SANUWAVE Health, Inc.NASDAQ: SNWV

Sanuwave Announces Q3 FY2026 Financial Results

· Issued by SANUWAVE Health, Inc. via GlobeNewswire

Summary by 6ix AI

Sanuwave Health, which sells wound care products cleared by the US Food and Drug Administration (FDA), reported revenue of $8.6 million for the third quarter ended September 30, 2026, down 24% from $11.3 million a year earlier, and a net loss of $1.4 million, compared with net income of $9.7 million in the third quarter of 2025.

Key details

  • Operating loss was $1.1 million, compared with operating income of $0.9 million in the third quarter of 2025. Gross margin was 77.3% of revenue, versus 77.6% a year earlier.
  • Sanuwave says the change in net result was primarily because the prior-year quarter included 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, neither of which recurred, plus the current operating loss, partially offset by a $1.5 million decrease in interest expense.
  • Sanuwave sold 40 Ultramist systems, down from 155 in the third quarter of 2025 and 82 in the second quarter of 2026. CEO Morgan Frank said a proposed rule from CMS, the US Medicare agency, and an ongoing market for used Ultramist units affected system sales. Applicator revenue rose 2% to $6.9 million, from $6.8 million a year earlier.
  • Adjusted EBITDA (earnings before interest, taxes, depreciation and amortization, adjusted for certain non-cash or infrequent items, a non-GAAP measure) was $0.7 million, versus $3.2 million a year earlier. Cash and cash equivalents were $6.6 million on September 30, 2026, after approximately $2.3 million paid during the quarter under sales tax voluntary disclosure agreements.
  • A business update conference call is scheduled for November 11, 2026 at 8:30 a.m. EST.

6ix AI wrote this summary from the release below and checked it against the release.

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)2026202520262025
Revenue$8,579$11,270$27,937$30,657
Cost of Revenues1,9502,5266,4526,690
Gross Margin6,6298,74421,48523,967
Gross Margin %77.3%77.6%76.9%78.2%
Total operating expenses7,7017,84123,96121,025
Operating (Loss) Income$(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)$4,121
NON-GAAP ADJUSTED EBITDA
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in thousands)2026202520262025
Net (Loss) Income$(1,416)$9,688$(3,537)$4,121
Non-GAAP Adjustments:
Interest expense2761,7951,3405,643
Depreciation and amortization1341264948757
Income tax expense63-69-
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 compensation1,4801,3974,6223,513
Loss on extinguishment of debt-477-477
State & local sales tax2(64)383(258)1,088
Loss on impairment of assets-19612196
Severance agreement and legal settlement-113-113
Gain on license and option agreement-(5,000)-(5,000)
Sale of excess inventory18-(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, 2026December 31, 2025
ASSETS
Current Assets:
Cash and cash equivalents$6,569$11,959
Accounts receivable, net of allowance of $1,489 and $1,265, respectively4,9655,422
Inventory6,7245,934
Prepaid expenses and other current assets1,0021,312
Secured revolving credit facility debt issuance costs, net39-
Total Current Assets19,29924,627
Non-Current Assets:
Property and equipment, net2,3511,972
Right of use assets, net913390
Intangible assets, net2,6983,026
Goodwill7,2607,260
Secured revolving credit facility debt issuance costs, net-68
Total Non-Current Assets13,22212,716
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 payable3,1503,251
Accrued expenses5,8778,382
Secured revolving credit facility655-
Current portion of operating lease liabilities9157
Current portion of contract liabilities606388
Note payable - insurance premium financing420-
Accrued interest1024
Other77
Total Current Liabilities16,39417,847
Non-Current Liabilities:
Secured term loan, net of current portion and debt issuance costs11,41915,667
Secured revolving credit facility-655
Operating lease liabilities, less current portion1,444854
Contract liabilities, less current portion414701
Total Non-Current Liabilities13,27717,877
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, respectively99
Additional paid-in capital249,053244,285
Accumulated deficit(246,222)(242,685)
Accumulated other comprehensive income1010
Total Stockholders’ Equity2,8501,619
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,
20262025
(As Restated)
20262025
(As Restated)
Revenue$8,579$11,270$27,937$30,657
Cost of Revenues1,9502,5266,4526,690
Gross Margin6,6298,74421,48523,967
Operating Expenses:
General and administrative5,1335,19315,28514,404
Selling and marketing1,8682,0816,1905,286
Research and development4263451,715747
Depreciation and amortization274222771588
Total Operating Expenses7,7017,84123,96121,025
Operating (Loss) Income(1,072)903(2,476)2,942
Other (Expense) Income:
Interest expense(276)(1,795)(1,340)(5,643)
Loss on extinguishment of debt-(477)-(477)
Change in fair value of derivative liabilities-6,097-2,186
Loss on impairment of assets-(196)(12)(196)
Other expense-(14)(125)(42)
Other income(5)5,1704855,351
Total Other (Expense) Income, net(281)8,785(992)1,179
Net (Loss) Income Before Income Taxes(1,353)9,688(3,468)4,121
Income tax expense63-69-
Net (Loss) Income$(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
Basic8,602,3098,571,1118,598,2028,560,174
Diluted8,602,3099,140,6688,598,2029,178,144
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 ValueAdditional Paid-
in Capital
Accumulated
Deficit
Accumulated Other
Comprehensive
Income
Total
Balances as of June 30, 20268,602,309$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, 20268,602,309$9$249,053$(246,222)$10$2,850
Three Months Ended September 30, 2025
Common Stock
Number of Shares
Issued and Outstanding
Par ValueAdditional 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 exercised8,159-122--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 ValueAdditional Paid-
in Capital
Accumulated
Deficit
Accumulated Other
Comprehensive
Income
Total
Balances as of December 31, 20258,588,876$9$244,285$(242,685)$10$1,619
Stock-based compensation-4,219--4,219
Stock options exercised5,433-77--77
Shares issued for services rendered8,000-164--164
Shares granted in lieu of board of director fees--308--308
Net loss---(3,537)-(3,537)
Balances as of September 30, 20268,602,309$9$249,053$(246,222)$10$2,850
Nine Months Ended September 30, 2025
Common Stock
Number of Shares
Issued and Outstanding
Par ValueAdditional 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 compensation4,787-3,630--3,630
Stock options exercised25,167-375--$375
Shares granted in lieu of board of director fees2,524-77--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)20262025
(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 compensation4,6223,513
Depreciation and amortization948634
Amortization of right-of-use assets95268
Provision for credit losses664112
Amortization of debt issuance and debt discounts1161,416
Write-off of inventory69-
Loss on disposal and impairment of assets18210
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 assets815(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 options77359
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 Period11,95910,237
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 bonus69117
Right-of-use assets obtained in exchange for lease liabilities619430
Insurance premiums financed through note payable466-
Transfer of deposits to property and equipment192-
Purchases of property and equipment in accounts payable and accrued liabilities59-
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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