Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 19, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Entity Registrant Name | CHF Solutions, Inc. | ||
Entity Central Index Key | 0001506492 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Address, State or Province | MN | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 8.3 | ||
Entity Common Stock, Shares Outstanding | 6,531,942 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 14,437 | $ 1,279 |
Accounts receivable | 905 | 799 |
Inventories | 2,957 | 1,797 |
Other current assets | 237 | 161 |
Total current assets | 18,536 | 4,036 |
Property, plant and equipment, net | 1,200 | 991 |
Operating lease right-of-use asset, net | 255 | 442 |
Other assets | 21 | 133 |
TOTAL ASSETS | 20,012 | 5,602 |
Current liabilities | ||
Accounts payable | 1,097 | 1,488 |
Accrued compensation | 2,192 | 1,592 |
Current portion of operating lease liability | 206 | 186 |
Current portion of finance lease liability | 24 | 0 |
Other current liabilities | 66 | 85 |
Total current liabilities | 3,585 | 3,351 |
Operating lease liability | 55 | 261 |
Finance lease liability | 54 | 0 |
Total liabilities | 3,694 | 3,612 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of December 31, 2020 and December 31, 2019, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 2,736,060 and 155,802, respectively | 0 | 0 |
Additional paid-in capital | 249,663 | 218,278 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | (7) | 1,214 |
Accumulated deficit | (233,338) | (217,502) |
Total stockholders' equity | 16,318 | 1,990 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 20,012 | 5,602 |
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, 2020 | Dec. 31, 2019 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,969,873 | 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) | 2,736,060 | 155,802 |
Common stock, shares outstanding (in shares) | 2,736,060 | 155,802 |
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) | 127 | 535 |
Preferred stock, shares issued (in shares) | 127 | 535 |
Preferred stock, shares outstanding (in shares) | 127 | 535 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||
Net sales | $ 7,441 | $ 5,511 |
Costs and Expenses: | ||
Cost of goods sold | 3,384 | 2,660 |
Selling, general and administrative | 17,417 | 16,285 |
Research and development | 3,668 | 4,672 |
Total costs and expenses | 24,469 | 23,617 |
Loss from operations | (17,028) | (18,106) |
Realized foreign currency translation gain from dissolution of subsidiary | 1,202 | 0 |
Other income (expense), net | (1) | 0 |
Loss before income taxes | (15,827) | (18,106) |
Income tax expense | (9) | (8) |
Net loss | $ (15,836) | $ (18,114) |
Basic and diluted loss per share (in dollars per share) | $ (10.67) | $ (278.90) |
Weighted average shares outstanding - basic and diluted (in shares) | 1,649 | 81 |
Other comprehensive loss: | ||
Realized foreign currency translation gain from dissolution of subsidiary | $ (1,202) | $ 0 |
Unrealized foreign currency translation adjustment | (19) | (9) |
Total comprehensive loss | $ (17,057) | $ (18,123) |
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, 2018 | $ 0 | $ 204,101 | $ 1,223 | $ (199,388) | $ 5,936 |
Balance (in shares) at Dec. 31, 2018 | 17,114 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (18,114) | (18,114) |
Realized foreign currency translation gain from dissolution of subsidiary | 0 | ||||
Unrealized 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) | 0 | ||||
Issuance of common stock, net | $ 0 | 12,665 | 0 | 0 | 12,665 |
Issuance of common stock, net (in shares) | 59,955 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 78,733 | ||||
Balance at Dec. 31, 2019 | $ 0 | 218,278 | 1,124 | (217,502) | 1,990 |
Balance (in shares) at Dec. 31, 2019 | 155,802 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (15,836) | (15,836) |
Realized foreign currency translation gain from dissolution of subsidiary | 0 | 0 | (1,202) | 0 | (1,202) |
Unrealized foreign currency translation adjustment | 0 | 0 | (19) | 0 | (19) |
Stock-based compensation, net | $ 0 | 1,349 | 0 | 0 | 1,349 |
Stock-based compensation, net (in shares) | 0 | ||||
Issuance of common stock, net | $ 0 | 25,921 | 0 | 0 | 25,921 |
Issuance of common stock, net (in shares) | 1,695,877 | ||||
Exercise of warrants | $ 0 | 4,115 | 0 | 0 | 4,115 |
Exercise of warrants (in shares) | 455,139 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 429,242 | ||||
Balance at Dec. 31, 2020 | $ 0 | $ 249,663 | $ (7) | $ (233,338) | $ 16,318 |
Balance (in shares) at Dec. 31, 2020 | 2,736,060 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Activities: | ||
Net loss | $ (15,836) | $ (18,114) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization | 376 | 239 |
Stock-based compensation expense | 1,349 | 1,512 |
Loss on disposal of property and equipment | 40 | 0 |
Realized foreign currency translation gain from dissolution of subsidiary | (1,202) | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (106) | (13) |
Inventories | (1,420) | (343) |
Other current assets | (76) | 42 |
Other assets and liabilities | 112 | 18 |
Accounts payable and accrued compensation | 191 | 292 |
Net cash used in operations | (16,572) | (16,367) |
Investing activities: | ||
Purchases of property and equipment | (298) | (490) |
Proceeds from sale of property and equipment | 31 | 0 |
Net cash used in investing activities | (267) | (490) |
Financing activities: | ||
Proceeds from public stock offerings, net | 25,921 | 12,665 |
Proceeds from warrant exercises | 4,115 | 0 |
Payments on finance lease liability | (20) | 0 |
Net cash provided by financing activities | 30,016 | 12,665 |
Effect of exchange rate changes on cash | (19) | (9) |
Net increase (decrease) in cash and cash equivalents | 13,158 | (4,201) |
Cash and cash equivalents - beginning of year | 1,279 | 5,480 |
Cash and cash equivalents - end of year | 14,437 | 1,279 |
Supplemental schedule of non-cash activities | ||
Financing fees incurred for subsequent equity financing included in other assets and accounts payable | 0 | 111 |
Inventory transferred to property, plant and equipment | 260 | 204 |
Equipment acquired through finance lease liability | 98 | 0 |
Supplemental cash flow information | ||
Cash paid for income taxes | $ 10 | $ 4 |
Nature of Business and Signific
Nature of Business and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Nature of Business and Significant Accounting Policies | Note 1—Nature of Business and Significant Accounting Policies 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 (collectively, the “Aquadex System”) for ultrafiltration therapy. The Aquadex SmartFlow™ system is indicated for temporary (up to eight hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20kg or more whose fluid overload is unresponsive to medical management, including diuretics In August 2016, the Company acquired the business associated with the Aquadex System (the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”), and refocused its strategy to fully devote its resources to the Aquadex Business. On October 6, 2020, the Company’s stockholders approved a reverse split of its outstanding common stock at a ratio in the range of 1-for-5 to 1-for-30 and, on October 9, 2020, the board of directors approved a 1-for-30 reverse split of the Company’s outstanding common stock that became effective after trading on October 16, 2020. This reverse stock split did not change the par value of the Company’s common stock or the number of common or preferred shares authorized by the Company’s Fourth Amended and Restated Certificate of Incorporation, as amended. All share and per-share amounts have been retroactively adjusted to reflect the reverse stock splits for all periods presented. Going Concern The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2020 and 2019, 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, 2020, the Company had an accumulated deficit of $233.3 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. 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 2019, 2020 and through March 19, 2021, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $57.7 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (see Note 5 –Stockholders’ Equity and Note 14 – 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. The Company believes that its existing capital resources will be sufficient to support its operating plan through December 31, 2022. However, the Company may seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. 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 Ltd (through November 2020) and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. During the year ended December 31, 2020, the Company closed its Australian subsidiary and recognized a gain of $1.2 million on the dissolution of the entity, due to the recognition of previously unrealized foreign currency translation gains. This subsidiary represented an immaterial portion of our operations and the dissolution did not represent a strategic shift and therefore, is not presented as a discontinued operation. Use of Estimates The preparation of consolidated 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, 2020 or December 31, 2019. As of December 31, 2020, no customer represented over 10% of the accounts receivable balance. As of December 31, 2019, two customers represented 13% and 12% of the accounts receivable balance. Inventories Inventories are recorded as the lower of cost or net realizable value using the first-in, first-out method. Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following as of December 31: 2020 2019 Finished Goods $ 1,343 $ 750 Work in Process 342 79 Raw Materials 1,272 968 Total $ 2,957 $ 1,797 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 1-5 years Leasehold improvements 3-5 years Depreciation expense was $376,000 and $239,000 for the years ended December 31, 2020, and 2019, 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. 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 continues to report operating losses and negative cash flows from operations, both of which it considers to be indicators of potential impairment. Therefore, the Company evaluates its long-lived assets for potential impairment at each reporting period. The Company has concluded that its cash flows from the various long-lived assets are highly interrelated and, as a result, the Company consists of a single asset group. As the Company expects to continue incurring losses in the foreseeable future, the undiscounted cash flow step was bypassed and the Company proceeded to fair value the asset group. The Company has determined the fair value of the asset group using expected cash flows associated with its loaner units by considering sales prices for similar assets and by estimating future discounted cash flows expected from the units. For recently acquired assets within the asset group, primarily equipment, the Company determined the fair value based on the replacement cost. Because the Company consists of one asset group, consideration is also given to the relationship between the Company’s market capitalization and its carrying value to further support the Company’s determination of fair value. There have been no impairment losses recognized for the years ended December 31, 2020 or 2019. 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 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 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, 2020, reflects a $1.8 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the public offering of Series H Convertible Preferred Stock on January 28, 2020. This net deemed dividend includes $0.2 million that resulted from the subsequent reduction in the exercise of price of the warrants as a result of the March 2020 offering. 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 – Stockholders’ 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 31, 2020 2019 Stock options 16,889 13,471 Warrants to purchase common stock 1,631,948 231,629 Series F convertible preferred stock 14,224 18,190 Total 1,663,061 263,290 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) 2020 2019 Net loss $ (15,836 ) $ (18,114 ) Deemed dividend to preferred stockholders (see Note 5) (1,757 ) (4,509 ) Net loss after deemed dividend (17,593 ) (22,623 ) Weighted average shares outstanding 1,649 81 Basic and diluted loss per share $ (10.67 ) $ (278.90 ) 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 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. There are no new accounting pronouncements not yet adopted that the Company believes will have a material impact on its consolidated financial statements. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2020 | |
Revenue Recognition [Abstract] | |
Revenue Recognition | Note 2 – Revenue Recognition 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 Austria, Brazil, Brunei, Germany, Greece, Hong Kong, India, Israel, Italy, Palestine, Singapore, Spain, Switzerland, Thailand and the United Kingdom. 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 we expect 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’s 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, 2020 and 2019. 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. Customers that are part of a group purchasing organization and have agreements with the Company receive administrative fees for purchases which are netted against revenues. Product Returns: believes that future returns of its products will be minimal. |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Note 3—Property, Plant and Equipment Property, plant and equipment were as follows: (in thousands) December 31, 2020 December 31, 2019 Production Equipment $ 1,201 $ 1,113 Loaners and Demo Equipment 1,073 801 Computer Software and Equipment 691 579 Office Furniture & Fixtures 364 291 Leasehold Improvements 242 224 Total 3,571 3,008 Accumulated Depreciation (2,371 ) (2,017 ) $ 1,200 $ 991 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2020 | |
Debt [Abstract] | |
Debt | Note 4—Debt 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 were available to the Company until March 31, 2020 and were to 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, were to be collateralized by all of the Company’s assets, excluding intellectual property which was subject to a negative pledge. The Revolving Line expired unused on March 31, 2020. There were no borrowings outstanding under this facility as of December 31, 2019. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity [Abstract] | |
Stockholders' Equity | Note 5—Stockholders’ Equity 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 $1,890.00 per share. Each share of Series F convertible 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 $1,890.00 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 $1,890.00 per share. The Series F convertible 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 convertible 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 convertible 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 9,557 shares of common stock and warrants to purchase 19,122 shares of common stock were issued in the offering. Effective March 12, 2019, the conversion price of the Series F convertible preferred stock was reduced from $890.40 to $157.50, the per share price to the public of the Series G convertible preferred stock issued in the March 2019 Offering, described below. Effective October 25, 2019, the conversion price of the Series F convertible preferred stock was reduced from $157.50 to $42.30, and on November 6, 2019 from $42.30 to $29.83, the per share price to the public in the October and November 2019 transactions, respectively, described below. Effective January 28, 2020, the conversion price of the Series F convertible preferred stock was reduced from $29.83 to $16.50, the per share price to the public of the Series H convertible preferred stock which closed in an underwritten public offering on January 28, 2020, described below. Effective March 23, 2020, the conversion price of the Series F convertible preferred stock was reduced from $16.50 to $9.00, the per share price to the public in the March 2020 transaction, described below. As of December 31, 2020, and December 31, 2019, 127 and 535 shares, respectively, of the Series F convertible preferred stock remained outstanding. Series G Convertible Preferred Stock and March 2019 Offering The March 2019 Offering was comprised of 15,173 shares of common stock priced at $157.50 per share and 1,910,536 shares of Series G convertible preferred stock, convertible into common stock at $157.50 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 78,863 shares of common stock and the Series 2 warrants are exercisable into 78,863 shares of common stock. Series 1 warrants expire on the fifth anniversary of the date of issuance and are exercisable at $157.50 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 30th trading day following the public announcement of the receipt from the U.S. Food and Drug Administration (FDA) 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 $157.50 per share of common stock. The Company announced it had received FDA clearance for use of its Aquadex System in pediatric patients on February 26, 2020, effectively setting the date of expiration of these warrants for April 8, 2020. As of December 31, 2019, all 63,685 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 25, 2019, the Company closed on a registered direct offering of 19,195 shares of common stock at a price of $34.50 per share, for gross proceeds of approximately $660,000, 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 19,196 shares of its common stock at an exercise price of $42.30 per share, which became exercisable six months from the date of issuance and will expire five years from the initial exercise date. On November 6, 2019, the Company closed on a registered direct offering of 40,637 shares of common stock, or common equivalents, at a price of $33.60 per share, for gross proceeds of approximately $1.36 million 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 warrants to purchase up to 40,638 shares of our common stock at an exercise price of $29.83 per share, which were exercisable upon the date of issuance, and will expire five years from the initial exercise date. Series H Convertible Preferred Stock and January 2020 Offering: The January 2020 Offering was comprised of 201,546 shares of common stock priced at $16.50 per share and 11,517,269 shares of Series H convertible preferred stock, convertible into common stock at $16.50 per share, . Each share of Series H convertible preferred stock and each share of common stock was accompanied by a warrant to purchase common stock. The warrants are exercisable into 585,460 shares of common stock. As of December 31, 2020, all 11,517,269 shares of the Series H convertible preferred stock had been converted into common stock and none remained outstanding. As of December 31, 2020, warrants to purchase 455,162 shares of common stock had been exercised for total cash proceeds of $4.1 million. March 2020 Offering: April 2020 Offering May 2020 Offering August 2020 Offering 1,064,678 shares of common stock priced at $13.50 per share. Each share of common stock was accompanied by a warrant to purchase common stock. The warrants are exercisable into 1,064,678 shares of common stock. Placement Agent Fees Market-Based Warrants |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2020 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | Note 6— Stock-Based Compensation 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 $1.3 million, and $1.5 million during the years ended December 31, 2020 and 2019, 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) 2020 2019 Selling, general and administrative $ 1,252 $ 1,387 Research and development 97 125 Total $ 1,349 $ 1,512 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 2020 2019 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 13,471 $ 515.33 4,638 $ 1,461.24 Granted 5,542 10.03 9,374 71.40 Exercised — — — — Forfeited/expired (2,124 ) 71.51 (541 ) 926.31 Outstanding at December 31 16,889 $ 405.34 13,471 $ 515.33 Vested at December 31 7,254 $ 697.37 2,383 $ 1,417.42 For options outstanding and vested at December 31, 2020, the weighted average remaining contractual life was 8.47 years and 8.07 years, respectively. There were no option exercises in 2020 or 2019. The total fair value of options that vested in 2020 and 2019 was $1.7 million, and $2.4 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: 2020 2019 Expected dividend yield 0 % 0 % Risk-free interest rate 0.65 % 1.85 % Expected volatility 127.87 % 121.67 % Expected life (in years) 5.91 6.22 The weighted-average fair value of stock options granted in 2020 and 2019 was $8.79 and $62.37, respectively. As of December 31, 2020, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $1.5 million and is expected to be recognized over the remaining weighted-average period of 2.53 years. Warrants Warrants to purchase 1,631,948 and 231,629 shares of common stock were outstanding at December 31, 2020 and 2019, respectively. As of December 31, 2020, warrants outstanding were exercisable at prices ranging from $9.00 to $53,550 per share, and are exercisable over a period ranging from 10 months to 4.9 years. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Note 7 - Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents and warrants. Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” • Level 1 • Level 2 • Level 3 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 were 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 Level 3 and there were no movements between these categories as of December 31, 2020 and December 31, 2019. 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, 2020 | |
Income Taxes [Abstract] | |
Income Taxes | Note 8—Income Taxes Domestic and foreign loss before income taxes, consists of the following for the years ended December 31: (in thousands) 2020 2019 Domestic $ (15,865 ) $ (18,114 ) Foreign 38 8 Loss before income taxes $ (15,827 ) $ (18,106 ) The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2020 2019 Current: United States and state $ — $ — Foreign, net (9 ) (8 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (9 ) $ (8 ) Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2020 2019 Statutory federal income tax benefit $ 3,324 $ 3,802 State tax benefit, net of federal taxes 94 46 Foreign tax (1 ) 1 Foreign deferred exchange rate adjustments 1,027 (59 ) Dissolution of foreign subsidiary (11,401 ) — Nondeductible/nontaxable items 34 (272 ) Other (255 ) (113 ) Valuation allowance (increase) decrease 7,169 (3,413 ) Total income tax expense $ (9 ) $ (8 ) Deferred taxes consist of the following as of December 31: (in thousands) 2020 2019 Deferred tax assets: Noncurrent: Accrued leave $ 61 $ 51 Other accrued expenses — — Stock based compensation 293 449 Net operating loss carryforward 37,665 44,572 Other 11 69 Intangibles 751 809 R&D credit carryforward 531 531 Total deferred tax assets 39,312 46,481 Less: valuation allowance (39,312 ) (46,481 ) Total $ — $ — As of December 31, 2020, 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, 2019 and 2020, 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, 2020 or 2019. 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, 2020 and 2019, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2017 through December 31, 2020 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 (through November 2020) and Irish subsidiary are subject to examination by tax authorities of those jurisdictions for the tax years ended and subsequent to June 30, 2015 and December 31, 2015, respectively. |
Operating Leases
Operating Leases | 12 Months Ended |
Dec. 31, 2020 | |
Operating Leases [Abstract] | |
Operating Leases | Note 9—Operating Leases 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 31, : (in thousands) 2020 2019 Operating lease cost $ 213 $ 213 Variable lease cost 114 102 Total $ 327 $ 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 31, : (in thousands) 2020 2021 $ 219 2022 55 Total lease payments 274 Less: Interest (13 ) Present value of lease liability $ 261 As of December 31, 2020, and 2019 the remaining lease terms were 1.25 and 2.25 years, respectively, and discount rates were 7.5% for each year. For the years ended December 31, 2020, and 2019 the operating cash outflows from the Company’s operating lease for office and manufacturing space were $213,000 and $206,000, respectively. |
Finance Lease Liability
Finance Lease Liability | 12 Months Ended |
Dec. 31, 2020 | |
Finance Lease Liability [Abstract] | |
Finance Lease Liability | Note 10—Finance Lease Liability In 2020, the Company entered into lease agreements to finance equipment valued at $98,000. The equipment consisted of computer hardware and audio-visual equipment and is included in Property, Plant and Equipment in the accompanying consolidated financial statements. The principal amount under the lease agreements was $93,000 at the date the lease commenced, the implied interest rate is 7.5%, and the term of the lease is 39 months. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 11—Commitments and Contingencies 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 $234,000 and $227,000 for the years ended December 31, 2020 and 2019, respectively. Contingent Consideration In connection with the Company’s purchase of the Aquadex Business in August 2016, 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 $126,000, 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 2019, this contingency had expired, therefore its fair value was $0. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 12—Related Party Transactions 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. There were no related party transactions requiring disclosure during the year ended December 31, 2020. |
Segment and Geographic Informat
Segment and Geographic Information | 12 Months Ended |
Dec. 31, 2020 | |
Segment and Geographic Information [Abstract] | |
Segment and Geographic Information | Note 13—Segment and Geographic Information 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 Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 14 – Subsequent Events On January 19, 2021, the Company announced that Nestor Jaramillo, Jr. was appointed as Chief Executive Officer and President of the Company. In connection with such appointment, he entered into an Executive Employment Agreement with the Company. Mr. Jaramillo had served as the Company’s chief operating officer and president since June 2020 and as the Company’s chief commercial officer from May 2019 to June 2020. John Erb, the predecessor Chief Executive Officer will remain a part-time employee for a period of six months to assist with the transition and thereafter will continue to serve as the Company’s Chairman of the Board. On March 19, 2021, the Company closed on an underwritten public offering of 3,795,816 shares of common stock, which includes the full exercise of the underwriter’s over-allotment option, for gross proceeds of approximately $20.9 million. Net proceeds totaled approximately $19.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering and after giving effect to the underwriters’ full exercise of their overallotment option. In connection with this transaction, the conversion price of the Series F convertible preferred stock was reduced from $9.00 to $5.50, the per share price to the public in the March 2021 transaction, described above. In addition, the exercise price of the common stock warrants issued in connection with the January 2020 Offering was reduced from $9.00 to $5.50, the per share price to the public in the March 2021 offering, described above. |
Nature of Business and Signif_2
Nature of Business and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Going Concern | Going Concern The Company’s consolidated financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2020 and 2019, 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, 2020, the Company had an accumulated deficit of $233.3 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. 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 2019, 2020 and through March 19, 2021, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $57.7 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (see Note 5 –Stockholders’ Equity and Note 14 – 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. The Company believes that its existing capital resources will be sufficient to support its operating plan through December 31, 2022. However, the Company may seek to raise additional capital to support its growth or other strategic initiatives through debt, equity or a combination thereof. |
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 Ltd (through November 2020) and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. During the year ended December 31, 2020, the Company closed its Australian subsidiary and recognized a gain of $1.2 million on the dissolution of the entity, due to the recognition of previously unrealized foreign currency translation gains. This subsidiary represented an immaterial portion of our operations and the dissolution did not represent a strategic shift and therefore, is not presented as a discontinued operation. |
Use of Estimates | Use of Estimates The preparation of consolidated 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, 2020 or December 31, 2019. As of December 31, 2020, no customer represented over 10% of the accounts receivable balance. As of December 31, 2019, two customers represented 13% and 12% of the accounts receivable balance. |
Inventories | Inventories Inventories are recorded as the lower of cost or net realizable value using the first-in, first-out method. Overhead is allocated to manufactured finished goods inventory based on the normal capacity of the Company’s production facilities. Abnormal amounts of overhead, if any, are expensed as incurred. Inventories consisted of the following as of December 31: 2020 2019 Finished Goods $ 1,343 $ 750 Work in Process 342 79 Raw Materials 1,272 968 Total $ 2,957 $ 1,797 |
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 1-5 years Leasehold improvements 3-5 years Depreciation expense was $376,000 and $239,000 for the years ended December 31, 2020, and 2019, 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. 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 continues to report operating losses and negative cash flows from operations, both of which it considers to be indicators of potential impairment. Therefore, the Company evaluates its long-lived assets for potential impairment at each reporting period. The Company has concluded that its cash flows from the various long-lived assets are highly interrelated and, as a result, the Company consists of a single asset group. As the Company expects to continue incurring losses in the foreseeable future, the undiscounted cash flow step was bypassed and the Company proceeded to fair value the asset group. The Company has determined the fair value of the asset group using expected cash flows associated with its loaner units by considering sales prices for similar assets and by estimating future discounted cash flows expected from the units. For recently acquired assets within the asset group, primarily equipment, the Company determined the fair value based on the replacement cost. Because the Company consists of one asset group, consideration is also given to the relationship between the Company’s market capitalization and its carrying value to further support the Company’s determination of fair value. There have been no impairment losses recognized for the years ended December 31, 2020 or 2019. |
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 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 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, 2020, reflects a $1.8 million increase for the net deemed dividend to preferred stockholders provided in connection with the close of the public offering of Series H Convertible Preferred Stock on January 28, 2020. This net deemed dividend includes $0.2 million that resulted from the subsequent reduction in the exercise of price of the warrants as a result of the March 2020 offering. 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 – Stockholders’ 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 31, 2020 2019 Stock options 16,889 13,471 Warrants to purchase common stock 1,631,948 231,629 Series F convertible preferred stock 14,224 18,190 Total 1,663,061 263,290 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) 2020 2019 Net loss $ (15,836 ) $ (18,114 ) Deemed dividend to preferred stockholders (see Note 5) (1,757 ) (4,509 ) Net loss after deemed dividend (17,593 ) (22,623 ) Weighted average shares outstanding 1,649 81 Basic and diluted loss per share $ (10.67 ) $ (278.90 ) |
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 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. There are no new accounting pronouncements not yet adopted that the Company believes will have a material impact on its consolidated financial statements. |
Nature of Business and Signif_3
Nature of Business and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Nature of Business and Significant Accounting Policies [Abstract] | |
Inventories | Inventories consisted of the following as of December 31: 2020 2019 Finished Goods $ 1,343 $ 750 Work in Process 342 79 Raw Materials 1,272 968 Total $ 2,957 $ 1,797 |
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 1-5 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 31, 2020 2019 Stock options 16,889 13,471 Warrants to purchase common stock 1,631,948 231,629 Series F convertible preferred stock 14,224 18,190 Total 1,663,061 263,290 |
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) 2020 2019 Net loss $ (15,836 ) $ (18,114 ) Deemed dividend to preferred stockholders (see Note 5) (1,757 ) (4,509 ) Net loss after deemed dividend (17,593 ) (22,623 ) Weighted average shares outstanding 1,649 81 Basic and diluted loss per share $ (10.67 ) $ (278.90 ) |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment were as follows: (in thousands) December 31, 2020 December 31, 2019 Production Equipment $ 1,201 $ 1,113 Loaners and Demo Equipment 1,073 801 Computer Software and Equipment 691 579 Office Furniture & Fixtures 364 291 Leasehold Improvements 242 224 Total 3,571 3,008 Accumulated Depreciation (2,371 ) (2,017 ) $ 1,200 $ 991 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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) 2020 2019 Selling, general and administrative $ 1,252 $ 1,387 Research and development 97 125 Total $ 1,349 $ 1,512 |
Summary of Plan Stock Option Activity | The following is a summary of the Plans’ stock option activity during the years ended December 31: 2020 2019 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 13,471 $ 515.33 4,638 $ 1,461.24 Granted 5,542 10.03 9,374 71.40 Exercised — — — — Forfeited/expired (2,124 ) 71.51 (541 ) 926.31 Outstanding at December 31 16,889 $ 405.34 13,471 $ 515.33 Vested at December 31 7,254 $ 697.37 2,383 $ 1,417.42 |
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: 2020 2019 Expected dividend yield 0 % 0 % Risk-free interest rate 0.65 % 1.85 % Expected volatility 127.87 % 121.67 % Expected life (in years) 5.91 6.22 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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) 2020 2019 Domestic $ (15,865 ) $ (18,114 ) Foreign 38 8 Loss before income taxes $ (15,827 ) $ (18,106 ) |
Components of Income Tax Expense | The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2020 2019 Current: United States and state $ — $ — Foreign, net (9 ) (8 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (9 ) $ (8 ) |
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) 2020 2019 Statutory federal income tax benefit $ 3,324 $ 3,802 State tax benefit, net of federal taxes 94 46 Foreign tax (1 ) 1 Foreign deferred exchange rate adjustments 1,027 (59 ) Dissolution of foreign subsidiary (11,401 ) — Nondeductible/nontaxable items 34 (272 ) Other (255 ) (113 ) Valuation allowance (increase) decrease 7,169 (3,413 ) Total income tax expense $ (9 ) $ (8 ) |
Deferred Taxes | Deferred taxes consist of the following as of December 31: (in thousands) 2020 2019 Deferred tax assets: Noncurrent: Accrued leave $ 61 $ 51 Other accrued expenses — — Stock based compensation 293 449 Net operating loss carryforward 37,665 44,572 Other 11 69 Intangibles 751 809 R&D credit carryforward 531 531 Total deferred tax assets 39,312 46,481 Less: valuation allowance (39,312 ) (46,481 ) Total $ — $ — |
Operating Leases (Tables)
Operating Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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 31, : (in thousands) 2020 2019 Operating lease cost $ 213 $ 213 Variable lease cost 114 102 Total $ 327 $ 315 |
Maturities of Lease Liability | Maturities of our lease liability for the Company’s operating lease are as follows as of December 31, : (in thousands) 2020 2021 $ 219 2022 55 Total lease payments 274 Less: Interest (13 ) Present value of lease liability $ 261 |
Nature of Business and Signif_4
Nature of Business and Significant Accounting Policies, Nature of Business, Going Concern, Basis of Presentation, Accounts Receivable and Inventories (Details) $ in Thousands | Oct. 09, 2020 | Oct. 06, 2020 | Dec. 31, 2020USD ($)Customer | Dec. 31, 2019USD ($)Customer | Mar. 19, 2021USD ($) |
Nature of Business [Abstract] | |||||
Reverse stock split ratio | 0.033 | ||||
Going Concern [Abstract] | |||||
Accumulated deficit | $ (233,338) | $ (217,502) | |||
Basis of Presentation [Abstract] | |||||
Gain on dissolution of foreign subsidiary | $ 1,202 | ||||
Accounts Receivable [Abstract] | |||||
Accounts receivables maximum credit period from invoice date | 30 days | ||||
Allowance for doubtful accounts | $ 0 | 0 | |||
Inventories [Abstract] | |||||
Finished Goods | 1,343 | 750 | |||
Work in Process | 342 | 79 | |||
Raw Materials | 1,272 | 968 | |||
Total | $ 2,957 | $ 1,797 | |||
Subsequent Event [Member] | |||||
Going Concern [Abstract] | |||||
Net proceeds from issuance of public offering | $ 57,700 | ||||
Minimum [Member] | |||||
Nature of Business [Abstract] | |||||
Reverse stock split ratio | 0.2 | ||||
Maximum [Member] | |||||
Nature of Business [Abstract] | |||||
Reverse stock split ratio | 0.033 | ||||
Accounts Receivable [Member] | |||||
Revenue, Performance Obligation [Abstract] | |||||
Number of major customers | Customer | 0 | 2 | |||
Accounts Receivable [Member] | Customer One [Member] | |||||
Revenue, Performance Obligation [Abstract] | |||||
Concentration risk percentage | 13.00% | ||||
Accounts Receivable [Member] | Customer Two [Member] | |||||
Revenue, Performance Obligation [Abstract] | |||||
Concentration risk percentage | 12.00% |
Nature of Business and Signif_5
Nature of Business and Significant Accounting Policies, Property, Plant and Equipment and Revenue Recognition (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 376 | $ 239 |
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 | 1 year | |
Loaners and Demo Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 5 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 | |
ASC 606 [Member] | Customer One [Member] | Net Sales [Member] | ||
Revenue, Performance Obligation [Abstract] | ||
Concentration risk percentage | 10.50% | 10.00% |
Nature of Business and Signif_6
Nature of Business and Significant Accounting Policies, Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
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) | 1,663,061 | 263,290 |
Reconciliation of reported net loss with reported net loss per share [Abstract] | ||
Net loss | $ (15,836) | $ (18,114) |
Deemed dividend to preferred shareholders (see Note 5) | (1,757) | (4,509) |
Net loss after deemed dividend | $ (17,593) | $ (22,623) |
Weighted average shares outstanding (in shares) | 1,649,000 | 81,000 |
Basic and diluted loss per share (in dollars per share) | $ (10.67) | $ (278.90) |
March 2020 Offering [Member] | ||
Loss per share [Abstract] | ||
Net deemed dividends resulting from subsequent reduction in exercise price of warrants | $ 200 | |
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) | 16,889 | 13,471 |
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) | 1,631,948 | 231,629 |
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) | 14,224 | 18,190 |
Revenue Recognition (Details)
Revenue Recognition (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2020-01-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||
Expected timing of satisfaction, period | 1 year | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2021-01-01 | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||
Expected timing of satisfaction, period | 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, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | $ 3,571 | $ 3,008 |
Accumulated Depreciation | (2,371) | (2,017) |
Property, Plant and Equipment, Net | 1,200 | 991 |
Production Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 1,201 | 1,113 |
Loaners and Demo Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 1,073 | 801 |
Computer Software and Equipment [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 691 | 579 |
Office Furniture & Fixtures [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | 364 | 291 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment, Gross [Abstract] | ||
Property, Plant and Equipment, Gross | $ 242 | $ 224 |
Debt (Details)
Debt (Details) - Silicon Valley Bank [Member] - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | 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 | ||
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% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Thousands | Aug. 21, 2020USD ($)$ / sharesshares | May 05, 2020USD ($)$ / sharesshares | Apr. 01, 2020USD ($)shares | Mar. 23, 2020USD ($)$ / sharesshares | Jan. 28, 2020USD ($)$ / sharesshares | Nov. 06, 2019USD ($)$ / sharesshares | Oct. 25, 2019USD ($)$ / sharesshares | Mar. 12, 2019USD ($)$ / sharesshares | Nov. 27, 2017USD ($)$ / sharesshares | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)shares | Apr. 02, 2020$ / sharesshares | May 30, 2019$ / sharesshares | Jul. 03, 2018$ / shares |
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | 585,460 | 40,638 | 19,196 | |||||||||||
Warrants exercised to purchase common stock (in shares) | 455,162 | |||||||||||||
Proceeds from warrant exercises | $ | $ 4,115 | $ 0 | ||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 11.18 | $ 16.50 | $ 29.83 | $ 42.30 | ||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||||||
Issuance of common stock, net (in shares) | 201,546 | 40,637 | 19,195 | |||||||||||
Public offering price (in dollars per share) | $ / shares | $ 33.60 | $ 34.50 | ||||||||||||
Gross proceeds from public stock offering | $ | $ 9,700 | $ 1,360 | $ 660 | |||||||||||
Net proceeds from public stock offering | $ | 8,600 | |||||||||||||
Down-round protection in connection with re-pricing of warrants | $ | 200 | |||||||||||||
Beneficial conversion amount | $ | $ 1,600 | |||||||||||||
Warrant expiry period | 5 years 6 months | 5 years | 5 years | |||||||||||
Warrants exercisable period | 6 months | 6 months | ||||||||||||
Expected Stock Price Volatility [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants measurement input | 1.3621 | |||||||||||||
March 2019 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Issuance of common stock, net (in shares) | 15,173 | |||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 157.50 | |||||||||||||
March 2020 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | 138,715 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 9 | |||||||||||||
Issuance of common stock, net (in shares) | 138,715 | |||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 9 | |||||||||||||
Gross proceeds from public stock offering | $ | $ 1,200 | |||||||||||||
Net proceeds from public stock offering | $ | $ 1,000 | |||||||||||||
April 2020 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | 85,506 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 11.15 | |||||||||||||
Issuance of common stock, net (in shares) | 171,008 | |||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 13.02 | |||||||||||||
Gross proceeds from public stock offering | $ | $ 2,200 | |||||||||||||
Warrant expiry period | 5 years 6 months | |||||||||||||
May 2020 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | 59,966 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 12.30 | |||||||||||||
Issuance of common stock, net (in shares) | 119,930 | |||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 14.18 | |||||||||||||
Gross proceeds from public stock offering | $ | $ 1,700 | |||||||||||||
Warrant expiry period | 5 years 6 months | |||||||||||||
August 2020 Offering [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Issuance of common stock, net (in shares) | 1,064,678 | |||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 13.50 | |||||||||||||
Gross proceeds from public stock offering | $ | $ 14,400 | |||||||||||||
Net proceeds from public stock offering | $ | $ 13,000 | |||||||||||||
Number of shares issuable on the exercise of warrants (in shares) | 1,064,678 | |||||||||||||
Warrant expiry period | 5 years | |||||||||||||
Warrants to Purchase Common Stock [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Number of warrants vested (in shares) | 0 | |||||||||||||
Warrants to Purchase Common Stock [Member] | Minimum [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 9 | |||||||||||||
Warrants to Purchase Common Stock [Member] | Consultant [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | 3,334 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 57.90 | $ 95.40 | ||||||||||||
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 | $ 9 | $ 16.50 | $ 29.83 | $ 42.30 | $ 157.50 | $ 1,890 | $ 890.40 | |||||||
Number of consecutive trading days considered for expiration | 20 days | |||||||||||||
Number of consecutive trading days | 30 days | |||||||||||||
Preferred stock issued (in shares) | 18,000 | 127 | 535 | |||||||||||
Number of shares issuable on conversion of preferred stock (in shares) | 9,557 | |||||||||||||
Preferred stock, shares outstanding (in shares) | 127 | 535 | ||||||||||||
Aggregate cash placement fee | 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 to Purchase Common Stock [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | 19,122 | |||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | 16 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,890 | |||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Warrants to purchase shares of common stock (in shares) | 16 | |||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,890 | |||||||||||||
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 | $ 157.50 | |||||||||||||
Number of consecutive trading days | 30 days | |||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | |||||||||||||
Beneficial conversion amount | $ | $ 4,500 | |||||||||||||
Beneficial ownership limitation | 4.99% | |||||||||||||
Conversion of preferred stock into common stock (in shares) | 63,685 | |||||||||||||
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 | $ 157.50 | |||||||||||||
Number of shares issuable on the exercise of warrants (in shares) | 78,863 | |||||||||||||
Series G Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 157.50 | |||||||||||||
Number of shares issuable on the exercise of warrants (in shares) | 78,863 | |||||||||||||
Series H Preferred Stock [Member] | ||||||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||||||
Conversion price (in dollars per share) | $ / shares | $ 16.50 | |||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | |||||||||||||
Issuance of common stock, net (in shares) | 11,517,269 | |||||||||||||
Public offering price (in dollars per share) | $ / shares | $ 16.50 | |||||||||||||
Maximum percentage of the applicable Unit offering price, by which exercise price can be lower than adjustment | 10.00% | |||||||||||||
Conversion of preferred stock into common stock (in shares) | 11,517,269 |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 1,349 | $ 1,512 |
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 | $ 1,252 | 1,387 |
Research and Development [Member] | ||
Stock-Based Compensation Expense Items [Abstract] | ||
Stock-based compensation expense | $ 97 | $ 125 |
Stock Options [Member] | ||
Stock Options Activity [Roll Forward] | ||
Outstanding, beginning balance (in shares) | 13,471 | 4,638 |
Granted (in shares) | 5,542 | 9,374 |
Exercised (in shares) | 0 | 0 |
Forfeited/expired (in shares) | (2,124) | (541) |
Outstanding, ending balance (in shares) | 16,889 | 13,471 |
Vested at the end of the year (in shares) | 7,254 | 2,383 |
Weighted Average Exercise Price [Abstract] | ||
Outstanding, beginning balance (in dollars per share) | $ 515.33 | $ 1,461.24 |
Granted (in dollars per share) | 10.03 | 71.40 |
Exercised (in dollars per share) | 0 | 0 |
Forfeited/expired (in dollars per share) | 71.51 | 926.31 |
Outstanding, ending balance (in dollars per share) | 405.34 | 515.33 |
Vested at the end of the year (in dollars per share) | $ 697.37 | $ 1,417.42 |
Weighted Average Remaining Contractual Term [Abstract] | ||
Options outstanding, weighted average remaining contractual life | 8 years 5 months 19 days | |
Options vested, weighted average remaining contractual life | 8 years 25 days | |
Aggregate Intrinsic Value [Abstract] | ||
Fair value of options, vested | $ 1,700 | $ 2,400 |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract] | ||
Expected dividend yield | 0.00% | 0.00% |
Risk-free interest rate | 0.65% | 1.85% |
Expected volatility | 127.87% | 121.67% |
Expected life | 5 years 10 months 28 days | 6 years 2 months 19 days |
Additional Disclosures [Abstract] | ||
Weighted-average fair value of options granted (in dollars per share) | $ 8.79 | $ 62.37 |
Total unrecognized compensation costs related to non-vested stock option awards | $ 1,500 | |
Unrecognized compensation costs related to non-vested stock option awards, recognition period | 2 years 6 months 11 days |
Stock-Based Compensation, Warra
Stock-Based Compensation, Warrants (Details) - $ / shares | 12 Months Ended | |||||
Dec. 31, 2020 | Mar. 23, 2020 | Jan. 28, 2020 | Dec. 31, 2019 | Nov. 06, 2019 | Oct. 25, 2019 | |
Class of Warrant or Right [Abstract] | ||||||
Exercise price of warrants (in dollars per share) | $ 11.18 | $ 16.50 | $ 29.83 | $ 42.30 | ||
Warrants [Member] | ||||||
Class of Warrant or Right [Abstract] | ||||||
Warrants outstanding (in shares) | 1,631,948 | 231,629 | ||||
Warrants [Member] | Minimum [Member] | ||||||
Class of Warrant or Right [Abstract] | ||||||
Exercise price of warrants (in dollars per share) | $ 9 | |||||
Warrants exercisable period | 10 months | |||||
Warrants [Member] | Maximum [Member] | ||||||
Class of Warrant or Right [Abstract] | ||||||
Exercise price of warrants (in dollars per share) | $ 53,550 | |||||
Warrants exercisable period | 4 years 10 months 24 days |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Details) - USD ($) $ in Millions | Dec. 31, 2020 | Dec. 31, 2019 |
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 |
Income Taxes, Domestic and Fore
Income Taxes, Domestic and Foreign Loss Before Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Loss before income taxes [Abstract] | ||
Domestic | $ (15,865) | $ (18,114) |
Foreign | 38 | 8 |
Loss before income taxes | $ (15,827) | $ (18,106) |
Income Taxes, Components of Inc
Income Taxes, Components of Income Tax Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Current [Abstract] | ||
United States and state | $ 0 | $ 0 |
Foreign, net | (9) | (8) |
Deferred [Abstract] | ||
United States and state | 0 | 0 |
Foreign | 0 | 0 |
Total income tax expense | $ (9) | $ (8) |
Income Taxes, Effective Income
Income Taxes, Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Effective income tax rate reconciliation [Abstract] | ||
Statutory federal income tax benefit | $ 3,324 | $ 3,802 |
State tax benefit, net of federal taxes | 94 | 46 |
Foreign tax | (1) | 1 |
Foreign deferred exchange rate adjustments | 1,027 | (59) |
Dissolution of foreign subsidiary | (11,401) | 0 |
Nondeductible/nontaxable items | 34 | (272) |
Other | (255) | (113) |
Valuation allowance (increase) decrease | 7,169 | (3,413) |
Total income tax expense | $ (9) | $ (8) |
Income Taxes, Deferred Taxes an
Income Taxes, Deferred Taxes and Other Information (Details) $ in Thousands, $ in Millions | 12 Months Ended | ||
Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2020AUD ($) | |
Noncurrent [Abstract] | |||
Accrued leave | $ 61 | $ 51 | |
Other accrued expenses | 0 | 0 | |
Stock based compensation | 293 | 449 | |
Net operating loss carryforward | 37,665 | 44,572 | |
Other | 11 | 69 | |
Intangibles | 751 | 809 | |
R&D credit carryforward | 531 | 531 | |
Total deferred tax assets | 39,312 | 46,481 | |
Less: valuation allowance | (39,312) | (46,481) | |
Total | 0 | 0 | |
Operating Loss Carryforwards [Abstract] | |||
Increase (decrease) in valuation allowance | (7,200) | 3,400 | |
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 | $ 168,200 | ||
Net operating loss (NOL) carryforwards with expiration date | 120,100 | ||
Net operating loss (NOL) carryforwards with no expiration date | 48,100 | ||
State [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 30,900 | ||
Australian [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 0 |
Operating Leases (Details)
Operating Leases (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020USD ($)$ / ft² | Dec. 31, 2019USD ($) | |
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 | $ 213 |
Variable lease cost | 114 | 102 |
Total | 327 | $ 315 |
Maturities of Lease Liability [Abstract] | ||
2021 | 219 | |
2022 | 55 | |
Total lease payments | 274 | |
Less: Interest | (13) | |
Present value of lease liability | $ 261 | |
Remaining lease term | 1 year 3 months | 2 years 3 months |
Discount rate | 7.50% | 7.50% |
Operating cash outflows from operating lease | $ 213 | $ 206 |
Finance Lease Liability (Detail
Finance Lease Liability (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Finance Lease Liability [Abstract] | |||
Value of finance lease equipment | $ 98 | $ 98 | $ 0 |
Principal amount under lease agreement | $ 93 | $ 93 | |
Implied interest rate | 7.50% | 7.50% | |
Finance lease term | 39 months | 39 months |
Commitments and Contingencies -
Commitments and Contingencies - (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Aug. 31, 2016 | |
Employee Retirement Plan [Abstract] | |||
Employer's matching contribution | $ 234 | $ 227 | |
Aquadex Product Line [Member] | |||
Contingent Consideration [Abstract] | |||
Fair value of contingent consideration | $ 126 | ||
Contingent consideration | $ 0 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Related Party Transaction [Abstract] | ||
Service charges from related party | $ 0 | |
Steven Brandt [Member] | ||
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, 2020Segment | |
Segment and Geographic Information [Abstract] | |
Number of reportable segments | 1 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Thousands | Mar. 19, 2021 | Mar. 23, 2020 | Jan. 28, 2020 | Nov. 06, 2019 | Oct. 25, 2019 | Mar. 12, 2019 | Jul. 03, 2018 | Nov. 27, 2017 |
Subsequent Events [Abstract] | ||||||||
Issuance of common stock, net (in shares) | 201,546 | 40,637 | 19,195 | |||||
Gross proceeds from public stock offering | $ 9,700 | $ 1,360 | $ 660 | |||||
Net proceeds from public stock offering | $ 8,600 | |||||||
Exercise price of warrants (in dollars per share) | $ 11.18 | $ 16.50 | $ 29.83 | $ 42.30 | ||||
Subsequent Event [Member] | ||||||||
Subsequent Events [Abstract] | ||||||||
Issuance of common stock, net (in shares) | 3,795,816 | |||||||
Gross proceeds from public stock offering | $ 20,900 | |||||||
Net proceeds from public stock offering | $ 19,000 | |||||||
March 2020 Offering [Member] | ||||||||
Subsequent Events [Abstract] | ||||||||
Issuance of common stock, net (in shares) | 138,715 | |||||||
Gross proceeds from public stock offering | $ 1,200 | |||||||
Net proceeds from public stock offering | $ 1,000 | |||||||
Exercise price of warrants (in dollars per share) | $ 9 | |||||||
March 2021 Offering [Member] | Subsequent Event [Member] | ||||||||
Subsequent Events [Abstract] | ||||||||
Exercise price of warrants (in dollars per share) | $ 5.50 | |||||||
Series F Convertible Preferred Stock [Member] | ||||||||
Subsequent Events [Abstract] | ||||||||
Conversion price (in dollars per share) | $ 9 | $ 16.50 | $ 29.83 | $ 42.30 | $ 157.50 | $ 890.40 | $ 1,890 | |
Series F Convertible Preferred Stock [Member] | Subsequent Event [Member] | ||||||||
Subsequent Events [Abstract] | ||||||||
Conversion price (in dollars per share) | $ 5.50 |