Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | May 07, 2018 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | CHF Solutions, Inc. | |
Entity Central Index Key | 1,506,492 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Smaller Reporting Company | |
Entity Common Stock, Shares Outstanding | 4,501,448 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 10,504 | $ 15,595 |
Accounts receivable | 658 | 545 |
Inventory | 2,525 | 1,588 |
Other current assets | 130 | 136 |
Total current assets | 13,817 | 17,864 |
Property, plant and equipment, net | 573 | 570 |
Other assets | 21 | 21 |
TOTAL ASSETS | 14,411 | 18,455 |
Current liabilities | ||
Accounts payable | 1,051 | 862 |
Accrued compensation | 650 | 1,021 |
Other current liabilities | 198 | 208 |
Total current liabilities | 1,899 | 2,091 |
Other liabilities | 126 | 126 |
Total liabilities | 2,025 | 2,217 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of March 31, 2018 and December 31, 2017, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 4,252,134 and 3,798,929, respectively | 0 | 0 |
Additional paid-in capital | 197,868 | 197,367 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | 1,228 | 1,227 |
Accumulated deficit | (186,710) | (182,356) |
Total stockholders' equity | 12,386 | 16,238 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 14,411 | 18,455 |
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 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2018 | Dec. 31, 2017 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,968,252 | 39,966,220 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 4,252,134 | 3,798,929 |
Common stock, shares outstanding (in shares) | 4,252,134 | 3,798,929 |
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) | 1,748 | 3,780 |
Preferred stock, shares issued (in shares) | 1,748 | 3,780 |
Preferred stock, shares outstanding (in shares) | 1,748 | 3,780 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) [Abstract] | ||
Net sales | $ 1,037 | $ 901 |
Costs and Expenses: | ||
Cost of goods sold | 901 | 514 |
Selling, general and administrative | 4,011 | 2,387 |
Research and development | 479 | 308 |
Total costs and expenses | 5,391 | 3,209 |
Loss from operations | (4,354) | (2,308) |
Other income (expense): | ||
Other income, net | 0 | 6 |
Warrant valuation expense | 0 | (67) |
Change in fair value of warrant liability | 0 | 1,429 |
Total other income (expense) | 0 | 1,368 |
Loss before income taxes | (4,354) | (940) |
Income tax expense | 0 | 0 |
Net loss | $ (4,354) | $ (940) |
Basic and diluted loss per share (in dollars per share) | $ (1.08) | $ (35.05) |
Weighted average shares outstanding - basic and diluted (in shares) | 4,031 | 79 |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments | $ 1 | $ (1) |
Total comprehensive loss | $ (4,353) | $ (941) |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Operating Activities | ||
Net loss | $ (4,354) | $ (940) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization | 54 | 215 |
Stock based compensation expense, net | 500 | 166 |
Change in fair value of warrant liability | 0 | (1,429) |
Warrant valuation expense | 0 | 67 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (113) | (124) |
Inventory | (937) | (153) |
Other current assets | 6 | 49 |
Accounts payable and accrued expenses | (192) | 535 |
Net cash used in operations | (5,036) | (1,614) |
Investing activities: | ||
Purchases of property and equipment | (57) | 0 |
Net cash used in investing activities | (57) | 0 |
Financing activities: | ||
Net proceeds from the sale of preferred stock and warrants | 0 | 184 |
Net proceeds from exercise of warrants | 0 | 1,768 |
Net cash provided by financing activities | 0 | 1,952 |
Effect of exchange rate changes on cash and cash equivalents | 2 | 0 |
Net increase (decrease) in cash and cash equivalents | (5,091) | 338 |
Cash and cash equivalents - beginning of period | 15,595 | 1,323 |
Cash and cash equivalents - end of period | 10,504 | 1,661 |
Supplemental schedule of non-cash activities | ||
Warrants issued as inducement to warrant exercise | 0 | 509 |
Conversion of temporary equity to permanent equity | 0 | 485 |
Supplemental cash flow information | ||
Cash paid for income taxes | $ 0 | $ 0 |
Nature of Business and Basis of
Nature of Business and Basis of Presentation | 3 Months Ended |
Mar. 31, 2018 | |
Nature of Business and Basis of Presentation [Abstract] | |
Nature of Business and Basis of Presentation | Note 1 – Nature of Business and Basis of Presentation Nature of Business : Prior to July 2016, the Company was focused on developing the C-Pulse® Heart Assist System for treatment of Class III and ambulatory Class IV heart failure. In August 2016, the Company acquired the Aquadex Business from a subsidiary of Baxter International, Inc. (“Baxter”), a global leader in the hospital products and dialysis markets (herein referred to as the “Aquadex Business.”) On September 29, 2016, the Company announced a strategic refocus of its strategy that included halting all clinical evaluations of its C-Pulse technology to fully focus its resources on its recently acquired Aquadex Business. On May 23, 2017, the Company announced it was changing its name from Sunshine Heart, Inc. to CHF Solutions, Inc. to more appropriately reflect the direction of its business. During 2017, the Company’s board of directors and stockholders approved two reverse stock splits (together, the Reverse Stock Splits). Neither reverse stock split changed 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. The first reverse stock split was a 1-for-30 reverse split of the Company’s outstanding common stock that became effective after trading on January 12, 2017. The second reverse stock split was a 1-for-20 reverse split of the Company’s outstanding common stock that became effective after trading on October 12, 2017. All share and per-share amounts have been retroactively adjusted to reflect the Reverse Stock Splits for all periods presented. Principles of Consolidation: For further information, refer to the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. Going Concern: 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 FlexFlow. This will require the Company to succeed in training personnel at hospitals and effectively and in efficiently manufacturing, marketing and distributing the Aquadex FlexFlow 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. On April 24, 2017, the Company closed on an underwritten public equity offering for net proceeds of approximately $8.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering. In addition, on November 27, 2017, the Company closed on a subsequent underwritten public equity offering for net proceeds of approximately $16.2 million after deducting the underwriting discounts and commissions and other costs associated with the offering (see Note 4 - Equity). The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. Revenue Recognition: Revenue from Contracts with Customers Accounts Receivable Inventories (000 in thousands) March 31, 2018 December 31, 2017 Finished Goods $ 1,088 $ 902 Work in Process 274 217 Raw Materials 1,163 469 Total $ 2,525 $ 1,588 Contingent consideration 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 period presented: March 31 2018 2017 Stock options 1,996,304 2,873 Restricted stock units 180 543 Warrants to purchase common stock 8,522,684 46,339 Series F convertible preferred stock 389,804 - Total 10,908,972 49,755 The following table reconciles reported net loss with reported net loss per share for the three months ended March 31: (in thousands, except per share amounts) 2018 2017 Net loss $ (4,354 ) $ (940 ) Deemed dividend to preferred shareholders (see Note 4) - (1,828 ) Net loss after deemed dividend (4,354 ) (2,768 ) Weighted average shares outstanding 4,031 79 Basic and diluted loss per share $ (1.08 ) $ (35.05 ) New Accounting Pronouncements: In February 2016, the FASB issued updated guidance to improve financial reporting about leasing transactions. This guidance will require organizations that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. This guidance is effective for the Company’s annual periods beginning January 1, 2020, and for quarterly periods thereafter. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2018 | |
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 the United Kingdom, Italy, and Southeast Asia. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. Revenue from product sales are recognized when the customer or distributor obtains control of the product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point, unless the customer requests that control and title to the inventory transfer upon delivery. Revenue includes shipment and handling fees charged to customers. 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 we satisfy our performance obligations under the contract. The majority of our 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 three months ended March 31, 2018. The unfulfilled performance obligations related to these extended service plans is included in deferred revenue in the amount of $32,000 and $38,000 as of March 31, 2018 and December 31, 2017, respectively. Deferred revenue is included in other current liabilities on the condensed consolidated balance sheet. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns: believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2018 | |
Debt [Abstract] | |
Debt | Note 3 - 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 a revolving line of credit in an aggregate principal amount not to exceed $1.0 million outstanding at any time (the “Revolving Line”). Advances under the Revolving Line are available to the Company until March 31, 2020 and accrue interest at a floating annual rate equal to 1.75% or 1.0% above the prime rate, depending on liquidity factors. Outstanding borrowings, if any, are collateralized by all of the Company’s assets, excluding intellectual property which is subject to a negative pledge. There were no borrowings outstanding under this facility as of March 31, 2018 or December 31, 2017. Warrants: |
Equity
Equity | 3 Months Ended |
Mar. 31, 2018 | |
Equity [Abstract] | |
Equity | Note 4 - Equity Series B/B-1 Convertible Preferred Stock Series C and D Convertible Preferred Stock . Series E Convertible Preferred Stock The offering comprised of Class A Units, priced at a public offering price of $20.0 per unit, with each unit consisting of one share of common stock and one five-year warrant to purchase one share of common stock with an exercise price of $22.0 per share, and Class B Units, priced at a public offering price of $1,000 per unit, with each unit comprised of one share of preferred stock, which was convertible into 50 shares of common stock, and warrants to purchase 50 shares of common stock, also with an exercise price of $22.0 per share. The conversion price of the Series E Convertible Preferred Stock as well as the exercise price of the warrants are fixed and do not contain any variable pricing features, nor any price based anti-dilutive features apart from customary adjustments for splits and reverse splits of common stock. A total of 140,000 shares of common stock, 6,400 shares of Series E Convertible Preferred Stock convertible into 320,000 shares of common stock and warrants to purchase 460,000 shares of common stock were issued in the offering including the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants . Series F Convertible Preferred Stock The offering was comprised of Series F preferred stock, convertible into shares of the Company’s common stock at a conversion price of $4.50 per share. Each share of Series F preferred stock was accompanied by a Series 1 warrant, which expires on the first anniversary of its issuance, to purchase 223 shares of the Company’s common stock at an exercise price of $4.50 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 223 shares of the Company’s common stock at an exercise price of $4.50 per share. The Series F preferred stock and the warrants were immediately separable and were issued separately . Placement Agent Fees Investor Warrants In connection with the issuance of the Series C and D Convertible Preferred Stock in November 2016, the Company issued the investor at no additional cost warrants to purchase 35,295 shares of common stock at an exercise price of $108 per share. In connection with the issuance of the Series D Convertible Preferred Stock at the second closing in January 2017, the Company issued the investor, at no additional cost, warrants to purchase 1,961 shares of common stock at an exercise price of $108 per share. The warrants were exercisable for 60 months commencing on the earlier of the day of the receipt of approval of the Company’s stockholders of a proposal to approve the issuance of the shares of common stock underlying the warrants, or the six-month anniversary of the date of issuance. These warrants were subject to a reduction of the exercise price if the Company subsequently issued common stock or equivalents at an effective price less than the current exercise price of such warrants. Warrant Exercise Agreement: The Company entered into the letter agreement with the investors to incent the exercise of the Original Warrants in order to receive the cash proceeds from the exercise of the Original Warrants and because the exercise of the Original Warrants would allow the Company to remove the warrant liability from its balance sheet and avoid future fair value adjustments and associated volatility in its consolidated financial statements, as the Replacement Warrants are not accounted for as liabilities based on their terms. As of March 31, 2018 and December 31, 2017, there were no Original Warrants outstanding and all Replacement Warrants under the letter agreement had been issued. Placement Agent Warrant: Warrant Valuation The Replacement Warrants were valued at $0.5 million using the Black Scholes valuation model with the following assumptions: an expected dividend yield of 0%, expected stock price volatility of 49.65%-50.38%, risk-free interest rates of 1.95%-1.97% and an expected life of 5 years. The warrants have a five-year life and were fully vested at the date of grant. The terms of these warrants do not require them to be accounted for as liabilities and are therefore recorded in equity. As in incentive to early exercise the Original Warrants, the fair value provided to investors through the Replacement Warrants exceeded the fair value of the Original Warrants that was relinquished by the warrant holders by approximately $0.1 million, which has been reflected as an expense in the statement of operations for the period ending March 31, 2017. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2018 | |
Stock-Based Compensation [Abstract] | |
Stock-Based Compensation | Note 5 - Stock-Based Compensation Under the fair value recognition provisions of U.S. GAAP for accounting for stock-based compensation, the Company measures stock-based compensation expense at the grant date based on the fair value of the award and recognizes the compensation expense over the requisite service period, which is generally the vesting period. The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended March 31, (in thousands) 2018 2017 Selling, general and administrative expense $ 450 $ 141 Research and development expense 50 25 Total stock-based compensation expense $ 500 $ 166 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Financial Instruments | Note 6 - Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, warrants, and contingent consideration. Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” · Level 1 · Level 2 · Level 3 The fair value of the Company’s common stock warrant liability related to the investor warrants was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy. All investor warrants classified as warrant liability were exercised during the three months ended March 31, 2017. The following is a rollforward of the fair value of Level 3 warrants: Three months ended March 31, 2017 (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Ending balance as of March 31, 2017 $ - Fair values were calculated using the following assumptions: As of Dec. 31, 2016 As of Date of Exercise Risk-free interest rates, adjusted for continuous compounding 1.47/1.96 % 1.45-1.99 % Term (years) 3.1/5.3 2.84-5.50 Expected volatility 55.3/49.8 % 49.9-58.5 % Dates and probability of future equity raises various various The fair value of the Company's contingent consideration related to the acquisition of the Aquadex Business from Baxter in August 2016, was $126,000 as of March 31, 2018 and December 31, 2017. The fair value was initially measured based on the consideration expected to be transferred (probability-weighted), discounted back to present value, and it is considered a Level 3 instrument. The discount rate used was determined at the time of measurement in accordance with accepted valuation methods. The Company measures the liability on a recurring basis using Level 3 inputs including probabilities of payment and projected payment dates. Changes to any of the inputs may result in significantly higher or lower fair value measurements. There were no changes in the fair value of the contingent consideration subsequent to the initial measurement. All cash equivalents are considered Level 1 measurements for all periods presented. The Company does not have any financial instruments classified as Level 2 or any other classified as Level 3 and there were no movements between these categories during the periods ended March 31, 2018 and December 31, 2017. 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 | 3 Months Ended |
Mar. 31, 2018 | |
Income Taxes [Abstract] | |
Income Taxes | Note 7 – Income Taxes 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 full 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 financial statements. As of March 31, 2018, there were no material changes to what the Company disclosed regarding tax uncertainties or penalties in its Annual Report on Form 10-K for the year ended December 31, 2017. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2018 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | Note 8 – Commitments and Contingencies Leases: Employee Retirement Plan: Contingent Consideration: |
Nature of Business and Basis 14
Nature of Business and Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2018 | |
Nature of Business and Basis of Presentation [Abstract] | |
Nature of Business | Nature of Business : Prior to July 2016, the Company was focused on developing the C-Pulse® Heart Assist System for treatment of Class III and ambulatory Class IV heart failure. In August 2016, the Company acquired the Aquadex Business from a subsidiary of Baxter International, Inc. (“Baxter”), a global leader in the hospital products and dialysis markets (herein referred to as the “Aquadex Business.”) On September 29, 2016, the Company announced a strategic refocus of its strategy that included halting all clinical evaluations of its C-Pulse technology to fully focus its resources on its recently acquired Aquadex Business. On May 23, 2017, the Company announced it was changing its name from Sunshine Heart, Inc. to CHF Solutions, Inc. to more appropriately reflect the direction of its business. During 2017, the Company’s board of directors and stockholders approved two reverse stock splits (together, the Reverse Stock Splits). Neither reverse stock split changed 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. The first reverse stock split was a 1-for-30 reverse split of the Company’s outstanding common stock that became effective after trading on January 12, 2017. The second reverse stock split was a 1-for-20 reverse split of the Company’s outstanding common stock that became effective after trading on October 12, 2017. All share and per-share amounts have been retroactively adjusted to reflect the Reverse Stock Splits for all periods presented. |
Principles of Consolidation | Principles of Consolidation: For further information, refer to the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. |
Going Concern | Going Concern: 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 FlexFlow. This will require the Company to succeed in training personnel at hospitals and effectively and in efficiently manufacturing, marketing and distributing the Aquadex FlexFlow 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. On April 24, 2017, the Company closed on an underwritten public equity offering for net proceeds of approximately $8.0 million after deducting the underwriting discounts and commissions and other costs associated with the offering. In addition, on November 27, 2017, the Company closed on a subsequent underwritten public equity offering for net proceeds of approximately $16.2 million after deducting the underwriting discounts and commissions and other costs associated with the offering (see Note 4 - Equity). The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. |
Revenue Recognition | Revenue Recognition: Revenue from Contracts with Customers |
Accounts Receivable | Accounts Receivable |
Inventories | Inventories (000 in thousands) March 31, 2018 December 31, 2017 Finished Goods $ 1,088 $ 902 Work in Process 274 217 Raw Materials 1,163 469 Total $ 2,525 $ 1,588 |
Contingent Consideration | Contingent consideration |
Loss per Share | 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 period presented: March 31 2018 2017 Stock options 1,996,304 2,873 Restricted stock units 180 543 Warrants to purchase common stock 8,522,684 46,339 Series F convertible preferred stock 389,804 - Total 10,908,972 49,755 The following table reconciles reported net loss with reported net loss per share for the three months ended March 31: (in thousands, except per share amounts) 2018 2017 Net loss $ (4,354 ) $ (940 ) Deemed dividend to preferred shareholders (see Note 4) - (1,828 ) Net loss after deemed dividend (4,354 ) (2,768 ) Weighted average shares outstanding 4,031 79 Basic and diluted loss per share $ (1.08 ) $ (35.05 ) |
New Accounting Pronouncements | New Accounting Pronouncements: In February 2016, the FASB issued updated guidance to improve financial reporting about leasing transactions. This guidance will require organizations that lease assets to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. This guidance is effective for the Company’s annual periods beginning January 1, 2020, and for quarterly periods thereafter. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. |
Nature of Business and Basis 15
Nature of Business and Basis of Presentation (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Nature of Business and Basis of Presentation [Abstract] | |
Schedule of Inventories | Inventories consisted of the following: (000 in thousands) March 31, 2018 December 31, 2017 Finished Goods $ 1,088 $ 902 Work in Process 274 217 Raw Materials 1,163 469 Total $ 2,525 $ 1,588 |
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 period presented: March 31 2018 2017 Stock options 1,996,304 2,873 Restricted stock units 180 543 Warrants to purchase common stock 8,522,684 46,339 Series F convertible preferred stock 389,804 - Total 10,908,972 49,755 |
Schedule of 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 three months ended March 31: (in thousands, except per share amounts) 2018 2017 Net loss $ (4,354 ) $ (940 ) Deemed dividend to preferred shareholders (see Note 4) - (1,828 ) Net loss after deemed dividend (4,354 ) (2,768 ) Weighted average shares outstanding 4,031 79 Basic and diluted loss per share $ (1.08 ) $ (35.05 ) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Stock-Based Compensation [Abstract] | |
Classification of Stock-Based Compensation Expense | The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended March 31, (in thousands) 2018 2017 Selling, general and administrative expense $ 450 $ 141 Research and development expense 50 25 Total stock-based compensation expense $ 500 $ 166 |
Fair Value of Financial Instr17
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value of Financial Instruments [Abstract] | |
Fair Value of Common Stock Warrant Liability Calculated Using a Monte Carlo Valuation Model Classified as Level 3 in Fair Value Hierarchy | The following is a rollforward of the fair value of Level 3 warrants: Three months ended March 31, 2017 (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Ending balance as of March 31, 2017 $ - |
Summary of Fair Value Assumptions Used in Calculation of Monte Carlo Valuation Model | Fair values were calculated using the following assumptions: As of Dec. 31, 2016 As of Date of Exercise Risk-free interest rates, adjusted for continuous compounding 1.47/1.96 % 1.45-1.99 % Term (years) 3.1/5.3 2.84-5.50 Expected volatility 55.3/49.8 % 49.9-58.5 % Dates and probability of future equity raises various various |
Nature of Business and Basis 18
Nature of Business and Basis of Presentation, Nature of Business, Going Concern, Accounts Receivable and Inventory (Details) $ in Thousands | Nov. 27, 2017USD ($) | Oct. 12, 2017 | Apr. 24, 2017USD ($) | Jan. 12, 2017 | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($)StockSplit |
Nature of Business [Abstract] | ||||||
Number of reverse stock split | StockSplit | 2 | |||||
Reverse stock split ratio | 20 | 30 | ||||
Going Concern [Abstract] | ||||||
Retained earnings (accumulated deficit) | $ (186,710) | $ (182,356) | ||||
Net proceeds from issuance of convertible preferred stock | $ 16,200 | $ 8,000 | ||||
Accounts Receivable [Abstract] | ||||||
Accounts receivables maximum credit period from invoice date | 30 days | |||||
Allowance for doubtful accounts | $ 0 | 0 | ||||
Inventory [Abstract] | ||||||
Finished Goods | 1,088 | 902 | ||||
Work in Process | 274 | 217 | ||||
Raw Materials | 1,163 | 469 | ||||
Total | $ 2,525 | $ 1,588 |
Nature of Business and Basis 19
Nature of Business and Basis of Presentation, Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 10,908,972 | 49,755 |
Reported net loss with reported net loss per share [Abstract] | ||
Net loss | $ (4,354) | $ (940) |
Deemed dividend to preferred shareholders (see Note 4) | 0 | (1,828) |
Net loss after deemed dividend | $ (4,354) | $ (2,768) |
Weighted average shares outstanding (in shares) | 4,031,000 | 79,000 |
Basic and diluted loss per share (in dollars per share) | $ (1.08) | $ (35.05) |
Series C and D Convertible Preferred Stock [Member] | ||
Reported net loss with reported net loss per share [Abstract] | ||
Deemed dividend to preferred shareholders (see Note 4) | $ 1,800 | |
Series F Convertible Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 389,804 | 0 |
Stock Options [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 1,996,304 | 2,873 |
Restricted Stock Units [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 180 | 543 |
Warrants to Purchase Common Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential shares of common stock that are not included in the calculation of diluted net loss per share (in shares) | 8,522,684 | 46,339 |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2017 | |
Disaggregation of Revenue [Line Items] | ||
Deferred revenue | $ 32 | $ 38 |
Expected timing of satisfaction, period | 1 year | |
Sales Revenue [Member] | Maximum [Member] | ASC 606 [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Percentage of net sales | 1.00% |
Debt, New Loan Agreement (Detai
Debt, New Loan Agreement (Details) - Revolving Line [Member] - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2017 | |
Debt Instrument [Line Items] | ||
Maximum borrowing capacity | $ 1,000 | |
Maturity date | Mar. 31, 2020 | |
Total borrowings outstanding | $ 0 | $ 0 |
Floating Annual Rate [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate | 1.75% | |
Prime Rate [Member] | ||
Debt Instrument [Line Items] | ||
Interest rate | 1.00% |
Debt, Warrants (Details)
Debt, Warrants (Details) | 3 Months Ended |
Mar. 31, 2018$ / sharesshares | |
Affiliates [Member] | |
Debt Instrument [Line Items] | |
Warrants issued (in shares) | shares | 55 |
Exercise price of warrants (in dollars per share) | $ 2,208 |
Value of warrants (in dollars per share) | $ 1,626 |
Expected dividend yield | 0.00% |
Expected stock price volatility | 87.04% |
Risk-free interest rate | 2.20% |
Expected warrant option life | 6 years 3 months |
Silicon Valley Bank [Member] | |
Debt Instrument [Line Items] | |
Warrants issued (in shares) | shares | 115 |
Exercise price of warrants (in dollars per share) | $ 3,132 |
Value of warrants (in dollars per share) | $ 2,316 |
Expected dividend yield | 0.00% |
Expected stock price volatility | 88.07% |
Risk-free interest rate | 1.86% |
Expected warrant option life | 6 years 3 months |
Equity, Convertible Preferred S
Equity, Convertible Preferred Stock (Details) - USD ($) | Nov. 27, 2017 | Apr. 24, 2017 | Jan. 10, 2017 | Nov. 03, 2016 | Oct. 30, 2016 | Jul. 20, 2016 | Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 |
Class of Stock [Line Items] | |||||||||
Proceeds from issuance of convertible preferred stock and Warrants | $ 3,600,000 | $ 3,800,000 | $ 3,500,000 | $ 0 | $ 184,000 | ||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||
Net proceeds from issuance of convertible preferred stock | $ 16,200,000 | $ 8,000,000 | |||||||
Common stock, shares issued (in shares) | 4,252,134 | 3,798,929 | |||||||
Series B-1 Convertible Preferred Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Proceed from issuance of preferred stock | $ 1,600,000 | ||||||||
Series B and B-1 Convertible Preferred Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||
Series C Convertible Preferred Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Beneficial conversion amount | $ 1,300,000 | ||||||||
Series D Convertible Preferred Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Proceeds from issuance of convertible preferred stock and Warrants | 200,000 | ||||||||
Beneficial conversion amount | $ 500,000 | ||||||||
Series C and D Convertible Preferred Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||
Series E Convertible Preferred Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Proceed from issuance of preferred stock | 9,200,000 | ||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||
Net proceeds from issuance of convertible preferred stock | $ 8,000,000 | ||||||||
Number of preferred shares converted to common stock (in shares) | 320,000 | ||||||||
Preferred stock issued (in shares) | 6,400 | ||||||||
Common stock, shares issued (in shares) | 140,000 | ||||||||
Percentage of underwriting discounts and commissions | 9.00% | ||||||||
Series E Convertible Preferred Stock [Member] | Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants to purchase shares of common stock (in shares) | 460,000 | ||||||||
Warrants issued to underwriter (in shares) | 0 | ||||||||
Class A Units [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Public offering price (in dollars per share) | $ 20 | ||||||||
Number of common stock (in shares) | 1 | ||||||||
Class A Units [Member] | Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Term of warrants | 5 years | ||||||||
Number of warrants (in shares) | 1 | ||||||||
Number of preferred shares converted to common stock (in shares) | 1 | ||||||||
Exercise price of warrants (in dollars per share) | $ 22 | ||||||||
Class B Units [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Public offering price (in dollars per share) | $ 1,000 | ||||||||
Number of preferred shares converted to common stock (in shares) | 50 | ||||||||
Number of preferred stock per unit (in shares) | 1 | ||||||||
Class B Units [Member] | Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Exercise price of warrants (in dollars per share) | $ 22 | ||||||||
Warrants to purchase shares of common stock (in shares) | 50 | ||||||||
Series F Convertible Preferred Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Proceed from issuance of preferred stock | 18,000,000 | ||||||||
Preferred stock, shares outstanding (in shares) | 1,748 | 3,780 | |||||||
Beneficial conversion amount | 8,700,000 | ||||||||
Net proceeds from issuance of convertible preferred stock | $ 16,200,000 | ||||||||
Conversion price (in dollars per share) | $ 4.50 | ||||||||
Number of convertible preferred shares converted (in shares) | 16,252 | 14,220 | |||||||
Number of preferred shares converted to common stock (in shares) | 4,000,000 | 3,624,196 | 3,171,060 | ||||||
Percentage of volume weighted average price of common stock, minimum | 300.00% | ||||||||
Minimum trading volume for each trading day | $ 200,000 | ||||||||
Preferred stock issued (in shares) | 18,000 | 1,748 | 3,780 | ||||||
Percentage of underwriting discounts and commissions | 8.00% | ||||||||
Series F Convertible Preferred Stock [Member] | Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants to purchase shares of common stock (in shares) | 8,000,000 | ||||||||
Warrants issued to underwriter (in shares) | 0 | ||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Number of preferred shares converted to common stock (in shares) | 223 | ||||||||
Exercise price of warrants (in dollars per share) | $ 4.50 | ||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Number of preferred shares converted to common stock (in shares) | 223 | ||||||||
Exercise price of warrants (in dollars per share) | $ 4.50 | ||||||||
Series B, C And D Convertible Preferred Stock [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Percentage of placement fee offered in cash | 6.00% |
Equity, Warrants (Details)
Equity, Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 15, 2017 | Jan. 10, 2017 | Nov. 03, 2016 | Jul. 26, 2016 | Mar. 31, 2017 | Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2017 |
Class of Stock [Line Items] | |||||||||
Proceeds from exercise of warrants | $ 0 | $ 1,768 | |||||||
Change in fair value of warrant liability | 0 | $ 1,429 | |||||||
Minimum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Expected stock price volatility | 49.90% | 49.80% | |||||||
Risk-free interest rate | 1.45% | 1.47% | |||||||
Expected warrant option life | 2 years 10 months 2 days | 3 years 1 month 6 days | |||||||
Maximum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Expected stock price volatility | 58.50% | 55.30% | |||||||
Risk-free interest rate | 1.99% | 1.96% | |||||||
Expected warrant option life | 5 years 6 months | 5 years 3 months 18 days | |||||||
Replacement Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants outstanding | $ 500 | ||||||||
Expected dividend yield | 0.00% | ||||||||
Expected warrant option life | 5 years | ||||||||
Replacement Warrants [Member] | Minimum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Expected stock price volatility | 49.65% | ||||||||
Risk-free interest rate | 1.95% | ||||||||
Replacement Warrants [Member] | Maximum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Expected stock price volatility | 50.38% | ||||||||
Risk-free interest rate | 1.97% | ||||||||
Series B Convertible Preferred Stock [Member] | Investor Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants issuance cost | $ 0 | ||||||||
Warrants to purchase shares of common stock (in shares) | 6,149 | ||||||||
Exercise price of warrants (in dollars per share) | $ 564 | ||||||||
Warrants exercisable period | 36 months | ||||||||
Period warrants became exercisable from closing date | 6 months | ||||||||
Series D Convertible Preferred Stock [Member] | Investor Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants issuance cost | $ 0 | ||||||||
Warrants to purchase shares of common stock (in shares) | 1,961 | ||||||||
Exercise price of warrants (in dollars per share) | $ 108 | ||||||||
Warrants exercisable period | 60 months | ||||||||
Period warrants became exercisable from closing date | 6 months | ||||||||
Series C and D Convertible Preferred Stock [Member] | Investor Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants issuance cost | $ 0 | ||||||||
Warrants to purchase shares of common stock (in shares) | 35,295 | ||||||||
Exercise price of warrants (in dollars per share) | $ 108 | ||||||||
Adjusted exercise price of warrants (in dollars per share) | $ 102 | ||||||||
Series B, C And D Convertible Preferred Stock [Member] | Placement Agent Warrant [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants issuance cost | $ 0 | ||||||||
Warrants to purchase shares of common stock (in shares) | 2,605 | ||||||||
Expiration term of warrants | 5 years | ||||||||
Series B, C And D Convertible Preferred Stock [Member] | Placement Agent Warrant [Member] | Minimum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Exercise price of warrants (in dollars per share) | $ 126 | ||||||||
Series B, C And D Convertible Preferred Stock [Member] | Placement Agent Warrant [Member] | Maximum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Exercise price of warrants (in dollars per share) | $ 810 | ||||||||
Warrant Exercise Agreement [Member] | Original Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Proceeds from exercise of warrants | $ 2,000 | ||||||||
Warrants outstanding | $ 0 | $ 0 | |||||||
Relinquished amount of warrants | $ 100 | ||||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Warrants to purchase shares of common stock (in shares) | 43,396 | 43,396 | |||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | Minimum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Exercise price of warrants (in dollars per share) | $ 34.6 | $ 34.6 | |||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | Maximum [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Exercise price of warrants (in dollars per share) | $ 99.8 | $ 99.8 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 500 | $ 166 |
Selling, General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 450 | 141 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 50 | $ 25 |
Fair Value of Financial Instr26
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | Feb. 15, 2017 | Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2017 |
Fair value of Level 3 [Roll Forward] | |||||
Change in fair value | $ 0 | $ 1,429 | |||
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 | |||
Aquadex Product Line [Member] | |||||
Fair Value Transfers between levels [Abstract] | |||||
Fair value of contingent consideration | $ 126 | $ 126 | |||
Minimum [Member] | |||||
Fair Value Assumptions [Abstract] | |||||
Risk-free interest rates, adjusted for continuous compounding | 1.45% | 1.47% | |||
Term | 2 years 10 months 2 days | 3 years 1 month 6 days | |||
Expected volatility | 49.90% | 49.80% | |||
Maximum [Member] | |||||
Fair Value Assumptions [Abstract] | |||||
Risk-free interest rates, adjusted for continuous compounding | 1.99% | 1.96% | |||
Term | 5 years 6 months | 5 years 3 months 18 days | |||
Expected volatility | 58.50% | 55.30% | |||
Level 3 [Member] | |||||
Fair value of Level 3 [Roll Forward] | |||||
Balance | 1,843 | ||||
Change in fair value | (1,475) | ||||
Exercise of warrants | (368) | ||||
Ending balance | $ 0 | $ 1,843 |
Commitments and Contingencies -
Commitments and Contingencies - (Details) - Aquadex Product Line [Member] - USD ($) $ in Thousands | Aug. 05, 2016 | Mar. 31, 2018 |
Contingent Consideration [Abstract] | ||
Sale or disposal of business assets threshold for contingent consideration | $ 4,000 | |
Percentage of additional payments on disposes of business assets | 40.00% | |
Maximum [Member] | ||
Contingent Consideration [Abstract] | ||
Contingent consideration period | 3 years |