Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
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þ |
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Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended September 30, 2009
or
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o |
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Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the transition period from to
Commission File Number: 000-23100
HEALTHSPORT, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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22-2649848 |
(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.) |
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6429 Independence Avenue |
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Woodland Hills, CA
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91367 |
(Address of principal executive offices)
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(Zip Code) |
(818) 593-4880
(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. Yes þ No o
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).
Yes o No o
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 the definitions 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). Yes o No þ
As of September 30, 2009, 55,802,753 shares of the issuers common stock, par value $0.0001 per
share, were outstanding.
HealthSport, Inc.
Quarterly Report on Form 10-Q
For the Period Ended September 30, 2009
TABLE OF CONTENTS
-i-
EXPLANATORY NOTE
In this report, unless the context indicates otherwise, the terms HealthSport, Company,
we, us, and our refer to HealthSport, Inc., a Delaware corporation, and its wholly-owned
subsidiaries: Enlyten, Inc. (Enlyten); InnoZen, Inc. (InnoZen) and InnoZens majority owned
subsidiary Pacific Manufacturing Group LLC (PMG) until its sale on December 30, 2008; Health
Strip Solutions, LLC (Health Strip); and HealthSport Nutraceutical Products, Inc.
(Nutraceutical).
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS
Certain statements in this report, including information incorporated by reference, are
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform
Act of 1995.
Forward-looking statements reflect our current views about future events and financial
performance based on certain assumptions. They include opinions, forecasts, intentions, plans,
goals, projections, guidance, expectations, beliefs or other statements that are not statements of
historical fact. Words such as may, will, should, could, would, expects, plans,
believes, anticipates, intends, estimates, approximates, predicts, or projects, and
similar expressions may identify a statement as a forward-looking statement. Any statements that
refer to projections of our future financial performance, anticipated trends in our business, our
goals, strategies, focus and plans, and other characterizations of future events or circumstances,
including statements expressing general optimism about future operating results and the development
of our products, are forward-looking statements. Forward-looking statements in this report may
include statements about our ability to:
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maintain operating costs and implement our current business plan; |
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obtain future financing or funds when needed; |
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effectively launch new products |
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develop and obtain a diverse and loyal customer base; |
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protect our intellectual property rights and avoid infringing on the rights of others; |
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attract and retain a qualified employee base; |
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respond to new technology developments before our competitors; |
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successfully complete acquisitions, strategic partnerships, and other significant
transactions; and |
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develop and execute a successful business strategy. |
The forward-looking statements in this report speak only as of the date of this report and
caution should be taken not to place undue reliance on any such forward-looking statements.
Forward-looking statements are subject to certain events, risks, and uncertainties that may be
outside of our control. When considering forward-looking statements, you should carefully review
the risks, uncertainties and other cautionary statements in this report as they identify certain
important factors that could cause actual results to differ materially from those expressed in or
implied by the forward-looking statements. These factors include, among others, the risks described
under Item 1A and elsewhere in this report and in our 2008 Annual Report, as well as in other
reports and documents we file with the SEC.
1
PART IFINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
HEALTHSPORT, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
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September 30, 2009 |
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December 31, 2008 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
25,443 |
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$ |
433,573 |
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Accounts receivable (less allowance of $2,000 in 2009 and
2008) |
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97,257 |
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486,967 |
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Inventory |
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256,043 |
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585,746 |
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Prepaid expenses and other assets |
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237,863 |
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293,318 |
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Total current assets |
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616,606 |
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1,799,604 |
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Property and equipment, net |
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719,951 |
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756,086 |
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Non-current accounts receivable |
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200,294 |
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225,000 |
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Goodwill |
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6,276,948 |
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10,276,948 |
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Patent costs and other intangible assets, net |
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17,824,169 |
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18,621,760 |
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Other assets |
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80,010 |
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137,170 |
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Total assets |
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$ |
25,717,978 |
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$ |
31,816,568 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
1,494,014 |
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$ |
1,462,148 |
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Accrued expenses |
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400,664 |
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900,837 |
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Current portion of capital lease obligation |
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69,108 |
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64,465 |
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Current portion of convertible promissory notes, Note 6 |
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1,182,500 |
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1,268,000 |
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Deferred revenue |
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588,401 |
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832,256 |
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Derivative Liability |
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648,987 |
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Total current liabilities |
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4,383,674 |
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4,527,706 |
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Convertible promissory notes, Note 6 |
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356,596 |
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277,450 |
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Capital lease obligation |
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221,840 |
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274,727 |
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Total liabilities |
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4,962,110 |
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5,079,883 |
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Commitments and contingencies, Note 7 |
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Stockholders equity: |
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Preferred stock: $2.75 par value; authorized 2,000,000
shares; no shares issued and outstanding |
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Common stock: $.0001 par value; authorized 500,000,000
shares; 55,802,753 and 49,366,120 shares issued and
outstanding
at September 30, 2009 and December 31, 2008, respectively |
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5,580 |
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4,937 |
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Additional paid-in capital |
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67,851,041 |
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69,241,594 |
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Accumulated deficit |
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(47,100,753 |
) |
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(42,509,846 |
) |
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Total stockholders equity |
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20,755,868 |
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26,736,685 |
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Total liabilities and stockholders equity |
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$ |
25,717,978 |
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$ |
31,816,568 |
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See accompanying notes to condensed consolidated financial statements.
2
HEALTHSPORT, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations (Unaudited)
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For the three months ended September 30, |
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For the nine months ended September 30, |
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2009 |
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2008 |
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2009 |
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2008 |
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Revenue |
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Product sales |
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$ |
61,931 |
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$ |
580,224 |
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$ |
2,215,181 |
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$ |
812,317 |
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License fees, royalties and services |
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29,692 |
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18,750 |
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107,192 |
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56,250 |
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Total revenues |
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91,623 |
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598,974 |
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2,322,373 |
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868,567 |
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Costs and expenses |
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Cost of product sold and manufacturing costs |
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269,233 |
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463,267 |
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2,075,570 |
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1,097,667 |
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General and administrative expense |
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675,631 |
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645,317 |
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1,714,748 |
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2,181,818 |
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Marketing and selling expense |
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10,672 |
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358,530 |
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220,820 |
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1,056,087 |
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Asset impairment |
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4,000,000 |
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648,600 |
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Inventory obsolescence |
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112,000 |
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262,000 |
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274,840 |
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Non-cash compensation expense |
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171,148 |
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351,747 |
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466,726 |
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2,033,325 |
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Depreciation and amortization expense |
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330,944 |
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294,982 |
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|
1,000,027 |
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1,053,313 |
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Research and development costs |
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24,931 |
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30,106 |
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69,140 |
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169,217 |
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Total costs and expenses |
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1,594,559 |
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2,143,949 |
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9,809,031 |
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8,514,867 |
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Net loss from operations |
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(1,502,936 |
) |
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(1,544,975 |
) |
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(7,486,658 |
) |
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(7,646,300 |
) |
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Other income (expense): |
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Interest income |
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6 |
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|
406 |
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304 |
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1,175 |
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Settlement income |
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3,850 |
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444,181 |
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Change in
fair value of derivative liability |
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372,063 |
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2,732,608 |
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Miscellaneous income |
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10,822 |
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19,728 |
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|
5,584 |
|
Interest expense |
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(181,792 |
) |
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(16,795 |
) |
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(301,071 |
) |
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(36,960 |
) |
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Other income (expense) |
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204,949 |
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(16,389 |
) |
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2,895,750 |
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(30,201 |
) |
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Net loss before income taxes and minority interest |
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(1,297,987 |
) |
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(1,561,364 |
) |
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(4,590,908 |
) |
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(7,676,501 |
) |
Provision for income taxes |
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Net loss before minority interest |
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(1,297,987 |
) |
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(1,561,364 |
) |
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(4,590,908 |
) |
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(7,676,501 |
) |
Minority interest |
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36,416 |
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88,842 |
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Net loss |
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$ |
(1,297,987 |
) |
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$ |
(1,524,948 |
) |
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$ |
(4,590,908 |
) |
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$ |
(7,587,659 |
) |
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Net loss per share, basic and diluted |
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$ |
(0.02 |
) |
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$ |
(0.03 |
) |
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$ |
(0.09 |
) |
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$ |
(0.17 |
) |
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Weighted average shares outstanding,
basic and diluted |
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54,747,503 |
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45,318,180 |
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52,274,767 |
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44,531,864 |
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See accompanying notes to condensed consolidated financial statements.
3
HEALTHSPORT, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows (Unaudited)
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For the nine months ended |
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September 30, 2009 |
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September 30, 2008 |
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Cash flows from operating activities |
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Net loss |
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$ |
(4,590,908 |
) |
|
$ |
(7,587,659 |
) |
Adjustment to reconcile net loss to net cash used in
operating activities: |
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Minority interest |
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(88,842 |
) |
Amortization of non-cash stock compensation |
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|
466,726 |
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|
1,811,575 |
|
Amortization of loan discount |
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|
129,254 |
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Depreciation and amortization |
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|
1,000,027 |
|
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|
1,053,313 |
|
Common stock issued for services |
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|
314,000 |
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|
221,750 |
|
Inventory obsolescence reserve |
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|
262,000 |
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|
274,840 |
|
Asset impairment |
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|
4,000,000 |
|
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|
648,600 |
|
Gain on debt settlement |
|
|
(444,181 |
) |
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|
Change in fair value of derivative liability |
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(2,732,608 |
) |
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Change in other assets and liabilities: |
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Accounts receivable |
|
|
389,710 |
|
|
|
136,471 |
|
Inventory |
|
|
67,703 |
|
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|
333,153 |
|
Prepaid expenses and other assets |
|
|
129,342 |
|
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|
242,337 |
|
Accounts payable |
|
|
138,478 |
|
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|
804,179 |
|
Accrued expenses |
|
|
26,560 |
|
|
|
526,857 |
|
Deferred revenue |
|
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(243,855 |
) |
|
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Net cash used in operating activities |
|
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(1,087,752 |
) |
|
|
(1,623,426 |
) |
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Cash flows from investing activities |
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Patent costs incurred |
|
|
(53,468 |
) |
|
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|
Acquisition of property and equipment |
|
|
(108,666 |
) |
|
|
(389,022 |
) |
|
|
|
|
|
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Net cash used in investing activities |
|
|
(162,134 |
) |
|
|
(389,022 |
) |
|
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Cash flows from financing activities |
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Collect stock subscription receivable |
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|
22,500 |
|
Funding from joint venture partner |
|
|
|
|
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|
990,000 |
|
Proceeds from loans |
|
|
90,000 |
|
|
|
545,000 |
|
Capital lease payments |
|
|
(48,244 |
) |
|
|
(161,504 |
) |
Sale of common stock |
|
|
800,000 |
|
|
|
660,000 |
|
|
|
|
|
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|
|
Net cash provided by financing activities |
|
|
841,756 |
|
|
|
2,055,996 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
(408,130 |
) |
|
|
43,548 |
|
Cash and cash equivalents, beginning of period |
|
|
433,573 |
|
|
|
167,323 |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
25,443 |
|
|
$ |
210,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information |
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
Cash paid for interest and income taxes: |
|
|
|
|
|
|
|
|
Interest |
|
$ |
167,639 |
|
|
$ |
7,733 |
|
Income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash investing and financing activities: |
|
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|
|
|
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|
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Reclassification of derivative liability |
|
|
3,252,341 |
|
|
|
|
|
Common stock issued for notes payable and accrued interest |
|
|
222,756 |
|
|
|
|
|
Common stock issued for rent payable |
|
|
62,762 |
|
|
|
|
|
Stock subscription receivable |
|
|
|
|
|
|
500 |
|
See accompanying notes to condensed consolidated financial statements.
4
HealthSport, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
NOTE 1: ORGANIZATION AND NATURE OF BUSINESS
Principles of Consolidation
The condensed consolidated financial statements include the accounts of HealthSport, Inc., a
Delaware corporation, and its wholly owned subsidiaries. All significant intercompany balances and
transactions have been eliminated in consolidation.
Financial Statement Preparation
The condensed consolidated financial statements included in this report have been prepared
pursuant to the rules and regulations of the Securities and Exchange Commission for interim
reporting and include all adjustments (consisting only of normal recurring adjustments) that are,
in the opinion of management, necessary for a fair presentation. These condensed consolidated
financial statements have not been audited.
Certain information and footnote disclosures normally included in financial statements
prepared in accordance with generally accepted accounting principles in the United States have been
condensed or omitted pursuant to such rules and regulations for interim reporting. These condensed
consolidated financial statements should be read in conjunction with the consolidated financial
statements and notes thereto included in the Companys Annual Report on Form 10-K for the year
ended December 31, 2008. The financial data for the interim periods presented may not necessarily
reflect the results to be anticipated for the complete year.
In preparing the accompanying unaudited condensed consolidated financial statements, the
Company has reviewed, as determined necessary by the Companys management, events that have
occurred after September 30, 2009, up until the issuance of the financial statements, which
occurred on November 16, 2009.
Reclassification
Certain reclassifications of the amounts presented for the comparative period have been made
to conform to the current presentation.
Estimates
In preparing financial statements in conformity with generally accepted accounting principles,
management makes estimates and assumptions that affect the reported amount of assets and
liabilities and disclosures of contingent assets and liabilities as of the date of the financial
statements, as well as the reported amounts of revenue and expenses during the reporting period.
Actual results could differ from those estimates.
5
Nature of Business
We are a company specializing in the development and manufacture of proprietary, edible thin
film products containing nutraceutical and pharmaceutical actives. Our thin film, which is similar
in size and shape to a postage stamp, dissolves rapidly and utilizes patent pending bi-layer
technology and other novel processes, including proprietary micro-encapsulation methods to mask the
taste of actives in the film products. The result of this superior technology is higher quality,
more stable products that support a platform capable of carrying larger product volumes and a more
diverse array of active ingredients. We believe these qualities render our thin film effective,
easy to use and suited for a multitude of consumer products in both the dietary supplement and
pharmaceutical arenas.
We currently manufacture and distribute a number of nutritional supplement products formulated
to contain electrolytes, vitamins, melatonin, caffeine, and other supplements. We are also
currently conducting research and development related to future potential products that will
contain over-the-counter and prescription drug actives.
Recent Accounting Pronouncements
On January 1, 2009, we adopted changes issued by the FASB to accounting for business
combinations. While retaining the fundamental requirements of accounting for business combinations,
including that the purchase method be used for all business combinations and for an acquirer to be
identified for each business combination, these changes define the acquirer as the entity that
obtains control of one or more businesses in the business combination and establishes the
acquisition date as the date that the acquirer achieves control instead of the date that the
consideration is transferred. These changes require an acquirer in a business combination,
including business combinations achieved in stages (step acquisition), to recognize the assets
acquired, liabilities assumed, and any non-controlling interest in the acquiree at the acquisition
date, measured at their fair values as of that date, with limited exceptions. This guidance also
requires the recognition of assets acquired and liabilities assumed arising from certain
contractual contingencies as of the acquisition date, measured at their acquisition-date fair
values. Additionally, these changes require acquisition-related costs to be expensed in the period
in which the costs are incurred and the services are received instead of including such costs as
part of the acquisition price. We have not engaged in any acquisitions since this new guidance was
issued, so there has been no impact to our consolidated financial statements.
On January 1, 2009, we adopted changes issued by the FASB to accounting for intangible assets.
These changes amend the factors that should be considered in developing renewal or extension
assumptions used to determine the useful life of a recognized intangible asset in order to improve
the consistency between the useful life of a recognized intangible asset outside of a business
combination and the period of expected cash flows used to measure the fair value of an intangible
asset in a business combination. The adoption of these changes did not have a material impact on
our consolidated results of operations, financial position or cash flows, and the required
disclosures regarding our intangible assets.
On January 1, 2009, we adopted changes issued by the FASB to consolidation accounting and
reporting that establish accounting and reporting for the non-controlling interest in a subsidiary
and for the deconsolidation of a subsidiary. This guidance defines a non-controlling interest,
previously called a minority interest, as the portion of equity in a subsidiary not attributable,
directly or indirectly, to a parent. These changes require, among other items, that a
non-controlling interest be included in the consolidated balance sheet within equity separate from
the parents equity; consolidated net income to be reported at amounts inclusive of both the
parents and non-controlling interests shares and, separately, the amounts
6
of consolidated net income attributable to the parent and non-controlling interest all on the
consolidated statement of operations; and if a subsidiary is deconsolidated, any retained
non-controlling equity investment in the former subsidiary be measured at fair value and a gain or
loss be recognized in net income based on such fair value. The adoption of these changes had no
impact on our consolidated financial statements.
On January 1, 2009, we adopted changes issued by the FASB to fair value accounting and
reporting as it relates to nonfinancial assets and nonfinancial liabilities that are not recognized
or disclosed at fair value in the consolidated financial statements on at least an annual basis.
These changes define fair value, establish a framework for measuring fair value in GAAP, and expand
disclosures about fair value measurements. This guidance applies to other GAAP that require or
permit fair value measurements and is to be applied prospectively with limited exceptions. The
adoption of these changes, as it relates to nonfinancial assets and nonfinancial liabilities, had
no impact on our consolidated financial statements. These provisions will be applied at such time a
fair value measurement of a nonfinancial asset or nonfinancial liability is required, which may
result in a fair value that is materially different than would have been calculated prior to the
adoption of these changes.
On April 1, 2009 we adopted changes issued by the FASB in June 2008 to provide guidance in
determining whether certain financial instruments (or embedded feature) are considered to be
indexed to an entitys own stock. Existing guidance under GAAP considers certain financial
instruments to be outside the scope of derivative accounting, specifying that a contract that would
otherwise meet the definition of a derivative but is both (a) indexed to the Companys own stock
and (b) classified in stockholders equity in the statement of financial position would not be
considered a derivative financial instrument. These changes provide a new two-step model to be
applied in determining whether a financial instrument or an embedded feature is indexed to an
entitys own stock and thus able to qualify for the derivative accounting scope exception. These
changes did not have any impact on our consolidated financial statements.
In June 2009, the FASB issued guidance that establishes the FASB Accounting Standards
Codification (the Codification) as the source of authoritative accounting principles recognized
by the FASB to be applied by nongovernmental entities in the preparation of financial statements in
conformity with generally accepted accounting principles (GAAP). Use of the new Codification is
effective for interim and annual periods ending after September 15, 2009. The Company has used the
new Codification in reference to GAAP in this quarterly report on Form 10-Q and such use has not
impacted the consolidated results of the Company.
In June 2009, the FASB amended U.S. GAAP with respect to the accounting for transfers of
financial assets. These amendments, among other things, clarified that the objective of U.S. GAAP
is to determine whether a transferor and all of the entities included in the transferors financial
statements being presented have surrendered control over transferred financial assets; limited the
circumstances in which a financial asset, or portion of a financial asset, should be derecognized
when the transferor has not transferred the entire original financial asset to an entity that is
not consolidated with the transferor in the financial statements being presented and/or when the
transferor has continuing involvement with the transferred financial asset; and removed the concept
of a qualifying special-purpose entity. The Company will be required to adopt these amendments
effective January 1, 2010, and is currently evaluating the potential impact, if any, on its
consolidated financial statements.
7
In June 2009, the FASB issued changes to the accounting for variable interest entities. These
changes require an enterprise to perform an analysis to determine whether the enterprises variable
interest or interests give it a controlling financial interest in a variable interest entity; to
require ongoing reassessments of whether an enterprise is the primary beneficiary of a variable
interest entity; to eliminate the quantitative approach previously required for determining the
primary beneficiary of a variable interest entity; to add an additional reconsideration event for
determining whether an entity is a variable interest entity when any changes in facts and
circumstances occur such that holders of the equity investment at risk, as a group, lose the power
from voting rights or similar rights of those investments to direct the activities of the entity
that most significantly impact the entitys economic performance; and to require enhanced
disclosures that will provide users of financial statements with more transparent information about
an enterprises involvement in a variable interest entity. These changes become effective for us
beginning on January 1, 2010. The adoption of this change is not expected to have a material impact
on our consolidated financial statements.
On June 30, 2009, we adopted changes issued by the FASB to fair value disclosures of financial
instruments. These changes require a publicly traded company to include disclosures about the fair
value of its financial instruments whenever it issues summarized financial information for interim
reporting periods. Such disclosures include the fair value of all financial instruments, for which
it is practicable to estimate that value, whether recognized or not recognized in the statement of
financial position; the related carrying amount of these financial instruments; and the method(s)
and significant assumptions used to estimate the fair value. Other than the required disclosures,
the adoption of these changes had no impact on our consolidated financial statements.
On June 30, 2009, we adopted changes issued by the FASB to fair value accounting. These
changes provide additional guidance for estimating fair value when the volume and level of activity
for an asset or liability have significantly decreased and includes guidance for identifying
circumstances that indicate a transaction is not orderly. This guidance is necessary to maintain
the overall objective of fair value measurements, which is, that fair value is the price that would
be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date under current market conditions. The adoption of these
changes had no impact on our consolidated financial statements.
On June 30, 2009, we adopted changes issued by the FASB to the recognition and presentation of
other-than-temporary impairments. These changes amend existing other-than-temporary impairment
guidance for debt securities to make the guidance more operational and to improve the presentation
and disclosure of other-than-temporary impairments on debt and equity securities. The adoption of
these changes had no impact on our consolidated statements.
On July 1, 2009, we adopted changes issued by the FASB to accounting for and disclosure of
events that occur after the balance sheet date but before financial statements are issued or are
available to be issued, otherwise known as subsequent events. Specifically, these changes set
forth the period after the balance sheet date during which management of a reporting entity should
evaluate events or transactions that may occur for potential recognition or disclosure in the
financial statements, the circumstances under which an entity should recognize events or
transactions occurring after the balance sheet date in its financial statements, and the
disclosures that an entity should make about events or transactions that occurred after the balance
sheet date. The adoption of these changes had no impact on our consolidated financial statements as
management already followed a similar approach prior to the adoption of this new guidance. We have
evaluated subsequent events through November 16, 2009, the filing date of this quarterly report,
and there is no material impact on to our consolidated financial statements.
8
In August 2009, the FASB issued Accounting Standards Update No. 2009-05, Measuring
Liabilities at Fair Value (ASU 2009-05). ASU 2009-05 amends the Fair Value Measurements and
Disclosures Topic of the FASB Accounting Standards Codification by providing additional guidance
clarifying the measurement of liabilities at fair value. The update reaffirms that fair value is
based on an orderly transaction between market participants, even though liabilities are
infrequently transferred due to contractual or other legal restrictions. However, identical
liabilities traded in the active market should be used when available. When quoted prices are not
available, the quoted price of the identical liability traded as an asset, quoted prices for
similar liabilities or similar liabilities traded as an asset, or another valuation approach should
be used. This update also clarifies that restrictions preventing the transfer of a liability should
not be considered as a separate input or adjustment in the measurement of fair value. We will
adopt the provisions of this update for fair value measurements of liabilities effective October 1,
2009, which we do not expect to have a material impact on our condensed consolidated financial
statements.
NOTE 2: DISPOSITION
On February 1, 2008 HealthSport and InnoZen executed a Limited Liability Company Operating
Agreement (LLC Agreement) with Migami, Inc. (Migami) for the formation of PMG. Among other
things, the LLC Agreement called for Migami to contribute $3,000,000 in cash to PMG for its
intended 48% ownership and InnoZen licensed its technology to PMG for its 52% ownership. PMG was
formed to build a world-wide regulatory compliant manufacturing facility with cutting edge
innovation and stringent quality control, which will be cGMP compliant. Migami was scheduled to
contribute $3,000,000 for its 48% interest in PMG. However, Migami was able to make only $990,000
of the required capital contributions. This resulted in substantial delays in completing the
manufacturing facility. Production commenced in January 2009, although all operations have not yet
been relocated to this facility. As a result of the delays in funding, Migami breached the LLC
Agreement and forfeited all rights under that agreement. With Migami in breach of its obligation,
PMG was unable to obtain the necessary capital to complete construction and incurring monthly
operating losses. Consequently, Innozen elected to sell its interest in PMG for nominal
consideration on December 30, 2008 and recognized a book gain of $869,453 on the transaction. The
gain was the difference between the Companys share of the PMG loss which was included in the
consolidated financial statements and its investment. Subsequently, operations related to the
manufacturing facility have continued in InnoZen. Accordingly, no separate disclosure of PMG is
included as the operations would have been included in InnoZen if PMG had not been formed.
NOTE 3: INVENTORY
Inventory at September 30, 2009 and December 31, 2008, consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Raw materials |
|
$ |
136,032 |
|
|
$ |
173,980 |
|
Work in progress |
|
|
227,988 |
|
|
|
286,711 |
|
Finished goods |
|
|
40,404 |
|
|
|
125,055 |
|
|
|
|
|
|
|
|
|
|
|
404,424 |
|
|
|
585,746 |
|
Reserve for obsolescence |
|
|
(148,381 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total Inventory |
|
$ |
256,043 |
|
|
$ |
585,746 |
|
|
|
|
|
|
|
|
9
NOTE 4: ASSET IMPAIRMENT
The Company accounts for goodwill in accordance with FASB codification guidance on accounting
for goodwill and intangible assets, which prohibits the amortization of goodwill and intangible
assets with indefinite useful lives and requires these assets to be reviewed for impairment at
least annually. A charge to earnings is required for any identified impairments. This charge to
earnings is to be recorded in the period in which the events causing the impairment occurred. The
Company tests goodwill for impairment using the two-step process prescribed under the FASB
codification guidance. The first step is a screen for potential impairment, while the second step
measures the amount of the impairment, if any.
Due to a significant reduction in business volume and a decline in the quoted market price of
the Companys stock in the second quarter of 2009, management determined that the fair value of the
Company had declined. Based on managements analysis, the fair value of the Company is no longer
in excess of the carrying value of the underlying net assets, including goodwill. Accordingly, the
Company recorded an impairment charge of $4,000,000 in the quarter ending June 30, 2009.
NOTE 5: DERIVATIVE LIABILITY
Fair value is defined as the price that would be received to sell an asset or paid to transfer
a liability in an orderly transaction between market participants at the measurement date. Assets
and liabilities recorded at fair value in the consolidated balance sheets are categorized based
upon the level of judgment associated with the inputs used to measure their fair value. The fair
value hierarchy distinguishes between (1) market participant assumptions developed based on market
data obtained from independent sources (observable inputs) and (2) an entitys own assumptions
about market participant assumptions developed based on the best information available in the
circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which
gives the highest priority to unadjusted quoted prices in active markets for identical assets or
liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of
the fair value hierarchy are described below:
|
|
|
Level Input: |
|
Input Definition: |
Level I
|
|
Inputs are unadjusted, quoted prices for identical assets or
liabilities in active markets at the measurement date. |
|
|
|
Level II
|
|
Inputs, other than quoted prices included in Level I, that
are observable for the asset or liability through
corroboration with market data at the measurement date. |
|
|
|
Level III
|
|
Unobservable inputs that reflect managements best estimate
of what market participants would use in pricing the asset or
liability at the measurement date. |
10
The following table summarizes fair value measurements by level at September 30, 2009 for
assets and liabilities measured at fair value on a recurring basis:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level I |
|
|
Level II |
|
|
Level III |
|
|
Total |
|
Cash and cash equivalents |
|
$ |
25,443 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
25,443 |
|
Derivatives liability |
|
|
|
|
|
|
|
|
|
$ |
(648,987 |
) |
|
$ |
(648,987 |
) |
We have issued convertible secured notes in 2008. The convertible notes require us to record the
value of the conversion feature as a liability, at fair value, pursuant to FASB accounting rules,
including provisions in the notes that protect the holders from declines in the Companys stock
price, which is considered outside the control of the Company. The derivative liabilities are
marked-to-market each reporting period and changes in fair value are recorded as a non-operating
gain or loss in our statement of operations, until they are completely settled. The fair value of
the conversion feature is determined each reporting period using the Black-Scholes option pricing
model, and is affected by changes in inputs to that model including our stock price, expected stock
price volatility, interest rates and expected term. The assumptions used in valuing the derivative
liability during 2009 were as follows:
|
|
|
|
|
Risk free interest rate |
|
|
0.45% |
|
Expected life |
|
0 - 0.5 years |
|
Dividend Yield |
|
|
0% |
|
Volatility |
|
|
121% |
|
The following is a reconciliation of the derivative liability for 2009:
|
|
|
|
|
Value at January 1, 2009 |
|
$ |
3,252,341 |
|
Modification of instruments |
|
|
129,254 |
|
Decrease in Value |
|
|
(2,732,608 |
) |
|
|
|
|
|
|
|
|
|
Value at September 30, 2009 |
|
$ |
648,987 |
|
|
|
|
|
NOTE 6: CONVERTIBLE PROMISSORY NOTES
Convertible promissory notes consisted of the following at September 30, 2009 and December 31,
2008:
11
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Senior secured convertible promissory notes of
$625,000 due March 31, 2010 with an option to
extend for another 6 months and $450,000 due
September 30, 2009 (in default); interest payable
at 12% annum and a default rate of 18% per annum;
secured by technology and patent rights;
principal and accrued interest convertible into
common stock at $0.15 per share (subject to
adjustment if the Company sells stock or grants
conversion rates at a lower price); accrued
interest due on March 31, 2010 (13 holders) and
accrued interest due on January 1, April 1, July
1 and Oct 1, 2009 not paid (11 holders) |
|
$ |
1,075,000 |
|
|
$ |
1,100,000 |
|
|
|
|
|
|
|
|
|
|
Convertible loan from Migami due September 22,
2009 with interest at 10% payable quarterly;
secured; convertible into common stock at $0.10
per share; interest due December 22, 2008, March
22, 2009 and June 22, 2009, principal and
interest not paid due to litigation involving Migami and SMI
Manufacturing, LLC (litigation does not involve the Company) |
|
|
100,000 |
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
Convertible promissory note to an individual due
December 24, 2010 including interest at 8% per
annum; unsecured; convertible into common stock
at $0.15 per share; interest due February 1, 2009
not paid |
|
|
48,000 |
|
|
|
63,000 |
|
|
|
|
|
|
|
|
|
|
Convertible promissory note to the Companys
former counsel due April 11, 2011 including
interest at 8% per annum; unsecured; convertible
into common stock at $0.15 per share; accrued
interest due March 29, 2009 not paid |
|
|
144,646 |
|
|
|
100,000 |
|
|
|
|
|
|
|
|
|
|
Convertible promissory note to a company due
November 1, 2010 including interest at 12% per
annum; unsecured; convertible into common stock
at $0.15 per share; accrued interest due monthly
commencing December 1, 2008 not paid |
|
|
|
|
|
|
126,000 |
|
|
|
|
|
|
|
|
|
|
Convertible promissory note to a company due
November 15, 2010 including interest at 12% per
annum; unsecured; convertible into common stock
at $0.15 per share; accrued interest due monthly
commencing December 1, 2008 not paid |
|
|
51,450 |
|
|
|
51,450 |
|
|
|
|
|
|
|
|
|
|
Convertible promissory note to a company due
December 24, 2010 including interest at 10% per
annum; unsecured; convertible into common stock
at $0.20 per share; accrued interest due
semi-annually commencing November, 21 2009 |
|
|
112,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible promissory note to an individual
dated October 21, 2008 and due October 21, 2009
including interest at 12% per annum; unsecured;
convertible into common stock at $0.15 per share |
|
|
5,000 |
|
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
Convertible promissory note to a company due
March 11, 2010 including interest at 6% per
annum; unsecured; convertible into common stock
at $0.20 per share; accrued interest due March
11, 2010 |
|
|
2,500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,539,096 |
|
|
|
1,545,450 |
|
Current portion of convertible promissory notes |
|
|
1,182,500 |
|
|
|
1,268,000 |
|
|
|
|
|
|
|
|
Convertible promissory notes, less current portion |
|
$ |
356,596 |
|
|
$ |
277,450 |
|
|
|
|
|
|
|
|
Substantially all promissory notes are with shareholders.
12
NOTE 7: COMMITMENTS AND CONTINGENCIES
The Company leases its office and current manufacturing facility in Woodland Hills,
California. The lease expires on January 1, 2010 and has a one-year renewal option. Rent under
the lease is $11,648 per month. The Company plans to consolidate all operations in the Oxnard
location (see below) by January 1, 2010.
The Company leases a manufacturing facility in Oxnard, California which contains approximately
25,000 square feet. The lease term is from December 1, 2007 through January 31, 2015 at lease
rates of $12,812 to $14,853 per month. The Company began manufacturing at this location in January
2008 and plans to consolidate all operations at this facility by January 1, 2010.
In January 2007, the Company executed a three-year lease agreement for 2,182 square feet of
office space in Amherst, New York for the Enlyten office at $2,455 per month. The Company closed
this office during 2008 and is attempting to sub-lease the space for the remainder of the lease
term.
The Company has the following royalty agreements:
|
1. |
|
Royalty agreement for an indefinite period covering all strip products except
Fix Strips and Enlyten Energy Strips of 1.0% of the first $100,000,000 in sales and
0.5% thereafter. |
|
|
2. |
|
Royalty agreement for an indefinite period of 1.0% of the first $20,000,000 in
sales of the Fix Strips and Enlyten Energy strips and 0.5% of the next $80,000,000 in
sales of the Fix Strips and Enlyten Energy strips. |
On March 11, 2008, the Company entered into a five-year distribution agreement with Perrigo
Florida, Inc. (Perrigo), formerly known as Unico Holdings, Inc. Perrigos customers include most
of the largest retailers and distributors in the U.S. in each of these sales channels. The
agreement calls for a minimum of $22 million of product purchases over a five-year term in order
for Perrigo to maintain its exclusive distribution right.
On September 11, 2008, the Company entered into a distribution agreement with T. Lynn Mitchell
Companies, LLC (T Lynn) for the production and sale of a variety of dietary supplement products,
including Enlyten branded Antioxidant Strips, Electrolytes Plus Strips, Energy Strips and Melatonin
Strips. National marketing of the products began in the first quarter of 2009. These sales are
subject to a 5% commission.
The
Company has failed to remit payroll tax payments of $140,930, as required by various
taxing authorities. When payment is ultimately made, management believes that the Company will be
assessed various penalties for the delayed payments. As of September 30, 2009, management was
unable to estimate the amount of penalties that the Company would incur as a result of these unpaid
taxes.
In the normal course of business, the Company may become a party in a legal proceeding. The
only significant matters of which the Company is aware are discussed below.
13
On October 30, 2007, the Companys wholly-owned subsidiary, Enlyten, Inc., filed a lawsuit
against The Gatorade Company and PepsiCo, Inc. (collectively, the Gatorade) in the State of New
York Supreme Court, County of Erie. The Complaint alleges that Gatorade has tortiously interfered
with Enlytens contractual agreement with the Buffalo Bills and with Enlytens business
relationships with various third parties including other NFL teams, in an attempt to wrongfully
restrain trade. Enlyten is represented by the law firm of Phillips Lytle, LLP in Buffalo, New
York. The alleged interference has severely limited the Companys ability to market and sell the
Sport Strip branded product. The case is still in the discovery phase. On November 21, 2008, the
Company was forced to bring a motion to compel discovery from the defendants and, on February 24,
2009, the Court ordered the defendant to produce discovery within 60 days. Defendant did
subsequently produce discovery during this time period. The next stage of the discovery process
will involve the scheduling of depositions.
On June 29, 2009, Robert Kusher filed suit against the Company in Circuit Court for the
Seventh District in Broward County, Florida (case no. 09035822). Mr. Kusher served as chief
executive officer of the Company from on or about March 2008 until August 2008. In August 2008 the
Company issued an 8-K announcing that Mr. Kusher had resigned his position. The complaint alleges
that Mr. Kusher never resigned from his position as chief executive officer. It asserts claims
against the Company for breach of contract, and fraudulent inducement of employment. The complaint
requests damages of $450,000, plus the issuance of 500,000 shares of the Companys common stock,
plus 1,000,000 options to purchase common stock at $1.00, plus 1,000,000 options to purchase common
stock at $1.50. The Company intends to file a responsive pleading in this action and defend this
lawsuit.
NOTE 8: GOING CONCERN
At September 30, 2009, the Company had current assets of $616,606; current liabilities of
$4,383,674; and a working capital deficit of $3,767,068. The Company incurred a loss of $4,590,908
during the nine months ended September 30, 2009, which included depreciation and amortization of
$1,000,027, amortization of non-cash stock compensation of $466,726,
a gain on change in fair value of derivative liability of $2,732,608 and a $4,000,000 impairment
loss of goodwill. The Company has incurred substantial losses to date and has an accumulated
deficit at September 30, 2009 of $47,100,753.
The Company is not currently generating sufficient income or cash flow to fund current
operations. Sales of product amounted to $2,215,181 during the first, second and third quarters of
2009. The Company is continually analyzing its current costs and is attempting to make additional
cost reductions where possible. However, in order to support the Companys current level of
operations, substantial additional sales will be required. We expect that we will continue to
generate losses from operations through the remainder of 2009.
We have historically funded our working capital requirements primarily through the private
placement of debt or equity securities. In order to fund the Companys current business plan, we
expect to need an additional $2 million to $4 million of capital, which we hope to secure through
the sale of debt or equity securities to investors or strategic partners.
On August 13, 2009, the Companys Innozen subsidiary entered into a Manufacturing License
Agreement (the Manufacturing Agreement) with Supplemental Manufacturing & Ingredients, LLC, an
Arizona limited liability company (SMI). The Manufacturing Agreement contained a subscription
agreement pursuant to which SMI has agreed to purchase an aggregate of 4,255,320 shares of the
Companys common stock at a purchase price of $1 million or $0.235 per share. Payment of the
purchase price is to be made on the basis of $150,000 on signing the agreement, $150,000 on each of
September 15, October 15 and November 15, 2009 and the remaining $400,000 is to be paid on or before
December 31, 2009. At September 30, 2009, SMI had made the initial two payments under the
subscription agreement. The subscription agreement is subject to cancellation contingent on the
closing of the Stock Purchase Agreement discussed in Note 9.
14
These conditions raise substantial doubt about our ability to continue as a going concern.
Because of our historic net losses, and our negative working capital position, our independent
auditors, in their report on our financial statements for the year ended December 31, 2008,
expressed substantial doubt about our ability to continue as a going concern. The accompanying
condensed consolidated financial statements have been prepared in conformity with accounting
principles generally accepted in the United States of America, which contemplate continuation of
the Company as a going concern. The condensed consolidated financial statements do not include any
adjustments relating to the recoverability and classification of recorded asset amounts or the
amounts and classification of liabilities that could result from the outcome of this uncertainty.
NOTE 9: SUBSEQUENT EVENTS
Stock Purchase Agreement
On November 6, 2009, the Company entered into a stock purchase agreement (the Stock Purchase
Agreement) with Supplemental Manufacturing & Ingredients, LLC, an Arizona limited liability
company (SMI), pursuant to which the Company agreed to issue 66,666,667 shares of its authorized
but unissued common stock (the Shares) in exchange for cash and a promissory note representing an
aggregate value of $10,000,000 (the SMI Financing).
At the time of closing of the transactions contemplated by the Stock Purchase Agreement (the
Closing) and in accordance with the terms of the Stock Purchase Agreement, SMI will pay to the
Company $2,000,000 and will issue a promissory note (the Promissory Note) to the Company in the
amount of $8,000,000. The promissory Note will be payable in five installments as follows:
|
|
|
$500,000 on or before November 15, 2009; |
|
|
|
|
$400,000 on or before December 31, 2009; |
|
|
|
|
$1,650,000 on or before February 28, 2010; |
|
|
|
|
$2,500,000 on or before April 30, 2010; and |
|
|
|
|
$2,950,000 on or before June 30, 2010. |
The Promissory Note will mature on June 30, 2010 and will accrue interest at the rate of 4%
per annum. The Company will issue and deliver 13,333,333 shares of our common stock to SMI at the
time of closing. The remaining shares will be issued in the name of SMI, but will be held by a
third party agent pursuant to a Stock Pledge Agreement and Escrow Agreement. The Pledge Agreement
provides for a partial release of shares as payments are made under the Promissory Note.
In addition to the issuance of the 66,666,667 shares of common stock, the Stock Purchase
Agreement provides for the issuance of additional shares of common stock, with or without
additional consideration, in the event of conversion of outstanding convertible securities, the
incursion in undisclosed liabilities, and certain other dilutive issuances, as more particularly
described in the Stock Purchase Agreement and in Part II, Item 1A. Risk Factors below.
The Closing of the transactions contemplated by the Stock Purchase Agreement is subject to
customary conditions, and no assurances can be given that those conditions will be met, or waived,
or that the transactions contemplated by the Stock Purchase Agreement will occur. If the SMI
Financing closes it will supersede and cancel the remaining payments under subscription agreement
of the Manufacturing Agreement.
15
Separation Agreements
In connection with the SMI Financing, three of the Companys six current directors, M.E. Hank
Durschlag, Anthony Seaber and Jeffrey Wattenberg, agreed to resign their positions as directors
effective and contingent upon the closing of the SMI Financing.
On November 4, 2009, the Company entered into a separation agreement with M.E. Hank Durschlag
that is effective and contingent upon the closing of the SMI Financing. Under the terms of the
separation agreement, Mr. Durschlag will receive (a) a $67,750 payment on or before December 1,
2009, (b) a $7,000 payment on the first day of each month beginning January 1, 2010 for ten (10)
months, (c) 300,000 shares of unregistered common stock of the Company, and (d) payment of Mr.
Durschlags health insurance coverage through December 31, 2009. Mr. Durschlag will also receive a
commission of 0.5% of the Net Sales Revenues received by the Company on the sale of any and all
dietary supplement/nutritional supplement edible film strip products for a period of seven years
and will receive 50,000 shares of unregistered stock of the Company for each $1,000,000 in Net
Sales Revenues received by the Company on the sale of any and all dietary supplement/nutritional
supplement film strip products up to a maximum of 500,000 shares. Net Sales Revenues is defined
in Mr. Durschlags separation agreement as the Companys gross sales and license revenues
actually received by the Company minus all discounts, credits, withholdings, returns, allowances,
deductions, freight costs, taxes and custom duties. The separation agreement includes a release of
claims by Mr. Durschlag.
On November 6, 2009, the Company entered into a separation agreement with Jeffrey Wattenberg
that is effective and contingent upon the closing of the SMI Financing. Under the terms of the
separation agreement, Mr. Wattenberg will receive (a) a $30,000 payment on or before December 1,
2009, (b) 400,000 shares of unregistered common stock of the Company, and (c) a broker agreement
between the Company and Mr. Wattenberg pursuant to which Mr. Wattenberg will receive a 4%
commission on the Net Sales Revenues received by the Company for products and customers that Mr.
Wattenberg brings to the Company and that the Company approves, and (d) 75,000 shares of
unregistered common stock of the Company for each $1,000,000 in JV-attributable Sales received by
the Company under the term sheet agreement by and between the Company and Destiny Productions and
Content Marketing Solutions dated July 2009 up to a maximum of 1,000,000 shares. Net Sales
Revenues is defined in the broker agreement as the Companys gross sales revenues actually
received by the Company minus all discounts, credits, withholdings, returns, allowances,
deductions, freight costs, taxes and custom duties. The separation agreement includes a release of
claims by Mr. Wattenberg.
On November 4, 2009, the Company entered into a separation agreement with Daniel Kelly that is
effective and contingent upon the Closing of the SMI Financing. Mr. Kelly, a board member and
former executive officer of the Company, had a consulting agreement with the Company. Under the
terms of the separation agreement, the consulting agreement will terminate and Mr. Kelly will
receive (a) a $45,000 payment on or before December 1, 2009, (b) a $10,000 payment on the first day
of each month beginning on January 1, 2010 for nine (9) months and (c) 100,000 shares of
unregistered common stock of our Company. The separation agreement includes a release of claims by
Mr. Kelly.
On November 4, 2009, the Company entered into a separation agreement with Matthew Burns that
is effective and contingent upon the Closing of the SMI Financing. Mr. Burns, a board member and
former executive officer of the Company, had a consulting agreement with the Company. Under the
terms of the separation agreement, the consulting agreement will terminate and Mr. Burns will
receive (a) a $35,000 payment on or before December 1, 2009 and (b) 100,000 shares of unregistered
common stock of the Company. The separation agreement includes a release of claims by Mr. Burns.
16
Employment Agreements
On November 4, 2009, we entered into an employment agreement with Robert Davidson that is
effective and contingent upon the closing of the SMI Financing. Under the terms of the employment
agreement, Mr. Davidson will receive (a) an annual base salary of $260,000 and (b) 2,000,000 shares
of restricted stock, subject to vesting in accordance with the schedule set forth in Mr. Davidsons
employment agreement. Mr. Davidson will also be eligible to participate in our employee benefit
programs.
On November 4, 2009, we entered into an employment agreement with Thomas Beckett that is
effective and contingent upon the closing of the SMI Financing. Under the terms of the employment
agreement, Mr. Beckett will receive (a) an annual base salary of $210,000 and (b) 1,500,000 shares
of restricted stock of our Company, which shall vest in accordance with the schedule set forth in
Mr. Becketts employment agreement. Mr. Beckett will also be eligible to participate in our
employee benefit programs.
Commitment and Contingencies
On October 22, 2009, Schering-Plough S.A. de C.V. (Schering) issued a demand letter
requesting payment of $150,000. The dispute arises out of an exclusive distribution agreement that
the Company entered into with Schering on June 27, 2007. The exclusive distribution agreement was
never fully performed and Schering is demanding the refund of a $150,000 payment that it made for
future research and development and purchases of products. In its demand letter, Schering states
that it intends to demand an arbitration proceeding in an effort to recover the disputed $150,000.
The Company intends to respond to this demand and to defend this action.
On October 28, 2009, Perkins Coie, LLP (Perkins), issued a demand letter requesting payment
of approximately $285,000. Perkins is a law firm that has provided services to the Company related
to the Companys intellectual property and patent filings. The payment demanded relates to unpaid
balances for professional services on an open account with Perkins. In the letter, Perkins
threatens to initiate legal proceedings against the Company to collect the unpaid account. The
Company intends to settle this matter.
17
|
|
|
Item 2. |
|
MANAGEMENTS
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS |
Forward-Looking Statements
Statements in the following discussion and throughout this report that are not historical in
nature are forward-looking statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You can
identify forward-looking statements by the use of words such as the words expect, anticipate,
estimate, may, will, should, intend, believe, and similar expressions. Although we
believe the expectations reflected in these forward-looking statements are reasonable, such
statements are inherently subject to risk and we can give no assurances that our expectations will
prove to be correct. Actual results could differ from those described in this report because of
numerous factors, many of which are beyond our control. These factors include, without limitation,
those described under Item 1A Risk Factors. We undertake no obligation to update these
forward-looking statements to reflect events or circumstances after the date of this report or to
reflect actual outcomes. Please see Special Note Regarding Forward Looking Statements at the
beginning of this report.
The following discussion of our financial condition and results of operations should be read
in conjunction with our condensed consolidated financial statements and the related notes and other
financial information appearing elsewhere in this report.
Overview
We are a company specializing in the development and manufacturing of proprietary, edible thin
film products containing nutraceutical and pharmaceutical actives. Our thin film, which is similar
in size and shape to a postage stamp, dissolves rapidly and utilizes patent pending bi-layer
technology and other novel processes, including proprietary micro-encapsulation methods to mask the
taste of actives in the film products. The result of this superior technology is a higher quality,
more stable products that support a platform capable of carrying larger product volumes and a more
diverse array of active ingredients. We believe these qualities render our thin film effective,
easy to use and suited for a multitude of consumer products both in the dietary supplement and
pharmaceutical arenas.
We currently manufacture and distribute a number of nutritional supplement products formulated
to contain electrolytes, vitamins, melatonin, caffeine, and other supplements. These are
marketed under such product names as SPORTSTRIPS, PEDIASTRIPS, FIX STRIPS, ENLYTEN ENERGY
STRIPS, SURVIVAL STRIPS, ENLYTEN MELATONIN STRIPS, ENLYTEN ANTIOXIDANT STRIPS, ENLYTEN ELECTROLYTES
PLUS STRIPS, ENLYTEN APPETITE SUPPRESSANT STRIPS, and ENLYTEN CALORIE BURNER STRIPS. We distribute
these products through two primary distributors. On March 11, 2008, we entered into a five-year
distribution agreement with Perrigo Florida, Inc. (Perrigo), formerly Unico Holdings, Inc.
Perrigos customers include most of the largest retailers and distributors in the U.S. in each of
these sales channels. The agreement calls for a minimum of $22 million of product purchases over a
five-year term in order for Perrigo to maintain its exclusive distribution right. On September 11,
2008, the Company entered into a distribution agreement with T. Lynn Mitchell Companies, LLC (T
Lynn) for the production and sale of a variety of dietary supplement products, including Enlyten
branded Antioxidant Strips, Electrolytes Plus Strips, Energy Strips and Melatonin Strips. National
marketing of the products began in the first quarter of 2009. These sales are subject to a 5%
commission.
18
We are in the process of developing thin film products that contain over-the-counter and
prescription drug actives. We are seeking to work with pharmaceutical companies to use our thin
film as a unique drug delivery system. We believe our thin film delivery technology has several
material benefits over existing drug delivery forms and should enjoy strong physician, patient and
consumer acceptance. Our thin film improves convenience and ease of use through discretion and
portability and precludes the need for water or liquids. Our thin film may also improve dosing
accuracy relative to liquid formulations thereby ensuring proper dosing for the pediatric,
geriatric and mentally ill patients where proper administration is often difficult. In addition,
our thin film provides ease of dosing for patients with conditions that make it difficult to
swallow other solid dosage forms such as tablets or capsules.
Our proprietary thin film drug delivery technology is supported by a significant portfolio of
intellectual property which we believe differentiates us from our competitors. We believe this
technology will enable pharmaceutical companies to better manage the life cycle of their products.
By combining our thin film delivery technology with existing drugs, we believe our thin film can
strategically differentiate existing or soon-to-be generic drugs from potential generic competitors
and can help protect branded prescription products against existing or new generic entries by
providing additional patent protection or exclusivity in the marketplace. Additionally, we believe
our thin film drug delivery technology can also be used to create new drug products with improved
efficacy.
Recent Developments
Total revenues for the third quarter declined to $91,623 from $563,841 in the second quarter
of 2009. The decline in revenues was attributable to weaker than expected demand for our products.
The Company sells substantially all products through two customersPerrigo and T. Lynn. The
Company believes that the lower sales are the result of the current difficult retail environment
and some seasonality in the consumption of its products. In response to the decline in revenues
the Company took additional steps to reduce headcount and other operating expenses during the
quarter. For its business and revenue development, the Company is focused on identifying national
and internationally recognized nutritional supplement companies and pharmaceutical companies who
can benefit from the Companys technology as a new distribution mechanism for their supplements or
drugs. For the nine months ended September 30, 2009, revenues were $2,322,373. We finished the
third quarter with cash and equivalents of $25,443 at September 30, 2009 and a working capital
deficit of $3,767,068. We expect to continue incurring net losses from operations for at least
the remainder of 2009.
We have taken a number of actions during and after the period ended September 30, 2009 to
increase our distribution channels, reduce our operating expenses and secure additional capital.
On July 14, 2009, the Company announced that it had entered into a strategic alliance with
Destiny Productions, LLC and Content Marketing Solutions, Inc. for strategic marketing, content
development, distribution and sale of our edible film-strip technology products.
The Company has formed a Business Advisory Panel (BAP) to provide independent expert
high-level business guidance and support as well as innovative thinking across a diversity of
areas. In August 2009, Jennifer M. McCallum, Ph.D., Esq. and Dennis Patrick were added to the BAP.
Ms. McCallum has a doctorate in reproductive physiology and has worked on many cases of first
impression, including obtaining the first permit for the production of pharmaceuticals in plants in
the State of Colorado. Ms. McCallum has won several awards, including Technology of the Year by the
Governor of the State of Iowa and was a semi-finalist for the same in the State of Utah. Mr.
Patrick is the Chairman of National Geographic Ventures, a wholly owned subsidiary of the National
Geographic Society. Prior to National Geographic, Mr. Patrick was the CEO of Patrick Communications Inc., a
telecommunications consulting firm, and Doeg Hill Ventures, LLC, a venture capital group focused on
early-stage investments in the communications industry. From 1999 to 2001 he was the first
president of AOL Wireless. Well known in the communication policy circles, Mr. Patrick served as
Commissioner and then as Chairman of the Federal Communications Commission from 1983 to 1989.
19
During the third quarter, our InnoZen subsidiary entered into a Manufacturing License
Agreement (the Manufacturing Agreement) with Supplemental Manufacturing & Ingredients, LLC, an
Arizona limited liability company (SMI). Under the terms of the Manufacturing Agreement, the
Company has granted SMI a non-exclusive license to manufacture certain of the Companys proprietary
edible film-strip products. SMI is granted a right of first negotiation for the manufacture of
Products, the pricing and terms of which will be established on a product by product basis. Both
parties have granted the other a right of first negotiation in the event either contemplates a
change in control transaction. In consideration of the rights granted to SMI by InnoZen, SMI shall
pay $150,000 to InnoZen upon execution of this agreement where as $100,000 has been paid and
$50,000 shall be paid within ninety (90) days of execution of the Manufacturing Agreement. In
addition, the Manufacturing Agreement contained a subscription agreement pursuant to which SMI has
agreed to purchase an aggregate of 4,255,320 shares of the Companys common stock at a purchase
price of $1 million or $0.235 per share. Payment of the purchase price is to be made on the basis
of $150,000 on signing the Manufacturing Agreement, $150,000 on each of September 15, October 15
and November 15, 2009 and the remaining $400,000 is to be paid on or before December 31, 2009. SMI
has made the initial payments under the Manufacturing Agreement. The subscription agreement is
subject to cancellation contingent on the closing of the Stock Purchase Agreement as discussed
herein.
During the third quarter we amended senior secured convertible promissory notes in the
principal amount of $625,000 by extending the maturity date to March 31, 2010 and waiving any
default. We have not yet amended the remaining $450,000 of aggregate principal amount of
promissory notes under the secured convertible debenture and continue to be in default on this
aggregate amount.
Subsequent to the end of the quarter, on November 6, 2009, we entered into a stock purchase
agreement (the Stock Purchase Agreement) with SMI, pursuant to which we agreed to issue
66,666,667 shares of our common stock (the Shares) in exchange for cash and a promissory note
representing an aggregate value of $10,000,000 (the SMI Financing). At the time of closing of
the transactions contemplated by the Stock Purchase Agreement (the Closing) and in accordance
with the terms of the Stock Purchase Agreement, SMI will pay to the Company $2,000,000 and will
issue a promissory note (the Promissory Note) to the Company in the amount of $8,000,000. The
promissory Note will be payable in five installments as follows:
|
|
|
$500,000 on or before November 15, 2009; |
|
|
|
|
$400,000 on or before December 31, 2009; |
|
|
|
|
$1,650,000 on or before February 28, 2010; |
|
|
|
|
$2,500,000 on or before April 30, 2010; and |
|
|
|
|
$2,950,000 on or before June 30, 2010. |
The Promissory Note will mature on June 30, 2010 and will accrue interest at the rate of 4%
per annum. The Company will issue and deliver 13,333,333 shares of our common stock to SMI at the
time of closing. The remaining shares will be issued in the name of SMI, but will be held by a
third party agent pursuant to a Stock Pledge Agreement and Escrow Agreement. The Pledge Agreement
provides for a partial release of shares as payments are made under the Promissory Note.
20
In addition to the issuance of the 66,666,667 shares of common stock, the Stock Purchase
Agreement provides for the issuance of additional shares of common stock, with or without
additional consideration, in the event of conversion of outstanding convertible securities, the
incursion in undisclosed liabilities, and certain other dilutive issuances, as more particularly
described in the Stock Purchase Agreement and in Part II, Item 1A. Risk Factors below.
The Closing of the transactions contemplated by the Stock Purchase Agreement is subject to
customary conditions, and no assurances can be given that those conditions will be met, or waived,
or that the transactions contemplated by the Stock Purchase Agreement will occur. If the SMI
Financing closes, it will supersede and cancel the final payments under the subscription agreement
contained within the Manufacturing Agreement. We anticipate that proceeds from the SMI Financing
will fulfill our working capital requirements for at least the next 12 months. Except for these
agreements with SMI, there are no arrangements or agreements in place for such capital at this time
and no assurances can be given as to the terms upon which the Company will be able to raise
capital, if at all. See Liquidity, Capital Resources and Going Concern below and Risk Factors
in Part II, Item 1A below.
The Stock Purchase Agreement contemplates a change in control of our Board of Directors as
well as a change in our executive officers. In connection with the SMI Financing, three of the
Companys six current directors, M.E. Hank Durschlag, Anthony Seaber and Jeffrey Wattenberg, agreed
to resign their positions as directors effective and contingent upon the closing of the SMI
Financing. The Stock Purchase Agreement provides that prior to the Closing the size of the Board
will be increased to seven members and that SMI shall be entitled to appoint four members to fill
the vacant positions on the Board. In connection with the Stock Purchase Agreement, each of the
four board designees, as a condition to their appointment, will place into escrow pursuant to the
Stock Pledge Agreement and the Escrow Agreement a written resignation which shall become effective,
at the Companys election, upon the occurrence of an Event of Default under the Promissory Note or
the Stock Pledge Agreement.
In addition, the Stock Purchase Agreement provides that for so long as any amounts remain
outstanding under the Promissory Note, the Company shall obtain the approval of not less than five
directors of a seven member board of directors (or not less than one plus the number of directors
appointed by the Investor if a different size board) prior to taking certain corporate actions,
including: (a) changing the Companys principal line of business; (b) any liquidation, dissolution
or winding-up; (c) any amendment or restatement to the Companys articles of incorporation or
bylaws; (d) increasing or decreasing the number of board members; (e) significant acquisitions,
dispositions, licenses or transfers of assets outside the ordinary course of business; (f) issuing
capital stock, except for shares issuable in accordance with the terms of outstanding employee
benefit plans or warrants, options or other derivative securities; (g) declaring dividends or
redeeming, purchasing or otherwise effecting any recapitalization or restructuring of outstanding
shares of capital stock; (h) incurring significant indebtedness; (i) effecting any change in
control transaction; (j) modifying any executive employment agreements; (k) amending any existing
agreement between the Company and SMI; or (l) any amendment modification or waiver of the use of
proceeds from the sale of the Shares from the agreed upon use of proceeds set forth in the Stock
Purchase Agreement.
On November 4 and 6, 2009, we entered into a separation agreements with certain of our Board
members and our executive officers, which are effective upon and contingent upon the Closing of the
SMI Financing. Under the terms of those separation agreements, (i) Messrs Durschlag, Seaber and
Wattenberg will resign as Board members and execute a release of claims against the Company, and
(ii) Messrs. Burns and Kelly will terminate certain consulting agreements with the Company and
execute a release of claims against the Company. In exchange, we have agreed to pay each certain
compensation, as follows.
21
Under the terms of his separation agreement, Mr. Durschlag will receive (a) a $67,750 payment
on or before December 1, 2009, (b) a $7,000 payment on the first day of each month beginning
January 1, 2010 for ten (10) months, (c) 300,000 shares of unregistered common stock of the Company
(d) payment of Mr. Durschlags health insurance coverage through December 31, 2009, (e) a
commission of 0.5% of the Net Sales Revenues received by the Company on the sale of any and all
dietary supplement/nutritional supplement edible film strip products for a period of seven (7)
years and (f) 50,000 shares of unregistered stock of the Company for each $1,000,000 in Net Sales
Revenues received by the Company on the sale of any and all dietary supplement/nutritional
supplement edible film strip products up to a maximum of 500,000 shares.
Mr. Wattenbergs separation agreement provides for Mr. Wattenberg to receive (a) a $30,000
payment on or before December 1, 2009, (b) 400,000 shares of unregistered common stock of the
Company, and (c) a broker agreement between the Company and Mr. Wattenberg pursuant to which Mr.
Wattenberg will receive a 4% commission on the Net Sales Revenues received by the Company for
products and customers that Mr. Wattenberg brings to the Company and that the Company approves, and
(d) 75,000 shares of unregistered common stock of the Company for each $1,000,000 in
JV-attributable Sales received by the Company under the term sheet agreement by and between the
Company and Destiny Productions and Content Marketing Solutions dated July 2009 up to a maximum of
1,000,000 shares.
Under his Separation Agreement Mr. Kelly will receive (a) a $45,000 payment on or before
December 1, 2009, (b) a $10,000 payment on the first day of each month beginning on January 1, 2010
for nine (9) months and (c) 100,000 shares of unregistered common stock of our Company.
Mr. Burns will receive (a) a $35,000 payment on or before December 1, 2009 and (b) 100,000
shares of unregistered common stock of the Company.
In connection with the SMI Financing, we agreed to appoint Kevin Taheri as our chief executive
officer, Robert Davidson as our president, and Thomas Beckett as our chief financial officer, chief
operating officer and secretary of the Company. The appointments of Messrs. Taheri, Davidson, and
Beckett to their respective positions are effective and contingent upon the closing of the SMI
Financing.
On November 4, 2009, we entered into an employment agreement with Robert Davidson that is
effective and contingent upon the closing of the SMI Financing. Under the terms of the employment
agreement, Mr. Davidson will receive (a) an annual base salary of $260,000 and (b) 2,000,000 shares
of restricted stock, subject to vesting in accordance with the schedule set forth in Mr. Davidsons
employment agreement. Mr. Davidson will also be eligible to participate in our employee benefit
programs.
On November 4, 2009, we entered into an employment agreement with Thomas Beckett that is
effective and contingent upon the closing of the SMI Financing. Under the terms of the employment
agreement, Mr. Beckett will receive (a) an annual base salary of $210,000 and (b) 1,500,000 shares
of restricted stock of our Company, which shall vest in accordance with the schedule set forth in
Mr. Becketts employment agreement. Mr. Beckett will also be eligible to participate in our
employee benefit programs.
22
Comparison of the Three Months Ended September 30, 2009 to the Three Months Ended September 30,
2008
Revenues
During the three months ended September 30, 2009, we had product sales of $61,931 and revenues
from license fees, royalties and services of $29,692, for a total of $91,623. There were product
sales of $580,224 and revenue from license fees, royalties and services of $18,750, for a total of
$598,974 in the corresponding 2008 period. Revenues have decreased during this period primarily
due to substantial declines in demand from our two primary customers. The Company is actively
seeking additional distribution channels and revenue opportunities.
Costs and Expenses
Costs and expenses are as follows for the three months ended September 30, 2009 and 2008:
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Cost of product sold and manufacturing costs |
|
$ |
269,233 |
|
|
$ |
463,267 |
|
General and administrative expense |
|
|
675,631 |
|
|
|
645,317 |
|
Marketing and selling expense |
|
|
10,672 |
|
|
|
358,530 |
|
Asset impairment |
|
|
|
|
|
|
|
|
Inventory obsolescence |
|
|
112,000 |
|
|
|
|
|
Non-cash compensation expense |
|
|
171,148 |
|
|
|
351,747 |
|
Depreciation and amortization expense |
|
|
330,944 |
|
|
|
294,982 |
|
Research and development costs |
|
|
24,931 |
|
|
|
30,106 |
|
|
|
|
|
|
|
|
|
|
$ |
1,594,559 |
|
|
$ |
2,143,949 |
|
|
|
|
|
|
|
|
Cost of product sold and manufacturing costs amounted to 435% of product sales in 2009 and 80%
of product sales in 2008. The Company had under-absorbed manufacturing costs of approximately
$266,784 in the 2009 quarter while revenues in the 2008 quarter were able to absorb all
manufacturing costs. Sales will need to increase substantially to absorb all of the manufacturing
costs at the current level of manufacturing operation. The under-absorbed overhead in 2009 was
primarily due to having two sites of operation in 2009 as compared to one operating site in 2008 as
well as a decrease in production volume while fixed costs remained the same.
General
and administrative expenses (G&A) increased to
$675,631 in the three months ended
September 30, 2009, from $645,317 in the 2008 period. The
increase of $30,314 (5%) in G&A is primarily the result of the
Company expensing the remaining balance of prepaid consulting
services in 2009, which was offset by decreases in corporate
overhead, payroll and the G&A costs at the former PMG manufacturing
operation.
Selling and marketing costs (SMC) were $10,672 in the three months ended September 30, 2009,
as compared to $358,530 in the 2008 period, a decrease of $347,858. The SMC reduction is primarily
due to the elimination of endorsements and sponsorship fees as a result of re-directing our
marketing efforts toward distributors rather than direct sales to customers and the elimination of
the New York office. Distribution center expenses and marketing and promotion expenses for
products also decreased in this period.
23
During the third quarter of 2009 the Company recorded $112,000 for an inventory obsolescence
reserve. There was no reserve for inventory obsolescence in 2008.
Non-cash
compensation expense was $171,148 in 2009 and $351,747 in 2008 and includes the
amortization of the grant date fair value of stock options granted to employees, consultants and
spokespersons over the relevant service periods. The decrease is the
result of options expiring in the 2008 period.
Depreciation and amortization expense increased from $294,982 in 2008 to $330,944 in 2009,
primarily due to property and equipment additions in 2009 as well as depreciating idle property and
equipment placed in service in 2009.
Research and development (R&D) costs amounted to $24,931 in 2009 and $30,106 in 2008. These
include contract services, supplies, materials and analytical testing costs incurred for new
products to be developed by the Company. Research and development expenses remain low due to
limited available funding.
Other Income (Expense)
Interest expense increased from $16,795 in 2008 to $181,792 in 2009 as a result of the
increase in debt incurred after the end of the June 2008 quarter.
Comparison of the Nine Months Ended September 30, 2009 to the Nine Months Ended September 30, 2008
Revenues
During the nine months ended September 30, 2009, we had product sales of $2,215,181 and
revenues from license fees, royalties and services of $107,192, for a total of $2,322,373. There
were product sales of $812,317 and revenue from license fees, royalties and services of $56,250,
for a total of $868,567 in the corresponding 2008 period. Revenues have increased substantially
from the prior year as a result of sales to one of our primary customers in the first and second
quarters of 2009.
Costs and Expenses
Costs and expenses are as follows for the nine months ended September 30, 2009 and 2008:
24
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Cost of product sold and manufacturing costs |
|
$ |
2,075,570 |
|
|
$ |
1,097,667 |
|
General and administrative expense |
|
|
1,714,748 |
|
|
|
2,181,818 |
|
Marketing and selling expense |
|
|
220,820 |
|
|
|
1,056,087 |
|
Asset impairment |
|
|
4,000,000 |
|
|
|
648,600 |
|
Inventory obsolescence |
|
|
262,000 |
|
|
|
274,840 |
|
Non-cash compensation expense |
|
|
466,726 |
|
|
|
2,033,325 |
|
Depreciation and amortization expense |
|
|
1,000,027 |
|
|
|
1,053,313 |
|
Research and development costs |
|
|
69,140 |
|
|
|
169,217 |
|
|
|
|
|
|
|
|
|
|
$ |
9,809,031 |
|
|
$ |
8,514,867 |
|
|
|
|
|
|
|
|
Cost of product sold and manufacturing costs amounted to 94% of product sales in 2009 and 135%
of product sales in 2008. The Company had under-absorbed manufacturing costs of approximately
$975,183 in the 2009 period as compared to $574,110 in the 2008 period. Sales will need to
increase substantially to absorb all of the manufacturing costs at the current level of
manufacturing operation.
G&A
decreased to $1,714,748 in the nine months ended September 30, 2009, from $2,181,818 in
the 2008 period. The decrease of $467,070 (21%) in G&A is the result of decreases at all levels of
the Company, including corporate overhead, consulting fees, payroll, insurance and the G&A costs at
the former PMG manufacturing operation.
SMC were $220,820 in the nine months ended September 30, 2009, as compared to $1,056,087 in
the 2008 period, a decrease of $835,267. SMC costs are down from the previous year, primarily due
to the elimination of endorsements and sponsorship fees as a result of re-directing our marketing
efforts toward distributors rather than direct sales to customers and the elimination of the New
York office. In addition, product promotional expenses decreased by $546,914 from 2008 to 2009.
Asset impairment of $4,000,000 was incurred in 2009 was for the impairment of goodwill. Asset
impairment of $648,600 in 2008 was incurred for the impairment of a client list.
In 2009, the Company recorded $262,000 reserve for inventory obsolescence. Inventory
obsolescence of $274,840 in 2008 was to write off inventory costs for a discontinued product.
Non-cash
compensation expense was $466,726 in 2009 and $2,033,325 in 2008 and includes the
amortization of the grant date fair value of stock options granted to employees, consultants and
spokespersons over the relevant service periods. The decline is
primarily the result of options expiring in the 2008 period.
Depreciation and amortization expense decreased to $1,000,027 in 2009 from $1,053,313 in 2008,
primarily due to the impairment of the client list in June of 2008. The client list amortization
was included in the 2008 period, but not in the 2009 period. However, the increase in the
depreciation of our property and equipment minimized the decrease in the amortization of our
intangibles.
R&D costs amounted to $69,140 in 2009 and $169,217 in 2008. These include contract services,
supplies, materials and analytical testing costs incurred for new products to be developed by the
Company. R&D costs have declined due to a limitation of available funding.
25
Other Income (Expense)
Interest expense increased from $36,960 in 2008 to $301,071 in 2009 as a result of the
increase in debt after the end of the June 2008 quarter.
During the second quarter of 2009 the Company was able to settle a debt with a former customer
which resulted in a gain of $440,331.
Liquidity, Capital Resources and Going Concern
At September 30, 2009, we had negative working capital of $3.7 million compared to working
capital deficit of $2.7 million at December 31, 2008. However, our liquidity had substantially
decreased. At September 30, 2009, we had cash and cash equivalents of $25,443 compared to $433,573
at December 31, 2008. In addition, at September 30, 2009, accounts receivable were $97,257,
compared to $486,967 at December 31, 2008. In addition, the Company has $450,000 of convertible
promissory notes that were due by September 30, 2009 and an additional $625,000 due by March 31,
2010.
For the nine months ended September 30, 2009, operating activities consumed $1,087,752 of
cash. This was primarily the result of a net loss for the period of
$4.5 million, offset by
non-cash compensation expenses of $466,726, depreciation and amortization of $1,000,027 during the
period, asset impairment of $4,000,000 and a gain on change in fair
value of derivative liability of $2,732,608.
Investment activities used an additional $162,134 of cash during the nine months ended
September 30, 2009, primarily as a result of payments for patent costs and property and equipment.
As of September 30, 2009, we did not have any significant commitments for capital expenditures.
Financing activities provided $841,756 of cash during the nine months ended September 30,
2009, primarily as the result from sales of common stock and proceeds from loans.
We are not currently generating sufficient income or cash flow to fund current operations.
Sales of product amounted to $2,215,181 during the first, second and third quarters of 2009. The
Company is continually analyzing its current costs and is attempting to make additional cost
reductions where possible. However, in order to support the Companys current level of operations,
substantial additional sales will be required. We expect that we will continue incurring losses
from operations through the remainder of 2009. In order to fund the Companys current business
plan, we expect to need an additional $2 million to $4 million of capital, which we hope to secure
through the sale of debt or equity securities to investors or strategic partners.
Other than cash and cash equivalents and cash flow provided by operations, our primary source
of working capital has been financing activities through the sale of debt or equity securities. We
do not have any unused sources of credit presently available to us. We intend to secure additional
working capital through the sale of debt or equity securities.
On August 13, 2009, our Innozen subsidiary entered into a Manufacturing Agreement with SMI
which contained a subscription agreement pursuant to which SMI has agreed to purchase an aggregate
of 4,255,320 shares of the Companys common stock at a purchase price of $1 million or $0.235 per
share. Payment of the purchase price was to be made on the basis of $150,000 on signing the
Manufacturing Agreement, $150,000 on each of September 15, October 15 and November 15, 2009 and the
remaining $400,000 is to be paid on or before December 31, 2009. SMI has made the contracted
payments through October 15, 2009. The subscription agreement is subject to cancellation contingent on the
closing of the Stock Purchase Agreement as discussed herein.
26
On November 6, 2009 we entered into a Stock Purchase Agreement with SMI which provides for SMI
to purchase an aggregate of 66,666,667 shares of our common stock for a purchase price of $10
million or $0.15 per share. The purchase price is to be paid $2 million on closing and $8 million
through delivery of a promissory note. The note bears interest at 4% per annum and matures on June
30, 2010. SMIs payment obligations under the promissory note are secured by a pledge of the
purchased common stock. We anticipate that the proceeds from the SMI Financing would be sufficient
to meet our operating requirements for at least the next 12 months. The closing of the
transactions contemplated by the Stock Purchase Agreement is subject to customary conditions, and
no assurances can be given that those conditions will be met, or waived, or that the transactions
contemplated by the stock purchase agreement will occur. If the SMI Financing does occur, it will
supersede and cancel the final payments under the subscription portion of the Management Agreement.
No other arrangements or commitments for any such financing are in place at this time, and we
cannot give any assurances about the availability or terms of any future financing. We believe the
recent worldwide financial crisis has significantly decreased the market for private financing.
The number of investment funds committing capital to microcap issuers has decreased, and costs for
financing both debt and equity have increased.
Because of our history of net losses and our negative working capital position, our
independent auditors, in their report on our financial statements for the year ended December 31,
2008, expressed substantial doubt about our ability to continue as a going concern.
Recent Accounting Pronouncements
Please see the section entitled Recent Accounting Pronouncements contained in Note 1
Basis of Presentation to our financial statements included in Part IItem 1. Financial
Statements of this report.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, as defined in Item 303(a)(4)(ii) of
Regulation S-K promulgated under the Securities Act of 1933.
Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Intentionally omitted pursuant to Item 305(e) of Regulation S-K.
Item 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to provide reasonable
assurance that material information is: (1) gathered and communicated to our management, including
our principal executive and financial officers, on a timely basis; and (2) recorded, processed,
summarized, reported and filed with the SEC as required under the Securities Exchange Act of 1934,
as amended.
27
Our management, with the participation of our chief executive officer and chief financial
officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30,
2009. Based on such evaluation, our chief executive officer and chief financial officer concluded
that our disclosure controls and procedures were effective for their intended purpose described
above.
Changes in Internal Controls Over Financial Reporting
In our annual report on Form 10-K for the year ended December 31, 2008, management reported on
weaknesses that it identified in the Companys internal control over financial reporting as of
December 31, 2008. The matters involving internal controls and procedures that our management
considered to be material weaknesses under the standards of the Public Company Accounting Oversight
Board were: (1) lack of a functioning audit committee due to a lack of a majority of independent
members and a lack of a majority of outside directors on our board of directors, resulting in
ineffective oversight in the establishment and monitoring of required internal controls and
procedures; (2) the Company has not maintained perpetual inventory records at its subsidiary
location in California and has not maintained adequate control of inventory stored off-site at a
third-party warehouse and (3) inadequate segregation of duties consistent with control objectives.
Management reported in the annual report on Form 10-K that its effort to remediate the
identified material weaknesses and other deficiencies and enhance our internal controls, included a
plan to implement a fully functioning perpetual inventory system for the Companys inventory and to
appoint two or more outside directors to be appointed to the audit committee. We added additional
outside directors and formed an audit committee of our board of directors during the second quarter
of 2009. Our limited resources do not currently permit us to adequately segregate duties
consistent with control objectives.
We undertook the following changes in our internal controls financial reporting during the
third quarter period covered by this report:
|
|
|
We continued implementation of a new perpetual inventory management system. That
system is expected to be fully implemented by the end of 2009. |
Limitations On Disclosure Controls And Procedures
Our management, including our chief executive officer and chief financial officer, does not
expect that our disclosure controls or internal controls over financial reporting will prevent all
errors or all instances of fraud. A control system, no matter how well designed and operated, can
provide only reasonable, not absolute, assurance that the control systems objectives will be met.
Further, the design of a control system must reflect the fact that there are resource constraints,
and the benefits of controls must be considered relative to their costs. Because of the inherent
limitations in all control systems, no evaluation of controls can provide absolute assurance that
all control issues and instances of fraud, if any, within our company have been detected. These
inherent limitations include the realities that judgments in decision-making can be faulty, and
that breakdowns can occur because of simple error or mistake. Controls can also be circumvented by
the individual acts of some persons, by collusion of two or more people, or by management override
of the controls. The design of any system of controls is based in part upon certain assumptions
about the likelihood of future events, and any design may not succeed in achieving its stated goals
under all potential future conditions. Over time, controls may become inadequate because of changes
in conditions or deterioration in the degree of compliance with policies or
procedures. Because of the inherent limitation of a cost-effective control system,
misstatements due to error or fraud may occur and not be detected.
28
PART IIOTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
From time to time, we may be involved in litigation relating to claims arising out of our
operations in the normal course of business, including claims of alleged infringement, misuse or
misappropriation of intellectual property rights of third parties. As of the date of this report,
except for as discussed below, we are not a party to any litigation which we believe would have a
material adverse effect on our business operations or financial condition.
On October 30, 2007, our wholly-owned subsidiary, Enlyten, Inc., filed a lawsuit against The
Gatorade Company and PepsiCo, Inc. (collectively referred to as Gatorade) in the State of New York
Supreme Court, County of Erie. The Complaint alleges that Gatorade has tortiously interfered with
Enlytens contractual agreement with the Buffalo Bills and with Enlytens business relationships
with various third parties including other NFL teams, in an attempt to wrongfully restrain trade.
Enlyten is represented by the law firm of Phillips Lytle, LLP in Buffalo, New York. The alleged
interference has severely limited our ability to market and sell the Sport Strip branded product.
The case is still in the discovery phase. On November 21, 2008, the Company was forced to bring a
motion to compel discovery from the defendants and, on February 24, 2009, the Court ordered the
defendant to produce discovery within 60 days. Defendant did subsequently produce discovery during
this time period. The next stage of the discovery process will involve the scheduling of
depositions.
On June 29, 2009, Robert Kusher filed suit against the Company in Circuit Court for the
Seventh District in Broward County, Florida. Mr. Kusher served as chief executive officer of the
Company from March 2008 until August 2008. In August 2008 the Company issued an 8-K announcing
that Mr. Kusher had resigned his position. The complaint alleges that Mr. Kusher never resigned
from his position as chief executive officer. It asserts claims against the Company for breach of
contract, and fraudulent inducement of employment. The complaint requests damages of $450,000,
plus the issuance of 500,000 shares of the Companys common stock, plus 1,000,000 options to
purchase common stock at $1.00, plus 1,000,000 options to purchase common stock at $1.50. The
Company intends to file a responsive pleading in this action and to defend this lawsuit.
On October 22, 2009, Schering-Plough S.A. de C.V. (Schering) issued a demand letter
requesting payment of $150,000. The dispute arises out of an exclusive distribution agreement that
the Company entered into with Schering on June 27, 2007. The exclusive distribution agreement has
not been fully performed and Schering is demanding the refund of a $150,000 payment that it made
for future research and development and purchases of products. In its demand letter, Schering
states that it intends to demand an arbitration proceeding in an effort to recover the disputed
$150,000. The Company intends to respond to this demand and to defend this action.
On October 28, 2009, Perkins Coie, LLP (Perkins), issued a demand letter requesting payment
of approximately $285,000. Perkins is a law firm that has provided services to the Company related
to the companys intellectual property The payment demanded relates to unpaid balances for
professional services on an open account with Perkins. In the letter, Perkins threatens to
initiate legal proceedings against the Company to collect the unpaid account. The Company intends
to settle this matter out of investment proceeds that we hope to secure in the next ninety (90)
days.
29
Item 1A. RISK FACTORS
Investment in our common stock involves a high degree of risk. Please carefully consider the
risks described below, in addition to the other information set forth in this report, before making
an investment decision. These risks and uncertainties have the potential to materially affect our
business, financial condition, results of operations, cash flows, projected results and future
prospects. If any of the following risks actually occur, our business, financial condition or
results of operations could suffer. In that case, the value of our common stock could decline, and
you may lose all or part of your investment. The risk factors described below are not exhaustive.
These risk factors represent only some of the risks associated with investment in our common stock.
We have experienced significant losses to date. If our business model is not successful, or if we
are unable to generate sufficient revenue to offset our expenditures, then we may not become
profitable and you may lose your entire investment in our company.
We have not been profitable on a quarterly or annual basis since the adoption of our thin film
pharmaceutical product business plan. Our operations resulted in a net loss of $8.9 million for
the year ended December 31, 2008, and $9.8 million for the year ended December 31, 2007. As of
December 31, 2008, our accumulated deficit was $42.5 million. We expect to make significant future
expenditures related to the development and expansion of our business. In addition, as a public
company, we will incur significant legal, accounting, and other expenses that private companies do
not incur. As a result of these increased expenditures, we will have to generate and sustain
increased revenue to achieve and maintain future profitability.
While our revenue has grown somewhat in recent periods, that growth has not been significant
and future revenue growth may not be sustainable and we may not achieve sufficient revenue to
achieve profitability. We have incurred and may continue to incur significant losses in the future
for a number of reasons, including due to the other risks described in this report, and we may
encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors.
Accordingly, we may not be able to achieve profitability and we may continue to incur significant
losses for the foreseeable future.
We have entered into a Stock Purchase Agreement with SMI which, upon closing, would require us to
sell sufficient shares of common stock to effect a change in control of the Company and require us
to appoint nominees of SMI to occupy a majority of the seats on our Board of Directors.
Under the terms of our Stock Purchase Agreement with SMI, at closing we are required to issue
to SMI 66,666,667 shares of our common stock, which will constitute more than 50% of the
outstanding voting stock of the Company. The Stock Purchase Agreement also entitles SMI to
nominate four of seven directors on our board of directors. SMI will therefore own a majority of
our common stock and will appoint a majority of our board of directors. As a result, if the SMI
Financing closes, SMI will be able to influence the outcome of stockholder votes on various
matters, including the election of directors and extraordinary corporate transactions, including
business combinations.
The interests of SMI may differ from other stockholders. Furthermore, if the SMI Financing
transaction closes, SMIs concentration of ownership in our common stock will reduce the percentage
of our company held in the public float, which may impact the liquidity and market price of our
common stock.
30
The Stock Purchase Agreement with SMI provides for anti-dilution protection, requiring us to issue
additional shares of common stock to SMI upon the occurrence of certain events. Any such issuance
may dilute your ownership interest in the Company.
In addition to the issuance of the 66,666,667 shares of common stock, the Stock Purchase
Agreement provides for the issuance of additional shares of common stock in the following
circumstances:
1. Exercise or Conversion of Outstanding Convertible Securities. If at any time after the
Closing, but prior to June 30, 2011, the Shares (plus any other shares of common stock issued to
SMI pursuant to the following paragraph) equal less than 55% of the Deemed Outstanding (as defined
below), then, provided that all amounts then currently due under the Promissory Note have been paid
in full and the Promissory Note is not otherwise in default, the Company is required to issue to
SMI, without additional consideration, such number of additional shares of common stock such that
the Shares together with the shares issued pursuant to this paragraph and the following paragraph
(collectively, the Supplemental Shares) shall equal 55% of the Deemed Outstanding. For purposes
of this paragraph, the Deemed Outstanding as of any particular date shall mean the shares of the
Companys common stock then issued and outstanding, excluding all shares of common stock issued
after the Closing other than (a) the Supplemental Shares and (b) issuances of common stock
resulting from the exercise or conversion of options, warrants or other derivative securities
(whether debt or equity) that were either (x) outstanding as of the Closing or (y) reserved for
issuance, as of the Closing, under any stock option plan, restricted stock plan, or other stock
plan.
2. Undisclosed Liabilities. In the event the Company has failed to disclose certain
liabilities (which undisclosed liabilities must exceed $100,000 individually and $300,000 in the
aggregate) in connection with the SMI Financing, the Company shall be required to issue to SMI,
without additional consideration, such number of Supplemental Shares as is equal to 55% of the
total amount of those undisclosed liabilities. For purposes of this paragraph, certain pending
lawsuits against the Company are deemed to be undisclosed and the fees, costs and other amounts
paid by the Company as a result of such lawsuits shall require the issuance of additional shares
hereunder provided the dollar thresholds referenced above have been met.
3. Other Dilutive Issuances. If on June 30, 2010, the Shares plus any Supplemental Shares
equal less than 55% of the Companys common stock issued and outstanding as of June 30, 2010, then,
provided the Promissory Note has been paid in full, SMI shall have the right and option to purchase
such number of additional shares of common stock (the Option Shares) such that the Shares
together with all Supplemental Shares and the Option Shares shall equal 55% of the Companys common
stock issued and outstanding as of June 30, 2010. The purchase price for the Option Shares shall
be $.15 per share (as adjusted for stock splits, stock dividends and recapitalizations). The right
to purchase Option Shares hereunder shall expire on August 31, 2010.
The issuance of shares pursuant to any of these provisions could result in substantial
dilution to our existing stockholders.
31
Our limited operating history may not serve as an adequate basis to judge our future prospects
and results of operations. We are subject to the risks and uncertainties of an early stage
company..
The Company was incorporated in 1985 but we did not adopt our current business plan relating
to edible film strip technology and for the development, manufacture, distribution, licensing and
sale of edible thin film products containing dietary supplement and drug active ingredients until
2006. Our limited operating history in the field of edible thin film technology and products may
not provide a meaningful basis on which to evaluate our business. We will continue to encounter
risks and difficulties frequently experienced by companies at a similar stage of development,
including our potential failure to:
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maintain and improve our technology; |
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|
|
expand our product and service offerings and maintain the high quality of products
and services offered; |
|
|
|
|
manage our expanding operations, including the integration of any future
acquisitions; |
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|
|
obtain sufficient working capital to support our expansion and to fill customers
orders on time; |
|
|
|
|
maintain adequate control of our expenses; |
|
|
|
|
implement our product development, marketing, sales, and acquisition strategies and
adapt and modify them as needed; and |
|
|
|
|
anticipate and adapt to changing conditions in the markets in which we operate as
well as the impact of any changes in government regulation, mergers and acquisitions
involving our competitors, technological developments, and other significant
competitive and market dynamics. |
If we are not successful in addressing any or all of these risks, then our business may be
materially and adversely affected.
Our auditors have expressed substantial doubt regarding our ability to continue as a going concern.
As of the date of our most recent audit, which included the fiscal years ended December 31,
2008 and December 31, 2007, we had not generated sufficient revenues to meet our cash flow needs.
In their audit report for those periods, our auditors expressed substantial doubt about our ability
to continue as a going concern. We cannot assure you that we will be able to obtain sufficient
funds from our operating or financing activities to support our continued operations. If we cannot
continue as a going concern, we may need to substantially revise our business plan or cease
operations, which may reduce or negate the value of your investment.
We require additional capital in order to fund our operating expenses, and if we fail to raise
sufficient additional capital we may be forced to curtail or cease operations.
Our continued operation is dependent upon our ability to raise capital from outside sources.
We have entered into arrangements to provide additional working capital to support our operations,
but those arrangements are subject to conditions and we cannot provide you with any assurance that
we will meet those conditions or that the financings will close.
Our ability to secure any other financing will depend upon a number of factors, including our
financial condition, business operations and prospects, as well as general economic conditions, and
conditions in the relevant financial markets. We cannot assure you that we will be able to secure
financing, as needed, and if we cannot we will be forced to curtail or cease operations. Moreover,
even if we identify a possible financing, the terms may not be favorable to us, or may involve
substantial dilution to our existing stockholders.
32
Our board of directors has the right to issue additional shares of common stock or preferred stock,
without stockholder consent, which could have the effect of creating substantial dilution or
impeding or discouraging a takeover transaction.
Pursuant to our certificate of incorporation, our board of directors may issue additional
shares of common or preferred stock. Any additional issuance of common stock or the issuance of
preferred stock could have the effect of impeding or discouraging the acquisition of control of us
by means of a merger, tender offer, proxy contest or otherwise, including a transaction in which
our stockholders would receive a premium over the market price for their shares, thereby protecting
the continuity of our management. Specifically, if in the due exercise of its fiduciary
obligations, our board of directors was to determine that a takeover proposal was not in the best
interest of the Company or our stockholders, shares could be issued by our board of directors
without stockholder approval in one or more transactions that might prevent or render more
difficult or costly the completion of the takeover by:
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|
|
diluting the voting or other rights of the proposed acquirer or insurgent
stockholder group; |
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|
diluting the voting or other rights of the proposed acquirer or insurgent
stockholder group; |
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|
putting a substantial voting block in institutional or other hands that might
undertake to support the incumbent board of directors; or |
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|
effecting an acquisition that might complicate or preclude the takeover |
We may encounter substantial competition in our business and our failure to compete effectively may
adversely affect our ability to generate revenue.
We believe that existing and new competitors will continue to improve the design and
performance of their products and to introduce new products with competitive price and performance
characteristics. We expect that we will be required to continue to invest in product development
and productivity improvements to compete effectively in our markets.
Our competitors may have substantially greater resources than us. They may be able to take
advantage of new technologies or products or undertake more aggressive and costly marketing
campaigns than ours, which may adversely affect our marketing strategies and could have a material
adverse effect on our business, results of operations, and financial condition.
We may not be able to prevent others from unauthorized use of our patents and other intellectual
property, which could harm our business and competitive position.
We rely on a combination of patent, copyright, service mark, trademark, and trade secret laws,
as well as confidentiality procedures and contractual restrictions, to establish and protect our
proprietary rights on a global basis, all of which provide only limited protection.
We own multiple filed United States and foreign patent applications covering our technology
and we expect to file more U.S. and foreign patent applications in the future. But the process of
seeking patent protection can be lengthy and expensive and we cannot assure that our patent
applications will result in patents being issued, or that our existing or future issued patents
will be sufficient to provide us with meaningful protection or commercial advantages. Since the
filing of some of these patent applications may have been, or will be, made after the date of first
sale or disclosure of the subject inventions, patent protection may not be available for these
inventions outside the United States.
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We also cannot assure that our current or potential competitors do not have, and will not
obtain, patents that will prevent, limit or interfere with our ability to make, use or sell our
technology.
Assertions by third parties that we infringe their intellectual property, whether successful or
not, could subject us to costly and time-consuming litigation or expensive licenses.
The medical device and pharmaceutical industries are characterized by the existence of a large
number of patents, copyrights, trademarks, and trade secrets and by frequent litigation based on
allegations of infringement or other violations of intellectual property rights. We cannot assure
you that our technologies do not infringe upon the intellectual property rights of others. If we
succeed in our business plan, the economic reward, and therefore the possibility that someone would
bring an intellectual property rights claims against will grow. The costs of defending
intellectual property infringement claims can be very large. Any intellectual property rights
claim against us, with or without merit, could be time-consuming, expensive to litigate or settle,
and could divert management attention and financial resources.
For any intellectual property rights claim against us we may have substantial direct and
indirect costs. Direct costs can include a requirement to pay damages or stop using technology
found to be in violation of a third partys rights. We may have to purchase a license for the
technology, which may not be available on reasonable terms, if at all, may significantly increase
our operating expenses, or may require us to restrict our business activities in one or more
respects. As a result, we may also be required to develop alternative non-infringing technology,
which could require significant effort and expense. Substantial indirect costs also may be
expected in the form of diversion of development and management resources in strategic planning for
legal, technology, and business defenses to such claims.
We are substantially dependent on third party distributors for the sale of our products.
Since 2008, substantially all of our product recent product sales have come through two
distributors. On March 11, 2008 we entered into a five year distribution agreement with Perrigo
Florida, Inc. which sells our products through a number of retail and pharmaceutical channels. On
September 11, 2008, we entered into a distribution agreement with T. Lynn Mitchell Companies LLC to
distribute certain products containing our bi-layered strip technology. During the third quarter
of 2009, we entered into a strategic alliance with Destiny Productions LLC and Content Marketing
Solutions, Inc. to provide additional strategic marketing, and distribution services for our
products.
We expect to continue to rely on the sales efforts of third party distributors for our
products. Our distributors are not exclusive to us and distribute other products from other
manufacturers. We do not have the ability to exercise control over the actions of our distributors
in the same manner that we would an internal sales team. If those distributors decide to terminate
their arrangements with us, or fail to exert substantial efforts on our behalf, our revenues and
results of operations will be significantly impacted.
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If we fail to maintain proper and effective internal controls over financial reporting or are
unable to remediate the material weakness in our internal controls, then our ability to produce
accurate and timely financial statements could be impaired and investors views of us could be
harmed.
Our internal control over financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements in accordance with generally accepted accounting principles. Implementing and
maintaining a system of internal controls over accounting and financial reporting is a costly and
time-consuming effort that needs to be re-evaluated frequently.
Implementing any appropriate changes to our internal controls may entail substantial
management time, costs to modify our existing processes, and take significant time to complete.
These changes may not, however, be effective in maintaining the adequacy of our internal controls,
and any failure to maintain that adequacy, or consequent inability to produce accurate financial
statements on a timely basis, could increase our operating costs and harm our business. In
addition, investors perceptions that our internal controls are inadequate or that we are unable to
produce accurate financial statements on a timely basis may harm our stock price and make it more
difficult for us to effectively market and distribute our products and services to new and existing
customers.
We are responsible for the indemnification of our officers and directors.
Our articles of incorporation and bylaws provide for the indemnification of our directors,
officers, employees, and agents, and, under certain circumstances, against costs and expenses
incurred by them in any litigation to which they become a party arising from their association with
or activities on our behalf. Consequently, if a claim is brought against any of our officers or
directors, we may be required to expend substantial funds to satisfy these indemnity obligations.
We have never paid dividends on our capital stock and we do not anticipate paying any cash
dividends in the foreseeable future.
We have paid no cash dividends on any of our classes of capital stock to date and we currently
intend to retain our future earnings, if any, to fund the development and growth of our business.
A material part of our growth strategy is the application of our technology to the drug delivery
market, but we do not have prior experience in this market and will not be successful if
pharmaceutical companies or consumers do not adopt our new products.
We plan to increase revenues and secure strategic distribution relationships by partnering
with pharmaceutical companies to use our thin film technology as a drug delivery method. To
succeed, we must secure the pharmaceutical communitys acceptance of our products. Even if we
successfully secure a relationship with a pharmaceutical company, we cannot provide assurance that
the end consumer will accept our products. Potential consumers of our products must:
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believe that our products offer benefits compared to the products that they are
currently using; |
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use our products and obtain acceptable results; |
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believe that our products are worth the price that they will be asked to pay; and |
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be willing to commit the time and resources required to change their current
purchasing. |
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Because we have a limited history of sales and are selling a relatively novel product, we have
limited ability to predict the level of growth or timing in sales of these efforts.
We may have to compete against new technologies developed by competitors. New technologies we
develop may not gain market acceptance by customers, or may not perform to expectations and result
in liability to us.
The medical device and pharmaceutical industries are subject to technological change as
competitors seek to identify more effective or cheaper treatments. Our future success will depend
on our ability to appropriately respond to changing technologies and changes in function of
products and quality. If we adopt products and technologies that are not attractive to consumers,
we may not be successful in capturing or retaining a significant share of our market. In addition,
some new technologies are relatively untested and unperfected and may not perform as expected or as
desired, in which event our adoption of such products or technologies may cause us to lose money in
extended development costs or product liability claims.
We may face product liability claims that could result in costly litigation and significant
liabilities.
The manufacture and sale of dietary supplement, medical and pharmaceutical products entail
significant risk of product liability claims. Any product liability claims, with or without merit,
could result in costly litigation, reduced sales, cause us to incur significant liabilities and
divert our managements time, attention and resources. Because of our limited operating history
and lack of experience with these claims, we cannot be sure that our product liability insurance
coverage is adequate or that it will continue to be available to us on acceptable terms, if at all.
Our products and our manufacturing activities are subject to extensive governmental regulation that
could prevent us from selling our products in the United States or introducing new and improved
products.
Our products and our manufacturing activities are subject to extensive regulation by a number
of governmental agencies, including the FDA and comparable international agencies. We are required
to:
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obtain the clearance of the FDA and international agencies before we can market and
sell our products; |
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satisfy these agencies content requirements for all of our labeling, sales and
promotional materials; and |
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undergo rigorous inspections by these agencies. |
Compliance with the regulations of these agencies may delay or prevent us from introducing any new
model of our existing products or other new products. Furthermore, we may be subject to sanctions,
including temporary or permanent suspension of operations, product recalls and marketing
restrictions if we fail to comply with the laws and regulations pertaining to our business. We are
also required to demonstrate compliance with the FDAs quality system regulations. The FDA
enforces its quality system regulations through pre-approval and periodic post-approval
inspections. These regulations relate to product testing, vendor qualification, design control and
quality assurance, as well as the maintenance of records and documentation. If we are unable to
conform to these regulations, the FDA may take actions which could seriously harm our business. In
addition, government regulation may be established that could prevent, delay, modify or rescind
regulatory clearance or approval of our products.
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Our securities trade on the Over-the-Counter Bulletin Board, which may not provide liquidity for
our investors and may increase volatility in our stock price.
Our common stock is quoted on the Over-the-Counter Bulletin Board. The Over-the-Counter
Bulletin Board is an inter-dealer, over-the-counter market that provides significantly less
liquidity than the NASDAQ Stock Market or other national exchanges. Securities traded on the
Over-the-Counter Bulletin Board are usually thinly traded, and as a consequence exhibit a broader
spread between the bid and ask price than stock traded on national exchanges. Securities traded on
the Over-the-Counter Bulletin Board can be highly volatile, have fewer market makers, and may not
be followed by analysts.
Our stock price may be volatile and you may not be able to sell your shares for more than what you
paid.
Our stock price is likely to be subject to significant volatility and you may not be able to
sell shares of common stock at or above the price you paid for them. The market price of our
common stock could continue to fluctuate in the future in response to various factors including:
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quarterly variations in operating results; |
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our ability to control costs and improve cash flow; |
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the occurrence of unanticipated costs or liabilities; |
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announcements of technological innovations or new products by us or our competitors;
and |
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changes in investor perceptions. |
The stock market in general has continued to experience volatility, which may further affect
our stock price. As such, you may not be able to resell your shares of common stock at or above
the price you paid for them.
Our common stock is subject to penny stock rules.
Our common stock is subject to Rule 15g-1 through 15g-9 under the Exchange Act, which imposes
certain sales practice requirements on broker-dealers which sell our common stock to persons other
than established customers and accredited investors (generally, individuals with a net worth in
excess of $1 million or annual incomes exceeding $200,000 or $300,000 thousand together with their
spouses). For transactions covered by this rule, a broker-dealer must make a special suitability
determination for the purchaser and have received the purchasers written consent to the
transaction prior to the sale. This rule adversely affects the ability of broker-dealers to sell
our common stock and purchasers of our common stock to sell their shares of such common stock.
Additionally, our common stock is subject to the SEC regulations for penny stock.
Penny stock includes any equity security that is not listed on a national exchange and has a market
price of less than $5.00 per share, subject to certain exceptions. The regulations require that
prior to any non-exempt buy/sell transaction in a penny stock, a disclosure schedule set forth by
the SEC relating to the penny stock market must be delivered to the purchaser of such penny stock.
This disclosure must include the amount of commissions payable to both the broker-dealer and the
registered representative and current price quotations for the common stock. The regulations also
require that monthly statements be sent to holders of penny stock which disclose recent price
information for the penny stock and information of the limited market for penny stocks. These
requirements adversely affect the market liquidity of our common stock.
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Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
The Company sold 400,000 shares of its common stock for $80,000 in cash to an accredited investor
in a private placement transaction during the three months ended September 30, 2009.
The Company issued 100,000 shares of its common stock in exchange for cancellation of a note
payable of $15,000 during the three months ended September 30, 2009.
The Company sold 1,276,596 shares of common stock for $300,000 in cash to SMI under the terms
of the Manufacturing Agreement.
All of the shares issued in the foregoing transactions were sold pursuant to an exemption from
registration under Section 4(2) promulgated under the Securities Act of 1933, as amended.
Item 3. DEFAULTS UPON SENIOR SECURITIES.
We have secured convertible promissory notes outstanding at September 30, 2009 in the
aggregate principal amount of $1,075,000. We have not made the scheduled interest payments on the
promissory notes. During the third quarter we amended promissory notes in the principal amount of
$625,000 to (i) extend the maturity date to March 31, 2010, and (ii) waive the payment defaults.
We did not amend $450,000 of aggregate principal amount of promissory notes, and continue to be in
default on their payment terms. The amount of accrued and unpaid interest under all of these
promissory notes at September 30, 2009 was $97,443. However, as a result of the default, the
holders of the promissory notes have the right to demand payment in full of all amounts outstanding
under those promissory notes.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
None.
Item 5. OTHER INFORMATION.
None.
Item 6. EXHIBITS.
See the exhibit index immediately following the signature page of this report.
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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.
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HEALTHSPORT, INC.
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Date: November 16, 2009 |
/s/ M.E. Hank Durschlag
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M.E. Hank Durschlag, Chief Executive Officer |
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(Duly Authorized Officer and Principal Executive
Officer) |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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4.1(1)
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Form of Promissory Note in the principal amount of $8 million issued by Supplemental
Manufacturing Ingredients, LLC |
10.1(1)
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Stock Purchase Agreement dated November 6, 2009 between the registrant and Supplemental
Manufacturing Ingredients, LLC |
10.2(1)
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Form of Pledge Agreement between the registrant and Supplemental Manufacturing Ingredients, LLC. |
10.3(1)
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Separation Agreement by and between the Company and M.E. Hank Durschlag dated November 4, 2009 |
10.4(1)
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Separation Agreement by and between the Company and Jeffrey Wattenberg dated November 6, 2009 |
10.5(1)
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Separation Agreement by and between the Company and Daniel Kelly dated November 4, 2009 |
10.6(1)
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Separation Agreement by and between the Company and Anthony Seaber dated November 4, 2009 |
10.7(1)
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Separation Agreement by and between the Company and Matthew Burns dated November 4, 2009 |
10.8(1)
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Employment Agreement by and between the Company and Robert Davidson dated November 4, 2009 |
10.9(1)
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Employment Agreement by and between the Company and Thomas Beckett dated November 4, 2009 |
31.1*
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Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the
Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002. |
31.2*
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Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the
Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002. |
32.1**
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Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
32.2**
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Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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* |
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Filed with this report |
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** |
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Furnished with this report |
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(1) |
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Incorporated by reference to the exhibits to the registrants current report on form 8-K filed with the Securities and
Exchange Commission on November 10, 2009 |
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