Document and Entity Information
Document and Entity Information | 9 Months Ended |
Sep. 30, 2019 | |
Cover [Abstract] | |
Entity Registrant Name | CHF Solutions, Inc. |
Entity Central Index Key | 0001506492 |
Entity Filer Category | Non-accelerated Filer |
Entity Small Business | true |
Entity Emerging Growth Company | false |
Document Type | S-1/A |
Amendment Flag | false |
Document Period End Date | Sep. 30, 2019 |
Consolidated Balance Sheets (FY
Consolidated Balance Sheets (FY) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 5,480 | $ 15,595 |
Accounts receivable | 786 | 545 |
Inventories | 1,658 | 1,588 |
Other current assets | 203 | 136 |
Total current assets | 8,127 | 17,864 |
Property, plant and equipment, net | 536 | 570 |
Other assets | 113 | 21 |
TOTAL ASSETS | 8,776 | 18,455 |
Current liabilities | ||
Accounts payable | 1,133 | 862 |
Accrued compensation | 1,498 | 1,021 |
Other current liabilities | 209 | 208 |
Total current liabilities | 2,840 | 2,091 |
Other liabilities | 0 | 126 |
Total liabilities | 2,840 | 2,217 |
Commitments and contingencies | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Common stock as of December 31, 2018 and December 31, 2017, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 513,445 and 271,357, respectively | 0 | 0 |
Additional paid-in capital | 204,101 | 197,367 |
Accumulated other comprehensive income: | ||
Foreign currency translation adjustment | 1,223 | 1,227 |
Accumulated deficit | (199,388) | (182,356) |
Total stockholders' equity | 5,936 | 16,238 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 8,776 | 18,455 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock | $ 0 | $ 0 |
Consolidated Balance Sheets (_2
Consolidated Balance Sheets (FY) (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Nov. 27, 2017 |
Stockholders' equity | ||||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |
Preferred stock, shares authorized (in shares) | 39,969,465 | 39,969,465 | 39,966,220 | |
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) | 2,879,162 | 513,445 | 271,357 | |
Common stock, shares outstanding (in shares) | 2,879,162 | 513,445 | 271,357 | |
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) | 535 | 535 | 3,780 | |
Preferred stock, shares issued (in shares) | 535 | 535 | 3,780 | 18,000 |
Preferred stock, shares outstanding (in shares) | 535 | 535 | 3,780 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (FY) - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||
Net sales | $ 4,998 | $ 3,553 |
Costs and Expenses: | ||
Cost of goods sold | 3,670 | 2,763 |
Selling, general and administrative | 15,311 | 10,170 |
Research and development | 3,053 | 1,481 |
Goodwill and intangibles impairment | 0 | 3,951 |
Total costs and expenses | 22,034 | 18,365 |
Loss from operations | (17,036) | (14,812) |
Other income (expense): | ||
Other income, net | 10 | 28 |
Warrant valuation expense | 0 | (67) |
Change in fair value of warrant liability | 0 | 1,475 |
Total other income, net | 10 | 1,436 |
Loss before income taxes | (17,026) | (13,376) |
Income tax expense | (6) | (6) |
Net loss | $ (17,032) | $ (13,382) |
Basic and diluted loss per share (in dollars per share) | $ (42.14) | $ (525.01) |
Weighted average shares outstanding - basic and diluted (in shares) | 404 | 48 |
Other comprehensive loss: | ||
Foreign currency translation adjustment | $ (4) | $ (8) |
Total comprehensive loss | $ (17,036) | $ (13,390) |
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, 2016 | $ 0 | $ 169,496 | $ 1,235 | $ (168,974) | $ 1,757 |
Balance (in shares) at Dec. 31, 2016 | 2,801 | ||||
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) | 17 | ||||
Issuance of common stock, net | $ 0 | 5,399 | 0 | 0 | 5,399 |
Issuance of common stock, net (in shares) | 42,017 | ||||
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) | 226,522 | ||||
Balance at Dec. 31, 2017 | $ 0 | 197,367 | 1,227 | (182,356) | 16,238 |
Balance (in shares) at Dec. 31, 2017 | 271,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,354) | (4,354) |
Foreign currency translation adjustment | 0 | 0 | 1 | 0 | 1 |
Stock-based compensation, net | $ 0 | 501 | 0 | 0 | 501 |
Stock-based compensation, net (in shares) | 3 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 32,365 | ||||
Balance at Mar. 31, 2018 | $ 0 | 197,868 | 1,228 | (186,710) | 12,386 |
Balance (in shares) at Mar. 31, 2018 | 303,725 | ||||
Balance at Dec. 31, 2017 | $ 0 | 197,367 | 1,227 | (182,356) | 16,238 |
Balance (in shares) at Dec. 31, 2017 | 271,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (12,776) | ||||
Foreign currency translation adjustment | (2) | ||||
Balance at Sep. 30, 2018 | $ 0 | 203,560 | 1,225 | (195,132) | 9,653 |
Balance (in shares) at Sep. 30, 2018 | 505,315 | ||||
Balance at Dec. 31, 2017 | $ 0 | 197,367 | 1,227 | (182,356) | 16,238 |
Balance (in shares) at Dec. 31, 2017 | 271,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (17,032) | (17,032) |
Foreign currency translation adjustment | 0 | (4) | (4) | ||
Stock-based compensation, net | $ 0 | 2,087 | 0 | 0 | 2,087 |
Stock-based compensation, net (in shares) | 12 | ||||
Issuance of unregistered shares | $ 0 | 0 | 0 | 0 | 0 |
Issuance of unregistered shares (in shares) | 7,116 | ||||
Issuance of common stock, net | $ 0 | 4,647 | 0 | 0 | 4,647 |
Issuance of common stock, net (in shares) | 181,941 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 53,019 | ||||
Balance at Dec. 31, 2018 | $ 0 | 204,101 | 1,223 | (199,388) | 5,936 |
Balance (in shares) at Dec. 31, 2018 | 513,445 | ||||
Balance at Mar. 31, 2018 | $ 0 | 197,868 | 1,228 | (186,710) | 12,386 |
Balance (in shares) at Mar. 31, 2018 | 303,725 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,181) | (4,181) |
Foreign currency translation adjustment | 0 | 0 | (2) | 0 | (2) |
Stock-based compensation, net | $ 0 | 606 | 0 | 0 | 606 |
Stock-based compensation, net (in shares) | 3 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 18,127 | ||||
Balance at Jun. 30, 2018 | $ 0 | 198,474 | 1,226 | (190,891) | 8,809 |
Balance (in shares) at Jun. 30, 2018 | 321,855 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,241) | (4,241) |
Foreign currency translation adjustment | 0 | 0 | (1) | 0 | (1) |
Stock-based compensation, net | $ 0 | 437 | 0 | 0 | 437 |
Stock-based compensation, net (in shares) | 3 | ||||
Issuance of common stock, net | $ 0 | 4,649 | 0 | 0 | 4,649 |
Issuance of common stock, net (in shares) | 181,941 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 1,516 | ||||
Balance at Sep. 30, 2018 | $ 0 | 203,560 | 1,225 | (195,132) | 9,653 |
Balance (in shares) at Sep. 30, 2018 | 505,315 | ||||
Balance at Dec. 31, 2018 | $ 0 | 204,101 | 1,223 | (199,388) | 5,936 |
Balance (in shares) at Dec. 31, 2018 | 513,445 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,727) | (4,727) |
Foreign currency translation adjustment | 0 | 0 | (2) | 0 | (2) |
Stock-based compensation, net | $ 0 | 362 | 0 | 0 | 362 |
Stock-based compensation, net (in shares) | 3 | ||||
Issuance of common stock, net | $ 0 | 10,959 | 0 | 0 | 10,959 |
Issuance of common stock, net (in shares) | 455,178 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 1,100,394 | ||||
Balance at Mar. 31, 2019 | $ 0 | 215,422 | 1,221 | (204,115) | 12,528 |
Balance (in shares) at Mar. 31, 2019 | 2,069,020 | ||||
Balance at Dec. 31, 2018 | $ 0 | 204,101 | 1,223 | (199,388) | 5,936 |
Balance (in shares) at Dec. 31, 2018 | 513,445 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (13,666) | ||||
Foreign currency translation adjustment | (4) | ||||
Balance at Sep. 30, 2019 | $ 0 | 216,173 | 1,219 | (213,054) | 4,338 |
Balance (in shares) at Sep. 30, 2019 | 2,879,162 | ||||
Balance at Mar. 31, 2019 | $ 0 | 215,422 | 1,221 | (204,115) | 12,528 |
Balance (in shares) at Mar. 31, 2019 | 2,069,020 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,430) | (4,430) |
Foreign currency translation adjustment | 0 | 0 | (3) | 0 | (3) |
Stock-based compensation, net | $ 0 | 339 | 0 | 0 | 339 |
Stock-based compensation, net (in shares) | 0 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 259,300 | ||||
Balance at Jun. 30, 2019 | $ 0 | 215,761 | 1,218 | (208,545) | 8,434 |
Balance (in shares) at Jun. 30, 2019 | 2,328,320 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,509) | (4,509) |
Foreign currency translation adjustment | 0 | 0 | 1 | 0 | 1 |
Stock-based compensation, net | $ 0 | 412 | 0 | 0 | 412 |
Stock-based compensation, net (in shares) | 0 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 550,842 | ||||
Balance at Sep. 30, 2019 | $ 0 | $ 216,173 | $ 1,219 | $ (213,054) | $ 4,338 |
Balance (in shares) at Sep. 30, 2019 | 2,879,162 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (FY) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Operating Activities | ||
Net loss | $ (17,032) | $ (13,382) |
Adjustments to reconcile net loss to cash flows from operating activities: | ||
Depreciation and amortization | 232 | 769 |
Stock-based compensation expense | 2,087 | 499 |
Goodwill and intangibles impairment | 0 | 3,951 |
Change in fair value of warrant liability | 0 | (1,475) |
Warrant valuation expense | 0 | 67 |
Changes in assets and liabilities: | ||
Accounts receivable | (241) | (263) |
Inventories | (70) | (911) |
Other current assets | (67) | 1 |
Other assets and liabilities | (14) | 0 |
Accounts payable and accrued expenses | 545 | (1,176) |
Net cash used in operating activities | (14,560) | (11,920) |
Investing activities: | ||
Purchase of property and equipment | (198) | (259) |
Net cash used in investing activities | (198) | (259) |
Financing activities: | ||
Net proceeds from public stock offering | 4,647 | 24,281 |
Net proceeds from exercise of warrants | 0 | 1,989 |
Net proceeds from the sale of preferred stock, common stock and warrants | 0 | 184 |
Net cash provided by financing activities | 4,647 | 26,454 |
Effect of exchange rate changes on cash | (4) | (3) |
Net decrease in cash and cash equivalents | (10,115) | 14,272 |
Cash and cash equivalents - beginning of period | 15,595 | 1,323 |
Cash and cash equivalents - end of period | 5,480 | 15,595 |
Supplemental schedule of non-cash activities | ||
Financing fees incurred for subsequent equity financing included in other assets and accounts payable | 78 | 0 |
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 | $ 2 | $ 6 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) (Q3) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets | |||
Cash and cash equivalents | $ 3,634 | $ 5,480 | $ 15,595 |
Accounts receivable | 528 | 786 | 545 |
Inventory | 1,612 | 1,658 | 1,588 |
Other current assets | 277 | 203 | 136 |
Total current assets | 6,051 | 8,127 | 17,864 |
Property, plant and equipment, net | 1,025 | 536 | 570 |
Operating lease right-of-use asset, net | 487 | 0 | |
Other assets | 21 | 113 | 21 |
TOTAL ASSETS | 7,584 | 8,776 | 18,455 |
Current liabilities | |||
Accounts payable | 1,427 | 1,133 | 862 |
Accrued compensation | 1,242 | 1,498 | 1,021 |
Current portion of operating lease liability | 181 | 0 | |
Other current liabilities | 87 | 209 | 208 |
Total current liabilities | 2,937 | 2,840 | 2,091 |
Operating lease liability | 309 | 0 | |
Total liabilities | 3,246 | 2,840 | 2,217 |
Commitments and contingencies | |||
Stockholders' equity | |||
Preferred stock | 0 | 0 | 0 |
Common stock as of September 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 2,879,162 and 513,445, respectively | 0 | 0 | 0 |
Additional paid-in capital | 216,173 | 204,101 | 197,367 |
Accumulated other comprehensive income: | |||
Foreign currency translation adjustment | 1,219 | 1,223 | 1,227 |
Accumulated deficit | (213,054) | (199,388) | (182,356) |
Total stockholders' equity | 4,338 | 5,936 | 16,238 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | 7,584 | 8,776 | 18,455 |
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 |
Series G Convertible Preferred Stock [Member] | |||
Stockholders' equity | |||
Preferred stock | $ 0 | $ 0 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Q3) (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 39,969,465 | 39,969,465 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 2,879,162 | 513,445 |
Common stock, shares outstanding (in shares) | 2,879,162 | 513,445 |
Series A Junior Participating Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 30,000 | 30,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Series F Convertible Preferred Stock [Member] | ||
Stockholders' equity | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 535 | 535 |
Preferred stock, shares issued (in shares) | 535 | 535 |
Preferred stock, shares outstanding (in shares) | 535 | 535 |
Series G 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 | 0 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 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, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Consolidated Statements of Operations and Comprehensive Loss [Abstract] | ||||||||||
Net sales | $ 1,252 | $ 1,363 | $ 4,144 | $ 3,499 | $ 4,998 | $ 3,553 | ||||
Costs and Expenses: | ||||||||||
Cost of goods sold | 540 | 915 | 1,987 | 2,686 | 3,670 | 2,763 | ||||
Selling, general and administrative | 4,107 | 3,713 | 12,098 | 11,489 | 15,311 | 10,170 | ||||
Research and development | 1,112 | 985 | 3,719 | 2,107 | 3,053 | 1,481 | ||||
Total costs and expenses | 5,759 | 5,613 | 17,804 | 16,282 | 22,034 | 18,365 | ||||
Loss from operations | (4,507) | (4,250) | (13,660) | (12,783) | (17,036) | (14,812) | ||||
Other income (loss), net | (1) | 10 | (1) | 10 | 10 | 1,436 | ||||
Loss before income taxes | (4,508) | (4,240) | (13,661) | (12,773) | (17,026) | (13,376) | ||||
Income tax expense | (1) | (1) | (5) | (3) | (6) | (6) | ||||
Net loss | $ (4,509) | $ (4,430) | $ (4,727) | $ (4,241) | $ (4,181) | $ (4,354) | $ (13,666) | $ (12,776) | $ (17,032) | $ (13,382) |
Basic and diluted loss per share (in dollars per share) | $ (1.70) | $ (8.50) | $ (9.49) | $ (34.59) | $ (42.14) | $ (525.01) | ||||
Weighted average shares outstanding - basic and diluted (in shares) | 2,646 | 499 | 1,915 | 369 | 404 | 48 | ||||
Other comprehensive loss: | ||||||||||
Foreign currency translation adjustments | $ 1 | $ (3) | $ (2) | $ (1) | $ (2) | $ 1 | $ (4) | $ (2) | $ (4) | $ (8) |
Total comprehensive loss | $ (4,508) | $ (4,242) | $ (13,670) | $ (12,778) | $ (17,036) | $ (13,390) |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) (Q3) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Other Comprehensive Income [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2016 | $ 0 | $ 169,496 | $ 1,235 | $ (168,974) | $ 1,757 |
Balance (in shares) at Dec. 31, 2016 | 2,801 | ||||
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 and stock awards, net | $ 0 | 499 | 0 | 0 | 499 |
Stock-based compensation and stock awards, net (in shares) | 17 | ||||
Issuance of common and preferred stock, net | $ 0 | 5,399 | 0 | 0 | 5,399 |
Issuance of common and preferred stock, net (in shares) | 42,017 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 226,522 | ||||
Balance at Dec. 31, 2017 | $ 0 | 197,367 | 1,227 | (182,356) | 16,238 |
Balance (in shares) at Dec. 31, 2017 | 271,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,354) | (4,354) |
Foreign currency translation adjustment | 0 | 0 | 1 | 0 | 1 |
Stock-based compensation and stock awards, net | $ 0 | 501 | 0 | 0 | 501 |
Stock-based compensation and stock awards, net (in shares) | 3 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 32,365 | ||||
Balance at Mar. 31, 2018 | $ 0 | 197,868 | 1,228 | (186,710) | 12,386 |
Balance (in shares) at Mar. 31, 2018 | 303,725 | ||||
Balance at Dec. 31, 2017 | $ 0 | 197,367 | 1,227 | (182,356) | 16,238 |
Balance (in shares) at Dec. 31, 2017 | 271,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (12,776) | ||||
Foreign currency translation adjustment | (2) | ||||
Balance at Sep. 30, 2018 | $ 0 | 203,560 | 1,225 | (195,132) | 9,653 |
Balance (in shares) at Sep. 30, 2018 | 505,315 | ||||
Balance at Dec. 31, 2017 | $ 0 | 197,367 | 1,227 | (182,356) | 16,238 |
Balance (in shares) at Dec. 31, 2017 | 271,357 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (17,032) | (17,032) |
Foreign currency translation adjustment | 0 | (4) | (4) | ||
Stock-based compensation and stock awards, net | $ 0 | 2,087 | 0 | 0 | 2,087 |
Stock-based compensation and stock awards, net (in shares) | 12 | ||||
Issuance of common and preferred stock, net | $ 0 | 4,647 | 0 | 0 | 4,647 |
Issuance of common and preferred stock, net (in shares) | 181,941 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 53,019 | ||||
Balance at Dec. 31, 2018 | $ 0 | 204,101 | 1,223 | (199,388) | 5,936 |
Balance (in shares) at Dec. 31, 2018 | 513,445 | ||||
Balance at Mar. 31, 2018 | $ 0 | 197,868 | 1,228 | (186,710) | 12,386 |
Balance (in shares) at Mar. 31, 2018 | 303,725 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,181) | (4,181) |
Foreign currency translation adjustment | 0 | 0 | (2) | 0 | (2) |
Stock-based compensation and stock awards, net | $ 0 | 606 | 0 | 0 | 606 |
Stock-based compensation and stock awards, net (in shares) | 3 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 18,127 | ||||
Balance at Jun. 30, 2018 | $ 0 | 198,474 | 1,226 | (190,891) | 8,809 |
Balance (in shares) at Jun. 30, 2018 | 321,855 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,241) | (4,241) |
Foreign currency translation adjustment | 0 | 0 | (1) | 0 | (1) |
Stock-based compensation and stock awards, net | $ 0 | 437 | 0 | 0 | 437 |
Stock-based compensation and stock awards, net (in shares) | 3 | ||||
Issuance of common and preferred stock, net | $ 0 | 4,649 | 0 | 0 | 4,649 |
Issuance of common and preferred stock, net (in shares) | 181,941 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 1,516 | ||||
Balance at Sep. 30, 2018 | $ 0 | 203,560 | 1,225 | (195,132) | 9,653 |
Balance (in shares) at Sep. 30, 2018 | 505,315 | ||||
Balance at Dec. 31, 2018 | $ 0 | 204,101 | 1,223 | (199,388) | 5,936 |
Balance (in shares) at Dec. 31, 2018 | 513,445 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,727) | (4,727) |
Foreign currency translation adjustment | 0 | 0 | (2) | 0 | (2) |
Stock-based compensation and stock awards, net | $ 0 | 362 | 0 | 0 | 362 |
Stock-based compensation and stock awards, net (in shares) | 3 | ||||
Issuance of common and preferred stock, net | $ 0 | 10,959 | 0 | 0 | 10,959 |
Issuance of common and preferred stock, net (in shares) | 455,178 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 1,100,394 | ||||
Balance at Mar. 31, 2019 | $ 0 | 215,422 | 1,221 | (204,115) | 12,528 |
Balance (in shares) at Mar. 31, 2019 | 2,069,020 | ||||
Balance at Dec. 31, 2018 | $ 0 | 204,101 | 1,223 | (199,388) | 5,936 |
Balance (in shares) at Dec. 31, 2018 | 513,445 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (13,666) | ||||
Foreign currency translation adjustment | (4) | ||||
Balance at Sep. 30, 2019 | $ 0 | 216,173 | 1,219 | (213,054) | 4,338 |
Balance (in shares) at Sep. 30, 2019 | 2,879,162 | ||||
Balance at Mar. 31, 2019 | $ 0 | 215,422 | 1,221 | (204,115) | 12,528 |
Balance (in shares) at Mar. 31, 2019 | 2,069,020 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,430) | (4,430) |
Foreign currency translation adjustment | 0 | 0 | (3) | 0 | (3) |
Stock-based compensation and stock awards, net | $ 0 | 339 | 0 | 0 | 339 |
Stock-based compensation and stock awards, net (in shares) | 0 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 259,300 | ||||
Balance at Jun. 30, 2019 | $ 0 | 215,761 | 1,218 | (208,545) | 8,434 |
Balance (in shares) at Jun. 30, 2019 | 2,328,320 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ 0 | 0 | 0 | (4,509) | (4,509) |
Foreign currency translation adjustment | 0 | 0 | 1 | 0 | 1 |
Stock-based compensation and stock awards, net | $ 0 | 412 | 0 | 0 | 412 |
Stock-based compensation and stock awards, net (in shares) | 0 | ||||
Conversion of preferred stock into common stock | $ 0 | 0 | 0 | 0 | 0 |
Conversion of preferred stock into common stock (in shares) | 550,842 | ||||
Balance at Sep. 30, 2019 | $ 0 | $ 216,173 | $ 1,219 | $ (213,054) | $ 4,338 |
Balance (in shares) at Sep. 30, 2019 | 2,879,162 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) (Q3) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating Activities: | ||
Net loss | $ (13,666) | $ (12,776) |
Adjustments to reconcile net loss to cash flows used in operating activities: | ||
Depreciation and amortization | 179 | 174 |
Stock-based compensation expense, net | 1,113 | 1,544 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 258 | (242) |
Inventory | (158) | (360) |
Other current assets | (74) | (104) |
Other assets and liabilities | (27) | 0 |
Accounts payable and accrued expenses | 38 | (79) |
Net cash used in operating activities | (12,337) | (11,843) |
Investing activities: | ||
Purchases of property, plant and equipment | (464) | (177) |
Net cash used in investing activities | (464) | (177) |
Financing activities: | ||
Net proceeds from public stock offering, net | 10,959 | 4,649 |
Net cash provided by financing activities | 10,959 | 4,649 |
Effect of exchange rate changes on cash | (4) | (2) |
Net decrease in cash and cash equivalents | (1,846) | (7,373) |
Cash and cash equivalents - beginning of period | 5,480 | 15,595 |
Cash and cash equivalents - end of period | 3,634 | 8,222 |
Supplemental schedule of non-cash activities: | ||
Inventory transferred to property, plant and equipment | $ 204 | $ 0 |
Nature of Business and Signific
Nature of Business and Significant Accounting Policies (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Nature of Business and Basis of Presentation, Significant Accounting Policies [Abstract] | ||
Nature of Business and Significant Accounting Policies | Note 1 – Nature of Business and Basis of Presentation Nature of Business : submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more Previously, the Company was focused on developing the C-Pulse® Heart Assist System for treatment of Class III and ambulatory Class IV heart failure. In August 2016, the Company acquired the business associated with the Aquadex FlexFlow system (herein referred to as the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”), and refocused its strategy to fully devote its resources to the Aquadex Business. In December 2018, the Company’s stockholders approved a reverse split of its outstanding common stock at a ratio in the range of 1-for-2 to 1-for 14 and, in January 2019, the board of directors approved a 1-for-14 reverse split of the Company’s outstanding common stock that became effective after trading on January 2, 2019. This reverse stock split did not change the par value of the Company’s common stock or the number of common or preferred shares authorized by the Company’s Fourth Amended and Restated Certificate of Incorporation. All share and per-share amounts have been retroactively adjusted to reflect the reverse stock split 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, 2018. Going Concern: The Company became a revenue generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex FlexFlow. This will require the Company to succeed in training personnel at hospitals and effectively and 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, November 27, 2017, July 3, 2018, March 12, 2019, October 25, 2019 and November 6, 2019, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $41.4 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (see Note 4 –Equity and Note 10-Subsequent Events). The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. Revenue Recognition: Revenue from Contracts with Customers Accounts Receivable Inventories ( in thousands) September30, 2019 December 31, 2018 Finished Goods $ 468 $ 517 Work in Process 185 34 Raw Materials 959 1,107 Total $ 1,612 $ 1,658 Contingent consideration Loss per share: Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented: September 30 2019 2018 Warrants to purchase common stock 5,430,721 608,787 Series F convertible preferred stock 102,185 19,210 Stock options 332,722 139,439 Restricted stock units - - 3 Total 5,865,628 767,439 The following table reconciles reported net loss with reported net loss per share for the periods ended September 30, 2019: (in thousands, except per share amounts) Three months Nine months Net loss $ (4,509 ) $ (13,666 ) Deemed dividend to preferred shareholders (see Note 4) — (4,509 ) Net loss after deemed dividend (4,509 ) (18,175 ) Weighted average shares outstanding 2,646 1,915 Basic and diluted loss per share $ (1.70 ) $ (9.49 ) New Accounting Pronouncements: In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard which allowed it to carry forward the historical lease classification. In August 2018, the FASB issued updated guidance to improve and simplify the disclosure requirements on fair value measurements for level 3 assets and liabilities valued at fair value. The Company early-adopted the guidance effective in its second quarter and the effect on the consolidated financial statements was not material. | 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. 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”). In September 2016, the Company announced a strategic refocus of its strategy that included halting all clinical evaluations of its C-Pulse related technology to fully focus all of 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. In December 2018, the Company’s stockholders approved a reverse split of its outstanding common stock at a ratio in the range of 1-for-2 to 1-for-14 and, in January 2019, the board of directors approved a 1-for-14 reverse split of the Company’s outstanding common stock that became effective after trading on January 2, 2019. In addition, during 2017, the Company’s stockholders and board of directors approved two reverse stock splits. 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. These reverse stock splits did not change the par value of the Company’s common stock or the number of common or preferred shares authorized by the Company’s Fourth Amended and Restated Certificate of Incorporation. 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, 2018 and 2017, 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, 2018, the Company had an accumulated deficit of $199.4 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 system. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing and distributing the Aquadex FlexFlow system and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. On April 24, 2017, November 27, 2017, and on July 3, 2018, Shareholder’s 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. Basis of Presentation The accompanying consolidated financial statements include the accounts of CHF Solutions, Inc. and its wholly-owned subsidiaries, CHF Solutions, LLC, Sunshine Heart Company Pty Limited, and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximate fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. Accounts Receivable Accounts receivable are unsecured, 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, 2018 or 2017. Inventories Inventories are recorded at the lower of cost or net realizable value using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2018 2017 Finished Goods $ 517 $ 902 Work in Process 34 217 Raw Materials 1,107 469 Total $ 1,658 $ 1,588 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 3-5 years Computer software and equipment 3-4 years Laboratory and research equipment 3-5 years Production equipment 3-7 years Leasehold improvements and capital lease asset 3-5 years Depreciation expense was $232,000 and $229,000 for the years ended December 31, 2018, and 2017, 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 periodically reviews its property and equipment for potential impairment and determines if the fair value of property and equipment equals or exceeds its carrying value. There have been no impairment losses recognized for the years ended December 31, 2018 or 2017. 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 reviewed its definite lived intangible assets for impairment when impairment indicators existed. When impairment indicators existed, the Company determined if the carrying value of the intangible assets exceeded the related undiscounted cash flows. In cases where the carrying value exceeded the undiscounted cash flows, and the carrying amount was not considered recoverable, the carrying value was written down to its fair value, generally using a discounted cash flow analysis. An impairment loss was recognized for the amount that the intangible assets exceeded 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 definite lived intangible assets. The Company had 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 included assumptions related to the Company’s product revenues, 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 reflected these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. Amortization expense was $0 and $540,000 for the years ended December 31, 2018 and 2017, respectively. Goodwill Goodwill was the cost paid for the Aquadex Business in excess of the fair value of acquired assets and liabilities, and was recorded as an asset on the balance sheet. Goodwill was not subject to amortization but was to be tested for impairment at least annually. This test required the Company to determine if the implied fair value of the goodwill was less than its carrying amount. The Company evaluated its recorded goodwill for impairment annually on November 1 st Simplifying the Test for Goodwill Impairment The Company had 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 included assumptions related to the Company’s product revenues, 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 reflected 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 in August 2016, the Company has an obligation to pay additional consideration that is contingent upon the occurrence of certain future events (see Note 10- Commitments and Contingencies). 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. As of December 31, 2018, the contingent consideration was recorded in current liabilities in the accompanying balance sheet to reflect its maturity during 2019. 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 was remeasured to its estimated fair value at the end of each reporting period with changes recorded to earnings. Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recognized to cumulative translation adjustment, a component of accumulated other comprehensive income other expense, net Stock-Based Compensation The Company recognizes all share-based payments to employees and directors, including grants of stock options, restricted stock units (RSUs) and common stock awards in the consolidated statements of operations and other comprehensive loss 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 or warrants to purchase shares of the Company’s common stock. These RSUs or warrants are either fully-vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. 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. The Tax Reform Act was enacted December 22, 2017. The new legislation made significant changes to U.S. tax law including 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 reduced the U.S corporate income tax rates from 34% to 21%. As a result of the enacted law, the Company was required to revalue its deferred tax assets and liabilities at the new enacted rate. There was no income tax impact from the re-measurement 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 allocable to common stockholders 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 for the year ended December 31, 2017, 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. (See Note 6). There were no deemed dividends during 2018. Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 31, 2018 2017 Stock options 140,546 2,766 Restricted stock units 3 15 Warrants to purchase common stock 599,293 608,787 Series F convertible preferred stock 18,190 60,480 Total 758,032 672,048 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) 2018 2017 Net loss $ (17,032 ) $ (13,382 ) Deemed dividend to preferred shareholders (see Note 6) — (11,590 ) Net loss after deemed dividend (17,032 ) (24,972 ) Weighted average shares outstanding 404 48 Basic and diluted loss per share $ (42.14 ) $ (525.01 ) 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. Recent Accounting Pronouncements In May 2014, August 2015, March 2016, April 2016 and May 2016, the Financial Accounting Standards Board (“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. 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 was 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 during the year ended December 31, 2017, and recognized a $0.2 million impairment loss related to its goodwill. 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 has nearly completed evaluating the impact that the adoption of this standard will have on its consolidated financial statements. The Company additional qualitative and quantitative disclosures as required. The Company expects to use the effective date of this standard as the date of initial application, with no retrospective adjustments to prior comparative periods. 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 (FY)
Revenue Recognition (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Revenue Recognition [Abstract] | ||
Revenue Recognition | Note 2 – Revenue Recognition Net Sales The Company sells its products in the United States primarily through a direct sales force. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in the United Kingdom, Italy, Spain, Germany, Southeast Asia, Brazil, India and Greece. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. Revenue from product sales are recognized when the customer or distributor obtains control of the product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point, unless the customer requests that control and title to the inventory transfer upon delivery. Revenue includes shipment and handling fees charged to customers. Revenue is measured as the amount of consideration we expect to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when we satisfy our performance obligations under the contract. The majority of our contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers which are recognized over time. This revenue represents less than 1% of net sales for the three and nine months ended September 30, 2019 and 2018. The unfulfilled performance obligations related to these extended service plans is included in deferred revenue, which is included in other current liabilities on the condensed consolidated balance sheet. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns: believes that future returns of its products will be minimal. | 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, Southeast Asia, Brazil and India. 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 represented less than 1% of net sales during each of the years ended December 31, 2018 and 2017. The unfulfilled performance obligations related to these extended service plans is included in deferred revenue in the amount of $43,000 and $38,000 as of December 31, 2018 and 2017, respectively. Deferred revenue is included in other current liabilities on the consolidated balance sheets. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns: believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns. |
Property, Plant and Equipment (
Property, Plant and Equipment (FY) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 December 31, 2017 Office Furniture & Fixtures $ 291 $ 287 Leasehold Improvements 224 224 Software 142 129 Production Equipment 991 926 Computer Equipment 357 277 Capital Lease Asset 309 307 Total 2,314 2,150 Accumulated Depreciation (1,778 ) (1,580 ) $ 536 $ 570 |
Intangible Assets (FY)
Intangible Assets (FY) | 12 Months Ended |
Dec. 31, 2018 | |
Intangible Assets [Abstract] | |
Intangible Assets | Note 4—Intangible Assets 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 definite-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 included assumptions related to the Company’s product revenues, 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 reflected 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, 2019 | Dec. 31, 2018 | |
Debt [Abstract] | ||
Debt | Note 3 - Debt On August 5, 2016, the Company entered into a loan and security agreement with Silicon Valley Bank (the Bank). Under this agreement, the Bank agreed to provide the Company with up to $5.0 million in debt financing, consisting of a term loan in an aggregate original principal amount not to exceed $4.0 million (the “Term Loan”) and a revolving line of credit in an aggregate principal amount not to exceed $1.0 million outstanding at any time (the “Revolving Line”). Proceeds from the loans were to be used for general corporate and working capital purposes. Advances under the Term Loan were available to the Company until November 30, 2016 and were subject to the Company’s compliance with liquidity covenants. The Term Loan expired unused on November 30, 2016 and the Term Loan is no longer available to be drawn. Advances under the Revolving Line are available to the Company until March 31, 2020 and accrue interest at a floating annual rate equal to 1.75% or 1.0% above the prime rate, depending on liquidity factors. Outstanding borrowings, if any, are collateralized by all of the Company’s assets, excluding intellectual property which is subject to a negative pledge. There were no borrowings outstanding under this facility as of September 30, 2019 or December 31, 2018. | Note 5—Debt On August 5, 2016, the Company entered into a loan and security agreement with Silicon Valley Bank (the Bank). Under the agreement, the Bank agreed to provide the Company with up to $5.0 million in debt financing, consisting of a term loan in an aggregate original principal amount not to exceed $4.0 million (the “Term Loan”) and a revolving line of credit in an aggregate principal amount not to exceed $1.0 million outstanding at any time (the “Revolving Line”; together with the Term Loan, the “Loans”). Proceeds from the Loans were to be used for general corporate and working capital purposes. The Term Loan expired unused on November 30, 2016. Advances under the Revolving Line, if any, are available to the Company until March 31, 2020 and accrue interest at a floating annual rate equal to 1.75% or 1.0% above the prime rate, depending on liquidity factors. Outstanding borrowings, if any, are collateralized by all of the Company’s assets, excluding intellectual property which is subject to a negative pledge. There were no borrowings outstanding under this facility as of December 31, 2018 or 2017. Warrants: |
Shareholder's Equity (FY)
Shareholder's Equity (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Equity [Abstract] | ||
Shareholder's Equity | Note 4 - Equity Series F Convertible Preferred Stock The offering was comprised of Series F convertible preferred stock, convertible into shares of the Company’s common stock at an initial conversion price of $63.00 per share. Each share of Series F preferred stock was accompanied by a Series 1 warrant, which was to expire on the first anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share. The Series F preferred stock and the warrants were immediately separable and were issued separately. The conversion price of the Series F preferred stock will be adjusted in the event of a stock split, combination, reclassification or stock dividend or if the Company consummates a fundamental transaction. The Series F preferred stock also has full ratchet price based anti-dilution protection, subject to customary carve outs, in the event of a down-round financing at a price per share below the conversion price of the Series F preferred stock (which protection will expire if, during any 20 of 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 300% of the then-effective conversion price of the Series F preferred stock and the daily dollar trading volume for each trading day during such period exceeds $200,000). The exercise price of the warrants is fixed and does not contain any variable pricing features, nor any price based anti-dilutive features, apart from customary adjustments for stock splits, combinations, reclassifications, stock dividends or fundamental transactions. A total of 18,000 shares of Series F Convertible Preferred Stock initially convertible into 286,714 shares of common stock and warrants to purchase 573,310 shares of common stock were issued in the offering. As noted below, effective July 3, 2018, the conversion price of the Series F convertible preferred stock was reduced from $63.00 to $29.68, the per share price in the July 2018 Offering described below. Effective March 12, 2019, the conversion price of the Series F convertible preferred stock was reduced again from $29.68 to $5.25, the per share price to the public of the Series G convertible preferred stock which closed in an underwritten public offering on March 12, 2019, and each share of the remaining Series F convertible preferred stock is convertible into 191 shares of the Company’s common stock. As of both September 30, 2019, and December 31, 2018, 535 shares of the Series F convertible preferred stock remained outstanding. July 2018 Offering: On July 3, 2018, the Company closed on an underwritten public offering of 181,941 shares of its common stock at a public offering price of $29.68 per share, for gross proceeds of $5.4 million, including the full exercise of the underwriters’ over-allotment option to purchase additional shares of the Company’s common stock (the “July 2018 Offering”). deducting underwriting discounts and commissions and offering expenses. 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. Pursuant to the terms of these agreements, the Company agreed, effective July 3, 2018, to reduce the per share exercise price of the November 2017 Warrants held by such institutional investors to $29.68 and to extend the expiration date of the warrants that were to expire on November 27, 2018 to November 27, 2019. The number of common shares underlying the warrants that were repriced did not change. The repriced warrants are exercisable for 554,322 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 $63.00 to $29.68, the per share price in the July 2018 Offering. Series G Convertible Preferred Stock and March 2019 Offering The March 2019 Offering was comprised of 455,178 shares of common stock priced at $5.25 per share and 1,910,536 shares of Series G convertible preferred stock, convertible into common stock at $5.25 per share. Each share of Series G convertible preferred stock and each share of common stock was accompanied by a Series 1 warrant and a Series 2 warrant. The Series 1 warrants are exercisable into 2,365,714 shares of common stock and the Series 2 warrants are exercisable into 2,365,714 shares of common stock. Series 1 warrants expire on the fifth anniversary of the date of issuance and are exercisable at $5.25 to purchase one share of common stock. Series 2 warrants expire on the earlier of: (i) the eighteen-month anniversary of the date of issuance and (ii) the 30th trading day following the public announcement of the receipt from the U.S. Food and Drug Administration of clearance or approval of a modification to the product label for the Aquadex FlexFlow system to include pediatric patients. Series 2 warrants are exercisable at $5.25 per share of common stock. As of September 30, 2019, all 1,910,536 shares of the Series G convertible preferred stock had been converted into common stock and none remained outstanding. As noted above, the Company’s outstanding Series F convertible 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 convertible preferred stock. As a result of the March 2019 Offering, the conversion price of the Series F convertible preferred stock was reduced from $29.68, to $5.25, the per share price of the Series G convertible preferred stock. Placement Agent Fees Market-Based Warrants | Note 6—Shareholder’s 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 year ended December 31, 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 an initial conversion price of $63.00 per share. Each share of Series F preferred stock was accompanied by a Series 1 warrant, which was to expire on the first anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share. The Series F preferred stock and the warrants were immediately separable and were issued separately . . As noted below, effective July 3, 2018, the conversion price of the Series F preferred stock was reduced from $63.00 to $29.68, the per share price to public in the July 2018 Offering described below, and now each share of the remaining Series F preferred stock is convertible into 34 shares of the Company’s common stock. As of December 31, 2018, and 2017, 17,465 and 14,220 shares of the Series F Convertible Preferred Stock had been converted into an aggregate of 279,526 and 226,504 shares of common stock and 535 and 3,780 remained outstanding, respectively. 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. Pursuant to the terms of these agreements, the Company agreed, effective July 3, 2018, to reduce the per share exercise price of the November 2017 Warrants held by such institutional investors to $29.68 and to extend the expiration date of the warrants that were to expire on November 27, 2018 to November 27, 2019. The number of common shares underlying the warrants that were repriced did not change. The repriced warrants are exercisable for 554,322 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 $63.00 to $29.68, 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 2,522 shares of common stock at an exercise price of $1,512 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 141 shares of common stock at an exercise price of $1,512 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, 2018, and 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, 2019 | Dec. 31, 2018 | |
Stock-Based Compensation [Abstract] | ||
Stock-Based Compensation | Note 5 - Stock-Based Compensation Under the fair value recognition provisions of U.S. GAAP for accounting for stock-based compensation, the Company measures stock-based compensation expense at the grant date based on the fair value of the award and recognizes the compensation expense over the requisite service period, which is generally the vesting period. The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended September 30, Nine months ended September 30, (in thousands) 2019 2018 2019 2018 Selling, general and administrative expense $ 383 $ 440 $ 1,018 $ 1,446 Research and development expense 29 (3 ) 95 98 Total stock-based compensation expense $ 412 $ 437 $ 1,113 $ 1,544 | 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 Company recognized stock-based compensation expense related to grants of stock options, RSUs and common stock awards to employees, directors and consultants of $2.1 million, and $0.5 million during the years ended December 31, 2018 and 2017, 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) 2018 2017 Selling, general and administrative $ 1,958 $ 452 Research and development 129 50 Total $ 2,087 $ 502 The majority of the RSUs and options to purchase common stock vest on the anniversary of the date of grant, which ranges from one to four years. Stock-based compensation expense related to these awards is recognized on a straight-line basis over the related vesting term in most cases, which generally is the service period. It is the Company’s policy to issue new shares upon the exercise of options. Stock Options 2018 2017 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 2,562 $ 1,049.93 272 $ 31,021.57 Granted 163,997 45.76 2,461 167.30 Exercised — — — — Forfeited/expired (26,013 ) 61.01 (171 ) 36,429.90 Outstanding at December 31 140,546 $ 61.25 2,562 $ 1,049.93 Vested at December 31 16,206 $ 169.07 148 $ 11,338.37 For options outstanding and vested at December 31, 2018, the weighted average remaining contractual life was 9.12 years and 9.07 years, respectively. There were no option exercises in 2018 or 2017. The total fair value of options that vested in 2018 and 2017 was $0.9 million, and $0.7 million, respectively, at the fair value of the options as of the date of grant. Valuation Assumptions The Company has not historically paid cash dividends to its stockholders, and currently does not anticipate paying any cash dividends in the foreseeable future. As a result, the Company has assumed a dividend yield of 0%. The risk-free interest rate is based upon the rates of U.S. Treasury bills with a term that approximates the expected life of the option. Since the Company has limited historical exercise data to reasonably estimate the expected life of its option awards, the expected life is calculated using a simplified method. Expected volatility is based on historical volatility of the Company’s stock. The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2018 2017 Expected dividend yield 0 % 0 % Risk-free interest rate 2.49 % 1.97 % Expected volatility 120.54 % 103 % Expected life (in years) 6.23 6.25 The weighted-average fair value of stock options granted in 2018 and 2017 was $41.04 and $167.3, respectively. As of December 31, 2018, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $3.9 and is expected to be recognized over the remaining weighted-average period of 3.1 years. Restricted Stock Awards 2018 2017 RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price Nonvested, beginning balance 15 $ 7,297.22 33 $ 9,052.37 Granted — — 11 1,514.80 Vested (12 ) 7,297.22 (29 ) 1,854.56 Forfeited — — - - Nonvested at December 31 3 $ 7,297.22 15 $ 7,297.22 Warrants Warrants to purchase 599,293, and 608,764 shares of common stock were outstanding at December 31, 2018 and 2017, respectively. As of December 31, 2018, warrants outstanding were exercisable at prices ranging from $29.68 to $43,848 per share, and are exercisable over a period ranging from eleven months to 6.5 years. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value of Financial Instruments [Abstract] | ||
Fair Value of Financial Instruments | Note 6 - Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, warrants, and contingent consideration. Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” • Level 1 • Level 2 • Level 3 The fair value of the Company's contingent consideration, as described in Note 1, was initially measured based on the consideration expected to be transferred (probability-weighted), discounted back to present value, and it was considered a Level 3 instrument. The discount rate used was determined at the time of measurement in accordance with accepted valuation methods. The Company measured the liability on a recurring basis using Level 3 inputs including probabilities of payment and projected payment dates. As of September 30, 2019, this contingency had expired, therefore its fair value was recorded at $0. The following is a rollforward of the fair value of Level 3 items: (in thousands) Balance December 31, 2018 $ 126 Change in fair value (126 ) Balance as of September 30, 2019 $ - The fair value of the market-based warrants described in Note 4 was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy. These warrants are classified as permanent equity and as a result, were measured at the grant date and are not required to be remeasured to fair value at each reporting period end. All cash equivalents are considered Level 1 measurements for all periods presented. The Company does not have any financial instruments classified as Level 2 or any other classified as Level 3 and there were no movements between these categories during the periods ended September 30, 2019 and December 31, 2018. The Company believes that the carrying amounts of all remaining financial instruments approximate their fair value due to their relatively short maturities. | 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 was classified as Level 3 in the fair value hierarchy. The following is a rollforward of the fair value of Level 3 warrants: (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Balance as of December 31, 2017 $ - 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, 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, 2018 and 2017. The Company believes that the carrying amounts of all remaining financial instruments approximate their fair value due to their relatively short maturities. |
Income Taxes (FY)
Income Taxes (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Income Taxes [Abstract] | ||
Income Taxes | Note 8 – 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 condensed consolidated financial statements. As of September 30, 2019, 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, 2018. | Note 9—Income Taxes Domestic and foreign loss before income taxes, consists of the following for the years ended December 31: (in thousands) 2018 2017 Domestic $ (17,027 ) $ (13,367 ) Foreign 1 (9 ) Loss before income taxes $ (17,026 ) $ (13,376 ) The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2018 2017 Current: United States and state $ — $ — Foreign, net (6 ) (6 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (6 ) $ (6 ) Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2018 2017 Statutory federal income tax benefit $ 3,578 $ 4,548 State tax benefit, net of federal taxes 45 48 Foreign tax (2 ) - Foreign deferred exchange rate adjustments (1,112 ) 899 Nondeductible/nontaxable items (259 ) (114 ) New federal rate adjustment — (16,081 ) Other (72 ) (1,085 ) Valuation allowance decrease (increase) (2,184 ) 11,779 Total income tax benefit expense $ (6 ) $ (6 ) Deferred taxes consist of the following as of December 31: (in thousands) 2018 2017 Deferred tax assets: Noncurrent: Accrued leave $ 50 $ 32 Other accrued expenses — 28 Stock based compensation 483 336 Net operating loss carryforward 41,032 38,947 Other 125 115 Intangibles 847 895 R&D credit carryforward 531 531 Total deferred tax assets 43,068 40,884 Less: valuation allowance (43,068 ) (40,884 ) Total $ — $ — As of December 31, 2017, the Company had federal net operating loss (“NOLs”) The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of the deferred tax assets. The Company has established a valuation allowance for U.S. and foreign deferred tax assets due to the uncertainty that enough taxable income will be generated in those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any benefit of such deferred tax assets in the accompanying consolidated financial statements. During 2017 and 2018, the Company believes it experienced an ownership change as defined in Section 382 of the Internal Revenue Code which will limit the ability to utilize the Company’s net operating losses (NOLs). The Company may have experienced additional ownership changes in earlier years further limiting the NOL carry-forwards that may be utilized. The Company has not yet completed a formal Section 382 analysis. The general limitation rules allow the Company to utilize its NOLs subject to an annual limitation that is determined by multiplying the federal long-term tax-exempt rate by the Company’s value immediately before the ownership change. The accounting guidance related to uncertain tax positions prescribes a recognition threshold and measurement attribute for recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company had no material uncertain tax positions as of December 31, 2018 or 2017. 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, 2018 and 2017, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2015 through December 31, 2018 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, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies [Abstract] | ||
Commitments and Contingencies | Note 9—Commitments and Contingencies Employee Retirement Plan: Contingent Consideration: In addition, it also agreed that if shares of its common stock cease to be publicly traded on the Nasdaq Capital Market, 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. | Note 10—Commitments and Contingencies Leases The Company leases office space under a non-cancelable operating lease that expires in March 2022. In August 2018, the Company entered into a Third Amendment to the lease, extending the term of the lease from March 31, 2019 to March 31, 2022. Beginning on April 1, 2019, the annual base rent shall be $9.00 per square foot, subject to annual increases of $0.25 per square foot. 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 September 2020. Rent expense related to operating leases was approximately $ 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 $197,000 and $138,000 for the years ended December 31, 2018 and 2017, respectively. Contingent Consideration 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 of the purchase of the Aquadex Business, 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, 2018 | |
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, 2018, long-lived assets were located primarily in the United States. |
Subsequent Event (FY)
Subsequent Event (FY) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Subsequent Events [Abstract] | ||
Subsequent Event | Note 10 – Subsequent Events On October 25, 2019, the Company closed on a registered direct offering of 575,830 shares of its common stock at a price of $1.15 per share, for gross proceeds of approximately $660,000, prior to deducting commissions and expenses related to the transaction. Additionally, 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 this offering, effective October 25, 2019, the conversion price of the Series F preferred stock was reduced from $5.25 to $1.15 per share, On November 6, 2019, the Company closed on a registered direct offering of 1,219,076 shares of its common stock, or common equivalents, at a price of $1.12 per share, for gross proceeds of approximately $1.36 million prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 1,219,076 shares of the Company’s common stock at an exercise price of $0.9942 per share, which will be exercisable upon the date of issuance, and will expire five years from the initial exercise date. Effective November 6, 2019, the conversion price of the Series F preferred stock was reduced from $1.15 to $0.9942, the exercise price of the warrants issued in connection with this financing. | Note 12 – Subsequent Event The Company filed an S-1 on December 31, 2018, which was amended January 22, 2019, to raise additional capital. Changing circumstances may cause the Company to consume capital significantly faster than it currently anticipates and could adversely affect the Company’s ability to raise additional capital. Additional financing may not be available when the Company needs it or may not be available on favorable terms. |
Nature of Business and Basis of
Nature of Business and Basis of Presentation (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Nature of Business and Basis of Presentation, Significant Accounting Policies [Abstract] | ||
Nature of Business and Basis of Presentation | Note 1 – Nature of Business and Basis of Presentation Nature of Business : submitted an application to the FDA requesting for 510(k) clearance of the Aquadex FlexFlow system to include pediatric patients who weigh 20kg or more Previously, the Company was focused on developing the C-Pulse® Heart Assist System for treatment of Class III and ambulatory Class IV heart failure. In August 2016, the Company acquired the business associated with the Aquadex FlexFlow system (herein referred to as the “Aquadex Business”) from a subsidiary of Baxter International, Inc. (“Baxter”), and refocused its strategy to fully devote its resources to the Aquadex Business. In December 2018, the Company’s stockholders approved a reverse split of its outstanding common stock at a ratio in the range of 1-for-2 to 1-for 14 and, in January 2019, the board of directors approved a 1-for-14 reverse split of the Company’s outstanding common stock that became effective after trading on January 2, 2019. This reverse stock split did not change the par value of the Company’s common stock or the number of common or preferred shares authorized by the Company’s Fourth Amended and Restated Certificate of Incorporation. All share and per-share amounts have been retroactively adjusted to reflect the reverse stock split 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, 2018. Going Concern: The Company became a revenue generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex FlexFlow. This will require the Company to succeed in training personnel at hospitals and effectively and 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, November 27, 2017, July 3, 2018, March 12, 2019, October 25, 2019 and November 6, 2019, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $41.4 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (see Note 4 –Equity and Note 10-Subsequent Events). The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. Revenue Recognition: Revenue from Contracts with Customers Accounts Receivable Inventories ( in thousands) September30, 2019 December 31, 2018 Finished Goods $ 468 $ 517 Work in Process 185 34 Raw Materials 959 1,107 Total $ 1,612 $ 1,658 Contingent consideration Loss per share: Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented: September 30 2019 2018 Warrants to purchase common stock 5,430,721 608,787 Series F convertible preferred stock 102,185 19,210 Stock options 332,722 139,439 Restricted stock units - - 3 Total 5,865,628 767,439 The following table reconciles reported net loss with reported net loss per share for the periods ended September 30, 2019: (in thousands, except per share amounts) Three months Nine months Net loss $ (4,509 ) $ (13,666 ) Deemed dividend to preferred shareholders (see Note 4) — (4,509 ) Net loss after deemed dividend (4,509 ) (18,175 ) Weighted average shares outstanding 2,646 1,915 Basic and diluted loss per share $ (1.70 ) $ (9.49 ) New Accounting Pronouncements: In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard which allowed it to carry forward the historical lease classification. In August 2018, the FASB issued updated guidance to improve and simplify the disclosure requirements on fair value measurements for level 3 assets and liabilities valued at fair value. The Company early-adopted the guidance effective in its second quarter and the effect on the consolidated financial statements was not material. | 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. 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”). In September 2016, the Company announced a strategic refocus of its strategy that included halting all clinical evaluations of its C-Pulse related technology to fully focus all of 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. In December 2018, the Company’s stockholders approved a reverse split of its outstanding common stock at a ratio in the range of 1-for-2 to 1-for-14 and, in January 2019, the board of directors approved a 1-for-14 reverse split of the Company’s outstanding common stock that became effective after trading on January 2, 2019. In addition, during 2017, the Company’s stockholders and board of directors approved two reverse stock splits. 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. These reverse stock splits did not change the par value of the Company’s common stock or the number of common or preferred shares authorized by the Company’s Fourth Amended and Restated Certificate of Incorporation. 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, 2018 and 2017, 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, 2018, the Company had an accumulated deficit of $199.4 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 system. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing and distributing the Aquadex FlexFlow system and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. On April 24, 2017, November 27, 2017, and on July 3, 2018, Shareholder’s 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. Basis of Presentation The accompanying consolidated financial statements include the accounts of CHF Solutions, Inc. and its wholly-owned subsidiaries, CHF Solutions, LLC, Sunshine Heart Company Pty Limited, and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximate fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. Accounts Receivable Accounts receivable are unsecured, 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, 2018 or 2017. Inventories Inventories are recorded at the lower of cost or net realizable value using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2018 2017 Finished Goods $ 517 $ 902 Work in Process 34 217 Raw Materials 1,107 469 Total $ 1,658 $ 1,588 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 3-5 years Computer software and equipment 3-4 years Laboratory and research equipment 3-5 years Production equipment 3-7 years Leasehold improvements and capital lease asset 3-5 years Depreciation expense was $232,000 and $229,000 for the years ended December 31, 2018, and 2017, 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 periodically reviews its property and equipment for potential impairment and determines if the fair value of property and equipment equals or exceeds its carrying value. There have been no impairment losses recognized for the years ended December 31, 2018 or 2017. 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 reviewed its definite lived intangible assets for impairment when impairment indicators existed. When impairment indicators existed, the Company determined if the carrying value of the intangible assets exceeded the related undiscounted cash flows. In cases where the carrying value exceeded the undiscounted cash flows, and the carrying amount was not considered recoverable, the carrying value was written down to its fair value, generally using a discounted cash flow analysis. An impairment loss was recognized for the amount that the intangible assets exceeded 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 definite lived intangible assets. The Company had 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 included assumptions related to the Company’s product revenues, 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 reflected these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. Amortization expense was $0 and $540,000 for the years ended December 31, 2018 and 2017, respectively. Goodwill Goodwill was the cost paid for the Aquadex Business in excess of the fair value of acquired assets and liabilities, and was recorded as an asset on the balance sheet. Goodwill was not subject to amortization but was to be tested for impairment at least annually. This test required the Company to determine if the implied fair value of the goodwill was less than its carrying amount. The Company evaluated its recorded goodwill for impairment annually on November 1 st Simplifying the Test for Goodwill Impairment The Company had 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 included assumptions related to the Company’s product revenues, 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 reflected 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 in August 2016, the Company has an obligation to pay additional consideration that is contingent upon the occurrence of certain future events (see Note 10- Commitments and Contingencies). 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. As of December 31, 2018, the contingent consideration was recorded in current liabilities in the accompanying balance sheet to reflect its maturity during 2019. 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 was remeasured to its estimated fair value at the end of each reporting period with changes recorded to earnings. Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recognized to cumulative translation adjustment, a component of accumulated other comprehensive income other expense, net Stock-Based Compensation The Company recognizes all share-based payments to employees and directors, including grants of stock options, restricted stock units (RSUs) and common stock awards in the consolidated statements of operations and other comprehensive loss 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 or warrants to purchase shares of the Company’s common stock. These RSUs or warrants are either fully-vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. 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. The Tax Reform Act was enacted December 22, 2017. The new legislation made significant changes to U.S. tax law including 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 reduced the U.S corporate income tax rates from 34% to 21%. As a result of the enacted law, the Company was required to revalue its deferred tax assets and liabilities at the new enacted rate. There was no income tax impact from the re-measurement 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 allocable to common stockholders 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 for the year ended December 31, 2017, 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. (See Note 6). There were no deemed dividends during 2018. Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 31, 2018 2017 Stock options 140,546 2,766 Restricted stock units 3 15 Warrants to purchase common stock 599,293 608,787 Series F convertible preferred stock 18,190 60,480 Total 758,032 672,048 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) 2018 2017 Net loss $ (17,032 ) $ (13,382 ) Deemed dividend to preferred shareholders (see Note 6) — (11,590 ) Net loss after deemed dividend (17,032 ) (24,972 ) Weighted average shares outstanding 404 48 Basic and diluted loss per share $ (42.14 ) $ (525.01 ) 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. Recent Accounting Pronouncements In May 2014, August 2015, March 2016, April 2016 and May 2016, the Financial Accounting Standards Board (“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. 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 was 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 during the year ended December 31, 2017, and recognized a $0.2 million impairment loss related to its goodwill. 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 has nearly completed evaluating the impact that the adoption of this standard will have on its consolidated financial statements. The Company additional qualitative and quantitative disclosures as required. The Company expects to use the effective date of this standard as the date of initial application, with no retrospective adjustments to prior comparative periods. 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 | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Revenue Recognition [Abstract] | ||
Revenue Recognition | Note 2 – Revenue Recognition Net Sales The Company sells its products in the United States primarily through a direct sales force. Customers who purchase the Company’s products include hospitals and clinics throughout the United States. In countries outside the United States, the Company sells its products through a limited number of specialty healthcare distributors in the United Kingdom, Italy, Spain, Germany, Southeast Asia, Brazil, India and Greece. These distributors resell the Company’s products to hospitals and clinics in their respective geographies. Revenue from product sales are recognized when the customer or distributor obtains control of the product, which occurs at a point in time, most frequently upon shipment of the product or receipt of the product, depending on shipment terms. The Company’s standard shipping terms are FOB shipping point, unless the customer requests that control and title to the inventory transfer upon delivery. Revenue includes shipment and handling fees charged to customers. Revenue is measured as the amount of consideration we expect to receive, adjusted for any applicable estimates of variable consideration and other factors affecting the transaction price, which is based on the invoiced price, in exchange for transferring products. All revenue is recognized when we satisfy our performance obligations under the contract. The majority of our contracts have a single performance obligation and are short term in nature. The Company has entered into extended service plans with customers which are recognized over time. This revenue represents less than 1% of net sales for the three and nine months ended September 30, 2019 and 2018. The unfulfilled performance obligations related to these extended service plans is included in deferred revenue, which is included in other current liabilities on the condensed consolidated balance sheet. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns: believes that future returns of its products will be minimal. | 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, Southeast Asia, Brazil and India. 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 represented less than 1% of net sales during each of the years ended December 31, 2018 and 2017. The unfulfilled performance obligations related to these extended service plans is included in deferred revenue in the amount of $43,000 and $38,000 as of December 31, 2018 and 2017, respectively. Deferred revenue is included in other current liabilities on the consolidated balance sheets. The majority of the deferred revenue is expected to be recognized within one year. Sales taxes and value added taxes in foreign jurisdictions that are collected from customers and remitted to governmental authorities are accounted for on a net basis and therefore are excluded from net sales. Revenue includes shipment and handling fees charged to customers. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of goods sold. Product Returns: believes that future returns of its products will be minimal. Therefore, revenue recognized is not currently impacted by variable consideration related to product returns. |
Debt (Q3)
Debt (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Debt [Abstract] | ||
Debt | Note 3 - Debt On August 5, 2016, the Company entered into a loan and security agreement with Silicon Valley Bank (the Bank). Under this agreement, the Bank agreed to provide the Company with up to $5.0 million in debt financing, consisting of a term loan in an aggregate original principal amount not to exceed $4.0 million (the “Term Loan”) and a revolving line of credit in an aggregate principal amount not to exceed $1.0 million outstanding at any time (the “Revolving Line”). Proceeds from the loans were to be used for general corporate and working capital purposes. Advances under the Term Loan were available to the Company until November 30, 2016 and were subject to the Company’s compliance with liquidity covenants. The Term Loan expired unused on November 30, 2016 and the Term Loan is no longer available to be drawn. Advances under the Revolving Line are available to the Company until March 31, 2020 and accrue interest at a floating annual rate equal to 1.75% or 1.0% above the prime rate, depending on liquidity factors. Outstanding borrowings, if any, are collateralized by all of the Company’s assets, excluding intellectual property which is subject to a negative pledge. There were no borrowings outstanding under this facility as of September 30, 2019 or December 31, 2018. | Note 5—Debt On August 5, 2016, the Company entered into a loan and security agreement with Silicon Valley Bank (the Bank). Under the agreement, the Bank agreed to provide the Company with up to $5.0 million in debt financing, consisting of a term loan in an aggregate original principal amount not to exceed $4.0 million (the “Term Loan”) and a revolving line of credit in an aggregate principal amount not to exceed $1.0 million outstanding at any time (the “Revolving Line”; together with the Term Loan, the “Loans”). Proceeds from the Loans were to be used for general corporate and working capital purposes. The Term Loan expired unused on November 30, 2016. Advances under the Revolving Line, if any, are available to the Company until March 31, 2020 and accrue interest at a floating annual rate equal to 1.75% or 1.0% above the prime rate, depending on liquidity factors. Outstanding borrowings, if any, are collateralized by all of the Company’s assets, excluding intellectual property which is subject to a negative pledge. There were no borrowings outstanding under this facility as of December 31, 2018 or 2017. Warrants: |
Equity (Q3)
Equity (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Equity [Abstract] | ||
Equity | Note 4 - Equity Series F Convertible Preferred Stock The offering was comprised of Series F convertible preferred stock, convertible into shares of the Company’s common stock at an initial conversion price of $63.00 per share. Each share of Series F preferred stock was accompanied by a Series 1 warrant, which was to expire on the first anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share. The Series F preferred stock and the warrants were immediately separable and were issued separately. The conversion price of the Series F preferred stock will be adjusted in the event of a stock split, combination, reclassification or stock dividend or if the Company consummates a fundamental transaction. The Series F preferred stock also has full ratchet price based anti-dilution protection, subject to customary carve outs, in the event of a down-round financing at a price per share below the conversion price of the Series F preferred stock (which protection will expire if, during any 20 of 30 consecutive trading days, the volume weighted average price of the Company’s common stock exceeds 300% of the then-effective conversion price of the Series F preferred stock and the daily dollar trading volume for each trading day during such period exceeds $200,000). The exercise price of the warrants is fixed and does not contain any variable pricing features, nor any price based anti-dilutive features, apart from customary adjustments for stock splits, combinations, reclassifications, stock dividends or fundamental transactions. A total of 18,000 shares of Series F Convertible Preferred Stock initially convertible into 286,714 shares of common stock and warrants to purchase 573,310 shares of common stock were issued in the offering. As noted below, effective July 3, 2018, the conversion price of the Series F convertible preferred stock was reduced from $63.00 to $29.68, the per share price in the July 2018 Offering described below. Effective March 12, 2019, the conversion price of the Series F convertible preferred stock was reduced again from $29.68 to $5.25, the per share price to the public of the Series G convertible preferred stock which closed in an underwritten public offering on March 12, 2019, and each share of the remaining Series F convertible preferred stock is convertible into 191 shares of the Company’s common stock. As of both September 30, 2019, and December 31, 2018, 535 shares of the Series F convertible preferred stock remained outstanding. July 2018 Offering: On July 3, 2018, the Company closed on an underwritten public offering of 181,941 shares of its common stock at a public offering price of $29.68 per share, for gross proceeds of $5.4 million, including the full exercise of the underwriters’ over-allotment option to purchase additional shares of the Company’s common stock (the “July 2018 Offering”). deducting underwriting discounts and commissions and offering expenses. 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. Pursuant to the terms of these agreements, the Company agreed, effective July 3, 2018, to reduce the per share exercise price of the November 2017 Warrants held by such institutional investors to $29.68 and to extend the expiration date of the warrants that were to expire on November 27, 2018 to November 27, 2019. The number of common shares underlying the warrants that were repriced did not change. The repriced warrants are exercisable for 554,322 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 $63.00 to $29.68, the per share price in the July 2018 Offering. Series G Convertible Preferred Stock and March 2019 Offering The March 2019 Offering was comprised of 455,178 shares of common stock priced at $5.25 per share and 1,910,536 shares of Series G convertible preferred stock, convertible into common stock at $5.25 per share. Each share of Series G convertible preferred stock and each share of common stock was accompanied by a Series 1 warrant and a Series 2 warrant. The Series 1 warrants are exercisable into 2,365,714 shares of common stock and the Series 2 warrants are exercisable into 2,365,714 shares of common stock. Series 1 warrants expire on the fifth anniversary of the date of issuance and are exercisable at $5.25 to purchase one share of common stock. Series 2 warrants expire on the earlier of: (i) the eighteen-month anniversary of the date of issuance and (ii) the 30th trading day following the public announcement of the receipt from the U.S. Food and Drug Administration of clearance or approval of a modification to the product label for the Aquadex FlexFlow system to include pediatric patients. Series 2 warrants are exercisable at $5.25 per share of common stock. As of September 30, 2019, all 1,910,536 shares of the Series G convertible preferred stock had been converted into common stock and none remained outstanding. As noted above, the Company’s outstanding Series F convertible 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 convertible preferred stock. As a result of the March 2019 Offering, the conversion price of the Series F convertible preferred stock was reduced from $29.68, to $5.25, the per share price of the Series G convertible preferred stock. Placement Agent Fees Market-Based Warrants | Note 6—Shareholder’s 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 year ended December 31, 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 an initial conversion price of $63.00 per share. Each share of Series F preferred stock was accompanied by a Series 1 warrant, which was to expire on the first anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share, and a Series 2 warrant, which expires on the seventh anniversary of its issuance, to purchase 16 shares of the Company’s common stock at an exercise price of $63.00 per share. The Series F preferred stock and the warrants were immediately separable and were issued separately . . As noted below, effective July 3, 2018, the conversion price of the Series F preferred stock was reduced from $63.00 to $29.68, the per share price to public in the July 2018 Offering described below, and now each share of the remaining Series F preferred stock is convertible into 34 shares of the Company’s common stock. As of December 31, 2018, and 2017, 17,465 and 14,220 shares of the Series F Convertible Preferred Stock had been converted into an aggregate of 279,526 and 226,504 shares of common stock and 535 and 3,780 remained outstanding, respectively. 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. Pursuant to the terms of these agreements, the Company agreed, effective July 3, 2018, to reduce the per share exercise price of the November 2017 Warrants held by such institutional investors to $29.68 and to extend the expiration date of the warrants that were to expire on November 27, 2018 to November 27, 2019. The number of common shares underlying the warrants that were repriced did not change. The repriced warrants are exercisable for 554,322 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 $63.00 to $29.68, 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 2,522 shares of common stock at an exercise price of $1,512 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 141 shares of common stock at an exercise price of $1,512 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, 2018, and 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, 2019 | Dec. 31, 2018 | |
Stock-Based Compensation [Abstract] | ||
Stock-Based Compensation | Note 5 - Stock-Based Compensation Under the fair value recognition provisions of U.S. GAAP for accounting for stock-based compensation, the Company measures stock-based compensation expense at the grant date based on the fair value of the award and recognizes the compensation expense over the requisite service period, which is generally the vesting period. The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended September 30, Nine months ended September 30, (in thousands) 2019 2018 2019 2018 Selling, general and administrative expense $ 383 $ 440 $ 1,018 $ 1,446 Research and development expense 29 (3 ) 95 98 Total stock-based compensation expense $ 412 $ 437 $ 1,113 $ 1,544 | 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 Company recognized stock-based compensation expense related to grants of stock options, RSUs and common stock awards to employees, directors and consultants of $2.1 million, and $0.5 million during the years ended December 31, 2018 and 2017, 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) 2018 2017 Selling, general and administrative $ 1,958 $ 452 Research and development 129 50 Total $ 2,087 $ 502 The majority of the RSUs and options to purchase common stock vest on the anniversary of the date of grant, which ranges from one to four years. Stock-based compensation expense related to these awards is recognized on a straight-line basis over the related vesting term in most cases, which generally is the service period. It is the Company’s policy to issue new shares upon the exercise of options. Stock Options 2018 2017 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 2,562 $ 1,049.93 272 $ 31,021.57 Granted 163,997 45.76 2,461 167.30 Exercised — — — — Forfeited/expired (26,013 ) 61.01 (171 ) 36,429.90 Outstanding at December 31 140,546 $ 61.25 2,562 $ 1,049.93 Vested at December 31 16,206 $ 169.07 148 $ 11,338.37 For options outstanding and vested at December 31, 2018, the weighted average remaining contractual life was 9.12 years and 9.07 years, respectively. There were no option exercises in 2018 or 2017. The total fair value of options that vested in 2018 and 2017 was $0.9 million, and $0.7 million, respectively, at the fair value of the options as of the date of grant. Valuation Assumptions The Company has not historically paid cash dividends to its stockholders, and currently does not anticipate paying any cash dividends in the foreseeable future. As a result, the Company has assumed a dividend yield of 0%. The risk-free interest rate is based upon the rates of U.S. Treasury bills with a term that approximates the expected life of the option. Since the Company has limited historical exercise data to reasonably estimate the expected life of its option awards, the expected life is calculated using a simplified method. Expected volatility is based on historical volatility of the Company’s stock. The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2018 2017 Expected dividend yield 0 % 0 % Risk-free interest rate 2.49 % 1.97 % Expected volatility 120.54 % 103 % Expected life (in years) 6.23 6.25 The weighted-average fair value of stock options granted in 2018 and 2017 was $41.04 and $167.3, respectively. As of December 31, 2018, the total compensation cost related to all non-vested stock option awards not yet recognized was approximately $3.9 and is expected to be recognized over the remaining weighted-average period of 3.1 years. Restricted Stock Awards 2018 2017 RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price Nonvested, beginning balance 15 $ 7,297.22 33 $ 9,052.37 Granted — — 11 1,514.80 Vested (12 ) 7,297.22 (29 ) 1,854.56 Forfeited — — - - Nonvested at December 31 3 $ 7,297.22 15 $ 7,297.22 Warrants Warrants to purchase 599,293, and 608,764 shares of common stock were outstanding at December 31, 2018 and 2017, respectively. As of December 31, 2018, warrants outstanding were exercisable at prices ranging from $29.68 to $43,848 per share, and are exercisable over a period ranging from eleven months to 6.5 years. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value of Financial Instruments [Abstract] | ||
Fair Value of Financial Instruments | Note 6 - Fair Value of Financial Instruments The Company’s financial instruments consist of cash and cash equivalents, warrants, and contingent consideration. Pursuant to the requirements of ASC Topic 820 “Fair Value Measurement,” • Level 1 • Level 2 • Level 3 The fair value of the Company's contingent consideration, as described in Note 1, was initially measured based on the consideration expected to be transferred (probability-weighted), discounted back to present value, and it was considered a Level 3 instrument. The discount rate used was determined at the time of measurement in accordance with accepted valuation methods. The Company measured the liability on a recurring basis using Level 3 inputs including probabilities of payment and projected payment dates. As of September 30, 2019, this contingency had expired, therefore its fair value was recorded at $0. The following is a rollforward of the fair value of Level 3 items: (in thousands) Balance December 31, 2018 $ 126 Change in fair value (126 ) Balance as of September 30, 2019 $ - The fair value of the market-based warrants described in Note 4 was calculated using a Monte Carlo valuation model and was classified as Level 3 in the fair value hierarchy. These warrants are classified as permanent equity and as a result, were measured at the grant date and are not required to be remeasured to fair value at each reporting period end. All cash equivalents are considered Level 1 measurements for all periods presented. The Company does not have any financial instruments classified as Level 2 or any other classified as Level 3 and there were no movements between these categories during the periods ended September 30, 2019 and December 31, 2018. The Company believes that the carrying amounts of all remaining financial instruments approximate their fair value due to their relatively short maturities. | 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 was classified as Level 3 in the fair value hierarchy. The following is a rollforward of the fair value of Level 3 warrants: (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Balance as of December 31, 2017 $ - 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, 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, 2018 and 2017. The Company believes that the carrying amounts of all remaining financial instruments approximate their fair value due to their relatively short maturities. |
Operating Leases (Q3)
Operating Leases (Q3) | 9 Months Ended |
Sep. 30, 2019 | |
Operating Leases [Abstract] | |
Operating Leases | Note 7 – Operating Leases The Company leases office and manufacturing space under a non-cancelable operating lease that expires in March 2022. In August 2018, the Company entered into a third amendment to the lease, extending the term of the lease from March 31, 2019 to March 31, 2022. Beginning on April 1, 2019, the annual base rent is $9.00 per square foot, subject to annual increases of $0.25 per square foot. The cost components of the Company’s operating lease were as follows for the three and nine months ended September 30, 2019: (in thousands) Three Months Nine Months Operating lease cost $ 53 $ 158 Variable lease cost 26 85 Total $ 79 $ 243 Variable lease costs consist primarily of taxes, insurance, and common area or other maintenance costs for our leased office and manufacturing space. Maturities of our lease liability for the Company’s operating lease are as follows as of September 30, 2019: (in thousands) 2019 $ 52 2020 213 2021 219 2022 55 Total lease payments 539 Less: Interest (49 ) Present value of lease liability $ 490 As of September 30, 2019, the remaining lease term was 2.5 years and discount rate was 7.5%. For the nine months ended September 30, 2019, the operating cash outflows from the Company’s operating lease for office and manufacturing space were $154,000. Rent expense related to operating leases for office and manufacturing space and office equipment was approximately $54,000 and $160,000 for the three and nine months ended September 30, 2018, respectively. Future minimum lease payments, under non-cancelable operating leases as of December 31, 2018, were approximately $217,000, $220,000, $219,000, $55,000, and $0 for each of the years ended December 31, 2019, through 2023, respectively. |
Income Taxes (Q3)
Income Taxes (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Income Taxes [Abstract] | ||
Income Taxes | Note 8 – 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 condensed consolidated financial statements. As of September 30, 2019, 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, 2018. | Note 9—Income Taxes Domestic and foreign loss before income taxes, consists of the following for the years ended December 31: (in thousands) 2018 2017 Domestic $ (17,027 ) $ (13,367 ) Foreign 1 (9 ) Loss before income taxes $ (17,026 ) $ (13,376 ) The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2018 2017 Current: United States and state $ — $ — Foreign, net (6 ) (6 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (6 ) $ (6 ) Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2018 2017 Statutory federal income tax benefit $ 3,578 $ 4,548 State tax benefit, net of federal taxes 45 48 Foreign tax (2 ) - Foreign deferred exchange rate adjustments (1,112 ) 899 Nondeductible/nontaxable items (259 ) (114 ) New federal rate adjustment — (16,081 ) Other (72 ) (1,085 ) Valuation allowance decrease (increase) (2,184 ) 11,779 Total income tax benefit expense $ (6 ) $ (6 ) Deferred taxes consist of the following as of December 31: (in thousands) 2018 2017 Deferred tax assets: Noncurrent: Accrued leave $ 50 $ 32 Other accrued expenses — 28 Stock based compensation 483 336 Net operating loss carryforward 41,032 38,947 Other 125 115 Intangibles 847 895 R&D credit carryforward 531 531 Total deferred tax assets 43,068 40,884 Less: valuation allowance (43,068 ) (40,884 ) Total $ — $ — As of December 31, 2017, the Company had federal net operating loss (“NOLs”) The Company provides for a valuation allowance when it is more likely than not that it will not realize a portion of the deferred tax assets. The Company has established a valuation allowance for U.S. and foreign deferred tax assets due to the uncertainty that enough taxable income will be generated in those taxing jurisdictions to utilize the assets. Therefore, the Company has not reflected any benefit of such deferred tax assets in the accompanying consolidated financial statements. During 2017 and 2018, the Company believes it experienced an ownership change as defined in Section 382 of the Internal Revenue Code which will limit the ability to utilize the Company’s net operating losses (NOLs). The Company may have experienced additional ownership changes in earlier years further limiting the NOL carry-forwards that may be utilized. The Company has not yet completed a formal Section 382 analysis. The general limitation rules allow the Company to utilize its NOLs subject to an annual limitation that is determined by multiplying the federal long-term tax-exempt rate by the Company’s value immediately before the ownership change. The accounting guidance related to uncertain tax positions prescribes a recognition threshold and measurement attribute for recognition and measurement of a tax position taken or expected to be taken in a tax return. It also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company had no material uncertain tax positions as of December 31, 2018 or 2017. 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, 2018 and 2017, the Company recorded no accrued interest or penalties related to uncertain tax positions. The tax years ended December 31, 2015 through December 31, 2018 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, 2019 | Dec. 31, 2018 | |
Commitments and Contingencies [Abstract] | ||
Commitments and Contingencies | Note 9—Commitments and Contingencies Employee Retirement Plan: Contingent Consideration: In addition, it also agreed that if shares of its common stock cease to be publicly traded on the Nasdaq Capital Market, 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. | Note 10—Commitments and Contingencies Leases The Company leases office space under a non-cancelable operating lease that expires in March 2022. In August 2018, the Company entered into a Third Amendment to the lease, extending the term of the lease from March 31, 2019 to March 31, 2022. Beginning on April 1, 2019, the annual base rent shall be $9.00 per square foot, subject to annual increases of $0.25 per square foot. 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 September 2020. Rent expense related to operating leases was approximately $ 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 $197,000 and $138,000 for the years ended December 31, 2018 and 2017, respectively. Contingent Consideration 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 of the purchase of the Aquadex Business, 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. |
Subsequent Events (Q3)
Subsequent Events (Q3) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Subsequent Events [Abstract] | ||
Subsequent Events | Note 10 – Subsequent Events On October 25, 2019, the Company closed on a registered direct offering of 575,830 shares of its common stock at a price of $1.15 per share, for gross proceeds of approximately $660,000, prior to deducting commissions and expenses related to the transaction. Additionally, 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 this offering, effective October 25, 2019, the conversion price of the Series F preferred stock was reduced from $5.25 to $1.15 per share, On November 6, 2019, the Company closed on a registered direct offering of 1,219,076 shares of its common stock, or common equivalents, at a price of $1.12 per share, for gross proceeds of approximately $1.36 million prior to deduction of commissions and offering expenses related to the transaction. In a concurrent private placement, the Company agreed to issue to the investors in the registered direct offering unregistered warrants to purchase up to 1,219,076 shares of the Company’s common stock at an exercise price of $0.9942 per share, which will be exercisable upon the date of issuance, and will expire five years from the initial exercise date. Effective November 6, 2019, the conversion price of the Series F preferred stock was reduced from $1.15 to $0.9942, the exercise price of the warrants issued in connection with this financing. | Note 12 – Subsequent Event The Company filed an S-1 on December 31, 2018, which was amended January 22, 2019, to raise additional capital. Changing circumstances may cause the Company to consume capital significantly faster than it currently anticipates and could adversely affect the Company’s ability to raise additional capital. Additional financing may not be available when the Company needs it or may not be available on favorable terms. |
Nature of Business and Signif_2
Nature of Business and Significant Accounting Policies (FY) (Policies) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Nature of Business and Basis of Presentation, 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 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, November 27, 2017, July 3, 2018, March 12, 2019, October 25, 2019 and November 6, 2019, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $41.4 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (see Note 4 –Equity and Note 10-Subsequent Events). The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. | 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, 2018 and 2017, 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, 2018, the Company had an accumulated deficit of $199.4 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 system. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing and distributing the Aquadex FlexFlow system and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. On April 24, 2017, November 27, 2017, and on July 3, 2018, Shareholder’s 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. |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of CHF Solutions, Inc. and its wholly-owned subsidiaries, CHF Solutions, LLC, Sunshine Heart Company Pty Limited, and Sunshine Heart Ireland Limited. All intercompany accounts and transactions between consolidated entities have been eliminated. | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. | |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash and term deposits with original maturities of three months or less. The carrying value of these instruments approximate fair value. The balances, at times, may exceed federally insured limits. The Company has not experienced any losses on its cash and cash equivalents. | |
Accounts Receivable | Accounts Receivable | Accounts Receivable 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, 2018 or 2017. |
Inventories | Inventories ( in thousands) September30, 2019 December 31, 2018 Finished Goods $ 468 $ 517 Work in Process 185 34 Raw Materials 959 1,107 Total $ 1,612 $ 1,658 | Inventories Inventories are recorded at the lower of cost or net realizable value using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2018 2017 Finished Goods $ 517 $ 902 Work in Process 34 217 Raw Materials 1,107 469 Total $ 1,658 $ 1,588 |
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 3-5 years Computer software and equipment 3-4 years Laboratory and research equipment 3-5 years Production equipment 3-7 years Leasehold improvements and capital lease asset 3-5 years Depreciation expense was $232,000 and $229,000 for the years ended December 31, 2018, and 2017, 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 periodically reviews its property and equipment for potential impairment and determines if the fair value of property and equipment equals or exceeds its carrying value. There have been no impairment losses recognized for the years ended December 31, 2018 or 2017. | |
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 reviewed its definite lived intangible assets for impairment when impairment indicators existed. When impairment indicators existed, the Company determined if the carrying value of the intangible assets exceeded the related undiscounted cash flows. In cases where the carrying value exceeded the undiscounted cash flows, and the carrying amount was not considered recoverable, the carrying value was written down to its fair value, generally using a discounted cash flow analysis. An impairment loss was recognized for the amount that the intangible assets exceeded 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 definite lived intangible assets. The Company had 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 included assumptions related to the Company’s product revenues, 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 reflected these uncertainties by assigning future cash flow estimations probability factors and an overall discount rate of 30%. Amortization expense was $0 and $540,000 for the years ended December 31, 2018 and 2017, respectively. | |
Goodwill | Goodwill Goodwill was the cost paid for the Aquadex Business in excess of the fair value of acquired assets and liabilities, and was recorded as an asset on the balance sheet. Goodwill was not subject to amortization but was to be tested for impairment at least annually. This test required the Company to determine if the implied fair value of the goodwill was less than its carrying amount. The Company evaluated its recorded goodwill for impairment annually on November 1 st Simplifying the Test for Goodwill Impairment The Company had 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 included assumptions related to the Company’s product revenues, 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 reflected 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 in August 2016, the Company has an obligation to pay additional consideration that is contingent upon the occurrence of certain future events (see Note 10- Commitments and Contingencies). 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. As of December 31, 2018, the contingent consideration was recorded in current liabilities in the accompanying balance sheet to reflect its maturity during 2019. |
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 was remeasured to its estimated fair value at the end of each reporting period with changes recorded to earnings. | |
Revenue Recognition | Revenue Recognition: Revenue from Contracts with Customers | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”), Topic 606, Revenue from Contracts with Customers |
Foreign Currency Translation | Foreign Currency Translation Sales and expenses denominated in foreign currencies are translated at average exchange rates in effect throughout the year. Assets and liabilities of foreign operations are translated at period-end exchange rates with the impacts of foreign currency translation recognized to cumulative translation adjustment, a component of accumulated other comprehensive income other expense, net | |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes all share-based payments to employees and directors, including grants of stock options, restricted stock units (RSUs) and common stock awards in the consolidated statements of operations and other comprehensive loss 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 or warrants to purchase shares of the Company’s common stock. These RSUs or warrants are either fully-vested and exercisable at the date of grant or vest over a certain period during which services are provided. The Company expenses the fair market value of fully vested awards at the time of grant, and of unvested awards over the period in which the related services are received. 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. The Tax Reform Act was enacted December 22, 2017. The new legislation made significant changes to U.S. tax law including 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 reduced the U.S corporate income tax rates from 34% to 21%. As a result of the enacted law, the Company was required to revalue its deferred tax assets and liabilities at the new enacted rate. There was no income tax impact from the re-measurement due to the 100% valuation allowance on the Company’s deferred tax assets. | |
Loss per Share | Loss per share: Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented: September 30 2019 2018 Warrants to purchase common stock 5,430,721 608,787 Series F convertible preferred stock 102,185 19,210 Stock options 332,722 139,439 Restricted stock units - - 3 Total 5,865,628 767,439 The following table reconciles reported net loss with reported net loss per share for the periods ended September 30, 2019: (in thousands, except per share amounts) Three months Nine months Net loss $ (4,509 ) $ (13,666 ) Deemed dividend to preferred shareholders (see Note 4) — (4,509 ) Net loss after deemed dividend (4,509 ) (18,175 ) Weighted average shares outstanding 2,646 1,915 Basic and diluted loss per share $ (1.70 ) $ (9.49 ) | Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 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 for the year ended December 31, 2017, 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. (See Note 6). There were no deemed dividends during 2018. Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 31, 2018 2017 Stock options 140,546 2,766 Restricted stock units 3 15 Warrants to purchase common stock 599,293 608,787 Series F convertible preferred stock 18,190 60,480 Total 758,032 672,048 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) 2018 2017 Net loss $ (17,032 ) $ (13,382 ) Deemed dividend to preferred shareholders (see Note 6) — (11,590 ) Net loss after deemed dividend (17,032 ) (24,972 ) Weighted average shares outstanding 404 48 Basic and diluted loss per share $ (42.14 ) $ (525.01 ) |
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. | |
Recent Accounting Pronouncements | New Accounting Pronouncements: In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard which allowed it to carry forward the historical lease classification. In August 2018, the FASB issued updated guidance to improve and simplify the disclosure requirements on fair value measurements for level 3 assets and liabilities valued at fair value. The Company early-adopted the guidance effective in its second quarter and the effect on the consolidated financial statements was not material. | Recent Accounting Pronouncements In May 2014, August 2015, March 2016, April 2016 and May 2016, the Financial Accounting Standards Board (“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. 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 was 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 during the year ended December 31, 2017, and recognized a $0.2 million impairment loss related to its goodwill. 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 has nearly completed evaluating the impact that the adoption of this standard will have on its consolidated financial statements. The Company additional qualitative and quantitative disclosures as required. The Company expects to use the effective date of this standard as the date of initial application, with no retrospective adjustments to prior comparative periods. 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, 2019 | Dec. 31, 2018 | |
Nature of Business and Basis of Presentation, 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, 2018. | |
Going Concern | Going Concern: The Company became a revenue generating company after acquiring the Aquadex Business in August 2016. The Company expects to incur additional losses in the near-term as it grows the Aquadex Business, including investments in expanding its sales and marketing capabilities, purchasing inventory, manufacturing components, and complying with the requirements related to being a U.S. public company. To become and remain profitable, the Company must succeed in expanding the adoption and market acceptance of the Aquadex FlexFlow. This will require the Company to succeed in training personnel at hospitals and effectively and 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, November 27, 2017, July 3, 2018, March 12, 2019, October 25, 2019 and November 6, 2019, the Company closed on underwritten public equity offerings for aggregate net proceeds of approximately $41.4 million after deducting the underwriting discounts and commissions and other costs associated with the offerings (see Note 4 –Equity and Note 10-Subsequent Events). The Company will require additional funding to grow its Aquadex Business, which may not be available on terms favorable to the Company, or at all. The Company may receive those funds from the proceeds from future warrant exercises, issuances of equity securities, or other financing transactions. Should warrant exercises not materialize or future capital raising be unsuccessful, the Company may not be able to continue as a going concern. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. | 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, 2018 and 2017, 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, 2018, the Company had an accumulated deficit of $199.4 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 system. This will require the Company to succeed in training personnel at hospitals and effectively and efficiently manufacturing, marketing and distributing the Aquadex FlexFlow system and related components. There can be no assurance that the Company will succeed in these activities, and it may never generate revenues sufficient to achieve profitability. On April 24, 2017, November 27, 2017, and on July 3, 2018, Shareholder’s 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 Recognition: Revenue from Contracts with Customers | Revenue Recognition The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”), Topic 606, 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, 2018 or 2017. |
Inventories | Inventories ( in thousands) September30, 2019 December 31, 2018 Finished Goods $ 468 $ 517 Work in Process 185 34 Raw Materials 959 1,107 Total $ 1,612 $ 1,658 | Inventories Inventories are recorded at the lower of cost or net realizable value using the first-in, first out method. Inventories consisted of the following as of December 31 (in thousands): 2018 2017 Finished Goods $ 517 $ 902 Work in Process 34 217 Raw Materials 1,107 469 Total $ 1,658 $ 1,588 |
Contingent Consideration | Contingent consideration | Contingent consideration In connection with the Company’s purchase of the Aquadex Business in August 2016, the Company has an obligation to pay additional consideration that is contingent upon the occurrence of certain future events (see Note 10- Commitments and Contingencies). 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. As of December 31, 2018, the contingent consideration was recorded in current liabilities in the accompanying balance sheet to reflect its maturity during 2019. |
Loss per Share | Loss per share: Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented: September 30 2019 2018 Warrants to purchase common stock 5,430,721 608,787 Series F convertible preferred stock 102,185 19,210 Stock options 332,722 139,439 Restricted stock units - - 3 Total 5,865,628 767,439 The following table reconciles reported net loss with reported net loss per share for the periods ended September 30, 2019: (in thousands, except per share amounts) Three months Nine months Net loss $ (4,509 ) $ (13,666 ) Deemed dividend to preferred shareholders (see Note 4) — (4,509 ) Net loss after deemed dividend (4,509 ) (18,175 ) Weighted average shares outstanding 2,646 1,915 Basic and diluted loss per share $ (1.70 ) $ (9.49 ) | Loss per share Basic loss per share is computed based on the net loss for each period divided by the weighted average number of common shares outstanding. The net loss allocable to common stockholders for the year ended December 31, 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 for the year ended December 31, 2017, 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. (See Note 6). There were no deemed dividends during 2018. Diluted earnings per share is computed based on the net loss allocable to common stockholders for each period divided by the weighted average number of common shares outstanding, increased by the number of additional shares that would have been outstanding had the potentially dilutive common shares been issued, and reduced by the number of shares the Company could have repurchased from the proceeds from issuance of the potentially dilutive shares. Potentially dilutive shares of common stock include shares underlying outstanding convertible preferred stock, warrants, stock options and other stock-based awards granted under stock-based compensation plans. The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 31, 2018 2017 Stock options 140,546 2,766 Restricted stock units 3 15 Warrants to purchase common stock 599,293 608,787 Series F convertible preferred stock 18,190 60,480 Total 758,032 672,048 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) 2018 2017 Net loss $ (17,032 ) $ (13,382 ) Deemed dividend to preferred shareholders (see Note 6) — (11,590 ) Net loss after deemed dividend (17,032 ) (24,972 ) Weighted average shares outstanding 404 48 Basic and diluted loss per share $ (42.14 ) $ (525.01 ) |
New Accounting Pronouncements | New Accounting Pronouncements: In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard which allowed it to carry forward the historical lease classification. In August 2018, the FASB issued updated guidance to improve and simplify the disclosure requirements on fair value measurements for level 3 assets and liabilities valued at fair value. The Company early-adopted the guidance effective in its second quarter and the effect on the consolidated financial statements was not material. | Recent Accounting Pronouncements In May 2014, August 2015, March 2016, April 2016 and May 2016, the Financial Accounting Standards Board (“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. 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 was 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 during the year ended December 31, 2017, and recognized a $0.2 million impairment loss related to its goodwill. 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 has nearly completed evaluating the impact that the adoption of this standard will have on its consolidated financial statements. The Company additional qualitative and quantitative disclosures as required. The Company expects to use the effective date of this standard as the date of initial application, with no retrospective adjustments to prior comparative periods. 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, 2019 | Dec. 31, 2018 | |
Nature of Business and Basis of Presentation, Significant Accounting Policies [Abstract] | ||
Inventories | Inventories consisted of the following: ( in thousands) September30, 2019 December 31, 2018 Finished Goods $ 468 $ 517 Work in Process 185 34 Raw Materials 959 1,107 Total $ 1,612 $ 1,658 | Inventories consisted of the following as of December 31 (in thousands): 2018 2017 Finished Goods $ 517 $ 902 Work in Process 34 217 Raw Materials 1,107 469 Total $ 1,658 $ 1,588 |
Estimated Useful Lives | Depreciation expense has been calculated using the following estimated useful lives: Office furniture and equipment 3-5 years Computer software and equipment 3-4 years Laboratory and research equipment 3-5 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 2019 2018 Warrants to purchase common stock 5,430,721 608,787 Series F convertible preferred stock 102,185 19,210 Stock options 332,722 139,439 Restricted stock units - - 3 Total 5,865,628 767,439 | The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 31, 2018 2017 Stock options 140,546 2,766 Restricted stock units 3 15 Warrants to purchase common stock 599,293 608,787 Series F convertible preferred stock 18,190 60,480 Total 758,032 672,048 |
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, 2019: (in thousands, except per share amounts) Three months Nine months Net loss $ (4,509 ) $ (13,666 ) Deemed dividend to preferred shareholders (see Note 4) — (4,509 ) Net loss after deemed dividend (4,509 ) (18,175 ) Weighted average shares outstanding 2,646 1,915 Basic and diluted loss per share $ (1.70 ) $ (9.49 ) | 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) 2018 2017 Net loss $ (17,032 ) $ (13,382 ) Deemed dividend to preferred shareholders (see Note 6) — (11,590 ) Net loss after deemed dividend (17,032 ) (24,972 ) Weighted average shares outstanding 404 48 Basic and diluted loss per share $ (42.14 ) $ (525.01 ) |
Property, Plant and Equipment_2
Property, Plant and Equipment (FY) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment were as follows: (in thousands) December 31, 2018 December 31, 2017 Office Furniture & Fixtures $ 291 $ 287 Leasehold Improvements 224 224 Software 142 129 Production Equipment 991 926 Computer Equipment 357 277 Capital Lease Asset 309 307 Total 2,314 2,150 Accumulated Depreciation (1,778 ) (1,580 ) $ 536 $ 570 |
Stock-Based Compensation (FY) (
Stock-Based Compensation (FY) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
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) 2019 2018 2019 2018 Selling, general and administrative expense $ 383 $ 440 $ 1,018 $ 1,446 Research and development expense 29 (3 ) 95 98 Total stock-based compensation expense $ 412 $ 437 $ 1,113 $ 1,544 | 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) 2018 2017 Selling, general and administrative $ 1,958 $ 452 Research and development 129 50 Total $ 2,087 $ 502 |
Summary of Plan Stock Option Activity | The following is a summary of the Plans’ stock option activity during the years ended December 31: 2018 2017 Options Outstanding Weighted Average Exercise Price Options Outstanding Weighted Average Exercise Price Beginning Balance 2,562 $ 1,049.93 272 $ 31,021.57 Granted 163,997 45.76 2,461 167.30 Exercised — — — — Forfeited/expired (26,013 ) 61.01 (171 ) 36,429.90 Outstanding at December 31 140,546 $ 61.25 2,562 $ 1,049.93 Vested at December 31 16,206 $ 169.07 148 $ 11,338.37 | |
Weighted Average Assumptions used in Black-Scholes Option Pricing Model | The following table provides the weighted average assumptions used in the Black-Scholes option pricing model for the years ended December 31: 2018 2017 Expected dividend yield 0 % 0 % Risk-free interest rate 2.49 % 1.97 % Expected volatility 120.54 % 103 % Expected life (in years) 6.23 6.25 | |
Summary of Restricted Stock Award Activity | The following table summarizes restricted stock award activity during 2018 and 2017: 2018 2017 RSUs Weighted Average Grant Price RSUs Weighted Average Grant Price Nonvested, beginning balance 15 $ 7,297.22 33 $ 9,052.37 Granted — — 11 1,514.80 Vested (12 ) 7,297.22 (29 ) 1,854.56 Forfeited — — - - Nonvested at December 31 3 $ 7,297.22 15 $ 7,297.22 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (FY) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value of Financial Instruments [Abstract] | ||
Fair Value of Common Stock Warrant Liability Calculated Using a Monte Carlo Valuation Model Classified as Level 3 in Fair Value Hierarchy | The following is a rollforward of the fair value of Level 3 items: (in thousands) Balance December 31, 2018 $ 126 Change in fair value (126 ) Balance as of September 30, 2019 $ - | The following is a rollforward of the fair value of Level 3 warrants: (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Balance as of December 31, 2017 $ - |
Income Taxes (FY) (Tables)
Income Taxes (FY) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Taxes [Abstract] | |
Domestic and Foreign Loss Before Income Taxes | Domestic and foreign loss before income taxes, consists of the following for the years ended December 31: (in thousands) 2018 2017 Domestic $ (17,027 ) $ (13,367 ) Foreign 1 (9 ) Loss before income taxes $ (17,026 ) $ (13,376 ) |
Components of Income Tax Expense | The components of income tax expense consist of the following for the years ended December 31: (in thousands) 2018 2017 Current: United States and state $ — $ — Foreign, net (6 ) (6 ) Deferred: United States and state — — Foreign — — Total income tax expense $ (6 ) $ (6 ) |
Actual Income Tax Expense Differs from Statutory Federal Income Tax Expense | Actual income tax expense differs from statutory federal income tax expense as follows for the years ended December 31: (in thousands) 2018 2017 Statutory federal income tax benefit $ 3,578 $ 4,548 State tax benefit, net of federal taxes 45 48 Foreign tax (2 ) - Foreign deferred exchange rate adjustments (1,112 ) 899 Nondeductible/nontaxable items (259 ) (114 ) New federal rate adjustment — (16,081 ) Other (72 ) (1,085 ) Valuation allowance decrease (increase) (2,184 ) 11,779 Total income tax benefit expense $ (6 ) $ (6 ) |
Deferred Taxes | Deferred taxes consist of the following as of December 31: (in thousands) 2018 2017 Deferred tax assets: Noncurrent: Accrued leave $ 50 $ 32 Other accrued expenses — 28 Stock based compensation 483 336 Net operating loss carryforward 41,032 38,947 Other 125 115 Intangibles 847 895 R&D credit carryforward 531 531 Total deferred tax assets 43,068 40,884 Less: valuation allowance (43,068 ) (40,884 ) Total $ — $ — |
Nature of Business and Basis _3
Nature of Business and Basis of Presentation (Q3) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Nature of Business and Basis of Presentation, Significant Accounting Policies [Abstract] | ||
Inventories | Inventories consisted of the following: ( in thousands) September30, 2019 December 31, 2018 Finished Goods $ 468 $ 517 Work in Process 185 34 Raw Materials 959 1,107 Total $ 1,612 $ 1,658 | Inventories consisted of the following as of December 31 (in thousands): 2018 2017 Finished Goods $ 517 $ 902 Work in Process 34 217 Raw Materials 1,107 469 Total $ 1,658 $ 1,588 |
Potential Shares of Common Stock not Included in Diluted Net Loss Per Share | The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each period presented: September 30 2019 2018 Warrants to purchase common stock 5,430,721 608,787 Series F convertible preferred stock 102,185 19,210 Stock options 332,722 139,439 Restricted stock units - - 3 Total 5,865,628 767,439 | The following table sets forth the potential shares of common stock that are not included in the calculation of diluted net loss per share because to do so would be anti-dilutive as of the end of each year presented: December 31, 2018 2017 Stock options 140,546 2,766 Restricted stock units 3 15 Warrants to purchase common stock 599,293 608,787 Series F convertible preferred stock 18,190 60,480 Total 758,032 672,048 |
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, 2019: (in thousands, except per share amounts) Three months Nine months Net loss $ (4,509 ) $ (13,666 ) Deemed dividend to preferred shareholders (see Note 4) — (4,509 ) Net loss after deemed dividend (4,509 ) (18,175 ) Weighted average shares outstanding 2,646 1,915 Basic and diluted loss per share $ (1.70 ) $ (9.49 ) | 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) 2018 2017 Net loss $ (17,032 ) $ (13,382 ) Deemed dividend to preferred shareholders (see Note 6) — (11,590 ) Net loss after deemed dividend (17,032 ) (24,972 ) Weighted average shares outstanding 404 48 Basic and diluted loss per share $ (42.14 ) $ (525.01 ) |
Stock-Based Compensation (Q3) (
Stock-Based Compensation (Q3) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Stock-Based Compensation [Abstract] | ||
Classification of Stock-Based Compensation Expense | The following table presents the classification of stock-based compensation expense recognized for the periods below: Three months ended September 30, Nine months ended September 30, (in thousands) 2019 2018 2019 2018 Selling, general and administrative expense $ 383 $ 440 $ 1,018 $ 1,446 Research and development expense 29 (3 ) 95 98 Total stock-based compensation expense $ 412 $ 437 $ 1,113 $ 1,544 | 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) 2018 2017 Selling, general and administrative $ 1,958 $ 452 Research and development 129 50 Total $ 2,087 $ 502 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments (Q3) (Tables) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Fair Value of Financial Instruments [Abstract] | ||
Fair Value of Level 3 Warrants | The following is a rollforward of the fair value of Level 3 items: (in thousands) Balance December 31, 2018 $ 126 Change in fair value (126 ) Balance as of September 30, 2019 $ - | The following is a rollforward of the fair value of Level 3 warrants: (in thousands) Balance December 31, 2016 $ 1,843 Change in fair value (1,475 ) Exercise of warrants (368 ) Balance as of December 31, 2017 $ - |
Operating Leases (Q3) (Tables)
Operating Leases (Q3) (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Operating Leases [Abstract] | |
Cost Components of Operating Leases | The cost components of the Company’s operating lease were as follows for the three and nine months ended September 30, 2019: (in thousands) Three Months Nine Months Operating lease cost $ 53 $ 158 Variable lease cost 26 85 Total $ 79 $ 243 |
Maturities of Lease Liability | Maturities of our lease liability for the Company’s operating lease are as follows as of September 30, 2019: (in thousands) 2019 $ 52 2020 213 2021 219 2022 55 Total lease payments 539 Less: Interest (49 ) Present value of lease liability $ 490 |
Nature of Business and Signif_4
Nature of Business and Significant Accounting Policies, Nature of Business, Going Concern, Accounts Receivable and Inventory (FY) (Details) $ in Thousands | Oct. 12, 2017 | Jan. 12, 2017 | Jan. 31, 2019 | Dec. 31, 2018USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2018USD ($)StockSplit | Jul. 03, 2018USD ($) | Nov. 06, 2019USD ($) | Dec. 31, 2017USD ($) |
Nature of Business [Abstract] | |||||||||
Number of reverse stock split | StockSplit | 2 | ||||||||
Reverse stock split ratio | 0.050 | 0.033 | 0.0714 | ||||||
Going Concern [Abstract] | |||||||||
Accumulated deficit | $ (199,388) | $ (213,054) | $ (199,388) | $ (182,356) | |||||
Net proceeds from issuance of convertible preferred stock | $ 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 | 517 | 468 | 517 | 902 | |||||
Work in Process | 34 | 185 | 34 | 217 | |||||
Raw Materials | 1,107 | 959 | 1,107 | 469 | |||||
Total | $ 1,658 | $ 1,612 | $ 1,658 | $ 1,588 | |||||
Subsequent Event [Member] | |||||||||
Nature of Business [Abstract] | |||||||||
Reverse stock split ratio | 0.0714 | ||||||||
Going Concern [Abstract] | |||||||||
Net proceeds from issuance of convertible preferred stock | $ 41,400 | ||||||||
Minimum [Member] | |||||||||
Nature of Business [Abstract] | |||||||||
Reverse stock split ratio | 0.5000 | 0.500 | |||||||
Maximum [Member] | |||||||||
Nature of Business [Abstract] | |||||||||
Reverse stock split ratio | 0.0714 | 0.0714 |
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, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 232 | $ 229 |
Impairment losses recognized | $ 0 | $ 0 |
Office Furniture and Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 3 years | |
Office Furniture and Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 5 years | |
Computer Software and Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 3 years | |
Computer Software and Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Abstract] | ||
Estimated useful lives | 4 years | |
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 | 5 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) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Finite-lived Intangible Assets [Roll Forward] | ||
Impairment charges related to definite-lived intangible assets | $ 3,800 | |
Amortization expense | $ 0 | $ 540 |
Goodwill [Abstract] | ||
Goodwill impairment loss | $ 200 | |
Discount Rate [Member] | ||
Finite-lived Intangible Assets [Roll Forward] | ||
Overall discount rate | 0.3 | |
Customer Relationships [Member] | ||
Finite-lived Intangible Assets [Roll Forward] | ||
Estimated useful life | 7 years | |
Customer Relationships [Member] | Discount Rate [Member] | ||
Finite-lived Intangible Assets [Roll Forward] | ||
Overall discount rate | 0.3 | |
Developed Technology [Member] | ||
Finite-lived Intangible Assets [Roll Forward] | ||
Estimated useful life | 7 years | |
Developed Technology [Member] | Discount Rate [Member] | ||
Finite-lived Intangible Assets [Roll Forward] | ||
Overall discount rate | 0.3 | |
Trade Names and Trademarks [Member] | ||
Finite-lived Intangible Assets [Roll Forward] | ||
Estimated useful life | 7 years | |
Trade Names and Trademarks [Member] | Discount Rate [Member] | ||
Finite-lived Intangible Assets [Roll Forward] | ||
Overall discount rate | 0.3 |
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, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | ||||||||||
U.S. corporate income tax rate | 21.00% | 34.00% | ||||||||
Percentage of valuation allowance on deferred tax assets | 100.00% | |||||||||
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) | 5,865,628 | 767,439 | 758,032 | 672,048 | ||||||
Reported net loss with reported net loss per share [Abstract] | ||||||||||
Net loss | $ (4,509,000) | $ (4,430,000) | $ (4,727,000) | $ (4,241,000) | $ (4,181,000) | $ (4,354,000) | $ (13,666,000) | $ (12,776,000) | $ (17,032,000) | $ (13,382,000) |
Deemed dividend to preferred shareholders (see Note 6) | 0 | (4,509,000) | 0 | (11,590,000) | ||||||
Net loss after deemed dividend | $ (4,509,000) | $ (18,175,000) | $ (17,032,000) | $ (24,972,000) | ||||||
Weighted average shares outstanding (in shares) | 2,646,000 | 499,000 | 1,915,000 | 369,000 | 404,000 | 48,000 | ||||
Basic and diluted loss per share (in dollars per share) | $ (1.70) | $ (8.50) | $ (9.49) | $ (34.59) | $ (42.14) | $ (525.01) | ||||
Recent Accounting Pronouncements [Abstract] | ||||||||||
Goodwill impairment loss | $ 200,000 | |||||||||
Right of use assets | $ 487,000 | $ 487,000 | $ 0 | |||||||
Lease liabilities | $ 490,000 | $ 490,000 | ||||||||
Series E Convertible Preferred Stock [Member] | ||||||||||
Reported net loss with reported net loss per share [Abstract] | ||||||||||
Deemed dividend to preferred shareholders (see Note 6) | $ (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) | 18,190 | 60,480 | ||||||||
Reported net loss with reported net loss per share [Abstract] | ||||||||||
Deemed dividend to preferred shareholders (see Note 6) | $ (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 (see Note 6) | $ (1,800,000) | |||||||||
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) | 332,722 | 139,439 | 140,546 | 2,766 | ||||||
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) | 0 | 3 | 3 | 15 | ||||||
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) | 5,430,721 | 608,787 | 599,293 | 608,787 | ||||||
ASU 2016-02 [Member] | Plan [Member] | Minimum [Member] | ||||||||||
Recent Accounting Pronouncements [Abstract] | ||||||||||
Right of use assets | $ 575,000 | |||||||||
Lease liabilities | 575,000 | |||||||||
ASU 2016-02 [Member] | Plan [Member] | Maximum [Member] | ||||||||||
Recent Accounting Pronouncements [Abstract] | ||||||||||
Right of use assets | 625,000 | |||||||||
Lease liabilities | $ 625,000 |
Revenue Recognition (FY) (Detai
Revenue Recognition (FY) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2018-07-01 | ||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||||||
Expected timing of satisfaction, period | 1 year | 1 year | ||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-01-01 | ||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||||||
Deferred revenue | $ 43 | $ 38 | ||||
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% | 1.00% | 1.00% | 1.00% | 1.00% |
Property, Plant and Equipment_3
Property, Plant and Equipment (FY) (Details) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | $ 2,314 | $ 2,150 | |
Accumulated Depreciation | (1,778) | (1,580) | |
Property, Plant and Equipment, Net | $ 1,025 | 536 | 570 |
Office Furniture & Fixtures [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | 291 | 287 | |
Leasehold Improvements [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | 224 | 224 | |
Software [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | 142 | 129 | |
Production Equipment [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | 991 | 926 | |
Computer Equipment [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | 357 | 277 | |
Capital Lease Asset [Member] | |||
Property, Plant and Equipment, Gross [Abstract] | |||
Property, Plant and Equipment, Gross | $ 309 | $ 307 |
Intangible Assets (FY) (Details
Intangible Assets (FY) (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017USD ($) | Dec. 31, 2018 | |
Finite-Lived Intangible Assets, Net [Abstract] | ||
Impairment charges related to definite-lived intangible assets | $ 3,800 | |
Discount Rate [Member] | ||
Finite-Lived Intangible Assets, Net [Abstract] | ||
Overall discount rate | 0.3 |
Debt, New Loan Agreement (FY) (
Debt, New Loan Agreement (FY) (Details) - Silicon Valley Bank [Member] - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2016 | Aug. 05, 2016 | |
Line of Credit Facility [Abstract] | |||||
Maximum borrowing capacity | $ 5,000 | $ 5,000 | |||
Term Loan [Member] | |||||
Line of Credit Facility [Abstract] | |||||
Maximum borrowing capacity | $ 4,000 | $ 4,000 | |||
Maturity date | Nov. 30, 2016 | Nov. 30, 2016 | |||
Revolving Line [Member] | |||||
Line of Credit Facility [Abstract] | |||||
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] | |||||
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 (FY) (Details)
Debt, Warrants (FY) (Details) | Sep. 30, 2019 | Dec. 31, 2018$ / sharesshares |
Expected Stock Price Volatility [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants measurement input | 1.3621 | |
Affiliates [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants issued (in shares) | shares | 4 | |
Exercise price of warrants (in dollars per share) | $ 30,912 | |
Value of warrants (in dollars per share) | $ 22,764 | |
Affiliates [Member] | Expected Dividend Yield [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants measurement input | 0 | |
Affiliates [Member] | Expected Stock Price Volatility [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants measurement input | 0.8704 | |
Affiliates [Member] | Risk-Free Interest Rate [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants measurement input | 0.0220 | |
Affiliates [Member] | Expected Warrant Option Life [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Expected warrant option life | 6 years 3 months | |
Silicon Valley Bank [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants issued (in shares) | shares | 9 | |
Exercise price of warrants (in dollars per share) | $ 43,848 | |
Value of warrants (in dollars per share) | $ 32,424 | |
Silicon Valley Bank [Member] | Expected Dividend Yield [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants measurement input | 0 | |
Silicon Valley Bank [Member] | Expected Stock Price Volatility [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants measurement input | 0.8807 | |
Silicon Valley Bank [Member] | Risk-Free Interest Rate [Member] | ||
Warrants and Rights Note Disclosure [Abstract] | ||
Warrants measurement input | 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 |
Shareholder's Equity, Convertib
Shareholder's Equity, Convertible Preferred Stock (FY) (Details) - USD ($) $ / shares in Units, $ in Thousands | Mar. 12, 2019 | Jul. 03, 2018 | Nov. 27, 2017 | Apr. 24, 2017 | Jan. 10, 2017 | Nov. 03, 2016 | Oct. 30, 2016 | Jul. 20, 2016 | Sep. 30, 2019 | Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 03, 2018 |
Class of Stock Disclosures [Abstract] | |||||||||||||
Proceeds from issuance of convertible preferred stock and Warrants | $ 200 | $ 3,600 | $ 3,800 | $ 3,500 | |||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | |||||||||
Net proceeds from issuance of convertible preferred stock | $ 28,800 | ||||||||||||
Warrants [Member] | Minimum [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 29.68 | ||||||||||||
Warrants [Member] | Maximum [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 43,848 | ||||||||||||
Series B Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Proceed from issuance of preferred stock | $ 1,600 | ||||||||||||
Series C Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Beneficial conversion amount | 1,300 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||||||
Series D Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Beneficial conversion amount | $ 500 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||||||
Series B and B-1 Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||||||
Series B, C And D Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Aggregate cash placement fee | 6.00% | ||||||||||||
Series E Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Proceed from issuance of preferred stock | $ 9,200 | ||||||||||||
Beneficial conversion amount | 1,000 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||||||||||
Net proceeds from issuance of convertible preferred stock | $ 8,000 | ||||||||||||
Series E Convertible Preferred Stock [Member] | Warrants [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Warrants issued to the placement agent (in shares) | 0 | ||||||||||||
Series F Convertible Preferred Stock [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Proceed from issuance of preferred stock | $ 18,000 | ||||||||||||
Beneficial conversion amount | 8,700 | ||||||||||||
Preferred stock, shares outstanding (in shares) | 535 | 535 | 535 | 3,780 | |||||||||
Net proceeds from issuance of convertible preferred stock | $ 16,200 | ||||||||||||
Conversion price (in dollars per share) | $ 5.25 | $ 29.68 | $ 63 | $ 29.68 | |||||||||
Number of consecutive trading days considered for expiration | 20 days | 20 days | |||||||||||
Number of consecutive trading days | 30 days | 30 days | |||||||||||
Number of preferred shares converted to common stock (in shares) | 34 | 286,714 | 279,526 | 226,504 | |||||||||
Preferred stock, shares issued (in shares) | 18,000 | 535 | 535 | 535 | 3,780 | ||||||||
Common stock issued (in shares) | 181,941 | ||||||||||||
Number of convertible preferred shares converted (in shares) | 17,465 | 14,220 | |||||||||||
Aggregate cash placement fee | 8.00% | 8.00% | 8.00% | 9.00% | |||||||||
Public offering price (in dollars per share) | $ 29.68 | $ 29.68 | |||||||||||
Gross proceeds from public stock offering | $ 5,400 | ||||||||||||
Warrants exercisable (in shares) | 554,322 | 554,322 | |||||||||||
Series F Convertible Preferred Stock [Member] | Minimum [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Percentage of volume weighted average price of common stock | 300.00% | ||||||||||||
Trading volume for each trading day | $ 200 | ||||||||||||
Series F Convertible Preferred Stock [Member] | Warrants [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Warrants to purchase shares of common stock (in shares) | 573,310 | ||||||||||||
Warrants issued to the placement agent (in shares) | 0 | 0 | |||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 29.68 | $ 63 | $ 29.68 | ||||||||||
Number of preferred shares converted to common stock (in shares) | 16 | ||||||||||||
Warrants to purchase shares of common stock (in shares) | 16 | ||||||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | |||||||||||||
Class of Stock Disclosures [Abstract] | |||||||||||||
Exercise price of warrants (in dollars per share) | $ 29.68 | $ 63 | $ 29.68 | ||||||||||
Number of preferred shares converted to common stock (in shares) | 16 | ||||||||||||
Warrants to purchase shares of common stock (in shares) | 16 |
Shareholder's Equity, Warrants
Shareholder's Equity, Warrants (FY) (Details) $ / shares in Units, $ in Thousands | Jan. 10, 2017USD ($)$ / sharesshares | Nov. 03, 2016USD ($)$ / sharesshares | Jul. 31, 2016USD ($)$ / sharesshares | Mar. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2019 |
Class of Stock Disclosures [Abstract] | |||||||
Proceeds from exercise of warrants | $ 0 | $ 1,989 | |||||
Warrants outstanding | 0 | 0 | |||||
Change in fair value of warrant liability | 0 | 1,475 | |||||
Replacement Warrants [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants outstanding | $ 500 | ||||||
Expected Dividend Yield [Member] | Replacement Warrants [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants measurement input | 0 | ||||||
Expected Stock Price Volatility [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants measurement input | 1.3621 | ||||||
Expected Stock Price Volatility [Member] | Replacement Warrants [Member] | Minimum [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants measurement input | 0.4965 | ||||||
Expected Stock Price Volatility [Member] | Replacement Warrants [Member] | Maximum [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants measurement input | 0.5038 | ||||||
Risk-Free Interest Rate [Member] | Replacement Warrants [Member] | Minimum [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants measurement input | 0.0195 | ||||||
Risk-Free Interest Rate [Member] | Replacement Warrants [Member] | Maximum [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants measurement input | 0.0197 | ||||||
Expected Warrant Option Life [Member] | Replacement Warrants [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Expected warrant option life | 5 years | ||||||
Series B Convertible Preferred Stock [Member] | Investor Warrants [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants issuance cost | $ 0 | ||||||
Warrants to purchase shares of common stock (in shares) | shares | 440 | ||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 7,896 | ||||||
Warrants exercisable period | 36 months | ||||||
Period warrants became exercisable from closing date | 6 months | ||||||
Series D Convertible Preferred Stock [Member] | Investor Warrants [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants issuance cost | $ 0 | ||||||
Warrants to purchase shares of common stock (in shares) | shares | 141 | ||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,512 | ||||||
Warrants exercisable period | 60 months | ||||||
Period warrants became exercisable from closing date | 6 months | ||||||
Series C and D Convertible Preferred Stock [Member] | Investor Warrants [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants issuance cost | $ 0 | ||||||
Warrants to purchase shares of common stock (in shares) | shares | 2,522 | ||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,512 | ||||||
Adjusted exercise price of warrants (in dollars per share) | $ / shares | $ 1,428 | ||||||
Warrant Exercise Agreement [Member] | Original Warrants [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Proceeds from exercise of warrants | $ 2,000 | ||||||
Warrants outstanding | $ 0 | 0 | |||||
Relinquished amount of warrants | $ 100 | ||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Warrants to purchase shares of common stock (in shares) | shares | 3,105 | ||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | Minimum [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 484.4 | ||||||
Warrant Exercise Agreement [Member] | Replacement Warrants [Member] | Maximum [Member] | |||||||
Class of Stock Disclosures [Abstract] | |||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1,397.2 |
Stock-Based Compensation, Stock
Stock-Based Compensation, Stock Options and Restricted Stock Awards (FY) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | $ 412 | $ 437 | $ 1,113 | $ 1,544 | $ 2,087 | $ 502 |
Minimum [Member] | ||||||
Additional Disclosures [Abstract] | ||||||
Award vesting period | 1 year | |||||
Maximum [Member] | ||||||
Additional Disclosures [Abstract] | ||||||
Award vesting period | 4 years | |||||
Selling, General and Administrative [Member] | ||||||
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | 383 | 440 | 1,018 | 1,446 | $ 1,958 | 452 |
Research and Development [Member] | ||||||
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | $ 29 | $ (3) | $ 95 | $ 98 | $ 129 | $ 50 |
Stock Options [Member] | ||||||
Stock Options Activity [Roll Forward] | ||||||
Outstanding, beginning balance (in shares) | 140,546 | 2,562 | 2,562 | 272 | ||
Granted (in shares) | 163,997 | 2,461 | ||||
Exercised (in shares) | 0 | 0 | ||||
Forfeited/expired (in shares) | (26,013) | (171) | ||||
Outstanding, ending balance (in shares) | 140,546 | 2,562 | ||||
Vested at the end of the year (in shares) | 16,206 | 148 | ||||
Weighted Average Exercise Price [Abstract] | ||||||
Outstanding, beginning balance (in dollars per share) | $ 61.25 | $ 1,049.93 | $ 1,049.93 | $ 31,021.57 | ||
Granted (in dollars per share) | 45.76 | 167.30 | ||||
Exercised (in dollars per share) | 0 | 0 | ||||
Forfeited/expired (in dollars per share) | 61.01 | 36,429.90 | ||||
Outstanding, ending balance (in dollars per share) | 61.25 | 1,049.93 | ||||
Vested at the end of the year (in dollars per share) | $ 169.07 | $ 11,338.37 | ||||
Weighted Average Remaining Contractual Term [Abstract] | ||||||
Options outstanding, weighted average remaining contractual life | 9 years 1 month 13 days | |||||
Options vested, weighted average remaining contractual life | 9 years 25 days | |||||
Aggregate Intrinsic Value [Abstract] | ||||||
Fair value of options, vested | $ 900 | $ 700 | ||||
Weighted Average Assumptions used in Black-Scholes Option Pricing Model [Abstract] | ||||||
Expected dividend yield | 0.00% | 0.00% | ||||
Risk-free interest rate | 2.49% | 1.97% | ||||
Expected volatility | 120.54% | 103.00% | ||||
Expected life | 6 years 2 months 23 days | 6 years 3 months | ||||
Additional Disclosures [Abstract] | ||||||
Weighted-average fair value of options granted (in dollars per share) | $ 41.04 | $ 167.30 | ||||
Total unrecognized compensation costs related to non-vested stock option awards | $ 3,900 | |||||
Unrecognized compensation costs related to non-vested stock option awards, recognition period | 3 years 1 month 6 days | |||||
Restricted Stock Units [Member] | ||||||
Restricted Stock Awards [Roll Forward] | ||||||
Nonvested, beginning balance (in shares) | 3 | 15 | 15 | 33 | ||
Granted (in shares) | 0 | 11 | ||||
Vested (in shares) | (12) | (29) | ||||
Forfeited (in shares) | 0 | 0 | ||||
Nonvested, ending balance (in shares) | 3 | 15 | ||||
Weighted Average Grant Price [Abstract] | ||||||
Nonvested, beginning balance (in dollars per share) | $ 7,297.22 | $ 7,297.22 | $ 7,297.22 | $ 9,052.37 | ||
Granted (in dollars per share) | 0 | 1,514.80 | ||||
Vested (in dollars per share) | 7,297.22 | 1,854.56 | ||||
Forfeited (in dollars per share) | 0 | 0 | ||||
Nonvested, ending balance (in dollars per share) | $ 7,297.22 | $ 7,297.22 |
Stock-Based Compensation, Warra
Stock-Based Compensation, Warrants (FY) (Details) - Warrants [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Class of Warrant or Right [Abstract] | ||
Warrants outstanding (in shares) | 599,293 | 608,764 |
Minimum [Member] | ||
Class of Warrant or Right [Abstract] | ||
Exercise price of warrants (in dollars per share) | $ 29.68 | |
Warrants exercisable period | 11 months | |
Maximum [Member] | ||
Class of Warrant or Right [Abstract] | ||
Exercise price of warrants (in dollars per share) | $ 43,848 | |
Warrants exercisable period | 6 years 6 months |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments (FY) (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair value of Level 3 warrants [Roll Forward] | |||
Beginning balance | $ 0 | $ 0 | |
Change in fair value | 0 | $ 1,475 | |
Ending balance | 0 | 0 | |
Fair Value Transfers between levels [Abstract] | |||
Level 1 to Level 2 asset transfers | 0 | 0 | 0 |
Level 2 to Level 1 asset transfers | 0 | 0 | 0 |
Level 1 to Level 2 liability transfers | 0 | 0 | 0 |
Level 2 to Level 1 liability transfers | 0 | 0 | 0 |
Level 3 [Member] | |||
Fair value of Level 3 warrants [Roll Forward] | |||
Beginning balance | 126 | 0 | 1,843 |
Change in fair value | (126) | (1,475) | |
Exercise of warrants | (368) | ||
Ending balance | $ 0 | $ 126 | $ 0 |
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, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Loss before income taxes [Abstract] | ||||||
Domestic | $ (17,027) | $ (13,367) | ||||
Foreign | 1 | (9) | ||||
Loss before income taxes | $ (4,508) | $ (4,240) | $ (13,661) | $ (12,773) | $ (17,026) | $ (13,376) |
Income Taxes, Components of Inc
Income Taxes, Components of Income Tax Expense (FY) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Current [Abstract] | ||||||
United States and state | $ 0 | $ 0 | ||||
Foreign, net | (6) | (6) | ||||
Deferred [Abstract] | ||||||
United States and state | 0 | 0 | ||||
Foreign | 0 | 0 | ||||
Total income tax benefit expense | $ (1) | $ (1) | $ (5) | $ (3) | $ (6) | $ (6) |
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, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Effective income tax rate reconciliation [Abstract] | ||||||
Statutory federal income tax benefit | $ 3,578 | $ 4,548 | ||||
State tax benefit, net of federal taxes | 45 | 48 | ||||
Foreign tax | (2) | 0 | ||||
Foreign deferred exchange rate adjustments | (1,112) | 899 | ||||
Nondeductible/nontaxable items | (259) | (114) | ||||
New federal rate adjustment | 0 | (16,081) | ||||
Other | (72) | (1,085) | ||||
Valuation allowance decrease (increase) | (2,184) | 11,779 | ||||
Total income tax benefit expense | $ (1) | $ (1) | $ (5) | $ (3) | $ (6) | $ (6) |
Income Taxes, Deferred Taxes an
Income Taxes, Deferred Taxes and Other Information (FY) (Details) $ in Thousands, $ in Millions | 12 Months Ended | ||
Dec. 31, 2018USD ($) | Dec. 31, 2018AUD ($) | Dec. 31, 2017USD ($) | |
Noncurrent [Abstract] | |||
Accrued leave | $ 50 | $ 32 | |
Other accrued expenses | 0 | 28 | |
Stock based compensation | 483 | 336 | |
Net operating loss carryforward | 41,032 | 38,947 | |
Other | 125 | 115 | |
Intangibles | 847 | 895 | |
R&D credit carryforward | 531 | 531 | |
Total deferred tax assets | 43,068 | 40,884 | |
Less: valuation allowance | (43,068) | (40,884) | |
Total | 0 | 0 | |
Unrecognized Tax Benefits [Abstract] | |||
Uncertain tax positions | 0 | 0 | |
Penalties and Interest Accrued [Abstract] | |||
Interest and penalties accrued on uncertain tax positions | $ 0 | 0 | |
Earliest Tax Year [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards, expiration date | Dec. 31, 2024 | ||
Latest Tax Year [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards, expiration date | Dec. 31, 2037 | ||
Federal [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | 135,200 | ||
Net operating loss (NOL) carryforwards with expiration date | 120,100 | ||
Net operating loss (NOL) carryforwards with no expiration date | 15,100 | ||
State [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 29,500 | ||
Australian [Member] | |||
Operating Loss Carryforwards [Abstract] | |||
Net operating loss (NOL) carryforwards | $ 49 |
Commitments and Contingencies_3
Commitments and Contingencies (FY) (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)$ / ft² | Sep. 30, 2018USD ($) | Mar. 31, 2020$ / ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Leases [Abstract] | ||||||
Annual base rent (in dollars per square foot) | $ / ft² | 9 | |||||
Annual base rent increase (in dollars per square foot) | $ / ft² | 0.25 | |||||
Rent expense related to operating leases | $ 54,000 | $ 160,000 | $ 293,000 | $ 290,000 | ||
Future minimum lease payments [Abstract] | ||||||
2019 | $ 217,000 | 217,000 | ||||
2020 | 220,000 | 220,000 | ||||
2021 | 219,000 | 219,000 | ||||
2022 | 55,000 | 55,000 | ||||
2023 | 0 | 0 | ||||
Employee Retirement Plan [Abstract] | ||||||
Employer's matching contribution | 197,000 | $ 138,000 | ||||
Plan [Member] | ||||||
Leases [Abstract] | ||||||
Annual base rent (in dollars per square foot) | $ / ft² | 9 | |||||
Annual base rent increase (in dollars per square foot) | $ / ft² | 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 |
Segment and Geographic Inform_2
Segment and Geographic Information (FY) (Details) | 12 Months Ended |
Dec. 31, 2018Segment | |
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 | Jan. 31, 2019 | Dec. 31, 2018USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2018 | Sep. 30, 2019USD ($) | Sep. 30, 2018 | Dec. 31, 2018USD ($) | Jul. 03, 2018USD ($) | Nov. 06, 2019USD ($) | Dec. 31, 2017USD ($) | Aug. 31, 2016USD ($) |
Nature of Business [Abstract] | |||||||||||||
Reverse stock split ratio | 0.050 | 0.033 | 0.0714 | ||||||||||
Going Concern [Abstract] | |||||||||||||
Accumulated deficit | $ (199,388) | $ (213,054) | $ (213,054) | $ (199,388) | $ (182,356) | ||||||||
Net proceeds from issuance of convertible preferred stock | $ 28,800 | ||||||||||||
Accounts Receivable [Abstract] | |||||||||||||
Accounts receivables maximum credit period from invoice date | 30 days | 30 days | |||||||||||
Allowance for doubtful accounts | 0 | 0 | $ 0 | $ 0 | |||||||||
Inventories [Abstract] | |||||||||||||
Finished Goods | 517 | 468 | 468 | 517 | 902 | ||||||||
Work in Process | 34 | 185 | 185 | 34 | 217 | ||||||||
Raw Materials | 1,107 | 959 | 959 | 1,107 | 469 | ||||||||
Total | $ 1,658 | 1,612 | 1,612 | $ 1,658 | $ 1,588 | ||||||||
Contingent Consideration [Abstract] | |||||||||||||
Fair value of contingent consideration | 0 | $ 0 | |||||||||||
Subsequent Event [Member] | |||||||||||||
Nature of Business [Abstract] | |||||||||||||
Reverse stock split ratio | 0.0714 | ||||||||||||
Going Concern [Abstract] | |||||||||||||
Net proceeds from issuance of convertible preferred stock | $ 41,400 | ||||||||||||
Customer One [Member] | Accounts Receivable [Member] | |||||||||||||
Revenue, Performance Obligation [Abstract] | |||||||||||||
Concentration risk percentage | 14.00% | 18.00% | |||||||||||
Customer Two [Member] | Accounts Receivable [Member] | |||||||||||||
Revenue, Performance Obligation [Abstract] | |||||||||||||
Concentration risk percentage | 12.00% | 13.00% | |||||||||||
Customer Three [Member] | Accounts Receivable [Member] | |||||||||||||
Revenue, Performance Obligation [Abstract] | |||||||||||||
Concentration risk percentage | 13.00% | ||||||||||||
Minimum [Member] | |||||||||||||
Nature of Business [Abstract] | |||||||||||||
Reverse stock split ratio | 0.5000 | 0.500 | |||||||||||
Maximum [Member] | |||||||||||||
Nature of Business [Abstract] | |||||||||||||
Reverse stock split ratio | 0.0714 | 0.0714 | |||||||||||
Aquadex Product Line [Member] | |||||||||||||
Contingent Consideration [Abstract] | |||||||||||||
Fair value of contingent consideration | $ 0 | $ 0 | |||||||||||
Contingent consideration | $ 126 | ||||||||||||
ASC 606 [Member] | Customer One [Member] | Net Sales [Member] | |||||||||||||
Revenue, Performance Obligation [Abstract] | |||||||||||||
Concentration risk percentage | 11.00% | 15.00% | 10.00% | 10.00% | |||||||||
ASC 606 [Member] | Customer Two [Member] | Net Sales [Member] | |||||||||||||
Revenue, Performance Obligation [Abstract] | |||||||||||||
Concentration risk percentage | 12.00% | 10.00% | |||||||||||
ASC 606 [Member] | Customer Three [Member] | Net Sales [Member] | |||||||||||||
Revenue, Performance Obligation [Abstract] | |||||||||||||
Concentration risk percentage | 12.00% |
Nature of Business and Basis _5
Nature of Business and Basis of Presentation, Loss Per Share (Q3) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||||
Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
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) | 5,865,628 | 767,439 | 758,032 | 672,048 | ||||||
Reported net loss with reported net loss per share [Abstract] | ||||||||||
Net loss | $ (4,509) | $ (4,430) | $ (4,727) | $ (4,241) | $ (4,181) | $ (4,354) | $ (13,666) | $ (12,776) | $ (17,032) | $ (13,382) |
Deemed dividend to preferred shareholders (see Note 4) | 0 | (4,509) | 0 | (11,590) | ||||||
Net loss after deemed dividend | $ (4,509) | $ (18,175) | $ (17,032) | $ (24,972) | ||||||
Weighted average shares outstanding (in shares) | 2,646,000 | 499,000 | 1,915,000 | 369,000 | 404,000 | 48,000 | ||||
Basic and diluted loss per share (in dollars per share) | $ (1.70) | $ (8.50) | $ (9.49) | $ (34.59) | $ (42.14) | $ (525.01) | ||||
New Accounting Pronouncement [Abstract] | ||||||||||
Operating lease right-of-use asset | $ 487 | $ 487 | $ 0 | |||||||
Operating lease liability | $ 490 | $ 490 | ||||||||
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) | 5,430,721 | 608,787 | 599,293 | 608,787 | ||||||
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) | 102,185 | 19,210 | ||||||||
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) | 332,722 | 139,439 | 140,546 | 2,766 | ||||||
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) | 0 | 3 | 3 | 15 | ||||||
ASU 2016-02 [Member] | Adjustments Due to Adoption of ASU 2016-02 [Member] | ||||||||||
New Accounting Pronouncement [Abstract] | ||||||||||
Operating lease right-of-use asset | $ 600 | |||||||||
Operating lease liability | $ 600 |
Revenue Recognition (Q3) (Detai
Revenue Recognition (Q3) (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2018-07-01 | ||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||||||
Expected timing of satisfaction, period | 1 year | 1 year | ||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-01-01 | ||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Abstract] | ||||||
Expected timing of satisfaction, period | 1 year | 1 year | ||||
Sales Revenue [Member] | ASC 606 [Member] | Maximum [Member] | ||||||
Revenue, Performance Obligation [Abstract] | ||||||
Percentage of net sales | 1.00% | 1.00% | 1.00% | 1.00% | 1.00% | 1.00% |
Debt (Q3) (Details)
Debt (Q3) (Details) - Silicon Valley Bank [Member] - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2016 | Aug. 05, 2016 | |
Line of Credit Facility [Abstract] | |||||
Maximum borrowing capacity | $ 5,000 | $ 5,000 | |||
Term Loan [Member] | |||||
Line of Credit Facility [Abstract] | |||||
Maximum borrowing capacity | $ 4,000 | $ 4,000 | |||
Maturity date | Nov. 30, 2016 | Nov. 30, 2016 | |||
Revolving Line [Member] | |||||
Line of Credit Facility [Abstract] | |||||
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] | |||||
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% |
Equity (Q3) (Details)
Equity (Q3) (Details) $ / shares in Units, $ in Thousands | Mar. 12, 2019USD ($)$ / sharesshares | Jul. 03, 2018USD ($)$ / sharesshares | Nov. 27, 2017USD ($)$ / sharesshares | Apr. 24, 2017 | Sep. 30, 2019$ / sharesshares | Sep. 30, 2019USD ($)$ / sharesshares | Dec. 31, 2018$ / sharesshares | Jul. 03, 2018USD ($)$ / sharesshares | May 30, 2019$ / sharesshares | Dec. 31, 2017shares |
Class of Stock Disclosures [Abstract] | ||||||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 28,800 | |||||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | 0 | ||||||
Expected Stock Price Volatility [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Warrants measurement input | 1.3621 | 1.3621 | ||||||||
July 2018 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Issuance of common stock, net (in shares) | 181,941 | |||||||||
Public offering price (in dollars per share) | $ / shares | $ 29.68 | $ 29.68 | ||||||||
Gross proceeds from public stock offering | $ | $ 5,400 | |||||||||
Net proceeds from public stock offering | $ | $ 4,600 | |||||||||
Number of shares issuable on the exercise of warrants (in shares) | 554,322 | 554,322 | ||||||||
March 2019 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Issuance of common stock, net (in shares) | 455,178 | |||||||||
Public offering price (in dollars per share) | $ / shares | $ 5.25 | |||||||||
Warrants [Member] | Minimum [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 29.68 | |||||||||
Warrants [Member] | Maximum [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 43,848 | |||||||||
Warrants [Member] | Consultant [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Warrants to purchase shares of common stock (in shares) | 100,000 | |||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.93 | $ 1.93 | $ 3.18 | |||||||
Series F Convertible Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Gross proceeds from issuance of convertible preferred stock | $ | $ 18,000 | |||||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 16,200 | |||||||||
Conversion price (in dollars per share) | $ / shares | $ 5.25 | $ 29.68 | $ 63 | 29.68 | ||||||
Number of consecutive trading days considered for expiration | 20 days | 20 days | ||||||||
Number of consecutive trading days | 30 days | 30 days | ||||||||
Preferred stock issued (in shares) | 18,000 | 535 | 535 | 535 | 3,780 | |||||
Number of shares issuable on conversion of preferred stock (in shares) | 191 | 286,714 | ||||||||
Preferred stock, shares outstanding (in shares) | 535 | 535 | 535 | 3,780 | ||||||
Issuance of common stock, net (in shares) | 181,941 | |||||||||
Public offering price (in dollars per share) | $ / shares | $ 29.68 | $ 29.68 | ||||||||
Number of shares issuable on the exercise of warrants (in shares) | 554,322 | 554,322 | ||||||||
Beneficial conversion amount | $ | $ 8,700 | |||||||||
Aggregate cash placement fee | 8.00% | 8.00% | 8.00% | 9.00% | ||||||
Series F Convertible Preferred Stock [Member] | Minimum [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Percentage of volume weighted average price of common stock | 300.00% | |||||||||
Trading volume for each trading day | $ | $ 200 | |||||||||
Series F Convertible Preferred Stock [Member] | Warrants [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Warrants to purchase shares of common stock (in shares) | 573,310 | |||||||||
Warrants issued to the placement agent (in shares) | 0 | 0 | ||||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Warrants to purchase shares of common stock (in shares) | 16 | |||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 29.68 | $ 63 | $ 29.68 | |||||||
Series F Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Warrants to purchase shares of common stock (in shares) | 16 | |||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 29.68 | $ 63 | $ 29.68 | |||||||
Series G Convertible Preferred Stock [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Gross proceeds from issuance of convertible preferred stock | $ | $ 12,400 | |||||||||
Net proceeds from issuance of convertible preferred stock | $ | $ 11,000 | |||||||||
Conversion price (in dollars per share) | $ / shares | $ 5.25 | |||||||||
Number of consecutive trading days | 30 days | |||||||||
Preferred stock issued (in shares) | 0 | 0 | 0 | |||||||
Preferred stock, shares outstanding (in shares) | 0 | 0 | 0 | |||||||
Beneficial conversion amount | $ | $ 4,500 | |||||||||
Beneficial ownership limitation | 4.99% | |||||||||
Conversion of preferred stock into common stock (in shares) | 1,910,536 | |||||||||
Series G Convertible Preferred Stock [Member] | March 2019 Offering [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Number of shares issuable on conversion of preferred stock (in shares) | 1,910,536 | |||||||||
Series G Convertible Preferred Stock [Member] | Warrant Series 1 [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 5.25 | |||||||||
Number of shares issuable on the exercise of warrants (in shares) | 2,365,714 | |||||||||
Series G Convertible Preferred Stock [Member] | Warrant Series 2 [Member] | ||||||||||
Class of Stock Disclosures [Abstract] | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 5.25 | |||||||||
Number of shares issuable on the exercise of warrants (in shares) | 2,365,714 |
Stock-Based Compensation (Q3)_2
Stock-Based Compensation (Q3) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | $ 412 | $ 437 | $ 1,113 | $ 1,544 | $ 2,087 | $ 502 |
Selling, General and Administrative Expense [Member] | ||||||
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | 383 | 440 | 1,018 | 1,446 | 1,958 | 452 |
Research and Development Expense [Member] | ||||||
Stock-Based Compensation Expense Items [Abstract] | ||||||
Stock-based compensation expense | $ 29 | $ (3) | $ 95 | $ 98 | $ 129 | $ 50 |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments (Q3) (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value of Financial Instruments [Abstract] | |||
Fair value of contingent consideration | $ 0 | ||
Fair value of Level 3 warrants [Roll Forward] | |||
Beginning balance | 0 | $ 0 | |
Change in fair value | 0 | $ 1,475 | |
Ending balance | 0 | 0 | |
Fair Value Transfers between levels [Abstract] | |||
Level 1 to Level 2 asset transfers | 0 | 0 | 0 |
Level 2 to Level 1 asset transfers | 0 | 0 | 0 |
Level 1 to Level 2 liability transfers | 0 | 0 | 0 |
Level 2 to Level 1 liability transfers | 0 | 0 | 0 |
Level 3 [Member] | |||
Fair value of Level 3 warrants [Roll Forward] | |||
Beginning balance | 126 | 0 | 1,843 |
Change in fair value | (126) | (1,475) | |
Ending balance | $ 0 | $ 126 | $ 0 |
Operating Leases (Q3) (Details)
Operating Leases (Q3) (Details) | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Sep. 30, 2019USD ($)$ / ft² | Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Operating Leases [Abstract] | ||||||
Annual base rent (per square foot) | $ / ft² | 9 | |||||
Annual increase per square foot (in dollars per square foot) | $ / ft² | 0.25 | |||||
Cost Components of Operating Leases [Abstract] | ||||||
Operating lease cost | $ 53,000 | $ 158,000 | ||||
Variable lease cost | 26,000 | 85,000 | ||||
Total | 79,000 | 243,000 | ||||
Maturities of Lease Liability [Abstract] | ||||||
2019 | 52,000 | 52,000 | ||||
2020 | 213,000 | 213,000 | ||||
2021 | 219,000 | 219,000 | ||||
2022 | 55,000 | 55,000 | ||||
Total lease payments | 539,000 | 539,000 | ||||
Less: Interest | (49,000) | (49,000) | ||||
Present value of lease liability | $ 490,000 | $ 490,000 | ||||
Remaining lease term | 2 years 6 months | |||||
Discount rate | 7.50% | 7.50% | ||||
Operating cash outflows from operating lease | $ 154,000 | |||||
Rent expense | $ 54,000 | $ 160,000 | $ 293,000 | $ 290,000 | ||
Future Minimum Lease Payments [Abstract] | ||||||
2019 | $ 217,000 | 217,000 | 217,000 | |||
2020 | 220,000 | 220,000 | 220,000 | |||
2021 | 219,000 | 219,000 | 219,000 | |||
2022 | 55,000 | 55,000 | 55,000 | |||
2023 | $ 0 | $ 0 | $ 0 |
Commitments and Contingencies_4
Commitments and Contingencies (Q3) (Details) - Aquadex Product Line [Member] - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2019 | Dec. 31, 2018 | |
Contingent Consideration [Abstract] | ||
Sale or disposal of business assets threshold for contingent consideration | $ 4,000 | $ 4,000 |
Percentage of contingent consideration payments on disposal of business assets | 40.00% | 40.00% |
Maximum [Member] | ||
Contingent Consideration [Abstract] | ||
Contingent consideration period | 3 years | 3 years |
Subsequent Events (Q3) (Details
Subsequent Events (Q3) (Details) - USD ($) $ / shares in Units, $ in Thousands | Nov. 06, 2019 | Oct. 25, 2019 | Jul. 03, 2018 | Nov. 05, 2019 | Oct. 24, 2019 | Mar. 12, 2019 | Nov. 27, 2017 |
Subsequent Event [Member] | |||||||
Subsequent Events [Abstract] | |||||||
Issuance of common stock, net (in shares) | 1,219,076 | 575,830 | |||||
Public offering price (in dollars per share) | $ 1.12 | $ 1.15 | |||||
Gross proceeds from public stock offering | $ 1,360 | $ 660 | |||||
Warrants to purchase shares of common stock (in shares) | 1,219,076 | 575,830 | |||||
Exercise price of warrants (in dollars per share) | $ 0.9942 | $ 1.41 | |||||
Warrants exercisable period | 6 months | ||||||
Warrant expiry period | 5 years | 5 years | |||||
Series F Preferred Stock [Member] | |||||||
Subsequent Events [Abstract] | |||||||
Issuance of common stock, net (in shares) | 181,941 | ||||||
Public offering price (in dollars per share) | $ 29.68 | ||||||
Conversion price (in dollars per share) | $ 29.68 | $ 5.25 | $ 63 | ||||
Series F Preferred Stock [Member] | Subsequent Event [Member] | |||||||
Subsequent Events [Abstract] | |||||||
Conversion price (in dollars per share) | $ 0.9942 | $ 1.15 | $ 5.25 |