PVCT 10KSB 12-31-05
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-KSB
(Mark
One)
xAnnual
Report Pursuant
to Section 13 or 15(d) of the Securities Exchange
Act
of
1934
For
the
fiscal year ended December 31, 2005; 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: 0-9410
Provectus
Pharmaceuticals, Inc.
(Name
of
Small Business Issuer 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,
Tennessee
|
37931
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
865/769-4011
(Issuer's
Telephone Number, Including Area Code)
Securities
registered under Section 12(b) of the Exchange Act:
None
_____________________________________________
(Title
of
Class)
Securities
registered under Section 12(g) of the Exchange Act:
Common
shares, par value $.001 per share
_______________________________________________
(Title
of
Class)
Check
whether the issuer is not
required to file reports pursuant to Section 13 or 15(d) of the Exchange Act.
o
Note
- Checking the box above will not relieve any registrant required to
file reports pursuant to Section 13 or 15(d) of the Exchange Act from their
obligations under those Sections.
Check
whether the issuer: (1) filed all
reports required to be filed by Section 13 or 15(d) of the Exchange Act 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 xNo o
Check
if
there is no disclosure of delinquent filers in response to Item 405 of
Regulation S-B contained in this form, and no disclosure will be contained,
to
the best of registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-KSB or any
amendment to this Form 10-KSB. 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
issuer’s revenues for the most recent fiscal year were $6,536.
The
aggregate market value of the
voting and non-voting common equity held by non-affiliates of the registrant
as
of February 13, 2006, was $31,212,267 (computed on the basis of $0.88 per
share).
The
number of shares outstanding of the issuer's stock, $0.001 par value per share,
as of February 13, 2006 was 35,468,485.
Documents
incorporated by reference in Part III hereof: Proxy Statement for 2006 Annual
Meeting of Stockholders.
Transitional
Small Business Disclosure Format (check one): Yes o No x
Table
of
Contents Page
Part I |
1
|
Item 1. Description of Business |
7
|
History |
7
|
Description of Business |
8
|
Intellectual Property |
14
|
Competition |
16
|
Federal Regulation of Therapeutic Products |
16
|
Personnel |
19
|
Available Information |
20
|
Item 1A. |
|
Risk
Factors |
|
Item 1B. |
|
Unresolved SEC Comments |
|
Item 2. Description of
Property |
20
|
Item 3. Legal Proceedings
|
20
|
Item 4. Submission of Matters to a
Vote of Security Holders |
20
|
Part II
|
21
|
Item 5. Market for Common Equitiy and
Related Stockholders Matter
|
21
|
Item 6. Managment's Discussion
and Analysis or Plan of Operation |
22
|
Plan of Operation |
23
|
Item 7. Financial Statements |
25
|
Forward-Looking Statements |
25
|
Item 8. Changes in and Disagreements
with Accountants on Accounting and Financial
Disclosures.
|
25
|
Item 8A. Controls and Procedures |
25
|
Item 8B. Other Information |
25
|
Part III |
|
Item 9. Directors, Executive
Officers, Promoters and Control Persons; Compliance with Section16(a)
of
the Exchange Act |
26
|
Item 10. Executive Compensation |
26
|
Item 11. Security Ownerhsip of Certain Beneficial
Owners and Management and Related
Transactions
|
26
|
Item 12. Certain Relationships and Related
Transactions
|
27
|
Item 13. Exhibits |
27
|
Item 14. Principal Accountant Fees and
Services |
27
|
Signatures |
28
|
PART
I
Item
1. Description of Business.
History
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, which we refer
to
as "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,
holders of 6,680,000 shares of common stock of Provectus Pharmaceutical
exchanged their shares 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.
For accounting purposes, we treat this transaction as a recapitalization of
PPI.
On
November 19, 2002, we acquired Valley Pharmaceuticals, Inc., a privately-held
Tennessee corporation formerly known as Photogen, Inc., by merging our
subsidiary PPI with and into Valley and naming the surviving corporation
"Xantech Pharmaceuticals, Inc." Valley had minimal operations and had no
revenues prior to the transaction with the Company. By acquiring Valley, we
acquired our most important intellectual property, including issued U.S. patents
and patentable inventions, with which we intend to develop:
o
prescription drugs, medical and other devices (including laser devices)
and over-the-counter pharmaceutical products in the fields of
dermatology and oncology; and
o
technologies for the preparation of human and animal vaccines, diagnosis
of infectious diseases and enhanced production of
genetically engineered drugs.
Prior
to
the acquisition of Valley, we were considered to be, and continue to be, in
the
development stage and had not generated any revenues from the assets we
acquired.
On
December 5, 2002, we acquired the assets of Pure-ific L.L.C., a Utah limited
liability company, and created a wholly owned subsidiary, Pure-ific Corporation,
to operate that business. We acquired the product formulations for Pure-ific
personal sanitizing sprays, along with the "Pure-ific" trademarks. We intend
to
continue product development and begin to market a line of personal sanitizing
sprays and related products to be sold over the counter under the "Pure-ific"
brand name.
Description
Of Business
Overview
Provectus,
and its five wholly owned subsidiaries:
o
Xantech
Pharmaceuticals, Inc.
o
Pure-ific
Corporation
o
Provectus
Biotech, Inc.
o
Provectus
Devicetech, Inc.
o
Provectus
Pharmatech, Inc.
(which
we
refer to as our subsidiaries) develop, license and market and plan to sell
products in three sectors of the healthcare industry:
o
Over-the-counter products, which we refer to in this report as
"OTC products;"
o
Prescription drugs; and
o
Medical
device systems
We
manage
Provectus and our subsidiaries on an integrated basis and when we refer to
"we"
or "us" or "the Company" in this Annual Report on Form 10-KSB, we refer to
all
six corporations considered as a single unit. Our principal executive offices
are located at 7327 Oak Ridge Highway, Suite A, Knoxville, Tennessee 37931,
telephone 865/769-4011.
Through
discovery and use of state-of-the-art scientific and medical technologies,
the
founders of our pharmaceutical business have developed a portfolio of patented,
patentable, and proprietary technologies that support multiple products in
the
prescription drug, medical device and OTC products categories (including
patented technologies for: (a) treatment of cancer; (b) novel therapeutic
medical devices; (c) enhancing contrast in medical imaging; (d) improving
signal
processing during biomedical imaging; and (e) enhancing production of
biotechnology products). Our prescription drug products encompass the areas
of
dermatology and oncology and involve several types of small molecule-based
drugs. Our medical device systems include therapeutic and cosmetic lasers,
while
our OTC products address markets primarily involving skincare applications.
Because our prescription drug candidates and medical device systems are in
the
early stages of development, they are not yet on the market and there is
no
assurance that they will advance to the point of commercialization.
Our
first
commercially available products are directed into the OTC market, as these
products pose minimal or no regulatory compliance barriers to market
introduction. For example, the active pharmaceutical ingredient (API) in
our
ethical products is already approved for other medical uses by the FDA and
has a
long history of safety for use in humans. This use of known APIs for novel
uses
and in novel formulations minimizes potential adverse concerns from the FDA,
since considerable safety data on the API is available (either in the public
domain or via license or other agreements with third parties holding such
information). In similar fashion, our OTC products are based on established
APIs
and, when possible, utilize formulations (such as aerosol or cream formulations)
that have an established precedent. (For more information on compliance issues,
see "Federal Regulation of Therapeutic Products” below.) In this fashion, we
believe that we can diminish the risk of regulatory bars to the introduction
of
safe, consumer-friendly products and minimize the time required to begin
generating revenues from product sales. At the same time, we continue to
develop
higher-margin prescription pharmaceuticals and medical devices, which have
longer development and regulatory approval cycles.
Over-the-Counter
Pharmaceuticals
Our
OTC
products are designed to be safer and more specific than competing products.
Our
technologies offer practical solutions for a number of intractable maladies,
using ingredients that have limited or no side effects compared with existing
products. To develop our OTC products, we typically use compounds with potent
antibacterial and antifungal activity as building blocks and combine these
building blocks with anti-inflammatory and moisture-absorbing agents. Products
with these properties can be used for treatment of a large number of skin
afflictions, including:
o
hand
irritation associated with use of disposable gloves
o
eczema
o
mild to
moderate acne
Where
appropriate, we have filed or will file patent applications and will seek other
intellectual property protection to protect our unique formulations for relevant
applications.
GloveAid
Personnel
in many occupations and industries now use disposable gloves daily in the
performance of their jobs, including:
o
Airport
security personnel;
o
Food
handling and preparation personnel;
o
Sanitation
workers;
o
Postal and
package delivery handlers and sorters;
o
Laboratory
researchers;
o
Health care
workers such as hospital and blood bank personnel; and
o
Police,
fire and emergency response personnel.
Accompanying
the increased use of disposable gloves is a mounting incidence of chronic skin
irritation. To address this market, we have developed GloveAid, a hand cream
with both antiperspirant and antibacterial properties, to increase the comfort
of users' hands during and after the wearing of disposable gloves. During 2003,
we ran a pilot scale run at the manufacturer of GloveAid. We now intend to
license this product to a third party with experience in the institutional
sales
market.
Pure-ific
Our
Pure-ific line of products includes two quick-drying sprays, Pure-ific and
Pure-ific Kids, that immediately kill up to 99.9% of germs on skin and prevent
regrowth for 6 hours. We have determined the effectiveness of Pure-ific based
on
our internal testing and testing performed by Paratus Laboratories H.B., an
independent research lab. Pure-ific products help prevent the spread of germs
and thus complement our other OTC products designed to treat irritated skin
or
skin conditions such as acne, eczema, dandruff and fungal infections. Our
Pure-ific sprays have been designed with convenience in mind and are targeted
towards mothers, travelers, and anyone concerned about the spread of
sickness-causing germs. During 2003 and 2004, we identified and engaged sales
and brokerage forces for Pure-ific. We emphasized getting sales in independent
pharmacies and mass (chain store) markets. The supply chain for Pure-ific was
established with the ability to support large-scale sales and a starting
inventory was manufactured and stored in a contract warehouse/fulfillment
center. In addition, a website for Pure-ific was developed with the ability
for
supporting online sales of the antibacterial hand spray. During 2005, most
of
our sales were generated from customers accessing our website for Pure-ific
and
making purchases online. We now intend to license the Pure-ific product and
sell the underlying assets.
Acne
A
number
of dermatological conditions, including acne and other blemishes result from
a
superficial infection which triggers an overwhelming immune response. We
anticipate developing OTC products similar to the GloveAid line for the
treatment of mild to moderate cases of acne and other blemishes. Wherever
possible, we intend to formulate these products to minimize or avoid significant
regulatory bars that might adversely impact time to market.
Prescription
Drugs
We
are
developing a number of prescription drugs which we expect will provide minimally
invasive treatment of chronic severe skin afflictions such as psoriasis, eczema,
and acne; and several life-threatening cancers such as those of the liver,
breast and prostate. We believe that our products will be safer and more
specific than currently existing products. Use of topical or other direct
delivery formulations allows these potent products to be conveniently and
effectively delivered only to diseased tissues, thereby enhancing both safety
and effectiveness. The ease of use and superior performance of these products
may eventually lead to extension into OTC applications currently serviced by
less safe, more expensive alternatives. All of these products are in the
pre-clinical or clinical trial stage.
Dermatology
Our
most
advanced prescription drug candidate for treatment of topical diseases on the
skin is Xantryl, a topical gel. PV-10, the active ingredient in Xantryl, is
"photoactive": it reacts to light of certain wavelengths, increasing its
therapeutic effects. PV-10 also concentrates in diseased or damaged tissue
but
quickly dissipates from healthy tissue. By developing a “photodynamic" treatment
regimen (one which combines a photoactive substance with activation by a source
emitting a particular wavelength of light) around these two properties of PV-10,
we can deliver a higher therapeutic effect at lower dosages of active
ingredient, thus minimizing potential side effects including damage to nearby
healthy tissues. PV-10 is especially responsive to green light, which is
strongly absorbed by the skin and thus only penetrates the body to a depth
of
about three to five millimeters. For this reason, we have developed Xantryl
combined with green-light activation for topical use in surface applications
where serious damage could result if medicinal effects were to occur in deeper
tissues.
Acute
psoriasis. Psoriasis is a common chronic disorder of the skin characterized
by
dry scaling patches, called "plaques," for which current treatments are few
and
those that are available have potentially serious side effects. According to
Roenigk and Maibach (Psoriasis, Third Edition, 1998), there are approximately
five million people in the United States who suffer from psoriasis, with an
estimated 160,000 to 250,000 new psoriasis cases each year. There is no known
cure for the disease at this time. According to the National Psoriasis
Foundation, the majority of psoriasis sufferers, those with mild to moderate
cases, are treated with topical steroids that can have unpleasant side effects;
none of the other treatments for moderate cases of psoriasis have proven
completely effective. The 25-30% of psoriasis patients who suffer from more
severe cases generally are treated with more intensive drug therapies or PUVA,
a
light-based therapy that combines the drug Psoralen with exposure to ultraviolet
A light. While PUVA is one of the more effective treatments, it increases a
patient's risk of skin cancer.
We
believe that Xantryl activated with green light offers a superior treatment
for
acute psoriasis because it selectively treats diseased tissue with negligible
potential for side effects in healthy tissue; moreover, the therapy has shown
promise in comprehensive Phase 1 clinical trials. The objective of a Phase
1
clinical trial is to determine if there are safety concerns with the therapy.
In
these studies, involving more than 50 test subjects, Xantryl was applied
topically to psoriatic plaques and then illuminated with green light. In our
first study, a single-dose treatment yielded an average reduction in plaque
thickness of 59% after 30 days, with further response noted at the final
follow-up examination 90 days later. Further, no pain, significant side effects,
or evidence of “rebound” (increased severity of a psoriatic plaque after the
initial reduction in thickness) were observed in any treated areas. This degree
of positive therapeutic response is comparable to that achieved with potent
steroids and other anti-inflammatory agents, but without the serious side
effects associated with such agents. We are continuing the required Food and
Drug Administration reporting to support the active Investigational New Drug
application for Xantryl’s Phase 2 clinical trials on psoriasis. The required
reporting includes the publication of results regarding the multiple treatment
scenario of the active ingredient in Xantryl. We expect to conduct Phase 2
studies in the near future, in which we expect to assess the potential for
remission of the disease using a regimen of weekly treatments similar to those
used for PUVA.
Actinic
Keratosis. According to Schwartz and Stoll (Fitzpatrick's Dermatology in General
Medicine, 1999), actinic keratosis, or "AK" (also called solar keratosis or
senile keratosis), is the most common pre-cancerous skin lesion among
fair-skinned people and is estimated to occur in over 50% of elderly
fair-skinned persons living in sunny climates. These experts note that nearly
half of the approximately five million cases of skin cancer in the U.S. may
have
begun as AK. The standard treatments for AK (primarily comprising excision,
cryotherapy, and ablation with topical 5-fluorouracil) are often painful and
frequently yield unacceptable cosmetic outcomes due to scarring. Building on
our
experience with psoriasis, we are assessing the use of Xantryl with green-light
activation as a possible improvement in treatment of early and more advanced
stages of AK. We completed an initial Phase 1 clinical trial of the therapy
for
this indication in 2001 with the predecessor company that was acquired in 2002.
This study, involving 24 subjects, examined the safety profile of a single
treatment using topical Xantryl with green light photoactivation; no significant
safety concerns were identified. We have decided to prioritize further clinical
development of Xantryl for treatment of psoriasis and eczema rather than AK
at
this time since the market is much larger for psoriasis and
eczema.
Severe
Acne. According to Berson et al. (Cutis. 72 (2003) 5-13), acne vulgaris affects
approximately 17 million individuals in the U.S., causing pain, disfigurement,
and social isolation. Moderate to severe forms of the disease have proven
responsive to several photodynamic regimens, and we anticipate that Xantryl
can
be used as an advanced treatment for this disease. Pre-clinical studies show
that the active ingredient in Xantryl readily kills bacteria associated with
acne. This finding, coupled with our clinical experience in psoriasis and
actinic keratosis, suggests that therapy with Xantryl will exhibit no
significant side effects and will afford improved performance relative to other
therapeutic alternatives. If correct, this would be a major advance over
currently available products for severe acne.
As
noted
above, we are researching multiple uses for Xantryl with green-light activation.
Multiple-indication use by a common pool of physicians - dermatologists, in
this
case - should reduce market resistance to this new therapy.
Oncology
Oncology
is another major market where our planned products may afford competitive
advantage compared to currently available options. We are developing Provecta,
a
sterile injectible form of PV-10, for direct injection into tumors. Because
PV-10 is retained in diseased or damaged tissue but quickly dissipates from
healthy tissue, we believe we can develop therapies that confine treatment
to
cancerous tissue and reduce collateral impact on healthy tissue. During 2003
and
2004, we worked toward completion of the extensive scientific and medical
materials necessary for filing an Investigational New Drug (IND) application
for
Provecta in anticipation of beginning Phase 1 clinical trials for breast and
liver cancer. This IND was filed and cleared by the FDA in 2004 setting the
stage for two Phase 1 clinical trials; namely, treating metastatic melanoma
and
recurrent breast carcinoma. We started both of these Phase 1 clinical
trials in 2005.
Liver
Cancer. The current standard of care for liver cancer is ablative therapy (which
seeks to reduce a tumor by poisoning, freezing, heating, or irradiating it)
using either a localized injection of ethanol (alcohol), cryosurgery,
radiofrequency ablation, or ionizing radiation such as X-rays. Where effective,
these therapies have many side effects; selecting therapies with fewer side
effects tends to reduce overall effectiveness. Combined, ablative therapies
have
a five-year survival rate of 33% - meaning that only 33% of those liver cancer
patients whose cancers are treated using these therapies survive for five years
after their initial diagnoses. In pre-clinical studies we have found that direct
injection of Provecta into liver tumors quickly ablates treated tumors, and
can
trigger an anti-tumor immune response leading to eradication of residual tumor
tissue and distant tumors. Because of the natural regenerative properties of
the
liver and the highly localized nature of the treatment, this approach appears
to
produce no significant side effects. Based on these encouraging preclinical
results, we are assessing strategies for initiation of clinical trials of
Provecta for treatment of liver cancer.
Breast
Cancer. Breast cancer afflicts over 200,000 U.S. citizens annually, leading
to
over 40,000 deaths. Surgical resection, chemotherapy, radiation therapy, and
immunotherapy comprise the standard treatments for the majority of cases,
resulting in serious side effects that in many cases are permanent. Moreover,
current treatments are relatively ineffective against metastases, which in
many
cases are the eventual cause of patient mortality. Pre-clinical studies using
human breast tumors implanted in mice have shown that direct injection of
Provecta into these tumors ablates the tumors, and, as in the case of liver
tumors, may elicit an anti-tumor immune response that eradicates distant
metastases. Since fine-needle biopsy is a routine procedure for diagnosis of
breast cancer, and since the needle used to conduct the biopsy also could be
used to direct an injection of Provecta into the tumor, localized destruction
of
suspected tumors through direct injection of Provecta clearly has the potential
of becoming a primary treatment. We are evaluating options for expanding
clinical studies of direct injection of Provecta into breast tumors while
conducting Phase 1 clinical studies of our indication for Provecta in recurrent
breast carcinoma.
Prostate
Cancer. Cancer of the prostate afflicts approximately 190,000 U.S. men annually,
leading to over 30,000 deaths. As with breast cancer, surgical resection,
chemotherapy, radiation therapy, and immunotherapy comprise the standard
treatments for the majority of cases, and can result in serious, permanent
side
effects. We believe that direct injection of Provecta into prostate tumors
may
selectively ablate such tumors, and, as in the case of liver and breast tumors,
may also elicit an anti-tumor immune response capable of eradicating distant
metastases. Since trans-urethral ultrasound, guided fine-needle biopsy and
immunotherapy, along with brachytherapy implantation, are becoming routine
procedures for diagnosis and treatment of these cancers, we believe that
localized destruction of suspected tumors through direct injection of Provecta
can become a primary treatment. We are evaluating options for initiating
clinical studies of direct injection of Provecta into prostate tumors, and
expect to formulate final plans based on results from clinical studies of our
indications for Provecta in the treatment of liver and breast
cancer.
Metastatic
Melanoma. Melanoma is expected to strike 62,000 people
in the U.S. this year, leading to 7,600 deaths. The incidence of melanoma in
Australia, where our Phase 1 clinical study is currently underway, is 4X that
of
the U.S. There have been no significant advances in the treatment of melanoma
for approximately 30 years. We are evaluating options for expanding clinical
studies of direct injection of Provecta into melanoma lesions while conducting
Phase 1 clinical studies of our indication for Provecta in Stage 3 metastatic
melanoma.
Medical
Devices
We
are
developing medical devices to address two major markets:
o
cosmetic treatments, such as reduction of wrinkles and elimination of
spider
veins and other cosmetic blemishes; and
o
therapeutic uses, including photoactivation of Xantryl other prescription
drugs and non-surgical destruction of certain skin cancers.
We
expect
to develop medical devices through partnerships with third-party device
manufacturers or, if appropriate opportunities arise, through acquisition of
one
or more device manufacturers.
Photoactivation.
Our clinical tests of Xantryl for dermatology have, up to the present, utilized
a number of commercially available lasers for activation of the drug. This
approach has several advantages, including the leveraging of an extensive base
of installed devices present throughout the pool of potential physician-adopters
for Xantryl; access to such a base could play an integral role in early market
capture. However, since the use of such lasers, which were designed for
occasional use in other types of dermatological treatment, is potentially too
cumbersome and costly for routine treatment of the large population of patients
with psoriasis, we have begun investigating potential use of other types of
photoactivation hardware, such as light booths. The use of such booths is
consistent with current care standards in the dermatology field, and may provide
a cost-effective means for addressing the needs of patients and physicians
alike. We anticipate that such photoactivation hardware would be developed,
manufactured, and supported in conjunction with one or more third-party device
manufacturer.
Melanoma.
A high priority in our medical devices field is the development of a laser-based
product for treatment of melanoma. We have conducted extensive research on
ocular melanoma at the Massachusetts Eye and Ear Infirmary (a teaching affiliate
of Harvard Medical School) using a new laser treatment that may offer
significant advantage over current treatment options. A single quick
non-invasive treatment of ocular melanoma tumors in a rabbit model resulted
in
elimination of over 90% of tumors, and may afford significant advantage over
invasive alternatives, such as surgical excision, enucleation, or radiotherapy
implantation. Ocular melanoma is rare, with approximately 2,000 new cases
annually in the U.S. However, we believed that our extremely successful results
could be extrapolated to treatment of primary melanomas of the skin, which
have
an incidence of over 52,000 new cases annually in the U.S. and a 13% five-year
survival rate after metastasis of the tumor. We have performed similar laser
treatments on large (averaging approximately 3 millimeters thick) cutaneous
melanoma tumors implanted in mice, and have been able to eradicate over 90%
of
these pigmented skin tumors with a single treatment. Moreover, we have shown
that this treatment stimulates an anti-tumor immune response that may lead
to
improved outcome at both the treatment site and at sites of distant metastasis.
From these results, we believe that a device for laser treatment of primary
melanomas of the skin and eye is nearly ready for human studies. We anticipate
partnering with a medical device manufacturer to bring it to market in reliance
on a 510(k) notification. For more information about the 510(k) notification
process, see "Federal Regulation of Therapeutic Products"
below.
Research
and Development
We
continue to actively develop projects that are product directed and are
attempting to conserve available capital and achieve full capitalization of
our
company through equity and convertible debt offerings, generation of product
revenues, and other means. All ongoing research and development activities
are
directed toward maximizing shareholder value and advancing our corporate
objectives in conjunction with our OTC product licensure, our current product
development and maintaining our intellectual property portfolio.
Production
We
have determined that the most efficient use of our capital in further developing
our OTC products is to license the products and sell the underlying assets
for
upfront consideration.
Sales
Our
first
commercially available products are directed into the OTC market, as these
products pose minimal or no regulatory compliance barriers to market
introduction. In this fashion, we believe that we can diminish the risk of
regulatory bars to the introduction of products and minimize the time required
to begin generating revenues from product sales. At the same time, we continue
to develop higher-margin prescription pharmaceuticals and medical devices,
which
have longer development and regulatory approval cycles.
We
have commenced limited sales of Pure-ific, our antibacterial hand spray. We
sold
small amounts of this product during 2004 and 2005. We will continue to seek
additional markets for our products through existing distributorships that
market and distribute medical products, ethical pharmaceuticals, and OTC
products for the professional and consumer marketplaces through licensure and
partnership arrangements, and through potential merger and acquisition
candidates.
In
addition to developing and selling products ourselves on a limited basis, we
are
negotiating actively with a number of potential licensees for several of our
intellectual properties, including patents and related technologies. To date,
we
have not yet entered into any licensing agreements; however, we anticipate
consummating one or more such licenses in the future.
Intellectual
Property
Patents
We
hold a
number of U.S. patents covering the technologies we have developed and are
continuing to develop for the production of prescription drugs, medical devices
and OTC pharmaceuticals, including those identified in the following
table:
U.S. Patent No. |
Title |
Issue Date |
Expiration Date |
5,829,448
|
Method
for improved selectivity in
photo-activation
of molecular agents
|
November
3, 1998 |
October
30, 2016 |
5,832,931
|
Method
for improved selectivity in photo-activation and detection of
molecular
diagnostic agents
|
November
10, 1998 |
October
30, 2016 |
5,998,597
|
Method
for improved selectivity in photo-activation of molecular agents |
December
7, 1999 |
October
30, 2016 |
6,042,603
|
Method
for improved selectivity in
photo-activation
of molecular agents
|
March
28, 2000 |
October
30, 2016 |
6,331,286
|
Methods
for high energy phototherapeutics |
December
18, 2001 |
December
21, 2018 |
6,451,597
|
Method
for enhanced protein stabilization and for production of cell lines
useful
for production of such stabilized proteins |
September
17, 2002 |
April
6, 2020 |
6,468,777
|
Method
for enhanced protein stabilization and for production of cell lines
useful
for production of such stabilized proteins |
October
22, 2002 |
April
6, 2020 |
6,493,570
|
Method
for improved imaging and photodynamic therapy |
December
10, 2002 |
December
10, 2019 |
6,495,360
|
Method
for enhanced protein stabilization
and
for production of cell lines useful
for
production of such stabilized proteins
|
December
17, 2002 |
April
6, 2020 |
6,519,076
|
Methods
and apparatus for optical imaging |
February
11, 2003 |
October
30, 2016 |
6,525,862
|
Methods
and apparatus for optical imaging |
February
25, 2003 |
October
30, 2016 |
6,541,223
|
Method
for enhanced protein stabilization and for production of cell lines
useful
for production of such stabilized proteins |
April
1, 2003 |
April
6, 2020 |
6,986,740
|
Ultrasound
contrast using halogenated xanthenes |
January
17, 2006 |
TBD |
6,991,771
|
Improved
intracorporeal medicaments for High energy phototherapeutic treatment
of
disease |
January
31, 2006 |
TBD |
We
continue to pursue patent applications on numerous other developments we
believe
to be patentable. We consider our issued patents, our pending patent
applications and any patentable inventions which we may develop to be extremely
valuable assets of our business.
Trademarks
We
own
the following trademarks used in this document: Xantryl(TM), Provecta(TM),
GloveAid(TM), and Pure-ific(TM) (including Pure-ific(TM) and Pure-ific(TM)
Kids). We also own the registered trademark PulseView(R). Trademark rights
are
perpetual provided that we continue to keep the mark in use. We consider
these
marks, and the associated name recognition, to be valuable to our
business.
Material
Transfer Agreement
We
have
entered into a Material Transfer Agreement dated as of July 31, 2003 with
Schering-Plough Animal Health Corporation, which we refer to as "SPAH", the
animal-health subsidiary of Schering-Plough Corporation, a major international
pharmaceutical company. This Material Transfer Agreement is still in effect
through 2005. We refer to this agreement in this report as the "Material
Transfer Agreement." Under the Material Transfer Agreement, we will provide
SPAH
with access to some of our patented technologies to permit SPAH to evaluate
those technologies for use in animal-health applications. If SPAH determines
that it can commercialize our technologies, then the Material Transfer Agreement
obligates us and SPAH to enter into a license agreement providing for us
to
license those technologies to SPAH in exchange for progress payments upon
the
achievement of goals. The Material Transfer Agreement covers four U.S. patents
that cover biological material manufacturing technologies (i.e., biotech
related). The Material Transfer Agreement continues indefinitely, unless
SPAH
terminates it by giving us notice or determines that it does not wish to
secure
from us a license for our technologies. The Material Transfer Agreement can
also
be terminated by either of us in the event the other party breaches the
agreement and does not cure the breach within 30 days of notice from the
other
party. We can give you no assurance that SPAH will determine that it can
commercialize our technologies or that the goals required for us to obtain
progress payments from SPAH will be achieved.
Competition
In
general, the pharmaceutical industry is intensely competitive, characterized
by
rapid advances in products and technology. A number of companies have developed
and continue to develop products that address the areas we have targeted. Some
of these companies are major pharmaceutical companies that are international
in
scope and very large in size, while others are niche players that may be less
familiar but have been successful in one or more areas we are targeting.
Existing or future pharmaceutical, device, or other competitors may develop
products that accomplish similar functions to our technologies in ways that
are
less expensive, receive faster regulatory approval, or receive greater market
acceptance than our products. Many of our competitors have been in existence
for
considerably longer than we have, have greater capital resources, broader
internal structure for research, development, manufacturing and marketing,
and
are in many ways further along in their respective product cycles.
At
present, our most direct competitors are smaller companies that are exploiting
niches similar to ours. In the field of photodynamic therapy, one competitor,
QLT, Inc., has received FDA approval for use of its agent Photofrin(R) for
treatment of several niche cancer indications, and has a second product,
Visudyne(R), approved for treatment of certain forms of macular degeneration.
Another competitor in this field, Dusa Pharmaceuticals, Inc. recently received
FDA approval of its photodynamic product Levulan(R) Kerastik(R) for treatment
of
actinic keratosis. We believe that QLT and Dusa, among other competitors, have
established a working commercial model in dermatology and oncology, and that
we
can benefit from this model by offering products that, when compared to our
competitors' products, afford superior safety and performance, greatly reduced
side effects, improved ease of use, and lower cost, compared to those of our
competitors.
While
it
is possible that eventually we may compete directly with major pharmaceutical
companies, we believe it is more likely that we will enter into joint
development, marketing, or other licensure arrangements with such
competitors.
We
also
have a number of market areas in common with traditional skincare cosmetics
companies, but in contrast to these companies, our products are based on unique,
proprietary formulations and approaches. For example, we are unaware of any
products in our targeted OTC skincare markets that our similar to our GloveAid
and Pure-ific products. Further, proprietary protection of our products may
help
limit or prevent market erosion until our patents expire.
Federal
Regulation of Therapeutic Products
All
of
the prescription drugs and medical devices we currently contemplate developing
will require approval by the FDA prior to sales within the United States and
by
comparable foreign agencies prior to sales outside the United States. The FDA
and comparable regulatory agencies impose substantial requirements on the
manufacturing and marketing of pharmaceutical products and medical devices.
These agencies and other entities extensively regulate, among other things,
research and development activities and the testing, manufacturing, quality
control, safety, effectiveness, labeling, storage, record keeping, approval,
advertising and promotion of our proposed products. While we attempt to minimize
and avoid significant regulatory bars when formulating our products, some degree
of regulation from these regulatory agencies is unavoidable. Some of the things
we do to attempt to minimize and avoid significant regulatory bars include
the
following:
o
Using
chemicals and combinations already allowed by the FDA;
o
Carefully
making product performance claims to avoid the need for regulatory
approval;
o
Using drugs
that have been previously approved by the FDA and that have
a long history of safe use;
o
Using
chemical compounds with known safety profiles; and
o
In many
cases, developing OTC products which face less regulation than prescription
pharmaceutical products.
The
regulatory process required by the FDA, through which our drug or device
products must pass successfully before they may be marketed in the U.S.,
generally involves the following:
o
Preclinical
laboratory and animal testing;
o
Submission
of an application that must become effective before clinical
trials may begin;
o
Adequate
and well-controlled human clinical trials to establish the safety
and efficacy of the product for its intended indication; and
o
FDA
approval of the application to market a given product for a given indication.
For
pharmaceutical products, preclinical tests include laboratory evaluation of
the
product, its chemistry, formulation and stability, as well as animal studies
to
assess the potential safety and efficacy of the product. Where appropriate
(for
example, for human disease indications for which there exist inadequate animal
models), we will attempt to obtain preliminary data concerning safety and
efficacy of proposed products using carefully designed human pilot studies.
We
will require sponsored work to be conducted in compliance with pertinent local
and international regulatory requirements, including those providing for
Institutional Review Board approval, national governing agency approval and
patient informed consent, using protocols consistent with ethical principles
stated in the Declaration of Helsinki and other internationally recognized
standards. We expect any pilot studies to be conducted outside the United
States; but if any are conducted in the United States, they will comply with
applicable FDA regulations. Data obtained through pilot studies will allow
us to
make more informed decisions concerning possible expansion into traditional
FDA-regulated clinical trials.
If
the
FDA is satisfied with the results and data from preclinical tests, it will
authorize human clinical trials. Human clinical trials typically are conducted
in three sequential phases which may overlap. Each of the three phases involves
testing and study of specific aspects of the effects of the pharmaceutical
on
human subjects, including testing for safety, dosage tolerance, side effects,
absorption, metabolism, distribution, excretion and clinical
efficacy.
Phase
1
clinical trials include the initial introduction of an investigational new
drug
into humans. These studies are closely monitored and may be conducted in
patients, but are usually conducted in healthy volunteer subjects. These studies
are designed to determine the metabolic and pharmacologic actions of the drug
in
humans, the side effects associated with increasing doses, and, if possible,
to
gain early evidence on effectiveness. While the FDA can cause us to end clinical
trials at any phase due to safety concerns, Phase 1 clinical trials are
primarily concerned with safety issues. We also attempt to obtain sufficient
information about the drug’s pharmacokinetics and pharmacological effects during
Phase 1 clinical trial to permit the design of well-controlled, scientifically
valid, Phase 2 studies.
Phase
1
studies also evaluate drug metabolism, structure-activity relationships, and
the
mechanism of action in humans. These studies also determine which
investigational drugs are used as research tools to explore biological phenomena
or disease processes. The total number of subjects included in Phase 1 studies
varies with the drug, but is generally in the range of twenty to
eighty.
Phase
2
clinical trials include the early controlled clinical studies conducted to
obtain some preliminary data on the effectiveness of the drug for a particular
indication or indications in patients with the disease or condition. This phase
of testing also helps determine the common short-term side effects and risks
associated with the drug. Phase 2 studies are typically well-controlled, closely
monitored, and conducted in a relatively small number of patients, usually
involving several hundred people.
Phase
3
studies are expanded controlled and uncontrolled trials. They are performed
after preliminary evidence suggesting effectiveness of the drug has been
obtained in Phase 2, and are intended to gather the additional information
about
effectiveness and safety that is needed to evaluate the overall benefit-risk
relationship of the drug. Phase 3 studies also provide an adequate basis for
extrapolating the results to the general population and transmitting that
information in the physician labeling. Phase 3 studies usually include several
hundred to several thousand people.
Applicable
medical devices can be cleared for commercial distribution through a
notification to the FDA under Section 510(k) of the applicable statute. The
510(k) notification must demonstrate to the FDA that the device is as safe
and
effective and substantially equivalent to a legally marketed or classified
device that is currently in interstate commerce. Such devices may not require
detailed testing. Certain high-risk devices that sustain human life, are of
substantial importance in preventing impairment of human health, or that present
a potential unreasonable risk of illness or injury, are subject to a more
comprehensive FDA approval process initiated by filing a premarket approval,
also known as a "PMA," application (for devices) or accelerated approval (for
drugs).
We
have
established a core clinical development team and have been working with outside
FDA consultants to assist us in developing product-specific development and
approval strategies, preparing the required submittals, guiding us through
the
regulatory process, and providing input to the design and site selection of
human clinical studies. Historically, obtaining FDA approval for photodynamic
therapies has been a challenge. Wherever possible, we intend to utilize lasers
or other activating systems that have been previously approved by the FDA to
mitigate the risk that our therapies will not be approved by the FDA. The FDA
has considerable experience with lasers by virtue of having reviewed and acted
upon many 510(k) and premarket approval filings submitted to it for various
photodynamic and non-photodynamic therapy laser applications, including a large
number of cosmetic laser treatment systems used by dermatologists.
The
testing and approval process requires substantial time, effort, and financial
resources, and we may not obtain FDA approval on a timely basis, if at all.
Success in preclinical or early-stage clinical trials does not assure success
in
later stage clinical trials. The FDA or the research institution sponsoring
the
trials may suspend clinical trials or may not permit trials to advance from
one
phase to another at any time on various grounds, including a finding that the
subjects or patients are being exposed to an unacceptable health risk. Once
issued, the FDA may withdraw a product approval if we do not comply with
pertinent regulatory requirements and standards or if problems occur after
the
product reaches the market. If the FDA grants approval of a product, the
approval may impose limitations, including limits on the indicated uses for
which we may market a product. In addition, the FDA may require additional
testing and surveillance programs to monitor the safety and/or effectiveness
of
approved products that have been commercialized, and the agency has the power
to
prevent or limit further marketing of a product based on the results of these
post-marketing programs. Further, later discovery of previously unknown problems
with a product may result in restrictions on the product, including its
withdrawal from the market.
Marketing
our products abroad will require similar regulatory approvals by equivalent
national authorities and is subject to similar risks. To expedite development,
we may pursue some or all of our initial clinical testing and approval
activities outside the United States, and in particular in those nations where
our products may have substantial medical and commercial relevance. In some
such
cases any resulting products may be brought to the U.S. after substantial
offshore experience is gained. Accordingly, we intend to pursue any such
development in a manner consistent with U.S. standards so that the resultant
development data is maximally applicable for potential FDA
approval.
OTC
products are subject to regulation by the FDA and similar regulatory agencies
but the regulations relating to these products are much less stringent than
those relating to prescription drugs and medical devices. The types of OTC
products developed and sold by us only require that we follow cosmetic rules
relating to labeling and the claims that we make about our product. The process
for obtaining approval of prescription drugs with the FDA does not apply to
the
OTC products which we sell. The FDA can, however, require us to stop selling
our
product if we fail to comply with the rules applicable to our OTC products.
Personnel
Executive
Officers
As
of
March 29, 2006, our executive officers are:
H.
Craig
Dees, Ph.D., 54, Chief Executive Officer. Dr. Dees has served as our Chief
Executive Officer and as a member of our Board of Directors since we acquired
PPI on April 23, 2002. Before joining us, from 1997 to 2002 he served as senior
member of the management team of Photogen Technologies, Inc., including serving
as a member of the Board of Directors of Photogen from 1997 to 2000. Prior
to
joining Photogen, Dr. Dees served as a Group Leader at the Oak Ridge National
Laboratory (ORNL), and as a senior member of the management teams of LipoGen
Inc., a medical diagnostic company which used genetic engineering technologies
to manufacture and distribute diagnostic assay kits for auto-immune diseases,
and TechAmerica Group Inc., now a part of Boehringer Ingelheim Vetmedica, Inc.,
the U.S. animal health subsidiary of Boehringer Ingelhem GmbH, an international
chemical and pharmaceutical company headquartered in Germany. He has developed
numerous products in a broad range of areas, including ethical vaccines, human
diagnostics, cosmetics and OTC pharmaceuticals, and has set several regulatory
precedents in licensing and developing biotechnology-derived products. For
example, Dr. Dees developed and commercialized the world's first live viral
vaccine produced by recombinant DNA technologies and licensed the first
recombinant antigen human diagnostic assay using a FDA Class II licensure.
While
at TechAmerica he developed and obtained USDA approval for the first in vitro
assay for releasing “killed" viral vaccines. Dr. Dees also has licensed
successfully a number of proprietary cosmetic products and formulated strategic
planning for developing cosmetic companies. He earned a Ph.D. in Molecular
Virology from the University of Wisconsin - Madison in 1984.
Timothy
C. Scott, Ph.D., 48, President. Dr. Scott has served as our President and as
a
member of our Board of Directors since we acquired PPI on April 23, 2002. Prior
to joining us, Dr. Scott was as a senior member of the Photogen management
team
from 1997 to 2002, including serving as Photogen’s Chief Operating Officer from
1999 to 2002, as a director of Photogen from 1997 to 2000, and as interim CEO
for a period in 2000. Before joining Photogen, he served as senior management
of
Genase LLC, a developer of enzymes for fabric treatment, and held senior
research and management positions at ORNL. Dr. Scott has been involved in
developing numerous high-tech innovations in a broad range of areas, including
separations science, biotechnology, biomedical, and advanced materials. He
has
licensed several of his innovations to the oil and gas and biotechnology
industries. As Director of the Bioprocessing R&D Center at ORNL, Dr. Scott
achieved a national presence in the area of use of advanced biotechnology for
the production of energy, fuels, and chemicals. He earned a Ph.D. in Chemical
Engineering from the University of Wisconsin - Madison in 1985.
Eric
A.
Wachter, Ph.D., 43, Vice President - Pharmaceuticals. Dr. Wachter has served
as
our Vice President - Pharmaceuticals and as a member of our Board of Directors
since we acquired PPI on April 23, 2002. Prior to joining us, from 1997 to
2002
he was a senior member of the management team of Photogen, including serving
as
Secretary and a director of Photogen since 1997 and as Vice President and
Secretary and a director of Photogen since 1999. Prior to joining Photogen,
Dr.
Wachter served as a senior research staff member with ORNL. Starting during
his
affiliation with Photogen, Dr. Wachter has been extensively involved in
pre-clinical development and clinical testing of pharmaceuticals and medical
device systems, as well as with coordination and filing of patents. He earned
a
Ph.D. in Chemistry from the University of Wisconsin - Madison in 1988.
Peter
R.
Culpepper, CPA, MBA, 46, Chief Financial Officer. Mr. Culpepper was appointed
to
serve as our Chief Financial Officer in February 2004. Previously, Mr. Culpepper
served as Chief Financial Officer for Felix Culpepper International, Inc. from
2001 to 2004; was a Registered Representative with AXA Advisors, LLC from 2002
to 2003; has served as Chief Accounting Officer and Corporate Controller for
Neptec, Inc. from 2000 to 2001; has served in various Senior Director positions
with Metromedia Affiliated Companies from 1998 to 2000; has served in various
Senior Director and other financial positions with Paging Network, Inc. from
1993 to 1998; and has served in a variety of financial roles in public
accounting and industry from 1982 to 1993. He earned an MBA in Finance from
the
University of Maryland - College Park in 1992. He earned an undergraduate degree
from the College of William and Mary - Williamsburg, Virginia in 1982. He is
a
licensed Certified Public Accountant in both Tennessee and Maryland.
Employees
We
currently employ five persons, all of whom are full-time employees.
Available
Information
Provectus
Pharmaceuticals, Inc. is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended, which we refer to as the “Exchange
Act." To comply with those requirements, we file annual reports, quarterly
reports, periodic reports and other reports and statements with the Securities
and Exchange Commission, which we refer to as the "SEC." You may read and copy
any materials that we file with the SEC at the SEC’s Public Reference Room, at
450 Fifth Street, N.W., Washington, D.C. 20549. You can obtain information
on
the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330.
In addition, the SEC maintains an Internet site at http://www.sec.gov, from
which you can access electronic copies of materials we file with the
SEC.
Our
Internet address is http://www.pvct.com. We have made available, through a
link
to the SEC's Web site, electronic copies of the materials we file with the
SEC
(including our annual reports on Form 10-KSB, our quarterly reports on Form
10-QSB, our current reports on Form 8-K, the Section 16 reports filed by our
executive officers, directors and 10% shareholders and amendments to those
reports). To receive paper copies of our SEC materials, please contact us by
U.S. mail, telephone, facsimile or electronic mail at the following address:
Provectus
Pharmaceuticals, Inc.
Attention:
President
7327
Oak Ridge
Highway, Suite A
Knoxville,
TN
37931
Telephone:
865/769-4011
Facsimile:
865/769-4013
Electronic
mail:
info@pvct.com
Item
1A. Risk Factors.
Risk
Factors
Our
business is subject to various risks, including those described below. You
should carefully consider these risk factors, together with all of the other
information included in this Annual Report on Form 10-KSB. Any of these risks
could materially adversely affect our business, operating results and financial
condition:
Our
technologies are in early stages of development. We have generated minimal
initial revenues from sales and operations in 2005 and 2004, but we do not
expect to generate sufficient revenues to enable us to be profitable for
several
calendar quarters unless we sell and/or license our technologies. We must
raise
substantial additional funds beyond 2006 in order to fully implement our
integrated business plan, including execution of the next phases in clinical
development of our pharmaceutical products. We estimate that our existing
capital resources will be sufficient to fund our current and planned
operations.
Ultimately,
we must achieve profitable operations if we are to be a viable entity unless
we
are acquired by another Company. We intend to proceed as rapidly as possible
with the asset sale and licensure of OTC products that can be sold with a
minimum of regulatory compliance and with the development of revenue sources
through licensing of our existing intellectual property portfolio. We cannot
assure you that we will be able to raise sufficient capital to sustain
operations beyond 2006 before we can commence revenue generation or that
we will
be able to achieve, or maintain, a level of profitability sufficient to meet
our
operating expenses.
Because
of our limited operations and the fact that we are currently generating limited
revenue, we may be unable to pay our debts when they become due in
2007.
As
of December 31, 2005, we had $878,941 in convertible debt, net of a debt
discount of $1,064,895 and $65,055 of accrued interest on our balance sheet,
consisting of $1,475,000 in principal and $61,408 in accrued but unpaid interest
owed to holders of our convertible debentures due on March 30, 2007 and $468,836
in principal and $3,647 in accrued interest owed to holders of our convertible
debentures due on November 26, 2006. Because of the convertible nature of
the
debt owed to the holders of the convertible debentures, we may not have to
repay
this debt if the debt is converted into shares of our common stock. However,
we
can not assure you that this debt will be converted into common stock and
we may
have to repay this indebtedness. Our ability to satisfy our current debt
service
obligations and any additional obligations we might incur will depend upon
our
future financial and operating performance, which, in turn, is subject to
prevailing economic conditions and financial, business, competitive, legislative
and regulatory factors, many of which are beyond our control. We cannot assure
you that our operating results, cash flow and capital resources will be
sufficient for payment of our debt service and other obligations in the future.
We
will
need additional capital to conduct our operations and develop our products
beyond 2006, and our ability to obtain the necessary funding is uncertain.
We
estimate that our existing capital resources will be sufficient to fund our
current and planned operations; however, we may need additional capital.
We have
based this estimate on assumptions that may prove to be wrong, and we cannot
assure that estimates and assumptions will remain unchanged. For example,
we are
currently assuming that we will continue to operate without any significant
staff or other resources expansion. We intend to acquire additional funding
through public or private equity financings or other financing sources that
may
be available. Additional financing may not be available on acceptable terms,
or
at all. As discussed in more detail below, additional equity financing could
result in significant dilution to shareholders. Further, in the event that
additional funds are obtained through licensing or other arrangements, these
arrangements may require us to relinquish rights to some of our technologies,
product candidates or products that we would otherwise seek to develop and
commercialize ourselves. If sufficient capital is not available, we may be
required to delay, reduce the scope of or eliminate one or more of our programs,
any of which could have a material adverse effect on our business, and may
impair the value of our patents and other intangible assets.
Existing
shareholders may face dilution from our financing
efforts.
We
must
raise additional capital from external sources to execute our business plan
beyond 2006. We plan to issue debt securities, capital stock, or a combination
of these securities, if necessary depending on licensure and asset sale
discussions. We may not be able to sell these securities, particularly under
current market conditions. Even if we are successful in finding buyers for
our
securities, the buyers could demand high interest rates or require us to
agree
to onerous operating covenants, which could in turn harm our ability to operate
our business by reducing our cash flow and restricting our operating activities.
If we were to sell our capital stock, we might be forced to sell shares at
a
depressed market price, which could result in substantial dilution to our
existing shareholders. In addition, any shares of capital stock we may issue
may
have rights, privileges, and preferences superior to those of our common
shareholders.
The
prescription drug and medical device products in our internal pipeline are
at an
early stage of development, and they may fail in subsequent development or
commercialization.
We
are
continuing to pursue clinical development of our most advanced pharmaceutical
drug products, Xantryl and Provecta, for use as treatments for specific
conditions. These products and other pharmaceutical drug and medical device
products that we are currently developing will require significant additional
research, formulation and manufacture development, and pre-clinical and
extensive clinical testing prior to regulatory licensure and commercialization.
Pre-clinical and clinical studies of our pharmaceutical drug and medical
device
products under development may not demonstrate the safety and efficacy necessary
to obtain regulatory approvals. Pharmaceutical and biotechnology companies
have
suffered significant setbacks in advanced clinical trials, even after
experiencing promising results in earlier trials. Pharmaceutical drug and
medical device products that appear to be promising at early stages of
development may not reach the market or be marketed successfully for a number
of
reasons, including the following:
o
a product
may be found to be ineffective or have harmful side effects
during subsequent pre-clinical testing or clinical trials;
o
a product
may fail to receive necessary regulatory clearance;
o
a product
may be too difficult to manufacture on a large scale;
o
a product
may be too expensive to manufacture or market;
o
a product
may not achieve broad market acceptance;
o
others may
hold proprietary rights that will prevent a product from
being marketed; or
o
others may
market equivalent or superior products.
We
do not
expect any pharmaceutical drug products we are developing to be commercially
available for at least several years, if at all. Our research and product
development efforts may not be successfully completed and may not result
in any
successfully commercialized products. Further, after commercial introduction
of
a new product, discovery of problems through adverse event reporting could
result in restrictions on the product, including withdrawal from the market
and,
in certain cases, civil or criminal penalties.
Our
OTC
products are at an early stage of introduction, and we cannot be sure that
they
will be sold through a combination of asset sale and licensure in the
marketplace or that we will have adequate capital to further develop these
products, if necessary, which are an important factor in the future success
of
our business.
We
recently have focused on marketing Pure-ific, one of our OTC products, on
a
limited basis to establish proof of concept. We have recognized minimal revenue
from this product, as the sales of this product has not been material. In
order
for this product, and our other OTC products, to become commercially successful,
unless we license and/or sell the underlying assets, we must increase
significantly our distribution of them. Increasing distribution of our products
requires, in turn, that we or distributors representing us increase marketing
of
these products. In view of our limited financial resources, we may be unable
to
afford increases in our marketing of our OTC products sufficient to
improve our distribution of our products. Even if we can and do increase
our
marketing of our OTC products, we cannot give you any assurances that we
can
successfully increase our distribution of our products.
If
we do begin increasing our distribution of our OTC products, we
must increase our production of these products in order to fill our distribution
channels. Increased production will require additional financial resources
that
we do not plan to allocate at present. Additionally, we may succeed in
increasing production without succeeding in increasing sales, which could
leave
us with excess, possibly unsaleable, inventory.
If
we are unable to successfully introduce, market and distribute
these products, our business, financial condition, results of operations
and
cash flows would likely require additional capital beyond 2006 to continue
as a
going concern.
Competition
in the prescription drug, medical device and OTC
pharmaceuticals markets is intense, and we may be unable to succeed if our
competitors have more funding or better marketing.
The
pharmaceutical and biotechnology industries are intensely
competitive. Other pharmaceutical and biotechnology companies and research
organizations currently engage in or have in the past engaged in research
efforts related to treatment of dermatological conditions or cancers of the
skin, liver and breast, which could lead to the development of products or
therapies that could compete directly with the prescription drug, medical
device
and OTC products that we are seeking to develop and market.
Many
companies are also developing alternative therapies to treat
cancer and dermatological conditions and, in this regard, are our competitors.
Many of the pharmaceutical companies developing and marketing these competing
products have significantly greater financial resources and expertise than
we do
in:
o
research and
development;
o
manufacturing;
o
preclinical and clinical testing;
o
obtaining regulatory approvals; and
o
marketing.
Smaller
companies may also prove to be significant competitors,
particularly through collaborative arrangements with large and established
companies. Academic institutions, government agencies and other public and
private research organizations also may conduct research, seek patent protection
and establish collaborative arrangements for research, clinical development
and
marketing of products similar to ours. These companies and institutions compete
with us in recruiting and retaining qualified scientific and management
personnel as well as in acquiring technologies complementary to our programs.
In
addition to the above factors, we expect to face competition in
the following areas:
o
product efficacy and safety;
o
the timing and scope of regulatory consents;
o
availability of resources;
o
reimbursement coverage;
o
price; and
o
patent position, including potentially dominant patent positions of
others.
As a result of the foregoing, our competitors may develop more effective
or
more affordable products or achieve earlier product commercialization than
we
do.
Product Competition. Additionally, since our currently marketed products
are generally established and commonly sold, they are subject to competition
from products with similar qualities.
Our OTC product Pure-ific competes in the market with other hand sanitizing
products, including in particular, the following hand sanitizers:
o
Purell (owned by Pfizer),
o
Avagard D (manufactured by 3M) and
o
a large number of generic and private-label equivalents to these market
leaders.
Our
OTC product GloveAid represents a new product category that
has no direct competitors; however, other types of products, such as
AloeTouch(R) disposable gloves (manufactured by Medline Industries) target
the
same market niche.
Since
our prescription products Provecta and Xantryl have not yet
been approved by the FDA or introduced to the marketplace, we cannot estimate
what competition these products might face when they are finally introduced,
if
at all. We cannot assure you that these products will not face significant
competition for other prescription drugs and generic equivalents.
If
we are unable to secure or enforce patent rights, trademarks,
trade secrets or other intellectual property our business could be harmed.
We
may not be successful in securing or maintaining proprietary
patent protection for our products or products and technologies we develop
or
license. In addition, our competitors may develop products similar to ours
using
methods and technologies that are beyond the scope of our intellectual property
protection, which could reduce our anticipated sales. While some of our products
have proprietary patent protection, a challenge to these patents can be subject
to expensive litigation. Litigation concerning patents, other forms of
intellectual property and proprietary technology is becoming more widespread
and
can be protracted and expensive and can distract management and other personnel
from performing their duties for us.
We
also rely upon trade secrets, unpatented proprietary know-how
and continuing technological innovation in order to develop a competitive
position. We cannot assure you that others will not independently develop
substantially equivalent proprietary technology and techniques or otherwise
gain
access to our trade secrets and technology, or that we can adequately protect
our trade secrets and technology.
If
we are unable to secure or enforce patent rights, trademarks,
trade secrets or other intellectual property, our business, financial condition,
results of operations and cash flows could be materially adversely affected.
If
we infringe on the intellectual property of others, our business could be
harmed.
We
could be sued for infringing patents or other intellectual
property that purportedly cover products and/or methods of using such products
held by persons other than us. Litigation arising from an alleged infringement
could result in removal from the market, or a substantial delay in, or
prevention of, the introduction of our products, any of which could have
a
material adverse effect on our business, financial condition, or results
of
operations and cash flows.
If
we do not update and enhance our technologies, they will become
obsolete.
The
pharmaceutical market is characterized by rapid technological
change, and our future success will depend on our ability to conduct successful
research in our fields of expertise, to discover new technologies as a result
of
that research, to develop products based on our technologies, and to
commercialize those products. While we believe that are current technology
is
adequate for our present needs, if we fail to stay at the forefront of
technological development, we will be unable to compete effectively. Our
competitors are using substantial resources to develop new pharmaceutical
technologies and to commercialize products based on those technologies.
Accordingly, our technologies may be rendered obsolete by advances in existing
technologies or the development of different technologies by one or more
of our
current or future competitors.
If we lose any of our key personnel, we may be unable to successfully
execute our business plan.
Our business is presently managed by four key employees:
o
H. Craig Dees, Ph.D., our Chief Executive Officer;
o
Timothy C. Scott, Ph.D., our President;
o
Eric A. Wachter, Ph.D. our Vice President - Pharmaceuticals; and
o
Peter R. Culpepper, CPA, our Chief Financial Officer.
In
addition to their responsibilities for management of our
overall business strategy, Drs. Dees, Scott and Wachter are our chief
researchers in the fields in which we are developing and planning to develop
prescription drug, medical device and OTC products. Also, as of December
31,
2005, we owe $179,170 in accrued but unpaid compensation to our employees.
The
loss of any of these key employees could have a material adverse effect on
our
operations, and our ability to execute our business plan might be negatively
impacted. Any of these key employees may leave their employment with us if
they
choose to do so, and we cannot assure you that we would be able to hire
similarly qualified executives if any of our key employees should choose
to
leave.
Because
we have only five employees in total, our management may
be unable to successfully manage our business.
In order to successfully execute our business plan, our management must
succeed in all of the following critical areas:
o
Researching diseases and possible therapies in the areas of dermatology and
skin care, oncology, and biotechnology;
o
Developing prescription drug, medical device and OTC products based on our
research;
o
Marketing and selling developed products;
o
Obtaining additional capital to finance research, development, production
and marketing of our products; and
o
Managing our business as it grows.
As
discussed above, we currently have only five employees, all of
whom are full-time employees. The greatest burden of succeeding in the above
areas therefore falls on Drs. Dees, Scott, Wachter, and Mr. Culpepper. Focusing
on any one of these areas may divert their attention from our other areas
of
concern and could affect our ability to manage other aspects of our business.
We
cannot assure you that our management will be able to succeed in all of these
areas or, even if we do so succeed, that our business will be successful
as a
result. We anticipate adding a part-time regulatory affairs officer, a part-time
lab technician in addition to the full-time lab technician that we have recently
employed, and a part-time office manager within the next year. While we have
not
historically had difficulty in attracting employees, our small size and limited
operating history may make it difficult for us to attract and retain employees
in the future which could further divert management's attention from the
operation of our business.
Our common stock price can be volatile because of several factors,
including a limited public float which has increased significantly from 2004
to
2005.
During the twelve-month period ended December 31, 2005, the sale
price of our common stock fluctuated from $1.25 to $0.52 per share. We believe
that our common stock is subject to wide price fluctuations because of several
factors, including:
o
absence of meaningful earnings and ongoing need for external financing,
o
a relatively thin trading market for our common stock, which causes trades
of small blocks of stock to have a significant impact on our stock
price,
o
general volatility of the stock markets and the market prices
of other publicly traded companies, and
o
investor sentiment regarding equity markets generally,
including public perception of corporate ethics and governance and
the accuracy and
transparency financial reporting.
Financings
that may be available to us under current market
conditions frequently involve sales at prices below the prices at which our
common stock trades on the Over the Counter Electronic Bulletin Board, as
well
as the issuance of warrants or convertible debt that require exercise or
conversion prices that are calculated in the future at a discount to the
then
market price of our common stock.
Any
agreement to sell, or convert debt or equity securities into,
common stock at a future date and at a price based on the then current market
price will provide an incentive to the investor or third parties to sell
the
common stock short to decrease the price and increase the number of shares
they
may receive in a future purchase, whether directly from us or in the market.
Financings
that may be available to us frequently involve high
selling costs.
Because
of our limited operating history, low market
capitalization, thin trading volume and other factors, we have historically
had
to pay high costs to obtain financing and expect to continue to be required
to
pay high costs for any future financings in which we may participate. For
example, our past sales of shares and our sale of the debentures have involved
the payment of finder's fees or placement agent’s fees. These types of fees are
typically higher for small companies like us. Payment of fees of this type
reduces the amount of cash that we receive from a financing transaction and
makes it more difficult for us to obtain the amount of financing that we
need to
maintain and expand our operations.
It
is our general policy to retain any earnings for use in our operation.
We
have
never declared or paid cash dividends on our common stock. We currently intend
to retain all of our future earnings, if any, for use in our business and
therefore do not anticipate paying any cash dividends on our common stock
in the
foreseeable future.
Our
stock
price is below $5.00 per share and is treated as a "penny stock" which places
restrictions on broker-dealers recommending the stock for purchase.
Our
common stock is defined as "penny stock" under the Exchange Act and its rules.
The SEC has adopted regulations that define “penny stock" to include common
stock that has a market price of less than $5.00 per share, subject to certain
exceptions. These rules include the following requirements:
o
broker-dealers must deliver, prior to the transaction a disclosure
schedule prepared by the SEC relating to the penny stock
market;
o
broker-dealers must
disclose the commissions payable to the broker-dealer
and its registered representative;
o
broker-dealers must disclose current quotations for the securities;
o
if a
broker-dealer is the sole market-maker, the broker-dealer must
disclose this fact and the broker-dealers presumed control over
the
market; and
o
a
broker-dealer must furnish its customers with monthly statements
disclosing recent price information for all pennies stocks
held in the customer’s
account and
information on the limited
market in penny stocks.
Additional
sales practice requirements are imposed on broker-dealers who sell penny
stocks
to persons other than established customers and accredited investors. For
these
types of transactions, the broker-dealer must make a special suitability
determination for the purchaser and must have received the purchaser's written
consent to the transaction prior to sale. If our common stock remains subject
to
these penny stock rules these disclosure requirements may have the effect
of
reducing the level of trading activity in the secondary market for our common
stock. As a result, fewer broker-dealers may be willing to make a market
in our
stock, which could affect a shareholder’s ability to sell their
shares.
Item
1B. Unresolved Staff Comments.
None.
Item
2. Description of Property.
We
currently lease approximately 6,000 square feet of space outside of Knoxville,
Tennessee for our corporate office and operations. Our monthly rental charge
for
these offices is approximately $4,000 per month, and the lease is renewed on
an
annual basis. We believe that these offices generally are adequate for our
needs
currently and in the immediate future.
Item
3. Legal Proceedings.
From
time
to time, we are party to litigation or other legal proceedings that we consider
to be a part of the ordinary course of our business. At present, we are not
involved in any legal proceedings nor are we party to any pending claims that
we
believe could reasonably be expected to have a material adverse effect on our
business, financial condition, or results of operations.
Item
4. Submission of Matters to a Vote of Security Holders.
During
the three months ended December 31, 2005, we did not submit any matters to
a
vote of our stockholders.
Part
II
Item
5. Market for Common Equity and Related
Stockholder Matters.
Market
Information and Holders
Quotations
for our common stock are reported on the OTC Bulletin Board under the symbol
“PVCT." The following table sets forth the range of high and low bid information
for the periods indicated since January 1, 2004:
|
|
High
|
|
Low
|
|
2004 |
|
|
|
|
|
First
Quarter (January 1 to March 31) |
|
$
|
1.70
|
|
$
|
0.80
|
|
Second
Quarter (April 1 to June 30) |
|
$ |
1.51 |
|
$ |
0.85 |
|
Third
Quarter (July 1 to September 30) |
|
$ |
1.68 |
|
$ |
0.52 |
|
Fourth
Quarter (October 1 to December 31) |
|
$ |
0.82 |
|
$ |
0.47 |
|
2005 |
|
|
|
|
|
|
|
First
Quarter (January 1 to March 31) |
|
$ |
1.25 |
|
$ |
0.64 |
|
Second
Quarter (April 1 to June 30) |
|
$ |
0.85 |
|
$ |
0.52 |
|
Third
Quarter (July 1 to September 30) |
|
$ |
0.99 |
|
$ |
0.60 |
|
Fourth
Quarter (October 1 to December 31) |
|
$ |
1.14 |
|
$ |
0.77 |
|
|
|
|
|
|
|
|
|
The
closing price for our common stock on February 13, 2006 was $0.88. High and
low
quotation information was obtained from data provided by Yahoo! Inc. Quotations
reflect inter-dealer prices, without retail mark-up, mark-down or commission,
and may not reflect actual transactions.
As
of
February 13, 2006, we had 1,888 shareholders of record of our common
stock.
Dividend
Policy
We
have
never declared or paid any cash dividends on our capital stock. We currently
plan to retain future earnings, if any, to finance the growth and development
of
our business and do not anticipate paying any cash dividends in the foreseeable
future. We may incur indebtedness in the future which may prohibit or
effectively restrict the payment of dividends, although we have no current
plans
to do so. Any future determination to pay cash dividends will be at the
discretion of our board of directors.
Recent
Sales of Unregistered Securities
During
the quarter ended December 31, 2005, we did not sell any securities which were
not registered under the Securities Act of 1933, as amended, which we refer
to
as the "Securities Act", except as follows:
During
the three months ended December 31, 2005, the Company completed a private
placement transaction with 62 accredited investors pursuant to which the Company
sold 10,065,605 shares of common stock at a purchase price of $0.75 per share
of
which 5,126,019 are committed to be issued at December 31, 2005, for an
aggregate purchase price of $7,549,202. In connection with the sale of common
stock, the Company also issued warrants to the investors to purchase up to
12,582,009 shares of common stock at an exercise price of $0.935 per share.
The
Company paid $959,540, issued 46,667 shares of common stock at a fair market
value of $46,467, issued 30,550 warrants, and committed to issue 950,461 shares
of common stock at a fair market value of $894,593 to a syndicate led by Network
1 Financial Securities, Inc. as placement agent for this transaction which
is
accrued at December 31, 2005. The cash and common stock costs have been off-set
against the proceeds received. We believe that this offering was exempt from
the
registration requirements of the Securities Act of 1933, as amended (the
“Securities Act”) by reason of Rule 506 of Regulation D and Section 4(2) of the
Securities Act, based upon the fact that the offer and issuance of the common
stock and warrants satisfied all the terms and conditions of Rules 501 and
502
of the Securities Act, the investors are financially sophisticated and had
access to complete information concerning us and acquired the securities for
investment and not with a view to the distribution thereof. Proceeds will be
used for general corporate purposes.
Item
6. Management's Discussion and Analysis or Plan of Operation.
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 Annual Report on Form
10-KSB. 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 assured due to our financing completed
in December, 2005. At the current rate of expenditures, we will not need to
raise additional capital until late 2007.
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 the asset sale and licensure of our
OTC
products that can be sold with a minimum of regulatory compliance and with
the
further development of revenue sources through 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 and 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 five employees during
the
immediate future, but we have added additional consultants and anticipate adding
employees 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 OTC products and core intellectual properties. This combination
represents the foundation for an operating company that we believe will provide
both profitability and long-term growth. In 2006 we plan to build on that
foundation to increase shareholder value through careful control of
expenditures, preparation for the asset sale and licensure of our OTC products,
medical device and biotech technologies, and issuance of equity only when it
makes sense to the Company and primarily for purposes of attracting strategic
investors.
In
the short term, we intend to develop our business by selling the OTC assets
and
licensing our existing OTC products, principally Pure-Stick, GloveAid and
Pure-ific. We will also sell and/or license our medical device and biotech
technologies. In the longer term, we expect to continue the process of
developing, testing, and obtaining the clearance and ultimately 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
and
additional treatments for those and other conditions.
Comparison
of the Years Ended December 31, 2005 and 2004.
Revenues.
OTC Product Revenue decreased by $13,176 in 2005 to $5,552 from $18,728 in
2004.
The decrease in OTC Product Revenue resulted primarily from lower sales of
Pure-ific in retail stores because we discontinued our proof of concept program
with major distributors and retailers. OTC Product Revenue continues due to
online sales. Medical Device Revenue decreased by $12,141 in 2005 to $984 from
$13,125 in 2004. The decrease in Medical Device Revenue resulted primarily
due
to a large beta unit sale in the 2004 that was not repeated in 2005, partially
offset by sales of three smaller devices in 2005.
Research
and development. The Company has completed the planning phase for the major
research and development projects anticipated in the next 12 months. The
Company’s Phase 1 metastatic melanoma and breast carcinoma clinical trials are
expected to be completed in early to mid 2006 for less than $1,000,000 in the
aggregate. At that time the planning phase for the expected Phase 2 trials
will
be completed, which cost approximately $1,000,000 in the aggregate. The
Company’s Phase 2 psoriasis trial is expected to commence in mid to late 2006
and will cost approximately $1,500,000 over 12 to 24 months. The Company’s Phase
1 liver cancer trial is expected to cost less than $500,000 in total, and is
expected to commence in mid 2006. Research and development costs comprising
the total of $2,044,391 for 2005 included depreciation expense of $1,708,
consulting of $805,915, lab supplies of $111,504, insurance of $120,493, legal
of $208,368, payroll of $747,197, and rent and utilities of $49,206. The
research and development costs are higher for 2005 because the Company has
initiated two Phase 1 clinical trials under the aegis of the Food & Drug
Administration (FDA). Research and development costs comprising the total
of $1,291,817 for 2004 included depreciation expense of $121,811, consulting
of
$493,305, lab expense of $10,958, insurance of $74,059, legal expense of
$127,775, office and other expense of $3,751, payroll of $431,068, rent and
utilities of $20,533, and taxes and fees of $8,557.
General
and administrative. General and administrative expenses increased by $1,308,493
in 2005 to $2,999,334 from $1,690,841 in 2004. The increase resulted primarily
from higher consulting and payroll expenses for general corporate purposes.
$733,269 of this increase was from consulting and $390,571 was from payroll
expenses.
CASH
FLOW
As
of February 13, 2006, we held approximately $6,600,000 in cash. At our current
cash expenditure rate, this amount will be sufficient to meet our needs. We
have
been increasing our expenditure rate by accelerating some of our research
programs for new research initiatives; in addition, we are seeking to improve
our cash flow through the asset sale and licensure of our OTC products. However,
we cannot assure you that we will be successful in selling the OTC assets and
licensing our existing OTC products. Moreover, even if we are successful in
improving our current cash flow position, we nonetheless plan to require
additional funds to meet our long-term needs in 2007 and beyond. We anticipate
these funds will come from the proceeds of private placements, the exercise
of
existing warrants outstanding, or public offerings of debt or equity
securities.
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 current
and
next phases in clinical development of our pharmaceutical products. We
anticipate that any required funds for our operating and development needs
beyond 2006 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. For further
information on funding sources, please see the notes to our financial statements
included in this report.
Recent
Accounting Pronouncements
In
November 2004, the FASB issued Statement of Financial Accounting Standards
No. 151, Inventory Costs, an amendment of ARB No. 43,
Chapter 4. The purpose of this statement is to clarify the accounting
of abnormal amounts of idle facility expense, freight, handling costs and waste
material. ARB No. 43 stated that under some circumstances these costs may
be so abnormal that they are required to be treated as current period costs.
SFAS 151 requires that these costs be treated, as current period costs
regardless if they meet the criteria of “so abnormal.” In addition, the
statement requires that allocation of fixed production overheads to the costs
of
conversion be based on the normal capacity of the production facilities. The
provision of this Statement shall be effective for inventory costs incurred
during fiscal years beginning after June 15, 2005. The adoption of SFAS 151
is not expected to have a material impact on the Company’s results of operations
or financial position.
In
December 2004, the FASB issued SFAS No. 153, Exchanges of
Nonmonetary Assets, an amendment of APB Opinion No. 29. SFAS 153 is
effective for nonmonetary asset exchanges occurring in fiscal periods beginning
after June 15, 2005, with earlier application permitted. The adoption of
SFAS 153 is not expected to have a material impact on the Company’s results of
operations or financial position.
In
December 2004, the FASB issued SFAS No. 123(R), Share-Based
Payments (revised 2004). This statement eliminates the option to apply the
intrinsic value measurement provisions of APB Board Opinion No. 25,
Accounting for Stock Issued to Employees, to stock compensation awards
issued to employees. Rather, the Statement requires companies to measure the
cost of employee services received in exchange for an award of equity
instruments based on the grant date fair value of the award. That cost will
be
recognized over the period during which an employee is required to provide
services in exchange for the award — the requisite service period (usually the
vesting period). In March 2005, the SEC staff expressed their views with
respect to SFAS No. 123(R) in Staff Accounting Bulletin No. 107,
Share-Based Payment, (SAB 107). SAB 107 provides guidance on valuing
options. SFAS 123(R) will be effective for the Company’s fiscal year beginning
January 1, 2006. The Company is currently evaluating the impact of the
adoption of this statement on its financial statements.
In
March 2005, the FASB issued FASB Interpretation No. 47, Accounting
for Conditional Asset Retirement Obligations, (FIN 47). FIN 47
is an interpretation of SFAS No. 143, Asset Retirement
Obligations, which was issued in June 2001. FIN 47 was issued to address
diverse accounting practices that have developed with regard to the timing
of
liability recognition for legal obligations associated with the retirement
of a
tangible long-lived asset in which the timing and/or method of settlement are
conditional on a future event that may or may not be within the control of
the
entity. According to FIN 47, uncertainty about the timing and/or method of
settlement of a conditional asset retirement obligation should be factored
into
the measurement of the liability when sufficient information exists. FIN 47
also
clarifies when an entity would have sufficient information to reasonably
estimate the fair value of an asset retirement obligation. FIN 47 is effective
no later than December 31, 2005 for the Company. The adoption of FIN
47 is not expected to have a material impact on the Company’s results of
operations or financial position.
In
May 2005, the FASB issued SFAS
No. 154, Accounting Changes and Error Corrections, a replacement
of APB Opinion No. 20 and Statement No. 3. SFAS 154 changes the
requirements for the accounting and reporting of a change in accounting
principle. SFAS 154 applies to all voluntary changes in accounting principle
as
well as to changes required by an accounting pronouncement that does not include
specific transition provisions. SFAS 154 is effective for accounting changes
and
corrections of errors made in fiscal years beginning after December 15,
2005. The adoption of SFAS 154 is not expected to have a material impact on
the
Company’s results of operations or financial position.
In
September
2005, the Emerging Issues Task Force (EITF) ratified Issue No. 05-8, "Income
Tax
Consequences of Issuing Convertible Debt with a Beneficial Conversion Feature."
When a company issues convertible debt with a beneficial conversion feature,
the
debt is bifurcated into a liability component and an equity component in
accordance with EITF Issues No. 98-5, "Accounting for Convertible Securities
with Beneficial Conversion Features or Contingently Adjustable Conversion
Ratios" and No. 00-27, "Application of Issue No. 98-5 to Certain Convertible
Instruments." The equity component is measured at the intrinsic value of the
beneficial conversion feature on the commitment date. For income tax purposes,
all of the proceeds are recorded as a liability and nothing is recorded in
shareholders' equity. The issues are whether the issuance of convertible debt
with a beneficial conversion feature results in a basis difference and, if
so,
whether that basis difference is a temporary difference under FASB Statement
No.
109, Accounting for Income Taxes. The adoption of EITF 05-8 is not
expected to have a material impact on the Company’s results of operations or
financial position. However, we do expect the adoption of EITF 05-8 to
result in a material change to our income tax disclosures.
Item
7. Financial Statements.
Our
consolidated financial statements, together with the report thereon of BDO
Seidman LLP, independent accountants, are set forth on the pages of this Annual
Report on Form 10-KSB indicated below.
|
Page |
Report of Independent Registered Public Accounting
Firm |
F-1 |
Consolidated
Balance Sheets as of December 31, 2005 and
December 31, 2004 |
F-2 |
Consolidated
Statements of Operations for the years ended
December 31, 2005 and 2004 |
F-3 |
Consolidated
Statements of Shareholders' Equity for the
years ended December 31, 2005 and 2004 |
F-4 |
Consolidated
Statements of Cash Flows for the year ended
December 31, 2005 and 2004 |
F-5 |
Notes to Consolidated Financial Statements |
F-7 |
|
|
Forward-Looking
Statements
This
Annual Report on Form 10-KSB 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 Annual Report on Form
10-KSB. 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 Annual Report
on
Form 10-KSB 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
8. Changes in and Disagreements with Accountants on Accounting and Financial
Disclosure.
None.
Item
8A. 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-14(c) under the Exchange Act) as of December 31, 2005. Based on
that
evaluation, the chief executive officer and chief financial officer
have concluded that our disclosure controls
and procedures are effective.
(b) Changes
in Internal Controls. There was no change in our internal control over financial
reporting identified in connection with the evaluation
during our fourth fiscal quarter that materially affected, or is reasonably
likely to materially affect, our internal control over
financial reporting.
Item
8B. Other Information.
None.
Item
9. Directors, Executive Officers, Promoters and Control Persons; Compliance
with
Section 16(a) of the Exchange Act.
Except
as set forth below, the information called for by this item with respect to
our
executive officers as of March 29, 2006 is furnished in Part I of this report
under the heading "Personnel--Executive Officers." The information called for
by
this item, to the extent it relates to our directors or to certain filing
obligations of our directors and executive officers under the federal securities
laws, is incorporated herein by reference to the Proxy Statement for our Annual
Meeting of Stockholders to be held on June 22, 2006, which will be filed with
the SEC pursuant to Regulation 14A under the Exchange Act.
Audit
Committee Financial Expert
We
do not currently have an "audit committee financial expert," as defined under
the rules of the SEC. Because the board of directors consists of only four
members and our operations remain amenable to oversight by a limited number
of
directors, the board has not delegated any of its functions to committees.
The
entire board of directors acts as our audit committee as permitted under Section
3(a)(58)(B) of the Exchange Act. We believe that all of the members of our
board
are qualified to serve as the committee and have the experience and knowledge
to
perform the duties required of the committee. We do not have any independent
directors who would qualify as an audit committee financial expert, as defined.
We believe that it has been, and may continue to be, impractical to recruit
such
a director unless and until we are significantly larger.
Code
of
Ethics
We
have not adopted a formal Code of Ethics. Since our company only has five
employees, we expect those employees to adhere to high standards of ethics
without the need for a formal policy.
Item
10. Executive Compensation.
The
information called for by this item is incorporated herein by reference to
the
Proxy Statement for our Annual Meeting of Stockholders to be held on June 22,
2006, which will be filed with the SEC pursuant to Regulation 14A under the
Exchange Act.
Item
11.
Security Ownership of Certain Beneficial Owners and Management and Related
Stockholder Matters.
The
information called for by this item is incorporated herein by reference to
the
Proxy Statement for our Annual Meeting of Stockholders to be held on June 22,
2006, which will be filed with the SEC pursuant to Regulation 14A under the
Exchange Act.
Item
12. Certain Relationships and Related Transactions.
The
information called for by this item is incorporated herein by reference to
the
Proxy Statement for our Annual Meeting of Stockholders to be held on June 22,
2006, which will be filed with the SEC pursuant to Regulation 14A under the
Exchange Act.
Item
13. Exhibits
Exhibits
required by Item 601 of Regulation S-B are incorporated herein by reference
and are listed on the attached Exhibit Index, which begins on page
X-1
of this Annual Report on Form 10-KSB.
Item
14. Principal Accountant Fees and Services.
The
information called for by this item is incorporated herein by reference to
the
Proxy Statement for our Annual Meeting of Stockholders to be held on June 22,
2006, which will be filed with the SEC pursuant to Regulation 14A under the
Exchange Act.
Signatures
In
accordance with Section 13 or 15(d) of the Exchange Act, the Registrant caused
this annual report on Form 10-KSB for the year ended December 31, 2005 to be
signed on its behalf by the undersigned, thereunto duly
authorized.
|
|
|
|
PROVECTUS
PHARMACEUTICALS, INC. |
|
|
|
Date: March
29, 2006 |
By: |
/s/ H.
Craig Dees |
|
H.
Craig Dees, Ph.D. |
|
Title:
Chief Executive Officer |
|
|
|
|
/s/ H.
Craig Dees |
|
|
/s/ Peter
R. Culpepper |
|
|
|
|
Name:
H. Craig Dees, Ph.D. Title: Chief Executive Officer (principal
executive officer) and Chairmain of the Board
Date:
March 29, 2006
|
|
|
Name: Peter R. Culpepper
Title: Chief Financial Officer (principal financial officer and
principal accounting officer) Date: March 29,
2006 |
|
|
|
|
/s/ Timothy
C. Scott |
|
|
/s/ Eric
A. Wachter |
|
|
|
|
Name:
Timothy C. Scott, Ph.D. Title: President and
Director Date: March 29, 2006 |
|
|
Name:
Eric A. Wachter Title: Vice President - Pharmaceuticals and
Director Date: March 29,
2006 |
|
|
|
|
/s/ Stuart
Fuchs |
|
|
|
|
|
|
|
Name:
Stuart Fuchs Title: Director Date:
March 29, 2006
|
|
|
|
Report
of
Independent Registered Public Accounting Firm
Board
of
Directors
Provectus
Pharmaceuticals, Inc.
Knoxville,
Tennessee
We
have
audited the accompanying consolidated balance sheets of Provectus
Pharmaceuticals, Inc., a development stage company, as of December 31, 2005
and
2004 and the related consolidated statements of operations, stockholders'
equity, and cash flows for the period from January 17, 2002 (inception) to
December 31, 2005 and for each of the two years in the period ended December
31,
2005. These financial statements are the responsibility of the Company's
management. Our responsibility is to express an opinion on these financial
statements based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we
plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. The Company is not required to
have, nor were we engaged to perform, an audit of its internal control over
financial reporting. Our audits included consideration of internal control
over
financial reporting as a basis for designing audit procedures that are
appropriate in the circumstances, but not for the purpose of expressing an
opinion on the effectiveness of the Company's internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures
in
the financial statements, assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In
our
opinion, the consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Provectus Pharmaceuticals,
Inc. at December 31, 2005 and 2004, and the results of its operations and its
cash flows for the period from January 17, 2002 (inception) to December 31,
2005
and for each of the two years in the period ended December 31, 2005 in
conformity with accounting principles generally accepted in the United States
of
America.
/s/BDO
Seidman, LLP
--------------------
Chicago,
Illinois
March
10,
2006
PROVECTUS
PHARMACEUTICALS, INC.
(A
Development-Stage Company)
CONSOLIDATED
BALANCE SHEETS
|
|
December
31,
2005
|
|
December
31,
2004
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Assets
|
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$
|
6,878,990
|
|
$
|
10,774
|
|
Prepaid
expenses and other current assets
|
|
|
67,962
|
|
|
114,724
|
|
Prepaid
consulting expense
|
|
|
-
|
|
|
205,427
|
|
Prepaid
commitment fee, net of amortization of $38,326 in 2004
|
|
|
-
|
|
|
272,540
|
|
|
|
|
|
|
|
|
|
Total
Current Assets
|
|
|
6,946,952
|
|
|
603,465
|
|
|
|
|
|
|
|
|
|
Equipment
and Furnishings, less accumulated depreciation of
$368,279
and $366,571
|
|
|
12,287
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Patents,
net of amortization of $2,091,657 and $1,420,537
|
|
|
9,623,788
|
|
|
10,294,908
|
|
|
|
|
|
|
|
|
|
Deferred
loan costs, net of amortization of $247,802 and $35,922
|
|
|
709,092
|
|
|
270,578
|
|
|
|
|
|
|
|
|
|
Other
assets
|
|
|
27,000
|
|
|
27,000
|
|
|
|
|
|
|
|
|
|
|
|
$
|
17,319,119
|
|
$
|
11,195,951
|
|
|
|
|
|
|
|
|
|
Liabilities
and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
|
|
Accounts
payable - trade
|
|
$
|
90,124
|
|
$
|
154,214
|
|
Accrued
compensation
|
|
|
179,170
|
|
|
156,377
|
|
Accrued
common stock costs
|
|
|
964,676
|
|
|
-
|
|
Accrued
consulting expense
|
|
|
692,512
|
|
|
-
|
|
Other
accrued expenses
|
|
|
61,500
|
|
|
6,240
|
|
Accrued
interest
|
|
|
65,055
|
|
|
43,670
|
|
March
2005 convertible debt, net of debt discount of $884,848 in
2005
|
|
|
221,401
|
|
|
-
|
|
November
2005 convertible debt, net of debt discount of $134,008 in
2005
|
|
|
334,828
|
|
|
-
|
|
Gryffindor
convertible debt, net of debt discount of $95,157 in 2004
|
|
|
-
|
|
|
1,090,802
|
|
|
|
|
|
|
|
|
|
Total
Current Liabilities
|
|
|
2,609,266
|
|
|
1,451,303
|
|
|
|
|
|
|
|
|
|
Loan
From Stockholder
|
|
|
-
|
|
|
149,000
|
|
|
|
|
|
|
|
|
|
Cornell
convertible debt, net of debt discount of $316,053 in 2004
|
|
|
-
|
|
|
433,947
|
|
|
|
|
|
|
|
|
|
March
2005 convertible debt, net of debt discount of $46,039 in
2005
|
|
|
322,712
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Stockholders’
Equity
|
|
|
|
|
|
|
|
Common
stock; par value $.001 per share; 100,000,000 shares
authorized;
27,822,977 and 16,133,876 shares issued and
outstanding,
respectively
|
|
|
27,823
|
|
|
16,134
|
|
Paid-in
capital
|
|
|
40,689,144
|
|
|
23,711,540
|
|
Deficit
accumulated during the development stage
|
|
|
(26,329,826
|
)
|
|
(14,565,973
|
)
|
|
|
|
|
|
|
|
|
Total
Stockholders’ Equity
|
|
|
14,387,141
|
|
|
9,161,701
|
|
|
|
|
|
|
|
|
|
|
|
$
|
17,319,119
|
|
$
|
11,195,951
|
|
See
accompanying notes to financial statements.
PROVECTUS
PHARMACEUTICALS, INC.
(A
Development-Stage Company)
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
Year
Ended
December
31, 2005
|
|
Year
Ended
December
31, 2004
|
|
Cumulative
Amounts from January 17, 2002 (Inception) Through
December
31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
OTC
Product Revenue
|
|
$
|
5,552
|
|
$
|
18,728
|
|
$
|
24,280
|
|
Medical
Device Revenue
|
|
|
984
|
|
|
13,125
|
|
|
14,109
|
|
Total
revenues
|
|
|
6,536
|
|
|
31,853
|
|
|
38,389
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of Sales
|
|
|
3,560
|
|
|
10,781
|
|
|
14,341
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
Profit
|
|
|
2,976
|
|
|
21,072
|
|
|
24,048
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
Research
and
development
|
|
$
|
2,044,391
|
|
$
|
1,291,817
|
|
$
|
4,111,846
|
|
General
and
administrative
|
|
|
2,999,334
|
|
|
1,690,841
|
|
|
13,195,371
|
|
Amortization
|
|
|
671,120
|
|
|
671,120
|
|
|
2,091,657
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating loss
|
|
|
(5,711,869
|
)
|
|
(3,632,706
|
)
|
|
(19,374,826
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Gain
on sale of fixed assets
|
|
|
-
|
|
|
-
|
|
|
55,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
on extinguishment of debt
|
|
|
(724,455
|
)
|
|
(101,412
|
)
|
|
(825,867
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
interest expense
|
|
|
(5,327,529
|
)
|
|
(610,407
|
)
|
|
(6,184,133
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(11,763,853
|
)
|
|
(4,344,525
|
)
|
|
(26,329,826
|
)
|
Basic
and Diluted Loss Per Common
Share
|
|
$
|
(0.62
|
)
|
|
(0.31
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
Average Number of
Common
Shares
Outstanding
-
Basic
and
Diluted
|
|
|
18,825,670
|
|
|
14,122,559
|
|
|
|
|
See
accompanying notes to financial statements.
PROVECTUS
PHARMACEUTICALS, INC.
(A
Development-Stage Company)
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS' EQUITY
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 |
|
|
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
|
|
|
-
|
|
|
3,049,362
|
|
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
|
|
|
-
|
|
|
-
|
|
|
39,529
|
|
|
-
|
|
|
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
|
|
See
accompanying notes to financial statements.
PROVECTUS
PHARMACEUTICALS, INC.
(A
Development-Stage Company)
CONSOLIDATED
STATEMENTS OF CASH FLOW
|
|
Year
Ended
December
31, 2005
|
|
Year
Ended
December
31, 2004
|
|
Cumulative
Amounts
from
January
17, 2002
(Inception)
through December 31, 2005
|
|
Cash
Flows From Operating Activities
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
(11,763,853
|
)
|
$
|
(4,344,525
|
)
|
$
|
(26,329,826
|
)
|
Adjustments
to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
1,708
|
|
|
121,811
|
|
|
391,280
|
|
Amortization
of
patents
|
|
|
671,120
|
|
|
671,120
|
|
|
2,091,657
|
|
Amortization
of
original issue discount
|
|
|
2,293,251
|
|
|
360,663
|
|
|
2,780,826
|
|
Amortization
of
commitment fee
|
|
|
272,540
|
|
|
38,326
|
|
|
310,866
|
|
Amortization
of
prepaid consultant expense
|
|
|
274,337
|
|
|
606,888
|
|
|
1,127,187
|
|
Amortization
of
deferred loan costs
|
|
|
1,411,970
|
|
|
120,953
|
|
|
1,552,492
|
|
Loss
on
extinguishment of debt
|
|
|
724,455
|
|
|
101,412
|
|
|
825,867
|
|
Loss
on
exercise of warrants
|
|
|
236,146
|
|
|
-
|
|
|
236,146
|
|
Beneficial
conversion of convertible interest
|
|
|
39,529
|
|
|
-
|
|
|
39,529
|
|
Convertible
interest
|
|
|
266,504
|
|
|
-
|
|
|
266,504
|
|
Compensation
through issuance of stock options
|
|
|
15,752
|
|
|
15,612
|
|
|
66,023
|
|
Compensation
through issuance of stock
|
|
|
-
|
|
|
-
|
|
|
932,000
|
|
Issuance
of
stock for services
|
|
|
388,373
|
|
|
76,558
|
|
|
5,968,931
|
|
Issuance
of
warrants for services
|
|
|
318,704
|
|
|
22,481
|
|
|
341,185
|
|
Issuance
of
warrants for contractual obligations
|
|
|
985,010
|
|
|
-
|
|
|
985,010
|
|
Gain
on
sale of equipment
|
|
|
-
|
|
|
-
|
|
|
(55,000
|
)
|
(Increase)
decrease in assets
|
|
|
|
|
|
|
|
|
|
|
Prepaid
expenses and other current assets
|
|
|
46,762
|
|
|
(15,919
|
)
|
|
(67,962
|
)
|
Increase
(decrease) in liabilities
|
|
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
|
(64,090
|
)
|
|
53,574
|
|
|
86,479
|
|
Accrued
expenses
|
|
|
98,196
|
|
|
(143,783
|
)
|
|
464,483
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities
|
|
|
(3,783,586
|
)
|
|
(2,314,829
|
)
|
|
(7,986,323
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flows From Investing Activities
|
|
|
|
|
|
|
|
|
|
|
Proceeds
from
sale of fixed asset
|
|
|
-
|
|
|
-
|
|
|
180,000
|
|
Capital
expenditures
|
|
|
(13,995
|
)
|
|
(396
|
)
|
|
(17,692
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash (used in) provided by investing activities
|
|
|
(13,995
|
)
|
|
(396
|
)
|
|
162,308
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Flows From Financing Activities
|
|
|
|
|
|
|
|
|
|
|
Net
proceeds from loans from stockholder
|
|
|
25,000
|
|
|
-
|
|
|
174,000
|
|
Proceeds
from
convertible debt
|
|
|
4,430,836
|
|
|
750,000
|
|
|
6,706,795
|
|
Net
proceeds from sale of common stock
|
|
|
7,477,853
|
|
|
2,169,873
|
|
|
9,965,198
|
|
Proceeds
from
exercise of warrants and stock options
|
|
|
1,203,649
|
|
|
5,000
|
|
|
1,209,102
|
|
Cash
paid to retire convertible debt
|
|
|
(1,885,959
|
)
|
|
(500,000
|
)
|
|
(2,385,959
|
)
|
Cash
paid for deferred loan costs
|
|
|
(515,582
|
)
|
|
(162,500
|
)
|
|
(747,612
|
)
|
Premium
paid on extinguishments of debt
|
|
|
(70,000
|
)
|
|
(100,519
|
)
|
|
(170,519
|
)
|
Purchase
and
retirement of common stock
|
|
|
-
|
|
|
-
|
|
|
(48,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Net
cash provided by financing activities
|
|
|
10,665,797
|
|
|
2,161,854
|
|
|
14,703,005
|
|
|
|
Year
Ended
December
31, 2005
|
|
Year
Ended
December
31, 2004
|
|
Cumulative
Amounts
from
January
17, 2002
(Inception)
through December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Change in Cash and cash equivalents
|
|
$6,868,216
|
|
$(153,371)
|
|
$6,878,990
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents, at beginning of period
|
|
$
|
10,774
|
|
$
|
164,145
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
and cash equivalents, at end of period
|
|
$
|
6,878,990
|
|
$
|
10,774
|
|
$
|
6,878,990
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
Disclosure of Cash Flow Information
|
|
|
|
|
|
|
|
|
|
|
December
31, 2005
|
|
|
|
|
|
|
|
|
|
|
Interest
paid
of $127,444
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
Disclosure of Noncash Investing and Financing
Activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
ended December 31, 2005
1.
Issuance of warrants in exchange for prepaid services of $68,910
2.
Shareholder debt of $174,000 and accrued interest of $24,528 converted to common
stock of $198,528
3.
Debt
converted to common stock of $2,537,000
4.
Payment of accrued interest through the issuance of stock of $196,031 and stock
committed to be issued of $61,408
5.
Beneficial conversion on convertible debt of $1,633,176
6.
Discount on convertible debt with warrants of $1,574,900
7.
Warrants issued for deferred loan costs of $1,215,700
8.
Accrual of $964,676 for stock committed to be issued for stock issuance
costs
9.
Stock
committed to be issued for deferred loan costs of $345,645
10.
Stock
committed to be issued for consulting expense of $304,998
Year
ended December 31, 2004
1.
Issuance of stock in exchange for prepaid services of $62,499
2.
Issuance of warrants in exchange for prepaid services of $329,000
3.
Issuance of stock in exchange for standby equity commitment of
$310,866
4.
Discount on convertible debt with warrants of $105,250
5.
Deferred loan costs through the issuance of warrants of $144,000
6.
Beneficial conversion on convertible debt of $360,256
7.
Conversion of accrued interest of $160,000 to convertible debt
See
accompanying notes to financial statement.
Provectus
Pharmaceuticals, Inc.
(A
Development Stage Company)
Notes
to
Consolidated Financial Statements
1. Organization
and Significant Accounting Policies
Nature
of Operations
Provectus
Pharmaceuticals, Inc. (together with its subsidiaries, the "Company") is a
development-stage biopharmaceutical company that is focusing on developing
minimally invasive products for the treatment of psoriasis and other topical
diseases, and certain forms of cancer including recurrent breast carcinoma,
metastatic melanoma, and liver cancer. The Company intends to license its laser
device and biotech technology. Through a previous acquisition, the Company
also
intends to further develop, if necessary, and license or sell the underlying
assets of its over-the-counter pharmaceuticals. To date the Company has no
material revenues.
Principles
of Consolidation
Intercompany
balances and transactions have been eliminated in consolidation.
Estimates
The
preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions
that
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting period.
Actual results could differ from those estimates.
Cash
and cash equivalents
The
Company considers all highly liquid investments purchased with a maturity of
three months or less to be cash equivalents.
Deferred
Loan Costs and Debt Discounts
The
costs
related to the issuance of the convertible debt, including lender fees, legal
fees, due diligence costs, escrow agent fees and commissions, have been recorded
as deferred loan costs and are being amortized over the term of the loan using
the effective interest method. Additionally, the Company recorded debt discounts
related to warrants and beneficial conversion features issued in connection
with
the debt. Debt discounts are being amortized over the term of the loan using
the
effective interest method.
Equipment
and Furnishings
Equipment
and furnishings acquired through the acquisition of Valley Pharmaceuticals,
Inc.
(Note 2) have been stated at carry over basis. Other equipment and furnishings
are stated at cost. Depreciation of equipment is provided for using the
straight-line method over the estimated useful lives of the assets. Computers
and laboratory equipment are being depreciated over five years, furniture and
fixtures are being depreciated over seven years.
Long-Lived
Assets
The
Company reviews the carrying values of its 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.
Patent
Costs
Internal
patent costs are expensed in the period incurred. Patents purchased are
capitalized and amortized over the remaining life of the patent.
Patents
at December 31, 2005 were acquired as a result of the merger with Valley
Pharmaceuticals, Inc. ("Valley") (Note 2). The majority shareholders of
Provectus also owned all of the shares of Valley and therefore the assets
acquired from Valley were recorded at their carry over basis. The patents are
being amortized over the remaining lives of the patents, which range from 12-16
years. Annual amortization of the patents is expected to be approximately
$671,000 per year for the next five years.
Revenue
Recognition
The
Company recognizes revenue when product is shipped. When advance payments are
received, these payments are recorded as deferred revenue and recognized when
the product is shipped.
Research
and Development
Research
and development costs are charged to expense when incurred. An allocation of
payroll expenses was 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, insurance, legal - patents,
office supplies, payroll expenses, rental - building, repairs, software, taxes
and fees, and utilities.
Income
Taxes
The
Company accounts for income taxes under the liability method in accordance
with
Statement of Financial Accounting Standards No. 109 (“SFAS No. 109”),
“Accounting for Income Taxes.” Under this method, deferred income tax assets and
liabilities are determined based on differences between financial reporting
and
tax bases of assets and liabilities and are measured using the enacted tax
rates
and laws that will be in effect when the differences are expected to reverse.
A
valuation allowance is established if it is more likely than not that all,
or
some portion, of deferred income tax assets will not be realized. The Company
has recorded a full valuation allowance to reduce its net deferred income tax
assets to zero. In the event the Company were to determine that it would be
able
to realize some or all its deferred income tax assets in the future, an
adjustment to the deferred income tax asset would increase income in the period
such determination was made.
Basic
and Diluted Loss Per Common Share
Basic
and
diluted loss per common share and diluted loss per common share is computed
based on the weighted Per Common Share average number of common shares
outstanding. Loss per share excludes the impact of outstanding options,
warrants, and convertible debt as they are antidilutive. Potential common shares
excluded from the calculation at December 31, 2005 are 4,973,484 options
26,811,958 warrants and 2,609,438 shares issuable upon the conversion of
convertible debt and accrued interest. Included in the weighted average number
of shares outstanding are 7,284,506 common shares committed to be issued but
not
outstanding at December 31, 2005.
Financial
Instruments
The
carrying amounts reported in the consolidated balance sheets for cash, accounts
payable and accrued expenses approximate fair value because of the short-term
nature of these amounts. The Company believes the fair value of its fixed-rate
borrowings approximates the market value.
Stock
Based Compensation
The
Company has adopted the disclosure-only provisions of Statement of Financial
Accounting Standards No. 148, "Accounting for Stock Based Compensation -
Transition and Disclosure" (SFAS No. 148), an amendment of FASB Statement No.
123, but applies the intrinsic value method where compensation expense, if
any,
is recorded as the difference between the exercise price and the market price,
as set forth in Accounting Principles Board Opinion No. 25 for stock options
granted to employees and directors. Options granted to non-employees are
accounted for under SAS 123. SAS 123 requires options to be accounted for based
on their fair value.
In
2003,
the Company issued stock options to employees in which the exercise price was
less than the market price on the date of grant. These options vest over three
years and accordingly, $15,752 and $15,612 of expense was recorded for the
year
ended December 31, 2005 and 2004, respectively.
For
stock
options granted to employees during 2005 and 2004, the Company has estimated
the
fair value of each option granted using the Black-Scholes option pricing model
with the following assumptions:
|
2005
|
2004
|
Weighted
average fair value per options granted |
$
0.66
|
$1.10
|
Significant
assumptions (weighted average) |
|
|
Risk-free
interest rate at grant date |
4.0%
|
2.0%
|
Expected
stock price volatility |
130%
|
150%
|
Expected
option life (years)
|
10
|
10
|
If
the
Company had elected to recognize compensation expense based on the fair value
at
the grant dates, consistent with the method prescribed by SFAS No. 123, net
loss
per share would have been changed to the pro forma amount indicated
below:
|
|
Year
Ended
December
31,
2005
|
|
Year
Ended
December
31,
2004
|
|
Net
loss, as reported |
|
$
|
(11,763,853
|
)
|
$
|
(4,344,525
|
)
|
Add
stock-based employee compensation
expense
included in reported net loss
|
|
|
15,752
|
|
|
15,612
|
|
Less
total stock-based employee compensation expense
determined under the fair value
based method for all awards |
|
|
(791,111
|
)
|
|
(698,125
|
)
|
Pro
forma net loss |
|
$
|
(12,539,212
|
)
|
$
|
(5,027,038
|
)
|
Basic
and diluted loss per common share, as
reported |
|
$
|
(0.62
|
)
|
$
|
(0.31
|
)
|
Basic
and diluted loss per common share, pro
forma |
|
$
|
(0.67
|
)
|
$
|
(0.36
|
)
|
|
|
|
|
|
|
|
|
Reclassifications
Certain
2004 amounts have been reclassified to conform to the 2005
presentation.
Recent
Accounting Pronouncements
In
November 2004, the FASB issued Statement of Financial Accounting Standards
No. 151, Inventory Costs, an amendment of ARB No. 43,
Chapter 4. The purpose of this statement is to clarify the accounting
of abnormal amounts of idle facility expense, freight, handling costs and waste
material. ARB No. 43 stated that under some circumstances these costs may
be so abnormal that they are required to be treated as current period costs.
SFAS 151 requires that these costs be treated, as current period costs
regardless if they meet the criteria of “so abnormal.” In addition, the
statement requires that allocation of fixed production overheads to the costs
of
conversion be based on the normal capacity of the production facilities. The
provision of this Statement shall be effective for inventory costs incurred
during fiscal years beginning after June 15, 2005. The adoption of SFAS 151
is not expected to have a material impact on the Company’s results of operations
or financial position.
In
December 2004, the FASB issued SFAS No. 153, Exchanges of
Nonmonetary Assets, an amendment of APB Opinion No. 29. SFAS 153 is
effective for nonmonetary asset exchanges occurring in fiscal periods beginning
after June 15, 2005, with earlier application permitted. The adoption of
SFAS 153 is not expected to have a material impact on the Company’s results of
operations or financial position.
In
December 2004, the FASB issued SFAS No. 123(R), Share-Based
Payments (revised 2004). This statement eliminates the option to apply the
intrinsic value measurement provisions of APB Board Opinion No. 25,
Accounting for Stock Issued to Employees, to stock compensation awards
issued to employees. Rather, the Statement requires companies to measure the
cost of employee services received in exchange for an award of equity
instruments based on the grant date fair value of the award. That cost will
be
recognized over the period during which an employee is required to provide
services in exchange for the award — the requisite service period (usually the
vesting period). In March 2005, the SEC staff expressed their views with
respect to SFAS No. 123(R) in Staff Accounting Bulletin No. 107,
Share-Based Payment, (SAB 107). SAB 107 provides guidance on valuing
options. SFAS 123(R) will be effective for the Company’s fiscal year beginning
January 1, 2006. The Company is currently evaluating the impact of the
adoption of this statement on its financial statements.
In
March 2005, the FASB issued FASB Interpretation No. 47, Accounting
for Conditional Asset Retirement Obligations, (FIN 47). FIN 47
is an interpretation of SFAS No. 143, Asset Retirement
Obligations, which was issued in June 2001. FIN 47 was issued to address
diverse accounting practices that have developed with regard to the timing
of
liability recognition for legal obligations associated with the retirement
of a
tangible long-lived asset in which the timing and/or method of settlement are
conditional on a future event that may or may not be within the control of
the
entity. According to FIN 47, uncertainty about the timing and/or method of
settlement of a conditional asset retirement obligation should be factored
into
the measurement of the liability when sufficient information exists. FIN 47
also
clarifies when an entity would have sufficient information to reasonably
estimate the fair value of an asset retirement obligation. FIN 47 is effective
no later than December 31, 2005 for the Company. The adoption of FIN
47 is not expected to have a material impact on the Company’s results of
operations or financial position.
In
May 2005, the FASB issued SFAS No. 154, Accounting Changes and Error
Corrections, a replacement of APB Opinion No. 20 and Statement No. 3.
SFAS 154 changes the requirements for the accounting and reporting of a change
in accounting principle. SFAS 154 applies to all voluntary changes in accounting
principle as well as to changes required by an accounting pronouncement that
does not include specific transition provisions. SFAS 154 is effective for
accounting changes and corrections of errors made in fiscal years beginning
after December 15, 2005. The adoption of SFAS 154 is not expected to have a
material impact on the Company’s results of operations or financial
position.
In
September 2005, the Emerging Issues Task Force (EITF) ratified Issue No. 05-8,
"Income Tax Consequences of Issuing Convertible Debt with a Beneficial
Conversion Feature." When a company issues convertible debt with a beneficial
conversion feature, the debt is bifurcated into a liability component and an
equity component in accordance with EITF Issues No. 98-5, "Accounting for
Convertible Securities with Beneficial Conversion Features or Contingently
Adjustable Conversion Ratios" and No. 00-27, "Application of Issue No. 98-5
to
Certain Convertible Instruments." The equity component is measured at the
intrinsic value of the beneficial conversion feature on the commitment date.
For
income tax purposes, all of the proceeds are recorded as a liability and nothing
is recorded in shareholders' equity. The issues are whether the issuance of
convertible debt with a beneficial conversion feature results in a basis
difference and, if so, whether that basis difference is a temporary difference
under FASB Statement No. 109, Accounting for Income Taxes. The adoption of
EITF
05-8 is not expected to have a material impact on the Company’s results of
operations or financial position. However, we do expect the adoption of
EITF 05-8 to result in a material change to our income tax
disclosures.
2.
Recapitalization and Merger
On
April
23, 2002, Provectus Pharmaceutical, Inc., a Nevada corporation and a Merger
"blank check" public company, acquired Provectus Pharmaceuticals, Inc.,
a
privately held Tennessee corporation ("PPI"), by issuing 6,680,000 shares of
common stock of Provectus Pharmaceutical to the stockholders of PPI
in
exchange for all of the issued and outstanding shares of PPI, as a result of
which Provectus Pharmaceutical changed its name to Provectus Pharmaceuticals,
Inc. (the "Company") and PPI became a wholly owned subsidiary of the Company.
Prior to the transaction, PPI had no significant operations
and had not generated any revenues.
For
financial reporting purposes, the transaction has been reflected in the
accompanying financial statements as a recapitalization of PPI and the
financial
statements reflect the historical financial information of PPI which was
incorporated on January 17, 2002. Therefore, for accounting purposes,
the shares recorded as issued in the reverse merger are the 265,763 shares
owned
by Provectus Pharmaceuticals, Inc. shareholders prior to
the
reverse merger.
The
issuance of 6,680,000 shares of common stock of Provectus Pharmaceutical, Inc.
to the stockholders of PPI in exchange for all of the issued and outstanding
shares of PPI was done in anticipation of PPI acquiring Valley Pharmaceuticals,
Inc, which owned the intellectual property to be used in the Company's
operations.
On
November 19, 2002, the Company acquired Valley Pharmaceuticals, Inc, ("Valley")
a privately-held Tennessee corporation by merging PPI with and into
Valley and naming the surviving company Xantech Pharmaceuticals, Inc. Valley
had
no significant operations and had not generated any revenues. Valley
was formed to hold certain intangible assets which were transferred from an
entity which was majority owned by the shareholders of Valley. Those
shareholders gave up their shares of the other company in exchange for the
intangible assets in a non-pro rata split off. The intangible assets
were valued based on the market price of the stock given up in the split-off.
The shareholders of Valley also owned the majority of the shares of
the
Company at the time of the transaction. The Company issued 500,007 shares of
stock in exchange for the net assets of Valley which were valued at
$12,226,320 and included patents of $11,715,445 and equipment and furnishings
of
$510,875.
3.
Commitments
The
Company leases office and laboratory space in Knoxville, Tennessee, on an annual
basis, renewable for one year at the option of the Company. The Company is
committed to pay a total of $12,000 in lease payments over three months, which
is the remainder of its current lease term at December 31, 2005. The Company
plans to renew the lease at the end of the current lease term. Rent expense
was
approximately $45,000 and $31,000 in 2005 and 2004, respectively.
4.
Equity
Transactions
(a)
During 2002, the Company issued 2,020,000 shares of stock in exchange for
consulting services. These services were valued based on the fair market value
of the stock exchanged which resulted in consulting costs charged to operations
of $5,504,000.
(b)
During 2002, the Company issued 510,000 shares of stock to employees in exchange
for services rendered. These services were valued based on the fair market
value
of the stock exchanged which resulted in compensation costs charged to
operations of $932,000.
(c)
In February 2002, the Company sold 50,000 shares of stock to a related party
in
exchange for proceeds of $25,000.
(d)
In June 2002, the Company issued a warrant to a consultant for the purchase
of
100,000 shares at $2.29 per share. The warrant is only exercisable upon the
successful introduction of the Company to a designated pharmaceutical
company. The warrant was forfeited in 2004.
(e)
In October 2002, the Company purchased 400,000 outstanding shares of stock
from
one shareholder for $48,000. These shares were then retired.
(f)
On December 5, 2002, the Company purchased the assets of Pure-ific L.L.C, a
Utah
limited liability company, and created a wholly owned subsidiary called
Pure-ific Corporation, to operate the Pure-ific business which consists of
product formulations for Pure-ific personal sanitizing sprays, along with the
Pure-ific trademarks. The assets of Pure-ific were acquired through the issuance
of 25,000 shares of the Company's stock with a fair market value of $0.50 and
the issuance of various warrants. These warrants included warrants to purchase
10,000 shares of the Company's stock at an exercise price of $0.50 issuable
on
the first, second and third anniversary dates of the acquisition. Accordingly,
the fair market value of these warrants of $14,500, determined using the
Black-Scholes option pricing model, was recorded as additional purchase price
for the acquisition of the Pure-ific assets. In 2004, 20,000 warrants were
issued for the first and second anniversary dates. 10,000 of these warrants
were
exercised in 2004. In 2005, 10,000 warrants were issued for the third
anniversary date. In addition, warrants to purchase 80,000 shares of stock
at an
exercise price of $0.50 will be issued upon the achievement of certain sales
targets of the Pure-ific product. At
December 31, 2005 and 2004, none of these targets have been met and accordingly,
no costs have been recorded.
(g)
In 2003, the Company issued 764,000 shares to consultants in exchange for
services rendered, consisting of 29,000 shares issued in January valued at
11,600, 35,000 shares issued in March valued at $11,200, and 700,000 shares
issued in October valued at $217,000. The value for these shares was based
on
the market value of the shares issued. As all of these amounts represented
payments for services to be provided in the future and the shares were fully
vested and non-forfeitable, a prepaid consulting expense was recorded in 2003
which was fully amortized as of December 31, 2004. Consulting costs charged
to operations in 2004 were $144,667.
(h)
In November and December 2003, the Company committed to issue 341,606 shares
to
consultants in exchange for services rendered. The total value for these shares
was $281,500 which was based on the market value of the shares issued. The
shares were issued in January 2004. As these amounts represented payments for
services to be provided in the future and the shares were fully vested and
non-forfeitable, a prepaid consulting expense was recorded in 2003 which was
fully amortized as of December 31, 2004. Consulting costs charged to
operations in 2004 were $231,983.
(i)
The Company applies the recognition provisions of SFAS No. 123, "Accounting
for
Stock-Based Compensation," in accounting for stock options
and warrants issued to nonemployees. In January 2003, the Company issued 25,000
warrants to a consultant for services rendered. In
February 2003, the Company issued 360,000 warrants to a consultant, 180,000
of
which were fully vested and non-forfeitable at the issuance and
180,000 of which were cancelled in August 2003 due to the termination of the
consulting contract. In September 2003, the Company issued
200,000 warrants to two consultants in exchange for services rendered. In
November 2003, the Company issued 100,000 warrants to one consultant
in exchange for services rendered. As the fair market value of these services
was not readily determinable, these services were valued
based on the fair market value, determined using the Black-Scholes
option-pricing model. Fair market value for the warrants issued in 2003 ranged
from $0.20 to $0.24 and totaled $145,479. As these amounts represented payments
for services to be provided in the future and the warrants were fully vested
and
non-forfeitable, a prepaid consulting expense was recorded in 2003 which was
fully amortized as of December 31, 2004. Consulting costs charged to operations
in 2004 were $44,167.
In
May
2004, the Company issued 20,000 warrants to consultants in exchange for services
rendered. Consulting costs charged to operations were
$18,800. In August 2004, the Company issued 350,000 warrants to consultants
in
exchange for services valued at $329,000. At December 31,
2004,
$123,375 of these costs have been charged to operations with the remaining
$205,427 recorded as prepaid consulting expense as it represents
payments for future services and the warrants are fully-vested and
non-forfeitable. In December 2004, the Company issued 10,000 warrants to
consultants in exchange for services valued at $3,680. Fair market value for
the
warrants issued in 2004 ranged from $0.37 to $0.94.
In
January 2005, the Company issued 16,000 warrants to consultants in exchange
for
services rendered. Consulting costs charged to operations were $6,944. In
February 2005, the Company issued 13,000 warrants to consultants in exchange
for
services rendered. Consulting costs charged to operations were $13,130. In
March
2005, the Company issued 100,000 warrants to consultants in exchange for
services rendered. Consulting costs charged to operations were $68,910. In
April
2005, the Company issued 410,000 warrants to consultants in exchange for
services rendered. Consulting costs charged to operations were $195,900. In
May
2005, the Company issued 25,000 warrants to consultants in exchange for services
rendered. Consulting costs charged to operations were $9,250. In December 2005,
the Company issued 33,583 warrants to consultants in exchange for services.
Consulting costs charged to operations were $24,571. The fair market value
for the warrants issued in 2005 ranged from $0.37 to $1.01.
(j)
In December 2003, the Company commenced an offering for sale of restricted
common stock. As of December 31, 2003, the Company had sold 874,871 shares
at an
average gross price of $1.18 per share. As of December 31, 2003, the Company
had
received net proceeds of $292,472 and recorded a stock subscription receivable
of $87,875 for stock subscriptions prior to December 31, 2003 for which payment
was received
subsequent to December 31, 2003. The transaction is a Regulation S offering
to
foreign investors as defined by Regulation S of
the
Securities Act. The restricted shares cannot be traded for 12 months. After
the
first 12 months, sales of the shares are subject to restrictions
under rule 144 for an additional year. The Company engaged a placement agent
to
assist the offering. Costs related to the placement
agent of $651,771 have been off-set against the gross proceeds of $1,032,118
and
therefore are reflected as a direct reduction of equity at December 31, 2003.
At
December 31, 2003, 195,051 shares had not yet been issued. These shares were
issued in the first quarter of 2004.
In
2004,
the Company sold 2,274,672 shares of restricted common stock under this offering
of which 1,672,439 shares were issued in the first quarter
2004 and 602,233 were issued in the second quarter 2004. Shares were sold during
2004 at an average gross price of $1.05 per share with net proceeds of $793,137.
Costs related to the placement agent for proceeds received in 2004 of $1,588,627
have been off-set against gross proceeds of $2,381,764.
(k)
In January 2004, the Company issued 10,000 shares to a consultant in
exchange for services rendered. Consulting costs charged to operations
were $11,500. In March 2004, the Company committed to issue 36,764 shares to
consultants in exchange for services. These shares were
recorded as a prepaid consulting expense and were fully amortized at December
31, 2004. Consulting costs charged to operations were $62,500.
These 36,764 shares, along with 75,000 shares committed in 2003 were issued
in
August 2004. The 75,000 shares committed to be issued
in
2003 were the result of a cashless exercise of 200,000 warrants in 2003, which
were not issued as of December 31, 2003. In August
2004, the Company also issued 15,000 shares to a consultant in exchange for
services rendered. Consulting costs charged to operations were
$25,200. In September 2004, the Company issued 16,666 shares to a consultant
in
exchange for services rendered. Consulting costs charged to operations were
$11,666. In October 2004, the Company issued 16,666 shares to a consultant
in
exchange for services rendered. Consulting costs charged to operations were
$13,666. In November 2004, the Company issued 16,666 shares to a consultant
in
exchange for services rendered. Consulting costs charged to operations were
$11,000. In December 2004, the Company issued 7,500 shares to a consultant
in
exchange for services rendered. Consulting costs charged to operations were
$3,525.
In
January 2005, the Company issued 7,500 shares to consultants in exchange for
services rendered. Consulting costs charged to operations were $4,950. In
February 2005, the Company issued 7,500 shares to consultants in exchange for
services. Consulting costs charged to operations were $7,574. In April 2005,
the
Company issued 190,733 shares to consultants in exchange for services.
Consulting costs charged to operations were $127,791. In May 2005, the Company
issued 21,000 shares to consultants in exchange for services. Consulting costs
charged to operations were $11,970. At December 31, 2005 the Company
committed to issue 332,911 shares to consultants in exchange for services
rendered in December, 2005. Consulting costs charged to operations were
$305,606.
(l)
On June 25, 2004, the Company entered into an agreement to sell 1,333,333 shares
of common stock at a purchase price of $.75 per share for
an
aggregate purchase price of $1,000,000. Payments were received in four
installments, the last of which was on August 9, 2004. Stock issuance
costs included 66,665 shares of stock valued at $86,666 and cash costs of
$69,000. The cash costs have been off-set against the proceeds
received. In conjunction with the sale of the common stock, the Company issued
1,333,333 warrants with an exercise price of $1.00 and a termination date of
three years from the installment payment dates. In addition, the Company has
given the investors an option to purchase 1,333,333 shares of additional stock
including the attachment of warrants under the same terms as the original
agreement. This option expired February 8, 2005.
(m)
Pursuant to a Standby Equity Distribution Agreement ("SEDA") dated July 28,
2004
between the Company and Cornell Capital Partners, L.P. ("Cornell"),
the Company may, at its discretion, issue shares of common stock to Cornell
at
any time until June 28, 2006. As of December 31, 2005 there were no
shares issued pursuant to the SEDA. The facility is subject to having in effect
a registration statement covering the shares. A registration statement covering
2,023,552 shares was declared effective by the Securities and Exchange
Commission on November 16, 2004. The maximum aggregate amount of the equity
placements pursuant to the SEDA is $20 million, and the Company may draw down
up
to $1 million per month. Pursuant to the SEDA, on July 28, 2004, the Company
issued 190,084 shares of common stock to Cornell and 7,920 shares of common
stock to Newbridge Securities Corporation as commitment shares. These 198,004
shares had a FMV of $310,866 on July 28, 2004 which was being amortized over
the
term of the commitment period which was one year from the date of registration.
The full amount was amortized as of December 31, 2005 with $310,866 and $38,326
amortized in 2005 and 2004, respectively.
(n)
On November 16, 2004, the Company completed a private placement transaction
with
14 accredited investors, pursuant to which the Company sold 530,166 shares
of
common stock at a purchase price of $0.75 per share, for an aggregate purchase
price of $397,625. In connection with the sale of the common stock, the Company
also issued warrants to the investors to purchase up to 795,249 shares of our
common stock at an exercise price of $1.00 per share. The Company paid $39,764
and issued 198,812 warrants to Venture Catalyst, LLC as placement agent for
this
transaction. The cash costs have been off-set against the proceeds received.
During
the three months ended March 31, 2005, the Company completed a private placement
transaction with 8 accredited investors, which were registered effective June
20, 2005, pursuant to which the Company sold 214,666 shares of common stock
at a
purchase price of $0.75 per share, for an aggregate purchase price of $161,000.
In connection with the sale of common stock, the Company also issued warrants
to
the investors to purchase up to 322,000 shares of common stock at an exercise
price of $1.00 per share. The Company paid $16,100 and issued 80,500 warrants
to
Venture Catalyst, LLC as placement agent for this transaction. The cash costs
have been off-set against the proceeds received.
During
the three months ended June 30, 2005, the Company completed a private placement
transaction with 4 accredited investors, which were registered effective June
20, 2005, pursuant to which the Company sold 230,333 shares of common stock
at a
purchase price of $0.75 per share, for an aggregate purchase price of $172,750.
In connection with the sale of common stock, the Company also issued warrants
to
the investors to purchase up to 325,500 shares of common stock at an exercise
price of $1.00 per share. The Company paid $16,275 and issued 81,375 warrants
to
Venture Catalyst, LLC as placement agent for this transaction. The cash costs
have been off-set against the proceeds received.
During
the three months ended September 30, 2005, the Company completed a private
placement transaction with 12 accredited investors pursuant to which the Company
sold 899,338 shares of common stock at a purchase price of $0.75 per share
of
which 109,333 are committed to be issued at December 31, 2005, for an aggregate
purchase price of $674,500. In connection with the sale of common stock, the
Company also issued warrants to the investors to purchase up to 1,124,167 shares
of common stock at an exercise price of $0.935 per share. The Company paid
$87,685 and committed to issue 79,000 shares of common stock at a fair market
value of $70,083 to Network 1 Financial Securities, Inc. as placement agent
for
this transaction which is accrued at December 31, 2005. The cash and common
stock costs have been off-set against the proceeds received.
During
the three months ended December 31, 2005, the Company completed a private
placement transaction with 62 accredited investors pursuant to which the Company
sold 10,065,605 shares of common stock at a purchase price of $0.75 per share
of
which 5,126,019 are committed to be issued at December 31, 2005, for an
aggregate purchase price of $7,549,202. In connection with the sale of common
stock, the Company also issued warrants to the investors to purchase up to
12,582,009 shares of common stock at an exercise price of $0.935 per share.
The
Company paid $959,540, issued 46,667 shares of common stock at a fair market
value of $46,467, issued 30,550 warrants, and committed to issue 950,461 shares
of common stock at a fair market value of $894,593 to a syndicate led by Network
1 Financial Securities, Inc. as placement agent for this transaction which
is
accrued at December 31, 2005. The cash and common stock costs have been off-set
against the proceeds received.
(o)
The Company issued 175,000 warrants each month from March 2005 to November
2005
resulting in total warrants of 1,575,000 to Gryffindor Capital Partners I,
L.L.C. pursuant to the terms of the Second Amended and Restated Note dated
November 26, 2004. Total interest costs charged to operations were $985,010.
5.
Stock
Incentive Plan and Warrants
The
Company maintains one long-term incentive compensation plan, the Provectus
Pharmaceuticals, Inc. 2002 Stock Plan, which provides for the issuance of up
to
5,000,000 shares of common stock pursuant to stock options, stock appreciation
rights, stock purchase rights and long-term performance awards granted to key
employees and directors of and consultants to the Company.
Options
granted under the 2002 Stock Plan may be either "incentive stock options" within
the meaning of Section 422 of the Internal Revenue Code or options which are
not
incentive stock options. The stock options are exercisable over a period
determined by the Board of Directors (through its Compensation Committee),
but
generally no longer than 10 years after the date they are granted.
On
March
1, 2004, the Company issued 1,200,000 stock options to employees. The options
vest over three years with 225,000 options vesting on the date of grant. The
exercise price is the fair market price on the date of issuance, and 1,173,484
options were outstanding at December 31, 2004. On May 27, 2004, the Company
issued 100,000 stock options to the Board of Directors. The options vested
immediately on the date of grant. The exercise price is the fair market price
on
the date of issuance, and all options were outstanding at December 31, 2005.
On
June 28, 2004, the Company issued 100,000 stock options to an employee. The
options vest over four years with 25,000 options vesting on the date of grant.
The exercise price is the fair market price on the date of issuance, and all
options were outstanding at December 31, 2005.
On
January 7, 2005, the Company issued 1,200,000 stock options to employees. The
options vest over four years with no options vesting on the date of grant.
The
exercise price is the fair market price on the date of issuance, and all options
were outstanding at December 31, 2005. On May 19, 2005, the Company issued
100,000 stock options to the Board of Directors. The options vested immediately
on the date of grant. The exercise price is the fair market price on the date
of
issuance, and all options were outstanding at December 31, 2005. On May 25,
2005, the Company issued 1,200,000 stock options to employees. The options
vest
over three years with no options vesting on the date of grant. The exercise
price is $0.75 which is greater than the fair market price on the date of
issuance, and all options were outstanding at December 31, 2005. On December
9,
2005, the Company issued 775,000 stock options to employees. The options vest
over three years with no options vesting on the date of grant. The exercise
price is the fair market price on the date of issuance, and all options were
outstanding at December, 31, 2005. During 2005 an employee of the Company
exercised 26,516 options at an exercise price of $1.10 per share of common
stock
for $29,167.
The
following table summarizes the options granted, exercised and outstanding as
of
December 31, 2004 and 2005, respectively. There were no options issued in
2002.
|
|
Shares
|
|
Exercise
Price
Per
Share
|
|
Weighted
Average
Exercise
Price
|
|
Outstanding
at January 1, 2004 |
|
|
356,250
|
|
$
|
0.26
- 0.60
|
|
$
|
0.40
|
|
Granted
|
|
|
1,400,000
|
|
$ |
0.95
- 1.25 |
|
$
|
1.10
|
|
Exercised |
|
|
- |
|
|
- |
|
|
- |
|
Forfeited |
|
|
(31,250 |
) |
$ |
0.26
- 0.32 |
|
$
|
0.30
|
|
Outstanding
at December 31, 2004 |
|
|
1,725,000
|
|
$ |
0.32
- 1.25 |
|
$
|
0.97
|
|
Options
exercisable at
December
31, 2004
|
|
|
562,500
|
|
$$ |
0.32
- 1.25 |
|
$
|
0.84
|
|
Outstanding
at January 1, 2005 |
|
|
1,725,000
|
|
$ |
0.32
- $1.25 |
|
$
|
0.97
|
|
Granted
|
|
|
3,275,000
|
|
$ |
0.64
- $0.94 |
|
$
|
0.75
|
|
Exercised |
|
|
(26,516 |
) |
$ |
1.10 |
|
$
|
$1.10
|
|
Forfeited
|
|
|
-
|
|
|
-
|
|
|
-
|
|
Outstanding
at December 31, 2005 |
|
|
4,973,484
|
|
$ |
0.32
- $1.25 |
|
$
|
0.83
|
|
Options
exercisable at December 31, 2005 |
|
|
1,017,234
|
|
$ |
0.32
- $1.25 |
|
$
|
0.88
|
|
The
following table summarizes information about stock options outstanding at
December 31, 2005.
Exercise Price
|
Number
Outstanding
at
December
31, 2005
|
Weighted
Average
Remaining
Contractual
Life
|
Weighted
Average
Exercise
Price
|
Number
Exercisable
at
December
31, 2005
|
Weighted
|
$0.32
|
225,000
|
7.58
years
|
$0.32
|
168,750
|
$0.32
|
$0.60
|
100,000
|
7.58
years
|
$0.60
|
100,000
|
$0.60
|
$1.10
|
1,173,484
|
8.17
years
|
$1.10
|
498,484
|
$1.10
|
$0.95
|
100,000
|
8.42
years
|
$0.95
|
100,000
|
$0.95
|
$1.25
|
100,000
|
8.50
years
|
$1.25
|
50,000
|
$1.25
|
$0.64
|
1,200,000
|
9.00
years
|
$0.64
|
-
|
$0.64
|
$0.75
|
1,300,000
|
9.42
years
|
$0.75
|
100,000
|
$0.75
|
$0.94
|
775,000
|
9.92
years
|
$0.94
|
-
|
$0.94
|
|
4,973,484
|
8.94
years
|
$0.83
|
1,017,234
|
$0.88
|
The
following table summarizes the warrants granted, exercised and outstanding
as of
December 31, 2004 and 2005, respectively.
|
|
Warrants
|
|
Exercise
Price
Per
Warrant
|
|
Weighted
Average
Exercise
Price
|
|
Outstanding
at January 1, 2004 |
|
|
1,005,000 |
|
$ |
0.25
- $2.29 |
|
$
|
1.01
|
|
Granted |
|
|
3,402,393 |
|
$ |
0.50
- $1.00 |
|
$
|
0.99
|
|
Exercised |
|
|
(190,000) |
) |
$ |
0.25
- $0.50 |
|
$
|
0.37
|
|
Forfeited |
|
|
(125,000) |
) |
$ |
0.75
- $2.29 |
|
$ |
1.98 |
|
Outstanding
at December 31, 2004 |
|
|
4,092,393 |
|
$ |
0.50
- $1.25 |
|
$
|
0.99
|
|
Warrants
exercisable at
December 31, 2004
|
|
|
4,092,393 |
|
$ |
0.50
- $1.25 |
|
$
|
0.99
|
|
Outstanding
at January 1, 2005 |
|
|
4,092,393 |
|
$ |
0.50
- $1.25 |
|
$ |
0.99 |
|
Granted |
|
|
26,179,565 |
|
$ |
0.50
- $1.25 |
|
$ |
0.95 |
|
Exercised |
|
|
(1,545,333) |
) |
$ |
0.75
- $1.00 |
|
$
|
0.76
|
|
Forfeited |
|
|
(1,894,667) |
) |
$ |
0.90
- $1.00 |
|
$ |
0.92 |
|
Outstanding
at December 31, 2005 |
|
|
26,831,958 |
|
$ |
0.50
- $1.25 |
|
$
|
0.96
|
|
Warrants
exercisable at
December
31, 2005
|
|
|
26,831,958 |
|
$ |
0.50
- $1.25 |
|
$ |
0.96 |
|
Warrants
exercised include a cashless exercise of 180,000 warrants in exchange for
122,608 shares in 2004.
The
following table summarizes information about warrants outstanding at December
31, 2005.
Warrants Outstanding and Exercisable
Exercise
Price
|
Number
Outstanding
and
Exercisable at
December
31, 2005
|
Weighted
Average
Remaining
Contractual
Life
|
Weighted
Average
Exercise
Price
|
$0.50
|
20,000
|
1.42
|
$0.50
|
$0.75
|
414,275
|
2.70
|
$0.75
|
$0.935
|
18,270,640
|
4.77
|
$0.935
|
$0.94
|
20,000
|
1.25
|
$0.94
|
$0.98
|
500,000
|
4.23
|
$0.98
|
$1.00
|
6,382,000
|
3.34
|
$1.00
|
$1.23
|
450,000
|
4.25
|
$1.23
|
$1.25
|
775,000
|
4.11
|
$1.25
|
|
26,831,958
|
4.35
|
$0.96
|
6.
Convertible Debt.
(a)
Pursuant to a Convertible Secured Promissory Note and Warrant Purchase Agreement
dated November 26, 2002 (the "Purchase Agreement") between the Company and
Gryffindor Capital Partners I, L.L.C., a Delaware limited liability company
("Gryffindor"), Gryffindor purchased the Company's $1 million Convertible
Secured Promissory Note dated November 26, 2002 (the "Note"). The Note bears
interest at 8% per annum, payable quarterly in arrears, and was due and payable
in full on November 26, 2004. Subject to certain exceptions, the Note was
convertible into shares of the Company's common stock on or after November
26,
2003, at which time the principal amount of the Note was convertible into common
stock at the rate of one share for each $0.737 of principal so converted and
any
accrued but unpaid interest on the Note was convertible at the rate of one
share
for each $0.55 of accrued but unpaid interest so converted. The Company's
obligations under the Note are secured by a first priority security interest
in
all of the Company's assets, including the capital stock of the Company's wholly
owned subsidiary Xantech Pharmaceuticals, Inc., a Tennessee corporation
("Xantech"). In addition, the Company's obligations to Gryffindor are guaranteed
by Xantech, and Xantech's guarantee is secured by a first priority security
interest in all of Xantech's assets.
Pursuant
to the Purchase Agreement, the Company also issued to Gryffindor and to another
individual Common Stock Purchase Warrants dated November 26, 2002 (the
"Warrants"), entitling these parties to purchase, in the aggregate, up to
452,919 shares of common stock at a price of $0.001 per share. Simultaneously
with the completion of the transactions described in the Purchase Agreement,
the
Warrants were exercised in their entirety. The $1,000,000 in proceeds received
in 2002 was allocated between the long-term debt and the warrants on a pro-rata
basis. The value of the warrants was determined using a Black-Scholes option
pricing model. The allocated fair value of these warrants was $126,587 and
was
recorded as a discount on the related debt and was being amortized over the
life
of the debt using the effective interest method. Amortization of $57,052 has
been recorded as additional interest expense in 2004.
In
2003,
an additional $25,959 of principal was added to the 2002 convertible debt
outstanding.
Pursuant
to an agreement dated November 26, 2004 between the Company and Gryffindor,
the
Company issued Gryffindor a Second Amended and Restated Senior Secured
Convertible Note dated November 26, 2004 in the amended principal amount of
$1,185,959 which included the original note principal plus accrued interest.
The
second amended note bears interest at 8% per annum, payable quarterly in
arrears, was due and payable in full on November 26, 2005, and amends and
restates the amended note in its entirety. Subject to certain exceptions, the
Note is convertible into shares of the Company's common stock on or after
November 26, 2004, at which time the principal amount of the Note is convertible
into common stock at the rate of one share for each $0.737 of principal so
converted and any accrued but unpaid interest on the Note is convertible at
the
rate of one share for each $0.55 of accrued but unpaid interest so converted.
The Company issued warrants to Gryffindor to purchase up to 525,000 shares
of
the Company's common stock at an exercise price of $1.00 per share in
satisfaction of issuing Gryffindor the Second Amended and Restated Senior
Secured Convertible Note dated November 26, 2004. The value of these warrants
was determined to be $105,250 using a Black-Scholes option-pricing model and
was
recorded as a discount on the related debt and is being amortized over the
life
of the debt using the effective interest method. Amortization of $95,157 and
$10,093 has been recorded as additional interest expense as of December 31,
2005
and 2004, respectively.
As
of
December 31, 2005, the Company recorded additional interest expense of $36,945
related to the beneficial conversion feature of the interest on the Gryffindor
convertible debt.
On
November 26, 2005 the Company entered into a redemption agreement with
Gryffindor to pay $1,185,959 of the Gryffindor convertible debt and accrued
interest of $94,877. Also on November 26, 2005 the Company issued a legal
assignment attached to and made a part of that certain Second Amended and
Restated Senior Secured Convertible Note dated November 26, 2004 in the original
principal amount of $1,185,959 together with interest of $94,877 paid to the
order of 8 investors dated November 26, 2005 for a total of $1,280,836. The
Company subsequently entered into debt conversion agreements with 7 of the
investors for an aggregate of $812,000 of convertible debt which was converted
into 1,101,764 shares of common stock at $0.737 per share. As of December
31, 2005, the Company had $468,836 in principal and $3,647 in accrued interest
owed to holders of our convertible debentures due on November 26, 2006. At
December 31, 2005, the Company recorded additional interest expense of $2,584
related to the beneficial conversion feature of the interest on the November
2005 convertible debt. The $1,280,836 in principal was issued when the
conversion price was lower than the market value of the Company's common stock
on the date of issue. As a result, a discount of $404,932 was recorded for
this
beneficial conversion feature. The debt discount of $404,932 is being amortized
over the life of the debt using the effective interest method. At December
31,
2005, $270,924 of the debt discount has been amortized which includes $256,711
of the unamortized portion of the debt discount related to the debt which was
converted.
At
December 31, 2005, the November 2005 convertible debentures totaled $334,828,
net of debt discount of $134,008. The entire principal, net of debt discount,
was recorded as a current liability.
In
conjunction with the November 26, 2005 financing, the Company incurred debt
issuance costs consisting of cash of $128,082, 356,335 shares of common stock
valued at $345,645 and 1,000,000 warrants valued at $789,000. The warrants
are
exercisable over 5 years, have an exercise price of $1.00, a fair market value
of $0.79 and were valued using the Black-Scholes option-pricing model. The
total
debt issuance costs of $1,262,727 were recorded as an asset and amortized over
the term of the debt. At December 31, 2005, $835,294 of the debt issuance costs
have been amortized which includes $800,520 related to the debt that was
converted as of December 31, 2005. The 356,335 shares of common stock were
not
issued as of December 31, 2005 and therefore have been recorded as an accrued
liability at December 31, 2005.
(b)
On
November 19, 2003, the Company completed a short-term unsecured debt financing
in the aggregate amount of $500,000. The notes bear interest of 8% and were
due
in full on November 19, 2004. The notes were convertible into common shares
at a
conversion rate equal to the lower of (i) 75% of the average market price for
the 20 trading days ending on the 20th trading day subsequent to the effective
date or (ii) $0.75 per share. Pursuant to the note agreements, the Company
also
issued warrants to purchase up to 500,000 shares of the Company's common stock
at an exercise price of $1.00 per share. During 2005, 52,000 of the warrants
were exercised and the remaining warrants expired on November 19,
2005.
The
$500,000 proceeds received was allocated between the debt and the warrants
on a
pro-rata basis. The value of the warrants was determined using a Black-Scholes
option-pricing model. The allocated fair value of these warrants was $241,655
and was recorded as a discount to the related debt. In addition, the conversion
price was lower than the market value of the Company's common stock on the
date
of issue. As a result, an additional discount of $258,345 was recorded for
this
beneficial conversion feature. The combined debt discount of $500,000 was being
amortized over the term of the debt using the effective interest method.
In
conjunction with the debt financing, the Company issued warrants to purchase
up
to 100,000 shares of the Company's common stock at an exercise price of $1.25
per share in satisfaction of a finder's fee. The value of these warrants was
determined to be $101,000 using a Black-Scholes option-pricing model. In
addition, the Company incurred debt issuance costs of $69,530 which were payable
in cash. Total debt issuance costs of $170,530 were recorded as an asset and
amortized over the term of the debt.
In
2004,
in conjunction with the June 25, 2004 transaction (Note 4(1)), the Company
entered into a redemption agreement for its $500,000 of short-term convertible
debt. Payments on the convertible debt corresponded to
payments received from the sale of common stock. As a result, the
unamortized portion of the debt discount at the date of extinguishment of
$193,308 and the unamortized portion of the deferred loan costs of $65,930
were
recorded as a loss on extinguishment of debt. In addition to principal payments,
the redemption payments included accrued interest and a premium payment of
$100,519. This premium payment has been recorded as a loss on extinguishement.
As part of this redemption, the Company has repurchased the beneficial
conversion feature amount of $258,345 in 2004. Amortization of the debt discount
up to the date of redemption was $249,316 for the year ended December 31, 2004
and amortization of deferred loans costs up to the date of redemption was
$85,031 for the year ended December 31, 2004. These amounts were recorded as
additional interest expense.
(c)
On
July 28, 2004, the Company entered into an agreement to issue 8% convertible
debentures to Cornell in the amount of $375,000 which was due together with
interest on July 28, 2007. This debt had a subordinated security interest in
the
assets of the Company. The Company issued a second secured convertible debenture
on October 7, 2004 which had the same conversion terms as the prior debenture
and was issued on the date the Company filed a registration statement for the
shares underlying both debentures. This was due together with interest on
October 7, 2007 and had a subordinated security interest in the assets of the
Company. The debentures were convertible into common stock at a price
per share equal to the lesser of (a) an amount equal to 120% of the closing
Volume Weighed Average Price (VWAP) of the common stock as of the Closing Date
($1.88 on Closing Date) or (b) an amount equal to 80% of the lowest daily VWAP
of the Company's common stock during the 5 trading days immediately preceding
the conversion date. There was a floor conversion price of $.75 until December
1, 2004.
Emerging
Issues Task Force Issue 98-5, "Accounting for Convertible Securities with
Beneficial Conversion Features or Contingently Adjustable Conversion Ratios"
("EITF 98-5") requires the issuer to assume that the holder will not convert
the
instrument until the time of the most beneficial conversion. EITF 98-5 also
requires that if the conversion terms are based on an unknown future amount,
which is the case in item (b) above, the calculation should be performed using
the commitment date which in this case is July 28, 2004 and October 7, 2004,
respectively. As a result, the beneficial conversion amount was computed using
80% of the lowest fair market value for the stock for the five days preceding
July 28, 2004 and October 7, 2004, respectively, which resulted in a beneficial
conversion amount of $254,006 and $106,250, respectively. The beneficial
conversion amount is being amortized over the term of the debt which is three
years. At December 31, 2004, $44,203 had been amortized.
In
conjunction with the debt financing, the Company issued warrants to purchase
up
to 150,000 shares of the Company's common stock at an exercise price of $1.00
per share in satisfaction of a finder's fee. The value of these warrants was
determined to be $144,000 using a Black-Scholes option-pricing model. In
addition, the Company incurred debt issuance costs of $162,500 which were
payable in cash. Total debt issuance costs of $306,500 were recorded as an
asset
and are being amortized over the term of the debt. Amortization of debt issuance
costs of $35,922 had been recognized as of December 31, 2004.
In
February 2005, the Company entered into a redemption agreement with Cornell
Capital Partners to pay $50,000 of the Cornell convertible debt. As a result,
the unamortized portion of the debt discount of $27,715 and deferred loan costs
of $20,702, which related to this amount at the date of extinguishments, were
recorded as a loss on extinguishment of debt. The Company also paid a $5,000
prepayment penalty which has been recorded as loss on extinguishment of debt.
As
part of this redemption, the Company has repurchased the beneficial conversion
feature related to the redeemed amount of $16,449.
In
March
2005, the Company entered into a debt conversion agreement with Cornell Capital
Partners for $50,000 of its convertible debt which was converted into 66,667
shares of common stock at $0.75 per share. As a result of this conversion,
the
unamortized portion of the debt discount of $24,890 and deferred loan costs
of
$18,779, which related to this amount at the date of conversion, have been
recorded as additional interest expense.
In
April
2005, the Company entered into a redemption agreement with Cornell Capital
Partners to pay $650,000 of the Cornell convertible debt. As a result, the
unamortized portion of the debt discount of $233,425 and deferred loan costs
of
$205,741, which related to this amount at the date of extinguishments, were
recorded as a loss on extinguishment of debt. The Company also paid a $65,000
prepayment penalty which has been recorded as loss on extinguishment of debt.
As
part of this redemption, the Company has repurchased the beneficial conversion
feature related to the redeemed amount of $127,679.
At
December 31, 2005, there was no amount outstanding related to the Cornell
debt.
(d)
In
March 2005, the Company entered into agreements to issue Senior Convertible
Debentures to 2 accredited investors with Network 1 Financial Securities, Inc.
in the aggregate amount of $450,000. This debt has a security interest in the
assets of the Company, a maturity date of March 30, 2007, and is convertible
into shares of the Company's common stock at a per share conversion price of
$0.75. In April 2005, the Company entered into agreements to issue Senior
Convertible Debentures to 5 accredited investors in the aggregate amount of
$2,700,000. This debt has a security interest in the assets of the Company,
a
maturity date of March 30, 2007, and is convertible into shares of the Company's
common stock at a per share conversion price of $0.75.
The
Company shall be obligated to pay the principal of the Senior Convertible
Debentures in installments as follows: Twelve (12) equal monthly payments
of
principal (the “Monthly Amount”) plus, to the extent not otherwise paid, accrued
but unpaid interest plus any other obligations of the Company to the Investor
under this Debenture, the Purchase Agreement, or the Registration Rights
Agreement, or otherwise. The first such installment payment shall be due
and
payable on March 30, 2006, and subsequent installments shall be due and payable
on the thirtieth (30th) day of each succeeding month thereafter (each a “Payment
Date”) until the Company’s obligations under this Debenture is satisfied in
full. The Company shall have the option to pay all or any portion of any
Monthly
Amount in newly issued, fully paid and nonassessable shares of Common Stock,
with each share of Common Stock having a value equal to (i) eighty-five percent
(85%) multiplied by (ii) the Market Price as of the third (3rd) Trading Day
immediately preceding the Payment Date (the “Payment Calculation Date”).
Interest
at the greater of (i) the prime rate (adjust monthly), plus 4% and (ii) 8%
is
due on a quarterly basis. At the time the interest is payable, upon certain
conditions, the Company has the option to pay all or any portion of accrued
interest in either cash or shares of the Company's common stock valued at
85%
multiplied by the market price as of the third trading date immediately
preceding the interest payment date.
The
Company may prepay the Senior Convertible Debentures in full by paying the
holders the greater of (i) 125% multiplied by the sum of the total outstanding
principal, plus accrued and unpaid interest, plus default interest, if any
or
(ii) the highest number of shares of common stock issuable upon conversion
of
the total amount calculated pursuant to (i) multiplied by the highest market
price for the common stock during the period beginning on the date until
prepayment.
On
or
after any event or series of events which constitutes a fundamental change,
the
holder may, in its sole discretion, require the Company to purchase the
debentures, from time to time, in whole or in part, at a purchase price equal
to
110% multiplied by the sum of the total outstanding principal, plus accrued
and
unpaid interest, plus any other obligations otherwise due under the debenture.
Under the senior convertible debentures, fundamental change means (i) any person
becomes a beneficial owner of securities representing 50% or more of the (a)
outstanding shares of common stock or (b) the combined voting power of the
then
outstanding securities; (ii) a merger or consolidation whereby the voting
securities outstanding immediately prior thereto fail to continue to represent
at least 50% of the combined voting power of the voting securities immediately
after such merger or consolidation; (iii) the sale or other disposition of
all
or substantially all or the Company's assets; (iv) a change in the composition
of the Board within two years which results in fewer than a majority of
directors are directors as of the date of the debenture; (v) the dissolution
or
liquidation of the Company; or (vi) any transaction or series of transactions
that has the substantial effect of any of the foregoing.
The
Purchasers of the $3,150,000 in Senior Convertible Debentures also purchased
Class A Warrants and Class B Warrants under the Securities Purchase Agreement.
Class A Warrants are exercisable at any time between March 10, 2005 through
and
including March 30, 2010 depending on the particular Purchaser. Class B Warrants
were exercisable for a period through and including 175 days after an effective
registration of the common stock underlying the warrants, which began June
20,
2005 and ended December 12, 2005. The range of the per share exercise price
of a
Class A Warrant is $0.93 to $0.99 and the range of the per share exercise price
of the Class B Warrant was $0.8925 to $0.945.
The
Purchasers of the Senior Convertible Debentures received a total of 4,200,000
Class A Warrants and a total of 2,940,000 Class B Warrants. 1,493,333 of the
Class B Warrants were exercised in December, 2005 for proceeds of $1,122,481.
The warrant holders were given an incentive to exercise their warrants due
to
the lowering of the exercise price to $0.75. Interest expense of $236,147 was
recorded to recognize expense related to this conversion incentive. The
remaining Class B Warrants were forfeited in December, 2005 at the expiration
of
their exercise period.
The
$3,150,000 proceeds received in March and April 2005 was allocated between
the
debt and the warrants on a pro-rata basis. The value of the warrants was
determined using a Black-Scholes option-pricing model. The allocated fair value
of these warrants was $1,574,900 and was recorded as a discount to the related
debt. In addition, the conversion prices were lower than the market value of
the
Company's common stock on the date of issue. As a result, an additional discount
of $1,228,244 was recorded for this beneficial conversion feature. The combined
debt discount of $2,803,144 is being amortized over the life of the debt using
the effective interest method.
In
June
2005, the Company entered into a debt conversion agreement with one of the
April
accredited investors for $150,000 of its convertible debt which was converted
into 200,000 shares of common stock at $0.75 per share, and $2,833 of accrued
interest was converted into 3,777 shares of common stock at $0.75 per share.
In
July 2005, the Company entered into a debt conversion agreement with two of
the
April accredited investors for an aggregate of $350,000 of convertible debt
which was converted into 466,666 shares of common stock at $0.75 per share.
In
September 2005, the Company entered into a debt conversion agreement with one
of
the March accredited investors for $400,000 of its convertible debt which was
converted into 533,333 shares of common stock at $0.75 per share. In October
2005, the Company entered into a debt conversion agreement with two of the
March
accredited investors for an aggregate of $100,000 of convertible debt which
was
converted into 133,334 shares of common stock at $0.75 per share. In
November 2005, the Company entered into a debt conversion agreement with three
of the April accredited investors for an aggregate of $675,000 of convertible
debt which was converted into 900,000 shares of common stock at $0.75 per
share.
At
December 31, 2005, $1,872,257 of the total debt discount has been amortized
which includes $1,454,679 of the unamortized portion of the debt discount
related to the converted debt at the time of the debt
conversions.
At
December 31, 2005, the Senior Convertible Debentures totaled $544,113, net
of
debt discount of $930,887. Of this total, $221,401 was recorded as a current
liability, net of debt discount of $884,848 and $322,712 was recorded as a
long-term liability, net of debt discount of $46,039.
In
conjunction with the financing, the Company incurred debt issuance costs
consisting of $387,500 in cash and 980,000 of warrants valued at $426,700.
The
warrants are exercisable over 5 years, have exercise prices ranging from $0.98
-
$1.23, fair market values ranging from $0.42 - $0.44 and were valued using
the
Black-Scholes option pricing model. The total debt issuance costs of $814,200
were recorded as an asset and amortized over the term of the debt. At December
31, 2005, $532,541 of the debt issuance costs have been amortized which includes
$413,109 related to the debt that was converted as of December 31,
2005.
The
Company chose to pay the quarterly interest due at June 30, 2005, September
30,
2005 and December 31, 2005 in common stock instead of cash. As a result, accrued
interest at June 30, 2005 of $78,904 was paid in 165,766 shares of common stock
resulting in additional interest expense of $28,843. 159,780 shares were issued
July 11, 2005 and the remaining 5,986 shares were issued November 7, 2005.
The
accrued interest due September 30, 2005 of $72,985 was converted into 97,955
shares of common stock resulting in additional interest expense of $15,299.
66,667 of these shares were issued on September 30, 2005 and the remaining
31,288 shares were issued October 20, 2005. The interest due December 31, 2005
of $50,486 was converted into 65,742 shares of common stock resulting in
additional interest expense of $10,922. The 65,742 shares were not issued as
of
December 31, 2005 and have been recorded in accrued liabilities at December
31,
2005.
7.
Loan
From Shareholder
During
2002, a shareholder who is also an employee and member of the Company's board
of
directors loaned the Company $109,000. During 2003, the same shareholder loaned
the Company an additional $40,000. During 2005, the same shareholder loaned
the
Company an additional $25,000. Interest on the loan is 5%, compounded monthly.
Principal is due on December 31, 2009 and interest is payable quarterly in
arrears beginning on June 30, 2003. Accrued interest was $-0- and $15,434
at December 31, 2005 and 2004, respectively. Interest expense was $16,525
and $8,003 at December 31, 2005 and 2004, respectively.
In
December 2005, the Company approved a request from the shareholder to exchange
the total loan amount of $174,000 plus accrued interest of $24,529 for 264,705
shares of common stock at $0.75 per share which are committed to be issued
at
December 31, 2005. In connection with this transaction which was based on the
same terms as the private placement conducted at the same time, the Company
also
issued warrants to the shareholder to purchase up to 330,881 shares of common
stock at an exercise price of $0.935 per share.
The
value
of the stock and warrants received by the shareholder was $311,000 greater
than
the face value of the debt and accrued interest. The $311,000 is a loss on
extinguishment of debt.
8.
Income
Taxes
Reconciliations
between the statutory federal income tax rate and the Company’s effective rate
were as follow:
Years
Ended December
|
|
2005
|
|
2004
|
|
|
|
Amount%
|
|
|
|
Amount%
|
|
|
|
Federal
statutory rate
|
|
$
|
(3,894,000
|
)
|
|
(34.0
|
)%
|
$
|
(1,477,000
|
)
|
|
(34.0
|
)%
|
Adjustment
to valuation allowance
|
|
|
3,184,000
|
|
|
27.8
|
%
|
|
1,217,000
|
|
|
28.0
|
%
|
Non-deductible
financing costs
|
|
|
475,000
|
|
|
4.1
|
%
|
|
38,000
|
|
|
1.0
|
%
|
Amortization
of patents
|
|
|
228,000
|
|
|
2.0
|
%
|
|
228,000
|
|
|
5.0
|
%
|
Other
|
|
|
7,000
|
|
|
0.1
|
%
|
|
(6,000
|
)
|
|
0.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual
tax benefit
|
|
$
|
-
|
|
|
-
|
%
|
$
|
-
|
|
|
-
|
%
|
The
components of the Company’s deferred income tax assets, pursuant to SFAS No.
109, are summarized as follow:
December
31,
|
|
|
2005
|
|
|
2004
|
|
|
|
|
|
|
|
|
|
Deferred
tax assets
|
|
|
|
|
|
|
|
Net
operating loss carryforwards
|
|
$
|
4,126,000
|
|
$
|
2,104,000
|
|
Warrants
for services
|
|
|
1,169,000
|
|
|
7,000
|
|
Deferred
tax asset before valuation allowance
|
|
|
5,295,000
|
|
|
2,111,000
|
|
|
|
|
|
|
|
|
|
Valuation
allowance
|
|
|
(5,295,000
|
)
|
|
(2,111,000
|
)
|
|
|
|
|
|
|
|
|
Net
deferred tax assets
|
|
$
|
-
|
|
$
|
-
|
|
SFAS
No.
109 required a valuation allowance against deferred tax assets if, based on
the
weight of available evidence, it is more likely than not that some or all of
the
deferred tax assets may not be realized. The Company is in the development
stage
and realization of the deferred tax assets is not considered more likely than
not. As a result, the Company has recorded a valuation allowance for entire
deferred tax asset.
Since
inception of the Company on January 17, 2002, the Company has generated tax
net
operating losses of approximately $12.1 million, expiring in 2022 through 2025.
The tax loss carryforwards of the Company may be subject to limitation by
Section 382 of the Internal Revenue Code with respect to the amount utilizable
each year. This limitation reduces the Company’s ability to utilize net
operating loss carryforwards. The amount of the limitation has not been
quantified by the Company. In addition, the Company may have acquired certain
net operating losses in its acquisition of Valley Pharmaceuticals, Inc. (Note
2). However, the amount of these net operating losses has not been determined
and even if recorded, the amount would be fully reserved.
9.
Subsequent Events
In
January 2006, the Company entered into a debt conversion agreement with one
of
its April 2005 accredited investors for $250,000 of convertible debt which
was
converted into 333,333 shares of common stock at $0.75 per share.
In
March
2006, the Company entered into debt conversion agreements with two of its April
2005 accredited investors for a total of $500,000 of convertible debt which
was
converted into 666,667 shares of common stock at $0.75 per share.
EXHIBIT
INDEX
2.1* Agreement
and Plan of Reorganization dated April 23, 2002, among Provectus Pharmaceutical,
Inc., a Nevada corporation ("Provectus"), Provectus Pharmaceuticals, Inc.,
a
Tennessee corporation ("PPI"), and the stockholders of PPI identified therein,
incorporated herein by reference to Exhibit 99 to the Company's Current Report
on Form 8-K dated April 23, 2002, as filed with the SEC on April 24,
2002.
2.2* Agreement
and Plan of Reorganization dated as of November 15, 2002 among the Company,
PPI,
Valley Pharmaceuticals, Inc., a Tennessee corporation formerly known as
Photogen, Inc., H. Craig Dees, Ph.D., Dees Family Foundation, Walter Fisher,
Ph.D., Fisher Family Investment Limited Partnership, Walt Fisher 1998 Charitable
Remainder Unitrust, Timothy C. Scott, Ph.D., Scott Family Investment Limited
Partnership, John T. Smolik, Smolik Family LLP, Eric A. Wachter, Ph.D., and
Eric
A. Wachter 1998 Charitable Remainder Unitrust, incorporated herein by reference
to Exhibit 2.1 to the Company's Current Report on Form 8-K dated November
19,
2002, as filed with the SEC on November 27, 2002.
2.3* Asset
Purchase Agreement dated as of December 5, 2002 among Pure-ific Corporation,
a
Nevada corporation ("Pure-ific"), Pure-ific, L.L.C., a Utah limited liability
company, and Avid Amiri and Daniel Urmann, incorporated herein by reference
to
Exhibit 2.1 to the Company's Current Report on Form 8-K dated December 5,
2002,
as filed with the SEC on December 20, 2002.
2.4* Stock
Purchase Agreement dated as of December 5, 2002 among the Company, Pure-ific,
and Avid Amiri and Daniel Urmann, incorporated herein by reference to Exhibit
2.2 to the Company's Current Report on Form 8-K dated December 5, 2002, as
filed
with the SEC on December 20, 2002.
3.1 Restated
Articles of Incorporation of Provectus, incorporated herein by reference
to
Exhibit 3.1 to the Company's Quarterly Report on Form 10-QSB for the fiscal
quarter ended June 30, 2003, as filed with the SEC on August 14,
2003.
3.2 Bylaws
of
Provectus, incorporated herein by reference to Exhibit 3.2 to the Company's
Quarterly Report on Form 10-QSB for the fiscal quarter ended March 31, 2003,
as
filed with the SEC on May 9, 2003.
4.1 Specimen
certificate for the common shares, $.001 par value per share, of Provectus
Pharmaceuticals, Inc., incorporated herein by reference to Exhibit 4.1 to
the
Company's Annual Report on Form 10-KSB for the fiscal year ended December
31,
2002, as filed with the SEC on April 15, 2003.
4.2.1 Convertible
Secured Promissory Note and Warrant Purchase Agreement dated as of November
26,
2002 between the Company and Gryffindor Capital Partners I, L.L.C.
("Gryffindor"), incorporated herein by reference to Exhibit 4.1 to the Company's
Current Report on Form 8-K dated November 26, 2002, as filed with the SEC
on
December 10, 2002.
4.2.2 Letter
Agreement dated January 31, 2003 between the Company and Gryffindor,
incorporated by reference to Exhibit 4.2.2 to the Company's Quarterly Report
on
Form 10-QSB for the quarter ended March 31, 2003, as filed with the SEC on
May
9, 2003.
4.3 Amended
and Restated Convertible Secured Promissory Note of the Company dated January
31, 2003, issued to Gryffindor, incorporated herein by reference to Exhibit
4.3
to the Company's Quarterly Report on Form 10-QSB dated March 31, 2003, as
filed
with the SEC on May 9, 2003.
4.4 Common
Stock Purchase Warrant dated November 26, 2002, issued to Gryffindor,
incorporated herein by reference to Exhibit 4.3 to the Company's Current
Report
on Form 8-K dated November 26, 2002, as filed with the SEC on December 10,
2002.
4.5 Common
Stock Purchase Warrant dated November 26, 2002, issued to Stuart Fuchs,
incorporated herein by reference to Exhibit 4.4 to the Company's Current
Report
on Form 8-K dated November 26, 2002, as filed with the SEC on December 10,
2002.
4.6 Stock
Pledge Agreement dated as of November 26, 2002 between the Company and
Gryffindor, incorporated herein by reference to Exhibit 4.5 to the Company's
Current Report on Form 8-K dated November 26, 002, as filed with the SEC
on
December 10, 2002.
4.7 Guaranty
dated November 26, 2002 from Xantech Pharmaceuticals, Inc., a Tennessee
corporation and a wholly owned subsidiary of Provectus ("Xantech"), to
Gryffindor, incorporated herein by reference to Exhibit 4.6 to the Company's
Current Report on Form 8-K dated November 26, 2002, as filed with the SEC
on
December 10, 2002.
4.8 Form
of
Security Agreement between the Company and Gryffindor, incorporated herein
by
reference to Exhibit 4.7 to the Company's Current Report on Form 8-K dated
November 26, 2002, as filed with the SEC on December 10, 2002.
4.9 Form
of
Patent and License Security Agreement between the Company and Gryffindor,
incorporated herein by reference to Exhibit 4.8 to the Company's Current
Report
on Form 8-K dated November 26, 2002, as filed with the SEC on December 10,
2002.
4.10 Form
of
Trademark Collateral Assignment and Security Agreement between the Company
and
Gryffindor, incorporated herein by reference to Exhibit 4.9 to the Company's
Current Report on Form 8-K dated November 26, 2002, as filed with the SEC
on
December 10, 2002.
4.11 Form
of
Copyright Security Agreement between the Company and Gryffindor, incorporated
herein by reference to Exhibit 4.10 to the Company's Current Report on Form
8-K
dated November 26, 2002, as filed with the SEC on December 10,
2002.
4.12 Registration
Rights Agreement dated as of November 26, 2002 between the Company and
Gryffindor, incorporated herein by reference to Exhibit 4.11 to the Company's
Current Report on Form 8-K dated November 26, 2002, as filed with the SEC
on
December 10, 2002.
4.13 Shareholders'
Agreement dated as of November 26, 2002 among Provectus, Gryffindor, H. Craig
Dees, Ph.D., Dees Family Foundation, Walter Fisher, Ph.D., Fisher Family
Investment Limited Partnership, Walt Fisher 1998 Charitable Remainder Unitrust,
Timothy C. Scott, Ph.D., Scott Family Investment Limited Partnership, John
T.
Smolik, Smolik Family LLP, Eric A. Wachter, Ph.D., and Eric A. Wachter 1998
Charitable Remainder Unitrust, incorporated herein by reference to Exhibit
4.12
to the Company's Current Report on Form 8-K dated November 26, 2002, as filed
with the SEC on December 10, 2002.
4.14 Warrant
Agreement dated as of December 5, 2002 among Provectus, Avid Amiri and Daniel
Urmann, incorporated herein by reference to Exhibit 4.1 to the Company's
Current
Report on Form 8-K dated December 5, 2002, as filed with the SEC on December
20,
2002.
4.15 Form
of
Warrant issuable pursuant to the Warrant Agreement, incorporated herein by
reference to Exhibit 4.2 to the Company's Current Report on Form 8-K dated
December 5, 2002, as filed with the SEC on December 20, 2002.
4.16 Promissory
Note of the Company dated December 31, 2002, issued to Eric A. Wachter,
incorporated herein by reference to Exhibit 4.16 to the Company's Annual
Report
on Form 10-KSB for the fiscal year ended December 31, 2002, as filed with
the
SEC on April 15, 2003.
4.17 Common
Share Purchase Warrant dated January 29, 2003, issued to Investor-Gate.com,
incorporated herein by reference to Exhibit 4.17 to the Company's Quarterly
Report on Form 10-QSB for the fiscal quarter ended March 31, 2003, as filed
with
the SEC on May 9, 2003.
4.18 Form
of
8% Convertible Debenture incorporated herein by reference to Annex I to Exhibit
10.16 to the Company's Registration Statement on Form S-2, as filed with
the SEC
on February 12, 2004.
4.19 Form
of
Warrant incorporated herein by reference to Annex IV to Exhibit 10.16 to
the
Company's Registration Statement on Form S-2, as filed with the SEC on February
12, 2004.
4.20 Registration
Rights Agreement dated as of November 19, 2003 by and among the Company and
the
investors named therein incorporated by reference to Annex IV to Exhibit
10.16
to the Company's Registration Statement on Form S-2, as filed with the SEC
on
February 12, 2004.
4.21 Registration
Rights Agreement dated as of September 4, 2003 by and among the Company and
Bruce A. Cosgrove and George F. Martin, incorporated herein by reference
to
Exhibit 4.4 to the Company's Registration Statement on Form S-2, as filed
with
the SEC on February 12, 2004.
4.22 Form
of
Warrant issued to selling shareholders other than holders of 8% Convertible
Debentures, incorporated herein by reference to Exhibit 4.5 to the Company's
Registration Statement on Form S-2, as filed with
the
SEC
on February 12, 2004.
4.23 Registration
Rights Agreement dated as of December 26, 2003 by and between the Company
and
The Research Foundation of State University of New York, incorporated herein
by
reference to Exhibit 4.6 to the Company's Registration Statement on Form
S-2, as
filed with the SEC on February 12, 2004.
10.1 Consultant
Compensation Agreement dated April 23, 2002 among Provectus and Russell Ratliff,
Justeene Blankenship, Michael L. Labertew, and Phillip Baker, incorporated
herein by reference to Exhibit 99.1 to the Company's Registration Statement
on
Form S-8 (Registration No. 333-86896), as filed with the SEC on April 24,
2002.
10.2** Provectus
Pharmaceuticals, Inc. Amended and Restated 2002 Stock Plan, incorporated
herein
by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10QSB
for
the fiscal quarter ended June 30, 2003, as filed with the SEC on August 14,
2003.
10.3 Consulting
Agreement dated August 15, 2002 between Provectus and Numark Capital Corporation
("Numark"), incorporated herein by reference to Exhibit 10.3 to the Company's
Annual Report on Form 10-KSB for the fiscal year ended December 31, 2002,
as
filed with the SEC on April 15, 2004.
10.4 Consulting
Agreement dated August 28, 2002 between Provectus and Robert S. Arndt,
incorporated herein by reference to Exhibit 4.1 to the Company's Registration
Statement on Form S-8 (Registration No. 333-99639), as filed with the SEC
on
September 17, 2002.
10.5 Consulting
Agreement dated August 28, 2002 between Provectus and Nunzio Valerie, Jr.,
incorporated herein by reference to Exhibit 4.2 to the Company's Registration
Statement on Form S-8 (Registration No. 333-99639), as filed with the SEC
on
September 17, 2002.
10.6 Letter
Agreement dated June 7, 2002 between Provectus and Nace Pharma, LLC,
incorporated herein by reference to Exhibit 10.6 to the Company's Annual
Report
on Form 10-KSB for the fiscal year ended December 31, 2002, as filed with
the
SEC on April 15, 2003.
10.7 Letter
Agreement dated August 29,2002 between Provectus and Nace Resources, Inc.,
incorporated herein by reference to Exhibit 10.7 to the Company's Annual
Report
on Form 10-KSB for the fiscal year ended December 31, 2002, as filed with
the
SEC on April 15, 2004.
10.8 Confidentiality,
Inventions and Non-competition Agreement between the Company and H. Craig
Dees,
incorporated herein by reference to Exhibit 10.8 to the Company's Annual
Report
on Form 10-KSB for the fiscal year ended December 31, 2002, as filed with
the
SEC on April 15, 2004.
10.9 Confidentiality,
Inventions and Non-competition Agreement between the Company and Timothy
C.
Scott, incorporated herein by reference to Exhibit 10.9 to the Company's
Annual
Report on Form 10-KSB for the fiscal year ended December 31, 2002, as filed
with
the SEC on April 15, 2004.
10.10 Confidentiality,
Inventions and Non-competition Agreement between the Company and Eric A.
Wachter, incorporated herein by reference to Exhibit 10.10 to the Company's
Annual Report on Form 10-KSB for the fiscal year ended December 31, 2002,
as
filed with the SEC on April 15, 2004.
10.11.1 Letter
Agreement dated January 8, 2003 between the Company and Investor-Gate.com,
incorporated herein by reference to Exhibit 10.11.1 to the Company's Quarterly
Report on Form 10-QSB for the fiscal quarter ended March 31, 2003, as filed
with
the SEC on May 9, 2003.
10.11.2 Termination
Letter dated February 28, 2003 from the Company to Investor-Gate.com,
incorporated herein by reference to Exhibit 10.11.2 to the Company's Quarterly
Report on Form 10-QSB for the fiscal quarter ended March 31, 2003, as filed
with
the SEC on May 9, 2003.
10.12 Letter
Agreement dated February 20, 2003 between the Company and SGI, incorporated
herein by reference to Exhibit 10.12 to the Company's Quarterly Report on
Form
10-QSB for the fiscal quarter ended March 31, 2003, as filed with the SEC
on May
9, 2003.
10.13 Letter
Agreement dated March 27, 2003 between the Company and Josephberg Grosz &
Co., Inc., incorporated herein by reference to Exhibit 10.13 to the Company's
Quarterly Report on Form 10-QSB for the fiscal quarter ended March 31, 2003,
as
filed with the SEC on May 9, 2003.
10.14 Settlement
Agreement dated as of June 16, 2003 among Kelly Adams, Justeene Blankenship,
Nicholas Julian, and Pacific Management Services, Inc.; and Provectus and
Xantech, incorporated herein by reference to Exhibit 10.14 to the Company's
Current Report on Form 8-K dated June 16, 2003, as filed with the SEC on
June
26, 2003.
10.15 Material
Transfer Agreement dated as of July 31, 2003 between Schering-Plough Animal
Health Corporation and Provectus, incorporated herein by reference to Exhibit
10.15 to the Company's Quarterly Report on Form 10-QSB for the fiscal quarter
ended June 30, 2003, as filed with the SEC on August 14, 2003.
10.16 Securities
Purchase Agreement dated as of November 19, 2003 by and among the Company
and
the lenders named therein, incorporated herein by reference to Exhibit 10.16
to
the Company's Registration Statement on Form S-2, as filed with the SEC on
February 12, 2004.
10.17 Securities
Purchase Agreement dated June 25, 2004 by and among the Company and A.I.
International Corporate Holdings, Ltd. and Castlerigg Master Investments,
Ltd.,
incorporated herein by reference to the Company's Registration Statement
on Form
S-2, as filed with the SEC on October 7, 2004.
10.18 Standby
Equity Distribution dated July 28, 2004 by and among the Company and Cornell
Capital Partners, LP, incorporated herein by reference to the Company's
Registration Statement on Form S-2, as filed with the SEC on October 7,
2004.
10.19 Securities
Purchase Agreement dated July 28, 2004 by and among the Company and Cornell
Capital Partners, LP, incorporated herein by reference to the Company's
Registration Statement on Form S-2, as filed with the SEC on October 7,
2004.
10.20 Second
Amended and Restated Senior Secured Convertible Note by and between the Company
and Gryffindor Capital Partners I, L.L.C. , incorporated herein by reference
to
Exhibit 10.20 to the Company's Annual Report on Form 10-KSB for the fiscal
year
ended December 31, 2004, as filed with the SEC on March 31, 2005.
10.21**+ Executive
Employment Agreement by and between the Company and H. Craig Dees, Ph.D,
dated
January 4, 2005.
10.22**+
Executive Employment Agreement by and between the Company and Eric Wachter,
Ph.D, dated January 4, 2005
10.23**+
Executive
Employment Agreement by and between the Company and Timothy C. Scott, Ph.D,
dated January 4, 2005
10.24**+
Executive
Employment Agreement by and between the Company and Peter Culpepper dated
January 4, 2005
10.25 Form
of
Secured Convertible Debenture related to the Securities Purchase Agreement,
incorporated herein by reference to the Company's Registration Statement
on Form
S-2, as filed with the SEC on May 16, 2005.
10.26 Form
of
Class A Warrant related to the Securities Purchase Agreement incorporated
herein
by reference to the Company's Registration Statement on Form S-2, as filed
with
the SEC on May 16, 2005.
10.27 Form
of
Class B Warrant related to the Securities Purchase Agreement incorporated
herein
by reference to the Company's Registration Statement on Form S-2, as filed
with
the SEC on May 16, 2005.
10.28 Registration
Rights Agreement dated as of March 30, 2005 by and among the Company and
the
initial investors named therein related to the Securities Purchase Agreement,
incorporated herein by reference to the Company's Registration Statement
on Form
S-2, as filed with the SEC on May 16, 2005.
10.29
Common
Stock Purchase Warrant dated November 26, 2004 issued to Gryffindor Capital
Partners I, L.L.C., incorporated herein by reference to the Company's
Registration Statement on Form S-2, as filed with the SEC on May 16, 2005.
10.30
Advisory
Agreement with Duncan Capital Group, LLC dated March 1, 2005, incorporated
herein by reference to the Company's Registration Statement on Form S-2,
as
filed with the SEC on May 16, 2005.
10.31
Form
of
Warrant issued to Duncan Capital Group, LLC designees, incorporated herein
by
reference to the Company's Registration Statement on Form S-2, as filed with
the
SEC on May 16, 2005.
10.32
Finders
Fee Agreement with Centre Capital Advisors, LLC incorporated herein by reference
to Exhibit 4.12 to the Company's 10-QSB for the quarter ended March 31, 2005,
as
filed with the SEC on May 16, 2005.
10.33
Form
of
Warrant issued to Centre Capital Advisors, LLC incorporated herein by reference
by Exhibit 4.13 to the Company's 10-QSB for the quarter ended March 31, 2005,
as
filed with the SEC on May 16, 2005.
10.34
General
Fee Agreement with Venture Catalyst, LLC dated May 3, 2004, incorporated
herein
by reference to the Company's Registration Statement on Form S-2/A, as filed
with the SEC on June 14, 2005.
10.35
Consulting
Agreement with Venture Catalyst, LLC dated December 8, 2004, incorporated
herein
by reference to the Company's Registration Statement on Form S-2/A, as filed
with the SEC on June 14, 2005.
10.36
Consulting
Agreement with Venture Catalyst, LLC dated April 1, 2005, incorporated herein
by
reference to the Company's Registration Statement on Form S-2/A, as filed
with
the SEC on June 14, 2005.
10.37
Form
of
Warrant issued to Kevin Richardson, incorporated herein by reference to the
Company's Registration Statement on Form S-2/A, as filed with the SEC on
June
14, 2005.
10.38 Securities
Purchase Agreement dated as of March 30, 2005 by and among the Company and
the
buyers named therein ("Securities Purchase Agreement"), incorporated herein
by
reference to the Company's Registration Statement on Form S-2, as filed with
the
SEC on May 16, 2005.
10.39 Amendment
No. 1 to Transaction Documents with Gryffindor Capital Partners I, L.L.C.
dated
November 26, 2004, incorporated herein by reference to the Company's
Registration Statement on Form S-2, as filed with the SEC on May 16,
2005.
10.40 Advisory
Agreement with Hunter Wise Securities, LLC dated January 19, 2005, incorporated
herein by reference to Exhibit 4.14 of the Company's 10-QSB for the quarter
ended March 31, 2005, as filed with the SEC on May 16, 2005.
10.41 Form
of
Warrant issued to Hunter Wise Securities, LLC and Daniel J. McCory, incorporated
herein by reference to Exhibit 4.15 of the Company's 10-QSB for the quarter
ended March 31, 2005, as filed with the SEC on May 16, 2005.
10.42
Financial Advisory and Investment Banking Agreement with Network 1
Financial Securities dated August 15, 2004, incorporated herein by reference
to
the Company's Registration Statement on Form S-2, as filed with the SEC on
May
16, 2005.
10.43
Form of Warrant issued to Damon D. Testaverde and Network 1 Financial
Securities, Inc., incorporated herein by reference to the Company's Registration
Statement on Form S-2, as filed with the SEC on May 16, 2005.
21.1 +
List
of
Subsidiaries
23.1
+ Consent
of
Independent Registered Public Accounting Firm
31.1
+ Certification
of CEO pursuant to Rules 13a - 14(a) of the Securities
Exchange
Act of 1934.
31.2+
Certification of CFO pursuant to Rules 13a-14(a)
of the Securities Exchange
Act of 1934.
32.1+
Certification Pursuant to 18 U.S.C. ss.
1350.
+
Filed
herewith.