UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-QSB
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[X]
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Quarterly
Report pursuant to Section 13 or 15(d) of the Securities Exchange
Act of
1934
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For
the quarterly period ended March
31, 2006
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[
]
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Transition
Report pursuant to 13 or 15(d) of the Securities Exchange Act of
1934
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For
the transition period _________
to
__________
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Commission
File Number: 000-25911
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Skinvisible,
Inc.
(Exact
name of small business issuer as specified in its charter)
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Nevada
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88-0344219
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(State
or other jurisdiction of incorporation or organization)
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(IRS
Employer Identification No.)
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6320
Sandhill Road, Suite 10, Las Vegas, Nevada 89120
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(Address
of principal executive offices)
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702-433-7154
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(Issuer’s
telephone number)
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_______________________________________________________________
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(Former
name, former address and former fiscal year, if changed since last
report)
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Check
whether the issuer (1) 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 issuer was required to file such reports),
and
(2) has been subject to such filing requirements for the past 90 days [X] Yes
[
] No
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). [ ] Yes [X] No
State
the
number of shares outstanding of each of the issuer’s classes of common stock, as
of the latest practicable date: 60,077,748 common shares as of March 31,
2006.
Transitional
Small Business Disclosure Format (check one): Yes [ ] No [X]
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Page
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Our
unaudited consolidated
financial statements included in this Form 10-QSB are as
follows:
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These
unaudited consolidated financial statements have been prepared in accordance
with accounting principles generally accepted in the United States of America
for interim financial information and the SEC instructions to Form 10-QSB.
In
the opinion of management, all adjustments considered necessary for a fair
presentation have been included. Operating results for the interim period ended
March 31, 2006 are not necessarily indicative of the results that can be
expected for the full year.
CONSOLIDATED
BALANCE SHEET
(UNAUDITED)
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ASSETS
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March
31, 2006
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Current
assets
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||
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Cash
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$
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79,993
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Accounts
receivable
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179,147
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Inventory
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59,871
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Due
from related party
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214
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Prepaid
expense and other current assets
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5,962
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Total
current assets
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325,187
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Fixed
assets, net
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22,608
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Intangible
and other assets
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||
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Patents
and trademarks, net
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48,874
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License
and distributor rights
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50,000
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Prepaid
royalty fees
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840,000
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Total
assets
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$
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1,286,669
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LIABILITIES
AND STOCKHOLDERS' DEFICIT
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||
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Current
liabilities
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||
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Accounts
payable and accrued liabilities
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$
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272,386
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Unearned
revenue
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1,036,000
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Total
current liabilities
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1,308,386
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Long-term
liabilities
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--
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Total
liabilities
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1,308,386
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Commitments
and contingencies
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--
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Stockholders'
deficit
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||
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Common
stock; $0.001 par value; 100,000,000 shares
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||
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60,077,748
shares issued and outstanding
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60,078
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Additional
paid-in capital
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12,480,171
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Stock
subscription receivable
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4,500
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Accumulated
deficit
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(12,566,466)
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Total
stockholders' deficit
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(21,717)
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Total
liabilities and stockholders' deficit
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$
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1,286,669
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See
accompanying Notes to Consolidated Financial Statements
CONSOLIDATED
STATEMENT OF OPERATIONS
(UNAUDITED)
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For
the three months ended
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For
the three months ended
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|||
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March
31, 2006
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March
31, 2005
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Revenues
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$
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235,167
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$
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254,730
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Cost
of revenues
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21,321
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70,065
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|||
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Gross
profit
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213,846
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184,665
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|||
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Operating
expenses
|
|||||
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Depreciation
and amortization
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66,692
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68,683
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|||
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Stock
based compensation
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723,399
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198,000
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|||
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Selling
general and administrative
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397,899
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314,771
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Total
operating expenses
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1,187,990
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581,454
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|||
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Loss
before provision for income taxes
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(974,144)
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(396,789)
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Other
income (expense)
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--
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--
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Total
other income (expense)
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--
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--
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Provision
for income taxes
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--
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--
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|||
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Net
loss
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$
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(974,144)
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$
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(396,789)
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Basic
income (loss) per common share
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$
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(0.02)
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$
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(0.01)
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Diluted
income (loss) per common share
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$
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(0.02)
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$
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(0.01)
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Basic
weighted average common
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|||||
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shares
outstanding
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59,141,998
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56,725,248
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|||
See
accompanying Notes to Consolidated Financial Statements
CONSOLIDATED
STATEMENT OF CASH FLOWS
(UNAUDITED)
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For
the three months ended
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For
the three months ended
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|||
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March
31, 2006
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March
31, 2005
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Cash
flows from operating activities:
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|||||
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Net
loss
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$
|
(974,144)
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$
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(396,789)
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Adjustments
to reconcile net loss to net
|
|||||
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cash
provided (used) by operating activities:
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|||||
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Depreciation
and amortization
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66,393
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68,683
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|||
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Stock
based compensation
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723,399
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198,000
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|||
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Changes
in operating assets and liabilities:
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|||||
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Change
in inventory
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13,923
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29,572
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|||
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Change
in accounts receivable
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(51,159)
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(70,229)
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Change
in prepaid expenses and other current assets
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382
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653
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Change
in related party receivable
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4,551
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(5,429)
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|||
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Change
in accounts payable and accrued liabilities
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65,669
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(2,629)
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Change
in unearned revenue
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58,000
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148,000
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Net
cash provided (used) by operating activities
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(92,986)
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(30,168)
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Cash
flows from investing activities:
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|||||
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Purchase
of fixed assets and untangible assets
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--
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(1,599)
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|||
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Net
cash used by investing activities
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--
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(1,599)
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|||
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Cash
flows from financing activities:
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|||||
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Proceeds
from stock subscription payable
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4,500
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--
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|||
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Proceeds
from issuance of common stock
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137,750
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--
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|||
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Net
cash provided by financing activities
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142,250
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--
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|||
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Net
change in cash
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49,264
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(31,767
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|||
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Cash,
beginning of period
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30,729
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92,434
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|||
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Cash,
end of period
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$
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79,993
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$
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60,667
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See
accompanying Notes to Consolidated Financial Statements
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
1.
DESCRIPTION
OF BUSINESS, HISTORY AND SUMMARY OF SIGNIFICANT POLICIES
Description
of business -
Skinvisible, Inc., (referred to as the “Company”) is focused on the development
and manufacture of innovative topical polymer-based delivery system technologies
and formulations incorporating its patent-pending formula/process for combining
hydrophilic and hydrophobic polymer emulsions. The technologies and formulations
have broad industry applications within the pharmaceutical, over-the-counter,
personal skincare and cosmetic arenas. The Company’s antibacterial/antimicrobial
hand sanitizer formulations, available for private label commercialization
opportunities, offer skincare solutions for the healthcare, food service,
industrial, cosmetic and salon industries, as well as for personal use in
the
retail marketplace. The Company maintains manufacturing, executive and sales
offices in Las Vegas, Nevada.
History
-
Skinvisible, Inc. ( referred to as the “Company”) was incorporated in Nevada on
March 6, 1998 under the name of Microbial Solutions, Inc. The Company underwent
a name change on February 26, 1999, when it changed its name to Skinvisible,
Inc. The Company’s subsidiary’s name of Manloe Labs, Inc. was also changed to
Skinvisible Pharmaceuticals, Inc.
During
1999, the Company also formed a subsidiary titled Skinvisible International,
Inc. and Skinvisible Pharmaceuticals (Canada), Inc. On January 1, 2000, the
Company decided to discontinue operations of its subsidiary, Skinvisible
International, Inc.
Skinvisible,
Inc. together with its subsidiaries shall herein be collectively referred
to as
the “Company”.
Going
concern -
The
accompanying financial statements have been prepared on a going concern basis,
which contemplates the realization of assets and the satisfaction of liabilities
in the normal course of business. The Company has incurred cumulative net
losses
of approximately $12,566,500 since its inception and requires capital for
its
contemplated operational and marketing activities to take place. The company’s
ability to raise additional capital through the future issuances of the common
stock is unknown. The obtainment of additional financing, the successful
development of the Company’s contemplated plan of operations, and its
transition, ultimately, to the attainment of profitable operations are necessary
for the Company to continue operations. The ability to successfully resolve
these factors raise substantial doubt about the Company’s ability to continue as
a going concern. The consolidated financial statements of the Company do
not
include any adjustments that may result from the outcome of these aforementioned
uncertainties.
Principles
of consolidation -
The
consolidated financial statements include the accounts of the Company and
its
subsidiaries. All significant intercompany balances and transactions have
been
eliminated.
Definition
of fiscal year -
The
Company’s fiscal year end is December 31.
Use
of
estimates -
The
preparation of consolidated financial statements in conformity with accounting
principles generally accepted in the United States requires management to
make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date
of
the consolidated financial statements and the reported amounts of revenue
and
expenses during the reporting period. Actual results could differ from those
estimates.
Revenue
recognition -
Revenues are recognized during the period in which the revenues are earned.
Costs and expenses are recognized during the period in which they are
incurred.
Inventory
-
Substantially all inventory consist of finished goods and are valued based
upon
first-in first-out ("FIFO") cost, not in excess of market. The determination
of
whether the carrying amount of inventory requires a write-down is based on
an
evaluation of inventory.
SKINVISIBLE,
INC.
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
1.
DESCRIPTION
OF BUSINESS AND SUMMARY OF SIGNIFICANT POLICIES (continued)
Fixed
assets -
Fixed
assets are stated at cost less accumulated depreciation. Depreciation is
provided principally on the straight-line method over the estimated useful
lives
of the assets, which are generally 3 to 10 years. The cost of repairs and
maintenance is charged to expense as incurred. Expenditures for property
betterments and renewals are capitalized. Upon sale or other disposition
of a
depreciable asset, cost and accumulated depreciation are removed from the
accounts and any gain or loss is reflected in other income (expense).
The
Company periodically evaluates whether events and circumstances have occurred
that may warrant revision of the estimated useful life of fixed assets or
whether the remaining balance of fixed assets should be evaluated for possible
impairment. The Company uses an estimate of the related undiscounted cash
flows
over the remaining life of the fixed assets in measuring their recoverability.
Goodwill
and intangible assets -
Beginning January 1, 2002, the Company adopted Statement of Financial Accounting
Standards (“SFAS”) No. 142, “Goodwill and Other Intangible Assets”. According to
this statement, goodwill and intangible assets with indefinite lives are
no
longer subject to amortization, but rather an annual assessment of impairment
by
applying a fair-value based test. Fair value for goodwill is based on discounted
cash flows, market multiples and/or appraised values as appropriate. Under
SFAS
No. 142, the carrying value of assets are calculated at the lowest level
for
which there are identifiable cash flows.
SFAS
142
requires the Company to compare the fair value of the reporting unit to its
carrying amount on an annual basis to determine if there is potential
impairment. If the fair value of the reporting unit is less than its carrying
value, an impairment loss is recorded to the extent that the fair value of
the
goodwill within the reporting unit is less than its carrying value. Upon
adoption and during 2002, the Company completed an impairment review and
did not
recognize any impairment of goodwill and other intangible assets already
included in the financial statements. The Company expects to receive future
benefits from previously acquired goodwill over an indefinite period of time.
Accordingly, beginning January 1, 2002, the Company has foregone all related
amortization expense. Prior to January 1, 2002, the Company amortized goodwill
over an estimated useful life ranging from 3 to 15 years using the straight-line
method.
Fair
value of financial instruments -
Financial accounting standards Statement No. 107, “Disclosure About Fair Value
of Financial Instruments”, requires the Company to disclose, when reasonably
attainable, the fair market values of its assets and liabilities which are
deemed to be financial instruments. The carrying amounts and estimated fair
values of the Company’s financial instruments approximate their fair value due
to the short-term nature.
Earnings
(loss) per share -
Basic
earnings (loss) per share exclude any dilutive effects of options, warrants
and
convertible securities. Basic earnings (loss) per share is computed using
the
weighted-average number of outstanding common stocks during the applicable
period. Diluted earnings per share is computed using the weighted-average
number
of common and common stock equivalent shares outstanding during the period.
Common stock equivalent shares are excluded from the computation if their
effect
is antidilutive.
Income
taxes -
The
Company accounts for its income taxes in accordance with Statement of Financial
Accounting Standards No. 109, which requires recognition of deferred tax
assets
and liabilities for future tax consequences attributable to differences between
the financial statement carrying amounts of existing assets and liabilities
and
their respective tax bases and tax credit carry-forwards. Deferred tax assets
and liabilities are measured using enacted tax rates expected to apply to
taxable income in the years in which those temporary differences are expected
to
be recovered or settled. The effect on deferred tax assets and liabilities
of a
change in tax rates is recognized in income in the period that includes the
enactment date.
Comprehensive
income (loss) -
The
Company has no components of other comprehensive income. Accordingly, net
loss
equals comprehensive loss for all periods.
SKINVISIBLE,
INC.
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
1.
DESCRIPTION
OF BUSINESS AND SUMMARY OF SIGNIFICANT POLICIES (continued)
Segment
information -
The
Company discloses segment information in accordance with Statements of Financial
Accounting Standards (SFAS) No. 131, “Disclosures about Segments of an
Enterprise and Related Information,” which uses the Management approach to
determine reportable segments. The Company operates under one segment.
Advertising
costs -
Advertising costs incurred in the normal course of operations are expensed
as
incurred. During the years ended March 31, 2006 and 2005, the Company incurred
advertising costs totaling $15,860 and $1,549, respectively.
Research
and development costs -
Research and development costs are charged to expense when incurred. Costs
incurred to internally develop the product, including costs incurred during
all
phases of development, are charged to expense as incurred.
Expenses
of offering -
The
Company accounts for specific incremental costs directly to a proposed or
actual
offering of securities as a direct charge against the gross proceeds of the
offering.
Stock-based
compensation -
The
Company applies Accounting Principles Board (“APB”) Opinion No. 25, Accounting
for Stock Issued to Employees, and Related Interpretations, in accounting
for
stock options issued to employees. Under APB No. 25, employee compensation
cost
is recognized when estimated fair value of the underlying stock on date of
the
grant exceeds exercise price of the stock option. For stock options and warrants
issued to non-employees, the Company applies SFAS No. 123, Accounting for
Stock-Based Compensation, which requires the recognition of compensation
cost
based upon the fair value of stock options at the grant date using the
Black-Scholes option pricing model.
The
following table represents the effect on net loss and loss per share if the
Company had applied the fair value based method and recognition provisions
of
Statement of Financial Accounting Standards (SFAS) No. 123, "Accounting for
Stock-Based Compensation", to stock-based employee compensation:
|
March
31, 2005
|
March
31, 2006
|
||||
|
Net
loss, as reported
|
$
|
(396,789)
|
$
|
(974,144)
|
|
|
Add:
Stock-based employee compensation expense
included in reported loss,
net
of related tax effects
|
|
-0-
|
|
-0-
|
|
|
Deduct:
Total stock-based employee
compensation
expense determined under
fair
value based methods for all awards,
net
of related tax effects
|
|
-0-
|
|
-0-
|
|
|
Pro
forma net
loss
|
$
|
(396,789)
|
$
|
(974,144)
|
|
|
Net
loss per common share
Basic
and diluted loss, as
reported
|
$
|
(0.01)
|
$
|
(0.02)
|
|
|
Basic
and diluted loss, pro
forma
|
$
|
(0.01)
|
$
|
(0.02)
|
SKINVISIBLE,
INC.
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
1.
DESCRIPTION
OF BUSINESS AND SUMMARY OF SIGNIFICANT POLICIES (continued)
As
required, the pro forma disclosures above include options granted for periods
ended March 31, 2005 and 2006. Consequently, the effects of applying SFAS
123
for providing pro forma disclosures may not be representative of the effects
on
reported net income for future years until all options outstanding are included
in the pro forma disclosures.
In
December 2003, the FASB issued SFAS No. 148, "Accounting for Stock-Based
Compensation-Transition and Disclosure". SFAS No. 148 amends the transition
and
disclosure provisions of SFAS No. 123. The Company is currently evaluating
SFAS
No. 148 to determine if it will adopt SFAS No. 123 to account for employee
stock
options using the fair value method and, if so, when to begin transition
to that
method.
New
accounting pronouncements
-
In
November 2004, the FASB issued SFAS No. 151, Inventory Costs, an amendment
of
ARB No. 43, Chapter 4. SFAS No. 151 amends the guidance in ARB No. 43, Chapter
4, Inventory Pricing, to clarify the accounting for abnormal amounts of idle
facility expense, freight, handing costs, and spoilage. This statement requires
that those items be recognized as current period charges regardless of whether
they meet the criterion of "so abnormal" which was the criterion specified
in
ARB No. 43. In addition, this Statement requires that allocation of fixed
production overheads to the cost of production be based on normal capacity
of
the production facilities. This pronouncement is effective for the Company
beginning October 1, 2005. The Company does not believe adopting this new
standard will have a significant impact to its financial
statements.
In
December 2004, the FASB issued SFAS No. 123 (revised 2004). Share-Based Payment,
which is a revision of SFAS No. 123, Accounting for Stock-Based Compensation.
SFAS No. 123(R) supersedes APB Opinion No. 25, Accounting for Stock Issued
to
Employees and amends SFAS No. 95, Statement of Cash Flows. Generally, the
approach in SFAS No. 123(R) is similar to the approach described in SFAS
No.
123. However, SFAS No. 123(R) requires all share-based payments to employees,
including grants of employee stock options, to be recognized in the income
statement based on their fair values. Pro forma disclosure is no longer an
alternative. The new standard will be effective for the Company in the first
interim or annual reporting period beginning after December 15, 2005. The
Company expects the adoption of this standard will have a material impact
on its
financial statements assuming employee stock options are granted in the
future.
In
May
2005, The Financial Accounting Standards Board issued Statement of Financial
Accounting Standard No. 154, “Accounting Changes and Error Corrections.” The
Statement applies to all voluntary changes in accounting principle and to
changes required by an accounting pronouncement that do not include explicit
transition provisions. SFAS No. 154 requires that changes in accounting
principle be retroactively applied, instead of including the cumulative effect
in the income statement. The correction of an error will continue to require
financial statement restatement. A change in accounting estimate will continue
to be accounted for in the period of change and in subsequent periods, if
necessary. SFAS No. 154 is effective for fiscal years beginning after December
31, 2005. We do not expect the adoption of this Statement to have a material
impact on our financial condition or results of operations.
Reclassification
-
The
financial statements from 2004 reflect certain reclassifications, which have
no
effect on net income, to conform to classifications in the current year.
2.
FIXED
ASSETS
Fixed
assets consist of the following as of March 31, 2006:
| Machinery and equipment |
$
|
55,463
|
| Furniture and fixtures |
113,635
|
|
| Computers, equipment and software |
40,620
|
|
| Lab equipment |
115,946
|
|
|
325,664
|
||
| Less: accumulated depreciation |
303,056
|
|
|
|
||
| Fixed assets, net |
$
|
22,608
|
SKINVISIBLE,
INC.
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
3.
INTANGIBLE
AND OTHER ASSETS
Patents
and trademarks are capitalized at its historical cost and are amortized over
their useful lives. As of March 31, 2006, patents and trademarks total $70,233,
net of accumulated amortization of $21,359.
License
and distributor rights (“agreement”) was acquired by the Company in January 1999
and provides exclusive use distribution of polymers and polymer based products.
The Company has a non-expiring term on the license and distribution rights.
Accordingly, the Company annually assesses this license and distribution rights
for impairment and has determined that no impairment write-down is considered
necessary as of March 31, 2006.
Prepaid
royalties fees are amounts prepaid by the Company related to the license and
distributor rights. The future royalties payments required by the Company total
$2,000,000. The royalties fees are to be paid at the equal to the greater of
(a)
$6,000 per month; or (b) 1.5% of net revenues realized by the sale of the
associated polymer products subject to a cap of $2,000,000. The Company will
make payments of $6,000 per month, and by a payment on any royalties in excess
of $72,000 in each year payable on annual basis calculated within 60 days of
each anniversary date of the agreement. As of March 31, 2006, the Company has
paid a total of $1,610,000 of which $770,000 has been expensed and $840,000
has
been recorded as prepaid royalties which will expense in the future in
accordance to the terms of the agreement. The remaining future royalties
payments related to the agreement approximates $390,000.
4.
STOCK
OPTIONS AND WARRANTS
Stock
options -
During
the periods ended March 31, 2006 and 2005, the Company granted stock options
totaling 6,787,525 and -0- shares of its common stock with a weighted average
strike price of $0.11 and $-0- per share, respectively. Certain stock options
were exercisable upon grant and have a life ranging from 3 months to 5 years.
As
of March 31, 2006, stock options outstanding totaled 1,810,000 with a weighted
average strike price of $0.11 per share.
Stock
warrants -
During
the periods ended March 31, 2006 and 2005, the Company granted stock warrants
totaling -0- and -0- shares of its common stock with a weighted average strike
price of $-0- and $-0- per share, respectively. As of March 31, 2006, stock
warrants outstanding totaled 5,460,000 with a weighted average strike price
of
$0.11 per share.
5.
MARKETING
AND DISTRIBUTION AGREEMENTS
In
March
2004, the Company entered into an agreement with Dermal Defense, Inc. for the
exclusive marketing and distribution rights to its patented Antimicrobial Hand
Sanitizer product for North America. Terms of the agreement require Dermal
Defense, Inc. to pay a fee of $1 million comprising of a non-refundable deposit
of $250,000 with the balance of $750,000 payable as to $75,000 per calendar
quarter or 5% of product sales (whichever is greater) until the entire $750,000
is received. The $1 million fee will be recognized as revenue ratably over
a
five year period. As of March 31, 2006, the Company has received $825,000 and
has reflected $475,000 as unearned revenue and $50,000 as revenue in the
accompanying consolidated financial statements. In addition and further to
the
payment fee of $1 million, Dermal Defense, Inc. agrees to pay a royalty fee
of
5% on product sales of the Antimicrobial Hand Sanitizer.
SKINVISIBLE,
INC.
NOTES
TO
CONSOLIDATED FINANCIAL STATEMENTS
5.
MARKETING
AND DISTRIBUTION AGREEMENTS(continued)
In
June
2004, the Company entered into an agreement with Cross Global, Inc. (“Cross
Global”) whereby, the Company would provide exclusive marketing and distribution
rights to its proprietary "Sunless Tanning Spray Formulation" for Canada, the
United States, Mexico, Austria, Belgium, Denmark, Finland, France, Germany,
Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United
Kingdom and Israel. In addition CGI is granted the right to use the name
"Solerra(TM)" within the territory. Terms of the agreement require Cross Global
to pay a fee of $1 million comprising of a non-refundable deposit of $200,000
with the balance of $800,000 payable as $200,000 due August 30, 2004, November
30, 2004, February 28, 2005 and May 30, 2005. The $1 million fee will be
recognized as revenue ratably over a five year period. As of March 31, 2006,
the
Company has received $700,000 and has reflected $425,000 as unearned revenue
and
$50,000 as revenue in the accompanying consolidated financial statements. In
addition and further to the payment fee of $1 million Cross Global agrees to
pay
a royalty fee of 5% on product sales of the Sunless Tanning Spray Formulation.
In
May
2005, the Company entered into a distribution agreement with Safe4Hours, Inc.
(“Safe4Hours”) whereby, the Company would provide exclusive marketing and
distribution rights to its proprietary antimicrobial hand sanitizer for all
countries of the world except Canada, United States, and Mexico. Terms of the
agreement require Safe4Hours to pay a fee of $1 million comprising of a
non-refundable deposit of $25,000 with the balance of $975,000 payable as
recognized as revenue ratably over a five year period. As of March 31, 2006,
the
Company has received $110,000 and has reflected $50,000 as revenue in the
accompanying consolidated financial statements. The Company has yet to receive
$110,000 as reflected under the contract. This amount that is due to the Company
has been record as an accounts receivable. In addition and further to the
payment fee of $1 million Safe4Hours, Inc. agrees to pay a royalty fee of 5%
on
product sales of the antimicrobial hand sanitizer beginning in the 3rd
quarter
of 2005.
In
October 2005, the Company entered into a distribution agreement with EMD
Chemicals Inc. (“EMD”) whereby, the Company would provide exclusive marketing
and distribution rights to its proprietary polymer delivery system “Invisicare”
for all countries of the world. Terms of the agreement states that the Company
would grant EMD options to purchase shares of their common stock. A stock option
agreement was executed on February 27, 2006, where the Company granted EMD
the
option to purchase 5,817,525 shares of common stock at the exercise price of
$0.172 per share until December 31, 2006.
6.
COMMITMENTS
AND CONTINGENCIES
Lease
obligations
- The
Company has operating leases for its offices. Future minimum lease payments
under the operating leases for the facilities as of March 31, 2006 are as
follows:
2006 $ 74,079
Rental
expense, resulting from operating lease agreements, approximated $23,967 for
the
year ended March 31, 2006.
7.
STOCK SUBSCRIPTION PAYABLE
During
March 2006, the Company received $4,500 for the shares issued in the period
ending June 30, 2006.
Forward-Looking
Statements
Historical
results and trends should not be taken as indicative of future operations.
Management’s statements contained in this report that are not historical facts
are forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities and
Exchange Act of 1934 (the “Exchange Act”), as amended. Actual results may differ
materially from those included in the forward-looking statements. We intend
such
forward-looking statements to be covered by the safe-harbor provisions for
forward-looking statements contained in the Private Securities Litigation Reform
Act of 1995, and are including this statement for purposes of complying with
those safe-harbor provisions. Forward-looking statements, which are based on
certain assumptions and describe our future plans, strategies and expectations,
are generally identifiable by use of the words “believe,” “expect,”
“intend,” “anticipate,” “estimate,” “project,” “prospects,” or similar
expressions. Our ability to predict results or the actual effect of future
plans
or strategies is inherently uncertain. Factors which could have a material
adverse affect on the operations and our future prospects on a consolidated
basis include, but are not limited to: changes in economic conditions,
legislative/regulatory changes, availability of capital, interest rates,
competition, and generally accepted accounting principles. These risks and
uncertainties should be considered in evaluating forward-looking statements
and
undue reliance should not be placed on such statements. Additional information
concerning our business, including additional factors that could materially
affect our financial results, are included in this discussion as well as in
our
other filings with the Securities and Exchange Commission.
Overview
We
develop innovative polymer delivery vehicles and related compositions that
hold active ingredients on the skin for up to four hours when topically
applied. We designed a process for combining water soluble and insoluble
polymers that is specifically formulated to carry water insoluble active
ingredients in water-based products without the use of alcohol, silicones,
waxes, or other organic solvents. This enables active agents the ability to
perform their intended functions for an extended period of time. Our polymer
delivery vehicles allow normal skin respiration and perspiration. The
polymer compositions we develop wear off as part of the natural exfoliation
process of the skin's outer layer cells.
Products
that successfully incorporate
our polymer delivery vehicles to
date
include antimicrobial hand sanitizers, suncare products, skincare moisturizers,
sunless tanning products as well as various dermatology products for various
skin disorders. On an ongoing basis, we are seeking to develop polymer
formulations that can successfully be incorporated into other products.
Our
primary objective is to license our polymer delivery vehicles to
established brand manufacturers and marketers of prescription and
over-the-counter products in the dermatological, medical, cosmetic,
and skincare markets. With the exception of sales to one vendor, our
management’s policy is to only sell our polymers to vendors that have executed a
license
agreement
with us. We conduct our research and development in-house.
Description
of Current Products and Agreements
Cosmetics
and Personal Care Markets
On
October 7, 2005, we entered into a Master Sales, Collaboration and Distribution
Agreement (“Agreement”) with EMD Chemicals Inc. (“EMD”), a New York corporation
and affiliate of Merck KGaA of Darmstadt, Germany. Under the terms of this
Agreement, we granted EMD the exclusive right to distribute and sell our
patented polymer delivery system, Invisicare®,
for the
cosmetics and personal care markets in the entire world. EMD will be entitled
to
commission income based upon the gross revenues from the sale of sublicensing
agreements as well as the polymers. The initial term of this Agreement is
until December 31, 2008 and this Agreement will automatically renew for
successive three year terms unless either party provides fourteen months advance
notice of its intention to terminate or not renew the Agreement.
Part
of
the consideration of the Agreement is that we would grant EMD options to
purchase shares of our common stock. The terms for the issuance of options
were
established and we executed a stock option agreement on February 27, 2006 where
we granted EMD the option to purchase 5,817,525 shares of common stock at the
exercise price of $0.172 per share exercisable until December 31, 2006.
Antibacterial/Antimicrobial
Hand Sanitizer
On
February 21, 2005, we entered into a definitive distribution agreement with
Dermal Defense, Inc. (“Dermal Defense”). Pursuant to this agreement, Dermal
Defense acquired the exclusive marketing and distribution rights in the United
States of America, Canada and Mexico for our antimicrobial hand sanitizer
composition which utilizes the active ingredient Triclosan 1% and incorporates
our patented Invisicare®
polymer
delivery system (the “Product”).
Dermal
Defense acquired these rights for the purchase price of $1,000,000. Dermal
Defense has already paid $775,000 of this purchase price. The remaining balance
is due and payable quarterly through September 30, 2006 in the amount of $75,000
or 5% of the gross revenues generated by Dermal Defense from sales of the
Product in the Territory in the prior quarter, whichever is greater. Under
the
terms of this agreement, Dermal Defense is also obligated to pay us a royalty
fee quarterly in the amount of $20,000 or 5% of gross revenues generated by
Dermal Defense from sales of the product in the quarter, whichever is
greater.
During
the second quarter of 2005 and with our approval, Dermal Defense entered into
an
exclusive sub-distribution agreement with JD Nelson & Associates of Columbus
Ohio (“JD Nelson”) and transferred all of its rights to distribute, market, and
sell our antimicrobial hand sanitizer in the United States of America, Canada
and Mexico. Under the terms of the sub-distribution agreement, JD Nelson will
pay a license fee and royalty on product sales to Dermal Defense and Dermal
Defense will continue to pay us as agreed in the Distribution Agreement of
February 21, 2005. As a result, the fees and royalties that we are due under
this agreement remain unchanged. Currently, all required fees and royalties
due
in accordance with this
agreement
are paid and current. Dermal Defense and JD Nelson & Associates are
prohibited
under this agreement from manufacturing, marketing, distributing, or selling
any
competing product while the Distribution Agreement is in full force and
effect.
In
May
2005, we entered into a Distribution Agreement (“Agreement”) with Safe4Hours,
Inc. (“Safe4Hours”), a Nevada corporation. Under the terms of this Agreement, we
granted Safe4Hours the exclusive right to distribute, market, sell, and promote
our antimicrobial hand sanitizer that utilizes the active ingredient Triclosan
1% in every country in the world except Canada, the United States, and Mexico.
As set forth above, the rights to distribute, market, sell, and promote our
antimicrobial hand sanitizer in Canada, the United States, and Mexico are held
by Dermal Defense. Safe4Hours acquired these rights for an up-front fee of
$1,000,000, of which $100,000 has been received and the remaining $900,000
is
payable in quarterly installments based upon a predetermined formula until
the
balance is received, and a royalty fee of no less than 5% of gross revenue
of
all sales. Currently, we are negotiating with Safe4Hours to revise the payment
terms for the remaining $900,000 due under this agreement. Safe4Hours
is
prohibited under this agreement from manufacturing, marketing, distributing,
or
selling any competing product while the Distribution Agreement is in full force
and effect.
Sunless
Tanning Spray Product
On
June
9, 2004, our wholly-owned subsidiary, Skinvisible Pharmaceuticals, Inc., entered
into a Trademark License Agreement and Distribution Agreement ("Distribution
Agreement") with Cross Global, Inc. ("Cross Global"), a Delaware corporation,
to
grant Cross Global the exclusive right to distribute, market, sell, and promote
our proprietary sunless tanning spray products in Canada, the United States,
Mexico, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland,
Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom, and Israel.
Cross Global is also utilizing our proprietary polymer formula to manufacture
nine additional sun care related products.
Pursuant
to the terms of the Distribution Agreement, Cross Global paid us the license
fee
of $1,000,000. Under the terms of this agreement, we will receive a royalty
fee
of no less than 5% of gross revenue of all sales of our
proprietary sunless tanning spray products. Cross Global is prohibited under
this agreement from manufacturing, marketing, distributing, or selling any
competing product while the Distribution Agreement is in full force and
effect.
Sunscreen
and Skin Care Products
We
developed and
successfully tested the application of our polymer delivery vehicles in
sunscreen
products with SPF 15 and SPF 30, sunless tanning lotions, moisturizing creams,
aloe after-sun products, and other skin care products.
We
currently offer our polymer delivery vehicles for incorporation into these
products on a private label basis and have multiple agreements in
place.
Status
of Research and Development for New Applications
We
are
continuing our research and development toward developing additional
applications for our polymer delivery vehicles. We are currently researching
whether
the following potential applications are suitable to incorporate our polymer
delivery vehicles:
| · |
Insect
repellents
|
| · |
Anti-fungal
|
| · |
Anti-flammatory
|
| · |
New
antibacterial/antimicrobial hand
sanitizer
|
Insect
Repellents
We
are in
the process of developing an insect repellent with an active ingredient that
incorporates our topical polymer-based delivery systems and are presently
undergoing in-house research. We anticipate that our research will be completed
during the second quarter of 2006. The active ingredient for the insect
repellent was provided by EMD. In the event that we are successful in
developing an effective insect repellent that incorporates our topical
polymer-based delivery systems, the rights to distribute and sell the developed
product will be subject to the terms of the Agreement with EMD entered into
on
October 7, 2005. There can be no assurance that we will be successful in
developing a viable insect repellent that incorporates our topical polymer-based
delivery systems and the active ingredient provided by EMD.
Anti-fungal
We
have
an oral agreement with a pharmaceutical company relating to the research and
development of an anti-fungal product that incorporates our topical
polymer-based delivery systems with an active compound they provided. This
company paid for our research and development activities as it relates to this
product in exchange for the ability to acquire the exclusive worldwide licensing
rights to distribute and sell the product should our research and development
prove successful. We have completed our initial research and development,
but further testing remains to be conducted. The company is presently
conducting certain skin sensitivity testing. In the event that the skin study
is
successfully completed and we execute a licensing agreement with the company,
the company agreed to commence a filing with the FDA for a new drug approval
in
the United States. A definitive licensing agreement would require the company
to
pay us an upfront license fee plus ongoing royalty payments based on worldwide
sales of the anti-fungal product. There can be no assurance that we will
successfully complete the research and development of this product or that
this
product will receive FDA approval to market and sell this potential product
in
the United States.
Anti-inflammatory
During
the reporting period, we entered into discussions with a pharmaceutical company
to conduct the research and development relating to an anti-inflammatory product
that incorporates our topical polymer-based delivery system. This product
is intended to treat hand skin disorders resulting from occupational
conditions. We are in discussions to grant a worldwide license for
the
exclusive rights to market and offer for sale the product in exchange for an
upfront license fee plus royalty payments based on sales generated by the
product should its development prove successful. We have not entered into
any definitive agreement and these discussions are ongoing. There can be
no assurance that we will be able to negotiate a definitive agreement. There
can
be no assurance that we will successfully complete the research and development
of this product or that this product will receive FDA approval to market and
sell this potential product in the United States.
New
Antibacterial/Antimicrobial Hand Sanitizer
We
have
developed and are currently testing a new antimicrobial hand sanitizer product
that utilizes the active ingredient Chlorhexidine (“Chlorhexidine antimicrobial
hand sanitizer”). Chlorhexidine is the active agent in scrub
soaps currently used in the operating rooms of most hospitals worldwide.
As
a part
our development efforts to develop the Chlorhexidine antimicrobial hand
sanitizer, we developed a research plan that comprises of several studies.
The first and second studies were in-vitro tests designed to gauge the
effectiveness of the Chlorhexidine antimicrobial hand sanitizer when exposed
to
certain bacteria. We received positive results from the first study.
The results of the second study indicated that further strengthening of the
product could improve the product’s effectiveness. Our research department
implemented the appropriate improvements and commenced a third study during
the
fourth quarter. The third study was conducted by Retroscreen Virology Ltd.
(“RVL”), a research company that is a division of St. Bartholomew's Hospital and
the Royal London Hospital based in London, England, and designed to test the
effectiveness of the Chlorhexidine antimicrobial hand sanitizer in killing
the
H5N1 virus also known as the bird flu virus or avian flu. In-vitro testing
conducted by RVL confirmed that the H5N1 virus was successfully killed by the
Chlorhexidine antimicrobial hand sanitizer 99% of the time at the following
four
points in time: 15 seconds, 30 seconds, 1 minute, and 5 minutes following
contact. This in-vitro study was conducted by placing the Chlorhexidine
antimicrobial hand sanitizer in a dish and then exposing the H5N1 virus at
the
forgoing time intervals. Based upon these positive results, we retained RVL
to
conduct a further ex-vivo study to provide data on the effectiveness of the
Chlorhexidine antimicrobial hand sanitizer when exposed to the H5N1 virus over
an extended period of time. This ex-vitro study will be conducted by
applying the Chlorhexadine antimicrobial hand sanitizer to dead skin specimens,
simulating normal conditions of wash-off and skin perspiration, and then
exposing the H5N1 virus to the skin specimen at various extended time intervals.
We anticipate that the results of this second study will be available in late
May 2006.
We
also
commenced another study referred to as a human repeat insult patch test
(HRIPT). This study exposes a minimum of 100 persons to the Chlorhexidine
antimicrobial hand sanitizer to determine if continued use and exposure to
the
product will result in skin complications or sensitivities. This study has
been extended and we expect a final report to be completed by the end of May
2006.
In
the
event that the Chlorhexidine antimicrobial hand sanitizer proves to be a viable
product, we may be required to file a New Drug Application with the US FDA
because the drug
Chlorhexidine
is not presently an approved drug under the FDA Tentative Final Monograph (TFM)
for Hand Sanitizers. We may also be required to seek similar regulatory
approvals in other foreign jurisdictions. If we are required to file a New
Drug
Application with the US FDA, further development of this product may be both
time and cost prohibitive for us. Under such circumstance, we would seek to
license the product to a third party with experience in working with the FDA
such as a pharmaceutical company. There can be no assurance that we will
successfully complete the research and development of this product or that
this
product will receive FDA approval to market and sell this potential product
in
the United States.
Results
of Operations for the Three Months Ended March 31, 2006 and
2005
For
the
three month period ended March 31, 2006, we generated total revenue of $235,167
compared to total revenue of $254,730 for the period ended March 31, 2005.
During the three months ended March 31, 2006, $175,000 of
the
revenue generated was attributable to payments for royalties and distribution
and licensing rights of our products and $35,511 of the revenue generated
was
attributable to product sales.
Our
cost
of revenues for the three months ended March 31, 2006 decreased to $21,321
from
the same reporting period in the prior year when cost of revenues was $70,065.
The decrease in our cost of revenues is attributable to a decrease in product
sales.
Gross
profit for the first quarter ended March 31, 2006 was $213,846 compared to
$184,665 for the first quarter ended March 31, 2005. The increase in gross
profit for the three months ended March 31, 2006 is primarily attributable
our
receipt of royalty fees and payments under the licensing agreements entered
into
with Dermal Defense, Inc., Safe4Hours, Inc., and Cross Global, Inc.
For
the
three month period ended March 31, 2006, we incurred operating expenses in
the
amount of $1,187,990 compared to operating costs of $581,454 in the same three
month period in the prior year. The increase is primarily attributable to stock
based compensation related to the stock options issued to EMD during the
reporting period. We recorded stock-based compensation of $723,399 for the
three
months ended March 31, 2006 and $198,000 for the three months ended March 31,
2005.
For
the
three month period ended March 31, 2006, we had a net loss of $974,144. Our
net
loss for the three month period ended March 31, 2005 was $396,789. The increase
in our net loss for the three month period ended March 31, 2006 when compared
to
the same reporting period in the prior year is primarily attributable to an
increase in stock based compensation.
Liquidity
and Capital Resources
As
of
March 31, 2006, we had total current assets of $325,187 and total assets in
the
amount of $1,286,669. Our total current liabilities as of March 31, 2006 were
$1,308,386. Included in our current liabilities is $1,036,000 in unearned
revenue due from our distribution agreements entered into with Dermal Defense,
Inc., Cross Global, Inc., and Safe4Hours, Inc. We had a working capital deficit
of $983,199 as of March 31, 2006.
Operating
activities used $92,986 in cash for the three months ended March 31, 2006.
Our
net loss of $974,144 was the primary component of our negative operating cash
flow. There were no investing activities during the three months ended March
31,
2006. Cash flows provided by financing activities during the three months ended
March 31, 2006 consisted of $137,500 as proceeds from the issuance of common
stock and $4,500 for proceeds from stock subscriptions receivable.
Management
believes that we have sufficient capital to finance our current operations
for
the
year
ending December 31, 2006 based
upon revenues anticipated to be received in the current fiscal year and royalty
payments due under the current license agreements. In
order
for us to expand our operations, additional funding will be required from
external sources. There can be no assurance that such additional financing
will
be available to us on acceptable terms, or at all.
Going
Concern
We
have
incurred net losses of approximately $12,566,500 since inception. Our
independent auditors have stated in their Auditor’s Report that we have suffered
recurring losses our ability to raise additional capital through future issuance
of common stock is unknown. To successfully develop and attain profitable
operations is unknown. As a result, our auditor’s concluded that there is a
substantial doubt about our ability to continue as a going concern.
The
accompanying financial statements have been prepared assuming that we will
continue as a going concern. These financial statements do not include any
adjustments that might result from the outcome of this uncertainty.
Revenue
Recognition
Revenues
are recognized during the period in which the revenues are earned. Costs and
expenses are recognized during the period in which they are
incurred.
Recently
Issued Accounting Pronouncements
In
November 2004, the FASB issued SFAS No. 151, Inventory Costs, an amendment
of
ARB No. 43, Chapter 4. SFAS No. 151 amends the guidance in ARB No. 43, Chapter
4, Inventory Pricing, to clarify the accounting for abnormal amounts of idle
facility expense, freight, handing costs, and spoilage. This statement requires
that those items be recognized as current period charges regardless of whether
they meet the criterion of "so abnormal" which was the criterion specified
in
ARB No. 43. In addition, this Statement requires that allocation of fixed
production overheads to the cost of production be based on normal capacity
of
the production facilities. This pronouncement is effective for us beginning
October 1, 2005. We do not believe adopting this new standard will have a
significant impact to its financial statements.
In
December 2004, the FASB issued SFAS No. 123 (revised 2004). Share-Based Payment,
which is a revision of SFAS No. 123, Accounting for Stock-Based Compensation.
SFAS No. 123(R) supersedes APB Opinion No. 25, Accounting for Stock Issued
to
Employees and amends SFAS No. 95, Statement of Cash Flows. Generally, the
approach in SFAS No. 123(R) is similar to the
approach
described in SFAS No. 123. However, SFAS No. 123(R) requires all share-based
payments to employees, including grants of employee stock options, to be
recognized in the income statement based on their fair values. Pro forma
disclosure is no longer an alternative. The new standard will be effective
for
us in the first interim or annual reporting period beginning after December
15,
2005. We expect the adoption of this standard will have a material impact on
our
financial statements assuming employee stock options are granted in the
future.
In
May
2005, The Financial Accounting Standards Board issued Statement of Financial
Accounting Standard No. 154, “Accounting Changes and Error Corrections.” The
Statement applies to all voluntary changes in accounting principle and to
changes required by an accounting pronouncement that do not include explicit
transition provisions. SFAS No. 154 requires that changes in accounting
principle be retroactively applied, instead of including the cumulative effect
in the income statement. The correction of an error will continue to require
financial statement restatement. A change in accounting estimate will continue
to be accounted for in the period of change and in subsequent periods, if
necessary. SFAS No. 154 is effective for fiscal years beginning after December
31, 2005. We do not expect the adoption of this Statement to have a material
impact on our financial condition or results of operations.
We
carried out an evaluation of the effectiveness of the design and operation
of
our disclosure controls and procedures (as defined in Exchange Act Rules
13a-15(e) and 15d-15(e)) as of March 31, 2006. This evaluation was carried
out
under the supervision and with the participation of our Chief Executive Officer
and Chief Financial Officer, Mr. Terry Howlett. Based upon that evaluation,
our
Chief Executive Officer and Chief Financial Officer concluded that, as of March
31, 2006, our disclosure controls and procedures are effective. There have
been
no significant changes in our internal controls over financial reporting during
the quarter ended March 31, 2006 that have materially affected or are reasonably
likely to materially affect such controls.
Disclosure
controls and procedures are controls and other procedures that are designed
to
ensure that information required to be disclosed in our reports filed or
submitted under the Exchange Act are recorded, processed, summarized and
reported, within the time periods specified in the SEC's rules and forms.
Disclosure controls and procedures include, without limitation, controls and
procedures designed to ensure that information required to be disclosed in
our
reports filed under the Exchange Act is accumulated and communicated to
management, including our Chief Executive Officer and Chief Financial Officer,
to allow timely decisions regarding required disclosure.
Limitations
on the Effectiveness of Internal Controls
Our
management does not expect that our disclosure controls and procedures or our
internal control over financial reporting will necessarily prevent all fraud
and
material error. An internal control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance that the
objectives of the control system are 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 the 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. Additionally, controls can be circumvented by the individual
acts of some persons, by collusion of two or more people, or by management
override of the internal control. The design of any system of controls also
is
based in part upon certain assumptions about the likelihood of future events,
and there can be no assurance that any design will succeed in achieving its
stated goals under all potential future conditions. Over time, control may
become inadequate because of changes in conditions, or the degree of compliance
with the policies or procedures may deteriorate.
There
have been no material developments in the ongoing legal proceedings previously
reported in which we are a party. A complete discussion of our ongoing legal
proceedings is discussed in our annual report on Form 10-KSB for the year ended
December 31, 2005.
The
information set forth below relates to our issuances of securities without
registration under the Securities Act of 1933 during the reporting period which
were not previously included in a Current Report on Form 8-K.
During
the three months ended March 31, 2005, we issued options to purchase 970,000
shares of our common stock, exercisable at $0.18 per share to our executive
officer, members of our board of directors, employees, and consultants in
exchange for services rendered. These options are fully vested and have a
termination date of January 4, 2011 or ninety days following their termination,
whichever is the first to occur. These securities were issued pursuant to
Section 4(2) of the Securities Act of 1933. We did not engage in any general
solicitation or advertising.
None
No
matters have been submitted to our security holders for a vote, through the
solicitation of proxies or otherwise, during the quarterly period ended March
31, 2006.
None
|
Exhibit
Number
|
Description
of Exhibit
|
SIGNATURES
In
accordance with the requirements of the Securities and Exchange Act of 1934,
the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
|
Skinvisible,
Inc.
|
|
|
Date:
|
May
15, 2006
|
|
By:
/s/ Terry Howlett
Terry
Howlett
Title: Chief
Executive Officer, Chief Financial Officer, and Director
|