GlobeNewswire Inc | Mar 2, 2021 08:00AM EST

March 02, 2021

EDEN PRAIRIE, Minn., March 02, 2021 (GLOBE NEWSWIRE) -- CHF Solutions, Inc. (Nasdaq: CHFS) announced today its results for the fourth quarter ended December 31, 2020.

Recent Highlights

-- Revenue for the fourth quarter of 2020 was $2 million, an increase of 49.5% compared to the prior year period -- Gross margin was 56.1% for the fourth quarter 2020, up from 50.8% in the corresponding period in 2019 and up from 46.1% in the third quarter of 2020 -- Critical Care revenue benefited in the quarter from increased utilization from hospitals treating COVID-19 patients with the Aquadex System. -- Continued to see strong momentum in pediatric accounts, adding 5 new locations including Childrens Hospitals in Philadelphia, Houston, and the San Francisco Bay Area -- Presented a 355 consecutive patient retrospective study at the Annual Scientific Meeting of Heart Failure Society of America, which showed substantial mean fluid removal with no negative changes in renal function and reduced rehospitalization rates in patients treated with Aquadex therapy -- Successfully submitted CPT code application for ultrafiltration using Aquadex SmartFlow, which will provide access to heart failure patients in the outpatient setting -- Cash and cash equivalents totaled $14.4 million with no debt as of December 31, 2020

CHF Solutions built on its momentum over the last few quarters, having delivered solid fourth quarter results, most notably within critical care and pediatric accounts, said Nestor Jaramillo, CEO of CHF Solutions. We anticipate that when healthcare systems return to some level of the new normal, we are strongly positioned to see accelerating sales growth as a leading and primary provider of ultrafiltration therapy to cardiologists, nephrologists, hospitalists, intensivists, cardiac surgeons, and pediatricians who treat fluid overload.

Fourth Quarter 2020 Financial ResultsRevenue for the fourth quarter was $2.0 million, an increase of 49.5% compared to $1.4 million in the prior year period. For the fifth straight quarter, the Company achieved sequential revenue growth, with revenues in the fourth quarter having increased 7.4% sequentially compared to the third quarter of 2020. Revenue growth in the quarter was driven by increased utilization among established pediatric accounts, the addition of five new pediatric accounts, and strong performance in critical care accounts. As COVID-19 cases accelerated in the back half of the quarter, the Company saw an increase in the number of hospitals treating COVID-19 patients with the Aquadex SmartFlow. CHF Solutions ended the year with a total of 14 centers using the Aquadex SmartFlow to treat COVID-19 patients, up from three earlier in the pandemic.

Gross margin was 56.1% for the fourth quarter 2020, up from 50.8% in the corresponding period in 2019 and up from 46.1% in the third quarter of 2020. Gross margins for the quarter were favorably impacted by increased consumables volume and improved manufacturing efficiencies.

Operating expenses for the fourth quarter of 2020 were $5.4 million, an increase of 5.7% as compared to the prior year period. The increase in operating expenses was primarily due to fully staffed sales territories and increased R&D expenses, up 10% as compared to the prior year period in 2019.

The Company recognized a gain of $1.2 million in the fourth quarter of 2020 related to the dissolution of a foreign subsidiary in Australia. The gain relates to the realization of cumulative foreign exchange adjustments previously recorded on the balance sheet. Net loss for the fourth quarter of 2020 was $3.1 million, as compared to a loss of $4.4 million in the prior year period in 2019.

The Company used $3.4 million of cash in the fourth quarter of 2020 to finance operations. Cash and cash equivalents were $14.4 million with no debt as of December 31, 2020.

Webcast and Conference Call InformationThe Company will host a conference call and webcast at 9:00 AM ET today to discuss its financial results and provide an update on the Companys performance. To access the live webcast, please visit http://ir.chf-solutions.com/events. Alternatively, you may access the live conference call by dialing (877) 303-9826 (U.S.) or (224) 357-2194 (international) and using conference ID: 5495878. An audio archive of the webcast will be available following the call at http://ir.chf-solutions.com/events.

About CHF Solutions CHF Solutions, Inc. (Nasdaq: CHFS) is a medical device company dedicated to changing the lives of patients suffering from fluid overload through science, collaboration and innovation. The company is focused on developing, manufacturing and commercializing the Aquadex SmartFlow system for ultrafiltration therapy. CHF Solutions is headquartered in Minneapolis, Minn., with wholly-owned subsidiaries in Australia and Ireland. The company has been listed on the Nasdaq Capital Market since February 2012.

About the Aquadex SmartFlow SystemThe 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 StatementsCertain 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 value that the company brings to its customers. 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 theSEC. Forward-looking statements speak only as of the date when made. CHF Solutions does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Financials

CHF SOLUTIONS, INC. AND SUBSIDIARIESCondensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except per share amounts)

Three months ended Twelve months ended December 31, December 31, 2020 2019 2020 2019Net sales $ 2,044 $ 1,367 $ 7,441 $ 5,511 Costs and expenses: Cost of goods sold 897 673 3,384 2,660 Selling, general and 4,384 4,187 17,417 16,285 administrativeResearch and development 1,047 953 3,668 4,672 Total costs and expenses 6,328 5,813 24,469 23,617 Loss from operations (4,284 ) (4,446 ) (17,028 ) (18,106 )Realized foreign currencytranslation gain from 1,202 - 1,202 - dissolution of subsidiaryOther income (expense), (2 ) 1 (1 ) - netLoss before income taxes (3,084 ) (4,445 ) (15,827 ) (18,106 )Income tax expense (2 ) (3 ) (9 ) (8 )Net loss $ (3,086 ) $ (4,448 ) $ (15,836 ) $ (18,114 ) Basic and diluted loss $ (1.13 ) $ (33.46 ) $ (10.67 ) $ (278.90 )per share Weighted average sharesoutstanding ? basic and 2,736 133 1,649 81 diluted Other comprehensive loss: Realized foreign currencytranslation gain from $ (1,202 ) $ - $ (1,202 ) $ - dissolution of subsidiaryUnrealized foreigncurrency translation $ (12 ) $ (5 ) $ (19 ) $ (9 )adjustmentsTotal comprehensive loss $ (4,300 ) $ (4,453 ) $ (17,057 ) $ (18,123 )

CHF SOLUTIONS,INC. AND SUBSIDIARIESCondensed Consolidated Balance Sheets(In thousands, except share and per share amounts)

December 31, December 31, 2020 2019ASSETS Current assets Cash and cash equivalents $ 14,437 $ 1,279 Accounts receivable 905 799 Inventories 2,957 1,797 Other current assets 237 161 Total current assets 18,536 4,036 Property, plant and equipment, net 1,200 991 Operating lease right-of-use asset, net 255 442 Other assets 21 133 TOTAL ASSETS $ 20,012 $ 5,602 LIABILITIES AND STOCKHOLDERS? EQUITY Current liabilities Accounts payable $ 1,097 $ 1,488 Accrued compensation 2,192 1,592 Current portion of operating lease liability 206 186 Current portion of finance lease liability 24 - Other current liabilities 66 85 Total current liabilities 3,585 3,351 Operating lease liability 55 261 Finance lease liability 54 - Total liabilities 3,694 3,612 Commitments and contingencies Stockholders? equity Series A junior participating preferred stock asof December 31, 2020 and December 31, 2019, par ? ? value $0.0001 per share; authorized 30,000shares, none outstandingSeries F convertible preferred stock as ofDecember 31, 2020 and December 31, 2019, parvalue $0.0001 per share; authorized 127 and 535 ? ? shares, respectively, issued and outstanding 127and 535 shares, respectivelyPreferred stock as of December 31, 2020 andDecember 31, 2019, par value $0.0001 per share; ? ? authorized 39,969,873 and 39,969,465 shares,respectively, none outstandingCommon stock as of December 31, 2020 and December31, 2019, par value $0.0001 per share; authorized ? ? 100,000,000 shares, issued and outstanding2,736,060 and 155,802, respectivelyAdditional paid-in capital 249,663 218,278 Accumulated other comprehensive income: Foreign currency translation adjustment (7 ) 1,214 Accumulated deficit (233,338 ) (217,502 )Total stockholders? equity 16,318 1,990 TOTAL LIABILITIES AND STOCKHOLDERS? EQUITY $ 20,012 $ 5,602

CHF SOLUTIONS,INC. AND SUBSIDIARIESConsolidated Statements of Cash Flows(In thousands)

For the yearsended December 31, 2020 2019Operating Activities Net loss $ (15,836 ) $ (18,114 )Adjustments to reconcile net loss to cash flows from operating activities:Depreciation and amortization 376 239 Stock-based compensation expense 1,349 1,512 Loss on disposal of property and equipment 40 ? Realized foreign currency translation gain from 1,202 ? dissolution of subsidiaryChanges in operating assets and liabilities: Accounts receivable (106 ) (13 )Inventories (1,420 ) (343 )Other current assets (76 ) 42 Other assets and liabilities 112 18 Accounts payable and accrued compensation 191 292 Net cash used in operations (16,572 ) (16,367 ) Investing activities: Purchase of property and equipment (298 ) (490 )Proceeds from the sale of property and equipment 31 ? Net cash used in investing activities (267 ) (490 ) Financing activities: Proceeds from public stock offerings, net 25,921 12,665 Proceeds from warrant exercises 4,115 ? Payments on finance lease liability (20 ) ? Net cash provided by financing activities 30,016 12,665 Effect of exchange rate changes on cash (19 ) (9 )Net increase (decrease) in cash and cash 13,158 (4,201 )equivalentsCash and cash equivalents?beginning of year 1,279 5,480 Cash and cash equivalents?end of year $ 14,437 $ 1,279 Supplemental schedule of non-cash activities Financing fees incurred for subsequent equityfinancing included in other assets and accounts $ ? $ 111 payableInventory transferred to property, plant and $ 260 $ 204 equipmentEquipment acquired through finance lease liability $ 98 $ ? Supplemental cash flow information Cash paid for income taxes $ 10 $ 4

CONTACTS:

INVESTORS:Claudia Napal DraytonChief Financial OfficerCHF Solutions, Inc.952-345-4205ir@chf-solutions.com

Matt Bacso, CFAGilmartin Group LLCMatt.bacso@gilmartinir.com

MEDIA:Jessica StebingHealth+Commerce260-336-6202jstebing@healthandcommerce.com