CHF Solutions, Inc. Announces 34 Percent Increase in Revenue for First Quarter 2020 Over Previous Year and Provides Company Update
- Revenue for the first quarter ended
March 31, 2020 , was$1.6 million , an increase of 34 percent compared to the same period of the prior year. Revenue increased by 19% from Q4 of 2019. - Received 510(k) clearance in the
U.S. and CE Mark in the EU for adult and pediatric patients who weigh 20 kg or more and for the next generation Aquadex console, the Aquadex SmartFlow™. - Announced that Aquadex therapy is helping COVID-19 patients by managing fluid overload when dialysis equipment is in short supply.
- Hosted two physician-led webinars on treatment of critically ill, COVID-19 patients, which addressed the importance of fluid management per the
World Health Organization guidelines, and real-life applications of simple ultrafiltration, such as Aquadex therapy, in COVID-19 patients. - Announced expansion of commercial presence in
Europe with distribution arrangement forGermany ,Austria andSwitzerland , and regulatory clearance to sell inIndia . - Ended the quarter with
$5.7 million in cash and no debt. Subsequent to quarter end, announced the closing of two registered direct offerings for net proceeds of approximately$3.5 million , and warrant exercises of approximately$1.0 million , for total pro forma cash balance as ofMarch 31, 2020 of$10.1 million .
“We are very pleased that we produce a product that is providing a meaningful therapy for treating the COVID-19 patients,” said
The Company will host a conference call and webcast at
About
About the Aquadex SmartFlow System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.
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 new market opportunities and anticipated growth in 2020 and beyond. 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 impact of the COVID-19 pandemic, 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 SEC. Forward-looking statements speak only as of the date when made.
FINANCIALS
Condensed Consolidated Statements of Operations and Comprehensive Loss
(unaudited, in thousands, except per share amounts)
Three months ended |
||||||
2020 | 2019 | |||||
Net sales | $ | 1,630 | $ | 1,215 | ||
Costs and Expenses: | ||||||
Cost of goods sold | 796 | 612 | ||||
Selling, general and administrative | 4,537 | 4,018 | ||||
Research and development | 864 | 1,310 | ||||
Total costs and expenses | 6,197 | 5,940 | ||||
Loss from operations | (4,567 | ) | (4,725 | ) | ||
Other income, net | 1 | - | ||||
Loss before income taxes | (4,566 | ) | (4,725 | ) | ||
Income tax expense | (2 | ) | (2 | ) | ||
Net loss | $ | (4,568 | ) | $ | (4,727 | ) |
Basic and diluted loss per share | $ | (0.37 | ) | $ | (11.47 | ) |
Weighted average shares outstanding – basic and diluted | 16,439 | 805 | ||||
Other comprehensive income: | ||||||
Foreign currency translation adjustments | $ | (3 | ) | $ | (2 | ) |
Total comprehensive loss | $ | (4,571 | ) | $ | (4,729 | ) |
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
2020 |
2019 |
|||||
ASSETS | (unaudited) | |||||
Current assets | ||||||
Cash and cash equivalents | $ | 5,669 | $ | 1,279 | ||
Accounts receivable | 727 | 799 | ||||
Inventory | 2,195 | 1,797 | ||||
Other current assets | 141 | 161 | ||||
Total current assets | 8,732 | 4,036 | ||||
Property, plant and equipment, net | 897 | 991 | ||||
Operating lease right-of-use asset | 397 | 442 | ||||
Other assets | 21 | 133 | ||||
TOTAL ASSETS | $ | 10,047 | $ | 5,602 | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||
Current liabilities | ||||||
Accounts payable | $ | 787 | $ | 1,488 | ||
Accrued compensation | 1,114 | 1,592 | ||||
Current portion of operating lease liability | 191 | 186 | ||||
Other current liabilities | 39 | 85 | ||||
Total current liabilities | 2,131 | 3,351 | ||||
Operating lease liability | 212 | 261 | ||||
Total liabilities | 2,343 | 3,612 | ||||
Commitments and contingencies | — | — | ||||
Stockholders’ equity | ||||||
Series A junior participating preferred stock as of none outstanding |
— | — | ||||
Series F convertible preferred stock as of 2019, par value respectively, issued and outstanding 435 and 535, respectively |
— | — | ||||
Series H convertible preferred stock as of 31, 2019, par value respectively, issued and outstanding 488,090 and 0, respectively |
||||||
Preferred stock as of outstanding |
— | — | ||||
Common stock as of 27,142,390 and 4,674,068, respectively |
3 | — | ||||
Additional paid‑in capital | 228,560 | 218,278 | ||||
Accumulated other comprehensive income: | ||||||
Foreign currency translation adjustment | 1,211 | 1,214 | ||||
Accumulated deficit | (222,070 | ) | (217,502 | ) | ||
Total stockholders’ equity | 7,704 | 1,990 | ||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 10,047 | $ | 5,602 | ||
Condensed Consolidated Statements of Cash Flows
(unaudited, in thousands)
Three months ended |
||||||||
2020 |
2019 | |||||||
Operating Activities: | ||||||||
Net loss | $ | (4,568 | ) | $ | (4,727 | ) | ||
Adjustments to reconcile net loss to cash flows used in operating activities: | ||||||||
Depreciation and amortization | 65 | 59 | ||||||
Stock-based compensation expense, net | 380 | 362 | ||||||
Loss on disposal of property and equipment | 46 | — | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | 72 | 164 | ||||||
Inventory | (398 | ) | (132 | ) | ||||
Other current assets | 20 | (147 | ) | |||||
Other assets and liabilities | 67 | 112 | ||||||
Accounts payable and accrued expenses | (1,179 | ) | (598 | ) | ||||
Net cash used in operating activities | (5,495 | ) | (4,907 | ) | ||||
Investing Activities: | ||||||||
Purchases of property and equipment | (17 | ) | (41 | ) | ||||
Net cash used in investing activities | (17 | ) | (41 | ) | ||||
Financing Activities: | ||||||||
Proceeds from public stock offerings, net | 9,616 | 10,959 | ||||||
Proceeds from warrant exercises | 289 | — | ||||||
Net cash provided by financing activities | 9,905 | 10,959 | ||||||
Effect of exchange rate changes on cash | (3 | ) | (2 | ) | ||||
Net increase (decrease) in cash and cash equivalents | 4,390 | 6,009 | ||||||
Cash and cash equivalents - beginning of period | 1,279 | 5,480 | ||||||
Cash and cash equivalents - end of period | $ | 5,669 | $ | 11,489 | ||||
Supplemental cash flow information | ||||||||
Cash paid for income taxes | $ | — | $ | — | ||||
CONTACTS: INVESTORS:Claudia Napal Drayton Chief Financial OfficerCHF Solutions, Inc. 952-345-4205 ir@chf-solutions.com MEDIA:Jessica Stebing Health+Commerce 260-336-6202 jstebing@healthandcommerce.com
Source: CHF Solutions, Inc.