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Nuwellis, Inc. Announces Fourth Quarter and Full Year 2021 Financial Results

March 1, 2022

MINNEAPOLIS, March 01, 2022 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE) announced today its results for the fourth quarter and full year ended December 31, 2021, which included the following highlights:

  • Generated $1.6 million in total revenue for the fourth quarter 2021, 19.6% below the prior-year period and a 20% increase above the comparable pre-pandemic period in 2019.
  • Generated $7.9 million in total revenue for the fiscal year 2021, representing 6.5% growth compared to the prior-year period and a 44% increase above the comparable pre-pandemic period in 2019
  • Announced the commencement of the REVERSE-HF randomized controlled multi-center trial designed to validate Aquadex therapy as a first-line treatment option for re-hospitalized heart failure patients
  • Received a Category III CPT Code effective January 1, 2022 specifically for the use of therapeutic ultrafiltration, thereby increasing reimbursement to professionals and facilities, an important step in advancing Aquadex to standard of care
  • Ended 2021 with approximately $24.2 million in cash and no debt

“We are encouraged by our progress executing our strategy throughout 2021. Our organization and its employees continued to show adaptability and resilience amid changing market conditions and customer requirements, and we ultimately succeeded in helping more patients benefit from our therapy during the year.” said Nestor Jaramillo, CEO of Nuwellis. “We anticipate that when this most recent Omicron variant wave dissipates, we will see accelerating sales growth by continuing to position ourselves as the primary provider of ultrafiltration therapy for treating patients suffering from fluid overload that are refractory to diuretics.”

Fourth Quarter 2021 Financial Results

Revenue for the fourth quarter of 2021 was $1.6 million, compared to $2.0 million the prior year period. The decrease was primarily due to lower U.S. product sales, which was affected by order timing, hospital budgetary constraints, and a reduction in elective procedures due to COVID headwinds. When comparing fourth quarter of 2021 to the pre-pandemic fourth quarter of 2019, U.S. product revenue increased 20%.

In the fourth quarter of 2021, Pediatrics posted positive sequential growth due to increased patient census in numerous accounts following an uncharacteristically low third quarter. Heart Failure was also modestly up sequentially, while Critical Care was down due to a combination of fewer new accounts, order timing and reduced utilization.

Gross margin was 54.4% for the fourth quarter 2021, compared to 56.1% in the prior-year period based on volume and an unfavorable product and geographic mix. In contrast, volume and favorable mix increased full-year gross margin to 56.7%, a 2.2% increase compared to prior year.

Selling, general and administrative (“SG&A”) expenses for the fourth quarter of 2021 were $4.1 million, representing a decline of 7% compared to the prior year period and 12% below third quarter of 2021 levels. Vigilant cost management amid the uncertain market environment led to our lowest quarterly SG&A spend in more than two years. For full year 2021, SG&A expenses were $19.0 million, a 9% increase from prior year due to sales and marketing investments plus non-recurring management transition and administrative costs earlier in the year.  

The net loss for the fourth quarter of 2021 was $4.4 million, compared to a net loss of $3.1 million in the prior year period. The primary difference in net loss compared to the prior year period is due to a one-time foreign currency translation gain of $1.2 million dollars resulting from the dissolution of an inactive Australian subsidiary.

Cash and cash equivalents were approximately $24.2 million as of December 31, 2021.

Webcast and Conference Call Information
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 http://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing (877) 303-9826 (U.S.) or (224) 357-2194 (international) and using conference ID: 9353528. An audio archive of the webcast will be available following the call at http://ir.nuwellis.com.

About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming 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. Nuwellis is headquartered in Minneapolis, MN, with a wholly-owned subsidiary in Ireland.

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 2022 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 risks 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. Nuwellis 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.


Financial Statements

NUWELLIS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share amounts)

    Three months ended
December 31,
Twelve months ended
December 31,
    2021   2020       2021 2020  
Net sales $ 1,642   $ 2,044     $ 7,921   $ 7,441  
Cost of goods sold   748     897       3,430     3,384  
Gross profit   894     1,147       4,491     4,057  
Operating expenses:                        
Selling, general and administrative   4,094     4,384       19,039     17,417  
Research and development   1,131     1,047       4,978            3,668  
Total operating expenses   5,225     5,431       24,017     21,085  
Loss from operations   (4,331 )   (4,284 )   (19,526 )   (17,028 )
Realized foreign currency translation gain from dissolution of subsidiary   -     1,202       -     1,202  
Other income (expense), net   (21 )   (2 )   (43 )   (1 )
Loss before income taxes   (4,352 )   (3,084 )   (19,569 )   (15,827 )
Income tax expense   (2 )   (2 )   (9 )   (9 )
Net loss $ (4,354 ) $ (3,086 ) $ (19,578 ) $ (15,836 )
                         
Basic and diluted loss per share $ (0.41 ) $ (1.13 ) $ (2.87 ) $ (10.67 )
                         
Weighted average shares outstanding – basic and diluted   10,538     2,736       6,852     1,649  
                         
Other comprehensive loss:                        
Realized foreign currency translation gain from dissolution of subsidiary $ -   $ (1,202 ) $ -   $ (1,202 )
Unrealized foreign currency translation adjustments   (1 )   (12 )     (4 )   (19 )
Total comprehensive loss $ (4,355 ) $ (4,300 ) $ (19,582 ) $ (17,057 )



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

    December 31,
2021
    December 31,
2020
ASSETS          
Current assets          
Cash and cash equivalents          $ 24,205     $ 14,437  
Accounts receivable   750       905  
Inventories   2,843       2,957  
Other current assets   328       237  
Total current assets   28,126       18,536  
Property, plant and equipment, net   1,188       1,200  
Operating lease right-of-use asset, net   1,082       255  
Other assets   21       21  
TOTAL ASSETS $ 30,417     $ 20,012  
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable $ 1,414     $ 1,097  
Accrued compensation   1,664       2,192  
Current portion of operating lease liability   167       206  
Current portion of finance lease liability   26       24  
Other current liabilities   36       66  
Total current liabilities   3,307       3,585  
Operating lease liability   956       55  
Finance lease liability   28       54  
Other long-term liability   179        
Total liabilities   4,470       3,694  
           
Commitments and contingencies          
           
Stockholders’ equity          
Series A junior participating preferred stock as of December 31, 2021 and December 31, 2020, par value $0.0001 per share; authorized 30,000 shares, none outstanding          
Series F convertible preferred stock as of December 31, 2021 and December 31, 2020, par value $0.0001 per share; authorized 127 shares, issued and outstanding 127 shares          
Preferred stock as of December 31, 2021 and December 31, 2020, par value $0.0001 per share; authorized 39,969,873 shares, none outstanding          
Common stock as of December 31, 2021 and December 31, 2020, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 10,537,606 and 2,736,060, respectively   1        
Additional paid-in capital   278,873       249,663  
Accumulated other comprehensive income:          
Foreign currency translation adjustment   (11 )     (7 )
Accumulated deficit   (252,916 )     (233,338 )
Total stockholders’ equity   25,947       16,318  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 30,417     $ 20,012  



NUWELLIS, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(In thousands)

    For the years ended
December 31,
  
    2021   2020    
Operating Activities            
Net loss            $ (19,578 ) $ (15,836 )  
Adjustments to reconcile net loss to cash flows from operating activities:            
Depreciation and amortization           488   376    
Stock-based compensation expense, net           1,314   1,349    
Loss on disposal of property and equipment              40    
Realized foreign currency translation gain from dissolution of subsidiary              (1,202 )  
Changes in operating assets and liabilities:            
Accounts receivable            155   (106 )  
Inventory            (143 ) (1,420 )  
Other current assets            (91 ) (76 )  
Other assets and liabilities           186   112    
Accounts payable and accrued expenses            (211 ) 191    
Net cash used in operations            (17,880 ) (16,572 )  
             
Investing activities:            
Purchase of property and equipment            (219 ) (298 )  
Proceeds from the sale of property and equipment     31    
Net cash used in investing activities            (219 ) (267 )  
             
Financing activities:            
Proceeds from public stock offerings, net   27,896   25,921    
Proceeds from warrant exercises   1   4,115    
Payments on finance lease liability   (26 ) (20 )  
Net cash provided by financing activities            27,871   30,016    
             
Effect of exchange rate changes on cash            (4 ) (19 )  
Net increase (decrease) in cash and cash equivalents            9,768   13,158    
Cash and cash equivalents—beginning of year            14,437   1,279    
Cash and cash equivalents—end of year            $ 24,205   $ 14,437    
             
Supplemental schedule of non-cash activities            
Inventory transferred to property, plant and equipment   $ 257   $ 260    
Equipment acquired through finance lease liability   $   $ 98    
Operating right-of-use asset recorded as an operating lease liability   $ 901   $    
                 
Supplemental cash flow information                
Cash paid for income taxes   $ 11   $ 10    


INVESTOR CONTACTS:

George Montague
Chief Financial Officer, Nuwellis, Inc.
ir@nuwellis.com

Matt Bacso
Gilmartin Group
Matt.Bacso@gilmartinir.com        


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Source: Nuwellis, Inc.

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