 5 – Shareholders' Equity), representing the intrinsic value of the shares at the time of issuance. Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 2019 2018 Stock options 405,730 140,546 Restricted stock units (RSU) — 3 Warrants to purchase common stock 6,948,466 599,293 Series F convertible preferred stock 538,210 18,190 Total 7,892,406 758,032 The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2019 2018 Net loss $ (18,114 ) $ (17,032 ) Deemed dividend to preferred shareholders (see Note 6) (4,509 ) — Net loss after deemed dividend (22,623 ) (17,032 ) Weighted average shares outstanding 2,433 404 Basic and diluted loss per share $ (9.30 ) $ (42.14 ) |
Research and Development | Research and Development Research and development costs include activities related to research, development, design, and testing improvements of the Aquadex System and potential related products. Research and development costs also include expenses related to clinical research that the Company may sponsor or conduct to enhance understanding of the product and its use. Research and development expenses are expensed as incurred. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued updated guidance to improve financial reporting about leasing transactions. This guidance required organizations that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. The original guidance required application on a modified retrospective basis with the earliest period presented. In August 2018, the FASB issued new guidance which included an option to not restate comparative periods in transition. retrospective adjustments to prior comparative periods assets and in short and long-term liabilities recorded on its consolidated balance sheet. In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard which allowed it to carry forward the historical lease classification. See Note 9 –Operating Leases for additional qualitative and quantitative disclosures In August 2018, the FASB issued updated guidance to improve and simplify the disclosure requirements on fair value measurements for level 3 assets and liabilities valued at fair value. The Company early-adopted the guidance effective in its second quarter of 2019 and the effect on the consolidated financial statements was not material. The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Nature of Business and Signif_3
Nature of Business and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Inventories | Inventories consisted of the following as of December 31: 2019 2018 Finished Goods $ 750 $ 517 Work in Process 79 34 Raw Materials 968 1,107 Total $ 1,797 $ 1,658 |
Estimated Useful Lives | Depreciation expense has been calculated using the following estimated useful lives: Production Equipment 3-7 years Office Furniture and Fixtures 3-5 years Computer Software and Equipment 3-4 years Loaners and Demo Equipment 3-7 years Leasehold Improvements 3-5 years |
Potential Shares of Common Stock not Included in Diluted Net Loss Per Share | The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 2019 2018 Stock options 405,730 140,546 Restricted stock units (RSU) — 3 Warrants to purchase common stock 6,948,466 599,293 Series F convertible preferred stock 538,210 18,190 Total 7,892,406 758,032 |
Reconciles Reported Net Loss with Reported Net Loss Per Share | The following table reconciles reported net loss with reported net loss per share for the years ended December 31: (in thousands, except per share amounts) 2019 2018 Net loss $ (18,114 ) $ (17,032 ) Deemed dividend to preferred shareholders (see Note 6) (4,509 ) — Net loss after deemed dividend (22,623 ) (17,032 ) Weighted average shares outstanding 2,433 404 Basic and diluted loss per share $ (9.30 ) $ (42.14 ) |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment were as follows: (in thousands) December December Production Equipment $ 1,113 $ 991 Loaners and Demo Equipment 801 309 Computer Software and Equipment 579 499 Office Furniture & Fixtures 291 291 Leasehold Improvements 224 224 Total 3,008 2,314 Accumulated Depreciation (2,017 ) (1,778 ) $ 991 $ 536 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Stock-Based Compensation [Abstract] | |
Summary of Stock-Based Compensation Expense | The following table summarizes the stock-based compensation expense which was recognized in the consolidated statements of operations for the years ended December 31, (Dollars in thousands) Selling, general and administrative $ 1,387 $ 1,958 Research and development 125 129 Total $ 1,512 $ 2,087 |
Summary of Plan Stock Option Activity | The following is a summary of the Plans’ stock option activity during the years ended December 31: 2019 2018 Options Weighted Options Weighted Beginning Balance 140,546 $ 61.25 2,562 $ 1,049.93 Granted 281,834 2.38 163,997 45.76 Exercised — — — — Forfeited/expired (16,650 ) 31.77 (26,013 ) 61.01 Outstanding at December 405,730 $ 21.56 140,546 $ 61.25 Vested at December 31 72,377 $ 74.21 16,206 $ 169.07 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model | The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2019 2018 Expected dividend yield 0 % 0 % Risk-free interest rate 1.85 % 2.49 % Expected volatility 121.67 % 120.54 % Expected life (in years) 6.22 6.23 |
Summary of Restricted Stock Award Activity | The following table summarizes restricted stock award activity during 2019 and 2018: 2019 2018 RSUs Weighted RSUs Weighted Nonvested, beginning balance 3 $ 7,297.22 15 $ 7,297.22 Granted — — — — Vested (3 ) $ 7,297.22 (12 ) 7,297.22 Forfeited — — — — Nonvested at December — — 3 $ 7,297.22 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Level 3 Warrants | The following is a rollforward of the fair value of Level 3 items: (in s) Balance December $ 126 Change in fair value (126 ) Balance as of December 31, 2019 $ - |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Taxes [Abstract] | |
Domestic and Foreign Loss Before Income Taxes | Domestic and foreign loss before income taxes, consists of the following for the years ended December 31: (in thousands) Domestic $ (18,114 ) $ (17,027 ) Foreign 8 1 Loss before income taxes $ (18,106 ) $ (17,026 ) |
Components of Income Tax Expense | The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2019 2018 Current: United States and state $ — $ — Foreign, net (8 ) (6 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (8 ) $ (6 ) |
Actual Income Tax Expense Differs from Statutory Federal Income Tax Expense | Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2019 2018 Statutory federal income tax benefit $ 3,802 $ 3,578 State tax benefit, net of federal taxes 46 45 Foreign tax 1 (2 ) Foreign deferred exchange rate adjustments (59 ) (1,112 ) Nondeductible/nontaxable items (272 ) (259 ) Other (113 ) (72 ) Valuation allowance increase (3,413 ) (2,184 ) Total income tax expense $ (8 ) $ (6 ) |
Deferred Taxes | Deferred taxes consist of the following as of December 31: (in thousands) 2019 2018 Deferred tax assets: Noncurrent: Accrued leave $ 51 $ 50 Other accrued expenses — — Stock based compensation 449 483 Net operating loss carryforward 44,572 41,032 Other 69 125 Intangibles 809 847 R&D credit carryforward 531 531 Total deferred tax assets 46,481 43,068 Less: valuation allowance (46,481 ) (43,068 ) Total $ — $ — |
Operating Leases (Tables)
Operating Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Operating Leases [Abstract] | |
Cost Components of Operating Leases | The cost components of the Company’s operating lease were as follows for the year ended December : (in s) Operating lease cost $ 213 Variable lease cost 102 Total $ 315 |
Maturities of Lease Liability | Maturities of our lease liability for the Company’s operating lease are as follows as of December : (in s) 2020 $ 213 2021 219 2022 55 Total lease payments 487 Less: Interest (40 ) Present value of lease liability $ 447 |
Nature of Business and Signif_4
Nature of Business and Significant Accounting Policies, Going Concern, Accounts Receivable and Inventories (Details) - USD ($) $ in Thousands | 12 Months Ended | 25 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | Jan. 28, 2020 | |
Going Concern [Abstract] | |||
Accumulated deficit | $ (217,502) | $ (199,388) | |
Accounts Receivable [Abstract] | |||
Accounts receivables maximum credit period from invoice date | 30 days | ||
Allowance for doubtful accounts | $ 0 | 0 | |
Inventories [Abstract] | |||
Finished Goods | 750 | 517 | |
Work in Process | 79 | 34 | |
Raw Materials | 968 | 1,107 | |
Total | $ 1,797 | $ 1,658 | |
Subsequent Event [Member] | |||
Going Concern [Abstract] | |||
Net proceeds from issuance of convertible preferred stock | $ 26,000 | ||
Accounts Receivable [Member] | Customer One [Member] | |||
Revenue, Performance Obligation [Abstract] | |||
Concentration risk percentage | 13.00% | 18.00% | |
Accounts Receivable [Member] | Customer Two [Member] | |||
Revenue, Performance Obligation [Abstract] | |||
Concentration risk percentage | 12.00% | 13.00% | |
Accounts Receivable [Member] | Customer Three [Member] | |||
Revenue, Performance Obligation [Abstract] | |||
Concentration risk percentage | 13.00% |
Nature of Business and Signif_5
Nature of Business and Significant Accounting Policies, Property, Plant and Equipment, Contingent Consideration and Revenue Recognition (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Aug. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expense | $ 239 | $ 232 | |
Impairment losses recognized | $ 0 | $ 0 | |
Production Equipment [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 3 years | ||
Production Equipment [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 7 years | ||
Office Furniture & Fixtures [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 3 years | ||
Office Furniture & Fixtures [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 5 years | ||
Computer Software and Equipment [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 3 years | ||
Computer Software and Equipment [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 4 years | ||
Loaners and Demo Equipment [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 3 years | ||
Loaners and Demo Equipment [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 7 years | ||
Leasehold Improvements [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 3 years | ||
Leasehold Improvements [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Abstract] | |||
Estimated useful lives | 5 years | ||
Aquadex Product Line [Member] | |||
Contingent Consideration [Abstract] | |||
Contingent consideration | $ 0 | $ 126 | |
Fair value of contingent consideration | $ 0 | $ 126 | |
ASC 606 [Member] | Customer One [Member] | Net Sales [Member] | |||
Revenue, Performance Obligation [Abstract] | |||
Concentration risk percentage | 10.00% | 10.00% |
Nature of Business and Signif_6
Nature of Business and Significant Accounting Policies, Loss Per Share and Recent Accounting Pronouncements (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 7,892,406 | 758,032 |
Reported net loss with reported net loss per share [Abstract] | ||
Net loss | $ (18,114) | $ (17,032) |
Deemed dividend to preferred shareholders (see Note 6) | (4,509) | 0 |
Net loss after deemed dividend | $ (22,623) | $ (17,032) |
Weighted average shares outstanding (in shares) | 2,433,000 | 404,000 |
Basic and diluted loss per share (in dollars per share) | $ (9.30) | $ (42.14) |
Recent Accounting Pronouncements [Abstract] | ||
Operating lease right-of-use asset, net | $ 442 | $ 0 |
Operating lease liability | $ 447 | |
Stock Options [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 405,730 | 140,546 |
Restricted Stock Units (RSU) [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 0 | 3 |
Warrants to Purchase Common Stock [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 6,948,466 | 599,293 |
Series F Convertible Preferred Stock [Member] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share [Abstract] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 538,210 | 18,190 |
ASU 2016-02 [Member] | Adjustments Due to Adoption of ASU 2016-02 [Member] | ||
Recent Accounting Pronouncements [Abstract] | ||
Operating lease right-of-use asset, net | $ 600 | |
Operating lease liability | $ 600 |
Revenue Recognition (Details)
Revenue Recognition (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-01-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||
Expected timing of satisfaction, period | 1 year | 1 year |
Sales Revenue [Member] | ASC 606 [Member] | Maximum [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Percentage of net sales | 1.00% | 1.00% |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | $ 3,008 | $ 2,314 |
Accumulated Depreciation | (2,017) | (1,778) |
Property, Plant and Equipment, Net | 991 | 536 |
Production Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 1,113 | 991 |
Loaners and Demo Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 801 | 309 |
Computer Software and Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 579 | 499 |
Office Furniture & Fixtures [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 291 | 291 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | $ 224 | $ 224 |
Debt (Details)
Debt (Details) - Silicon Valley Bank [Member] - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Aug. 05, 2016 | |
Line of Credit Facility [Abstract] | |||
Maximum borrowing capacity | $ 5 | ||
Term Loan [Member] | |||
Line of Credit Facility [Abstract] | |||
Maximum borrowing capacity | $ 4 | ||
Maturity date | Nov. 30, 2016 | ||
Revolving Line [Member] | |||
Line of Credit Facility [Abstract] | |||
Maximum borrowing capacity | $ 1 | ||
Maturity date | Mar. 31, 2020 | ||
Total borrowings outstanding | $ 0 | $ 0 | |
Revolving Line [Member] | Floating Annual Rate [Member] | |||
Line of Credit Facility [Abstract] | |||
Interest rate | 1.75% | ||
Revolving Line [Member] | Prime Rate [Member] | |||
Line of Credit Facility [Abstract] | |||
Interest rate | 1.00% |
Shareholder's Equity (Details)
Shareholder's Equity (Details) $ / shares in Units, $ in Thousands | Nov. 06, 2019USD ($)$ / sharesshares | Oct. 25, 2019USD ($)$ / sharesshares | Mar. 12, 2019USD ($)$ / sharesshares | Jul. 03, 2018USD ($)$ / sharesshares | Nov. 27, 2017USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | May 30, 2019$ / sharesshares | Dec. 31, 2018shares |
Class of Stock Disclosures [Abstract] | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.9942 | $ 1.41 | ||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||
Issuance of common stock, net (in shares) | 1,219,076 | 575,830 | ||||||
Public offering price (in dollars per share) | $ / shares | $ 1.12 | $ 1.15 | ||||||
Warrants to purchase shares of common stock (in shares) | 1,219,076 | 575,830 | ||||||
Gross proceeds from public stock offering | $ | $ 1,360 | $ 660 | ||||||
Warrant expiry period | 5 years | 5 years | ||||||
Warrants exercisable period | 6 months | |||||||
Expected Stock Price Volatility [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Warrants measurement input | 1.3621 | |||||||
July 2018 Offering [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Issuance of common stock, net (in shares) | 181,941 | |||||||
Public offering price (in dollars per share) | $ / shares | $ 29.68 | |||||||
Gross proceeds from public stock offering | $ | $ 5,400 | |||||||
Net proceeds from public stock offering | $ | $ 4,600 | |||||||
Number of shares issuable on the exercise of warrants (in shares) | 554,322 | |||||||
March 2019 Offering [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Issuance of common stock, net (in shares) | 455,178 | |||||||
Public offering price (in dollars per share) | $ / shares | $ 5.25 | |||||||
Warrants [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Number of warrants vested (in shares) | 0 | |||||||
Warrants [Member] | Minimum [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 0.99 | |||||||
Warrants [Member] | Maximum [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | 43,848 | |||||||
Warrants [Member] | Consultant [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.93 | $ 3.18 | ||||||
Warrants to purchase shares of common stock (in shares) | 100,000 | |||||||
Series F Convertible Preferred Stock [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Gross proceeds from issuance of convertible preferred stock | $ | $ 18,000 | |||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 16,200 | |||||||
Conversion price (in dollars per share) | $ / shares | $ 0.9942 | $ 1.41 | $ 5.25 | $ 29.68 | $ 63 | |||
Number of consecutive trading days considered for expiration | 20 days | |||||||
Number of consecutive trading days | 30 days | |||||||
Preferred stock, shares issued (in shares) | 18,000 | 535 | 535 | |||||
Number of shares issuable on conversion of preferred stock (in shares) | 286,714 | |||||||
Preferred stock, shares outstanding (in shares) | 535 | 535 | ||||||
Aggregate cash placement fee | 8.00% | 8.00% | 8.00% | 8.00% | ||||
Series F Convertible Preferred Stock [Member] | Minimum [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Percentage of volume weighted average price of common stock | 300.00% | |||||||
Trading volume for each trading day | $ | $ 200 | |||||||
Series F Convertible Preferred Stock [Member] | Warrants [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Warrants to purchase shares of common stock (in shares) | 573,310 | |||||||
Warrants issued to the placement agent (in shares) | 0 | |||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 29.68 | $ 63 | ||||||
Warrants to purchase shares of common stock (in shares) | 16 | |||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 29.68 | $ 63 | ||||||
Warrants to purchase shares of common stock (in shares) | 16 | |||||||
Series G Convertible Preferred Stock [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Gross proceeds from issuance of convertible preferred stock | $ | $ 12,400 | |||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 11,000 | |||||||
Conversion price (in dollars per share) | $ / shares | $ 5.25 | |||||||
Number of consecutive trading days | 30 days | |||||||
Preferred stock, shares outstanding (in shares) | 0 | |||||||
Beneficial conversion amount | $ | $ 4,500 | |||||||
Conversion of preferred stock into common stock (in shares) | 1,910,536 | |||||||
Beneficial ownership limitation | 4.99% | |||||||
Series G Convertible Preferred Stock [Member] | March 2019 Offering [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Number of shares issuable on conversion of preferred stock (in shares) | 1,910,536 | |||||||
Series G Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 5.25 | |||||||
Number of shares issuable on the exercise of warrants (in shares) | 2,365,714 | |||||||
Series G Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | ||||||||
Class of Stock Disclosures [Abstract] | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 5.25 | |||||||
Number of shares issuable on the exercise of warrants (in shares) | 2,365,714 |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock Options and Restricted Stock Awards (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 1,512 | $ 2,087 |
Minimum [Member] | ||
Additional Disclosures [Abstract] | ||
Award vesting period | 1 year | |
Maximum [Member] | ||
Additional Disclosures [Abstract] | ||
Award vesting period | 4 years | |
Selling, General and Administrative [Member] | ||
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 1,387 | 1,958 |
Research and Development [Member] | ||
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 125 | $ 129 |
Stock Options [Member] | ||
Stock Options Activity [Roll Forward] | ||
Outstanding, beginning balance (in shares) | 140,546 | 2,562 |
Granted (in shares) | 281,834 | 163,997 |
Exercised (in shares) | 0 | 0 |
Forfeited/expired (in shares) | (16,650) | (26,013) |
Outstanding, ending balance (in shares) | 405,730 | 140,546 |
Vested at the end of the year (in shares) | 72,377 | 16,206 |
Weighted Average Exercise Price [Abstract] | ||
Outstanding, beginning balance (in dollars per share) | $ 61.25 | $ 1,049.93 |
Granted (in dollars per share) | 2.38 | 45.76 |
Exercised (in dollars per share) | 0 | 0 |
Forfeited/expired (in dollars per share) | 31.77 | 61.01 |
Outstanding, ending balance (in dollars per share) | 21.56 | 61.25 |
Vested at the end of the year (in dollars per share) | $ 74.21 | $ 169.07 |
Weighted Average Remaining Contractual Term [Abstract] | ||
Options outstanding, weighted average remaining contractual life | 9 years 1 month 17 days | |
Options vested, weighted average remaining contractual life | 8 years 2 months 5 days | |
Aggregate Intrinsic Value [Abstract] | ||
Fair value of options, vested | $ 2,400 | $ 900 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract] | ||
Expected dividend yield | 0.00% | 0.00% |
Risk-free interest rate | 1.85% | 2.49% |
Expected volatility | 121.67% | 120.54% |
Expected life | 6 years 2 months 19 days | 6 years 2 months 23 days |
Additional Disclosures [Abstract] | ||
Weighted-average fair value of options granted (in dollars per share) | $ 2.07 | $ 41.04 |
Total unrecognized compensation costs related to non-vested stock option awards | $ 2,900 | |
Unrecognized compensation costs related to non-vested stock option awards, recognition period | 3 years 2 months 12 days | |
Restricted Stock Units (RSU) [Member] | ||
Restricted Stock Awards [Roll Forward] | ||
Nonvested, beginning balance (in shares) | 3 | 15 |
Granted (in shares) | 0 | 0 |
Vested (in shares) | (3) | (12) |
Forfeited (in shares) | 0 | 0 |
Nonvested, ending balance (in shares) | 0 | 3 |
Weighted Average Grant Price [Abstract] | ||
Nonvested, beginning balance (in dollars per share) | $ 7,297.22 | $ 7,297.22 |
Granted (in dollars per share) | 0 | 0 |
Vested (in dollars per share) | 7,297.22 | 7,297.22 |
Forfeited (in dollars per share) | 0 | 0 |
Nonvested, ending balance (in dollars per share) | $ 0 | $ 7,297.22 |
Stock-Based Compensation, Warra
Stock-Based Compensation, Warrants (Details) - $ / shares | 12 Months Ended | |||
Dec. 31, 2019 | Nov. 06, 2019 | Oct. 25, 2019 | Dec. 31, 2018 | |
Class of Warrant or Right [Abstract] | ||||
Exercise price of warrants (in dollars per share) | $ 0.9942 | $ 1.41 | ||
Warrants [Member] | ||||
Class of Warrant or Right [Abstract] | ||||
Warrants outstanding (in shares) | 6,948,466 | 599,293 | ||
Warrants [Member] | Minimum [Member] | ||||
Class of Warrant or Right [Abstract] | ||||
Exercise price of warrants (in dollars per share) | $ 0.99 | |||
Warrants exercisable period | 9 months | |||
Warrants [Member] | Maximum [Member] | ||||
Class of Warrant or Right [Abstract] | ||||
Exercise price of warrants (in dollars per share) | $ 43,848 | |||
Warrants exercisable period | 5 years 6 months |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Fair Value Transfers between levels [Abstract] | ||
Level 1 to Level 2 asset transfers | $ 0 | $ 0 |
Level 2 to Level 1 asset transfers | 0 | 0 |
Level 1 to Level 2 liability transfers | 0 | 0 |
Level 2 to Level 1 liability transfers | 0 | $ 0 |
Level 3 [Member] | ||
Fair value of Level 3 warrants [Roll Forward] | ||
Beginning balance | 126 | |
Change in fair value | (126) | |
Ending balance | $ 0 |
Income Taxes, Domestic and Fore
Income Taxes, Domestic and Foreign Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Loss before income taxes [Abstract] | ||
Domestic | $ (18,114) | $ (17,027) |
Foreign | 8 | 1 |
Loss before income taxes | $ (18,106) | $ (17,026) |
Income Taxes, Components of Inc
Income Taxes, Components of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Current [Abstract] | ||
United States and state | $ 0 | $ 0 |
Foreign, net | (8) | (6) |
Deferred [Abstract] | ||
United States and state | 0 | 0 |
Foreign | 0 | 0 |
Total income tax expense | $ (8) | $ (6) |
Income Taxes, Effective Income
Income Taxes, Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Effective income tax rate reconciliation [Abstract] | ||
Statutory federal income tax benefit | $ 3,802 | $ 3,578 |
State tax benefit, net of federal taxes | 46 | 45 |
Foreign tax | 1 | (2) |
Foreign deferred exchange rate adjustments | (59) | (1,112) |
Nondeductible/nontaxable items | (272) | (259) |
Other | (113) | (72) |
Valuation allowance increase | (3,413) | (2,184) |
Total income tax expense | $ (8) | $ (6) |
Income Taxes, Deferred Taxes an
Income Taxes, Deferred Taxes and Other Information (Details) $ in Thousands, $ in Millions | 12 Months Ended | ||
Dec. 31, 2019USD ($) | Dec. 31, 2019AUD ($) | Dec. 31, 2018USD ($) | |
Noncurrent [Abstract] | |||
Accrued leave | $ 51 | $ 50 | |
Other accrued expenses | 0 | 0 | |
Stock based compensation | 449 | 483 | |
Net operating loss carryforward | 44,572 | 41,032 | |
Other | 69 | 125 | |
Intangibles | 809 | 847 | |
R&D credit carryforward | 531 | 531 | |
Total deferred tax assets | 46,481 | 43,068 | |
Less: valuation allowance | (46,481) | (43,068) | |
Total | 0 | 0 | |
Unrecognized Tax Benefits [Abstract] | |||
Uncertain tax positions | 0 | 0 | |
Penalties and Interest Accrued [Abstract] | |||
Interest and penalties accrued on uncertain tax positions | $ 0 | $ 0 | |
Earliest Tax Year [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards, expiration date | Dec. 31, 2024 | ||
Latest Tax Year [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards, expiration date | Dec. 31, 2037 | ||
Federal [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 152,100 | ||
Net operating loss (NOL) carryforwards with expiration date | 120,100 | ||
Net operating loss (NOL) carryforwards with no expiration date | 32,000 | ||
State [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 30,100 | ||
Australian [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 49 |
Operating Leases (Details)
Operating Leases (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019USD ($)$ / ft² | Dec. 31, 2018USD ($) | |
Operating Leases [Abstract] | ||
Annual base rent (per square foot) | $ / ft² | 9 | |
Annual increase per square foot (in dollars per square foot) | $ / ft² | 0.25 | |
Cost Components of Operating Leases [Abstract] | ||
Operating lease cost | $ 213 | |
Variable lease cost | 102 | |
Total | 315 | |
Maturities of Lease Liability [Abstract] | ||
2020 | 213 | |
2021 | 219 | |
2022 | 55 | |
Total lease payments | 487 | |
Less: Interest | (40) | |
Present value of lease liability | $ 447 | |
Remaining lease term | 2 years 3 months | |
Discount rate | 7.50% | |
Operating cash outflows from operating lease | $ 206 | |
Rent expense | $ 293 | |
Future Minimum Lease Payments [Abstract] | ||
2019 | 217 | |
2020 | 220 | |
2021 | 219 | |
2022 | 55 | |
2023 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Aug. 31, 2016 | |
Employee Retirement Plan [Abstract] | |||
Employer's matching contribution | $ 227 | $ 197 | |
Aquadex Product Line [Member] | |||
Contingent Consideration [Abstract] | |||
Fair value of contingent consideration | 0 | $ 126 | |
Contingent consideration | $ 0 | $ 126 |
Related Party Transactions (Det
Related Party Transactions (Details) - Steven Brandt [Member] | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Related Party Transaction [Abstract] | |
Monthly fee with related party | $ 19,000 |
Service charges from related party | 76,000 |
Reimbursement expenses with related party | $ 2,453 |
Segment and Geographic Inform_2
Segment and Geographic Information (Details) | 12 Months Ended |
Dec. 31, 2019Segment | |
Segment and Geographic Information [Abstract] | |
Number of reportable segments | 1 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands | Jan. 28, 2020 | Nov. 06, 2019 | Oct. 25, 2019 |
Subsequent Events [Abstract] | |||
Issuance of common stock, net (in shares) | 1,219,076 | 575,830 | |
Warrants to purchase shares of common stock (in shares) | 1,219,076 | 575,830 | |
Gross proceeds from public stock offering | $ 1,360 | $ 660 | |
Subsequent Event [Member] | |||
Subsequent Events [Abstract] | |||
Issuance of common stock, net (in shares) | 6,046,367 | ||
Warrants to purchase shares of common stock (in shares) | 17,563,636 | ||
Gross proceeds from public stock offering | $ 9,700 | ||
Net proceeds from public stock offering | $ 8,600 | ||
Series H Preferred Stock [Member] | Subsequent Event [Member] | |||
Subsequent Events [Abstract] | |||
Issuance of common stock, net (in shares) | 11,517,269 |