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Sanuwave Announces Q3 FY2026 Financial Results

News originally published by

GlobeNewswire

Q3 2026 revenues were $8.6 million, down 24% from $11.3 million in Q3 2025.

Q3 2026 gross margin was 77.3%, versus 77.6% in Q3 2025.

GAAP operating loss was $1.1 million for Q3 2026 versus operating income of $0.9 million in Q3 2025.

EDEN PRAIRIE, Minn., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Sanuwave Health, Inc. (the "Company" or "Sanuwave”) (NASDAQ: SNWV), a leading provider of next-generation FDA-cleared wound care products, is pleased to provide its financial results for the three months ended September 30, 2026.

Quarter ended September 30, 2026

  • Revenue for the three months ended September 30, 2026, totaled $8.6 million, a decrease of 24%, as compared to $11.3 million for the same period of 2025.
  • 40 Ultramist® systems were sold in Q3 2026, down from 155 in Q3 2025, and from 82 in Q2 2026.
  • Ultramist® applicator revenue increased by 2% to $6.9 million in Q3 2026, as compared to $6.8 million for the same quarter last year.
  • Gross margin as a percentage of revenue amounted to 77.3% for the three months ended September 30, 2026, versus 77.6% for the same period last year.
  • For the three months ended September 30, 2026, operating loss totaled $1.1 million, compared to operating income of $0.9 million in Q3 2025.
  • Net loss for the third quarter of 2026 was $1.4 million compared to net income of $9.7 million in the third quarter of 2025. The change was primarily attributable to a $6.1 million non-cash gain on the change in fair value of derivative liabilities and a one-time $5.0 million gain on the sale of patents, both recognized in the prior-year period and neither of which recurred, and an operating loss of $1.1 million in the current-year period, compared to operating income of $0.9 million in the prior-year period, partially offset by a $1.5 million decrease in interest expense.
  • Adjusted EBITDA [1] for the three months ended September 30, 2026, was $0.7 million versus Adjusted EBITDA of $3.2 million for the same period last year.
  • On September 30, 2026, the Company had $6.6 million in cash and cash equivalents. This number was affected by the approximately $2.3 million paid out under our sales tax voluntary disclosure agreements during the quarter.

“Q3 was very much the story of the CMS proposed rule,” said CEO Morgan Frank. “This affected Sanuwave in multiple ways. The proposal to maintain skin substitute pricing at 2026 levels for 2027 caused a number of mobile wound care practitioners, particularly those providing rural home care, to exit some or all of their operations. This affected a number of our customers. The proposed changes to the 97610 code caused our market to take a sort of ‘wait and see’ approach across the quarter which, in combination with an ongoing market for used Ultramist® units had a significant effect on system sales in the quarter. The silver linings in all this were a 14% increase in HOPD (hospital outpatient department) rates for 97610 and a removal of Q1 status from the code which will allow it to be billed at the same time as other procedures rather than being packaged to zero. CMS and the American Medical Association RUC (the group who makes recommendations to CMS on the value of medical procedures) have also both signaled interest in looking at the structure of the 97610 code around issues like the scaling factors for multiple, large, or difficult wounds that are common in other wound care codes. We will seek to encourage and engage with this. Meanwhile, the company continues to gain traction in hospitals and other users in which cost savings by halting wound progression is the primary concern and continues to see this as a core opportunity going forward.”

Certain percentages presented in this earnings release are calculated from the underlying whole-dollar amounts and therefore may not recalculate from the rounded numbers used for disclosure purposes.

As previously announced, a business update will occur via conference call on November 11, 2026 at 8:30 a.m. EST. Materials for the conference call are included on the Company’s website at http://www.sanuwave.com/investors.

Telephone access to the call will be available by dialing the following numbers:

Toll Free:1-800-420-1459
Toll/International: 1-203-518-9861
Conference ID: SANUWAVE

OR use the link for instant telephone access to the event.

https://viavid.webcasts.com/starthere.jsp?ei=1777177&tp_key=6fc0abed5c 

A replay will be made available through November 25, 2026:
Toll-Free: 1-844-512-2921 or 1-412-317-6671
Replay Access ID: 11162619

[1] This is a non-GAAP financial measure. Refer to “Non-GAAP Financial Measures” and the reconciliations in this release for further information.

About Sanuwave
Sanuwave Health is focused on the research, development, and commercialization of its patented, non-invasive and biological response-activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.

Sanuwave's end-to-end wound care portfolio of regenerative medicine products and product candidates helps restore the body’s normal healing processes. Sanuwave applies and researches its patented energy transfer technologies in wound healing, orthopedic/spine, aesthetic/cosmetic, and cardiac/endovascular conditions.

Non-GAAP Financial Measures
This press release includes certain financial measures that are not presented in our financial statements prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). These financial measures are considered "non-GAAP financial measures" and are intended to supplement, and should not be considered as superior to, or a replacement for, financial measures presented in accordance with U.S. GAAP.

The Company uses Earnings Before Interest, Taxes, Depreciation and Amortization (“EBITDA”) and Adjusted EBITDA to assess its operating performance. Adjusted EBITDA is Earnings before Interest, Taxes, Depreciation and Amortization adjusted for the change in fair value of derivatives and any significant non-cash or infrequent charges. EBITDA and Adjusted EBITDA should not be considered as alternatives to net (loss) income, as a measure of financial performance or any other performance measure derived in accordance with U.S. GAAP, and they should not be construed as an inference that the Company’s future results will be unaffected by unusual or infrequent items. These non-GAAP financial measures are presented in a consistent manner for each period, unless otherwise disclosed. The Company uses these measures for the purpose of evaluating its historical and prospective financial performance, as well as its performance relative to competitors. These measures also help the Company to make operational and strategic decisions. The Company believes that providing this information to investors, in addition to U.S. GAAP measures, allows them to see the Company’s results through the eyes of management, and to better understand its historical and future financial performance. These non-GAAP financial measures are also frequently used by analysts, investors, and other interested parties to evaluate companies in our industry, when considered alongside other U.S. GAAP measures.

EBITDA and Adjusted EBITDA have their limitations as analytical tools, and you should not consider them in isolation or as a substitute for analysis of the Company’s results as reported under U.S. GAAP. For example, some of these limitations are that EBITDA and Adjusted EBITDA:

  • Do not reflect every expenditure, future requirements for capital expenditures or contractual commitments.
  • Do not reflect all changes in our working capital needs.
  • Do not reflect interest expense, or the amount necessary to service our outstanding debt.
  • Do not reflect stock-based compensation, which is a recurring expense and an important part of our compensation strategy, income tax expense, or the cost of replacing assets being depreciated and amortized.

As presented in the U.S. GAAP to Non-GAAP Reconciliations section below, the Company’s non-GAAP financial measures exclude the impact of certain charges that contribute to our net (loss) income.

Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to future financial results, market acceptance of and demand for Ultramist®, the estimated size of the wound care market, industry trends, regulatory actions that could adversely affect the price of or demand for the Company’s approved products, the Company's ability to comply with the financial and other covenants under its credit agreement with JPMorgan Chase Bank, N.A., production expectations, and plans for future business development activities. Forward-looking statements include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company's ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are: anticipated reimbursement levels for skin substitutes, allografts, or other advanced wound care products, and their effect on customer behavior and capital budgets; the financial distress, closure, or liquidation of wound care practices and the resulting impact on demand for the Company's systems; the emergence and growth of a secondary market for used Ultramist systems and the cannibalizing effect of such resales on sales of new systems; the Company's ability to qualify, train, and support new users acquiring systems through the secondary market, and the related regulatory, quality, and product-liability considerations; the Company's ability to sustain applicator and consumable volumes and convert system placements into recurring consumable revenue; risks associated with regulatory oversight; the Company's ability to regain and maintain compliance with the Nasdaq listing requirements; the Company's ability to manage its capital resources; competition; and the other factors discussed in detail in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

Contact: investors@sanuwave.com 

           
SELECTED FINANCIAL DATA
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2026 AND 2025
           
      Three Months Ended
September 30,
  Nine Months Ended
September 30,
(in thousands)       2026       2025       2026       2025  
                   
Revenue     $ 8,579     $ 11,270     $ 27,937     $ 30,657  
Cost of Revenues       1,950       2,526       6,452       6,690  
                   
Gross Margin       6,629       8,744       21,485       23,967  
Gross Margin %       77.3 %     77.6 %     76.9 %     78.2 %
                   
Total operating expenses       7,701       7,841       23,961       21,025  
Operating (Loss) Income     $ (1,072 )   $ 903     $ (2,476 )   $ 2,942  
                   
Total other (expense) income       (281 )     8,785       (992 )     1,179  
                   
Net (Loss) Income     $ (1,416 )   $ 9,688     $ (3,537 )   $ 4,121  


       
NON-GAAP ADJUSTED EBITDA
       
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
(in thousands)   2026       2025       2026       2025  
               
Net (Loss) Income $ (1,416 )   $ 9,688     $ (3,537 )   $ 4,121  
Non-GAAP Adjustments:              
Interest expense   276       1,795       1,340       5,643  
Depreciation and amortization1   341       264       948       757  
Income tax expense   63       -       69       -  
EBITDA   (736 )     11,747       (1,180 )     10,521  
               
Non-GAAP Adjustments for Adjusted EBITDA:              
Change in fair value of derivative liabilities   -       (6,097 )     -       (2,186 )
Other non-cash or infrequent charges and gains:              
Stock-based compensation   1,480       1,397       4,622       3,513  
Loss on extinguishment of debt   -       477       -       477  
State & local sales tax2   (64 )     383       (258 )     1,088  
Loss on impairment of assets   -       196       12       196  
Severance agreement and legal settlement   -       113       -       113  
Gain on license and option agreement   -       (5,000 )     -       (5,000 )
Sale of excess inventory   18       -       (202 )     -  
Adjusted EBITDA $ 698     $ 3,216     $ 2,994     $ 8,722  

1 Depreciation and amortization excludes amortization of right-of-use (ROU) leases. Prior period amounts have been retroactively revised to conform to this presentation. This change had no effect on previously reported U.S. GAAP results.

2 The charges represent a non-recurring state and local sales tax (benefit) expense related to the restatement of prior period financial statements.

       
CONDENSED CONSOLIDATED BALANCE SHEETS
       
(In thousands, except share data) September 30, 2026   December 31, 2025
ASSETS      
Current Assets:      
Cash and cash equivalents $ 6,569     $ 11,959  
Accounts receivable, net of allowance of $1,489 and $1,265, respectively   4,965       5,422  
Inventory   6,724       5,934  
Prepaid expenses and other current assets   1,002       1,312  
Secured revolving credit facility debt issuance costs, net   39       -  
Total Current Assets   19,299       24,627  
Non-Current Assets:      
Property and equipment, net   2,351       1,972  
Right of use assets, net   913       390  
Intangible assets, net   2,698       3,026  
Goodwill   7,260       7,260  
Secured revolving credit facility debt issuance costs, net   -       68  
Total Non-Current Assets   13,222       12,716  
       
Total Assets $ 32,521     $ 37,343  
LIABILITIES      
Current Liabilities:      
Current portion of secured term loan, net of debt issuance costs $ 5,660     $ 5,638  
Accounts payable   3,150       3,251  
Accrued expenses   5,877       8,382  
Secured revolving credit facility   655       -  
Current portion of operating lease liabilities   9       157  
Current portion of contract liabilities   606       388  
Note payable - insurance premium financing   420       -  
Accrued interest   10       24  
Other   7       7  
Total Current Liabilities   16,394       17,847  
Non-Current Liabilities:      
Secured term loan, net of current portion and debt issuance costs   11,419       15,667  
Secured revolving credit facility   -       655  
Operating lease liabilities, less current portion   1,444       854  
Contract liabilities, less current portion   414       701  
Total Non-Current Liabilities   13,277       17,877  
Total Liabilities $ 29,671     $ 35,724  
       
       
STOCKHOLDERS’ EQUITY      
       
Preferred Stock, par value $0.001, 5,000,000 shares authorized; 6,175 shares Series A, 293 shares Series B, 90 shares Series C and 8 shares Series D designated, respectively; no shares issued and outstanding at September 30, 2026 and December 31, 2025 $ -     $ -  
Common stock, par value $0.001, 2,500,000,000 shares authorized; 8,602,309 and 8,588,876 issued and outstanding at September 30, 2026 and December 31, 2025, respectively   9       9  
Additional paid-in capital   249,053       244,285  
Accumulated deficit   (246,222 )     (242,685 )
Accumulated other comprehensive income   10       10  
Total Stockholders’ Equity   2,850       1,619  
Total Liabilities and Stockholders’ Equity $ 32,521     $ 37,343  


       
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
       
(In thousands, except share and per share data) Three Months Ended
September 30,
  Nine Months Ended
September 30,
    2026     2025
(As Restated)
    2026     2025
(As Restated)
               
Revenue $ 8,579     $ 11,270     $ 27,937     $ 30,657  
Cost of Revenues   1,950       2,526       6,452       6,690  
Gross Margin   6,629       8,744       21,485       23,967  
               
Operating Expenses:              
General and administrative   5,133       5,193       15,285       14,404  
Selling and marketing   1,868       2,081       6,190       5,286  
Research and development   426       345       1,715       747  
Depreciation and amortization   274       222       771       588  
Total Operating Expenses   7,701       7,841       23,961       21,025  
               
Operating (Loss) Income   (1,072 )     903       (2,476 )     2,942  
               
Other (Expense) Income:              
Interest expense   (276 )     (1,795 )     (1,340 )     (5,643 )
Loss on extinguishment of debt   -       (477 )     -       (477 )
Change in fair value of derivative liabilities   -       6,097       -       2,186  
Loss on impairment of assets   -       (196 )     (12 )     (196 )
Other expense   -       (14 )     (125 )     (42 )
Other income   (5 )     5,170       485       5,351  
Total Other (Expense) Income, net   (281 )     8,785       (992 )     1,179  
               
Net (Loss) Income Before Income Taxes   (1,353 )     9,688       (3,468 )     4,121  
               
Income tax expense   63       -       69       -  
               
Net (Loss) Income $ (1,416 )   $ 9,688     $ (3,537 )   $ 4,121  
               
Total Comprehensive (Loss) Income $ (1,416 )   $ 9,688     $ (3,537 )   $ 4,121  
               
(Loss) Earnings per Share:              
Basic $ (0.16 )   $ 1.13     $ (0.41 )   $ 0.48  
Diluted $ (0.16 )   $ 0.39     $ (0.41 )   $ 0.21  
Weighted average shares outstanding              
Basic   8,602,309       8,571,111       8,598,202       8,560,174  
Diluted   8,602,309       9,140,668       8,598,202       9,178,144  
               


 
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
(In thousands, except share data)
 
Three Months Ended September 30, 2026
    Common Stock                
    Number of Shares
Issued and Outstanding
  Par Value   Additional Paid-
in Capital
  Accumulated
Deficit
  Accumulated Other
Comprehensive
Income
  Total
                         
Balances as of June 30, 2026   8,602,309   $ 9   $ 247,574   $ (244,806 )   $ 10   $ 2,787  
Stock-based compensation   -     -     1,377     -       -     1,377  
Shares granted in lieu of board of director fees   -     -     103     -       -     103  
Net loss   -     -     -     (1,416 )     -     (1,416 )
                         
Balances as of September 30, 2026   8,602,309   $ 9   $ 249,053   $ (246,222 )   $ 10   $ 2,850  
                         
Three Months Ended September 30, 2025
    Common Stock                
    Number of Shares
Issued and Outstanding
  Par Value   Additional Paid-
in Capital
  Accumulated
Deficit
  Accumulated Other
Comprehensive
Income
  Total
                         
Balances as of June 30, 2025 (As Restated)   8,568,005   $ 9   $ 241,248   $ (260,066 )   $ 10   $ (18,799 )
Stock-based compensation   -     -     1,397     -       -     1,397  
Stock options exercised   8,159     -     122     -       -     122  
Net income (As Restated)   -     -     -     9,688       -     9,688  
                         
Balances as of September 30, 2025 (As Restated)   8,576,164   $ 9   $ 242,767   $ (250,378 )   $ 10   $ (7,592 )


Nine Months Ended September 30, 2026
    Common Stock                
    Number of Shares
Issued and Outstanding
  Par Value   Additional Paid-
in Capital
  Accumulated
Deficit
  Accumulated Other
Comprehensive
Income
  Total
                         
Balances as of December 31, 2025   8,588,876   $  9    $  244,285    $  (242,685 )   $  10    $  1,619   
Stock-based compensation          -       4,219       -         -       4,219   
Stock options exercised   5,433      -       77       -         -       77   
Shares issued for services rendered   8,000      -       164       -         -       164   
Shares granted in lieu of board of director fees   -      -       308       -         -       308   
Net loss   -      -       -       (3,537 )      -       (3,537 )
                         
Balances as of September 30, 2026   8,602,309   $  9    $  249,053    $  (246,222 )   $  10    $  2,850   
                         
Nine Months Ended September 30, 2025
    Common Stock                
    Number of Shares
Issued and Outstanding
  Par Value   Additional Paid-
in Capital
  Accumulated
Deficit
  Accumulated Other
Comprehensive
Income
  Total
                         
Balances as of December 31, 2024 (As Restated)   8,543,686   $  9    $  238,685    $  (254,499 )   $  10    $  (15,795 )
Stock-based compensation   4,787      -       3,630       -         -       3,630   
Stock options exercised   25,167      -       375       -         -    $  375   
Shares granted in lieu of board of director fees   2,524      -       77       -         -       77   
Net income (As Restated)   -      -       -       4,121         -       4,121   
                         
Balances as of September 30, 2025 (As Restated)   8,576,164   $  9    $  242,767    $  (250,378 )   $  10    $  (7,592 )


   
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
   
  Nine Months Ended September 30,
(in thousands)   2026     2025
(As Restated)
Cash Flows - Operating Activities:      
Net (loss) income $ (3,537 )   $ 4,121  
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities      
Stock-based compensation   4,622       3,513  
Depreciation and amortization   948       634  
Amortization of right-of-use assets   95       268  
Provision for credit losses   664       112  
Amortization of debt issuance and debt discounts   116       1,416  
Write-off of inventory   69       -  
Loss on disposal and impairment of assets   18       210  
Loss on extinguishment of debt   -       477  
Change in fair value of derivative liabilities   -       (2,186 )
Gain on sale of patents   -       (5,000 )
Gain on lease modification   -       (7 )
Proceeds from tenant improvement funds   -       586  
Changes in operating assets and liabilities      
Accounts receivable   (206 )     (1,387 )
Inventory   (859 )     (2,665 )
Prepaid expenses and other assets   815       (1,009 )
Accounts payable   (77 )     264  
Accrued expenses and contract liabilities   (2,519 )     1,289  
Operating leases   (178 )     (79 )
Net Cash Flows (Used in) Provided by Operating Activities   (29 )     557  
       
Cash Flows - Investing Activities:      
Purchase of property and equipment   (593 )     (1,846 )
Investment in software development   (218 )     -  
Proceeds from sale of patents   -       5,000  
Net Cash Flows (Used in) Provided by Investing Activities   (811 )     3,154  
       
Cash Flows - Financing Activities:      
Repayment of principal secured term loan   (4,313 )     -  
Repayment of insurance premium financing note payable   (315 )     -  
Proceeds from exercises of stock options   77       359  
Payment of note payable   -       (27,747 )
Proceeds from secured term loan   -       23,000  
Proceeds from secured revolving credit facility   -       655  
Payment of debt issuance costs   -       (371 )
Payments of principal on finance lease and extinguishment of lease liability   -       (242 )
Net Cash Flows Used in Financing Activities   (4,550 )     (4,346 )
       
Net Change in Cash During Period   (5,390 )     (635 )
       
Cash at Beginning of Period   11,959       10,237  
Cash at End of Period $ 6,569     $ 9,602  
       
Supplemental Information:      
Cash paid for interest $ 1,511     $ 3,291  
Cash paid for taxes $ 87     $ -  
       
Non-cash Investing and Financing Activities:      
Stock options granted in lieu of cash bonus   69       117  
Right-of-use assets obtained in exchange for lease liabilities   619       430  
Insurance premiums financed through note payable   466       -  
Transfer of deposits to property and equipment   192       -  
Purchases of property and equipment in accounts payable and accrued liabilities   59       -  
Capitalize interest into senior secured debt   -       549  
Shares granted in lieu of board of director fees   -       77  
Lease liabilities reduced upon lease modification   -       99  
RSUs granted in exchange for services   -       10  



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