SANUWAVE Health, Inc. - Quarter Report: 2010 June (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2010
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ________ to
Commission File Number 000-52985
SANUWAVE Health, Inc.
(Exact name of registrant as specified in its charter)
Nevada | 20-1176000 | |
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification No.) | |
11680 Great Oaks Way, Suite 350 | ||
Alpharetta, GA | 30022 | |
(Address of principal executive offices) | (Zip Code) |
(678) 581-6843
(Registrants telephone number, including area code)
(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
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):
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller reporting company þ |
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 August 13, 2010, there were issued and outstanding 12,509,657 shares of the registrants
common stock.
SANUWAVE Health, Inc.
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Exhibit 32.1 | ||||||||
Exhibit 32.2 |
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Table of Contents
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 for the year ended December 31, 2009, 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 for the year ended December 31, 2009, 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.
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PART I FINANCIAL INFORMATION
Item 1. | CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) |
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
(Unaudited) | (Audited) | |||||||
ASSETS |
||||||||
CURRENT ASSETS |
||||||||
Cash and cash equivalents |
$ | 277,258 | $ | 1,786,369 | ||||
Accounts receivable trade, net of allowance for doubtful accounts
of $29,769 in 2010 and $20,762 in 2009 |
69,683 | 47,966 | ||||||
Inventory (Note 8) |
547,544 | 592,589 | ||||||
Prepaid expenses |
132,842 | 121,157 | ||||||
Due from Pulse Veterinary Technologies, LLC |
151,102 | 127,878 | ||||||
TOTAL CURRENT ASSETS |
1,178,429 | 2,675,959 | ||||||
PROPERTY AND EQUIPMENT, at cost, less accumulated depreciation
(Note 9) |
37,342 | 88,706 | ||||||
OTHER ASSETS |
31,820 | 32,169 | ||||||
INTANGIBLE ASSETS, at cost, less accumulated amortization (Note 10) |
1,993,916 | 2,147,295 | ||||||
ASSETS HELD FOR SALE (Note 7) |
591,435 | 922,956 | ||||||
TOTAL ASSETS |
$ | 3,832,942 | $ | 5,867,085 | ||||
LIABILITIES |
||||||||
CURRENT LIABILITIES |
||||||||
Accounts payable |
$ | 1,816,924 | $ | 1,069,423 | ||||
Payroll and related |
809,171 | 509,905 | ||||||
Accrued expenses (Note 11) |
376,360 | 629,029 | ||||||
Promissory notes (Note 13) |
1,518,428 | | ||||||
Liabilities related to discontinued operations (Note 6) |
655,061 | 655,061 | ||||||
TOTAL CURRENT LIABILITIES |
5,175,944 | 2,863,418 | ||||||
NOTES PAYABLE, RELATED PARTIES (Note 14) |
9,329,678 | 8,887,981 | ||||||
TOTAL LIABILITIES |
14,505,622 | 11,751,399 | ||||||
COMMITMENTS AND CONTINGENCIES (Note 16) |
| | ||||||
GOING CONCERN (Note 3) |
| | ||||||
STOCKHOLDERS DEFICIT |
||||||||
COMMON STOCK, par value $0.001, 50,000,000 shares
authorized, 12,509,657 issued and outstanding |
12,510 | 12,510 | ||||||
ADDITIONAL PAID-IN CAPITAL |
33,679,293 | 32,741,593 | ||||||
ACCUMULATED OTHER COMPREHENSIVE LOSS |
17,703 | 21,864 | ||||||
RETAINED DEFICIT |
(44,382,186 | ) | (38,660,281 | ) | ||||
TOTAL STOCKHOLDERS DEFICIT |
(10,672,680 | ) | (5,884,314 | ) | ||||
TOTAL LIABILITIES AND STOCKHOLDERS DEFICIT |
$ | 3,832,942 | $ | 5,867,085 | ||||
See accompanying notes to unaudited condensed consolidated
financial statements.
financial statements.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
Three Months Ended | Three Months Ended | Six Months Ended | Six Months Ended | |||||||||||||
June 30, | June 30, | June 30, | June 30, | |||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
REVENUES |
$ | 117,226 | $ | 141,965 | $ | 260,328 | $ | 404,047 | ||||||||
COST OF REVENUES |
40,936 | 38,381 | 88,580 | 98,663 | ||||||||||||
GROSS PROFIT |
76,290 | 103,584 | 171,748 | 305,384 | ||||||||||||
OPERATING EXPENSES |
||||||||||||||||
Research and development |
895,651 | 808,774 | 1,981,625 | 1,622,285 | ||||||||||||
General and administrative |
1,498,236 | 653,590 | 3,096,760 | 1,903,167 | ||||||||||||
Depreciation |
185,202 | 43,378 | 379,934 | 103,846 | ||||||||||||
Amortization |
76,690 | 76,689 | 153,379 | 153,378 | ||||||||||||
TOTAL OPERATING EXPENSES |
2,655,779 | 1,582,431 | 5,611,698 | 3,782,676 | ||||||||||||
OPERATING LOSS |
(2,579,489 | ) | (1,478,847 | ) | (5,439,950 | ) | (3,477,292 | ) | ||||||||
OTHER INCOME (EXPENSE) |
||||||||||||||||
Gain/(loss) on sale of assets |
2,065 | (13,651 | ) | 2,065 | (13,651 | ) | ||||||||||
Transitional services provided to Pulse Veterinary Technologies, LLC |
90,125 | 33,750 | 180,125 | 33,750 | ||||||||||||
Interest expense, net |
(240,243 | ) | (191,017 | ) | (457,524 | ) | (329,075 | ) | ||||||||
Gain (loss) on foreign currency exchange |
392 | (28,325 | ) | (6,621 | ) | (37,773 | ) | |||||||||
TOTAL OTHER INCOME (EXPENSE) |
(147,661 | ) | (199,243 | ) | (281,955 | ) | (346,749 | ) | ||||||||
LOSS FROM CONTINUING OPERATIONS BEFORE INCOME TAXES |
(2,727,150 | ) | (1,678,090 | ) | (5,721,905 | ) | (3,824,041 | ) | ||||||||
INCOME TAX EXPENSE |
| | | | ||||||||||||
LOSS FROM CONTINUING OPERATIONS |
(2,727,150 | ) | (1,678,090 | ) | (5,721,905 | ) | (3,824,041 | ) | ||||||||
DISCONTINUED OPERATIONS |
||||||||||||||||
Income from discontinued operations, net of tax |
| 258,821 | | 581,306 | ||||||||||||
Gain on sale of veterinary division, net of tax |
| 2,492,273 | | 2,492,273 | ||||||||||||
INCOME FROM DISCONTINUED OPERATIONS |
| 2,751,094 | | 3,073,579 | ||||||||||||
NET INCOME (LOSS) |
(2,727,150 | ) | 1,073,004 | (5,721,905 | ) | (750,462 | ) | |||||||||
OTHER COMPREHENSIVE INCOME (LOSS), net of tax |
||||||||||||||||
Foreign currency translation adjustments |
(3,593 | ) | 1,906 | (4,161 | ) | (47,226 | ) | |||||||||
TOTAL COMPREHENSIVE INCOME (LOSS) |
$ | (2,730,743 | ) | $ | 1,074,910 | $ | (5,726,066 | ) | $ | (797,688 | ) | |||||
EARNINGS (LOSS) PER SHARE: |
||||||||||||||||
Loss from continuing operations basic |
$ | (0.22 | ) | $ | (0.15 | ) | $ | (0.46 | ) | $ | (0.35 | ) | ||||
Loss from continuing operations diluted |
$ | (0.22 | ) | $ | (0.15 | ) | $ | (0.46 | ) | $ | (0.35 | ) | ||||
Income from discontinued operations basic |
$ | | $ | 0.25 | $ | | $ | 0.28 | ||||||||
Income from discontinued operations diluted |
$ | | $ | 0.25 | $ | | $ | 0.28 | ||||||||
Net earnings (loss) basic |
$ | (0.22 | ) | $ | 0.10 | $ | (0.46 | ) | $ | (0.07 | ) | |||||
Net earnings (loss) diluted |
$ | (0.22 | ) | $ | 0.10 | $ | (0.46 | ) | $ | (0.07 | ) | |||||
Weighted average shares outstanding basic |
12,509,657 | 11,009,657 | 12,509,657 | 11,009,657 | ||||||||||||
Weighted average shares outstanding diluted |
12,509,657 | 11,009,657 | 12,509,657 | 11,009,657 | ||||||||||||
See accompanying notes to unaudited condensed consolidated
financial statements.
financial statements.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Six Months Ended | Six Months Ended | |||||||
June 30, | June 30, | |||||||
2010 | 2009 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES |
||||||||
Net loss from continuing operations |
$ | (5,721,905 | ) | $ | (3,824,041 | ) | ||
Adjustments to reconcile net loss to net cash
used by operating activities |
||||||||
Amortization |
153,379 | 153,378 | ||||||
Accrued interest |
460,125 | 330,642 | ||||||
Depreciation |
379,934 | 103,846 | ||||||
Change in allowance for doubtful accounts |
9,007 | (33,400 | ) | |||||
(Gain) loss on sale of property and equipment |
(2,065 | ) | 13,651 | |||||
Stock-based compensation |
937,700 | 267,392 | ||||||
Changes in assets (increase)/decrease |
||||||||
Accounts receivable trade |
(30,724 | ) | (3,509 | ) | ||||
Inventory |
45,045 | 104,943 | ||||||
Prepaid expenses |
(11,685 | ) | (18,959 | ) | ||||
Due from Pulse Veterinary Technologies, LLC |
(23,224 | ) | (157,009 | ) | ||||
Other assets |
349 | (430 | ) | |||||
Assets held for sale |
2,516 | | ||||||
Changes in liabilities increase/(decrease) |
||||||||
Accounts payable |
747,501 | (698,787 | ) | |||||
Payroll and related |
299,266 | (160,100 | ) | |||||
Accrued expenses |
(252,669 | ) | (98,255 | ) | ||||
NET CASH USED BY CONTINUING OPERATIONS |
(3,007,450 | ) | (4,020,638 | ) | ||||
NET CASH PROVIDED BY DISCONTINUED OPERATIONS |
| 1,018,505 | ||||||
NET CASH USED BY OPERATING ACTIVITIES |
(3,007,450 | ) | (3,002,133 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES |
||||||||
Continuing operations |
||||||||
Proceeds from sale of property and equipment |
2,500 | | ||||||
Purchase of property and equipment |
| (21,147 | ) | |||||
NET CASH PROVIDED (USED) BY CONTINUING
OPERATIONS |
2,500 | (21,147 | ) | |||||
NET CASH PROVIDED BY DISCONTINUED OPERATIONS |
| 3,540,948 | ||||||
NET CASH PROVIDED BY INVESTING ACTIVITIES |
2,500 | 3,519,801 | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES |
||||||||
Continuing operations |
||||||||
Proceeds from promissory notes |
1,500,000 | | ||||||
Proceeds from notes payable, related parties |
| 2,125,000 | ||||||
NET CASH PROVIDED BY FINANCING ACTIVITIES |
1,500,000 | 2,125,000 | ||||||
FOREIGN CURRENCY TRANSLATION ADJUSTMENTS |
(4,161 | ) | (47,226 | ) | ||||
NET INCREASE (DECREASE) IN CASH |
(1,509,111 | ) | 2,595,442 | |||||
CASH, BEGINNING OF PERIOD |
1,786,369 | 543,626 | ||||||
CASH, END OF PERIOD |
$ | 277,258 | $ | 3,139,068 | ||||
See accompanying notes to unaudited condensed consolidated
financial statements.
financial statements.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 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 June 30, 2010 and for the three and six months ended June 30, 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 and six month period ended June 30, 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 for the year ended December 31, 2009, 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 $5,721,905 and $750,462 for the six months ended June 30, 2010 and 2009,
respectively. The Company incurred a net loss from continuing operations of $5,721,905 and
$3,824,041 for the six months ended June 30, 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, convertible promissory notes 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. During the six months ended June 30, 2010, the Company issued seven
promissory notes totaling $1,500,000. In addition, subsequent to quarter end, on July 13, 2010,
the Company issued a convertible promissory note for $500,000.
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Table of Contents
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 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.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 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 Ossatron devices and related parts inventory were subsequently
reclassified, on October 1, 2009, to assets held for sale (see Note 7 Assets held for sale).
The operating results of the discontinued operations are summarized as follows:
Three Months Ended | Three Months Ended | Six Months Ended | Six Months Ended | |||||||||||||
June 30, | June 30, | June 30, | June 30, | |||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Revenue |
$ | | $ | 675,292 | $ | | $ | 1,458,107 | ||||||||
Cost of revenues |
| 198,562 | | 372,547 | ||||||||||||
Gross profit |
| 476,730 | | 1,085,560 | ||||||||||||
Operating expenses |
| 223,480 | | 506,790 | ||||||||||||
Operating income |
| 253,250 | | 578,770 | ||||||||||||
Other income |
| 5,571 | | 2,536 | ||||||||||||
Income from discontinued operations
before income taxes |
| 258,821 | | 581,306 | ||||||||||||
Income tax expense |
| | | | ||||||||||||
Income from discontinued operations,
net of income tax |
$ | | $ | 258,821 | $ | | $ | 581,306 | ||||||||
The Companys assets (liabilities) related to discontinued operations were as follows:
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
Accounts payable and accrued expenses |
$ | (655,061 | ) | $ | (655,061 | ) | ||
Net assets (liabilities) of discontinued operations |
$ | (655,061 | ) | $ | (655,061 | ) | ||
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Table of Contents
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 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 should be 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:
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
Ossatron devices |
$ | 4,837,165 | $ | 4,837,165 | ||||
Accumulated depreciation |
(4,411,479 | ) | (4,082,474 | ) | ||||
Net property and equipment |
425,686 | 754,691 | ||||||
Inventory Ossatron device parts |
220,949 | 210,169 | ||||||
Provision for losses and obsolescence |
(55,200 | ) | (41,904 | ) | ||||
Net inventory |
165,749 | 168,265 | ||||||
Total assets held for sale |
$ | 591,435 | $ | 922,956 | ||||
The aggregate depreciation charged to operations was $160,781 for the three months ended
June 30, 2010, and $329,005 for the six months ended June 30, 2010. There was no depreciation
expense charged to operations for the three and six months ended June 30, 2009.
8. Inventory
Inventory consists of the following:
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
Inventory finished goods |
$ | 648,687 | $ | 667,998 | ||||
Inventory parts |
81,522 | 108,068 | ||||||
730,209 | 776,066 | |||||||
Provision for losses and obsolescence |
(182,665 | ) | (183,477 | ) | ||||
Net inventory |
$ | 547,544 | $ | 592,589 | ||||
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
9. Property and equipment
Property and equipment consists of the following:
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
Machines and equipment |
$ | 199,520 | $ | 199,520 | ||||
Office and computer equipment |
296,120 | 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 |
4,585 | 4,585 | ||||||
Total |
671,389 | 687,060 | ||||||
Accumulated depreciation |
(634,047 | ) | (598,354 | ) | ||||
Net property and equipment |
$ | 37,342 | $ | 88,706 | ||||
The aggregate depreciation charged to operations was $24,421 and $43,378 for the three
months ended June 30, 2010 and 2009, respectively, and $50,929 and $103,846 for the six months
ended June 30, 2010 and 2009, respectively.
10. Intangible assets
Intangible assets consist of the following:
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
Patents, at cost |
$ | 3,502,135 | $ | 3,502,135 | ||||
Less accumulated amortization |
(1,508,219 | ) | (1,354,840 | ) | ||||
Net intangible assets |
$ | 1,993,916 | $ | 2,147,295 | ||||
The aggregate amortization charged to operations was $76,690 and $76,689 for the three
months ended June 30, 2010 and 2009, respectively, and $153,379 and $153,378 for the six months
ended June 30, 2010 and 2009, respectively.
11. Accrued expenses
Accrued expenses consist of the following:
June 30, | December 31, | |||||||
2010 | 2009 | |||||||
Accrued legal professional fees |
$ | 73,628 | $ | 249,418 | ||||
Accrued clinical site payments |
115,000 | 192,023 | ||||||
Accrued audit and tax preparation |
75,232 | 77,771 | ||||||
Accrued other |
112,500 | 109,817 | ||||||
$ | 376,360 | $ | 629,029 | |||||
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 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.
At June 30, 2010, the Company had federal net operating loss (NOL) carryforwards of
$32,753,067 that will begin to expire in 2025. The use of deferred tax assets, including federal
net operating losses, is limited to future taxable earnings. Based on the required analysis of
future taxable income under the provisions on ASC 740, Income Taxes (formerly SFAS No. 109), the
Companys management believes that there is not sufficient evidence at June 30, 2010, indicating
that the results of operations will generate sufficient taxable income to realize the net deferred
tax asset in years beyond 2010. As a result, a valuation allowance was provided for the entire net
deferred tax asset related to future years, including loss carryforwards.
The Companys ability to use it NOL carryforwards could be limited and subject to annual
limitations. In connection with future offerings, the Company may realize a more than 50% change
in ownership which would further limit its ability to use its NOL carryforwards accumulated to
date to reduce future taxable income and tax liabilities. Additionally, because U.S. tax laws
limit the time during which NOL carryforwards may be applied against future taxable income and tax
liabilities, the Company may not be able to take advantage of all or portions of its NOL
carryfowards for federal income tax purposes.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
13. Promissory notes
The promissory notes consist of the following:
June 30, | ||||
2010 | ||||
Promissory note, 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 was due on June 1, 2010. The principal was not repaid at
the due date and therefore, in accordance with the terms of the promissory note, the
interest rate increased to 10% effective June 1, 2010. Accrued interest totaled $4,198
at June 30, 2010. |
$ | 204,198 | ||
Promissory note, 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 was due on June 4, 2010. The principal was
not repaid at the due date and therefore, in accordance with the terms of the
promissory note, the interest rate increased to 10% effective June 4, 2010. Accrued
interest totaled $3,973 at June 30, 2010. |
203,973 | |||
Promissory note, 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 was due on June 30, 2010. The principal was not repaid at
the due date and therefore, in accordance with the terms of the promissory note, the
interest rate increased to 10% effective June 30, 2010. Accrued interest totaled $3,766
at June 30, 2010. |
303,766 | |||
Promissory note, 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 was due on June 30, 2010. The principal
was not repaid at the due date and therefore, in accordance with the terms of the
promissory note, the interest rate increased to 10% effective June 30, 2010. Accrued
interest totaled $3,766 at June 30, 2010. |
303,766 | |||
Sub-total promissory notes |
1,015,703 |
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
13. Promissory notes (continued)
June 30, | ||||
2010 | ||||
Convertible promissory note, unsecured, bearing interest at 5% issued to Kevin
and Margaret Richardson on May 12, 2010. Interest is accrued and added to the
principal balance. All accrued interest and principal is due August 12, 2010. If
the
convertible promissory note is not paid or converted prior to the maturity date, the
Company shall issue to the holder a warrant to purchase shares of the Companys
common stock, par value $0.001 per share, at a purchase price of $4.00 per share.
The
number of shares issuable upon the exercise of the warrant shall be determined by
dividing the sum of the principal and interest payable under the convertible
promissory note by 20. Accrued interest totaled $2,003 at June 30, 2010. |
302,003 | |||
Convertible promissory note, unsecured, bearing interest at 5% issued to Durk
V. Irwin on June 4, 2010. Interest is accrued and added to the principal balance.
All
accrued interest and principal is due September 4, 2010. If the convertible
promissory
note is not paid or converted prior to the maturity date, the Company shall issue to
the holder a warrant to purchase shares of the Companys common stock, par value
$0.001 per share, at a purchase price of $4.00 per share. The number of shares
issuable
upon the exercise of the warrant shall be determined by dividing the sum of the
principal and interest payable under the convertible promissory note by 20. Accrued
interest totaled $361 at June 30, 2010. |
100,361 | |||
Convertible promissory note, unsecured, bearing interest at 5% issued to Todd
R. Pedersen on June 4, 2010. Interest is accrued and added to the principal
balance.
All accrued interest and principal is due September 4, 2010. If the convertible
promissory note is not paid or converted prior to the maturity date, the Company
shall
issue to the holder a warrant to purchase shares of the Companys common stock, par
value $0.001 per share, at a purchase price of $4.00 per share. The number of
shares
issuable upon the exercise of the warrant shall be determined by dividing the sum of
the principal and interest payable under the convertible promissory note by 20.
Accrued interest totaled $361 at June 30, 2010. |
100,361 | |||
Sub-total convertible promissory notes |
502,725 | |||
Total promissory notes |
$ | 1,518,428 | ||
Upon the consummation of a qualified financing on or prior to the prepayment of the
convertible promissory notes or the maturity date, the Company shall cause the conversion of the
unpaid principal and interest on the convertible promissory notes into (A) shares of common stock
(the number of shares to be determined by dividing the unpaid principal and interest on the
convertible promissory note by the conversion price), (B) a warrant to purchase the same number of
shares of common stock that the holder would have received if the holder had invested an amount
equal to the unpaid principal and interest on the convertible promissory notes in the qualified
financing, and (C) any other securities to be issued pursuant to the qualified financing in the
same amounts and under the same terms that the holder would have received if the holder had
invested an amount equal to the unpaid principal and interest on the convertible promissory notes
in the qualified financing. Pursuant to the terms of the convertible promissory notes, a qualified
financing means the consummation, on or prior to the prepayment of the convertible promissory notes
or the maturity date, of a private placement of not less than $3,000,000, in the aggregate, of
common stock. The conversion price of any securities issued to the holder shall be equal to the
per share purchase price of the common stock issued in the qualified financing.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
13. Promissory notes (continued)
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. David N. Nemelka, Durk V. Irwin, and
Todd R. Pedersen are shareholders of the Company.
Interest expense on promissory notes totaled $16,872 for the three months ended June 30, 2010
and $18,428 for the six months ended June 30, 2010.
There were no promissory notes outstanding during fiscal year 2009.
14. Notes payable, related parties
The notes payable, related parties consist of the following:
June 30, | 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 $1,372,743 and $1,215,253 at
June 30, 2010 and December 31, 2009, respectively. |
$ | 5,372,743 | $ | 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 June 30, 2010 is accrued and added to
the principal balance. Interest is paid quarterly in arrears
if elected by the holder. As of June 30, 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 $756,935 and $472,728
at June 30, 2010 and December 31, 2009, respectively. At
the option of the holder, all of any portion of the unpaid
principal can be converted into common stock with a
conversion price of $2.92 per share. |
3,956,935 | 3,672,728 | ||||||
Total |
9,329,678 | 8,887,981 | ||||||
Less current portion |
| | ||||||
Non-current portion |
$ | 9,329,678 | $ | 8,887,981 | ||||
Interest expense on notes payable, related parties totaled $224,517 and $192,288 for the
three months ended June 30, 2010 and 2009, respectively, and $441,697 and $330,642 for the six
months ended June 30, 2010 and 2009, respectively.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 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 from continuing operations for the six months ended June 30, 2010
and 2009, 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
1,767,259 shares and 948,913 shares for the three months ended June 30, 2010 and 2009,
respectively, and 1,728,021 shares and 854,383 shares for the six months ended June 30, 2010 and
2009, respectively.
16. Commitments and Contingencies
The Company leases office and warehouse space. Rent expense was $83,193 and $128,792 for the
three months ended June 30, 2010 and 2009, respectively, and $170,282 and $248,038 for the six
months ended June 30, 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. 401(k) plan
The Company sponsors a 401(k) 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 $18,089 and $17,108 to the plan for the three months ended June 30, 2010
and 2009, respectively, and $34,784 and $34,360 to the plan for the six months ended June 30, 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 June 30, 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
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. The Company adopted and assumed
the Plan pursuant to the Merger.
On January 29, 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
resulting in total compensation cost of $455,625. Compensation cost will be recognized over the
applicable service period.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
18. Stock-based compensation (continued)
The Company recognized as compensation cost for all outstanding stock options, restricted
stock and warrants granted to employees and directors, $454,430 and $133,696 for the three months
ended June 30, 2010 and 2009, respectively, and $937,700 and $267,392 for the six months ended June
30, 2010 and 2009, respectively.
The assumptions used are as follows:
Six Months Ended | ||||
June 30, | ||||
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 June 30, 2010 and December 31, 2009, and the changes during
the three and six months ended June 30, 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 | |||||
Granted |
| $ | | |||||
Exercised |
| $ | | |||||
Forfeited or expired |
(3,750 | ) | $ | 3.30 | ||||
Outstanding as of June 30, 2010 |
2,085,796 | $ | 3.72 | |||||
Exercisable |
1,857,986 | $ | 3.68 | |||||
The weighted average remaining contractual term for outstanding and exercisable stock options
is 5.8 years as of June 30, 2010 and 6.3 years as of December 31, 2009.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
18. Stock-based compensation (continued)
A summary of the Companys nonvested options as of June 30, 2010 and December 31, 2009, and
changes during the three and six months ended June 30, 2010, is presented as follows:
Weighted | ||||||||
Average | ||||||||
Grant-Date | ||||||||
Options | Fair Value | |||||||
Nonvested 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 | ) | ||||
Nonvested as of March 31, 2010 |
362,560 | 1,384,854 | ||||||
Granted |
| | ||||||
Vested |
(131,000 | ) | (453,422 | ) | ||||
Forfeited or expired |
(3,750 | ) | (12,363 | ) | ||||
Nonvested as of June 30, 2010 |
227,810 | $ | 919,069 | |||||
A summary of the Companys restricted stock as of June 30, 2010 and December 31, 2009, and
changes during the six months ended June 30, 2010, is presented as follows:
Restricted | ||||
Stock | ||||
Outstanding as of December 31, 2009 |
403,030 | |||
Granted |
| |||
Vested |
| |||
Forfeited or expired |
| |||
Outstanding as of June 30, 2010 |
403,030 | |||
19. Warrants
As of June 30, 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.
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
June 30, 2010
19. Warrants (continued)
On July 17, 2010, by mutual agreement with the warrant holder, the Company cancelled 900,000
Class C Warrants.
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 nonunion 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
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 to complete the patient follow-up phase of this trial in early September 2010,
to report top-line results in the fourth quarter of 2010, to file our Premarket Approval
Application
(PMA) with the FDA no later than the first quarter of 2011, and, pending a favorable response
from the FDA, to launch dermaPACE in the United States in 2011.
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Table of Contents
We launched in Europe the orthoPACE device intended for use in orthopedic, trauma and sports
medicine indications following CE Mark approval in June 2010. The device features a new, unique
applicator that is less painful for some indications and may reduce or completely eliminate
anesthesia for some patients. In the orthopedic setting, the orthoPACE will initially be used to
treat tendinopathies and acute and nonunion fractures, including the soft tissue surrounding the
fracture to accelerate healing and prevent secondary complications and their associated treatment
costs. The orthoPACE can also be used as an adjunctive treatment to fixation, fusion costs. The
first shipments of the new orthoPACE device were made in July 2010, and the corresponding revenue
and cost of goods sold will be recorded in the third quarter of 2010.
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.
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 June 30, 2010, the balance of cash and
cash equivalents totaled $0.3 million. Subsequent to quarter end, we issued a $0.5 million
convertible promissory note on July 13, 2010.
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 June 30, 2010,
we had an accumulated deficit of $44.4 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; |
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| 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 recession. |
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 for the year ended December 31, 2009, 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.
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 for the year ended
December 31, 2009, 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, they are 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. Shipments under agreements with distributors are invoiced at a fixed
price, are not subject to return, and payment for these shipments is not contingent on sales by the
distributor. The Company recognizes revenue on shipments to distributors in the same manner as
with other customers. Fees from services performed are recognized when the 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.
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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), which was assumed by the Company following the Merger. The Plan
provides that stock options, other equity interests or equity-based incentives may be granted to
key personnel at an exercise price determined by the Companys 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.
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 June 30, 2010 and 2009 (Unaudited)
Revenues and Cost of Revenues
Revenues for the three months ended June 30, 2010 were $117,226, compared to $141,965 for the
same period in 2009, a decrease of $24,739, or 17%. 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 June 30,
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 June 30, 2010 was $40,936, compared to $38,381 for
the same period in 2009. Gross profit as a percentage of revenues was 65% for the three months
ended June 30, 2010, as compared to 73% for the same period in 2009. The decrease in gross profit
in 2010 was primarily due to higher freight costs in 2010 associated with the Company assembling
its products in the United States for sale in Europe instead of assembling in Europe as it did in
2009.
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Research and Development Expenses
Research and development expenses for the three months ended June 30, 2010 were $895,651,
compared to $808,774 for the same period in 2009, an increase of $86,877, or 11%. 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 ended during the first quarter of 2010 and new consultants were engaged to assist in the
patient follow-up phase of the clinical trial.
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 June 30, 2010 were $1,498,236,
compared to $653,590 for the same period in 2009, an increase of $844,646, or 129%. General and
administrative expenses include the non-cash compensation costs for stock compensation of $454,430
for the three months ended June 30, 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 in September
2009 and January 2010.
Excluding the non-cash compensation costs for stock compensation, general and administrative
expenses were $1,043,806 for the three months ended June 30, 2010, as compared to $519,894 for the
same period in 2009, an increase of $523,912 or 101%. The Company recorded bonus expense for
fiscal year 2010 of $147,288 for the three months ended June 30, 2010, as compared to a bonus
expense credit of $303,285 for the three months ended June 30, 2009, which resulted in an increase
in bonus expense of $450,573 for the three months ended June 30, 2010, as compared to the same
period in 2009. The bonus expense credit for the three months ended June 30, 2009, was due to the
reversal of the 2008 bonus accrual determined, at that time, not to be payable due to the capital
constraints of the Company.
We expect that general and administrative expenses will continue to 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 June 30, 2010 was $261,892, compared
to $120,067 for the same period in 2009, an increase of $141,825, or 118%.
On October 31, 2008, the Company discontinued its Ossatron mobile service business and
accordingly displayed the related assets of this business as discontinued operations. As of
October 1, 2009, management determined that the Ossatron device fixed assets and related parts
inventory should be reclassified 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 $160,781 for the three months ended June 30, 2010. There was no depreciation expense recorded
for these assets for the three months ended June 30, 2009.
Other Income
On June 3, 2009, we sold our veterinary division to Pulse Vet. Under terms of the asset
purchase agreement, we will continue to provide production services at the direction of 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 $90,125 and $33,750 for the three months
ended June 30, 2010 and 2009, respectively.
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Interest expense, net, for the three months ended June 30, 2010 was $240,243, compared to
$191,017 for the same period in 2009, an increase of $49,226, or 26%. 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, and
interest at 5% to 10% per annum on promissory notes totaling $1,500,000 issued during the six
months ended June 30, 2010.
Provision for Income Taxes
At June 30, 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.
Income from Discontinued Operations
On June 3, 2009, we sold our veterinary division for $3,500,000 in cash to Pulse Vet and
recognized a gain, net of taxes, of $2,492,273. The income from discontinued operations was
$258,821 for the three months ended June 30, 2009.
Net Income (Loss)
Net loss for the three months ended June 30, 2010 was $2,727,150, or $(0.22) per basic and
diluted share, compared to net income of $1,073,004, or $0.10 per basic and diluted share, for the
three months ended June 30, 2009. The net income for the three months ended June 30, 2009,
included a gain, net of taxes, of $2,492,273 attributable to the sale of our veterinary division.
The loss from continuing operations was $2,727,150, or $(0.22) per basic and diluted share, for the
three months ended June 30, 2010, compared to a loss of $1,678,090, or $(0.15) per basic and
diluted share, for the three months ended June 30, 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.
Results of Operations for the Six Months ended June 30, 2010 and 2009 (Unaudited)
Revenues and Cost of Revenues
Revenues for the six months ended June 30, 2010 were $260,328, compared to $404,047 for the
same period in 2009, a decrease of $143,719, or 36%. 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 six months ended June 30,
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 six months ended June 30, 2010 was $88,580, compared to $98,663 for
the same period in 2009. Gross profit as a percentage of revenues was 66% for the six months ended
June 30, 2010, as compared to 76% 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 in the United States for sale in Europe instead of assembling in Europe as it did in 2009.
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2010 were $1,981,625,
compared to $1,622,285 for the same period in 2009, an increase of $359,340, or 22%. 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 ended during the first quarter of 2010 and new consultants were engaged to assist in the
patient follow-up phase of the clinical trial.
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General and Administrative Expenses
General and administrative expenses for the six months ended June 30, 2010 were $3,096,760,
compared to $1,903,167 for the same period in 2009, an increase of $1,193,593, or 63%. General
and administrative expenses include the non-cash compensation costs for stock compensation of
$937,700 for the six months ended June 30, 2010, compared to $267,392 for the same period in 2009,
due to new grants of options and restricted stock to management and directors of the Company in
September 2009 and January 2010.
Excluding the non-cash compensation costs for stock compensation, general and administrative
expenses were $2,159,060, for the six months ended June 30, 2010, as compared to $1,635,775 for the
same period in 2009, an increase of $523,285 or 32%. The Company recorded bonus expense for fiscal
year 2010 of $297,288 for the six months ended June 30, 2010, as compared to a bonus expense credit
of $150,000 for the six months ended June 30, 2009, which resulted in an increase in bonus expense
of $447,288 for the six months ended June 30, 2010, as compared to the same period in 2009. The
bonus expense credit for the six months ended June 30, 2009, was due to the reversal of the 2008
bonus accrual determined, at that time, not to be payable due to the capital constraints of the
Company.
Depreciation and Amortization
Depreciation and amortization for the six months ended June 30, 2010 was $533,313, compared to
$257,224 for the same period in 2009, an increase of $276,089, or 107%.
On October 31, 2008, the Company discontinued its Ossatron mobile service business and
accordingly displayed the related assets of this business as discontinued operations. As of
October 1, 2009, management determined that the Ossatron device fixed assets and related parts
inventory should be reclassified 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 $329,005 for the six months ended June 30, 2010. There was no depreciation expense recorded
for these assets for the six months ended June 30, 2009.
Other Income
On June 3, 2009, we sold our veterinary division to Pulse Vet. Under terms of the asset
purchase agreement, we will continue to provide production services at the direction of 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 for the six months ended June 30, 2010 was
$180,125, compared to $33,750 for the same period in 2009, an increase of $146,375, or 434%.
Interest expense, net, for the six months ended June 30, 2010 was $457,524, compared to
$329,075 for the same period in 2009, an increase of $128,449, or 39%. 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, and interest at 5% to 10% per annum on promissory notes totaling
$1,500,000 issued during the six months ended June 30, 2010.
Provision for Income Taxes
At June 30, 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.
Income from Discontinued Operations
On June 3, 2009, we sold our veterinary division for $3,500,000 in cash to Pulse Vet and
recognized a gain, net of taxes, of $2,492,273. The income from discontinued operations was
$581,306 for the six months ended June 30, 2009.
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Net Income (Loss)
Net loss for the six months ended June 30, 2010 was $5,721,905, or $(0.46) per basic and
diluted share, compared to net loss of $750,462, or $(0.07) per basic and diluted share, for the
six months ended June 30, 2009. The net loss for the six months ended June 30, 2009, included a
gain, net of taxes, of $2,492,273 attributable to the sale of our veterinary division. The loss
from continuing operations was $5,721,905, or $(0.46) per basic and diluted share, for the six
months ended June 30, 2010, compared to a loss of $3,824,041, or $(0.35) per basic and diluted
share, for the six months ended June 30, 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.
Liquidity and Capital Resources
We incurred a net loss of $5,721,905 for the six months ended June 30, 2010, and 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, issuance of convertible promissory notes 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, at the option of the holder, 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. For the six
months ended June 30, 2010, the Company issued seven promissory notes totaling $1,500,000. In
addition, subsequent to quarter end, the Company issued a convertible promissory note for $500,000
on July 13, 2010.
At June 30, 2010, we had $277,258 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 six months ended June 30, 2010, net cash used by continuing operations for operating
activities was $3,007,450, 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 six months ended June 30, 2010 was $1,500,000, which
consisted of the proceeds from issuance of promissory notes. Cash and cash equivalents decreased
by $1,509,111 for the six months ended June 30, 2010.
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For the six months ended June 30, 2009, net cash used by continuing operations for operating
activities was $4,020,638, 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 six months ended June 30, 2009 was $2,125,000, which
consisted of the proceeds from the issuance of notes payable to related parties. Net cash provided
by discontinued operations for operating activities was $1,018,505 for the six months ended June
30, 2009. Net cash provided by discontinued operations for investing activities was $3,540,948 for
the six months ended June 30, 2009 due to
the sale of the veterinarian division. Cash and cash equivalents increased by $2,595,442 for
the six months ended June 30, 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.
Other Comprehensive Income (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 other comprehensive income (loss) as
defined by ASC 220 is the total of net income (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 expired on 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 $1,372,743 and $1,215,253 at June 30, 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 June 30, 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. At the option of the holder, 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 $756,935 and $472,728 at June 30, 2010 and December
31, 2009, respectively.
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On March 1, 2010, we issued a promissory note to David N. Nemelka in the amount of $200,000.
The promissory note bears interest at 5% annually. All accrued interest and principal was due June
1, 2010. The accrued interest and principal was not paid on the due date and therefore, in
accordance with the terms of the promissory note, the interest rate increased to 10% effective June
1, 2010. Accrued interest on the promissory note totaled $4,198 at June 30, 2010.
On March 4, 2010, we issued a promissory note to Kevin and Margaret Richardson in the amount
of $200,000. The promissory note bears interest at 5% annually. All accrued interest and
principal was due June 4, 2010. The accrued interest and principal was not paid on the due date
and therefore, in accordance with the terms of the promissory note, the interest rate increased to
10% effective June 4, 2010. Accrued interest on the promissory note totaled $3,973 at June 30,
2010.
On March 31, 2010, we issued a promissory note to David N. Nemelka in the amount of $300,000.
The promissory note bears interest at 5% annually. All accrued interest and principal was due June
30, 2010. The accrued interest and principal was not paid on the due date and therefore, in
accordance with the terms of the promissory note, the interest rate increased to 10% effective June
30, 2010. Accrued interest on the promissory note totaled $3,766 at June 30, 2010.
On March 31, 2010, we issued a promissory note to Kevin and Margaret Richardson in the amount
of $300,000. The promissory note bears interest at 5% annually. All accrued interest and
principal was due June 30, 2010. The accrued interest and principal was not paid on the due date
and therefore, in accordance with the terms of the promissory note, the interest rate increased to
10% effective June 30, 2010. Accrued interest on the promissory notes totaled $3,766 at June 30,
2010.
On May 12, 2010, we issued a convertible promissory note to Kevin and Margaret Richardson in
the amount of $300,000. The promissory note bears interest at 5% annually. All accrued interest
and principal is due August 12, 2010. If the convertible promissory note is not paid or converted
prior to the maturity date, the Company shall issue to the holder a warrant to purchase shares of
the Companys common stock, par value $0.001 per share, at a purchase price of $4.00 per share.
The number of shares issuable upon the exercise of the warrant shall be determined by dividing the
sum of the principal and interest payable under the convertible promissory note by 20. Accrued
interest on the convertible promissory note totaled $2,003 at June 30, 2010.
On June 4, 2010, we issued a convertible promissory note to Durk V. Irwin in the amount of
$100,000. The promissory note bears interest at 5% annually. All accrued interest and principal
is due September 4, 2010. If the convertible promissory note is not paid or converted prior to the
maturity date, the Company shall issue to the holder a warrant to purchase shares of the Companys
common stock, par value $0.001 per share, at a purchase price of $4.00 per share. The number of
shares issuable upon the exercise of the warrant shall be determined by dividing the sum of the
principal and interest payable under the convertible promissory note by 20. Accrued interest on
the convertible promissory note totaled $361 at June 30, 2010.
On June 4, 2010, we issued a convertible promissory note to Todd R. Pedersen in the amount of
$100,000. The promissory note bears interest at 5% annually. All accrued interest and principal
is due September 4, 2010. If the convertible promissory note is not paid or converted prior to the
maturity date, the Company shall issue to the holder a warrant to purchase shares of the Companys
common stock, par value $0.001 per share, at a purchase price of $4.00 per share. The number of
shares issuable upon the exercise of the warrant shall be determined by dividing the sum of the
principal and interest payable under the convertible promissory note by 20. Accrued interest on
the convertible promissory note totaled $361 at June 30, 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.
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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.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
Item 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures, as defined in Rule 13a-15(e) and 15d-15(e)
promulgated under the Securities Exchange Act of 1934, as amended (the Exchange Act), that are
designed to provide reasonable assurance that information required to be disclosed by us in the
reports that we file or submit under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and forms. Disclosure controls and
procedures include, without limitation, controls and procedures designed to ensure that information
required to be disclosed by the Company in the reports that it files or submits under the Exchange
Act is accumulated and communicated to the Companys management, including its principal executive
and principal financial officers, or persons performing similar functions, as appropriate to allow
timely decisions regarding required disclosure. We carried out an evaluation under the supervision
and with the participation of our management, including our Chief Executive Officer and Chief
Financial Officer, of the effectiveness of the design and operation of our disclosure controls and
procedures as of June 30, 2010. Based on this evaluation, the Chief Executive Officer and Chief
Financial Officer concluded that our disclosure controls and procedures were effective as of June
30, 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.
PART II OTHER INFORMATION
Item 1. 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 for the year ended December
31, 2009, 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 6. EXHIBITS
Exhibit No. | Description | |
2.1
|
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). | |
3.1
|
Articles of Incorporation (Incorporated by reference to the Form 10-SB filed with the SEC on December 18, 2007). | |
3.2
|
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). | |
3.3
|
Bylaws (Incorporated by reference to the Form 10-SB filed with the SEC on December 18, 2007). | |
4.1
|
Convertible Promissory Note, dated May 12, 2010, issued by SANUWAVE Health, Inc. to Kevin and Margaret Richardson. (Incorporated by reference to the Form 8-K filed with the SEC on May 17, 2010). | |
4.2
|
Convertible Promissory Note, dated June 4, 2010, issued by SANUWAVE Health, Inc. to Durk V. Irwin. (Incorporated by reference to the Form 8-K filed with the SEC on June 9, 2010). | |
4.3
|
Convertible Promissory Note, dated June 4, 2010, issued by SANUWAVE Health, Inc. to Todd R. Pedersen. (Incorporated by reference to the Form 8-K filed with the SEC on June 9, 2010). | |
4.4
|
Convertible Promissory Note, dated July 13, 2010, issued by SANUWAVE Health, Inc. to Kevin and Margaret Richardson. (Incorporated by reference to the Form 8-K filed with the SEC on July 16, 2010). | |
31.1*
|
Rule 13a-14(a)/15d-14(a) Certification of the Chief Executive Officer. | |
31.2*
|
Rule 13a-14(a)/15d-14(a) Certification of the Chief Financial Officer. | |
32.1*
|
Section 1350 Certification of the Chief Executive Officer. | |
32.2*
|
Section 1350 Certification of the Chief Financial Officer. |
* | Filed herewith |
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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: August 13, 2010
SANUWAVE HEALTH, INC. |
||||
By: | /s/ Christopher M. Cashman | |||
Christopher M. Cashman | ||||
Chief Executive Officer and President | ||||
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