Table
of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM 10-Q
(Mark One)
x
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period
ended June 30, 2009
or
o
TRANSITION REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the transition period from
to
Commission File Number: 000-51774
ProUroCare
Medical Inc.
(Exact name of registrant
as specified in its charter)
Nevada
|
|
20-1212923
|
(State or other
jurisdiction
of incorporation
or organization)
|
|
(IRS Employer
Identification
No.)
|
6440 Flying Cloud Drive, Suite 101
Eden Prairie, MN 55344
(Address of principal
executive offices, and Zip Code)
(952) 476-9093
(Registrants telephone
number, including area code)
Indicate by check mark
whether the registrant (1) has filed all reports required to be filed by Section 13
or 15(d) of the Securities Exchange Act of 1934 during the preceding 12
months (or for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements for
the past 90 days. YES
x
NO
o
Indicate by check
mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of
this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit and post such files). YES
o
NO
o
Indicate by check mark
whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer, and smaller reporting company in Rule 12b-2
of the Exchange Act.
Large
accelerated filer
o
|
|
Accelerated
filer
o
|
|
|
|
Non-accelerated filer
o
|
|
Smaller reporting
company
x
|
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
9,894,991 shares of common stock outstanding as of August 6, 2009.
Table
of Contents
PART I.
FINANCIAL INFORMATION
Item
1. Financial Statements
ProUroCare Medical Inc.
(A Development Stage Company)
Condensed Consolidated Balance Sheets
|
|
June 30,
2009
|
|
December 31,
2008
*
|
|
|
|
(Unaudited)
|
|
|
|
Assets
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash
|
|
$
|
14,594
|
|
$
|
3,900
|
|
Other
current assets
|
|
108,165
|
|
75,848
|
|
Total
current assets
|
|
122,759
|
|
79,748
|
|
|
|
|
|
|
|
Equipment
and furniture, net
|
|
499
|
|
|
|
Other
assets
|
|
30,687
|
|
996,806
|
|
|
|
$
|
153,945
|
|
$
|
1,076,554
|
|
Liabilities and Shareholders
Deficit
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
and notes payable
|
|
$
|
2,819,661
|
|
$
|
5,685,371
|
|
Other
liabilities
|
|
418,128
|
|
2,265,088
|
|
Total
current liabilities
|
|
3,237,789
|
|
7,950,459
|
|
|
|
|
|
|
|
Commitments
and contingencies
|
|
|
|
|
|
Long-term
convertible debt, net of original issue discount
|
|
|
|
221,199
|
|
Long-term
convertible debt - related parties net of original issue discount
|
|
|
|
162,759
|
|
Total
liabilities
|
|
3,237,789
|
|
8,334,417
|
|
Shareholders
deficit:
|
|
|
|
|
|
Common
stock, $0.00001 par. Authorized 50,000,000 shares; issued and outstanding 9,894,991
and 1,811,429 shares on June 30, 2009 and December 31, 2008,
respectively
|
|
99
|
|
18
|
|
Additional
paid-in capital
|
|
20,185,096
|
|
13,677,932
|
|
Deficit
accumulated during development stage
|
|
(23,269,039
|
)
|
(20,935,813
|
)
|
Total
shareholders deficit
|
|
(3,083,844
|
)
|
(7,257,863
|
)
|
|
|
$
|
153,945
|
|
$
|
1,076,554
|
|
*
The Balance Sheet as of December 31, 2008 has
been derived from the audited financial statements at that date.
See accompanying notes to consolidated financial
statements.
1
Table
of Contents
ProUroCare Medical Inc.
(A Development Stage Company)
Consolidated Statements
of Operations
(Unaudited)
|
|
Three Months Ended
June 30
|
|
Six Months Ended
June 30
|
|
Period from August 17,1999 (Inception) to
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
June 30, 2009
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$
|
108,881
|
|
$
|
300,155
|
|
$
|
208,881
|
|
$
|
300,155
|
|
$
|
5,664,188
|
|
General
and administrative
|
|
286,110
|
|
216,372
|
|
711,627
|
|
462,534
|
|
10,542,800
|
|
Total
operating expenses
|
|
394,991
|
|
516,527
|
|
920,508
|
|
762,689
|
|
16,206,988
|
|
Operating
loss
|
|
(394,991
|
)
|
(516,527
|
)
|
(920,508
|
)
|
(762,689
|
)
|
(16,206,988
|
)
|
Interest
income
|
|
|
|
125
|
|
21
|
|
378
|
|
18,316
|
|
Interest
expense
|
|
(40,949
|
)
|
(465,182
|
)
|
(1,088,472
|
)
|
(854,491
|
)
|
(6,250,939
|
)
|
Debt
extinguishment expense
|
|
(157,919
|
)
|
(20,491
|
)
|
(324,267
|
)
|
(45,831
|
)
|
(829,428
|
)
|
Net
loss
|
|
$
|
(593,859
|
)
|
$
|
(1,002,075
|
)
|
$
|
(2,333,226
|
)
|
$
|
(1,662,633
|
)
|
$
|
(23,269,039
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss per common share:
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
$
|
(0.06
|
)
|
$
|
(0.58
|
)
|
$
|
(0.26
|
)
|
$
|
(0.96
|
)
|
$
|
(16.20
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
Basic
and diluted
|
|
9,574,042
|
|
1,727,350
|
|
8,827,218
|
|
1,727,340
|
|
1,436,224
|
|
See accompanying notes to
consolidated financial statements.
2
Table
of Contents
ProUroCare Medical Inc.
(A Development Stage
Company)
Consolidated
Statements of Cash Flows
(Unaudited)
|
|
Six Months
Ended
June 30
|
|
Period
from August
17, 1999 (inception) to
|
|
|
|
2009
|
|
2008
|
|
June 30,
2009
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(2,333,226
|
)
|
$
|
(1,662,633
|
)
|
$
|
(23,269,039
|
)
|
Adjustments to reconcile net loss to net cash used
in operating activities:
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
62
|
|
306
|
|
20,859
|
|
Gain on sale of furniture and equipment
|
|
|
|
|
|
(2,200
|
)
|
Stock-based compensation
|
|
158,233
|
|
29,719
|
|
1,922,580
|
|
Common stock issued for services rendered
|
|
|
|
|
|
207,371
|
|
Common stock issued for debt guarantees
|
|
|
|
|
|
106,667
|
|
Common stock issued for debt issuance cost
|
|
|
|
|
|
6,667
|
|
Common stock issued for debt extinguishment
|
|
33,333
|
|
|
|
33,333
|
|
Notes payable issued for intangibles expensed as
research and development
|
|
|
|
150,000
|
|
150,000
|
|
Warrants issued for services
|
|
|
|
|
|
540,636
|
|
Warrants issued for debt guarantees
|
|
|
|
|
|
355,197
|
|
Warrants issued for debt extinguishment
|
|
607
|
|
45,831
|
|
360,007
|
|
Warrants issued for debt extinguishment-related
parties
|
|
|
|
|
|
26,828
|
|
Warrants issued for debt issuance cost
|
|
|
|
|
|
12,834
|
|
Amortization of note payable-original issue discount
|
|
|
|
|
|
152,247
|
|
Amortization of note payable-related parties
original issue discount
|
|
2,720
|
|
50,828
|
|
142,964
|
|
Amortization of convertible debt-original issue
discount
|
|
507,902
|
|
165,776
|
|
1,146,587
|
|
Amortization of convertible debt-related parties
original issue discount
|
|
444,328
|
|
248,230
|
|
1,194,132
|
|
Amortization of debt issuance costs
|
|
309,529
|
|
185,819
|
|
2,015,262
|
|
Bargain conversion option added to note payable-related
parties for debt extinguishment
|
|
|
|
|
|
48,214
|
|
Write-off debt issuance cost for debt extinguishment
|
|
|
|
|
|
42,797
|
|
Write-off of deferred offering cost
|
|
|
|
|
|
59,696
|
|
License rights expensed as research and development,
paid by issuance of common stock to CS Medical Technologies, LLC
|
|
|
|
|
|
475,000
|
|
License rights expensed as research and development,
paid by issuance of common stock to Profile, LLC
|
|
|
|
|
|
1,713,600
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
Other current assets
|
|
4,814
|
|
(249
|
)
|
(50,848
|
)
|
Accounts payable
|
|
(144,493
|
)
|
105,874
|
|
785,341
|
|
Other liabilities
|
|
(911,880
|
)
|
(68,659
|
)
|
1,555,751
|
|
Net cash used in operating activities
|
|
(1,928,071
|
)
|
(749,158
|
)
|
(10,247,517
|
)
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
Purchases of equipment and furniture
|
|
(561
|
)
|
|
|
(21,358
|
)
|
Net cash used in investing activities
|
|
(561
|
)
|
|
|
(21,358
|
)
|
|
|
|
|
|
|
|
|
|
|
|
3
Table of Contents
ProUroCare Medical Inc.
(A Development Stage
Company)
Consolidated Statements
of Cash Flows (continued)
(Unaudited)
|
|
Six Months
Ended
June 30
|
|
Period
from August
17, 1999 (Inception) to
|
|
|
|
2009
|
|
2008
|
|
June 30,
2009
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
Proceeds of note payable, bank
|
|
100,000
|
|
|
|
600,000
|
|
Payments of note payable, bank
|
|
(400,000
|
)
|
|
|
(900,000
|
)
|
Proceeds of notes payable
|
|
|
|
|
|
340,500
|
|
Payment of notes payable
|
|
(87,864
|
)
|
(153,793
|
)
|
(1,458,382
|
)
|
Proceeds of notes payable - related parties
|
|
67,638
|
|
112,500
|
|
627,738
|
|
Payments of notes payable - related parties
|
|
(34,000
|
)
|
(74,250
|
)
|
(237,300
|
)
|
Proceeds from long-term notes payable and bank debt
|
|
|
|
348,750
|
|
3,807,337
|
|
Proceeds from long-term notes payable, related
parties
|
|
|
|
245,000
|
|
1,120,500
|
|
Payments on long-term bank debt
|
|
|
|
|
|
(600,000
|
)
|
Proceeds from warrants
|
|
|
|
31,250
|
|
104,500
|
|
Payments for debt issuance costs
|
|
(600
|
)
|
(105,152
|
)
|
(674,037
|
)
|
Payment for rescission of common stock
|
|
|
|
|
|
(100,000
|
)
|
Payments for offering expenses
|
|
(363,662
|
)
|
(41,046
|
)
|
(480,969
|
)
|
Cost of reverse merger
|
|
|
|
|
|
(162,556
|
)
|
Net proceeds from issuance of common stock
|
|
2,613,600
|
|
|
|
8,296,138
|
|
Net cash provided by financing activities
|
|
1,895,112
|
|
363,259
|
|
10,283,469
|
|
Net increase (decrease) in cash
|
|
(33,520
|
)
|
(385,899
|
)
|
14,594
|
|
Cash, beginning of the period
|
|
48,114
|
|
444,613
|
|
|
|
Cash, end of the period
|
|
$
|
14,594
|
|
$
|
58,714
|
|
$
|
14,594
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
71,883
|
|
$
|
60,611
|
|
$
|
788,292
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
|
|
Deferred offering costs included in accounts payable
|
|
(200,508
|
)
|
70,061
|
|
370,936
|
|
Deferred offering costs included in accrued expenses
|
|
(70,000
|
)
|
(22,650
|
)
|
|
|
Debt issuance costs included in accounts payable
|
|
|
|
36,373
|
|
114,156
|
|
Warrants issued pursuant to notes payable
|
|
3,327
|
|
68,048
|
|
467,191
|
|
Warrants issued for debt issuance costs
|
|
|
|
|
|
298,021
|
|
Prepaid expenses financed by note payable
|
|
81,345
|
|
43,860
|
|
246,871
|
|
Convertible debt issued in lieu of cash for accrued
expenses
|
|
|
|
|
|
31,413
|
|
Common stock issued in lieu of cash for accrued
expenses
|
|
20,250
|
|
|
|
259,053
|
|
Common stock issued in lieu of cash for accrued
development cost
|
|
500,000
|
|
|
|
500,000
|
|
Common stock issued for debt issuance cost
|
|
72,734
|
|
|
|
237,568
|
|
Warrants issued in lieu of cash for accrued expenses
|
|
|
|
|
|
1,250
|
|
Conversion of notes payable, related parties into convertible
debentures
|
|
|
|
|
|
200,000
|
|
4
Table of Contents
ProUroCare Medical Inc.
(A Development Stage
Company)
Consolidated Statements
of Cash Flows (continued)
(Unaudited)
|
|
Six Months
Ended
June 30
|
|
Period
from August
17, 1999 (Inception) to
|
|
|
|
2009
|
|
2008
|
|
June 30,
2009
|
|
Common stock issued in lieu of cash for accounts
payable
|
|
|
|
|
|
|
|
|
122,291
|
|
Common stock issued in lieu of cash for notes
payable-related parties
|
|
|
|
|
|
10,300
|
|
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
|
|
|
|
|
|
650,000
|
|
Conversion of accounts payable to note payable
|
|
12,293
|
|
|
|
253,906
|
|
Conversion of accrued expenses to note payable
|
|
13,569
|
|
|
|
13,569
|
|
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
|
|
Proceeds from sale of furniture and equipment
|
|
|
|
|
|
2,200
|
|
Deposits applied to accrued expenses
|
|
|
|
|
|
1,076
|
|
Deferred offering costs offset against gross
proceeds of offering
|
|
823,078
|
|
|
|
823,078
|
|
Conversion of convertible debt to units (see Note 2)
|
|
1,638,750
|
|
|
|
1,638,750
|
|
Conversion of convertible debt-related parties to
units (see Note 2)
|
|
1,323,334
|
|
|
|
1,323,334
|
|
Conversion of convertible debt-related parties to
common stock
|
|
281,000
|
|
|
|
281,000
|
|
Conversion of accrued expenses to units (see Note 2)
|
|
331,261
|
|
|
|
331,261
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial
statements.
5
Table of Contents
ProUroCare Medical Inc.
(A
Development Stage Company)
Notes to Consolidated Financial
Statements
June 30, 2009 and 2008 and the period from
August 17, 1999 (Inception) to June 30, 2009
(Unaudited)
(1)
Description of Business and Summary of Significant Accounting Policies.
(a)
Description of
Business, Development Stage Activities
ProUroCare
Medical Inc. (ProUroCare, the Company, we or us) is a development stage
company engaged in the business of developing for market innovative products
for the detection and characterization of male urological prostate
disease. The primary focus of the
Company is currently the prostate mechanical imaging system, designed for use
as an aid to the physician in visualizing and documenting tissue abnormalities
in the prostate that have been previously detected by a digital rectal
exam. The Companys developmental
activities, conducted by its wholly owned operating subsidiary ProUroCare Inc.
(PUC), have included acquiring several technology licenses, purchasing
intellectual property, entering into product development agreements and
conducting clinical studies.
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 Companys capital stock (the Reverse Split). The Reverse 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.
On January 12, 2009, the Company closed a
public offering of 3,050,000 units at $1.00 per unit (the 2009 Public Offering)
(see Note 2). Each unit sold (the 2009
Units) consisted of one share of common stock and one redeemable warrant to
purchase one share of common stock at an exercise price of $1.30 per share.
6
Table
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(b)
Basis of Presentation
The accompanying unaudited condensed consolidated
financial statements have been prepared in accordance with accounting
principles generally accepted in the United States 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, although the Company believes that the disclosures made are
adequate to make the information not misleading. Operating results for the three and six
months ended June 30, 2009 are not necessarily indicative of the results
that may be expected for the year ending December 31, 2009 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-K for the year ended December 31, 2008.
The accompanying condensed consolidated financial statements
include the accounts of the Company and its wholly owned subsidiary, PUC. Significant intercompany accounts and
transactions have been eliminated in consolidation. Certain comparative figures have been
reclassified to conform to the financial statement presentation adopted in the
current year, including the reclassification of transactions with related
parties. 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)
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.
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 and six months ended June 30,
2009 and 2008, and the period from August 17, 1999 (inception) to June 30,
2009 due to the Companys net losses.
8,236,533 shares of common stock issuable under stock options and
warrants were excluded from the computation of diluted net loss per common
share for each of the three and six months ended June 30, 2009. 1,368,371 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 each of the three and six
months ended June 30, 2008. Also
excluded for the three and six months ended June 30, 2008 were the
undetermined number of shares issuable pursuant to the convertible notes and
warrants issued in connection with our private placements, whose terms of
conversion were based on the price of the equity securities offered in the
Companys public offering. The number of
such shares was determined on the January 7, 2009 effective date of the
2009 Public Offering to be 2,675,004 shares.
7
Table
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(d)
Stock-Based Compensation
Effective
August 17, 1999, the Company adopted the fair value recognition provisions
of Statement of Financial Accounting Standards (SFAS) No. 123 Accounting
for Stock-Based Compensation
(SFAS 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 No. 123 (revised 2004)
Share-Based
Payment
(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 and
warrants was $9,527, $158,233 and $2,463,216 for the three and six months ended
June 30, 2009 and the period from August 17, 1999 (inception) to June 30,
2009, respectively, or $0.00, $0.02, and $1.72 on a per share basis.
Stock-based employee and non-employee compensation cost related to stock
options and warrants was $(437) and $29,719 for the three and six months ended June 30,
2008, respectively. The Company
estimates the amount of future stock-based compensation expense related to
currently outstanding options to be approximately $175,000, $24,000 and $12,000
for the years ending December 31, 2009, 2010 and 2011, respectively. The Company recognizes the expense related to
the fair value of the award on a straight-line basis over the vesting period.
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, 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 month period ended June 30, 2009 or
in the three and six months ended June 30, 2008. In determining the compensation cost of the
options and warrants granted during the six months ended June 30, 2009, 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:
8
Table of Contents
|
|
Three Months Ended June 30
|
|
Six Months Ended June 30
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
Risk-free
Interest Rate
|
|
n/a
|
|
n/a
|
|
2.98%
|
|
n/a
|
|
Expected Life of
Options Granted
|
|
n/a
|
|
n/a
|
|
3.85 years
|
|
n/a
|
|
Expected
Volatility
|
|
n/a
|
|
n/a
|
|
130.6%
|
|
n/a
|
|
Expected
Dividend Yield
|
|
n/a
|
|
n/a
|
|
0
|
|
n/a
|
|
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. 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.
(e)
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.
Excluding the 2009 Units, no warrants were granted during the three and
six months ended June 30, 2009.
The weighted-average fair value of the
warrants granted during the three and six months ended June 30, 2008 was
$1.24 and $1.48, respectively, and such warrants were immediately vested and
exercisable on the date of grant.
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:
|
|
Three Months Ended June 30
|
|
Six Months Ended June 30
|
|
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
Risk-free
Interest Rate
|
|
n/a
|
|
2.91%
|
|
n/a
|
|
3.09%
|
|
Expected Life of
Warrants Granted (1)
|
|
n/a
|
|
5.0 years
|
|
n/a
|
|
5.0 years
|
|
Expected
Volatility
|
|
n/a
|
|
130.0%
|
|
n/a
|
|
129.1%
|
|
Expected
Dividend Yield
|
|
n/a
|
|
n/a
|
|
n/a
|
|
n/a
|
|
(1)
The contractual term of the warrants.
The 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.
9
Table
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(f)
Other assets
Other
assets consist of deferred offering costs and debt issuance costs.
The
legal, accounting, printing and certain other expenses directly related to the
2009 Public Offering that became effective on January 7, 2009 were
recorded as a deferred offering cost asset as of December 31, 2008. The deferred offering costs were recorded as
a cost of the offering and a reduction of additional paid-in capital upon its
closing on January 12, 2009.
Unamortized
debt issuance costs at December 31, 2008 totaling $266,882, consisting of
legal and
accounting fees, printing costs and
commissions paid to the placement agents
related to the
Companys 2007 and 2008 private placements and the 2008 unit put arrangement,
were expensed as interest expense upon the conversion of the related debt
following the closing of the Companys 2009 Public Offering (see Note 2).
On March 19, 2009, pursuant
to guaranties received relating to the Companys renewal of its $1.2 million
Crown Bank promissory note, the Company issued an aggregate of 133,334 shares
of its common stock
as consideration to the guarantors (see Note 3). The $66,667 value of the shares on the
issuance date was recorded as debt issuance cost and is being amortized on a
straight-line basis through August 31, 2009.
On June 16,
2009, pursuant to a guarantee received relating to the Companys $100,000 Crown
Bank promissory note, the Company issued 6,667 shares of its common stock as
consideration to the guarantor (see Note 3).
The $6,067 value of the shares on the issuance date along with $600 of
loan origination fees was recorded on the balance sheet as debt issuance cost
and is being amortized on a straight-line basis through December 31, 2009.
Other assets
are summarized as follows:
|
|
June 30, 2009
|
|
December 31,
2008
|
|
Deferred offering costs
|
|
$
|
|
|
$
|
729,924
|
|
Debt issuance costs, gross
|
|
73,334
|
|
701,238
|
|
Less amortization
|
|
(42,647
|
)
|
(434,356
|
)
|
|
|
|
|
|
|
Other assets
|
|
$
|
30,687
|
|
$
|
996,806
|
|
Amortization expense related to debt issuance costs was $40,329,
$309,529 and $2,015,262 for the three and six months ended June 30, 2009
and the period from August 17, 1999 (inception) to June 30, 2009,
respectively. Amortization expense
related to debt issuance costs was $94,301 and $185,819 for the three and six
months ended June 30, 2008, respectively.
(g)
Restricted Cash
Pursuant
to the 2007 renewal of the Crown Bank promissory notes, the Company agreed to
deposit with Crown Bank four months worth of future interest payments due under
the notes. On March 19, 2009,
pursuant to the renewal of a Crown Bank promissory note, this restriction was
removed.
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(h)
Going
Concern
We have incurred operating losses, accumulated
deficit and negative cash flows from operations since inception. As of June 30, 2009, we had an
accumulated deficit of approximately $23,269,000. 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.
(i)
Recent
Accounting Pronouncements
During May 2009, the Financial Accounting
Standards Board (FASB) issued SFAS No. 165, Subsequent Events (SFAS
165). SFAS 165 requires all public
entities to evaluate subsequent events through the date that the financial
statement are available to be issued and disclose in the notes the date through
which the Company has evaluated subsequent events and whether the financial
statements were issued or were available to be issued on the disclosed
date. SFAS 165 defines two types of
subsequent events, as follows: the first type consists of transactions that
provide additional evidence about conditions that existed at the date of the
balance sheet and the second type consists of events that provide evidence
about conditions that did not exist at the date of the balance sheet but arose
after that date. SFAS 165 is effective
for interim and annual periods ending after June 15, 2009 and must be
applied prospectively. The disclosure of
the subsequent events did not have a material effect on the consolidated
financial statements.
Note 2. 2009 Public
Offering; Automatic Conversion of Convertible Debt.
On January 7,
2009, the Companys 2009 Public Offering was declared effective by the SEC, and
on January 12, 2009 the 2009 Public Offering was closed. In the offering, the Company sold 3,050,000 of
2009 Units at $1.00 per unit resulting in net cash received of $1,790,442,
after offering costs of $1,259,558.
The completion
of the 2009 Public Offering triggered automatic conversion provisions of
several outstanding convertible debt instruments:
·
Upon the January 7, 2009 effective date
of the 2009 Public Offering, $733,334 of convertible
debentures originally issued a
s consideration to guarantors of the Crown Bank loan,
along with $143,815 interest accrued thereon, converted into
292,384 shares of the Companys common stock.
Unamortized original issue discount relating to the
convertible debentures totaling $33,796 was expensed as interest expense upon
the conversion.
·
Upon the January 12,
2009 closing of the 2009 Public Offering, the $1,757,500 aggregate amount of
promissory notes issued in private debt placements between December 27,
2007 and July 30, 2008, along with $162,959 of interest accrued thereon,
automatically converted into 2,743,535 units identical to the 2009 Units (based
on 70 percent of the offering price, or $0.70 per share). Also, the $142,500 promissory note issued to
James Davis, a greater than five percent shareholder of the Company, on December 27,
2007, along with $14,923 of interest accrued thereon, automatically converted
into 314,846 units identical to the 2009 Units (based on 50 percent of the
offering price, or $0.50 per share). The
closing of the 2009 Public Offering resolved a contingent conversion feature of
the promissory notes.
11
Table
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Consequently, the valuation
of the beneficial conversion feature of the promissory notes was recalculated,
resulting in the recording of a $47,046 increase in the original issue
discount. Unamortized original issue
discount relating to the warrants and the beneficial conversion feature of
these notes (including the adjustment resulting from the new valuation)
totaling $434,215 and unamortized debt issuance cost of $207,575 was expensed
as interest expense upon the conversion.
·
On February 6, 2009 (30
days after the effective date of the 2009 Public Offering), the $299,250
outstanding promissory notes issued pursuant to the Companys unit put
arrangement, along with the $9,563 interest accrued thereon, automatically
converted into 441,165 shares of the Companys common stock. The notes and accrued interest converted at
70 percent of the 2009 Public Offering price, or $0.70 per share. The closing of the 2009 Public Offering
resolved a contingent conversion feature of the promissory notes. Consequently, the valuation of the beneficial
conversion feature of the promissory notes was recalculated, resulting in the
recording of a $81,059 increase in the original issue discount. Unamortized original issue discount relating
to the warrants and the beneficial conversion feature of the notes (including
the adjustment resulting from the new valuation) totaling $209,879 and
unamortized debt issuance cost of $44,686 was expensed as interest expense upon
the conversion.
Note 3. Notes
Payable Bank.
On
March 19, 2009, the Company renewed its $1.2 million Crown Bank promissory
note, and repaid its $400,000 Crown Bank promissory note. The renewed note matures on March 28,
2010 and bears interest at the prime rate plus one percent
,
but never less
than 6.00 percent. No other note terms
were changed. The note remains
collateralized by all Company assets and guaranteed by Mr. Davis and
William Reiling, greater than five percent shareholders of the Company. The Company issued an aggregate of 133,334
shares of its common stock as
consideration to the guarantors (see Note 6(a)).
On June 16, 2009, the Company borrowed $100,000
from Crown Bank pursuant to a promissory note that is collateralized by all
Company assets and guaranteed by Ian Friendly.
The note matures on March 28, 2010 and bears interest at the prime
rate plus one percent
,
but never less than 6.00 percent. The Company issued 6,667 shares of its common
stock as consideration to the guarantor
(see Note 6(a)).
Note 4. Notes
Payable.
On January 13, 2009,
following the closing of the 2009 Public Offering,
the Company repaid the remaining $9,350 principal
amount of the loan from Roman Pauly and issued an immediately exercisable
five-year warrant to acquire 4,295 shares of the Companys common stock at
$1.50 per share pursuant to the terms of the note.
On
January 22, 2009,
the Company repaid the remaining $34,000
principal balance of a promissory note due and issued to the Phillips W. Smith
Family Trust (the Smith Trust) a five-year, immediately exercisable warrant
to acquire 28,656 shares of the Companys common stock at $5.00 per share
pursuant to the terms of the note.
On
March 19, 2009, the Company amended the $600,000 Smith Trust promissory
note. Under the terms of the amendment, the notes maturity date was extended
to March 28, 2010 and the interest rate floor was lowered from 6.50
percent to 6.00 percent. No other terms
were changed.
12
Table
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Note 5. Convertible Notes
Payable.
On April 3, 2008, the
Company borrowed $112,500 pursuant to three promissory notes
that were convertible upon the
Companys closing of an underwritten public offering at 70 percent of the
public offering price. On January 15,
2009, the Company repaid $37,500 of the notes to Mr. Reiling. On January 22, 2009, the Company repaid
$8,000 and converted $29,500 of the notes due to the Smith Trust pursuant to
the terms of the note. On March 19,
2009, the remaining $37,500 promissory note, due to Mr. Davis, was refinanced
along with another $150,000 promissory note due to Mr. Davis.
On September 25, 2008, the Company borrowed $150,000 pursuant to a
convertible promissory note issued in favor of Mr. Davis. As the holders ability to exercise the
conversion feature of the note was contingent upon an event outside the control
of the holder, the bargain conversion feature valued at $103,396 was not
recorded until the January 12, 2009 closing of the 2009 Public Offering
when the contingency was removed.
On March 19, 2009, Mr. Davis
agreed to refinance the $150,000 debt (and $7,291 of interest accrued thereon)
along with the $37,500 note discussed above (and $3,646 of accrued interest
thereon), another $2,632 payable to Mr. Davis and $12,293 of expenses paid
by Mr. Davis on behalf of the Company.
Mr. Davis also agreed to loan to the Company an additional $67,638
to pay for the exhibition of the prostate mechanical imaging system at the
annual American Urology Association meeting, the retention of an investor
relations firm and the initiation of a clinical advisory board. He also agreed to have certain website
maintenance services performed for the Company. Pursuant to the refinancing and
the other arrangements, the Company issued a $281,000 unsecured convertible
promissory note to Mr. Davis. The
promissory note was to mature on March 19, 2010, bore no interest and was
convertible into our common stock at $0.55 per share at the option of Mr. Davis. 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. As the present
value of the cash flows under the new convertible promissory note was greater
than 10 percent different from the present value of the cash flows under the
original note, the issuance of the new note was treated as a debt
extinguishment. Accordingly, $113,709 of
unamortized original issue discount related to the original $150,000 note was
expensed as debt extinguishment expense and the bargain conversion option of
the new note, valued at $123,000 using the Black-Sholes pricing model, was
recorded as original issue discount and was amortized as debt extinguishment
expense over the term of the note. On May 26,
2009, Mr. Davis exercised his conversion rights under the promissory note,
and the note was converted into 510,909 shares of the Companys common stock.
Note 6.
Shareholders Equity.
(a)
Common
Stock
On January 7, 2009, upon the effective date of
the 2009 Public Offering, the Company issued 292,384 shares of common stock to
the guarantors of the Crown Bank loan pursuant to the automatic conversion of
$733,334 of convertible debentures and $143,815 interest accrued thereon.
On January 12, 2009, the Company issued 3,050,000
of 2009 Units pursuant to the closing of the 2009 Public Offering, and
3,058,381 units identical to the 2009 Units pursuant to the automatic
conversions of convertible debt (see Note 2).
13
Table
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On January 15, 2009, the Company issued 454,546
shares of common stock to Artann Laboratories Inc. (Artann) in satisfaction of
a $500,000 liability pursuant to the Artann license agreement.
On January 22, 2009, pursuant to the conversion
of $29,500 of the principal balance of a convertible promissory note, the
Company issued 42,143 shares of common stock to the Smith Trust (see Note 5).
On February 6, 2009,
the $299,250 outstanding promissory notes issued
pursuant to the Companys 2008 unit put arrangement, along with the $9,563
interest accrued thereon, automatically converted into 441,165 shares of the
Companys common stock (see Note 2)
On March 19, 2009, pursuant to the renewal of its
$600,000 Smith Trust promissory note, the Company issued 66,667 shares of its
common stock
as consideration to the Smith Trust and will issue a further 11,111
shares per month for each month the related notes remain outstanding after August 31,
2009. The guidance provided by EITF
96-19 indicates that a substantial modification of debt terms should be
accounted for as an extinguishment of debt.
As the present value of the cash flows under the loan renewal was
greater than 10 percent different from the present value of the cash flows
under the original agreement, the renewal of the note was treated as a debt
extinguishment. Accordingly, the $33,333
value of the initial 66,667 shares issued was expensed as debt extinguishment
expense. Additional accruals of stock to
be issued if the promissory notes remain outstanding after August 31, 2009
will be expensed each month as debt extinguishment expense.
On March 19, 2009, pursuant to guaranties
received relating to the Companys renewal of its $1.2 million Crown Bank
promissory note, the Company issued an aggregate 133,334 shares of its common
stock
as consideration to Mr. Davis and Mr. Reiling, and will issue a
further 22,222 shares per month for each month the related notes remain
outstanding after August 31, 2009.
Pursuant to EITF 96-19, since the present value of the cash flows under
the loan renewal was greater than 10 percent different from the present value
of the cash flows under the original agreement, the renewal of the note was
treated as a debt extinguishment.
Accordingly, the $66,667 value of the initial 133,334 shares issued was
capitalized as debt issuance cost and is being expensed as debt extinguishment
expense on a straight-line basis through August 31, 2009. Additional accruals of stock to be issued if
the promissory notes remain outstanding after August 31, 2009 will be
expensed each month as debt extinguishment expense. In addition, the $12,000 loan origination fee
was immediately expensed as debt extinguishment expense.
On April 13, 2009, the
Company issued an aggregate of 27,366 shares of its common stock its independent directors, David Koenig, Robert
Rudelius and Scott Smith, as payment of $20,250 directors fees accrued through
December 31, 2008, in lieu of cash.
On May 26, 2009, the Company issued 510,909
shares of common stock to Mr. Davis upon the conversion of a $281,000
convertible promissory note pursuant to the terms thereof (see Note 5).
On June 16, 2009, the Company issued 6,667 shares
to Mr. Friendly as consideration for providing a guarantee of a $100,000
bank loan (see Note 3).
14
Table
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(b)
Stock Options
On
March 3, 2009, the Company granted non-qualified stock options to acquire
an aggregate of 70,000 shares of its common stock to its non-employee
directors, and incentive options to acquire 45,000 shares of its common stock
to Richard Thon, its Chief Financial Officer (the CFO). The options are fully vested and are
exercisable for a period of seven years at an exercise price of $0.85 per
share. The 115,000 options were valued
at $0.68 per share using the Black-Scholes pricing model and were immediately
expensed as general and administrative expense.
Also
on March 3, 2009, the Company granted an incentive stock option to acquire
an aggregate of 100,000 shares of its common stock to Richard Carlson, its
Chief Executive Officer (the CEO). Of
the options, 90,000 shares vest immediately and 10,000 shares will vest on January 2,
2010. At the same time, Mr. Carlson
agreed to cancel existing, unvested stock options to acquire 5,000 shares of
common stock at an exercise price of $7.50 per share. SFAS 123R requires that options that are
cancelled and reissued simultaneously be accounted for as a modification of the
terms of the original option. Accordingly,
the incremental compensation cost of the fully vested portion of the newly
issued options valued at $0.68 per share using the Black-Scholes pricing model
over the $0.07 per share value of the cancelled options on the cancellation
date, or $61,200, was expensed immediately as general and administrative
expense.
(c)
Warrants
On January 12, 2009, the
Company issued 3,050,000 2009 Units pursuant to the closing of the 2009 Public
Offering, and 3,058,381 units identical to the 2009 Units pursuant to the
automatic conversions of convertible debt (see Notes 2 and 6(a)).
Each five-year warrant is exercisable at $1.30 per share. The Company may redeem
outstanding
warrants at a price of $0.01 per warrant upon a minimum 30 days prior
written notice if the last sale price of its common stock equals or exceeds
$1.82 per share for a period of ten consecutive trading days.
As
additional compensation pursuant to the 2009 Public Offering, we sold to the
underwriter, Feltl & Company, for nominal consideration, a warrant
(the Underwriters Warrant) to purchase up to 305,000 units. The Underwriters
Warrant is not exercisable until January 7, 2010 and thereafter is
exercisable at a price per unit equal to $1.20 for a period of four years. The warrants underlying the units that are
subject to the Underwriters Warrant are subject to redemption as described
above commencing January 7, 2010.
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 13, 2009,
the Company repaid the remaining $9,350
principal amount of a promissory note due to Mr. Pauly, and issued an
immediately exercisable five-year warrant to Mr. Pauly to acquire 4,295
shares of the Companys common stock at $1.50 per share pursuant to the terms
of the note (see Note 4).
On
January 22, 2009,
the Company repaid the remaining $34,000 principal
balance of an outstanding convertible promissory note due to the Smith Trust
and issued to the Smith Trust a five-year, immediately exercisable warrant to
acquire 28,656 shares of the
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Companys
common stock at $5.00 per share pursuant to the terms of the note
(see Note 4)
.
On July 23, 2009,
the Company issued a two-year warrant to purchase 30,000 shares of our common
stock at an exercise price of $1.25 per share to Kohnstamm Communications as
consideration for services provided to the Company (see Note 9).
Note
7. Income Taxes.
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 June 30, 2009 and December 31, 2008 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. Any interest or penalties are
expensed as general and administrative expense as incurred.
The Company has generated net operating loss
carryforwards of approximately $6.1 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 2009 Public
Offering along with previous changes and believes that such an ownership change
has not occurred, and that the Companys use of its net operating loss
carryforwards is not subject to such restrictions.
EITF 05-8 Income Tax Consequences of Issuing
Convertible Debt with a Beneficial Conversion Feature (EITF 05-8) provides (i) that
the recognition of a beneficial conversion feature creates a difference between
book basis and tax basis of a convertible debt instrument, (ii) that basis
difference is a temporary basis for which a deferred tax liability should be
recorded, and (iii) the effect of recognizing the deferred tax liability
should be charged to equity in accordance with SFAS No. 109 Accounting
for Income Taxes. The Company applied EITF 05-8 to the issuances of
convertible debt from January 1, 2006 through June 30, 2009 and had
no differences in book and tax basis and no deferred tax liability as of June 30,
2009. The Company reduced its net operating loss carryover and valuation
allowance by approximately $881,000 for the non-deductibility of the beneficial
conversion features during this period. When the valuation allowance related to
deferred tax assets reverses, the Company will record an $881,000 tax benefit
related to the beneficial conversion feature with a corresponding decrease to
additional paid-in capital.
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 2005 - 2007
State of Minnesota 2005 - 2007
Note
8. Related Parties.
The Company considers its
directors, executives and beneficial shareholders of more than five percent of
its common stock to be related parties.
During the six months ended June 30, 2009, the following
significant transactions were made between the Company and those parties that
were related parties at the time of each transaction:
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On January 15, 2009, the Company repaid an
outstanding $37,500 loan along with accrued interest thereon to Mr. Reiling.
On March 19, 2009, pursuant to the guaranties
received relating to the Companys renewal of its $1,200,000 Crown Bank
promissory note, the Company issued an aggregate 66,667 shares of its common
stock
as consideration to each of Mr. Davis and Mr. Reiling, and will
issue a further 11,111 shares to each per month for each month the notes remain
outstanding after August 31, 2009.
On March 19,
2009, a $37,500 convertible promissory note and a $150,000 convertible
promissory note due to Mr. Davis were refinanced and combined with other
loans and advances on behalf of the Company from Mr. Davis in a $281,000
convertible promissory note. On May 26,
2009, Mr. Davis exercised his conversion rights under the promissory note
and the note was converted into 510,909 shares of the Companys common stock.
On April 13, 2009, the Company
issued an aggregate of 27,366 shares of its common stock to Mr. Koenig, Mr. Rudelius
and Mr. Smith as payment of $20,250 directors fees accrued through December 31,
2008, in lieu of cash.
During June 2009,
Mr. Davis advanced $22,000 to the Company to cover specific operating
expenses.
Note
9. Subsequent Events.
The
Company had the following significant subsequent events through August 14,
2009, which is the date the financial statements were available to be issued
for events requiring recording or disclosure in the financial statements for
the three and six months ended June 30, 2009.
On July 23,
2009, the Company issued a two-year warrant to purchase 30,000 shares of our
common stock at an exercise price of $1.25 per share to Kohnstamm Communications
as consideration for services provided to the Company. The warrant, valued at $24,900 using the
Black-Scholes pricing model, will be recorded as general and administrative
expense.
On July 15,
2009, RPI filed a lawsuit against the Company seeking payment of $202,716 plus
interest, penalties, costs and disbursements, including attorneys fees. In the
complaint, RPI alleges that the Company has breached obligations to pay RPI an
aggregate of $202,716 under the terms of a License Agreement dated July 13,
2001 between RPI and the Company and a Sponsored Research Agreement dated as of
December 9, 2005 between RPI and the Company. The Company believes that the amounts being
sought by RPI substantially exceed any amounts due to RPI under such agreements
and intends to defend itself vigorously against such claims.
On July 29, 2009, Mr. Davis provided the Company with a
$100,000 short-term loan. The loan bears
no interest, has no defined due date and is not documented. The Company expects to repay the loan as soon
as it is able.
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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 June 30, 2009.
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 2009 and 2010 working
capital needs and introduce our products into the marketplace; 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)) has developed and
intends
to market an innovative
prostate imaging system known as the ProUroScan
TM
system. The ProUroScan system incorporates our new
proprietary elasticity imaging technology to create a map and an electronic
record of the prostate.
The
ProUroScan system is an imaging system designed for use as an aid to the
physician in visualizing and documenting tissue abnormalities in the prostate
that have been previously detected by a digital rectal exam (DRE). As an
adjunct to DRE, the ProUroScan system will be used following an abnormal DRE to
generate a real time image and map of the prostate and to store this
information electronically.
The
ProUroScans unique technology uses measurements of relative tissue elasticity
as detected by mechanical sensors and interpreted by mathematical algorithms to
create images, rather than using ultrasound or other high-cost alternatives. Our approach to imaging is based on the fact
that most abnormal tissue in otherwise homogenous organ tissue is less elastic
than normal tissue. Using the systems specially
designed rectal probe, physicians can visualize the prostate gland and document
specific areas of concern. The real-time
map can be saved as a permanent electronic record and compared to maps created
in successive evaluations.
Our
imaging technology is based on work originally performed in the late 1990s by
Artann Laboratories Inc. (Artann) a scientific technology company based
in Trenton, New Jersey, that is
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focused
on early-stage technology development. In 2002, we licensed the rights to this
technology and since then have worked with Artann on its 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 the
ProUroScan system by the U.S. Food and Drug Administration (FDA). In April 2008, we acquired the patents,
patent applications and other know how associated with this technology. In July 2008,
the Company entered into new license and development and commercialization
agreements with Artann relating to their existing technology and know-how and
all future technology developed by Artann in our field of use. After we obtain
FDA clearance, it is our intent to expand our working relationship with Artann
to include their participation in the development and licensing of future
mechanical imaging technology.
The
ProUroScan system is not currently marketed or sold and is not cleared for
marketing by the FDA. Our initial goal is to obtain a basic mapping and data
maintenance claim from the FDA under a 510(k) application for the current
generation system. Once FDA 510(k) clearance is obtained on our current
generation ProUroScan system, we intend to have the systems manufactured by one
or more FDA-regulated contract manufacturers and market the system in
cooperation with a medical device company that has an established presence in
the urology market.
The
ProUroScan imaging system is currently in the final stages of a multi-site FDA
clinical study designed to provide sufficient documentation of the systems
effectiveness in mapping the prostate and identifying abnormalities detected by
DRE. We expect to complete and submit a
510(k) application for market clearance for this technology in the U.S. in
the third quarter of 2009. Once
submitted, the FDA will have 90 days to review and grant clearance, ask
questions or reject the 510(k) application. However, the 510(k) application
process may be significantly longer if the FDA has questions upon its review or
requests additional information. No
assurances can be given in regard to the timing of any of these events.
During the remainder of 2009, assuming our financing
efforts are successful (see
Liquidity and Capital Resources, below
), we expect to 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 are currently exploring potential marketing relationships with
medical product 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 engineering,
regulatory, clinical, manufacturing and marketing capabilities.
Recent
Financing Activity
On
January 12, 2009, we closed on the 2009 Public Offering and realized net
proceeds of approximately $1,790,000. In
addition, the closing of the 2009 Public Offering triggered the automatic
conversion of certain debt instruments into equity, as follows:
·
$733,334 convertible
debentures together with $143,815 of interest accrued thereon converted into
292,384 shares of our common stock;
·
$1,900,000 of convertible
notes issued in the 2007 and 2008 private placements together with $177,882 of
interest accrued thereon converted into 3,058,381 units, each consisting of one
share of common stock and one warrant to purchase common stock at $1.30 per
share (a Unit); and
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·
$299,250 of convertible notes issued pursuant
to the unit put arrangement together with $9,563 of interest accrued thereon
converted into 441,165 shares of our common stock.
On March 19, 2009, we
reached an agreement with James Davis to refinance a $150,000 promissory note
(and $7,291 of interest accrued thereon) along with a $37,500 note (and $3,646
of accrued interest thereon), another $2,632 payable to Mr. Davis and
$12,293 of expenses paid by Mr. Davis on our behalf. Mr. Davis also agreed to lend to us an
additional $67,638 to pay for our exhibition of the prostate mechanical imaging
system at the annual American Urology Association meeting, the retention of an
investor relations firm and the initiation of a clinical advisory board. He also agreed to have certain website
maintenance services performed for us.
Pursuant to the refinancing and the other arrangements, we issued a
$281,000 unsecured convertible promissory note to Mr. Davis. On May 26, 2009, Mr. Davis exercised his conversion rights under the
promissory note and the note was converted into 510,909 shares of the Companys
common stock
In
March 2009, we renewed $1.2 million of the secured bank debt to mature on March 28,
2010 and repaid $400,000 of the secured debt.
On June 16, 2009, we borrowed $100,000 pursuant to a promissory
note issued in favor of Crown Bank. The
promissory note matures on March 28, 2010 and bears interest at the Prime
Rate plus 1.0 percent
,
but never
less than 6.00 percent. The note is
guaranteed by Ian Friendly. The note,
along with the existing $1.2 million promissory note, is collateralized by all
Company assets.
Results of Operations
The following discussion of the financial condition and results of
operations should be read in conjunction with the consolidated 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 June 30,
2009 compared to the three months ended June 30, 2008:
Operating Expenses/Operating Loss
.
Our operating expenses (and our operating loss) for the three months
ended June 30, 2009 were $394,991, a decrease of $121,536, or 24 percent,
compared to $516,527 last year. The
decrease was primarily due to the 2008 acquisition of patents for $300,000,
which was expensed at the time of the purchase.
In addition, during the three months ended June 30, 2008, we
incurred approximately $37,000 of legal fees related to negotiating development
and licensing agreements. Increased
research and development spending offset these expense reductions, including
$59,000 of consulting costs related to the management of the ProUroScan
clinical trials and $50,000 of product development expenses incurred under the
Artann development agreement, compared to $0 in 2008.
Net Interest Expense
.
Net interest expense for the three months ended June 30,
2009 was $40,949, a decrease of 91 percent, compared to $465,182 last
year. Included in the 2008 expense was
approximately $357,000 of original issue discount and debt issuance cost
amortization primarily related to our 2006, 2007 and 2008 private debt
placements. Upon the closing of the 2009
Public Offering and the subsequent automatic conversion of approximately $3.3
million of debt and accrued interest into equity, the related original issue
discount and debt issuance cost was expensed.
Consequently, the related amortization expense has been eliminated going
forward. Also included in the 2008
expense was approximately $61,000 of interest on the 2007 and 2008 private debt
placements. Other interest expense
declined about 16% to approximately $40,000 in the three months ended June 30,
2009 compared to
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approximately $48,000 last year reflecting the $400,000 reduction in
outstanding Crown Bank loans through much of the period.
Debt Extinguishment Expense
.
Our debt extinguishment expense arises primarily from the issuance of
stock or warrants pursuant to the provisions of short-term loans from lenders
in certain refinancing transactions. Our debt extinguishment expense for the
three months ended June 30, 2009 was $157,919, an increase of 671 percent,
compared to $20,491 last year. The
increase is due to the write-off of approximately $119,000 of unamortized
original issue discount related to a beneficial conversion feature of a
$281,000 promissory note issued to Mr. Davis upon its conversion. Additionally, during the three months ended June 30,
2009, approximately $39,000 of the cost of stock issued to guarantors of $1.3
million of Crown Bank loans was amortized.
Six months ended June 30, 2009
compared to the six months ended June 30, 2008:
Operating Expenses/Operating Loss
.
Our operating expenses (and our operating loss) for the six months ended
June 30, 2009 were $920,508, an increase of $157,819, or 21 percent,
compared to $762,689 last year.
Compensation and benefits costs in the six months ended June 30,
2009 increased approximately $42,000, or 26 percent, compared to last year as a
result of a $40,000 bonus awarded in recognition of the efforts of the Companys
officers in the completion of the 2009 Public Offering. Stock-based compensation increased
approximately $129,000, or 432 percent, compared to last year, as a result of
the granting of immediately vested stock options to directors and officers
valued at $139,400. Other increases in
operating expenses during the first six months of 2009 included product
development expenses of $150,000 incurred under the Artann development
agreement, approximately $59,000 of consulting costs related to the management
of the ProUroScan clinical trials, new investor and public relations programs
that cost approximately $29,000 and trade show attendance costs of
approximately $20,000. No costs were
incurred for these activities during the six months ended June 30, 2008.
Offsetting these increases were one-time costs incurred in 2008 including
acquisition of patents for $300,000, which was expensed at the time of the
purchase and approximately $70,000 of legal fees related to negotiating
development and licensing agreements.
Net Interest Expense
.
Net interest expense for the six months ended June 30,
2009 was $1,088,451, an increase of 27 percent, compared to $854,113 last
year. Included in the 2009 expense was
the approximately $980,000 write-off of unamortized original issue discount and
debt issuance costs related to our 2006, 2007 and 2008 private debt placements
and the 2008 unit put arrangement upon the closing of the 2009 Public Offering
and the subsequent automatic conversion of approximately $3.3 million of debt
and accrued interest into equity.
Included in the 2008 expense was approximately $651,000 of original
issue discount and debt issuance cost amortization primarily related to our
2006, 2007 and 2008 private debt placements.
Also included in the 2008 expense was approximately $115,000 of interest
on the 2007 and 2008 private debt placements.
Other interest expense increased about 12 % to approximately $100,000 in
the six months ended June 30, 2009 compared to approximately $89,000 last
year as a result of vendor finance charges.
Debt Extinguishment Expense
.
Our debt extinguishment expense arises primarily from the issuance of
stock or warrants issued pursuant to the provisions of short-term loans from
certain lenders in certain refinancing transactions. Our debt extinguishment
expense for the six months ended June 30, 2009 was $324,267, an increase
of 608 percent, compared to $45,831 last year.
The increase is due to the write-off of $113,000 of unamortized original
issue discount upon the refinancing of a $150,000 note with Mr. Davis, the
expensing of approximately $123,000 of original issue discount related to a
beneficial conversion feature of a $281,000 promissory note issued to Mr. Davis
upon its conversion, the issuance of 66,667 shares of stock valued at $33,333
to the Phillips W. Smith Family Trust (the Smith Trust)
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upon the extension of the $600,000 Smith Trust loan, and a $13,000 fee
associated with refinancing of $1.3 million loans with Crown Bank during the
six months ended June 30, 2009.
Additionally, during the six months ended June 30, 2009,
approximately $51,000 of the cost of stock issued to guarantors of the Crown
Bank loans was amortized.
Current
Operations Employees and Expenses
We currently employ two
employees. We conduct our research and development, market research, regulatory
and other business operations through the use of consultants and medical device
development contractors, primarily Artann. 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. During the second half of 2009, we expect to
complete the clinical and regulatory process leading to FDA 510(k) market
clearance and establish a contract manufacturing capability in anticipation of
regulatory clearance to enter the market.
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 rent approximately 750 square feet of office
space on a month-to-month basis at a cost of approximately $800 per month.
Other expenses incurred include executive officer compensation, travel,
insurance, telephone, supplies and other miscellaneous expenses.
Liquidity
and Capital Resources
Net cash used in operating activities
was
approximately $1.9 million during the six months ended June 30, 2009
compared to approximately $749,000 last year.
The increase in cash used was primarily the result of payments to Artann
of $600,000 and $250,000 for accrued licensing fees and accrued development
costs pursuant to our licensing and development agreements, respectively. We
also paid $129,500 to Artann for development work performed under the
development agreement. In addition to
normal operating expenses, other uses of cash included payments for accounts
payable and other accrued expenses, including accrued compensation, following
the completion of the 2009 Public Offering.
Net
cash provided by financing activities was approximately $1.9 million during the
six months ended June 30, 2009 compared to approximately $363,000 last
year. Proceeds from the 2009 Public
Offering less underwriters commissions and other payments for expenses of the
offering were approximately $2.3 million during the six months ended June 30,
2009. Offsetting this was our temporary
pay-down of $400,000 of the secured bank debt in March 2009 pending the
re-establishment of a suitable guarantee of the loan. In June 2009, we reestablished $100,000
of this debt. During the six months ended June 30, 2008, net proceeds of
our private convertible debt placements with individual investors of
approximately $584,000 were offset by repayments of notes payable and loans
from directors of approximately $228,000.
As of July 31, 2009, we had
approximately $69,000 cash on hand and current liabilities of approximately
$3.4 million.
We currently
have $1.9 million of short-term debt that has been collateralized by the
Companys assets and guaranteed by several individuals. We plan to reestablish the remaining $300,000
of secured bank debt that was temporarily repaid and increase the amount by up
to an additional $500,000 during the third quarter of 2009, pending the
identification of suitable individual guarantors. There can be no assurance that suitable
guarantors can be identified during this period, or at all.
In addition to the guaranteed bank loans mentioned above, we are
actively pursuing several potential near-term sources of funding to position us
for a commercial launch into the urology market and repay
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certain existing liabilities.
These sources include potential additional guaranteed bank debt and one
or more rounds of private placements of debt or equity securities. We are also working to establish a
distribution relationship with a medical products company during the next three
to six months. We expect such a
distribution partner could provide financial support in the form of licensing
fees, loans, equity investment or some combination. In addition to financial support, a
successful collaboration with such a partner would allow us to gain access to
down stream engineering, manufacturing, clinical and marketing support. Finally, as a result of the closing on the
2009 Public Offering and the subsequent conversion of convertible notes into
Units, we have 6,108,381 redeemable warrants outstanding. These warrants have an exercise price of
$1.30 per share, which we may redeem once the last sale price of our common
stock equals or exceeds $1.82 per share for a period of ten consecutive trading
days. If this event were to occur, it
will allow all holders of warrants a period of 30 days to exercise their
warrants. If all such warrant holders
exercise their warrants, we could realize up to approximately $7.9 million,
depending on the number of shares actually exercised. There can be no assurance that we will be
able to redeem the warrants, or of how much would be realized if such a
redemption were to occur.
If
additional funds are raised by the issuance of convertible debt or equity
securities or by the exercise of outstanding warrants, then existing
shareholders will likely experience dilution in their ownership interest. 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 our existing holders of common stock.
During the remainder of 2009, we expect to submit an
FDA 510(k) application for market clearance and make certain preparations
for market entry. Our ability to pursue
additional activities, such as establishing a contract manufacturing
capability, developing a more portable imaging system and other product
enhancements and expanding the number of our clinical study sites, is dependent
upon the success and timing of our financing efforts outlined above.
We expect that our cash needs for our normal
operating expenses (excluding the milestone payments due to Artann explained
below) will be approximately $575,000 over the last five months of 2009.
In addition, we expect to
make cash payments to Artann totaling approximately $90,000 for development
services that they are to provide during the remainder of 2009. To
the extent we are successful in obtaining sufficient financing, we will advance
other projects and activities needed for the long-term success of the
business. These projects include
establishing a contract manufacturing capability, including production tooling
and molds, estimated to cost approximately $450,000; contracting for certain
product engineering and development work to reduce the size of the ProUroScan
system and make certain enhancements that we estimate will cost approximately
$725,000; and placing systems and performing additional patient studies at certain
key institutions, at a cost of between $275,000 and $300,000. Finally, we expect to make payments of
approximately $170,000 towards certain outstanding liabilities before year end.
Pursuant to the terms of the
Artann development agreement, we are required to make cash and equity payments
upon the achievement of several project milestones along with a monthly
retainer fee. Upon the submission of our
510(k) application to the FDA, we are required to make a cash payment to
Artann of $250,000 and an equity payment of our common shares valued at
$1,000,000. Upon receipt of FDA 510(k) clearance, we are required to
make a further cash payment of $750,000 and a second $1,000,000 equity payment.
If adequate funds are not
available through these initiatives on a timely basis or on acceptable terms,
we may be unable to commercialize our products during the expected time
frame. We do not know what impact the
current unprecedented volatility in worldwide credit and equity markets may
have on our ability to obtain future financing. Since September 2008, we
have seen unprecedented turmoil in equity
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and credit markets that has
resulted in record-setting losses in the stock markets, dramatic decreases of
liquidity in the credit markets, bank failures, hedge fund closures and massive
market intervention by the United States and foreign governments. Because of
the unprecedented nature of these market events, and because the markets remain
highly-volatile today, we cannot predict what effect these events will have on
our ability to obtain financing in the future.
If we are forced to slow or stop our regulatory clearance process, it
would delay market entry for our products. Ultimately, if no additional
financing is obtained beyond what has been secured to date, we likely would be
forced to cease operations. There can be no assurance we will be successful in
raising such funds.
Assets;
Property Acquisitions and Dispositions
Our primary assets are
patents and patent applications, which are the foundation for our proposed
product offerings. These assets secure $1.3 million of senior bank notes
and a $600,000 note issued to the Smith Trust and, as a result, are not
available to secure other senior debt financing.
Assuming we are successful
in obtaining the financing required to establish a contract manufacturing
capability, we anticipate purchasing approximately $200,000 of tooling molds
and other capital for production, computer equipment, software and general
office furniture and equipment during the remainder of 2009. We do not
anticipate selling any significant assets in the near term.
Going
Concern
We have incurred operating
losses, accumulated deficit and negative cash flows from operations since
inception. As of June 30, 2009, we had an accumulated deficit of
approximately $23.3 million. These factors, among others, raise
substantial doubt about our ability to continue as a going concern. Our
consolidated financial statements included in this Quarterly Report on Form 10-Q
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.
Critical
Accounting Policies
Our financial statements are prepared in
accordance with accounting principles generally accepted in the United States,
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-K for the
year ended December 31, 2008. There
were not any material changes to our critical accounting policies during the
three months ended June 30, 2009.
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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 Securities and Exchange Act of 1934, as amended (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 June 30, 2009, 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 Rule 13a-15 under
the Exchange Act. 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 June 30, 2009,
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.
PART II. OTHER INFORMATION.
Item 1. Legal Proceedings.
On July 28, 2009,
(the Company) was notified that the Rensselaer Polytechnic Institute (RPI)
filed a complaint against the Company on July 15, 2009 in the Supreme
Court of the State of New York, County of Rensselaer. In the complaint, RPI alleges that the
Company has breached obligations to pay RPI an aggregate of $202,716 under the
terms of a License Agreement dated July 13, 2001 between RPI and the
Company and a Sponsored Research Agreement dated as of December 9, 2005
between RPI and the Company. RPI is
seeking damages in the amount of $202,716, plus interest, penalties, costs and
disbursements, including attorneys fees.
The Company believes that the amounts being sought by RPI substantially
exceed any amounts due to RPI under such agreements and intends to defend
itself vigorously against such claims.
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 1A
of our Annual Report on Form 10-K for the year ended December 31,
2008, as well as the material changes to those risk factors set forth in Part II-Item
1A to our Quarterly Report on Form 10-Q for the quarter ended March 31,
2009 and the material changes 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.
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Risk factors
disclosed in our Annual Report on
Form 10-K relating to our need for
additional financing and potential dilution to existing shareholders have been
revised to read as follows:
We will need additional financing, and any such financing
will likely be dilutive to our existing shareholders.
As of July 31, 2009, we
had approximately $69,000 of cash on hand and current liabilities of $3.4
million, including $1.9 million of secured debt. In March 2009, we temporarily paid down
$400,000 of the secured bank debt and in June 2009 we re-established
$100,000 of this debt. We plan to
re-establish the remaining $300,000 of secured bank debt and increase the
amount by up to an additional $500,000 during the third quarter of 2009,
pending the identification of suitable individual guarantors. We will need additional financing to complete
and submit a 510(k) application to the FDA and obtain clearance for a
basic mapping and data maintenance claim. In addition, we will need funding to
pay, for example, up to $1,000,000 of future payments to Artann related to
FDA 510(k) clearance milestones.
If we fail to secure a distribution partner on terms acceptable to us,
or at all, we could be required to undertake distribution activity at our
expense, which could significantly increase our capital requirements and may
delay the commercialization of our products.
We are actively pursuing
several potential near-term sources of funding to provide the working capital
needed to repay our existing debt and to fund a commercial launch into the
urology market. These sources include
cash advances from shareholders, additional guaranteed bank debt, conversion of
existing debt to equity and one or more rounds of private placements of debt or
equity securities.
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, the conversion of
existing debt into equity or the issuance and conversion of convertible debt,
then existing shareholders will experience dilution in their ownership
interest. 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. There can be no assurance that we will be successful in obtaining
such additional financing, if needed. Additional financing may not be available
to us, may not be available on favorable terms and will likely be dilutive to
existing shareholders.
Our assets are pledged to secure $1.3 million of senior
bank notes and $600,000 of notes issued to an investor which become due in March 2010
and, as a result, are not available to secure other senior debt financing. Upon
the occurrence of an event of default, the banks security interests in our
assets will be assigned to guarantors of the senior bank notes and the holder
of such $600,000 promissory note.
Our $1.3 million senior
debt financing through Crown Bank, Minneapolis, Minnesota, has required us to
pledge all of our assets and certain licenses, as well as to provide personal
guarantees of certain shareholders. In addition, we have issued a subordinated
promissory note in the amount of $600,000 to an investor that has a
subordinated interest in all of our assets and certain licenses. Both the
$1.3 million senior bank notes and the $600,000 note become due on March 28,
2010. Due to such security interests, the Company will not be in a position in
the future to pledge its assets to secure any debt or lending facility, in the
event we desire or need to borrow such funds on a secured lending basis. It is
doubtful that the Company would be able to obtain significant additional debt
financing on an unsecured basis.
Moreover, under the terms
and conditions of the Crown Bank facility and our agreement with such
guarantors, in the event of any default by us with our senior lender that
causes the personal guarantees to be called and honored, we and our lender have
agreed that all of the banks security interests in the
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Companys assets shall be
assigned to such guarantors, pro rata, in consideration of such breach and
obligation to pay under the respective guarantees. In addition, the holders of
the $600,000 promissory note has a subordinated interest in all of the Companys
assets in the event of a default under the note. Thus, our common shareholders,
and any existing and future investors in our common stock, would, if the
foregoing breach and circumstances occurred, not have access or recourse to the
Companys assets and collateral, and thus, would likely face a complete loss of
their investment in the Company.
For a more detailed discussion of the risk factors that have
not been materially changed, see Item 1 of our Annual Report on Form 10-K
for the year ended December 31, 2008 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.
Common Stock
On April 13, 2009, the Company issued an aggregate of
27,366 shares of its common stock to our independent directors, David Koenig,
Robert Rudelius and Scott Smith, as payment of $20,250 directors fees accrued
through December 31, 2008, in lieu of cash.
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 provided 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.
Item
5. Other Information.
None.
Item
6. Exhibits
.
Exhibit No.
|
|
Description
|
|
|
|
10.1 *
|
|
Promissory Note dated
June 12, 2009 issued in favor of Crown Bank.
|
|
|
|
10.2 *
|
|
Security Agreement with
Crown Bank dated June 12, 2009.
|
|
|
|
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.
27
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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: August 14, 2009
|
By:
|
/s/ Richard C. Carlson
|
|
Name: Richard C. Carlson
|
|
Title: Chief Executive
Officer
|
|
|
|
|
|
Date: August 14, 2009
|
By:
|
/s/ Richard Thon
|
|
Name: Richard Thon
|
|
Title: Chief Financial
Officer
|
28
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Exhibit Index
Exhibit No.
|
|
Description
|
|
|
|
10.1 *
|
|
Promissory Note dated
June 12, 2009 issued in favor of Crown Bank.
|
|
|
|
10.2 *
|
|
Security Agreement with
Crown Bank dated June 12, 2009.
|
|
|
|
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.
29
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