CHF Solutions, Inc. Announces 53 Percent Increase in Revenues for Second Quarter 2019 Over Previous Year and 38 Percent Increase from Q1 2019
- Revenue for second quarter ended
June 30, 2019 was$1.7 million , an increase of 53 percent compared to the same period of the prior year, and 38% sequentially from Q1 2019. Gross margin percentages increased to 50 percent from 21 percent during the same period a year ago, after transition to in-house manufactured inventory. - Opened 7 new hospitals and hospital systems. In Q3 expect to open more than 10 new accounts including several new hospital systems.
- Increased field education specialists from 5 to 14 to support new account launches and rapid growth.
- Continued progress towards obtaining regulatory clearance for an expanded label in pediatrics. Pre-submission meeting with the
FDA held inMay 2019 ; submission expected in Q3 2019 and clearance in Q4 2019. - Working with a large hospital system in
New York on a 700 patient retrospective study to evaluate the clinical impact of utilizing the Aquadex FlexFlow® system on post-surgery patients, and with a large hospital inPhiladelphia on a 344 patient retrospective study to evaluate the impact of ultrafiltration on fluid removal, renal outcomes, and readmission rates.
“We continue to deliver impressive double-digit increase in our revenue, and we believe we are well-poised to continue to grow in the quarters to come,” said
FINANCIALS
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited and in thousands, except per share amounts)
|
Three months ended June 30, |
Six months ended June 30, |
|||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Net sales | $ | 1,677 | $ | 1,099 | $ | 2,892 | $ | 2,136 | |||||||
Costs and expenses: | |||||||||||||||
Cost of goods sold | 835 | 870 | 1,447 | 1,771 | |||||||||||
Selling, general and administrative | 3,973 | 3,765 | 7,991 | 7,776 | |||||||||||
Research and development | 1,297 | 643 | 2,607 | 1,122 | |||||||||||
Total costs and expenses | 6,105 | 5,278 | 12,045 | 10,669 | |||||||||||
Loss from operations | (4,428 | ) | (4,179 | ) | (9,153 | ) | (8,533 | ) | |||||||
Loss before income taxes | (4,428 | ) | (4,179 | ) | (9,153 | ) | (8,533 | ) | |||||||
Income tax expense | (2 | ) | (2 | ) | (4 | ) | (2 | ) | |||||||
Net loss | $ | (4,430 | ) | $ | (4,181 | ) | $ | (9,157 | ) | $ | (8,535 | ) | |||
Basic and diluted loss per share | $ | (1.93 | ) | $ | (13.03 | ) | $ | (8.82 | ) | $ | (28.03 | ) | |||
Weighted average shares outstanding – basic and diluted | 2,295 | 321 | 1,550 | 304 | |||||||||||
Other comprehensive loss: | |||||||||||||||
Foreign currency translation adjustments | $ | (3 | ) | $ | (2 | ) | $ | (5 | ) | $ | (1 | ) | |||
Total comprehensive loss | $ | (4,433 | ) | $ | (4,183 | ) | $ | (9,162 | ) | $ | (8,536 | ) |
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
June 30, 2019 |
December 31, 2018 |
|||||
ASSETS | (unaudited) | |||||
Current assets | ||||||
Cash and cash equivalents | $ | 7,402 | $ | 5,480 | ||
Accounts receivable | 932 | 786 | ||||
Inventory | 1,690 | 1,658 | ||||
Other current assets | 278 | 203 | ||||
Total current assets | 10,302 | 8,127 | ||||
Property, plant and equipment, net | 574 | 536 | ||||
Operating lease right-of-use asset | 531 | — | ||||
Other assets | 21 | 113 | ||||
TOTAL ASSETS | $ | 11,428 | $ | 8,776 | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
Current liabilities | ||||||
Accounts payable | $ | 1,178 | $ | 1,133 | ||
Accrued compensation | 1,186 | 1,498 | ||||
Current portion of operating lease liability | 176 | — | ||||
Other current liabilities | 97 | 209 | ||||
Total current liabilities | 2,637 | 2,840 | ||||
Operating lease liability | 357 | - | ||||
Total liabilities | 2,994 | 2,840 | ||||
Commitments and contingencies | — | — | ||||
Stockholders’ equity | ||||||
Series A junior participating preferred stock as of June 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 30,000 shares, none outstanding | — | — | ||||
Series F convertible preferred stock as of June 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 535 and 535 shares, respectively, issued and outstanding 535 and 535, respectively | — | — | ||||
Series G convertible preferred stock as of June 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 550,842 and 0 shares, respectively, issued and outstanding 550,842 and 0, respectively | ||||||
Preferred stock as of June 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 39,418,623 and 39,969,465 shares, none outstanding |
— | — | ||||
Common stock as of June 30, 2019 and December 31, 2018, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 2,328,320 and 513,445, respectively |
— | — | ||||
Additional paid‑in capital | 215,761 | 204,101 | ||||
Accumulated other comprehensive income: | ||||||
Foreign currency translation adjustment | 1,218 | 1,223 | ||||
Accumulated deficit | (208,545 | ) | (199,388 | ) | ||
Total stockholders’ equity | 8,434 | 5,936 | ||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 11,428 | $ | 8,776 |
CHF SOLUTIONS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Stockholders’ Equity
(Unaudited, In thousands, except share amounts)
Outstanding Shares of Common Stock |
Common Stock |
Additional Paid in Capital |
Accumulated Other Comprehensive Income |
Accumulated Deficit |
Stockholders’ Equity |
||||||||||||||||||
Balance December 31, 2017 | 271,357 | $ | — | $ | 197,367 | $ | 1,227 | $ | (182,356 | ) | $ | 16,238 | |||||||||||
Net loss | — | — | — | — | (4,354 | ) | (4,354 | ) | |||||||||||||||
Foreign currency translation adjustment | — | — | — | 1 | — | 1 | |||||||||||||||||
Stock-based compensation and stock awards, net | 3 | — | 501 | — | — | 501 | |||||||||||||||||
Conversion of preferred stock into common stock | 32,365 | — | — | — | — | — | |||||||||||||||||
Balance March 31, 2018 | 303,725 | $ | — | $ | 197,868 | $ | 1,228 | $ | (186,710 | ) | $ | 12,386 | |||||||||||
Net loss | — | — | — | — | (4,181 | ) | (4,181 | ) | |||||||||||||||
Foreign currency translation adjustment | — | — | — | (2 | ) | — | (2 | ) | |||||||||||||||
Stock-based compensation, net | 3 | — | 606 | — | — | 606 | |||||||||||||||||
Conversion of preferred stock into common stock | 18,127 | — | — | — | — | — | |||||||||||||||||
Balance June 30, 2018 | 321,855 | $ | — | $ | 198,474 | $ | 1,226 | $ | (190,891 | ) | $ | 8,809 | |||||||||||
Outstanding Shares of Common Stock |
Common Stock |
Additional Paid in Capital |
Accumulated Other Comprehensive Income |
Accumulated Deficit |
Stockholders’ Equity |
||||||||||||||||||
Balance December 31, 2018 | 513,445 | $ | — | $ | 204,101 | $ | 1,223 | $ | (199,388 | ) | $ | 5,936 | |||||||||||
Net loss | — | — | — | — | (4,727 | ) | (4,727 | ) | |||||||||||||||
Foreign currency translation adjustment | — | — | — | (2 | ) | — | (2 | ) | |||||||||||||||
Stock-based compensation, net | 3 | — | 362 | — | — | 362 | |||||||||||||||||
Issuance of common and preferred stock, net | 455,178 | — | 10,959 | — | — | 10,959 | |||||||||||||||||
Conversion of preferred stock into common stock | 1,100,394 | — | — | — | — | — | |||||||||||||||||
Balance March 31, 2019 | 2,069,020 | $ | — | $ | 215,422 | $ | 1,221 | $ | (204,115 | ) | $ | 12,528 | |||||||||||
Net loss | — | — | — | — | (4,430 | ) | (4,430 | ) | |||||||||||||||
Foreign currency translation adjustment | — | — | — | (3 | ) | — | (3 | ) | |||||||||||||||
Stock-based compensation, net | — | — | 339 | — | — | 339 | |||||||||||||||||
Conversion of preferred stock into common stock | 259,300 | — | — | — | — | — | |||||||||||||||||
Balance June 30, 2019 | 2,328,320 | $ | — | $ | 215,761 | $ | 1,218 | $ | (208,545 | ) | $ | 8,434 |
Condensed Consolidated Statements of Cash Flows
(Unaudited and in thousands)
Six months ended June 30, |
|||||||
2019 | 2018 | ||||||
Operating Activities: | |||||||
Net loss | $ | (9,157 | ) | $ | (8,535 | ) | |
Adjustments to reconcile net loss to cash flows used in operating activities: | |||||||
Depreciation and amortization | 120 | 115 | |||||
Stock-based compensation expense, net | 701 | 1,107 | |||||
Changes in operating assets and liabilities: | |||||||
Accounts receivable | (146 | ) | (107 | ) | |||
Inventory | (32 | ) | (727 | ) | |||
Other current assets | (75 | ) | (48 | ||||
Other assets and liabilities | (18 | ) | — | ||||
Accounts payable and accrued expenses | (267 | ) | (283 | ) | |||
Net cash used in operating activities | (8,874 | ) | (8,478 | ) | |||
Investing Activities: | |||||||
Purchases of property and equipment | (158 | ) | (121 | ) | |||
Net cash used in investing activities | (158 | ) | (121 | ) | |||
Financing Activities: | |||||||
Net proceeds from public stock offering, net | 10,959 | — | |||||
Net cash provided by financing activities | 10,959 | — | |||||
Effect of exchange rate changes on cash | (5 | ) | (1 | ) | |||
Net increase (decrease) in cash and cash equivalents | 1,922 | (8,600 | ) | ||||
Cash and cash equivalents - beginning of period | 5,480 | 15,595 | |||||
Cash and cash equivalents - end of period | $ | 7,402 | $ | 6,995 | |||
The Company will host a conference call and webcast at
To access the live webcast, please visit the Investors page of the
About
Forward-Looking Statements
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the Company’s ability to grow revenue and add new accounts in future quarters and the timing of the regulatory clearance for an expanded label in pediatrics. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risk associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the
CONTACTS:
INVESTORS:
Chief Financial Officer
952-345-4205
ir@chf-solutions.com
-or-
Managing Partner
CORE IR
516-222-2560
brets@coreir.com
www.coreir.com
MEDIA
917-885-7378
jabraham@jqapartners.com
Source: CHF Solutions, Inc.