Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2010
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o |
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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)
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Nevada
(State or other jurisdiction of
incorporation or organization)
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20-1176000
(I.R.S. Employer
Identification No.) |
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11680 Great Oaks Way, Suite 350
Alpharetta, GA
(Address of principal executive offices)
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30022
(Zip Code) |
(678) 581-6843
(Registrants 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. þ Yes o No
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
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 and post such
files).
o Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See definition of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act (Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). o Yes þ No
As of May 7, 2010, there were issued and outstanding 12,509,657 shares of the registrants common
stock.
SANUWAVE Health, Inc.
Table of Contents
- 1 -
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 Companys future financial results, operating results, business
strategies, projected costs, products, competitive positions, managements plans and objectives for
future operations, and industry trends. These forward-looking statements are based on managements
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, specifically the sections titled Risk Factors and Managements Discussion
and Analysis of Financial Condition and Results of Operations in the Companys Annual Report on
Form 10-K filed on March 31, 2010. Other risks and uncertainties are and will be disclosed in the
Companys prior and future Securities and Exchange Commission filings. These and many other factors
could affect the Companys 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 Companys Annual Report on Form 10-K
filed on March 31, 2010.
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.
- 2 -
PART I FINANCIAL INFORMATION
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Item 1. |
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CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
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March 31, |
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December 31, |
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2010 |
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2009 |
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ASSETS
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CURRENT ASSETS |
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Cash and cash equivalents |
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$ |
1,065,691 |
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$ |
1,786,369 |
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Accounts receivable trade, net of allowance for doubtful accounts
of $31,383 in 2010 and $20,762 in 2009 |
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71,361 |
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47,966 |
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Inventory (Note 8) |
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561,169 |
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592,589 |
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Prepaid expenses |
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121,613 |
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121,157 |
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Due from Pulse Veterinary Technologies, LLC |
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200,399 |
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127,878 |
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TOTAL CURRENT ASSETS |
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2,020,233 |
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2,675,959 |
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PROPERTY AND EQUIPMENT, at cost, less accumulated depreciation (Note 9) |
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62,191 |
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88,706 |
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OTHER ASSETS |
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31,893 |
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32,169 |
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INTANGIBLE ASSETS, at cost, less accumulated amortization (Note 10) |
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2,070,606 |
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2,147,295 |
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ASSETS HELD FOR SALE (Note 7) |
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765,531 |
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922,956 |
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TOTAL ASSETS |
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$ |
4,950,454 |
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$ |
5,867,085 |
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LIABILITIES
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CURRENT LIABILITIES |
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Accounts payable |
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$ |
1,454,161 |
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$ |
1,069,423 |
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Payroll and related |
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661,203 |
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509,905 |
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Accrued expenses (Note 11) |
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469,679 |
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629,029 |
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Promissory notes (Note 13) |
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1,001,556 |
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Liabilities related to discontinued operations (Note 6) |
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655,061 |
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655,061 |
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TOTAL CURRENT LIABILITIES |
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4,241,660 |
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2,863,418 |
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NOTES PAYABLE, RELATED PARTIES (Note 14) |
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9,105,161 |
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8,887,981 |
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TOTAL LIABILITIES |
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13,346,821 |
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11,751,399 |
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COMMITMENTS AND CONTINGENCIES (Note 16) |
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GOING CONCERN (Note 3) |
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STOCKHOLDERS EQUITY (DEFICIT)
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COMMON STOCK, par value $0.001, 50,000,000 shares
authorized, 12,509,657 issued and outstanding |
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12,510 |
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12,510 |
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ADDITIONAL PAID-IN CAPITAL |
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33,224,863 |
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32,741,593 |
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ACCUMULATED OTHER COMPREHENSIVE INCOME |
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21,296 |
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21,864 |
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RETAINED DEFICIT |
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(41,655,036 |
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(38,660,281 |
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TOTAL STOCKHOLDERS EQUITY (DEFICIT) |
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(8,396,367 |
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(5,884,314 |
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TOTAL LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
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$ |
4,950,454 |
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$ |
5,867,085 |
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See accompanying notes to unaudited condensed consolidated financial statements.
- 3 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
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Three Months Ended |
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Three Months Ended |
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March 31, |
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March 31, |
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2010 |
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2009 |
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REVENUES |
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$ |
143,102 |
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$ |
262,082 |
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COST OF REVENUES |
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47,644 |
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60,282 |
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GROSS PROFIT |
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95,458 |
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201,800 |
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OPERATING EXPENSES |
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Research and development |
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1,085,974 |
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813,510 |
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General and administrative |
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1,598,524 |
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1,249,577 |
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Depreciation |
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194,732 |
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60,468 |
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Amortization |
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76,689 |
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76,689 |
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TOTAL OPERATING EXPENSES |
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2,955,919 |
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2,200,244 |
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OPERATING LOSS |
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(2,860,461 |
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(1,998,444 |
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OTHER INCOME (EXPENSE) |
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Transitional services provided to Pulse Veterinary Technologies, LLC |
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90,000 |
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Interest expense, net |
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(217,281 |
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(138,059 |
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Loss on foreign currency exchange |
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(7,013 |
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(9,448 |
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TOTAL OTHER INCOME (EXPENSE) |
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(134,294 |
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(147,507 |
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LOSS FROM CONTINUING OPERATIONS BEFORE INCOME TAXES |
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(2,994,755 |
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(2,145,951 |
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INCOME TAX EXPENSE |
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LOSS FROM CONTINUING OPERATIONS |
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(2,994,755 |
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(2,145,951 |
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DISCONTINUED OPERATIONS |
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Income from discontinued operations, net of tax |
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322,485 |
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NET LOSS |
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(2,994,755 |
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(1,823,466 |
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OTHER COMPREHENSIVE LOSS, net of tax |
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Foreign currency translation adjustments |
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(568 |
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(49,132 |
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TOTAL COMPREHENSIVE LOSS |
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$ |
(2,995,323 |
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$ |
(1,872,598 |
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EARNINGS (LOSS) PER SHARE: |
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Loss from continuing operations basic |
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$ |
(0.24 |
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$ |
(0.20 |
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Loss from continuing operations diluted |
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$ |
(0.24 |
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$ |
(0.20 |
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Income from discontinued operations basic |
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$ |
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$ |
0.03 |
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Income from discontinued operations diluted |
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$ |
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$ |
0.03 |
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Net loss basic |
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$ |
(0.24 |
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$ |
(0.17 |
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Net loss diluted |
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$ |
(0.24 |
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$ |
(0.17 |
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Weighted average shares outstanding basic |
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12,509,657 |
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11,009,657 |
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Weighted average shares outstanding diluted |
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12,509,657 |
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11,009,657 |
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See accompanying notes to unaudited condensed consolidated financial statements.
- 4 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
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Three Months Ended |
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Three Months Ended |
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March 31, |
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March 31, |
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2010 |
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2009 |
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Loss from continuing operations |
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$ |
(2,994,755 |
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$ |
(2,145,951 |
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Adjustments to reconcile loss from continuing operations to net cash
used by operating activities |
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Amortization |
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76,689 |
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76,689 |
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Accrued interest |
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218,736 |
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138,354 |
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Depreciation |
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194,732 |
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60,468 |
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Change in allowance for doubtful accounts |
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10,621 |
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(4,825 |
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Stock-based compensation |
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483,270 |
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133,696 |
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Changes in assets (increase)/decrease |
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Accounts receivable trade |
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(34,016 |
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(16,655 |
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Inventory |
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31,420 |
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(14,656 |
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Prepaid expenses |
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(456 |
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(6,465 |
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Due from Pulse Veterinary Technologies, LLC |
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(72,521 |
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Other assets |
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276 |
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387 |
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Assets held for sale |
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(10,792 |
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Changes in liabilities increase/(decrease) |
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Accounts payable |
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384,738 |
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(358,572 |
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Payroll and related |
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151,298 |
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97,634 |
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Accrued expenses |
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(159,350 |
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(219,200 |
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NET CASH USED BY CONTINUING OPERATIONS |
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(1,720,110 |
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(2,259,096 |
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NET CASH PROVIDED BY DISCONTINUED OPERATIONS |
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722,663 |
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NET CASH USED BY OPERATING ACTIVITIES |
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(1,720,110 |
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(1,536,433 |
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CASH FLOWS FROM FINANCING ACTIVITIES |
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Continuing operations |
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Proceeds from promissory notes |
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1,000,000 |
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Proceeds from notes payable, related parties |
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1,575,000 |
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NET CASH PROVIDED BY FINANCING ACTIVITIES |
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1,000,000 |
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1,575,000 |
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FOREIGN CURRENCY TRANSLATION ADJUSTMENTS |
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(568 |
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(49,132 |
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NET DECREASE IN CASH AND CASH EQUIVALENTS |
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(720,678 |
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(10,565 |
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CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
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1,786,369 |
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543,626 |
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CASH AND CASH EQUIVALENTS, END OF PERIOD |
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$ |
1,065,691 |
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$ |
533,061 |
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See accompanying notes to unaudited condensed consolidated financial statements.
- 5 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2010
1. Nature of the Business
SANUWAVE Health, Inc. and subsidiaries (the Company) is an emerging global medical
technology company focused on the development and commercialization of noninvasive, biological
response activating devices in the regenerative medicine area for the repair and regeneration of
tissue, musculoskeletal and vascular structures. Our portfolio of products and product candidates
activate biologic signaling and angiogenic responses, including new vascularization and
microcirculatory improvement, helping to restore the bodys normal healing processes and
regeneration. We intend to apply our Pulsed Acoustic Cellular Expression (PACE) technology in
wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions.
2. Basis of Presentation and Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements of the Company have
been prepared in accordance with United States generally accepted accounting principles for interim
financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X.
Accordingly, these financial statements do not include all the information and footnotes required
by United States generally accepted accounting principles for complete financial statements. The
financial information as of March 31, 2010 and for the three months ended March 31, 2010 and 2009
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-month period ended March 31, 2010 are not necessarily indicative of the
results that may be expected for any other interim period or for the year ending December 31, 2010.
The condensed consolidated balance sheet at December 31, 2009 has been derived from the
audited consolidated financial statements at that date, but does not include all of the information
and footnotes required by United States generally accepted accounting principles for complete
financial statements.
For further information and a summary of significant accounting policies, refer to the
consolidated financial statements and footnotes thereto included in the Companys Annual Report on
Form 10-K filed on March 31, 2010. Please refer also to Note 5 of this Form 10-Q regarding the
Companys adoption of recent accounting pronouncements.
3. Going concern
As shown in the accompanying condensed consolidated financial statements, the Company incurred
a net loss of $2,994,755 and $1,823,466 for the three months ended March 31, 2010 and 2009,
respectively. The Company incurred a net loss from continuing operations of $2,994,755 and
$2,145,951 for the three months ended March 31, 2010 and 2009, respectively. These operating
losses create an uncertainty about the Companys ability to continue as a going concern.
Management of the Company believes potential additional investors, outstanding warrant exercises or
other potential financing will provide the necessary funding for the Company. 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. The Company is economically dependent upon
future financing to fund ongoing operations. On June 3, 2009, the Company sold its veterinary
business for a total cash consideration of $3,500,000 (Note 6). In addition, in September 2009,
the Company issued additional shares of stock to stockholders for total cash proceeds of
$1,819,844. In March 2010, the Company issued four promissory notes totaling $1,000,000 to two
stockholders. The notes bear interest at 5% per annum and are due in June 2010 (Note 13).
- 6 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
March 31, 2010
4. Reverse Merger Transaction
On September 25, 2009, the Company (formerly named Rub Music Enterprises, Inc.) and RME
Delaware Merger Sub, Inc., a Nevada corporation and wholly-owned subsidiary of the Company (the
Merger Sub) entered into a reverse merger agreement (the Merger Agreement) with SANUWAVE, Inc.
Pursuant to the Merger Agreement, the Merger Sub merged with and into SANUWAVE, Inc., with
SANUWAVE, Inc. as the surviving entity (the Merger). In connection with the Merger, the Company
acquired 100% of the outstanding capital stock of SANUWAVE, Inc. and the stockholders of SANUWAVE,
Inc. received 11,009,657 shares of the Companys common stock, warrants to purchase 1,106,627
shares of the Companys common stock at $4.00 per share, and warrants to purchase an additional
1,106,627 shares of the Companys common stock at $8.00 per share. In addition, in connection with
the Merger, certain stockholders of the Company agreed to cancel all of their shares of common
stock of the Company, except for 1,500,000 shares of common stock, for an aggregate price of
$180,000 (the Share Repurchase). At the time of the Merger, the Company had 1,500,000 warrants
outstanding to purchase the Companys common stock at $4.00 per share.
As a result of the Merger and the Share Repurchase, the stockholders of SANUWAVE, Inc. control
approximately 88% of the Companys outstanding common stock, holding 11,009,657 of the 12,509,657
outstanding shares, and SANUWAVE, Inc. was considered the accounting acquirer in this Merger. The
Company was a shell company as such term is defined in Rule 12b-2 under the Securities Exchange
Act of 1934, as amended (the Exchange Act) immediately prior to the Merger. As a result of the
Merger, the Companys operations are now focused in global medical technology and the Company is no
longer a shell company.
5. Recently Issued Accounting Standards
In January 2010, the Financial Accounting Standards Board (FASB) issued Accounting Standards
Update (ASU) 2010-06, Fair Value Measurements and Disclosures Topic 855 (ASU 2010-06). ASU
2010-06 provides amendments to ASC 820-10, Fair Value Measurements (ASC 820-10). ASC 820-10
defines fair value, establishes a framework for measuring fair value hierarchy for assets and
liabilities measured at fair value, and requires expanded disclosures about fair value
measurements. The ASC 820-10 hierarchy ranks the quality and reliability of inputs, or
assumptions, used in the determination of fair value and requires financial assets and liabilities
carried at fair value to be classified and disclosed in one of the three categories (level 1, level
2 or level 3). ASU 2010-06 provides amendments to ASC 820-10 to require new disclosures for
transfers in and out of levels 1 and 2, as well as a reconciliation of activity within level
3. Furthermore, ASU 2010-06 provides amendments that clarify existing disclosures regarding levels
of disaggregation and inputs and valuation techniques. The new disclosures and clarifications of
existing disclosures required by ASU 2010-06 are effective for interim and annual reporting periods
beginning after December 31, 2009 (except for disclosures in the reconciliation of activity within
level 3, which are effective for fiscal years beginning after December 15, 2010 and for interim
periods within those fiscal years). The Company adopted ASU 2010-06 as of January 1, 2010, and the
adoption did not have a material impact on the Companys condensed consolidated financial
statements.
In February 2010, the FASB issued ASU 2010-09, Subsequent Events (Topic 855): Amendments to
Certain Recognition and Disclosure Requirements (ASU 2010-09), to amend ASC 855, Subsequent
Events (ASC 855). ASC 855, which was originally issued by the FASB in May 2009 (as SFAS No. 165,
Subsequent Events ), provides guidance on events that occur after the balance sheet date but prior
to the issuance of the financial statements. ASC 855 distinguishes events requiring recognition in
the financial statements and those that may require disclosure in the financial statements. As a
result of ASU 2010-09, companies are not required to disclose the date through which management
evaluated subsequent events in the financial statements, either in originally issued financial
statements or reissued financial statements. ASC 855 was effective for interim and annual periods
ending after June 15, 2009, and ASU 2010-09 is effective immediately. The Company has evaluated
subsequent events in accordance with ASU 2010-09, and the evaluation did not have a material impact
on the Companys condensed consolidated financial statements.
- 7 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
March 31, 2010
6. Discontinued operations
On October 31, 2008, the Company discontinued its Ossatron® mobile service business.
On June 3, 2009, the Company sold its veterinary business to Pulse Veterinary Technologies,
LLC (Pulse Vet) for a total cash consideration of $3,500,000. As a result of the sale, the
Company recorded a gain, before income taxes, of $2,463,283.
Accordingly, the Companys condensed consolidated financial statements have been prepared with
the net assets, results of operations, and cash flows of these businesses displayed separately as
discontinued operations.
The operating results of the discontinued operations are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
|
Revenue |
|
$ |
|
|
|
$ |
782,815 |
|
Cost of revenues |
|
|
|
|
|
|
173,985 |
|
|
|
|
|
|
|
|
Gross profit |
|
|
|
|
|
|
608,830 |
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
283,310 |
|
|
|
|
|
|
|
|
Operating income |
|
|
|
|
|
|
325,520 |
|
|
|
|
|
|
|
|
|
|
Other expense |
|
|
|
|
|
|
(3,035 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from discontinued operations
before income taxes |
|
|
|
|
|
|
322,485 |
|
Income tax expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from discontinued operations,
net of income tax |
|
$ |
|
|
|
$ |
322,485 |
|
|
|
|
|
|
|
|
The Companys assets (liabilities) related to discontinued operations were as follows:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
(655,061 |
) |
|
$ |
(655,061 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net assets (liabilities) of discontinued operations |
|
$ |
(655,061 |
) |
|
$ |
(655,061 |
) |
|
|
|
|
|
|
|
- 8 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
March 31, 2010
7. Assets held for sale
On October 31, 2008, the Company discontinued its Ossatron mobile service business and
accordingly displayed the related assets of this business as discontinued operations (Note 6).
In accordance with FASB ASC 205-20, Presentation of Financial Statements Discontinued Operations,
a quarterly review of the discontinued assets was performed to determine if they should continue to
be recorded as discontinued operations. As of October 1, 2009, management determined that the
Ossatron device fixed assets and related parts inventory were not likely to be sold within the next
twelve months. Therefore, the Ossatron device fixed assets and related parts inventory were
reclassified to continuing operations and depreciation on the Ossatron device fixed assets was
restarted at October 1, 2009.
Assets held for sale consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Ossatron devices |
|
$ |
4,837,165 |
|
|
$ |
4,837,165 |
|
Accumulated depreciation |
|
|
(4,250,698 |
) |
|
|
(4,082,474 |
) |
|
|
|
|
|
|
|
Net property and equipment |
|
|
586,467 |
|
|
|
754,691 |
|
|
|
|
|
|
|
|
Inventory Ossatron device parts |
|
|
220,968 |
|
|
|
210,169 |
|
Provision for losses and obsolescence |
|
|
(41,904 |
) |
|
|
(41,904 |
) |
|
|
|
|
|
|
|
Net inventory |
|
|
179,064 |
|
|
|
168,265 |
|
|
|
|
|
|
|
|
Total assets held for sale |
|
$ |
765,531 |
|
|
$ |
922,956 |
|
|
|
|
|
|
|
|
The aggregate depreciation charged to operations was $168,224 for the three months ended
March 31, 2010. There was no depreciation expense charged to operations for the three months ended
March 31, 2009.
8. Inventory
Inventory consists of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Inventory finished goods |
|
$ |
657,493 |
|
|
$ |
667,998 |
|
Inventory parts |
|
|
90,733 |
|
|
|
108,068 |
|
|
|
|
|
|
|
|
|
|
|
748,226 |
|
|
|
776,066 |
|
Provision for losses and obsolescence |
|
|
(187,057 |
) |
|
|
(183,477 |
) |
|
|
|
|
|
|
|
Net Inventory |
|
$ |
561,169 |
|
|
$ |
592,589 |
|
|
|
|
|
|
|
|
- 9 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
March 31, 2010
9. Property and equipment
Property and equipment consists of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Machines and equipment |
|
$ |
199,520 |
|
|
$ |
199,520 |
|
Office and computer equipment |
|
|
311,791 |
|
|
|
311,791 |
|
Leasehold improvements |
|
|
67,421 |
|
|
|
67,421 |
|
Furniture and fixtures |
|
|
24,613 |
|
|
|
24,613 |
|
Vehicles |
|
|
38,897 |
|
|
|
38,897 |
|
Software |
|
|
40,233 |
|
|
|
40,233 |
|
Other assets |
|
|
4,509 |
|
|
|
4,585 |
|
|
|
|
|
|
|
|
Total |
|
|
686,984 |
|
|
|
687,060 |
|
Accumulated depreciation |
|
|
(624,793 |
) |
|
|
(598,354 |
) |
|
|
|
|
|
|
|
Net property and equipment |
|
$ |
62,191 |
|
|
$ |
88,706 |
|
|
|
|
|
|
|
|
The aggregate depreciation charged to operations was $26,508 and $60,468 for the three
months ended March 31, 2010 and 2009, respectively.
10. Intangible assets
Intangible assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Patents, at cost |
|
$ |
3,502,135 |
|
|
$ |
3,502,135 |
|
Less accumulated amortization |
|
|
(1,431,529 |
) |
|
|
(1,354,840 |
) |
|
|
|
|
|
|
|
Net intangible assets |
|
$ |
2,070,606 |
|
|
$ |
2,147,295 |
|
|
|
|
|
|
|
|
The aggregate amortization charged to amortization expense was $76,689 for each of the
three months ended March 31, 2010 and 2009.
11. Accrued expenses
Accrued expenses consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Accrued legal professional fees |
|
$ |
104,031 |
|
|
$ |
249,418 |
|
Accrued clinical site payments |
|
|
192,000 |
|
|
|
192,023 |
|
Accrued audit and tax preparation |
|
|
54,898 |
|
|
|
77,771 |
|
Accrued other |
|
|
118,750 |
|
|
|
109,817 |
|
|
|
|
|
|
|
|
|
|
$ |
469,679 |
|
|
$ |
629,029 |
|
|
|
|
|
|
|
|
- 10 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
March 31, 2010
12. Income taxes
Deferred income taxes are provided for temporary differences between the carrying amounts and
tax basis of assets and liabilities. Deferred taxes are classified as current or noncurrent based
on the financial statement classification of the related asset or liability giving rise to the
temporary difference. For those deferred tax assets or liabilities (such as the tax effect of the
net operating loss carryforward) which do not relate to a financial statement asset or liability,
the classification is based on the expected reversal date of the temporary difference.
13. Promissory notes
The promissory notes consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Notes payable, unsecured, bearing interest at
5% issued to David N. Nemelka on March 1, 2010.
Interest is accrued and added to the principal balance.
All accrued interest and principal is due June 1, 2010.
Accrued interest totaled $834 at March 31, 2010. |
|
$ |
200,834 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Notes payable, unsecured, bearing interest at
5% issued to Kevin and Margaret Richardson on
March 4, 2010. Interest is accrued and added to the
principal balance. All accrued interest and principal
is due June 4, 2010. Accrued interest totaled $722 at
March 31, 2010. |
|
|
200,722 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable, unsecured, bearing interest at
5% issued to David N. Nemelka on March 31, 2010.
Interest is accrued and added to the principal balance.
All accrued interest and principal is due June 30, 2010. |
|
|
300,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable, unsecured, bearing interest at
5% issued to Kevin and Margaret Richardson on
March 31, 2010. Interest is accrued and added to the
principal balance. All accrued interest and principal
is due June 30, 2010. |
|
|
300,000 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,001,556 |
|
|
$ |
|
|
|
|
|
|
|
|
|
David N. Nemelka is a shareholder of the Company. Kevin Richardson is a member of the
Board of Directors of the Company and is the managing partner of Prides Capital LLC, a shareholder
of the Company.
Interest expense on promissory notes totaled $1,556 for the three months ended March 31, 2010.
- 11 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
March 31, 2010
14. Notes payable, related parties
The notes payable, related parties consist of the following:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2010 |
|
|
2009 |
|
Notes payable, unsecured, bearing interest at
6% to HealthTronics, Inc., a shareholder
of the Company. The notes were issued in
conjunction with the Companys purchase of
the orthopedic division of HealthTronics, Inc. on
August 1, 2005. Quarterly interest through
June 30, 2010 is accrued and added to the
principal balance. Interest is paid quarterly in
arrears beginning September 30, 2010. All
remaining unpaid accrued interest and
principal is due August 1, 2015. Accrued
interest totaled $1,292,977 and $1,215,253 at
March 31, 2010 and December 31, 2009, respectively. |
|
$ |
5,292,977 |
|
|
$ |
5,215,253 |
|
|
|
|
|
|
|
|
|
|
Notes payable, unsecured, bearing interest at
15% to Prides Capital Fund I, LP and NightWatch
Capital Partners II, LP, shareholders of the Company.
Quarterly interest through March 31, 2010
is accrued and added to the principal balance.
Interest is paid quarterly in arrears if elected by
the holder. As of March 31, 2010, the holder has
not elected to have interest paid. All remaining
unpaid accrued interest and principal is due
September 30, 2011. Accrued interest totaled
$612,184 and $472,728 at March 31, 2010 and
December 31, 2009, respectively. All or any
portion of the unpaid principal can be
converted into common stock with a
conversion price of $2.92 per share. |
|
|
3,812,184 |
|
|
|
3,672,728 |
|
|
|
|
|
|
|
|
Total |
|
|
9,105,161 |
|
|
|
8,887,981 |
|
Less current portion |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current portion |
|
$ |
9,105,161 |
|
|
$ |
8,887,981 |
|
|
|
|
|
|
|
|
Interest expense on notes payable, related parties totaled $217,180 and $138,354 for the
three months ended March 31, 2010 and 2009, respectively.
- 12 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
March 31, 2010
15. Earnings (Loss) Per Share
The Company calculates net income (loss) per share in accordance with ASC 260, Earnings Per
Share (formerly
SFAS No. 128, Earnings Per Share). Under the provisions of ASC 260, basic net income (loss)
per share is computed by dividing the net income (loss) attributable to common stockholders for the
period by the weighted average number of shares of common stock outstanding for the
period. Diluted net income (loss) per share is computed by dividing the net income (loss)
attributable to common stockholders by the weighted average number of shares of common stock and
dilutive common stock equivalents then outstanding. To the extent that securities are
anti-dilutive, they are excluded from the calculation of diluted net income (loss) per share.
As a result of the net loss for the three months ended March 31, 2010 and 2009, respectively,
all potentially dilutive shares were anti-dilutive and therefore excluded from the computation of
diluted net income (loss) per share. The anti-dilutive common shares totaled 1,662,042 shares and
640,028 shares for the three months ended March 31, 2010 and 2009, respectively.
16. Commitments and Contingencies
The Company leases office and warehouse space. Rent expense was $87,089 and $119,246 for the
three months ended March 31, 2010 and 2009, respectively.
The Company is involved in various legal matters that have arisen in the ordinary course of
business. While the ultimate outcome of these matters is not presently determinable, it is the
opinion of management that the resolution will not have a material adverse effect on the
consolidated financial position or results of operations of the Company.
17. 401k plan
The Company sponsors a 401k plan that covers all employees who meet the eligibility
requirements. The Company matches 50% of employee contributions up to 6% of their compensation.
The Company contributed $16,661 and $17,702 to the plan for the three months ended March 31, 2010
and 2009, respectively.
18. Stock-based compensation
During 2006, SANUWAVE, Inc. approved the 2006 Stock Incentive Plan (the Plan) and certain
Nonstatutory Stock Option Agreements with key employees. The Nonstatutory Stock Option Agreements
have terms substantially the same as the Plan. As of March 31, 2010, the Plan reserved
approximately 684,666 shares of common stock for grant. The Plan permits granting of awards to
selected employees and directors of the Company in the form of restricted stock or options to
purchase shares of common stock. Options granted may include Nonstatutory Options as well as
Non-qualified Incentive Stock Options. The Plan is currently administered by the board of
directors of SANUWAVE, Inc. The Plan gives broad powers to the board of directors of SANUWAVE,
Inc. to administer and interpret the particular form and conditions of each option. The stock
options granted were nonstatutory options which, under the Plan, vest equally over a four-year
period, and have a ten-year term. The options were granted to employees at an exercise price
deemed to be the fair market value of the common stock on the date of the grant. It is the
Companys policy to issue new stock certificates to satisfy stock option exercises. The Company
intends to adopt and assume the Plan.
For the three months ended March 31, 2010, the Company granted 112,500 options to employees
and directors at an exercise price of $4.05 per share. Using the Black-Scholes option pricing
model, management has determined that the options granted in 2010 had a weighted average fair value
per share of $2.06 at March 31, 2010 resulting in total compensation cost of $455,625.
Compensation cost will be recognized over the applicable service period.
For the three months ended March 31, 2010 and 2009, the Company recognized $483,270 and
$133,696 as compensation cost, respectively for all outstanding stock options, restricted stock and
warrants granted to employees and directors.
- 13 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
March 31, 2010
18. Stock-based compensation (continued)
The assumptions used are as follows:
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2010 |
|
Expected life in years |
|
|
6.0 |
|
Risk free interest rate |
|
|
2.41 |
% |
Weighted average volatility |
|
|
65.00 |
% |
Expected dividend yield (1) |
|
|
|
|
|
|
|
(1) |
|
The Company has not paid dividends on its common stock and does not expect to pay dividends on
its common stock in the near future. |
A summary of option activity as of March 31, 2010 and December 31, 2009, and the changes
during the three months ended March 31, 2010, is presented as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Exercise |
|
|
|
Options |
|
|
Price |
|
Outstanding as of December 31, 2009 |
|
|
1,979,546 |
|
|
$ |
3.70 |
|
Granted |
|
|
112,500 |
|
|
$ |
4.05 |
|
Exercised |
|
|
|
|
|
$ |
|
|
Forfeited or expired |
|
|
(2,500 |
) |
|
$ |
2.92 |
|
|
|
|
|
|
|
|
|
Outstanding as of March 31, 2010 |
|
|
2,089,546 |
|
|
$ |
3.72 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable |
|
|
1,726,986 |
|
|
$ |
3.70 |
|
|
|
|
|
|
|
|
|
The weighted average remaining contractual term for outstanding and exercisable stock options
is 6.0 years as of March 31, 2010 and 6.3 years as of December 31, 2009.
A summary of the Companys nonvested options as of March 31, 2010 and December 31, 2009, and
changes during the three months ended March 31, 2010, is presented as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant-Date |
|
|
|
Options |
|
|
Fair Value |
|
Outstanding as of December 31, 2009 |
|
|
273,471 |
|
|
$ |
997,589 |
|
Granted |
|
|
112,500 |
|
|
|
455,625 |
|
Vested |
|
|
(20,911 |
) |
|
|
(61,060 |
) |
Forfeited or expired |
|
|
(2,500 |
) |
|
|
(7,300 |
) |
|
|
|
|
|
|
|
Outstanding as of March 31, 2010 |
|
|
362,560 |
|
|
$ |
1,384,854 |
|
|
|
|
|
|
|
|
- 14 -
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
March 31, 2010
18. Stock-based compensation (continued)
A summary of the Companys restricted stock as of March 31, 2010 and December 31, 2009, and
changes during the three months ended March 31, 2010, is presented as follows:
|
|
|
|
|
|
|
Restricted |
|
|
|
Stock |
|
Outstanding as of December 31, 2009 |
|
|
403,030 |
|
Granted |
|
|
|
|
Vested |
|
|
|
|
Forfeited or expired |
|
|
|
|
|
|
|
|
Outstanding as of March 31, 2010 |
|
|
403,030 |
|
|
|
|
|
19. Warrants
As of March 31, 2010, the Company had (1) Class A Warrants to purchase up to 1,106,627 shares
of common stock outstanding, (2) Class B Warrants to purchase up to 1,106,627 shares of common
stock outstanding, and (3) Class C Warrants to purchase up to 1,500,000 shares of common stock
outstanding. The Class A Warrants and Class B Warrants expire on September 25, 2014, and the Class
C Warrants expire on September 25, 2011. The Class C Warrants are not exercisable until September
25, 2010. The Class A Warrants and Class C Warrants have an exercise price of $4.00 per share, and
the Class B Warrants have an exercise price of $8.00 per share.
The exercise price and the number of shares covered by the Class A, B and C Warrants will be
adjusted if the Company has a stock split, if there is a recapitalization of the Companys common
stock, or if the Company consolidates with or merges into another corporation. The Class C
Warrants may be redeemed by the Company if the closing price of the Companys common stock on the
trading market is $5.00 per share or more, with 15,000 shares of average daily volume, for 20
consecutive trading days, or if the Company consummates a private offering of the Companys common
stock. In both cases, the redemption price will be $0.01 per warrant.
- 15 -
|
|
|
Item 2. |
|
MANAGEMENTS 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 Managements Discussion and Analysis of Financial
Condition and Results of Operations as of and for the year ended December 31, 2009 included in our
Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31,
2010.
Overview
We are an emerging medical technology company focused on the development and commercialization
of noninvasive, biological response activating devices in the regenerative medicine area for the
repair and regeneration of tissue, musculoskeletal and vascular structures. Our portfolio of
products and product candidates activate biologic signaling and angiogenic responses, including new
vascularization and microcirculatory improvement, helping to restore the bodys normal healing
processes and regeneration. We intend to apply our Pulsed Acoustic Cellular Expression (PACE)
technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions.
We believe we have demonstrated that our PACE technology is safe and effective in stimulating
healing in chronic conditions of the foot and the elbow through our United States FDA Class III PMA
approved Ossatron® device, and in the stimulation of bone and chronic tendonitis regeneration in
the musculoskeletal environment through the utilization of our Ossatron and Evotron® devices in
Europe. Our lead product candidate for the global wound care market, dermaPACE, has received the
European Conformity Marking (CE Mark) allowing for commercial use on acute and chronic defects of
the skin and subcutaneous soft tissue.
With the divestiture of our worldwide Versatron® veterinary product line in June 2009, we are
now entirely focused on developing our PACE technology to stimulate healing in:
|
|
|
wound conditions, including diabetic foot ulcers, venous ulcers, pressure sores, burns
and other skin eruption conditions; |
|
|
|
|
orthopedic/spine applications, such as speeding the healing of fractures (including
non-union or delayed-union conditions), improving bone density in osteoporosis, fusing
bones in the extremities and spine, eliminating chronic pain in joints from trauma or
arthritis, 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 procedures for removing plaque due to atherosclerosis and improving heart muscle
performance. |
Recent Developments
As of March 31, 2010, we have completed enrolling patients for our first IDE wound care
clinical study focused on the healing of diabetic foot ulcers utilizing our lead product candidate,
dermaPACE. The primary study goal is to establish superiority in diabetic foot ulcer healing rates
using the dermaPACE treatment compared to sham control, when both are combined with the current
standard of care. The standard of care includes wet-to-dry dressings, the most widely used primary
dressing material in the United States, and offloading with a walking boot. A total of 206
patients have entered the dermaPACE study at 24 sites. The patients in the study must be followed
for a total of 24 weeks. The studys primary endpoint, wound closure, is defined as successful
if the skin is reepithelialized without drainage or dressing requirements confirmed at two
consecutive study visits. We expect final study data, including time to closure, total wound size
reduction, long-term safety, and study subject assessments to be available by the fourth quarter of
2010. The Company is finalizing its regulatory submission plan with the FDA and will provide
further information when the plan is established.
We believe our experience from preclinical research and the clinical use of our predecessor
devices in Europe and Asia, as well as our Ossatron device in the United States for the last nine
years, demonstrates the safety, clinical utility and efficacy of our product candidates. In
addition, we have preclinical programs focused on the development and better understanding of
treatments specific to our target applications, as well as toward the development of next
generation devices utilizing our PACE technology to maximize healing response and intervention.
- 16 -
We believe that these studies suggest that our platform technology will be effective in our
target applications. If successful, we expect these clinical studies should lead to regulatory
approval of our regenerative product candidates in the United States, Europe and Asia. If approved
by the appropriate regulatory authorities, we believe that our product candidates will offer new,
effective and non-invasive treatment options in wound healing, orthopedic/spine injuries,
plastic/cosmetic uses and cardiac procedures, improving the quality of life for millions of
patients suffering from injuries or deterioration of tissue, bones and vascular structures.
Financial Overview
Since our inception in 2005, we have funded our operations from the sale of capital stock, the
issuance of notes payable to related parties, the issuance of promissory notes, the sale of our
veterinary division in June 2009, and product sales. At March 31, 2010, the balance of cash and
cash equivalents totaled $1.1 million.
We continue to incur research and development expenses for clinical trials and the development
of products for additional indications. We expect that research and development expenses will
continue to increase as a result of new and ongoing clinical and pre-clinical studies in the United
States and in Europe, as well as expenses associated with regulatory filings. In addition, we
anticipate that our general and administrative expenses will continue to increase as we expand our
operations, facilities and other administrative activities related to our efforts to bring our
product candidates to commercialization.
Since our inception, we have incurred losses from operations each year. As of March 31, 2010,
we had an accumulated deficit of $41.7 million. Although the size and timing of our future
operating losses are subject to significant uncertainty, we expect that operating losses will
continue over the next few years as we continue to fund our research and development activities and
clinical trials, and as we prepare for a future sales network to represent our products. In
addition, given the sale of our veterinary division in 2009 and the discontinuation of the Ossatron
mobile service business in 2008, we do not currently have an FDA approved product in
commercialization in the United States.
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 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; |
|
|
|
|
the cost and timing associated with establishing reimbursement for our products; |
|
|
|
|
the timing and results of our pre-clinical research programs; |
|
|
|
|
the effects of competing technologies and market developments; and |
|
|
|
|
the industry demand and patient wellness behavior as businesses and individuals
suffer from the current economic downturn. |
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 in our Annual Report on Form 10-K filed with the SEC on March 31, 2010.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are 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.
- 17 -
On an ongoing basis, we evaluate our estimates and judgments, including those related to
revenue recognition, accrued expenses, fair valuation of inventory, fair valuation of stock related
to stock-based compensation and income
taxes. 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 discussion and analysis of our
financial condition and results of operations are based upon our condensed consolidated financial
statements. The results of our operations for any historical period are not necessarily indicative
of the results of our operations for any other future period.
While our significant accounting policies are more fully described in Note 1 to our
consolidated financial statements filed with our Annual Report on Form 10-K filed with the SEC on
March 31, 2010, we believe that the following accounting policies relating to revenue recognition,
research and development costs, inventory valuation, stock-based compensation and income taxes are
significant and; therefore, important to aid you in fully understanding and evaluating our reported
financial results.
Revenue Recognition
Sales of medical devices, including related applicators and applicator kits, are recognized
when shipped to the customer. Fees from services performed are recognized when the related service
is performed.
Research and Development Costs
We expense costs associated with research and development activities as incurred. We evaluate
payments made to suppliers and other vendors and determine the appropriate accounting treatment
based on the nature of the services provided, the contractual terms, and the timing of the
obligation. Research and development costs include payments to third parties that specifically
relate to our products in clinical development, such as payments to contract research
organizations, clinical investigators, clinical related consultants, contract manufacturer
development costs and insurance premiums for clinical studies. In addition, employee costs
(salaries, payroll taxes, benefits and travel) for employees of the regulatory affairs, clinical
affairs, quality assurance, quality control, and research and development departments are
classified as research and development costs.
Inventory Valuation
We value our inventory at the lower of our actual cost or the current estimated market value.
We regularly review existing inventory quantities and expiration dates of existing inventory to
evaluate a provision for excess, expired, obsolete and scrapped inventory based primarily on our
historical usage and anticipated future usage. Although we make every effort to ensure the
accuracy of our forecasts of future product demand, any significant unanticipated change in demand
or technological developments could have an impact on the value of our inventory and our reported
operating results.
Stock-based Compensation
During 2006, SANUWAVE, Inc.s board of directors approved the adoption of the 2006 Stock
Incentive Plan (the Plan). The Plan provides that stock options, other equity interests or
equity-based incentives in SANUWAVE, Inc. may be granted to key personnel at an exercise price
determined by SANUWAVE, Inc.s board of directors, at the time the option is granted, taking into
account the fair value of the common stock on the date of grant. The maximum term of any option
granted pursuant to the Plan is ten years from the date of grant.
In accordance with ASC 718, Compensation Stock Compensation (formerly included in SFAS
No. 123(R), Accounting for Stock-Based Compensation), the fair value of each option award is
estimated on the date of grant using the Black-Scholes option pricing model. The expected terms of
options granted represent the period of time that options granted are estimated to be outstanding
and are derived from the contractual terms of the options granted. We amortize the fair value of
each option over each options vesting period.
- 18 -
Income Taxes
We account for income taxes utilizing the asset and liability method prescribed by the
provisions of ASC 740, Income Taxes (formerly SFAS No. 109, Accounting for Income Taxes).
Deferred tax assets and liabilities are determined
based on differences between the financial reporting and tax bases of assets and liabilities
and are measured using the enacted tax rates and laws that will be in effect when the differences
are expected to reverse. A valuation allowance is provided for the deferred tax assets related to
future years, including loss carry-forwards, if there is not sufficient evidence to indicate that
the results of operations will generate sufficient taxable income to realize the net deferred tax
asset in future years.
We have adopted a provision of ASC 740, Income Taxes (formerly FASB Interpretation No. 48,
Accounting for Uncertainty in Income Taxes (FIN 48)). ASC 740 specifies the way public companies
are to account for uncertainties in income tax reporting, and prescribes a methodology for
recognizing, reversing, and measuring the tax benefits of a tax position taken, or expected to be
taken, in a tax return. ASC 740 requires the evaluation of tax positions taken or expected to be
taken in the course of preparing the Companys tax returns to determine whether the tax positions
would more-likely-than-not be sustained if challenged by the applicable tax authority. Tax
positions not deemed to meet the more-likely-than-not threshold would be recorded as a tax benefit
or expense in the current year.
Results of Operations for the Three Months ended March 31, 2010 and 2009 (Unaudited)
Revenues and Cost of Revenues
Revenues for the three months ended March 31, 2010 were $143,102, compared to $262,082 for the
same period in 2009, a decrease of $118,980, or 45%. These revenues result primarily from sales of
devices and applicators in Europe of our legacy Evotron® device for orthopedic conditions and our
dermaPACE device for advanced wound care. Revenues decreased for the three months ended March 31,
2010 compared to 2009 primarily because of declining sales of the legacy Evotron device due to the
elimination in 2009 of our European sales and marketing staff to focus our resources in the United
States.
Cost of revenues for the three months ended March 31, 2010 was $47,644, compared to $60,282
for the same period in 2009. Gross profit as a percentage of revenues was 67% for the three months
ended March 31, 2010, as compared to 77% for the same period in 2009. The decrease in gross profit
in 2010 was primarily due to higher freight cost in 2010 associated with the Company assembling its
products for sale in Europe in the United States instead of in Europe as it did in 2009.
Research and Development Expenses
Research and development expenses for the three months ended March 31, 2010 were $1,085,974,
compared to $813,510 for the same period in 2009, an increase of $272,464, or 33%. Research and
development costs include payments to third parties that specifically relate to our products in
clinical development, such as payments to contract research organizations, clinical investigators,
clinical related consultants, contract manufacturer development costs and insurance premiums for
clinical studies. In addition, employee costs (salaries, payroll taxes, benefits, and travel) for
employees of the regulatory affairs, clinical affairs, quality assurance, quality control, and
research and development departments are classified as research and development costs. Research
and development costs increased in 2010 as compared to the same period in 2009 due to higher costs
of the ongoing clinical trial of dermaPACE for diabetic foot ulcers in the United States as
enrollment had increased as the enrollment period was coming to an end during the period ended
March 31, 2010.
We expect that research and development expenses will continue to increase as a result of next
generation technology development, the ongoing clinical trial of dermaPACE for diabetic foot
ulcers in the United States and other new product candidates, as well as continuing expenses
associated with pre-clinical studies and regulatory filings.
General and Administrative Expenses
General and administrative expenses for the three months ended March 31, 2010 were $1,598,524,
compared to $1,249,577 for the same period in 2009, an increase of $348,947, or 28%. General and
administrative expenses include the non-cash compensation costs for stock compensation of $483,270
for the three months ended March 31, 2010, compared to $133,696 for the same period in 2009, due to
new grants of options and restricted stock to management and directors of the Company primarily in
September 2009.
- 19 -
Excluding the non-cash compensation costs for stock compensation, general and administrative
expenses were $1,115,254 for the three months ended March 31, 2010, as compared to $1,115,881 for
the same period in 2009, a decrease of $627.
We expect that general and administrative expenses will increase as we expand our operations
and other administrative activities related to our efforts to bring our products to
commercialization.
Depreciation and Amortization
Depreciation and amortization for the three months ended March 31, 2010 was $271,421, compared
to $137,157 for the same period in 2009, an increase of $134,264, or 98%.
On October 31, 2008, the Company discontinued its Ossatron mobile service business and
accordingly displayed the related assets of this business as discontinued operations (Note 6).
As of October 1, 2009, management determined that the Ossatron device fixed assets and related
parts inventory were not likely to be sold within the next twelve months. Therefore, the Ossatron
device fixed assets and related parts inventory were reclassed to continuing operations and
depreciation on the Ossatron device fixed assets was restarted at October 1, 2009. The
depreciation expense related to these assets was $168,224 for the three months ended March 31,
2010.
Other Income (Expense)
On June 3, 2009, we sold our veterinary division to Pulse Vet. Under terms of the asset
purchase agreement, we will continue to provide purchasing, production, shipping and warehousing
services to Pulse Vet for a fee until April 30, 2011, unless Pulse Vet elects to terminate the
agreement at an earlier date. The revenue for these transitional services was $90,000 for the
three months ended March 31, 2010.
Interest expense, net, for the three months ended March 31, 2010 was $217,281, compared to
$138,059 for the same period in 2009, an increase of $79,222, or 57%. The increase was due to
interest at 15% per annum on notes payable, related parties, totaling $1,575,000 issued during the
three months ended March 31, 2009.
Provision for Income Taxes
At March 31, 2010, we had Federal net operating loss carryforwards of approximately $32.8
million that will begin to expire in 2025. Our ability to use these net operating loss
carryforwards to reduce our future Federal income tax liabilities could be subject to annual
limitations. Additionally, because United States tax laws limit the time during which net
operating loss carryforwards may be applied against future taxable income and tax liabilities, we
may not be able to take advantage of our net operating loss carryforwards for Federal income tax
purposes.
Disposal of Veterinary Division
On June 3, 2009, we sold our veterinary division for $3,500,000 in cash to Pulse Vet. The
income from discontinued operations was $322,485 for the three months ended March 31, 2009.
Net Income (Loss)
Net loss for the three months ended March 31, 2010 was $2,994,755, or $(0.24) per basic and
diluted share, compared to net loss of $1,823,466, or $(0.17) per basic and diluted share, for the
three months ended March 31, 2009. This included a loss from continuing operations of $2,994,755,
or $(0.24) per basic and diluted share, for the three months ended March 31, 2010, compared to a
loss from continuing operations of $2,145,951, or $(0.20) per basic and diluted share, for the
three months ended March 31, 2009. We anticipate that our operating losses will continue over the
next few years as we continue to fund our research and development activities and clinical trials,
and as we prepare for a future sales network to represent our products.
- 20 -
Liquidity and Capital Resources
We incurred a net loss of $2,994,755 and $1,823,466 for the three months ended March 31, 2010
and 2009, respectively. We incurred a net loss of $6,153,040 for the year ended December 31, 2009.
These operating losses create
an uncertainty about our ability to continue as a going concern. Management believes we will
raise additional capital through public or private equity offerings, outstanding warrant exercises
or other potential financing sources. Our condensed consolidated financial statements do not
include any adjustments that might be necessary if we are unable to continue as a going concern.
We are economically dependent upon future capital contributions or financing to fund ongoing
operations. On June 3, 2009, we sold our veterinary division for $3,500,000 in cash to Pulse Vet.
During the year ended December 31, 2009, we obtained cash infusions totaling $2,125,000 in the form
of notes payable from related parties. The notes payable can be converted into additional shares
of common stock, with all or any portion of the unpaid principal, at a conversion price of $2.92
per share. In addition, for the year ended December 31, 2009, additional shares of stock were
issued to stockholders for total cash proceeds of $1,819,844. In March 2010, the Company issued
four promissory notes totaling $1,000,000 to two stockholders. The notes bear interest at 5% per
annum and are due in June, 2010.
At March 31, 2010, we had $1,065,691 in cash and cash equivalents held in three
financial institutions. Our excess cash reserves are invested in money market accounts.
We expect to devote substantial resources to continue our research and development
efforts, including clinical trials. Clinical study costs are comprised of payments for work
performed by contract research organizations, universities and hospitals. Because of the
significant time it will take for our products to complete the clinical trial process, and for us
to obtain approval from regulatory authorities and successfully commercialize our products, we will
require substantial additional capital resources. We may raise additional capital through public
or private equity offerings, outstanding warrant exercises, debt financings, corporate
collaborations or other means. 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 stockholders will experience dilution, 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. Additional financing may not be available on
acceptable terms, if at all. Capital may become difficult or impossible to obtain due to poor
market or other conditions outside of our control. If at any time sufficient capital is not
available, either through existing capital resources or through raising additional funds, we may be
required to delay, reduce the scope of, eliminate or divest one or more of our research,
pre-clinical or clinical programs.
For the three months ended March 31, 2010, net cash used by continuing operations for
operating activities was $1,720,110, primarily consisting of salaries, clinical trials, research
and development activities and general corporate operations. Net cash provided by continuing
operations for financing activities for the three months ended March 31, 2010 was $1,000,000, which
consisted of the proceeds from issuance of promissory notes. Cash and cash equivalents decreased
by $720,678 for the three months ended March 31, 2010.
For the three months ended March 31, 2009, net cash used by continuing operations for
operating activities was $2,259,096, primarily consisting of salaries, clinical trials, research
and development activities and general corporate operations. Net cash provided by continuing
operations for financing activities for the three months ended March 31, 2009 was $1,575,000, which
consisted of the proceeds from the issuance of notes payable to related parties. Net cash provided
by discontinued operations was $722,663 for the three months ended March 31, 2009. Cash and cash
equivalents decreased by $10,565 for the three months ended March 31, 2009.
Segment Information
We have determined that we are principally engaged in one operating segment. Our product
candidates are primarily used for the repair and regeneration of tissue, musculoskeletal and
vascular structures in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions.
- 21 -
Comprehensive Loss
FASB ASC 220, Comprehensive Income (formerly SFAS No. 130, Reporting Comprehensive Income),
establishes standards for reporting and display of comprehensive income (loss) and its components
in the condensed consolidated financial statements. Our comprehensive loss as defined by ASC 220
is the total of net loss and all other
changes in equity resulting from non-owner sources, including unrealized gains (losses) on
foreign currency translation adjustments.
Contractual Obligations
Our major outstanding contractual obligations relate to our operating leases for our
facilities, purchase and supplier obligations for product component materials and equipment, and
our notes payable.
In October 2006, we entered into a sublease agreement for our corporate office in
Alpharetta, Georgia, which consists of 15,025 square feet of space. Under the terms of the
sublease, we pay monthly rent of $18,468, as adjusted on an annual basis for additional
proportionate operating and insurance costs associated with the building over the base amount. The
initial term of the sublease expired September 30, 2009, and we have exercised the option to extend
the term to October 31, 2012.
In April 2007, we entered into a lease agreement for our production and research and
development office, which consists of 5,168 square feet of space. Under the terms of the lease, we
pay monthly rent of $8,075, as adjusted on an annual basis for additional proportionate operating
and insurance costs associated with the building over the base amount. The initial term of the
lease continues until July 31, 2010, and we have extended the lease until July 31, 2011.
We have developed a network of suppliers, manufacturers, and contract service providers to
provide sufficient quantities of product component materials for our products through the
development, clinical testing and commercialization phases. We have contractual obligations under
a supply agreement with Swisstronics Contract Manufacturing AG for the manufacture of our devices.
In August 2005, as part of the purchase of the orthopedic division assets of
HealthTronics, we entered into two promissory notes with HealthTronics for $2,000,000 each. The
promissory notes bear interest at 6% annually. Quarterly interest through June 30, 2010 is accrued
and added to the principal balance. Interest is paid quarterly in arrears beginning September 30,
2010. All remaining unpaid accrued interest and principal is due August 1, 2015. Accrued interest
on the promissory notes totaled $1,292,977 and $1,215,253 at March 31, 2010 and December 31, 2009,
respectively.
During the years ended December 31, 2009 and 2008, we issued notes payable to Prides Capital
Fund I, L.P. for $3,125,000 in total and one note payable to NightWatch Capital Partners II, L.P.
for $75,000. The notes payable bear interest at 15% annually. Interest is paid quarterly in
arrears if elected by the holders of the notes payable. As of March 31, 2010, the holders of the
notes payable had not elected to receive interest quarterly. All remaining unpaid accrued interest
and principal is due September 30, 2011. All or any portion of the unpaid principal can be
converted into common stock with a conversion price of $2.92 per share. Accrued interest on the
notes payable totaled $612,184 and $472,728 at March 31, 2010 and December 31, 2009, respectively.
During March 2010, we issued promissory notes to David N. Nemelka in the amount of $500,000
and to Kevin and Margaret Richardson in the amount of $500,000. The promissory notes bear interest
at 5% annually. All accrued interest and principal is due June 2010. Accrued interest on the
promissory notes totaled $1,556 at March 31, 2010.
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
Because 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. |
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QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Not applicable.
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Item 4. |
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CONTROLS AND PROCEDURES |
Not applicable.
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Item 4T. |
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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 SECs rules and forms. These controls and
procedures are designed to ensure that the required information is accumulated and communicated to
our management, including our Chief Executive Officer and Chief Financial Officer, 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 and
Chief Financial Officer, of the effectiveness of the design and operation of our disclosure
controls and procedures as of March 31, 2010. Based on this evaluation, the Chief Executive Officer
and Chief Financial Officer concluded that our disclosure controls and procedures were effective as
of March 31, 2010.
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 affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
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PART II OTHER INFORMATION
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Item 1. |
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LEGAL PROCEEDINGS |
Other than legal proceedings described below and those relating to our intellectual property,
there are no material pending legal proceedings to which we are a party or of which any of our
properties are subject; nor are there material proceedings known to us to be contemplated by any
governmental authority. We have several material pending legal proceedings relating to our
patents. For information regarding these legal proceedings, please see the section entitled
Intellectual Property Patents in our Annual Report on Form 10-K filed with the SEC on March 31,
2010.
HealthTronics, along with the Company, are defendants in an alleged breach of contract lawsuit
dated April 21, 2006 brought in the Miami-Dade County Circuit Court, Florida by a former limited
partner of a former limited partnership of the Company, Bone & Joint Treatment Centers of America.
The plaintiff is seeking greater than $3 million. HealthTronics has been responsible for the
defense of the lawsuit on behalf of the Company and believes the case is unfounded and is
contesting the claims vigorously.
There are no material proceedings known to us, pending or contemplated, in which any of our
directors, officers or affiliates or any of our principal security holders, or any associate of any
of the foregoing, is a party or has an interest adverse to us.
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Item 2. |
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UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
None.
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Item 3. |
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DEFAULTS UPON SENIOR SECURITIES |
None.
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Item 4. |
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[REMOVED AND RESERVED] |
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Item 5. |
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OTHER INFORMATION |
None.
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Exhibit No. |
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Description |
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2.1 |
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Agreement and Plan of Merger, dated as of September 25, 2009, by and between Rub
Music Enterprises, Inc., RME Delaware Merger Sub, Inc. and SANUWAVE, Inc. (Incorporated
by reference to Form 8-K filed with the SEC on September 30, 2009). |
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3.1 |
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Articles of Incorporation (Incorporated by reference to the Form 10-SB filed with
the SEC on December 18, 2007). |
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3.2 |
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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). |
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3.3 |
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Bylaws (Incorporated by reference to the Form 10-SB filed with the SEC on
December 18, 2007). |
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4.1 |
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Form of Class A Warrant Agreement (Incorporated by reference to Form 8-K filed
with the SEC on September 30, 2009). |
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4.2 |
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Form of Class B Warrant Agreement (Incorporated by reference to Form 8-K filed
with the SEC on September 30, 2009). |
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4.3 |
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Form of Amended and Restated Class C Warrant Agreement (Incorporated by reference
to Form 8-K filed with the SEC on September 30, 2009). |
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4.4 |
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Form of Amended Senior Note issued by SANUWAVE, Inc. to Prides Capital Fund I,
L.P. and NightWatch Capital Partners II, L.P. (Incorporated by reference to Form 8-K
filed with the SEC on September 30, 2009). |
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4.5 |
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Form of Promissory Note, dated August 1, 2005, issued by SANUWAVE, Inc. to
HealthTronics, Inc. (Incorporated by reference to Form 8-K filed with the SEC on
September 30, 2009). |
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10.1 |
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Promissory Note, dated March 1, 2010, issued by SANUWAVE Health, Inc. to David N.
Nemelka. (Incorporated by reference to the Form 8-K filed with the SEC on March 5,
2010). |
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10.2 |
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Promissory Note, dated March 4, 2010, issued by SANUWAVE Health, Inc. to Kevin
and Margaret Richardson. (Incorporated by reference to the Form 8-K filed with the SEC
on March 5, 2010). |
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10.3 |
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Promissory Note, dated March 31, 2010, issued by SANUWAVE Health, Inc. to David
N. Nemelka. (Incorporated by reference to the Form 8-K filed with the SEC on April 1,
2010). |
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10.4 |
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Promissory Note, dated March 31, 2010, issued by SANUWAVE Health, Inc. to Kevin
and Margaret Richardson. (Incorporated by reference to the Form 8-K filed with the SEC
on April 1, 2010). |
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31.1 |
* |
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Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer. |
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31.2 |
* |
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Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer. |
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32.1 |
* |
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Section 1350 Certification of the Chief Executive Officer. |
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32.2 |
* |
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Section 1350 Certification of the Chief Financial Officer. |
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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.
Dated: May 14, 2010
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SANUWAVE HEALTH, INC.
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By: |
/s/ Christopher M. Cashman
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Christopher M. Cashman |
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Chief Executive Officer and President |
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