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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

Current Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 8, 2022

Nuwellis, Inc.
(Exact Name of Registrant as Specified in its Charter)

Delaware
001-35312
No. 68-0533453
(State or Other Jurisdiction of Incorporation or Organization)
(Commission File Number)
(I.R.S. Employer Identification No.)

12988 Valley View Road, Eden Prairie, MN 55344
(Address of Principal Executive Offices) (Zip Code)

(952) 345-4200
(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.0001 per share
NUWE
Nasdaq Capital Market

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02
Results of Operations and Financial Condition.

On November 8, 2022, Nuwellis, Inc. (the “Company”) issued a press release reporting its financial results for the three and nine months ended September 30, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information included in this Current Report on Form 8-K (including Exhibit 99.1) is furnished pursuant to Item 2.02 and shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section.

Item 9.01
Financial Statements and Exhibits.

  (d)
Exhibits

Exhibit No. Description

Press Release, dated November 8, 2022, reporting the financial results of Nuwellis, Inc. for the three and nine months ended September 30, 2022.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: November 8, 2022
NUWELLIS, INC.
   
 
By:
/s/ Nestor Jaramillo, Jr.
  
 
Name:
Nestor Jaramillo, Jr.
  
 
Title:
President and Chief Executive Officer
  


Exhibit 99.1

 

Nuwellis, Inc. Reports Third Quarter 2022 Financial Results

Minneapolis, MN, November 8, 2022 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today reported financial results for the third quarter ended September 30, 2022.

Q3 Results and Recent Highlights:


 •
Revenue of $2.1 million in the third quarter 2022, an 11% increase over the same year ago period

•
Gross margin of 61% was consistent with the same period last year

•
Activated three additional sites for pivotal REVERSE-HF clinical study

•
Announced AVOID-HF clinical study analysis demonstrating statistically superior benefit of ultrafiltration over diuretics for fluid-overloaded heart failure patients at 30 and 90 days

•
Announced clinical data demonstrating reduced mortality rates, with 100% survival rate in post-operative CABG patients at 30 days following use of ultrafiltration

•
Awarded U.S. patent for novel innovation that improves fluid balance and safety in pediatric dialysis and hemofiltration

•
Closed an underwritten public offering on October 18, with $11.0 million of gross proceeds

“We made meaningful progress this quarter on the continued execution of our key strategic initiatives and achieved 11% year-over-year revenue growth.  These results not only demonstrate that we are gaining traction on the sales front but also continuing to achieve key milestones toward making the Aquadex system the standard of care for restoring fluid balance.  We are confident that continued expansion of our field sales team, including clinical education specialists, bolstered by our market penetration initiatives and growing body of clinical evidence, will position Nuwellis well for strong growth in 2023 and beyond,” said Nestor Jaramillo, CEO of Nuwellis.

Third Quarter 2022 Financial Results

Total revenue for the third quarter of 2022 was $2.1 million, an increase of 11% compared to the third quarter of 2021.

Gross margin was 61.0% for the third quarter of 2022 compared to 60.4% in the prior-year period.

Selling, general and administrative expenses for the third quarter of 2022 were $4.3 million, compared to $4.6 million in the prior-year period. This reduction resulted from continued spending vigilance, as well as some open positions in the current year quarter.

Third quarter research and development expenses were $0.9 million, compared to $1.7 million in the third quarter of 2021, while continuing to advance the most critical new product development initiatives.

The net loss for the third quarter of 2022 was $3.9 million, or a loss of $0.37 per basic and diluted common share, compared to a net loss of $5.3 million, or a loss of $0.75 per basic and diluted common share in the prior-year period.

Cash and cash equivalents were approximately $12.1 million at September 30, 2022. On October 18, Nuwellis closed an underwritten public offering with gross proceeds of $11.0 million. After deducting underwriting discounts and commissions on the offering, pro forma cash at the end of the third quarter would have been $21.9 million.

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 the Investors page of the Nuwellis website at https://ir.nuwellis.com. Alternatively, you may access the live conference call by dialing 1-844-825-9789 (U.S) or 1-412-317-5180 (international) and using the conference ID: 10172214. An audio archive of the webcast will be available following the call on the Investors page at  https://ir.nuwellis.com.

About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology 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 superior 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 healthcare provider, in 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.

CONTACTS

INVESTORS:

Vivian Cervantes
Gilmartin Group
ir@nuwellis.com

MEDIA:

Sarah Lundberg
Health+Commerce
sarahlundberg@healthandcommerce.com

FINANCIAL STATEMENTS

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

   
September 30,
2022
    
December 31,
2021
  
ASSETS
  
(unaudited)
        
Current assets
            
Cash and cash equivalents
  
$
12,053
    
$
24,205
  
Accounts receivable
    
1,100
      
750
  
Inventories
    
2,919
      
2,843
  
Other current assets
    
368
      
328
  
Total current assets
    
16,440
      
28,126
  
Property, plant and equipment, net
    
1,027
      
1,188
  
Operating lease right-of-use asset
    
949
      
1,082
  
Other assets
    
21
      
21
  
TOTAL ASSETS
  
$
18,437
    
$
30,417
  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY
                
Current liabilities
                
Accounts payable
  
$
1,561
    
$
1,414
  
Accrued compensation
    
1,751
      
1,664
  
Current portion of operating lease liability
    
191
      
167
  
Current portion of finance lease liability
    
35
      
26
  
Other current liabilities
    
73
      
36
  
Total current liabilities
    
3,611
      
3,307
  
Operating lease liability
    
810
      
956
  
Finance lease liability
  

 —      
28
  
Other long-term liability
    
—
      
179
  
Total liabilities
    
4,421
      
4,470
  
                 
Commitments and contingencies
                
                 
Stockholders’ equity
                
Series A junior participating preferred stock as of September 30, 2022 and
December 31, 2021, par value $0.0001 per share; authorized 30,000 shares, none outstanding
    
—
      
—
  
Series F convertible preferred stock as of both September 30, 2022 and
December 31, 2021, par value $0.0001 per share; authorized 127 shares, issued and outstanding 127 shares
    
—
      
—
  
Preferred stock as of both September 30, 2022 and December 31, 2021, par value
$0.0001 per share; authorized 39,969,873 shares, none outstanding
    
—
      
—
  
Common stock as of September 30, 2022 and December 31, 2021, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding 10,537,606 shares
    
1
       1
  
Additional paid-in capital
    
279,570
      
278,873
  
Accumulated other comprehensive income:
                
Foreign currency translation adjustment
    
(10
)
    
(11
)
Accumulated deficit
    
(265,545
)
    
(252,916
)
Total stockholders’ equity
    
14,016
      
25,947
  
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
  
$
18,437
    
$
30,417
  

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

   
Three months ended
September 30,
    
Nine months ended
September 30,
  
   
2022
    
2021
    
2022
    
2021
  
Net sales
  
$
2,065
    
$
1,853
    
$
6,204
    
$
6,279
  
Cost of goods sold
    
806
      
733
      
2,780
      
2,682
  
Gross profit
    
1,259
      
1,120
      
3,424
      
3,597
  
Operating expenses:
                                
Selling, general and administrative
    
4,251
      
4,645
      
12,920
      
14,945
  
Research and development
    
928
      
1,726
      
3,141
      
3,847
  
Total operating expenses
    
5,179
      
6,371
      
16,061
      
18,792
  
Loss from operations
    
(3,920
)
    
(5,251
)
    
(12,637
)
    
(15,195
)
Other income (expense), net
    
52
      
(19
)
    
14
      
(22
)
Loss before income taxes
    
(3,868
)
    
(5,270
)
    
(12,623
)
    
(15,217
)
Income tax expense
    
(2
)
    
(2
)
    
(6
)
    
(7
)
Net loss
  
$
(3,870
)
  
$
(5,272
)
  
$
(12,629
)
  
$
(15,224
)
                                 
Basic and diluted loss per share
  
$
(0.37
)
  
$
(0.75
)
  
$
(1.20
)
  
$
(2.72
)
                                 
Weighted average shares outstanding – basic and diluted
    
10,538
      
7,098
      
10,538
      
5,624
  
                                 
Other comprehensive loss:
                                
Foreign currency translation adjustments
  
$
2
    
$
—
    
$
1
    
$
(3
 )
Total comprehensive loss
  
$
(3,868
)
  
$
(5,272
)
  
$
(12,628
)
  
$
(15,227
)

NUWELLIS, INC. AND SUBSIDIARY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)

   
Nine months ended
September 30,
  
   
2022
    
2021
  
Operating Activities:
            
Net loss
  
$
(12,629
)
  
$
(15,224
)
Adjustments to reconcile net loss to cash flows used in operating activities:
                
Depreciation and amortization
    
301
      
383
  
Stock-based compensation expense, net
    
697
      
993
  
Changes in operating assets and liabilities:
                
Accounts receivable
    
(350
)
    
(164
)
Inventory
    
(113
)
    
(105
)
Other current assets
    
(40
)
    
(183
)
Other assets and liabilities
    
(142
)
    
279
  
Accounts payable and accrued expenses
    
254
      
333
  
Net cash used in operating activities
    
(12,022
)
    
(13,688
)
                 
Investing Activities:
                
Purchases of property and equipment
    
(103
)
    
(191
)
Net cash used in investing activities
    
(103
)
    
(191
)
                 
Financing Activities:
                
Proceeds from public stock offerings, net
    
—
      
27,896
  
Proceeds from warrant exercises
    
—
      
1
  
Payments on finance lease liability
    
(28
)
    
(21
)
Net cash provided (used in) by financing activities
    
(28
)
    
27,876
  
                 
Effect of exchange rate changes on cash
    
1
      
(3
)
Net increase (decrease) in cash and cash equivalents
    
(12,152
)
    
13,994
  
Cash and cash equivalents - beginning of period
    
24,205
      
14,437
  
Cash and cash equivalents - end of period
  
$
12,053
    
$
28,431
  
                 
Supplemental cash flow information
                
Inventory transferred to property, plant and equipment
  
$
37
    
$
257