424B3 1 snwv_424b3.htm 424B3 snwv_424b3
 
Filed pursuant to Rule 424(b)(3)
File No. 333-232170
Prospectus Supplement No. 3
(To Prospectus dated June 28, 2019, as previously amended)
 
SANUWAVE HEALTH, INC.
 
76,204,992 Shares
(Common Stock, $0.001 par value)
 
 
 
This prospectus supplement supplements the prospectus dated June 28, 2019, as previously amended (the “Prospectus”), related to the resale of up to 76,204,992 shares of our common stock, par value $0.001 (“Common Stock”) being offered by the selling stockholders named in the Prospectus. The shares consist of (i) 8,528,249 shares of Common Stock issued upon the conversion of certain promissory notes held by such selling stockholders, (ii) 26,666,487 shares of Common Stock issuable upon the conversion of certain promissory notes held by such selling stockholders, (iii) 3,803,932 shares of Common Stock issued upon the exercise of certain warrants held by such selling stockholders, (iv) 22,124,998 shares of Common Stock issuable upon the exercise of certain warrants held by such selling stockholders, (v) 182,217 shares of Common Stock issued upon exercise of certain warrants issued to the placement agent for the private placements described in the Prospectus, (vi) 2,089,317 shares of Common Stock issuable upon exercise of certain warrants issued to the placement agent for the private placements described in the Prospectus, (vii) 8,049,091 shares of Common Stock issuable upon the exercise of certain warrants issued to employees, board of directors, medical advisory board members and vendors and (viii) 4,760,701 shares of Common Stock issuable upon the conversion of short term notes payable held by such selling stockholders. The shares offered by the Prospectus may be sold by the selling stockholders from time to time in the over-the-counter market or any other national securities exchange or automated interdealer quotation system on which our Common Stock is then listed or quoted, through negotiated transactions or otherwise at market prices prevailing at the time of sale or at negotiated prices, as described under “Plan of Distribution” in the Prospectus. This prospectus supplement should be read in conjunction with the Prospectus. 
 
This prospectus supplement contains the attached Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2020 filed by the Company with the Securities and Exchange Commission on May 15, 2020 (the “10-Q”). This prospectus supplement is not complete without, and may not be delivered or used except in connection with, the Prospectus. This prospectus supplement is qualified by reference to the Prospectus except to the extent that the information in this prospectus supplement updates and supersedes the information contained in the Prospectus.
 
Our common stock is quoted on the OTC Bulletin Board under the symbol SNWV.QB. On May 14, 2020, the last reported sale price of our common stock on the OTC Bulletin Board was $0.29 per share. 
 
__________________________________
 
Investing in our common stock involves a high degree of risk.
See Risk Factors beginning on page 8 of the Prospectus.
 
__________________________________ 
 
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed on the adequacy or accuracy of this prospectus supplement. Any representation to the contrary is a criminal offense.
__________________________________ 
 
The date of this prospectus supplement is May 27, 2020.
 
 
 

  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, 2020
 
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.)
 
 
3360 Martin Farm Road, Suite 100
Suwanee, GA
30024
(Address of principal executive offices)
(Zip Code)
 
(770) 419-7525
(Registrant's telephone number, including area code)
 
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 (Check one):
 
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
 
Securities registered pursuant to Section 12(b) of the Exchange Act: None
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.001
SNWV
OTCQB
 
 As of May 13, 2020, there were issued and outstanding 298,663,672 shares of the registrant’s common stock, $0.001 par value.
    

 
 
  
 SANUWAVE Health, Inc.
 
Table of Contents
 
 
 Page
 
   
 
Financial Statements (Unaudited)
 
   
   
 
 
Condensed Consolidated Balance Sheets as of March 31, 2020 and December 31, 2019
 3
 
 
 
 
Condensed Consolidated Statements of Comprehensive Loss for the threemonths ended March 31, 2020 and 2019
 4
 
 
 
 
Condensed Consolidated Statements of Stockholders’ Deficit for the threemonths ended March 31, 2020 and 2019
 5
 
 
 
 
Condensed Consolidated Statements of Cash Flows for the three months endedMarch 31, 2020 and 2019
 6
 
 
 
 
Notes to Unaudited Condensed Consolidated Financial Statements
 7
 
 
 
Management’s Discussion and Analysis of Financial Condition and Results of Operations
 19
 
 
 
Quantitative and Qualitative Disclosures About Market Risk
 25
  
  
 
Controls and Procedures
 25
  
  
 
  
 
  
  
 
Legal Proceedings
 26
  
  
 
Risk Factors
 26
  
  
 
Unregistered Sales of Equity Securities and Use of Proceeds
 26
  
  
 
Defaults Upon Senior Securities
 26
    
    
 
Mine Safety Disclosures
 26
    
    
 
Other Information
26
    
    
 
Exhibits
26
    
    
 
SIGNATURES
    
 27
 
 
 
 
 
Special Note Regarding Forward-Looking Statements
 
This Quarterly Report on Form 10-Q of SANUWAVE Health, Inc. and its subsidiaries (“SANUWAVE” or the “Company”) 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: the potential impact of the COVID-19 pandemic on our business, results of operations, liquidity, and operations, including the effect of governmental lockdowns, 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 dermaPACE and our product candidates; 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 our products; timing of clinical studies and eventual FDA approval of our products; financial markets; the competitive environment; 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, 2019, filed on March 30, 2020 and in the Company’s Quarterly Reports on Form 10-Q. Other risks and uncertainties are and will be disclosed in the Company’s prior and future SEC filings. 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, 2019, filed on March 30, 2020.
 
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.
 
 
 
 
PART I — FINANCIAL INFORMATION
 
Item 1. FINANCIAL STATEMENTS
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
 
 
 
 March 31,
 
 
 December 31,
 
 
 
2020
 
 
2019
 
 ASSETS
 
 (Unaudited)
 
 
 
 
CURRENT ASSETS
 
 
 
 
 
 
Cash and cash equivalents
 $1,346,892 
 $1,760,455 
Accounts receivable, net of allowance for doubtful accounts
    
    
of $15,682 in 2020 and $72,376 in 2019
  103,611 
  75,543 
Inventory
  518,767 
  542,955 
Prepaid expenses and other current assets
  229,519 
  125,405 
TOTAL CURRENT ASSETS
  2,198,789 
  2,504,358 
 
    
    
PROPERTY AND EQUIPMENT, net
  591,485 
  512,042 
 
    
    
RIGHT OF USE ASSETS, net
  283,456 
  323,661 
 
    
    
OTHER ASSETS
  43,096 
  41,931 
TOTAL ASSETS
 $3,116,826 
 $3,381,992 
 
    
    
 LIABILITIES
    
    
CURRENT LIABILITIES
    
    
Accounts payable
 $1,116,372 
 $1,439,413 
Accrued expenses
  1,176,235 
  1,111,109 
Accrued employee compensation
  1,741,816 
  1,452,910 
Contract liabilities
  555,208 
  66,577 
Operating lease liability
  176,397 
  173,270 
Finance lease liability
  159,789 
  121,634 
Advances from related parties
  16,000 
  18,098 
Line of credit, related parties
  214,505 
  212,388 
Accrued interest, related parties
  2,042,541 
  1,859,977 
Short term notes payable
  323,249 
  587,233 
Notes payable, related parties, net
  5,372,743 
  5,372,743 
TOTAL CURRENT LIABILITIES
  12,894,855 
  12,415,352 
 
    
    
NON-CURRENT LIABILITIES
    
    
Contract liabilities
  61,938 
  573,224 
Operating lease liability
  139,333 
  185,777 
Finance lease liability
  332,641 
  271,240 
TOTAL NON-CURRENT LIABILITIES
  533,912 
  1,030,241 
TOTAL LIABILITIES
  13,428,767 
  13,445,593 
 
    
    
COMMITMENTS AND CONTINGENCIES
    
    
 
    
    
 
REDEEMABLE PREFERRED STOCK, SERIES C CONVERTIBLE, par value $0.001,
 
    
90 designated; 90 shares issued and outstanding in 2020
  2,250,000 
  - 
 
    
    
 
    
    
 STOCKHOLDERS' DEFICIT
    
    
PREFERRED STOCK, par value $0.001, 5,000,000
    
    
shares authorized; 6,175 and 293 shares designated Series A and
  - 
  - 
Series B, respectively; none issued and outstanding in 2020 and
    
    
    2019, respectively
    
    
 
    
    
COMMON STOCK, par value $0.001, 350,000,000 shares authorized;
    
    
297,663,672 and 293,780,400 issued and outstanding in 2020 and
    
    
2019, respectively
  297,664 
  293,781 
 
    
    
ADDITIONAL PAID-IN CAPITAL
  115,951,907 
  115,457,808 
 
    
    
ACCUMULATED DEFICIT
  (128,754,104)
  (125,752,956)
 
    
    
ACCUMULATED OTHER COMPREHENSIVE LOSS
  (57,408)
  (62,234)
TOTAL STOCKHOLDERS' DEFICIT
  (12,561,941)
  (10,063,601)
TOTAL LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS' DEFICIT
 $3,116,826 
 $3,381,992 
 
 The accompanying notes to condensed consolidated financial statements are an integral part of these statements.
 
 
3
 
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
 
 
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
 
 
(UNAUDITED)
 
 
 
 
 
 
 
 
 
 
 Three Months Ended
 
 
 Three Months Ended
 
 
 
 March 31,
 
 
 March 31,
 
 
 
2020
 
 
2019
 
 
 
 
 
 
 
 
REVENUES
 
 
 
 
 
 
Product
 $74,559 
 $64,565 
License fees
  10,000 
  106,250 
Other revenue
  64,033 
  7,148 
TOTAL REVENUES
  148,592 
  177,963 
 
    
    
COST OF REVENUES
    
    
Product
  78,915 
  65,112 
Other
  9,962 
  28,741 
TOTAL COST OF REVENUES
  88,877 
  93,853 
 
    
    
GROSS MARGIN
  59,715 
  84,110 
 
    
    
OPERATING EXPENSES
    
    
Research and development
  286,754 
  261,002 
Selling and marketing
  607,850 
  158,083 
General and administrative
  1,907,917 
  1,517,100 
Depreciation
  53,023 
  8,357 
TOTAL OPERATING EXPENSES
  2,855,544 
  1,944,542 
 
    
    
OPERATING LOSS
  (2,795,829)
  (1,860,432)
 
    
    
OTHER INCOME (EXPENSE)
    
    
Gain on warrant valuation adjustment
  - 
  32,359 
Interest expense
  (18,732)
  (148,261)
Interest expense, related party
  (182,564)
  (219,687)
Loss on foreign currency exchange
  (4,023)
  (1,296)
TOTAL OTHER INCOME (EXPENSE), NET
  (205,319)
  (336,885)
 
    
    
NET LOSS
  (3,001,148)
  (2,197,317)
 
    
    
OTHER COMPREHENSIVE INCOME (LOSS)
    
    
Foreign currency translation adjustments
  4,628 
  (2,398)
TOTAL COMPREHENSIVE LOSS
 $(2,996,520)
 $(2,199,715)
 
    
    
LOSS PER SHARE:
    
    
Net loss - basic and diluted
 $(0.01)
 $(0.01)
 
    
    
Weighted average shares outstanding - basic and diluted
  296,061,866 
  157,112,875 
 
    
    
 
The accompanying notes to condensed consolidated financial statements are an integral part of these statements. 
 
 
4
 
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
 
 
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT
 
 
(UNAUDITED)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Preferred Stock
 
 
Common Stock
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of
 
 
 
 
 
Number of
 
 
 
 
 
 
 
 
 
 
 
Accumulated
 
 
 
 
 
 
Shares
 
 
 
 
 
Shares
 
 
 
 
 
 
 
 
 
 
 
Other
 
 
 
 
 
 
Issued and
 
 
 
 
 
Issued and
 
 
 
 
 
Additional Paid-
 
 
Accumulated
 
 
Comprehensive
 
 
 
 
 
 
Outstanding
 
 
Par Value
 
 
Outstanding
 
 
Par Value
 
 
in Capital
 
 
Deficit
 
 
Loss
 
 
Total
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balances as of Janaury 1, 2019
  - 
 $- 
  155,665,138 
 $155,665 
 $101,153,882 
 $(116,602,778)
 $(62,868)
 $(15,356,099)
Net loss
  - 
  - 
  - 
  - 
  - 
  (2,197,317)
  - 
  (2,197,317)
Cashless warrant exercises
  - 
  - 
  704,108 
  704 
  (704)
  - 
  - 
  - 
Proceeds from warrant exercise
  - 
  - 
  620,000 
  620 
  52,580 
  - 
  - 
  53,200 
Conversion of short term notes and convertible notes payable
  - 
  - 
  3,333,334 
  3,334 
  263,333 
  - 
  - 
  266,667 
Reclassification of warrant liability to equity due to adoption of ASU 2017-11
  - 
  - 
  - 
  - 
  262,339 
  1,279,661 
  - 
  1,542,000 
Foreign currency translation adjustment
  - 
  - 
  - 
  - 
  - 
  - 
  (2,398)
  (2,398)
 
    
    
    
    
    
    
    
    
Balances as of March 31, 2019
  - 
 $- 
  160,322,580 
 $160,323 
 $101,731,430 
 $(117,520,434)
 $(65,266)
 $(15,693,947)
 
    
    
    
    
    
    
    
    
 
    
    
    
    
    
    
    
    
 
    
    
    
    
    
    
    
    
Balances as of Janaury 1, 2020
  - 
 $- 
  293,780,400 
 $293,781 
 $115,457,808 
 $(125,752,956)
 $(62,234)
 $(10,063,601)
Net loss
  - 
  - 
  - 
  - 
  - 
  (3,001,148)
  - 
  (3,001,148)
Proceeds from warrant exercise
  - 
  - 
  1,000,000 
  1,000 
  9,000 
  - 
  - 
  10,000 
Shares issued for services
  - 
  - 
  1,000,000 
  1,000 
  199,000 
  - 
  - 
  200,000 
Stock-based compensation
  - 
  - 
  - 
  - 
  21,900 
  - 
  - 
  21,900 
Conversion of short term notes
  - 
  - 
  1,820,461 
  1,820 
  262,164 
  - 
  - 
  263,984 
Conversion of advances from related partis
  - 
  - 
  62,811 
  63 
  2,035 
  - 
  - 
  2,098 
Foreign currency translation adjustment
  - 
  - 
  - 
  - 
  - 
  - 
  4,826 
  4,826 
 
    
    
    
    
    
    
    
    
Balances as of March 31, 2020
  - 
 $- 
  297,663,672 
 $297,664 
 $115,951,907 
 $(128,754,104)
 $(57,408)
 $(12,561,941)
 
The accompanying notes to condensed consolidated financial statements are an integral part of these statements. 
 
 
5
 
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
 
 
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 
 
(UNAUDITED)
 
 
 
 
 
 
 
 
 
 
 Three Months Ended
 
 
 Three Months Ended
 
 
 
 March 31,
 
 
 March 31,
 
 
 
2020
 
 
2019
 
 
 
 
 
 
 
 
CASH FLOWS FROM OPERATING ACTIVITIES
 
 
 
 
 
 
Net loss
 $(3,001,148)
 $(2,197,317)
  Adjustments to reconcile net loss
    
    
    to net cash used by operating activities
    
    
Depreciation
  53,023 
  8,357 
Change in allowance for doubtful accounts
  83,306 
  (8,645)
Share-based payment
  221,900 
  - 
Gain on warrant valuation adjustment
  - 
  (32,359)
Amortization of operating leases
  (3,112)
  (1,735)
Accrued interest
  2,117 
  147,028 
Interest payable, related parties
  182,564 
  219,687 
Changes in operating assets and liabilities
    
    
     Accounts receivable - trade
  (111,374)
  103,579 
     Inventory
  24,188 
  29,436 
     Prepaid expenses
  (104,114)
  (71,450)
     Due from related parties
  - 
  (1,471)
     Other assets
  (1,165)
  (7,013)
     Operating leases
  - 
  44,623 
     Accounts payable
  (323,041)
  187,465 
     Accrued expenses
  65,126 
  64,114 
     Accrued employee compensation
  288,906 
  236,807 
     Contract liabilties
  (22,655)
  (6,657)
NET CASH USED BY OPERATING ACTIVITIES
  (2,645,479)
  (1,285,551)
 
    
    
CASH FLOWS FROM INVESTING ACTIVITIES
    
    
Purchases of property and equipment
  (4,855)
  (22,054)
NET CASH USED BY INVESTING ACTIVITIES
  (4,855)
  (22,054)
 
    
    
CASH FLOWS FROM FINANCING ACTIVITIES
    
    
Proceeds from sale of convertible preferred stock
  2,250,000 
  - 
Proceeds from warrant exercise
  10,000 
  53,200 
Proceeds from short term note
  - 
  965,000 
Advances from related parties
  - 
  26,200 
Payments of principal on finance leases
  (28,055)
  - 
NET CASH PROVIDED BY FINANCING ACTIVITIES
  2,231,945 
  1,044,400 
 
    
    
EFFECT OF EXCHANGE RATES ON CASH
  4,826 
  (2,398)
 
    
    
NET DECREASE IN CASH AND CASH EQUIVALENTS
  (413,563)
  (265,603)
 
    
    
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
  1,760,455 
  364,549 
CASH AND CASH EQUIVALENTS, END OF PERIOD
 $1,346,892 
 $98,946 
 
    
    
NONCASH INVESTING AND FINANCING ACTIVITIES
    
    
Conversion of short term notes payable to equity
 $263,984 
 $266,667 
 
    
    
 
    
    
Conversion of advances from related parties to equity
 $2,098 
 $- 
 
    
    
 
    
    
Additions to right of use assets from new finance lease liabilities
 $127,611 
 $- 
 
    
    
 
    
    
Reclassification of warrant liability to equity
 $- 
 $262,339 
 
  The accompanying notes to condensed consolidated financial statements are an integral part of these statements.
 
 
6
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
1. Nature of the Business
 
SANUWAVE Health, Inc. and Subsidiaries (the “Company”) is a shock wave technology company using a patented system of noninvasive, high-energy, acoustic shock waves for regenerative medicine and other applications. The Company’s initial focus is regenerative medicine – utilizing noninvasive, acoustic shock waves to produce a biological response resulting in the body healing itself through the repair and regeneration of tissue, musculoskeletal and vascular structures. The Company’s lead regenerative product in the United States is the dermaPACE® device, used for treating diabetic foot ulcers, which was subject to two double-blinded, randomized Phase III clinical studies. On December 28, 2017, the U.S. FDA granted the Company’s request to classify the dermaPACE System as a Class II device via the de novo process.  As a result of this decision, the Company was able to immediately market the product for the treatment of Diabetic Foot Ulcers (DFU) as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.
 
The Company’s portfolio of healthcare products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration. The Company is marketing its dermaPACE System for treatment usage in the United States and is able to generate revenue from sales of the European Conformity Marking (CE Mark) devices and accessories in Europe, Canada, Asia, and Asia/Pacific. The Company generates revenue streams from dermaPACE treatments, product sales, licensing transactions and other activities.
 
In March 2020, the World Health Organization characterized COVID-19 as a pandemic and the President of the United States declared the COVID-19 outbreak a national emergency. Since then, the COVID-19 pandemic has rapidly spread across the globe and has already resulted in significant volatility, uncertainty and economic disruption. While the COVID-19 pandemic has not had a material adverse financial impact on the Company’s operations to date, the future impacts of the pandemic and any resulting economic impact are largely unknown and rapidly evolving. It is difficult at this time to predict the impact that COVID-19 will have on the Company’s business, financial position and operating results in future periods due to numerous uncertainties. The Company is closely monitoring the impact of the pandemic on all aspects of its business and operations.
 
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 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 footnotes required by U.S. GAAP for complete financial statements. The financial information as of March 31, 2020 and for the three months ended March 31, 2020 and 2019 is unaudited; however, in the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three months ended March 31, 2020 are not necessarily indicative of the results that may be expected for any other interim period or for the year ending December 31, 2020.
 
The condensed consolidated balance sheet at December 31, 2019 has been derived from the audited consolidated financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These financial statements should be read in conjunction with the Company’s Form 10-K filed with the Securities and Exchange Commission on March 30, 2020 (the “2019 Annual Report”).
 
 
7
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
2. Going Concern
 
The Company does not currently generate significant recurring revenue and will require additional capital during 2020. As of March 31, 2020, the Company had cash and cash equivalents of $1,346,892. For the three months ended March 31, 2020, the net cash used by operating activities was $2,645,479. The Company incurred a net loss of $3,001,148 for the three months ended March 31, 2020. The operating losses and the events of default on the Company’s short term notes payable (see Note 6) and the notes payable, related parties (see Note 8) raised substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months from the filing of this report.
 
The continuation of the Company’s business is dependent upon raising additional capital to fund operations. Management’s plans are to obtain additional capital through investments by strategic partners for market opportunities, which may include strategic partnerships or licensing arrangements, or raise capital through the 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 shareholders. Although no assurances can be given, management of the Company believes that potential additional issuances of equity or other potential financing transactions as discussed above should provide the necessary funding for the Company to continue as a going concern. If these efforts are unsuccessful, the Company may be forced to seek relief through a filing under the U.S. Bankruptcy Code. The condensed consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
 
3.            
Summary of Significant Accounting Policies
 
The significant accounting policies followed by the Company are summarized below and should be read in conjunction with the 2019 Annual Report:
 
Principles of consolidation - The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany accounts and transactions have been eliminated.
 
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 doubtful accounts, estimate of the net realizable value of inventory, the determination of the valuation allowances for deferred taxes, estimated fair value of stock-based compensation, and estimated fair value of warrants.
 
Inventory - Inventory consists of finished medical equipment and parts and is stated at the lower of cost, which is valued using the first in, first out (“FIFO”) method, or net realizable value less allowance for selling and distribution expenses. The Company analyzes its inventory levels and writes down inventory that has, or is expected to, become obsolete. As of March 31, 2020, inventory consists of goods of $308,501 and parts of $210,266 for a total inventory of $518,767. As of December 31, 2019, inventory consisted of goods of $357,264 and parts of $185,691 for a total inventory of $542,955.
 
 
8
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
3.            
Summary of Significant Accounting Policies (continued)
 
Preferred stock – The Company evaluates Preferred Stock issuances for liability or equity classification in accordance with the provisions of ASC 480, Distinguishing Liabilities from Equity, and determines appropriate equity or liability accounting treatment. Additionally, the Company determines, if classified as equity, whether it would be recorded as permanent or temporary equity.
 
Sequencing policy – The Company has granted certain options and warrants which, upon settlement, may exceed the limit on the authorized number of shares of common stock. The Company follows a sequencing policy for which in the event partial reclassifications of contracts subject to ASC 815-40-25 is necessary, due to the Company’s inability to demonstrate it has sufficient authorized shares, shares will be allocated on the basis of earliest issuance date of potentially dilutive instruments with the earliest grants receiving first allocation of shares. The Company evaluated such instruments and determined that there was no impact to the Company’s condensed consolidated financial statements.
 
4.            
Accrued expenses
 
Accrued expenses consist of the following:
 
 
 
 March 31,
 
 
 December 31,
 
 
 
2020
 
 
2019
 
 
 
 
 
 
 
 
Accrued board of director's fees
 $356,667 
 $400,000 
Shares issuable
  200,000 
  - 
Accrued legal and professional fees
  173,387 
  134,970 
Accrued executive severance
  158,500 
  154,000 
Accrued travel
  122,500 
  120,000 
Accrued outside services
  100,033 
  108,033 
Accrued inventory
  50,275 
  167,050 
Accrued clinical study expenses
  13,650 
  13,650 
Accrued other
  1,223 
  13,406 
 
 $1,176,235 
 $1,111,109 
 
5.            
Contract liabilities
 
As of March 31, 2020, the Company has contract assets and liabilities from contracts with customers (see Note 13).
 
Contract liabilities consist of the following:
 
 
 
 
 March 31,
 
 
 December 31,
 
 
 
2020
 
 
2019
 
 
 
 
 
 
 
 
Service agreement
 $110,855 
 $133,510 
License fees
  500,000 
  500,000 
Other
  6,291 
  6,291 
     Total Contract liabilities
  617,146 
  639,801 
Non-Current
  (61,938)
  (573,224)
     Total Current
 $555,208 
 $66,577 
 
 
9
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
5.            
Contract liabilities (continued)
 
The timing of the Company’s revenue recognition may differ from the timing of payment by its customers. A receivable is recorded when revenue is recognized prior to payment and the Company has an unconditional right to payment. Alternatively, when payment precedes the satisfaction of performance obligations, the Company records a contract liability (deferred revenue) until the performance obligations are satisfied. Of the aggregate contract liability balances as of March 31, 2020, the Company expects to satisfy its remaining performance obligations associated with $555,208 and $61,938 of contract liability balances within the next twelve months and following thirty-five months, respectively. Of the aggregate contract liability balances as of December 31, 2019, the Company expects to satisfy its remaining performance obligations associated with $66,577 and $573,224 of contract liability balances within the next twelve months and following thirty-eight months, respectively.
 
6.            
Short term notes payable
 
During the three months ended March 31, 2020, the Company converted $263,984 of the short term notes payable into 1,820,461 shares of common stock.
 
 
7.            
Advances from related parties
 
                              Due to the timing of receipt of cash and issuance of the Company’s common stock the funds have been recorded as advances from related parties and will be properly recorded as equity when the common stock is issued.                 Advances from related parties totaled $16,000 at March 31, 2020.
 
8.            
Notes payable, related parties
 
The notes payable, related parties as amended were issued in conjunction with the Company’s purchase of the orthopedic division of HealthTronics, Inc. The notes payable, related parties bear interest at 8% per annum, as amended. All remaining unpaid accrued interest and principal was due on December 31, 2018, as amended. HealthTronics, Inc. is a related party because it is a shareholder in the Company and has a security agreement with the Company detailed below.
 
The Company is a party to a security agreement with HealthTronics, Inc. to provide a first security interest in the assets of the Company. During any period when an Event of Default occurs, the applicable interest rate shall increase by 2% per annum. Events of Default under the notes payable, related parties have occurred and are continuing on account of the failure of SANUWAVE, Inc., a Delaware corporation, a wholly owned subsidiary of the Company and the borrower under the notes payable, related parties, to make the required payments of interest which were due on December 31, 2016, March 31, 2017, June 30, 2017, September 30, 2017, December 31, 2017, June 30, 2018, September 30, 2018, December 31, 2018, March 31, 2019, June 30, 2019, September 30, 2019, December 31, 2019 and March 31, 2020 (collectively, the “Defaults”). As a result of the Defaults, the notes payable, related parties have been accruing interest at the rate of 10% per annum since January 2, 2017 and continue to accrue interest at such rate. The Company will be required to make mandatory prepayments of principal on the notes payable, related parties equal to 20% of the proceeds received by the Company through the issuance or sale of any equity securities in cash or through the licensing of the Company’s patents or other intellectual property rights. The Company has not made the mandatory prepayments of principal to HealthTronics, Inc. on the notes payable, related parties as amended from proceeds received through the issuance or sale of any equity securities in cash through March 31, 2020.
 
The notes payable, related parties had an aggregate outstanding principal balance of $5,372,743 at March 31, 2020 and December 31, 2019.
 
Accrued interest, related parties currently payable totaled $2,042,541 at March 31, 2020 and $1,859,977 at December 31, 2019. Interest expense on notes payable, related parties totaled $182,564 and $219,687 for the three months ended March 31, 2020 and 2019, respectively.
 
As of March 31, 2020, we are in default under the notes, as amended, and as a result HealthTronics, Inc. could, among other rights and remedies, exercise its rights under its first priority security interest in our assets. We are in negotiations with HealthTronics, Inc. to address the event of default.
 
 
10
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
9.            
Preferred Stock
 
On February 6, 2020, the Company entered into a Series C Preferred Stock Purchase Agreement (the “Purchase Agreement”) with certain accredited investors for the sale by the Company in a private placement of an aggregate of 90 shares of the Company’s Series C Convertible Preferred Stock, par value $0.001 per share at a stated value equal to $25,000 per share (the “Series C Preferred Stock”), for an aggregate total purchase price of $2,250,000.
 
Subject to the terms of the Certificate of Designation, each share of Series C Preferred Stock is convertible into shares of Common Stock of the Company at a rate equal to the stated value of such share of Series C Preferred Stock of $25,000, divided by the conversion price of $0.14 per share (subject to adjustment from time to time upon the occurrence of certain events as described in the Certificate of Designation). The Certificate of Designation became effective upon filing with the Secretary of State of the State of Nevada. If all outstanding shares of Series C Preferred Stock were converted into Common Stock at the original conversion rate, such shares would convert into an aggregate of 16,071,429 shares of Common Stock. On January 31, 2020, the Company filed a Certificate of Designation of Preferences, Right and Limitations of Series C Convertible Preferred Stock of the Company with the Nevada Secretary of State which amended our Articles of Incorporation to designate 90 shares of our preferred stock as Series C Convertible Preferred Stock.
 
Notwithstanding the foregoing, the Series C Preferred Stock is not currently convertible into shares of Common Stock because the Company does not currently have sufficient authorized and unissued shares of its Common Stock to permit conversion in full of all issued and outstanding shares of Series C Preferred Stock. Accordingly, the Certificate of Designation provides that the Series C Preferred Stock is only convertible into Common Stock once the Company amends its Articles of Incorporation to increase its authorized and unissued Common Stock to an amount sufficient to permit such conversion of the Series C Preferred Stock. Each investor has agreed in the Purchase Agreement that such investor will, within five business days following such amendment to the Articles of Incorporation, convert all of such investor’s shares of Series C Preferred Stock into shares of Common Stock.
 
The Certificate of Designation provides that if the Company has not obtained the approval of its shareholders to amend the Company’s Articles of Incorporation to increase the authorized shares of Common Stock sufficient to permit such conversion, or if such amendment has not otherwise been filed with the Nevada Secretary of State on or before December 31, 2020 (either such event, an “Authorization Failure”), then the Company shall be required to redeem all outstanding shares of Series C Preferred Stock for a per-share redemption price, payable in cash in a single installment not later than thirty (30) days following the date of such Authorization Failure, equal to the greater of (a) two hundred percent (200%) of the stated value of such share, and (b)(i) the volume-weighted average sale price of a share of Common Stock reported on the trading market on which the Common Stock is then traded for the thirty (30) consecutive trading days immediately preceding the date of such Authorization Failure, multiplied by (ii) the number of shares of Common Stock such share of Series C Preferred Stock would otherwise be convertible into as of such date had such Authorization Failure not occurred. The closing of the private placement occurred on February 6, 2020 and the preferred stock was recorded in temporary equity on the related condensed consolidated balance sheet at fair value of $2,250,000. Ninety shares of the Series C Preferred Stock have been issued as of March 31, 2020.
 
10.            
Equity transactions
 
Warrant Exercises
 
During the three months ended March 31, 2020, the Company issued 1,000,000 shares of Common Stock upon the exercise of 1,000,000 Class P Warrant to purchase shares of stock and an exercise price of $0.01 per share under the terms of the respective warrant agreement.
 
 
11
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
10.            
Equity transactions (continued)
 
Conversion of liabilities
 
During the three months ended March 31, 2020, the Company issued 1,820,461 shares of Common Stock upon the conversion of short term notes payable in the principal and accrued interest amount of $263,984 with the receipt of notices of Class L warrant exercises, all pursuant to the terms of the short term notes payable.
 
Conversion of advances from related parties
 
During the three months ended March 31, 2020, the Company issued 62,811 shares of Common Stock upon the conversion of advances from related parties in the amount of $2,098 with the receipt of notice of Series A Warrant exercise to purchase shares of stock under the terms of the respective warrant agreement.
 
Consulting Agreement
 
In January 2020, the Company entered into a six month consulting agreement for which the fee for the services was to be paid with Common Stock. The number of shares to be paid with Common Stock was 1,000,000 earned upon signing and an additional 1,000,000 upon agreement by both consultant and the Company no later than May 1, 2020. The Company issued 1,000,000 shares in March 2020. The fair value of the shares of $200,000 was recorded as a non-cash general and administrative expense during the period ended March 31, 2020. Subsequent to March 31, 2020, the remaining 1,000,000 shares were issued to the consultant.
 
11.            
Warrants
 
A summary of the warrant activity during the three months ended March 31, 2020 is presented as follows:
 
 
 
 Outstanding
 
 
 
 
 
 
 
 
 
 
 
 Outstanding
 
 
 
 as of
 
 
 
 
 
 
 
 
 
 
 
 as of
 
 
 
 December 31,
 
 
 
 
 
 
 
 
 
 
 
 March 31,
 
Warrant class
 
2019
 
 
 Issued
 
 
 Exercised
 
 
 Expired
 
 
2020
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Class K Warrants
  7,200,000 
  - 
  - 
  - 
  7,200,000 
Class O Warrants
  909,091 
  - 
  - 
  - 
  909,091 
Class P Warrants
  1,365,000 
  - 
  (1,000,000)
  (100,000)
  265,000 
 
  9,474,091 
  - 
  (1,000,000)
  (100,000)
  8,374,091 
 
A summary of the warrant exercise price per share and expiration date is presented as follows:
 
 
 
 Exercise
 
 Expiration
 
 
 price/share
 
 date
 
 
 
 
 
Class K Warrants
 $0.08 
June 2025
Class K Warrants
 $0.11 
August 2027
Class O Warrants
 $0.11 
 January 2022
Class P Warrants
 $0.20 
June 2024
 
The Company has 616,667 Class L Warrants that have been exercised but the common stock has not yet been issued. The cash for these issuable shares was previously received and recorded in Advances from related parties and Short term notes payable.
 
The estimated fair value of the Class K Warrants at the date of grant was $36,989 and recorded as debt discount, which is accreted to interest expense through the maturity date of the related notes payable, related parties.
 
 
12
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
11.            
Warrants (continued)
 
The estimated fair values were determined using a binomial option pricing model based on various assumptions.  The Company’s derivative liabilities have been classified as Level 3 instruments and are adjusted to reflect estimated fair value at each period end, with any decrease or increase in the estimated fair value being recorded in other income or expense accordingly, as adjustments to the fair value of derivative liabilities. 
 
12.            
Commitments and contingencies
 
Operating Leases
 
The Company is a party to certain operating leases. The Company has entered into a lease agreement, as amended, for office space for office, research and development, quality control, production and warehouse space which expires on December 31, 2021. Under the terms of the lease, the Company pays monthly rent of $14,651, subject to a 3% adjustment on an annual basis.
 
For leases where the Company is the lessee, ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date (except we used the practical expedients and recorded the outstanding operating lease at January 1, 2019) based on the present value of lease payments over the lease term. As the Company’s lease did not provide an implicit interest rate, the Company used the equivalent borrowing rate for a secured financing with the term of that equal to the remaining life of the lease at inception. The lease terms used to calculate the ROU asset and related lease liability did not include options to extend or termination of the lease; there are none and there is no reasonable certainty that the Company would extend the lease at expiration. Lease expense for operating leases is recognized on a straight-line basis over the lease term as an operating expense. The Company has lease agreements which require payments for lease and non-lease components and has elected to account for these as separate lease components. Non-leasing components are not included in the ROU asset.
 
Right of use assets and Lease liability – right of use consist of the following:
 
 
 
 
 March 31,
 
 
 
2020
 
 
 
 
 
Right of use assets
 $283,456 
 
 
 
 March 31,
 
 
 
2020
 
 
 
 
 
Lease liability - right of use
 
 
 
     Current portion
 $176,397 
     Long term portion
  139,333 
 
 $315,730 
 
 
13
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
12.            
Commitments and contingencies (continued)
 
As of March 31, 2020, the maturities of the Company’s lease liability – right of use which have initial or remaining lease terms in excess of one year consist of the following:
 
Year ending December 31,
 
 Amount
 
2020 (remainder)
 $144,377 
2021
  197,462 
Total lease payments
  341,839 
Less: Present value adjustment
  (26,109)
Lease liability - right of use
 $315,730 
 
As of March 31, 2020, the Company’s operating lease had a weighted average remaining lease term of 1.75 years and a weighted average discount rate of 7%.
 
Rent expense for the three months ended March 31, 2020 and 2019 was $52,330 and $52,838, respectively.
 
Financing Lease
 
For leases where the Company is the lessee, ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent an obligation to make lease payments arising from the lease. ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. The present value of the lease payment exceeds 90% of the sales price of the equipment, therefore this lease will be considered a financing lease is included in Property and equipment, net on our Condensed Consolidated Balance Sheets. Lease expense will be recognized as payment of financing lease, depreciation expense and interest expense.
 
Right of use assets and Lease liability – right of use consist of the following:
 
 
 
 
 March 31,
 
 
 
2020
 
 
 
 
 
Right of use assets
 $504,352 
 
 
 
 March 31,
 
 
 
2020
 
 
 
 
 
Lease liability - right of use
 
 
 
     Current portion
 $159,789 
     Long term portion
  332,641 
 
 $492,430 
 
 
14
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
12.            
Commitments and contingencies (continued)
 
As of March 31, 2020, the maturities of the Company’s lease liability – right of use which have initial or remaining lease terms in excess of one year consist of the following:
 
Year ending December 31,
 
 Amount
 
2020 (remainder)
 $159,490 
2021
  212,652 
2022
  177,852 
2023
  12,903 
Total
 $562,897 
 
As of March 31, 2020, the Company’s financing leases had a weighted average remaining lease term of 2.65 years based on annualized base payments expiring through 2022 and a weighted average discount rate of 13.2%.
 
As of March 31, 2020, the Company did not have additional operating or financing leases that have yet commenced.
 
Litigation
 
The Company is a defendant in various legal actions, claims and proceedings arising in the ordinary course of business, including claims related to breach of contracts and intellectual property matters resulting from our business activities. As with most actions such as these, an estimation of any possible and/or ultimate liability cannot always be determined. We believe that all pending claims, if adversely decided, would not have a material adverse effect on our business, financial position or results of operations.
 
13.            
Revenue
 
The Company accounts for revenue in accordance with ASC 606, which we adopted beginning January 1, 2018, using the modified retrospective method. The core principle of 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. ASC 606 defines a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within the revenue recognition process than required under GAAP, including identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation.
 
 
15
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
13.            
Revenue (continued)
 
Pursuant to ASC 606, we apply the following the five-step model:
 
1.            Identify the contract(s) with a customer. A contract with a customer exists when (i) we enter into an enforceable contract with a customer that defines each party’s rights regarding the goods to be transferred and identifies the payment terms related to these goods, (ii) the contract has commercial substance and, (iii) we determine that collection of substantially all consideration for services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration.
 
2.           Identify the performance obligation(s) in the contract. If a contract promises to transfer more than one good or service to a customer, each good or service constitutes a separate performance obligation if the good or service is distinct or capable of being distinct.
 
3.           Determine the transaction price. The transaction price is the amount of consideration to which the entity expects to be entitled in exchanging the promised goods or services to the customer.
 
4.           Allocate the transaction price to the performance obligations in the contract. For a contract that has more than one performance obligation, an entity should allocate the transaction price to each performance obligation in an amount that depicts the amount of consideration to which an entity expects to be entitled in exchange for satisfying each performance obligation.
 
5.           Recognize revenue when (or as) the Company satisfies a performance obligation. For each performance obligation, an entity should determine whether the entity satisfies the performance obligation at a point in time or over time. Appropriate methods of measuring progress include output methods and input methods.
 
The Company recognizes revenue primarily from the following types of contracts:
 
Product sales
 
Product 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.
 
Procedure revenue from the dermaPACE System is not material to the condensed consolidated financial statements as of March 31, 2020.
 
Licensing transactions
 
Licensing transactions include distribution licenses and intellectual property licenses. Licensing revenue is recognized as the Company satisfies its performance obligations, which may vary with the terms of the licensing agreement.
 
 
16
 
 
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
13.            
Revenue (continued)
 
Other activities
 
Other activities primarily include warranties, repairs and billed freight. Device product sales are bundled with an initial one-year warranty and the Company offers a separately priced second-year warranty. The Company allocates the device sales price to the product and the embedded warranty by reference to the stand-alone extended warranty price. Because the warranty represents a stand-ready obligation, revenue is recognized over the time period 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.
 
Disaggregation of Revenue
 
The disaggregation of revenue is based on geographical region. The following table presents revenue from contracts with customers for the three months ended March 31, 2020 and 2019:
 
 
 
 Three months ended March 31, 2020
 
 
 
United States
 
 
International
 
 
Total
 
 
 
 
 
 
 
 
 
 
 
Product
 $33,655 
 $40,904 
 $74,559 
License fees
  - 
  10,000 
  10,000 
Other Revenue
  541 
  63,492 
  64,033 
 
 $34,196 
 $114,396 
 $148,592 
 
 
Three months ended March 31, 2019
 
 
United States
 
 
International
 
 
Total
 
 
 
 
 
 
 
 
 
 
 $17,678 
 $46,887 
 $64,565 
  6,250 
  100,000 
  106,250 
  - 
  7,148 
  7,148 
 $23,928 
 $154,035 
 $177,963 
 
Management routinely assesses the financial strength of its customers and, as a consequence, believes accounts receivable are stated at the net realizable value and credit risk exposure is limited. Two distributors accounted for 66% and 9% of revenues for the three months ended March 31, 2020 and 10% and 0% of accounts receivable at March 31, 2020. Three distributors accounted for 58%, 11% and 10% of revenues for the three months ended March 31, 2019 and 39%, 5% and 0% of accounts receivable at March 31, 2019.
 
14.            
Related party transactions
 
During the three months ended March 31, 2020 and 2019, the Company recorded $13,105 and $17,678, respectively, in revenue from an entity owned by A. Michael Stolarski, a member of the Company’s board of directors and an existing shareholder of the Company. Contract liabilities includes a balance at March 31, 2020 and 2019, of $104,048 and $138,887, respectively from this related party.
 
15.            
Stock-based compensation
 
During the three months ended March 31, 2020, the Company granted to employees options to purchase 100,000 shares of common stock under a previously issued incentive plan. The options have an exercise price of $0.26 per share for an aggregate grant date value of approximately $21,900. The options vested upon issuance and have a term of ten years.

The range of exercise prices for options was $0.04 to $2.00 for options outstanding at March 31, 2020 and December 31, 2019, respectively. The aggregate intrinsic value for all vested and exercisable options was $1,565,916 and $2,085,866 at March 31, 2020 and December 31, 2019, respectively.
 
The weighted average remaining contractual term for outstanding exercisable stock options was 6.4 and 6.6 years as of March 31, 2019 and December 31, 2019, respectively.
 
 
17
 
 
 SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2020
 
16.            
Earnings (loss) per share
 
Basic 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 outstanding for the period.  Diluted net loss per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. Potentially dilutive securities are excluded from the computation of diluted net loss per share as their inclusive would be anti-dilutive and consist of the following:
 
 
 
 March 31,
 
 
 March 31,
 
 
 
2020
 
 
2019
 
 
 
 
 
 
 
 
Stock options
  34,403,385 
  31,703,385 
Warrants
  8,374,091 
  98,728,335 
Short term notes payable
  2,250,000 
  - 
Preferred stock conversion
  16,071,429 
  - 
Convertible promissory notes
  - 
  25,058,432 
Anti-dilutive equity securities
  61,098,905 
  155,490,152 
 
 
17.            
Subsequent events
 
                              The Company evaluates events that occur after the year-end date through the date the financial statements are available to be issued.
 
 
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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, 2019 included in our Annual Report on Form 10-K, filed with the SEC on March 30, 2020 (the “2019 Annual Report”).
 
Overview
 
We are a shock wave technology company using a patented system of noninvasive, high-energy, acoustic shock waves for regenerative medicine and other applications. Our initial focus is regenerative medicine utilizing noninvasive, acoustic shock waves to produce a biological response resulting in the body healing itself through the repair and regeneration of tissue, musculoskeletal, and vascular structures. Our lead regenerative product in the United States is the dermaPACE® device, used for treating diabetic foot ulcers, which was subject to two double-blinded, randomized Phase III clinical studies. On December 28, 2017, the U.S. FDA granted the Company’s request to classify the dermaPACE System as a Class II device via the de novo process.  As a result of this decision, the Company was able to immediately market the product for the treatment of Diabetic Foot Ulcers (DFU) as described in the De Novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.
 
Our portfolio of healthcare products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal healing processes and regeneration. We intend to apply our Pulsed Acoustic Cellular Expression (PACE®) technology in wound healing, orthopedic, plastic/cosmetic and cardiac conditions. The Company is marketing its dermaPACE System for treatment usage in the United States and will continue to generate revenue from sales of the European Conformity Marking (CE Mark) devices and accessories in Europe, Canada, Asia, and Asia/Pacific. The Company generates revenue streams from dermaPACE treatments, product sales, licensing transactions and other activities.
 
Our lead product candidate for the global wound care market, dermaPACE, has received FDA clearance for commercial use to treat diabetic foot ulcers in the United States and the CE Mark allowing for commercial use on acute and chronic defects of the skin and subcutaneous soft tissue. We believe we have demonstrated that our patented technology is safe and effective in stimulating healing in chronic conditions of the foot and the elbow through our United States FDA Class III Premarket Approvals ("PMAs") approved OssaTron® device, and in the stimulation of bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of our OssaTron, Evotron®, and orthoPACE® devices in Europe and Asia.
 
We are focused on developing our Pulsed Acoustic Cellular Expression (PACE) technology to activate healing in:
 
wound conditions, including diabetic foot ulcers, venous and arterial ulcers, pressure sores, burns and other skin eruption conditions;
orthopedic applications, such as eliminating chronic pain in joints from trauma, arthritis or tendons/ligaments inflammation, speeding the healing of fractures (including nonunion or delayed-union conditions), improving bone density in osteoporosis, fusing bones in the extremities and spine, and other potential sports injury applications;
plastic/cosmetic applications such as cellulite smoothing, graft and transplant acceptance, skin tightening, scarring and other potential aesthetic uses; and
cardiac applications for removing plaque due to atherosclerosis improving heart muscle performance.
 
In addition to healthcare uses, our high-energy, acoustic pressure shock waves, due to their powerful pressure gradients and localized cavitational effects, may have applications in secondary and tertiary oil exploitation, for cleaning industrial waters and food liquids and finally for maintenance of industrial installations by disrupting biofilms formation. Our business approach will be through licensing and/or partnership opportunities.
 
 
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In March 2020, the World Health Organization characterized COVID-19 as a pandemic and the President of the United States declared the COVID-19 outbreak a national emergency. Since then, the COVID-19 pandemic has rapidly spread across the globe and has already resulted in significant volatility, uncertainty and economic disruption. While the COVID-19 pandemic has not had a material adverse financial impact on the Company’s operations to date, the pandemic has resulted in the decreased demand for a broad variety of products, including from our customers, and will also disrupt supply channels and marketing activities for an unknown period of time until the disease is contained. Future impacts of the pandemic and any resulting economic impact are largely unknown and rapidly evolving. It is difficult at this time to predict the impact that COVID-19 will have on the Company’s business, financial position and operating results in future periods due to numerous uncertainties. The Company is closely monitoring the impact of the pandemic on all aspects of its business and operations. We have applied for disaster relief loans through the SBA to help minimize the impact on our business.
 
We were formed as a Nevada corporation in 2004. We maintain a public internet site at www.sanuwave.com. The information on our websites is not part of this Form 10-Q.
 
Recent Clinical Highlights and Updates
 
A dosage study has been developed for launch in Poland to optimize dermaPACE system treatment dosage for producing a more rapid reduction in size of a diabetic foot ulcer (“DFU”).  The focus will be on increasing the number of shock waves delivered per treatment, as a function of DFUs area.  To determine the dosage necessary, three new distinctive regimens will be assessed during the study.  This study started in April 2019 and is expected to be finalized in the fourth quarter of 2020, depending on availability of patients due to the COVID-19 pandemic.
 
A post-market pilot study to evaluate the effects of high energy acoustic shock wave therapy on local skin perfusion and healing of DFUs will be conducted at two sites: one in New Jersey and one in California. The intent of this trial is to quantify the level of increased perfusion and oxygenation during and after treatment with the dermaPACE system. This study started in April 2019 and is expected to be finalized in the fourth quarter of 2020, depending on availability of patients due to the COVID-19 pandemic.
 
Financial Overview
 
Since our inception, our operations have primarily been funded from the sale of capital stock, notes payable, and convertible debt securities. We expect to devote substantial resources for the commercialization of the dermaPACE System and will continue to research and develop the non-medical uses of the PACE technology, both of which will require additional capital resources. We incurred a net loss of $3,001,148 and $10,429,839 for the three months ended March 31, 2020 and the year ended December 31, 2019, respectively. These factors, and the events of default on the notes payable to HealthTronics, Inc. and our short term notes payable, create substantial doubt about our ability to continue as a going concern for a period of at least twelve months from the financial statement issuance date. Although no assurances can be given, we believe that potential additional issuances of equity, debt or other potential financing will provide the necessary funding for us to continue as a going concern for the next year. See “Liquidity and Capital Resources” for further information regarding our financial condition.
 
We cannot reasonably estimate the nature, timing and costs of the efforts necessary to complete the development and approval of, or the period in which material net cash flows are expected to be generated from, any of our products, due to the numerous risks and uncertainties associated with developing and marketing products, including the uncertainty of:
 
the scope, rate of progress and cost of our clinical trials;
future clinical trial results;
the cost and timing of regulatory approvals;
the establishment of successful marketing, sales and distribution channels and partnerships, including our efforts to expand our marketing, sales and distribution reach through joint ventures and other contractual arrangements;
the cost and timing associated with establishing reimbursement for our products;
the effects of competing technologies and market developments; and
the industry demand and patient wellness behavior.
 
 
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Any failure to complete the development of our product candidates in a timely manner, or any failure to successfully market and commercialize our product candidates, would have a material adverse effect on our operations, financial position and liquidity. A discussion of the risks and uncertainties associated with us and our business are set forth under the section entitled “Risk Factors – Risks Related to Our Business” in our 2019 Annual Report.
 
On March 27, 2020, Congress enacted the CARES Act to provide certain relief as a result of the COVID-19 pandemic. The CARES Act provides numerous tax provisions and other stimulus measures, including temporary changes regarding the prior and future utilization of net operating losses, temporary changes to the prior and future limitations on interest deductions, temporary suspension of certain payment requirements for the employer portion of Social Security taxes, technical corrections from prior tax legislation for tax depreciation of certain qualified improvement property, and the creation of certain refundable employee retention credits. This legislation was enacted before the date of filing this Form 10-Q and the effective date is subsequent to March 25, 2020. We are currently evaluating the impact on our financial statements and have not yet quantified what material impacts to the financial statements, if any, that may result from the CARES Act. 
 
Critical Accounting Policies and Estimates
     
Management’s Discussion and Analysis of Financial Condition and Results of Operations is based on our condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of our condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses.
 
                 On an ongoing basis, we evaluate our estimates and judgments, including those related to the recording of the allowances for doubtful accounts, estimated reserves for inventory, estimated useful life of property and equipment, the determination of the valuation allowance for deferred taxes, the estimated fair value of the warrant liability, and the estimated fair value of stock-based compensation. We base our estimates on authoritative literature and pronouncements, historical experience and on various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ from these estimates under different assumptions or conditions. The results of our operations for any historical period are not necessarily indicative of the results of our operations for any future period.
     
Our significant accounting policies are more fully described in Note 2 to our consolidated financial statements filed with our 2019 Annual Report. For a description of recent accounting policies and the impact on our financial statements, refer to Note 3 in the condensed consolidated financial statements in this 10-Q filing.
 
Results of Operations for the Three Months ended March 31, 2020 and 2019
 
Revenues and Cost of Revenues
 
Revenues for the three months ended March 31, 2020 were $148,592, compared to $177,963 for the same period in 2019, a decrease of $29,371, or 17%. Revenue resulted primarily from sales in Europe of our orthoPACE devices, related applicators and spare parts for refurbishment services performed by our Italian distributor. The decrease in revenue for 2020 is primarily due to lower upfront international distribution fees, as compared to the prior year. This is partially offset by higher sales of spare parts for refurbishment of applicators.
 
Cost of revenues for the three months ended March 31, 2020 were $88,877 compared to $93,853 for the same period in 2019. Gross profit as a percentage of revenues was 40% for the three months ended March 31, 2020, compared to 47% for the same period in 2019. The decrease in gross profit as a percentage of revenues in 2020 was primarily due to the cost of building new and refurbished dermaPACE applicators in the United States as a result of placements and lower high margin distribution fees.
 
 
21
 
 
Research and Development Expenses
 
Research and development expenses for the three months ended March 31, 2020 were $286,754, compared to $261,002 for the same period in 2019, an increase of $25,752, or 10%. The increase in research and development expenses in 2020, as compared to 2019, was due to higher salary and related costs as a result of hiring temporary employee and costs of Poland clinical trial started in April 2019.
 
Selling and Marketing Expenses
 
Selling and marketing expenses for the three months ended March 31, 2020 were $607,850, compared to $158,083 for the same period in 2019, an increase of $449,767, or 285%. The increase in selling and marketing expenses in 2020, as compared to 2019, was due to an increase in hiring of clinical account managers and salespeople, increased travel expenses for placement and training related to the commercialization of dermaPACE and increased commissions.
 
General and Administrative Expenses
 
General and administrative expenses for the three months ended March 31, 2020 were $1,907,917, as compared to $1,517,101 for the same period in 2019, an increase of $390,816, or 26%. The increase in general and administrative expenses in 2020, as compared to 2019, was due to engagement of specialists to assist with distribution partner searches, increase in legal and consulting fees related to merger and acquisition opportunities and increased director and officer insurance which was partially offset by lower investor relations costs and lower travel costs.
 
Depreciation
 
Depreciation for the three months ended March 31, 2020 was $53,023, compared to $8,357 for the same period in 2019, an increase of $44,666 or 534%. The increase was due to the higher depreciation related to increase in fixed assets and leased dermaPACE devices.
 
Other Income (Expense)
 
Other income (expense) was a net expense of $205,319 for the three months ended March 31, 2020 as compared to a net expense of $336,885 for the same period in 2019, a decrease of $131,566, or 39%. The decrease was primarily due to decreased interest expense. This is partially offset by a non-cash gain for valuation adjustment on outstanding warrants of $0, as compared to $32,359 for the same period in 2019.
 
Net Loss
 
Net loss for the three months ended March 31, 2020 was $3,001,148, or ($0.01) per basic and diluted share, compared to a net loss of $ 2,197,317, or ($0.01) per basic and diluted share, for the same period in 2019, a decrease in the net loss of $803,830, or 37%.
 
 
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Liquidity and Capital Resources
 
We expect to devote substantial resources for the commercialization of the dermaPACE System and will continue to research and develop the next generation of our technology as well as the non-medical uses of the PACE technology, both of which will require additional capital resources. We incurred a net loss of $3,001,148 and $10,429,839 for the three months ended March 31, 2020 and the year ended December 31, 2019, respectively. These factors and the events of default on the notes payable to HealthTronics, Inc. and the Company’s short term notes payable create substantial doubt about the Company’s ability to continue as a going concern for a period of at least twelve months from the financial issuance date.
 
Since inception in 2005, our operations have primarily been funded from the sale of capital stock, notes payable, and convertible debt securities.
 
The continuation of our business is dependent upon raising additional capital to fund operations. Management expects the cash used in operations for the Company will be approximately $225,000 to $300,000 per month for the first half of 2020 and $300,000 to $375,000 per month for the second half of 2020 as resources are devoted to the commercialization of the dermaPACE product including hiring of new employees, expansion of our international business and continued research and development of next generation of our technology as well as non-medical uses of our technology. Management’s plans are to obtain additional capital in 2020 through investments by strategic partners for market opportunities, which may include strategic partnerships or licensing arrangements, or raise capital through the 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 shareholders. Although no assurances can be given, management believes that potential additional issuances of equity or other potential financing transactions as discussed above should provide the necessary funding for us. If these efforts are unsuccessful, we may be required to significantly curtail or discontinue operations or obtain funds through financing transactions with unfavorable terms. The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, 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 financial statements do not necessarily purport to represent realizable or settlement values. The consolidated financial statements do not include any adjustment that might result from the outcome of this uncertainty. Our 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 we be unable to continue as a going concern.
 
 
 
23
 
 
On January 31, 2020, the Company filed a Certificate of Designation of Preferences, Right and Limitations of Series C Convertible Preferred Stock of the Company with the Nevada Secretary of State which amended our Articles of Incorporation to designate 90 shares of our preferred stock as Series C Convertible Preferred Stock. As of March 31, 2020, there are 90 shares issued and outstanding.
 
We may also attempt to raise additional capital if there are favorable market conditions or other strategic considerations even if we have sufficient funds for planned operations. To the extent that we raise additional funds by issuance of equity securities, our shareholders will experience dilution and we may be required to use some or all of the net proceeds to repay our indebtedness, and debt financings, if available, may involve restrictive covenants or may otherwise constrain our financial flexibility. To the extent that we raise additional funds through collaborative arrangements, it may be necessary to relinquish some rights to our intellectual property or grant licenses on terms that are not favorable to us. In addition, payments made by potential collaborators or licensors generally will depend upon our achievement of negotiated development and regulatory milestones. Failure to achieve these milestones would harm our future capital position.
 
For the three months ended March 31, 2020 and 2019, net cash used by operating activities was $2,645,479 and $1,285,551, respectively, primarily consisting of compensation costs, research and development activities and general corporate operations. The increase in the use of cash for operating activities for the three months ended March 31, 2020, as compared to the same period for 2019, of $1,359,928, or 106%, was primarily due to an increase in accounts receivable of $111,374, an increase in prepaid expenses of $104,114, a decrease in accounts payable of $323,041, an increase of accrued employee compensation and accrued expenses of $354,032 and increase in interest payable, related parties of $182,564. Net cash used by investing activities in 2020 was $4,855 as compared to net cash used by investing activities in 2019 of $22,054. The decrease in cash used by investing activities is due decrease purchasing of property and equipment. Net cash provided by financing activities for the three months ended March 31, 2020 was $2,231,945, which primarily consisted of $2,250,000 of proceeds from issuance of Series C Convertible Preferred Shares, $10,000 of proceeds from exercise of warrants net of $28,055 of principal payments on finance leases. Net cash provided by financing activities for the three months ended March 31, 2019 was $1,044,400, which primarily consisted of $965,000 of proceeds from short term note, $53,200 of proceeds from exercise of warrants and $26,200 of proceeds from advances from related parties. Cash and cash equivalents decreased by $413,564 for the three months ended March 31, 2020.
 
Segment and Geographic Information
 
We have determined that we have one operating segment. Our revenues are generated from sales in United States, Europe, Canada, Asia and Asia/Pacific. All significant expenses are generated in the United States and all significant assets are located in the United States.
 
Contractual Obligations
 
Our major outstanding contractual obligations relate to our operating lease for our facility, purchase and supplier obligations for product component materials and equipment, and our notes payable, related parties. We have disclosed these obligations in our 2019 Annual Report.
 
Off-Balance Sheet Arrangements
     
Since inception, we have not engaged in any off-balance sheet activities, including the use of structured finance, special purpose entities or variable interest entities.
 
Effects of Inflation
     
Due to the fact that our assets are, to an extent, liquid in nature, they are not significantly affected by inflation. However, the rate of inflation affects such expenses as employee compensation, office space leasing costs and research and development charges, which may not be readily recoverable during the period of time that we are bringing the product candidates to market. 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.
 
 
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Item 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
Not required under Regulation S-K for “smaller reporting companies”.
 
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, 2020. 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, 2020. Our disclosure controls and procedures were not effective because of the “material weakness” described below under “Management’s Annual Report on Internal Control over Financial Reporting.”
 
Management’s Annual Report on Internal Control over Financial Reporting
 
Management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) for the Company. The Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP.
 
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives.
 
 Management, with the participation of the Chief Executive Officer (principal executive officer) and the Chief Financial Officer (principal financial and accounting officer), evaluated the effectiveness of the Company’s internal control over financial reporting as of March 31, 2020. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control — Integrated Framework (2013).
 
We previously reported three material weaknesses in our internal control over financial reporting process resulting from a lack of internal expertise and resources to analyze and properly apply generally accepted accounting principles to complex and non-routine transactions such as complex financial instruments and derivatives and complex sales distribution agreements, a lack of internal resources to analyze and properly apply generally accepted accounting principles to accounting for equity components of service agreements with select vendors and cybersecurity breaches from email spoofing. As a result, management concluded that our internal control over reporting was not effective as of March 31, 2020.
 
Management’s Plan to Remediate Material Weaknesses
 
During 2019, we engaged external consultants with appropriate experience applying GAAP technical accounting guidance, and we have hired additional accounting personnel. We engaged external consultants to review revenue recognition for new products, lease agreements, internal controls and related procedures and review of documentation of internal controls in addition to new equity and debt financing arrangements. Accounting memos were produced for all technical issues during 2019 and reviewed with management. All internal controls were reviewed, in addition to new controls created and documented. We hired an accounting manager in April 2019 to enhance the accounting knowledge and abilities of the department. The accounting manager’s skill set includes restructuring of accounting procedure, preparation of budgets and key analytical reports and managing all accounting functions. Adding an additional member to the accounting team also enabled some segregation of duties and additional review procedures.
 
We have also implemented cybersecurity training for all employees and redesign of procedures that cyber security breaches may impact and worked with our third party IT vendor to develop a training plan for all existing and new employees related to cyber and implemented related controls around information technology infrastructure. In addition, an additional employee was hired to assist with the management of IT controls and enhance internal IT resources. Going forward, this employee will monitor our third party IT vendor’s testing and monitoring efforts and where necessary implement new controls as the Company grows. These internal controls have been documented and procedures implemented.
 
There is no assurance that the measures described above will be sufficient to remediate the previously identified material weaknesses.
 
Changes in Internal Control over Financial Reporting
 
There have been no changes in our internal control over financial reporting that occurred during the period covered by this report that materially affect, or are reasonably likely to materially affect, our internal control over financial reporting. Management is in the process of designing updated changes to its controls as discussed above in “Management’s Plan to Remediate Material Weaknesses.”
 
 
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PART II — OTHER INFORMATION
 
Item 1. LEGAL PROCEEDINGS.
 
None.
 
Item 1A. RISK FACTORS.
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.
 
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
 Not applicable.
 
Item 3. DEFAULTS UPON SENIOR SECURITIES.
 Not applicable.
 
Item 4. MINE SAFETY DISCLOSURES.
Not applicable.
 
Item 5. OTHER INFORMATION.
 Not applicable.
 
Item 6.      EXHIBITS
 
Exhibit No.
Description
Certificate of Designation of Preferences, Rights and Limitations of Series C ConvertiblePreferred Stock of the Company dated January 31, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on February 6, 2020). 

 
Series C Preferred Stock Purchase Agreement, by and among the Company and the accredited investors party thereto, dated February 6, 2020 (Incorporated by reference to the Form 8-K filed with the SEC on February 6, 2020).
 
 
Rule 13a-14(a)/15d-14(a) Certification of the Principal 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.
 
______________________________________________________________
* Filed herewith.
** Furnished herewith.
† XBRL-related documents are not deemed filed for purposes of section 11 of the Securities Act of 1933, as amended, section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject the liabilities of these sections, and are not part of any registration statement to which they relate.
 
 
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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.
 
 
 
 
 
Date: May 15, 2020 
By:  
/s/ Kevin A. Richardson, II  
 
 
 
Name: Kevin A. Richardson, II  
 
 
 
Title: Chief Executive Officer  
 
 
                  Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated:
 
 
 
 
 
 
 
Signatures
 
Capacity
 
Date
 
 
 
 
 
By: /s/ Kevin A. Richardson, II
 
Chief Executive Officer and Chairman of the Board of Director
 
May 15, 2020
Name: Kevin A. Richardson, II

(principal executive officer)


 
 
 
 
 
By: /s/ Lisa E. Sundstrom
 
Chief Financial Officer
 
May 15, 2020
Name: Lisa E. Sundstrom    
 
(principal financial and accounting officer)
 
 
 
 
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