UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM 10-Q
(Mark One)
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,
2008
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or
o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the transition period from
to
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Commission File Number 333-103781
ProUroCare Medical Inc.
(Exact name of registrant
as specified in its charter)
Nevada
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20-1212923
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(State or other
jurisdiction
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(IRS Employer
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of incorporation or
organization)
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Identification No.)
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5500 Wayzata Blvd., Suite 310
Golden Valley, Minnesota 55416
(Address of principal
executive offices, and Zip Code)
(952) 476-9093
(Registrants telephone
number, including area code)
Indicate by checkmark
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
x
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 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
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller reporting
company
x
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(Do not check if a
smaller reporting company)
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Indicate by check mark whether the registrant is a
shell company (as defined in Rule 12b-2 of the Exchange Act).
YES
o
NO
x
The registrant has 1,725,350 shares of common stock
outstanding as of May 2, 2008.
ProUroCare
Medical Inc.
Form 10-Q
for the
Quarter
Ended March 31, 2008
Table of Contents
PART I.
FINANCIAL INFORMATION
Item 1.
Financial Statements
ProUroCare Medical Inc.
A Development Stage Company
Consolidated Balance Sheets
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March 31, 2008
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December 31, 2007
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(Unaudited)
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(Audited)
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Assets
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Current assets:
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Cash
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$
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133,626
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$
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400,613
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Restricted cash
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44,087
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44,000
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Prepaid expenses
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17,543
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21,733
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Total current
assets
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195,256
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466,346
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Equipment and
furniture, net
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452
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605
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Deferred
offering expenses
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190,421
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132,638
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Debt issuance
costs, net
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449,782
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439,321
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$
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835,911
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$
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1,038,910
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Liabilities and Shareholders Deficit
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Current
liabilities:
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Notes payable,
bank
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$
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1,600,000
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$
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Notes payable,
net of original issue discount
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643,350
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263,143
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Convertible
debentures, net of original issue discount
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515,369
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Accounts payable
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610,042
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484,375
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Accrued expenses
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633,740
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801,925
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Loans from
officers and directors
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2,200
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10,450
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Total current
liabilities
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4,004,701
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1,559,893
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Commitments and
contingencies
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Long-term bank
debt
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1,600,000
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Long-term note
payable
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600,000
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Long-term
convertible notes, net of original issue discount
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851,316
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970,600
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Total
liabilities
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4,856,017
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4,730,493
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Shareholders
deficit:
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Common stock,
$0.00001 par. Authorized 50,000,000 shares; issued and outstanding 1,727,350
and 1,727,311 shares on March 31, 2008 and December 31, 2007,
respectively
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17
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17
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Additional
paid-in capital
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12,918,531
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12,586,496
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Deficit accumulated
during development stage
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(16,938,654
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)
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(16,278,096
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)
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Total
shareholders deficit
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(4,020,106
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)
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(3,691,583
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)
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$
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835,911
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$
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1,038,910
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See accompanying notes to financial statements.
1
ProUroCare Medical Inc.
A Development Stage Company
Consolidated Statements
of Operations
(Unaudited)
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Three months
ended
March 31,
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Three months
ended
March 31,
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Period from
August 17,1999
(inception) to
March 31,
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2008
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2007
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2008
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Operating
expenses:
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Research and
development
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$
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$
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24,820
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$
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4,857,552
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General and
administrative
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246,162
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444,441
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8,050,658
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Total operating
expenses
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246,162
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469,261
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12,908,210
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Operating loss
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(246,162
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)
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(469,261
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)
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(12,908,210
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)
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Interest income
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253
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18,011
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Interest expense
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(389,309
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)
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(295,195
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)
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(3,641,739
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)
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Debt
extinguishment cost
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(25,340
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)
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(83,700
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)
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(406,716
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)
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Net loss
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$
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(660,558
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)
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$
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(848,156
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)
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$
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(16,938,654
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)
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Net loss per common
share:
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Basic and
diluted
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$
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(0.38
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)
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$
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(0.57
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)
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$
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(17.25
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)
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Weighted-average
number of shares outstanding:
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Basic and
diluted
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1,727,331
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1,500,997
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982,226
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See accompanying notes to
financial statements.
2
ProUroCare Medical Inc.
A Development Stage Company
Consolidated Statements
of Cash Flows
(Unaudited)
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Three months
ended
March 31,
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Three months
ended
March 31,
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Period from
August 17,1999
(inception) to
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2008
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2007
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March 31, 2008
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Cash flows from
operating activities:
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Net loss
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$
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(660,558
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)
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$
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(848,156
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)
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$
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(16,938,654
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)
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Adjustments to
reconcile net loss to net cash used in operating activities:
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Depreciation and
amortization
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153
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974
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20,345
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Gain on sale of
furniture and equipment
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(2,200
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)
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Stock-based
compensation
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30,156
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184,224
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1,735,258
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Issuance of
common stock for services rendered
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156,904
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Issuance of
common stock for debt guarantees
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88,889
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Warrants issued
for services
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540,636
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Warrants issued
for debt guarantees
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320,974
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Warrants issued
for debt extinguishment
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25,340
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83,700
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335,997
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Amortization of
note payable original issue discount
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12,904
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23,162
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255,091
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Amortization of
convertible debt original issue discount
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189,720
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60,273
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644,562
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Amortization of
debt issuance and deferred offering costs
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91,518
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130,028
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1,375,687
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Write-off debt
issuance cost for debt extinguishment
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42,797
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Write-off of
deferred offering cost
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59,696
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License rights
expensed as research and development, paid by issuance of common stock to CS
Medical Technologies, LLC
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475,000
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License rights
expensed as research and development, paid by issuance of common stock to
Profile, LLC
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1,713,600
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Changes in
operating assets and liabilities:
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Deposits
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(189,554
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)
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Prepaid expenses
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4,190
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(24,407
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)
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93,479
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Other assets
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13,773
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Accounts payable
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30,142
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60,216
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760,597
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Accrued expenses
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(155,864
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)
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26,467
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854,124
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Net cash used in
operating activities
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(432,299
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)
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(289,746
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)
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(7,656,772
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)
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Cash flows from
investing activities:
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Purchases of
equipment and furniture
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(20,797
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)
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Deposit into a
restricted cash account
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(87
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)
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(44,087
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)
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Net cash used in
investing activities
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(87
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)
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(64,884
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)
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Cash flows from
financing activities:
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Net advances
from (payments to) line of credit, bank
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Proceeds of note
payable, bank
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500,000
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Payments of note
payable, bank
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(500,000
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)
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Proceeds of
notes payable
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615,500
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Payment of notes
payable
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(219,793
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)
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(29,100
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)
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(1,257,089
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)
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Proceeds from
long-term notes payable and bank debt
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446,500
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4,196,500
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Payments on
long-term bank debt
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(600,000
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)
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Proceeds from
warrants
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23,500
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73,500
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Payments for
debt issuance costs
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(76,558
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)
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(601,784
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)
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Payment for
rescission of common stock
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(100,000
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)
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Proceeds from
loans from officers and directors
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172,600
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Payments of
loans from officers and directors
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(8,250
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)
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(135,100
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)
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Payments for
deferred offering expenses
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(28,827
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)
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Cost of reverse
merger
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(162,556
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)
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Net proceeds
from issuance of common stock
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335,111
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5,682,538
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Net cash
provided by financing activities
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165,399
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306,011
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7,855,282
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Net increase in
cash
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(266,987
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)
|
16,265
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|
133,626
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Cash, beginning
of the period
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400,613
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2,407
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Cash, end of the
period
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$
|
133,626
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$
|
18,672
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|
$
|
133,626
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|
3
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Three months
ended
March 31,
|
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Three months
ended
March 31,
|
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Period from
August 17,1999
(inception) to
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2008
|
|
2007
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March 31, 2008
|
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Supplemental
cash flow information:
|
|
|
|
|
|
|
|
Cash paid for
interest
|
|
$
|
44,236
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$
|
80,304
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$
|
637,572
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Non-cash
investing and financing activities:
|
|
|
|
|
|
|
|
Conversion of
notes payable into long-term convertible debentures
|
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|
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175,000
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Conversion of
loans from directors into long-term convertible debentures
|
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|
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25,000
|
|
Deferred
offering costs included in accounts payable
|
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70,104
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|
|
|
180,092
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|
Deferred
offering costs included in accrued expenses
|
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(12,321
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)
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|
10,329
|
|
Debt issuance
costs included in accounts payable
|
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25,421
|
|
|
|
81,238
|
|
Warrants issued
pursuant to notes payable
|
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12,904
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|
23,162
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|
337,091
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Prepaid expenses
financed by note payable
|
|
|
|
|
|
111,022
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Common stock
issued in lieu of cash for accrued expenses
|
|
|
|
49,911
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|
229,636
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|
Common stock
issued for debt issuance cost
|
|
|
|
|
|
158,167
|
|
Common stock
issued in lieu of cash for accounts payable
|
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|
|
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122,291
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|
Common stock
issued in lieu of cash for loans from officers and directors
|
|
|
|
7,000
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|
10,300
|
|
Proceeds from
sale of furniture and equipment
|
|
|
|
|
|
2,200
|
|
Convertible debt
issued as debt issuance costs related to guarantee of long-term debt
(recorded as a beneficial conversion in additional paid-in capital) applied
to accounts payable
|
|
|
|
|
|
733,334
|
|
Issuance of note
payable for redemption of common stock
|
|
|
|
|
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650,000
|
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Warrants issued
for debt issuance costs
|
|
|
|
|
|
242,612
|
|
Conversion of
accounts payable to note payable
|
|
|
|
|
|
241,613
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|
Deposits applied
to note payable and accrued interest
|
|
|
|
|
|
142,696
|
|
Deposits applied
to accounts payable
|
|
|
|
|
|
45,782
|
|
Assumption of
liabilities in the Profile, LLC transaction
|
|
|
|
|
|
25,000
|
|
Deposits applied
to accrued expenses
|
|
|
|
|
|
1,076
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to financial statements.
4
ProUroCare
Medical Inc.
A Development Stage Company
Notes to Consolidated
Financial Statements
March 31, 2008 and 2007 and the period from
August 17, 1999 (inception) to March 31, 2008
(Unaudited)
(1)
Description of Business and Summary of Significant Accounting Policies
(a)
Description of
Business, Development Stage Activities and Basis of Presentation
ProUroCare Medical Inc. (ProUroCare,
the Company, we or us) is a development stage company that is developing
diagnostic equipment and treatments for enlarged prostates and other male
urological conditions. The Companys
developmental activities, conducted by its wholly owned operating subsidiary
ProUroCare Inc. (PUC), have included the acquisition of several technology
licenses, the development of a strategic business plan and a senior management
team, product development and fund raising activities.
PUC had no activities from
its incorporation in August 1999 until July 2001, when it acquired a
license to certain microwave technology from CS Medical Technologies, LLC (CS
Medical). In January 2002, PUC
acquired a license to certain prostate imaging technology from Profile, LLC (Profile).
Pursuant to a merger
agreement effective April 5, 2004 (the Merger), PUC became a wholly
owned operating subsidiary of Global Internet Communications, Inc. (Global),
which changed its name to ProUroCare Medical Inc. on April 26, 2004. In connection with the Merger, the Company
completed a private placement of 220,500 shares, as adjusted for the Reverse
Split (as defined below), of common stock (the 2004 Private Placement)
pursuant to Rule 506 under the Securities Act of 1933, as amended (the Securities
Act).
On December 27,
2007, the Companys shareholders approved a one-for-ten reverse split of the
Companys common stock
without a corresponding reduction in the
number of authorized shares of the Company capital stock (the Reverse Split). The reverse stock split became effective on February 14,
2008. The exercise price and the number
of shares of common stock issuable under the Companys outstanding convertible
debentures, options and warrants were proportionately adjusted to reflect the
Reverse Split for all periods presented.
The accompanying
consolidated financial statements include the accounts of the Company and its
wholly owned subsidiary, PUC.
Significant inter-company accounts and transactions have been eliminated
in consolidation.
(b)
Restatement of
Share Data
All share data has been
adjusted to give effect to the Reverse Split.
5
At the effective time of the
Merger, all 350,100 shares of common stock of PUC that were outstanding
immediately prior to the Merger and held by PUC shareholders were cancelled,
with one share of ProUroCare common stock issued to Global. Simultaneously, the non-dissenting
shareholders of PUC received an aggregate of 960,300 shares of common stock of
Global in exchange for their aggregate of 320,100 shares of PUC. All share data has been adjusted to give
effect to the Merger under which each PUC share was converted into three shares
of Global. The share data in this
paragraph has been restated to give effect to the Reverse Split, as noted
above.
(b)
Interim
Financial Information
The accompanying unaudited financial statements have been prepared in
accordance with accounting principles generally accepted in the United States
of America and pursuant to the rules and regulations of the Securities and
Exchange Commission (the SEC) for interim financial information. Accordingly, certain information and footnote
disclosures normally included in financial statements prepared in accordance
with accounting principles generally accepted in the United States have been
omitted pursuant to such rules and regulations. Operating results for the three months March 31,
2008 are not necessarily indicative of the results that may be expected for the
year ending December 31, 2008 or any other period. The accompanying financial statements and
related notes should be read in conjunction with the audited financial
statements of the Company, and notes thereto, contained in our Annual Report on
Form 10-KSB for the year ended December 31, 2007.
The
financial information furnished reflects, in the opinion of management, all adjustments,
consisting of normal recurring accruals, necessary for a fair presentation of
the results of the interim periods presented.
(c)
Accounting
Estimates
The preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America 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 financial statements and the reported amounts of expenses
during the reporting periods. The Companys significant estimates include the
determination of the fair value of its common stock and stock-based
compensation awarded to employees, directors, loan guarantors and consultants
and the accounting for debt with beneficial conversion features. Actual results
could differ from those estimates.
Valuation of Stock-Based Compensation.
E
ffective as of August 17,
1999 (inception), the Company adopted Statement of Financial Accounting
Standard (SFAS) No. 123
Share-Based
Payment
and on January 1, 2006 adopted SFAS No. 123
(revised 2004),
(SFAS 123R), which requires the
measurement and recognition of compensation expense for all share-based payment
awards made to employees and directors including employee stock options based
on fair values. The Companys
determination of fair value of share-based payment awards is based on the date
of grant using an option-pricing model which incorporates a number of highly
complex and subjective variables. These
variables include, but are not limited to, the Companys expected stock price
volatility and estimates regarding projected employee stock option exercise
behaviors and forfeitures. The Company recognizes
the expense related to the fair value of the award straight-line over the
vesting period.
6
Debt with Beneficial Conversion Features
. The beneficial conversion features of the
promissory notes were valued using the Black-Scholes pricing model. The resulting
original issue discount is amortized over the life of the promissory notes
(generally no more that 24 months) using the straight-line method, which
approximates the interest method.
(d)
Net Loss Per
Common Share
Basic
and diluted loss per common share is computed by dividing net loss by the
weighted-average number of common shares outstanding for the reporting
period. These calculations reflect the
effects of the Companys Reverse Split (see Note 1(b)). Dilutive common-equivalent shares have not
been included in the computation of diluted net loss per share because their
inclusion would be antidilutive.
Antidilutive common equivalent shares issuable based on future exercise
of stock options or warrants could potentially dilute basic loss per common
share in subsequent years. All options
and warrants outstanding were anti-dilutive for the three months ended March 31,
2008 and 2007, and the period from August 17, 1999 (inception) to March 31,
2008 due to the Companys net losses.
1,160,748 and 536,433 shares of common stock issuable under stock
options, warrants, convertible debentures and contingent shares and warrants
issuable under agreements with loan guarantors were excluded from the
computation of diluted net loss per common share for the periods ended March 31,
2008 and 2007, respectively, as were the undetermined number of shares issuable
pursuant to the convertible notes and warrants issued in connection with our
private placements as described and defined in Note 5.
(e)
Stock-Based
Compensation
Effective as of August 17,
1999, the Company adopted the fair value recognition provisions of SFAS No. 123
to record option and warrant issuances, including stock-based employee
compensation. The Companys policy is to
grant stock options at fair value at the date of grant and to record the
expense at fair value as required by SFAS 123, using the Black-Scholes pricing
model.
Effective January 1, 2006, the Company adopted SFAS
123R, that focuses primarily on accounting for transactions in which an entity
obtains employee services in share-based payment transactions. This statement replaced SFAS 123 and
supersedes Accounting Principles Board (APB) Opinion No. 25, Accounting
for Stock Issued to Employees. SFAS
123R requires all companies to expense the fair value of employee stock options
and similar awards, which has been the Companys policy to date. Stock-based employee and non-employee
compensation cost related to stock options was $15,656, $184,224 and $1,597,734
for the three months ended March 31, 2008 and 2007, and the period from August 17,
1999 (inception) to March 31, 2008, respectively. The Company estimates the amount of future
stock-based compensation expense related to currently outstanding options to be
approximately $37,300 and $1,800 for the years ending December 31, 2008
and 2009, respectively.
The Black-Scholes
option-pricing model was developed for use in estimating the fair value of
traded options that have no vesting restrictions and are fully transferable. In
addition,
7
option pricing models
require the input of highly subjective assumptions. Because the Companys
employee and consultant stock options have characteristics significantly
different from those of traded options, and because changes in the subjective
input assumptions can materially affect the fair value estimate, the existing
models may not necessarily provide a reliable single measure of the fair value
of the Companys employee stock options.
No stock options were issued
in the three months ended March 31, 2008.
In determining the compensation cost of the options and warrants granted
during the three months ended March 31, 2007, as specified by SFAS 123R,
the fair value of each option grant has been estimated on the date of grant
using the Black-Scholes pricing model and the weighted-average assumptions used
in these calculations are summarized as follows:
|
|
For the three months ended
March 31,
|
|
|
|
2008
|
|
2007
|
|
Risk-free
Interest Rate
|
|
n/a
|
|
4.86%
|
|
Expected Life of
Options Granted
|
|
n/a
|
|
4.0 years
|
|
Expected
Volatility
|
|
n/a
|
|
133.4%
|
|
Expected
Dividend Yield
|
|
n/a
|
|
0
|
|
The expected life of the options is determined using a
simplified method, computed as the average of the option vesting periods and
the contractual term of the option. For
performance based options that vest upon the occurrence of an event, the
Company uses an estimate of when the event will occur as the vesting period
used in the Black-Scholes calculation for each option grant. Because of the limited trading history of the
Companys stock, until December 31, 2007 the expected volatility was based
on a simple average of daily price data since the date of the Merger on April 5,
2004. Beginning on January 1, 2008,
expected volatility is based on a simple average of weekly price data since the
date of the Merger. Based on the lack of
history to calculate a forfeiture rate, the Company has not adjusted the
calculated value of the options. The
risk-free rates for the expected terms of the stock options and awards are
based on the U.S. Treasury yield curve in effect at the time of grant.
(f)
Warrants
In accordance with Emerging Issues Task Force (EITF) Issue No. 96-18,
Accounting for Equity Instruments that are Issued to Other than Employees for
Acquiring, or in Conjunction with Selling, Goods and Services (EITF 96-18)
and EITF Issue No. 98-5, Accounting for Convertible Securities with
Beneficial Conversion Features or Contingently Adjustable Conversion Ratios (EITF
98-5), the Company has elected to utilize the fair-value method of accounting
for warrants issued to non-employees as consideration for goods or services
received, including warrants issued to lenders and guarantors of Company debt. On January 4, 2008, pursuant to a final
separation agreement with a former employee, the Company issued to the former
employee five-year, immediately exercisable warrants to acquire up to 14,500
shares of the Companys common stock at an exercise price of $5.00 per
share. The fair value of the warrants
was estimated at $1.00 per share using the Black-Scholes pricing model
resulting in expense of $14,500 for the three months ended March 31,
2008. No other warrants were granted
during the three months ended March 31, 2008. The weighted-average per share fair value of
warrants granted during the three months ended March 31, 2007 was $4.20,
and such warrants were immediately vested and exercisable on the date of grant.
8
The fair value of stock
warrants is the estimated present value at grant date using the Black-Scholes
pricing model with the following weighted average assumptions:
|
|
For the three months ended
March 31,
|
|
|
|
2008
|
|
2007
|
|
Risk-free
Interest Rate
|
|
3.74%
|
|
4.73%
|
|
Expected Life of
Warrants Issued(1)
|
|
5 years
|
|
5 years
|
|
Expected
Volatility
|
|
125.8%
|
|
135.1%
|
|
Expected
Dividend Yield
|
|
0
|
|
0
|
|
(1) The contractual term of the warrants.
Because of the limited trading history of the Companys
stock, until December 31, 2007 the expected volatility was based on a
simple average of daily price data since the date of the Merger on April 5,
2004. Beginning on January 1, 2008,
expected volatility is based on a simple average of weekly price data since the
date of the Merger. Based on the lack of
history to calculate a forfeiture rate, the Company has not adjusted the
calculated value of the warrants. The
risk-free rates for the expected terms of the stock warrants are based on the
U.S. Treasury yield curve in effect at the time of grants.
(g)
Debt Issuance
Costs
Debt issuance costs at December 31,
2007 consisted of
legal and
accounting fees, printing costs and
commissions paid to the placement agents
related to the Companys Crown Bank
promissory notes, a promissory note issued to the Phillips W. Smith Family
Trust (the Smith Trust) and the Companys December 27, 2007 private
placements of convertible debentures and warrants (the 2007 Private Placement). During the three month period ended March 31,
2008, the Company incurred additional debt issuance costs related to a second
closing on the 2007 Private Placement and on closings on an aggregate of $390,000 of units consisting
of unsecured, subordinated, convertible promissory notes and common stock
purchase warrants in another private placement (the February 2008 Private Placement). Debt
issuance costs are amortized over the term of the related debt as interest
expense using the straight-line method, which approximates the interest method.
9
Debt issuance costs are
summarized as follows:
|
|
March 31,
2008
|
|
December 31,
2007
|
|
Debt issuance
costs, gross
|
|
$
|
554,092
|
|
$
|
452,113
|
|
Less
amortization
|
|
(104,310
|
)
|
(12,792
|
)
|
|
|
|
|
|
|
Debt issuance
costs, net
|
|
$
|
449,782
|
|
$
|
439,321
|
|
Amortization
expense related to debt issuance costs was $91,518, $130,028, and $1,375,687
for the three months ended March 31, 2008 and 2007, and the period from August 17,
1999 (inception) to March 31, 2008, respectively.
(h)
Deferred
Offering Costs
The
legal fees related to the Companys private placement of convertible debentures
that closed on May 2, 2008 (the May 2008 Private Placement)(see
Note 8) and an anticipated public offering the Company expects to complete in
mid-2008 were recorded as a deferred offering cost asset as of March 31,
2008. The deferred costs related to the
anticipated May 2008 Private Placement and the public offering will be
recorded as a cost of the offering upon their closings, or expensed as a
general and administrative expense if no such closings occur.
(i)
Restricted Cash
Pursuant to the renewal of
the Crown Bank promissory notes (see Note 2), the Company agreed to deposit
with Crown Bank four months worth of future interest payments due under the
notes. The Company has further agreed to
deposit with Crown Bank all of the interest due on the notes through maturity
upon the closing, and out of the net proceeds of, a future underwritten public offering of equity securities of the
Company. The funds on deposit are
not available to the Company for any purpose other than for debt service on the
Crown Bank promissory notes.
(j)
Going
Concern
We have incurred operating losses, accumulated deficit and negative
cash flows from operations since inception.
As of March 31, 2008, we had an accumulated deficit of
approximately $16,939,000. These
factors, among others, raise substantial doubt about our ability to continue as
a going concern. The accompanying
unaudited consolidated financial statements do not include any adjustments
related to recoverability and classification of asset carrying amounts or the
amount and classification of liabilities that might result should we be unable
to continue as a going concern.
Note 2. Notes
Payable Bank.
In
February 2006, the Company completed two closings of senior debt financing
totaling $2,200,000 pursuant to promissory notes issued to Crown Bank at an
interest rate of the prime rate plus one percent (6.25 percent and 8.25 percent
at March 31, 2008 and December 31, 2007, respectively). The average interest rate of the notes was
7.24 percent for the three months ended March 31, 2008. On October 15, 2007, the Company retired
$600,000 of the Crown Bank Promissory notes, and on October 31, 2007, the
Company renewed the remaining $1,600,000 of
10
notes
to mature in February 2009. The
promissory notes are secured by a pledge of all Company assets, including its
intellectual property, and are guaranteed by Bruce Culver, James Davis and
William Reiling, each five percent shareholders of the Company.
In
connection with the renewal, and as a condition to the effectiveness of the
terms and conditions of the renewal of the notes, the Company agreed to deposit
into escrow with Crown Bank four months worth of future interest payments due
under the notes. On December 28,
2007, the Company deposited $44,000 with Crown Bank as the four months interest
requirement, thereby making effective the terms of the renewed notes. The Company has further agreed to deposit
into escrow with Crown Bank all of the interest due on the notes through
maturity upon the closing, and out of the net proceeds of, an underwritten public offering of equity
securities of the Company.
Note 3. Notes
Payable.
On June 1, 2006, the Company borrowed
$75,000 from Mr. Roman Pauly, and in connection therewith issued to Mr. Pauly
a promissory note to mature on August 30, 2006 (the Pauly Note). On March 20, 2007 the Pauly Note was
amended to extend the due date of the note until the Company closes on an
aggregate of $750,000 of incremental debt or equity financing. On January 22, 2007, January 3,
2008 and February 29, 2008, the Company repaid $25,000, $33,000 and $7,650
of the principal of the Pauly Note, respectively. At March 31, 2008, the outstanding
balance of the Pauly Note was $9,350.
The Pauly Note, as amended, bears interest at the prime rate (6.25
percent and 8.25 percent at March 31, 2008 and December 31, 2007,
respectively). In connection with the
amendments, following repayment of the Pauly Note, the Company will issue a
five-year warrant to Mr. Pauly to acquire 41.7 shares of the Companys
common stock at $5.00 per share for each day the promissory note is outstanding
after August 30, 2006. The guidance
provided by EITF Issue No. 96-19 Debtors Accounting for a Modification
or exchange of Debt Instruments (EITF 96-19) indicates that a substantial
modification of debt terms should be accounted for as an extinguishment of
debt. The present value of the cash
flows under the August 24, 2006 modification was greater than 10 percent
different from the present value of the cash flows under the original
agreement. Accordingly, the accrual of
warrants to be issued pursuant to the amended note was recorded as debt
extinguishment expense (see Note 6).
On November 30, 2006, the Company
borrowed $100,000 from Adron Holdings, LLC (Adron). In connection therewith, the Company issued
to Adron an unsecured promissory note that bore an annual interest rate of 60
percent and was set to mature on January 2, 2007 (the Adron Note). On each of March 20, 2007 and August 8,
2007, the Company amended the Adron Note, resulting in a change of the annual
interest rate to 42 percent, the extension of its due dates and an agreement to
issue to Adron 167 five-year warrants to acquire a total of 5,000 shares at
$5.00 per share for each day the principal remained unpaid on and after March 1,
2007. In January 2008, the Company
repaid all of the outstanding principal amount of the Adron Note and issued
five-year, immediately exercisable warrants to acquire up to 52,357 shares of
the Companys common stock at $5.00 per share (see Note 6). The guidance
provided by EITF 96-19 indicates that a substantial modification of debt terms
should be accounted for as an extinguishment of debt. The present value of the cash flows under the
modifications was greater than 10 percent different from the present value of
the cash flows under the existing agreement.
Accordingly, the accrual of warrants to be issued pursuant to the Adron
Note were recorded as debt extinguishment expense (see Note 6).
On
May 25, 2007, the Company borrowed $42,585 from a commercial lender
pursuant to an insurance policy financing agreement. The financing agreement
called for ten monthly installment payments of $4,453 beginning July 1,
2007, with an imputed annual interest rate of 9.85 percent.
11
The
proceeds were paid directly to an insurance company as a prepayment on an
insurance policy.The remaining principal balance of the financing agreement was
repaid during the three months ended March 31, 2008.
On July 31,
2007, the Company borrowed, for working capital purposes, $100,000 from the
Smith Trust (a five percent shareholder) pursuant to a promissory note. The note bears interest at the prime rate
(5.25 percent on March 31, 2008)
.
Following repayment of the promissory note, the Company
will issue a five-year warrant to the Smith Trust to acquire 1 share of the
Companys common stock per $1,000 principal balance outstanding at $5.00 per
share, for each day the promissory note is outstanding (see Note 6(c)).
On January 3, 2008, the Company repaid
$66,000 of this note.
On March 11, 2008, the Company amended the promissory
note with the Smith Trust. Under the
terms of the amendment, unpaid principal and interest will be payable upon the
Companys closing of an aggregate of $500,000 or more of incremental debt or
equity financing following the date of the amendment.
Interest expense recorded during the three months
ended March 31, 2008 and 2007, and the period from August 17, 1999
(inception) to March 31, 2008
was $575, $0 and $3,903, respectively.
At various
times the Company receives short-term, unsecured loans from certain officers
and directors solely for short-term working capital needs. These loans are made without any interest or
other consideration accruing to the officers and directors, and had no defined
terms. As of December 31, 2007, the
Company had borrowed a total of $10,450 from David Koenig, a director. During the three months ended March 31,
2008, the Company repaid $8,250 of the loan.
On October 31, 2007, the Company issued
a promissory note for $600,000 in favor of the Smith Trust, effective as of October 15,
2007. The proceeds were used to retire
$600,000 of the Crown Bank promissory notes.
The promissory note issued to the Smith Trust matures on February 28,
2009, bears interest at the prime rate plus one percent (6.25 percent at March 31,
2008 and 8.25 percent at December 31, 2007, respectively) and has a
subordinated security interest in all of the Companys assets. Interest expense recorded during the three
months ended March 31, 2008 and 2007, and the period from August 17,
1999 (inception) to March 31, 2008 was $10,954, $0 and $21,846,
respectively. In consideration for this
loan, on November 7, 2007, the Company agreed to issue 33,333 shares of
its common stock to the Smith Trust, the value of which was recorded as debt
issuance cost asset (see Note 1(h)). We
also agreed to issue to the Smith Trust: (i) an aggregate amount of 6,667
shares of our common stock if the Crown Bank promissory notes remain
outstanding on October 31, 2008 and (ii) five-year warrants to
acquire a maximum aggregate of 16,667 shares of our common stock at an exercise
price of $2.00. The total aggregate
number of shares subject to the warrants will be determined by dividing 100,000
by the per share price in an underwritten public offering (not less than
$2.00), minus 33,333. The warrants will
be issued on the earlier of (i) the date of an underwritten public
offering or (ii) October 31, 2008, and will be exercisable beginning
on the one-year anniversary of that date.
On March 11, 2008, the
Company amended the promissory note with the Smith Trust. Under the terms of the amendment, interest
accrued pursuant to the promissory note will be payable on the maturity date,
rather than payable monthly.
On April 3, 2008, the Company borrowed
an aggregate of $112,500 pursuant to three promissory notes, each in the amount
of $37,500. The promissory notes were
issued in favor of James Davis, William Reiling and the Smith Trust, each five
percent shareholders of the Company.
Payment in full of the promissory notes and the interest accrued thereon
at an annual rate of 10 percent is due on September 1, 2008. The promissory notes were issued in
connection with the Companys purchase of certain intellectual property from
Profile (see Note 8).
12
Note 4. Convertible Debentures.
As
consideration to the original guarantors (Bruce Culver, James Davis, William
Reiling and the Smith Trust) to provide their guarantees for the Crown Bank
promissory notes, the Company issued $733,334 of unsecured convertible 10
percent debentures. Of the $733,334,
$400,000 matures on February 16, 2009 and $333,334 matures on February 28,
2009. The debentures are convertible
into Company common stock at a price of $3.00 per share. The $733,334 face value of the convertible
debentures (before the impact of the calculation of the beneficial conversion
feature see below) are recorded as current liabilities, with the offset of
the cost of the debentures recorded as a debt issuance cost asset. The debt issuance cost asset is being
amortized as interest expense over the term of the underlying bank note
payable. The convertible debentures are being treated as debt issuance cost
because they represent the costs directly attributable to the bank promissory
note financing.
The
embedded conversion feature of the convertible debentures does not meet all the
characteristics of a derivative instrument as described in SFAS No. 133, Accounting
for Derivative Instruments and Hedging Activities (SFAS 133), and therefore
was not separated from the host contract and accounted for as a
derivative. The embedded conversion
feature does not provide for net settlement, the shares to be issued pursuant
to the exercise of the conversion feature will be unregistered and, due to the
large number of shares involved and the thinly traded market for the Companys
shares, cannot be readily settled net by a means outside the contract. The value of the beneficial conversion
feature was computed as the difference between the fair market value of the
shares at the transaction dates and the lowest possible conversion price during
the debenture term ($3.00 per share), multiplied by the number of conversion
shares that would be issued at that conversion price (244,445 shares). The value so computed was in excess of the
face value of the convertible debentures issued, and was therefore limited to
the face value of the debentures issued ($733,334). The beneficial conversion feature was
recorded as an original issue discount as defined in EITF 98-5 against the
convertible debt liability and is also
being amortized as interest expense over the term of the convertible
debentures.
On March 21, 2007, the Company and the
four convertible debenture holders agreed to amend the debenture
agreements. Pursuant to the revised
debenture agreements, among other things, the Company issued a total of 12,478
shares of its Investment Units to the four guarantors in lieu of $49,911 of
accrued interest. Each Investment Unit
consists of one share of the Companys common stock and a 3-year warrant
(immediately exercisable) to acquire 0.5 shares of the Companys common stock
for $2.50 ($5.00 per share). The
guidance provided by EITF 96-19 indicates that a substantial modification of
debt terms should be accounted for as an extinguishment of debt. The present value of the cash flows under the
March 20, 2007 modification was greater than 10 percent different from the
present value of the cash flows under the original agreement. Accordingly, the warrants issued, valued at
$26,829 using the Black-Scholes method, were recorded as debt extinguishment
expense. No other gain or loss was
recorded.
On December 27, 2007, the
four convertible debenture holders
agreed to
amend the terms of their debentures to provide for automatic conversion of the
principal amount of the debentures and the unpaid interest accrued thereon into
shares of the Companys common stock at $3.00 per share upon the closing of an
underwritten public offering by the Company.
The $733,334 outstanding principal amount of the debentures will convert
into 244,445 shares of the Companys common stock. As of March 31, 2008, $86,851 of unpaid
accrued interest related to the debentures was outstanding. Interest will continue to accrue on the
debentures until they are converted or
13
otherwise retired.
Interest expense recorded during the three months
ended March 31, 2008 and 2007, and the period from August 17, 1999
(inception) to March 31, 2008 was $18,538, $18,335 and $156,661,
respectively.
Note 5. Long-term Convertible
Debentures.
On December 27, 2007, the Company closed on the
sale of $1,050,000 of units consisting of unsecured, subordinated, convertible
promissory notes (the 2007 Notes) and common stock purchase warrants (the 2007
Warrants) in a private placement (the 2007 Private Placement). Net cash proceeds to the Company were
$712,923, after deducting $337,077 of expenses of the offering (including
$105,000 of commissions paid to the placement agent) and excluding from the
cash proceeds the conversion into units of $25,000 of loans made to the Company
by James Davis and $25,000 of certain loans from the Companys directors.
At the closing, the Company issued $997,500 in
principal amount of 2007 Notes and 2007 Warrants to purchase 210,000 shares of
common stock. The 2007 Notes bear
interest at 10 percent per year, mature on June 27, 2009 and will convert
into the type of equity securities offered by the Company in any underwritten
public offering prior to maturity at 70 percent of the public offering
price. In the event a public offering is
not completed before the maturity date, the entire principal and unpaid accrued
interest will convert into the Companys common stock at $0.05 per share. The Company may, at its option, prepay the
2007 Notes anytime on or after December 27, 2008. The 2007 Warrants will become exercisable
upon the earlier of the closing of a public offering or the maturity date of
the 2007 Notes, and will remain exercisable until December 31, 2012. The exercise price will be 50 percent of the
public offering price, or in the event a public offering is not completed
before the maturity date, at 50 percent of the closing price of the Companys
common stock on the maturity date of the 2007 Notes.
On December 27, 2007, the Company also converted
$150,000 of existing loans from James Davis into a note (the Davis Note) and
warrants (the Davis Warrants). The
principal amount of the note issued to Mr. Davis was $142,500. Mr. Davis also received warrants to
purchase 30,000 shares of the Companys common stock. The terms of the Davis Note and Davis
Warrants are the same as those issued in the 2007 Private Placement, except
that, the Davis note is convertible into the type of equity securities offered
by the Company in an underwritten public offering at 50 percent of the public
offering price. In addition, Mr. Davis
agreed that the equity securities issued upon conversion of the Davis Note and
the common stock issued upon exercise of the Davis Warrants will not be
transferable for a period of one year beginning on the effective date of the
public offering triggering conversion of the note.
On January 4, 2008, the Company closed on the sale of
$80,000 of additional units as part of the 2007 Private Placement. Net cash proceeds to the Company were
$69,600, after deducting $10,400 of commissions paid to the placement
agent. At closing, the Company issued
$76,000 in principal amount of 2007 Notes and 2007 Warrants to purchase 16,000
shares of common stock. In total, in the
two closings of the 2007 Private Placement, the Company issued a total of
$1,073,500 in principal amount of 2007 Notes and 2007 Warrants to purchase
226,000 shares of common stock.
On February 13 and February 28,
2008, the Company closed on an aggregate $390,000 of units
consisting of
unsecured, subordinated, convertible promissory notes and common stock purchase
warrants in the February 2008
Private Placement. Net cash proceeds to
the Company were approximately $298,000, after deducting approximately $92,000
of expenses of the offering (including $50,700 of commissions paid to the
placement agent). Each $10,000 unit
consists of a
14
note
in the principal amount of
$9,500 (the February 2008 Notes) and
a warrant to purchase 2,000 shares of our common stock (the February 2008
Warrants). The terms of the February 2008
Notes and February 2008 Warrants are identical to the 2007 Notes and 2007
Warrants, respectively, except that the Companys option to prepay the February 2008
Notes begins anytime on or after February 13, 2009 and the maturity date
of the February 2008 Notes is August 13, 2009.
The
embedded conversion features of the 2007 Notes, Davis Notes and the February 2008
Notes do not meet all the characteristics of a derivative instrument as
described in SFAS 133, and therefore were not separated from the host contracts
and accounted for as derivatives. The
embedded conversion features are indexed to the Companys common stock, and
would be classified in shareholders equity under the guidance of EITF Issue No. 00-19
Accounting for Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Companys Own Stock (EITF 00-19), if they were freestanding
derivatives. The embedded conversion
feature contains an explicit limit on the number of shares to be delivered, the
Company has sufficient authorized and unissued shares available to settle the
maximum number of shares and the debenture agreement does not contain a net
cash settlement feature. The beneficial
conversion features of the promissory notes, valued at $809,512 using the
Black-Scholes pricing model, along with the $51,065 relative fair value of the
2007 Warrants, the Davis Warrants, and the February 2008 Warrants, were
recorded as an original issue discount as defined in EITF 98-5 against the
convertible debt liability, and is being amortized as interest expense over the
term of the convertible debentures. During
the three months ended March 31, 2008, $128,776 of the original issue
discount was amortized as interest expense.
On May 2, 2008 the Company closed on
an aggregate $155,000 of units
consisting of unsecured,
subordinated, convertible promissory notes and common stock purchase warrants
in the May 2008 Private Placement
(see Note 8).
Note 6.
Shareholders Equity.
(a)
Common
Stock
No common stock was issued during
the three months ended March 31, 2008.
(b)
Stock Options
No stock options were issued
during the three months ended March 31, 2008.
(c)
Warrants
The warrants described below, issued or to be issued, are
exempt from registration under Section 4(2) of the Securities Act as
they were or will be issued in non-public offerings to a limited number of
subscribers. Each of the following
warrants was valued using the Black-Scholes pricing model:
·
On January 4, 2008, pursuant to a final separation agreement with a
former employee of the Company, the Company issued to the former employee
five-year warrants (immediately exercisable) to acquire up to 14,500 shares of
the Companys common stock at an exercise price of $5.00 per share, and amended
a previously issued warrant to
15
acquire up to 30,000 shares of the Companys
common stock to provide for cashless exercise thereof. The warrants, valued at $14,500 using the
Black-Scholes pricing model, were recorded as compensation expense during the
three months ended March 31, 2008.
·
Pursuant to the
terms of the Adron Note (see Note 3), upon the repayment of the principal
thereon on January 16, 2008, the Company issued five-year, immediately
exercisable warrants to acquire up to 52,357 shares of the Companys common
stock at $5.00 per share. During the
three months ended March 31, 2008, the accrual of 1,347 warrants valued at
$4,849 using the Black-Scholes pricing model was expensed as debt
extinguishment expense. During the three
months ended March 31, 2007, the issuance of 5,167 warrants valued at
$23,162 using the Black-Scholes pricing model was expensed as interest expense
and the accrual of 10,168 warrants valued at $36,604 was recorded as debt
extinguishment expense.
·
In connection
with amendments to the Pauly Note (see Note 3), following repayment of the
Pauly Note, the Company will issue a five-year warrant (immediately
exercisable) to Mr. Pauly to acquire 41.7 shares of the Companys common
stock at $5.00 per share for each day the Pauly Note is outstanding after August 30,
2006. As of March 31, 2008, the
Company had accrued for issuance warrants to acquire 24,186 shares of the
Companys common stock pursuant to this arrangement. During the three months ended March 31,
2008 and 2007, the accrual of 3,795 and 3,753 warrants valued using the
Black-Scholes pricing model at $20,492 and $20,267, respectively, were expensed
as debt extinguishment expense.
·
On July 31, 2007, the
Company borrowed $100,000 for short-term working capital needs pursuant to a
promissory note issued to the Smith Trust (see Note 3). Following repayment of the promissory note,
the Company will issue a five-year warrant (immediately exercisable) to the
Smith Trust to acquire 1 share of the Companys common stock per $1,000
principal outstanding at $5.00 per share for each day the promissory note is
outstanding after August 30, 2006.
As of March 31, 2008, the Company had accrued for issuance warrants
to acquire 18,626 shares of the Companys common stock pursuant to this
arrangement. During the three months
ended March 31, 2008, the accrual of 3,226 warrants valued at $12,904
using the Black-Scholes pricing model was expensed as interest expense.
·
On April 3,
2008, as consideration to James Davis, William Reiling and the Smith Trust, for
providing certain loans to the Company, the Company issued five-year warrants
(immediately exercisable) to purchase a total of 75,000 shares of the Companys
common stock at $1.50 per share to each lender (see Note 8). The gross proceeds were allocated between the
note and the warrants based on the relative fair value at the time of issuance. The warrants, valued at $69,000 using the
Black-Scholes pricing model, were allocated $42,769 which will be recorded as
original issue discount on the related promissory notes and will be expensed as
interest expense over the term of the promissory notes.
Note 7. Income Taxes.
In
July 2006, the FASB issued Interpretation No. 48, Accounting for
Uncertainty in Income Taxes (FIN 48). FIN 48 prescribes a recognition
threshold and measurement attribute for the
16
financial
statement recognition and measurement of a tax position taken or expected to be
taken in its tax return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. The Company adopted FIN 48 as of January 1,
2007, and the adoption had no significant impact on the consolidated financial
statements.
The Company has adopted the policy of classifying interest in interest
expense and penalties in general and administrative expense. The Company had recorded no accrued interest
or penalties as of the date of adoption.
The Company had no significant unrecognized tax benefits as of March 31,
2008 and December 31, 2007 and, likewise, no significant unrecognized tax
benefits that, if recognized, would affect the effective tax rate. The Company had no positions for which it
deemed that it is reasonably possible that the total amounts of the
unrecognized tax benefit will significantly increase or decrease.
The Company has generated net operating loss carryforwards of approximately
$4.2 million which, if not used, will begin to expire in 2021. Federal and state tax laws impose significant
restrictions on the utilization of net operating loss carryforwards in the
event of a change in ownership of the Company that constitutes an ownership
change, as defined by Section 382 of the Internal Revenue Code of 1986,
as amended (the Code). The Company has
analyzed the Merger and private placement transactions that occurred in April 2004,
and believes that they do not constitute such an ownership change. However, additional shares and warrants
likely to be issued pursuant to the Companys financing efforts, together with
certain transactions occurring in the previous 36-month period, may constitute
a change in ownership that could subject the Companys use of its net operating
loss carryforwards to the above limitations.
Based on the Companys estimates, the limitation would apply to
substantially all of the $4.2 million net operating loss carryforwards.
The net operating loss carryforwards are subject to examination until
they expire. The tax years that remain
subject to examination by major tax jurisdictions currently are:
Federal 2004 - 2006
State of Minnesota 2004 - 2006
Note
8. Subsequent Events.
Asset Purchase
Agreement and Promissory Note
On April 3, 2008, the Company purchased certain
patents, patent applications and know-how (the Assets) from Profile pursuant
to an asset purchase agreement (the Asset Purchase Agreement). The purchase price of the Assets was
$300,000, of which $150,000 was paid in cash and $150,000 was financed under a
secured promissory note issued in favor of Profile (the Profile Note). Pursuant to the terms of the Profile Note,
the principal and interest accrued thereon becomes due and payable five
business days following the close of a public offering of the Companys equity
securities or August 29, 2008, whichever occurs first (the Maturity Date). Interest will accrue at an annual rate of 10
percent prior to the Maturity Date and 18 percent thereafter. In the event the Profile Note is not fully
paid at the Maturity Date or within 45 days thereafter, Profile may enforce its
right to have the Assets returned, and the Company will not be able to recoup
any monies that were previously paid to Profile. The Profile Note was made in connection with,
and subject to the terms and conditions of, a Security Agreement dated April 3,
2008 between the Company and Profile under which the Company granted to Profile
a security interest in the Assets. As noted by SFAS No.
2, Accounting for Research and Development Costs,
regarding costs of intangibles that are
17
purchased
from others for a particular research and development project and that have no
alternative future uses,
the Assets will be immediately
expensed as research and development expense
Prior to purchasing the Assets, the Company had
licensed certain rights to the Assets from Profile. Profile is a five percent shareholder of the
Company. The technology encompassed by
the Assets provides the basis for the ProUroScan
TM
system, the
Companys initial product currently in the final stages of development.
Issuance of
Notes and Warrants
On April 3, 2008, the Company borrowed
an aggregate of $112,500 pursuant to three unsecured promissory notes, each in
the amount of $37,500. The promissory
notes were issued in favor of James Davis, William Reiling and the Smith
Trust. Payment in full of the promissory
notes and the interest accrued thereon at an annual rate of 10 percent is due
on September 1, 2008. As
consideration for providing the loans, the Company issued immediately
exercisable, five-year warrants to purchase 25,000 shares of the Companys
common stock at $1.50 per share to each lender.
The gross proceeds were allocated between the note and the warrants
based on the relative fair value at the time of issuance. The warrants, valued at $69,000 using the
Black-Scholes pricing model, with a relative fair value of $42,769, will be
recorded as original issue discount on the related promissory notes, and will
be expensed as interest expense over the term of the promissory notes. The proceeds of the loans were used to pay
for the purchase of the Assets from Profile, as described above.
Private
Placement Closing
On May 2, 2008 the Company closed on
an aggregate $155,000 of units
consisting of unsecured,
subordinated, convertible promissory notes and common stock purchase warrants
in the May 2008 Private
Placement. Net cash proceeds to the Company
were approximately $120,000, after deducting approximately $35,000 of expenses
of the offering (including $20,150 of commissions paid to the placement
agent). Each $10,000 unit consists of a
note in the principal amount of $9,500 and a warrant to purchase 2,000 shares of our common stock. The
terms of the notes and warrants are identical to the 2007 Notes and 2007
Warrants, respectively, except that the Companys option to prepay the May 2008
notes begins anytime on or after May 2, 2009 and the maturity date of the May notes
is November 2, 2009.
18
Item
2. Managements Discussion and Analysis
of Financial Condition and Results of
Operation.
The accompanying
Managements Discussion and Analysis of Financial Condition and Results of
Operation should be read in conjunction with our unaudited consolidated
financial statements, and notes thereto, filed with our Quarterly Report on Form 10-Q
for the quarter ended March 31, 2008
.
Disclosure Regarding Forward-Looking Statements
Certain
statements contained in this Quarterly Report on Form 10-Q may be deemed
to be forward-looking statements as defined by the Private Securities
Litigation Reform Act of 1995, and the Company intends that such
forward-looking statements be subject to the safe-harbor created thereby. Such forward-looking statements relate to,
among other things: general economic or industry conditions, nationally
and in the physician, urology and medical device communities in which we intend
to do business; our ability to raise capital to fund our 2008 and 2009 working
capital needs and launch our products into the marketplace in subsequent years;
our ability to complete the development of our existing and proposed products
on a timely basis or at all; legislation or regulatory requirements, including
our securing of all U.S. Food and Drug Administration (FDA) and other
regulatory approvals on a timely basis, or at all, prior to being able to
market and sell our products in the United States; competition from larger and
more well established medical device companies and other competitors; the
development of products that may be superior to the products offered by us;
securing and protecting our intellectual property and assets, and enforcing breaches
of the same; clinical results not anticipated by management of the Company; the
quality or composition of our products and the strength and reliability of our
contract vendors and partners; changes in accounting principles, policies or
guidelines; financial or political instability; acts of war or terrorism; and
other economic, competitive, governmental, regulatory and technical factors
affecting our operations, proposed products and prices. We caution that these statements are qualified by important factors
that could cause actual results to differ materially from those reflected by
the forward-looking statements contained herein.
Overview;
Product Offerings.
ProUroCare Medical Inc. (ProUroCare,
the Company, we, us or our, which terms include reference to our wholly
owned subsidiary, ProUroCare Inc. (PUC)) is a development stage company that
is focused on developing advanced mechanical imaging technology for assessing
the size, shape and volume of the prostate by creating a visual image of the
prostate gland for use in identifying and characterizing abnormal lesions or
tissue and monitoring the effects of prostate treatments.
The Companys primary
activities to date have focused on acquiring technology, intellectual property
rights and working with Artann Laboratories Inc. (Artann) to complete
development of the ProUroScan
TM
prostate imaging system. We have assembled an experienced management
team and identified the necessary clinical, regulatory and reimbursement
resources to assist us in moving the product to market. We have aggressively worked to obtain the
funding to complete development of the ProUroScan
TM
system and to
bring it to market.
Our
initial product is the ProUroScan
TM
system, a mechanical imaging
system that enables physicians to identify and characterize the existence of
abnormal prostate tissue and monitor changes in prostate tissue over time. During the next 12 months, assuming our
financing efforts are successful (see
Liquidity and Capital Resources, below
), we expect to
prepare the ProUroScan
TM
system for clinical trials, obtain FDA
clearance on a basic mapping and data
maintenance labeling claim and prepare to launch our product into the
market, although there can be no assurance that we will be successful in meeting
these milestones. We
19
are
currently exploring potential marketing relationships with medical device
companies that are interested in marketing products in the prostate cancer
detection market. We expect such a relationship would provide both
financial support and access to down stream marketing, engineering,
manufacturing and sales capabilities.
The
ProUroScan
TM
system has been developed by us under development
contracts with Artann, a scientific technology company focused on early-stage
technology development. In September 2006,
Artann was awarded a $3 million Small Business Innovation Research Phase II
Competitive Renewal grant from the National Cancer Institute (the 2006 NIH
Grant) to help advance the development and application for clearance of our
ProUroScan
TM
system by the FDA.
It is our intent to work with Artann under this grant to finalize our
current system for clinical trials, and to expand our working relationship with
Artann to include their participation in the development and licensing of
future generations of the ProUroScan
TM
system. We
are currently in active negotiations with Artann to enter into a development
and licensing agreement that will
provide the foundation for future development of the ProUroScan
TM
system.
Current
Developments
On April 3, 2008,
we purchased certain patents, patent applications and know-how (the Assets)
from Profile LLC (Profile) for $300,000.
The technology encompassed by the Assets provides the basis for the
ProUroScan
TM
system, our initial product currently in the final
stages of development. Prior to
purchasing the Assets, we had licensed rights to the Assets from Profile. By purchasing the Assets, we both secure our
key intellectual property and eliminate potentially very significant royalty
payments to Profile upon commercialization of the ProUroScan
TM
system. As discussed in Note 8 to the
consolidated financial statements, we financed the purchase of the Assets by
issuing a $150,000 promissory note to Profile (secured by the Assets) and by
issuing an aggregate $112,500
of unsecured promissory notes to three individual investors.
On May 2, 2008, the Company closed on
an aggregate $155,000 of units
consisting of unsecured,
subordinated, convertible promissory notes and common stock purchase warrants
in a private placement on terms
essentially the same as the 2007 Private Placement and the February 2008
Private Placement. As of May 2,
2008, the Company has closed on a total of $1,825,000 of units in the three
private placements, including the conversion of $175,000 of existing debt into
units.
Results
of Operations
The following discussion
of the financial condition and results of operations should be read in
conjunction with the financial statements included herewith. This discussion
should not be construed to imply that the results discussed herein will
necessarily continue into the future, or that any conclusion reached herein
will necessarily be indicative of actual operating results in the future.
Three
months ended March 31, 2008 compared to the three months ended March 31,
2007:
Operating
Expenses/Operating Loss
.
Our operating
expenses (and our operating loss) for the three months ended March 31,
2008 were $246,162, a decrease of $233,099, or 48 percent, compared to $469,261
last year. The decrease is primarily the
result of cost cutting efforts in early 2007 that included the retirement of our former Chief Executive
Officer and the terminations of our former President and Chief Operating
Officer and another employee.
20
Compensation and benefits
costs in the three months ended March 31, 2008 decreased approximately
$84,000, or 51 percent, compared to last year.
Stock-based compensation declined approximately $154,000, or 84 percent,
compared to last year, as several employee stock options became fully vested
during 2007 and were therefore fully expensed prior to 2008, and a one-time,
$96,000 expense was recognized during the three months ended March 31,
2007 related to an extension of the exercise period of a warrant. Additionally, work on our ProUroVision
product was also terminated in early 2007; approximately $24,000 of research
costs was recorded in the three months ended March 31, 2007. These decreases were off set by approximately
$20,000 of legal fees associated with one-time costs of our reverse stock
split, the filing of our Registration Statement on Form S-8 and other SEC
filings and an approximately $9,000 increase in audit fees, during the three
months ended March 31, 2008.
Net
Interest Expense
.
Net interest expense for the three months
ended March 31, 2008 was $389,056, an increase of 32 percent, compared to
$295,195 last year. The increased
interest can be attributed to the issuance of convertible notes to investors in
our 2007 Private Placement and our February 2008 Private Placement. Amortization of the original issue discount
attributable to warrants issued in the private placements resulted in
approximately $130,000 of recorded interest expense in the three months ended March 31,
2008, while the interest on the convertible notes totaled approximately
$35,000. These increases were partially
offset by interest expense reductions resulting from declining interest rates
(down approximately 30 percent from last year) and a reduction in the amounts
of loans that were outstanding.
Debt Extinguishment Expense
.
Our debt extinguishment expense for the three months ended March 31,
2008 was $25,340, a decrease of 70 percent, compared to $83,700 last year. Our debt extinguishment expense arises
primarily from the cost of warrants accrued for issuance pursuant to the
provisions of short-term loans from certain individual lenders. The decrease was due to the repayment of a
significant portion of these outstanding short term loans in late 2007 and in
early 2008.
Assets; Property Acquisitions and Dispositions
Our primary assets are patents and patent
applications, which are the foundation for our proposed product offerings. These assets
are pledged as
collateral on a $150,000 loan, and also secure a $1.6 million senior bank note
and a note issued to an investor in the amount of $600,000 and, as a result,
are not available to secure other senior debt financing. We anticipate purchasing
approximately $135,000 of computer equipment, development tools and molds,
software and production tooling during the next 12 months. We do not anticipate selling any significant
equipment or other assets in the near term.
Current Operations Employees and Expenses
We currently employ only two employees. We conduct our research and development,
market research, regulatory and other business operations through the use of a
variety of consultants and medical device development contractors. We believe that using consultants and
contractors to perform these functions is more cost effective than hiring
full-time employees and affords us flexibility in directing our resources
during our development stage. As we
prepare for submission to the FDA and market launch of our ProUroScan
TM
system, over the next 12 months we expect to hire approximately 7 employees in
the areas of engineering, regulatory compliance, marketing and quality
control. During the next 12 months, we
expect to complete the development of clinical ProUroScan
TM
systems,
conduct clinical trials and file a 510(k) submission with the FDA, begin
the registration process in the European Union and establish strategic
marketing and contract manufacturing relationships in anticipation of regulatory
clearance to enter the market.
21
We
incur ongoing expenses that are directly related to being a publicly traded
company, including professional audit and legal fees, financial printing, press
releases and transfer agent fees. We
currently occupy temporary offices within the office of a former Company
director, for which we accrue rent on a month-to-month basis of approximately
$2,200 per month. Upon successful
completion of our current funding efforts, we expect to relocate to permanent
offices of approximately 2,000 square feet.
Other expenses incurred include executive officer compensation,
expensing of stock options, travel, insurance, telephone, supplies and other
miscellaneous expenses. In the next 12
months, the Company anticipates that it will spend approximately $1.3 million
in marketing and administrative expenses.
Of these, the Company expects that approximately $550,000 will be for
compensation, benefits and payroll taxes and approximately $180,000 will be for
consulting costs.
The
remaining work to prepare the ProUroScan
TM
system for FDA clinical studies consists primarily of
engineering and user interface refinements, safety and bio-testing and
completion of documentation and validation studies. Over the next 12 months, we expect this work
to be performed by Artann and other independent contractors. We are actively engaged in negotiations with
Artann to complete the remaining phases of the ProUroScan
TM
project, and anticipate
completing a development agreement in the second quarter of 2008. A significant portion of these costs are
eligible for coverage under the 2006 NIH Grant.
Although the terms of our development agreement have yet to be
finalized, we expect that a combination of cash and equity will be provided to
Artann, spread out over the next five years.
We are also negotiating a license agreement with Artann to provide
access to know how and future intellectual property associated with prostate
mechanical imaging. We expect that
payment for these interests will be paid by a combination of fees and
royalties. Over the next 12 months, we
expect that cash and equity payments to all outside contractors for research,
development and clinical work, net of amounts reimbursed from the 2006 NIH
Grant, may range between $2 and $3 million.
We
also anticipate developing a small internal engineering team with competencies
in electrical and mechanical engineering and software design and development to
fill specific project requirements not covered by Artann or other outside
contractors. Internal salaries, benefits
and miscellaneous departmental expenses for software and hardware development,
regulatory work and project management over the next 12 months are estimated to
be $240,000.
Liquidity and Capital Resources
Net cash used in operating activities
was
approximately $432,000 during the first quarter of 2008 compared to
approximately $290,000 in the first quarter of 2007. The increase in cash used was primarily the
result of payments of accrued expenses, including accrued compensation, in the
first quarter of 2008.
Net cash provided by financing activities was approximately $165,000
during the first quarter of 2008 compared to approximately $306,000 in the
first quarter of 2007. Net proceeds of
our private placements during the first quarter of 2008 of approximately
$393,000 were offset by payments of notes payable and loans from directors of
approximately $228,000. During the first
quarter of 2007, net proceeds from the issuance of common stock of
approximately $335,000 was offset by payments of notes payable of approximately
$29,000.
We do not currently have sufficient funds to
complete the development of our products and gain approval of them from the
FDA. As of March 31, 2008, we had
approximately $134,000 cash on hand and current liabilities of approximately
$4.0 million. We estimate that we will
need approximately $3.5 million of cash over the next 12 months to complete the
development of a first generation system, submit a premarket notification
application to the FDA and obtain FDA 510(k) clearance for basic mapping
and
22
data maintenance labeling claims. In addition, we have $2.2 million of secured
debt and $733,334 of convertible debt, both of which mature at the end of February 2009,
and other short term liabilities exceeding $1,150,000.
During the next 12 months, we plan to raise
approximately $5.1 million through private or public offerings of our debt or
equity securities, alternative financing sources that may become available to
us or some combination of these. We
anticipate that the net proceeds from such financings will be sufficient to
fund our operations and retire approximately $700,000 of short term liabilities.
We intend to address the $2.2 million secured debt that matures in February 2009
by seeking an equity investment or licensing fee from a strategic marketing
partner, or by seeking an extension of the maturity dates. We expect that the convertible debt will be
converted into common stock during the next 12 months. If we are unsuccessful in obtaining an equity
investment or licensing fee, or an extension of the maturity date of the
secured debt, or if the convertible debt is not converted into our common
stock, we will need to raise additional funds.
Sources of alternative
financing include possible strategic investments from medical device companies
that may be interested in marketing products in the prostate cancer detection
market. In addition to financial
support, a successful collaboration with such a company would allow us to gain
access to down stream marketing, engineering, manufacturing and sales support.
Approximately $2.3 million
of our outstanding convertible debentures will automatically convert into
equity upon our closing of an underwritten public offering. In addition, to date we have issued a total
of 334,000 warrants in our 2007 and 2008 private placements, and additional
warrants may be issued pursuant to our financing efforts.
We
are attempting to raise enough cash to complete the development of a first
generation ProUroScan
TM
system and to seek or obtain FDA 510(k) clearance
for basic mapping and data maintenance labeling claims. However, if our financing efforts are
unsuccessful or significantly delayed for any reason, or if our product
development efforts experience significant unforeseen delays, we may not have
sufficient funds to complete these objectives, and will require additional
financing. If additional funds are
raised by the issuance of convertible debt or equity securities, such as the
issuance of stock, or the issuance and exercise of warrants or the issuance and
conversion of convertible debentures, then existing shareholders will
experience dilution in their ownership interests. If additional funds are raised by the
issuance of debt or certain equity instruments, we may become subject to
certain operational limitations and such securities may have rights senior to
those of existing holders of common stock.
If adequate funds are not
available through these initiatives on a timely basis, or are not available on
acceptable terms, we may be unable to fund expansion, or to develop or enhance
our products. Ultimately, if no
additional financing is obtained beyond what has been secured to date, we could
potentially be forced to cease operations.
See Part II, Item 1A of this Quarterly Report on Form 10-Q and
Item 1 of our Annual Report on Form 10-KSB for the year ended December 31,
2007 for a complete discussion of our risk factors.
Going Concern
We have incurred operating losses, accumulated
deficit and negative cash flows from operations since inception. As of March 31, 2008, we had an
accumulated deficit of approximately $16.9 million. These factors, among others, raise
substantial doubt about our ability to continue as a going concern. Our unaudited consolidated financial
statements included in this Quarterly Report on Form 10Q do not include
any adjustments related to recoverability and classification of asset carrying
amounts or the amount and classification of liabilities that might result
should we be unable to continue as a going concern.
23
Critical
Accounting Policies
Our
financial statements are prepared in accordance with accounting principles
generally accepted in the United States of America, or GAAP. The application of
GAAP requires that we make estimates that affect our reported amounts of assets
and liabilities and disclosure of contingent assets and liabilities at the date
of the financial statements and the reported amounts of revenue and expenses
during the reporting period. We base our estimates on historical experience and
on various other assumptions that we believe to be reasonable under the
circumstances. We evaluate our estimates and assumptions on an ongoing basis.
Our actual results may differ significantly from these estimates.
A
description of the Companys critical accounting policies that represent the
more significant judgments and estimates used in the preparation of the Companys
financial statements was provided in the Managements Discussion and Analysis
of Financial Condition and Results of Operations section of the Companys
Annual Report on Form 10-KSB for the year ended December 31, 2007.
Item 4T.
Controls and Procedures.
Disclosure Controls and Procedures
We maintain disclosure controls and procedures designed to ensure that
information required to be disclosed in our reports filed or submitted under
the Exchange Act is recorded, processed, summarized and reported within the
time periods specified in the rules and forms of the Securities and
Exchange Commission (the SEC). As of March 31, 2008, the end of the
period covered by this Quarterly Report on Form 10-Q, we carried out an
evaluation, under the supervision and with the participation of management,
including our Chief Executive Officer and Chief Financial Officer, of the
effectiveness of the design and operation of our disclosure controls and
procedures pursuant to Exchange Act Rule 13a-15. Based upon that
evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures are effective.
Changes in Internal Control Over Financial Reporting
During
the quarter ended March 31, 2008, there has been no change in the Companys
internal control over financial reporting (as defined in Rule 13a-15(f) under
the Exchange Act) that has materially affected, or is reasonably likely to
materially affect, the Companys internal control over financial reporting.
24
PART II.
OTHER INFORMATION.
Item 1. Legal Proceedings.
The Company, like most other public
companies, is involved in legal proceedings in the conduct of the ordinary
course of its business.
Item
1A. Risk Factors
Investing in our common stock
involves a high degree of risk. You should carefully consider the risks and
uncertainties set forth under Item 1 of our Annual Report on Form 10-KSB
for the year ended December 31, 2007, as well as the material changes to
those risk factors set forth below before purchasing our common stock. These risks and uncertainties are not the
only ones facing our Company; additional risks and uncertainties may also
impair our business operations. If any of the following risks actually occur,
our business, financial condition, results of operations or cash flows would
likely suffer. In that case, the trading price of our common stock could fall,
and you may lose all or part of your investment. We undertake no obligation to update or
revise any forward-looking statement except as required by the SEC.
The following risk factors
disclosed in our Annual Report on Form 10-KSB have been deleted as a
result of our April 3, 2008 acquisition of key patents, patent
applications and know-how from Profile that we had previously licensed:
·
We license from third parties, and do not own
or control, key intellectual property critical to our products.
·
If we lose our right to license and use from
third parties certain critical intellectual property for any reason, our entire
business would be in jeopardy.
·
The protections for the intellectual property
we license from other parties may be successfully challenged by third parties.
·
We will begin to
lose patent protection on our licensed prostate-imaging systems and related
patent technologies beginning in 2012. As we lose patent protection on
our critical licensed technologies, it may have a material adverse effect on
our business
The following risk factors
replace the deleted risk factors noted above as a result of our April 3,
2008 acquisition of key patents, patent applications and know-how from Profile
that we had previously licensed:
The intellectual property we own is subject to a secured
$150,000 loan which, if not settled upon maturity, could lead to the loss of
our patent rights and put
our entire business in jeopardy.
We have purchased certain patents, patent applications and know-how
from Profile
that is
critical to our proposed products.
A portion of the purchase price of the
patents, patent applications and know-how was financed under a secured,
$150,000 promissory note issued in favor of Profile. Pursuant to the terms of the note, the
principal and interest accrued thereon becomes due and payable five business
days following the close of a public offering of our equity securities or August 29,
2008, whichever occurs first. In the
event the note is not fully paid upon maturity or within 45 days thereafter,
Profile may enforce its right, which is secured by an agreement under which we
granted to Profile a security interest, to have the patents, patent
applications and know-how returned, and we will not be able to recoup any
monies that were previously paid to Profile.
If the
foregoing breach and circumstances occurred, the viability of the Company would
be in question. Our only alternatives would be to find existing and
non-infringing
25
technology
to replace the lost technology, if any exists, or develop new technology
ourselves. The pursuit of any such
alternative would likely cause significant delay in the development and
introduction of our proposed products and could have a material adverse effect
on our business.
The
protections for our key intellectual property may be successfully challenged by
third parties.
We own various key intellectual properties. No assurance can be given that any
intellectual property claims will not be successfully challenged by third
parties. Any challenge to our
intellectual property, regardless of merit, would likely involve costly
litigation which could have a material adverse effect on our business. If a successful challenge were made to
intellectual property that is critical to our proposed products, the pursuit of
any such alternative would likely cause significant delay in the development
and introduction of such products. Moreover, a successful challenge could call
into question the validity of our business.
We will begin to lose patent protection on our prostate-imaging systems
and related patent technologies beginning in 2012. As we lose patent
protection on our critical technologies, it may have a material adverse effect
on our business.
We
rely on certain patents to provide us with exclusive rights for our
technology. One of these patents will
expire in 2012, another in 2013, while the remainder will expire between 2016
and 2021. As we begin to lose certain
patent protections on our prostate-imaging systems and related critical
patented technologies in 2012, we may face strong competition as a result,
which could have a material adverse effect our business.
The risks and uncertainties
listed below are fully described in our Annual Report on Form 10-KSB, to
which no material changes have been made:
·
As a development stage company, we have no operating
history and our business plan has not yet been fully tested. We anticipate incurring future losses until
our products are completed, regulatory approval is secured and our products are
introduced into the United States and worldwide markets.
·
We have a history of operating losses and
have received a going-concern qualification from our independent registered
public accounting firm.
·
We are currently in need of financing and
will need additional financing during 2008, and any such financing will likely
be dilutive to our existing shareholders.
·
Even if we raise enough cash in our financing
efforts to complete development of a first generation ProUroScan
TM
system and to obtain FDA clearance of a 510(k) on
a basic mapping and data maintenance claim, we will still require additional
financing to launch our product into the market.
·
If
we are unable to secure a distribution partner for the commercial launch of our
first generation ProUroScan
TM
system, we may require additional
financing to launch our product into the market.
·
If FDA clearance is delayed, including because we
are not able to raise enough funds to get us through the regulatory process, we
could potentially be forced to cease operations.
26
·
Our assets are pledged to secure a $1.2
million senior bank note and a $600,000 note issued to an investor and, as a
result, are not available to secure other senior debt financing. Upon the occurrence of an event of default,
our assets will be assigned to guarantors of the senior bank note and the
holder of such $600,000 promissory note.
·
Our products have not been, and may never be,
fully commercially completed and developed.
·
We are relying upon Artann Laboratories, Inc.
(Artann) to complete development of the ProUroScan
TM
system and will not be able
to control the pace of that development.
Failure to establish a new
development and licensing agreement on terms acceptable to the Company would
significantly delay the development and market introduction of the ProUroScan
TM
system and would have a material adverse effect on our business.
·
Failure to obtain a license for intellectual
properties owned by Artann would have a material adverse effect on our
business.
·
The commercialization of our products may be
significantly delayed by governmental regulation and any and all such delays,
if they occur, may have a material adverse effect on our business.
·
Even if successfully developed, our products
may not be commercially viable.
·
Even if successfully developed, our products
may not be accepted by the marketplace.
·
A
failure to successfully implement a patient pay sales model prior to
establishing third party reimbursement would have a material adverse effect on
product sales and our financial results.
·
Our failure to receive third-party coverage
and reimbursement for our products, when in the marketplace, could result in
diminished marketability of our products.
·
Once we
commercialize the ProUroScan
TM
system, we may be subject, directly or indirectly, to
federal and state healthcare fraud and abuse laws and regulations and could
face substantial penalties if we are unable to fully comply with such laws.
·
Any failure in our efforts or our contractors
efforts to train physicians or other medical staff could result in lower than
expected product sales.
·
There is no guarantee that the FDA will grant 510(k) clearance
or PMA approval of our future products and failure to obtain necessary
clearances or approvals for our future products would adversely affect our
ability to grow our business.
·
Clinical trials necessary to support our
future submissions will be expensive and may require the enrollment of large
numbers of patients, and suitable patients may be difficult to identify and
recruit
. Delays or failures in our clinical trials will prevent us from
commercializing any modified or new products and will adversely affect our
business, operating results and prospects.
·
If the third parties on which we rely to
conduct our clinical trials and to assist us with pre-clinical development do
not perform as contractually required or expected, we may not be able to obtain
regulatory approval for or commercialize our products.
27
·
Even if our products are cleared or approved by regulatory authorities,
if we or our contract manufacturers or suppliers fail to comply with ongoing
FDA or other foreign regulatory authority requirements, or if we experience
unanticipated problems with our products, these products could be subject to
restrictions or withdrawal from the market.
·
Our products may in the future be subject to product
recalls that could harm our reputation, business and financial results.
·
If our products cause or contribute to a death or a
serious injury, or malfunction in certain ways, we will be subject to medical
device reporting regulations, which can result in voluntary corrective actions
or agency enforcement actions.
·
We have limited experience in assembling and testing our products and
may encounter problems or delays in the assembly of our products or fail to
meet certain regulatory requirements which could result in an adverse effect on
our business and financial results.
·
Federal regulatory reforms may adversely affect our
ability to sell our products profitably.
·
Rapid technological change in our competitive
marketplace may render our proposed products obsolete or may diminish our
ability to compete in the marketplace.
·
We will depend upon others for the
manufacturing of our products, which will subject our business to the risk that
we will be unable to fully control the supply of our products to the market.
·
Our reliance on third-party manufacturers and
other third parties in other aspects of our business may reduce any profits we
may earn from our products and may negatively affect future product
development.
·
We may not be able to enter into
manufacturing agreements or other collaborative agreements on terms acceptable
to us, if at all, which could have a material adverse effect on our business.
·
We expect to rely materially on Artann and
other consultants and contractors, some of whom may be partially or wholly paid
through issuances of common stock dilutive to our shareholders.
·
The funding provided by the government from
the $3,000,000 Small Business Innovation Research Phase II Competitive Renewal
grant awarded to Artann by the National Institutes of Health (NIH) may be
reduced or delayed. If such reduction or
delay occurs, this may have a material adverse effect on our business.
·
We are highly dependent on the services
provided by certain key personnel.
·
We may not be able to successfully compete
against companies in our industry with greater resources, or with any
competition.
·
Our common stock is illiquid and may be
difficult to sell.
·
There is currently limited trading volume in
our common stock, which may make it difficult to sell shares of our common
stock.
28
·
Because our stock is deemed a penny stock,
you may have difficulty selling shares of our common stock.
·
The shares and
warrants that may be issued in future financings may trigger an ownership
change as defined by the Internal Revenue Code of 1986, as amended (the Code)
and our ability to use operating
loss carryforwards to offset income in future years may be limited.
·
Our business and products subject us to the
risk of product liability claims.
·
We have never paid dividends and do not
expect to pay dividends in the foreseeable future.
For a more detailed discussion of the
risk factors listed above that have not been materially changed, see Item 1 of
our Annual Report on Form 10-KSB for the year ended December 31, 2007
under the heading Risk Factors Associated with our Business, Operations and
Securities. We undertake no obligation to update or revise any forward looking
statements, except as required by the SEC.
Item 2. Unregistered Sales of
Equity Securities and Use of Proceeds.
Convertible Promissory
Note Issuances
On January 4, 2008, in the second and final closing of a private
placement (the 2007 Private Placement), we closed on the sale of $80,000 of
units consisting of unsecured, subordinated, convertible promissory notes (the 2007
Notes) and common stock purchase warrants (the 2007 Warrants). At the
closing, the Company issued $76,000 in principal amount of 2007 Notes and 2007
Warrants to purchase 16,000 shares of common stock. Net cash proceeds to the Company were
$69,600, after deducting $10,400 of commissions paid to the placement
agent. The 2007 Notes bear interest at
10 percent per year, mature on June 27, 2009 and will convert into the
type of equity securities offered by the Company in any underwritten public
offering prior to maturity at 70 percent of the public offering price. In the event a public offering is not
completed before the maturity date, the entire principal and unpaid accrued
interest will convert into the Companys common stock at $0.05 per share. The Company may, at its option, prepay the
Notes anytime on or after December 27, 2008. The 2007 Warrants will become exercisable
upon the earlier of the closing of a public offering or the maturity date of
the 2007 Notes and will remain exercisable until December 31, 2012. The exercise price will be 50 percent of the
public offering price, or in the event that a public offering is not completed
before the maturity date, at 50 percent of the closing price of the Companys
common stock on the maturity date.
On February 13 and February 28, 2008, the Company closed on
the sale of a total of $390,000 of units consisting of unsecured, subordinated,
convertible promissory notes (the February 2008 Notes) and common stock
purchase warrants (the February 2008 Warrants) in a private placement
(the February 2008 Private Placement).
Net cash proceeds to the Company were approximately $298,000, after
deducting approximately $92,000 of expenses of the offering (including $50,700
of commissions paid to the placement agent).
At the closing, the Company issued $370,500 in principal amount of February 2008
Notes and February 2008 Warrants to purchase 78,000 shares of common stock. The February 2008 Notes bear interest at
10 percent per year, mature on August 13, 2009 and will convert into the
type of equity securities offered by the Company in any underwritten public
offering prior to maturity at 70 percent of the public offering price. In the event a public offering is not
completed before the maturity date, the entire principal and unpaid accrued
interest will convert into the Companys common stock at $0.05 per share. The Company may, at its option, prepay the February 2008
Notes anytime on or after February 13, 2009. The February 2008 Warrants will become
exercisable upon the earlier of the closing of a public offering or the
maturity
29
date of the February 2008 Notes and will remain exercisable until December 31,
2012. The exercise price will be 50
percent of the public offering price, or in the event that a public offering is
not completed before the maturity date, at 50 percent of the closing price of
the Companys common stock on the maturity date.
Sales of the securities described above were made in compliance with
the requirements of Rule 506 of Regulation D under the Securities Act of
1933, as amended (the Securities Act) and the exemption from registration
provide thereby under Section 4(2) of the Securities Act. In qualifying for such exemption the Company
relied upon representations from the investors regarding their status as accredited
investors under Regulation D and the limited manner of the offering as conducted
by the placement agent and the
Company.
Warrants
On January 4, 2008, pursuant to a final
separation agreement with a former employee of the Company, the Company issued
to the former employee five-year warrants (immediately exercisable) to acquire
up to 14,500 shares of the Companys common stock at an exercise price of $5.00
per share and amended a previously issued warrant to acquire up to 30,000
shares of the Companys common stock to provide for cashless exercise thereof.
Pursuant to the terms of a promissory note
with Adron Holdings, LLC (Adron), upon the repayment of the principal thereon
on January 16, 2008, the Company issued five-year warrants (immediately
exercisable) to acquire up to 52,357 shares of the Companys common stock at
$5.00 per share to Adrons partners.
The above warrant issuances were made, and the prospective issuances
will be made, in reliance on exemption from registration provided under Section 4(2) of
the Securities Act, for issuance by an issuer not involving a public offering.
Item 5. Other Information.
Private Placements of Notes and Warrants
On May 2, 2008, the Company closed on the sale of $155,000 of
units consisting of unsecured, subordinated, convertible promissory notes (the Notes)
and common stock purchase warrants (the Warrants) in a private
placement. Net cash proceeds to the
Company were approximately $120,000, after deducting approximately $35,000 of
expenses of the offering (including $20,150 of commissions and fees paid to the
placement agent). The net proceeds will
be used to pay certain existing obligations and for general corporate purposes.
At the closing, the Company issued $147,250 in principal amount of
Notes, and Warrants to purchase 31,000 shares of common stock. The Notes bear interest at 10% per year,
mature on November 2, 2009, and will convert into the type of equity
securities offered by the Company in any underwritten public offering prior to
maturity at 70% of the public offering price.
In the event a public offering is not completed before the maturity
date, the entire principal and unpaid accrued interest will convert into the
Companys common stock at $0.05 per share.
The Company may, at its option, prepay the Notes anytime on or after May 2,
2009. The Warrants will become
exercisable upon the earlier of the closing of a public offering or the
maturity date of the Notes, and will remain exercisable until December 31,
2012. The exercise price will be 50% of
the public offering price, or in the event a public offering is not completed
before the maturity date, at 50% of the closing price of the Companys common
stock on the maturity date.
30
In combination with its earlier private placement closings in late 2007
and early 2008, the Company has sold a total of $1,675,000 of investment units
to date, and has converted an additional $150,000 of debt into investment
units.
Sales of the securities described above were made in compliance with
the requirements of Rule 506 of Regulation D under the Securities Act of
1933 and the exemption from registration provide thereby under Section 4(2) of
the Securities Act of 1933. In
qualifying for such exemption the Company relied upon representations from the
investors regarding their status as accredited investors under Regulation D,
and the limited manner of the offering as conducted by the placement agent and
the Company.
Item
6. Exhibits
Exhibit No.
|
|
Description
|
|
|
|
4.1
*
|
|
Form of warrants issued to William Reiling, James Davis and the
Phillips W. Smith Family Trust dated April 3, 2008.
|
|
|
|
10.1
*
|
|
Asset Purchase Agreement by and between ProUroCare Medical Inc. and
Profile, LLC dated April 3, 2008.
|
|
|
|
10.2
*
|
|
Security Agreement by and between ProUroCare Medical Inc. and
Profile, LLC dated April 3, 2008.
|
|
|
|
10.3
*
|
|
Promissory Note by and between ProUroCare Medical Inc. and Profile,
LLC dated April 3, 2008.
|
|
|
|
10.4
*
|
|
Form of Promissory Notes by and between ProUroCare Medical Inc.
and each of William Reiling, James Davis and the Phillips W. Smith Family
Trust dated April 3, 2008.
|
|
|
|
31.1
*
|
|
Certification of Principal Executive Officer pursuant to
Rule 13a-14(a)/15d-14(a) of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2
*
|
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) of
the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1
*
|
|
Certification of Chief Executive Officer and Chief Financial Officer
pursuant to pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
|
*Filed herewith.
31
SIGNATURES
Pursuant to the Securities
Exchange Act of 1934, as amended, the Company has duly caused this report to be
signed on its behalf by the undersigned thereunto duly authorized.
|
ProUroCare
Medical Inc.
|
|
|
|
|
Date:
May 7, 2008
|
By:
|
/s/
Richard C. Carlson
|
|
Name:
Richard C. Carlson
|
|
Title:
Chief Executive Officer
|
|
|
|
|
Date:
May 7, 2008
|
By:
|
/s/
Richard Thon
|
|
Name:
Richard Thon
|
|
Title:
Chief Financial Officer
|
32
Exhibit Index
Exhibit No.
|
|
Description
|
|
|
|
4.1 *
|
|
Form of warrants issued to William Reiling, James Davis and the
Phillips W. Smith Family Trust dated April 3, 2008
|
|
|
|
10.1 *
|
|
Asset Purchase Agreement by and between ProUroCare Medical Inc. and
Profile, LLC dated April 3, 2008.
|
|
|
|
10.2 *
|
|
Security Agreement by and between ProUroCare Medical Inc. and
Profile, LLC dated April 3, 2008.
|
|
|
|
10.3 *
|
|
Promissory Note by and between ProUroCare Medical Inc. and Profile,
LLC dated April 3, 2008.
|
|
|
|
10.4 *
|
|
Form of Promissory Notes by and between ProUroCare Medical Inc.
and each of William Reiling, James Davis and the Phillips W. Smith Family
Trust dated April 3, 2008.
|
|
|
|
31.1 *
|
|
Certification of Principal Executive Officer pursuant to
Rule 13a-14(a)/15d-14(a) of the Sarbanes-Oxley Act of 2002.
|
|
|
|
31.2 *
|
|
Certification of Chief Financial Officer pursuant to
Rule 13a-14(a)/15d-14(a) of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.1 *
|
|
Certification of Chief Executive Officer and Chief Financial Officer
pursuant to pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
|
*Filed herewith.
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