SANUWAVE Health, Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 6, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-07.
0001628280-25-038937
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001628280-25-050280
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 54 previous paragraphs and 54 current paragraphs.
25 unchanged; 19 reworded; 10 added; 10 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
Net income for the three months ended September 30, 2025, was$10.3 million compared tonet loss of$20.7 million for the same period in 2024. Theincrease in our net income for the three months ended September 30, 2025, was primarily related to the change in fair value of derivative liabilities of$6.1 million for the three months ended September 30, 2025 compared to a loss of$18.8 million for the three months ended September 30, 2024 and $5.2 million in other incomefor the three months ended September 30, 2025 compared tonone for the three months ended September 30, 2024. The change in fair value of derivative liability relates to the valuationof warrants previously issued by the Company. Other income for the three months ended September 30, 2025 mainly consists of the one-time payment of $5.0 million related to the patent purchase agreement as described in Note 15 of our condensed consolidated financial statements for the period. For the three months ended September 30, 2025, our operating income totaled $1.5 million compared to $2.0 million for the same period of 2024. The decrease in net income was mainly due to an increase in non-cash charges for stock-based compensation of $1.4 million for the three months ended September 30, 2025 as compared to the same period of 2024.
Current report
General and administrative expenses for thenine months ended September 30, 2025, were $13.3 million as compared to $8.1 million for the same period of 2024, anincrease of $5.3 million, or 65%. Theincrease in thenine months ended September 30, 2025, as compared to the same period of 2024, was primarily due to non-cash charges for stock-based compensation expense totaling $2.9 million, increased headcount expenses of $1.7 million, and public company costs of $0.3 million.
Current report
Total Other Income (Expense)
Current report
Other income (expense) consists of the following:
Current report
Total other income (expense) increased by$22.9 million to other income of$1.4 million for thenine months ended September 30, 2025, as compared to other expense of$21.5 million for the same period of 2024. The increase was primarily driven by the change in fair value of derivative liabilities of$19.8 million, interest expense of $5.6 million, and other income of $2.5 million, partially offset by the gain on extinguishment of debt of $5.7 million. The change in fair value of derivative liability relates to the valuationof warrants previously issued by the Company. Other income for the nine months ended September 30, 2025 mainly consists of the one-time payment of $5.0 million related to the patent purchase agreement as described in Note 15 of our condensed consolidated financial statements for the period. Other income for the nine months ended September 30, 2024 mainly consists of the one-time payment of $2.5 million related to the Patent License agreement as described in Note 15 of our condensed consolidated financial statements for the period.
Current report
However, as described in Note 7 of our condensed consolidated financial statements for the period, we successfully refinanced our outstanding debt during the three months ended September 30, 2025. The refinancing extended the maturity of our debt and provided the option for additional liquidity to support ongoing operations through the secured revolving credit facility. In addition, the operating income achieved in the current year, the receipt of $5 million from the patent purchase agreement, and the capital raised from a private placement in October 2024 have all contributed to a significant improvement in our financial position.
Current report
As discussed in Note 2, management has evaluated our ability to continue as a going concern in light of these developments. Based on the successful refinancing and other recent initiatives, management believes the Company has sufficient resources to meet its obligations as they become due and to continue as a going concern for at least the next 12 months. We continue to monitor our financial position, liquidity, and compliance with debt covenants on an ongoing basis.
Current report
Management remains focused on maintaining the Company’s improved financial position and operational momentum. While we continue to monitor our liquidity and capital resources closely, we believe that the successful refinancing of our debt, as described in Note 7, together with our recent operating income and capital initiatives, have significantly strengthened our ability to meet our obligations as they come due. As discussed in Note 2, these actions have alleviated the substantial doubt about our ability to continue as a going concern. We will continue to evaluate opportunities to further enhance our capital structure and support our growth strategy. Although we cannot predict all future events or guarantee that unforeseen circumstances will not arise, we are confident that the steps taken to date position the Company well to support ongoing operations and execute on our strategic objectives.
Current report
Cash used in financing activities for the nine months ended September 30, 2025, totaled$4.3 million and consisted primarily of paying off the Existing Debt as described in Note 7 to the condensed consolidated financial statements and offset by the proceeds of the secured term loan and secured revolving credit facility as also described in Note 7 to the condensed consolidated financial statements.
Current report
Cash used in financing activities for the nine months ended September 30, 2024, totaled$0.1 million and consisted primarily of payment of a note payable and offset by proceeds from a note payable.
Removed paragraphs (10)
Previous report
Net income for the three months ended June 30, 2025, was$1.1 million compared to net income of$6.6 million for the same period in 2024. Thedecrease in our net income for the three months ended June 30, 2025, was primarily related to the a gain on extinguishment of debt for the three months ended June 30, 2024 that did not recur during the three months ended June 30, 2025 and the change in fair value of derivative liabilities. For the three months ended June 30, 2025, our operating income totaled$1.9 million, which is flat compared to the same period of 2024.
Previous report
General and administrative expenses for the three months ended June 30, 2025, were $4.0 million as compared to $1.8 million for the same period of 2024, anincrease of $2.2 million, or 120%. Theincrease in the three months ended June 30, 2025, as compared to the same period of 2024, was primarily due to increased headcount expenses of $1.1 million and non-cash charges for stock-based compensation expense totaling $0.9 million. There was a release of historical accrued expenses relating to headcount expenses for the three months ended June 30, 2024 of$0.6 million which did not recur in the three months ended June 30, 2025.
Previous report
Other (Expense) Income, net
Previous report
Other (expense) income, net consists of the following:
Previous report
Other (expense) income, net decreased by$5.4 million to other expense of $0.8 million for the three months ended June 30, 2025, as compared to other income of$4.6 million for the same period of 2024. The decrease was primarily driven bya decrease in gain on extinguishment of debt of $5.3 million and a decrease from the change in the fair value of derivative liabilities of$2.7 million, partially offset by a decrease in interest expense of$1.9 million. The change in fair value of derivative liability relates to the valuation of warrants previously issued by the Company.
Previous report
During the three and six months ended June 30, 2025, and prior fiscal year ended December 31, 2024, we achieved operating income. This is attributable to the implementation and execution of several strategic initiatives, primarily, revenue growth initiatives and a capital raise from a private placement in October 2024, which have positively impacted our operations.
Previous report
Despite the positive operating income in the current year, we continue to monitor our financial position closely.
Previous report
In addition to the operational improvements, we are addressing our financial obligations, including the significant portion of debt that matures in September 2025. Management is actively engaged in discussions with lenders and financial institutions to refinance this debt, which could extend the maturity of the debt and provide additional liquidity to support ongoing operations and strategic initiatives.
Previous report
Although no assurances can be given that our plans to obtain refinancing will be successful or on the terms or timeline we expect, or at all, management believes that the actions taken to date, along with the planned initiatives, will enable the
Previous report
Company to meet its obligations as they become due and to continue as a going concern.. If these efforts are unsuccessful, we may be required to significantly curtail or discontinue operations or obtain funds through financing transactions with unfavorable terms.
Reworded paragraphs (19)
Previous wording
We continued to realize significant revenue growth during the three months ended June 30, 2025, as compared to the same period in 2024. Revenue for the three months ended June 30, 2025, totaled$10.2 million, an increase of 42%, as compared to$7.2 million for the same period of 2024. Revenue for the six months ended June 30, 2025, totaled$19.5 million, an increase of 51%, as compared to$12.9 million for the same period of 2024.
Current wording
We continued to realize significant revenue growth during the three months ended September 30, 2025, as compared to the same period in 2024. Revenue for the three months ended September 30, 2025, totaled$11.5 million, an increase of 22%, as compared to$9.4 million for the same period of 2024. Revenue for the nine months ended September 30, 2025, totaled$31.0 million, an increase of 39%, as compared to$22.3 million for the same period of 2024.
Previous wording
Net loss for the six months ended June 30, 2025, was$4.6 million compared to a net income of$2.0 million for the same period in 2024. The change from net income for the six months ended June 30, 2025 to net loss for the six months ended June 30, 2024, was primarily related to a gain on extinguishment of debt for the six months ended June 30,2024 that did not recur during the six months ended June 30, 2025 and the change of fair value of derivative liabilities. For the six months ended June 30, 2025, our operating income totaled$2.9 million, which is an improvement of$1.9 million compared to the same period of 2024. The increase in operating income was mainly driven by an increase in revenue and gross margin for the six months ended June 30, 2025.
Current wording
Net incomefor thenine months ended September 30, 2025, was$5.7 million compared to a net loss of$18.6 million for the same period in 2024. The increase in net income for the nine months ended September 30, 2025, was primarily related to the change in fair value of derivative liabilities of$2.2 million for the nine months ended September 30, 2025 compared to a loss of$17.6 millionfor the nine months ended September 30, 2024 and a decrease in interest expense in the nine months ended September 30, 2025 of$4.5 million compared to the same period of 2024. For thenine months ended September 30, 2025, our operating income totaled$4.3 million, which is an improvement of$1.4 million compared to the same period of 2024. The increase in operating income was mainly driven by an increase in revenue and gross margin for thenine months ended September 30, 2025.
Previous wording
Revenues for the three months ended June 30, 2025, were$10.2 million, compared to$7.2 million for the same period of 2024, anincrease of$3.0 million or 42%. Theincrease in net sales was primarily driven by the growth in quantity of UltraMIST® disposables and systems sold as well as a strategic focus on price discipline. The quantity of UltraMIST® disposables sold increased by 29% in the three months ended June 30, 2025, as compared to the same period of 2024. The quantity of UltraMIST® systems sold increased by 61% in the three months ended June 30, 2025, as compared to the same period of 2024. Pricing of the UltraMIST® system and disposables also showed growth in the three months ended June 30, 2025, as compared to the same period of 2024; the average selling price of disposables increased 6% in the three months ended June 30, 2025, and the average selling price of systems increased 1% in the three months ended June 30, 2025. Revenue from UltraMIST® totaled 99% of total revenue in the three months ended June 30, 2025, and over 95% in the same period of 2024.
Current wording
Revenues for the three months ended September 30, 2025, were$11.5 million, compared to$9.4 million for the same period of 2024, anincrease of$2.1 million or 22%. Theincrease in net sales was primarily driven by the growth in quantity of UltraMIST® disposables and systems sold. The quantity of UltraMIST® disposables sold increased by 23% in the three months ended September 30, 2025, as compared to the same period of 2024. The quantity of UltraMIST® systems sold increased by 25% in the three months ended September 30, 2025, as compared to the same period of 2024. Pricing of the UltraMIST®disposables showed growth in the three months ended September 30, 2025, as compared to the same period of 2024; the average selling price of disposables increased 3% in the three months ended September 30, 2025. The average selling price of systems decreased 4% in the three months ended September 30, 2025. Revenue from UltraMIST® totaled 99% of total revenue in the three months ended September 30, 2025, and over 99% in the same period of 2024.
Previous wording
Revenues for the six months ended June 30, 2025, were$19.5 million, compared to$12.9 million for the same period of 2024, anincrease of$6.6 million or 51%. Theincrease in net sales was primarily driven by the growth in quantity of UltraMIST® disposables and systems sold as well as a strategic focus on price discipline. The quantity of UltraMIST® disposables sold increased by 31% in the six months ended June 30, 2025, as compared to the same period of 2024. The quantity of UltraMIST® systems sold increased by 86% in the six months ended June 30, 2025, as compared to the same period of 2024. Pricing of the UltraMIST® system and disposables also showed growth in the six months ended June 30, 2025, as compared to the same period of 2024; the average selling price of disposables increased 7% in the six months ended June 30, 2025, and the average selling price of systems increased 4% in the six months ended June 30, 2025. Revenue from UltraMIST® totaled 99% of total revenue in the six months ended June 30, 2025, and over 94% in the same period of 2024.
Current wording
Revenues for thenine months ended September 30, 2025, were$31.0 million, compared to$22.3 million for the same period of 2024, anincrease of$8.6 million or 39%. Theincrease in net sales was primarily driven by the growth in quantity of UltraMIST® disposables and systems sold as well as a strategic focus on price discipline. The quantity of UltraMIST® disposables sold increased by 28% in thenine months ended September 30, 2025, as compared to the same period of 2024. The quantity of UltraMIST® systems sold increased by 54% in thenine months ended September 30, 2025, as compared to the same period of 2024. Pricing of the UltraMIST® system and disposables also showed growth in thenine months ended September 30, 2025, as compared to the same period of 2024; the average selling price of disposables increased 6% in thenine months ended September 30, 2025, and the average selling price of systems increased 1% in thenine months ended September 30, 2025. Revenue from UltraMIST® totaled 99% of total revenue in thenine months ended September 30, 2025, and over 98% in the same period of 2024.
Previous wording
Cost of revenues for the six months ended June 30, 2025, was$4.2 million, compared to$3.5 million for the same period of 2024. Gross profit as a percentage of revenues was 79% for the six months ended June 30, 2025, compared to 73% for the same period in 2024. This increase in gross margin was largely driven by improved pricing initiatives on our UltraMIST® systems and applicators.
Current wording
Cost of revenues for the three months ended September 30, 2025, was$2.5 million, compared to$2.3 million for the same period of 2024. Gross profit as a percentage of revenues was 78% for the three months ended September 30, 2025, compared to 76% for the same period in 2024. This increase in gross margin was largely driven by improved pricing initiatives on our UltraMIST® systems and applicators as well as a decrease in the cost of systems.
Previous wording
Cost of revenues for the three months ended June 30, 2025, was$2.2 million, compared to$1.9 million for the same period of 2024. Gross profit as a percentage of revenues was 78% for the three months ended June 30, 2025, compared to 73% for the same period in 2024. This increase in gross margin was largely driven by improved pricing initiatives on our UltraMIST® systems and applicators.
Current wording
Cost of revenues for thenine months ended September 30, 2025, was$6.7 million, compared to$5.8 million for the same period of 2024. Gross profit as a percentage of revenues was 78% for thenine months ended September 30, 2025, compared to 74% for the same period in 2024. This increase in gross margin was largely driven by improved pricing initiatives on our UltraMIST® systems and applicators.
Previous wording
General and administrative expenses for the six months ended June 30, 2025, were $8.5 million as compared to $5.5 million for the same period of 2024, anincrease of $3.0 million, or 54%. Theincrease in the six months ended June 30, 2025, as compared to the same period of 2024, was primarily due to non-cash charges for stock-based compensation expense totaling $1.7 million and increased headcount expenses of $1.2 million. There was a release of historical accrued expenses relating to headcount expenses for the six months ended June 30, 2024 of$0.6 million which did not recur in the three months ended June 30, 2025.
Current wording
General and administrative expenses for the three months ended September 30, 2025, were $4.8 million as compared to $2.5 million for the same period of 2024, anincrease of $2.3 million, or 89%. Theincrease in the three months ended September 30, 2025, as compared to the same period of 2024, was primarily due to non-cash charges for stock-based compensation totaling $1.2 million, increased headcount expenses of $0.5 million, legal expenses of $0.1 million, and software expenses of $0.1 million.
Previous wording
Selling and marketing expenses for the three months ended June 30, 2025, were$1.7 million as compared to$1.0 million for the same period of 2024, anincrease of$0.6 million, or 62%. The year-over-year increase in sales and marketing expenses in the three months ended June 30, 2025, was primarily due to increased headcount expenses of $0.4 million, including commissions as revenues increased, and non-cash charges for stock-based compensation of $0.2 million.
Current wording
Selling and marketing expenses for the three months ended September 30, 2025, were$2.1 million as compared to$2.2 million for the same period of 2024, adecrease of$0.1 million, or 5%. The year-over-year decrease in sales and marketing expenses in the three months ended September 30, 2025, was primarily due to a decrease of$1.0 million in outside commission expense, partially offset by an increase in headcount expenses of$0.8 million.
Previous wording
Selling and marketing expenses for the six months ended June 30, 2025, were$3.2 million as compared to$2.3 million for the same period of 2024, anincrease of$0.9 million, or 41%. The year-over-year increase in sales and marketing expenses the six months ended June 30, 2025, was primarily due to increased headcount expenses of $0.7 million and non-cash charges for stock-based compensation of $0.4 million; partially offset by decreases in Travel & Entertainment expenses of $0.1 million and Service Contracts of $0.1 million.
Current wording
Selling and marketing expenses for thenine months ended September 30, 2025, were$5.3 million as compared to$4.5 million for the same period of 2024, anincrease of$0.8 million, or 18%. The year-over-year increase in sales and marketing expenses for thenine months ended September 30, 2025, was primarily due to increased headcount expenses of$2.2 million, partially offset by a decrease in outside commission expense of$1.3 million.
Previous wording
Research and development expenses for each of the three months ended June 30, 2025, and June 30, 2024, were$0.2 million. The research and development costs in the three months ended June 30, 2025, remained approximately consistent with the costs in the same period of 2024.
Current wording
Research and development expenses for the three months ended September 30, 2025 were$0.3 million compared to $0.2 millionfor the three months ended September 30, 2024. The research and development costs in the three months ended September 30, 2025, remained approximately consistent with the costs in the same period of 2024.
Previous wording
Research and development expenses for each of the six months ended June 30, 2025, and June 30, 2024, were$0.4 million. The research and development costs in the six months ended June 30, 2025, remained approximately consistent with the costs in the same period of 2024.
Current wording
Research and development expenses for thenine months ended September 30, 2025 were$0.7 million compared to $0.5 million for the nine months ended September 30, 2024. The research and development costs in the nine months ended September 30, 2025, remained approximately consistent with the costs in the same period of 2024.
Previous wording
Other (expense) income, net decreased by$8.6 million to an expense of$7.5 million for the six months ended June 30, 2025, as compared to other income of$1.1 million for the same period of 2024. The decrease was primarily driven bya decrease in gain on extinguishment of debt of $5.2 million and a decrease from the change in the fair value of derivative liabilities of$5.1 million, partially offset by a decrease in interest expense of$3.6 million. The change in fair value of derivative liability relates to the valuation of warrants previously issued by the Company. Other income for the six months ended June 30, 2024 mainly consists of theone-time payment of $2.5 million related to the Patent and License Agreement as described in Note 16.
Current wording
Total other income (expense) increased by$31.5 million to other income of $8.9 million for the three months ended September 30, 2025, as compared to an expense of$22.6 million for the same period of 2024. The increase was primarily driven by the change in fair value of derivative liabilities of$24.9 million and other income of $5.2 million. The change in fair value of derivative liability relates to the valuation of warrants previously issued by the Company. Other income for the three months ended September 30, 2025 mainly consists of the one-time payment of $5.0 million related to the patent purchase agreement as described in Note 15 of our condensed consolidated financial statements for the period.
Previous wording
From inception through the year ended December 31, 2023, we incurred losses from operations each year. As of June 30, 2025, we had an accumulated deficit of$256.0 million. Historically, our operations have primarily been funded from the sale of capital stock, issuances of notes payable, and convertible debt securities.
Current wording
From inception through the year ended December 31, 2023, we incurred losses from operations each year. As of September 30, 2025, we had an accumulated deficit of$245.7 million. Historically, our operations have primarily been funded from the sale of capital stock, issuances of notes payable, and convertible debt securities.
Previous wording
We have incurred recurring net losses in prior years, currently have a significant accumulated deficit, have negative working capital, and the Senior Secured Note (as defined in Note 8) becomes due in September 2025, which raises substantial doubt about our ability to continue as a going concern for a period of 12 months from the filing of this Form 10-Q.
Current wording
We have incurred recurring net losses in prior years, currently have a significant accumulated deficit, and have experienced negative working capital. Previously, the scheduled maturity of the Senior Secured Note (as defined in Note 7) in September 2025 raised substantial doubt about our ability to continue as a going concern for a period of 12 months from the filing of the prior Form 10-Q.
Previous wording
Cash used in operating activities forthe six months ended June 30, 2025, totaled$0.5 million and consisted primarily of a net loss of $4.6 million and a decrease in net operating assets of $4.1 million, partially offset by non-cash charges of $3.9 million related to a change in the fair value of derivative liabilities, $2.1 million related to stock-based compensation expense, and $1.1 million related to amortization of debt issuance and debt discounts. Net operating assets consisted primarily of inventory, accrued expenses, prepaid expenses and accounts receivable to support the growth of our operations. In addition, we received $0.4 million in tenant improvement funds, as described in Note 7 to the financial statement, which partially offsets leasehold improvement investments. The related leasehold improvements are included in purchases of property and equipment under investing activities.
Current wording
Cash provided by operating activities forthe nine months ended September 30, 2025, totaled$0.6 million and consisted primarily of net income of $5.7 million and an increase in net operating assets of $5.1 million, partially offset by non-cash charges of $3.5 million related to stock-based compensation expense, $2.2 million related to a change in the fair value of derivative liabilities, and $1.4 million related to amortization of debt issuance and debt discounts. Net operating assets consisted primarily of inventory, accrued expenses, prepaid expenses and accounts receivable to support the growth of our operations.
Previous wording
Cash provided by operating activities for the six months ended June 30, 2024 totaled $0.4 million and consisted primarily of net income of $2.0 million, partially offset by non-cash charges of $1.2 million related to a change in the fair value of derivative liabilities and $3.3 million related to amortization of debt issuance and debt discounts, as well as the receipt of $2.5 million related to the License and Option Agreement, as further discussed in Note 16 to the financial statements.
Current wording
Cash provided by operating activities for the nine months ended September 30, 2024 totaled $1.7 million and consisted primarily of a net loss of $18.6 million and a gain of extinguishment of debt of $5.2 million, partially offset by non-cash charges of $17.6 million related to a change in the fair value of derivative liabilities and $4.8 million related to amortization of debt issuance and debt discounts, as well as the receipt of $2.5 million related to the Patent License, as further discussed in Note 15 to the condensed consolidated financial statements.
Previous wording
Cash used in investing activities for the six months ended June 30, 2025, totaled$1.3 million and consisted primarily of purchases of property and equipment of $1.3 million, of which $0.9 million was related to leasehold improvements at our new headquarters.
Current wording
Cash provided by investing activities for the nine months ended September 30, 2025, totaled$3.2 million and consisted primarily of proceeds from the patent purchase agreement of $5.0 million partially offset by purchases of property and equipment of $1.8 million, of which $0.9 million was related to leasehold improvements at our new headquarters and $0.7 million was related to purchases of property and equipment related to manufacturing equipment.
Previous wording
Cash used in investing activities for the six months ended June 30, 2024, totaled$0.2 million and primarily consisted of purchases of property and equipment related to manufacturing equipment.
Current wording
Cash used in investing activities for the nine months ended September 30, 2024, totaled$0.3 million and primarily consisted of purchases of property and equipment related to manufacturing equipment.
Previous wording
We have determined that we have one operating segment. Our revenues are generated from sales primarily in the United States. International sales include sales in Europe, Canada, the Middle East, Central America, South America, Asia, and Asia/Pacific. All significant expenses are generated in the United States and all significant assets are in the United States. For further information on the Company's operating segment, refer to Note 18 to the condensed consolidated financial statements.
Current wording
We have determined that we have one operating segment. Our revenues are generated from sales primarily in the United States. All significant expenses are generated in the United States and all significant assets are in the United States. For further information on the Company's operating segment, refer to Note 17 to the condensed consolidated financial statements.