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

FORM 10-Q
 
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2024

☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to

Commission File Number 000-52985

SANUWAVE Health, Inc.
(Exact name of registrant as specified in its charter)

Nevada
  
20-1176000
(State or other jurisdiction of incorporation or organization)
  
(I.R.S. Employer Identification No.)

11495 Valley View Road
Eden Prairie, MN
  
55344
(Address of principal executive offices)
  
(Zip Code)

(952) 656-1029
(Registrant’s telephone number, including area code)

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

Title of each class
Trading Symbol(s)
Name of each exchange on which
registered
None
N/A
 N/A

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    ☒  Yes  ☐ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    ☒ Yes  ☐  No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

 
Large accelerated filer ☐
Accelerated filer ☐
 
Non-accelerated filer ☒
Smaller reporting company  ☒
   
Emerging growth company  ☐

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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   Yes   ☐     No  ☒  

As of May 7, 2024 there were issued and outstanding 1,145,974,342 shares of the registrant’s common stock, $0.001 par value per share.

SANUWAVE Health, Inc.
 
Table of Contents

 
Page
PART I – FINANCIAL INFORMATION
  
   
Item 1.
 4
   
  4
   
  5
   
  6
   
  7
   
  8
   
Item 2.
 15
   
Item 3.
 18
   
Item 4.
 19
   
PART II – OTHER INFORMATION
   
Item 1.
 20
   
Item 1A.
 20
   
Item 2.
 20
   
Item 3.
 20
   
Item 4.
 20
   
Item 5.
 20
   
Item 6.
 20
   
  23

2
Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q of SANUWAVE Health, Inc. and its subsidiaries (“SANUWAVE,” the “Company,” “we,” “us,” and “our”) contains forward-looking statements. All statements in this Quarterly Report on Form 10-Q, including those made by the management of the Company, other than statements of historical fact, are forward-looking statements. Examples of forward-looking statements include statements regarding: our proposed business combination with SEP Acquisition, Corp., results of operations, liquidity, and operations, restrictions and new regulations on our operations and processes, including the execution of clinical trials; the Company’s future financial results, operating results, and projected costs; market acceptance of and demand for UltraMIST and PACE®; success of future business development and acquisition activities; management’s plans and objectives for future operations; industry trends; regulatory actions that could adversely affect the price of or demand for our approved products; our intellectual property portfolio; our business, marketing and manufacturing capacity and strategy; estimates regarding our capital requirements, the anticipated timing of the need for additional funds, and our expectations regarding future capital-raising transactions, including through investments by strategic partners for market opportunities, which may include strategic partnerships or licensing agreements, or raising capital through the conversion of outstanding warrants or issuances of securities; product liability claims; economic conditions that could adversely affect the level of demand for or the cost of our products; timing of clinical studies and any eventual U.S. Food and Drug Administration (“FDA”) approval of new products and new uses of our current products; financial markets; the competitive environment; supplier and customer disputes; and our plans to remediate our material weaknesses in our disclosure controls and procedures and our internal control over financial reporting. These forward-looking statements are based on management’s estimates, projections, and assumptions as of the date hereof and include the assumptions that underlie such statements. Forward-looking statements may contain words such as “may,” “will,” “should,” “could,” “would,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” and “continue,” the negative of these terms, or other comparable terminology. Any expectations based on these forward-looking statements are subject to risks and uncertainties and other important factors, including those discussed in the reports we file with the Securities and Exchange Commission (the “SEC”), specifically the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on March 21, 2024. Other risks and uncertainties are and will be disclosed in the Company’s subsequent SEC filings, including this Quarterly Report on Form 10-Q. These and many other factors could affect the Company’s future financial condition and operating results and could cause actual results to differ materially from expectations based on forward-looking statements made in this document or elsewhere by the Company or on its behalf. The Company undertakes no obligation to revise or update any forward-looking statements. The following information should be read in conjunction with the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed on March 21, 2024.

Except as otherwise indicated by the context, references in this Quarterly Report on Form 10-Q to “we,” “us” and “our” are to the consolidated business of the Company.

3
PART I -- FINANCIAL INFORMATION

ITEM 1.
FINANCIAL STATEMENTS
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share data)

   
March 31, 2024
    
December 31, 2023
  
ASSETS
            
Current Assets:
            
Cash and cash equivalent
  
$
2,936
    
$
1,797
  
Accounts receivable, net of allowance of $1,237, respectively
    
3,008
      
3,314
  
Inventory
    
2,461
      
2,951
  
Prepaid expenses and other current assets
    
2,426
      
1,722
  
Total Current Assets
    
10,831
      
9,784
  
Property, equipment and other, net
    
975
      
938
  
Intangible assets, net
    
4,258
      
4,434
  
Goodwill
    
7,260
      
7,260
  
Total Non-current Assets     12,493       12,632  
Total Assets
  
$
23,324
    
$
22,416
  
                 
LIABILITIES
                
Current Liabilities:
                
Senior secured debt, in default
 
$
18,910
    
$
18,278
  
Convertible promissory notes payable
    7,477       5,404  
Convertible promissory notes payable, related parties
    2,527       1,705  
Asset-backed secured promissory notes
     -       3,117  
Asset-backed secured promissory notes, related parties
     -       1,458  
Accounts payable
    
5,062
      
5,705
  
Accrued expenses
    
6,849
      
5,999
  
Factoring liabilities
     1,561       1,490  
Warrant liability
    
19,818
      
14,447
  
Accrued interest
    
6,118
      
5,444
  
Accrued interest, related parties
    
786
      
669
  
Current portion of contract liabilities
    
107
      
92
  
Other
    
969
      
947
  
Total Current Liabilities
    
70,184
      
64,755
  
Non-current Liabilities
                
Lease liabilities
    
395
      
492
  
Contract liabilities
    
340
      
347
  
Total Non-current Liabilities
    
735
      
839
  
Total Liabilities
  
$
70,919
    
$
65,594
  
                 
Commitments and Contingencies (Footnote 13)
            
                 
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 no shares issued and outstanding at March 31, 2024 and December 31, 2022
  
$
-
    
$
-
  
Common stock, par value $0.001, 2,500,000,000 shares authorized; 1,140,559,527 issued and outstanding at March 31, 2024 and December 31, 2023, respectively
    
1,140
      
1,140
  
Additional paid-in capital
    
175,842
      
175,842
  
Accumulated deficit
    
(224,577
)
    
(220,049
)
Accumulated other comprehensive loss
    
-
   
(111
)
Total Stockholders’ Deficit
    
(47,595
)
    
(43,178
)
Total Liabilities and Stockholders’ Deficit
  
$
23,324
    
$
22,416
  

The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.

4
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share data)

   
Three Months Ended March 31,
  
   
2024
    
2023
  
             
Revenue
  
$
5,786
    
$
3,775
  
Cost of Revenues
    
1,584
      
1,262
  
Gross Margin
    
4,202
      
2,513
  
                 
Operating Expenses:
                
General and administrative
    
3,675
      
2,759
  
Selling and marketing
    
1,232
      
1,412
  
Research and development
    
163
      
131
  
Depreciation and amortization
     182       189  
Total Operating Expenses
    
5,252
      
4,491
  
                 
Operating Loss
    
(1,050
)
    
(1,978
)
                 
Other (Expense)/Income:
                
Interest expense
    
(3,237
)
    
(3,512
)
Interest expense, related party
    
(323
)
    
(766
)
Loss on extinguishment of debt
     (105 )     -  
Change in fair value of derivative liabilities
    
(2,501
)
    
(6,797
)
Other expense
     (102 )     (27 )
Other income
     2,790       -  
Total Other Expense
    
(3,478
)
    
(11,102
)
                 
                 
Net Loss
    
(4,528
)
    
(13,080
)
                 
Other Comprehensive Loss
                
Foreign currency translation adjustments
     111       (4 )
Total Comprehensive Loss
  
$
(4,417
)
  
$
(13,084
)
                 
Loss per Share:
                
Basic and diluted
  
$
(0.00
)
  
$
(0.02
)
Weighted average shares outstanding                
Basic and diluted
    
1,162,250,687
      
575,028,811
  

The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.

5
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ DEFICIT
(UNAUDITED)
(In thousands, except share data)

Three Months Ended March 31, 2024
  
 
Common Stock
                          
   
Number of
                      
Accumulated
        
    Shares                       Other        
   
Issued and
          
Additional Paid-
    
Accumulated
    
Comprehensive
        
    Outstanding    
Par Value
    
in Capital
    
Deficit
     Loss     Total  
                                     
Balances as of December 31, 2023
    
1,140,559,527
    
$
1,140
    
$
175,842
    
$
(220,049
)
  
$
(111
)
  
$
(43,178
)
Foreign currency translation adjustment
     -       -       -       -       111       111  
Net loss
     -       -       -       (4,528 )     -       (4,528 )
                                                 
Balances as of March 31, 2024
    
1,140,559,527
    
$
1,140
    
$
175,842
    
$
(224,577
)
  
$
-
    
$
(47,595
)

Three Months Ended March 31, 2023  
  Common Stock                  
 
Number of
              
Accumulated
      
  Shares               Other
     
 
Issued and
      
Additional Paid-
  
Accumulated
   Comprehensive
     
  Outstanding   Par Value
 
in Capital
   Deficit
  Loss   Total  
                         
Balances as of December 31, 2022
    
548,737,651
    
$
549
    
$
152,750
    
$
(194,242
)
  
$
(67
)
  
$
(41,010
)
Shares issued for settlement of debt and warrants
     6,900,000       7       296       -       -       303  
Foreign currency translation adjustment
     -       -       -       -       (4 )     (4 )
Net loss
    
-
      
-
      
-
      
(13,080
)
    
-
      
(13,080
)
                                                 
Balances as of March 31, 2023
    
555,637,651
    
$
556
    
$
153,046
    
$
(207,322
)
  
$
(71
)
  
$
(53,791
)

The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.

6
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)

   
Three Months Ended March 31,
  
   
2024
    
2023
  
Cash Flows - Operating Activities:
            
Net loss
  
$
(4,528
)
  
$
(13,080
)
Adjustments to reconcile net loss to net cash used by operating activities
                
Depreciation and amortization
    
218
      
259
  
Bad debt expense
    
147
      
156
  
Loss on extinguishment of debt
     105       -  
Change in fair value of derivative liabilities
     2,501      
6,797
  
Amortization of debt issuance costs and original issue discount
    
1,553
      
1,931
  
Accrued interest
    
955
      
1,365
  
Changes in operating assets and liabilities
                
Accounts receivable
    
152
      
906
  
Inventory
    
490
      
(203
)
Prepaid expenses and other assets
    
192
      
195
  
Accounts payable
    
(643
)
    
864
  
Accrued expenses
    
(20
)
    
450
  
Contract liabilities
    
(22
)
    
(11
)
Net Cash Provided by/(Used) in Operating Activities
    
1,100
      
(371
)
                 
Cash Flows - Investing Activities
                
Purchase of property and equipment
     (114 )     (18 )
Net Cash Flows Used in Investing Activities
    
(114
)
    
(18
)
                 
Cash Flows - Financing Activities
                
Proceeds/(Payments) from factoring, net
     71       (610 )
Payments of principal on finance leases
    
(29
)
    
(44
)
Net Cash Flows Provided by/ (Used in) Financing Activities
    
42
      
(654
)
                 
Effect of Exchange Rates on Cash
    
111
      
(4
)
                 
Net Change in Cash During Period
    
1,139
      
(1,047
)
                 
Cash at Beginning of Period
    
1,797
      
1,153
  
Cash at End of Period
  
$
2,936
    
$
106
  
                 
Supplemental Information:
                
Cash paid for interest
  
$
971
    
$
908
  
                 
Non-cash Investing and Financing Activities:
                
Warrants issued in conjunction with convertible promissory notes
    2,784       -  
Conversion of asset-backed secured promissory notes to convertible promissory notes
     4,584       -  
Common shares issued for advisory shares
    -       302  

 The accompanying notes to condensed consolidated financial statements are an integral part of these financial statements.

7
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2024

1.
Nature of the Business and Basis of Presentation

SANUWAVE Health, Inc. and subsidiaries (“SANUWAVE” or the “Company”) is focused on the commercialization of its patented noninvasive and biological response activating medical systems for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.

Basis of Presentation – The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, these condensed consolidated financial statements do not include all the information and disclosures required by U.S. GAAP for comprehensive financial statements.

The financial information as of March 31, 2024, and for the three months ended March 31, 2024, and 2023 is unaudited; however, in the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair statement have been included. Operating results for the three months ended March 31, 2024, are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2024.
 
The condensed consolidated balance sheet on December 31, 2023, has been derived from the audited consolidated financial statements at that date but does not include all the information and disclosures required by U.S. GAAP for comprehensive financial statements. These financial statements should be read in conjunction with the Company’s December 31, 2023, Annual Report on Form 10-K filed with the SEC on March 21, 2024 (the “2023 Annual Report”).

2.
Going Concern

Our recurring losses from operations, the events of default on the Company’s notes payable, and dependency upon future issuances of equity or other financing to fund ongoing operations have raised substantial doubt as to our ability to continue as a going concern for a period of at least twelve months from the filing of this Form 10-Q. We will be required to raise additional fund to finance our operations and remain a going concern; we may not be able to do so, and/or the terms of any financing may not be advantageous to us.

The continuation of our business is dependent upon raising additional capital. We expect to devote substantial resources for the commercialization of UltraMIST and PACE systems which will require additional capital resources to remain a going concern.
 
Management’s plans are to obtain additional capital in 2024, primarily through closing the Merger, as described in Note 4. The Company could also obtain additional capital through the conversion of outstanding warrants, issuance of common or preferred stock, securities convertible into common stock, or secured or unsecured debt. These possibilities, to the extent available, may be on terms that result in significant dilution to the Company’s existing stockholders. In addition, there can be no assurances that the Company’s plans to obtain additional capital will be successful on the terms or timeline it expects, or at all. If these efforts are unsuccessful, the Company may be required to significantly curtail or discontinue operations or, if available, obtain funds through financing transactions with unfavorable terms.

The accompanying condensed consolidated financial statements have been prepared in conformity with U.S. GAAP, which contemplate continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in the condensed consolidated financial statements do not necessarily purport to represent realizable or settlement values. The condensed consolidated financial statements do not include any adjustment that might result from the outcome of this uncertainty. The Company’s condensed consolidated financial statements do not include any adjustments relating to the recoverability of assets and classification of assets and liabilities that might be necessary should the Company be unable to continue as a going concern.

8
3.
Summary of Significant Accounting Policies

Significant accounting policies followed by the Company are summarized below and should be read in conjunction with those described in Note 3 of the consolidated financial statements in our 2023 Annual Report.

Estimates – These condensed consolidated financial statements have been prepared in accordance with U.S. GAAP. Because a precise determination of assets and liabilities, and correspondingly revenues and expenses, depend on future events, the preparation of condensed consolidated financial statements for any period necessarily involves the use of estimates and assumptions. Actual amounts may differ from these estimates. These condensed consolidated financial statements have, in management’s opinion, been properly prepared within reasonable limits of materiality and within the framework of the accounting policies summarized herein.

Significant estimates include the recording of allowances for credit losses, the net realizable value of inventory, fair value of goodwill and other intangible assets, the determination of the valuation allowances for deferred taxes, litigation contingencies, and the estimated fair value of financial instruments, including warrants and embedded conversion options.

Revenue Recognition - The core principle of Accounting Standards Codification (“ASC”) Topic 606 “Revenue from Contracts with Customers” (“ASC 606”) requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The Company allocates the transaction price to all contractual performance obligations included in the contract. If a contract has more than one performance obligation, we allocate the transaction price to each performance obligation based on standalone selling price, which depicts the amount of consideration we expect to be entitled in exchange for satisfying each performance obligation. The Company recognizes revenue primarily from the following types of contracts:

System Sales, Consumables and Part Sales - System sales, consumables and part sales include devices and applicators (new and refurbished). Performance obligations are satisfied at the point in time when the customer obtains control of the goods, which is generally at the point in time that the product is shipped.

Other Revenue - Other revenue primarily includes warranties, repairs, and billed freight. The Company allocates the device sales price to the product and the embedded warranty by reference to the stand-alone extended warranty price. Warranty revenue is recognized over the time that the Company satisfies its performance obligations, which is generally the warranty term. Repairs (parts and labor) and billed freight revenue are recognized at the point in time that the service is performed, or the product is shipped, respectively.

Deferred Offering Costs - Deferred stock offering costs represent amounts paid for legal, consulting, and other offering expenses directly attributable to the offering of securities in conjunction with the recapitalization under the Merger Agreement, as defined in Note 4 and further described in Note 4 and are deferred and charged against the gross proceeds of the offering. In the event of a significant delay or cancellation of a planned offering of securities, all the costs would be expensed. As of March 31, 2024, $1.6 million in Merger costs were deferred until the closing of the Merger.

Recent Accounting Pronouncements - In December 2023, the Financial Accounting Standards Board issued ASC Update No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. Update No. 2023-09 aims to enhance the transparency and decision usefulness of income tax disclosures. Update No. 2023-09 modifies the rules on income tax disclosures to require entities to disclose (1) specific categories in the rate reconciliation, (2) the income or loss from continuing operations before income tax expense or benefit (separated between domestic and foreign) and (3) income tax expense or benefit from continuing operations (separated by federal, state, and foreign). Update 2023-09 also requires entities to disclose their income tax payments to international, federal, state and local jurisdictions, among other changes. Update No. 2023-09 is effective for fiscal years beginning after December 15, 2024. We expect to adopt Update No. 2023-09 prospectively. We are currently evaluating the potential impact of adopting this new guidance on our condensed consolidated financial statements and related disclosures.

4.
Merger Agreement
 
On August 23, 2023, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) by and among SEP Acquisition Corp., a Delaware corporation (“SEPA”), SEP Acquisition Holdings Inc., a Nevada corporation and a wholly owned subsidiary of SEPA (“Merger Sub”). Pursuant to the terms of the Merger Agreement, a business combination between the Company and SEPA (the “Merger”) will be affected. More specifically, and as described in greater detail below, at the effective time of the Merger (the “Effective Time”):


•
Merger Sub will merge with and into the Company, with the Company being the surviving company following the Merger.

•
Each issued and outstanding share of the Company’s common stock, will automatically be converted into Class A common stock of SEPA, par value $0.0001 per share (the “Class A Common Stock”), at the Conversion Ratio (as defined in the Merger Agreement); and

•
Outstanding convertible securities of the Company will be assumed by SEPA and will be converted into the right to receive Class A Common Stock of SEPA.

9
Table of Contents
If the Merger Agreement is consummated SEPA will acquire 100% of the Company’s issued and outstanding equity securities. The proposed merger will be accounted for as a “reverse recapitalization” in accordance with US GAAP. Under the reverse recapitalization model, the transaction will be treated as the Company issuing equity for the net assets of SEPA, with no goodwill or intangible assets recorded. Under this method of accounting, SEPA will be treated as the acquired company for financial reporting purposes. This determination is primarily based on the fact that following the merger, the Company’s stockholders are expected to have a majority voting power of the combined company, approximately 69 – 70%, the Company will comprise all of the ongoing operations of the combined company, Company representatives will comprise a majority of the governing body of the combined company, and the Company’s senior management will comprise all of the senior management of the combined company. As a result of the merger, SEPA will be renamed Sanuwave Health, Inc. 

Merger Consideration - The consideration to be delivered to the Company’s securityholders by SEPA in connection with the consummation of the Merger (the “Closing”) will consist solely of 7,793,000 shares of Class A Common Stock and, in the case of certain securityholders, of securities convertible into or exercisable for new shares of Class A Common Stock reserved for issuance from the merger consideration (the “Merger Consideration”). The Merger Consideration deliverable to the Company’s stockholders will be allocated pro rata based on their ownership after giving effect to the required conversion or exercise, as applicable, of all the outstanding convertible notes, in-the-money options, and in-the-money warrants immediately prior to the Closing.

Out-of-the-money options and out-of-the-money warrants will be assumed by SEPA and converted into options or warrants, respectively, exercisable for shares of Class A Common Stock based on the Conversion Ratio; however, such out-of-the-money options and warrants shall not be reserved for issuance from the Merger Consideration.

Conditions to Closing - The Merger Agreement contains customary conditions to Closing, including the following mutual conditions of the parties (unless waived): (i) approval of the stockholders of the Company and SEPA; (ii) approvals of any required governmental authorities; (iii) no law or order preventing the transactions; (iv) the filing of the Charter Amendments (as defined in the Merger Agreement);  (v) the appointment of SEPA’s post-closing board of directors; (vi) the Registration Statement having been declared effective by the SEC; (vii) approval of the Class A Common Stock of SEPA for listing on Nasdaq; (viii) holders of 80% or more of the Company’s convertible notes with a maturity date occurring after the date of the Closing (the “Closing Date”), measured by number of shares into which such convertible notes may be converted, agreeing to convert their convertible notes into shares of common stock immediately prior to the Effective Time; and (ix) holders of 80% or more of the Company’s warrants that would be outstanding on the Closing Date, measured by number of shares subject to all such warrants in the aggregate, agreeing to convert their warrants into shares of common stock immediately prior to the Effective Time.

In addition, unless waived by the Company, the obligations of the Company to consummate the business combination are subject to the satisfaction of the following additional Closing conditions, in addition to the delivery by SEPA of customary certificates and other Closing deliverables: (ii) SEPA having performed in all material respects its obligations and complied in all material respects with its covenants and agreements under the Merger Agreement required to be performed or complied with by it on or prior to the Closing Date; (iii) SEPA having delivered a fairness opinion of the Purchaser Financial Advisor (as defined in the Merger Agreement), in form and substance reasonably satisfactory to the Company; (iv) SEPA having, at the Closing, at least $12,000,000 in cash and cash equivalents, including funds remaining in the trust account (after giving effect to the completion and payment of any redemptions) and the proceeds of any PIPE Investment; and other customary conditions to Closing as defined in the Merger Agreement.

In February 2024, the Company amended the Merger Agreement to extend the date after which the Company or SEPA, in its discretion, can elect to terminate the Merger Agreement if any of the conditions to closing of the other party have not been met or waived, from February 28, 2024, to April 30, 2024 (the “Outside Date”).  In April 2024, the Company amended the Merger Agreement to further extend the Outside Date to May 31, 2024.

5.
Loss per Share

Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares outstanding for the three months ended March 31, 2024, and 2023. The weighted average number of shares outstanding includes outstanding common stock and shares issuable for nominal consideration. Accordingly, warrants issued with a $0.01 per share exercise price, are included in weighted average shares outstanding as follows:

   
Three Months Ended
  
(in Thousands)
  
March 31, 2024
    
March 31, 2023
  
Weighted average shares outstanding
            
Common shares
    
1,140,560
      
553,338
  
Common shares issuable assuming exercise of nominally priced warrants
    
21,691
      
21,691
  
Weighted average shares outstanding
    
1,162,251
      
575,029
  

10
Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock and dilutive common stock equivalents outstanding. To the extent that securities are “anti-dilutive,” they are excluded from the calculation of diluted net loss per share. As a result of the net loss for each the three months ended March 31, 2024, and March 31, 2023, all potentially dilutive shares in such periods were anti-dilutive and therefore excluded from the computation of diluted net loss per share.

    Three Months Ended  
(in thousands)  
March 31, 2024
    
March 31, 2023
  
Common stock options
    
16,287
      
19,286
  
Common stock purchase warrants
    
1,427,764
      
1,186,522
  
Convertible notes payable, including interest
    
284,123
      
624,577
  
     
1,728,174
      
1,830,385
  

6.
Accrued Expenses

Accrued expenses consist of the following:

(in Thousands)
  
March 31, 2024
    
December 31, 2023
  
Registration penalties
  
$
1,583
    
$
1,583
  
License fees
    
892
      
892
  
Board of directors fees
    
1,072
      
942
  
Employee compensation
     2,449       2,298  
Other
    
853
      
284
  
 
  
$
6,849
    
$
5,999
  

7.
Senior Secured Debt, In Default

The following table summarizes outstanding senior secured debt, in default:

   
March 31, 2024
    
December 31, 2023
  
(in thousands)
  
Principal
    
Debt Discount
    
Carrying Value
    
Accrued Interest
    
Principal
    
Debt Discount
    
Carrying Value
    
Accrued Interest
  
Senior secured debt
  
$
21,726
    
$
(2,816
)
  
$
18,910
    
$
3,479
    
$
21,562
    
$
(3,284
)
  
$
18,278
    
$
3,206
  

Senior secured promissory note payable, in default (“Senior Secured Note”) – In August 2020, the Company entered into a Note and Warrant Purchase and Security Agreement (the “NWPSA”). In accordance with the NWPSA, the Company issued a $15 million Senior Secured Promissory Note Payable (the “Senior Secured Note”) and a warrant exercisable for shares of the Company’s common stock in exchange for cash to support operations, repay outstanding debt and close on the acquisition of the UltraMIST assets from Celularity Inc. (Celularity) among other transactions.

In February 2022, the Company entered into a Second Amendment to Note and Warrant Purchase and Security Agreement (the “Second NWPSA”) for $3.0 million, for a total of $18.0 million outstanding. Along with the issuance of the note, the Company also issued warrants to purchase 16.2 million shares of common stock with an exercise price of $0.18 and 20.6 million shares of common stock.

Interest is charged at the greater of the prime rate or 3% plus 9%. The principal increases at a rate of 3% of the outstanding principal balance (PIK interest) on each quarterly interest payment date. The original maturity date of the Senior Secured Note is September 20, 2025, and it can be prepaid.

In March 2024, the Company entered into a Consent, Limited Waiver and Fifth Amendment to Note and Warrant Purchase Agreement (the “Fifth Amendment”). The Fifth Amendment provides (i) consent to enter into a License and Option Agreement and consummation of a License and Option Transaction a waiver of any event of default that may occur under the NWPSA, because of the License and Option Agreement or License and Option Transaction and (iii) amended the NWPSA to release certain patents from the collateral. The Fifth Amendment also provides for a forbearance of exercising remedies in connection with certain existing events of default under the NWPSA until the earlier of (x) the occurrence of another event of default under the NWPSA and (y) April 30, 2024. During the forbearance period, the outstanding obligations under the NWPSA continue to accrue interest at the default rate.

11
As of March 31, 2024, the Company is in default on the minimum liquidity provisions in the Senior Secured Note and, as a result, it is classified in current liabilities in the accompanying condensed consolidated balance sheets. The Company is accruing interest at the default interest rate of an incremental 5%.

The debt issuance costs, and debt discount related to the Senior Secured Note were capitalized as a reduction in the principal amount and are being amortized to interest expense over the life of the Senior Secured Note. The amortization of the debt issuance costs and debt discount, included in interest expense, for the three months ended March 31, 2024, and 2023, totaled $0.5 million and $0.4 million, respectively. Interest expense on the Senior Secured Note totaled $1.9 million and $1.6 million for the three months ended March 31, 2024, and 2023, respectively.

8.
Convertible Promissory Notes Payable

 

The following two tables summarize outstanding notes payable as of March 31, 2024, and December 31, 2023:

 
 
  
As of March 31, 2024
  
(In thousands, except conversion price)
  
Conversion
Price
    
Principal
    
Remaining
Debt Discount
    
Carrying Value
  
Acquisition convertible promissory note, in default
  
$
0.10
      
4,000
      
-
      
4,000
  
Historical convertible promissory notes payable, related parties, in default
  
$
0.10
      
1,373
      
-
      
1,373
  
Convertible notes payable
  
$
0.04
      
5,761
      
(2,284
)
    
3,477
  
Convertible notes payable, related parties
  
$
0.04
      
1,912
      
(758
)
    
1,154
  
Total Convertible Promissory Notes Payable
          
$
13,046
    
$
(3,042
)
  
$
10,004
  

 
  
As of December 31, 2023
  
(In thousands, except conversion price)
  
Conversion
Price
    
Principal
    
Remaining
Debt Discount
    
Remaining
Embedded
Conversion
Option
    
Carrying
Value
  
Acquisition convertible promissory note, in default
  
$
0.10
      
4,000
      
-
      
-
      
4,000
  
Historical convertible promissory note, related party, in default
  
$
0.10
      
1,373
      
-
      
-
      
1,373
  
Convertible notes payable
  
$
0.04
      
2,639
      
(1,235
)
    
-
      
1,404
  
Convertible notes payable, related parties
  
$
0.04
      
450
      
(118
)
    
-
      
332
  
Total Convertible Promissory Notes Payable
          
$
8,462
    
$
(1,353
)
  
$
-
    
$
7,109
  


Convertible Notes Payable and Convertible Notes Payable, Related Parties – In August 2022, November 2022, May 2023, December 2023, and January 2024, the Company entered into Securities Purchase Agreements (the “Purchase Agreements”), for the sale in a private placement of (i) Future Advance Convertible Promissory Notes (the “Notes”) in an aggregate principal amount of approximately $16.2 million in August approximately $4.0 million in November, $1.2 million in May, $1.9 million in December 2023, and $4.6 million in January 2024 related to the conversion of the Asset-Backed Secured Promissory Notes (described in Note 9)  (ii) Common Stock Purchase Warrants to purchase an additional 695.6 million shares of common stock with an exercise price of $0.067 per share and (iii) Common Stock Purchase Warrants to purchase an additional 695.6 million shares of common stock with an exercise price of $0.04 per share. Interest expense for the three months ended March 31, 2024, and 2023 totaled $1.6 million and $2.3 million respectively.

The Notes have a term of 12 months from the date of issue. Pursuant to the Notes, the Company promised to pay in cash and/or in shares of common stock, at a conversion price of $0.04 (the “Conversion Price”), the principal amount and interest at a rate of 15% per annum on any outstanding principal. The Conversion Price of the Notes is subject to adjustment, including if the Company issues or sells shares of common stock for a price per share less than the Conversion Price of the Notes or if the Company lists its shares of common stock on The Nasdaq Capital Market and the average volume weighted average price of such common stock for the five trading days preceding such listing is less than $0.04 per share; provided, however, that the Conversion Price shall never be less than $0.01. The Notes contain customary events of default and covenants, including limitations on incurrences of indebtedness and liens.

9.
Asset-Backed Secured Promissory Notes
 
In July 2023, the Company issued Asset-Backed Secured Promissory Notes (the “ABS Promissory Notes”) in an aggregate principal amount of $4.6 million to certain accredited investors (the “Purchasers”) at an original issue discount of 33.33%. The ABS Promissory Notes bear an interest rate of 0% per annum and mature on January 21, 2024 (the “Maturity Date”).  The Company received total proceeds of approximately $3.0 million. The Company entered into a Security Agreement providing for a continuing and unconditional security interest in any and all property of the Company.  This security interest is subordinate to the Senior Secured Debt described in Note 7. Interest expense for the three March 31, 2024, totaled $0.1 million prior to conversion at the Maturity Date.
 
12
Table of Contents
On January 21, 2024, pursuant to the side letter, which the parties agreed that upon the Maturity Date, the Company will issue each Purchaser a Convertible Note Payable with the same principal amount as the principal amount of such Purchasers’ ABS Promissory Notes. Pursuance to this side letter the ABS Promissory Notes converted to convertible promissory notes, as described in Note 8. The Company recorded a net loss on extinguishment of debt totaling $0.1 million for the three months ended March 31, 2024.

10.
Fair Value Measurements

The Company uses various inputs to measure the outstanding warrants and certain embedded conversion features associated with a convertible debt on a recurring basis to determine the fair value of the liabilities.

The following tables classify the Company’s liabilities measured at fair value on a recurring basis into the fair value hierarchy:

   
Fair value measured at March 31, 2024
  
   
Fair value at
    
Quoted prices in
active markets
   
Significant other
observable inputs
   
Significant
unobservable inputs
 
(in thousands)
  
March 31, 2024
    
(Level 1)
    
(Level 2)
    
(Level 3)
  
Warrant liability
  
$
19,818
    
$
-
    
$
-
    
$
19,818
  

   
Fair value measured at December 31, 2023
  
    Fair value at    
Quoted prices in
active markets
   
Significant other
observable inputs
    
Significant
unobservable inputs
  
(in thousands)
 
December 31, 2023
    
(Level 1)
    
(Level 2)
    
(Level 3)
  
Warrant liability
  
$
14,447
    
$
-
    
$
-
    
$
14,447
  
Embedded conversion option
    
93
      
-
      
-
      
93
  
Total fair value
  
$
14,540
    
$
-
    
$
-
    
$
14,540
  

There were no transfers among Levels 1, 2 or 3 during the three months ended March 31, 2024, and 2023. Both observable and unobservable inputs were used to determine the fair value of positions that the Company has classified within the Level 3 category. Unrealized gains and losses associated with liabilities within the Level 3 category include changes in fair value that were attributable to both observable (e.g. changes in market interest rates) and unobservable (e.g., changes in unobservable long-dated volatilities) inputs.

Warrant Liability

The Company’s liability classified warrants as of March 31, 2024 and the value of initial warrant liability from the conversion of the ABS Promissory Notes, were valued using a probability weighted expected value considering the Merger Agreement and the previous Black Scholes valuation model, with significant value stemming from the Merger Agreement. Significant inputs under the Merger Agreement valuation included the expected exchange ratio 0.003, the value of SEPA’s Class A Common Stock, the expected timing of the closing of the Merger (estimated by May 31, 2024), and the probability of the Merger closing (90% probability).

A summary of the warrant liability activity for the three months ended March 31, 2024, is as follows:


 
Warrants
    
Fair Value
    
Fair Value
  
(in thousands, except per share data)
  
Outstanding
    
per Share
    
(in thousands)
  
Balance at December 31, 2023
    
1,221,308
    
$
0.01
    
$
14,447
  
Issuance
    227,882       0.01       2,784  
Loss on remeasurement of warrant liability
    
-
              
2,587
  
Balance at March 31, 2024
    
1,449,190
    
$
0.01
    
$
19,818
  
 
11.
Revenue

The disaggregation of revenue is based on type and geographical region. The following table presents revenue from contracts with customers:

13
Table of Contents
   
Three Months Ended March 31, 2024
    
Three Months Ended March 31, 2023
  
   
United States
    
International
    
Total
    
United States
    
International
    
Total
  
Consumables and parts revenue
  
$
4,241
    
$
66
    
$
4,307
    
$
2,574
    
$
32
 
$
2,606
  
System revenue
    
1,301
      
71
      
1,372
      
833
      
36
      
869
  
License fees and other
    
-
      
5
      
5
      
7
      
10
      
17
  
Product Revenue
  
$
5,542
    
$
142
    
$
5,684
    
$
3,414
    
$
78
    
$
3,492
  
Rental Income
    
102
      
-
      
102
      
283
      
-
      
283
  
Total Revenue
  
$
5,644
    
$
142
    
$
5,786
    
$
3,697
    
$
78
    
$
3,775
  


12.
Concentration of Credit Risk and Limited Suppliers
 
The Company currently purchases most of its product component materials from single suppliers and the loss of any of these suppliers could result in a disruption in the Company’s production. The percentage of purchases from major vendors of the Company that exceeded ten percent of total purchases for the three months ended March 31, 2024, and 2023 were as follows:
 
   
Three Months Ended
  
   
March 31, 2024
    
March 31, 2023
  
Purchases:
            
Vendor A
     -  %    
20
%

13.
License and Option Agreement

In March 2024, the Company entered into an exclusive license and option agreement with a third-party licensee in connection with a portfolio of Sanuwave, Inc. patents related to the field of intravascular shockwave applications. The Company received a one-time payment of $2.5 million related to this patent license, which was recorded in other income during the three months ended March 31, 2024. Sanuwave, Inc. granted the Licensee an exclusive license to the Patents and an option to acquire the Patents for an additional one-time payment in the single-digit millions of dollars.  If the Licensee does not exercise its option to acquire the Patents during a specified option period, the license terminates and all rights revert back to Sanuwave, Inc.

14.
Commitments and Contingencies

In the ordinary course of business, the Company from time to time becomes involved in various legal proceedings involving a variety of matters. The Company does not believe there are any pending legal proceedings that will have a material adverse effect on the Company’s business, consolidated financial position, results of operations, or cash flows. However, the outcome of such legal matters is inherently unpredictable and subject to significant uncertainties. The Company expenses legal fees in the period in which they are incurred.
 
Termination Agreement – In February 2024, the Company entered into a termination agreement with an advisor to agree on termination fees owed with respect to a previous engagement agreement. The company agreed to a contingent payment of $670 thousand upon the closure of the Merger disclosed in note 4.

Acquisition dispute – In May 2021, the Company received notification alleging that it is not in compliance with the license agreement with Celularity entered into in connection with the acquisition of the UltraMIST assets. The Company has responded and asserted that the Company is not in breach and that the supplier has breached various agreements. It is too early to determine the outcome of this matter. Any potential impact on the Company cannot be fully determined at this time and there is no guarantee that the dispute will be resolved in a manner beneficial to the Company.

14
Item 2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements and the related notes appearing elsewhere in this report, and together with our audited consolidated financial statements, related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” as of and for the year ended December 31, 2023 included in our Annual Report on Form 10-K, filed with the SEC on March 21, 2024 (the “2023 Annual Report”).

Executive Summary

We continued to realize significant revenue growth during the three months ended March 31, 2024, as compared to the same periods in 2023.  Revenue for the three months ended March 31, 2024, totaled $5.8 million, an increase of 53%, as compared to $3.8 million for the same period of 2023.

Net loss for the three months ended March 31, 2024, was $4.5 million, or $0.00 per basic and diluted share, compared to a net loss of $13.1 million, or $0.02 per basic and diluted share, for the same period in 2023.  The decrease in our net loss for the three months ended March 31, 2024, was primarily related to a decrease in change of fair value of derivative liabilities.  For the three months ended March 31, 2024, our operating loss totaled $1.1 million, which is an improvement of $0.9 million compared to 2023.

Merger Agreement with SEPA

On August 23, 2023, we entered into an Agreement and Plan of Merger (the “Merger Agreement”) by and among SEP Acquisition Corp., a Delaware corporation (“SEPA”), SEP Acquisition Holdings Inc., a Nevada corporation, and a wholly owned subsidiary of SEPA (“Merger Sub”). Pursuant to the terms of the Merger Agreement, a business combination between the Company and SEPA (the “Merger”) will be affected. More specifically, and as described in greater detail below, at the effective time of the Merger (the “Effective Time”):


 •
Merger Sub will merge with and into the Company, with the Company being the surviving company following the merger.

•
Each issued and outstanding share of the Company common stock will automatically be converted into Class A common stock of SEPA, par value $0.0001 per share, at the Conversion Ratio (as defined in the Merger Agreement); and

•
Outstanding Company convertible securities of the Company will be assumed by SEPA and will be converted into the right to receive Class A Common Stock of SEPA.

Pursuant to the terms of the Merger Agreement, the holders of (i) Company common stock, (ii) in-the-money options to purchase Company common stock, (iii) in-the-money warrants to purchase Company common stock, and (iv) convertible promissory notes, collectively will be entitled to receive 7,793,000 shares of Class A Common Stock of SEPA. Out-of-the-money options and out-of-the-money warrants will be assumed by SEPA and converted into options or warrants, respectively, exercisable for shares of Class A Common Stock based on the Conversion Ratio; however, such out-of-the-money options and out-of-the-money warrants shall not be reserved for issuance from the Merger Consideration.

The Merger Agreement contains certain conditions to Closing, including the following:


 •
holders of 80% or more of the Company’s convertible notes with a maturity date occurring after the date of the Closing (the “Closing Date”), measured by number of shares of our common stock into which such convertible notes may be converted, agreeing to convert their convertible notes into shares of common stock immediately prior to the Effective Time.


•
holders of 80% or more of the Company’s warrants that would be outstanding on the Closing Date, measured by number of shares of our common stock subject to all such warrants in the aggregate, agreeing to convert their warrants into shares of common stock immediately prior to the Effective Time.


•
SEPA having, at the Closing, at least $12,000,000 in cash and cash equivalents, including funds remaining in the trust account (after giving effect to the completion and payment of any redemptions) and the proceeds of any private placement in SEPA.

Non-GAAP Financial Measures

Throughout this Management’s Discussion and Analysis of Financial Condition and Results of Operations, we present certain financial measures that facilitate management's review of the operational performance of the Company and as a basis for strategic planning; however, such financial measures are not presented in our financial statements prepared in accordance with accounting principles generally accepted in the United States (U.S.) (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 non-recurring one-time charges.  EBITDA and Adjusted EBITDA should not be considered as alternatives to net 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 our future results will be unaffected by unusual or non-recurring 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 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 our results as reported under U.S. GAAP. Some of these limitations are that EBITDA and Adjusted EBITDA:

15
•
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, our non-GAAP financial measure excludes the impact of certain charges that contribute to our net loss (Non-GAAP Adjustments).

   
Three months ended March 31,
  
(in thousands)
  
2024
    
2023
  
             
Net (Loss)/Income
  
$
(4,528
)
  
$
(13,084
)
Non-GAAP Adjustments:
                
Interest expense
    
3,560
      
4,278
  
Depreciation and amortization
    
218
      
259
  
EBITDA
    
(750
)
    
(8,547
)
 
Non-GAAP Adjustments for Adjusted EBITDA:
                
Change in fair value of derivative liabilities
    
2,501
      
6,797
  
Other non-cash or non-recurring charges:
                
Loss on extinguishment of debt
    
105
      
-
  
Severance agreement and legal settlement
    
585
      
-
  
License and option agreement
    
(2,500
)
    
-
  
Adjusted EBITDA
  
$
(59
)
  
$
(1,750
)

Results of Operations

   
For the Three Months Ended
  
   
March 31,
    
Change
  
(in Thousands)
  
2024
    
2023
     $    

%
  
Revenues:
                          
Total Revenue
  
$
5,786
    
$
3,775
    
$
2,011
      
53
%
Cost of Revenues
    
1,584
      
1,262
      
322
      
26
%
Gross Margin
    
4,202
      
2,513
      
1,709
      
68
%
Gross Margin %
    
73
%
    
67
%
  
600 bps
          
Operating Expenses:
                                
General and administrative
    
3,675
      
2,759
      
916
      
33
%
Selling and marketing
    
1,232
      
1,412
      
(180
)
    
-13
%
Research and Development
    
163
      
131
      
32
      
24
%
Depreciation and amortization
    
182
      
189
      
(7
)
    
-4
%
Operating Loss
    
(1,050
)
    
(1,978
)
    
928
      
47
%
Other Expense
    
3,478
      
11,102
      
(7,624
)
    
-69
%
Net Loss
  
$
(4,528
)
  
$
(13,080
)
    
8,552
      
65
%
nm - Not Meaningful

Revenues and Gross Margin

Revenues for the three month-period ended March 31, 2024, were $5.8 million compared to $3.8 million for the same period of 2023, an increase of $2.0 million, or 53%. The increase was primarily driven by the continued increased sales of our UltraMIST® system.  The increase in revenues was due to an increase in the average selling price of our consumables and parts revenue of 28% year over year, and the remainder of the growth in the number of consumables and systems sold year over year.  Gross margin as a percentage of revenue increased to 73% during the three months ended March 31, 2024, from 67% in the same period of 2023.

General and Administrative Expenses

General and administrative expenses increased $0.9 million or 33% for the three months ended March 31, 2024, compared with the same period of 2023. The increase for the three months ended March 31, 2024, was primarily due to severance costs and non-recurring legal settlement.

16
Selling and Marketing Expenses

Selling and marketing expenses decreased by $0.2 million or 13% for the three months ended March 31, 2024, as compared with the same period of 2023. The decrease was primarily due to severance payments in 2023.

Research and Development Expenses

Research and development expenses increased 24% for the three months ended March 31, 2024, as compared with the same period of 2023. Research and development expenses as a percentage of revenue stayed flat at 3% during the three months ended March 31, 2024, and for the same period in 2023.

Other (Expense)/Income, net

   
For the three months
ended March 31,
    
Change
  
   
2024
    
2023
     $    

%
  
                           
Interest expense
  
$
(3,560
)
  
$
(4,278
)
  
$
718
      
17
%
Loss on extinguishment of debt
    
(105
)
    
-
      
(105
 )
 
nm
  
Change in fair value of derivatives
    
(2,501
)
    
(6,797
)
    
4,296
      
63
%
Other income / (expense)
    
2,688
      
(27
)
    
2,715
    
nm
  
Other (expense)/income, net
  
$
(3,478
)
  
$
(11,102
)
  
$
7,624
      
69
%
nm - not meaningful

Other expense, net decreased by $7.6 million to $3.5 million for the three months ended March 31, 2024, as compared to the same period for 2023. The decrease was primarily due to a decrease in change in fair value of derivatives expense of $4.3 million, recognition of a non-recurring loss on extinguishment of debt of $105 thousand and offset by the receipt of $2.5 million from a third-party license and option agreement.

Liquidity and Capital Resources

Since inception, we have incurred losses from operations each year. As of March 31, 2024, we had an accumulated deficit of $225 million. Historically, our operations have primarily been funded from the sale of capital stock, notes payable, and convertible debt securities. The recurring losses from operations, the events of default on our notes payable, and dependency upon future issuances of equity or other financing to fund ongoing operations have raised substantial doubt as to our ability to continue as a going concern for a period of at least twelve months from the filing of this Form 10-Q. We expect to devote substantial resources for the commercialization of UltraMIST and PACE systems which will require additional capital resources to remain a going concern.

Management’s plans are to obtain additional capital in 2024 primarily through the closure of the Merger, which is expected to add additional capital and funding to the Company.  We could alternatively obtain capital through the conversion of outstanding warrants, issuance of common or preferred stock, securities convertible into common stock, or secured or unsecured debt. These possibilities, to the extent available, may be on terms that result in significant dilution to our existing stockholders. In addition, there can be no assurances that our plans to obtain additional capital will be successful on the terms or timeline we expect, or at all. If these efforts are unsuccessful, we may be required to significantly curtail or discontinue operations or, if available, obtain funds through financing transactions with unfavorable terms.

Statement of Cash Flows

   
For the three months ended March 31,
  
(in thousands)
  
2024
    
2023
  
Cash flows provided by (used by) operating activities
  
$
1,100
    
$
(371
)
Cash flows used by investing activities
  
$
(114
)
  
$
(18
)
Cash flows provided by (used in) financing activities
  
$
42
    
$
(654
)

17
Cash provided by operating activities during the three months ended March 31, 2024, totaled $1.1 million as compared to cash used in operating activities of $371 thousand in the previous period. This improvement in cash provided by operations is driven by the receipt of $2.5 million related to a license agreement and option agreement.

Critical Accounting Estimates

We have used various accounting policies to prepare the condensed consolidated financial statements in accordance with U.S. GAAP. Our significant accounting policies are disclosed in Note 3 to the consolidated financial statements in Part II Item 8. “Financial Statements and Supplementary Data” in our Annual Report on Form 10-K filed with the SEC on March 21, 2024.

The preparation of the condensed consolidated financial statements, in conformity with U.S. GAAP, requires us to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses. These estimates reflect our best judgment about economic and market conditions and the potential effects on the valuation and/or carrying value of assets and liabilities based upon relevant information available. We base our estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

The following accounting estimates are deemed critical:

Litigation Contingencies
We may be involved in legal actions involving product liability, intellectual property and commercial disputes, tax disputes, and governmental proceedings and investigations. The outcomes of these legal actions are not completely within our control and may not be known for prolonged periods of time. In some actions, the enforcement agencies or private claimants seek damages that could require significant expenditures or result in lost revenues or limit our ability to conduct business in the applicable jurisdictions. Estimating probable losses from our litigation and governmental proceedings is inherently difficult, particularly when the matters are in early procedural stages, with incomplete scientific facts or legal discovery; involve unsubstantiated or indeterminate claims for damages; potentially involve penalties, fines, or punitive damages; or could result in a change in business practice. The Company records a liability in the condensed consolidated financial statements for loss contingencies when a loss is known or considered probable, and the amount may be reasonably estimated. If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better estimate than any other, the minimum amount of the range is accrued. If a loss is reasonably possible but not known or probable, and may be reasonably estimated, the estimated loss or range of loss is disclosed. Our significant legal proceedings are discussed in Note 13 to the condensed consolidated financial statements.

Derivative Liabilities from Embedded Conversion Options and Warrants
The Company classified certain convertible instruments as having embedded conversion options which qualified as derivative financial instruments to be separately accounted for. The Company also determined that certain warrants also qualified as derivative financial instruments.  Various valuation models were used to estimate the fair value of these derivative financial instruments that are classified as derivative liabilities on the consolidated balance sheets. The models include subjective input assumptions that can materially affect the fair value estimates and as such are subject to uncertainty. Our significant input assumptions are discussed in Note 10 to the condensed consolidated financial statements.

Segment and Geographic Information

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.

Effects of Inflation

Our assets are, to an extent, liquid in nature, so they are not significantly affected by inflation. However, the rate of inflation, which has increased, affects expenses such as employee compensation, office space leasing costs and research and development charges, which may not be readily recoverable. To the extent inflation results in rising interest rates and has other adverse effects on the market, it may adversely affect our consolidated financial condition and results of operations.

Item 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide the information required under this item.

18
Item 4.
CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

We carried out an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer and accounting officer), of the effectiveness of the design and operation of our disclosure controls and procedures as of March 31, 2024. Based on this evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not operating effectively as of March 31, 2024. Our disclosure controls and procedures were not effective because of the “material weakness” described below.

We have identified three existing material weaknesses in internal control over financial reporting from prior periods.  A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be prevented or detected on a timely basis.  Because the items described below could have resulted in material misstatement of our annual or interim financial statements, we determined this constitutes a material weakness.

As of March 31, 2024, the Company has still identified the following material weaknesses:


 1.
The Company lacked expertise and resources to analyze and properly apply U.S. GAAP to complex and non-routine transactions such as complex financial instruments and derivatives and complex sales distributing agreements with select vendors.

2.
The Company lacked internal resources to analyze and properly apply U.S. GAAP to accounting for financial instruments included in service agreements with select vendors.

3.
The Company has failed to design and implement controls around all accounting and IT processes and procedures and, as such, we believe that all its accounting and IT processes and procedures need to be re-designed and tested for operating effectiveness.

As a result, management concluded that its internal control over reporting was not effective as of March 31, 2024.

Remediation Plan

Our management is committed to remediating these material weaknesses and has implemented several steps to enhance our internal controls and ensure appropriate resourcing with the required knowledge and expertise to conduct our business activities. Management hired a third-party consultant to help us design and document internal controls and perform a risk assessment of our processes over financial reporting. The risk assessment performed resulted in a qualitative and quantitative view of all processes that will help inform remediation efforts and prioritize high risk processes for remediation. The third-party consultant has also provided recommendations to standardize, automate and implement effectively designed internal controls over financial reporting. We intend to remediate and implement internal controls for high-risk processes over the course of 2024. We also intend to hire and segregate certain duties so that control activities are appropriate and fully mitigate risk. The material weaknesses will not be considered remediated until a sustained period of time has passed to allow management to test the design and operational effectiveness of the corrective actions. Until the material weaknesses are remediated, we plan to continue to perform additional analyses and other procedures to ensure that our consolidated financial statements are prepared in accordance with U.S GAAP. In addition, we may discover additional material weaknesses that require additional time and resources to remediate and we may decide to take additional measures to address the material weaknesses or modify the remediation steps described above.

We are also working with an outside vendor to improve our IT general controls over our enterprise resource planning system and set up a proper framework for IT general controls to be executed with the objective to remediate the weaknesses regarding internal controls and provide the framework for testing going forward.

The existence of any material weakness or significant deficiency requires management to devote significant time and incur significant expense to remediate any such material weaknesses or significant deficiencies and management may not be able to remediate any such material weaknesses or significant deficiencies in a timely manner. The existence of any material weakness in our internal control over financial reporting could also result in errors in our financial statements that could require us to restate our financial statements, cause us to fail to meet our reporting obligations and cause shareholders to lose confidence in our reported financial information, all of which could materially and adversely affect our business and stock price.

19
Changes in Internal Control over Financial Reporting

There have been no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 2024, that materially affect, or are reasonably likely to materially affect, our internal control over financial reporting, except as disclosed in “Remediation Plan” above.

PART II — OTHER INFORMATION

Item 1.
LEGAL PROCEEDINGS.

For information regarding legal proceedings at March 31, 2024, see Note 13 to the condensed consolidated financial statements, which information is incorporated herein by reference.

Item 1A.
RISK FACTORS.

There have been no material changes from our risk factors as previously reported in Part I, Item 1A “Risk Factors” in our 2023 Annual Report.

Item 2.
UNREGISTERED SALES OF EQUITY SECURITIES ANDUSE OF PROCEEDS.

None.

Item 3.
DEFAULTS UPON SENIOR SECURITIES.

Not applicable.

Item 4.
MINE SAFETY DISCLOSURES.

Not applicable.

Item 5.
OTHER INFORMATION.

During the three months ended March 31, 2024, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act or any non-Rule 10b5-1 trading arrangement (as defined in the SEC’s rules).

Item 6.
EXHIBITS

Agreement and Plan of Merger, dated as of August 23, 2023, by and among SEP Acquisition Corp., SEP Acquisition Holdings Inc., and SANUWAVE Health, Inc. (Incorporated by reference to Exhibit 2.1 to the Form 8-K filed with the SEC on August 23, 2023).
   
Amendment Number one to Agreement and Plan of Merger, dated February 27, 2024, by and between SEP Acquisition Corp. and Sanuwave Health, Inc. (Incorporated by reference to Exhibit 2.1 to the Form 8-K filed with the SEC on February 28, 2024).
   
Amendment Number Two to Agreement and Plan of Merger, dated as of April 25, 2024, by and between SEP Acquisition Corp. and Sanuwave Health, Inc. (Incorporated by reference to Exhibit 2.1 to the Form 8-K filed with the SEC on April 26, 2024).
   
Articles of Incorporation (Incorporated by reference to Exhibit 3.1 to the Form 10-SB filed with the SEC on December 18, 2007).
   
Certificate of Amendment to the Articles of Incorporation (Incorporated by reference to Appendix A to the Definitive Schedule 14C filed with the SEC on October 16, 2009).
   
Certificate of Amendment to the Articles of Incorporation (Incorporated by reference to Exhibit A to the Definitive Schedule 14C filed with the SEC on April 16, 2012).

20
Bylaws (Incorporated by reference to Exhibit 3.02 to the Form 10-SB filed with the SEC on December 18, 2007).
   
Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Company dated March 14, 2014 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on March 18, 2014).
   
Certificate of Amendment to the Articles of Incorporation, dated September 8, 2015 (Incorporated by reference to Exhibit 3.6 to the Form 10-K filed with the SEC on March 30, 2016).
   
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock of the Company dated January 12, 2016 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on January 19, 2016).
   
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock of the Company dated January 31, 2020 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on February 6, 2020).
   
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock of the Company dated January 31, 2020 (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on February 6, 2020).
   
Certificate of Designation of Series D Convertible Preferred Stock (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on May 20, 2020).
   
Certificate of Amendment of the Articles of Incorporation (Incorporated by reference to Exhibit 3.1 to the Form 8-K filed with the SEC on January 5, 2021).
   
Certificate of Amendment of the Articles of Incorporation, dated January 31, 2023 (Incorporated by reference to Exhibit 3.12 to the Form S-1/A filed with the SEC on January 31, 2023).
   
Form of Future Advance Convertible Promissory Note issued to certain purchasers, dated January 21, 2024 (Incorporated by reference to Exhibit 4.1 to the Form 8-K filed with the SEC on January 25, 2024).
   
Forms of Common Stock Purchase Warrants issued to certain purchasers, dated January 21, 2024 (Incorporated by reference to Exhibit 4.2 to the Form 8-K filed with the SEC on January 25, 2024).
   
Securities Purchase Agreement, dated January 21, 2024, by and among the Company and the purchasers identified on the signature pages thereto (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on January 25, 2024).
   
Security Agreement, dated January 21, 2024, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed with the SEC on January 25, 2024).
   
Subordination Agreement, dated January 21, 2024, by and among the Company, NH Expansion Credit Fund Holdings LP and certain creditors (Incorporated by reference to Exhibit 10.3 to the Form 8-K filed with the SEC on January 25, 2024).
   
Registration Rights Agreement, dated January 21, 2024, by and among the Company and certain lenders (Incorporated by reference to Exhibit 10.4 to the Form 8-K filed with the SEC on January 25, 2024).
   
Form of waiver letter with purchasers in January 2024 offering (Incorporated by reference to Exhibit 10.5 to the Form 8-K filed with the SEC on January 25, 2024).
   
Form of letter agreement with purchasers in January 2024 offering (Incorporated by reference to Exhibit 10.6 to the Form 8-K filed with the SEC on January 25, 2024).
   
Consent, Limited Waiver and Fifth Amendment to Note and Warrant Purchase Agreement with NH Expansion Credit Fund Holdings LP and the noteholders party thereto, dated March 6, 2024 (Incorporated by reference to Exhibit 10.7 to the Form 8-K filed with the SEC on March 7, 2024).
   
Separation and Release Agreement, dated March 29, 2024 (Incorporated by reference to Exhibit 10.1 to the Form 8-K filed with the SEC on April 1, 2024).

21
Offer Letter of Peter Sorensen, dated March 26, 2024 (Incorporated by reference to Exhibit 10.2 to the Form 8-K filed with the SEC on April 1, 2024).

Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer.
   
Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer.
   
Section 1350 Certification of the Principal Executive Officer.
   
Section 1350 Certification of the Chief Financial Officer.
   
101.INS*
XBRL Instance.
   
101.SCH*
XBRL Taxonomy Extension Schema.
   
101.CAL*
XBRL Taxonomy Extension Calculation.
   
101.DEF*
XBRL Taxonomy Extension Definition.
   
101.LAB*
XBRL Taxonomy Extension Labels.
   
101.PRE*
XBRL Taxonomy Extension Presentation.
   
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

*Filed herewith.

22
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 thereunto duly authorized.

 
SANUWAVE HEALTH, INC.
   
Dated: May 9, 2024
By:
/s/ Morgan Frank
     
Morgan Frank
     
Chief Executive Officer
(Duly Authorized Officer and Principal Executive Officer)
     
Dated: May 9, 2024
By:
/s/ Peter Sorensen
     
Peter Sorensen
     
Chief Financial Officer
(Principal Financial and Accounting Officer)


23
ATTACHMENTS / EXHIBITS

ATTACHMENTS / EXHIBITS

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