CHFS - CHF Solutions Inc. Announces 17 Percent Increase in Revenues for First Quarter 2019 Over Previous Year and Provides Company Update

May, 07 2019 08:00 AM Nuwellis

EDEN PRAIRIE, Minn., May 07, 2019 (GLOBE NEWSWIRE) -- CHF Solutions, Inc. (Nasdaq: CHFS) announced today its results for the first quarter ended March 31, 2019, which included the following highlights:

Revenue for first quarter ended March 31, 2019 was $1.2 million, an increase of 17 percent compared to the same period of the prior year. Gross margin percentages increased to 50 percent from 13 percent from the same period a year ago, after transition to in-house manufactured inventory.
Continued progress towards obtaining regulatory clearance for an expanded label in pediatrics. Pre-submission meeting with the FDA scheduled for May 2019.
Continued expansion into cardiovascular surgery and announced the launch of two new accounts with surgery focus.
Exhibited at three cardiovascular surgery conferences: Society of Thoracic Surgeons in January 2019, International Conference of Heart and Lung Transplantation in March 2019, and the American Association for Thoracic Surgery conference in May 2019. Sponsored seminar led by renowned cardiothoracic surgeon, Dr. Daniel Beckles, MD, PhD.
Announced the publication of an article in the Journal of Medical Economics, a peer reviewed journal that evaluated the cost saving benefits of the Aquadex FlexFlow® system in the hospital setting.
Closed on an underwritten public offering of stock, for net proceeds of $11.0 million. Ended quarter with $11.5 million in cash and no debt.

“We began the year strong with continued double-digit increase in our revenues over the previous year and we believe we are well-poised to continue to grow in the quarters to come,” said John Erb, chairman and CEO of CHF Solutions. “We will continue to develop and refine our strategic focus toward driving revenue, which is the key metric our employees, shareholders and potential investors use to measure performance.”

FINANCIALS

CHF SOLUTIONS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited and in thousands, except per share amounts)



Three months ended March 31,


2019


2018

Net sales
$
1,215

$
1,037

Costs and Expenses:






Cost of goods sold

612


901

Selling, general and administrative

4,018


4,011

Research and development

1,310


479

Total costs and expenses

5,940


5,391

Loss from operations

(4,725
)

(4,354
)
Loss before income taxes

(4,725
)

(4,354
)
Income tax expense

(2
)

—

Net loss
$
(4,727
)
$
(4,354
)







Basic and diluted loss per share
$
(11.47
)
$
(15.12
)







Weighted average shares outstanding – basic and diluted

805


288








Other comprehensive income:






Foreign currency translation adjustments
$
(2
)
$
1

Total comprehensive loss
$
(4,729
)
$
(4,353
)

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



March 31, 2019


December 31, 2018

ASSETS

(unaudited)




Current assets






Cash and cash equivalents
$
11,489

$
5,480

Accounts receivable

622


786

Inventory

1,790


1,658

Other current assets

350


203

Total current assets

14,251


8,127

Property, plant and equipment, net

518


536

Operating lease right-of-use asset

574


—

Other assets

20


113

TOTAL ASSETS
$
15,363

$
8,776








LIABILITIES AND STOCKHOLDERS’ EQUITY






Current liabilities






Accounts payable
$
1,202

$
1,133

Accrued compensation

831


1,498

Current portion of operating lease liability

171


—

Other current liabilities

228


209

Total current liabilities

2,432


2,840

Operating lease liability

403


-

Total liabilities

2,835


2,840








Commitments and contingencies

—


—








Stockholders’ equity






Series A junior participating preferred stock as of March 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 30,000 shares, none outstanding

—


—

Series F convertible preferred stock as of March 31, 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 March 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 810,142 and 0 shares, respectively, issued and outstanding 810,142 and 0, respectively






Preferred stock as of March 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 39,159,323 and 39,969,465 shares, none outstanding

—


—

Common stock as of March 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 2,069,020 and 513,445, respectively

—


—

Additional paid?in capital

215,422


204,101

Accumulated other comprehensive income:






Foreign currency translation adjustment

1,221


1,223

Accumulated deficit

(204,115
)

(199,388
)
Total stockholders’ equity

12,528


5,936

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
15,363

$
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






















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

CHF SOLUTIONS, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited and in thousands)




Three months ended March 31,




2019

2018








Operating Activities:

Net loss

$
(4,727
)
$
(4,354
)
Adjustments to reconcile net loss to cash flows used in operating activities:







Depreciation and amortization


59


54

Stock-based compensation expense, net


362


500

Changes in operating assets and liabilities:







Accounts receivable


164


(113
)
Inventory


(132
)

(937
)
Other current assets


(147
)

6

Other assets and liabilities


112


—

Accounts payable and accrued expenses


(598
)

(192
)
Net cash used in operating activities


(4,907
)

(5,036
)








Investing Activities:







Purchases of property and equipment


(41
)

(57
)
Net cash used in investing activities


(41
)

(57
)








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


(2
)

2

Net increase (decrease) in cash and cash equivalents


6,009


(5,091
)
Cash and cash equivalents - beginning of period


5,480


15,595

Cash and cash equivalents - end of period

$
11,489

$
10,504









Supplemental cash flow information







Cash paid for income taxes

$
—

$
—

The 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 Company’s performance.

To access the live webcast, please visit the Investors page of the CHF Solutions website at http://ir.chf-solutions.com or access the webcast directly at 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: 7369669. An audio archive of the webcast will be available following the call on the Investor page at http://ir.chf-solutions.com/events.

About CHF Solutions

CHF Solutions, Inc. (NASDAQ:CHFS) is a medical device company focused on commercializing the Aquadex FlexFlow system for Aquapheresis therapy. The Aquadex FlexFlow system 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. All treatments must be administered by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies. The company's mission is to predict, measure, and control patient fluid balance through science, collaboration, and innovative medical technology. CHF Solutions is a Delaware corporation headquartered in Minneapolis, Minnesota with wholly owned subsidiaries in Australia and Ireland. The company has been listed on the NASDAQ Capital Market since February 2012.

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 in future quarters. 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 SEC. 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.

CONTACTS:

INVESTORS:
Claudia Napal Drayton
Chief Financial Officer
CHF Solutions, Inc.
952-345-4205
ir@chf-solutions.com

-or-
Bret Shapiro
Managing Partner
CORE IR
516-222-2560
brets@coreir.com
www.coreir.com

MEDIA
Jules Abraham
JQA Partners, Inc.
917-885-7378
jabraham@jqapartners.com

Company Name:	Nuwellis
Stock Symbol:	CHFS
Market:	NASDAQ
Website:	nuwellis.com

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