Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2018 | |
Document and Entity Information [Abstract] | |
Entity Registrant Name | CHF Solutions, Inc. |
Entity Central Index Key | 1,506,492 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Entity Ex Transition Period | false |
Document Type | S1 |
Amendment Flag | false |
Document Period End Date | Sep. 30, 2018 |
Consolidated Balance Sheets (FY
Consolidated Balance Sheets (FY) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets | ||
Cash and cash equivalents | $ 15,595 | $ 1,323 |
Accounts receivable | 545 | 282 |
Inventories | 1,588 | 677 |
Other current assets | 136 | 137 |
Total current assets | 17,864 | 2,419 |
Property, plant and equipment, net | 570 | 540 |
Intangible assets, net | 0 | 4,302 |
Goodwill | 0 | 189 |
Other assets | 21 | 21 |
TOTAL ASSETS | 18,455 | 7,471 |
Current liabilities | ||
Accounts payable | 862 | 1,987 |
Accrued compensation | 1,021 | 909 |
Other current liabilities | 208 | 364 |
Total current liabilities | 2,091 | 3,260 |
Common stock warrant liability | 0 | 1,843 |
Other liabilities | 126 | 126 |
Total liabilities | 2,217 | 5,229 |
Commitments and contingencies | ||
Temporary Stockholders' Equity | ||
Series D convertible preferred stock as of December 31, 2017 and December 31, 2016, par value $0.0001 per share; authorized 0 and 900 shares, respectively, issued and outstanding 0 and 700, respectively | 0 | 485 |
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of December 31, 2017 and December 31, 2016, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 3,798,929 and 38,862, respectively | 0 | 0 |
Additional paid-in capital | 197,367 | 169,496 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | 1,227 | 1,235 |
Accumulated deficit | (182,356) | (168,974) |
Total stockholders' equity | 16,238 | 1,757 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 18,455 | 7,471 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Series B-1 Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Series C Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | $ 0 | $ 0 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (FY) (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,966,220 | 39,964,375.6 |
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) | 3,798,929 | 38,862 |
Common stock, shares outstanding (in shares) | 3,798,929 | 38,862 |
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 B-1 Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 0 | 1,824.4 |
Preferred stock, shares issued (in shares) | 0 | 1,824.4 |
Preferred stock, shares outstanding (in shares) | 0 | 1,824.4 |
Series C Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 0 | 2,900 |
Preferred stock, shares issued (in shares) | 0 | 2,900 |
Preferred stock, shares outstanding (in shares) | 0 | 2,900 |
Series D Convertible Preferred Stock [Member] | ||
Temporary Stockholders' Equity | ||
Temporary stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Temporary stock, shares authorized (in shares) | 0 | 900 |
Temporary stock, shares issued (in shares) | 0 | 700 |
Temporary stock, shares outstanding (in shares) | 0 | 700 |
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) | 3,780 | 0 |
Preferred stock, shares issued (in shares) | 3,780 | 0 |
Preferred stock, shares outstanding (in shares) | 3,780 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (FY) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||
Net sales | $ 3,553 | $ 1,289 |
Costs and Expenses: | ||
Cost of goods sold | 2,763 | 713 |
Selling, general and administrative | 10,170 | 8,129 |
Research and development | 1,481 | 8,109 |
Goodwill and intangibles impairment | 3,951 | 0 |
Total costs and expenses | 18,365 | 16,951 |
Loss from operations | (14,812) | (15,662) |
Other income (expense): | ||
Interest expense | 0 | (504) |
Loss on early retirement of long-term debt | 0 | (500) |
Other income, net | 28 | 2 |
Warrant valuation expense | (67) | 0 |
Change in fair value of warrant liability | 1,475 | 818 |
Total other income (expense) | 1,436 | (184) |
Loss before income taxes | (13,376) | (15,846) |
Income tax (expense) benefit, net | (6) | 54 |
Net loss | $ (13,382) | $ (15,792) |
Basic and diluted loss per share (in dollars per share) | $ (37.51) | $ (536.12) |
Weighted average shares outstanding - basic and diluted (in shares) | 665 | 33 |
Other comprehensive income: | ||
Foreign currency translation adjustment | $ (8) | $ (11) |
Total comprehensive loss | $ (13,390) | $ (15,803) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (FY) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2015 | $ 0 | $ 164,107 | $ 1,246 | $ (153,182) | $ 12,171 |
Balance (in shares) at Dec. 31, 2015 | 30,574 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (15,792) | (15,792) |
Foreign currency translation adjustment | 0 | 0 | (11) | 0 | (11) |
Stock based compensation, net | $ 0 | 949 | 0 | 0 | 949 |
Stock based compensation, net (in shares) | 472 | ||||
Issuance of preferred stock, net | $ 0 | 4,440 | 0 | 0 | 4,440 |
Issuance of common stock for acquisition | $ 0 | 0 | 0 | 0 | 0 |
Issuance of common stock for acquisition (in shares) | 1,667 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 6,149 | ||||
Balance at Dec. 31, 2016 | $ 0 | 169,496 | 1,235 | (168,974) | 1,757 |
Balance (in shares) at Dec. 31, 2016 | 38,862 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (13,382) | (13,382) |
Foreign currency translation adjustment | 0 | 0 | (8) | 0 | (8) |
Stock based compensation, net | $ 0 | 499 | 0 | 0 | 499 |
Stock based compensation, net (in shares) | 375 | ||||
Issuance of common stock, net | $ 0 | 5,399 | 0 | 0 | 5,399 |
Issuance of common stock, net (in shares) | 194,794 | ||||
Issuance of preferred stock, net | $ 0 | 21,973 | 0 | 0 | 21,973 |
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 3,564,898 | ||||
Balance at Dec. 31, 2017 | $ 0 | $ 197,367 | $ 1,227 | $ (182,356) | 16,238 |
Balance (in shares) at Dec. 31, 2017 | 3,798,929 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (12,776) | ||||
Foreign currency translation adjustment | (2) | ||||
Balance at Sep. 30, 2018 | $ 9,653 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (FY) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Operating Activities | ||
Net loss | $ (13,382) | $ (15,792) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Depreciation and amortization | 769 | 697 |
Stock based compensation expense, net | 499 | 949 |
Amortization of debt discount and financing fees | 0 | 187 |
Goodwill and intangibles impairment | 3,951 | 0 |
Loss on retirement of long-term debt | 0 | 500 |
Change in fair value of warrant liability | (1,475) | (818) |
Warrant valuation expense | 67 | 0 |
Changes in assets and liabilities: | ||
Accounts receivable | (263) | (282) |
Inventory | (911) | (677) |
Other current assets | 1 | 342 |
Other assets and liabilities | 0 | (464) |
Accounts payable and accrued expenses | (1,176) | (934) |
Net cash used in operations | (11,920) | (16,292) |
Investing activities: | ||
Purchase of property and equipment | (259) | (117) |
Purchase of Aquadex product line | 0 | (4,000) |
Net cash used in investing activities | (259) | (4,117) |
Financing activities: | ||
Net proceeds from public stock offerings | 24,281 | 0 |
Net proceeds from exercise of warrants | 1,989 | 0 |
Net proceeds from the sale of preferred stock, common stock and warrants | 184 | 6,636 |
Repayments of long-term debt | 0 | (8,000) |
Net cash provided by (used in) financing activities | 26,454 | (1,364) |
Effect of exchange rate changes on cash | (3) | (17) |
Net increase (decrease) in cash and cash equivalents | 14,272 | (21,790) |
Cash and cash equivalents - beginning of period | 1,323 | 23,113 |
Cash and cash equivalents - end of period | 15,595 | 1,323 |
Supplemental schedule of non-cash activities | ||
Warrants issued as inducement to warrant exercise | 509 | 0 |
Conversion of temporary equity to permanent equity | 485 | 0 |
Common stock issued for business acquisition | 0 | 950 |
Supplemental cash flow information | ||
Interest paid on debt borrowings | 0 | 840 |
Cash paid for income taxes | $ 6 | $ 47 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) (Q3) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets | |||
Cash and cash equivalents | $ 8,222 | $ 15,595 | $ 1,323 |
Accounts receivable | 787 | 545 | 282 |
Inventory | 1,948 | 1,588 | 677 |
Other current assets | 240 | 136 | 137 |
Total current assets | 11,197 | 17,864 | 2,419 |
Property, plant and equipment, net | 573 | 570 | 540 |
Other assets | 21 | 21 | 21 |
TOTAL ASSETS | 11,791 | 18,455 | 7,471 |
Current liabilities | |||
Accounts payable and accrued expenses | 617 | 862 | |
Accrued compensation | 1,315 | 1,021 | 909 |
Other current liabilities | 80 | 208 | 364 |
Total current liabilities | 2,012 | 2,091 | 3,260 |
Other liabilities | 126 | 126 | 126 |
Total liabilities | 2,138 | 2,217 | 5,229 |
Commitments and contingencies | |||
Stockholders' equity | |||
Preferred stock | 0 | 0 | 0 |
Common stock as of September 30, 2018 and December 31, 2017, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 7,074,407 and 3,798,929, respectively | 1 | 0 | 0 |
Additional paid-in capital | 203,559 | 197,367 | 169,496 |
Accumulated other comprehensive income: | |||
Foreign currency translation adjustment | 1,225 | 1,227 | 1,235 |
Accumulated deficit | (195,132) | (182,356) | (168,974) |
Total stockholders' equity | 9,653 | 16,238 | 1,757 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 11,791 | 18,455 | 7,471 |
Series A Junior Participating Preferred Stock [Member] | |||
Stockholders' equity | |||
Preferred stock | 0 | 0 | 0 |
Series F Convertible Preferred Stock [Member] | |||
Stockholders' equity | |||
Preferred stock | $ 0 | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Q3) (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Stockholders' equity | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,969,435 | 39,966,220 | 39,964,375.6 |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 7,074,407 | 3,798,929 | 38,862 |
Common stock, shares outstanding (in shares) | 7,074,407 | 3,798,929 | 38,862 |
Series A Junior Participating Preferred Stock [Member] | |||
Stockholders' equity | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 30,000 | 30,000 | 30,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 |
Series F Convertible Preferred Stock [Member] | |||
Stockholders' equity | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 565 | 3,780 | 0 |
Preferred stock, shares issued (in shares) | 565 | 3,780 | 0 |
Preferred stock, shares outstanding (in shares) | 565 | 3,780 | 0 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Q3) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||||||
Net sales | $ 1,363 | $ 957 | $ 3,499 | $ 2,722 | $ 3,553 | $ 1,289 |
Costs and expenses: | ||||||
Cost of goods sold | 915 | 782 | 2,686 | 1,912 | 2,763 | 713 |
Selling, general and administrative | 3,713 | 2,671 | 11,489 | 7,478 | 10,170 | 8,129 |
Research and development | 985 | 367 | 2,107 | 1,002 | 1,481 | 8,109 |
Total costs and expenses | 5,613 | 3,820 | 16,282 | 10,392 | 18,365 | 16,951 |
Loss from operations | (4,250) | (2,863) | (12,783) | (7,670) | (14,812) | (15,662) |
Other income (expense): | ||||||
Other income, net | 10 | 17 | 10 | 28 | 28 | 2 |
Warrant valuation expense | 0 | 0 | 0 | (67) | (67) | 0 |
Change in fair value of warrant liability | 0 | 4 | 0 | 1,470 | 1,475 | 818 |
Total other income (expense) | 10 | 21 | 10 | 1,431 | 1,436 | (184) |
Loss before income taxes | (4,240) | (2,842) | (12,773) | (6,239) | (13,376) | (15,846) |
Income tax expense, net | (1) | (5) | (3) | (6) | (6) | 54 |
Net loss | $ (4,241) | $ (2,847) | $ (12,776) | $ (6,245) | $ (13,382) | $ (15,792) |
Basic and diluted loss per share (in dollars per share) | $ (0.61) | $ (4.55) | $ (2.47) | $ (25.36) | $ (37.51) | $ (536.12) |
Weighted average shares outstanding - basic and diluted (in shares) | 6,987 | 626 | 5,171 | 359 | 665 | 33 |
Other comprehensive loss: | ||||||
Foreign currency translation adjustments | $ (1) | $ (1) | $ (2) | $ (7) | $ (8) | $ (11) |
Total comprehensive loss | $ (4,242) | $ (2,848) | $ (12,778) | $ (6,252) | $ (13,390) | $ (15,803) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows (Unaudited) (Q3) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Operating Activities: | ||
Net loss | $ (12,776) | $ (6,245) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization expense | 174 | 656 |
Stock-based compensation expense | 1,544 | 391 |
Change in fair value of warrant liability | 0 | (1,470) |
Warrant valuation expense | 0 | 67 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (242) | (498) |
Inventory | (360) | (660) |
Other current and long-term assets | (104) | 28 |
Accounts payable and accrued expenses | (79) | (1,038) |
Net cash used in operations | (11,843) | (8,769) |
Investing Activities: | ||
Purchases of property and equipment | (177) | (206) |
Net cash used in investing activities | (177) | (206) |
Financing Activities: | ||
Net proceeds from public stock offering | 4,649 | 8,002 |
Net proceeds from exercise of warrants | 0 | 1,981 |
Net proceeds from the sale of common stock, preferred stock, and warrants | 0 | 184 |
Net cash provided by (used in) financing activities | 4,649 | 10,167 |
Effect of exchange rate changes on cash | (2) | (2) |
Net increase (decrease) in cash and cash equivalents | (7,373) | 1,190 |
Cash and cash equivalents - beginning of period | 15,595 | 1,323 |
Cash and cash equivalents - end of period | 8,222 | 2,513 |
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 | $ 8 |
Nature of Business and Signific
Nature of Business and Significant Accounting Policies (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Nature of Business and Significant Accounting Policies [Abstract] | ||
Nature of Business and Significant Accounting Policies | Note 1 – Nature of Business and Basis of Presentation Nature of Business : the Nasdaq Capital Market 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 FlexFlow 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 Aquadex. This will require the Company to succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing and distributing Aquadex 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 July 3, 2018, April 24, 2017 and on November 27, 2017, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $28.8 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (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 warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. Revenue Recognition: Revenue from Contracts with Customers Accounts Receivable Inventories (in thousands) September 30, 2018 December 31, 2017 Finished Goods $ 810 $ 902 Work in Process 91 217 Raw Materials 1,047 469 Total $ 1,948 $ 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: September 30 2018 2017 Stock options 1,987,502 36,874 Restricted stock units 90 324 Warrants to purchase common stock 8,522,672 496,629 Series F convertible preferred stock 266,680 - Total 10,776,944 533,827 The following table reconciles reported net loss with reported net loss per share for the periods ended September 30, 2017: (in thousands, except per share amounts) Three months Nine Months Net loss $ (2,847 ) $ (6,245 ) Deemed dividend to preferred shareholders (see Note 4) - (2,851 ) Net loss after deemed dividend (2,847 ) (9,096 ) Weighted average shares outstanding 626 359 Basic and diluted loss per share $ (4.55 ) $ (25.36 ) 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 and quarterly periods beginning January 1, 2019. T he Company is in the process of evaluating the impact that the adoption of this standard will have on its consolidated financial statements and is currently assessing its leases. The Company The Securities and Exchange Commission (“ SEC | Note 1—Nature of Business and Significant Accounting Policies Nature of Business CHF Solutions, Inc. (the “Company”) is a medical device company focused on commercializing the Aquadex FlexFlow® System for Aquapheresis® therapy. The Aquadex FlexFlow System (Aquadex) is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. CHF Solutions, Inc. is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia, Ireland and Delaware. The Company has been listed on Nasdaq since February 2012. 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. The C-Pulse System utilized the known concept of counterpulsation applied to the aorta. In March 2016, the Company announced that it was no longer enrolling patients into its two clinical studies for the C-Pulse System and that it planned to pursue a new strategic direction. In July 2016, the Company announced that it was moving forward with a therapeutic strategy utilizing neuromodulation rather than counterpulsation. 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 near-term strategy that included halting clinical evaluations of its neuromodulation technology to fully focus its resources on its recently acquired Aquadex Business, taking actions to reduce its cash burn, and reviewing potential strategic alliances and financing alternatives. 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. Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2017 and 2016, 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, 2017, the Company had an accumulated deficit of $182.4 million and it expects to incur losses for the foreseeable future. To date, the Company has been funded by debt and equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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 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 6 - Equity). The Company may require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. Basis of Presentation The accompanying consolidated financial statements include the accounts of CHF Solutions, Inc. and its wholly owned subsidiaries, CHF Solutions, LLC, Sunshine Heart Company Pty Limited, and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States 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, are 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 uncollectability, 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 its accounts receivable aging, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2017 or 2016. Inventories Inventories are recorded as the lower of cost or market using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2017 2016 Finished Goods $ 902 $ 644 Work in Process 217 — Raw Materials 469 33 Total $ 1,588 $ 677 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 and capital lease assets 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: Office furniture and equipment 5-15 years Computer software and equipment 3-4 years Laboratory and research equipment 3-15 years Production equipment 3-7 years Leasehold improvements and capital lease asset 3-5 years Depreciation expense was $229,000 and $419,000 for the years ended December 31, 2017, and 2016, 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 exceeds its carrying amount. The Company generally measures fair value by considering sale prices for similar assets or asset groups, or by discounting estimated future cash flows from such assets or asset groups using an appropriate discount rate. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company reviewed its property and equipment in conjunction with its intangible asset impairment analysis and determined that the fair value of property and equipment equaled or exceeded its carrying value. As a result, there have been no impairment losses recognized for the years ended December 31, 2017 or 2016. Intangible assets The Company’s intangible assets consisted of customer relationships, developed technology, and trademarks and tradenames. All intangible assets recognized by the Company resulted from the acquisition of the Aquadex Business. All intangible assets were estimated to have a useful life of 7 years. The Company reviews its definite lived intangible assets for impairment when impairment indicators exist. When impairment indicators exist, the Company determines if the carrying value of the intangible assets exceeds the related undiscounted cash flows. In cases where the carrying value exceeds the undiscounted cash flows, and the carrying amount is not considered recoverable, the carrying value is written down to its fair value, generally using a discounted cash flow analysis. An impairment loss is recognized for the amount that the intangible assets exceeds their fair value, generally based on discounted cash flow methods and other fair market value indicators. The Company’s review of its intangible assets during the year ended December 31, 2017, resulted in $3.8 million of impairment charges related to its finite-lived intangible assets. The Company has a single reporting unit. The impairment charges were based on fair values determined using market value indicators such as the quoted market prices of the Company’s common stock on Nasdaq, as well discounted cash flow models. Discounted cash flow models include assumptions related to the Company’s product revenue, gross margins, and operating margins, under varying assumptions about the Company’s ability to either achieve profitability or obtain the necessary financings to realize such projections. As discussed above, the Company became a revenue generating company after acquiring the Aquadex Business in August 2016 and expects to incur losses in the near-term as it grows the Aquadex Business. To become and remain profitable, and to generate cash flows from operations, the Company must succeed in expanding the adoption and market acceptance of its products. This will require that the Company succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing, and distributing its products. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability or positive cash flows. The discounted cash flow models reflect these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. Amortization expense was $540,000 and $278,000 for the years ended December 31, 2017 and 2016, respectively. Goodwill Goodwill is the cost of an acquisition in excess of the fair value of acquired assets and liabilities and is recorded as an asset on the balance sheet. Goodwill is not subject to amortization but must be tested for impairment at least annually. This test requires the Company to determine if the implied fair value of the goodwill is less than its carrying amount. The Company evaluates goodwill for impairment annually on November 1 st Simplifying the Test for Goodwill Impairment The Company has a single reporting unit. The impairment charge was based on fair values determined using market value indicators such as the quoted market prices of the Company’s common stock on Nasdaq, as well discounted cash flow models. Discounted cash flow models include assumptions related to the Company’s product revenue, gross margins, and operating margins, under varying assumptions about the Company’s ability to either achieve profitability or obtain the necessary financings to realize such projections. As discussed above, the Company became a revenue generating company after acquiring the Aquadex Business in August 2016 and expects to incur losses in the near-term as it grows the Aquadex Business. To become and remain profitable, and to generate cash flows from operations, the Company must succeed in expanding the adoption and market acceptance of its products. This will require that the Company succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing, and distributing its products. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability or positive cash flows. The discounted cash flow models reflect these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. Contingent consideration In connection with the Company’s purchase of the Aquadex Business, the Company has an obligation to pay additional consideration that is contingent upon the occurrence of certain future events. Contingent consideration is recognized at the acquisition date at the estimated fair value of the contingent milestone payments. The fair value of the contingent consideration is remeasured to its estimated fair value at the end of each reporting period, with changes recorded to earnings. Common stock warrant liability The Company recorded its common stock warrant liability at fair value at the date of issuance using primarily a Monte Carlo valuation model. The fair value is remeasured to its estimated fair value at the end of each reporting period with changes recorded to earnings. Revenue Recognition The Company recognizes revenues from product sales when earned. Specifically, revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred, the price is fixed or determinable, and collectability is reasonably assured. Revenue is not recognized until title and risk of loss have transferred to the customer. The shipping terms for the Company’s revenue arrangements are generally FOB shipping point. 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, restricted stock units (RSUs) and common stock awards in the income statement as an operating expense, based on their fair value. The Company’s stock awards use a graded vesting schedule. The Company recognizes the option expense over the requisite service period, which is generally the vesting period. The Company computes the estimated fair values of stock options and certain of its warrants using the Black-Scholes option pricing model. The closing market price of the Company’s common stock 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. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Equity instruments issued to non-employees include RSUs, warrants or options to purchase shares of the Company’s common stock. These RSUs, warrants or options 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. Unvested awards are remeasured to fair value until they vest. See Note 7- 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. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (Tax Reform Act) was signed into law making significant changes to the Internal Revenue Code. Changes include a reduction in the corporate tax rates, changes to operating loss carry-forwards and carrybacks, and a repeal of the corporate alternative minimum tax. The legislation reduces the U.S. corporate income tax rates from 34% to 21%. As a result of the enacted law, the Company is required to revalue its deferred tax assets and liabilities at the new enacted rate. The Company re-measured the U.S. deferred income tax assets and liabilities balances using the new enacted tax rate (see Note 9). There was no income tax impact from the remeasurement due to the 100% valuation allowance on the Company’s deferred tax assets. 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 for the year ended December 31, 2017, reflects increases for net deemed dividends to preferred stockholders provided in connection with the close of the public offering of Series E Convertible Preferred Stock in April of 2017, and the close of the public offering of Series F Convertible Preferred Stock in November of 2017, of $1.0 million and $8.7 million, respectively, representing the intrinsic value of the shares at the time of issuance. In addition, the net loss allocable to common stockholders reflects an increase for net deemed dividends of $1.8 million to preferred stockholders provided in connection with the shareholder approval of the Series C and D Convertible Preferred Stock transactions in January of 2017, representing the intrinsic value of the shares at the time of issuance. The net loss allocable to common shareholders for 2016 reflects a $1.9 million increase for the net deemed dividend to preferred shareholders provided in connection with the 2016 Series B and B-1 offering (See Note 5). 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 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 period presented: December 31, 2017 2016 Stock options 36,362 4,354 Restricted stock units 245 499 Warrants to purchase common stock 8,522,684 44,268 Series B, C and D convertible preferred stock — 53,179 Series F convertible preferred stock 842,940 —- Total 9,402,231 102,300 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) 2017 2016 Net loss $ (13,382 ) $ (15,792 ) Deemed dividend to preferred shareholders (see Note 6) (11,590 ) (1,900 ) Net loss after deemed dividend (24,972 ) (17,692 ) Weighted average shares outstanding 665 33 Basic and diluted loss per share $ (37.51 ) $ (536.12 ) Research and Development Research and development costs include activities related to research, development, design, and testing improvements of the Aquadex FlexFlow 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. Reclassification For comparability, certain December 31, 2016 amounts have been reclassified to conform to classifications adopted in December 31, 2017. The reclassifications had no impact on previously reported net loss or equity. Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (FASB), issued amended stock compensation guidance to simplify various aspects of employee share-based payments accounting and presentation in the financial statements. The new guidance requires all income tax effects of awards to be recognized in the income statement when the awards vest or are settled, allows an employer to repurchase more of an employee’s shares than previously allowed for tax withholding purposes without triggering liability accounting, allows a company to make a policy election to account for forfeitures as they occur, and eliminates the requirement that excess tax benefits be realized before companies can recognize them. The new guidance also requires excess tax benefits and tax shortfalls to be presented on the cash flow statement as an operating activity rather than as a financing activity, and clarifies that cash paid to a tax authority when shares are withheld to satisfy its statutory income tax withholding obligation are to be presented as a financing activity. The standard was effective for our interim and annual periods beginning after January 1, 2017. The Company adopted the guidance in the current year. The adoption of this standard did not have a material impact to the Company’s consolidated financial statements. In May 2014, August 2015, March 2016, April 2016 and May 2016, the FASB issued amended revenue recognition guidance to clarify the principles for recognizing revenue from contracts with customers. The guidance requires an entity to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. The standard allows the Company to transition to the new model using either a full or modified retrospective approach, and early adoption is not permitted. The Company has determined that it will use the modified retrospective approach. This guidance will be effective for the Company's interim and annual periods beginning January 1, 2018. As of the end of the fourth quarter of 2017, the Company had nearly completed its assessment of this amended guidance and it does not expect that the adoption of this standard will not have a material impact on the timing and amount of revenue recognized, but it expects to provide expanded disclosures as a result of the adoption. The Company will continue to evaluate the impact of the amended guidance as it pertains to presentation and disclosure. In November 2015, the FASB issued amended guidance concerning the classification of deferred taxes on the balance sheet to require that deferred tax assets and deferred tax liabilities be presented as noncurrent in a classified balance sheet. The amendment is effective for our annual and interim reporting periods beginning January 1, 2017, with early adoption permitted. The adoption of this standard did not have an impact on the Company’s consolidated financial statements as all deferred tax assets are fully reserved. In January 2017, the FASB issued amended guidance to simplify the accounting for goodwill impairment by removing Step 2 of the goodwill impairment test. A goodwill impairment will now be measured as the amount by which a reporting unit’s carrying value exceeds its fair value, limited to the amount of goodwill allocated to that reporting unit. This guidance is to be applied on a prospective basis effective for the Company’s interim and annual periods beginning after January 1, 2019, with early adoption permitted for any impairment tests performed after January 1, 2017. The Company adopted this amended guidance in the current year, as further described above under Significant Accounting Policies. 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 reporting period ending December 31, 2020, and for annual and interim periods thereafter. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. 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. |
Aquadex Acquisition (FY)
Aquadex Acquisition (FY) | 12 Months Ended |
Dec. 31, 2017 | |
Aquadex Acquisition [Abstract] | |
Aquadex Acquisition | Note 2 – Aquadex Acquisition On August 5, 2016, the Company completed the acquisition of certain assets used in the production and sale of the Aquadex product line from Baxter. The acquisition of these assets meets the criteria for the purchase of a business and has been accounted for in accordance with Accounting Standards Codification (ASC) 805, Business Combinations In connection with the acquisition of the Aquadex Business, the Company entered into a manufacturing and supply agreement with Baxter whereby Baxter agreed to manufacture and supply all of the Company’s finished goods for a period of up to 18 months from the close of the transaction. During the years ended December 31, 2017 and 2016, the Company recorded $3.6 and $1.2 million of revenue from the sale of Aquadex products. The Company completed the acquisition in order to strengthen its presence in the heart failure market. Purchase Consideration: (in thousands) Cash consideration $ 4,000 Common stock consideration 950 Fair value of contingent consideration 126 Total purchase consideration $ 5,076 - Common Stock Consideration: - Contingent Consideration: Purchase price consideration does not include expenses of $0.9 million for accounting, audit, legal, and valuation services that were incurred as part of the transaction and were expensed as incurred as general and administrative expense in the accompanying consolidated statement of operations. The acquisition was recorded by recognizing the assets acquired at their estimated fair value at the acquisition date. The excess of the cost of the acquisition over the fair value of the assets acquired was recorded as goodwill. The fair values were based on management’s analysis, including work performed by third-party valuation specialists. The following presents the amounts recognized for the assets acquired on August 5, 2016 (in thousands): Capital lease asset $ 307 Intangible assets 4,580 Total identifiable assets acquired 4,887 Goodwill 189 Total purchase consideration $ 5,076 The goodwill is primarily attributable to new and/or future customer relationships that were not acquired in the transaction. All recorded goodwill is expected to be deductible for tax purposes. The fair value of the capital lease asset utilized a combination of the cost and market approaches, depending on the characteristics of the asset classification. Pro Forma Condensed Combined Financial Information (Unaudited) The following unaudited pro forma combined financial information summarizes the results of operations for the periods indicated as if the acquisition of Aquadex had been completed on of January 1, 2016. Pro forma information reflects adjustments that are expected to have a continuing impact on our results of operations and are directly attributable to the acquisition. The unaudited pro forma results include adjustments to reflect, among other things, direct transaction costs relating to the acquisition, the difference in intangible asset amortization to be incurred based on the preliminary values of each identifiable intangible asset, and the difference in depreciation expense to be incurred based on preliminary value of the capital lease asset. The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the acquisition had occurred as of January 1, 2016 or that may be obtained in the future, and do not reflect future synergies, integration costs, or other such costs or savings. Twelve months ended December 31, 2016 (in thousands, except share amounts) Pro forma net sales $ 3,160 Pro forma net loss from operations (15,340 ) Pro forma basic and diluted net loss per share $ (464.84 ) |
Property, Plant and Equipment (
Property, Plant and Equipment (FY) | 12 Months Ended |
Dec. 31, 2017 | |
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, 2017 December 31, 2016 Office Furniture & Fixtures $ 287 $ 280 Leasehold Improvements 224 145 Software 129 124 Production Equipment 926 968 Computer Equipment 277 245 Capital Lease Asset 307 307 Total 2,150 2,069 Accumulated Depreciation (1,580 ) (1,529 ) $ 570 $ 540 |
Intangible Assets (FY)
Intangible Assets (FY) | 12 Months Ended |
Dec. 31, 2017 | |
Intangible Assets [Abstract] | |
Intangible Assets | Note 4—Intangible Assets Intangible assets were as follows: (in thousands) December 31, 2017 December 31, 2016 Customer Relationships $ 3,090 $ 3,090 Developed Technology 1,050 1,050 Trade Names and Trademarks 440 440 Total 4,580 4,580 Accumulated Amortization (818 ) (278 ) Impairment Charge (3,762 ) — $ — $ 4,302 The Company’s review of its intangible assets during the year ended December 31, 2017, resulted in $3.8 million of impairment charges related to its finite-lived intangible assets. The impairment charges were based on fair values determined using market value indicators such as the quoted market prices of the Company’s common stock on Nasdaq, as well discounted cash flow models. Discounted cash flow models include assumptions related to the Company’s product revenue, gross margins, and operating margins, under varying assumptions about the Company’s ability to either achieve profitability or obtain the necessary financings to realize such projections. As discussed in Note 1, the Company became a revenue generating company after acquiring the Aquadex Business in August 2016 and expects to incur losses in the near-term as it grows the Aquadex Business. To become and remain profitable, and to generate cash flows from operations, the Company must succeed in expanding the adoption and market acceptance of its products. This will require that the Company succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing, and distributing its products. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability or positive cash flows. The discounted cash flow models reflect these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. |
Debt (FY)
Debt (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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”) for a $1.0 million revolving line of credit (the “Revolving Line”). Under the Revolving Line, the Company may borrow the lesser of $1.0 million or 80% of its eligible accounts (subject to customary exclusions), minus the outstanding principal balance of any advances under the Revolving Line. Advances under the Revolving Line, if any, accrue interest at a floating annual rate equal to 1.75% or 1.0% above the prime rate, depending on liquidity factors. The loan agreement contains customary representations, as well as customary affirmative and negative covenants. Outstanding borrowings, if any, are collateralized by all of the Company’s assets, excluding intellectual property which is subject to a negative pledge. Advances under the Revolving Line are subject to various conditions precedent, including compliance with financial covenants relating to net liquidity relative to monthly cash burn, which the Company may or may not meet depending on its cash position at any given point. The Revolving Line expires March 31, 2020. There were no borrowings outstanding under this facility as of September 30, 2018 or December 31, 2017. Warrants: | Note 5—Debt Prior Loan Agreement On August 4, 2016, the Company repaid all amounts outstanding under its existing debt facility of $5.5 million and incurred a $0.5 million loss on early extinguishment of debt, including the accelerated write-off of unamortized warrants and debt issuance costs. There were no borrowings outstanding under this facility as of December 31, 2017 or 2016. Warrants: New Loan Agreement: |
Shareholder's Equity (FY)
Shareholder's Equity (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Equity [Abstract] | ||
Shareholder's Equity | Note 4 – Equity Series B/B-1 Convertible Preferred Stock Series C and D Convertible Preferred Stock . Series E Convertible Preferred Stock The Series E Convertible Preferred Stock included a beneficial conversion amount of $1.0 million, representing the intrinsic value of the shares at the time of issuance. This amount is reflected as an increase to the loss per share allocable to common stockholders in the nine months ended September 30, 2017 . 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 . July 2018 Offering: underwritten public offering of 2,547,169 shares of its common stock at a public offering price of $2.12 per share, for gross proceeds of $5.4 million, prior to deducting underwriting discounts and commissions and offering expenses (the “July 2018 Offering”). In connection with the July 2018 Offering, and to induce certain institutional investors who hold warrants issued by the Company in November 2017 (“November 2017 Warrants”) to participate in the July 2018 Offering, the Company entered into letter agreements with such institutional investors (collectively, the “Warrant Reprice Agreements”). Pursuant to the terms of the Warrant Reprice Agreements, the Company agreed, effective July 3, 2018, to (a) reduce the per share exercise price of the November 2017 Warrants held by such institutional investors (the “Repriced Warrants”) to $2.12 and (b) extend the expiration date of the Repriced Warrants that were to expire on November 27, 2018 to November 27, 2019. The number of shares underlying the Repriced Warrants after the price reduction did not change. The Repriced Warrants are exercisable for 7,760,400 shares of common stock in the aggregate, of which, following such amendment, half expire on November 27, 2019 and half expire on November 27, 2024. The repricing of the warrants was accounted as an equity financing cost, with no impact to net proceeds from the offering. As noted above, the Company’s outstanding Series F preferred stock is subject to full-ratchet anti-dilution protection in the event the Company sells any common stock at a price lower than the then-conversion price of the Series F preferred stock. As a result of the July 2018 Offering, effective July 3, 2018, the conversion price of the Series F preferred stock was reduced from $4.50 to $2.12, the per share price to public in the July 2018 Offering. 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 consolidated 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 September 30, 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 nine-month period ending September 30, 2017. | Note 6—Shareholder’s Equity Series B/B-1 Convertible Preferred Stock On October 30, 2016, the Company entered into an exchange agreement with the holders of its Series B Convertible Preferred Stock and agreed to issue such holders 2,227.2 shares of the Company’s Series B-1 Convertible Preferred Stock in exchange for the cancellation of all shares of Series B Convertible Preferred Stock held by such holders. The Series B-1 Convertible Preferred Stock had similar terms as the Series B Convertible Preferred Stock, except that the initial conversion price of the Series B-1 Convertible Preferred Stock was $102 per share. As of December 31, 2016, 402.8 shares of the Series B-1 Convertible Preferred Stock had been converted into 3,948 shares of common stock, and 1,824.4 shares of Series B-1 Convertible Preferred Stock remained outstanding. As of December 31, 2017, all remaining Series B-1 Convertible Preferred Stock had been converted into an additional 17,866 shares of common stock and none remained outstanding. The Series B and B-1 convertible preferred stock include a net deemed dividend in the amount of $1.9 million, representing the intrinsic value of the shares at the time of issuance, which is reflected as an increase to the loss per share allocable to common shareholders. Series C and D Convertible Preferred Stock The Series D Convertible Preferred Stock with a carrying value of $0.5 million was classified as temporary equity in the consolidated balance sheet as of December 31, 2016 because the Company could not control the settlement of its redemption in common stock. The temporary equity was not remeasured to fair value each period through earnings because the events that could trigger its redemption were not probable of occurrence. There were no shares of the Series D Convertible Preferred Stock outstanding as of December 31, 2017. Series E Convertible Preferred Stock The offering comprised of Class A Units, priced at a public offering price of $20.00 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 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 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 640,000 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. The Series E Convertible Preferred Stock included a beneficial conversion amount of $1.0 million, representing the intrinsic value of the shares at the time of issuance. This amount is reflected as an increase to the loss per share allocable to common stockholders in the year ended December 31, 2017. As of December 31, 2017, all shares of the Series E Convertible Preferred Stock had been converted into an aggregate of 320,000 shares of common stock and none remained outstanding. 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. The conversion price of the Series F 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 18,000 shares of Series F Convertible Preferred Stock convertible into approximately 4.0 million shares of common stock and warrants to purchase approximately 8.0 million shares of common stock were issued in the offering. The Series F Convertible Preferred Stock included a beneficial conversion amount of $8.7 million, representing the intrinsic value of the shares at the time of issuance. This amount is reflected as an increase to the loss per share allocable to common stockholders in the year ended December 31, 2017. As of December 31, 2017, 14,220 shares of the Series F Convertible Preferred Stock had been converted into an aggregate of 3,171,060 shares of common stock and 3,780 remained outstanding. In connection with the issuance of the Series B, C and D Convertible Preferred Shares, the Company paid the placement agent an aggregate cash placement fee equal to 6% of the aggregate gross proceeds raised in the offering and issued warrants as described below. In connection with the issuance of the Series E and F Convertible Preferred Shares, the Company paid the placement agent an aggregate cash placement fee equal to 9% and 8%, respectively, of the aggregate gross proceeds raised in the offering and issued no warrants to the placement agent. 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 December 31, 2017, there were no Original Warrants outstanding and all Replacement Warrants under the letter agreement had been issued. Warrant Valuation The Replacement Warrants were valued at $0.5 million using the Black Scholes option pricing 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 the Replacement 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 consolidated statement of operations for the year ended December 31, 2017. |
Stock-Based Compensation (FY)
Stock-Based Compensation (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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 September 30, Nine months ended September 30, (in thousands) 2018 2017 2018 2017 Selling, general and administrative expense $ 440 $ 106 $ 1,446 $ 351 Research and development expense (3 ) 5 98 43 Total stock-based compensation expense $ 437 $ 111 $ 1,544 $ 394 | Note 7— 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 Plans are designed to assist in attracting, motivating and retaining employees and directors and to recognize the importance of employees to the long-term performance and success of the Company. The Company has also granted stock options to certain non-employees outside of the Plans. The Company recognized share-based compensation expense related to grants of stock options, RSUs and common stock awards to employees, directors and consultants of $0.5 million, and $1.0 million during the years ended December 31, 2017 and 2016, 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) 2017 2016 Selling, general and administrative $ 452 $ 630 Research and development 50 385 Total $ 502 $ 1,015 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. Share-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 2017 2016 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 4,354 $ 2,295.37 3,260 $ 3,664.61 Granted 34,651 $ 11.57 2,257 $ 543.63 Exercised — — — — Forfeited/expired (2,643 ) $ 2,666.48 (1,163 ) $ 2,729.60 Outstanding at December 31 36,362 $ 91.48 4,354 $ 2,295.37 Vested at December 31 2,344 $ 964.27 2,134 $ 3,780.79 For options outstanding and vested at December 31, 2017, the weighted average remaining contractual life was 9.33 years and 8.29 years, respectively. There were no option exercises in 2017 or 2016. The total fair value of options that vested in 2017 and 2016 was $0.7 million, and $1.1 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 weighed average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2017 2016 Expected dividend yield 0 % 0 % Risk-free interest rate 1.97 % 1.71 % Expected volatility 103 % 86 % Expected life (in years) 6.25 6.25 The weighted-average fair value of stock options granted in 2017 and 2016 was $11.97 and $543.63, respectively. As of December 31, 2017, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $744,000 and is expected to be recognized over the remaining weighted-average period of 3.1 years. Restricted Stock Awards 2017 2016 RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price Nonvested, beginning balance 499 $ 583.29 15 $ 2,574.00 Granted 138 $ 108.20 1,131 $ 553.88 Vested (392 ) $ 132.70 (619 ) $ 443.40 Forfeited — — (28 ) $ 426.00 Nonvested at December 31 245 $ 521.23 499 $ 583.29 During 2017, and 2016, employees tendered restricted stock units totaling 15, and 165, respectively, to cover related payroll tax withholdings. Warrants Warrants to purchase 8,522,684, and 44,268 shares of common stock were outstanding at December 31, 2017 and 2016, respectively. As of December 31, 2017, warrants outstanding were exercisable at prices ranging from $4.50 to $383.57 per share, and are exercisable over a period ranging from eleven months to 7.5 years. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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 Original Warrants was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy. All Original Warrants were exercised during the nine months ended September 30, 2017. The fair value of the Company’s warrant liability related to the placement agent warrants was calculated using a Black Scholes valuation model and is classified as Level 3 in the fair value hierarchy. The following is a rollforward of the fair value of Level 3 warrants: Nine months ended September 30, 2017 (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,469 ) Exercise of warrants (368 ) Ending balance as of September 30, 2017 $ 6 Fair values were calculated using the following assumptions: As of Dec. 31, 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 (see Note 8 – Commitments and Contingencies), was $126,000 as of both September 30, 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 September 30, 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. | Note 8 - 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. The fair value of the Company’s common stock warrant liability related to the placement agent warrants is calculated using a Black Scholes option pricing model and is classified as Level 3 in the fair value hierarchy. The following is a rollforward of the fair value of Level 3 warrants: (in thousands) July 26, 2016 warrant issuance $ 1,883 November 3, 2016 warrant issuance 778 Change in fair value (818 ) Ending balance December 31, 2016 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Ending balance as of December 31, 2017 $ — Fair values were calculated using the following assumptions: July 26, 2016 Nov. 3, 2016 Dec. 31, 2016 Risk-free interest rates, adjusted for continuous compounding 0.94 % 1.33 % 1.47/1.96 % Term (years) 3.5 5.5 3.1/5.3 Expected volatility 78 % 41.4 % 55.3/49.8 % Dates and probability of future equity raises various various various A significant change in the inputs used for the Monte Carlo and Black Scholes option pricing models such as the expected volatility, bond yield of equivalent securities, or probability of future equity financings, in isolation, would result in significantly higher or lower fair value measurements. In combination, changes in these inputs could result in a significantly higher or lower fair value measurement if the input changes were to be aligned or could result in a minimally higher or lower fair value measurement if the input changes were of a compensating nature. The fair value of the Company’s contingent consideration, as described in Note 2, 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 December 31, 2017 and 2016. The Company believes that the carrying amounts of all remaining financial instruments approximate their fair value due to their relatively short maturities. |
Income Taxes (FY)
Income Taxes (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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 consolidated financial statements. As of September 30, 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. | Note 9—Income Taxes Domestic and foreign loss before income taxes, consists of the following for the years ended December 31: (in thousands) 2017 2016 Domestic $ (13,367 ) $ (15,877 ) Foreign (9 ) 31 Loss before income taxes $ (13,376 ) $ (15,846 ) The components of income tax benefit (expense) consist of the following for the years ended December 31: (in thousands) 2017 2016 Current: United States and state $ — $ — Foreign, net (6 ) 54 Deferred: United States and state — — Foreign — — Total income tax benefit (expense) $ (6 ) $ 54 Actual income tax benefit (expense) differs from statutory federal income tax benefit (expense) as follows for the years ended December 31: (in thousands) 2017 2016 Statutory federal income tax benefit $ 4,548 $ 5,388 State tax benefit, net of federal taxes 48 2 Foreign tax — 3 R&D tax credit — 80 Foreign deferred exchange rate adjustments 899 — Nondeductible/nontaxable items (114 ) (86 ) New federal rate adjustment (16,081 ) — Other (1,085 ) (257 ) Valuation allowance decrease (increase) 11,779 (5,076 ) Total income tax benefit (expense) $ (6 ) $ 54 Deferred taxes consist of the following as of December 31: (in thousands) 2017 2016 Deferred tax assets: Noncurrent: Accrued leave $ 32 $ 43 Other accrued expenses 28 97 Stock based compensation 336 1,477 Net operating loss carryforward 38,947 49,720 Deferred rent 7 17 Other 108 777 Intangibles 895 R&D credit carryforward 531 531 Total deferred tax assets $ 40,884 $ 52,662 Less: valuation allowance (40,884 ) (52,662 ) Total $ — $ — On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (Tax Reform Act) was signed into law making significant changes to the Internal Revenue Code. Changes include a reduction in the corporate tax rates, changes to operating loss carry-forwards and carrybacks, and a repeal of the corporate alternative minimum tax. The legislation reduces the U.S. corporate income tax rates from 34% to 21%. As a result of the enacted law, the Company is required to revalue its deferred tax assets and liabilities at the new enacted rate. The Company re-measured the U.S. deferred income tax assets and liabilities balances using the new enacted tax rate. There was no income tax impact from the re-measurement due to the 100% valuation allowance on the Company’s deferred tax assets. As of December 31, 2017, the Company had net operating loss (“NOLs”) Commonwealth of Australia of approximately AU$49.0 million which the Company can carry forward indefinitely. U.S. NOLs cannot be used to offset taxable income in foreign jurisdictions. In addition, future utilization of NOL carryforwards in the U.S. may be subject to certain limitations under Section 382 of the Internal Revenue Code. The Company received $80,000 fully refundable research and development tax credits in 2016, related to qualified research and development expenditures of its Australian subsidiary for its tax years ended June 30, 2015, and recorded the benefit in the year that the refund was received. The Company received no refunds in 2017 as it has ceased its research and development activities in Australia. 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 financial statements. For the year ended December 31, 2017, the valuation allowance decreased by $11.8 million primarily as result of the impact of the tax reform re-measurement of deferred tax assets. For the year ended December 31, 2016 the valuation allowance increased by $5.8 million primarily due to current year operating losses. During 2017, the Company 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, 2017 or 2016. 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, 2017 and 2016, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2014 through December 31, 2017 remain open to examination by the Internal Revenue Service and for the various states where we are subject to taxation. Additionally, the returns of the Company’s Australian and Irish subsidiary are subject to examination by tax authorities of those jurisdictions for the tax years ended and subsequent to June 30, 2013 and December 31, 2014, respectively. |
Commitments and Contingencies (
Commitments and Contingencies (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Commitments and Contingencies [Abstract] | ||
Commitments and Contingencies | Note 8 - Commitments and Contingencies Leases: Employee Retirement Plan: Contingent Consideration: | Note 10—Commitments and Contingencies Leases The Company leases office space under a non-cancelable operating lease that expires in March 2019. The lease contains provisions for future annual inflationary adjustments. Rent expense is recognized using the straight-line method over the term of the lease. The Company leases office equipment under non-cancelable operating leases that expire at various times through February 2019. Rent expense related to operating leases was approximately $290,000, and $286,000 for the years ended December 31, 2017 and 2016, respectively. Future minimum lease payments under non-cancelable operating leases as of December 31, 2017, were approximately $212,000, $60,000, $7,000, $0, and $0 for each of the years ended December 31, 2018, through 2022, respectively. 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 $138,000 and $122,000 for the years ended December 31, 2017 and 2016, respectively. Inventory Purchase Commitments In connection with the acquisition of the Aquadex Business, the Company entered into a manufacturing and supply agreement with Baxter that was to expire within a period not to exceed 18 months from the close of the transaction. In May 2017, the Company notified Baxter to cease the manufacturing of the Aquadex product line as of June 30, 2017. In connection with this notification, the Company agreed to purchase the remaining Aquadex inventory, which consists mainly of raw materials priced at cost, through February 2018, for a total of $2.4 million. As of December 31, 2017, the Company had purchased and paid $1.2 million of this inventory and $1.2 million remained to be purchased. Contingent Consideration As described on Note 2, the Company agreed that if it disposes of any of the Aquadex assets for a price that exceeds $4.0 million within three years of the closing, it will pay Baxter 40% of the amount of such excess. In addition, it also agreed that if shares of its common stock cease to be publicly traded on Nasdaq, Baxter has the option to require the Company to repurchase, in cash, all or any part of the common shares held by Baxter at a price equal to their fair market value, as determined by a third-party appraiser. |
Segment and Geographic Informat
Segment and Geographic Information (FY) | 12 Months Ended |
Dec. 31, 2017 | |
Segment and Geographic Information [Abstract] | |
Segment and Geographic Information | Note 11—Segment and Geographic Information The Company has one reportable segment, cardiac and coronary disease products. At December 31, 2017, long-lived assets were located primarily in the United States. |
Nature of Business and Basis of
Nature of Business and Basis of Presentation (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Nature of Business and Significant Accounting Policies [Abstract] | ||
Nature of Business and Basis of Presentation | Note 1 – Nature of Business and Basis of Presentation Nature of Business : the Nasdaq Capital Market 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 FlexFlow 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 Aquadex. This will require the Company to succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing and distributing Aquadex 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 July 3, 2018, April 24, 2017 and on November 27, 2017, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $28.8 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (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 warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. Revenue Recognition: Revenue from Contracts with Customers Accounts Receivable Inventories (in thousands) September 30, 2018 December 31, 2017 Finished Goods $ 810 $ 902 Work in Process 91 217 Raw Materials 1,047 469 Total $ 1,948 $ 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: September 30 2018 2017 Stock options 1,987,502 36,874 Restricted stock units 90 324 Warrants to purchase common stock 8,522,672 496,629 Series F convertible preferred stock 266,680 - Total 10,776,944 533,827 The following table reconciles reported net loss with reported net loss per share for the periods ended September 30, 2017: (in thousands, except per share amounts) Three months Nine Months Net loss $ (2,847 ) $ (6,245 ) Deemed dividend to preferred shareholders (see Note 4) - (2,851 ) Net loss after deemed dividend (2,847 ) (9,096 ) Weighted average shares outstanding 626 359 Basic and diluted loss per share $ (4.55 ) $ (25.36 ) 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 and quarterly periods beginning January 1, 2019. T he Company is in the process of evaluating the impact that the adoption of this standard will have on its consolidated financial statements and is currently assessing its leases. The Company The Securities and Exchange Commission (“ SEC | Note 1—Nature of Business and Significant Accounting Policies Nature of Business CHF Solutions, Inc. (the “Company”) is a medical device company focused on commercializing the Aquadex FlexFlow® System for Aquapheresis® therapy. The Aquadex FlexFlow System (Aquadex) is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. CHF Solutions, Inc. is a Delaware corporation headquartered in Minneapolis with wholly owned subsidiaries in Australia, Ireland and Delaware. The Company has been listed on Nasdaq since February 2012. 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. The C-Pulse System utilized the known concept of counterpulsation applied to the aorta. In March 2016, the Company announced that it was no longer enrolling patients into its two clinical studies for the C-Pulse System and that it planned to pursue a new strategic direction. In July 2016, the Company announced that it was moving forward with a therapeutic strategy utilizing neuromodulation rather than counterpulsation. 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 near-term strategy that included halting clinical evaluations of its neuromodulation technology to fully focus its resources on its recently acquired Aquadex Business, taking actions to reduce its cash burn, and reviewing potential strategic alliances and financing alternatives. 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. Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2017 and 2016, 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, 2017, the Company had an accumulated deficit of $182.4 million and it expects to incur losses for the foreseeable future. To date, the Company has been funded by debt and equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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 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 6 - Equity). The Company may require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. Basis of Presentation The accompanying consolidated financial statements include the accounts of CHF Solutions, Inc. and its wholly owned subsidiaries, CHF Solutions, LLC, Sunshine Heart Company Pty Limited, and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States 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, are 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 uncollectability, 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 its accounts receivable aging, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2017 or 2016. Inventories Inventories are recorded as the lower of cost or market using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2017 2016 Finished Goods $ 902 $ 644 Work in Process 217 — Raw Materials 469 33 Total $ 1,588 $ 677 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 and capital lease assets 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: Office furniture and equipment 5-15 years Computer software and equipment 3-4 years Laboratory and research equipment 3-15 years Production equipment 3-7 years Leasehold improvements and capital lease asset 3-5 years Depreciation expense was $229,000 and $419,000 for the years ended December 31, 2017, and 2016, 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 exceeds its carrying amount. The Company generally measures fair value by considering sale prices for similar assets or asset groups, or by discounting estimated future cash flows from such assets or asset groups using an appropriate discount rate. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company reviewed its property and equipment in conjunction with its intangible asset impairment analysis and determined that the fair value of property and equipment equaled or exceeded its carrying value. As a result, there have been no impairment losses recognized for the years ended December 31, 2017 or 2016. Intangible assets The Company’s intangible assets consisted of customer relationships, developed technology, and trademarks and tradenames. All intangible assets recognized by the Company resulted from the acquisition of the Aquadex Business. All intangible assets were estimated to have a useful life of 7 years. The Company reviews its definite lived intangible assets for impairment when impairment indicators exist. When impairment indicators exist, the Company determines if the carrying value of the intangible assets exceeds the related undiscounted cash flows. In cases where the carrying value exceeds the undiscounted cash flows, and the carrying amount is not considered recoverable, the carrying value is written down to its fair value, generally using a discounted cash flow analysis. An impairment loss is recognized for the amount that the intangible assets exceeds their fair value, generally based on discounted cash flow methods and other fair market value indicators. The Company’s review of its intangible assets during the year ended December 31, 2017, resulted in $3.8 million of impairment charges related to its finite-lived intangible assets. The Company has a single reporting unit. The impairment charges were based on fair values determined using market value indicators such as the quoted market prices of the Company’s common stock on Nasdaq, as well discounted cash flow models. Discounted cash flow models include assumptions related to the Company’s product revenue, gross margins, and operating margins, under varying assumptions about the Company’s ability to either achieve profitability or obtain the necessary financings to realize such projections. As discussed above, the Company became a revenue generating company after acquiring the Aquadex Business in August 2016 and expects to incur losses in the near-term as it grows the Aquadex Business. To become and remain profitable, and to generate cash flows from operations, the Company must succeed in expanding the adoption and market acceptance of its products. This will require that the Company succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing, and distributing its products. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability or positive cash flows. The discounted cash flow models reflect these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. Amortization expense was $540,000 and $278,000 for the years ended December 31, 2017 and 2016, respectively. Goodwill Goodwill is the cost of an acquisition in excess of the fair value of acquired assets and liabilities and is recorded as an asset on the balance sheet. Goodwill is not subject to amortization but must be tested for impairment at least annually. This test requires the Company to determine if the implied fair value of the goodwill is less than its carrying amount. The Company evaluates goodwill for impairment annually on November 1 st Simplifying the Test for Goodwill Impairment The Company has a single reporting unit. The impairment charge was based on fair values determined using market value indicators such as the quoted market prices of the Company’s common stock on Nasdaq, as well discounted cash flow models. Discounted cash flow models include assumptions related to the Company’s product revenue, gross margins, and operating margins, under varying assumptions about the Company’s ability to either achieve profitability or obtain the necessary financings to realize such projections. As discussed above, the Company became a revenue generating company after acquiring the Aquadex Business in August 2016 and expects to incur losses in the near-term as it grows the Aquadex Business. To become and remain profitable, and to generate cash flows from operations, the Company must succeed in expanding the adoption and market acceptance of its products. This will require that the Company succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing, and distributing its products. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability or positive cash flows. The discounted cash flow models reflect these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. Contingent consideration In connection with the Company’s purchase of the Aquadex Business, the Company has an obligation to pay additional consideration that is contingent upon the occurrence of certain future events. Contingent consideration is recognized at the acquisition date at the estimated fair value of the contingent milestone payments. The fair value of the contingent consideration is remeasured to its estimated fair value at the end of each reporting period, with changes recorded to earnings. Common stock warrant liability The Company recorded its common stock warrant liability at fair value at the date of issuance using primarily a Monte Carlo valuation model. The fair value is remeasured to its estimated fair value at the end of each reporting period with changes recorded to earnings. Revenue Recognition The Company recognizes revenues from product sales when earned. Specifically, revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred, the price is fixed or determinable, and collectability is reasonably assured. Revenue is not recognized until title and risk of loss have transferred to the customer. The shipping terms for the Company’s revenue arrangements are generally FOB shipping point. 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, restricted stock units (RSUs) and common stock awards in the income statement as an operating expense, based on their fair value. The Company’s stock awards use a graded vesting schedule. The Company recognizes the option expense over the requisite service period, which is generally the vesting period. The Company computes the estimated fair values of stock options and certain of its warrants using the Black-Scholes option pricing model. The closing market price of the Company’s common stock 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. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Equity instruments issued to non-employees include RSUs, warrants or options to purchase shares of the Company’s common stock. These RSUs, warrants or options 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. Unvested awards are remeasured to fair value until they vest. See Note 7- 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. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (Tax Reform Act) was signed into law making significant changes to the Internal Revenue Code. Changes include a reduction in the corporate tax rates, changes to operating loss carry-forwards and carrybacks, and a repeal of the corporate alternative minimum tax. The legislation reduces the U.S. corporate income tax rates from 34% to 21%. As a result of the enacted law, the Company is required to revalue its deferred tax assets and liabilities at the new enacted rate. The Company re-measured the U.S. deferred income tax assets and liabilities balances using the new enacted tax rate (see Note 9). There was no income tax impact from the remeasurement due to the 100% valuation allowance on the Company’s deferred tax assets. 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 for the year ended December 31, 2017, reflects increases for net deemed dividends to preferred stockholders provided in connection with the close of the public offering of Series E Convertible Preferred Stock in April of 2017, and the close of the public offering of Series F Convertible Preferred Stock in November of 2017, of $1.0 million and $8.7 million, respectively, representing the intrinsic value of the shares at the time of issuance. In addition, the net loss allocable to common stockholders reflects an increase for net deemed dividends of $1.8 million to preferred stockholders provided in connection with the shareholder approval of the Series C and D Convertible Preferred Stock transactions in January of 2017, representing the intrinsic value of the shares at the time of issuance. The net loss allocable to common shareholders for 2016 reflects a $1.9 million increase for the net deemed dividend to preferred shareholders provided in connection with the 2016 Series B and B-1 offering (See Note 5). 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 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 period presented: December 31, 2017 2016 Stock options 36,362 4,354 Restricted stock units 245 499 Warrants to purchase common stock 8,522,684 44,268 Series B, C and D convertible preferred stock — 53,179 Series F convertible preferred stock 842,940 —- Total 9,402,231 102,300 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) 2017 2016 Net loss $ (13,382 ) $ (15,792 ) Deemed dividend to preferred shareholders (see Note 6) (11,590 ) (1,900 ) Net loss after deemed dividend (24,972 ) (17,692 ) Weighted average shares outstanding 665 33 Basic and diluted loss per share $ (37.51 ) $ (536.12 ) Research and Development Research and development costs include activities related to research, development, design, and testing improvements of the Aquadex FlexFlow 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. Reclassification For comparability, certain December 31, 2016 amounts have been reclassified to conform to classifications adopted in December 31, 2017. The reclassifications had no impact on previously reported net loss or equity. Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (FASB), issued amended stock compensation guidance to simplify various aspects of employee share-based payments accounting and presentation in the financial statements. The new guidance requires all income tax effects of awards to be recognized in the income statement when the awards vest or are settled, allows an employer to repurchase more of an employee’s shares than previously allowed for tax withholding purposes without triggering liability accounting, allows a company to make a policy election to account for forfeitures as they occur, and eliminates the requirement that excess tax benefits be realized before companies can recognize them. The new guidance also requires excess tax benefits and tax shortfalls to be presented on the cash flow statement as an operating activity rather than as a financing activity, and clarifies that cash paid to a tax authority when shares are withheld to satisfy its statutory income tax withholding obligation are to be presented as a financing activity. The standard was effective for our interim and annual periods beginning after January 1, 2017. The Company adopted the guidance in the current year. The adoption of this standard did not have a material impact to the Company’s consolidated financial statements. In May 2014, August 2015, March 2016, April 2016 and May 2016, the FASB issued amended revenue recognition guidance to clarify the principles for recognizing revenue from contracts with customers. The guidance requires an entity to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. The standard allows the Company to transition to the new model using either a full or modified retrospective approach, and early adoption is not permitted. The Company has determined that it will use the modified retrospective approach. This guidance will be effective for the Company's interim and annual periods beginning January 1, 2018. As of the end of the fourth quarter of 2017, the Company had nearly completed its assessment of this amended guidance and it does not expect that the adoption of this standard will not have a material impact on the timing and amount of revenue recognized, but it expects to provide expanded disclosures as a result of the adoption. The Company will continue to evaluate the impact of the amended guidance as it pertains to presentation and disclosure. In November 2015, the FASB issued amended guidance concerning the classification of deferred taxes on the balance sheet to require that deferred tax assets and deferred tax liabilities be presented as noncurrent in a classified balance sheet. The amendment is effective for our annual and interim reporting periods beginning January 1, 2017, with early adoption permitted. The adoption of this standard did not have an impact on the Company’s consolidated financial statements as all deferred tax assets are fully reserved. In January 2017, the FASB issued amended guidance to simplify the accounting for goodwill impairment by removing Step 2 of the goodwill impairment test. A goodwill impairment will now be measured as the amount by which a reporting unit’s carrying value exceeds its fair value, limited to the amount of goodwill allocated to that reporting unit. This guidance is to be applied on a prospective basis effective for the Company’s interim and annual periods beginning after January 1, 2019, with early adoption permitted for any impairment tests performed after January 1, 2017. The Company adopted this amended guidance in the current year, as further described above under Significant Accounting Policies. 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 reporting period ending December 31, 2020, and for annual and interim periods thereafter. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Revenue Recognition (Q3)
Revenue Recognition (Q3) | 9 Months Ended |
Sep. 30, 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, Spain, Germany, and Southeast Asia. The majority of 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 the Company expects to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when the Company satisfies its performance obligations under the contract. The majority of the Company’s contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers that are recognized over time. Revenue from extended service plans represents less than 1% of net sales for the both the three- and nine-month periods ended September 30, 2018. The unfulfilled performance obligations related to these extended service plans is included in deferred revenue in the amount of $41,250 and $38,000 as of September 30, 2018 and December 31, 2017, respectively. Deferred revenue is included in other current liabilities on the condensed consolidated balance sheets. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns: believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns. |
Debt (Q3)
Debt (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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”) for a $1.0 million revolving line of credit (the “Revolving Line”). Under the Revolving Line, the Company may borrow the lesser of $1.0 million or 80% of its eligible accounts (subject to customary exclusions), minus the outstanding principal balance of any advances under the Revolving Line. Advances under the Revolving Line, if any, accrue interest at a floating annual rate equal to 1.75% or 1.0% above the prime rate, depending on liquidity factors. The loan agreement contains customary representations, as well as customary affirmative and negative covenants. Outstanding borrowings, if any, are collateralized by all of the Company’s assets, excluding intellectual property which is subject to a negative pledge. Advances under the Revolving Line are subject to various conditions precedent, including compliance with financial covenants relating to net liquidity relative to monthly cash burn, which the Company may or may not meet depending on its cash position at any given point. The Revolving Line expires March 31, 2020. There were no borrowings outstanding under this facility as of September 30, 2018 or December 31, 2017. Warrants: | Note 5—Debt Prior Loan Agreement On August 4, 2016, the Company repaid all amounts outstanding under its existing debt facility of $5.5 million and incurred a $0.5 million loss on early extinguishment of debt, including the accelerated write-off of unamortized warrants and debt issuance costs. There were no borrowings outstanding under this facility as of December 31, 2017 or 2016. Warrants: New Loan Agreement: |
Equity (Q3)
Equity (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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 Series E Convertible Preferred Stock included a beneficial conversion amount of $1.0 million, representing the intrinsic value of the shares at the time of issuance. This amount is reflected as an increase to the loss per share allocable to common stockholders in the nine months ended September 30, 2017 . 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 . July 2018 Offering: underwritten public offering of 2,547,169 shares of its common stock at a public offering price of $2.12 per share, for gross proceeds of $5.4 million, prior to deducting underwriting discounts and commissions and offering expenses (the “July 2018 Offering”). In connection with the July 2018 Offering, and to induce certain institutional investors who hold warrants issued by the Company in November 2017 (“November 2017 Warrants”) to participate in the July 2018 Offering, the Company entered into letter agreements with such institutional investors (collectively, the “Warrant Reprice Agreements”). Pursuant to the terms of the Warrant Reprice Agreements, the Company agreed, effective July 3, 2018, to (a) reduce the per share exercise price of the November 2017 Warrants held by such institutional investors (the “Repriced Warrants”) to $2.12 and (b) extend the expiration date of the Repriced Warrants that were to expire on November 27, 2018 to November 27, 2019. The number of shares underlying the Repriced Warrants after the price reduction did not change. The Repriced Warrants are exercisable for 7,760,400 shares of common stock in the aggregate, of which, following such amendment, half expire on November 27, 2019 and half expire on November 27, 2024. The repricing of the warrants was accounted as an equity financing cost, with no impact to net proceeds from the offering. As noted above, the Company’s outstanding Series F preferred stock is subject to full-ratchet anti-dilution protection in the event the Company sells any common stock at a price lower than the then-conversion price of the Series F preferred stock. As a result of the July 2018 Offering, effective July 3, 2018, the conversion price of the Series F preferred stock was reduced from $4.50 to $2.12, the per share price to public in the July 2018 Offering. 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 consolidated 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 September 30, 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 nine-month period ending September 30, 2017. | Note 6—Shareholder’s Equity Series B/B-1 Convertible Preferred Stock On October 30, 2016, the Company entered into an exchange agreement with the holders of its Series B Convertible Preferred Stock and agreed to issue such holders 2,227.2 shares of the Company’s Series B-1 Convertible Preferred Stock in exchange for the cancellation of all shares of Series B Convertible Preferred Stock held by such holders. The Series B-1 Convertible Preferred Stock had similar terms as the Series B Convertible Preferred Stock, except that the initial conversion price of the Series B-1 Convertible Preferred Stock was $102 per share. As of December 31, 2016, 402.8 shares of the Series B-1 Convertible Preferred Stock had been converted into 3,948 shares of common stock, and 1,824.4 shares of Series B-1 Convertible Preferred Stock remained outstanding. As of December 31, 2017, all remaining Series B-1 Convertible Preferred Stock had been converted into an additional 17,866 shares of common stock and none remained outstanding. The Series B and B-1 convertible preferred stock include a net deemed dividend in the amount of $1.9 million, representing the intrinsic value of the shares at the time of issuance, which is reflected as an increase to the loss per share allocable to common shareholders. Series C and D Convertible Preferred Stock The Series D Convertible Preferred Stock with a carrying value of $0.5 million was classified as temporary equity in the consolidated balance sheet as of December 31, 2016 because the Company could not control the settlement of its redemption in common stock. The temporary equity was not remeasured to fair value each period through earnings because the events that could trigger its redemption were not probable of occurrence. There were no shares of the Series D Convertible Preferred Stock outstanding as of December 31, 2017. Series E Convertible Preferred Stock The offering comprised of Class A Units, priced at a public offering price of $20.00 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 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 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 640,000 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. The Series E Convertible Preferred Stock included a beneficial conversion amount of $1.0 million, representing the intrinsic value of the shares at the time of issuance. This amount is reflected as an increase to the loss per share allocable to common stockholders in the year ended December 31, 2017. As of December 31, 2017, all shares of the Series E Convertible Preferred Stock had been converted into an aggregate of 320,000 shares of common stock and none remained outstanding. 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. The conversion price of the Series F 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 18,000 shares of Series F Convertible Preferred Stock convertible into approximately 4.0 million shares of common stock and warrants to purchase approximately 8.0 million shares of common stock were issued in the offering. The Series F Convertible Preferred Stock included a beneficial conversion amount of $8.7 million, representing the intrinsic value of the shares at the time of issuance. This amount is reflected as an increase to the loss per share allocable to common stockholders in the year ended December 31, 2017. As of December 31, 2017, 14,220 shares of the Series F Convertible Preferred Stock had been converted into an aggregate of 3,171,060 shares of common stock and 3,780 remained outstanding. In connection with the issuance of the Series B, C and D Convertible Preferred Shares, the Company paid the placement agent an aggregate cash placement fee equal to 6% of the aggregate gross proceeds raised in the offering and issued warrants as described below. In connection with the issuance of the Series E and F Convertible Preferred Shares, the Company paid the placement agent an aggregate cash placement fee equal to 9% and 8%, respectively, of the aggregate gross proceeds raised in the offering and issued no warrants to the placement agent. 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 December 31, 2017, there were no Original Warrants outstanding and all Replacement Warrants under the letter agreement had been issued. Warrant Valuation The Replacement Warrants were valued at $0.5 million using the Black Scholes option pricing 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 the Replacement 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 consolidated statement of operations for the year ended December 31, 2017. |
Stock-Based Compensation (Q3)
Stock-Based Compensation (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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 September 30, Nine months ended September 30, (in thousands) 2018 2017 2018 2017 Selling, general and administrative expense $ 440 $ 106 $ 1,446 $ 351 Research and development expense (3 ) 5 98 43 Total stock-based compensation expense $ 437 $ 111 $ 1,544 $ 394 | Note 7— 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 Plans are designed to assist in attracting, motivating and retaining employees and directors and to recognize the importance of employees to the long-term performance and success of the Company. The Company has also granted stock options to certain non-employees outside of the Plans. The Company recognized share-based compensation expense related to grants of stock options, RSUs and common stock awards to employees, directors and consultants of $0.5 million, and $1.0 million during the years ended December 31, 2017 and 2016, 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) 2017 2016 Selling, general and administrative $ 452 $ 630 Research and development 50 385 Total $ 502 $ 1,015 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. Share-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 2017 2016 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 4,354 $ 2,295.37 3,260 $ 3,664.61 Granted 34,651 $ 11.57 2,257 $ 543.63 Exercised — — — — Forfeited/expired (2,643 ) $ 2,666.48 (1,163 ) $ 2,729.60 Outstanding at December 31 36,362 $ 91.48 4,354 $ 2,295.37 Vested at December 31 2,344 $ 964.27 2,134 $ 3,780.79 For options outstanding and vested at December 31, 2017, the weighted average remaining contractual life was 9.33 years and 8.29 years, respectively. There were no option exercises in 2017 or 2016. The total fair value of options that vested in 2017 and 2016 was $0.7 million, and $1.1 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 weighed average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2017 2016 Expected dividend yield 0 % 0 % Risk-free interest rate 1.97 % 1.71 % Expected volatility 103 % 86 % Expected life (in years) 6.25 6.25 The weighted-average fair value of stock options granted in 2017 and 2016 was $11.97 and $543.63, respectively. As of December 31, 2017, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $744,000 and is expected to be recognized over the remaining weighted-average period of 3.1 years. Restricted Stock Awards 2017 2016 RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price Nonvested, beginning balance 499 $ 583.29 15 $ 2,574.00 Granted 138 $ 108.20 1,131 $ 553.88 Vested (392 ) $ 132.70 (619 ) $ 443.40 Forfeited — — (28 ) $ 426.00 Nonvested at December 31 245 $ 521.23 499 $ 583.29 During 2017, and 2016, employees tendered restricted stock units totaling 15, and 165, respectively, to cover related payroll tax withholdings. Warrants Warrants to purchase 8,522,684, and 44,268 shares of common stock were outstanding at December 31, 2017 and 2016, respectively. As of December 31, 2017, warrants outstanding were exercisable at prices ranging from $4.50 to $383.57 per share, and are exercisable over a period ranging from eleven months to 7.5 years. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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 Original Warrants was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy. All Original Warrants were exercised during the nine months ended September 30, 2017. The fair value of the Company’s warrant liability related to the placement agent warrants was calculated using a Black Scholes valuation model and is classified as Level 3 in the fair value hierarchy. The following is a rollforward of the fair value of Level 3 warrants: Nine months ended September 30, 2017 (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,469 ) Exercise of warrants (368 ) Ending balance as of September 30, 2017 $ 6 Fair values were calculated using the following assumptions: As of Dec. 31, 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 (see Note 8 – Commitments and Contingencies), was $126,000 as of both September 30, 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 September 30, 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. | Note 8 - 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. The fair value of the Company’s common stock warrant liability related to the placement agent warrants is calculated using a Black Scholes option pricing model and is classified as Level 3 in the fair value hierarchy. The following is a rollforward of the fair value of Level 3 warrants: (in thousands) July 26, 2016 warrant issuance $ 1,883 November 3, 2016 warrant issuance 778 Change in fair value (818 ) Ending balance December 31, 2016 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Ending balance as of December 31, 2017 $ — Fair values were calculated using the following assumptions: July 26, 2016 Nov. 3, 2016 Dec. 31, 2016 Risk-free interest rates, adjusted for continuous compounding 0.94 % 1.33 % 1.47/1.96 % Term (years) 3.5 5.5 3.1/5.3 Expected volatility 78 % 41.4 % 55.3/49.8 % Dates and probability of future equity raises various various various A significant change in the inputs used for the Monte Carlo and Black Scholes option pricing models such as the expected volatility, bond yield of equivalent securities, or probability of future equity financings, in isolation, would result in significantly higher or lower fair value measurements. In combination, changes in these inputs could result in a significantly higher or lower fair value measurement if the input changes were to be aligned or could result in a minimally higher or lower fair value measurement if the input changes were of a compensating nature. The fair value of the Company’s contingent consideration, as described in Note 2, 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 December 31, 2017 and 2016. The Company believes that the carrying amounts of all remaining financial instruments approximate their fair value due to their relatively short maturities. |
Income Taxes (Q3)
Income Taxes (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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 consolidated financial statements. As of September 30, 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. | Note 9—Income Taxes Domestic and foreign loss before income taxes, consists of the following for the years ended December 31: (in thousands) 2017 2016 Domestic $ (13,367 ) $ (15,877 ) Foreign (9 ) 31 Loss before income taxes $ (13,376 ) $ (15,846 ) The components of income tax benefit (expense) consist of the following for the years ended December 31: (in thousands) 2017 2016 Current: United States and state $ — $ — Foreign, net (6 ) 54 Deferred: United States and state — — Foreign — — Total income tax benefit (expense) $ (6 ) $ 54 Actual income tax benefit (expense) differs from statutory federal income tax benefit (expense) as follows for the years ended December 31: (in thousands) 2017 2016 Statutory federal income tax benefit $ 4,548 $ 5,388 State tax benefit, net of federal taxes 48 2 Foreign tax — 3 R&D tax credit — 80 Foreign deferred exchange rate adjustments 899 — Nondeductible/nontaxable items (114 ) (86 ) New federal rate adjustment (16,081 ) — Other (1,085 ) (257 ) Valuation allowance decrease (increase) 11,779 (5,076 ) Total income tax benefit (expense) $ (6 ) $ 54 Deferred taxes consist of the following as of December 31: (in thousands) 2017 2016 Deferred tax assets: Noncurrent: Accrued leave $ 32 $ 43 Other accrued expenses 28 97 Stock based compensation 336 1,477 Net operating loss carryforward 38,947 49,720 Deferred rent 7 17 Other 108 777 Intangibles 895 R&D credit carryforward 531 531 Total deferred tax assets $ 40,884 $ 52,662 Less: valuation allowance (40,884 ) (52,662 ) Total $ — $ — On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (Tax Reform Act) was signed into law making significant changes to the Internal Revenue Code. Changes include a reduction in the corporate tax rates, changes to operating loss carry-forwards and carrybacks, and a repeal of the corporate alternative minimum tax. The legislation reduces the U.S. corporate income tax rates from 34% to 21%. As a result of the enacted law, the Company is required to revalue its deferred tax assets and liabilities at the new enacted rate. The Company re-measured the U.S. deferred income tax assets and liabilities balances using the new enacted tax rate. There was no income tax impact from the re-measurement due to the 100% valuation allowance on the Company’s deferred tax assets. As of December 31, 2017, the Company had net operating loss (“NOLs”) Commonwealth of Australia of approximately AU$49.0 million which the Company can carry forward indefinitely. U.S. NOLs cannot be used to offset taxable income in foreign jurisdictions. In addition, future utilization of NOL carryforwards in the U.S. may be subject to certain limitations under Section 382 of the Internal Revenue Code. The Company received $80,000 fully refundable research and development tax credits in 2016, related to qualified research and development expenditures of its Australian subsidiary for its tax years ended June 30, 2015, and recorded the benefit in the year that the refund was received. The Company received no refunds in 2017 as it has ceased its research and development activities in Australia. 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 financial statements. For the year ended December 31, 2017, the valuation allowance decreased by $11.8 million primarily as result of the impact of the tax reform re-measurement of deferred tax assets. For the year ended December 31, 2016 the valuation allowance increased by $5.8 million primarily due to current year operating losses. During 2017, the Company 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, 2017 or 2016. 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, 2017 and 2016, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2014 through December 31, 2017 remain open to examination by the Internal Revenue Service and for the various states where we are subject to taxation. Additionally, the returns of the Company’s Australian and Irish subsidiary are subject to examination by tax authorities of those jurisdictions for the tax years ended and subsequent to June 30, 2013 and December 31, 2014, respectively. |
Commitments and Contingencies_2
Commitments and Contingencies (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Commitments and Contingencies [Abstract] | ||
Commitments and Contingencies | Note 8 - Commitments and Contingencies Leases: Employee Retirement Plan: Contingent Consideration: | Note 10—Commitments and Contingencies Leases The Company leases office space under a non-cancelable operating lease that expires in March 2019. The lease contains provisions for future annual inflationary adjustments. Rent expense is recognized using the straight-line method over the term of the lease. The Company leases office equipment under non-cancelable operating leases that expire at various times through February 2019. Rent expense related to operating leases was approximately $290,000, and $286,000 for the years ended December 31, 2017 and 2016, respectively. Future minimum lease payments under non-cancelable operating leases as of December 31, 2017, were approximately $212,000, $60,000, $7,000, $0, and $0 for each of the years ended December 31, 2018, through 2022, respectively. 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 $138,000 and $122,000 for the years ended December 31, 2017 and 2016, respectively. Inventory Purchase Commitments In connection with the acquisition of the Aquadex Business, the Company entered into a manufacturing and supply agreement with Baxter that was to expire within a period not to exceed 18 months from the close of the transaction. In May 2017, the Company notified Baxter to cease the manufacturing of the Aquadex product line as of June 30, 2017. In connection with this notification, the Company agreed to purchase the remaining Aquadex inventory, which consists mainly of raw materials priced at cost, through February 2018, for a total of $2.4 million. As of December 31, 2017, the Company had purchased and paid $1.2 million of this inventory and $1.2 million remained to be purchased. Contingent Consideration As described on Note 2, the Company agreed that if it disposes of any of the Aquadex assets for a price that exceeds $4.0 million within three years of the closing, it will pay Baxter 40% of the amount of such excess. In addition, it also agreed that if shares of its common stock cease to be publicly traded on Nasdaq, Baxter has the option to require the Company to repurchase, in cash, all or any part of the common shares held by Baxter at a price equal to their fair market value, as determined by a third-party appraiser. |
Nature of Business and Signif_2
Nature of Business and Significant Accounting Policies (FY) (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Nature of Business and Significant Accounting Policies [Abstract] | ||
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 Aquadex. This will require the Company to succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing and distributing Aquadex 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 July 3, 2018, April 24, 2017 and on November 27, 2017, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $28.8 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (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 warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. | Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2017 and 2016, 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, 2017, the Company had an accumulated deficit of $182.4 million and it expects to incur losses for the foreseeable future. To date, the Company has been funded by debt and equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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 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 6 - Equity). The Company may require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of CHF Solutions, Inc. and its wholly owned subsidiaries, CHF Solutions, LLC, Sunshine Heart Company Pty Limited, and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States 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 Accounts receivable are unsecured, are 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 uncollectability, 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 its accounts receivable aging, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2017 or 2016. |
Inventories | Inventories (in thousands) September 30, 2018 December 31, 2017 Finished Goods $ 810 $ 902 Work in Process 91 217 Raw Materials 1,047 469 Total $ 1,948 $ 1,588 | Inventories Inventories are recorded as the lower of cost or market using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2017 2016 Finished Goods $ 902 $ 644 Work in Process 217 — Raw Materials 469 33 Total $ 1,588 $ 677 |
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 and capital lease assets 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: Office furniture and equipment 5-15 years Computer software and equipment 3-4 years Laboratory and research equipment 3-15 years Production equipment 3-7 years Leasehold improvements and capital lease asset 3-5 years Depreciation expense was $229,000 and $419,000 for the years ended December 31, 2017, and 2016, 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 exceeds its carrying amount. The Company generally measures fair value by considering sale prices for similar assets or asset groups, or by discounting estimated future cash flows from such assets or asset groups using an appropriate discount rate. Assets to be disposed of are carried at the lower of their carrying value or fair value less costs to sell. Considerable management judgment is necessary to estimate the fair value of assets or asset groups, and accordingly, actual results could vary significantly from such estimates. The Company reviewed its property and equipment in conjunction with its intangible asset impairment analysis and determined that the fair value of property and equipment equaled or exceeded its carrying value. As a result, there have been no impairment losses recognized for the years ended December 31, 2017 or 2016. | |
Intangible Assets | Intangible assets The Company’s intangible assets consisted of customer relationships, developed technology, and trademarks and tradenames. All intangible assets recognized by the Company resulted from the acquisition of the Aquadex Business. All intangible assets were estimated to have a useful life of 7 years. The Company reviews its definite lived intangible assets for impairment when impairment indicators exist. When impairment indicators exist, the Company determines if the carrying value of the intangible assets exceeds the related undiscounted cash flows. In cases where the carrying value exceeds the undiscounted cash flows, and the carrying amount is not considered recoverable, the carrying value is written down to its fair value, generally using a discounted cash flow analysis. An impairment loss is recognized for the amount that the intangible assets exceeds their fair value, generally based on discounted cash flow methods and other fair market value indicators. The Company’s review of its intangible assets during the year ended December 31, 2017, resulted in $3.8 million of impairment charges related to its finite-lived intangible assets. The Company has a single reporting unit. The impairment charges were based on fair values determined using market value indicators such as the quoted market prices of the Company’s common stock on Nasdaq, as well discounted cash flow models. Discounted cash flow models include assumptions related to the Company’s product revenue, gross margins, and operating margins, under varying assumptions about the Company’s ability to either achieve profitability or obtain the necessary financings to realize such projections. As discussed above, the Company became a revenue generating company after acquiring the Aquadex Business in August 2016 and expects to incur losses in the near-term as it grows the Aquadex Business. To become and remain profitable, and to generate cash flows from operations, the Company must succeed in expanding the adoption and market acceptance of its products. This will require that the Company succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing, and distributing its products. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability or positive cash flows. The discounted cash flow models reflect these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. Amortization expense was $540,000 and $278,000 for the years ended December 31, 2017 and 2016, respectively. | |
Goodwill | Goodwill Goodwill is the cost of an acquisition in excess of the fair value of acquired assets and liabilities and is recorded as an asset on the balance sheet. Goodwill is not subject to amortization but must be tested for impairment at least annually. This test requires the Company to determine if the implied fair value of the goodwill is less than its carrying amount. The Company evaluates goodwill for impairment annually on November 1 st Simplifying the Test for Goodwill Impairment The Company has a single reporting unit. The impairment charge was based on fair values determined using market value indicators such as the quoted market prices of the Company’s common stock on Nasdaq, as well discounted cash flow models. Discounted cash flow models include assumptions related to the Company’s product revenue, gross margins, and operating margins, under varying assumptions about the Company’s ability to either achieve profitability or obtain the necessary financings to realize such projections. As discussed above, the Company became a revenue generating company after acquiring the Aquadex Business in August 2016 and expects to incur losses in the near-term as it grows the Aquadex Business. To become and remain profitable, and to generate cash flows from operations, the Company must succeed in expanding the adoption and market acceptance of its products. This will require that the Company succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing, and distributing its products. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability or positive cash flows. The discounted cash flow models reflect these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. | |
Contingent Consideration | Contingent consideration | Contingent consideration In connection with the Company’s purchase of the Aquadex Business, the Company has an obligation to pay additional consideration that is contingent upon the occurrence of certain future events. Contingent consideration is recognized at the acquisition date at the estimated fair value of the contingent milestone payments. The fair value of the contingent consideration is remeasured to its estimated fair value at the end of each reporting period, with changes recorded to earnings. |
Common Stock Warrant Liability | Common stock warrant liability The Company recorded its common stock warrant liability at fair value at the date of issuance using primarily a Monte Carlo valuation model. The fair value is remeasured to its estimated fair value at the end of each reporting period with changes recorded to earnings. | |
Revenue Recognition | Revenue Recognition The Company recognizes revenues from product sales when earned. Specifically, revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred, the price is fixed or determinable, and collectability is reasonably assured. Revenue is not recognized until title and risk of loss have transferred to the customer. The shipping terms for the Company’s revenue arrangements are generally FOB shipping point. | |
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, restricted stock units (RSUs) and common stock awards in the income statement as an operating expense, based on their fair value. The Company’s stock awards use a graded vesting schedule. The Company recognizes the option expense over the requisite service period, which is generally the vesting period. The Company computes the estimated fair values of stock options and certain of its warrants using the Black-Scholes option pricing model. The closing market price of the Company’s common stock 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. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Equity instruments issued to non-employees include RSUs, warrants or options to purchase shares of the Company’s common stock. These RSUs, warrants or options 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. Unvested awards are remeasured to fair value until they vest. See Note 7- 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. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (Tax Reform Act) was signed into law making significant changes to the Internal Revenue Code. Changes include a reduction in the corporate tax rates, changes to operating loss carry-forwards and carrybacks, and a repeal of the corporate alternative minimum tax. The legislation reduces the U.S. corporate income tax rates from 34% to 21%. As a result of the enacted law, the Company is required to revalue its deferred tax assets and liabilities at the new enacted rate. The Company re-measured the U.S. deferred income tax assets and liabilities balances using the new enacted tax rate (see Note 9). There was no income tax impact from the remeasurement due to the 100% valuation allowance on the Company’s deferred tax assets. | |
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: September 30 2018 2017 Stock options 1,987,502 36,874 Restricted stock units 90 324 Warrants to purchase common stock 8,522,672 496,629 Series F convertible preferred stock 266,680 - Total 10,776,944 533,827 The following table reconciles reported net loss with reported net loss per share for the periods ended September 30, 2017: (in thousands, except per share amounts) Three months Nine Months Net loss $ (2,847 ) $ (6,245 ) Deemed dividend to preferred shareholders (see Note 4) - (2,851 ) Net loss after deemed dividend (2,847 ) (9,096 ) Weighted average shares outstanding 626 359 Basic and diluted loss per share $ (4.55 ) $ (25.36 ) | 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 for the year ended December 31, 2017, reflects increases for net deemed dividends to preferred stockholders provided in connection with the close of the public offering of Series E Convertible Preferred Stock in April of 2017, and the close of the public offering of Series F Convertible Preferred Stock in November of 2017, of $1.0 million and $8.7 million, respectively, representing the intrinsic value of the shares at the time of issuance. In addition, the net loss allocable to common stockholders reflects an increase for net deemed dividends of $1.8 million to preferred stockholders provided in connection with the shareholder approval of the Series C and D Convertible Preferred Stock transactions in January of 2017, representing the intrinsic value of the shares at the time of issuance. The net loss allocable to common shareholders for 2016 reflects a $1.9 million increase for the net deemed dividend to preferred shareholders provided in connection with the 2016 Series B and B-1 offering (See Note 5). 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 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 period presented: December 31, 2017 2016 Stock options 36,362 4,354 Restricted stock units 245 499 Warrants to purchase common stock 8,522,684 44,268 Series B, C and D convertible preferred stock — 53,179 Series F convertible preferred stock 842,940 —- Total 9,402,231 102,300 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) 2017 2016 Net loss $ (13,382 ) $ (15,792 ) Deemed dividend to preferred shareholders (see Note 6) (11,590 ) (1,900 ) Net loss after deemed dividend (24,972 ) (17,692 ) Weighted average shares outstanding 665 33 Basic and diluted loss per share $ (37.51 ) $ (536.12 ) |
Research and Development | Research and Development Research and development costs include activities related to research, development, design, and testing improvements of the Aquadex FlexFlow 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. | |
Reclassification | Reclassification For comparability, certain December 31, 2016 amounts have been reclassified to conform to classifications adopted in December 31, 2017. The reclassifications had no impact on previously reported net loss or equity. | |
Recent 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 and quarterly periods beginning January 1, 2019. T he Company is in the process of evaluating the impact that the adoption of this standard will have on its consolidated financial statements and is currently assessing its leases. The Company The Securities and Exchange Commission (“ SEC | Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (FASB), issued amended stock compensation guidance to simplify various aspects of employee share-based payments accounting and presentation in the financial statements. The new guidance requires all income tax effects of awards to be recognized in the income statement when the awards vest or are settled, allows an employer to repurchase more of an employee’s shares than previously allowed for tax withholding purposes without triggering liability accounting, allows a company to make a policy election to account for forfeitures as they occur, and eliminates the requirement that excess tax benefits be realized before companies can recognize them. The new guidance also requires excess tax benefits and tax shortfalls to be presented on the cash flow statement as an operating activity rather than as a financing activity, and clarifies that cash paid to a tax authority when shares are withheld to satisfy its statutory income tax withholding obligation are to be presented as a financing activity. The standard was effective for our interim and annual periods beginning after January 1, 2017. The Company adopted the guidance in the current year. The adoption of this standard did not have a material impact to the Company’s consolidated financial statements. In May 2014, August 2015, March 2016, April 2016 and May 2016, the FASB issued amended revenue recognition guidance to clarify the principles for recognizing revenue from contracts with customers. The guidance requires an entity to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. The standard allows the Company to transition to the new model using either a full or modified retrospective approach, and early adoption is not permitted. The Company has determined that it will use the modified retrospective approach. This guidance will be effective for the Company's interim and annual periods beginning January 1, 2018. As of the end of the fourth quarter of 2017, the Company had nearly completed its assessment of this amended guidance and it does not expect that the adoption of this standard will not have a material impact on the timing and amount of revenue recognized, but it expects to provide expanded disclosures as a result of the adoption. The Company will continue to evaluate the impact of the amended guidance as it pertains to presentation and disclosure. In November 2015, the FASB issued amended guidance concerning the classification of deferred taxes on the balance sheet to require that deferred tax assets and deferred tax liabilities be presented as noncurrent in a classified balance sheet. The amendment is effective for our annual and interim reporting periods beginning January 1, 2017, with early adoption permitted. The adoption of this standard did not have an impact on the Company’s consolidated financial statements as all deferred tax assets are fully reserved. In January 2017, the FASB issued amended guidance to simplify the accounting for goodwill impairment by removing Step 2 of the goodwill impairment test. A goodwill impairment will now be measured as the amount by which a reporting unit’s carrying value exceeds its fair value, limited to the amount of goodwill allocated to that reporting unit. This guidance is to be applied on a prospective basis effective for the Company’s interim and annual periods beginning after January 1, 2019, with early adoption permitted for any impairment tests performed after January 1, 2017. The Company adopted this amended guidance in the current year, as further described above under Significant Accounting Policies. 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 reporting period ending December 31, 2020, and for annual and interim periods thereafter. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Nature of Business and Basis _2
Nature of Business and Basis of Presentation (Q3) (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Nature of Business and Significant Accounting Policies [Abstract] | ||
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 Aquadex. This will require the Company to succeed in training personnel at hospitals and in effectively and efficiently manufacturing, marketing and distributing Aquadex 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 July 3, 2018, April 24, 2017 and on November 27, 2017, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $28.8 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (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 warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. | Going Concern The Company’s financial statements have been prepared and presented on a basis assuming it continues as a going concern. During the years ended December 31, 2017 and 2016, 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, 2017, the Company had an accumulated deficit of $182.4 million and it expects to incur losses for the foreseeable future. To date, the Company has been funded by debt and equity financings, and although the Company believes that it will be able to successfully fund its operations, there can be no assurance that it will be able to do so or that it will ever operate profitably. These factors raise substantial doubt about the Company’s ability to continue as a going concern through at least twelve months from the report date. 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 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 6 - Equity). The Company may require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. |
Revenue Recognition | Revenue Recognition: Revenue from Contracts with Customers | |
Accounts Receivable | Accounts Receivable | Accounts Receivable Accounts receivable are unsecured, are 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 uncollectability, 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 its accounts receivable aging, and therefore, no allowance for doubtful accounts was considered necessary as of December 31, 2017 or 2016. |
Inventories | Inventories (in thousands) September 30, 2018 December 31, 2017 Finished Goods $ 810 $ 902 Work in Process 91 217 Raw Materials 1,047 469 Total $ 1,948 $ 1,588 | Inventories Inventories are recorded as the lower of cost or market using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2017 2016 Finished Goods $ 902 $ 644 Work in Process 217 — Raw Materials 469 33 Total $ 1,588 $ 677 |
Contingent Consideration | Contingent consideration | Contingent consideration In connection with the Company’s purchase of the Aquadex Business, the Company has an obligation to pay additional consideration that is contingent upon the occurrence of certain future events. Contingent consideration is recognized at the acquisition date at the estimated fair value of the contingent milestone payments. The fair value of the contingent consideration is remeasured to its estimated fair value at the end of each reporting period, with changes recorded to earnings. |
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: September 30 2018 2017 Stock options 1,987,502 36,874 Restricted stock units 90 324 Warrants to purchase common stock 8,522,672 496,629 Series F convertible preferred stock 266,680 - Total 10,776,944 533,827 The following table reconciles reported net loss with reported net loss per share for the periods ended September 30, 2017: (in thousands, except per share amounts) Three months Nine Months Net loss $ (2,847 ) $ (6,245 ) Deemed dividend to preferred shareholders (see Note 4) - (2,851 ) Net loss after deemed dividend (2,847 ) (9,096 ) Weighted average shares outstanding 626 359 Basic and diluted loss per share $ (4.55 ) $ (25.36 ) | 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 for the year ended December 31, 2017, reflects increases for net deemed dividends to preferred stockholders provided in connection with the close of the public offering of Series E Convertible Preferred Stock in April of 2017, and the close of the public offering of Series F Convertible Preferred Stock in November of 2017, of $1.0 million and $8.7 million, respectively, representing the intrinsic value of the shares at the time of issuance. In addition, the net loss allocable to common stockholders reflects an increase for net deemed dividends of $1.8 million to preferred stockholders provided in connection with the shareholder approval of the Series C and D Convertible Preferred Stock transactions in January of 2017, representing the intrinsic value of the shares at the time of issuance. The net loss allocable to common shareholders for 2016 reflects a $1.9 million increase for the net deemed dividend to preferred shareholders provided in connection with the 2016 Series B and B-1 offering (See Note 5). 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 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 period presented: December 31, 2017 2016 Stock options 36,362 4,354 Restricted stock units 245 499 Warrants to purchase common stock 8,522,684 44,268 Series B, C and D convertible preferred stock — 53,179 Series F convertible preferred stock 842,940 —- Total 9,402,231 102,300 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) 2017 2016 Net loss $ (13,382 ) $ (15,792 ) Deemed dividend to preferred shareholders (see Note 6) (11,590 ) (1,900 ) Net loss after deemed dividend (24,972 ) (17,692 ) Weighted average shares outstanding 665 33 Basic and diluted loss per share $ (37.51 ) $ (536.12 ) |
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 and quarterly periods beginning January 1, 2019. T he Company is in the process of evaluating the impact that the adoption of this standard will have on its consolidated financial statements and is currently assessing its leases. The Company The Securities and Exchange Commission (“ SEC | Recent Accounting Pronouncements In March 2016, the Financial Accounting Standards Board (FASB), issued amended stock compensation guidance to simplify various aspects of employee share-based payments accounting and presentation in the financial statements. The new guidance requires all income tax effects of awards to be recognized in the income statement when the awards vest or are settled, allows an employer to repurchase more of an employee’s shares than previously allowed for tax withholding purposes without triggering liability accounting, allows a company to make a policy election to account for forfeitures as they occur, and eliminates the requirement that excess tax benefits be realized before companies can recognize them. The new guidance also requires excess tax benefits and tax shortfalls to be presented on the cash flow statement as an operating activity rather than as a financing activity, and clarifies that cash paid to a tax authority when shares are withheld to satisfy its statutory income tax withholding obligation are to be presented as a financing activity. The standard was effective for our interim and annual periods beginning after January 1, 2017. The Company adopted the guidance in the current year. The adoption of this standard did not have a material impact to the Company’s consolidated financial statements. In May 2014, August 2015, March 2016, April 2016 and May 2016, the FASB issued amended revenue recognition guidance to clarify the principles for recognizing revenue from contracts with customers. The guidance requires an entity to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration to which an entity expects to be entitled in exchange for those goods or services. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required about customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. The standard allows the Company to transition to the new model using either a full or modified retrospective approach, and early adoption is not permitted. The Company has determined that it will use the modified retrospective approach. This guidance will be effective for the Company's interim and annual periods beginning January 1, 2018. As of the end of the fourth quarter of 2017, the Company had nearly completed its assessment of this amended guidance and it does not expect that the adoption of this standard will not have a material impact on the timing and amount of revenue recognized, but it expects to provide expanded disclosures as a result of the adoption. The Company will continue to evaluate the impact of the amended guidance as it pertains to presentation and disclosure. In November 2015, the FASB issued amended guidance concerning the classification of deferred taxes on the balance sheet to require that deferred tax assets and deferred tax liabilities be presented as noncurrent in a classified balance sheet. The amendment is effective for our annual and interim reporting periods beginning January 1, 2017, with early adoption permitted. The adoption of this standard did not have an impact on the Company’s consolidated financial statements as all deferred tax assets are fully reserved. In January 2017, the FASB issued amended guidance to simplify the accounting for goodwill impairment by removing Step 2 of the goodwill impairment test. A goodwill impairment will now be measured as the amount by which a reporting unit’s carrying value exceeds its fair value, limited to the amount of goodwill allocated to that reporting unit. This guidance is to be applied on a prospective basis effective for the Company’s interim and annual periods beginning after January 1, 2019, with early adoption permitted for any impairment tests performed after January 1, 2017. The Company adopted this amended guidance in the current year, as further described above under Significant Accounting Policies. 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 reporting period ending December 31, 2020, and for annual and interim periods thereafter. The Company is evaluating the impact that the adoption of this standard will have, if any, on its financial statements and disclosures. The Company evaluates events through the date the consolidated financial statements are filed for events requiring adjustment to or disclosure in the consolidated financial statements. |
Nature of Business and Signif_3
Nature of Business and Significant Accounting Policies (FY) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Nature of Business and Significant Accounting Policies [Abstract] | ||
Schedule of Inventories | Inventories consisted of the following: (in thousands) September 30, 2018 December 31, 2017 Finished Goods $ 810 $ 902 Work in Process 91 217 Raw Materials 1,047 469 Total $ 1,948 $ 1,588 | Inventories are recorded as the lower of cost or market using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2017 2016 Finished Goods $ 902 $ 644 Work in Process 217 — Raw Materials 469 33 Total $ 1,588 $ 677 |
Summary of Estimated Useful Lives | Depreciation expense has been calculated using the following estimated useful lives: Office furniture and equipment 5-15 years Computer software and equipment 3-4 years Laboratory and research equipment 3-15 years Production equipment 3-7 years Leasehold improvements and capital lease asset 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 period presented: September 30 2018 2017 Stock options 1,987,502 36,874 Restricted stock units 90 324 Warrants to purchase common stock 8,522,672 496,629 Series F convertible preferred stock 266,680 - Total 10,776,944 533,827 | 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: December 31, 2017 2016 Stock options 36,362 4,354 Restricted stock units 245 499 Warrants to purchase common stock 8,522,684 44,268 Series B, C and D convertible preferred stock — 53,179 Series F convertible preferred stock 842,940 —- Total 9,402,231 102,300 |
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 periods ended September 30, 2017: (in thousands, except per share amounts) Three months Nine Months Net loss $ (2,847 ) $ (6,245 ) Deemed dividend to preferred shareholders (see Note 4) - (2,851 ) Net loss after deemed dividend (2,847 ) (9,096 ) Weighted average shares outstanding 626 359 Basic and diluted loss per share $ (4.55 ) $ (25.36 ) | 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) 2017 2016 Net loss $ (13,382 ) $ (15,792 ) Deemed dividend to preferred shareholders (see Note 6) (11,590 ) (1,900 ) Net loss after deemed dividend (24,972 ) (17,692 ) Weighted average shares outstanding 665 33 Basic and diluted loss per share $ (37.51 ) $ (536.12 ) |
Aquadex Acquisition (FY) (Table
Aquadex Acquisition (FY) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Aquadex Acquisition [Abstract] | |
Purchase Consideration for Business | Purchase Consideration: (in thousands) Cash consideration $ 4,000 Common stock consideration 950 Fair value of contingent consideration 126 Total purchase consideration $ 5,076 |
Amount Recognized for Assets Acquired | Capital lease asset $ 307 Intangible assets 4,580 Total identifiable assets acquired 4,887 Goodwill 189 Total purchase consideration $ 5,076 |
Summary of Pro Forma Information | The following unaudited pro forma combined financial information summarizes the results of operations for the periods indicated as if the acquisition of Aquadex had been completed on of January 1, 2016. Pro forma information reflects adjustments that are expected to have a continuing impact on our results of operations and are directly attributable to the acquisition. The unaudited pro forma results include adjustments to reflect, among other things, direct transaction costs relating to the acquisition, the difference in intangible asset amortization to be incurred based on the preliminary values of each identifiable intangible asset, and the difference in depreciation expense to be incurred based on preliminary value of the capital lease asset. The pro forma amounts do not purport to be indicative of the results that would have actually been obtained if the acquisition had occurred as of January 1, 2016 or that may be obtained in the future, and do not reflect future synergies, integration costs, or other such costs or savings. Twelve months ended December 31, 2016 (in thousands, except share amounts) Pro forma net sales $ 3,160 Pro forma net loss from operations (15,340 ) Pro forma basic and diluted net loss per share $ (464.84 ) |
Property, Plant and Equipment_2
Property, Plant and Equipment (FY) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property, Plant and Equipment | Property, plant and equipment were as follows: (in thousands) December 31, 2017 December 31, 2016 Office Furniture & Fixtures $ 287 $ 280 Leasehold Improvements 224 145 Software 129 124 Production Equipment 926 968 Computer Equipment 277 245 Capital Lease Asset 307 307 Total 2,150 2,069 Accumulated Depreciation (1,580 ) (1,529 ) $ 570 $ 540 |
Intangible Assets (FY) (Tables)
Intangible Assets (FY) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Intangible Assets [Abstract] | |
Summary of Intangible Assets | Intangible assets were as follows: (in thousands) December 31, 2017 December 31, 2016 Customer Relationships $ 3,090 $ 3,090 Developed Technology 1,050 1,050 Trade Names and Trademarks 440 440 Total 4,580 4,580 Accumulated Amortization (818 ) (278 ) Impairment Charge (3,762 ) — $ — $ 4,302 |
Stock-Based Compensation (FY) (
Stock-Based Compensation (FY) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Stock-Based Compensation [Abstract] | ||
Summary of Stock-Based Compensation Expense | The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended September 30, Nine months ended September 30, (in thousands) 2018 2017 2018 2017 Selling, general and administrative expense $ 440 $ 106 $ 1,446 $ 351 Research and development expense (3 ) 5 98 43 Total stock-based compensation expense $ 437 $ 111 $ 1,544 $ 394 | 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) 2017 2016 Selling, general and administrative $ 452 $ 630 Research and development 50 385 Total $ 502 $ 1,015 |
Summary of Plan Stock Option Activity | The following is a summary of the Plans’ stock option activity during the years ended December 31: 2017 2016 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 4,354 $ 2,295.37 3,260 $ 3,664.61 Granted 34,651 $ 11.57 2,257 $ 543.63 Exercised — — — — Forfeited/expired (2,643 ) $ 2,666.48 (1,163 ) $ 2,729.60 Outstanding at December 31 36,362 $ 91.48 4,354 $ 2,295.37 Vested at December 31 2,344 $ 964.27 2,134 $ 3,780.79 | |
Schedule of Weighted Average Assumptions used in Black-Scholes Option Pricing Model | The following table provides the weighed average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2017 2016 Expected dividend yield 0 % 0 % Risk-free interest rate 1.97 % 1.71 % Expected volatility 103 % 86 % Expected life (in years) 6.25 6.25 | |
Summary of Restricted Stock Award Activity | The following table summarizes restricted stock award activity during 2017 and 2016: 2017 2016 RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price Nonvested, beginning balance 499 $ 583.29 15 $ 2,574.00 Granted 138 $ 108.20 1,131 $ 553.88 Vested (392 ) $ 132.70 (619 ) $ 443.40 Forfeited — — (28 ) $ 426.00 Nonvested at December 31 245 $ 521.23 499 $ 583.29 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (FY) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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: Nine months ended September 30, 2017 (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,469 ) Exercise of warrants (368 ) Ending balance as of September 30, 2017 $ 6 | The following is a rollforward of the fair value of Level 3 warrants: (in thousands) July 26, 2016 warrant issuance $ 1,883 November 3, 2016 warrant issuance 778 Change in fair value (818 ) Ending balance December 31, 2016 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Ending balance as of December 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, 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 | Fair values were calculated using the following assumptions: July 26, 2016 Nov. 3, 2016 Dec. 31, 2016 Risk-free interest rates, adjusted for continuous compounding 0.94 % 1.33 % 1.47/1.96 % Term (years) 3.5 5.5 3.1/5.3 Expected volatility 78 % 41.4 % 55.3/49.8 % Dates and probability of future equity raises various various various |
Income Taxes (FY) (Tables)
Income Taxes (FY) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Taxes [Abstract] | |
Summary of 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) 2017 2016 Domestic $ (13,367 ) $ (15,877 ) Foreign (9 ) 31 Loss before income taxes $ (13,376 ) $ (15,846 ) |
Summary of Components of Income Tax Benefit (Expense) | The components of income tax benefit (expense) consist of the following for the years ended December 31: (in thousands) 2017 2016 Current: United States and state $ — $ — Foreign, net (6 ) 54 Deferred: United States and state — — Foreign — — Total income tax benefit (expense) $ (6 ) $ 54 |
Summary of Actual Income Tax Benefit (Expense) Differs from Statutory Federal Income Tax Benefit (Expense) | Actual income tax benefit (expense) differs from statutory federal income tax benefit (expense) as follows for the years ended December 31: (in thousands) 2017 2016 Statutory federal income tax benefit $ 4,548 $ 5,388 State tax benefit, net of federal taxes 48 2 Foreign tax — 3 R&D tax credit — 80 Foreign deferred exchange rate adjustments 899 — Nondeductible/nontaxable items (114 ) (86 ) New federal rate adjustment (16,081 ) — Other (1,085 ) (257 ) Valuation allowance decrease (increase) 11,779 (5,076 ) Total income tax benefit (expense) $ (6 ) $ 54 |
Summary of Components of Deferred Taxes | Deferred taxes consist of the following as of December 31: (in thousands) 2017 2016 Deferred tax assets: Noncurrent: Accrued leave $ 32 $ 43 Other accrued expenses 28 97 Stock based compensation 336 1,477 Net operating loss carryforward 38,947 49,720 Deferred rent 7 17 Other 108 777 Intangibles 895 R&D credit carryforward 531 531 Total deferred tax assets $ 40,884 $ 52,662 Less: valuation allowance (40,884 ) (52,662 ) Total $ — $ — |
Nature of Business and Basis _3
Nature of Business and Basis of Presentation (Q3) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
Nature of Business and Significant Accounting Policies [Abstract] | ||
Inventories | Inventories consisted of the following: (in thousands) September 30, 2018 December 31, 2017 Finished Goods $ 810 $ 902 Work in Process 91 217 Raw Materials 1,047 469 Total $ 1,948 $ 1,588 | Inventories are recorded as the lower of cost or market using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2017 2016 Finished Goods $ 902 $ 644 Work in Process 217 — Raw Materials 469 33 Total $ 1,588 $ 677 |
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: September 30 2018 2017 Stock options 1,987,502 36,874 Restricted stock units 90 324 Warrants to purchase common stock 8,522,672 496,629 Series F convertible preferred stock 266,680 - Total 10,776,944 533,827 | 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: December 31, 2017 2016 Stock options 36,362 4,354 Restricted stock units 245 499 Warrants to purchase common stock 8,522,684 44,268 Series B, C and D convertible preferred stock — 53,179 Series F convertible preferred stock 842,940 —- Total 9,402,231 102,300 |
Reconciliation of Reported Net Loss with Reported Net Loss Per Share | The following table reconciles reported net loss with reported net loss per share for the periods ended September 30, 2017: (in thousands, except per share amounts) Three months Nine Months Net loss $ (2,847 ) $ (6,245 ) Deemed dividend to preferred shareholders (see Note 4) - (2,851 ) Net loss after deemed dividend (2,847 ) (9,096 ) Weighted average shares outstanding 626 359 Basic and diluted loss per share $ (4.55 ) $ (25.36 ) | 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) 2017 2016 Net loss $ (13,382 ) $ (15,792 ) Deemed dividend to preferred shareholders (see Note 6) (11,590 ) (1,900 ) Net loss after deemed dividend (24,972 ) (17,692 ) Weighted average shares outstanding 665 33 Basic and diluted loss per share $ (37.51 ) $ (536.12 ) |
Stock-Based Compensation (Q3) (
Stock-Based Compensation (Q3) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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 September 30, Nine months ended September 30, (in thousands) 2018 2017 2018 2017 Selling, general and administrative expense $ 440 $ 106 $ 1,446 $ 351 Research and development expense (3 ) 5 98 43 Total stock-based compensation expense $ 437 $ 111 $ 1,544 $ 394 | 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) 2017 2016 Selling, general and administrative $ 452 $ 630 Research and development 50 385 Total $ 502 $ 1,015 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments (Q3) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2017 | |
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: Nine months ended September 30, 2017 (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,469 ) Exercise of warrants (368 ) Ending balance as of September 30, 2017 $ 6 | The following is a rollforward of the fair value of Level 3 warrants: (in thousands) July 26, 2016 warrant issuance $ 1,883 November 3, 2016 warrant issuance 778 Change in fair value (818 ) Ending balance December 31, 2016 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Ending balance as of December 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, 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 | Fair values were calculated using the following assumptions: July 26, 2016 Nov. 3, 2016 Dec. 31, 2016 Risk-free interest rates, adjusted for continuous compounding 0.94 % 1.33 % 1.47/1.96 % Term (years) 3.5 5.5 3.1/5.3 Expected volatility 78 % 41.4 % 55.3/49.8 % Dates and probability of future equity raises various various various |
Nature of Business and Signif_4
Nature of Business and Significant Accounting Policies, Nature of Business, Going Concern, Accounts Receivable and Inventory (FY) (Details) | Nov. 27, 2017USD ($) | Oct. 12, 2017 | Apr. 24, 2017USD ($) | Jan. 12, 2017 | Mar. 31, 2016Study | Sep. 30, 2018USD ($) | Dec. 31, 2017USD ($)StockSplit | Dec. 31, 2016USD ($) |
Nature of Business [Abstract] | ||||||||
Number of clinical studies for C-Pulse System | Study | 2 | |||||||
Number of reverse stock split | StockSplit | 2 | |||||||
Reverse stock split ratio | 20 | 30 | ||||||
Going Concern [Abstract] | ||||||||
Retained earnings (accumulated deficit) | $ (195,132,000) | $ (182,356,000) | $ (168,974,000) | |||||
Net proceeds from issuance of convertible preferred stock | $ 16,200,000 | $ 8,000,000 | ||||||
Accounts Receivable [Abstract] | ||||||||
Accounts receivables maximum credit period from invoice date | 30 days | 30 days | ||||||
Allowance for doubtful accounts | $ 0 | $ 0 | 0 | |||||
Inventories [Abstract] | ||||||||
Finished Goods | 810,000 | 902,000 | 644,000 | |||||
Work in Process | 91,000 | 217,000 | 0 | |||||
Raw Materials | 1,047,000 | 469,000 | 33,000 | |||||
Total | $ 1,948,000 | $ 1,588,000 | $ 677,000 |
Nature of Business and Signif_5
Nature of Business and Significant Accounting Policies, Property, Plant and Equipment (FY) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 229 | $ 419 |
Impairment losses recognized | $ 0 | $ 0 |
Office Furniture and Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 5 years | |
Office Furniture and Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 15 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 | |
Laboratory and Research Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 3 years | |
Laboratory and Research Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 15 years | |
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 | |
Leasehold Improvements and Capital Lease Asset [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 3 years | |
Leasehold Improvements and Capital Lease Asset [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 5 years |
Nature of Business and Signif_6
Nature of Business and Significant Accounting Policies, Intangible assets and Goodwill (FY) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Finite-Lived Intangible Assets [Line Items] | ||
Impairment charges related to finite-lived intangible assets | $ 3,800,000 | |
Overall discount rate | 30.00% | |
Amortization expense | $ 540,000 | $ 278,000 |
Goodwill [Abstract] | ||
Goodwill impairment loss | $ 200,000 | |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Estimated useful life | 7 years | |
Overall discount rate | 30.00% | |
Developed Technology [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Estimated useful life | 7 years | |
Overall discount rate | 30.00% | |
Trade Names and Trademarks [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Estimated useful life | 7 years | |
Overall discount rate | 30.00% |
Nature of Business and Signif_7
Nature of Business and Significant Accounting Policies, Income Taxes and Loss Per Share (FY) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Line Items] | |||||||
U.S. corporate income tax rate | 34.00% | ||||||
Percentage of valuation allowance on deferred tax assets | 100.00% | ||||||
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) | 10,776,944 | 533,827 | 9,402,231 | 102,300 | |||
Reported net loss with reported net loss per share [Abstract] | |||||||
Net loss | $ (4,241,000) | $ (2,847,000) | $ (12,776,000) | $ (6,245,000) | $ (13,382,000) | $ (15,792,000) | |
Deemed dividend to preferred shareholders | 0 | (2,851,000) | (11,590,000) | (1,900,000) | |||
Net loss after deemed dividend | $ (2,847,000) | $ (9,096,000) | $ (24,972,000) | $ (17,692,000) | |||
Weighted average shares outstanding (in shares) | 6,987,000 | 626,000 | 5,171,000 | 359,000 | 665,000 | 33,000 | |
Basic and diluted loss per share (in dollars per share) | $ (0.61) | $ (4.55) | $ (2.47) | $ (25.36) | $ (37.51) | $ (536.12) | |
Series E Convertible Preferred Stock [Member] | |||||||
Reported net loss with reported net loss per share [Abstract] | |||||||
Deemed dividend to preferred shareholders | $ 1,000,000 | $ (1,000,000) | |||||
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) | 266,680 | 0 | 842,940 | 0 | |||
Reported net loss with reported net loss per share [Abstract] | |||||||
Deemed dividend to preferred shareholders | $ (8,700,000) | ||||||
Series C and D Convertible Preferred Stock [Member] | |||||||
Reported net loss with reported net loss per share [Abstract] | |||||||
Deemed dividend to preferred shareholders | $ 1,800,000 | (1,800,000) | |||||
Series B and B-1 Convertible Preferred Stock [Member] | |||||||
Reported net loss with reported net loss per share [Abstract] | |||||||
Deemed dividend to preferred shareholders | $ (1,900,000) | $ (1,900,000) | |||||
Series B, C And D 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) | 0 | 53,179 | |||||
Plan [Member] | |||||||
Income Tax Disclosure [Line Items] | |||||||
U.S. corporate income tax rate | 21.00% | ||||||
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) | 1,987,502 | 36,874 | 36,362 | 4,354 | |||
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) | 90 | 324 | 245 | 499 | |||
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) | 8,522,672 | 496,629 | 8,522,684 | 44,268 |
Aquadex Acquisition (FY) (Detai
Aquadex Acquisition (FY) (Details) - USD ($) $ / shares in Units, $ in Thousands | Aug. 05, 2016 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 |
Business Acquisition [Line Item] | |||||||
Revenue | $ 1,363 | $ 957 | $ 3,499 | $ 2,722 | $ 3,553 | $ 1,289 | |
Amounts recognized for assets acquired [Abstract] | |||||||
Goodwill | 0 | 189 | |||||
Aquadex Product Line [Member] | |||||||
Business Acquisition [Line Item] | |||||||
Revenue | $ 3,600 | 1,200 | |||||
Total purchase consideration [Abstract] | |||||||
Cash consideration | $ 4,000 | ||||||
Common stock consideration | 950 | ||||||
Fair value of contingent consideration | 126 | ||||||
Total purchase consideration | $ 5,076 | ||||||
Common stock issued in acquisition (in shares) | 1,666 | ||||||
Closing market value (in dollars per share) | $ 570 | ||||||
Contingent consideration payable in excess of sale or disposal of business assets | 40.00% | 40.00% | |||||
Sale or disposal of business assets threshold for contingent consideration | $ 4,000 | $ 4,000 | |||||
Acquisition related expenses | 900 | ||||||
Amounts recognized for assets acquired [Abstract] | |||||||
Capital lease asset | 307 | ||||||
Intangible assets | 4,580 | ||||||
Total identifiable assets acquired | 4,887 | ||||||
Goodwill | 189 | ||||||
Total purchase consideration | $ 5,076 | ||||||
Pro forma information [Abstract] | |||||||
Pro forma net sales | 3,160 | ||||||
Pro forma net loss from operations | $ (15,340) | ||||||
Pro forma basic and diluted net loss per share (in dollars per share) | $ (464.84) | ||||||
Aquadex Product Line [Member] | Maximum [Member] | |||||||
Business Acquisition [Line Item] | |||||||
Agreement term | 18 months | ||||||
Total purchase consideration [Abstract] | |||||||
Contingent consideration period | 3 years | 3 years |
Property, Plant and Equipment_3
Property, Plant and Equipment (FY) (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | $ 2,150 | $ 2,069 | |
Accumulated Depreciation | (1,580) | (1,529) | |
Property, Plant and Equipment, Net | $ 573 | 570 | 540 |
Office Furniture & Fixtures [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | 287 | 280 | |
Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | 224 | 145 | |
Software [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | 129 | 124 | |
Production Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | 926 | 968 | |
Computer Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | 277 | 245 | |
Capital Lease Asset [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | $ 307 | $ 307 |
Intangible Assets (FY) (Details
Intangible Assets (FY) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Gross | $ 4,580 | $ 4,580 |
Accumulated Amortization | (818) | (278) |
Impairment Charge | (3,762) | 0 |
Intangible Assets, Net | $ 0 | 4,302 |
Discount rate | 30.00% | |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Gross | $ 3,090 | 3,090 |
Discount rate | 30.00% | |
Developed Technology [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Gross | $ 1,050 | 1,050 |
Discount rate | 30.00% | |
Trade Names and Trademarks [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Intangible Assets, Gross | $ 440 | $ 440 |
Discount rate | 30.00% |
Debt, Prior Loan Agreement (FY)
Debt, Prior Loan Agreement (FY) (Details) $ in Thousands | Aug. 04, 2016USD ($) | Jan. 01, 2016Installment | Jun. 26, 2015USD ($) | Feb. 18, 2015USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 5,000 | |||||
Repayment of outstanding debt | 0 | $ (8,000) | ||||
Loss on early retirement of long-term debt | 0 | (500) | ||||
Silicon Valley Bank [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 10,000 | |||||
Annual interest rate | 7.00% | |||||
Proceeds from term loan used for general corporate and working capital | $ 2,000 | $ 6,000 | ||||
Consecutive equal monthly installments | Installment | 24 | |||||
Repayment of outstanding debt | $ (5,500) | |||||
Loss on early retirement of long-term debt | $ (500) | |||||
Total borrowings outstanding | $ 0 | $ 0 |
Debt, Warrants (FY) (Details)
Debt, Warrants (FY) (Details) | 12 Months Ended | |||
Dec. 31, 2017$ / sharesshares | Sep. 30, 2018$ / sharesshares | Nov. 03, 2016 | Jul. 26, 2016 | |
Risk-Free Interest Rate [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants measurement input | 0.0133 | 0.0094 | ||
Expected Warrant Option Life [Member] | ||||
Debt Instrument [Line Items] | ||||
Expected warrant option life | 5 years 6 months | 3 years 6 months | ||
Affiliates [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants issued (in shares) | shares | 55 | 55 | ||
Exercise price of warrants (in dollars per share) | $ 2,208 | $ 2,208 | ||
Value of warrants (in dollars per share) | $ 1,626 | $ 1,626 | ||
Term of warrants | 10 years | |||
Affiliates [Member] | Expected Dividend Yield [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants measurement input | 0 | 0 | ||
Affiliates [Member] | Expected Stock Price Volatility [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants measurement input | 0.8704 | 0.8704 | ||
Affiliates [Member] | Risk-Free Interest Rate [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants measurement input | 0.0220 | 0.0220 | ||
Affiliates [Member] | Expected Warrant Option Life [Member] | ||||
Debt Instrument [Line Items] | ||||
Expected warrant option life | 6 years 3 months | 6 years 3 months | ||
Silicon Valley Bank [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants issued (in shares) | shares | 115 | 115 | ||
Exercise price of warrants (in dollars per share) | $ 3,132 | $ 3,132 | ||
Value of warrants (in dollars per share) | $ 2,316 | $ 2,316 | ||
Term of warrants | 10 years | |||
Silicon Valley Bank [Member] | Expected Dividend Yield [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants measurement input | 0 | 0 | ||
Silicon Valley Bank [Member] | Expected Stock Price Volatility [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants measurement input | 0.8807 | 0.8807 | ||
Silicon Valley Bank [Member] | Risk-Free Interest Rate [Member] | ||||
Debt Instrument [Line Items] | ||||
Warrants measurement input | 0.0186 | 0.0186 | ||
Silicon Valley Bank [Member] | Expected Warrant Option Life [Member] | ||||
Debt Instrument [Line Items] | ||||
Expected warrant option life | 6 years 3 months | 6 years 3 months |
Debt, New Loan Agreement (FY) (
Debt, New Loan Agreement (FY) (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Debt Instrument [Line Items] | |||
Maximum borrowing capacity | $ 5,000 | ||
Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Maximum borrowing capacity | $ 4,000 | ||
Maturity date | Nov. 30, 2016 | ||
Revolving Line [Member] | |||
Debt Instrument [Line Items] | |||
Maximum borrowing capacity | $ 1,000 | $ 1,000 | |
Maturity date | Mar. 31, 2020 | Mar. 31, 2020 | |
Total borrowings outstanding | $ 0 | $ 0 | $ 0 |
Revolving Line [Member] | Floating Annual Rate [Member] | |||
Debt Instrument [Line Items] | |||
Interest rate | 1.75% | 1.75% | |
Revolving Line [Member] | Prime Rate [Member] | |||
Debt Instrument [Line Items] | |||
Interest rate | 1.00% | 1.00% |
Shareholder's Equity, Convertib
Shareholder's Equity, Convertible Preferred Stock (FY) (Details) - USD ($) | Jul. 03, 2018 | Nov. 27, 2017 | Apr. 24, 2017 | Jan. 10, 2017 | Nov. 03, 2016 | Oct. 30, 2016 | Jul. 26, 2016 | Jul. 20, 2016 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 |
Class of Stock [Line Items] | |||||||||||||
Proceeds from issuance of convertible preferred stock and Warrants | $ 3,600,000 | $ 3,800,000 | $ 3,500,000 | ||||||||||
Net proceeds from issuance of convertible preferred stock | $ 16,200,000 | $ 8,000,000 | |||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | ||||||||||
Temporary equity | $ 0 | $ 485,000 | |||||||||||
Net deemed dividend | $ 0 | $ (2,851,000) | $ (11,590,000) | $ (1,900,000) | |||||||||
Common stock, shares issued (in shares) | 7,074,407 | 3,798,929 | 38,862 | ||||||||||
Series B Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock, shares issued (in shares) | 3,468 | ||||||||||||
Number of preferred shares converted to common stock (in shares) | 6,149 | ||||||||||||
Conversion price (in dollars per share) | $ 564 | ||||||||||||
Proceed from issuance of preferred stock | $ 1,600,000 | ||||||||||||
Series B-1 Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock, shares issued (in shares) | 2,227.2 | 0 | 1,824.4 | ||||||||||
Number of preferred shares converted to common stock (in shares) | 17,866 | 3,948 | |||||||||||
Conversion price (in dollars per share) | $ 102 | ||||||||||||
Number of convertible preferred shares converted (in shares) | 402.8 | ||||||||||||
Proceed from issuance of preferred stock | $ 1,600,000 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 1,824.4 | |||||||||||
Series C Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock, shares issued (in shares) | 2,900 | 0 | 2,900 | ||||||||||
Number of preferred shares converted to common stock (in shares) | 0 | ||||||||||||
Conversion price (in dollars per share) | $ 102 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 2,900 | |||||||||||
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 | ||||||||||||
Preferred stock, shares issued (in shares) | 200 | ||||||||||||
Number of preferred shares converted to common stock (in shares) | 0 | ||||||||||||
Conversion price (in dollars per share) | $ 102 | $ 102 | |||||||||||
Temporary stock, shares issued (in shares) | 700 | 0 | 700 | ||||||||||
Beneficial conversion amount | $ 500,000 | ||||||||||||
Temporary stock, shares outstanding (in shares) | 0 | 700 | |||||||||||
Temporary equity | $ 485,000 | ||||||||||||
Series C and D Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Proceeds from issuance of convertible preferred stock and Warrants | $ 3,600,000 | ||||||||||||
Number of preferred shares converted to common stock (in shares) | 55,712 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||||||
Series B and B-1 Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||||||
Net deemed dividend | $ (1,900,000) | $ (1,900,000) | |||||||||||
Series B, C And D Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Percentage of placement fee offered in cash | 6.00% | 6.00% | |||||||||||
Series E Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock, shares issued (in shares) | 6,400 | 6,400 | |||||||||||
Number of preferred shares converted to common stock (in shares) | 6,400,000 | 320,000 | |||||||||||
Proceed from issuance of preferred stock | $ 9,200,000 | ||||||||||||
Net proceeds from issuance of convertible preferred stock | 8,000,000 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||||||
Beneficial conversion amount | $ 1,000,000 | $ 1,000,000 | |||||||||||
Percentage of placement fee offered in cash | 9.00% | ||||||||||||
Net deemed dividend | $ 1,000,000 | $ (1,000,000) | |||||||||||
Common stock, shares issued (in shares) | 140,000 | ||||||||||||
Series E Convertible Preferred Stock [Member] | Warrants [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Warrants to purchase shares of common stock (in shares) | 9,200,000 | 640,000 | |||||||||||
Warrants issued to the placement agent (in shares) | 0 | 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] | |||||||||||||
Number of preferred shares converted to common stock (in shares) | 1 | ||||||||||||
Term of warrants | 5 years | ||||||||||||
Number of warrants (in shares) | 1 | ||||||||||||
Exercise price of warrants (in dollars per share) | $ 22 | ||||||||||||
Class B Units [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Number of preferred shares converted to common stock (in shares) | 50 | ||||||||||||
Public offering price (in dollars per share) | $ 1,000 | ||||||||||||
Number of preferred stock per unit (in shares) | 1 | ||||||||||||
Class B Units [Member] | Warrants [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Warrants to purchase shares of common stock (in shares) | 50 | ||||||||||||
Exercise price of warrants (in dollars per share) | $ 22 | ||||||||||||
Series F Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock [Line Items] | |||||||||||||
Preferred stock, shares issued (in shares) | 18,000 | 565 | 3,780 | 0 | |||||||||
Number of preferred shares converted to common stock (in shares) | 472 | 4,000,000 | 3,899,210 | 3,171,060 | |||||||||
Conversion price (in dollars per share) | $ 2.12 | $ 4.50 | |||||||||||
Number of convertible preferred shares converted (in shares) | 17,435 | 14,220 | |||||||||||
Proceed from issuance of preferred stock | $ 18,000,000 | ||||||||||||
Net proceeds from issuance of convertible preferred stock | 16,200,000 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 565 | 3,780 | 0 | ||||||||||
Beneficial conversion amount | $ 8,700,000 | ||||||||||||
Percentage of placement fee offered in cash | 8.00% | ||||||||||||
Net deemed dividend | $ (8,700,000) | ||||||||||||
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 the placement agent (in shares) | 0 | 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 |
Shareholder's Equity, Warrants
Shareholder's Equity, Warrants (FY) (Details) $ / shares in Units, $ in Thousands | Jan. 10, 2017USD ($)$ / sharesshares | Nov. 03, 2016USD ($)$ / sharesshares | Jul. 26, 2016USD ($)$ / sharesshares | Mar. 31, 2017USD ($)$ / sharesshares | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Feb. 15, 2017 |
Class of Stock [Line Items] | |||||||||||
Proceeds from exercise of warrants | $ 0 | $ 1,981 | $ 1,989 | $ 0 | |||||||
Warrants outstanding | 0 | 1,843 | |||||||||
Change in fair value of warrant liability | $ 0 | $ 4 | 0 | 1,470 | 1,475 | $ 818 | |||||
Risk-Free Interest Rate [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants measurement input | 0.0133 | 0.0094 | |||||||||
Risk-Free Interest Rate [Member] | Minimum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants measurement input | 0.0147 | 0.0145 | |||||||||
Risk-Free Interest Rate [Member] | Maximum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants measurement input | 0.0196 | 0.0199 | |||||||||
Expected Warrant Option Life [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Expected warrant option life | 5 years 6 months | 3 years 6 months | |||||||||
Expected Warrant Option Life [Member] | Minimum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Expected warrant option life | 3 years 1 month 6 days | 2 years 10 months 2 days | |||||||||
Expected Warrant Option Life [Member] | Maximum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Expected warrant option life | 5 years 3 months 18 days | 5 years 6 months | |||||||||
Replacement Warrants [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants outstanding | $ 500 | $ 500 | $ 500 | ||||||||
Replacement Warrants [Member] | Expected Dividend Yield [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants measurement input | 0 | 0 | 0 | ||||||||
Replacement Warrants [Member] | Expected Stock Price Volatility [Member] | Minimum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants measurement input | 0.4965 | 0.4965 | 0.4965 | ||||||||
Replacement Warrants [Member] | Expected Stock Price Volatility [Member] | Maximum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants measurement input | 0.5038 | 0.5038 | 0.5038 | ||||||||
Replacement Warrants [Member] | Risk-Free Interest Rate [Member] | Minimum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants measurement input | 0.0195 | 0.0195 | 0.0195 | ||||||||
Replacement Warrants [Member] | Risk-Free Interest Rate [Member] | Maximum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants measurement input | 0.0197 | 0.0197 | 0.0197 | ||||||||
Replacement Warrants [Member] | Expected Warrant Option Life [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Expected warrant option life | 5 years | 5 years | 5 years | ||||||||
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) | shares | 6,149 | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 564 | ||||||||||
Warrants exercisable period | 36 months | 36 months | |||||||||
Period warrants became exercisable from closing date | 6 months | 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) | shares | 1,961 | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 108 | ||||||||||
Warrants exercisable period | 60 months | 60 months | |||||||||
Period warrants became exercisable from closing date | 6 months | 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) | shares | 35,295 | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 108 | ||||||||||
Adjusted exercise price of warrants (in dollars per share) | $ / shares | $ 102 | ||||||||||
Warrant Exercise Agreement [Member] | Original Warrants [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Proceeds from exercise of warrants | $ 2,000 | ||||||||||
Warrants outstanding | $ 0 | $ 0 | $ 0 | ||||||||
Relinquished amount of warrants | $ 100 | $ 100 | |||||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 43,396 | ||||||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | Minimum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 34.6 | ||||||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | Maximum [Member] | |||||||||||
Class of Stock [Line Items] | |||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 99.8 |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock Options and Restricted Stock Awards (FY) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||||
Stock-based compensation expense | $ 437,000 | $ 111,000 | $ 1,544,000 | $ 394,000 | $ 502,000 | $ 1,015,000 |
Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Award vesting period | 1 year | |||||
Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Award vesting period | 4 years | |||||
Selling, General and Administrative [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||||
Stock-based compensation expense | 440,000 | 106,000 | 1,446,000 | 351,000 | $ 452,000 | 630,000 |
Research and Development [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||||
Stock-based compensation expense | $ (3,000) | $ 5,000 | $ 98,000 | $ 43,000 | $ 50,000 | $ 385,000 |
Stock Options [Member] | ||||||
Share-based Payment Award, Options, Outstanding [Roll Forward] | ||||||
Outstanding, beginning balance (in shares) | 36,362 | 4,354 | 4,354 | 3,260 | ||
Granted (in shares) | 34,651 | 2,257 | ||||
Exercised (in shares) | 0 | 0 | ||||
Forfeited/expired (in shares) | (2,643) | (1,163) | ||||
Outstanding, ending balance (in shares) | 36,362 | 4,354 | ||||
Vested at the end of the year (in shares) | 2,344 | 2,134 | ||||
Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||||||
Outstanding at the beginning of the year (in dollars per share) | $ 91.48 | $ 2,295.37 | $ 2,295.37 | $ 3,664.61 | ||
Granted (in dollars per share) | 11.57 | 543.63 | ||||
Exercised (in dollars per share) | 0 | 0 | ||||
Forfeited/expired (in dollars per share) | 2,666.48 | 2,729.60 | ||||
Outstanding at the end of the year (in dollars per share) | 91.48 | 2,295.37 | ||||
Vested at the end of the year (in dollars per share) | $ 964.27 | $ 3,780.79 | ||||
Share Based Payment Award, Options Weighted Average Remaining Contractual Term [Abstract] | ||||||
Options outstanding, weighted average remaining contractual life | 9 years 3 months 29 days | |||||
Options vested, weighted average remaining contractual life | 8 years 3 months 14 days | |||||
Share Based Payment Award, Aggregate Intrinsic Value [Abstract] | ||||||
Fair value of options, vested | $ 700,000 | $ 1,100,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||||
Expected dividend yield | 0.00% | 0.00% | ||||
Risk-free interest rate | 1.97% | 1.71% | ||||
Expected volatility | 103.00% | 86.00% | ||||
Expected life | 6 years 3 months | 6 years 3 months | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||||||
Weighted-average fair value of options granted (in dollars per share) | $ 11.97 | $ 543.63 | ||||
Total unrecognized compensation costs related to non-vested stock option awards | $ 744,000 | |||||
Unrecognized compensation costs related to non-vested stock option awards, recognition period | 3 years 1 month 6 days | |||||
Restricted Stock Units [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | ||||||
Nonvested beginning balance (in shares) | 245 | 499 | 499 | 15 | ||
Granted (in shares) | 138 | 1,131 | ||||
Vested (in shares) | (392) | (619) | ||||
Forfeited (in shares) | 0 | (28) | ||||
Nonvested ending balance (in shares) | 245 | 499 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||||||
Nonvested weighted average grant price beginning balance (in dollars per share) | $ 521.23 | $ 583.29 | $ 583.29 | $ 2,574 | ||
Granted (in dollars per share) | 108.20 | 553.88 | ||||
Vested (in dollars per share) | 132.70 | 443.40 | ||||
Forfeited (in dollars per share) | 0 | 426 | ||||
Nonvested weighted average grant price ending balance (in dollars per share) | $ 521.23 | $ 583.29 | ||||
Employees tendered restricted stock units (in shares) | 15 | 165 |
Stock-Based Compensation, Warra
Stock-Based Compensation, Warrants (FY) (Details) - Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Class of Warrant or Right [Line Items] | ||
Warrants outstanding (in shares) | 8,522,684 | 44,268 |
Minimum [Member] | ||
Class of Warrant or Right [Line Items] | ||
Exercise price of warrants (in dollars per share) | $ 4.50 | |
Warrants exercisable period | 11 months | |
Maximum [Member] | ||
Class of Warrant or Right [Line Items] | ||
Exercise price of warrants (in dollars per share) | $ 383.57 | |
Warrants exercisable period | 7 years 6 months |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments (FY) (Details) $ in Thousands | Nov. 03, 2016USD ($) | Jul. 26, 2016USD ($) | Dec. 31, 2016USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Feb. 15, 2017 |
Fair value of Level 3 [Roll Forward] | ||||||||||
Warrant issuance | $ 0 | $ 509 | $ 509 | $ 0 | ||||||
Change in fair value | $ 0 | $ 4 | 0 | 1,470 | 1,475 | 818 | ||||
Ending balance | $ 1,843 | 0 | 1,843 | |||||||
Fair Value Transfers between levels [Abstract] | ||||||||||
Level 1 to Level 2 Asset Transfers | 0 | 0 | 0 | 0 | 0 | |||||
Level 2 to Level 1 Asset Transfers | 0 | 0 | 0 | 0 | 0 | |||||
Level 1 to Level 2 Liability Transfers | 0 | 0 | 0 | 0 | 0 | |||||
Level 2 to Level 1 Liability Transfers | $ 0 | $ 0 | $ 0 | 0 | $ 0 | |||||
Risk-Free Interest Rates, Adjusted for Continuous Compounding [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.0133 | 0.0094 | ||||||||
Risk-Free Interest Rates, Adjusted for Continuous Compounding [Member] | Minimum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.0147 | 0.0147 | 0.0145 | |||||||
Risk-Free Interest Rates, Adjusted for Continuous Compounding [Member] | Maximum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.0196 | 0.0196 | 0.0199 | |||||||
Term [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Term | 5 years 6 months | 3 years 6 months | ||||||||
Term [Member] | Minimum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Term | 3 years 1 month 6 days | 3 years 1 month 6 days | 2 years 10 months 2 days | |||||||
Term [Member] | Maximum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Term | 5 years 3 months 18 days | 5 years 3 months 18 days | 5 years 6 months | |||||||
Expected Volatility [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.4140 | 0.7800 | ||||||||
Expected Volatility [Member] | Minimum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.498 | 0.498 | 0.499 | |||||||
Expected Volatility [Member] | Maximum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.5530 | 0.5530 | 0.585 | |||||||
Level 3 [Member] | ||||||||||
Fair value of Level 3 [Roll Forward] | ||||||||||
Change in fair value | $ (818) | (1,469) | (1,475) | |||||||
Exercise of warrants | 368 | (368) | ||||||||
Ending balance | $ 1,843 | $ 6 | $ 6 | $ 0 | $ 1,843 | |||||
Level 3 [Member] | Warrants Issued July 26 2016 [Member] | ||||||||||
Fair value of Level 3 [Roll Forward] | ||||||||||
Warrant issuance | $ 1,883 | |||||||||
Level 3 [Member] | Warrants Issued November 3 2016 [Member] | ||||||||||
Fair value of Level 3 [Roll Forward] | ||||||||||
Warrant issuance | $ 778 |
Income Taxes, Domestic and Fore
Income Taxes, Domestic and Foreign Loss Before Income Taxes (FY) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Loss before income taxes [Abstract] | ||||||
Domestic | $ (13,367) | $ (15,877) | ||||
Foreign | (9) | 31 | ||||
Loss before income taxes | $ (4,240) | $ (2,842) | $ (12,773) | $ (6,239) | $ (13,376) | $ (15,846) |
Income Taxes, Components of Inc
Income Taxes, Components of Income Tax Benefit (FY) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Current [Abstract] | ||||||
United States and state | $ 0 | $ 0 | ||||
Foreign, net | (6) | 54 | ||||
Deferred [Abstract] | ||||||
United States and state | 0 | 0 | ||||
Foreign | 0 | 0 | ||||
Total income tax benefit (expense) | $ (1) | $ (5) | $ (3) | $ (6) | $ (6) | $ 54 |
Income Taxes, Effective Income
Income Taxes, Effective Income Tax Rate Reconciliation (FY) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Effective income tax rate reconciliation [Abstract] | ||||||
Statutory federal income tax benefit | $ 4,548 | $ 5,388 | ||||
State tax benefit, net of federal taxes | 48 | 2 | ||||
Foreign tax | 0 | 3 | ||||
R&D tax credit | 0 | 80 | ||||
Foreign deferred exchange rate adjustments | 899 | 0 | ||||
Nondeductible/nontaxable items | (114) | (86) | ||||
New federal rate adjustment | (16,081) | 0 | ||||
Other | (1,085) | (257) | ||||
Valuation allowance decrease (increase) | 11,779 | (5,076) | ||||
Total income tax benefit (expense) | $ (1) | $ (5) | $ (3) | $ (6) | $ (6) | $ 54 |
Income Taxes, Deferred Taxes an
Income Taxes, Deferred Taxes and Other Information (FY) (Details) $ in Thousands, $ in Thousands | 12 Months Ended | ||||
Dec. 31, 2018 | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2017AUD ($) | Dec. 31, 2016AUD ($) | |
Noncurrent [Abstract] | |||||
Accrued leave | $ 32 | $ 43 | |||
Other accrued expenses | 28 | 97 | |||
Stock based compensation | 336 | 1,477 | |||
Net operating loss carryforward | 38,947 | 49,720 | |||
Deferred rent | 7 | 17 | |||
Other | 108 | 777 | |||
Intangibles | 895 | ||||
R&D credit carryforward | 531 | 531 | |||
Total deferred tax assets | 40,884 | 52,662 | |||
Less: valuation allowance | (40,884) | (52,662) | |||
Total | $ 0 | 0 | |||
Income Tax Disclosure [Line Items] | |||||
U.S. corporate income tax rate | 34.00% | ||||
Percentage of valuation allowance on deferred tax assets | 100.00% | ||||
Operating Loss Carryforwards [Line Items] | |||||
Uncertain tax positions | $ 0 | 0 | |||
Interest and penalties related to uncertain tax positions accrued during the period | 0 | $ 0 | |||
Research Tax Credit Carryforward [Member] | Australian Taxation Office [Member] | |||||
Tax Credit Carryforward [Line Items] | |||||
Fully refundable research and development tax credits | $ 0 | $ 80 | |||
Plan [Member] | |||||
Income Tax Disclosure [Line Items] | |||||
U.S. corporate income tax rate | 21.00% | ||||
United States [Member] | |||||
Operating Loss Carryforwards [Line Items] | |||||
Net operating loss (NOL) carryforwards | $ 120,200 | ||||
Australian [Member] | |||||
Operating Loss Carryforwards [Line Items] | |||||
Net operating loss (NOL) carryforwards | $ 49,000 |
Commitments and Contingencies_3
Commitments and Contingencies (FY) (Details) - USD ($) | Aug. 05, 2016 | Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jun. 30, 2017 |
Leases [Abstract] | |||||
Rent expense related to operating leases | $ 290,000 | $ 286,000 | |||
Future minimum lease payments [Abstract] | |||||
2,018 | 212,000 | ||||
2,019 | 60,000 | ||||
2,020 | 7,000 | ||||
2,021 | 0 | ||||
2,022 | 0 | ||||
Employee Retirement Plan [Abstract] | |||||
Employer's matching contribution | 138,000 | $ 122,000 | |||
Aquadex Product Line [Member] | |||||
Inventory Purchase Commitments [Abstract] | |||||
Remaining inventory obligation | 1,200,000 | $ 2,400,000 | |||
Inventory purchases | $ 1,200,000 | ||||
Contingent Consideration [Abstract] | |||||
Sale or disposal of business assets threshold for contingent consideration | $ 4,000,000 | $ 4,000,000 | |||
Percentage of additional payments on disposal of business assets | 40.00% | 40.00% | |||
Aquadex Product Line [Member] | Maximum [Member] | |||||
Inventory Purchase Commitments [Abstract] | |||||
Agreement term | 18 months | ||||
Contingent Consideration [Abstract] | |||||
Contingent consideration period | 3 years | 3 years |
Segment and Geographic Inform_2
Segment and Geographic Information (FY) (Details) | 12 Months Ended |
Dec. 31, 2017Segment | |
Segment and Geographic Information [Abstract] | |
Number of reportable segments | 1 |
Nature of Business and Basis _4
Nature of Business and Basis of Presentation, Nature of Business, Going Concern, Accounts Receivable and Inventories (Q3) (Details) $ in Thousands | Oct. 12, 2017 | Jan. 12, 2017 | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($)StockSplit | Dec. 31, 2016USD ($) | Jul. 03, 2018USD ($) |
Nature of Business [Abstract] | |||||||
Number of reverse stock split | StockSplit | 2 | ||||||
Reverse stock split ratio | 20 | 30 | |||||
Going Concern [Abstract] | |||||||
Accumulated deficit | $ (195,132) | $ (182,356) | $ (168,974) | ||||
Net proceeds from public stock offering | $ 4,649 | $ 8,002 | $ 24,281 | 0 | $ 28,800 | ||
Accounts Receivable [Abstract] | |||||||
Accounts receivables maximum credit period from invoice date | 30 days | 30 days | |||||
Allowance for doubtful accounts | $ 0 | $ 0 | 0 | ||||
Inventories [Abstract] | |||||||
Finished Goods | 810 | 902 | 644 | ||||
Work in Process | 91 | 217 | 0 | ||||
Raw Materials | 1,047 | 469 | 33 | ||||
Total | $ 1,948 | $ 1,588 | $ 677 |
Nature of Business and Basis _5
Nature of Business and Basis of Presentation, Loss Per Share (Q3) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
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) | 10,776,944 | 533,827 | 9,402,231 | 102,300 | ||
Reported net loss with reported net loss per share [Abstract] | ||||||
Net loss | $ (4,241,000) | $ (2,847,000) | $ (12,776,000) | $ (6,245,000) | $ (13,382,000) | $ (15,792,000) |
Deemed dividend to preferred shareholders | 0 | (2,851,000) | (11,590,000) | (1,900,000) | ||
Net loss after deemed dividend | $ (2,847,000) | $ (9,096,000) | $ (24,972,000) | $ (17,692,000) | ||
Weighted average shares outstanding (in shares) | 6,987,000 | 626,000 | 5,171,000 | 359,000 | 665,000 | 33,000 |
Basic and diluted loss per share (in dollars per share) | $ (0.61) | $ (4.55) | $ (2.47) | $ (25.36) | $ (37.51) | $ (536.12) |
Series C and D Convertible Preferred Stock [Member] | ||||||
Reported net loss with reported net loss per share [Abstract] | ||||||
Deemed dividend to preferred shareholders | $ 1,800,000 | $ (1,800,000) | ||||
Series E Convertible Preferred Stock [Member] | ||||||
Reported net loss with reported net loss per share [Abstract] | ||||||
Deemed dividend to preferred shareholders | $ 1,000,000 | $ (1,000,000) | ||||
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) | 266,680 | 0 | 842,940 | 0 | ||
Reported net loss with reported net loss per share [Abstract] | ||||||
Deemed dividend to preferred shareholders | $ (8,700,000) | |||||
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) | 1,987,502 | 36,874 | 36,362 | 4,354 | ||
Restricted Stock Units [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) | 90 | 324 | 245 | 499 | ||
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) | 8,522,672 | 496,629 | 8,522,684 | 44,268 |
Revenue Recognition (Q3) (Detai
Revenue Recognition (Q3) (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2018 | Dec. 31, 2017 | |
Revenue, Performance Obligation [Abstract] | |||
Deferred revenue | $ 41,250 | $ 41,250 | $ 38,000 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2018-07-01 | |||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | |||
Expected timing of satisfaction, period | 1 year | 1 year | |
Sales Revenue [Member] | Maximum [Member] | ASC 606 [Member] | |||
Revenue, Performance Obligation [Abstract] | |||
Percentage of net sales | 1.00% | 1.00% |
Debt, New Loan Agreement (Q3) (
Debt, New Loan Agreement (Q3) (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Line of Credit Facility [Abstract] | |||
Maximum borrowing capacity | $ 5,000 | ||
Revolving Line [Member] | |||
Line of Credit Facility [Abstract] | |||
Maximum borrowing capacity | $ 1,000 | $ 1,000 | |
Maximum borrowing capacity percentage of eligible accounts | 80.00% | ||
Maturity date | Mar. 31, 2020 | Mar. 31, 2020 | |
Total borrowings outstanding | $ 0 | $ 0 | $ 0 |
Revolving Line [Member] | Floating Annual Rate [Member] | |||
Line of Credit Facility [Abstract] | |||
Interest rate | 1.75% | 1.75% | |
Revolving Line [Member] | Prime Rate [Member] | |||
Line of Credit Facility [Abstract] | |||
Interest rate | 1.00% | 1.00% |
Debt, Warrants (Q3) (Details)
Debt, Warrants (Q3) (Details) | Sep. 30, 2018$ / sharesshares | Dec. 31, 2017$ / sharesshares | Nov. 03, 2016 | Jul. 26, 2016 |
Risk-Free Interest Rate [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Warrants measurement input | 0.0133 | 0.0094 | ||
Expected Warrant Option Life [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Expected warrant option life | 5 years 6 months | 3 years 6 months | ||
Affiliates [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Warrants issued (in shares) | shares | 55 | 55 | ||
Exercise price of warrants (in dollars per share) | $ 2,208 | $ 2,208 | ||
Value of warrants (in dollars per share) | $ 1,626 | $ 1,626 | ||
Affiliates [Member] | Expected Dividend Yield [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Warrants measurement input | 0 | 0 | ||
Affiliates [Member] | Expected Stock Price Volatility [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Warrants measurement input | 0.8704 | 0.8704 | ||
Affiliates [Member] | Risk-Free Interest Rate [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Warrants measurement input | 0.0220 | 0.0220 | ||
Affiliates [Member] | Expected Warrant Option Life [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Expected warrant option life | 6 years 3 months | 6 years 3 months | ||
Silicon Valley Bank [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Warrants issued (in shares) | shares | 115 | 115 | ||
Exercise price of warrants (in dollars per share) | $ 3,132 | $ 3,132 | ||
Value of warrants (in dollars per share) | $ 2,316 | $ 2,316 | ||
Silicon Valley Bank [Member] | Expected Dividend Yield [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Warrants measurement input | 0 | 0 | ||
Silicon Valley Bank [Member] | Expected Stock Price Volatility [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Warrants measurement input | 0.8807 | 0.8807 | ||
Silicon Valley Bank [Member] | Risk-Free Interest Rate [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Warrants measurement input | 0.0186 | 0.0186 | ||
Silicon Valley Bank [Member] | Expected Warrant Option Life [Member] | ||||
Warrants and Rights Note Disclosure [Abstract] | ||||
Expected warrant option life | 6 years 3 months | 6 years 3 months |
Equity, Convertible Preferred S
Equity, Convertible Preferred Stock (Q3) (Details) - USD ($) | Jul. 03, 2018 | Nov. 27, 2017 | Apr. 24, 2017 | Jan. 10, 2017 | Nov. 03, 2016 | Oct. 30, 2016 | Jul. 20, 2016 | Sep. 30, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Class of Stock Disclosures [Abstract] | ||||||||||
Proceeds from issuance of convertible preferred stock and Warrants | $ 3,600,000 | $ 3,800,000 | $ 3,500,000 | |||||||
Common stock issued (in shares) | 2,800,000 | |||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||||||
Net proceeds from issuance of convertible preferred stock | $ 16,200,000 | $ 8,000,000 | ||||||||
Series B-1 Convertible Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Proceed from issuance of preferred stock | $ 1,600,000 | |||||||||
Preferred stock, shares outstanding (in shares) | 0 | 1,824.4 | ||||||||
Conversion price (in dollars per share) | $ 102 | |||||||||
Number of convertible preferred shares converted (in shares) | 402.8 | |||||||||
Number of preferred shares converted to common stock (in shares) | 17,866 | 3,948 | ||||||||
Preferred stock issued (in shares) | 2,227.2 | 0 | 1,824.4 | |||||||
Series B and B-1 Convertible Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||
Series C Convertible Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 2,900 | ||||||||
Beneficial conversion amount | $ 1,300,000 | |||||||||
Conversion price (in dollars per share) | $ 102 | |||||||||
Number of preferred shares converted to common stock (in shares) | 0 | |||||||||
Preferred stock issued (in shares) | 2,900 | 0 | 2,900 | |||||||
Series D Convertible Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Proceeds from issuance of convertible preferred stock and Warrants | 200,000 | |||||||||
Beneficial conversion amount | $ 500,000 | |||||||||
Conversion price (in dollars per share) | $ 102 | $ 102 | ||||||||
Number of preferred shares converted to common stock (in shares) | 0 | |||||||||
Preferred stock issued (in shares) | 200 | |||||||||
Series C and D Convertible Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Proceeds from issuance of convertible preferred stock and Warrants | $ 3,600,000 | |||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||
Number of preferred shares converted to common stock (in shares) | 55,712 | |||||||||
Series E Convertible Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Proceed from issuance of preferred stock | 9,200,000 | |||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | ||||||||
Beneficial conversion amount | 1,000,000 | $ 1,000,000 | ||||||||
Net proceeds from issuance of convertible preferred stock | $ 8,000,000 | |||||||||
Percentage of placement fee offered in cash | 9.00% | |||||||||
Number of preferred shares converted to common stock (in shares) | 6,400,000 | 320,000 | ||||||||
Preferred stock issued (in shares) | 6,400 | 6,400 | ||||||||
Percentage of underwriting discounts and commissions | 9.00% | |||||||||
Series E Convertible Preferred Stock [Member] | Warrants [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Warrants to purchase shares of common stock (in shares) | 9,200,000 | 640,000 | ||||||||
Warrants issued to underwriter (in shares) | 0 | 0 | ||||||||
Series F Convertible Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Common stock issued (in shares) | 2,547,169 | |||||||||
Proceed from issuance of preferred stock | 18,000,000 | |||||||||
Preferred stock, shares outstanding (in shares) | 565 | 3,780 | 0 | |||||||
Beneficial conversion amount | 8,700,000 | |||||||||
Net proceeds from issuance of convertible preferred stock | $ 16,200,000 | |||||||||
Conversion price (in dollars per share) | $ 2.12 | $ 4.50 | ||||||||
Number of convertible preferred shares converted (in shares) | 17,435 | 14,220 | ||||||||
Percentage of placement fee offered in cash | 8.00% | |||||||||
Public offering price (in dollars per share) | $ 2.12 | |||||||||
Number of preferred shares converted to common stock (in shares) | 472 | 4,000,000 | 3,899,210 | 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 | 565 | 3,780 | 0 | ||||||
Gross proceeds from public stock offering | $ 5,400,000 | |||||||||
Warrants exercisable (in shares) | 7,760,400 | |||||||||
Percentage of underwriting discounts and commissions | 8.00% | 8.00% | ||||||||
Series F Convertible Preferred Stock [Member] | Warrants [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Warrants to purchase shares of common stock (in shares) | 8,000,000 | |||||||||
Warrants issued to underwriter (in shares) | 0 | 0 | ||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
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 Disclosures [Abstract] | ||||||||||
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 Disclosures [Abstract] | ||||||||||
Percentage of placement fee offered in cash | 6.00% | 6.00% |
Equity, Warrants (Q3) (Details)
Equity, Warrants (Q3) (Details) $ / shares in Units, $ in Thousands | Jan. 10, 2017USD ($)$ / sharesshares | Nov. 03, 2016USD ($)$ / sharesshares | Jul. 26, 2016USD ($)$ / sharesshares | Mar. 31, 2017USD ($)$ / sharesshares | Sep. 30, 2018USD ($)$ / sharesshares | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($)$ / sharesshares | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Feb. 15, 2017 |
Warrants and Rights Disclosure [Abstract] | |||||||||||
Proceeds from exercise of warrants | $ 0 | $ 1,981 | $ 1,989 | $ 0 | |||||||
Warrants outstanding | 0 | 1,843 | |||||||||
Change in fair value of warrant liability | $ 0 | $ 4 | 0 | 1,470 | 1,475 | $ 818 | |||||
Risk-Free Interest Rate [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants measurement input | 0.0133 | 0.0094 | |||||||||
Risk-Free Interest Rate [Member] | Minimum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants measurement input | 0.0147 | 0.0145 | |||||||||
Risk-Free Interest Rate [Member] | Maximum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants measurement input | 0.0196 | 0.0199 | |||||||||
Expected Warrant Option Life [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Expected warrant option life | 5 years 6 months | 3 years 6 months | |||||||||
Expected Warrant Option Life [Member] | Minimum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Expected warrant option life | 3 years 1 month 6 days | 2 years 10 months 2 days | |||||||||
Expected Warrant Option Life [Member] | Maximum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Expected warrant option life | 5 years 3 months 18 days | 5 years 6 months | |||||||||
Replacement Warrants [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants outstanding | $ 500 | $ 500 | $ 500 | ||||||||
Replacement Warrants [Member] | Expected Dividend Yield [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants measurement input | 0 | 0 | 0 | ||||||||
Replacement Warrants [Member] | Expected Stock Price Volatility [Member] | Minimum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants measurement input | 0.4965 | 0.4965 | 0.4965 | ||||||||
Replacement Warrants [Member] | Expected Stock Price Volatility [Member] | Maximum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants measurement input | 0.5038 | 0.5038 | 0.5038 | ||||||||
Replacement Warrants [Member] | Risk-Free Interest Rate [Member] | Minimum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants measurement input | 0.0195 | 0.0195 | 0.0195 | ||||||||
Replacement Warrants [Member] | Risk-Free Interest Rate [Member] | Maximum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants measurement input | 0.0197 | 0.0197 | 0.0197 | ||||||||
Replacement Warrants [Member] | Expected Warrant Option Life [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Expected warrant option life | 5 years | 5 years | 5 years | ||||||||
Series B Convertible Preferred Stock [Member] | Investor Warrants [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants issuance cost | $ 0 | ||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 6,149 | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 564 | ||||||||||
Warrants exercisable period | 36 months | 36 months | |||||||||
Period warrants became exercisable from closing date | 6 months | 6 months | |||||||||
Series D Convertible Preferred Stock [Member] | Investor Warrants [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants issuance cost | $ 0 | ||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 1,961 | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 108 | ||||||||||
Warrants exercisable period | 60 months | 60 months | |||||||||
Period warrants became exercisable from closing date | 6 months | 6 months | |||||||||
Series C and D Convertible Preferred Stock [Member] | Investor Warrants [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants issuance cost | $ 0 | ||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 35,295 | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 108 | ||||||||||
Adjusted exercise price of warrants (in dollars per share) | $ / shares | $ 102 | ||||||||||
Series B, C And D Convertible Preferred Stock [Member] | Placement Agent Warrant [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants issuance cost | $ 0 | ||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 2,605 | 2,605 | |||||||||
Expiration term of warrants | 5 years | ||||||||||
Series B, C And D Convertible Preferred Stock [Member] | Placement Agent Warrant [Member] | Minimum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 126 | $ 126 | |||||||||
Series B, C And D Convertible Preferred Stock [Member] | Placement Agent Warrant [Member] | Maximum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 810 | $ 810 | |||||||||
Warrant Exercise Agreement [Member] | Original Warrants [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Proceeds from exercise of warrants | $ 2,000 | ||||||||||
Warrants outstanding | $ 0 | $ 0 | $ 0 | ||||||||
Relinquished amount of warrants | $ 100 | $ 100 | |||||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Warrants to purchase shares of common stock (in shares) | shares | 43,396 | ||||||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | Minimum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 34.6 | ||||||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | Maximum [Member] | |||||||||||
Warrants and Rights Disclosure [Abstract] | |||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 99.8 |
Stock-Based Compensation (Q3)_2
Stock-Based Compensation (Q3) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | $ 437 | $ 111 | $ 1,544 | $ 394 | $ 502 | $ 1,015 |
Selling, General and Administrative Expense [Member] | ||||||
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | 440 | 106 | 1,446 | 351 | 452 | 630 |
Research and Development Expense [Member] | ||||||
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | $ (3) | $ 5 | $ 98 | $ 43 | $ 50 | $ 385 |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments (Q3) (Details) $ in Thousands | 2 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2016USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Feb. 15, 2017 | Nov. 03, 2016 | Jul. 26, 2016 | |
Fair value of Level 3 [Roll Forward] | ||||||||||
Balance | $ 0 | $ 1,843 | $ 1,843 | |||||||
Change in fair value | $ 0 | $ 4 | 0 | 1,470 | 1,475 | $ 818 | ||||
Ending balance | $ 1,843 | 0 | 1,843 | |||||||
Fair Value Transfers between levels [Abstract] | ||||||||||
Level 1 to Level 2 Asset Transfers | 0 | 0 | 0 | 0 | 0 | |||||
Level 2 to Level 1 Asset Transfers | 0 | 0 | 0 | 0 | 0 | |||||
Level 1 to Level 2 Liability Transfers | 0 | 0 | 0 | 0 | 0 | |||||
Level 2 to Level 1 Liability Transfers | $ 0 | 0 | 0 | 0 | $ 0 | |||||
Risk-Free Interest Rates, Adjusted for Continuous Compounding [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.0133 | 0.0094 | ||||||||
Risk-Free Interest Rates, Adjusted for Continuous Compounding [Member] | Minimum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.0147 | 0.0147 | 0.0145 | |||||||
Risk-Free Interest Rates, Adjusted for Continuous Compounding [Member] | Maximum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.0196 | 0.0196 | 0.0199 | |||||||
Term [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Term | 5 years 6 months | 3 years 6 months | ||||||||
Term [Member] | Minimum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Term | 3 years 1 month 6 days | 3 years 1 month 6 days | 2 years 10 months 2 days | |||||||
Term [Member] | Maximum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Term | 5 years 3 months 18 days | 5 years 3 months 18 days | 5 years 6 months | |||||||
Expected Volatility [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.4140 | 0.7800 | ||||||||
Expected Volatility [Member] | Minimum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.498 | 0.498 | 0.499 | |||||||
Expected Volatility [Member] | Maximum [Member] | ||||||||||
Fair Value Assumptions [Abstract] | ||||||||||
Fair value assumptions measurement input | 0.5530 | 0.5530 | 0.585 | |||||||
Aquadex Product Line [Member] | ||||||||||
Fair Value Transfers between levels [Abstract] | ||||||||||
Fair value of contingent consideration | $ 126 | 126 | 126 | |||||||
Level 3 [Member] | ||||||||||
Fair value of Level 3 [Roll Forward] | ||||||||||
Balance | $ 0 | 1,843 | 1,843 | |||||||
Change in fair value | $ (818) | (1,469) | (1,475) | |||||||
Exercise of warrants | (368) | 368 | ||||||||
Ending balance | $ 1,843 | $ 6 | $ 6 | $ 0 | $ 1,843 |
Commitments and Contingencies_4
Commitments and Contingencies (Q3) (Details) - USD ($) | Aug. 05, 2016 | Sep. 30, 2018 | Dec. 31, 2017 |
Leases [Abstract] | |||
Annual base rent from April 1, 2019 per square foot | $ 9 | ||
Annual increase per square foot | 0.25 | ||
Aquadex Product Line [Member] | |||
Contingent Consideration [Abstract] | |||
Sale or disposal of business assets threshold for contingent consideration | $ 4,000,000 | $ 4,000,000 | |
Percentage of additional payments on disposal of business assets | 40.00% | 40.00% | |
Aquadex Product Line [Member] | Maximum [Member] | |||
Contingent Consideration [Abstract] | |||
Contingent consideration period | 3 years | 3 years |