PROVECTUS BIOPHARMACEUTICALS, INC. - Quarter Report: 2009 March (Form 10-Q)
United
States
Securities
And Exchange Commission
Washington,
DC 20549
FORM
10-Q
(Mark
One)
x Quarterly
Report under Section 13 or 15(d) of the Securities Exchange Act of
1934
For the quarterly period ended March
31, 2009
OR
o Transition Report
under Section 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from
__________ to _______________
Commission
file number: 0-9410
Provectus
Pharmaceuticals, Inc.
(Exact
Name of Registrant as Specified in its Charter)
|
Nevada
|
90-0031917
|
|
(State
or other jurisdiction of incorporation or organization)
|
(I.R.S.
Employer Identification Number)
|
7327
Oak Ridge Highway Suite A, Knoxville, TN 37931
(Address
of Principal Executive Offices)
866/594-5999
(Issuer's
Telephone Number, Including Area Code)
N/A
(Former
Name, Former Address and Former Fiscal Year, if Changed Since Last
Report)
Indicate by check mark whether the
registrant: (1) filed all reports required to be filed by Section 13
or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the 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, or a
non-accelerated filer. (Check one):
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 number of shares outstanding of the
issuer's stock, $0.001 par value per share, as of April 24, 2009 was
54,051,728.
Transitional Small Business Disclosure
Format (check one): Yes o
No x
Item
1. Financial Statements
PROVECTUS
PHARMACEUTICALS, INC.
(A
Development-Stage Company)
CONSOLIDATED
BALANCE SHEETS
|
March
31,
2009
|
December
31, 2008
|
|||||||
|
(Unaudited)
|
(Audited)
|
|||||||
|
Assets
|
||||||||
|
Current
Assets
|
||||||||
|
Cash and cash
equivalents
|
$ | 1, 498,668 | $ | 2,796,020 | ||||
|
Prepaid expenses and other
current assets
|
82,989 | 50,691 | ||||||
|
Total
Current Assets
|
1,581,657 | 2,846,711 | ||||||
|
Equipment
and furnishings, less accumulated depreciation of $393,547 and
$391,233, respectively
|
31,376 | 33,690 | ||||||
|
Patents,
net of amortization of $4,272,797 and $4,105,017,
respectively
|
7,442,648 | 7,610,428 | ||||||
|
Other
assets
|
27,000 | 27,000 | ||||||
| $ | 9,082,681 | $ | 10,517,829 | |||||
|
Liabilities
and Stockholders' Equity
|
||||||||
|
Current
Liabilities
|
||||||||
|
Accounts payable –
trade
|
$ | 134,621 | $ | 267,093 | ||||
|
Accrued compensation and payroll
taxes
|
107,692 | 79,955 | ||||||
|
Accrued consulting
expense
|
144,287 | 66,250 | ||||||
|
Cash
received in advance for pending stock transaction
|
144,000 | -- | ||||||
|
Other accrued
expenses
|
119,737 | 48,995 | ||||||
|
Total
Current Liabilities
|
650,337 | 462,293 | ||||||
|
Stockholders'
Equity
Preferred
stock; par value $.001 per share; 25,000,000 shares authorized;
no shares issued and outstanding
|
-- | -- | ||||||
|
Common stock; par value $.001 per
share; 100,000,000 shares
authorized;
53,384,188 and 53,017,076 shares issued and
outstanding,
respectively
|
53,384 | 53,017 | ||||||
|
Paid-in capital
|
66,236,530 | 65,478,126 | ||||||
|
Deficit accumulated during the development stage
|
(57,857,570 | ) | (55,475,607 | ) | ||||
|
Total
Stockholders' Equity
|
8,432,344 | 10,055,536 | ||||||
| $ | 9,082,681 | $ | 10,517,829 | |||||
See
accompanying notes to consolidated financial statements.
1
PROVECTUS
PHARMACEUTICALS, INC.
(A
Development-Stage Company)
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
|
Three
Months Ended
March 31,
2009
|
Three
Months Ended
March 31,
2008
|
Cumulative
Amounts from January 17, 2002 (Inception) Through
March 31,
2009
|
||||||||||
|
Revenues
|
||||||||||||
|
OTC
product revenue
|
$ | -- | $ | -- | $ | 25,648 | ||||||
|
Medical
device revenue
|
-- | -- | 14,109 | |||||||||
|
Total
revenues
|
-- | -- | 39,757 | |||||||||
|
Cost
of sales
|
-- | -- | 15,216 | |||||||||
|
Gross
profit
|
-- | -- | 24,541 | |||||||||
|
Operating
expenses
|
||||||||||||
|
Research
and development
|
915,933 | 1,063,116 | 16,874,714 | |||||||||
|
General
and administrative
|
1,299,424 | 1,164,994 | 28,512,302 | |||||||||
|
Amortization
|
167,780 | 167,780 | 4,272,797 | |||||||||
|
Total
operating loss
|
(2,383,137 | ) | (2,395,890 | ) | (49,635,272 | ) | ||||||
|
Gain
on sale of fixed assets
|
-- | -- | 55,075 | |||||||||
|
Loss
on extinguishment of debt
|
-- | -- | (825,867 | ) | ||||||||
|
Investment
income
|
1,174 | 39,905 | 646,498 | |||||||||
|
Interest
expense
|
-- | -- | (8,098,004 | ) | ||||||||
|
Net
loss
|
$ | (2,381,963 | ) | $ | (2,355,985 | ) | $ | (57,857,570 | ) | |||
|
Basic
and diluted loss per common share
|
$ | (0.04 | ) | $ | (0.05 | ) | ||||||
|
Weighted
average number of common shares outstanding - basic and
diluted
|
53,263,059 | 49,885,162 | ||||||||||
See
accompanying notes to consolidated financial statements.
2
PROVECTUS
PHARMACEUTICALS, INC.
(A
Development-Stage Company)
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY
(Unaudited)
|
Common
Stock
|
||||||||||||||||||||
|
Number
of shares
|
Par
value
|
Paid-in
capital
|
Accumulated
deficit
|
Total
|
||||||||||||||||
|
Balance,
at January 17, 2002
|
-- | $ | -- | $ | -- | $ | -- | $ | -- | |||||||||||
|
Issuance
to founding shareholders
|
6,000,000 | 6,000 | (6,000 | ) | -- | -- | ||||||||||||||
|
Sale
of stock
|
50,000 | 50 | 24,950 | -- | 25,000 | |||||||||||||||
|
Issuance
of stock to employees
|
510,000 | 510 | 931,490 | -- | 932,000 | |||||||||||||||
|
Issuance
of stock for services
|
120,000 | 120 | 359,880 | -- | 360,000 | |||||||||||||||
|
Net
loss for the period from January 17, 2002 (inception) to April 23,
2002 (date of reverse merger)
|
-- | -- | -- | (1,316,198 | ) | (1,316,198 | ) | |||||||||||||
|
Balance,
at April 23, 2002
|
6,680,000 | $ | 6,680 | $ | 1,310,320 | $ | (1,316,198 | ) | $ | 802 | ||||||||||
|
Shares
issued in reverse merger
|
265,763 | 266 | (3,911 | ) | -- | (3,645 | ) | |||||||||||||
|
Issuance
of stock for services
|
1,900,000 | 1,900 | 5,142,100 | -- | 5,144,000 | |||||||||||||||
|
Purchase
and retirement of stock
|
(400,000 | ) | (400 | ) | (47,600 | ) | -- | (48,000 | ) | |||||||||||
|
Stock
issued for acquisition of Valley Pharmaceuticals
|
500,007 | 500 | 12,225,820 | -- | 12,226,320 | |||||||||||||||
|
Exercise
of warrants
|
452,919 | 453 | -- | -- | 453 | |||||||||||||||
|
Warrants
issued in connection with convertible debt
|
-- | -- | 126,587 | -- | 126,587 | |||||||||||||||
|
Stock
and warrants issued for acquisition of Pure-ific
|
25,000 | 25 | 26,975 | -- | 27,000 | |||||||||||||||
|
Net
loss for the period from April 23, 2002 (date of reverse merger) to
December 31, 2002
|
-- | -- | -- | (5,749,937 | ) | (5,749,937 | ) | |||||||||||||
|
Balance,
at December 31, 2002
|
9,423,689 | $ | 9,424 | $ | 18,780,291 | $ | (7,066,135 | ) | $ | 11,723,580 | ||||||||||
|
Issuance
of stock for services
|
764,000 | 764 | 239,036 | -- | 239,800 | |||||||||||||||
|
Issuance
of warrants for services
|
-- | -- | 145,479 | -- | 145,479 | |||||||||||||||
|
Stock
to be issued for services
|
-- | -- | 281,500 | -- | 281,500 | |||||||||||||||
|
Employee
compensation from stock options
|
-- | -- | 34,659 | -- | 34,659 | |||||||||||||||
|
Issuance
of stock pursuant to Regulation S
|
679,820 | 680 | 379,667 | -- | 380,347 | |||||||||||||||
|
Beneficial
conversion related to convertible debt
|
-- | -- | 601,000 | -- | 601,000 | |||||||||||||||
|
Net
loss for the year ended December 31, 2003
|
-- | -- | -- | (3,155,313 | ) | (3,155,313 | ) | |||||||||||||
|
Balance,
at December 31, 2003
|
10,867,509 | $ | 10,868 | $ | 20,461,632 | $ | (10,221,448 | ) | $ | 10,251,052 | ||||||||||
|
Issuance
of stock for services
|
733,872 | 734 | 449,190 | -- | 449,923 | |||||||||||||||
|
Issuance
of warrants for services
|
-- | -- | 495,480 | -- | 495,480 | |||||||||||||||
|
Exercise
of warrants
|
132,608 | 133 | 4,867 | -- | 5,000 | |||||||||||||||
|
Employee
compensation from stock options
|
-- | -- | 15,612 | -- | 15,612 | |||||||||||||||
|
Issuance
of stock pursuant to Regulation S
|
2,469,723 | 2,469 | 790,668 | -- | 793,137 | |||||||||||||||
|
Issuance
of stock pursuant to Regulation D
|
1,930,164 | 1,930 | 1,286,930 | -- | 1,288,861 | |||||||||||||||
|
Beneficial
conversion related to convertible debt
|
-- | -- | 360,256 | -- | 360,256 | |||||||||||||||
|
Issuance
of convertible debt with warrants
|
-- | -- | 105,250 | -- | 105,250 | |||||||||||||||
|
Repurchase
of beneficial conversion feature
|
-- | -- | (258,345 | ) | -- | (258,345 | ) | |||||||||||||
|
Net
loss for the year ended December 31, 2004
|
-- | -- | -- | (4,344,525 | ) | (4,344,525 | ) | |||||||||||||
|
Balance,
at December 31, 2004
|
16,133,876 | $ | 16,134 | $ | 23,711,540 | $ | (14,565,973 | ) | $ | 9,161,701 | ||||||||||
|
Issuance
of stock for services
|
226,733 | 227 | 152,058 | -- | 152,285 | |||||||||||||||
|
Issuance
of stock for interest payable
|
263,721 | 264 | 195,767 | -- | 196,031 | |||||||||||||||
|
Issuance
of warrants for services
|
-- | -- | 1,534,405 | -- | 1,534,405 | |||||||||||||||
|
Issuance
of warrants for contractual obligations
|
-- | -- | 985,010 | -- | 985,010 | |||||||||||||||
|
Exercise
of warrants and stock options
|
1,571,849 | 1,572 | 1,438,223 | -- | 1,439,795 | |||||||||||||||
|
Employee
compensation from stock options
|
-- | -- | 15,752 | -- | 15,752 | |||||||||||||||
|
Issuance
of stock pursuant to Regulation D
|
6,221,257 | 6,221 | 6,506,955 | -- | 6,513,176 | |||||||||||||||
|
Debt
conversion to common stock
|
3,405,541 | 3,405 | 3,045,957 | -- | 3,049,795 | |||||||||||||||
|
Issuance
of warrants with convertible debt
|
-- | -- | 1,574,900 | -- | 1,574,900 | |||||||||||||||
|
Beneficial
conversion related to convertible debt
|
-- | -- | 1,633,176 | -- | 1,633,176 | |||||||||||||||
|
Beneficial
conversion related to interest expense
|
-- | -- | 39,259 | -- | 39,529 | |||||||||||||||
|
Repurchase
of beneficial conversion feature
|
-- | -- | (144,128 | ) | -- | (144,128 | ) | |||||||||||||
|
Net
loss for the year ended 2005
|
-- | -- | -- | (11,763,853 | ) | (11,763,853 | ) | |||||||||||||
|
Balance,
at December 31, 2005
|
27,822,977 | $ | 27,823 | $ | 40,689,144 | $ | (26,329,826 | ) | $ | 14,387,141 | ||||||||||
|
Issuance
of stock for services
|
719,246 | 719 | 676,024 | -- | 676,743 | |||||||||||||||
|
Issuance
of stock for interest payable
|
194,327 | 195 | 183,401 | -- | 183,596 | |||||||||||||||
|
Issuance
of warrants for services
|
-- | -- | 370,023 | -- | 370,023 | |||||||||||||||
|
Exercise
of warrants and stock options
|
1,245,809 | 1,246 | 1,188,570 | -- | 1,189,816 | |||||||||||||||
|
Employee
compensation from stock options
|
-- | -- | 1,862,456 | -- | 1,862,456 | |||||||||||||||
|
Issuance
of stock pursuant to Regulation D
|
10,092,495 | 10,092 | 4,120,329 | -- | 4,130,421 | |||||||||||||||
|
Debt
conversion to common stock
|
2,377,512 | 2,377 | 1,573,959 | -- | 1,576,336 | |||||||||||||||
|
Beneficial
conversion related to interest expense
|
-- | -- | 16,447 | -- | 16,447 | |||||||||||||||
|
Net
loss for the year ended 2006
|
-- | -- | -- | (8,870,579 | ) | (8,870,579 | ) | |||||||||||||
|
Balance,
at December 31, 2006
|
42,452,366 | $ | 42,452 | $ | 50,680,353 | $ | (35,200,405 | ) | $ | 15,522,400 | ||||||||||
3
|
Issuance
of stock for services
|
150,000 | 150 | 298,800 | -- | 298,950 | |||||||||||||||
|
Issuance
of stock for interest payable
|
1,141 | 1 | 1,257 | -- | 1,258 | |||||||||||||||
|
Issuance
of warrants for services
|
-- | -- | 472,635 | -- | 472,635 | |||||||||||||||
|
Exercise
of warrants and stock options
|
3,928,957 | 3,929 | 3,981,712 | -- | 3,985,641 | |||||||||||||||
|
Employee
compensation from stock options
|
-- | -- | 2,340,619 | -- | 2,340,619 | |||||||||||||||
|
Issuance
of stock pursuant to Regulation D
|
2,376,817 | 2,377 | 1,845,761 | -- | 1,848,138 | |||||||||||||||
|
Debt
conversion to common stock
|
490,000 | 490 | 367,010 | -- | 367,500 | |||||||||||||||
|
Net
loss for the year ended 2007
|
-- | -- | -- | (10,005,631 | ) | (10,005,631 | ) | |||||||||||||
|
Balance,
at December 31, 2007
|
49,399,281 | $ | 49,399 | $ | 59,988,147 | $ | (45,206,036 | ) | $ | 14,831,510 | ||||||||||
|
Issuance
of stock for services
|
350,000 | 350 | 389,650 | -- | 390,000 | |||||||||||||||
|
Issuance
of warrants for services
|
-- | -- | 517,820 | -- | 517,820 | |||||||||||||||
|
Exercise
of warrants and stock options
|
3,267,795 | 3,268 | 2,636,443 | -- | 2,639,711 | |||||||||||||||
|
Employee
compensation from stock options
|
-- | -- | 1,946,066 | -- | 1,946,066 | |||||||||||||||
|
Net
loss for the year ended 2008
|
-- | -- | -- | (10,269,571 | ) | (10,269,571 | ) | |||||||||||||
|
Balance,
at December 31, 2008
|
53,017,076 |
$
|
53,017 | $ | 65,478,126 |
$
|
(55,475,607 | ) |
$
|
10,055,536 | ||||||||||
|
Issuance
of stock for services
|
75,000 | 75 | 70,175 | -- | 70,250 | |||||||||||||||
|
Issuance
of warrants for services
|
-- | -- | 149,437 | -- | 149,437 | |||||||||||||||
|
Exercise
of warrants and stock options
|
292,112 | 292 | 218,792 | -- | 219,084 | |||||||||||||||
|
Employee
compensation from stock options
|
-- | -- | 320,000 | -- | 320,000 | |||||||||||||||
|
Net
loss for the three months ended March 31, 2009
|
-- | -- | -- | (2,381,963 | ) | (2,381,963 | ) | |||||||||||||
|
Balance,
at March 31, 2009
|
53,384,188 | $ | 53,384 | $ | 66,236,530 | $ | (57,857,570 | ) | $ | 8,432,344 |
See
accompanying notes to consolidated financial statements.
4
PROVECTUS
PHARMACEUTICALS, INC.
(A
Development-Stage Company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
|
Three
Months Ended
March 31,
2009
|
Three
Months Ended
March 31,
2008
|
Cumulative
Amounts from January 17, 2002 (Inception) through
March 31,
2009
|
||||||||||
|
Cash
Flows From Operating Activities
|
||||||||||||
|
Net
loss
|
$ | (2,381,963 | ) | $ | (2,355,985 | ) | $ | (57,857,570 | ) | |||
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
||||||||||||
|
Depreciation
|
2,314 | 2,314 | 416,548 | |||||||||
|
Amortization
of patents
|
167,780 | 167,780 | 4,272,797 | |||||||||
|
Amortization
of original issue discount
|
-- | -- | 3,845,721 | |||||||||
|
Amortization
of commitment fee
|
-- | -- | 310,866 | |||||||||
|
Amortization
of prepaid consultant expense
|
-- | -- | 1,295,226 | |||||||||
|
Amortization
of deferred loan costs
|
-- | -- | 2,261,584 | |||||||||
|
Accretion
of United States Treasury Notes
|
-- | (12,805 | ) | (373,295 | ) | |||||||
|
Loss
on extinguishment of debt
|
-- | -- | 825,867 | |||||||||
|
Loss
on exercise of warrants
|
-- | -- | 236,146 | |||||||||
|
Beneficial
conversion of convertible interest
|
-- | -- | 55,976 | |||||||||
|
Convertible
interest
|
-- | -- | 389,950 | |||||||||
|
Compensation
through issuance of stock options
|
320,000 | 494,231 | 6,535,164 | |||||||||
|
Compensation
through issuance of stock
|
-- | -- | 932,000 | |||||||||
|
Issuance
of stock for services
|
70,250 | 93,833 | 6,782,898 | |||||||||
|
Issuance
of warrants for services
|
149,437 | 45,467 | 1,683,061 | |||||||||
|
Issuance
of warrants for contractual obligations
|
-- | -- | 985,010 | |||||||||
|
Gain
on sale of equipment
|
-- | -- | (55,075 | ) | ||||||||
|
(Increase)
decrease in assets
|
||||||||||||
|
Prepaid
expenses and other current assets
|
(32,298 | ) | 26,723 | (82,989 | ) | |||||||
|
Increase
(decrease) in liabilities
|
||||||||||||
|
Accounts
payable
|
(132,472 | ) | (321,469 | ) | 130,976 | |||||||
|
Accrued
expenses
|
176,516 | (182,236 | ) | 521,346 | ||||||||
|
Net
cash used in operating activities
|
(1,660,436 | ) | (2,042,147 | ) | (26,887,793 | ) | ||||||
|
Cash
Flows from Investing Activities
|
||||||||||||
|
Proceeds
from sale of fixed assets
|
-- | -- | 180,075 | |||||||||
|
Capital
expenditures
|
-- | -- | (62,049 | ) | ||||||||
|
Proceeds
from investments
|
-- | 4,820,000 | 37,010,481 | |||||||||
|
Purchases
of investments
|
-- | (3,101,282 | ) | (36,637,186 | ) | |||||||
|
Net
cash provided by investing activities
|
-- | 1,718,718 | 491,321 | |||||||||
|
Cash
Flows from Financing Activities
|
||||||||||||
|
Net
proceeds from loans from stockholder
|
-- | -- | 174,000 | |||||||||
|
Proceeds
from convertible debt
|
-- | -- | 6,706,795 | |||||||||
|
Net
proceeds from sales of common stock
|
-- | -- | 14,979,081 | |||||||||
|
Proceeds
from exercises of warrants and stock options
|
219,084 | 184,402 | 9,243,354 | |||||||||
|
Cash
received in advance for pending stock transaction
|
144,000 | -- | 144,000 | |||||||||
|
Cash
paid to retire convertible debt
|
-- | -- | (2,385,959 | ) | ||||||||
|
Cash
paid for deferred loan costs
|
-- | -- | (747,612 | ) | ||||||||
|
Premium
paid on extinguishments of debt
|
-- | -- | (170,519 | ) | ||||||||
|
Purchase
and retirement of common stock
|
-- | -- | (48,000 | ) | ||||||||
|
Net
cash provided by financing activities
|
363,084 | 184,402 | 27,895,140 | |||||||||
|
Net
change in cash and cash equivalents
|
$ | (1,297,352 | ) | $ | (139,027 | ) | $ | 1,498,668 | ||||
|
Cash
and cash equivalents, at beginning of period
|
$ | 2,796,020 | $ | 352,389 | $ | -- | ||||||
|
Cash
and cash equivalents, at end of period
|
$ | 1,498,668 | $ | 213,362 | $ | 1,498,668 |
See
accompanying notes to consolidated financial statements.
5
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Basis of
Presentation
The accompanying unaudited condensed
consolidated financial statements have been prepared in accordance with
accounting principles generally accepted in the United States of America for
interim financial information pursuant to Regulation
S-X. Accordingly, they do not include all of the information and
footnotes required by accounting principles generally accepted in the United
States of America for complete financial statements. In the opinion
of management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation have been
included. Operating results for the three months ended March 31, 2009
are not necessarily indicative of the results that may be expected for the year
ended December 31, 2009.
2. Recapitalization and
Merger
Provectus Pharmaceuticals, Inc.,
formerly known as "Provectus Pharmaceutical, Inc." and "SPM Group, Inc.," was
incorporated under Colorado law on May 1, 1978. SPM Group ceased
operations in 1991, and became a development-stage company effective January 1,
1992, with the new corporate purpose of seeking out acquisitions of properties,
businesses, or merger candidates, without limitation as to the nature of the
business operations or geographic location of the acquisition
candidate.
On April 1, 2002, SPM Group changed its
name to "Provectus Pharmaceutical, Inc." and reincorporated in Nevada in
preparation for a transaction with Provectus Pharmaceuticals, Inc., a
privately-held Tennessee corporation ("PPI"). On April 23, 2002, an Agreement
and Plan of Reorganization between Provectus Pharmaceutical and PPI was approved
by the written consent of a majority of the outstanding shares of Provectus
Pharmaceutical. As a result, Provectus Pharmaceuticals, Inc. issued
6,680,000 shares of common stock in exchange for all of the issued and
outstanding shares of PPI. As part of the acquisition, Provectus
Pharmaceutical changed its name to "Provectus Pharmaceuticals, Inc." and PPI
became a wholly-owned subsidiary of Provectus. This transaction was
recorded as a recapitalization of PPI.
On November 19, 2002, the Company
acquired Valley Pharmaceuticals, Inc., a privately-held Tennessee corporation
formerly known as Photogen, Inc., by merging PPI with and into Valley and naming
the surviving corporation "Xantech Pharmaceuticals, Inc." Photogen, Inc. was
separated from Photogen Technologies, Inc. in a non-pro-rata split-off to some
of its shareholders. The assets of Photogen, Inc. consisted primarily
of the equipment and intangibles related to its therapeutic activity and were
recorded at their fair value. The majority shareholders of Valley
were also the majority shareholders of Provectus. Valley had no
revenues prior to the transaction with the Company. By acquiring
Valley, the Company acquired its intellectual property, including issued U.S.
patents and patentable inventions.
3. Basic and Diluted Loss Per Common
Share
Basic and diluted loss per common share
is computed based on the weighted average number of common shares
outstanding. Loss per share excludes the impact of outstanding
options and warrants as they are antidilutive. Potential common shares excluded
from the calculation at March 31, 2009 and 2008 relate to 20,976,672 and
22,718,776 from warrants, and 8,848,427 and 8,903,169 from options.
4. Equity and Debt
Transactions
(a) During
the three months ended March 31, 2009, the Company issued 75,000 shares of
common stock to consultants in exchange for services. Consulting
costs charged to operations were $70,250.
(b) During
the three months ended March 31, 2009, the Company issued 243,612 warrants to
consultants in exchange for services. Consulting costs charged to
operations were $131,476. During the three months ended March 31,
2009, 292,112 warrants were exercised for $219,084 resulting in 292,112 shares
being issued. 292,112 of the warrants exercised had an exercise price
of $0.935 that was reduced to $0.75. Additional consulting costs of
$17,961 were charged to operations as a result of the reduction of the exercise
price of the 292,112 warrants.
5. Stock-Based
Compensation
Effective
January 1, 2006, the Company adopted FASB 123R. This change in accounting
replaces existing requirements under FASB 123 and eliminates the ability to
account for share-based compensation transaction using APB 25. The compensation
cost relating to share-based payment transactions is measured based on the fair
value of the equity or liability instruments issued. For purposes of estimating
the fair value of each stock option on the date of grant, the Company utilized
the Black-Scholes option-pricing model. The Black-Scholes option valuation model
was developed for use in estimating the fair value of traded options, which have
no vesting restrictions and are fully transferable. In addition, option
valuation models require the input of highly subjective assumptions including
the expected volatility factor of the market price of the company’s common stock
(as determined by reviewing its historical public market closing prices).
Because the Company's employee 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, in management's
opinion, the existing models do not necessarily provide a reliable single
measure of the fair value of its employee stock options. Included in the results
for the three months ended March 31, 2009 and 2008, is $320,000 and $494,231,
respectively, of stock-based compensation expense which relates to the fair
value of stock options.
6.
Subsequent
Events
Approximately
$3,200,000 in cash has been received in April and thus far in May 2009 due
primarily to warrant exercises and sales of equity securities. The
Company has received $1,500,000 from warrant exercises and $700,000
received in advance for pending stock transactions. The Company has also
received $1,000,000 from sales of equity securities which resulted in
1,001,663 shares of common stock and 500,837 additional warrants
issued.
6
Item
2. Management's Discussion and Analysis of Financial Condition and Results of
Operations.
The following discussion is intended to
assist in the understanding and assessment of significant changes and trends
related to our results of operations and our financial condition together with
our consolidated subsidiaries. This discussion and analysis should be
read in conjunction with the consolidated financial statements and notes thereto
included elsewhere in this Quarterly Report on Form 10-Q. Historical
results and percentage relationships set forth in the statement of operations,
including trends which might appear, are not necessarily indicative of future
operations.
Capital
Structure
Our
ability to continue as a going concern is reasonably assured due to our
financing completed thus far in 2009 which includes an additional $3,200,000 in
cash that has been received in April and thus far in May 2009 due primarily to
warrant exercises and an immaterial amount of sales of equity securities. Given our current rate
of expenditures, we expect to raise additional capital in 2009 to ensure we
continue as a going concern. However, our existing funds are
sufficient to meet minimal necessary expenses during 2009.
We have
implemented our integrated business plan, including execution of the current and
next phases in clinical development of our pharmaceutical products and continued
execution of research programs for new research initiatives.
We intend
to proceed as rapidly as possible with a majority stake asset sale and
subsequent licensure of our OTC products that can be sold with a minimum of
regulatory compliance and with the further development of revenue sources
through a majority stake asset sale and subsequent licensing of our existing
medical device and biotech intellectual property portfolio. Although we believe
that there is a reasonable basis for our expectation that we will become
profitable due to the asset sale of a majority stake via a spin-out transaction
of the wholly-owned subsidiary that contains the OTC assets and subsequent
licensure of our OTC products, we cannot assure you that we will be able to
achieve, or maintain, a level of profitability sufficient to meet our operating
expenses.
Our
current plans include continuing to operate with our four employees during the
immediate future, but we have added two additional consultants and anticipate
adding two more consultants in the next 12 months. Our current plans also
include minimal purchases of new property, plant and equipment, and increased
research and development for additional clinical trials.
Plan
of Operation
With the
reorganization of Provectus and PPI and the acquisition and integration into the
Company of Valley and Pure-ific, we believe we have obtained a unique
combination of core intellectual properties and OTC and other non-core products.
This combination represents the foundation for an operating company that we
believe will provide both profitability and long-term growth. In 2008
and the first quarter of 2009, we continued to carefully control expenditures in
preparation for the asset sale and licensure or spin out of our OTC products,
medical device and biotech technologies, and we will issue equity only when it
makes sense and primarily for purposes of attracting strategic
investors.
In the
short term, we intend to develop our business by licensing our existing OTC
products, principally Pure-Stick, GloveAid and Pure-ific, and selling a majority
stake of the OTC assets. We are planning the majority sale of the OTC
assets via a spin-out transaction of the wholly-owned subsidiary that contains
the OTC assets. We also plan to license our medical device and
biotech technologies and sell a majority stake via a spin-out transaction of
those non-core wholly-owned subsidiaries. In the longer term, we
expect to continue the process of developing, testing and obtaining the approval
of the U. S. Food and Drug Administration for prescription drugs in
particular. Additionally, we have restarted our research programs
that will identify additional conditions that our intellectual properties may be
used to treat as well as additional treatments for those and other
conditions.
We have
continued to make significant progress with the major research and development
projects expected to be ongoing in the next 12 months. The Phase 2
trial in metastatic melanoma has been significantly completed which is expected
to cost approximately $362,000 during the remainder of 2009 and has cost
approximately $2,638,000 through March 31, 2009. Additionally, we
planned $675,000 of expenditures in 2007 and 2008 to substantially advance our
work with other oncology indications which included the third group of our
expanded Phase 1 breast carcinoma clinical trial. The third group of
our expanded Phase 1 breast carcinoma clinical trial was completed in September
2008. Our Phase 2 psoriasis trial commenced in November 2007 and is
expected to cost approximately $1,725,000, of which approximately $1,508,000 has
been expended thus far. Our Phase 2 atopic dermatitis trial commenced
in May 2008 and the cost is included in the psoriasis trial budget and actual
figures. Our Phase 1 liver cancer trial is expected to commence in
the first half of 2009 and is expected to cost approximately $600,000, of which
approximately $501,000 has been expended thus far. We anticipate
expending $678,000 during the remainder of 2009 for direct clinical trial
expense. This includes the remaining 2009 expenditures for all
projects currently planned. The table below summarizes our projects,
the actual costs expended to date and costs expected after March 31,
2009.
7
| Projects |
Planned
Project Cost
|
Expenditures
through
March
31, 2009
|
Expected
after
March
31, 2009
|
|||||||||
|
Melanoma
|
$ | 3,000,000 | $ | 2,638,000 | $ | 362,000 | ||||||
|
Breast/Other
|
$ | 675,000 | $ | 675,000 | $ | -0- | ||||||
|
Psoriasis/AD
|
$ | 1,725,000 | $ | 1,508,000 | $ | 217,000 | ||||||
|
Liver
|
$ | 600,000 | $ | 501,000 | $ | 99,000 | ||||||
Comparison
of Three Months Ended March 31, 2009 and March 31, 2008
Revenues
OTC Product Revenue was $-0- in both
the three months ended March 31, 2009 and 2008. We discontinued our
proof-of-concept program in November 2006 and have therefore ceased selling our
OTC products. There was no medical device revenue in both the three
months ended March 31, 2009 and 2008. The lack of medical device revenue
resulted due to no emphasis on selling. The Company has designated
the OTC and medical device products as non-core and is considering the sale of
the underlying assets in conjunction with the planned spin-out of the respective
wholly-owned subsidiaries.
Research and development
Research and development costs of
$915,933 for the three months ended March 31, 2009 included payroll of $517,437,
consulting and contract labor of $272,083, legal of $51,789, insurance of
$32,328, lab supplies and pharmaceutical preparations of $22,175, rent and
utilities of $17,807, and depreciation expense of $2,314. Research
and development costs of $1,063,116 for the three months ended March 31, 2008
included payroll of $734,001, consulting and contract labor of $176,045, legal
of $91,948, insurance of $18,523, lab supplies and pharmaceutical preparations
of $19,492, rent and utilities of $20,793, and depreciation expense of
$2,314. The decrease in payroll is the result of lower stock-based
compensation expense and less pension expense due to quarterly versus annual
allocation, offset partially by an increase in salaries. The increase
in consulting and contract labor is primarily the result of expense necessary to
manage the Phase 2 metastatic melanoma clinical trial which is operating at full
speed.
General and administrative
General and administrative expenses
increased by $134,430 in the three months ended March 31, 2009 to $1,299,424
from $1,164,994 for the three months ended March 31, 2008. The
increase resulted primarily from approximately $260,000 of additional investor
relations and conference expenses. This increase was partially offset
by approximately $170,000 of lower payroll expenses for general corporate
purposes as a result of lower stock-based compensation expense and less pension
expense due to quarterly versus annual allocation, offset partially by an
increase in salaries.
Investment
income
Investment income decreased by $38,731
in the three months ended March 31, 2009 to $1,174 from $39,905 in the three
months ended March 31, 2008. The decrease resulted due to lower
interest rates on cash and cash equivalents as well as lower balances in 2009
versus 2008.
Cash Flow
Our
cash and cash equivalents were $1,500,000 at March 31, 2009, compared
with $2,800,000 at December 31, 2008. The decrease of $1,300,000 was
due primarily to cash of $1,519,000 used in operating activities, partially
offset by $219,000 from the exercises of warrants and stock options during the
three months ended March 31, 2009. We have maintained our expenditure
rate in 2009 primarily with our clinical trial projects and our investor
relations efforts to communicate the progress of the Company. In
addition, approximately $3,200,000 in cash has been received in April and
thus far in May 2009 due primarily to warrant exercises and sales of equity
securities. The Company has received $1,500,000 from warrant
exercises and $700,000 received in advance for pending stock
transactions. The Company has also received $1,000,000 from sales of
equity securities which resulted in 1,001,663 shares of common stock and 500,837
additional warrants issued.
8
At our
current cash expenditure rate, our cash and cash equivalents will be sufficient
to meet our current and planned needs in 2009 since we expect additional cash
inflows from the exercise of existing warrants and sales of equity
securities. If we do not have sufficient cash inflows from the
exercise of existing warrants and sales of equity securities, then we will
reduce administrative expenses including management salaries which will enable
us to meet minimum expenditures planned during the remainder of
2009. Since we plan for $678,000 of direct clinical trial expense and
$650,000 of fixed expenses to operate during the remainder of 2009, we have
enough cash to fund the remainder of the 2009 operations with the cash on
hand at March 31, 2009 and the $3,200,000 of additional proceeds received in
April and thus far in May 2009.
We are
seeking to improve our cash flow through the majority stake asset sale and
licensure of our OTC products as well as other non-core
assets. However, we cannot assure you that we will be successful in
selling a majority stake of the OTC and other non-core assets via a spin-out
transaction and licensing our existing OTC products. Moreover, even
if we are successful in improving our current cash flow position, we nonetheless
plan to seek additional funds to meet our long-term requirements in 2010 and
beyond. We anticipate that these funds will come from the proceeds of
private placements, the exercise of existing warrants outstanding, or public
offerings of debt or equity securities. We also intend to license our
dermatology drug product candidate portfolio once we have completed our Phase 2
psoriasis and atopic eczema studies later in 2009.
Capital
Resources
As noted above, our present cash flow
is currently sufficient to meet our short-term operating
needs. Excess cash will be used to finance the next phases in
clinical development of our pharmaceutical products. We anticipate
that any required funds for our operating and development needs beyond 2009 will
come from the proceeds of private placements, the exercise of existing warrants
outstanding, or public offerings of debt or equity securities. While
we believe that we have a reasonable basis for our expectation that we will be
able to raise additional funds, we cannot assure you that we will be able to
complete additional financing in a timely manner. In addition, any
such financing may result in significant dilution to shareholders.
Critical
Accounting Policies
Long-Lived
Assets
We review
the carrying values of our long-lived assets for possible impairment whenever an
event or change in circumstances indicates that the carrying amount of the
assets may not be recoverable. Any long-lived assets held for
disposal are reported at the lower of their carrying amounts or fair value less
cost to sell. Management has determined there to be no
impairment.
Patent
Costs
Internal
patent costs are expensed in the period incurred. Patents purchased are
capitalized and amortized over their remaining lives, which range from 8-13
years. Annual amortization of the patents is expected to be
approximately $671,000 for the next year.
Stock-Based
Compensation
We
adopted Financial Accounting Standards Board (“FASB”) Statement No. 123 (revised
2004), “Share-Based Payment” (FASB 123R), effective January 1, 2006 under the
modified prospective method, which recognizes compensation cost beginning with
the effective date (a) based on the requirements of FASB 123R for all
share-based payments granted after the effective date and to awards modified,
repurchased, or cancelled after that date and (b) based on the requirements of
FASB 123 for all awards granted to employees prior to the effective date of FASB
123R that remain unvested on the effective date.
The
compensation cost relating to share-based payment transactions is measured based
on the fair value of the equity or liability instruments issued and is expensed
on a straight-line basis. For purposes of estimating the fair value of each
stock option, on the date of grant, we utilized the Black-Scholes option-pricing
model. The Black-Scholes option valuation model was developed for use in
estimating the fair value of traded options, which have no vesting restrictions
and are fully transferable. In addition, option valuation models require the
input of highly subjective assumptions including the expected volatility factor
of the market price of the company’s common stock (as determined by reviewing
its historical public market closing prices). Because our employee 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, in management’s opinion, the existing models do not
necessarily provide a reliable single measure of the fair value of its employee
stock options.
The
Company records the fair value of warrants granted to non-employees in exchange
for services in accordance with EITF 96-18 “Accounting for Equity Instruments
That are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services.” Warrants to non-employees are
generally vested and nonforfeitable upon the date of the
grant. Accordingly fair value is determined on the grant
date.
9
Research
and Development
Research
and development costs are charged to expense when incurred. An allocation of
payroll expenses to research and development is made based on a percentage
estimate of time spent. The research and development costs include the
following: consulting - IT, depreciation, lab equipment repair, lab supplies and
pharmaceutical preparations, insurance, legal - patents, office supplies,
payroll expenses, rental - building, repairs, software, taxes and fees, and
utilities.
Accounting
Pronouncement
None.
Contractual
Obligations - Leases
We lease
office and laboratory space in Knoxville, Tennessee, on an annual basis,
renewable for one year at our option. We are committed to pay a total of $13,500
in lease payments over three months, which is the remainder of our current lease
term at March 31, 2009.
Forward-Looking
Statements
This Quarterly Report on Form 10-Q
contains forward-looking statements regarding, among other things, our
anticipated financial and operating results. Forward-looking statements reflect
our management’s current assumptions, beliefs, and expectations. Words such as
"anticipate," "believe, “estimate," "expect," "intend," "plan," and similar
expressions are intended to identify forward-looking statements. While we
believe that the expectations reflected in our forward-looking statements are
reasonable, we can give no assurance that such expectations will prove correct.
Forward-looking statements are subject to risks and uncertainties that could
cause our actual results to differ materially from the future results,
performance, or achievements expressed in or implied by any forward-looking
statement we make. Some of the relevant risks and uncertainties that could cause
our actual performance to differ materially from the forward-looking statements
contained in this report are discussed below under the heading "Risk Factors"
and elsewhere in this Quarterly Report on Form 10-Q. We caution investors that
these discussions of important risks and uncertainties are not exclusive, and
our business may be subject to other risks and uncertainties which are not
detailed there.
Investors
are cautioned not to place undue reliance on our forward-looking statements. We
make forward-looking statements as of the date on which this Quarterly Report on
Form 10-Q is filed with the SEC, and we assume no obligation to update the
forward-looking statements after the date hereof whether as a result of new
information or events, changed circumstances, or otherwise, except as required
by law.
Item
3. Quantitative and Qualitative Disclosures About Market
Risk.
Item
4T. Controls and Procedures.
(a) Evaluation of Disclosure
Controls and Procedures. Our chief executive officer and chief
financial officer have evaluated the effectiveness of the design and operation
of our "disclosure controls and procedures" (as that term is defined in Rule
13a-15(e) under the Exchange Act) as of March 31, 2009, the end of the fiscal
quarter covered by this Quarterly Report on Form 10-Q. Based on that
evaluation, the chief executive officer and chief financial officer have
concluded that our disclosure controls and procedures are effective to ensure
that material information relating to the Company and the Company's consolidated
subsidiaries is made known to such officers by others within these entities,
particularly during the period this Quarterly Report on Form 10-Q was prepared,
in order to allow timely decisions regarding required disclosure.
(b) Changes in Internal
Controls. There has been no change in our internal control over financial
reporting that occurred during the fiscal quarter covered by this Quarterly
Report on Form 10-Q that has materially affected, or is reasonably likely to
materially affect, our internal control over financial
reporting.
10
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings.
The Company was
not involved in any legal proceedings during the fiscal quarter covered by this
Quarterly Report of Form 10-Q.
Item 2. Unregistered Sales of Equity
Securities and Use of Proceeds.
None.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Submission of Matters to a Vote of Security Holders.
None.
Item
5. Other Information.
None.
Item
6. Exhibits.
31.1 Certification Pursuant to Rule 13a-14(a) (Section 302
Certification), dated May 15, 2009, executed by H. Craig Dees, Ph.D.,
Chief Executive Officer of the Company.
31.2 Certification Pursuant to Rule 13a-14(a) (Section 302 Certification),
dated May 15, 2009, executed by Peter R. Culpepper, Chief Financial
Officer of the Company.
32.1 Certification Pursuant to 18 U.S.C. ss. 1350 (Section 906 Certification),
dated May 15, 2009, executed by H. Craig Dees, Ph.D., Chief Executive Officer of
the Company, and Peter R. Culpepper, Chief Financial Officer of the
Company.
11
Signatures
In
accordance with Section 13 or 15(d) of the Exchange Act, the Registrant caused
this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
| Provectus Pharmaceuticals, Inc. | |||
|
Date:
May 15, 2009
|
By:
|
/s/ H. Craig Dees, Ph.D. | |
| H. Craig Dees, Ph.D. | |||
| Chief Executive Officer | |||
12
EXHIBIT
INDEX
| Exhibit No. | Description |
|
31.1
|
Certification Pursuant to Rule 13a-14(a) (Section 302 Certification), dated May 15, 2009, executed by H. Craig Dees, Ph.D., Chief Executive Officer of the Company. |
|
31.2
|
Certification Pursuant to Rule 13a-14(a) (Section 302 Certification), dated May 15, 2009, executed by Peter R. Culpepper, Chief Financial Officer of the Company. |
|
32.1
|
Certification Pursuant to 18 U.S.C. ss. 1350 (Section 906 Certification), dated May 15, 2009, executed by H. Craig Dees, Ph.D., Chief Executive Officer of the Company, and Peter R. Culpepper, Chief Financial Officer of the Company. |
13