FALSE000141766300014176632024-11-082024-11-08

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, 2024
SANUWAVE Health, Inc.
(Exact name of registrant as specified in its charter)
Nevada000-5298520-1176000
(State or other jurisdiction of incorporation)(Commission File Number)(IRS Employer Identification No.)
11495 Valley View Road,Eden Prairie,Minnesota55344
(Address of principal executive offices)(Zip Code)
Registrant’s telephone number, including area code(952)656-1029
N/A
(Former name or former address, if changed since last report)
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 (see General Instruction A.2. below):

☐
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))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)
Name of each exchange on which
registered
N/AN/AN/A

Indicate by check mark whether the registration is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company o
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. o


Item 2.02              Results of Operations and Financial Condition.
On November 8, 2024, Sanuwave Health, Inc., a Nevada corporation (the “Company”), issued a press release announcing its financial results for the third quarter ended September 30, 2024. As previously announced, a business update via conference call will occur on November 8, 2024 at 8:30 am EST. Materials are provided on the Company’s website at www.sanuwave.com/investors.
The information in this Item 2.02 of this Current Report on Form 8-K and the exhibit attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01              Financial Statements and Exhibits.
(d)Exhibits.
Exhibit
No.
Description
Press Release dated November 8, 2024
104Cover Page Interactive Data File--the cover page XBRL tags are embedded within the Inline XBRL document.


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.
SANUWAVE HEALTH, INC.
Dated: November 8, 2024
By:/s/ Peter Sorensen
Name:Peter Sorensen
Title:Chief Financial Officer


Exhibit 99.1
logoa.jpg

SANUWAVE Announces Record Quarterly Revenues: Q3 FY2024 Financial Results

Q3 2024 revenues were $9.4 million, up 89% from Q3 2023. This was an all-time quarterly record for the Company.

Q3 2024 gross margin was 75.5%, vs 71.5% in Q3 2023

GAAP Operating Income was $2.0 million

Company provides guidance for revenue growth of 40-50% for Q4 2024 versus Q4 2023

EDEN PRAIRIE, MN, November 8, 2024 (GLOBE NEWSWIRE) -- SANUWAVE Health, Inc. (the "Company" or "Sanuwave”) (OTCQB: SNWV), a leading provider of next-generation FDA-approved wound care products, is pleased to provide its financial results for the three months ended September 30, 2024.

Q3 2024 ended September 30, 2024

•Revenue for the three months ended September 30, 2024, totaled $9.4 million, an increase of 89%, as compared to $5.0 million for the same period of 2023. This growth is greater than the previously provided guidance for a 65 – 75% increase.
•124 UltraMist® systems were sold in Q3 2024 up from 55 in Q3 2023 and from 72 in Q2 2024.
•UltraMist® consumables revenue increased by 75% to $5.4 million (58% of revenues) in Q3 2024, versus $3.1 million for the same quarter last year. UltraMIST systems and consumables remained the primary revenue growth driver and continued to represent over 97% of SANUWAVE’s overall revenues in Q3 2024.
•Gross margin as a percentage of revenue amounted to 75.5% for the three months ended September 30, 2024, versus 71.5% for the same period last year.
•For the three months ended September 30, 2024, operating income totaled $2.0 million, an increase of $2.5 million compared to Q3 2023 as a result of the Company’s continued efforts to drive profitable growth and manage expenses.
•Net loss for the third quarter of 2024 was $20.7 million, driven predominantly by the change in the fair value of derivative liabilities. This compares to a net loss of $23.7 million in the third quarter of 2023. Net loss year to date was $18.6 million versus a net loss of $44.0 million in the nine months ended September 30, 2023.
•Adjusted EBITDA [1] for the three months ended September 30, 2024, was $2.1 million versus Adjusted EBITDA of $(0.3) million for the same period last year, an improvement of $2.4 million. Year to date Adjusted EBITDA was $3.5 million versus a loss of $1.8 million in the prior year period.

“The third quarter showed acceleration in revenue growth rate from the first half of the year with growth of 89% year on year (and 31% sequentially) leading the company to a growth rate of 68% for the first nine months of 2024 as compared to the same period in 2023,” said Morgan Frank, CEO. “Obviously, we’re very pleased with these results, especially to have achieved operating income and Adjusted EBITDA positivity again this quarter and, for the first time, became cash


generative from operations even after cash interest expense. We have begun to gain traction with some larger customers and our sales funnel remains the most promising it has ever been. As we look to the fourth quarter, we will seek to build on this progress as we continue to hire additional sales and commercial staff. We expect to experience a bit of a “pigs through a python” scenario for us over the coming months and quarters, as large orders move the needle on revenues in significant and variable fashion, but we anticipate finishing 2024 strongly as a breakout year for Sanuwave.”

Financial Outlook

The Company forecasts Q4 2024 revenue of $9.7 to $10.5 million (40-50% increase from Q4 2023) and therefore for revenues for 2024 as a whole to be in excess of $32 million (an increase of 57% vs full year 2023).
The Company forecasts Q4 gross margin as a percentage of revenue to remain in the mid-70s.

Subsequent to quarter end, the Company effected a 1-for-375 reverse stock split on October 18, 2024, completed its note and warrant exchange, and raised $10.3 million in a private placement, simplifying the Company’s capital structure and leaving it with approximately 8.5 million shares outstanding. Details of this transaction can be found on the Sanuwave website https://sanuwave.com/investors/press-release-details?newsId=OxzYFl0t620enXp1VyUG or in its filings with the SEC.

As previously announced, a business update will occur via conference call on November 8, 2024 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: 1-800-267-6316
Toll/International: 1-203-518-9783
Conference ID: SANUWAVE

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

https://viavid.webcasts.com/starthere.jsp?ei=1692398&tp_key=e3cff43c54


A replay will be made available through November 29, 2024:
Toll-Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Access ID: 11157276

[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 income (loss) 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. 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.

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 income (loss).



Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to future financial results, production expectations, and plans for future business development activities. Forward-looking statements include all statements that are not statements of historical fact regarding 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 risks associated with regulatory oversight, 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 QUARTERS ENDED SEPTEMBER 30, 2024 AND 2023
(in thousands)20242023
Revenue$9,360 $4,953 
    Cost of Revenues2,293 1,412 
Gross Margin7,067 3,541 
    Gross Margin %75.5 %71.5 %
    Total operating expenses5,114 4,072 
Operating Income (Loss)$1,953 $(531)
Total other expense(22,610)(23,169)
Net Income (Loss)$(20,657)$(23,700)

NON-GAAP ADJUSTED EBITDA
Three Months Ended September 30,Nine Months Ended September 30,
(in thousands)2024202320242023
Net Income/(Loss)$(20,657)$(23,700)$(18,624)$(44,042)
Non-GAAP Adjustments:
Interest expense3,661 3,845 11,004 12,504 
Depreciation and amortization256 266 736 780 
EBITDA(16,740)(19,589)(6,884)(30,758)
Non-GAAP Adjustments for Adjusted EBITDA:
Change in fair value of derivative liabilities18,849 19,325 17,633 29,943 
Other non-cash or non-recurring charges:
Gain on extinguishment of debt- - (5,205)- 
Severance agreement and legal settlement- - 585 - 
Release of historical accrued expenses- - (579)(1,250)
Shares for services- - - 224 
License and option agreement- - (2,500)- 
Prepaid legal fees expensed from termination of Merger Agreement- - 457 - 
Adjusted EBITDA$2,109 $(264)$3,507 $(1,841)






CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)September 30, 2024December 31, 2023
ASSETS
Current Assets:
Cash and cash equivalent$3,259 $1,797 
Accounts receivable, net of allowance of $1,056 and $1,237, respectively
2,836 3,314 
Inventory3,431 2,951 
Prepaid expenses and other current assets378 1,722 
Total Current Assets9,904 9,784 
Non-Current Assets:
Property, equipment and other, net774 938 
Intangible assets, net3,906 4,434 
Goodwill7,260 7,260 
Total Non-current Assets 11,940 12,632 
Total Assets$21,844 $22,416 
LIABILITIES
Current Liabilities:
Senior secured debt, in default $24,426 $18,278 
Convertible promissory notes payable 4,817 5,404 
Convertible promissory notes payable, related parties 2,838 1,705 
Asset-backed secured promissory notes payable— 3,117 
Asset-backed secured promissory notes, related parties— 1,458 
Promissory note payable, related party500 - 
Accounts payable4,137 5,705 
Accrued expenses5,241 5,999 
Factoring liabilities1,938 1,490 
Warrant liability35,509 14,447 
Accrued interest643 5,444 
Accrued interest, related parties952 669 
Current portion of contract liabilities137 92 
Other375 947 
Total Current Liabilities81,513 64,755 
Non-current Liabilities
Lease liabilities, less current portion236 492 
Contract liabilities, less current portion358 347 
Total Non-current Liabilities594 839 
Total Liabilities$82,107 $65,594 


STOCKHOLDERS’ DEFICIT
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 authorized; no shares issued and outstanding at September 30, 2024 and December 31, 2023
$- $- 
Common stock, par value $0.001, 2,500,000,000 shares authorized; 3,150,062 and 3,041,492 issued and outstanding at September 30, 2024 and December 31, 2023, respectively *
3 3 
Additional paid-in capital178,397 176,979 
Accumulated deficit(238,673)(220,049)
Accumulated other comprehensive income (loss)10 (111)
Total Stockholders’ Deficit(60,263)(43,178)
Total Liabilities and Stockholders’ Deficit$21,844 $22,416 
* Reflects a one-for-three hundred seventy-five (1:375) reverse stock split of the outstanding shares of the Company's common stock effected on October 18, 2024


CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands, except share data)Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Revenue$9,360 $4,953 $22,308 $13,404 
Cost of Revenues2,293 1,412 5,799 3,876 
Gross Margin7,067 3,541 16,509 9,528 
Operating Expenses:
General and administrative2,545 2,681 8,059 6,678 
Selling and marketing2,202 1,039 4,468 3,430 
Research and development161 165 519 436 
Depreciation and amortization206 187 568 563 
Total Operating Expenses5,114 4,072 13,614 11,107 
Operating Income (Loss)1,953 (531)2,895 (1,579)
Other Income (Expense):
Interest expense(3,315)(2,907)(9,948)(10,125)
Interest expense, related party(346)(938)(1,056)(2,379)
Gain on extinguishment of debt— - 5,205 - 
Change in fair value of derivative liabilities(18,849)(19,325)(17,633)(29,943)
Other expense(106)- (893)(16)
Other income
6 1 2,806 - 
Total Other Expense(22,610)(23,169)(21,519)(42,463)
Net Loss(20,657)(23,700)(18,624)(44,042)
Other Comprehensive Loss
Foreign currency translation adjustments— 7 121 (6)
Total Comprehensive Loss$(20,657)$(23,693)$(18,503)$(44,048)
Net Loss per share:
   Basic and Diluted *$(6.49)$(9.95)$(5.92)$(24.15)
Weighted average shares outstanding:
   Basic and Diluted *3,185 2,381 3,146 1,823 
* Reflects a one-for-three hundred seventy-five (1:375) reverse stock split of the outstanding shares of the Company's common stock effected on October 18, 2024


CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT
(In thousands, except share data)
Three Months Ended September 30, 2024
Common Stock
Number of Shares
 Issued and Outstanding		Par ValueAdditional Paid-
in Capital		Accumulated
Deficit 		Accumulated Other Comprehensive
Loss 		Total
Balances as of June 30, 20243,150,062$3 $178,397 $(218,016)$10 $(39,606)
Net loss
-- - (20,657)- (20,657)
Balances as of September 30, 20243,150,062$3 $178,397 $(238,673)$10 $(60,263)

Three Months Ended September 30, 2023
Common Stock

Number of Shares
Issued and Outstanding		Par ValueAdditional Paid-
in Capital		Accumulated Deficit Accumulated Other Comprehensive
Loss		 Total
Balances as of June 30, 20231,497,700$2 $153,824 $(214,584)$(80)$(60,838)
Shares issued for settlement of debt1,238,5091 18,576 - - $18,577 
Foreign currency translation adjustment-- - - 7 $7 
Net loss-- - (23,700)- $(23,700)
Balances as of September 30, 20232,736,209$3 $172,400 $(238,284)$(73)$(65,954)
* Reflects a one-for-three hundred seventy-five (1:375) reverse stock split of the outstanding shares of the Company's common stock effected on October 18, 2024


Nine Months Ended September 30,
Common Stock
Number of Shares
 Issued and Outstanding		Par ValueAdditional Paid-
in Capital		Accumulated
Deficit 		Accumulated Other Comprehensive
Loss 		Total
Balances as of December 31, 20233,041,492$3 $176,979 $(220,049)$(111)$(43,178)
Shares issued for settlement of warrants14,440- 6 - - 6 
Shares issued for settlement of debt94,130- 1,412 - - 1,412 
Foreign currency translation adjustment-- - - 121 121 
Net loss
-- - (18,624)- (18,624)
Balances as of September 30, 20243,150,062$3 $178,397 $(238,673)$10 $(60,263)

Nine Months Ended September 30, 2023
Common Stock

Number of Shares
Issued and Outstanding		Par ValueAdditional Paid-
in Capital		Accumulated Deficit Accumulated Other Comprehensive
Loss		 Total
Balances as of December 31, 20221,463,300$1 $153,298 $(194,242)$(67)$(41,010)
Shares issued for services34,4001 526 - - 527 
Shares issued for settlement of debt1,238,5091 18,576 - - $18,577 
Foreign currency translation adjustment-- - - (6)(6)
Net loss-- - (44,042)- (44,042)
Balances as of September 30, 20232,736,209$3 $172,400 $(238,284)$(73)$(65,954)

* Reflects a one-for-three hundred seventy-five (1:375) reverse stock split of the outstanding shares of the Company's common stock effected on October 18, 2024


CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)Nine Months Ended September 30,
20242023
Cash Flows - Operating Activities:
Net Loss$(18,624)$(44,042)
Adjustments to reconcile net loss to net cash used by operating activities
Depreciation and amortization736 780 
Bad debt expense16 547 
Shares issued for services- 224 
Gain on extinguishment of debt(5,205)- 
Change in fair value of derivative liabilities17,633 29,943 
Amortization of debt issuance costs and original issue discount4,792 5,656 
Accrued interest2,749 5,529 
Changes in operating assets and liabilities
Accounts receivable66 253 
Inventory(480)(844)
Prepaid expenses and other assets225 (487)
Accounts payable(1,013)464 
Accrued expenses763 (1,326)
Contract liabilities
56 50 
Net Cash Provided by (Used in) Operating Activities1,714 (3,253)
Cash Flows - Investing Activities
Proceeds from sale of property and equipment- 13 
Purchase of property and equipment
(254)(169)
Net Cash Flows Used in Investing Activities(254)(156)
Cash Flows - Financing Activities
Proceeds from convertible promissory notes- 1,202 
Payment of note payable(2,175)- 
Proceeds from convertible notes payable1,300 - 
Proceeds from promissory note payable, related party500 - 
Proceeds from bridge notes advance- 2,994 
Proceeds (Payments) from factoring, net449 (710)
Payments of principal on finance leases(193)(130)
Net Cash Flow (Used in) Provided by Financing Activities(119)3,356 
Effect of Exchange Rates on Cash121 (5)
Net Change in Cash During Period1,462 (58)
Cash at Beginning of Period
1,797 1,153 
Cash at End of Period
$3,259 $1,095 
Supplemental Information:
Cash paid for interest$3,189 $984 
Non-cash Investing and Financing Activities:
Shares issued for settlement of debt1,412 - 


Write off deferred merger costs1,226 - 
Warrants issued in conjunction with convertible promissory notes3,633 570 
Conversion of convertible notes payable to common stock- 18,577 
Capitalize default interest into senior secured debt3,850 - 
Conversion of asset-based secured promissory notes to convertible promissory notes4,584 - 
Embedded conversion feature on convertible promissory notes payable- (520)
Common shares issued for advisory shares- 302 

v3.24.3
Cover
Nov. 08, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 08, 2024
Entity Registrant Name SANUWAVE Health, Inc.
Entity Incorporation, State or Country Code NV
Entity File Number 000-52985
Entity Tax Identification Number 20-1176000
Entity Address, Address Line One 11495 Valley View Road,
Entity Address, City or Town Eden Prairie,
Entity Address, State or Province MN
Entity Address, Postal Zip Code 55344
City Area Code (952)
Local Phone Number 656-1029
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Amendment Flag false
Entity Central Index Key 0001417663
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